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 .
Status of Application, Amendments, And/Or Claims
The Applicants amendments/remarks received 2/12/2026 are acknowledged. Claims 1, 7, 9, 14-15 and 17-18 are amended; claims 2, 5, 8 are canceled; no claims are withdrawn; claims 24-25 are new; claims 1, 3-4, 6-7 and 9-25 are pending and have been examined on the merits.
Claim Objections
The objection to claims 2, 8-9, 15 and 18, as set forth at pp. 2-4 of the previous Office Action, is moot regarding claims 2 and 8 due to cancelation of the claims and is withdrawn regarding claims 9, 15 and 18 in view of the amendment of the claims.
Claim Rejections - 35 USC § 112
The rejection of claim 14 under 35 U.S.C. § 112(b), as set forth at p. 4 of the previous Office Action, is withdrawn in view of the amendment of the claims.
The rejection of claim 15 under 35 U.S.C. § 112(d), as set forth at pp. 4-5 of the previous Office Action, is withdrawn in view of the amendment of the claims.
Claim Rejections - 35 USC § 102
The rejection of claims 1-4, 6-9 and 12 under 35 U.S.C. 102(a)(1)/102(a)(2) over Wang et al., US 2018/0051132 (US Patent Application Publication cite 2, IDS, 5/5/2023; herein “Wang”) as set forth at pp. 5-7 of the previous Office Action, is moot regarding claims 2 and 8 due to cancelation of the claims and is withdrawn regarding claims 1, 3-4, 6-7, 9 and 12 in view of the amendment of the claims.
The rejection of claims 1-3, 5-9 and 12 under 35 U.S.C. 102(a)(1) over Gabriele et al., WO 2019/014349 (cite N, attached PTO-892; herein “Gabriele”) as set forth at pp. 7-8 of the previous Office Action, is moot regarding claims 2, 5 and 8 due to cancelation of the claims and is withdrawn regarding the remaining claims in view of the amendment of the claims.
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 13, 15-17 and 19-20 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Wang et al., US 2018/0051132 (US Patent Application Publication cite 2, IDS, 5/5/2023; herein “Wang”).
Wang discloses a poly(glycerol sebacate) (PGS) polymer comprising pendant aliphatic carboxylate groups wherein each pendant aliphatic carboxylate group is covalently bound to the glycerol group of the glycerol sebacate backbone of the polymer wherein the pendant aliphatic carboxylate group, i.e., R1, is a polyunsaturated omega - 6 fatty acid or a polyunsaturated omega - 3 fatty acid, which can be the C18 aliphatic carboxylate linoleic acid, wherein the polymer is at least partially crosslinked ([0089-108], [0115-118]).
Wang discloses a poly(glycerol sebacate) (PGS) polymer comprising pendant aliphatic carboxylate groups wherein each pendant aliphatic carboxylate group is covalently bound to the glycerol group of the glycerol sebacate backbone of the polymer wherein the pendant aliphatic carboxylate group, i.e., R1, is a polyunsaturated omega - 6 fatty acid or a polyunsaturated omega - 3 fatty acid, which can be the C18 aliphatic carboxylate linoleic acid, wherein the polymer comprises the structure of instant claims 2 and 8 wherein m = 0% and n = 100% (p. 10, claim 16).
Wang teaches that said polymer or polymeric material can be in the form of a fiber [0069] anticipating claim 13.
Wang teaches that said polymer or polymeric material can be in the form of a fiber [0069] wherein the one or more poly(glycerol sebacate)(s) and/or one or more polymer materials is/are at least partially crosslinked [0054] anticipating claim 15.
Wang teaches that said polymer or polymeric material can be in the form of a fiber [0069], and further discloses a material comprising a plurality of one or more of said fiber(s) in the form of a tissue graft which is a vascular graft [0064] anticipating claims 16 and 19-20.
Wang teaches that said fiber can be in the form of a fabric ([0061], [0069]) anticipating claim 17.
Response to Arguments
Applicant's arguments filed 2/12/2026 have been fully considered but they are not persuasive. Arguments of the Applicant’s Response on pp. 7-10 regarding the claim objections and rejections under 35 U.S.C. §§ 112(b), 112(d), 102(a)(1)/102(a)(2) over Gabrielle are moot as the rejections have been withdrawn.
