-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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on October 22, 2025 has been entered.
Priority
This application claims benefit in provisional application 62/893,565 filed on 08/29/2019.
This application is a CIP 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 1, 4-16, and 18-20 are pending. Claims 2, 3, and 17 were canceled. Claim 1 was amended. Claims 12-16 are withdrawn. Claims 1, 4-11, and 18-20 are examined.
Withdrawn Claim Rejections – 35 USC § 103
Rejections of claims 1, 4-11, and 18 over Peniston et al. (US 2013/0267972; Published Oct. 10, 2013 - of record in PTO-892 dated 03/06/2024), Aoshima et al. (US 2009/0171037; Published Jul. 2, 2009 - of record in PTO-892 dated 03/06/2024), and Martin et al. (US 2015/0126615; Pub. Date: May 7, 2015- of record in PTO-892 dated 07/08/2024) as evidenced by Koyfman et al. (2017/0239383; Pub. Date: Aug. 24, 2017 – of record in PTO-892 dated 03/06/2024) are withdrawn because claim 1 was amended to require the limitations of claim 17, which are not obvious over the cited references.
Claim Rejections – 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4-11, and 18-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The written description rejection is made in view of applicant’s arguments against the obviousness rejection. The applicant continues to argue that there would not have been a reasonable expectation of success in achieving the properties of fibers and meshes made from P4HB as disclosed by Ganatra in Porbeni’s fibers and meshes made from PBS because P4HB and PBS are structurally different polymers. Instant specification provides one example of a specific polyester derived from 1,4-butanediol, succinic acid, and malic acid, which is structurally different from poly(butylene succinate) in that it also contains repeating units derived from malic acid, and the exemplified polyester is encompassed by the genus of copolymers of poly(butylene succinate). The exemplified polyester and fibers and meshes made from said fibers do not provide adequate written description for the claimed invention as described below.
Claim 1 encompasses an implant comprising oriented monofilament fibers or oriented multifilament fibers wherein the fibers comprise an oriented polymeric composition comprising poly(butylene succinate) and/or copolymers thereof, and wherein the fiber is characterized by a knot pull tensile strength of 200-1000 MPa and wherein the implant comprises a mesh, the mesh is completely resorbable, and the polymeric composition excludes urethane bonds and is not prepared with a diisocyanate. Claim 5 further defines the fiber by one or more properties including a range of tensile strengths, a range of Young’s Moduli, and a range of elongations to break. Claim 18 further defines the implant by a range of suture pullout strengths. The specification provides insufficient written description for the implant encompassed by the claims.
The specification discloses an example of a succinic acid-1,4-butanediol-malic acid copolyester, fibers made from the copolyester having a knot pull tensile strength of 511, 512, 369, and 353 MPa, having tensile strength of 722, 833, and 725 MPa, having a Young’s Modulus of 2.09, 2.19, 1.88, and 2.14 GPa, and having an elongation to break of 19.5%, 24.0,%, 27.5%, and 27.1% (Table 18), and meshes formed from the copolyester. The exemplified fibers have a specific diameter and the fibers were made from a specific copolyester having a specific molecular weight and melting point. The claims do not limit the fiber by diameter, the polymers are not limited by molecular weight and melting point, nor by concentration in the fiber. Table 20 teaches properties of monofilament meshes prepared from monofilament fibers of different diameters where suture pullout strengths include 3.68, 2.08, 1.424, 4.496, 1.41, and 1.118 kfg.
The specification does not provide sufficient written description for the claimed fibers which are described as being formed from a polymeric composition comprising poly(butylene succinate) and/or copolymers thereof. The claimed fibers comprise an undefined amount of the polymeric composition and the polymeric composition comprises an undefined amount of poly(butylene succinate) and/or copolymers thereof. The copolymer of poly(butylene succinate) is not limited in any way other than that the polymeric composition excludes urethane bonds and is not prepared with a diisocyanate. The scope of copolymer is broad and includes crosslinked, not crosslinked, linear, branched, cyclic, graft, star, dendrimer, random, block, gradient, etc. types of polymers. The units copolymerized with poly(butylene succinate) are only limited to the extent that they do not comprise urethane bonds and are not prepared with a diisocyanate; which includes virtually any compound that can be copolymerized with 1,4-butanediol and succinic acid to form a copolymer of poly(butylene succinate). The polymeric composition is also not limited in any way other than that it requires the presence of an undefined amount of the poly(butylene succinate) and/or copolymers thereof, and excludes urethane bonds and is not prepared with diisocyanate. The polymeric composition and the fibers are open to containing anything in any amount. It is noted that the mesh is not required to be formed from the claimed fibers, thus the limitation that requires the mesh to be completely resorbable does not affect the scope of the polymeric composition and the fibers.
