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
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119
(a)-(d). Acknowledgment is made of Applicants’ claim for benefit to foreign applications EP20169933.7 filed 04/16/2020.
Acknowledgement is made of Applicants’ claim for benefit to prior filed to Patent Application Number PCT/EP2021/059909, filed on 04/16/2021.
Information Disclosure Statement
The Information Disclosure Statements filed 04/28/2023, 09/03/2024, and 03/10/2025 have been considered by the Examiner.
Status of Claims
Claims 28, 30, 36-43, and 45-46 are under examination.
Claim 1-27, 29, 31-35, 44, and 47 are cancelled.
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.
Rejection of claims 28-30, 36, and 42-46 under 35 U.S.C. 102(a)(1) as being anticipated by Inaba et al. (WO2016/204298A1, citation 2 in 4/28/2023 IDS) have been withdrawn in view of applicant’s amendment filed 09/19/2025.
Rejection of claims 28, 32 and 36-39 under 35 U.S.C. 102(a)(2) as being anticipated by Yamanaka et al. (US8058065B2) have been withdrawn in view of the applicant’s amendment.
Rejection of claim 31 under 35 U.S.C. 102(a)(1) as being anticipated by Esteban et al. (Molecular Basis of Cell and Developmental Biology, 2009) has been withdrawn in view of applicant canceling the claim.
The following rejection is maintained from the Office Action of 06/17/2025 and modified in view of amendments filed 09/19/2025:
Claims 28 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Esteban et al. (Molecular Basis of Cell and Developmental Biology, 2009).
Regarding claim 28 Esteban teach porcine induced pluripotent stem cells (page 17634, abstract). While Esteban does not define the pluripotent stem cells by their expression pattern the iPSCs of Esteban inherently express the same genes as other iPSCs induced following the nuclear reprogramming technique. The specification provides no evidence of a structural difference between the induced pluripotent stem cells produced by the method disclosed and the iPS cells taught by Esteban. In fact, given the pluripotent nature of the claimed cells, the ordinary artisan would believe the induced pluripotent stem cells to be structurally the same. Therefore, the induced pluripotent stem cells of Esteban would inherently express all of the genes of the present application including LMNA, HTRA1, PHLDA1, FGF1 and GASK1B.
Response to Argument
Applicant's arguments filed 09/19/2025 have been fully considered but they are not persuasive
Applicant’s arguments: Applicant argues Esteban does not disclose or teach expression of LMNA, HTRA1, PHLDA1, FGF1 and GASKIB. Applicant argues the markers were specifically identified through comparative analysis as being differentially expressed compared to prior art porcine iPSCs. Applicant argues the present disclosure is additionally the first to identify the genetic fingerprint of a true porcine iPSC. Applicant argues the porcine iPSCs of the disclosure have specific phenotypical properties that characterize true pluripotency, and these have been successfully defined according to a novel gene expression profile of the porcine iPSCs (Remarks, page 5).
Examiner’s Response: While the applicant did identify expression patterns of porcine iPSCs, the higher expression within the population versus the publicly available data does not separate the cells from the art applied. Induced pluripotent stem cells which have been developed through the same methods are capable of similar expression patterns. While the disclosure may be the first to identify the genetic fingerprint of a true porcine iPSC this is not a limitation of the claims. The claims are to iPSC cells expressing LMNA, HTRA1, PHLDA1, FGF1 and GASK1B. Furthermore, while the inventors identified markers of porcine iPSCs, the identification of which does not separate the cells from porcine iPSCs developed utilizing the current methods.
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.
Rejection of claim 34 under 35 U.S.C. 103 as being unpatentable over Yamanaka et al. (US8058065B2) as applied to claim 28 above, and further in view of Inaba et al. (WO2016/204298A1) has been withdrawn in view of the applicant canceling the claim in amendments filed 09/19/2025.