The rejection of claims 1-4, 6-9 and 12 under 35 U.S.C. 102(a)(1)/102(a)(2) over Wang has been withdrawn in view of the claim amendments.
Regarding the rejection of claims 1-4, 6-9, 12-13, 15-17 and 19-20 under 35 U.S.C. 102(a)(1)/102(a)(2), Applicant argues (pp. 8-9) that “With respect to claims 3, 4, 6, 9, 12-13, 15-17, and 19-20, Applicant does not comment here on any specific rejection of these claims, where posited, and reserves the right to comment on the rejection if the Examiner provides a sustainable rejection of current claim 1 or 7.
Claims 3, 4, 6, 9, 12-13, 15-17, and 19-20 are dependent on claim 1 or 7. As claim 1 is not anticipated by the cited reference, it is axiomatic that claims dependent on claim 1 or 7 are not anticipated by the cited reference. Accordingly, claims 3, 4, 6, 9, 12-13, 15-17, and 19-20 are not anticipated by the cited reference for at least the same reason as claim 1 or 7.”
Claims 13, 15-17 and 19-20 do not depend from claim 1 or 7; hence, Applicant’s argument is moot and the rejection of claims 13, 15-17 and 19-20 under 35 U.S.C. 102(a)(1)/102(a)(2) over Wang is maintained at least for this reason.
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, 3-4, 6-7, 9, 12-13, 15-17 and 19-25 are rejected under 35 U.S.C. 103 as being unpatentable over Wang.
The discussion of Wang regarding claims 13, 15-17 and 19-20 set forth in the rejection above is incorporated herein.
Wang teaches that said polymer or polymeric material can be in the form of a fiber [0069], and further discloses a material comprising a plurality of one or more of said fiber(s) in the form of a tissue graft which is a vascular graft [0064]. Wang does not specifically call the vascular graft an arterial graft or a small artery graft. However, a person of ordinary skill in the art at the time of filing would have found it obvious that the vascular graft can be a small artery graft because Wang teaches that the vascular graft can be used as an implant for a damaged or defective artery [0035], teaches that tissues which can benefit from the materials of the invention can be an artery [0066] and teaches that the lumen of the vascular graft can be about 0.7-5 mm [0077]; hence, a person of ordinary skill in the art at the time of filing would have found it obvious to use the vascular graft as a small arterial graft with a lumen diameter less than 6 mm; therefore, claims 21-23 are prima facie obvious.
Regarding claims 1-4, 6-9 and 12, Wang teaches that the poly(glycerol sebacate)-derived polymer comprising pro-angiogenic fatty acids, such as linoleate, is synthesized by polycondensation of glycerol, sebacic acid and linoleic acid [0037]. Wang teaches that the PGS-fatty acid polymer is internally crosslinked via attachment of repeating subunits at the R1 position, i.e., corresponding to the R’ position of the instant claim, giving a polymeric network [0054]; and that the PGS-fatty acid polymer comprises subunits wherein the R1 position is linoleate, i.e., corresponding to the R position of the instant claims; hence, Wang teaches a PGS-fatty acid polymer meeting the limitations of claim 1 wherein “m” and “n” are both non-zero. The process of polymer synthesis in Wang can comprise reacting the fatty acid with a hydroxyl group on the PGS prepolymer which does not affect the elongation of the PGS polymer [0059]; thus, the fatty acid can form a pendant group on the PGS backbone ([0053], [0059]) wherein the PGS polymer comprises a polymeric network [0054], i.e., R’ of the instant claims is non-zero. Unless the addition of the fatty acid to the PGS pre-polymer is 100.0000000% complete, the PGS polymer would necessarily also comprise “m” subunits wherein R’ is a hydrogen group, i.e., the unmodified middle hydroxyl group of the glycerol (see the reaction in [0115-116]). Real world reactions are never 100.0000000% efficient; hence, Wang’s PGS polymer would necessarily also comprise “m” subunits wherein R’ is a hydrogen group, i.e., wherein at least a portion of the R' groups are hydrogen groups with a proviso that not each R' is a hydrogen group.
