--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 .
Applicant’s response dated November 24, 2025 is acknowledged.
Priority
This application is a continuation of 16/290,718 filed on 03/01/2019, which claims benefit in provisional application 62/733,384 filed on 09/19/2018 and provisional application 62/636,930 filed on 03/01/2018.
Claim Status
Claims 30-32, 34, and 36-55 are pending. Claims 45-49 and 51 remain withdrawn. Claims 1-29, 33, and 35 were canceled. Claims 30-32, 34, 36-44, 50, and 52-55 are examined.
Maintained 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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 30-32, 34, 36-41, 44, 50, and 52-55 are rejected under 35 U.S.C. 103 as being unpatentable over Porbeni (US 2012/0315225 Al Published December 13, 2012 — of record in IDS dated 05/02/2025) and Ganatra (US 2016/0166727 Al Published June 16, 2016).
The claims encompass a monofilament fiber formed of a polymeric composition, wherein the polymeric composition comprises an oriented polymer comprising poly(butylene succinate) and/or copolymers thereof; wherein the polymeric composition has a weight average molecular weight of 50,000 to 300,000, excludes urethane bonds, and is not prepared with a diisocyanate; and wherein the oriented polymer forming the monofilament fiber results in the monofilament fiber having a tensile strength between 400 MPa and 1200 MPa and an elongation to break of 10 % to 50 %.
The teachings of Porbeni are related to dimensionally stable nonwoven fibrous webs including a multiplicity of continuous fibers formed from one or more thermoplastic polyesters and polypropylene. A spunbond process may be used to produce substantially continuous fibers that exhibit molecular orientation (Abstract). Porbeni teaches dimensionally stable nonwoven fibrous webs and methods of making and using such webs. One embodiment discloses a web including a plurality of continuous fibers comprising one or more thermoplastic aliphatic polyesters, an antishrinkage additive in an amount greater than 0% and no more than 10 % by weight of the web, and an antistatic additive in an amount greater than 0% and no more than 10% by weight of the web, wherein the fibers exhibit molecular orientation and extend
substantially endlessly through the web, and further wherein the web has at least one dimension which decreases by no greater than 10% in the plane of the web when the web is heated to a temperature above a glass transition temperature of the fibers, but below the melting point of the fibers (paragraph 0008). The thermoplastic polyester comprises at least one aliphatic polyester including polybutylene succinate. The molecular weight of the aliphatic polyester is at least 10,000. Although higher molecular weight polymers generally yield fibers with better mechanical properties, for both melt processed and solvent cased polymers, excessive viscosity in undesirable. The molecular weight of the aliphatic polyester is preferably no greater than 300,000 Daltons (paragraphs 0111-0113). In some embodiments a web of multiple fibers is produced wherein the thermoplastic fibers are bonded together to form a dimensionally stable porous web. In these embodiments the fibers preferably are bonded together after formation and at least partially cooling in a secondary thermal process, for example, by a heated calender (pressure nip) roll or using a hot gas such as heated air (paragraph 0015). "Continuous oriented microfibers” herein refers to essentially continuous fibers issuing from a die and traveling through a processing station in which the fibers are drawn and at least portions of the molecules within the fibers are oriented into alignment with the longitudinal axis of the fibers ("oriented" as used with respect to fibers means that at least portions of the molecules of the fibers are aligned along the longitudinal axis of the fibers) (paragraph 0054). "Web" as used herein is a network of entangled fibers forming a sheet like or fabric like structure (paragraph 0065). Paragraphs 0070 to 0074 teach further details about molecularly oriented fibers. Aliphatic polyesters include copolymers derived from one or more diacids including succinic acid, and one or more diols including 1,4-butanediol (paragraph 0117). The dimensionally stable nonwoven fibrous webs are
useful for making medical devices, in whole or in part, including surgical mesh (paragraph 0289).
Porbeni does not teach a tensile strength and an elongation to break of the monofilament fiber.