Rejection of claim 41 under 35 U.S.C. 103 as being unpatentable over Yamanaka et al. (US8058065B2) as applied to claim 39 above, and further in view of Inaba et al. (WO2016/204298A1) has been withdrawn in view of the applicants amendments filed 09/19/2025.
Rejection to claims 33, and 35 under 35 U.S.C. 103 as being unpatentable over Esteban et al. (Molecular Basis of Cell and Developmental Biology, 2009) as applied to claim 28 above, and further in view of Inaba et al. (WO2016/204298A1) have been withdrawn in view of the applicant canceling the claims.
The following rejections are maintained from the Office Action of 06/17/2025 and modified in view of Amendments filed 09/19/2025:
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Esteban et al. (Molecular Basis of Cell and Developmental Biology, 2009) as applied to claim 28 above, and further in view of Inaba et al. (WO2016/204298A1, citation 2 in 4/28/2023 IDS).
Esteban teach porcine induced pluripotent stem cells (page 17634, abstract).
Regarding claim 30, Esteban teach the limitations of claim 28 but does not teach the stem cells are derived from neural stem cells (NSC).
Inaba et al. teach the iPSC can be derived from a neural stem cell (NSC) (page 2, paragraph 5).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified the teachings of Esteban for a porcine iPSC with the teachings of Inaba et al. for an iPSC derived from a neural stem cell. Inaba et al. provide motivation by teaching that various somatic cells could be used interchangeably in the present invention, where a neural cell could replace the somatic cell of Esteban. One of skill in the art would have had a reasonable expectation of success at combining Esteban et al. and Inaba et al. because both define methods for inducing pluripotency by dedifferentiating mammalian somatic cells.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Yamanaka et al. (US8058065B2).
Regarding claim 28 Yamanaka et al. teach induced pluripotent stem cells of mammalian origin Yamanaka make obvious cells of porcine origin because they are mammalian and often used in research and medicine (column 20, lines 64-66). While Yamanaka et al. does not define the full expression pattern of the cells produced, however pluripotent stem cells are capable of expressing various genes. The induced pluripotent stem cells of Yamanaka et al. would be capable of expressing any of the genes expressed by stem cells induced by nuclear reprogramming factors. The induced pluripotent stem cells of Yamanaka et al. would be capable of expressing LMNA, HTRA1, PHLDA1, FGF1 and GASK1B as they are all are expressed in the iPS cells of the present application.
Rejections maintained and New Rejections added to claims 36-39 necessitated by amendments filed 09/19/2025:
Claims 30 and 36-43, and 45-46 are rejected under 35 U.S.C. 103 as being unpatentable over Yamanaka et al. (US8058065B2) as claim 28 above and in further view of Inaba et al. (WO2016/204298A1).
Regarding claims 30, Yamanaka et al. teach the limitations of claim 28 as described above. Yamanaka et al. do not teach the iPSC is derived from a neural stem cell (NSC).
Inaba et al. teach the iPSC can be derived from a neural stem cell (NSC) (page 2, paragraph 5).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified the teachings of Yamanaka et al. for an iPSC with the teachings of Inaba et al. for an iPSC derived from a neural stem cell. Inaba et al. provide motivation by teaching that various somatic cells could be used interchangeably in the present invention, where a neural cell could replace the somatic cell of Yamanaka et al. One of skill in the art would have had a reasonable expectation of success at combining Yamanaka et al. and Inaba et al. because both define methods for inducing pluripotency by dedifferentiating mammalian somatic cells.
Regarding claim 36-39, Yamanaka et al. teach the iPSCs express REX1, SSEA-3, SSEA-4 and NANOG (column 20, lines 11-30).
Regarding claim 40, Yamanaka et al. teach the limitations of claim 37 and teach iPSCs derived from somatic cells but do not specifically teach they are derived from neural stem cells.
