DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
This office action is in response to the amendment filed July 31, 2025. As directed by the amendment, claim 21 has been amended. As such, claims 21-33 remain under consideration in the instant application.
Claim Rejections - 35 USC § 103
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, 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 said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 21-33 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Dong et al. (US 2006/0058862), hereinafter “Dong”.
Regarding claim 21, Dong discloses a method of making a surgical implant (10) comprising:(a) flat knitting a plurality of biocompatible polymer fibers into a knitted ribbon (¶66); (b) heat shrinking the knitted ribbon to reduce at least a width of the knitted ribbon and interlock at least some of the biocompatible polymer fibers (¶100), the heat shrinking stabilizing the knitted ribbon against fraying when cut (“bonds” ¶21); and (c) making a plurality of cuts along a length of the knitted ribbon to separate the knitted ribbon into a plurality of surgical implants (¶159). However, Dong is silent regarding reducing at least a width of the knitted ribbon by at least 10%. It would have been obvious to one having ordinary skill in the art at the time the invention was made to shrink the width by at least 10%, since Dong discloses the material having “low or moderate shrinkage properties or combinations thereof” (¶90); additionally 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.
Regarding claim 22, Dong discloses the method of claim 21 wherein heat shrinking the ribbon comprises thermally crimping the knitted ribbon (¶124).
Regarding claim 23, Dong discloses the method of claim 22 wherein thermally crimping the knitted ribbon stabilizes the surgical implants against fraying (¶66).
Regarding claim 24, Dong is silent regarding heat shrinking the knitted ribbon to reduce the width of the knitted ribbon by at least 25% to 60%. It would have been obvious to one having ordinary skill in the art at the time the invention was made to shrink the width by at least 25% to 60%, since Dong discloses the material having “low or moderate shrinkage properties or combinations thereof” (¶90); additionally 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.
Regarding claim 25, Dong discloses the method of claim 21 wherein heat shrinking the knitted ribbon comprises heat shrinking the knitted ribbon such that a thickness of the knitted ribbon increases (inherent).
Regarding claim 26, Dong is silent regarding heat shrinking the knitted ribbon to reduce the width of the knitted ribbon by at least 35% to 55%. It would have been obvious to one having ordinary skill in the art at the time the invention was made to shrink the width by at least 35% to 55%, since Dong discloses the material having “low or moderate shrinkage properties or combinations thereof” (¶90); additionally 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.
Regarding claim 27, Dong discloses the method of claim 21 wherein making the plurality of cuts along the length of the knitted ribbon comprises making the plurality of cuts along the length of the heat shrunk knitted ribbon (¶159).
Regarding claim 28, Dong discloses the method of claim 21 wherein flat knitting the plurality of biocompatible polymer fibers comprises flat knitting a plurality of biocompatible polymer fibers at least some of which comprising a poly urethane urea material (¶90).
Regarding claim 29, Dong discloses the method of claim 21 wherein flat knitting the plurality of biocompatible polymer fibers comprises flat knitting a plurality of biocompatible polymer fibers at least some of which comprising at least one of poly urethane urea, poly(ortho ester), poly(glycolic acid), poly(lactic acid), poly(glycolic, lactic acid), poly(glycolic/lactic acid, s-caprolactone), poly(p-hydroxybutyric acid), poly(imino carbonate), poly(s-caprolactone), poly(ethyleneterephthalate), poly(etheretherketone), polyurea, poly(urethane urea), polyurethane, and polyamide (¶90).
Regarding claim 30, Dong discloses the method of claim 21 wherein flat knitting the plurality of biocompatible polymer fibers comprises flat knitting a plurality of biocompatible, biodegradable polymer fibers at least some of which comprising a poly urethane urea material (¶90).
Regarding claim 31, Dong discloses the method of claim 21 wherein flat knitting the plurality of biocompatible polymer fibers comprises flat knitting a plurality of biocompatible polymer fibers at least some of which comprise a biocompatible polymer material having either a glass transition temperature or at least one thermally induced conformational mobility threshold that is not a melting threshold, within a temperature ranging from 20° C to 170° C (¶101-102).
Regarding claim 32, Dong discloses the method of claim 21 wherein flat knitting the plurality of biocompatible polymer fibers comprises flat knitting a plurality of biocompatible polymer fibers at least some of which comprise a biocompatible polymer material having either a glass transition temperature or at least one thermally induced conformational mobility threshold that is not a melting threshold, within a temperature ranging from 35° C to 120° C (¶101-102).
Regarding claim 33, Dong discloses the method of claim 21 wherein making the plurality of cuts along the length of the knitted ribbon comprises making the plurality of cuts along the length of the knitted ribbon across a warp of the knitted ribbon (¶159).
Response to Arguments
In response to Applicant's argument that Dong fails to disclose “the heat shrinking stabilizing the knitted ribbon against fraying when cut,” Examiner respectfully disagrees. As heat shrinking occurs, Dong states that “the heat-setting temperature…bonds portions of the expanded polytetrafluoroethylene to portions of the graft” (¶18). The bonding that transpires will necessarily improve the fray resistance of the material if not prevent it altogether. Either way, it is “stabilized”/becomes more stable against fraying when cut.
Conclusion
THIS ACTION IS MADE FINAL. 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA C CHANG whose telephone number is (571) 270-5017. The examiner can normally be reached Monday-Friday, 7:30AM-5:00PM.
If attempts to reach the examiner by telephone are unsuccessful, please contact the 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.
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/OLIVIA C CHANG/Primary Examiner, Art Unit 3775