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 Claims
Claims 1-6 and 8-10 are pending in the current application.
Claims 1 and 4 are amended in the current application.
Claim 7 is canceled in the current application.
Response to Arguments
Applicant's remarks and amendments filed on December 22, 2025 have been fully considered.
Applicant requests withdrawal of the rejection under 35 USC 112(b) set forth in the previous office action.
The rejection under 35 USC 112(b) set forth in the previous office action is withdrawn due to the present claim amendments.
Applicant argues that Liao does not anticipate the features of newly amended claim 1.
Examiner acknowledges. The rejections under 35 USC 102 are withdrawn due to the present claim amendments. However, new rejections are set forth under 35 USC 103 as necessitated by the present claim amendments.
Applicant argues Zhu in view Liao does not disclose a substitution degree of poly(gamma-glutamic acid) being 6% or more.
This is not persuasive for the following reasons. Liao teaches a grafting rate (i.e., a substitution degree of the photo-crosslinkable functional group ᵞ-PGA-GMA) is 5% to 12% (Liao, Pg 2). Liao’s grafting rate overlaps the claimed substitution degree of 6% or more, and therefore, renders obvious the claimed range (MPEP 2144.05). It would have been obvious to one of ordinary skill in the art to have grafted poly(glutamic acid) with glycidyl (meth)acrylate according to Liao’s guidance and grafting rate to form Zhu’s photosensitive polymer derivative component to yield a hydrogel that can achieve good mechanical properties and improved biocompatibility (Liao, Abstract, Pg 1).
Applicant argues the invention of claim 1 exhibits a desirable swelling ratio of 50% or less making it useful as a tissue adhesive, sealant, or anti-adhesion agent and also exhibits excellent flexibility.
Examiner acknowledges. However, it is noted that the features upon which applicant relies (i.e., swelling ratio of 50% or less; limitations pertaining to tissue adhesive, sealant, or anti-adhesion agent; and quantitative flexibility properties) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Moreover, if Applicant is asserting that the invention of claim 1 exhibits superior and/or unexpected results, whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). See MPEP 716.02(d). The invention of claim 1 is not sufficiently commensurate in scope with the examples of the specification as originally filed. For example, the inventive examples all utilize poly(gamma-glutamic acid) and glycidyl methacrylate with photo-initiators of LAP, VA-086, or Irgacure 2959 in specific amounts of 2, 10, or 25 mM, where all examples are exposed to specific UV intensity from 15-150 mW/cm2 (Spec, Table 1). Whereas claim 1 much more broadly recites “a photo-crosslinkable functional group” instead of specifying glycidyl methacrylate; much more broadly recites “a photo-initiator” instead of specifying LAP, VA-086, or Irgacure 2959; does not recite a content amount of photo-initiator; and does not specify a UV intensity for irradiation. Therefore, the invention of claim 1 is not sufficiently commensurate in scope with the inventive examples to establish superior and/or unexpected results.
Applicant argues that Liao is a dual-network hydrogel and Zhu is directed to a photo-crosslinked hydrogel material, where both are distant from the technical concept of the present invention.
This is not persuasive for the following reasons. It has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Liao, Zhu, and the present invention all pertain to hydrogels formed with poly(glutamic acid) and crosslinked with a photo-initiator and UV irradiation. In view of the foregoing, the teachings of Liao and Zhu are considered sufficiently analogous to the field of the inventor’s endeavor.
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 1-5, 8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Liao et al. (CN 106589410 A, herein English machine translation utilized for all citations).
Regarding Claim 1, Liao teaches a high-strength double network hydrogel comprising poly(gamma-glutamic acid) grafted with a glycidyl methacrylate photo-crosslinkable functional group (ᵞ-PGA-GMA) that is crosslinked with a photo-initiator of Irgacure 2959 after being irradiated at an ultraviolet wavelength of 365 nm (UV A region) (Liao, Abstract, Pgs 1-3). Liao teaches a grafting rate (i.e., a substitution degree of the photo-crosslinkable functional group ᵞ-PGA-GMA) is 5% to 12% (Liao, Pg 2). Liao’s grafting rate overlaps the claimed substitution degree of 6% or more, and therefore, renders obvious the claimed range (MPEP 2144.05). Liao teaches the hydrogel forms after irradiation at an ultraviolet wavelength of 365 nm (UV A region), where crosslinking can be seen after irradiation with the ultraviolet wavelength of 365 nm after 30 seconds (Liao, Abstract, Pgs 1-3, Fig 1). Although Liao remains silent regarding a crosslinking time of within 10 seconds, "even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113, I. Liao appears to disclose a hydrogel product that is the same as the claimed hydrogel product (see rejection of claims 1-5 above, and claims 8 and 10 below) and teaches that some degree of crosslinking is necessarily present within 30 seconds or less after irradiation at an ultraviolet wavelength of 365 nm (Liao, Pg 3, Fig 1). Therefore, Liao’s hydrogel product is considered to at least render obvious the claimed hydrogel product (that is capable of being crosslinked within 10 seconds) even though it was made by a different process (MPEP 2113, I).
Regarding Claims 2, 3, and 4, Liao teaches the photo-crosslinkable functional group is a methacrylate group of a glycidyl methacrylate (GMA), where the GMA is grafted to the ᵞ-PGA via the carboxyl group the ᵞ-PGA (Liao, Pgs 1-3).
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Regarding Claim 5, Liao teaches the photo-initiator Irgacure 2959 is activated and irradiated at an ultraviolet wavelength of 365 nm (UV A region) for photo-crosslinking (Liao, Abstract, Pgs 1-3).