The teachings of Ganatra are related to monofilament fibers suitable for making a mesh (paragraph 0029). The monofilament fibers have a tensile strength higher than 500 MPa (paragraph 0030), an elongation to break between 15% and 120%, a Young’s modulus less than 2 GPa (paragraph 0032), and a minimum average knot pull tensile strength greater than 0.25 kgf (paragraph 0034). The meshes made from monofilaments have a suture pullout strength of at least 1 Kgf (paragraph 0075). Ganatra teaches a medical device such as monofilament mesh, wherein the device has been sterilized to contain less than 20 endotoxin units (page 18 claims 20 and 22).
The teachings of Porbeni and Ganatra are related to surgical meshes and it would have been obvious to have combined their teachings because they are in the same field of endeavor.
Regarding claims 30, 50, and 54, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have formed an oriented monofilament fiber wherein the fiber comprises a polymeric composition comprising poly(butylene succinate), with a reasonable expectation of success because Porbeni teaches a dimensionally stable nonwoven fibrous web formed from polybutylene succinate, and wherein the web is used to form a surgical mesh. It would have been obvious to have formed the fibers as oriented monofilament fibers because Porbeni teaches oriented monofilament fibers. It would have been obvious to have used poly(butylene succinate) having a molecular weight in the range of 10,000 to 300,000 Da because Porbeni teaches that the aliphatic polyester such as polybutylene succinate used for making the fiber has a molecular weight greater than 10,000 and preferably no greater than 300,000 Daltons. The claimed ranges of molecular weights are obvious because they overlap with 10,000-300,000 Daltons. It would have been obvious to interpret a copolymer having the chemical name polybutylene succinate to only contain repeating units derived from 1,4-butanediol and succinic acid, which meets the limitation that requires exclusion of urethan bonds and diisocyanate from the polymeric composition.
Porbeni does not teach mechanical properties of the fibers.
Regarding fiber properties in claims 30-32, it would have been prima facie obvious to a person of ordinary skill in the art to have formed Porbeni’s monofilament fiber surgical mesh having mechanical properties that are required for a surgical mesh. It would have been obvious to have formed the fiber having a tensile strength higher than 500 MPa, an elongation to break between 15% and 120%, and a Young’s modulus less than 2 GPa, with a reasonable expectation of success because it was known from Ganatra that monofilament fiber intended for making a mesh has mechanical properties including a tensile strength higher than 500 MPa, an elongation to break between 15% and 120%, and a Young’s modulus less than 2 GPa. Claimed tensile strength, Young’s modulus, and elongation at break are obvious because claimed ranges overlap with their corresponding ranges in the prior art.
Claim 34 describes fiber properties under in vivo conditions. Porbeni’s fiber modified by Ganatra is formed from the same polymer as claimed and having a range of molecular weights that overlaps claimed range of molecular weights, and where the prior art fiber has a range of tensile strength, Young’s modulus, and elongation to break that overlap with claimed ranges tensile strength, Young’s modulus, and elongation to break; and it would have been reasonable to
expect prior art fiber to have the same properties as claimed fiber when placed under identical conditions because a composition and its properties are inseparable.
Regarding claim 36, it would have been obvious to have formed the fibers in Porbeni with neat polybutylene succinate without additives because Porbeni exemplifies webs formed from neat polylactic acid (paragraphs 0297-0309), and according to Porbeni polylactic acid and polybutylene succinate are equally suitable thermoplastic polyesters for making the nonwoven webs. The resulting web would have only contained polybutylene succinate, which meets the claimed limitations.
Porbeni’s polymeric composition, which is used to form the fibers, contains polybutylene succinate in a range of molecular weights of 10,000-300,000 Da, which is the same polymer as claimed and overlaps with the claimed range of molecular weights. It would have been reasonable to expect Porbeni’s polymeric composition to have a range of melt temperatures that overlaps with the claimed range of melt temperatures because Porbeni’s and claimed compositions contain the same polymer in a range of molecular weights that overlaps. The Office does not have the means to test properties of prior art products to show that they overlap with the claimed properties. Since Porbeni’s polymeric composition meets all of the structural requirements of the claimed polymeric composition, it would have been reasonable to expect them to have the same properties when tested under the same conditions because a chemical composition and its properties are inseparable.
