DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application Nos. 14/313685, 15/465571, and 16/999,057, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior-filed applications do not disclose a first perforation formed through the membrane that is aligned with the predrilled hole formed in the at least one elongated member that receives a fastener having a diameter that is different from a diameter of a second perforation formed in the membrane as claimed in claim 1. Fig.16 is the only figure that shows first perforations aligned with the predrilled holes formed in the elongated members. Fig.16 does not show second perforations different in diameter from the aligned first perforations. While fig.1 shows larger perforations closer to the edge, fig.1 does not show first perforations aligned with predrilled holes. Therefore, there is no disclosure of the relative size difference between the perforations aligned with the predrilled holes and other perforations of the membrane. Such a feature is also not addressed in the written description. Additionally, there is no support for lines 16-17 of claim 1 which recite “a second perforation formed in the membrane during manufacture of the membrane”. The specification only discloses the first pores and pore channels being formed during manufacture. It appears the perforations are formed after manufacture of the membrane. Because claims 1-20 are original claims in the instant application, they are not considered to be directed to new matter, however, because of the limitations discussed above which are not disclosed in the prior-filed applications, claims 1-20 have an effective filing date of the instant application, which is 7/8/2024.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1, line 14 recites “that that”, which should recite --that--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10 and 11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 10 and 11 recite “wherein the membrane is trimmed after manufacture” which is unclear because a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph (see MPEP 2173.05(p)). To overcome the 112(b) rejection, the claims could be amended to recite that the membrane is configured to be trimmed….which clarifies that it’s a functional limitation/intended use as opposed to a method step within a product claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Bartee US 2021/0085471 (hereafter referred to as Bartee 2021) in view of Bartee et al. US 2017/0189159 (hereafter referred to as Bartee 2017). (Both references include the inventor of the instant application but are published more than one year prior to the effective filing date of the claimed invention which is 7/8/2024 as discussed above.)
Regarding claim 1, Bartee 2021 discloses a membrane 200 (fig.2) for covering a bone defect, the membrane comprising: a first layer 212 made of expanded polytetrafluoroethylene (par.31) capable of contacting bone surrounding the bone defect and including first pores in a size range of 30 micrometers to 1000 micrometers (par.35 discloses a size range of 30-500 micrometers which is within the claimed range); a second layer 214 fixedly coupled to the first layer and made of an unsintered, substantially unexpanded PTFE that has a denser structure compared to the first layer (par.34) and that has pore channels formed therein with a nominal pore channel size of less than 2 micrometers (par.36 discloses less than 0.2 micrometers); and a reinforcement binder 210 comprising elongated members extending from a junction (fig.2), the elongated members including at least one elongated member that has a free end extending away from the junction with a predrilled hole 208 formed at the free end, wherein a substantially circular first perforation 208 formed through the membrane is aligned with the predrilled hole formed in the at least one elongated member and is capable of receiving a fastener that that is capable of coupling the reinforcement binder to the bone surrounding the bone defect (fig.2 profile view shows perforations 208 extending through both layers and the binder), wherein a second perforation 204 formed in the membrane by a user has a diameter that is different from the diameter of the first perforation (fig.2 shows 204 has a greater diameter than 208). While Bartee 2021 discloses the invention substantially as claimed, Bartee 2021 does not specifically disclose that the first perforation has a diameter of between 0.1 mm and 3.0 mm.
Bartee 2017 teaches a membrane for covering a bone defect, in the same field of endeavor, wherein perforations that extend through the membrane can have a diameter of 0.1 mm or larger and up to about 3.0 mm (par.45) wherein the size and shape of the perforations may be determined based on the material that forms the membrane, a thickness of the membrane, a size of the membrane, and a shape and/or size of the binder (par.46).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form the first perforations of the membrane of Bartee 2021 to have a diameter of between 0.1 mm and 3.0 mm as taught by Bartee 2017 since 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, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), MPEP 2144.05 II A). A person of ordinary skill in the art would have found it obvious to select a first perforation diameter from the range taught by Bartee 2017 since Bartee 2017 discloses this is a suitable perforation diameter range for a membrane.
Regarding claim 2, see Bartee 2021 par.39 for an adhesive layer.
Regarding claim 3, Bartee 2017 teaches a perforation diameter of about 0.5 mm to about 1.0 mm in par.45. It would have been obvious to a person of ordinary skill in the art to select a second perforation diameter of Bartee 2021 of about 0.5 mm to about 1.0 mm since Bartee 2017 discloses this is a suitable perforation diameter for a membrane 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, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), MPEP 2144.05 II A).