Regarding Claim 8, Liao teaches a high-strength double network hydrogel comprising the poly(gamma-glutamic acid) grafted with the glycidyl methacrylate photo-crosslinkable functional group (ᵞ-PGA-GMA) as discussed above for claim 1 (Liao, Abstract, Pgs 1-3).
Regarding Claim 10, Liao teaches a method for preparing the high-strength double network hydrogel comprising the poly(gamma-glutamic acid) grafted with the glycidyl methacrylate photo-crosslinkable functional group (ᵞ-PGA-GMA) as discussed above for claim 1 by irradiating at an ultraviolet wavelength of 365 nm (UV A region) to form the hydrogel (Liao, Abstract, Pgs 1-3).
Claims 1-6 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu et al. (US 2020/0262802 A1) in view of Liao et al. (CN 106589410 A, herein English machine translation utilized for all citations).
Regarding Claim 1, Zhu teaches a photo-crosslinked hydrogel composition comprising a photosensitive polymer derivative component P1 with a o-nitrobenzyl group and a double bond photo-crosslinkable functional group and a photo-initiator, where the photo-sensitive polymer derivative component P1 can be poly(glutamic acid) and the double bond photo-crosslinkable functional group can be incorporated by reacting with glycidyl acrylate or glycidyl methacrylate (Zhu, Abstract, [0037]-[0059], [0142]-[0152], [0158]-[0172], [0203]-[0219], Claims 5, 13). Zhu teaches the photo-initiator improves crosslinking speed and efficiency, where a gelation crosslinking point can be achieved in 1-2 seconds and finalized in 10-20 seconds (Zhu, [0237]-[0245]). Zhu teaches the photo-initiator improves crosslinking speed and efficiency, where a gelation crosslinking point can be achieved in 1-2 seconds and finalized in 10-20 seconds (Zhu, [0237]-[0245]). Zhu’s gelation crosslinking point range of 1-2 seconds falls within the claimed range of within 10 seconds, and therefore, satisfies the claimed range (MPEP 2131.03).
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Zhu – Formula A-III
Zhu suggests the photo-crosslinked hydrogel composition can be formed with poly(glutamic acid) and glycidyl acrylate or glycidyl methacrylate, but remains silent regarding any specific embodiments with these components.
Liao, however, teaches a high-strength double network hydrogel comprising poly(gamma-glutamic acid) grafted with a glycidyl methacrylate photo-crosslinkable functional group (ᵞ-PGA-GMA) that is crosslinked with a photo-initiator (Liao, Abstract, Pgs 1-3). Liao teaches a grafting rate (i.e., a substitution degree of the photo-crosslinkable functional group ᵞ-PGA-GMA) is 5% to 12% (Liao, Pg 2). Liao’s grafting rate overlaps the claimed substitution degree of 6% or more, and therefore, renders obvious the claimed range (MPEP 2144.05).
Since Zhu suggests utilizing poly(glutamic acid) and glycidyl acrylate or glycidyl methacrylate to form a hydrogel composition and Liao teaches specifically utilizing poly(gamma-glutamic acid) grafted with glycidyl methacrylate to form a hydrogel composition, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have specifically selected poly(glutamic acid) with glycidyl acrylate or glycidyl methacrylate and to have grafted these together according to Liao’s guidance and grafting rate to form Zhu’s photosensitive polymer derivative component to yield a hydrogel that can achieve good mechanical properties and improved biocompatibility as taught by Liao (Liao, Abstract, Pg 1).
Regarding Claims 2, 3, and 4, modified Zhu teaches the photo-crosslinked hydrogel composition has poly(glutamic acid) (ᵞ-PGA) grafted with glycidyl methacrylate (GMA), where the GMA is grafted to the ᵞ-PGA via the carboxyl group the ᵞ-PGA (Liao, Pgs 1-3).
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Regarding Claims 5 and 6, modified Zhu teaches the photo-initiator can be Lithium phenyl-2,4,6-trimethylbenzoylphosphinate (LAP; i.e., a phosphorus-containing aromatic photo-initiator compound required by claim 6) (Zhu, [0172], [0210], [0646]-[0647], [0672]). LAP is identical to the photoinitiator utilized within the specification as originally filed having a maximum absorbance of about 375 nm in the UV A region (Spec, Pgs 6-7). "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. See MPEP 2112.01, II. Therefore, modified Zhu’s LAP inherently exhibits a maximum absorbance of about 375 nm in the UV A region (MPEP 2112.01, II).
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Lithium phenyl-2,4,6-trimethylbenzoylphosphinate (LAP)
Regarding Claim 8, modified Zhu teaches a photo-crosslinked hydrogel composition as discussed above for claim 1 (Zhu, Abstract, [0037]-[0059], [0142]-[0152], [0158]-[0172], [0203]-[0219], Claims 5, 13).
Regarding Claim 9, modified Zhu teaches the photo-crosslinked hydrogel composition is for use as a tissue adhesive or a sealant (Zhu, Abstract, [0213]-[0219], [0238]-[0245]).
Regarding Claim 10, modified Zhu teaches a method of preparing the photo-crosslinked hydrogel composition comprising irradiating the composition with ultraviolet rays in the UV A region (Zhu, [0170], [0669], [0681], [0685]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELI D STRAH whose telephone number is (571)270-7088. The examiner can normally be reached M-F 9 am - 7 pm.
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/Eli D. Strah/Primary Examiner, Art Unit 1782