Information Disclosure Statement
© Practising Law Institute
Chapter 10
Information Disclosure Statement
§ 10:1 Introduction § 10:2 What Information Must Be Disclosed § 10:2.1 The Current Materiality Standard § 10:2.2 The Pre-1992 Standard § 10:2.3 The Current Patent Office Standard § 10:2.4 Ethical Considerations § 10:2.5 Recommendations [A] Checklist of Material Information § 10:3 When Should the Information Disclosure Statement Be Filed? § 10:4 Content of Information Disclosure Statement § 10:5 Submission of Listed Documents § 10:6 Electronic Filing of an Information Disclosure Statement § 10:7 Example Exhibit 10-1 Sample Information Disclosure Statement
§ 10:1
Introduction
It is a very rare patent application that is not accompanied by an information disclosure statement. This is because the Patent Office and the courts impose upon inventors and their attorneys and agents a duty of candor and good faith toward the Patent Office. That duty requires the attorney and agent to disclose to the Patent Office any information known to them that is material to the patentability of the application.1 The duty also extends to any other individual who is
1.
37 C.F.R. § 1.56.
10–1
© Practising Law Institute § 10:1
HOW
TO
WRITE
A
PATENT APPLICATION
involved in the substantive preparation or in the prosecution of the application.2 Even if the Patent Office did not explicitly require disclosure of material information, a good practitioner should voluntarily disclose that information. It is usually in the best interest of any inventor to have the most relevant art before the Patent Office when the examiner examines the application. This is because any resulting patent is much stronger and much less vulnerable to collateral attack if the Patent Office considered all material prior art and still allowed the patent to issue. In any subsequent patent infringement action, the accused infringer will have a difficult time at trial trying to persuade the trial judge or jury that the Patent Office made a mistake in issuing the patent when the infringer can find no art more pertinent than that already considered by the examiner. The consequences of failing to comply with this duty to disclose material information can be substantial. For example, it becomes much easier for an accused infringer to overcome the presumption of validity of the patent at trial by producing documents that are more material to the patentability of an invention than those cited by the patent holder than it is without such documents. Moreover, intentional withholding of material prior art can result in a finding of inequitable conduct, even if at least some of the claims of the patent would have issued the patent had the prior art been disclosed to the Patent Office.3 A finding of inequitable conduct can have the following disastrous consequences: 1.
Unenforceability of the entire patent, even if the inequitable conduct occurred in relation to fewer than all the claims in the patent.4 Moreover, inequitable conduct can render related patents unenforceable.5
2.
Awarding of attorneys’ fees: a finding of inequitable conduct can result in the case’s being considered exceptional, resulting in an award of attorneys’ fees under 35 U.S.C. § 285.6
2. 3. 4. 5. 6.
Id. Merck & Co. v. Danbury Pharmacal, Inc., 873 F.2d 1418, 1421, 10 U.S.P.Q.2d 1682 (Fed. Cir. 1989). Kingsdown Med. Consultants, Ltd. v. Hollister, 863 F.2d 867, 9 U.S.P.Q.2d 1384, 1392 (Fed. Cir. 1988). Consol. Aluminum Corp. v. Foseco Int’l Ltd., 910 F.2d 804 (Fed. Cir. 1990) (concealment of best mode rendered related patents unenforceable). J.P. Stevens & Co. v. Lex Tex, Ltd., 822 F.2d 1047, 233 U.S.P.Q. 1089 (Fed. Cir. 1987).
10–2
© Practising Law Institute Information Disclosure Statement
§ 10:2.2
3.
Antitrust liability if the inequitable conduct amounts to fraudulent procurement of a patent.7
4.
Suspension, disbarment, or both suspension and disbarment of the attorney or patent agent responsible for the inequitable conduct under 35 U.S.C. § 32.
At a minimum, even if the patentee ultimately prevails in persuading the court that the uncited prior art need not have been brought to the attention of the Patent Office, substantial sums will have been spent litigating the issue.
§ 10:2
What Information Must Be Disclosed
§ 10:2.1
The Current Materiality Standard
A recent decision by the Federal Circuit has most likely changed the materiality standard applied by the Patent Office with regard to submitting information disclosure statements. In Therasense, Inc. v. Becton, Dickinson & Co.,8 the Federal Circuit held that the materiality required for establishing inequitable conduct is a but-for materiality standard. In other words, when an applicant fails to disclose prior art to the Patent Office, that prior art is material if the Patent Office would not have allowed a claim but for a lack of awareness of the undisclosed prior art, applying a preponderance of evidence standard and giving the claims their broadest reasonable construction. The Patent Office has proposed rules to conform the Code of Federal Regulations to the Therasense decision. However, until those rules become final, it makes sense to discuss the prior Patent Office materiality standards, which is done in the following sections. The Patent Office’s proposed rules also provide another basis for materiality in conformance with the Therasense decision, namely, if the applicant engages in affirmative egregious misconduct before the Patent Office as to information.9
§ 10:2.2
The Pre-1992 Standard
According to 37 C.F.R. § 1.56, all information that is material to the examination of the application must be disclosed. According to 37
7. 8. 9.
Walker Process Equip., Inc. v. Food Mach. & Chem. Corp., 382 U.S. 172, 147 U.S.P.Q. 404. Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276, 99 U.S.P.Q.2d 1065 (Fed. Cir. 2011) (en banc). Revision of the Materiality to Patentability Standard for the Duty to Disclose Information in Patent Applications, 76 Fed. Reg. 43,631 (July 21, 2011).
10–3
© Practising Law Institute § 10:2.3
HOW
TO
WRITE
A
PATENT APPLICATION
C.F.R. § 1.56, as it existed prior to March 16, 1992, information is material “where there is substantial likelihood that a reasonable examiner would consider it in deciding whether to allow the application to issue as a patent.” This is not a “but for” test. Under a “but for” test, information would need to be disclosed to the Patent Office only if the Patent Office would not have issued the patent, as it issued, had the Patent Office been aware of the withheld information. As discussed above, even if the patent would have issued had the uncited information been disclosed to the Patent Office, there may be a violation of 37 C.F.R. § 1.56 if the nondisclosed information is found to be material.
§ 10:2.3
The Current Patent Office Standard
By a notice published in the Federal Register on January 17, 1992, 37 C.F.R. § 1.56 and related rules were changed. These changes included a change in the standard of materiality. The new rules are effective with respect to all applications and re-examination procedures pending or filed after March 16, 1992. Under the new standards, the test for materiality is much closer to a “but for” test. Under this standard, information is material if: 1.
the information establishes by itself or in combination with other information a prima facie case of unpatentability of a claim; or
2.
the information refutes, or is inconsistent with, a position the applicant takes in either, (a)
opposing an argument of unpatentability relied on by the Patent Office; or
(b)
asserting an argument of patentability.
The new rule also includes a definition of “prima facie case of unpatentability.” A prima facie case of unpatentability “is established when the information compels a conclusion that a claim is unpatentable under the preponderance of evidence, burden-of-proof standard.” This standard is applied by “giving each term in the claim its broadest reasonable construction consistent with the specification, and before any consideration is given to evidence which may be submitted in an attempt to establish a contrary conclusion of patentability.” 10 Information is not material when the information is cumulative with respect to information already of record or being made of record in the application.
10.
37 C.F.R. § 1.56.
10–4
© Practising Law Institute Information Disclosure Statement
§ 10:2.5
It is not necessary that the information be material to the broadest claims in the application. Information material only to a dependent claim is still considered material and should be cited in an information disclosure statement.11
§ 10:2.4
Ethical Considerations
What is a patent attorney to do when Rule 56 requires disclosure of client confidential information and the client refuses permission to disclose that information? The problem could arise because ABA Model Rule 1.6 requires attorneys to keep client information confidential except in specific circumstances. The Patent Office adopts the same basic requirement in its corresponding ethics rule, section 11.106. However, subsection C of that rule states that client confidentiality must be breached when necessary to comply with the agency’s disclosure requirements, which mandate compliance with 37 C.F.R. § 1.56. Arguably, that information can be cited to the Patent Office without violating the client confidentiality rule, because both the Patent Office rules and ABA Model Rule 1.6(b) allow an attorney to reveal information to prevent a client from committing a crime or fraud that would result in substantial injury to the financial interest of another party. However, this does not protect an attorney prosecuting patent applications for a first client who discovers information obtained from a different client that is material. Probably the safest thing to do is withdraw from representation. This is less of a problem for patent agents, because they are not subject to the state bar ethical rules governing attorney conduct.
