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Claims 17, 19, 22-24, and 32-34 are withdrawn.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 4-6, 10-14, 16, 18, 20-21 are canceled.
Claims 1-3, 7-9, 15, and 25-31 are pending and represent all claims currently under consideration.
Priority
This application is a 371 of PCT/US2021/053693, which claims priority to PRO 63/244,615 and PRO 63/088,253.
Claims 1-3, 7-9, 15, and 25-31 are considered to have an effective filing date of 10/06/2020.
Election/Restrictions
Applicant’s election of Group I in the reply filed on 09/26/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Due to the amendment to the claims filed 09/26/2025, Group I comprises claims 1-3, 7-9, 15, and 25-31.
Claims 17, 19, 22-24, and 32-34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/26/2025.
Information Disclosure Statement
The information disclosure statements filed 04/05/2023, 10/28/2024, 02/13/2025, 03/18/2025, and 09/26/2025 have been considered.
Specification
The use of the terms Irgacure, Esacure, Pluronic, Agilent, and Zorbax, which are trade names or marks used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Drawings
The drawings are objected to because Fig 7B is missing a label on the righthand Y-axis and the unit label on the righthand Y-axis of Fig 7C-D, 8A-B, and 9A is unclear. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim 1-3, 9, and 28 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 1-3, 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).
Regarding claim 28, the parenthetical recitation of "(e.g., bis-oxiranes)" and the use of the phrase “e.g.” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 28, the phrase “derivatives thereof” is a relative phrase which renders the claim indefinite. The term “derivatives” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how far one can deviate from the parent compound without the “derivative” being so far removed therefrom as to be considered a different compound.
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, 29, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Choi (BioTechniques, 2019).
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 a hydrogel comprising GelMA in 3% w/v (Choi, table 3, hydrogel 4), which lies within the claimed range.
Choi is considered to be analogous to the claimed invention, because both Choi and the instant invention are in the same field of polymer hydrogels. 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 arrived at the claimed invention based on the teachings of Choi under the meaning of 35 U.S.C. 103.
Regarding claim 2, Choi teaches all the elements of the current invention as applied to claim 1. Choi teaches a hydrogel comprising PEGDA in 5-25% w/v (Choi, table 3, hydrogel 1), 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).
Regarding claim 3, Choi teaches 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 teaches 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 teaches 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 teaches 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 teaches 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 teaches 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 teaches 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 teaches 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 31, Choi teaches 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) as applied to claims 1-3, 7-9, 15, 25-26, 29, and 31, further in view of Li (Polymers, 2017).
Regarding claim 27, Choi teaches all the elements of the current invention as applied to claim 1. As above, Choi teaches photo-crosslinked GelMA hydrogels (Choi, abstract), but Choi does not mention the use of crosslinking agents 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 and Li are considered to be analogous to the claimed invention, because Choi, 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 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 teaches all the elements of the current invention as applied to claim 27. As above, Choi teaches photo-crosslinked GelMA hydrogels (Choi, abstract), but Choi does not mention the use of crosslinking agents as claimed. 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 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).
Claims 30 is rejected under 35 U.S.C. 103 as being unpatentable over Choi (BioTechniques, 2019) as applied to claims 1-3, 7-9, 15, 25-26, 29, and 31, further in view of Dana (WO 2020081673 A1; IDS reference, 04/05/2023).
Regarding claim 30, Choi teaches 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).
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 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).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHASITY P JANOSKO whose telephone number is (703)756-5307. The examiner can normally be reached 7:30-3:30 ET.
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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613