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 instant application is a DIV of 17/021,651, now U.S. Pat. No. 12,018,826.
Claim Objections
Claims 2 and 3 are objected to because of the following informalities: claims 2 and 3 are not grammatically correct. The word “Claim” should be replaced with the word “claim”. Appropriate correction is required.
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 1-4 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claims do not recite something significantly different than a judicial exception. The rationale for this determination is explained below.
The Claims
The claims are directed to:
A composition comprising a cell culture media comprising a nephron progenitor cells or a podocyte cell and FGFR, BMP and WNT pathway inhibitors.
Teachings in the Art
Regarding nephron progenitor cells and podocytes, the art teaches that nephron progenitor cells and podocytes naturally occur in the kidney (see Shankland et al., 2014, Semin. Nephrol. Vol. 34(4), pgs. 418-428)
Regarding an FGFR pathway inhibitor, the art teaches that FGFR1 is a naturally occurring inhibitor of the FGFR pathway (Silva et al. 2013, JBC, Vol. 288(24), pgs. 17859-17870).
Regarding a BMP pathway inhibitor, the art teaches that chordin and noggin are naturally occurring inhibitors of the BMP pathway (Anderson et al. 2006, Dev. Dyn., Vol. 235(9), pgs. 2507-2520).
Regarding a WNT pathway inhibitor, the art teaches that Dickkopf and Frizzled-related proteins are naturally occurring inhibitors of the WNT pathway (Rismani et al. 2022, Recent Advances in Homeostasis, Insights into the Wnt Signaling Pathway Evolution, pgs. 1-31).
Teachings in the Specification
The specification teaches in Example 1 the stepwise differentiation of nephron progenitor cells into podocytes. However, the claimed nephron progenitor cells and podocytes were not subjected to any modification that would markedly distinguish them from their natural occurring counterparts. While the claimed cells were obtained from an in vitro differentiation method, the claimed cells recite no structural or functional feature that would distinguish them from those that occur in nature.
Accordingly, the claims are directed to a composition using only a nature-based product, i.e., nephron progenitor cells and podocytes, these nature-based products are then analyzed to determine whether they have markedly different characteristics from any naturally occurring counterpart(s) in their natural state. The claims thus encompass nephron progenitor cells and podocytes which are identical (no difference in characteristics) to naturally occurring nephron progenitor cells and podocytes.
Because there is no difference between the nephron progenitor cells and podocytes used in the claimed composition, the claimed nephron progenitor cells and podocytes do not have markedly different characteristics, and thus are a “product of nature” exception. In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1338-39 (Fed. Cir. 2014). Accordingly, the claimed compositions are directed to an exception. Because the claimed compositions do not include any additional features that could add significantly more to the exception, the claimed nephron progenitor cells and podocytes do not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
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An examination of Step 2A in the revised 101 guidance, with respect to the claimed invention, the answer is yes since the claimed composition and system comprise only naturally occurring products (judicial exceptions), in the instant case this naturally occurring products are nephron progenitor cells, podocytes and FGFR, BMP and WNT pathway inhibitors.
It is only the recited limitations in the claims that are examined under 101 and not aspects such as what the cells are capable of being used for (i.e. for use in transplantation). In this case only nephron progenitor cells and podocytes are examined with respect their status as a judicial exception. It is emphasized that the claimed invention is a composition and not a method.
An examination of Step 2B, the answer is no with respect to the claimed invention. There are no other additional elements recited in the claims that would amount to significantly more than the judicial exceptions. This is because while the claimed invention is drawn to nephron progenitor cells, podocytes and FGFR, BMP and WNT pathway inhibitors, there are no additional components which impart any additional element or structural limitations to the recited cells. It should be noted that there is not definition for what is encompassed by a “system” and this broadly encompasses the nephron progenitor cells and podocytes in one container and the inhibitors in another. The container does not markedly change the nephron progenitor cells and podocytes. The nephron progenitor cells and podocytes of the claims are indistinguishable from nephron progenitor cells and podocytes that exist in nature. The nephron progenitor cells and podocytes of the claims have the same capability as those that exist in nature and the fact that they are present in an isolated population or a container does not change the nephron progenitor cells and podocytes in significant or meaningful way to amount to more than the judicial exception.
The only factors which can be examined under 101 in the claimed composition are those that are recited in the claim i.e. a nephron progenitor cells and podocytes.
How the cells are obtained and the knowledge of using said cells and population are not considered with respect to a composition, it is only the judicial exceptions themselves that are analyzed under 101 and in this case all of the components in the claimed composition are naturally-occurring products and thus qualify as a judicial exception.
Closest Prior Art
The closest prior art is the teachings of Begum S. (2/2019, Am. J. Transl. Res., Vol. 11(2), pgs. 1102-1115) who teaches a variety of methods to generate podocytes from nephron progenitor cells, however the prior art does not teach the claimed composition or the system comprising the combination of inhibitors recited in the claims.
Conclusion
No claims are allowed. The claims are free of the prior art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID A MONTANARI whose telephone number is (571)272-3108. The examiner can normally be reached M-Tr 8-6.
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/DAVID A MONTANARI/Examiner, Art Unit 1632
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