The specification does not provide adequate written description for fibers made from a polymeric composition comprising poly(butylene succinate). The exemplified polymer contains repeating units derived from butanediol, succinic acid, and malic acid, however the specification does not teach a correlation between functional properties and the polymer structure and it is unknown if having only repeating units derived only from butanediol and succinic acid is sufficient to provide the required properties to the fiber and the mesh.
The specification does not provide a correlation between structure and function and the skilled artisan would not have been capable of recognizing or understanding the structure of the polymeric composition, the copolymers of poly(butylene succinate), the fiber, and the implant from mere recitation of functional properties of these components. The disclosure of function alone is a little more than a wish for possession.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing characteristics of the genus. The factors to be considered include disclosure of structures, formulas, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus.
The MPEP states that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not define what constitutes a sufficient number of representative species, the Courts have indicated what does not constitute a representative number of species to adequately describe a broad generic. In
Gostelli, the Court determined that the disclosure of two chemical compounds within a subgenus
did not describe that subgenus. In re Gostelli, 872 F.2d at 1012, 10 USPQ2d at 1618. In the current case, providing one example of a specific polymer, and fibers and meshes formed from said polymer is not a sufficient number of species to provide adequate written description for the claimed genus.
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 1, 4-11, and 18-20 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.
Claim 1 was amended by deleting “and” between third and fourth “wherein” clauses and adding a fifth “wherein” clause. The claim is indefinite because it does not recite a conjunction between the last two “wherein” and it is unknown if all five are required or alternatives. For the purpose of applying prior art, the claim is interpreted as requiring all five “wherein” because this interpretation is consistent with applicant’s statement that applicant intended to move the limitations of claim 17 into claim 1 to further limit claim 1. Appropriate correction is required.
Claims 4-11 and 18-20 are indefinite because the claims depend from an indefinite base claim and do not resolve the indefiniteness issue of claim 1.
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.
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 1, 4-11, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over
Porbeni (US 2012/0315225 Al Published December 13, 2012), Ganatra (US 2016/0166727 Al
Published June 16, 2016), and Martin (US 2015/0126615 Al Published May 7, 2015).
The claims encompass an implant comprising an oriented monofilament fiber, wherein
the fiber comprises an oriented polymeric composition comprising poly(butylene succinate)
and/or copolymers thereof, and wherein the fiber has a knot pull tensile strength of 200 MPa to
1000 MPa, and wherein the polymeric composition has an endotoxin content of <2.5 EU/g,
wherein the implant comprises a mesh, wherein the mesh is completely resorbable, wherein the polymeric composition excludes urethane bonds and is not prepared with a diisocyanate.
The teachings of Porbeni are related dimensionally stable nonwoven fibrous webs include
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 (paragraph 0009). Preferred antishrinkage thermoplastic semicrystalline polymers
include polypropylene, nylon 6, nylon 66, polycaprolactone, and polyethylene oxides (paragraph
0012). In some embodiments, the fibers exhibit a median fiber diameter of no greater than about
25 um, and more preferably no greater than 12 um and even more preferably no greater than 10
um. In certain of these embodiments, the fibers exhibit a median fiber diameter of at least 1 um.
In additional exemplary embodiments, the web is biocompatible (paragraph 0013). 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). Commercially available aliphatic polyesters include poly(butylene succinate) (paragraph 0119). The dimensionally stable nonwoven fibrous webs are useful for making medical devices,
in whole or in part, including surgical mesh (paragraph 0289).
Preparatory example 1 (paragraphs 0297-0299), preparatory example 2 (paragraphs 0300-
0302), and preparatory example 3 (paragraphs 0303-0309) teach methods of making nonwoven
webs using the spunbond process from neat poly(lactic acid) and from mixtures of PLA and
polypropylene and other additives.
Porbeni does not teach a knot pull tensile strength of the fiber and an endotoxin content
of the polymeric composition.
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). Table 1 in paragraph 0073 knot pull tensile strength of fibers having various diameters expressed in mm, where average minimum knot pull tensile strength ranges from 0.025 to 7.29 kgf. 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 Martin are related to highly pure poly-4-hydroxybutyratc compositions
suitable for preparing implants for soft and hard tissue repair (Abstract). Implants made using
high purity P4HB polymer have substantially improved properties for many medical
applications. In particular, these implants have low levels of organic impurities, inorganic
impurities, and residual solvents that can react with the body upon implantation. The low levels
of these impurities will reduce or minimize undesirable reactions such as inflammation,
cytotoxicity, irritation, pyrogenicity, subchronic and chronic toxicity. Devices made from or
including high purity P4HB may be prepared with endotoxin contents of less than 20 endotoxin
units per device (paragraph 0077). The endotoxin content of the purified P4HB polymer was
0.22 endotoxin units (EU)/g which is low enough to allow the manufacture of implants using
P4HB with an endotoxin content of less than 20 endotoxin units per device (paragraph 0082).
