DETAILED ACTION
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 17, 19, 22-24, and 32-34 are withdrawn.
Claims 1-3, 7-9, 15, and 25-31 are pending and represent all claims currently under consideration.
Response to Amendment
The amendment filed 04/16/2026 has been entered.
Claims 1-2 were amended. No new material was added.
Applicant’s amendments have overcome the previous objections to the specification and drawings; the previous rejections under 35 U.S.C. 112(b) of claims 1 and 28; and the previous rejections under 35 U.S.C. 103.
The previous rejection of claims 2-3 and 9 under 35 U.S.C. 112(b) are maintained.
Claims 1-3, 7-9, 15, and 25-31 are newly rejected under 35 U.S.C. 103 due to the amendment.
Response to Arguments
Applicant’s arguments, see Remarks, filed 04/16/2026, with respect to the rejection(s) of claim(s) 1-3, 7-9, 15, and 25-31 under 35 U.S.C. 103 have been fully considered and are persuasive due to the amendment. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Choi, Dana, and Li.
Applicant argues that the claimed polymer composition exhibits unexpected properties suitable for use as soft tissue adhesives, specifically improved swelling and swelling mass (Remarks, page 11-13, “C”). This argument is not persuasive, because Choi teaches the crosslinkable hydrogels are used in the field of tissue engineering and include tunable properties such as the degree of swelling (Choi, page 43, 1st paragraph), suggesting the cited properties are not unexpected.
Modified/Maintained Claim Rejections - 35 USC § 112
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 2-3 and 9 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.
Regarding claims 2-3 and 9, the parenthetical recitation of “w/v” renders the claims indefinite because it is unclear whether the limitations in parentheses are part of the claimed invention or describing an example or preference. See MPEP § 2173.05(d). The Examiner suggests removing the parentheses so that each “(w/v)” instead reads “w/v”.
New Claim Rejections - 35 USC § 103
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.
Claims 1-3, 7-9, 15, 25-26, and 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Choi (BioTechniques, 2019), further in view of Dana (WO 2020081673 A1; IDS reference, 04/05/2023). The references were cited previously.
Regarding claim 1, Choi teaches a photo-crosslinkable hydrogel (i.e., a polymer composition) including PEGDA (i.e., a chemically modified PEG), GelMA (i.e., a gelatin acryloyl), and hyaluronic acid (Choi, table 1, hydrogel 3). Choi teaches a photoinitiator for photo-crosslinking (Choi, table 2), and teaches MeHA (i.e., a chemically modified HA) as an alternative to hyaluronic acid due to an improved mechanical properties and degradation rate (Choi, page 49, 1st paragraph). Choi further teaches GelMA in 3% w/v (Choi, table 3, hydrogel 4) and MeHA in 1-3% w/v (Choi, table 3, hydrogel 6), which each lie within the claimed range.
Choi teaches PEGDA and teaches the mechanical properties of a PEGDA hydrogel are tunable by varying the concentration (Choi, page 43, “Synthesis of photo-crosslinkable PEGDA hydrogel”), but does not specify a PEGDA concentration within the claimed range. Dana teaches a hydrogel comprising GelMA and PEGDA (Dana, page 29, example 1), and teaches the compositions comprise the acryloyl-substituted gelatin and polyethylene glycol in about 1-40% weight by volume each (Dana, claims 3-4), which overlaps the claimed ranges of each. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I).
Choi and Dana are considered to be analogous to the claimed invention, because Choi, Dana, and the instant invention are in the same field of therapeutic hydrogel compositions. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Choi to include PEGDA in the amount taught by Dana, because Choi teaches the mechanical properties of a PEGDA hydrogel are tunable by varying the concentration (Choi, page 43, “Synthesis of photo-crosslinkable PEGDA hydrogel”), and Dana teaches compositions comprising PEGDA about 1-40% are known in the field (Dana, claims 4 and 8).
Regarding claim 2, Choi and Dana together teach all the elements of the current invention as applied to claim 1. As above, Choi teaches PEGDA and teaches the mechanical properties of a PEGDA hydrogel are tunable by varying the concentration (Choi, page 43, “Synthesis of photo-crosslinkable PEGDA hydrogel”), but does not specify a PEGDA concentration within the claimed range. Dana teaches a hydrogel comprising GelMA and PEGDA (Dana, page 29, example 1), and teaches the compositions comprise the acryloyl-substituted gelatin and polyethylene glycol in about 1-40% weight by volume each (Dana, claims 3-4), which encompasses the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Choi to include PEGDA in the amount taught by Dana, because Choi teaches the mechanical properties of a PEGDA hydrogel are tunable by varying the concentration (Choi, page 43, “Synthesis of photo-crosslinkable PEGDA hydrogel”), and Dana teaches compositions comprising PEGDA about 1-40% are known in the field (Dana, claims 4 and 8).