Regarding claim 38, it would have been obvious to have formed the polymeric composition from a copolymer of 1,4-butanediol, succinic acid, ethylene glycol, and adipic acid, with a reasonable expectation of success because Porbeni teaches that the aliphatic polyesters are polybutylene succinate, polyethylene adipate, among others, and copolymers thereof (paragraph
0113). The skilled artisan would have recognized that in order to form a copolymer of polybutylene succinate and polyethylene adipate the copolymer would have to be formed from 1,4-butanediol, succinic acid, ethylene glycol, and adipic acid.
Regarding claims 39 and 40, it would have been obvious to have modified the polymeric composition by including maleic acid, with a reasonable expectation of success because Porbeni teaches forming the aliphatic polyester from one or more diacids such as succinic acid and maleic acid, and one or more diols such as 1,4-butanediol (paragraph 0117).
Regarding claim 41, it would have been obvious to have modified the polymeric composition by including a lactic acid unit in the copolymer, with a reasonable expectation of success because Porbeni teaches copolymers, block or random, of polylactic acid with other aliphatic polyesters may be used. Porbeni further teaches additional co-monomers such as 2- hydroxybutyric acid (paragraph 0123). Therefore, it would have been obvious to have modified the polybutylene succinate by including additional repeating units derived from lactic acid and co-monomers such as 2-hydroxybutyric acid.
Regarding claims 44 and 53, Porbeni does not teach the presence of tin in the polymeric composition, and it would have been reasonable to expect that Porbeni’s polymeric composition does not comprise tin.
Regarding claim 52, Porbeni’s polymeric composition, which is used to form the fibers, contains polybutylene succinate in a range of molecular weights of 10,000-300,000 Da, which is the same polymer as claimed and overlaps with the claimed range of molecular weights. It would have been reasonable to expect Porbeni’s polymeric composition to be transparent because Porbeni’s and claimed compositions contain the same polymer in a range of molecular weights that overlaps. The Office does not have the means to test properties of prior art products to show
that they are the same as claimed properties. Since Porbeni’s polymeric composition meets all of the structural requirements of the claimed polymeric composition, it would have been reasonable to expect them to have the same properties when tested under the same conditions because a chemical composition and its properties are inseparable.
Regarding claim 55, Porbeni does not teach the presence of metals in the polymeric composition, and it would have been reasonable to expect that Porbeni’s polymeric composition does not comprise any metals. The Office does not have the means to test Porbeni’s compositions to determine if they contain metals according to claim 55. Since Porbeni does not teach metal in the compositions, it would have been reasonable to expect that the compositions do not contain any metal.
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Porbeni and Ganatra as applied to claims 30-32, 34, 36-41, 44, 50, and 52-55 above, and further in view of Aoshima (US 2009/0171037 Al Published July 2, 2009).
The claim further defines the monofilament fiber of claim 30. While Porbeni teaches copolymers of one or more dicarboxylic acid and one or more diols, Porbeni does not specifically teach malic acid as a suitable diacid for making the aliphatic polyesters.
The teachings of Aoshima are related to polyesters (Abstract), where the polyesters may be molded to make surgical yarns (paragraphs 0243 and 0245). The polyesters are formed from a diacid such as succinic acid and a diol such as 1,4-butanediol (paragraph 0100). The polyesters comprise an additional third component, which is at least one polyfunctional compound selected from bi-, tri-, or higher functional oxycarboxylic acids. The tri- or higher functional oxycarboxylic acids are preferred because they facilitate preparation of polyesters having a
higher degree of polymerization without the using a chain extender (paragraph 0104). Examples of tri- or higher functional oxycarboxylic acids include malic acid, tartaric acid, and citric acid (paragraph 0110).
The teachings of Aoshima, and Porbeni modified by Ganatra are related to polymeric compositions intended to make fibers intended for surgical applications, and it would have been obvious to have combined their teachings because they are in the same field of endeavor. It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the polybutylene succinate polyester of Porbeni by including a repeating unit selected from malic acid, citric acid, and tartaric acid, with a reasonable expectation of success because it was known from Aoshima that repeating units derived from malic acid, citric acid, and tartaric acid may be incorporated into polyesters formed from succinic acid and 1,4-butanediol and used to make surgical yarns. One of skill in the art would have been motivated to modify Porbeni’s polymer Aoshima’s multifunctional oxycarboxylic acids because Aoshima teaches that tri- or higher functional oxycarboxylic acids are preferably used to facilitate the production of a polyester having a high degree of polymerization without using a chain extender. Combining prior art elements according to known methods to obtain predictable results supports obviousness.