The teachings of Porbeni, Ganatra, and Martin 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 claim 1, 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 a surgical mesh
comprising 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 aliphatic polyester copolymers derived from 1,4-butanediol and succinic acid, and teaches that poly(butylene succinate) is a commercially available aliphatic polyester, and wherein the web is used to form a surgical mesh. It would have been obvious to have formed the polymeric composition from neat poly(butylene succinate) because Porbeni exemplifies nonwoven webs formed from neat polylactic acid, and according to Porbeni polylactic acid and polybutylene succinate are equally suitable thermoplastic polyesters for making the nonwoven webs (paragraphs 0113-0120).
Replacing one equivalent with another to obtain predictable results supports obviousness. Poly(butylene succinate) does not include urethan bonds and is not prepared with a diisocyanate.
It would have been obvious to have formed the fibers as oriented monofilament fibers because Porbeni teaches oriented monofilament fibers. Porbeni's nonwoven web made from neat
polybutylene succinate meets the limitation of a mesh that is completely resorbable.
It would have been obvious to have formed Porbeni's surgical mesh as a monofilament
mesh because it is apparent from the teachings of Porbeni that the fibers are monofilament fibers.
Additionally, it would have been obvious to have formed Porbeni's surgical mesh as a
monofilament mesh because Ganatra teaches a surgical mesh in the form of a monofilament
mesh.
Porbeni does not teach mechanical properties of the fibers and the surgical mesh.
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 in order to render the mesh suitable for its intended use. It would have been obvious to have formed the fiber having a minimum knot pull tensile strength of 0.25 kgf, with a reasonable expectation of success because Ganatra teaches that monofilament fibers have a minimum knot pull tensile strength of 0.25 kgf and teaches a minimum average knot pull tensile strength for fibers having various diameters in the range of 0.025 to 7.29. Since the fiber diameters are expressed in mm, it would have been reasonable to interpret the knot pull tensile strength to be in units of kgf/mm2. A tensile strength range of at least 0.25 kgf/mm2 is equivalent a range of at least 2.45 MPa. Similarly, the minimum average values of 0.025 to 7.29 kgf/mm2 in Table 1 are equivalent to minimum average values of 0.245 MPa to 71.44 MPa. The claimed range of 200 MPa to 1000 MPa is obvious because it overlaps with the range of at least 2.45 MPa and minimum values disclosed in Table 1.
It would have been obvious to have formed the surgical mesh to have less than 20
endotoxin units, with a reasonable expectation of success because Ganatra teaches that an
implant such as a surgical mesh should have less than 20 endotoxin units. Ganatra does not
endotoxin units per gram. It would have been obvious to have formed the polymeric composition
of the fiber to comprise 0.22 EU/g, with a reasonable expectation of success because it was
known from Martin that the endotoxin content of a purified polymeric composition of 0.22
endotoxin units (EU)/g is low enough to allow the manufacture of implants using the polymeric
composition with an endotoxin content of less than 20 endotoxin units per device. The claimed
range of endotoxin units per gram is obvious because it encompasses 0.22 EU/G.
Regarding claim 4, the combination of references teaches a monofilament mesh.
Regarding claim 5, 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 in order to render the mesh suitable for its intended use. 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 clongation 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.
Claims 6-11 are product by process claims. Prior art fiber could have been formed by
claimed method steps, absent evidence to the contrary. See MPEP 2113.
Regarding claim 18, it would have been obvious to have formed the surgical mesh of
Porbeni to have a suture pullout strength of at least 1 Kgf or greater than 10 N, with a reasonable expectation of success because Ganatra teaches a surgical mesh having a suture pullout strength of at least 1 Kcf (paragraph 0158), which is equivalent to 9.8 N, and Ganatra teaches a suture pullout strength of mesh products of at least 10 N (paragraph 0154). The claimed range is obvious because it encompasses at least 9.8 N and at least 10 N.
A person skilled in the art would have been motivated to make Porbeni's monofilament
mesh having mechanical properties as suggested by Ganatra because Ganatra teaches said
mechanical properties as suitable for a monofilament mesh. A person skilled in the art would
have been capable of determining conditions for forming the oriented monofilament fiber where
the conditions result in a fiber having mechanical properties that fall in the ranges described by
Ganatra. Present application was reviewed and there is no evidence that claimed ranges are
critical.