Regarding claim 4, see fig.2 of Bartee 2021 for second perforation 204 having a larger diameter than the diameter of the first perforation 208.
Regarding claim 5, see fig.2 of Bartee 2021 for third perforations 206 located closer to the reinforcement binder that have a smaller diameter than the second perforation 204.
Regarding claim 6, see fig.2 of Bartee 2021 for second perforation 204 being near an edge of the membrane.
Regarding claims 7 and 8, see fig.2 of Bartee 2021 for a discontinuous surface that inherently has a texture from the distribution of pores.
Regarding claim 9, see Bartee 2021 par.32 for the thickness claimed.
Regarding claims 10 and 11, the membrane of Bartee 2021 in view of Bartee 2017 is capable of being trimmed and used as claimed. As least Bartee 2021 discloses trimming throughout the specification.
Regarding claim 12, see Bartee 2021 par.70 for the fasteners claimed. Note that the claims do not actually require fasteners since they are not positively recited in claim 1.
Regarding claim 13, see Bartee 2021 fig.2, specifically, the profile view which shows the binder between the layers.
Regarding claims 14 and 15, see Bartee 2021 par.35 for the first pores being formed during manufacture of the ePTFE and being formed as cavities in the ePTFE.
Regarding claim 16, Bartee 2021 par.35 discloses the first pores have a size from 30-500 micrometers.
Regarding claims 17 and 18, see Bartee 2021 par.36 for a pore channel size of less than 0.2 micrometers.
Regarding claims 19 and 20, see Bartee 2021 par.36 for unsintered, substantially unexpanded d-PTFE having pore channels of less than about 0.2 micrometers. Since the material of the dense layer of Bartee 2021 is the same, the properties are the same.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 11-14 of U.S. Patent No. 12,059,335 in view of Bartee 2021.
Regarding claim 1 of the application, claim 1 of the patent discloses the invention substantially as claimed, but claim 1 of the patent does not disclose that the first perforations are formed through the membrane and aligned with the pre-drilled holes formed in elongated member, wherein the first aligned perforations are smaller than the second perforations.
Bartee 2021 teaches a membrane, in the same field of endeavor, wherein first perforations 208 extend through the membrane and are aligned with pre-drilled holes of a binder 210, wherein the first perforations are smaller than second perforations 204 located near an edge of the membrane (fig.2) for the purpose of better facilitating bone regeneration as well as allowing the surgeon to more readily visualize pilot holes for securing the membrane fixation screws, pins, or tacks (par.27).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the membrane of claim 1 of the patent to include that the first perforations are formed through the membrane and aligned with the pre-drilled holes formed in elongated member, and the first aligned perforations are smaller than the second perforations as taught by Bartee 2021 in order to better facilitate bone regeneration and to allow the surgeon to more readily visualize pilot holes for securing the membrane fixation screws, pins, or tacks.
Regarding claim 2 of the application, see claim 14 of the patent.
Regarding claim 3 of the application, see claim 2 of the patent which teaches a perforation diameter about 0.5 mm to about 1.0 mm. It would have been obvious to select a second perforation diameter of about 0.5 mm to about 1.0 mm since patent claim 2 teaches this is a suitable perforation diameter for a membrane 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, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), MPEP 2144.05 II A).
Regarding claim 4 of the application, see claim 1 of the patent and Bartee 2021 fig.2.
Regarding claims 5 and 6 of the application, see Bartee 2021 fig.2 which shows third perforations 206 near the reinforcement binder which are smaller than the second perforations 204 near an edge.
Regarding claims 7 and 8 of the application, the second perforations of patent claim 1 in view of Bartee 2021 inherently have the claimed characteristics since the material is the same.
Regarding claim 9 of the application, see claim 3 of the patent.
Regarding claims 10-11 of the application, the membrane of claim 1 of the patent is capable of being trimmed as claimed.
Regarding claim 12 of the application, see claim 4 of the patent.
Regarding claim 13 of the application, see claim 5 of the patent.
Regarding claim 14 of the application, see claim 6 of the patent.
Regarding claim 15 of the application, see claim 7 of the patent.
Regarding claim 16 of the application, see claim 13 of the patent.
Regarding claim 17 of the application, see claim 11 of the patent.
Regarding claim 18 of the application, see claim 12 of the patent.
Regarding claim 19 of the application, see claim 8 of the patent.
Regarding claim 20 of the application, see claim 9 of the patent.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Niiranen et al. US 6,692,498 discloses smaller perforations 46 for a fastener and larger perforations 47 for tissue healing in a membrane (fig.7J; col.9, lines 39-42).
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774