UNITED STATES DEPARTlVIENT OF COlVHVIERCE
United States Patent and Trademark Office Address: COlVflVHSSlONER FOR PATENTS PO. Box 1450 Alexandria1 Virginia 22313-1450 www.uspto.gov
APPLICATION NO.
FILINGDATE
FIRST NAMED INVENTOR
13/852,100
03/28/2013
MORDECHAY BEYAR
67801
7590
l ATTORNEY DOCKET NO. 56167
03/02/2016
MARTIN D. MOYNTHAN d/b/a PRTST, INC.
CONFIRMATION NO.
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5130
EXAMINER I
RO- BOX 16446
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BECCIA, CHRISTOPHER I
ARLINGTON, VA 22215
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ART UNIT
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PAPER NUMBER
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DELIVERY MODE
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3775 l NOTIFICATION DATE 03/02/20 1 6
ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the following e—mail address(es): usptomail @ipatent.c0.il
PTOL—90A (Rev. 04/07)
Application No.
Applicant(s)
13/852,100
Office Action Summary
BEYAR ET AL.
Examiner
Art Unit
AIA (First Inventor to File)
CHRISTOPHER BECCIA
3775
if?“
-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
Period for Reply
A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE g MONTHS FROM THE MAILING DATE OF THIS COMMUNICATION. -
Extensions of time may be available under the provisions of 37 CFR1.136(a). In no event, however, may a reply be timely filed after SIX (6) MONTHS from the mailing date of this communication. If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication. Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133). Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any earned patent term adjustment. See 37 CFR 1 .704(b).
Status 1)IZI Responsive to communication(s) filed on W.
El A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on _. 2a)|Z| This action is FINAL.
2b)|:l This action is non-final.
3)|:I An election was made by the applicant in response to a restriction requirement set forth during the interview on _; the restriction requirement and election have been incorporated into this action.
4)|:| Since this application is in condition for allowance except for formal matters, prosecution as to the merits is closed in accordance with the practice under Exparte Quay/e, 1935 CD. 11, 453 O.G. 213.
Disposition of Claims*
5)IZI CIaim(s)1-_26is/are pending in the application. 5a) Of the above cIaim(s) 17-19 and 22-25 is/are withdrawn from consideration.
6)|:I Claim(s) is/are allowed. 7)|Z| Claim(s) 1-8 10-16 20 21 and 26 is/are rejected. 8)IZI Claim(s) Q is/are objected to. 9)|:I Claim(s)
are subject to restriction and/or election requirement.
* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a participating intellectual property office for the corresponding application. For more information, please see hitszilwww.usctoeov/natents/init events/neb/indexjsn or send an inquiry to PPI-ifeedback{®usgtc.00v.
Application Papers 10)I:l The specification is objected to by the Examiner.
11)|Xl The drawing(s) filed on May 271 2013 is/are: a)IXI accepted or b)|:l objected to by the Examiner. Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a). Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
Priority under 35 U.S.C. § 119 12)I:| Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
Certified copies: a)I:l AII b)|:l Some” c)I:l None of the: 1.I:I Certified copies of the priority documents have been received. 2.|:l
Certified copies of the priority documents have been received in Application No.
3.|:|
Copies of the certified copies of the priority documents have been received in this National Stage application from the International Bureau (PCT Rule 17.2(a)).
** See the attached detailed Office action for a list of the certified copies not received.
Attachment(s)
1) E Notice of References Cited (PTO-892)
3) D Interview Summary (PTO-413)
. . 2) E Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
Paper No(s)/Mai| Date. 4 D Oh _
Paper No(s)/Mai| Date US. Patent and Trademark Office PTOL—326 (Rev. 11-13)
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Office Action Summary
1 er.
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Part of Paper No./Mai| Date 20160223
Application/Control Number: 13/852,100
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Art Unit: 3775 DETAILED ACTION The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments 1.
Applicant’s arguments, filed January 25, 2016, with respect to the rejection(s) of c|aim(s) 1-16,
20, and 21 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made. Please direct attention to rejection below, specifically reference Dup/essis regarding the amended limitations regarding an insert having a volume that is at least 60% enclosed in a distal portion of a screw body.
Allowable Subject Matter 1.
Claim 9 is objected to as being dependent upon a rejected base claim, but would be allowable if
rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 103 1.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness
rejections set forth in this Office action: (a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which the subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
2.
Claims 1-8, 12, 14-16, and 26 are rejected under pre-AIA 35 U.S.C. 103(a) as being
unpatentable over U.S. Patent Pub. No. 2008/0234762 to Forstein etal. in view of U.S. Patent Pub. No. 201 1/0295319 to Dup/essis.
As to Claim 1, Fa/ahee discloses a composite material bone screw (2, Fig. 2, [0021, 0030]). The screw comprises a head (16) configured at a proximal end (6) of the screw (Fig. 1), a body extending from
Application/Control Number: 13/852,100
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Art Unit: 3775 the head to a distal end (4) of the screw (Fig. 1), the body being at least partially threaded (24), and an insert (4). The insert is at least partially embedded within a distal portion of the body (4 embedded within
15, Fig. 3, [0023]). As to Claim 2, Forstein discloses a composite material bone screw comprising an insert (4)
configured to cover a cutting edge of a screw (Fig. 3, [0023]). As to Claim 3, Forstein discloses a composite material bone screw wherein the portion is an extension of the insert (planar surface of 4 from which 13 protrudes proximally, Fig. 3). As to Claim 4, Forstein discloses a composite material bone screw wherein the insert comprises a plurality of extensions for covering at least one cutting edge intended for self-tapping (planar surfaces of 4 from which 13 protrudes proximally, Fig. 3). As to Claim 5, Forstein discloses a composite material bone screw wherein the extension is shaped according to a cross-section of a thread of the screw (circular cross section of 6, Fig. 3). As to Claim 6, Forstein discloses a composite material bone screw wherein the extension is configured to cover at least a perimeter of a cutting edge of the screw (planar surface of 4 from which 13 protrudes proximally covers distal surface 14 of 6, Fig. 3).