Regarding claim 19, Porbeni teaches forming a nonwoven web from neat thermoplastic
polyesters, which renders the claimed concentration range obvious because the entire mesh is
formed from thermoplastic polyester polybutylene succinate. It would have been obvious to have
formed the nonwoven web from neat polybutylene succinate because Porbeni exemplifies
nonwoven webs made from neat polylactic acid and it would have been obvious to have replaced
polylactic acid with polybutylene succinate because the two are known as equally suitable
thermoplastic polyesters for making nonwoven webs intended for use as surgical implants.
Regarding claim 20, Porbeni teaches that at least portions of the molecules within the
fibers are oriented into alignment with the longitudinal axis of the fibers (paragraph 0054), which renders the claimed limitation obvious because at least portions includes a range that extends
from some fibers to all fibers being oriented into alignment.
Combining prior art elements according to known methods to obtain predictable results
supports obviousness and the selection of a known material suitable for its intended purpose
supports obviousness.
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 cTerminal Disclaimer may be filled out completely
online using web-screens. An eTerminal Disclaimer that meets all requirements is autoprocessed and approved immediately upon submission. For more information about eTerminal
Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/elerminal-disclamer.
Claims 1, 4-11, and 18-20 are rejected in midwifed form and claim 17 is newly rejected
on the grounds of nonstatutory double patenting as being unpatentable over claims 1-30 of US
Patent No: 11,878,087 (of record in PTO-892 dated 03/06/2024) and further in view of Ganatra
and Martin.
The teachings of Ganatra and Martin are relied upon as summarized above.
Patented claims, Ganatra, and Martin are related to a surgical mesh and it would have
been obvious to have combined their teachings because they are in the same field of endeavor.
Regarding claim 1, it would have been obvious to have formed an implant comprising
monofilament fiber mesh comprising fibers, wherein the fiber comprises a polymeric
composition comprising copolymers of polybutylene succinate, with a reasonable expectation of
success because patented claim 1 teaches an implant comprising fibers comprising a polymeric
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, wherein the
implant comprises a mesh and patented claim 4 teaches that fibers are oriented and patented
claim 12 teaches specific copolymers of polybutylene succinate. The fibers in patented claims
comprise the copolymers of polybutylene succinate, therefore oriented fibers would have
comprised an oriented polymeric composition of said copolymers. Patented claim 21 teaches a polymeric composition that excludes urethane bonds and is not prepared with a diisocyanate.
Patented claims do not teach a knot pull tensile strength of the fiber, and it would have
been obvious to have formed the fiber to have a knot pull tensile strength of at least 0.25 kgf
because Ganatra teaches a knot pull tensile strength of at least 0.25 kef in fibers intended for
making a monofilament mesh. The claimed range of a knot pull tensile strength is obvious
because it overlaps with at least 0.25 kgf, which is equivalent to at least 0.025 MPa. It would
have been obvious to have formed the claimed implant to contain less than 20 endotoxin units as determined by the limulus amebocyte lysate (LAL) assay, with a reasonable expectation of
success because patented claim 18 teaches said range of endotoxin units per implant. It would
have been obvious to have formed the polymeric composition to contain 0.22 EU/g, with a
reasonable expectation of success because Martin teaches that a polymeric composition having
0.22 EU/g is suitable for making an implant that contains less than 20 EU per implant. The
claimed range is obvious because it encompasses 0.22 EU/g.
Regarding claim 5, patented claim 23 teaches a range of each of elongation at break, a
tensile strength, and Young's modulus that overlaps presently claimed ranges, rendering claim 5
obvious.
Claims 6-11 are product by process claims and fiber in patented claims could have been
formed by presently claimed method steps. See MPEP 2113.
Regarding claim 18, patented claims do not teach a suture pullout strength. It would have
been obvious to have formed the surgical mesh of patented claims to have a suture pullout
strength of at least 1 Kgf, with a reasonable expectation of success because Ganatra teaches a
surgical mesh having a suture pullout strength of at least 1 Kgf, which is equivalent to 9.8 N.
Claimed range is obvious because it encompasses 9.8 N.
Regarding claim 19, the polymeric composition is described as comprising copolymers of
polybutylene succinate and combinations thereof in patented claim 12, which meets the claimed
concentration range obvious.
Regarding claim 20, patented claims teach oriented fibers and it would have been
reasonable to interpret this teaching to mean that all of the polymer chains are substantially
oriented.
