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
Applicant’s election without traverse of claims 1-19 in the reply filed on 02/02/2026 is acknowledged. Claims 1-19 are currently under examination and the subject of the present Office Action. Claims 20-21 are withdrawn from consideration without traverse.
As such, the restriction is made final.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 04/19/2024 and 02/05/2024 have been considered here.
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 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over KR 102266384 B1 (Lee, 2021; as submitted on IDS of 04/19/2024; machine translation provided by PE2E via FIT).
The applied reference KR 102266384 has a common inventors with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). The common inventors are: Ham Jung Ryul, and Kwon Han Jin
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
In regards to claim 1, Lee teaches a filler composition comprising hydrophilic surface-treated biodegradable polymer microparticles and a carrier (see Lee, abstract). The microparticles are taught to be polydioxanone (PDA), polylactic acid, polyglycolic acid, copolymers thereof, and mixtures thereof (see Lee, page 7, paragraph 5). Specifically, a polylactic acid-glycolic acid copolymer (i.e., poly(lactic-co-glycolic acid)) is taught as well (see Lee, page 8, paragraph 5). The microparticles are surface-treated using plasma injection (see Lee, page 4, paragraphs 1-6), mixing with a biocompatible carrier and distilled water, then freeze-drying the mixture to form a final product (see Lee, page 12, paragraph 5).
In regards to claims 2-3, while a weight ratio of the PDO and polylactic acid-glycolic acid copolymer is not mentioned directly in Lee, it is taught that a mixture of the two polymer microparticles is taught. It would be within the purview of one with ordinary skill in the art to envisage an equal mixture (i.e., 50% of PDO microparticles and 50% of PGLA microparticles) as a starting point for the mixture.
In regards to claims 4-5, it is taught that the biocompatible carrier is hyaluronic acid or alginic acid and its salts (e.g., alginate) (see Lee, page 4, paragraph 4).
In regards to claim 6, the freeze-drying is done at -70°C for 1 to 72 hours or more specifically from 15-24 hours (see Lee, page 12, paragraph 6). MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
In regards to claim 7, MPEP §2112.01(I) states that “[w]here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” The method of the prior art while not identical to the conditions listed in claim 7, the method produces a final product that is identical to the instant claims. As such, the burden is shifted to the applicant to show that the effect of the conditions of the method claimed by claim 7 provides different or unexpected result from the method of the prior art.
In regards to claims 8-19, the microparticles are taught to be formed by providing a first composition comprising an organic solvent miscible with water, and a biodegradable polymer; providing a second composition comprising a surfactant and water; preparing a mixture by mixing the first composition and the second composition; preparing a third composition comprising fine polymer particles by stirring the mixture; separating the polymer microparticles from the third composition; and selecting the polymer microparticles having an average particle diameter of 20 to 50 µm from the separated polymer microparticles (see Lee, page 8, paragraph 3). It is taught that the microparticles are washed after precipitation and filtration (see Lee, page 11, paragraphs 3-5). MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
It is taught that the organic solvent miscible with water is HFIP (1,1,1,3,3,3-Hexafluoro-2-propanol), acetone (Acetone), acetonitrile (Acetonitrile), acetic acid (Acetic acid), Dioxane, ethanol, methanol, isopropyl alcohol (IPA), propanol (Propanol), tetrahydrofuran (Tetrahydrofuran, THF), pentane (Pentane) and mixtures thereof (see Lee, page 9, paragraph 2). Specifically, it is taught when polydioxanone is used, HFIP is the organic solvent used (see Lee, page 9, paragraph 2). The surfactant is taught to be polyvinyl alcohol (PVA) (see Lee, page 9, paragraph 7).
Lee does not teach with sufficient specificity to anticipate and so the claims are obvious. It would be obvious to one with ordinary skill in the art before the effective filing date to rearrange the teachings of Lee with a reasonable expectation of success to obtain the method of the instant claims.
A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. “[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. A person of ordinary skill in the art who is not an automaton is capable of producing the method of the instant claims with predictable results.
Conclusion
No claims allowed.
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/Isis A Ghali/Primary Examiner, Art Unit 1611
/A.A.A./Examiner, Art Unit 1611
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