Inaba et al. teach the iPSC can be derived from a neural stem cell (NSC) (page 2, paragraph 5).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified the teachings of Yamanaka et al. for an iPSC with the teachings of Inaba et al. for an iPSC derived from a neural stem cell. Inaba et al. provide motivation by teaching that various somatic cells could be used interchangeably in the present invention, where a neural stem cell could replace the somatic cell of Yamanaka. One of skill in the art would have had a reasonable expectation of success at combining Yamanaka et al. and Inaba et al. because both define methods for inducing pluripotency by dedifferentiating mammalian somatic cells.
Regarding claim 41, Yamanaka et al. teach the limitations of claim 39, however Yamanaka et al. do not teach the derivation from neural stem cells.
Inaba et al. teach canine induced pluripotent stem cell (iPSC) (page 1, paragraph 1) which can be derived from neural stem cells (page 2, paragraph 5).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified the teachings of Yamanaka et al. for an iPSC with the teachings of Inaba et al. for an iPSC derived from a neural stem cell. Inaba et al. provide motivation by teaching that various somatic cells could be used interchangeably in the present invention, where a neural stem cell could replace the somatic cell of Yamanaka. One of skill in the art would have had a reasonable expectation of success at combining Yamanaka et al. and Inaba et al. because both define methods for inducing pluripotency by dedifferentiating mammalian somatic cells.
Regarding claim 42, Yamanaka et al. teach a method of inducing pluripotency comprising culturing ovine or porcine stem cells (column 20, lines 61-66) in the presence of an adenovirus (column 41, lines 20-25) expressing one or more reprogramming factors (column 18, lines 65-67).
Yamanaka et al. do not teach the iPSC is derived from a neural stem cell (NSC).
Inaba et al. teach the iPSC can be derived from a neural stem cell (NSC) (page 2, paragraph 5).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have or modified the teachings of Yamanaka et al. a method of inducing pluripotency in porcine stem cells with the teachings of Inaba et al. for an iPSC derived from a neural stem cell. Inaba et al. provide motivation by teaching that various somatic cells could be used interchangeably in the present invention, where a neural cell could replace the somatic cell of Yamanaka et al. One of skill in the art would have had a reasonable expectation of success at combining Yamanaka et al. and Inaba et al. because both define methods for inducing pluripotency by dedifferentiating mammalian somatic cells.
Regarding claim 43, Yamanaka et al. further teach the nuclear reprogramming factors are Oct4, Sox2 cMYC and Klf4 (column 103, claim 1).
Regarding claim 45, Inaba et al. teach the vector can be Sendai viral vectors (page 3, paragraph 3).
Regarding claims 46, Yamanaka et al. and Inaba et al. teach a porcine iPSC. Yamanaka et al. and Inaba et al. do not define all of the genes expressed by the porcine iPSC. The induced pluripotent stem cells of Yamanaka et al. and Inaba would be capable of expressing any of the genes expressed by stem cells induced by nuclear reprogramming factors. The induced pluripotent stem cells of Yamanaka et al. would be capable of expressing LMNA, HTRA1, PHLDA1, FGF1 and GASK1B as they are all are expressed in the iPS cells of the present application.
Response to Argument
Applicant's arguments filed 09/19/2025 have been fully considered but they are not persuasive.
Applicant’s Arguments: Applicant argues neither Inaba nor Yamanaka disclose or suggest porcine iPSCs (Remarks, page 4).
Examiner’s Response: Yamanaka teaches the generation of iPSCs in any mammalian cell, generation of porcine cells would be an obvious cell type due to their utilization in medicine and medical research. Inaba teaches a canine cell which is a mammalian cell and therefore the concepts could be used with Yamanaka.
Applicant’s Arguments: Applicant argues there would have been no motivation for the skilled person to replace starting cell population for an alternative cell population (Remarks, pages 6-7).
Examiner’s Response: Inaba provides motivation to replace the starting population teaching that various somatic cells could be used interchangeably in the present invention.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/C.L.M./Examiner, Art Unit 1638
/Anna Skibinsky/
Primary Examiner, AU 1635