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 the Claims
Claims 31-35 and 39-45 are pending in the application. Claims 1-30 and 36-38 have been cancelled.
Amendments to claims 31-32, 39-40 and 45, filed on 6/25/2026, 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 31-35 and 39-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and/or 6-8 of U.S. Patent No. 11,959,207 B2 in view of Tang et al. (US Patent No. 5,274,074).
The limitations of claim 31 are met by claims 6-8 of U.S. Patent No. 11,959,207 B2 with the exception of the following limitations: wherein the non-absorbable synthetic polymeric monofilament fiber comprises polyethylene terephthalate (PET), wherein at least one of the absorbable polymeric multifilament fiber or the non-absorbable synthetic polymeric monofilament fiber comprises a radio-opaque or ultrasound opaque additive as a filler material of the fiber, in an amount effective to render the single-layer sheet polymeric mesh detectable by a radioscope or ultrasound device, and wherein said single-layer sheet polymeric mesh does not comprise a bioactive agent. (The limitations of claim 31 are also met by claim 1 of U.S. Patent No. 11,959,207 B2 with the exception of the limitations identified above, and with the exception of the following limitation: wherein the first fiber type consists of an absorbable polymeric multifilament fiber of a polyaxial, segmented biodegradable copolyester, a glycolide-lactide-trimethylene carbonate copolymer, or a homopolymer of polydioxanone).
However, Tang teaches totally and partially bioresorbable devices, such as fibrous devices that can be fabricated from the fibers of Tang’s invention using conventional techniques for forming woven or knitted articles from fibers made of synthetic polymers (col. 1, lines 22-26 and col. 5, lines 33-39). The examiner notes that these fibers meet the claimed polyaxial, segmented biodegradable copolyester limitation (col. 14, lines 11-18, and col. 15, lines 14-47). Tang teaches that dental and orthopedic repair devices may be used in composite structures with or without such materials as calcium hydroxyapatite, Bioglass, calcium triphosphate, drugs, and the like (col. 9, lines 10-13). Other biocompatible components besides polymeric components may be combined with polymers during or before they are formed into the devices, or added to, coated onto and the like, after their formation (col. 20, lines 30-31). Components such as certain barium salts to render devices formed with them radio-opaque are also within the contemplation of Tang’s invention (col. 20, lines 45-48). Illustrative of biodurable materials useful in the fabrication of devices are silicone, silicone rubber, poly(ethylene), poly(ethylene terephthalate) (and others) (col. 20, lines 56-59).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the invention to have used a polyaxial, segmented biodegradable copolyester as the absorbable fiber, substituted the polyethylene in the non-absorbable fiber with a polymer such as poly(ethylene terephthalate), and included a barium salt radio-opaque additive in the polymer(s), with or without incorporating materials such as drugs, in order to obtain dental and orthopedic repair devices that are detectable and are capable of degrading to biodurable materials suitable for contacting blood and/or living systems, particularly as Tang shows that poly(ethylene) and poly(ethylene terephthalate) were art-recognized equivalents prior to the effective filing date of the invention (see the paragraphs cited above).
The limitations of claims 32-35 are further met by claims 2-5 of U.S. Patent No. 11,959,207 B2.
The limitations of claim 39 are met by claim 1 of U.S. Patent No. 11,959,207 B2 in the same manner applied above to claim 31, with the exception of the following claim 39 limitation: an anti-adhesive coating. With respect to this limitation, Tang teaches that biopolymers of Tang’s invention may be used to fabricate the total device, or may be use to fabricate only a part of the device, for example, as a coating or a layer (col. 5, lines 21-28, and col. 17, lines 21-28). Tang also teaches that soft and pliable coatings and devices can be obtained from a homopolymer of trimethylene carbonate, random copolymers of trimethylene carbonate and lactide (90:10), block copolymers of trimethylene carbonate and lactide (95:5), and random and block copolymers of dimethyl trimethylene carbonate and trimethylene carbonate (56:44) (col. 18, lines 44-50). The examiner notes that these are the same materials disclosed by applicant as examples of anti-adhesive materials. Thus, it is the position of the Office that the composition of Tang would have the claimed property 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 property would be so provided, as the reference teaches the same materials as the claimed structure, 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).
