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 .
This action is responsive to claims 1-8 filed on May 17, 2024.
Priority
The present application is a DIV of a 35 U.S.C. 371 national stage filing of the International Application No. PCT/JP2018/00048389, filed Dec. 27, 2018, which claims foreign priority 35 U.S.C. 119(a)-(d) to Japanese Patent Application No. JP2017-252420 filed on Dec. 27, 2018.
Thus, the earliest possible priority for the instant application is Dec. 27, 2018.
Information Disclosure Statement
The information disclosure statements filed May 17, 2024; June 5, 2024; June 28, 2024; Sept. 3, 2024; and Oct. 23, 2024 are in compliance with the provisions of 37 CFR 1.97. 1.97. As such, the IDSs have been considered by the examiner.
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.
Claim(s) 1-5, 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over
Cinatl et al. (US 5,393,668) in view of Lee et al. (1998, Science and Technology of
Polymers and Advanced Materials), Kumaki et al. (US 6,984,692), and Pinschmidt et al. (EP0339371), all cited in the IDS filed on May 17, 2024.
The claims are directed to scaffolding material for cell culture that includes a synthetic resin having a graft copolymer with a polyvinyl alcohol on a main chain and a vinyl on a graft chain, where the graft chain includes an amine, imine or amide structure. The synthetic resin further has a nitrogen content of 0.1 -10% nitrogen by mass.
With respect to independent claim 1, Cinatl et al. teach a substrate used for culturing mammalian cells that includes a polyvinylformal or polyvinyl butyral surface (col. 2, lines 31-39). Cinatl et al. teach that PVF and PVB are known polymers belonging to the "polyvinylacetals" which are formed by reaction of aldehyde (formaldehyde or butyraldehyde) and polyvinyl alcohol (col. 3, lines 15-18).
Cinatl et al. do not teach the substrate containing the synthetic resin, i.e. polyvinylacetals (PVF or PVB), has a nitrogen content of 0.1% by mass or more and 10% by mass or less.
Lee et al. teach that the behavior of the cell adhesion and proliferation of different
types of cells on polymeric materials depend on the surface characteristics such as
wettability, chemistry, charge, roughness and rigidity, and the polymeric surface of the
cell culture substrate can be modified by using different functional groups including
amine group (p. 537-538; Fig. 3). Lee et al. teach that the surface modification using
-CH2-NH2 (amine group) on PE surface as shown in Fig. 3 was improved with cell
adhesion of CHO cells.
It would have been obvious to a person skilled in the art to modify the PVF or
PVB resin of Cinatl et al. used for cell culturing to contain a functional group such as
amine group in order to facilitate cell adhesion in the cell culturing process.
Kumaki et al. teach polyvinylaetals produced by N-vinylamide-having PVA
interacting with aldehyde to form polyvinyl acetal (col. 3, lines 33-37). Kumaki et al.
teach that N-vinylamide can be N-vinylacetamide or N-methyl-N-vinylacetamide having formula (1) (col. 3, lines 14-22).
Thus, it would have been obvious to a person skilled in the art to use n-
vinylamide containing PVA interacting with aldehyde to produce amino-functional
polyvinyl acetals as taught by Kumaki in the method of Cinatl et al. in view of Lee et al.
with a reasonable expectation of success.
Pinschmidt et al. teach that PVA can be copolymerized with polyvinylamine to produce poly(vinyl alcohol)-co-poly(vinylamine) (Abstract). As the copolymer of Pinschmidt et al. contain amine group, the copolymer of Pinschmidt et al. is considered to be a suitable amino-functionalized PVA to produce amino-functionalized PVF or PVB. Thus, it would have been obvious to a person skilled in the art to use the poly(vinyl alcohol)-co-poly(vinylamine) taught by Pinschmidt et al. to form amino-functionalized PVF or PVB for the method of Cinatl et al.
in view of Lee et al. with a reasonable expectation of success. It is noted that the
specification discloses that PVA can be a copolymer with polyvinylamine (formula 3) as
discussed in the previous OA. The formula of Pinschmidt et al. contain polyvinylamine
as it is a copolymer of poly(vinyl alcohol) and poly(vinylamide). Furthermore, the specification of the application teaches an amino group or amino structure as a side chain is the same as it being on the graft chain o the modified PVA resin (published application, pg. 81).
With respect to the claimed nitrogen content, Cinatl et al. in view of Lee and Kumaki et al. do not teach the limitation.
However, the amount of nitrogen in the PVF or PVB of Cinatl et al. in view of Lee and Kumaki et al. or Pinschmidt et al. would be readily modified by the amount of amino-compound (i.e. amide and/or amine) present in the PVA in the production of amino-functionalized PVA or PVA copolymerized with polyvinylamine with a reasonable expectation of success.
With respect to dependent claims 2, 3 and 7, the process of forming polyvinyl acetal (PVF or PVB) made by the combined teachings of Cinatl et al. in view of Lee and Kumaki et al.
as discussed above would inherently contain the claimed amine-, amide- and/or imine-based structures as the PVF or PVB produced by using N- vinylamide containing PVA and aldehyde taught by Cinatl et al. in view of Lee and Kumaki et al. is considered the same as the claimed invention. Particularly, the specification discloses that PVA can be a copolymer with polyvinylamine (formula 3) or amide group (formula 4), and these formulas are present in the copolymer of Pinschmidt et al. Therefore, it is expected that upon the reaction forming PVF or PVB using the copolymer of Pinschmidt et al. with an aldehyde, the resulting PVF or PVB derived from poly(vinyl alcohol)-co-poly(vinylamine) of Pinschimdt et al. would inherently contain amine, amide and/or imine structure.