Claims 1, 4-11, and 18-20 are rejected in midwifed form and claim 17 is newly rejected
on the grounds of nonstatutory double patenting as being unpatentable over claims 1-12 of US
Patent No: 10,994,057 (of record in PTO-892 dated 03/06/2024) and further in view of Ganatra
and Martin.
The teachings of Ganatra and Martin are relied upon as summarized above.
Patented claims, Ganatra, and Martin are related to a surgical mesh and it would have
been obvious to have combined their teachings because they are in the same field of endeavor.
Regarding claim 1, it would have been obvious to have formed an implant comprising
monofilament fiber mesh wherein the fiber comprises a polymeric composition comprising 1,4-
butanediol and succinic acid units, with a reasonable expectation of success because patented
claim 1 teaches an implant comprising fibers of a polymeric 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, and wherein the implant comprises a mesh. It
would have been obvious to have formed the fibers from a polymeric composition comprising
copolymers of butanediol and succinic acid because patented claims require the polymeric
composition to comprise units derived from said monomers but do not limit how the units are
arranged in the composition and both units would have been either in the same polymer chain or
in different polymer chains. An implant made from copolymers of butanediol and succinic acid
would have been completely resorbable. Patented claims do not teach the presence of urethane bonds and preparing the composition with a diisocyanate, therefore it would have been reasonable to expect the patented polymeric composition to exclude these elements.
Patented claims do not teach oriented fibers. It would have been obvious to have formed
the fiber in patented claims as oriented fiber with a reasonable expectation of success because
Ganatra teaches using oriented fibers to make a surgical mesh (page 18 claim 16). Since the
fibers are made from the polymeric composition, the polymer chains of the polymeric
composition would have been oriented.
Patented claims do not teach a knot pull tensile strength of the fiber, and it would have
been obvious to have formed the fiber to have a knot pull tensile strength of at least 0.25 kgf
because Ganatra teaches a knot pull tensile strength of at least 0.25 kgf in fibers intended for
making a monofilament mesh. The claimed range of a knot pull tensile strength is obvious
because it overlaps with at least 0.25 kgf, which is equivalent to at least 0.025 MPa.
It would have been obvious to have formed the polymeric composition to contain 0.22
EU/g, with a reasonable expectation of success because Martin teaches that a polymeric
composition having 0.22 EU/g is suitable for making an implant that contains less than 20 EU
per implant. The claimed range is obvious because it encompasses 0.22 EU/g.
Regarding claim 5, patented claim 1 teaches a range of a tensile strength that overlaps
presently claimed range, rendering claim 5 obvious.
Claims 6-11 are product by process claims and fiber in patented claims could have been
formed by presently claimed method steps. See MPEP 2113.
Regarding claim 18, patented claims do not teach a suture pullout strength. It would have
been obvious to have formed the surgical mesh of patented claims to have a suture pullout
strength of at least 1 Kgf, with a reasonable expectation of success because Ganatra teaches a
surgical mesh having a suture pullout strength of at least 1 Kgf, which is equivalent to 9.8 N.
Claimed range is obvious because it encompasses 9.8 N.
Regarding claim 19, patented claims require an implant comprising a polymeric
composition comprising butanediol and succinic acid units and monofilament fibers, and it is
apparent from claim 7 that the monofilament fibers are made from the polymeric composition,
therefore the patented implant includes embodiments where the entire implant is made from the
polymeric composition, which meets the claimed concentration range of greater than 99 wt. %.
Regarding claim 20, it would have been obvious to have formed the fibers having
substantially all polymer chains in the polymeric composition oriented because Ganatra teaches
forming oriented fibers which reads on fibers having substantially all oriented polymer chains.
Claims 1, 4-11, and 18-20 are rejected on the ground of nonstatutory double patenting as
being unpatentable over claims 1-16 of U.S. Patent No. 12,151,050 B2 in view of Ganatra and
Martin.
The teachings of Ganatra and Martin are relied upon as summarized above.
Patented claims, Ganatra, and Martin are related to a surgical mesh and it would have
been obvious to have combined their teachings because they are in the same field of endeavor.
Regarding claim 1, it would have been obvious to have formed an implant such as a
surgical mesh comprising a polymeric composition comprising 1,4-butanediol and succinic acid
units, with a reasonable expectation of success because patented claim 1 teaches an implant
comprising a polymeric composition comprises one or more 1,4-butanediol units and one or
more succinic acid units, and patented claim 9 teaches wherein the implant is a surgical mesh. It would have been obvious to have formed the fibers from a polymeric composition comprising
copolymers of butanediol and succinic acid because patented claims require the polymeric
composition to comprise units derived from said monomers but do not limit how the units are
arranged in the composition and both units would have been either in the same polymer chain or
in different polymer chains. An implant made from copolymers of butanediol and succinic acid
would have been completely resorbable. Patented claims do not teach the presence of urethane bonds and preparing the composition with a diisocyanate, and it would have been reasonable to expect the patented polymeric composition to exclude these components. Patented claims modified in view of Ganatra teach a monofilament mesh.