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Porbeni and Ganatra as applied to claims 30-32, 34, 36-41, 44, 50, and 52-55 above, and further in view of Martin (US 2017/0014552 Al Published January 19, 2017).
Claim 43 further defines the polymeric composition of claim 30.
The teachings of Porbeni and Ganatra are relied upon as summarized above. They do not teach whether or not the polymeric composition is isotopically enriched.
The teachings of Martin are related to compositions and devices of poly-4- hydroxybutyrate and implants comprising said polymers (Abstract). Implants include monofilament meshes (paragraph 0078). The polymer compositions contain carbon, hydrogen, and oxygen in their natural isotopic ratios or are enriched for one or more isotopes of carbon, hydrogen, and oxygen (paragraphs 0021, 0025, 0043, 0045, and 0051).
The teachings of Martin and Porbeni modified by Ganatra are related to polyesters intended for making monofilament meshes, and it would have been obvious to have combined their teachings because they are in the same field of endeavor. It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have formed Porbeni’s polymeric composition as an isotopically enriched composition, with a reasonable expectation of success because it was known from Martin that polyesters intended for making monofilament meshes may be in the form of an isotopically enriched polymeric composition or may be in the form of a polymeric composition having a natural isotopic ratio of carbon, oxygen, and hydrogen. Combining prior art elements according to known methods to obtain predictable results supports obviousness.
Maintained Double Patenting Rejections
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 30-32, 34, 36-42, 44, 50, and 52-55 are rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1, 6, 7, 10-12, 14, 15, and 20-27 a of US Patent No: 11,878,087 (of record in PTO-892 dated 05/15/2024) and Porbeni.
Patented claims require an implant comprising fibers of a polymer composition, wherein the polymeric composition comprises one or more 1,4-butanediol units and one or more succinic acid units, wherein the fibers comprise a monofilament fiber having a tensile strength of 400- 2000 MPa and elongation to break between 15% and 50%.
Patented claims do not specifically teach polybutylene succinate and the molecular weight range of the polybutylene succinate.
The teachings of Porbeni are relied upon as summarized above and it would have been obvious to combined Porbeni’s teachings with patented claims because they are in the same field of endeavor.
Regarding claims 30-32, 50, and 54, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have formed the monofilament fiber in patented claims using polybutylene succinate having a molecular weight in the range of 10,000-300,000, with a reasonable expectation of success because it was known from Porbeni that aliphatic polyesters such as polybutylene succinate are a suitable polyester for making monofilament fibers intended for implants, where the polyesters have a range of molecular weights from 10,000 to 300,000 Da. The claimed ranges of molecular weights are obvious because they overlap with 10,000-300,000 Da. It is apparent from patented claims 24-27, that fibers are made by drawing, which is known to produce oriented polymers. Patented claim 14 excludes urethane bonds and is not prepared using a diisocyante. Therefore, patented monofilament fibers are formed from an oriented polymeric composition. The claimed range of tensile strength, elongation to break, and Young’s modulus are obvious over the ranges in patented claims 1, 22, and 23.
Instant claim 34 describes fiber properties under in vivo conditions. Patented fiber is structurally same as instantly claimed fiber and would have had the same properties had it been tested under identical conditions, because a composition and its properties are inseparable.
Regarding claim 36, it would have been obvious to have formed the polymeric composition from polymers that are not a blend of two or more polymers because patented claims do not require a blend, and therefore encompass embodiments of polymer compositions that contain a single type of polymer such as polybutylene succinate.
Instant claim 37 is obvious over patented claim 15.
Instant claim 38 is obvious over patented claim 12.
Instant claim 39 is obvious over patented claim 11.
Instant claim 40 is obvious over patented claim 11.
Instant claim 41 is obvious over patented claim 10.
Instant claim 42 is obvious over patented claim 12.
Instant claim 44 is obvious over patented claim 14.
Instant claims 53 and 55 are obvious over patented claim 14.