With respect to dependent claims 4 and 5, directed to the degree of acetalization,
Kumaki et al. teach that the degree of acetalization of the polymer is 45-80 mol% (co. 3,
lines 33-48).
With respect to dependent claim 8, Cinatl et al. teach that PVF or PVB is coated on a substate (col. 4, ll. 64-66), thus teaching a “resin film”.
Note that claim 6 is not rejected as it recites the limitation that the polyvinyl acetal resin is a polyvinyl butyral resin. The affidavit and arguments submitted in parent case 16/958,182 (dated Nov. 27, 2023) demonstrated that a CPB scaffold (commensurate with claim 6) had similar of higher efficiencies than ECM substrates for cell culture. As such, the inclusion of this limitation rebuts a prima facie case of obviousness for this claim.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, 6, 8-10, 12 and 15-18 of U.S. Patent No. 12,116,557 (the ‘557 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘557 patent teaches culturing a cell on a scaffolding material that include a synthetic, polyvinyl acetal resin with a nitrogen content of 0.1% -10% by mass (claim 1); that the synthetic resin has a structural unit with an amine, imine or amide structure (claims 4-6); an acetylation of 54% or more (claims 8 and 9); the polyvinyl acetal resin is a polyvinyl butyral resin (claim 10); the scaffolding material is a resin film (claim 12); the polyvinyl acetyl resin is a graft copolymer with a graft chain containing an amine, imine or amide structure (claim 15); the graft copolymer has a polyvinyl acetal on a main chain and vinyl compound on the graft chain (claim 16); the vinyl compound includes ethylene, allylamine, vinylpyrrolidone, maleic anhydride, maleimide, itaconic acid and meth(acrylic) acids (claim 17); and the vinyl compound includes N-vinylpyrrolidone and N-isopropylacrylamide. (claim 18). As such, all the limitations of the rejected claims in the application are taught by the claims in the ‘557 patent.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-9, and 11-19 of U.S. Patent No. 12,180,450 (the ‘450 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘450 patent teaches a scaffolding material for cell culture that include a synthetic, polyvinyl acetal resin that is a graft copolymer with a vinyl compound (claim 1); that the vinyl compound includes ethylene, allylamine, vinylpyrrolidone, maleic anhydride, maleimide, itaconic acid and meth(acrylic) acids (claim 2); the scaffolding material is a resin film (claim 4); the polyvinyl acetal resin is a polyvinyl butyral resin (claim 5); that the synthetic resin has a structural unit with an amine, imine or amide structure having 0.1 mol% - 10 mol% (claim 6); an acetylation of more than 60% (claim 7). The recitation of amine, imine or amide structure having 0.1 mol% - 10 mol% renders obvious the claimed nitrogen content of 0.1% -10% by mass (see claims 6, 9, and 12), as the corresponding presence of the mol% of the nitrogen-containing side chains would overlap with the cited range of nitrogen content. As such, all the limitations of the rejected claims in the application are rendered obvious by the claims in the ‘450 patent.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,365,860 (the ‘860 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘860 patent teaches a scaffolding material for cell culture that include a synthetic, polyvinyl acetal resin (claim 1); that the synthetic resin has a structural unit with an amine, imine or amide structure (claim 3); that the amino group or amide structure has 0.1 mol% - 20 mol% (claim 4); an acetylation of more than 60-90 mol% (claim 6); that the polyvinyl acetal resin has an amino group or amide structure on its graft chain (claim 10). The recitation of amino groups or amide structure having 0.1 mol% - 20 mol% renders obvious the claimed nitrogen content of 0.1% -10% by mass (see claim 4), as the corresponding presence of the mol% of the nitrogen-containing side chains would overlap with the cited range of nitrogen content. As such, all the limitations of the rejected claims in the application are rendered obvious by the claims in the ‘860 patent.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,152,228 (the ‘228 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘228 patent teaches a scaffolding material for cell culture that include a synthetic, polyvinyl acetyl resin film with a structural unit with an amine, imine or amide structure (claim 1); that the amine, imeine or amide structure has 0.1 mol% - 30 mol% (claim 3); that the polyvinyl acetal resin is a polyvinyl butyral resin (claim 4); an acetylation of 54% or more (claim 5); the polyvinyl acetyl resin is a graft copolymer with a vinyl; (claim 6). The recitation of amino groups or amide structure having 0.1 mol% - 30 mol% renders obvious the claimed nitrogen content of 0.1% -10% by mass (see claim 3), as the corresponding presence of the mol% of the nitrogen-containing side chains would overlap with the cited range of nitrogen content. As such, all the limitations of the rejected claims in the application are rendered obvious by the claims in the ‘228 patent.
Conclusion
No claims are allowed.
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/TERESA E KNIGHT/Primary Examiner, Art Unit 1634
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