As to Claim 7, Forstein discloses a composite material bone screw wherein the insert (4) is sandwiched between two portions of the body (sandwiched between medial and lateral portions of distal portion 15). As to Claim 8, Forstein discloses a composite material bone screw wherein the insert is flat
(proximal surface of 13). As to Claim 12, Forstein discloses a composite material bone screw wherein the insert (4) extends to the distal tip (15) of the screw (Fig. 3). As to Claim 14, Forstein discloses a composite material bone screw wherein the insert is harder
than a cortical bone [0028]. As to Claim 15, Forstein discloses a composite material bone screw wherein the insert is harder
than the composite material of the body [0028].
Application/Control Number: 13/852,100
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Art Unit: 3775 As to Claim 16, Forstein discloses a composite material bone screw wherein the screw body comprises a radiopaque material thick enough for visualizing under fluoroscopy [0030]. As to Claims 1-8, 12, 14-16, and 26, Forstein discloses the claimed invention except for wherein
at least 60% of a total volume of the insert is enclosed within the composite material of the body, wherein at least 50% of the surface area of the insert contacts the composite material of the screw, wherein the screw comprises a cutting edge, and wherein most of the insert does not extend axially past said distal
end of the composite material body. Dup/essis discloses a bone screw (10) including a self-tapping insert (18, [0082]) wherein at least
60% of a total volume of the insert is enclosed within the composite material of the body (more than 60% of insert 18 as seen in Fig. 13, enclosed within 46, seen in Figs. 11a and 11b). The screw includes a cutting edge (along 14, [0080]). Most of the insert does not extend axially past said distal end of the composite material body (>50% of the insert does not extend axially beyond distal end of body, seen in Figs. 11a and 11b) in order to ensure engagement between the screw body and insert during insertion of
the assembly into bone [0083]. It would have been obvious to one having ordinary skill in the art at the time the invention was
made to modify the bone screw of Forstein with the insert and cutting edge modification of Dup/essis in order to ensure engagement between the screw body and insert during insertion of the assembly into bone.
3.
Claims 10, 11, and 13 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over
U.S. Patent Pub. No. 2008/0234762 to Forstein etal. in view of U.S. Patent Pub. No. 2011/0295319 to Dup/essis in further view of U.S. Patent Pub. No. 2012/0330361 to Gepstein. As to Claims 10, 11, and 13, Forstein and Dup/essis disclose the claimed invention except for wherein the composite material comprises a fiber-reinforced polymer matrix, wherein the insert extends
at least 3 mm along a long axis of the screw, wherein the insert extends at least 2 mm along a diameter of the screw.
Application/Control Number: 13/852,100
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Art Unit: 3775 Gepstein discloses a bone fixation component (10) wherein the composite material comprises a fiber-reinforced polymer matrix [0007] in order to provide a screw with increased elasticity while maintaining strength [0003]. It would have been obvious to one having ordinary skill in the art at the time the invention was
made to construct the screw and insert with the given dimensions, since Gepstein discloses general conditions of length and diameter of the screw in [0065-0066], and it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges
involves only routine skill in the art. In re Aller, 105 USPQ 233. It would have been obvious to one having ordinary skill in the art at the time the invention was
made to modify the bone fixation system of Forstein and Dup/essis with the material modification of Gepstein in order to provide a screw with increased elasticity while maintaining strength.
4.
Claims 20 and 21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S.
Patent Pub. No. 2008/0234762 to Forstein etal. in view of U.S. Patent Pub. No. 2011/0295319 to Dup/essis in further view of U.S. Patent Pub. No. 2010/0217333 to McShane etal. As to Claims 20 and 21, Forstein and Dup/essis disclose the claimed invention except for
wherein the screw is a lag screw and wherein a thin hard foil covers at least 70% of a thread of the screw, and does not cover the insert. McShane discloses a bone fixation component (22) wherein the screw is a lag screw (described
in [0026] and wherein a thin hard foil covers at least 70% of a thread of the screw, and does not cover the insert (titanium coating described in [0023]) in order to allow for the screw to be used in compression and to provide a desired material hardness [0023, 0026]. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the bone fixation system of Forstein and Dup/essis with the lag screw and coating
modification of McShane in order to allow for the screw to be used in compression and to provide a desired material hardness.
Application/Control Number: 13/852,100
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Art Unit: 3775 Conclusion Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date
of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action
is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christopher Beccia whose telephone number is (571 )270-7391. The examiner can normally be reached on Mon-Fri from 9:00am — 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, please contactthe examiner’s supervisor, Kevin Truong, at (571) 272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571 -273-8300. Information regarding the status of an application may be obtained from the Patent Application
Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC)
at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571 -2721000. /CHR|STOPHER BECCIA/ Primary Examiner, Art Unit 3775