§ 10:2.5
Recommendations
The author recommends that everyone who can conceivably be considered to have a duty to disclose material information to the Patent Office be interviewed. This includes all individuals associated with the filing or prosecution of the patent application, and not only the inventors. “Substantively involved” under 37 C.F.R. § 1.56(c)(3) means any involvement related to the content of the application and decisions related thereto, where that involvement is not wholly administrative or secretarial in nature. Thus, a noninventor president of a closely held company was held to have a duty of disclosure. 12 The author also recommends that a “rule of doubt” be followed when deciding whether certain information should be disclosed to
11. 12.
Taltech Ltd. v. Esquel Enters. Ltd., 604 F.3d 1324 (Fed. Cir. 2010). Avid Identification Sys., Inc. v. Crystal Imp. Corp., 603 F.3d 967 (Fed. Cir. 2010).
10–5
© Practising Law Institute § 10:2.5
HOW
TO
WRITE
A
PATENT APPLICATION
the Patent Office. Even if there is doubt as to whether particular information is “material” under either old or new Rule 56, it should nevertheless be cited to the Patent Office. It is better to cite a reference than incur the risk of a finding of inequitable conduct. The Federal Circuit decision in Therasense is unlikely to have a large effect on what information is cited to the Patent Office for two reasons. First, the time and cost associated with determining whether each possible piece of prior art is but-for material is something most clients are not willing to incur. It is easier and simpler to cite whatever information is available to the Patent Office. Second, the Patent Office endorses this rule of doubt: When in doubt, it is desirable and safest to submit information. Even though the attorney, agent, or applicant does not consider it necessarily material, someone else may see it differently and embarrassing questions can be avoided. . . . “In short, the questions of relevancy in close cases, should be left to the examiner 13 and not the applicant.”
Another reason to use a rule of doubt is that the filing of an information disclosure statement is not construed as an admission that the information cited in the statement is, or is considered to be, material to the patentability of the invention.14 This “rule of doubt” means that in most situations, even when the practitioner preparing or prosecuting an application believes that the information does not affect the patentability of a particular invention, the practitioner should let the Patent Office make the decision. Exemplary of situations that can arise are the following: 1.
Nonanalogous art: The examiner should be given the opportunity to determine whether a particular reference is analogous or nonanalogous.
2.
“Prior” art or nonprior art: Even if the publication date of a reference is after the filing date of a parent or foreign application from which priority is claimed, the reference should be cited to the Patent Office.15 That allows the examiner to
13. 14. 15.
M.P.E.P. § 2004(10) (quoting U.S. Indus. v. Norton Co., 210 U.S.P.Q. 94, 107 (N.D.N.Y. 1980)). Avid Identification Sys., Inc. v. Crystal Imp. Corp., 603 F.3d 967 (Fed. Cir. 2010). This does not apply in the situation of divisional and continuation applications, since the specifications of the parent and subsequent application are supposed to be identical.
10–6
© Practising Law Institute Information Disclosure Statement
§ 10:2.5
independently determine whether the applicant is entitled to the benefit of the filing date of the parent application or foreign priority application. Similarly, even if the applicant can swear behind the filing date of a U.S. patent or publication date of a reference with a declaration under 37 C.F.R. § 1.131, the Patent Office should determine that the showing complies with the requirements of 37 C.F.R. § 1.131. 3.
On sale, publicly known, or experimental uses: Sufficient relevant facts and documents should be presented to the Patent Office to let the examiner reach his or her own conclusion regarding whether a particular activity amounts to an “on sale” or “public use,” or whether the experimental use exception applies.16 A sale for “on sale” purposes can occur when a contract supplier offers a product to the inventor or the inventor ’s assignee.17 The Patent Office’s position on this issue is very much in favor of disclosure. The Patent Office believes it is desirable to submit information about prior uses and sales even if it appears that they may have been experimental, did not specifically involve the claimed invention, or did not encompass a complete invention. 18
4.
Inventorship: Because facts relating to inventorship issues can be material, even if inventorship is correct,19 consider presenting facts relating to inventorship to the PTO. This is particularly true where there may be a motive for misjoinder of an inventor or nonjoinder of an inventor, such as where a potential inventor has no obligation to assign the invention to the client.20
If information is specifically considered and discarded as not being material, that should be noted in the attorney’s or applicant’s file, along with the reasons for discarding it. An honest and excusable mistake can help prevent a finding of fraud or inequitable conduct. 21
16. 17. 18. 19. 20. 21.
Avid Identification Sys., Inc. v. Crystal Imp. Corp., 603 F.3d 967 (Fed. Cir. 2010). Hamilton Beach Brands, Inc. v. Sunbeam Prods., Inc., 726 F.3d 1370 (Fed. Cir. 2013). M.P.E.P. § 2004(11). Perspective Biosystems, Inc. v. Pharmacia Biotech, Inc., 225 F.3d 1315 (Fed. Cir. 2000). Advanced Magnetic Closures, Inc. v. Rome Fastener Corp., 607 F.3d 817 (Fed. Cir. 2010). M.P.E.P. § 2004(18).
10–7
© Practising Law Institute § 10:2.5
HOW
TO
WRITE
A
PATENT APPLICATION
[A] Checklist of Material Information A good practitioner expends extra effort in identifying information that should be brought to the attention of the Patent Office. Not only will this ensure that the practitioner complies with the duty of good faith and candor under 37 C.F.R. § 1.56, but it also allows for preparation of a better patent application. It is much easier to write a strong patent application knowing all the prior art. The following checklist is useful for identifying material information. q
Publications and patents that belong to the inventor(s). It is very difficult for an inventor charged with inequitable conduct to deny knowledge of his or her own publications or patents.
q
Other documents known to the inventor, such as posters shown at a conference.22
q
Information obtained by the inventors and others at conventions, plant visits, in-house reviews, etc.
q
Any references developed by any search in the technology, including prior art, novelty, state-of-the-art, infringement, and patentability searches.
q
References cited in related U.S. applications, including parent and sister applications. According to the Patent Office, prior art references from one application must be made of record in another, subsequent application.23
q
References cited in related foreign applications. 24 The Patent Office believes there is a strong inference that prior art or other information is material when it has been used in rejecting the same or similar claims in a related foreign application or is the only prior art cited in a related foreign application.25 It is recommended that any search report issued by a foreign patent office be included with the documents cited.
q
Published related foreign applications.
q
Related U.S. applications or patents, including parent and sister applications and patents. These applications and patents can raise double-patenting issues, and a parent patent can be the closest prior art for claims not supported by the parent patent. Practitioners cannot assume that the examiner of a particular application is necessarily aware of
22. 23. 24. 25.
Monsanto Co. v. Bayer Bioscience N.B., 514 F.3d 1229 (Fed. Cir. 2008). M.P.E.P. § 2001.06(b). 37 C.F.R. § 1.56(a)(1). M.P.E.P. § 2001.06(a).
10–8
© Practising Law Institute Information Disclosure Statement
§ 10:2.5
other applications that may be material. This situation can arise when a particular inventor has different applications pending with patentably indistinct claims present. 26 Moreover, failure to disclose the rejection of claims in a copending application before a different examiner that are substantially similar to the claims present can constitute inequitable conduct.27 q
Any commercial activity relating to the invention. This can result in an “on sale” or “publicly known” bar under 35 U.S.C. § 102. Once an attorney is on notice that a possibly material event, such as a sale, public use, publication, or issuance of a patent occurred about one year before the filing date of the application, there is a duty to investigate that event.28 The America Invents Act (AIA) has changed what qualifies as prior art. A grace period is provided for an inventor ’s own disclosure, but the exact scope of that grace period is not clear. Accordingly, any disclosure of an invention that is not on a confidential basis, even if it is less than one year before the filing date, should be submitted to the Patent Office. It is unclear whether such a disclosure would be prior art as to claims that include limitations not present in that disclosure. Also confusing the issue as to what needs to be disclosed is the position of the Patent Office that “on sale” or “publicly known” under the AIA requires that the invention be available to the public. (See section 8:2.2.) It is unknown if the courts will follow that interpretation of 35 U.S.C. § 102. Until there is a definite interpretation, it is recommended that even if it is believed that the claimed invention was not available to the public, “on sale” or “publicly known” information, applying the pre-AIA standard, should be cited to the Patent Office.
q
Clinical studies, because without sufficient confidentiality, they can amount to public use.29
q
Information from related litigation,30 such as art cited by the opposing party, motions filed by the opposing party, and any
26. 27. 28. 29. 30.
