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 arguments, filed 2/20/2025, have been fully considered but they are not deemed to be fully persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objects are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
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.
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, 9, 12, 21, and 23-33 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018185770 to Kaufmann in view of Alves (Macromol. Biosci. 2011). Kauffman discloses a polymer conjugate composition comprising at least one pharmacological agent wherein the conjugate comprises a polymer made up of backbone units “X,” said polymer is linked to a pendant group bearing a bioactive functional group “Y” by linker “L” (abstract; page 6, line 20 to page 7, line 5). In some embodiments, the polymer is used to form a sponge, which is shrunk to a small size (a particle; wherein the functionalized polyvinyl alcohol is present at a surface of the particle; sponges are characterized by their network of pores and accompanying pore surfaces (“at a surface”)) (page 45, line 32). Further, Kaufman contemplates attaching the polymer to a nanoparticle or microparticle (a particle; wherein the functionalized polyvinyl alcohol is present at a surface of the particle) (page 45, lines 3-19). Further, Kauffman recites that the purpose of the invention is to provide medical grade and non-medical grade materials which are configured to change their property following stimulation, and teaches one form that provides the desired property are nanoparticles and microparticles (a particle; wherein the functionalized polyvinyl alcohol is present at a surface of the particle), these being desired by Kauffman as providing "an improved polymer delivery system” having the structure of polymeric microparticle compositions, wherein the polymeric microparticle compositions and porous microparticles formed therefrom encapsulate at least one substance, such as a biologic substance (page 2, lines 21-29). The polymer may be polyvinyl alcohol (an emulsifier) (page 7, lines 26-28; and page 17, line 8). The functional group may be acryl (a small molecule having a weight average molecular weight of less than 2000 g/mol) (page 7, lines 15-16). The composition may be prepared in layers (sheets) (page 50, lines 2-5; 14-16). The conjugate may be incorporated with a particle comprising a polymeric matrix comprising a biocompatible and biodegradable polymer and a bioactive agent carried by the polymeric matrix (page 6, line 22; page 44, lines 3-12; claim 25)). The linker may be thiocarbamate (S-thiocarbamate; page 8, line 25; page 27, line 4; page 38, line 28; page 39, lines 10 and 25; page 40, lines 2 and 21; page 43, line 30 to page 44). The composition may comprise halide groups including fluoride (page 42, lines 12), vinyl fluoride (page 23, lines 4-7), and fluoropolymers (page 7, lines 26-28; page 22, lines 23-29) (optically detectable labels). The polymer(vinyl alcohol) may be a homopolymer or copolymer (page 7, lines 26-28)
Kauffman fails to expressly teach the combination of polyvinyl alcohol as the polymer with thiocarbamate, the presently claimed molecular weight ranges, and the particle size required by claim 27.
Alves is directed to polyvinyl alcohol crosslinked implants (Introduction; Molecular Polymer Engineering and Bioconjugation). The molecular weight may be 14 kDa and 89-97 kDa) (Figure 7).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to incorporate polyvinyl alcohol as the polymer and thiocarbamate as the linking group. The motivation for this is Kauffman teaches use of this polymer and use of the linking group is one embodiment that affords a polymer conjugate composition. Kauffman provides sufficient guidance to this end, as polyvinyl alcohol is selected out of eight choices of preferred polymers (page 7, lines 26-28), and is preferred throughout the disclosure (page 7, lines 26-28; and page 17, line 8; page 20, line 20 to page 22, line 9); and thiocarbamate (S-thiocarbamate) is further preferred throughout the disclosure (page 8, line 25; page 27, line 4; page 38, line 28; page 39, lines 10 and 25; page 40, lines 2 and 21; page 43, line 30 to page 44). It would have been further obvious to optimize the molecular weight of the polyvinyl alcohol to optimize the efficacy of the conjugate. In this way, one would find applicant’s ranges through routine experimentation. The prior art provides sufficient guidance to this end, as Alves teaches molecular weight of 14 kDa (14,000 g/mol) and 89-97 kDa (89,000-97,000 g/mol), which overlaps with the present ranges. It would have been further obvious to optimize the diameter of the particle of Kauffman, and in this way would find the present range of a diameter of 40 micrometers or less. Kauffman provides sufficient guidance to this end, as it teaches microparticle systems, which the artisan would understand indicates a diameter range on the order of micrometers, and would find the present value “‘[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)” MPEP § 2144.05, II.
Applicant’s arguments have been fully considered but are not found persuasive. Regarding applicant’s arguments related to the claim language “a particle,” applicant’s arguments are predicated on the claimed particle being very small, and the art providing no motivation to prepare a very small particle. However, the examiner notes that in claims 1-6, 9, 12, 21, 23-26, and 28-32, there is no limitation on the size of the “a particle.” The term “particle,” in its broadest most reasonable interpretation, is a small, discrete piece of something, and includes macroscopic objects like the discrete materials cited in the references which applicant interprets to be outside the scope of “a particle.” As there is no limitation on the size of the claimed “a particle” in in these claims, it is deemed that the discreet macroscopic objects referenced by applicant fairly read on “a particle.” See page 45, line 32, wherein Kauffman teaches that when the polymer is used to form a sponge, it is shrunk to a small size, which is a small, discrete piece of sponge (a particle; wherein the functionalized polyvinyl alcohol is present at a surface of the particle) (page 45, line 32). Regarding those claims that require a microparticle, Kaufman contemplates attaching the polymer to a nanoparticle or microparticle (a particle; wherein the functionalized polyvinyl alcohol is present at a surface of the particle) (page 45, lines 3-19). Regarding applicant’s argument that and artisan would not optimize or improve on the disclosure of Kauffman without an explicit teaching in Kauffman that teaches the artisan to do so, the examiner’s response is that the standard for obviousness is what the artisan would be motivated to do and does not require an express teaching within the reference that the disclosure may be improved upon. It would be obvious to optimize the molecular weight of the polyvinyl alcohol for the reasons given above, and in this way, one would find applicant’s ranges through routine experimentation. The prior art provides sufficient guidance to this end, as Alves teaches molecular weight of 14 kDa (14,000 g/mol) and 89-97 kDa (89,000-97,000 g/mol), which overlaps with the present range.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL W DICKINSON/Primary Examiner, Art Unit 1618
May 30, 2025