The limitations of claims 40-43 are further met by claims 2-5 of U.S. Patent No. 11,959,207 B2.
Claims 31-35 and 39-43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-9 of copending Application No. 18/604,036 in view of Tang et al. (US Patent No. 5,274,074).
The limitations of claim 31 are met by claims 1 and 7-9 of copending Application No. 18/604,036, with the exception of the following limitations: wherein the non-absorbable synthetic polymeric monofilament fiber comprises polyethylene terephthalate (PET), wherein at least one of the absorbable polymeric multifilament fiber or the non-absorbable synthetic polymeric monofilament fiber comprises a radio-opaque or ultrasound opaque additive as a filler material of the fiber, in an amount effective to render the single-layer sheet polymeric mesh detectable by a radioscope or ultrasound device, and wherein said single-layer sheet polymeric mesh does not comprise a bioactive agent.
However, Tang teaches totally and partially bioresorbable devices, such as fibrous devices that can be fabricated using conventional techniques for forming woven or knitted articles from fibers made of synthetic polymers (col. 1, lines 22-26 and col. 5, lines 33-39). Tang teaches that dental and orthopedic repair devices may be used in composite structures with or without such materials as calcium hydroxyapatite, Bioglass, calcium triphosphate, drugs, and the like (col. 9, lines 10-13). Other biocompatible components besides polymeric components may be combined with polymers during or before they are formed into the devices, or added to, coated onto and the like, after their formation (col. 20, lines 30-31). Components such as certain barium salts to render devices formed with them radio-opaque are also within the contemplation of Tang’s invention (col. 20, lines 45-48). Illustrative of biodurable materials useful in the fabrication of devices are silicone, silicone rubber, poly(ethylene), poly(ethylene terephthalate) (and others) (col. 20, lines 56-59).
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 polypropylene in the non-absorbable fiber with a polymer such as poly(ethylene terephthalate), and to have included a barium salt radio-opaque additive in the polymer, with or without incorporating materials such as drugs, in order to obtain dental and orthopedic repair devices that are detectable and are capable of degrading to biodurable materials suitable for contacting blood and/or living systems, particularly as Tang shows that poly(propylene) and poly(ethylene terephthalate) were art-recognized equivalents prior to the effective filing date of the invention (see the paragraphs cited above, and cols. 19-20, lines 63-20).
The limitations of claims 32-35 are further met by claims 3-6 of copending Application No. 18/604,036.
The limitations of claim 39 are met by claim 1 of copending Application No. 18/604,036 in the same manner applied above to claim 31, with the exception of the following claim 39 limitation: an anti-adhesive coating. With respect to this limitation, Tang teaches that biopolymers of Tang’s invention may be used to fabricate the total device, or may be use to fabricate only a part of the device, for example, as a coating or a layer (col. 5, lines 21-28, and col. 17, lines 21-28). Tang also teaches that soft and pliable coatings and devices can be obtained from a homopolymer of trimethylene carbonate, random copolymers of trimethylene carbonate and lactide (90:10), block copolymers of trimethylene carbonate and lactide (95:5), and random and block copolymers of dimethyl trimethylene carbonate and trimethylene carbonate (56:44) (col. 18, lines 44-50). The examiner notes that these are the same materials disclosed by applicant as examples of anti-adhesive materials. Thus, it is the position of the Office that the composition of Tang would have the claimed property 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 property would be so provided, as the reference teaches the same materials as the claimed structure, 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).
The limitations of claims 40-43 are further met by claims 3-6 of copending Application No. 18/604,036.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant’s arguments with respect to claim(s) 31-35 and 39-45 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
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 Kevin Worrell whose telephone number is (571)270-7728. The examiner can normally be reached on Monday-Friday.
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/Kevin Worrell/Examiner, Art Unit 1789 /MARLA D MCCONNELL/Supervisory Patent Examiner, Art Unit 1789
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