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 .
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.
This office action is a response to applicant’s election submitted August 17, 2026, claims filed December 15, 2023 wherein claims 6-7, 11-12, 18, 20, 24 were preliminarily amended and claims 3, 5, 14, 19, 23, 26 were canceled are examined herein.
Claims 1-2, 4, 6-13, 15-18, 20-22, 24a, 24b-25 are pending in this application. The Examiner notes that claim 24 is used twice, the first appearing claim is 24a and the second appearing claim is 24b.
Priority
This application is a 371 of PCT/US2022/073803 filed 07/15/2022 and claims benefit to US provisional application 63/222,195 filed 07/15/2021.
Election/Restrictions
Applicant's election without traverse of Group I, claims 1-2, 4, 6-13, 15-16, drawn to a hydrogel and a method of making said hydrogel in the reply filed on August 17, 2026 is acknowledged.
Claims 17-18, 20-22, 24a, 24b-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 August 17, 2026.
Claims 1-2, 4, 6-13, 15-16 are encompassed by the election and are examined herein.
Drawings
The drawings are objected to because:
In figure 1 there is a line overlapping “pH”, and the degree symbol is illegible
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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.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (pg. 54, para. 0264). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Interpretation
Claims 1-2, 4, 7-8, 10-14, and 16 are product by process claims. The Examiner notes that, "[E]ven 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)). Instant claim 1 states that the hydrogel is prepared from a polypeptide with one or more of a primary cross-linkable group and a polysaccharide with one or more of a secondary cross-linkable group. However, given that claim 1 is drawn to a product, a method which results in the same structure of the claimed product anticipates the claim regardless of where the cross-linkable groups originate from.
Claims 12-13 are directed to wt% of cross-linkable groups in each individual component of the hydrogel, not wt% of the polysaccharide or polypeptide.
Claim Rejections - 35 USC § 112 (b)
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 7 and 16 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 claim 7: Claim 7 recites the phrase “The hydrogel of claim 1, wherein: said first and second cross-linkable groups are methacrylates”. However, claim 1 recites inter alia, “the polypeptide with more or more of a primary cross-linkable group….a polysaccharide with one or more of a secondary cross-linkable group”. The phrase first and second cross-linkable group renders the claim indefinite as it is unclear whether first and second is in reference to the “one or more”, or is in reference to primary or secondary as recited in instant claim 1. These to leads to a lack of clarity in scope as a person of ordinary skill in the art would be unable to ascertain the metes and bounds of the invention.
Regarding claim 16: Claim 16 recites inter alia, “The method of claim 10”, however, claim 10 is directed to a hydrogel. The claims are directed towards separate statutory categories of subject matter and there is no acknowledgement of the difference in statutory category. Thus claim 16 is indefinite as there is a lack in clarity of scope. A person of ordinary skill in the art would be unable to ascertain the metes and bounds of the invention.
Claim Rejections - 35 USC § 102
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 1-2, 4, 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu (Biomaterials, 2009, IDS filed December 15, 2023).
Regarding claims 1-2, 4, 11: Liu teaches the preparation of a novel cell-encapsulating hydrogel based on the interpenetrating polymer network of gelatin and dextran bifunctionalized with methacrylate and aldehyde (Dex-MA-AD) (abstract). The hydrogel was used to encapsulate cells (abstract).
Claims 1, 4, 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yan (CN103146002, cited on PTO-892, English translation cited on PTO-892).
Regarding claims 1, 4, 6, and 16: Yan teaches the preparation of a chemically cross-linked polyglutamic acid injectable hydrogel as the first component with a modified polysaccharide (such as alginic acid, hydroxyproyl cellulose, methyl cellulose, chitosan (abstract). Yan teaches the invention provides a novel medical material with excellent biocompatibility, which has good application prospects in the fields of tissue engineering, drug controlled release, regenerative medicine and the like (English translation, pg. 3, para. 4). Yan teaches the hydrogel is prepared from poly-gamma-sodium glutamate reacted with adipic acid dihydrazide, followed by reacting with hydroxypropyl methyl cellulose treated with sodium periodate (English translation, pg. 3, embodiment five). Yan teaches the reaction comprises an aminated polyglutamic acid (i.e. from adipic acid dihydrazide, which has an acyl hydrazine) with an aldehyde polysaccharide (English translation, pg. 1, claim 1).