Dayco Prods., Inc. v. Total Containment, Inc., 329 F.3d 1358, 66 U.S.P.Q.2d 1801 (Fed. Cir. 2003); M.P.E.P. § 2001.06(b). Dayco Prods., Inc., 329 F.3d at 1358; see also Larson Mfg. Co. v. Aluminart Prods. Ltd., 559 F.3d 1317 (Fed. Cir. 2009). Brasseler, U.S.A. I, LP v. Stryker Sales Corp., 267 F.3d 888 (Fed. Cir. 2001); Dippin’ Dots, Inc. v. Mosey, 476 F.3d 1337 (Fed. Cir. 2007). Dey, L.P. v. Sunovion Pharm., Inc., 715 F.3d 1351 (Fed. Cir. 2013). M.P.E.P. § 2001.06(c); Outside the Box Innovations, LLC v. Travel Caddy, Inc., 695 F.3d 1285 (Fed. Cir. 2012).
10–9
© Practising Law Institute § 10:2.5
HOW
TO
WRITE
A
PATENT APPLICATION
claim construction by the court. This applies to related patents, such as a parent patent.31 q
Information relating to claims copied from a patent. When claims are copied or are substantially the same as claims from a patent, 37 C.F.R. § 1.607(c) requires the applicant to identify the patent and the numbers of the patent claims.32 However, this may apply only in the context of an interference.33
q
Information relating to a potential priority conflict, even if the information is not prior art. It can be dangerous to unilaterally determine that such information is not prior art.34
q
Information that is relevant to enablement, even if it is not prior art.35
q
Any translation available for foreign prior art submitted. Partial translations can be troublesome. It is best to get a full translation, because an opponent in litigation can allege that the partial translation was deceptive. 36
q
Information relating to the claimed invention submitted to government agencies such as the FDA, and particularly prior art so identified.37
q
Information about a related application, such as issuance of a notice of allowance, because it may raise double patenting issues. Citation of the related application is insufficient. 38
q
Office actions from related applications, which can provide bases for rejections. Citation of the related application is insufficient.39
31. 32. 33. 34. 35.
36. 37.
38. 39.
Leviton Mfg. Co. v. Universal Sec. Instruments, Inc., 606 F.3d 1353 (Fed. Cir. 2010). M.P.E.P. § 2001.06(d). Leviton Mfg. Co. v. Universal Sec. Instruments, Inc., 606 F.3d 1353 (Fed. Cir. 2010). GFI Inc. v. Franklin Corp., 265 F.3d 1268, 60 U.S.P.Q.2d 1141 (Fed. Cir. 2001). Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer, Inc., 326 F.3d 1226, 66 U.S.P.Q.2d 1481 (Fed. Cir. 2003) (non-prior-art article by the inventors reporting unsuccessful use of compounds specifically taught in the patent as being successful was material as to enablement). Semiconductor Energy Lab. Co. v. Samsung Elec. Co., 204 F.3d 1368 (Fed. Cir. 2000). Bruno Indep. Living Aids, Inc. v. Acorn Mobility Servs. Ltd., 394 F.3d 1348 (Fed. Cir. 2005) (failure to cite to the PTO prior art submitted to the FDA resulted in a finding of inequitable conduct and exceptional case). McKesson Info. Sols., Inc. v. Bridge Med., Inc., 487 F.3d 897 (Fed. Cir. 2007). Id.
10–10
© Practising Law Institute Information Disclosure Statement
§ 10:3
q
During prosecution of a foreign application, the remarks regarding a reference, where those remarks are inconsistent with a statement made during prosecution of a related U.S. patent application.40
q
Even if it is unclear whether certain information has a sufficiently early date to qualify as prior art, it should be cited to the Patent Office to give the examiner an opportunity to determine whether or not it is prior art.41
§ 10:3
When Should the Information Disclosure Statement Be Filed?
Whenever possible, the information disclosure statement should be filed with the patent application. This makes certain that the information is brought to the attention of the examiner at the time the application is originally examined. Moreover, the prior art is fresh in the mind of the practitioner when the application is filed. The practitioner of course had to consider the prior art when drafting the claims in the application, and it is much easier to discuss the relevance of the references, as is required under 37 C.F.R. § 1.56, when the references are fresh in mind. Whether or not an information disclosure statement is timely depends on when it is filed. A filing is timely if the statement is filed within three months of the filing date of the application or before the mailing date of a first office action on the merits, whichever event occurs last. The three-month period does not apply to continued prosecution applications because of their expedited examination. 42 Thus, it is still possible to make a timely filing when it is not possible to file the information disclosure statement with the application, such as when copies of references are not available or when the filing is done on short notice to avoid a statutory bar date. A late filed information disclosure statement will be considered by the Patent Office if certain requirements are met. For the Patent Office to consider an information disclosure statement that is not timely filed but that is filed before a final action or a notice of allowance, the applicant must pay an extension fee as set forth in 37 C.F.R. § 1.17(b), or provide a statement as to why the information disclosure statement was not filed in time.43
40. 41. 42. 43.
Therasense, Inc. v. Becton, Dickinson & Co., 593 F.3d 1325 (Fed. Cir. 2010). Golden Hour Data Sys., Inc. v. emsCharts, Inc., 614 F.3d 1367 (Fed. Cir. 2010). 37 C.F.R. § 1.97(b). 37 C.F.R. § 1.97(c).
10–11
© Practising Law Institute § 10:3
HOW
TO
WRITE
A
PATENT APPLICATION
Late filing of an information disclosure statement can reduce the patent term. Lateness of an information disclosure statement can be considered to be failure to engage in a reasonable effort to conclude prosecution under 37 C.F.R. § 1.704(c)(8).44 The statement must state that the information was cited in a communication from a foreign patent office in a counterpart foreign patent application within the past three months, or that the information was not known to any individual associated with the filing or prosecution of the patent application within the three months prior to filing the information disclosure statement.45 These individuals include the inventor(s), the attorney or agent who prepares or prosecutes the application, and “every other person who is substantively involved in the preparation or prosecution of the application, and who is associated with the inventor, with the assignee or with anyone to whom there is an obligation to assign the application.” 46 It is best to cite the art cited in a corresponding foreign application or corresponding U.S. application, even after issuance of a notice of allowance, within thirty days. This is to avoid any reduction of the patent term that can occur if more than thirty days is taken.47 No extensions of time for filing an information disclosure statement are permitted under section 1.136. If a bona fide attempt is made to comply with section 1.98, but part of the required content is inadvertently omitted, additional time may be given to enable full compliance.48 It is very difficult to get the Patent Office to consider information after the issuance of a final action or a notice of allowance. To have the information disclosure statement considered, it is necessary to (1)
provide the statement regarding lateness discussed above,
(2)
provide the fee specified, and
(3)
file the statement before the issue fee is paid.49
It is strongly recommended that before submitting any nontimely information disclosure statement, a telephone call be placed to the examiner to let the examiner know that additional information is being transmitted. It is very frustrating for an examiner to examine an application or amendment and issue an office action that crosses in the mail with the submission of information more material than what the examiner had before him. It is not in the best interest of a
44. 45. 46. 47. 48. 49.
Gilead Scis., Inc. v. Lee, 778 F.3d 1341 (Fed. Cir. 2015). 37 C.F.R. § 1.97(e). 37 C.F.R. § 1.56(c). 37 C.F.R. § 1.704(d). 37 C.F.R. § 1.97(f). 37 C.F.R. § 1.97(d).
10–12
© Practising Law Institute Information Disclosure Statement
§ 10:4
practitioner or inventor to have a frustrated examiner. If the identity of the examiner is not known, the secretary or clerk of the group identified on the filing receipt can be contacted. The secretary can then identify the examiner assigned to an application.
§ 10:4
Content of Information Disclosure Statement
The information disclosure statement itself is composed of two parts: (1) a list of patents, publications, or other information, and (2) a concise explanation of the relevance of each listed item that is not in the English language.50 It is recommended that the listing of the information be provided on Form PTO-1449 or a form substantially in the same format. A form is provided as part of Exhibit 10-1.51 The form has been modified by providing a coded designation, that is, AA, AB, AC, and so on, for each document. This provides an easy way to refer to each listed reference. The code letters can also be written on each document submitted to the Patent Office to help the examiner coordinate the documents with the information. Alternatively, the Patent Office has an online information disclosure statement form that can be used. Nothing submitted to the PTO, including the form listing the disclosed information and the accompanying statement, should refer to the information as being “prior art.” This avoids the information becoming prior art by admission.52 There can be information that is submitted that does not qualify as prior art, and it is important to retain the ability to prove that. For example, it may be possible to swear behind an issued patent, or the information submitted may be partly the work of the named inventor. Identification of a reference in an Information Disclosure Statement is not an admission that the reference constitutes prior art.53 Whether or not the PTO form is used, all U.S. patents should be identified by their patent number, patent date, and inventor. Each foreign published application or patent should be cited by identifying the country or office that issued it, the document number, and the publication date indicated in the document. Printed publications should be identified by author (if any), title of the publication, relevant pages, publisher, and the date and place of publication. 54
50. 51. 52.
