DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Analysis
Claims 14 – 27 contain a requirement that a cell culture microcarrier having a “specific gravity of 1.10 g/cm3 or more”. Specific gravity is generally (but not always) defined as the ratio between the density of the substance in question to the density of water at 4°C. Specific gravity is therefore a dimensionless quantity. No special definition is provided that defines specific gravity in any way other than the plain meaning of the term. However, the prior art consistently conflates the density of a cell culture microcarrier with its specific gravity, sometimes reporting specific gravity with units and other times as the ratio. Accordingly, the Examiner interprets the term “specific gravity” to be synonymous with “density”, which has units of [mass]/[length]3.
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 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 14:
Present claim 14 recites “a step (2) of forming a coating layer on the outer surface of a base particle by … separating the base particle impregnated with the solution”. There is a lack of antecedent basis for the action of impregnating the base particle as recited. It then becomes unclear whether such impregnation is a substep of the obtaining the recited solution, an unrecited step, or a property of the base particle, rendering the claim indefinite.
Dependent claims are rejected on the basis of the deficiencies of their parent claims.
Claim Rejections - 35 USC § 103
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.
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.
Claim 14 – 18, 20 – 21, 23 – 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shannon et al. US 2012/0052579 A1 (hereinafter “Shannon”).
Regarding claims 14, 16, 17, 18:
Shannon is directed to cell culture articles and methods of making such articles (Abstract). Shannon discloses that the cell culture article comprises a microcarrier base [base particle], an outer binding polymer layer, and covalently bonded peptides grafted onto the binding polymer layer or as part of the binding polymer layer (Fig. 2, 3; [0046], [0050], [0056], [0064], [0078], [0106]). Shannon discloses that in embodiments, the microcarriers may have a density [specific gravity relative to water] between 1.01 to about 1.10 grams per cubic centimeter, which allows for readily maintaining cell culture medium with gentle stirring ([0047]).
Shannon discloses that their method comprises: preparing a solution containing a solvent(s) and a binding polymer ([0075] – [0076]); and attaching the binding polymer onto the microcarrier base by e.g. spraying of the solution, or dipping by solution [impregnation and separation in light of the indefiniteness of the claim] ([0085]). The binding polymer may be a poly(vinyl acetate-maleic anhydride) copolymer [polyvinyl alcohol derivative skeleton] or a copolymer derived from maleic anhydride and (meth)acylates [poly(meth)acrylic acid ester skeleton] ([0069], [0075] – [0076]). Afterwards a polypeptide may be conjugated [reacted] with the binding polymer ([0043], [0046], [0106]).
While Shannon does not expressly teach a specific embodiment of their method that results in a cell culture microcarrier having a specific gravity of 1.10 g/cm3 or more, Shannon does expressly teach a range that shares an endpoint with the claimed range and discloses that the disclosed range is advantageous in allowing cell culture medium to stay in suspension with gentle stirring ([0047]). Furthermore, the density may be controlled by the amount of binding polymer attached ([0096]). 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, 191USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66(Fed. Cir. 1997). See MPEP 2144.05. Additionally, in the case where the claimed ranges exists where the claimed ranges or amounts do not overlap with the prior art but are merely close, a prima facie case of obviousness exists. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).
Regarding claims 15, 20, 23, 24:
Shannon discloses that linkers or spacers may be provided to conjugated between the binding polymer to a peptide ([0110]).
Shannon does not expressly teach that the resin at step 1 has a peptide, linker moiety, or both per se.
However, Shannon discloses the binding polymer coating may be the binding polymer itself or the binding polymer with polypeptides present ([0046]; Fig. 2, 3). Shannon further discloses steps of conjugating the binding polymer with the linker and conjugating the binding polymer or the linker to a peptide ([0078], [0089], [0106], [0110], [0126]). Therefore, the difference between Shannon’s disclosure and the instant claim is the ordering of steps. Outside a showing of unexpected results, a prima facie case of obviousness exists where the difference between the prior art and the claimed method/process is the order of the performance of the steps taught by the prior art. See Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959) and In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946).
Regarding claim 21:
Shannon discloses that the linker may be a polyamine [amino groups] or with terminal amines ([0089], [0110]).
Regarding claims 25, 26:
Shannon discloses that the microcarrier base may be a polymeric material of polystyrenes or polymethylmethacrylates [polymer of a monomer having an ethylenically unsaturated group] ([0056]).