Regarding new claim 52, patented fibers are made from the same polymeric composition as presently claimed and it would have been reasonable to expect patented polymeric composition to have the same properties as presently claimed including being transparent.
Claim 43 is rejected on the grounds of nonstatutory double patenting as being unpatentable over US Patent No: 11,878,087 and Porbeni as applied to claims 30-32, 34, 36-42, 44, 50, and 52-55 and further in view Martin.
The teachings of Martin are relied upon as summarized above.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have formed patented polymeric composition as an isotopically enriched composition, with a reasonable expectation of success because it was known from Martin that polyesters intended for making monofilament meshes may be in the form of an isotopically enriched polymeric composition or may be in the form of a polymeric composition having a natural isotopic ratio of carbon, oxygen, and hydrogen. Combining prior art elements according to known methods to obtain predictable results supports obviousness.
Claims 30-32, 34, 36-44, 50, and 52-55 are rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-10 a of US Patent No: 10,994,057 and Porbeni, Ganatra, Aoshima, and Martin.
The teachings of patented claims, Porbeni, Ganatra, Aoshima and Martin are related to polymeric compositions intended for making monofilament fibers for surgical implants and it would have been obvious to have combined them because they are in the same field of endeavor.
Regarding claims 30, 50, and 54, it would have been prima facie obvious to a person skilled in the art to have fiber of patented claims using a polymeric composition of polybutylene succinate, with a reasonable expectation of success because it was known from Porbeni that polybutylene succinate is a suitable polyester for making monofilament fibers intended for implantable meshes. The claimed ranges of molecular weights are obvious because they overlap with the range in patented claim 2. The limitation that requires exclusion of urethan bonds and diisocyanate is obvious patented claims do not require these elements in the composition. The claimed tensile strength is obvious because it overlaps with the patented tensile strength range. It is apparent from patented claim 7 that the fibers are formed by drawing the composition into fibers, which is known to result in oriented polymer fibers. Additionally, Porbeni teaches oriented polymer fibers. It would have been obvious to have formed the patented fibers having an elongation to break as taught by Ganatra, with a reasonable expectation of success because Ganatra teaches suitable ranges of elongation to break for fibers intended for making implantable devices. The claimed range is obvious over Ganatra’s range of between 15% and 120%.
Claimed Young’s modulus in claims 31 and 32 are obvious over patented claim 10.
Claims 34 and 52 describe fiber properties and polymeric composition properties, and it would have been reasonable to expect the fiber in patented claims and the polymeric composition
in the patented claims to have the same properties as instantly claimed because a composition and its properties are inseparable.
Regarding claim 36, patented claims do not require blends of polymers, therefore it would have been reasonable to interpret the claims are encompassing embodiments that comprise one type of polymer.
Regarding claim 37, the melting temperature is obvious over patented claim 7 which teaches heating the polymer to a temperature of 150-250°C in order to draw the polymer into fiber. The skilled artisan would have understood that the polymer composition would have be melted in order to be drawn into a fiber.
Regarding claims 38-41, it would have been obvious to have modified the patented claims in view of Porbeni to arrive at the instantly claimed limitations for the same reasons as described above in the obviousness rejections.
Regarding claim 42, it would have been obvious to have modified the patented claims in view of Aoshima to arrive at the instantly claimed limitations for the same reasons as described above in the obviousness rejections.
Regarding claim 43, it would have been obvious to have modified the patented claims in view of Martin to arrive at the instantly claimed limitations for the same reasons as described above in the obviousness rejections.
Regarding claims 44, 53, and 55, patented claims do not teach the presence of tin in the polymeric composition and it would have been reasonable to expect the composition to not include tin or any other metal as required by claim 55.
Claims 30-32, 34, 36-44, 50, and 52-55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, and 20 copending Application No. 17/006,705, Porbeni, Ganatra, Aoshima, and Martin.
The copending claims, Porbeni, Ganatra, Aoshima, and Martin are related to mesh implants formed form fibers and it would have been obvious to have combined their teachings because they are in the same field of endeavor.
It would have been obvious to a person skilled in art before the effective filing date of the claimed invention to have modified the patented oriented monofilament fiber in view of Porbeni, Ganatra, Aoshima, and Martin in order to arrive at the instantly claimed invention, for the same reasons as described in detail above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 30-32, 34, 36-44, 50, and 52-55 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-5 of Application No. 17/006,710, Porbeni, Ganatra, Aoshima, and Martin.