53. 54.
37 C.F.R. § 1.98. PTO-1449 is provided by the Patent Office in M.P.E.P. § 609. Riverwood Int’l Corp. v. R.A. Jones & Co., 324 F.3d 1346, 66 U.S.P.Q.2d 1331 (Fed. Cir. 2003) (discusses the law regarding prior art by admission and holds that an inventor ’s own work, even though labeled prior art, is not prior art by admission); Abbott Labs. v. Baxter Pharm. Prods., Inc., 334 F.3d 1274, 67 U.S.P.Q.2d 1191 (Fed. Cir. 2003). ResQNet.com, Inc. v. Lansa, Inc., 594 F.3d 860 (Fed. Cir. 2010). 37 C.F.R. § 1.98(b).
10–13
© Practising Law Institute § 10:4
HOW
TO
WRITE
A
PATENT APPLICATION
There is no longer a requirement to write a discussion of the relevance of the references in English. Therefore, beyond what is required on Form PTO-1449, nothing should be stated about English-language references, unless the statement would help achieve allowability of the application. When the reference is a non-Englishlanguage reference, either an accurate translation should be provided, or its relevance has to be discussed. If a translation is provided, it needs to be accurate, or else a reference can be deemed not to have been considered by the examiner.55 As little as possible should be stated about the references. Moreover, the references should not be interpreted, because whatever is stated could come back to haunt the applicant in litigation. Statements made in the information disclosure statement can be a basis for interpreting the scope of the claims and can create an estoppel that precludes a finding of infringement under the doctrine of equivalents.56 Thus, say as little as possible about prior art references in an information disclosure statement. For example, when discussing the relevance of the document, it is best to quote language from the document, such as the Abstract or the Summary portion of a patent. If a search report discusses the reference (and is accurate), then quote the search report. The explanation of the relevance of each listed item need not be elaborate. It can consist of nothing more than identification of a particular figure or paragraph of the patent or publication that has some relation to the claimed invention. It might be a simple statement pointing out the similarities between the item of information and the claimed invention. Even a statement that an item is listed because it was cited during the prosecution of a counterpart foreign application and is not considered material to the examination of the U.S. application is considered to satisfy the concise explanation requirement.57 If there is a portion of a reference that is particularly relevant, the examiner can be referred to that portion by column and line number or by page and paragraph number. Certainly any statement regarding the teachings of the prior art needs to be accurate. Misrepresenting material facts regarding the prior art can lead to a finding of inequitable conduct. 58
55. 56. 57. 58.
Taltech Ltd. v. Esquel Enters. Ltd., 604 F.3d 1324 (Fed. Cir. 2010). Ekchian v. Home Depot, Inc., 104 F.3d 1299, 41 U.S.P.Q.2d 1364 (Fed. Cir. 1997). M.P.E.P. § 609. Apotex Inc. v. UCB, Inc., 2014 WL 3973498, 763 F.3d 1354 (Fed. Cir. 2014).
10–14
© Practising Law Institute Information Disclosure Statement
§ 10:4
The disclosure of the prior art must be complete, and include the material portions. An incomplete disclosure can result in a finding of inequitable conduct.59 Arguments about the patentability of the invention over the cited information should not be included in the information disclosure statement. By arguing and distinguishing a reference, the practitioner can create a prosecution history estoppel situation. Why do that prematurely? Arguments should wait until the examiner actually relies on the reference. Often the examiner may not consider a reference as material as does the practitioner who prepared the application and will not apply the reference against the claims. When there are a large number of references, in excess of about fifteen, it is best to identify to the examiner those documents that are believed to be the most significant.60 Failure to do that could result in a charge by an accused infringer that the inventor “buried” the most relevant art by citing a large number of obscure references. It is recommended that an explicit reference be made to the file history of any related U.S. patent or pending application in the information disclosure statement. “Related” applications are applications from which the present application claims priority, and applications that claim priority from the same application from which the present application claims priority. As noted above in section 10:2.5, related patents and applications can raise double-patenting issues. Also, rejection of similar claims in a co-pending application, not disclosed to the Patent Office, can give rise to a charge of inequitable conduct. The author has also noted that in litigation there can be charges of inequitable conduct for not disclosing the Patent Office’s reason for allowance in a related application. There can also be a charge of inequitable conduct for not disclosing an objection in a related application. To avoid these types of charges, it is prudent not to rely solely on disclosure of the related application or patent, but also, in a separate line, to make reference to the file history of that related application or patent. It is recommended that if papers from litigation are submitted to the Patent Office, and there is a claim construction order, and the applicant disagrees with the claim construction, that be explicitly stated. In one case, the Federal Circuit held that submission of a stipulated construction for a term in a patent claim constituted a disclaimer with regard to the scope of the claim.61
59. 60. 61.
Am. Calcar, Inc. v. Am. Honda Motor Co., 768 F.3d 1185 (Fed. Cir. 2014). M.P.E.P. § 2004(13). Golden Bridge Tech., Inc. v. Apple, Inc., 758 F.3d 1362 (Fed. Cir. 2014).
10–15
© Practising Law Institute § 10:5
§ 10:5
HOW
TO
WRITE
A
PATENT APPLICATION
Submission of Listed Documents
The information disclosure statement must be accompanied by a copy of each patent or publication or other item or information listed, or at least the portions that are considered to be pertinent. 62 There are three exceptions to this rule. The first exception is that issued U.S. patents and published U.S. patent applications need not be submitted. The second exception applies when two or more patents or publications are substantially cumulative, and that is stated; in this situation, only a representative document has to be provided. 63 The third exception applies when copies are in the file of the applicant’s prior application, provided the earlier application is identified in the information disclosure statement and is relied on for an earlier effective filing date under 35 U.S.C. § 120. Reference to the submission in the prior application is sufficient for the continuing application.64 A translation of the pertinent portions of foreign-language patents or publications is to be transmitted if an existing translation is readily available to the applicant.65 Whenever possible, provide clean copies of the references, that is, copies not having any markings on them. Markings can unduly attract an examiner ’s attention to portions of a document. It can be particularly troublesome if the marked or highlighted portions are the lesspertinent portions of the references. An accused infringer can argue that the examiner ’s attention was distracted from the more significant portions of the references. Submission of nonpatent literature may create a copyright infringement issue if the material submitted is copyrighted, such as a journal article. It is the position of the PTO that such a submission is fair use.66 However, that does not answer the copyright infringement question regarding electronic copies or hard copies maintained by the practitioner. It is recommended that any potential liability for copyright infringement be passed on to the client by way of an attorneyclient agreement or an express provision when the client submits nonpatent literature to the practitioner. Alternatively, as is the case with many journal articles, it is possible to purchase a copy.
62. 63. 64. 65. 66.
37 C.F.R. § 1.98(a)(2). 37 C.F.R. § 1.98(c). 37 C.F.R. § 1.98(d); M.P.E.P. § 609(2). 37 C.F.R. § 1.98(c). U.S. Patent & Trademark Office, Office of the General Counsel, Memorandum: USPTO Position on Fair Use of Copies of NPL Made in Patent Examination (Jan. 19, 2012).
10–16
© Practising Law Institute Information Disclosure Statement
§ 10:6
§ 10:7
Electronic Filing of an Information Disclosure Statement
It is possible to file an information disclosure statement (IDS) electronically. This is effective for up to fifty references, and the references are limited to U.S. patents and U.S. published applications. For other references, it is necessary to file a paper IDS. If there are more than fifty references, it is necessary to file multiple IDSs. The software for filing an electronic IDS is obtainable at the PTO website.67 It can be filed when the filing receipt is received, or by obtaining the application confirmation number using the PAIR system.68 An advantage of electronic filing is that it avoids the delays associated with the PTO mailroom.
§ 10:7
Example
A sample information disclosure statement is provided as Exhibit 10-1. It is recommended that the explanation of relevance of Englishlanguage references not be included in information disclosure statements submitted under the current rules. Anything that is said about the references can provide an opening during litigation for an opponent to argue noninfringement, invalidity, or inequitable conduct. The only exception to this recommendation occurs when a large number of references are provided. Under these circumstances, the examiner should be advised as to the most pertinent references. This would be helpful to the examiner and would avoid an argument during litigation that the most pertinent references were “buried.”
67. 68.
The PTO website is www.uspto.gov. Carl Oppedahl, Electronic Filing of Information Disclosure Statements, INTELL. PROP. TODAY, Oct. 2002, at 10.
