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
This action is in response to the papers filed on September 3, 2024. Pursuant to amendment filed September 3, 2024, claims 3-4 and 6 are amended.
Claims 1-8 are currently under examination.
Priority
The present application is a 35 U.S.C. 371 national stage filing of the International Application No. PCT/JP2022/033459, filed September 06, 2022, which claims priority to Japanese Application No. JP2022-033391, filed on March 4, 2022 is acknowledged.
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Japan on March 4, 2022. Filing on September 3, 2024 of certified untranslated copy of the Japanese publication JP2022-033391 filed on March 4, 2022 is acknowledged. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CPR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Thus, priority date is not yet perfected, and the earliest possible priority for the instant application is March 4, 2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on September 3, 2024 is acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim objection
Claim 5 is objected to because of the following informalities: the phrase “the cell culture substrate is insolubilized is performed” contains a typographical and grammatical error. Applicant may obviate the objection by reconstructing the claim language and amending the language to remove the grammatical error.
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.
Claims 1-8 are 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.
Claim 1 recites “one or more proteins of a silk protein, a silk protein hydrolysate, fibroin, and a fibroin hydrolysate.” The phrase “one or more proteins of a silk protein” renders the scope of the claim unclear because a silk protein is itself a protein and therefore cannot reasonably be interpreted as comprising “one or more proteins” of the same silk protein. It is unclear whether the claim encompasses one or more silk proteins, one or more proteins selected from the recited group, or other subject matter. Applicant may obviate this rejection by amending the claim to clarify the intended scope, such as reciting “one or more silk proteins.”
Claim 6 recites the limitation "the cultured adherent cells" in line 3. There is insufficient antecedent basis for this limitation in the claim. If it was applicant’s intention to find antecedent basis in claims 1 or 4, applicant may obviate the rejection by reciting “adherent cells” in the parent claims.
Claims 2-5 and 7-8 are rejected for being dependent from the rejected claims 1 and 6 and also for failing to further clarify the basis of the rejection.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Masuhiro et al. (JP-H11243948 A; see IDS).
Regarding claims 1-2, Masuhiro discloses a cell culture bed base material for growth of animal cells, including adherent cells, comprising a membrane body containing silk proteins, including silk fibroin, attached to a cell culture substrate ([0011-0013]; [0020]; [0057]). Masuhiro further discloses coating a cell culture vessel with a sterilized aqueous silk protein solution, drying the coating, and insolubilizing the coating to form a silk coating film ([0014-0016]).
Regarding claim 3, dependent on claim 1, Masuhiro discloses sterilizing silk fibroin solutions by autoclaving ([0030]).
Regarding claims 4-5, dependent on claim 1, Masuhiro disclose cell culture vessels, including petri dishes, cylinders, or flasks coated with silk protein and insolubilizing the coating, by contact with alcohol, aldehyde, or UV irradiation ([0014-0018]; [0031-0032]; [0073]).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Masuhiro et al. (JP 11-243948 A, see IDS), in view of Xu et al. (Adv. Mater. Interfaces. 2019, 6, 1801822.) and Li et al. (Biomaterials. 2003 Jan;24(2):357-65.).
Regarding claims 1-2, Masuhiro discloses a cell culture bed base material for growth of animal cells, including adherent cells, comprising a membrane body containing silk proteins, including silk fibroin, attached to a cell culture substrate ([0011-0013]; [0020]; [0057]). Masuhiro further discloses coating a cell culture vessel with a sterilized aqueous silk protein solution, drying the coating, and insolubilizing the coating to form a silk coating film ([0014-0016]).
Regarding claim 3, dependent on claim 1, Masuhiro discloses sterilizing silk fibroin solutions by autoclaving ([0030]).
Regarding claims 4-5, dependent on claim 1, Masuhiro disclose cell culture vessels, including polystyrene (hydrophobic) petri dishes, cylinders, or flasks coated with silk protein and insolubilizing the coating, by contact with alcohol, aldehyde, or UV irradiation ([0014-0018]; [0031-0032]; [0073]).
Regarding claim 6, dependent on claims 1 and 4, Masuhiro does not tach detaching adherent cells by degrading the silk protein coating with an enzyme capable of degrading the protein.
However, before the effective filing date of the instant application, the ordinary artisan would have recognized that silk fibroin cell-culture substrates are enzymatically degradable, further in view of the teachings of Xu and Li.
Xu teaches micropatterned silk fibroin cell substrates that support cell adhesion and proliferation and further teaches proteolytic degradation of the fibroin substrate using Protease XIV (Abstract; pg. 5, Section: 2.2. Proteolytic Degradation of Fibroin Substrates In Vitro; pg. 7, column 1, last para.).
Moreover, Li teaches that silk fibroin sheets are susceptible to enzymatic degradation by Protease XIV and demonstrates fibroin matrix proteolytic digestion (Abstract; Fig. 1-2; pg. 358, Section: 3.1. Quantitative changes in porous silk fibroin sheets during enzymatic degradation).
Therefore, the ordinary artisan would have found it obvious to apply a known fibroin-degrading enzyme, such as Protease XIV, as taught by Xu and Li, to the known silk fibroin cell-culture substrate of, as taught by Masuhiro, with a reasonable expectation of success at detaching adherent cells. Xu and Li teach fibroin substrates are predicably degraded under cell-culture conditions by such enzymes.
Regarding claim 7, dependent on claims 1, 4, and 6, the combined teachings of Masuhiro, Xu, or Li do not expressly teach removing culture medium and adding the degrading enzyme without washing the cell-culture substrate. However, washing is a conventional preparatory step in standard cell culture protocols, and its inclusion or omission represents a matter of routine optimization within the ordinary skill of the artisan. Since the enzyme acts on the fibroin substrate rather than the washing solution itself, the ordinary artisan would have reasonably expected that omission of the washing step would still permit degradation of the fibroin substrate and detachment of adherent cells. Therefore, the ordinary artisan would have found it obvious to omit the washing step to simplify the procedure while obtaining the predicable result of cell release.
Regarding claim 8, dependent on claims 1, 4, and 6, the combined teachings of Masuhiro, Xu, or Li do not expressly teach adding the degrading enzyme without first removing the liquid culture medium. However, the presence or absence of culture medium during enzyme treatment represents a matter of routine optimization within the ordinary skill in the art. Since Xu (pg. 7, Section: 4. Experimental Section) and Li (pg. 358, column 1, para. 1-2 and 4) teach that fibroin substrates are susceptible to enzymatic degradation under aqueous biological conditions, one of ordinary skill in the art would have reasonably expected that the degrading enzyme would remain capable of degrading the fibroin substrate in the presence of culture medium. Therefore, the ordinary artisan would have found it obvious to add the degrading enzyme directly to the culture vessel without first removing the culture medium in order to simplify the detachment procedure while still obtaining the predictable results of enzymatic degradation of the fibroin substrate and release adherent cells.
Conclusion
Claims 1-8 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL D LEVIN whose telephone number is (571)270-0616. The examiner can normally be reached Fulltime Teleworker.
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/J.D.L./Examiner, Art Unit 1633
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699
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