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 .
DETAILED ACTION
Claims 1-10 as filed April 1, 2025 are under consideration.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 24, 2025 was considered.
Claim Objections
Claim 7 is objected to because of the following informalities: “or” should be “and” because Markush language is set forth as "selected from the group consisting of A, B, and C". See MPEP 2173.05 (h) I Markush Groups. Appropriate correction is required.
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
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.
Claim 6 is 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 pre-AIA the applicant regards as the invention.
Claim 6 recites the loaded protein. There is insufficient antecedent basis for this limitation in the claim.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Choi et al. (KR 102221924 B1, published March 2, 2021, as evidenced by the KIPO translation, IDS references filed June 24, 2024) in view of Lim et al. “Marine collagen as a promising biomaterial for biomedical applications,” marine drugs 17:467, 2019.
Choi teaches hybrid gel particles comprising plasmonic nanoparticles and their application in photothermal drug delivery (page 1, title).
The particles comprise a heat-sensitive macromolecular monomer for hydrogel formation selected from N-isopropyl acrylamide, N-vinyl caprolactam, dimethyl amino ethyl methacrylate and N,N-dimethylacrylamide (pages 2-3, claims 1 and 3), as required by instant claim 4.
The particles comprise linker molecules selected from the group inclusive of collagen (pages 2-3, claims 1 and 5).
The plasmonic nanoparticles are prepared from metal salts comprising a metal selected from gold, silver, platinum, aluminum and copper (pages 2-3, claims 1 and 7-9), as required by instant claims 7, 8. The content of metal salt is 1 to 10 vol% (page 3, claim 9), as required by instant claim 5.
The particles further comprise a photoinitiator (page 3, claim 10).
The particles are prepared by ultraviolet radiation (a step of irradiating) (page 3, claim 11), as required by instant claim 10.
The particles may be part of a drug delivery system (vehicle) (page 3, claim 12), as required by instant claim 9.
Regarding the preamble recitation of an intended use for protein delivery, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP 2111.02. Furthermore, Choi teaches the hybrid gel particles are capable of delivering drugs inclusive of proteins (page 13, last full paragraph).
Regarding the intended use recitation of claim 6 of protein release by irradiation with light, see MPEP 2111.02. Furthermore, Choi teaches molecules loaded on the hybrid gel particles are released in response to light or heat (page 5, summary of invention, last full paragraph).
Choi does not specifically teach collagen of 1 to 30 kDa as required by claims 1, 9, 10.
Choi does not teach collagen from marine organisms as required by claim 2.
Choi does not teach collagen of 3 to 10 kDa as required by claim 3.
These deficiencies are made up for in the teachings of Lim.
Lim teaches marine collagen, collagen derived from marine organisms, is a promising biomaterial for biomedical applications inclusive of drug delivery (title; abstract; section 4.2, drug delivery), as required by instant claim 2. Marine collagen offers advantages over mammalian collagen due to its biocompatibility, biodegradability, easy extractability, water solubility, safety, low immunogenicity and low production costs (abstract; Figure 1). Hydrolyzed collagen generally has a molecular weight in the range of 500 to 25,000 Daltons (0.5 to 25 kDa) (page 6, last full paragraph), as required by instant claim 3. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). "[W]here 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05. Hydrolyzed marine collagen has improved chemical and physical properties and enhanced function in comparison to their non-hydrolyzed form (page 6, last full paragraph; Figure 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the collagen linker molecules of the hybrid gel particles of Choi to comprise a marine collagen and in particular a hydrolyzed marine collagen having a molecular weight in the range of 500 to 25,000 Daltons (0.5 to 25 kDa) as taught by Lim because marine sourced collagen offers advantages over mammalian collagen and because hydrolyzed collagen has improved chemical and physical properties and enhanced function in comparison to non-hydrolyzed forms. There would be a reasonable expectation of success because the collagen of Lim falls within the genus embraced by Choi.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kim et al. “Photothermally modulated intracellular delivery of therapeutic proteins using gold-collagen hybrid nanoparticles,” ACS Materials Letters 6:409-417, 2024, published December 28, 2023
Zhang et al. (CN 113662924, as evidenced by the Google translation) teaches a fish skin collagen peptide – photosensitizer nanocomposite comprising a low molecular weight collagen peptide having a molecular weight of less than 2000; the peptide is obtained by hydrolysis (title; abstract; claims).
Qazi et al. (WO 2013/015674) teaches collagen nanostructures comprising metal particles comprising silver and polymers inclusive of poly (N-isopropylacrylamide)
(title; abstract; claims, in particular 1, 18-20).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISSA PROSSER whose telephone number is (571)272-5164. The examiner can normally be reached M - Th, 10 am - 6 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, DAVID BLANCHARD can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALISSA PROSSER/
Examiner, Art Unit 1619
/BENNETT M CELSA/Primary Examiner, Art Unit 1600
