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 .
Election/Restrictions
Applicant’s election of Group I, claims 1-6 and 10-14 in the reply filed on April 29, 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)).
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claims 1, 3, 5, and 13 are objected to because of the following informalities:
Claim 1 lacks a period at the end of the claim.
In claim 3, lines 8-9, “2-hydroxyethly methacrylate” is misspelled and should read “2-hydroxyethyl methacrylate.”
Claim 5 lacks a period at the end of the claim.
In claim 13, “Bis-Tris buffer” (lines 2-3), Bis-Tris propane buffer (line 4), “Tricine buffer” (line 7), and “Gly-Gly buffer” (line 7) should not be capitalized and should instead read “bis-tris buffer”, “bis-tris propane buffer”, “tricine buffer”, and “gly-gly buffer”.
Appropriate correction is required.
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 1-6 and 13 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 1: It is unclear what is meant by “hydrogel prepolymer” in line 2 because typically, prepolymers are partially polymerized (i.e. oligomers). However, the claim recites that “the photopolymerizable monomer and the photopolymerizable gel-forming component have not undergone photopolymerization reaction,” which calls into question whether the prepolymer is simply a mixture of the monomer and the gel-forming component, or if it is the reaction product of the monomer and the gel-forming component obtained by a method other than photopolymerization (condensation reaction, thermal polymerization, etc). For the purpose of examination, it will be taken to mean that the hydrogel prepolymer comprises a mixture of a photopolymerizable monomer and a photopolymerizable gel-forming component.
In lines 6-9, claim 1 recites “wherein the crosslinked hydrogel polymer refers to the hydrogel polymer produced by photopolymerization of a hydrogel prepolymer and a photoinitiator”. This directly contradicts the limitation in lines 3-5, “wherein the photopolymerizable monomer and the photopolymerizable gel-forming component have not undergone photopolymerization reaction”. For the purpose of examination, the composition is taken to comprise a first hydrogel prepolymer (a), which has not been photopolymerized, and a crosslinked hydrogel polymer produced by a photopolymerization reaction of a second hydrogel prepolymer (b).
In lines 6-10, claim 1 recites “the hydrogel polymer produced by photopolymerization of a hydrogel prepolymer and a photoinitiator; and a photoinitiator”. It is unclear if the photoinitiator in line 10 is the same as the photoinitiator in line 9. For the purpose of further examination, line 10 will be taken to read as “a second photoinitiator.”
Claims 2-6 are indefinite due to dependence on indefinite claim 1.
Claim 2 recites the limitation "the photoinitiator" in lines 1-2. It is unclear which photoinitiator of claim this is referring to. See rejection above. For the purpose of further examination, it will be taken to read as “the second photoinitiator”.
Claim 3 recites “wherein the hydrogel prepolymer is selected from…” in lines 1-2. It is unclear if this refers to the hydrogel prepolymer (a), the hydrogel prepolymer (b), or both. Furthermore, the hydrogel prepolymer (a) refers to a mixture of a monomer and a gel-forming component, while claim 3 indicates that the prepolymer is one component, which further calls into question what the claimed prepolymer is. For the purpose of examination, claim 3 will be taken to read “wherein the hydrogel prepolymer (b) is selected from…”
Claim 13 recites a plurality of acronyms (HEPES buffer, MES buffer, ADA buffer, ACES buffer, PIPES buffer, MOPSO buffer, BES buffer, MOPS buffer, TES buffer, DIPSO buffer, MOBS buffer, TAPSO buffer, HEPPSO buffer, POPSO buffer, EPPS (HEPPS) buffer, HEPBS buffer, TAPS buffer, AMPD buffer, TABS buffer, AMPSO buffer, PIPPS buffer). It would not be readily apparent to one of ordinary skill in the art what the meanings of these acronyms are. It is suggested to replace the acronyms with the full names of the buffers.
The parentheses in Claim 13 around “HEPPS” render the claim indefinite and must be removed. It is unclear if the text within the parentheses is included in the claim and further limits the subject matter of the claim, or whether it is an aside to the claim and is not further limiting. For the purpose of further examination, it is taken that the text within the parentheses further limits the claim. Appropriate correction is required. It is suggested to delete the parentheses.
Claim Rejections - 35 USC § 102
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.
Claims 10-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Luo et al (Thermo/photo dual-crosslinking chitosan-gelatin methacrylate hydrogel with controlled shrinking property for contraction fabrication, 25 February 2020, Carbohydrate Polymers, Vol. 236, 116067, p. 1-10).
With regard to Claim 10, lines 2-4, “wherein the crosslinked hydrogel polymer refers to the hydrogel polymer produced by photopolymerization of a hydrogel prepolymer and a photoinitiator” is a product-by-process limitation. MPEP § 2113 states that “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”. Therefore, the structure implied by the process step of photopolymerization will be considered when assessing patentability of Claim 10. However, the Applicant should note that “the Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). See MPEP § 2113(II).
Regarding Claims 10-13: Luo teaches a hydrogel blended composition comprising a crosslinked hydrogel polymer (p. 3, Fig. 1(c), thermo-crosslinked; p.3, col. 2, section 3.1), a photoinitiator (p.2, col. 1, section 2.3 – Irgacure 2959; p.3, Fig 1(c)), and a phosphate buffer (p.2, col. 1, section 2.3 – PBS), wherein the crosslinked hydrogel polymer is produced by the polymerization of gelatin methacryloyl and methacrylated hydroxybutyl chitosan (p.2, col. 1, section 2.2).