10–17
© Practising Law Institute
© Practising Law Institute
Exhibit 10-1
Sample Information Disclosure Statement
10EX–1
© Practising Law Institute
Chapter 10
Information Disclosure Statement
§ 10:1 Introduction § 10:2 What Information Must Be Disclosed § 10:2.1 The Current Materiality Standard § 10:2.2 The Pre-1992 Standard § 10:2.3 The Current Patent Office Standard § 10:2.4 Ethical Considerations § 10:2.5 Recommendations [A] Checklist of Material Information § 10:3 When Should the Information Disclosure Statement Be Filed? § 10:4 Content of Information Disclosure Statement § 10:5 Submission of Listed Documents § 10:6 Electronic Filing of an Information Disclosure Statement § 10:7 Example Exhibit 10-1 Sample Information Disclosure Statement
§ 10:1
Introduction
It is a very rare patent application that is not accompanied by an information disclosure statement. This is because the Patent Office and the courts impose upon inventors and their attorneys and agents a duty of candor and good faith toward the Patent Office. That duty requires the attorney and agent to disclose to the Patent Office any information known to them that is material to the patentability of the application.1 The duty also extends to any other individual who is
1.
37 C.F.R. § 1.56.
10–1
© Practising Law Institute § 10:1
HOW
TO
WRITE
A
PATENT APPLICATION
involved in the substantive preparation or in the prosecution of the application.2 Even if the Patent Office did not explicitly require disclosure of material information, a good practitioner should voluntarily disclose that information. It is usually in the best interest of any inventor to have the most relevant art before the Patent Office when the examiner examines the application. This is because any resulting patent is much stronger and much less vulnerable to collateral attack if the Patent Office considered all material prior art and still allowed the patent to issue. In any subsequent patent infringement action, the accused infringer will have a difficult time at trial trying to persuade the trial judge or jury that the Patent Office made a mistake in issuing the patent when the infringer can find no art more pertinent than that already considered by the examiner. The consequences of failing to comply with this duty to disclose material information can be substantial. For example, it becomes much easier for an accused infringer to overcome the presumption of validity of the patent at trial by producing documents that are more material to the patentability of an invention than those cited by the patent holder than it is without such documents. Moreover, intentional withholding of material prior art can result in a finding of inequitable conduct, even if at least some of the claims of the patent would have issued the patent had the prior art been disclosed to the Patent Office.3 A finding of inequitable conduct can have the following disastrous consequences: 1.
Unenforceability of the entire patent, even if the inequitable conduct occurred in relation to fewer than all the claims in the patent.4 Moreover, inequitable conduct can render related patents unenforceable.5
2.
Awarding of attorneys’ fees: a finding of inequitable conduct can result in the case’s being considered exceptional, resulting in an award of attorneys’ fees under 35 U.S.C. § 285.6
2. 3. 4. 5. 6.
Id. Merck & Co. v. Danbury Pharmacal, Inc., 873 F.2d 1418, 1421, 10 U.S.P.Q.2d 1682 (Fed. Cir. 1989). Kingsdown Med. Consultants, Ltd. v. Hollister, 863 F.2d 867, 9 U.S.P.Q.2d 1384, 1392 (Fed. Cir. 1988). Consol. Aluminum Corp. v. Foseco Int’l Ltd., 910 F.2d 804 (Fed. Cir. 1990) (concealment of best mode rendered related patents unenforceable). J.P. Stevens & Co. v. Lex Tex, Ltd., 822 F.2d 1047, 233 U.S.P.Q. 1089 (Fed. Cir. 1987).
10–2
© Practising Law Institute Information Disclosure Statement
§ 10:2.2
3.
Antitrust liability if the inequitable conduct amounts to fraudulent procurement of a patent.7
4.
Suspension, disbarment, or both suspension and disbarment of the attorney or patent agent responsible for the inequitable conduct under 35 U.S.C. § 32.
At a minimum, even if the patentee ultimately prevails in persuading the court that the uncited prior art need not have been brought to the attention of the Patent Office, substantial sums will have been spent litigating the issue.
§ 10:2
What Information Must Be Disclosed
§ 10:2.1
The Current Materiality Standard
A recent decision by the Federal Circuit has most likely changed the materiality standard applied by the Patent Office with regard to submitting information disclosure statements. In Therasense, Inc. v. Becton, Dickinson & Co.,8 the Federal Circuit held that the materiality required for establishing inequitable conduct is a but-for materiality standard. In other words, when an applicant fails to disclose prior art to the Patent Office, that prior art is material if the Patent Office would not have allowed a claim but for a lack of awareness of the undisclosed prior art, applying a preponderance of evidence standard and giving the claims their broadest reasonable construction. The Patent Office has proposed rules to conform the Code of Federal Regulations to the Therasense decision. However, until those rules become final, it makes sense to discuss the prior Patent Office materiality standards, which is done in the following sections. The Patent Office’s proposed rules also provide another basis for materiality in conformance with the Therasense decision, namely, if the applicant engages in affirmative egregious misconduct before the Patent Office as to information.9
§ 10:2.2
The Pre-1992 Standard
According to 37 C.F.R. § 1.56, all information that is material to the examination of the application must be disclosed. According to 37
7. 8. 9.
Walker Process Equip., Inc. v. Food Mach. & Chem. Corp., 382 U.S. 172, 147 U.S.P.Q. 404. Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276, 99 U.S.P.Q.2d 1065 (Fed. Cir. 2011) (en banc). Revision of the Materiality to Patentability Standard for the Duty to Disclose Information in Patent Applications, 76 Fed. Reg. 43,631 (July 21, 2011).
10–3
© Practising Law Institute § 10:2.3
HOW
TO
WRITE
A
PATENT APPLICATION
C.F.R. § 1.56, as it existed prior to March 16, 1992, information is material “where there is substantial likelihood that a reasonable examiner would consider it in deciding whether to allow the application to issue as a patent.” This is not a “but for” test. Under a “but for” test, information would need to be disclosed to the Patent Office only if the Patent Office would not have issued the patent, as it issued, had the Patent Office been aware of the withheld information. As discussed above, even if the patent would have issued had the uncited information been disclosed to the Patent Office, there may be a violation of 37 C.F.R. § 1.56 if the nondisclosed information is found to be material.
§ 10:2.3
The Current Patent Office Standard
By a notice published in the Federal Register on January 17, 1992, 37 C.F.R. § 1.56 and related rules were changed. These changes included a change in the standard of materiality. The new rules are effective with respect to all applications and re-examination procedures pending or filed after March 16, 1992. Under the new standards, the test for materiality is much closer to a “but for” test. Under this standard, information is material if: 1.
the information establishes by itself or in combination with other information a prima facie case of unpatentability of a claim; or
2.
the information refutes, or is inconsistent with, a position the applicant takes in either, (a)
opposing an argument of unpatentability relied on by the Patent Office; or
(b)
asserting an argument of patentability.
The new rule also includes a definition of “prima facie case of unpatentability.” A prima facie case of unpatentability “is established when the information compels a conclusion that a claim is unpatentable under the preponderance of evidence, burden-of-proof standard.” This standard is applied by “giving each term in the claim its broadest reasonable construction consistent with the specification, and before any consideration is given to evidence which may be submitted in an attempt to establish a contrary conclusion of patentability.” 10 Information is not material when the information is cumulative with respect to information already of record or being made of record in the application.
10.
37 C.F.R. § 1.56.
10–4
© Practising Law Institute Information Disclosure Statement
§ 10:2.5
It is not necessary that the information be material to the broadest claims in the application. Information material only to a dependent claim is still considered material and should be cited in an information disclosure statement.11
§ 10:2.4
Ethical Considerations
What is a patent attorney to do when Rule 56 requires disclosure of client confidential information and the client refuses permission to disclose that information? The problem could arise because ABA Model Rule 1.6 requires attorneys to keep client information confidential except in specific circumstances. The Patent Office adopts the same basic requirement in its corresponding ethics rule, section 11.106. However, subsection C of that rule states that client confidentiality must be breached when necessary to comply with the agency’s disclosure requirements, which mandate compliance with 37 C.F.R. § 1.56. Arguably, that information can be cited to the Patent Office without violating the client confidentiality rule, because both the Patent Office rules and ABA Model Rule 1.6(b) allow an attorney to reveal information to prevent a client from committing a crime or fraud that would result in substantial injury to the financial interest of another party. However, this does not protect an attorney prosecuting patent applications for a first client who discovers information obtained from a different client that is material. Probably the safest thing to do is withdraw from representation. This is less of a problem for patent agents, because they are not subject to the state bar ethical rules governing attorney conduct.
