DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Disposition of Claims
Claims 1, 3-9, 11, 15, 17-18 and 21-23 are pending in the application. Claims 2, 10, 12-14, 16 and 19-20 have been cancelled.
The amendments to claims 1, 3, 15 and 21-22, filed on 8/6/2026, have been entered.
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.
Claims 1, 3-9, 11, 15, 17-18 and 21-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 31-35 of copending Application No. 13/858,704 in view of Bayon et al. (US 2010/0016872 A1).
The limitations of claims 1, 7, 9 and 22 are met by claim 31 of copending Application No. 13/858,704, with the exception of the following limitations: wherein the one layer has essentially identical first and second sides, and wherein the second fiber type consists of a polypropylene with a denier of 130-180 g/9000 m.
However, Bayon teaches an implant that includes a porous layer including collagen, a non-porous layer including a collagenic constituent, and a reinforcement component (Abstract). In embodiments, the reinforcement member is a mesh having a weight density less than 100 g/m2, for example less than 50 g/m2 ([0024]). In such embodiments, in particular, the mesh may be isoelastic ([0024]). By "isoelastic" is meant that the mesh shows substantially similar elastic properties in all directions ([0024]). In embodiments, the reinforcement member is a surgical mesh made from polyester, polypropylene (and/or other polymers) ([0102]). It is envisioned as well that the reinforcing member may be knitted from bioabsorbable yarns, non bioabsorbable yarns or both of them, in any combination ([0102]). The examiner notes that, in an embodiment, Bayon teaches using a 150 dtex (135 g/9000m, as calculated by the examiner) monofilament ([0114]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the invention to have substituted the polyethylene terephthalate of the non-absorbable fiber with a polymer such as polypropylene because Bayon shows that polypropylene and polyester were art-recognized equivalents prior to the effective filing date of the invention ([0102]). It would further have been obvious to one having ordinary skill in the art prior to the effective filing date of the invention to provide the fibers in the mesh with a titer of around 150 dtex (135 g/9000m) in order to obtain a knitted reinforcing member for use in a variety of medical implant applications, wherein the mesh pore sizes potentially allow for a good integration to tissues, and it would also have been obvious to provide the knitted mesh with essentially identical first and second sides in order to obtain a mesh that is isoelastic, as suggested by Bayon (see [0105], [0113] and the paragraphs cited above).
The limitations of claims 3-6 are further met by claims 32-35 of copending Application No. 13/858,704.
The limitations of claim 8 are further met by claim 31 of copending Application No. 13/858,704 in view of Bayon. Claim 31 of copending Application No. 13/858,704 discloses a glycolide-lactide-trimethylene carbonate copolymer. Claim 31 of copending Application No. 13/858,704 does not explicitly disclose wherein the lactide is l-lactide. However, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the invention to have provided lactide in the form of l-lactide as PLLA, PDLA and PDLLA are well known forms of polylactide.
The limitations of claim 11 are further met by Bayon’s teaching of providing fibers with a titer of around 150 dtex (135 g/9000m), in the same manner applied above to claim 1.
The limitations of claim 15 are further met by claim 31 of copending Application No. 13/858,704 in view of Bayon. With respect to the claimed properties, the examiner notes that the materials taught by claim 31 of copending Application No. 13/858,704 in view of Bayon are the same as or substantially the same as those disclosed by applicant. Therefore, it is the position of the Office that the composition of claim 31 of copending Application No. 13/858,704 in view of Bayon would have the claimed properties as the same compound necessarily has the same properties. In the alternative, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the invention to expect that the claimed properties would be so provided, as the references teach the same materials as those claimed, and as the properties cannot be separated from the materials. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Therefore, absent an objective showing to the contrary, claim 31 of copending Application No. 13/858,704 in view of Bayon meets the claimed limitations.
The limitations of claim 17 are further met by Bayon’s teaching that, in embodiments, the reinforcement member is a mesh having a weight density less than 100 g/m2, for example less than 50 g/m2 ([0024]). In addition, claim 31 of copending Application No. 13/858,704 discloses that the absorbable polymeric multifilament fiber provides from 30% to 60% by weight of the single-layer polymeric mesh.
The limitations of claim 18 are further met by Bayon’s teaching that, in embodiments, the porosity of the mesh is from about 20% to about 98% ([0113]). Bayon further teaches that the pores size of the mesh are from about 1 mm to 5 mm, in embodiments from about 1 mm to 2.5 mm ([0109]).
The limitations of claim 21 are further met by Bayon’s teaching that polyethylene materials may also be incorporated into the implant to add stiffness ([0102]).
The limitations of claim 23 are further met by Bayon’s teaching that, in embodiments, the mesh is a flat mesh, essentially a two dimensional mesh, displaying a thickness lower than about 1 mm ([0104]).
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 3-9, 11, 15, 17-18 and 21-23 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kevin Worrell whose telephone number is (571)270-7728. The examiner can normally be reached Monday-Friday.
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/Kevin Worrell/Examiner, Art Unit 1789
/MARLA D MCCONNELL/Supervisory Patent Examiner, Art Unit 1789