It would have been obvious to have formed the surgical mesh from an oriented
monofilament fiber because Ganatra teaches making a surgical mesh from an oriented
monofilament fiber (page 18 claims 14 and 16). Since the fibers are made from the polymeric
composition, the polymer chains of the polymeric composition would have been oriented.
Patented claims do not teach a knot pull tensile strength of the fiber, and it would have
been obvious to have formed the fiber to have a knot pull tensile strength of at least 0.25 kgf
because Ganatra teaches a knot pull tensile strength of at least 0.25 kgf in fibers intended for
making a monofilament mesh. The claimed range of a knot pull tensile strength is obvious
because it overlaps with at least 0.25 kgf, which is equivalent to at least 0.025 MPa.
It would have been obvious to have formed the polymeric composition to contain 0.22
EU/g, with a reasonable expectation of success because Martin teaches that a polymeric
composition having 0.22 EU/g is suitable for making an implant that contains less than 20 EU
per implant. The claimed range is obvious because it encompasses 0.22 EU/g.
Regarding claim 5, patented claim 5 teaches a range of a tensile strength that overlaps
presently claimed range, rendering claim 5 obvious.
Claims 6-11 are product by process claims and fiber in patented claims could have been
formed by presently claimed method steps. See MPEP 2113.
Regarding claim 18, patented claim 5 teaches a suture pullout strength of at least 5 N.
Regarding claim 19, patented claims require an implant comprising a polymeric
composition comprising butanediol and succinic acid units wherein the implant is a mesh,
therefore the patented implant includes embodiments where the entire implant is made from the
polymeric composition, which meets the claimed concentration range of greater than 99 wt. %.
Regarding claim 20, it would have been obvious to have formed the fibers having
substantially all polymer chains in the polymeric composition oriented because Ganatra teaches
forming oriented fibers which reads on fibers having substantially all oriented polymer chains.
Claims 1, 4-11, and 18-20 are rejected on the grounds of nonstatutory double patenting as
being unpatentable over claims 1-21 of Patent No. 11,786,632 (of record in IDS dated
03/04/2024) and further in view of Ganatra and Martin.
The teachings of Ganatra and Martin are relied upon as summarized above.
Patented claims, Ganatra, and Martin are related to a surgical mesh and it would have
been obvious to have combined their teachings because they are in the same field of endeavor.
Regarding claim 1, it would have been obvious to have formed an implant comprising
oriented monofilament fiber mesh wherein the fiber comprises a polymeric composition
comprising 1,4-butanediol and succinic acid units, with a reasonable expectation of success
because patented claim 1 teaches an implant comprising oriented monofilament fibers, wherein the polymeric composition comprises one or more 1,4-butanediol units and one or more succinic
acid units and claim 21 teaches that the mesh is free of fibers formed from polymers other than
poly(butylene succinate) or copolymers thereof, which meets the limitation that requires the
mesh to be completely resorbable. Patented claims do not require the polymeric composition to
comprise urethane bonds and preparing the composition with a diisocyanate and it would have
been reasonable to expect the polymeric composition in the patented claims to exclude these components.
Patented claims do not teach a knot pull tensile strength of the fiber, and it would have
been obvious to have formed the fiber to have a knot pull tensile strength of at least 0.25 kgf
because Ganatra teaches a knot pull tensile strength of at least 0.25 kgf in fibers intended for
making a monofilament mesh. The claimed range of a knot pull tensile strength is obvious
because it overlaps with at least 0.25 kgf, which is equivalent to at least 0.025 MPa.
It would have been obvious to have formed the polymeric composition to contain 0.22
EU/g, with a reasonable expectation of success because Martin teaches that a polymeric
composition having 0.22 EU/g is suitable for making an implant that contains less than 20 EU
per implant. The claimed range is obvious because it encompasses 0.22 EU/g.
Regarding claim 5, patented claim 8 teaches a range of each of elongation at break, a
tensile strength, and Young's modulus that overlaps presently claimed ranges, rendering claim 5
obvious.
Claims 6-11 are product by process claims and fiber in patented claims could have been
formed by presently claimed method steps. See MPEP 2113.
Regarding claim 18, patented claim 9 teaches a suture pullout strength of at least 1ON,
which renders the claimed range obvious because the ranges overlap.
Regarding claim 19, patented claim 21 renders the instantly claimed range obvious.
