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
Claim 1 is currently pending in the instant application.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on October 11, 2024 has been considered. An initialed copy of the IDS accompanies this Office Action.
Priority
The present application filed October 11, 2024 is a Continuing Application of PCT/US2023/065824, filed April 14, 2023, which claims priority to Provisional Application 63/331,632, h filed April 15, 2022.
Therefore, the earliest priority date is April 15, 2022.
Nonstatutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the grounds of nonstatutory double patenting as being unpatentable of claims 1 – 48 of PCT/US23/65824. Claim 1 of PCT/US23/65824 is identical to instant claim 1. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are wholly encompassed by, and significantly overlap in scope with claims 1, 25 – 26, and 28 - 46 of application 17/633,146.
Claims 1 – 17 are directed to a composition comprising a population of isolated mesenchymal stem stromal cells (MSCs), wherein no more than 25% of the population of isolated MSCs are in the S phase of the cell cycle. Claims 18 – 48 are directed to a method of preparing a population of isolated MSCs. Claim 19 is directed to a method of storing isolated MSCs, and claim 48 is directed to a method for treating a disease, comprising administering the MSCs.
Claim 1 of the instant invention is directed to a composition comprising a population of isolated mesenchymal stem stromal cells (MSCs), wherein no more than 25% of the population of isolated MSCs are in the S phase of the cell cycle.
PCT/US23/65824 claims compositions and methods, while the instant application is directed a composition. However, double-patenting rejections of claims to a method of use based on a claimed composition are proper. This rejection is necessitated by the decision of the Court of Appeals for the Federal Circuit in Pfizer Inc. v Teva pharmaceuticals USA Inc., 86 USPQ2d 1001, at page 1008 (March 2008), which indicates that there is no patentable distinction between claims to a product and a method of using that product disclosed in the specification of the application and that the preclusion of such a double patenting rejection under 35 USC 121 does not apply where the present application is other than a divisional application of the patent application containing such patentably indistinct claims.
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 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. An analysis with respect to the claims as a whole reveals that they do not include additional elements that are sufficient to amount to significantly more than the judicial exception. See; Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 110 U.S.P.Q.2d 1976 (2014); Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2116, 106 U.S.P.Q.2d 1972 (2013); Mayo Collaborative Svcs. v. Prometheus Laboratories, Inc., 132 S. Ct. 1289, 101 U.S.P.Q.2d 1961 (2012). See also 2014 Interim Guidance on Patent Subject Matter Eligibility, available at http://www.gpo.gov/fdsys/pkg /FR-2014-12-16/pdf/2014-29414.pdf (“2014 Interim Guidance”), and the Office’s examples to be considered in conjunction with the 2014 Interim Guidance in examination of nature-based products, available online at: http://www.uspto.gov/patents/law/exam/mdc_ examples_ nature-based _products.pdf (“Nature-Based Products Examples”). This rejection is proper.
Analysis of subject-matter eligibility under 35 U.S.C. § 101 requires consideration of three issues: (1) whether the claim is directed to one of the four categories recited in §101; (2) whether the claim recites or involves a judicial exception (i.e., a law of nature, natural phenomenon, or natural product); and (3) whether the claim as a whole recites something that amounts to significantly more than the judicial exception. In the instant case, the claims are directed to a natural phenomenon/law of nature in the form of a natural process comprising the administration of a PDE4 inhibitor and/or cyclosporine A and the expansion, culturing and/or reproduction of PGC or PGCLCs. Therefore, they must each be considered to determine whether, given their broadest reasonable interpretation, they amount to significantly more than the judicial exception.
The claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claims as a whole, claim 1 does not recite something significantly different than a judicial exception. The rationale for this determination is explained below:
In the instant case, claims 1 is directed to a composition comprising a population of isolated mesenchymal stem stromal cells (MSCs), wherein no more than 25% of the population of isolated MSCs are in the S phase of the cell cycle.
Beginning with Step I of the analysis, which asks whether the claimed invention falls within a statutory category, such that the instant claims are directed to a composition of matter, thus, the instant claims are directed to a statutory category. Step I [YES].
Proceeding to Step IIA – Prong One of the analysis, which asks if the claimed invention is directed to a judicial exception. The instant claims are directed to a law of nature and/or a natural phenomenon, in the case of a product of nature (the isolated MSCs), such that the claims are directed to at least one exception. Step IIA – Prong One [YES].
Step IIA - Prong Two asks whether the claim recites additional elements that integrate the exception into a practical application of the exception. In the instant case, the claims are directed to a judicial exception in the form of a law of nature and/or a natural phenomenon. The claims do not integrate the judicial exceptions into a practical application of the exceptions. Step IIA – Prong Two [NO].
Proceeding to Step IIB of the analysis: the question then becomes what element or what combination of elements is sufficient to amount to significantly more than the judicial exception? The instant independent claim is recited at a high level of generality, such that substantially all practical applications of the judicial exception related to isolating the MSCS, without any specificity of the type of MSCs, special characteristics or modifications of the MSCS, or any applications of the MSCs. Moreover, the isolated MSCs are well known, purely conventional or routine in the art.
The claims amount to nothing more than a law of nature and/or a natural process that occurs upon when isolating MSCs, wherein no more than 25% of the population of isolated MSCs are in the S phase of the cell cycle. For example, it was known in the art that a population of human mesenchymal stem cells comprises 18% of the cells in S phase, as taught by Clark et al. (US 20170260509, published September 14, 2017) (Paragraph [0101]), and Table 2).
Further it was known in the art that MSCs are characterized by having only 10% of the cells in the S, G2, and M phases of the cell cycle, as evidenced by Keuhn, R. (Keuhn, R. Characterization of Embryonic Stem Cell-Differentiated Cells as Characterization of Embryonic Stem Cell-Differentiated Cells as Mesenchymal Stem Cells, University of Southern Mississippi, December 2015) (pg. 36, first paragraph).
In sum, when the relevant factors are analyzed, the claims as a whole do NOT recite additional elements that amount to significantly more than the judicial exception itself. Accordingly, claim 1 DOES NOT qualify as eligible subject matter.
In light of the above consideration and the new guidance, claim 1 is non-statutory. This rejection is newly recited as necessitated by the new Guidance set forth in the
Memorandum of July 30, 2015 updating the June 25, 2014 guidance (see June 25, 2014 memorandum from Deputy Commissioner for Patent Examination Policy Andrew Hirshfeld titled Preliminary Examination Instructions in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al. (Alice Corp. Preliminary Examination Instructions) and the Revised Patent Subject Matter Eligibility Guidance (See, Federal Register, vol. 84, No. 4, January 7, 2019).
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 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.
Claim 1 is rejected under 35 U.S.C. 102 (a)(1)/(a)(2) as being anticipated by Clark et al. (hereinafter referred to as “Clark”) (US 20170260509, published September 14, 2017).
Regarding claim 1, Clark teaches flow cytometry was used to determine cell cycle phase time for human mesenchymal stem cells, and the population of cells in each phase for each synchronization technique is described in table 2 (Paragraph [0101]. The asychnronous cells, which were used as a control, comprise 18% of the cells in S phase (Table 2) (interpreted as no more than 25% of the isolated MSCs are in the S phase of the cell cycle).
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Conclusion
Claim 1 is rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VYOMA SHUBHAM TIWARI whose telephone number is (571)272-2954. The examiner can normally be reached M-F 8:30 - 5:30 EST.
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/VYOMA SHUBHAM TIWARI/ Examiner, Art Unit 1634
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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