§ 10:2.5
Recommendations
The author recommends that everyone who can conceivably be considered to have a duty to disclose material information to the Patent Office be interviewed. This includes all individuals associated with the filing or prosecution of the patent application, and not only the inventors. “Substantively involved” under 37 C.F.R. § 1.56(c)(3) means any involvement related to the content of the application and decisions related thereto, where that involvement is not wholly administrative or secretarial in nature. Thus, a noninventor president of a closely held company was held to have a duty of disclosure. 12 The author also recommends that a “rule of doubt” be followed when deciding whether certain information should be disclosed to
11. 12.
Taltech Ltd. v. Esquel Enters. Ltd., 604 F.3d 1324 (Fed. Cir. 2010). Avid Identification Sys., Inc. v. Crystal Imp. Corp., 603 F.3d 967 (Fed. Cir. 2010).
10–5
© Practising Law Institute § 10:2.5
HOW
TO
WRITE
A
PATENT APPLICATION
the Patent Office. Even if there is doubt as to whether particular information is “material” under either old or new Rule 56, it should nevertheless be cited to the Patent Office. It is better to cite a reference than incur the risk of a finding of inequitable conduct. The Federal Circuit decision in Therasense is unlikely to have a large effect on what information is cited to the Patent Office for two reasons. First, the time and cost associated with determining whether each possible piece of prior art is but-for material is something most clients are not willing to incur. It is easier and simpler to cite whatever information is available to the Patent Office. Second, the Patent Office endorses this rule of doubt: When in doubt, it is desirable and safest to submit information. Even though the attorney, agent, or applicant does not consider it necessarily material, someone else may see it differently and embarrassing questions can be avoided. . . . “In short, the questions of relevancy in close cases, should be left to the examiner 13 and not the applicant.”
Another reason to use a rule of doubt is that the filing of an information disclosure statement is not construed as an admission that the information cited in the statement is, or is considered to be, material to the patentability of the invention.14 This “rule of doubt” means that in most situations, even when the practitioner preparing or prosecuting an application believes that the information does not affect the patentability of a particular invention, the practitioner should let the Patent Office make the decision. Exemplary of situations that can arise are the following: 1.
Nonanalogous art: The examiner should be given the opportunity to determine whether a particular reference is analogous or nonanalogous.
2.
“Prior” art or nonprior art: Even if the publication date of a reference is after the filing date of a parent or foreign application from which priority is claimed, the reference should be cited to the Patent Office.15 That allows the examiner to
13. 14. 15.
M.P.E.P. § 2004(10) (quoting U.S. Indus. v. Norton Co., 210 U.S.P.Q. 94, 107 (N.D.N.Y. 1980)). Avid Identification Sys., Inc. v. Crystal Imp. Corp., 603 F.3d 967 (Fed. Cir. 2010). This does not apply in the situation of divisional and continuation applications, since the specifications of the parent and subsequent application are supposed to be identical.
10–6
© Practising Law Institute Information Disclosure Statement
§ 10:2.5
independently determine whether the applicant is entitled to the benefit of the filing date of the parent application or foreign priority application. Similarly, even if the applicant can swear behind the filing date of a U.S. patent or publication date of a reference with a declaration under 37 C.F.R. § 1.131, the Patent Office should determine that the showing complies with the requirements of 37 C.F.R. § 1.131. 3.
On sale, publicly known, or experimental uses: Sufficient relevant facts and documents should be presented to the Patent Office to let the examiner reach his or her own conclusion regarding whether a particular activity amounts to an “on sale” or “public use,” or whether the experimental use exception applies.16 A sale for “on sale” purposes can occur when a contract supplier offers a product to the inventor or the inventor ’s assignee.17 The Patent Office’s position on this issue is very much in favor of disclosure. The Patent Office believes it is desirable to submit information about prior uses and sales even if it appears that they may have been experimental, did not specifically involve the claimed invention, or did not encompass a complete invention. 18
4.
Inventorship: Because facts relating to inventorship issues can be material, even if inventorship is correct,19 consider presenting facts relating to inventorship to the PTO. This is particularly true where there may be a motive for misjoinder of an inventor or nonjoinder of an inventor, such as where a potential inventor has no obligation to assign the invention to the client.20
If information is specifically considered and discarded as not being material, that should be noted in the attorney’s or applicant’s file, along with the reasons for discarding it. An honest and excusable mistake can help prevent a finding of fraud or inequitable conduct. 21
16. 17. 18. 19. 20. 21.
Avid Identification Sys., Inc. v. Crystal Imp. Corp., 603 F.3d 967 (Fed. Cir. 2010). Hamilton Beach Brands, Inc. v. Sunbeam Prods., Inc., 726 F.3d 1370 (Fed. Cir. 2013). M.P.E.P. § 2004(11). Perspective Biosystems, Inc. v. Pharmacia Biotech, Inc., 225 F.3d 1315 (Fed. Cir. 2000). Advanced Magnetic Closures, Inc. v. Rome Fastener Corp., 607 F.3d 817 (Fed. Cir. 2010). M.P.E.P. § 2004(18).
10–7
© Practising Law Institute § 10:2.5
HOW
TO
WRITE
A
PATENT APPLICATION
[A] Checklist of Material Information A good practitioner expends extra effort in identifying information that should be brought to the attention of the Patent Office. Not only will this ensure that the practitioner complies with the duty of good faith and candor under 37 C.F.R. § 1.56, but it also allows for preparation of a better patent application. It is much easier to write a strong patent application knowing all the prior art. The following checklist is useful for identifying material information. q
Publications and patents that belong to the inventor(s). It is very difficult for an inventor charged with inequitable conduct to deny knowledge of his or her own publications or patents.
q
Other documents known to the inventor, such as posters shown at a conference.22
q
Information obtained by the inventors and others at conventions, plant visits, in-house reviews, etc.
q
Any references developed by any search in the technology, including prior art, novelty, state-of-the-art, infringement, and patentability searches.
q
References cited in related U.S. applications, including parent and sister applications. According to the Patent Office, prior art references from one application must be made of record in another, subsequent application.23
q
References cited in related foreign applications. 24 The Patent Office believes there is a strong inference that prior art or other information is material when it has been used in rejecting the same or similar claims in a related foreign application or is the only prior art cited in a related foreign application.25 It is recommended that any search report issued by a foreign patent office be included with the documents cited.
q
Published related foreign applications.
q
Related U.S. applications or patents, including parent and sister applications and patents. These applications and patents can raise double-patenting issues, and a parent patent can be the closest prior art for claims not supported by the parent patent. Practitioners cannot assume that the examiner of a particular application is necessarily aware of
22. 23. 24. 25.
Monsanto Co. v. Bayer Bioscience N.B., 514 F.3d 1229 (Fed. Cir. 2008). M.P.E.P. § 2001.06(b). 37 C.F.R. § 1.56(a)(1). M.P.E.P. § 2001.06(a).
10–8
© Practising Law Institute Information Disclosure Statement
§ 10:2.5
other applications that may be material. This situation can arise when a particular inventor has different applications pending with patentably indistinct claims present. 26 Moreover, failure to disclose the rejection of claims in a copending application before a different examiner that are substantially similar to the claims present can constitute inequitable conduct.27 q
Any commercial activity relating to the invention. This can result in an “on sale” or “publicly known” bar under 35 U.S.C. § 102. Once an attorney is on notice that a possibly material event, such as a sale, public use, publication, or issuance of a patent occurred about one year before the filing date of the application, there is a duty to investigate that event.28 The America Invents Act (AIA) has changed what qualifies as prior art. A grace period is provided for an inventor ’s own disclosure, but the exact scope of that grace period is not clear. Accordingly, any disclosure of an invention that is not on a confidential basis, even if it is less than one year before the filing date, should be submitted to the Patent Office. It is unclear whether such a disclosure would be prior art as to claims that include limitations not present in that disclosure. Also confusing the issue as to what needs to be disclosed is the position of the Patent Office that “on sale” or “publicly known” under the AIA requires that the invention be available to the public. (See section 8:2.2.) It is unknown if the courts will follow that interpretation of 35 U.S.C. § 102. Until there is a definite interpretation, it is recommended that even if it is believed that the claimed invention was not available to the public, “on sale” or “publicly known” information, applying the pre-AIA standard, should be cited to the Patent Office.
q
Clinical studies, because without sufficient confidentiality, they can amount to public use.29
q
Information from related litigation,30 such as art cited by the opposing party, motions filed by the opposing party, and any
26. 27. 28. 29. 30.