Regarding claim 20, it would have been obvious to have formed the fibers having
substantially all polymer chains in the polymeric composition oriented because Ganatra teaches
forming oriented fibers which reads on fibers having substantially all oriented polymer chains.
Claims 1, 4-11, and 18-20 are provisionally rejected on the grounds of nonstatutory
double patenting as being unpatentable over claims 23, 26, 27, 30, 31, 33-46 of Application No.
18/462,346 and further in view of Ganatra and Martin.
The teachings of Ganatra and Martin are relied upon as summarized above.
Copending claims, Ganatra, and Martin are related to a surgical a mesh and it would have
been obvious to have combined their teachings because they are in the same field of endeavor.
Regarding claim 1, it would have been obvious to have formed an implant comprising
monofilament fiber mesh wherein the fiber comprises a polymeric composition comprising 1,4-
butanediol and succinic acid units, with a reasonable expectation of success because copending
claim 23 teaches an implant comprising fibers formed from a polymeric 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, copending claim 23 teaches a mesh
comprising monofilament fibers formed from oriented polymer comprising polybutylene
succinate or copolymers thereof and copending and copending claim 31 teaches a resorbable
mesh comprising monofilament fibers formed from a polymer comprising polybutylene
succinate or copolymers thereof. The mesh of copending claims encompasses embodiments where fibers are made from a composition that only contains the polybutylene succinate or
copolymers thereof, which meets the limitations of instant claim 19 and the requirement that the
mesh is completely resorbable. At least copending claim 23 teaches that the oriented polymer excludes urethane bonds and is not prepared with a diisocyanate.
Copending claims do not teach a knot pull tensile strength of the fiber, and it would have
been obvious to have formed the fiber to have a knot pull tensile strength of at least 0.25 kgf
because Ganatra teaches a knot pull tensile strength of at least 0.25 kgf in fibers intended for
making a monofilament mesh. The claimed range of a knot pull tensile strength is obvious
because it overlaps with at least 0.25 kgf, which is equivalent to at least 0.025 MPa.
It would have been obvious to have formed the polymeric composition to contain 0.22
EU/g, with a reasonable expectation of success because Martin teaches that a polymeric
composition having 0.22 EU/g is suitable for making an implant that contains less than 20 EU
per implant. The claimed range is obvious because it encompasses 0.22 EU/g.
Regarding claim 5, copending claims do not teach elongation at break, a tensile strength,
and Young's modulus. It would have been obvious to have formed the mesh in copending claims
in which fibers have mechanical properties as described by Ganatra as described above, with a
reasonable expectation of success because Ganatra teaches mechanical properties of
monofilament fibers intended for making a surgical mesh. Claimed ranges are obvious because
they overlap with ranges taught by Ganatra.
Claims 6-11 are product by process claims and fiber in patented claims could have been
formed by presently claimed method steps. See MPEP 2113.
Regarding claim 18, copending claim 37 teaches a suture pullout strength of greater than or equal to 5N.
Regarding claim 20, the copending claims teach a fiber made from an oriented polymer
composition, which reads on substantially all polymer chains of the polymeric composition
within each fiber are oriented.
This is a provisional nonstatutory double patenting rejection because the patentably
indistinct claims have not in fact been patented.
Claims 1, 4-11, and 17-20 are provisionally rejected in modified form on the grounds of
nonstatutory double patenting as being unpatentable over claims 1-5, 8, and 23-27 of Application
No. 17/006,710 and further in view of Ganatra.
The teachings of Ganatra are relied upon as summarized above.
Copending claims and Ganatra are related to a surgical mesh and it would have been
obvious to have combined their teachings because they are in the same field of endeavor.
Regarding claim 1, it would have been obvious to have formed an implant comprising
monofilament fiber mesh wherein the fiber comprises a polymeric composition having an
endotoxin content of <2.5EU/g and comprises 1,4-butanediol and succinic acid units, with a
reasonable expectation of success because copending claim 1 teaches an implant comprising a polymeric composition having an endotoxin content of <2.5EU/g, wherein the polymeric
composition comprises 1,4-butanediol units and a diacid unit, copending claim 2 teaches succinic
acid units, and copending claim 5 teaches monofilament fibers. Copending claim 1 teaches a polymeric composition that excludes urethane bonds and is not prepared with a diisocyanate.
It would have been obvious to have formed the fibers from a polymeric composition
comprising copolymers of butanediol and succinic acid because patented claims require the
polymeric composition to comprise units derived from said monomers but do not limit how the
units are arranged in the composition and both units would have been either in the same polymer
chain or in different polymer chains. An implant made from copolymers of butanediol and
succinic acid would have been completely resorbable.