Wang does not explicitly state that “m”, i.e., the subunits with a pendant group attached to the middle oxygen of the glycerol wherein the pendant group is a hydrogen group, sebacate group, oligo(glycerol sebacate) group or poly(glycerol sebacate) group, is between 1 to 99 molar percent and that “n”, i.e., the subunits with a pendant group attached to the middle oxygen of the glycerol wherein the pendant group is an aliphatic carboxylate group (claim 7: or an aryl carboxylate group) is between 1 to 99 molar percent or comprises 2-30% of the glycerol groups; however, a person of ordinary skill in the art at the time of filing would have found it obvious to adjust the relative amounts of glycerol, sebacic acid and fatty acid when synthesizing the polymer to give the amount of network crosslinking (i.e. wherein the pendant group is an R’ group) versus the amount of fatty acid loading (i.e. wherein the pendant group is a fatty acid, i.e., an R group) desired and would have arrived at polymer compositions wherein the subunits with R groups, i.e., “n” is 2-30%; thus, the value for “m” would necessarily be 70-98% wherein at least a portion, but not all, of the R' groups are hydrogen groups as discussed above; therefore, claims 1, 3-4, 6-7, 9 and 12 are prima facie obvious over Wang.
Regarding claims 24-25, Wang recites using C18-C22 polyunsaturated fatty acids [0053], but because the fatty acid is conjugated to the PGS polymer via the carboxylic acid moiety, a person of ordinary skill in the art at the time of filing would have found it obvious that Wang’s process could be used to produce PGS-fatty acid conjugates wherein the fatty acid is a C6 to C20 saturated fatty acid, i.e., C6 to C20 saturated aliphatic carboxylate groups, because the carboxylic acid moiety is used for conjugation to the polymer not the unsaturated bonds. Hence, a person of ordinary skill in the art at the time of filing would have found it obvious to use the method of Wang to produce polymeric material wherein R is independently chosen from C6 to C20 saturated aliphatic carboxylate groups and 2 to 30% of the glycerol groups have a pendant group; therefore, claims 24-25 are prima facie obvious.
Response to Arguments
Regarding the rejection of claims 1-4, 6-9, 12, 13, 15-17, and 19-23 under 35 U.S.C. 103 over Wang, Applicant argues (p. 11) that “Applicant reiterates the arguments presented above with regard to current claims 1 and 7. Based at least in part on these arguments, Wang does not teach or suggest all of the features of current claim 1 or 7. As claims 3, 4, 6, 9, 12, 13, 15-17, and 19-23 are dependent on claim 1 or 7, it necessarily follows that Wang does not teach all of the features of any of these dependent claims. For this reason alone, the cite reference does not establish a prima facie case of obviousness of claim and claims 1, 3, 4, 6, 7, 9, 12, 13, 15-17, and 19-23 are not obvious over the cited reference.
Applicant does not comment here on any specific rejection of claims 3, 4, 6, 9, 12, 13, 15-17, and 19-23, where posited. Applicant reserves the right to rebut any rejection of these claims if a sustainable rejection of current claim 1 or 7 is established.”
Claims 13, 15-17 and 19-23 do not depend from claim 1 or 7; hence, Applicant’s argument is moot and the rejection of claims 13, 15-17 and 19-23 under 35 U.S.C. 103 over Wang is maintained at least for this reason.
Regarding claims 1-4, 6-9 and 12, Wang clearly teaches that the polymer comprises both a) subunits wherein the R group is a sebacate group, oligo(glycerol sebacate) groups, and/or poly(glycerol sebacate) groups [0054], i.e., “m” subunits in the parlance of claims 1 and 7, and b) subunits wherein the R group is a fatty acid [0053], i.e., “n” subunits in the parlance of claims 1 and 7.
Applicant’s argument appears to be that because Wang does not explicitly state that R can be a hydrogen, i.e. wherein the group remains the glycerol’s original hydroxyl group, that the claims are novel over Wang (Remarks, p. 9). This is completely unpersuasive. If the prior art discloses the material of claim 1, i.e., a PGS polymer wherein at least a portion of the R' groups are hydrogen groups, then the claim is rejected over the prior art regardless of whether the prior art states the exact terms of the claim because examination is not drawn to the statements made in the prior art but to the actual material which is anticipated or made obvious by the prior art.