Claims 1, 2, 4, 7-8, 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huang (WO 2022/076505, cited on PTO-892).
Regarding claims 1, 2, 4, 7-8, 11: Huang teaches improved polymer compositions comprising gelatin methacryloyl (GelMA) or polymerically crosslinked derivatives thereof (abstract). Huang teaches in certain embodiments, the polymer compositions can comprise chemically-modified gelatin (e.g., GelMA), chemically modified hyaluronic acid (e.g., MeHA), and one or more polymer crosslinking initiators, such as light-activated photoinitiator elements (pg. 9, para. 0034). Huang teaches preparation of GelMA and MeHA
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(drawings pg. 1, figures 1A-1B). Huang teaches the following steps to crosslink the polymer composition
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(drawings pg. 2, figure 2). Huang teaches the crosslinking conditions in the presence of a photoinitiator can result in one more acryloyl groups in the polymer composition to react with other acryloyl groups to crosslink the polymer composition and form a gel polymer composition (pg. 38, para. 096).
Claims 1, 2, 4, 6, 9, 11, 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chang (Acta Biomaterialia, 2021, cited on PTO-892).
Regarding claims 1, 2, 4, 6, 9, 11: Chang teaches the synthesis of a dually-modified gelatin macromer –gelatin-norbornene-carbohydrazide (GelNB-CH), which is susceptible to both thiol- norbornene photopolymerization and hydrazone click chemistry (abstract). We demonstrate that the crosslinking density of cell-laden thiol-norbornene hydrogels can be dynamically tuned via simple incubation with aldehyde-bearing macromers (e.g., oxidized dextran (oDex) or oHA) (abstract). The GelNB-CH hydrogel system is highly cytocompatible, as demonstrated by in situ encapsulation of pancreatic cancer cells (PCC) and cancer-associated fibroblasts (CAF) (abstract). Chang teaches the following synthesis and cross linking
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(pg. 162, figure 1). Hydrazone hydrogels were prepared with GelNB-CH and an aldehyde-containing macromer (i.e. oDex, pg. 163, col. 2, para. 2).
Regarding claim 15: Chang teaches the hydrogels were synthesized by preparing precursor solutions, one with GelNB-CH and an aldehyde containing macromer (i.e. oDex), incubating in DPBS (i.e. a saline) and then mixing to stiffen (i.e. cross-linking) (pg. 163, col. 2, paras. 2-3).
Claims 1-2, 4, 7, 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang (J Mater Sci: Mater Med,, 2014, cited on PTO-892).
Regarding claims 1-2, 4, 7, 11: Wang teaches gelatin methacrylate (GelMA) and dextran glycidyl methacrylate (DexMA) with tunable mechanical and biological properties were utilized to prepared novel bicomponent polymeric hydrogels by cross-linking polymerization using photoinitiation (abstract). The hydrogels were crosslinked in the presence of a photoinitiator following exposure to UV light and used to encapsulate cells
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(pg. 2175, col. 1, last para., pg. 2177, fig. 2).
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.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Chang (Acta Biomaterialia, 2021, cited on PTO-892) as applied to claims 1, 2, 4, 6, 9, 11, 15 above, in view of Wang (J Mater Sci: Mater Med,, 2014, cited on PTO-892).
Regarding claim 15: Even if assuming for the sake of argument Chang does not explicitly teach dissolving each individual solution in DPBS prior to crosslinking the claims would have still been rendered obvious in view of Wang.
As discussed above, Chang teaches the hydrogels were synthesized by preparing precursor solutions, one with GelNB-CH and an aldehyde containing macromer (i.e. oDex), incubating in DPBS (i.e. a saline) and then mixing to stiffen (i.e. cross-linking) (pg. 163, col. 2, paras. 2-3).
Chang does not explicitly teach dissolving each individual solution in DPBS prior to crosslinking.
However, Wang teaches the preparation of comparable gelatin and dextran hydrogels which were mixed into DPBS and crosslinked (pg. 2174, col. 2, last para.).