Dayco Prods., Inc. v. Total Containment, Inc., 329 F.3d 1358, 66 U.S.P.Q.2d 1801 (Fed. Cir. 2003); M.P.E.P. § 2001.06(b). Dayco Prods., Inc., 329 F.3d at 1358; see also Larson Mfg. Co. v. Aluminart Prods. Ltd., 559 F.3d 1317 (Fed. Cir. 2009). Brasseler, U.S.A. I, LP v. Stryker Sales Corp., 267 F.3d 888 (Fed. Cir. 2001); Dippin’ Dots, Inc. v. Mosey, 476 F.3d 1337 (Fed. Cir. 2007). Dey, L.P. v. Sunovion Pharm., Inc., 715 F.3d 1351 (Fed. Cir. 2013). M.P.E.P. § 2001.06(c); Outside the Box Innovations, LLC v. Travel Caddy, Inc., 695 F.3d 1285 (Fed. Cir. 2012).
10–9
© Practising Law Institute § 10:2.5
HOW
TO
WRITE
A
PATENT APPLICATION
claim construction by the court. This applies to related patents, such as a parent patent.31 q
Information relating to claims copied from a patent. When claims are copied or are substantially the same as claims from a patent, 37 C.F.R. § 1.607(c) requires the applicant to identify the patent and the numbers of the patent claims.32 However, this may apply only in the context of an interference.33
q
Information relating to a potential priority conflict, even if the information is not prior art. It can be dangerous to unilaterally determine that such information is not prior art.34
q
Information that is relevant to enablement, even if it is not prior art.35
q
Any translation available for foreign prior art submitted. Partial translations can be troublesome. It is best to get a full translation, because an opponent in litigation can allege that the partial translation was deceptive. 36
q
Information relating to the claimed invention submitted to government agencies such as the FDA, and particularly prior art so identified.37
q
Information about a related application, such as issuance of a notice of allowance, because it may raise double patenting issues. Citation of the related application is insufficient. 38
q
Office actions from related applications, which can provide bases for rejections. Citation of the related application is insufficient.39
31. 32. 33. 34. 35.
36. 37.
38. 39.
Leviton Mfg. Co. v. Universal Sec. Instruments, Inc., 606 F.3d 1353 (Fed. Cir. 2010). M.P.E.P. § 2001.06(d). Leviton Mfg. Co. v. Universal Sec. Instruments, Inc., 606 F.3d 1353 (Fed. Cir. 2010). GFI Inc. v. Franklin Corp., 265 F.3d 1268, 60 U.S.P.Q.2d 1141 (Fed. Cir. 2001). Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer, Inc., 326 F.3d 1226, 66 U.S.P.Q.2d 1481 (Fed. Cir. 2003) (non-prior-art article by the inventors reporting unsuccessful use of compounds specifically taught in the patent as being successful was material as to enablement). Semiconductor Energy Lab. Co. v. Samsung Elec. Co., 204 F.3d 1368 (Fed. Cir. 2000). Bruno Indep. Living Aids, Inc. v. Acorn Mobility Servs. Ltd., 394 F.3d 1348 (Fed. Cir. 2005) (failure to cite to the PTO prior art submitted to the FDA resulted in a finding of inequitable conduct and exceptional case). McKesson Info. Sols., Inc. v. Bridge Med., Inc., 487 F.3d 897 (Fed. Cir. 2007). Id.
10–10
© Practising Law Institute Information Disclosure Statement
§ 10:3
q
During prosecution of a foreign application, the remarks regarding a reference, where those remarks are inconsistent with a statement made during prosecution of a related U.S. patent application.40
q
Even if it is unclear whether certain information has a sufficiently early date to qualify as prior art, it should be cited to the Patent Office to give the examiner an opportunity to determine whether or not it is prior art.41
§ 10:3
When Should the Information Disclosure Statement Be Filed?
Whenever possible, the information disclosure statement should be filed with the patent application. This makes certain that the information is brought to the attention of the examiner at the time the application is originally examined. Moreover, the prior art is fresh in the mind of the practitioner when the application is filed. The practitioner of course had to consider the prior art when drafting the claims in the application, and it is much easier to discuss the relevance of the references, as is required under 37 C.F.R. § 1.56, when the references are fresh in mind. Whether or not an information disclosure statement is timely depends on when it is filed. A filing is timely if the statement is filed within three months of the filing date of the application or before the mailing date of a first office action on the merits, whichever event occurs last. The three-month period does not apply to continued prosecution applications because of their expedited examination. 42 Thus, it is still possible to make a timely filing when it is not possible to file the information disclosure statement with the application, such as when copies of references are not available or when the filing is done on short notice to avoid a statutory bar date. A late filed information disclosure statement will be considered by the Patent Office if certain requirements are met. For the Patent Office to consider an information disclosure statement that is not timely filed but that is filed before a final action or a notice of allowance, the applicant must pay an extension fee as set forth in 37 C.F.R. § 1.17(b), or provide a statement as to why the information disclosure statement was not filed in time.43
40. 41. 42. 43.
Therasense, Inc. v. Becton, Dickinson & Co., 593 F.3d 1325 (Fed. Cir. 2010). Golden Hour Data Sys., Inc. v. emsCharts, Inc., 614 F.3d 1367 (Fed. Cir. 2010). 37 C.F.R. § 1.97(b). 37 C.F.R. § 1.97(c).
10–11
© Practising Law Institute § 10:3
HOW
TO
WRITE
A
PATENT APPLICATION
Late filing of an information disclosure statement can reduce the patent term. Lateness of an information disclosure statement can be considered to be failure to engage in a reasonable effort to conclude prosecution under 37 C.F.R. § 1.704(c)(8).44 The statement must state that the information was cited in a communication from a foreign patent office in a counterpart foreign patent application within the past three months, or that the information was not known to any individual associated with the filing or prosecution of the patent application within the three months prior to filing the information disclosure statement.45 These individuals include the inventor(s), the attorney or agent who prepares or prosecutes the application, and “every other person who is substantively involved in the preparation or prosecution of the application, and who is associated with the inventor, with the assignee or with anyone to whom there is an obligation to assign the application.” 46 It is best to cite the art cited in a corresponding foreign application or corresponding U.S. application, even after issuance of a notice of allowance, within thirty days. This is to avoid any reduction of the patent term that can occur if more than thirty days is taken.47 No extensions of time for filing an information disclosure statement are permitted under section 1.136. If a bona fide attempt is made to comply with section 1.98, but part of the required content is inadvertently omitted, additional time may be given to enable full compliance.48 It is very difficult to get the Patent Office to consider information after the issuance of a final action or a notice of allowance. To have the information disclosure statement considered, it is necessary to (1)
provide the statement regarding lateness discussed above,
(2)
provide the fee specified, and
(3)
file the statement before the issue fee is paid.49
It is strongly recommended that before submitting any nontimely information disclosure statement, a telephone call be placed to the examiner to let the examiner know that additional information is being transmitted. It is very frustrating for an examiner to examine an application or amendment and issue an office action that crosses in the mail with the submission of information more material than what the examiner had before him. It is not in the best interest of a
44. 45. 46. 47. 48. 49.
Gilead Scis., Inc. v. Lee, 778 F.3d 1341 (Fed. Cir. 2015). 37 C.F.R. § 1.97(e). 37 C.F.R. § 1.56(c). 37 C.F.R. § 1.704(d). 37 C.F.R. § 1.97(f). 37 C.F.R. § 1.97(d).
10–12
© Practising Law Institute Information Disclosure Statement
§ 10:4
practitioner or inventor to have a frustrated examiner. If the identity of the examiner is not known, the secretary or clerk of the group identified on the filing receipt can be contacted. The secretary can then identify the examiner assigned to an application.
§ 10:4
Content of Information Disclosure Statement
The information disclosure statement itself is composed of two parts: (1) a list of patents, publications, or other information, and (2) a concise explanation of the relevance of each listed item that is not in the English language.50 It is recommended that the listing of the information be provided on Form PTO-1449 or a form substantially in the same format. A form is provided as part of Exhibit 10-1.51 The form has been modified by providing a coded designation, that is, AA, AB, AC, and so on, for each document. This provides an easy way to refer to each listed reference. The code letters can also be written on each document submitted to the Patent Office to help the examiner coordinate the documents with the information. Alternatively, the Patent Office has an online information disclosure statement form that can be used. Nothing submitted to the PTO, including the form listing the disclosed information and the accompanying statement, should refer to the information as being “prior art.” This avoids the information becoming prior art by admission.52 There can be information that is submitted that does not qualify as prior art, and it is important to retain the ability to prove that. For example, it may be possible to swear behind an issued patent, or the information submitted may be partly the work of the named inventor. Identification of a reference in an Information Disclosure Statement is not an admission that the reference constitutes prior art.53 Whether or not the PTO form is used, all U.S. patents should be identified by their patent number, patent date, and inventor. Each foreign published application or patent should be cited by identifying the country or office that issued it, the document number, and the publication date indicated in the document. Printed publications should be identified by author (if any), title of the publication, relevant pages, publisher, and the date and place of publication. 54
50. 51. 52.