As discussed in the rejection above, unless the conjugation reaction coupling the fatty acid to the glycerol hydroxyl group is absolutely effective leaving no unreacted hydroxyl group on any glycerol moiety, then the PGS polymer produced by the methods of Wang would clearly comprise R1 groups consisting of a hydrogen, i.e., the unreacted hydroxyl groups of the glycerol which did not become conjugated with a fatty acid. Applicant has not shown that absolutely every hydroxyl of every glycerol becomes conjugated with a fatty acid in Wang’s methods, nor does Applicant provide any rational explanation suggesting that absolutely every hydroxyl of every glycerol becomes conjugated with a fatty acid in the method of Wang; hence, Applicant’s argument that the PGS compositions of Wang must not have any unmodified hydroxyl on any glycerol molecule because Wang does not state that the R group can be a hydrogen is completely unpersuasive.
In addition, Applicant appears to argue that because Wang did not anticipate the amended claims; therefore, Wang does not make obvious the claims (pp. 10-11). It does not follow that if a prior art does not anticipate that it therefore cannot make the invention obvious.
Thus, claims 1, 3-4, 6-7, 9, 12-13, 15-17, and 19-25 are obvious over Wang as set forth in the rejection above.
Claims 1, 3-4, 6-7 and 9-25 are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Claeyssens et al., WO 2019/ 215441 (Foreign Patent Document cite 1, IDS, 5/5/2023; herein “Claeyssens”).
The discussion of Wang regarding claims 1, 3-4, 6-7, 9, 12-13, 15-17, and 19-25 set forth in the rejection above is incorporated herein.
Wang discloses a poly(glycerol sebacate) (PGS) polymer comprising pendant aliphatic carboxylate groups wherein each pendant aliphatic carboxylate group is covalently bound to the glycerol group of the glycerol sebacate backbone of the polymer wherein the pendant aliphatic carboxylate group, i.e., R1, is a polyunsaturated omega - 6 fatty acid or a polyunsaturated omega - 3 fatty acid, which can be the C18 aliphatic carboxylate linoleic acid, wherein the polymer is at least partially crosslinked ([0089-108], [0115-118]); but does not specifically disclose that the copolymer is a block copolymer. However, a person of ordinary skill in the art at the time of filing would have found it obvious for the polymer to be a block copolymer in view of the disclosure of Claeyssens.
Claeyssens discloses tissue grafts (scaffolds) comprising PGS, poly(caprolactone) (PCL), copolymers or polymer blends of PGS and PCL (hydrophobic) (p. 2, ll. 6-9); hence, a person of ordinary skill in the art at the time of filing would have found it obvious to produce the copolymers, fibers and materials of Wang wherein the copolymer of Wang comprises a block copolymer comprising blocks of Wang’s PGS copolymer (with aliphatic or aryl carboxylates) and blocks of PCL (hydrophobic block) and/or fibers of PCL; therefore, claims 10-11, 14 and 18 are prima facie obvious.
Response to Arguments
Regarding the rejection of claims 1-4 and 6-23 under 35 U.S.C. 103 over Wang, Applicant argues (p. 12) that “Based on the foregoing, the purported combination of Wang and Claeyssens does not teach or suggest all of the features of current claim 7. As claims 9-11, 14, and 18 are dependent on claim 7, it necessarily follows the purported combination of Wang and Claeyssens does not teach all of the features of any of these dependent claims. For this reason alone, the cite reference does not establish a prima facie case of obviousness of claim and claims 9-11, 14, and 18 are not obvious over the cited reference.
Applicant does not comment here on any specific rejection of claims 9-11, 14, and 18. Applicant reserves the right to rebut any rejection of these claims if a sustainable rejection of current claim 7 is established.”
Applicant argues (p. 12) that “Claeyssens does not cure the aforementioned deficiencies of Wang with regard to current claim 7”. The disclosure of Wang is discussed in the Response to argument on pp. 10-12 above. Applicant does not specifically provide any reason why Claeyssens cannot be combined with Wang. The rejection set forth above meets all limitations of the amended claims.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Trent R Clarke whose telephone number is (571)272-2904. The examiner can normally be reached M-F 10-7 MST.
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/TRENT R CLARKE/ Examiner, Art Unit 1651
/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651
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