It would have been obvious to have formed the surgical mesh from an oriented
monofilament fiber because Ganatra teaches making a surgical mesh from an oriented
monofilament fiber (page 18 claims 14 and 16). Since the fibers are made from the polymeric
composition, the polymer chains of the polymeric composition would have been oriented.
Copending claims do not teach a knot pull tensile strength of the fiber, and it would have
been obvious to have formed the fiber to have a knot pull tensile strength of at least 0.25 kgf
because Ganatra teaches a knot pull tensile strength of at least 0.25 kgf in fibers intended for
making a monofilament mesh. The claimed range of a knot pull tensile strength is obvious
because it overlaps with at least 0.25 kgf, which is equivalent to at least 0.025 MPa.
Regarding claim 5, copending claim 5 teaches elongation at break, a tensile strength, and
Young's modulus that overlaps with presently claimed ranges, rendering claim 5 obvious.
Claims 6-11 are product by process claims and fiber in patented claims could have been
formed by presently claimed method steps. See MPEP 2113.
Regarding claim 18, copending claim 1 teaches a suture pullout strength of at least 0.5-20
kgf, which renders the claimed range obvious.
Regarding claim 19, the implant of copending claims encompass embodiments where the
implant is a mesh having oriented monofilament fibers where the fibers are made from a
polymeric composition of polybutylene succinate, which meets the instantly claimed range.
Regarding claim 20, copending implant modified in view of Gantra comprises oriented
fibers made from polybutylene succinate, which reads on substantially all polymer chains are
oriented. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments submitted in the remarks dated October 22, 2025 were fully considered but are not persuasive for the following reasons.
As an initial matter, the examiner acknowledges the error made in the conversion of knot pull strength expressed in kgf in Ganatra to MPa, in response to applicant’s footnote 3. The rejection has been modified to clarify that the units of the knot pull strength in Ganatra are interpreted as kgf/mm2 because in Table 1 the fiber diameters are expressed in mm next to the corresponding knot pull tensile strength in kgf and it would have been reasonable to interpret the units to be kgf/mm2.
Applicant’s statement that the Office’s position is that it would have been obvious to form a mesh using the fibers of Porbeni which comprise a resorbable thermoplastic polyester and a non-resorbable thermoplastic polymer is not correct because the Office action relies on an embodiment of a mesh formed only from the resorbable thermoplastic polyester.
Applicant’s statement that Ganatra fails to teach that knot pull strengths falling within in claimed range are required for a surgical mesh as the Office asserts, is not persuasive because the rejection does not state that properties taught by Ganatra are required. The rejection states that a surgical mesh is required to have properties that render it useful for its intended purpose. Since Porbeni does not teach properties of fibers and a surgical mesh made from the fibers, the skilled artisan would have been motivated to look to other references that teach fiber and mesh properties, such as Ganatra, to determine which properties are known in the art as suitable and useful in fibers and surgical meshes made form said fibers. Since Ganatra uses fibers to form a surgical mesh, the skilled artisan would have been motivated to make Porbeni’s fibers having properties such as a knot pull tensile strength as disclosed by Ganatra.
Porbeni teaches a surgical mesh made from an aliphatic thermoplastic polyester and teaches poly(butylene succinate) as a suitable polymer, therefore it would have been obvious to have made a surgical mesh from poly(butylene succinate). The skilled artisan would have recognized that a surgical mesh is required to have certain properties in order to function as a surgical mesh. It would not have been inventive to make said mesh to have properties that were known in the art as suitable properties for fibers and meshes. Ganatra’s mesh is formed from a linear aliphatic thermoplastic polyester P4HB and Porbeni’s mesh is formed from a linear aliphatic thermoplastic polyester PBS. While there are differences in their chemical structures, the teachings of Ganatra are still relevant to Porbeni because fiber properties and 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 fibers and surgical mesh. The skilled artisan would have been capable of making Porbeni’s fibers and mesh having properties taught by Ganatra through routine experimentation by varying polymer molecular weight, polymer composition, and processing conditions.
Instant application was reviewed and there is no evidence that any one of the claimed properties is critical or unexpected in view of the teachings of the prior art. There is no evidence on the record that Ganatra’s properties are unique and only achievable in fibers and meshes made from P4HB. Similarly, there is no evidence on the record that Ganatra’s properties cannot be achieved in fibers and meshes made from other materials such as PSB.
Double patenting rejections are maintained because applicant indicated that double patenting rejections will be addressed when one of the claims is otherwise found allowable.
Conclusion
No claims are allowed.
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/ALMA PIPIC/
Primary Examiner, Art Unit 1617