Regarding claim 27:
Shannon discloses that the cell culture microcarrier manufactured may have a diameter between 20 µm to 1000µm ([0048]).
Claim(s) 19, 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shannon as applied to claims 14 – 18, 20 – 21, 23 – 27 above, and further in view of Iguchi et al. WO 2020/230886 A1 (of record), with US 2022/0227898 A1 acting as the official translation and referenced herein (hereinafter “Iguchi”).
Regarding claims 19, 22:
Shannon does not expressly teach that the polyvinyl acetal skeleton is a polyvinyl butyral skeleton; and the linker includes (meth)acrylic acid, carboxyl group-containing acrylamide or both.
Iguchi is directed to resin films formed in cell culture scaffold materials (Abstract). Cell culture scaffold materials include particles ([0140]). Iguchi discloses that linkers between the resin coating and peptides include (meth)acrylic acid, a carboxyl group-containing acrylamide ([0130]). Iguchi also discloses that a polyvinyl acetal resin coating may be a polyvinyl butyral resin and that such resin in combination with linkers and peptides enhance the adhesion of cells after seeding the cell culture scaffold ([0029], [0091]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the method of Shannon by using a linker including (meth)acrylic acid or carboxyl group-containing acrylamide or both and that the polyvinyl acetal skeleton is a polyvinyl butyral skeleton because as taught by Iguchi, the use of such linkers and skeletons, respectively, are known to be suitable for the purpose of linking between a resin and a peptide. The courts have held that the selection of a known material/device/product based for its intended use supports a prima facie case of obviousness. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Additionally, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the method of Shannon to have the polyvinyl acetal skeleton is a polyvinyl butyral skeleton because Iguchi teaches that the use of such a skeleton enhances the adhesion of cells after seeding the cell culture scaffold, including microcarriers.
With regards to Iguchi:
The Examiner notes that the publishing date of Iguchi is November 19, 2020, which is more than one year away from the effective filing date of the present application, February 2, 2022. However, the Applicant has a claim of foreign priority with the earliest date being February 3, 2021. Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
If such a translation is provided to perfect the foreign priority claim, the effective filing date would then change to February 3, 2021. Iguchi is qualified as prior art under 35 U.S.C. 102 (a)(1).
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that lists exceptions to what may be considered prior art:
(b)(1) DISCLOSURES MADE 1 YEAR OR LESS BEFORE THE EFFECTIVE FILING DATE OF THE CLAIMED INVENTION.—A disclosure made 1 year or less before the effective filing date of a claimed invention shall not be prior art to the claimed invention under subsection (a)(1) if—
(A) the disclosure was made by the inventor or joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor; or
(B) the subject matter disclosed had, before such disclosure, been publicly disclosed by the inventor or a joint inventor or another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor.
Should the effective filing date become the earliest foreign priority date, the Examiner notes that Iguchi is coauthored by the joint inventors of the instant application, that the publication date of Iguchi is before a potential effective filing date of February 3, 2021, which would be within the grace period of 1 year before the potential effective filing date of the claimed invention. However, Iguchi also lists six other inventors that were part of the disclosure within both Iguchi; Iguchi therefore is a different inventive entity than that of the instant application and it is not immediately clear what parts of both Iguchi are attributed to one or more of the joint inventors. Should the effective filing date become February 3, 2021, the Applicant may file an affidavit or declaration under 37 CFR 1.130 to establish that a disclosure is not prior art under 35 USC 102(a) due to an exception in 35 USC 102(b). Where the authorship of the prior art disclosure includes the inventor or a joint inventor named in the application, an "unequivocal" statement from the inventor or a joint inventor that he/she (or some specific combination of named joint inventors) invented the subject matter of the disclosure or relevant parts of the disclosure, accompanied by a reasonable explanation of the presence of additional authors, may be acceptable in the absence of evidence to the contrary. See In re DeBaun, 687 F.2d 459, 463, 214 USPQ 933, 936 (CCPA 1982).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSE I HERNANDEZ-KENNEY whose telephone number is (571)270-5979. The examiner can normally be reached M-F 6:30-3:30.
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/JOSE I HERNANDEZ-KENNEY/
Primary Examiner
Art Unit 1717