The copending claims, Porbeni, Ganatra, Aoshima, and Martin are related to mesh implants formed form fibers and it would have been obvious to have combined their teachings because they are in the same field of endeavor.
It would have been obvious to a person skilled in art before the effective filing date of the claimed invention to have modified the patented oriented monofilament fiber in view of Porbeni, Ganatra, Aoshima, and Martin in order to arrive at the instantly claimed invention, for the same reasons as described in detail above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Double patenting rejections are maintained because the applicant did not traverse the rejections nor filed a terminal disclaimer. Applicant plans to address double patenting rejections when present claims are otherwise found allowable.
Response to Arguments
Applicant’s arguments submitted in the remarks dated November 24, 2025 were fully considered but are not persuasive for the following reasons.
Porbeni teaches a surgical mesh made from polybutylene succinate, therefore there would have been a reasonable expectation of success in forming a surgical mesh from polybutylene succinate. A person skilled in the art would have understood that in order to make a surgical mesh that is actually useful for its intended purpose, the surgical mesh would be required to have properties that fall within certain parameters. Porbeni does not teach properties suitable or required in a surgical mesh. A person skilled in the art would have been motivated to look to a secondary reference for properties that are suitable or required in a surgical mesh, such as Ganatra. In order for a surgical mesh to be useful, regardless of the material from which it is formed, the mesh is required to have properties that make it suitable for its intended purpose. Thus, while Ganatra teaches a surgical mesh made from a linear aliphatic thermoplastic polyester different from Porbeni’s linear aliphatic thermoplastic polyester, its teachings are still relevant to Porbeni because surgical mesh properties taught by Ganatra are known to be suitable for a surgical mesh and therefore would have been useful and suitable for making Porbeni’s surgical mesh. A person skilled in the art would have been capable of forming Porbeni’s mesh having properties taught by Ganatra by varying polymer molecular weight, polymer composition, and processing conditions, through routine experimentation. The specification was reviewed and there is no evidence of criticality or unexpected results. The applicant did not present any evidence that the claimed ranges of properties are critical or unexpected in view of the prior art. Porbeni teaches forming the mesh from poly(butylene succinate) which is structurally identical to the claimed poly(butylene succinate), in a range of molecular weights that substantially overlaps with the claimed range, 10,000-300,000 Da compared to 50,000-300,000 Da. There is no evidence on the record that properties described by Ganatra are only achievable in fibers and meshes formed from poly(4-hydroxybutyrate). There is also no evidence on the record that properties described by Ganatra cannot be achieved in fibers and meshes made from other materials, such as poly(butylene succinate).
Poly(4-hydroxybutyrate) and poly(butylene succinate) are structurally similar as shown below
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132
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83
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.
Both polymers are linear aliphatic thermoplastic polyesters having C2-C4 linear alkylene chains; and considering this structural similarity there would have been a reasoanble expecation of success in forming fibers and sugrical meshes from PBS having properties of fibers and surgical meshes obtianed from P4HB as described by Ganatra. In order for Porberni’s mesh to function for its intended purpose, the mesh is required to have properties that render it suitable for its intended use and the skilled artisan would have been motivated to look to Ganatra for said properties because Ganatra teaches properties of a surgical mesh made from a structually similar linear thermoplastic polyester.
It would have been obvious to the skilled artisan to combine the teachings of Ganatra and Porbeni because their teachings are related to surgical meshes formed from linear aliphatic thermoplastic polyesters. The Office does not have the means to create and test prior art products to determine whether they have the same properties as claimed products. Surgical meshes made from poly(butylene succinate) were known in the art and properties of surgical meshes were known in the art. It would have been obvious to make a surgical mesh from poly(butylene succinate) having properties known to be suitable for a surgical mesh, absent evidence to the contrary.
Arguments against rejections of claims 42 and 43 are not persuasive because Porbeni and Ganatra are not deficient for reasons described above.
Conclusion
No claims are allowed.
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 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.
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/ALMA PIPIC/
Primary Examiner, Art Unit 1617