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 .
Priority
This application is a DIVISION of U.S. Patent Application No. 17/006,138, filed 12/30/2024. Acknowledgement is made of the applicant’s claim for benefit to prior-filed U.S. patent applications 17/006,138 (filed 08/28/2020) and PCT Application PCT/JP2019/011389 (filed 03/19/2019), as well as foreign priority based on an application JP2018054310 filed in Japan on 03/22/2018.
Claim Objections
Claim 2 is objected to because of the following informalities: Claim 2 has extra spaces between the word “wherein” and the word “the” in line 1. Appropriate correction is required.
Claim Interpretation
Instant claims 1-2 are directed to a cultured cell (a product), the cell is manufactured by the method as recited in instant claims. The claims are product-by-process claims. MPEP 2113 states: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). In instant case, the disclosure of the structure is a cultured cell (i.e., a cell which is alive under in vitro condition), and more specifically, a cultured renal cell.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (a product of nature) without reciting additional elements that amount to significantly more than the exception.
As stated above, claim 1 is directed to a composition of matter (a cultured cell). As such, the claim falls within a statutory category (Step 1: YES). However, the claimed composition recites only nature-based components, namely a cell, grown outside of a living organism in an artificial environment such as a culture vessel. A cell is a naturally occurring material, which can be alive/grown in vivo (i.e., in a living organism such as animal) or in vitro (i.e., in culture vessel). The claimed cultured cell is therefore a nature-based product that must be analyzed to determine whether it is “markedly different” from its naturally occurring counterparts under the markedly different characteristics analysis set forth in MPEP 2106.04(c) and related guidance.
Under Step 2A, Prong 1, the claim recites a nature-based product limitation, namely a cultured cell. Under Step 2A, Prong 2, the cultured cell is compared to its closest natural counterparts, which is a cell of a living organism such as a cell in animal tissue. The claim does not positively recite any structural, functional, or other property of the cell that is different from, or improved over, the properties of a cell as it occurs in nature. The cultured cell in the claim remains a (viable) cell, there is no indication in the claim of a change in structure (e.g., fractionation, chemical modification, or formation of a new substance) or of a new functional characteristic (e.g., unexpected or changed cell function) that is markedly different from the natural products themselves. Merely place a cell (originally from a living organism) in vitro (i.e., in a culture vessel) to grow/keep it alive, does not by itself confer markedly different characteristics when the components retain their natural properties, as explained in USPTO examples and case law applying the product-of-nature exception. Accordingly, the claimed composition is directed to a product-of-nature judicial exception (Step 2A: YES).
Under Step 2B, the claim is evaluated to determine whether any additional elements, individually or in combination, amount to significantly more than the product-of-nature exception. The only elements in the claim are the nature-based product components (a cell), together with the statement of cell growing condition (being cultured, i.e., in vitro in a culture vessel). The recited cell culturing condition is a limitation that does not impose any structural or functional requirement on the cell beyond its natural properties, and therefore does not amount to significantly more than the judicial exception. The claim as a whole therefore does not include any additional features that integrate the product-of-nature exception into a practical application, nor does it add an inventive concept sufficient to amount to significantly more than the judicial exception itself.
For these reasons, claim 1 is rejected under 35 U.S.C. 101 as being directed to a judicial exception (a product of nature) without reciting additional elements that amount to significantly more than the exception. Claim 2 further limits the cultured cell is a renal cell, based on the same reason, is also rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
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 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 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Valente et al. (PLoS One. 2011 May 4;6(5):e19337).
As stated above, claims 1-2 are directed to a cultured cell, more specifically, a cultured renal cell. Valente et al. teach a technically simple and rapid protocol for the isolation and culture of human proximal tubular epithelial cells and human renal tumor cells from surgical specimens (Abstract). Human proximal tubular epithelial cells (HPTEC) correspond to the major cell type in the human cortical tubulointerstitium (p1, left column), the HPTEC is a renal cell. A cultured HPTEC (see, i.e., p5, figure 3A) reads on the cultured renal cell as recited in instant claims. Thus Valente et al. anticipate instant claims.
Conclusion
No claims are allowed.
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/Q.G./
Examiner, Art Unit 1633
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699
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