Regarding claim 3, Choi and Dana together teach all the elements of the current invention as applied to claim 1. Choi teaches a hydrogel comprising MeHA (i.e., an acryloyl-substituted HA) in 1-3% w/v (Choi, table 3, hydrogel 6), which lies within the claimed range.
Regarding claim 7, Choi and Dana together teach all the elements of the current invention as applied to claim 1. Choi teaches a photoinitiator for crosslinking which is eosin-Y (Choi, table 2).
Regarding claim 8, Choi and Dana together teach all the elements of the current invention as applied to claim 1. Choi teaches the composition consists of photoinitiators and pre-polymers (i.e., a precursor polymer composition; Choi, page 41, 1st paragraph).
Regarding claim 9, Choi and Dana together teach all the elements of the current invention as applied to claim 8. Choi teaches a hydrogel comprising the pre-polymer GelMA (i.e., a gelatin acryloyl) in 3% w/v (Choi, table 3, hydrogel 4), which lies within the claimed range.
Regarding claim 15, Choi and Dana together teach all the elements of the current invention as applied to claim 1. Choi teaches compositions which are photo-crosslinkable hydrogels (i.e., gel polymer compositions; Choi, table 1).
Regarding claim 25, Choi and Dana together teach all the elements of the current invention as applied to claim 1. Choi teaches a photo-crosslinkable hydrogel (i.e., a polymer composition) including GelMA (Choi, table 1, hydrogel 3).
Regarding claim 26, Choi and Dana together teach all the elements of the current invention as applied to claim 3. Choi teaches a photo-crosslinkable hydrogel (i.e., a polymer composition) including MeHA (Choi, table 1, hydrogel 8).
Regarding claim 29, Choi and Dana together teach all the elements of the current invention as applied to claim 1. Choi teaches hydrogels comprising therapeutic molecules (i.e., at least one therapeutic agent; Choi, page 41, 1st paragraph).
Regarding claim 30, Choi and Dana together teach all the elements of the current invention as applied to claim 8. Choi teaches GelMA is formed by the methacrylation of gelatin and teaches the degree of methacrylation can be adjusted (Choi, pages 46-47. “synthesis of photo-crosslinkable GelMA hydrogel”), but does not teach a specific degree as claimed. Dana teaches a hydrogel comprising GelMA and PEGDA (Dana, page 29, example 1), and teaches GelMA with a degree of acryloyl substitution of 50-90% (Dana, pages 10-11, paragraphs 0041-0042), which overlaps the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Choi to include GelMA with a degree of substitution as taught by Dana, because both Choi and Dana teach the degree of methacrylation can be adjusted to optimize the mechanical properties of a hydrogel (Choi, pages 46-47. “synthesis of photo-crosslinkable GelMA hydrogel”; Dana, page 17, paragraph 0065).
Regarding claim 31, Choi and Dana together teach all the elements of the current invention as applied to claim 15. Choi teaches compositions which are photo-crosslinkable hydrogels (Choi, table 1).
Claims 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Choi (BioTechniques, 2019) and Dana (WO 2020081673 A1; IDS reference, 04/05/2023) as applied to claims 1-3, 7-9, 15, 25-26, and 29-31, further in view of Li (Polymers, 2017).
Regarding claim 27, Choi and Dana together teach all the elements of the current invention as applied to claim 1. Choi teaches photo-crosslinked GelMA hydrogels (Choi, abstract), and Dana teaches a crosslinkable GelMA/PEGDA hydrogel (Dana, page 29, example 1), but neither specifies a crosslinking agent as claimed. Li teaches crosslinked GelMA hydrogels (Li, abstract) and teaches the use of crosslinking reagents as an alternative to irradiation (Li, page 11, 2nd paragraph).
Choi, Dana, and Li are considered to be analogous to the claimed invention, because Choi, Dana, Li, and the instant invention are in the same field of therapeutic hydrogel compositions. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Choi and Dana to include a crosslinking reagent in place of UV irradiation, because Li teaches the use of UV irradiation may induce cellular damage (Li, page 11, 2nd paragraph).
Regarding claim 28, Choi and Dana together teach all the elements of the current invention as applied to claim 27. Li teaches a crosslinking reagent such as glutaraldehyde (Li, page 11, 2nd paragraph). As above, it would have been prima facie obvious to one of ordinary skill in the art to have modified the teachings of Choi and Dana to include a crosslinking reagent in place of UV irradiation, because Li teaches the use of UV irradiation may induce cellular damage (Li, page 11, 2nd paragraph).
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.
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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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