53. 54.
37 C.F.R. § 1.98. PTO-1449 is provided by the Patent Office in M.P.E.P. § 609. Riverwood Int’l Corp. v. R.A. Jones & Co., 324 F.3d 1346, 66 U.S.P.Q.2d 1331 (Fed. Cir. 2003) (discusses the law regarding prior art by admission and holds that an inventor ’s own work, even though labeled prior art, is not prior art by admission); Abbott Labs. v. Baxter Pharm. Prods., Inc., 334 F.3d 1274, 67 U.S.P.Q.2d 1191 (Fed. Cir. 2003). ResQNet.com, Inc. v. Lansa, Inc., 594 F.3d 860 (Fed. Cir. 2010). 37 C.F.R. § 1.98(b).
10–13
© Practising Law Institute § 10:4
HOW
TO
WRITE
A
PATENT APPLICATION
There is no longer a requirement to write a discussion of the relevance of the references in English. Therefore, beyond what is required on Form PTO-1449, nothing should be stated about English-language references, unless the statement would help achieve allowability of the application. When the reference is a non-Englishlanguage reference, either an accurate translation should be provided, or its relevance has to be discussed. If a translation is provided, it needs to be accurate, or else a reference can be deemed not to have been considered by the examiner.55 As little as possible should be stated about the references. Moreover, the references should not be interpreted, because whatever is stated could come back to haunt the applicant in litigation. Statements made in the information disclosure statement can be a basis for interpreting the scope of the claims and can create an estoppel that precludes a finding of infringement under the doctrine of equivalents.56 Thus, say as little as possible about prior art references in an information disclosure statement. For example, when discussing the relevance of the document, it is best to quote language from the document, such as the Abstract or the Summary portion of a patent. If a search report discusses the reference (and is accurate), then quote the search report. The explanation of the relevance of each listed item need not be elaborate. It can consist of nothing more than identification of a particular figure or paragraph of the patent or publication that has some relation to the claimed invention. It might be a simple statement pointing out the similarities between the item of information and the claimed invention. Even a statement that an item is listed because it was cited during the prosecution of a counterpart foreign application and is not considered material to the examination of the U.S. application is considered to satisfy the concise explanation requirement.57 If there is a portion of a reference that is particularly relevant, the examiner can be referred to that portion by column and line number or by page and paragraph number. Certainly any statement regarding the teachings of the prior art needs to be accurate. Misrepresenting material facts regarding the prior art can lead to a finding of inequitable conduct. 58
55. 56. 57. 58.
Taltech Ltd. v. Esquel Enters. Ltd., 604 F.3d 1324 (Fed. Cir. 2010). Ekchian v. Home Depot, Inc., 104 F.3d 1299, 41 U.S.P.Q.2d 1364 (Fed. Cir. 1997). M.P.E.P. § 609. Apotex Inc. v. UCB, Inc., 2014 WL 3973498, 763 F.3d 1354 (Fed. Cir. 2014).
10–14
© Practising Law Institute Information Disclosure Statement
§ 10:4
The disclosure of the prior art must be complete, and include the material portions. An incomplete disclosure can result in a finding of inequitable conduct.59 Arguments about the patentability of the invention over the cited information should not be included in the information disclosure statement. By arguing and distinguishing a reference, the practitioner can create a prosecution history estoppel situation. Why do that prematurely? Arguments should wait until the examiner actually relies on the reference. Often the examiner may not consider a reference as material as does the practitioner who prepared the application and will not apply the reference against the claims. When there are a large number of references, in excess of about fifteen, it is best to identify to the examiner those documents that are believed to be the most significant.60 Failure to do that could result in a charge by an accused infringer that the inventor “buried” the most relevant art by citing a large number of obscure references. It is recommended that an explicit reference be made to the file history of any related U.S. patent or pending application in the information disclosure statement. “Related” applications are applications from which the present application claims priority, and applications that claim priority from the same application from which the present application claims priority. As noted above in section 10:2.5, related patents and applications can raise double-patenting issues. Also, rejection of similar claims in a co-pending application, not disclosed to the Patent Office, can give rise to a charge of inequitable conduct. The author has also noted that in litigation there can be charges of inequitable conduct for not disclosing the Patent Office’s reason for allowance in a related application. There can also be a charge of inequitable conduct for not disclosing an objection in a related application. To avoid these types of charges, it is prudent not to rely solely on disclosure of the related application or patent, but also, in a separate line, to make reference to the file history of that related application or patent. It is recommended that if papers from litigation are submitted to the Patent Office, and there is a claim construction order, and the applicant disagrees with the claim construction, that be explicitly stated. In one case, the Federal Circuit held that submission of a stipulated construction for a term in a patent claim constituted a disclaimer with regard to the scope of the claim.61
59. 60. 61.
Am. Calcar, Inc. v. Am. Honda Motor Co., 768 F.3d 1185 (Fed. Cir. 2014). M.P.E.P. § 2004(13). Golden Bridge Tech., Inc. v. Apple, Inc., 758 F.3d 1362 (Fed. Cir. 2014).
10–15
© Practising Law Institute § 10:5
§ 10:5
HOW
TO
WRITE
A
PATENT APPLICATION
Submission of Listed Documents
The information disclosure statement must be accompanied by a copy of each patent or publication or other item or information listed, or at least the portions that are considered to be pertinent. 62 There are three exceptions to this rule. The first exception is that issued U.S. patents and published U.S. patent applications need not be submitted. The second exception applies when two or more patents or publications are substantially cumulative, and that is stated; in this situation, only a representative document has to be provided. 63 The third exception applies when copies are in the file of the applicant’s prior application, provided the earlier application is identified in the information disclosure statement and is relied on for an earlier effective filing date under 35 U.S.C. § 120. Reference to the submission in the prior application is sufficient for the continuing application.64 A translation of the pertinent portions of foreign-language patents or publications is to be transmitted if an existing translation is readily available to the applicant.65 Whenever possible, provide clean copies of the references, that is, copies not having any markings on them. Markings can unduly attract an examiner ’s attention to portions of a document. It can be particularly troublesome if the marked or highlighted portions are the lesspertinent portions of the references. An accused infringer can argue that the examiner ’s attention was distracted from the more significant portions of the references. Submission of nonpatent literature may create a copyright infringement issue if the material submitted is copyrighted, such as a journal article. It is the position of the PTO that such a submission is fair use.66 However, that does not answer the copyright infringement question regarding electronic copies or hard copies maintained by the practitioner. It is recommended that any potential liability for copyright infringement be passed on to the client by way of an attorneyclient agreement or an express provision when the client submits nonpatent literature to the practitioner. Alternatively, as is the case with many journal articles, it is possible to purchase a copy.
62. 63. 64. 65. 66.
37 C.F.R. § 1.98(a)(2). 37 C.F.R. § 1.98(c). 37 C.F.R. § 1.98(d); M.P.E.P. § 609(2). 37 C.F.R. § 1.98(c). U.S. Patent & Trademark Office, Office of the General Counsel, Memorandum: USPTO Position on Fair Use of Copies of NPL Made in Patent Examination (Jan. 19, 2012).
10–16
© Practising Law Institute Information Disclosure Statement
§ 10:6
§ 10:7
Electronic Filing of an Information Disclosure Statement
It is possible to file an information disclosure statement (IDS) electronically. This is effective for up to fifty references, and the references are limited to U.S. patents and U.S. published applications. For other references, it is necessary to file a paper IDS. If there are more than fifty references, it is necessary to file multiple IDSs. The software for filing an electronic IDS is obtainable at the PTO website.67 It can be filed when the filing receipt is received, or by obtaining the application confirmation number using the PAIR system.68 An advantage of electronic filing is that it avoids the delays associated with the PTO mailroom.
§ 10:7
Example
A sample information disclosure statement is provided as Exhibit 10-1. It is recommended that the explanation of relevance of Englishlanguage references not be included in information disclosure statements submitted under the current rules. Anything that is said about the references can provide an opening during litigation for an opponent to argue noninfringement, invalidity, or inequitable conduct. The only exception to this recommendation occurs when a large number of references are provided. Under these circumstances, the examiner should be advised as to the most pertinent references. This would be helpful to the examiner and would avoid an argument during litigation that the most pertinent references were “buried.”
67. 68.
The PTO website is www.uspto.gov. Carl Oppedahl, Electronic Filing of Information Disclosure Statements, INTELL. PROP. TODAY, Oct. 2002, at 10.
10–17
© Practising Law Institute
© Practising Law Institute
Exhibit 10-1
Sample Information Disclosure Statement
10EX–1
© Practising Law Institute