Luo does not teach that the hydrogel composition is recrosslinkable. However, Luo teaches all of the claimed ingredients in the claimed amounts made by a substantially similar process. The original specification does not identify a feature that results in the claimed effect or physical property outside of the presence of the claimed components in the claimed amount. Therefore, the claimed effects and physical properties, i.e. recrosslinkability, would naturally arise and be achieved by a composition with all the claimed ingredients. "Products of identical chemical composition cannot 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. See MPEP § 2112.01. If it is the applicant’s position that this would not be the case: (1) evidence would need to be provided to support the applicant’s position; and (2) it would be the Office’s position that the application contains inadequate disclosure that there is no teaching as to how to obtain the claimed properties with only the claimed ingredients.
Regarding Claim 14: Luo teaches that the hydrogel composition is used for 3D cell culture (p.1, Abstract).
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.
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 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Chirila et al (Sequential Homo-Interpenetrating Polymer Networks of Poly(2-hydroxyethyl methacrylate): Synthesis, Characterization, and Calcium Uptake, 13 May 2012, Journal of Applied Polymer Science, Vol. 126, E455-E466).
With regard to Claim 1, lines 6-9, “wherein the crosslinked hydrogel polymer refers to the hydrogel polymer produced by photopolymerization of a hydrogel prepolymer and a photoinitiator” is a product-by-process limitation. MPEP § 2113 states that “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”. Therefore, the structure implied by the process step of [step] will be considered when assessing patentability of Claim [x]. However, the Applicant should note that “the Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). See MPEP § 2113(II).
With regard to Claim 2, lines 1-3, ”wherein the photoinitiator is the remaining photoinitiator in the crosslinked hydrogel polymer” is a product-by-process limitation. MPEP § 2113 states that “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”. Therefore, the structure implied by the photoinitiator being the remaining photoinitiator in the crosslinked hydrogel polymer will be considered when assessing patentability of Claim 2. However, the Applicant should note that “the Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). See MPEP § 2113(II).
Regarding Claims 1-4: Chirila teaches a hydrogel composition comprising a crosslinked hydrogel polymer (p. E457, col. 2, Parent network (PHEMA), formed from the prepolymer 2-hydroxyethyl methacrylate), a prepolymer comprising a photopolymerizable monomer (2-hydroxyethyl methacrylate) and a gel-forming component (ethylene dimethacrylate), and an initiator (p. E457, col. 2, IPN-I).
Although Chirila does not teach that the initiator is a photoinitiator, Chirila teaches that PHEMA may be formed by photopolymerization (p. E460, col. 2, Table III, footnote (g)). When prior art teaches a genus, a prima facie case of obviousness of the claimed species may exist. MPEP 2144.08. In the present case, because Chirila teaches that photopolymerization is a suitable process for making PHEMA hydrogels, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a photoinitiator in the composition taught by Chirila.
Regarding Claim 5: Chirila teaches ethylene dimethacrylate (p. E457, col. 2, IPN-I), which shares a close structural similarity with the claimed diacrylate gel-forming component. When chemical compounds have close structural similarities and similar utilities, a prima facie case of obviousness exists. MPEP 2144.09. In the present case, Chirila uses the ethylene dimethacrylate as a gel-forming component/crosslinking agent (p. E459, col. 2, Synthesis of IPNs). One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to use a diacrylate gel-forming component, based on Chirila’s teachings that the structurally similar ethylene dimethacrylate would behave in the same way.
Regarding Claim 6: Chirila teaches that the hydrogel composition is used in biomedical applications (p. E456, col. 1, para. 3), but does not teach the specific applications of claim 6. However, the selection of a known material based on its suitability for its intended use supports a prima facie obviousness. MPEP 2144.07. One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to use the hydrogel composition taught by Chirila for wound repair, three-dimensional cell cultivation, or improvement of viscosity or yield stress of biological products because of its suitability for that purpose.
Additional Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Chen (CN 106866993 A) is directed toward photo-catalyzed re-crosslinking of hydrogels.
He et al (Fabrication of circular microfluidic network in enzymatically-crosslinked gelatin hydrogel, 7 October 2015, Materials Science and Engineering C, Vol. 59, p.53-60) is directed toward the use of partially-crosslinked hydrogels for molding.
Jalalvandi et al (Shear thinning/self-healing hydrogel based on natural polymers with secondary photocrosslinking for biomedical applications, 12 October 2018, Journal of the Mechanical Behavior of Biomedical Materials, Vol. 90, p. 191-201) is directed toward dual-crosslinked hydrogel systems.
Lou et al (Synthesis, physical characterization, and biological performance of sequential homointerpenetrating polymer network sponges based on poly(2-hydroxyethyl methacrylate), 16 September 1999, Journal of Biomedical Material Research, Vol. 47, Issue 3, p. 404-411) is directed toward sequential homo-interpenetrating polymer networks.
Choi et al (Recent advances in photo-crosslinkable hydrogels for biomedical applications, January 2019, BioTechniques, Vo. 66, No. 1, p. 40-53) is directed toward the state of the art for hydrogels in biomedical applications.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAITLIN N ILLING whose telephone number is (571)270-1940. The examiner can normally be reached Monday-Friday 8AM-4PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mark Eashoo can be reached at (571)272-1197. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.N.I./Examiner, Art Unit 1767
/MARK EASHOO/Supervisory Patent Examiner, Art Unit 1767