Taken together, it would have been prima facie obvious to dissolve the initial components in DBPS and mix prior to crosslinking as the art recognizes using DPBS as a solvent for dissolving hydrogel precursors for crosslinking and the selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results (See MPEP 2144.04 (IV))
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (J Mater Sci: Mater Med, 2014, cited on PTO-892) as applied to claims 1-2, 4, 7, and 11 above, further in view of Aguilar (Soft Matter, 2019, cited on PTO-892).
Regarding claims 12-13: As discussed above, Wang teaches the hydrogel of claim 1.
Wand does not teach wherein the hydrogel comprises up to 5 wt% of the primary crosslinkable group and 0.5 wt% of the secondary cross-linkable group.
However, Wang further teaches by varying the DS of DexMA in the copolymer hydrogels, the biophysical, structural and biological properties of the resulting copolymer hydrogels could be controlled. The tunable GelMA–DexMA copolymer hydrogels would be an attractive and significative biomaterial to meet different requirements in the tissue engineering applications (pg. 2181, col. 2, para. 2). Additionally Aguilar teaches controlling the release of bioactive agents has important potential applications in tissue engineering, whereas the cellular environment in tissue engineering is more typically a hydrogel scaffold (abstract). The mechanical and physical properties of the GelMA-based hydrogels can be modified by changing the polymer concentration, the photoinitiator type, UV irradiation time and by varying the degree of functionalization (pg. 3784, col. 2, last para.). The rheological and mechanical compression and swelling properties are influenced by the degree of functionalization of the GelMA component (pgs. 3784-3785, bridging para.).
Thus the art recognizes the degree of substitution of crosslinking groups in both crosslinker modified gelatin and dextran are recognized as result-effective variables. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation (See MPEP 2144.05 (II).
Taken together it would have been prima facie obvious to optimize the degree of substitution of both gelatin and dextran crosslinking groups as suggested by both Wang and Aguilar. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as degree of crosslinker substitution is a result-effective variable in order fine tune the physical properties of the resulting hydrogel.
Claim 10 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Huang (WO 2022/076505, cited on PTO-892) as applied to claims 1, 2, 4, 7-8, 11 above, further in view of Chen (J. Controlled Release, 2007, cited on PTO-892).
Regarding claim 10: As discussed above, Huang teaches the method of claim 1. Huang teaches wherein the polysaccharide is hyaluronic acid with a glycidyl methacrylate. Huang teaches the polymer compositions are hydrogels which compositions can be used as a soft-tissue adhesive for use in sealing, repairing and/or treating injuries, defects, or diseases in the soft tissue of a subject (abstract).
Huang does not teach wherein the polysaccharide is dextran with a glycidyl methacrylate.
However, Chen teaches a novel temperature-sensitive and biodegradable Dex-GMA/gelatin scaffold containing microspheres loaded with BMP could be successfully developed from both dextran- and gelatin-based biomaterials, which could promisingly satisfy the need, desire, and expectation of both self-regulated drug delivery and tissue-engineering applications (abstract). Chen teaches dextran hydrogel scaffolds are particularly compelling as scaffolds for soft tissue-engineering applications because dextran has been shown to be resistant to both protein adsorption and cell adhesion (pg. 73, col. 2, para. 2). Chen teaches the crosslinking of glycidyl methacrylated dextran (Dex-GMA) and gelatin (abstract).
Taken together, it would have been prima facie obvious to modify the composition of Huang such that glycidyl methacrylated dextran hyaluronic acid is replaced with glycidyl methacrylated dextran as suggested by Chen. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as both dextran and hyaluronic acid derivatives have been applied as gelatin-crosslinked scaffolds for soft tissue engineering applications and dextran scaffolds offer resistance to protein adsorption and cell adhesion. Additionally wherein dextran and hyaluronic acid derivatives have been used in gelatin hydrogels for tissue-engineering applications it is prima facie obvious to substitute equivalents for the same purpose (See MPEP 2144.06 (II)).
Regarding claim 16: As best understood n view of the 112(b) rejections above. Wherein the hydrogel of claim 10 is rendered obvious in view Chen and includes the use of a photo-initiator, claim 16 is necessarily rendered obvious as well.
Conclusion
No claims are allowed in this action.
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/S.L.G./ Examiner, Art Unit 1693
/ANDREA OLSON/ Primary Examiner, Art Unit 1693
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