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 .
Election/Restrictions
Applicant’s election without traverse of Group I, a method for classifying a subject, in the reply filed on 3/2/26 is acknowledged.
Claims 1-22 are pending. Claims 9-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/5/26.
Claims 23-82 are cancelled.
Claims 1-8 are currently under examination.
Priority
The instant application 18/281,068 filed on 9/8/23 is a 371 US national phase of
PCT/US2022/019127 filed on 3/7/22, and claims domestic priority to provisional application
63/158,125 filed on 3/8/21. The priority date is determined to be 3/8/21.
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 1-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more. The claims have been evaluated using the 2019 Revised Patent Subject Matter Eligibility Guidance (see Federal Register Vol. 84, No. 4 Monday, January 7, 2019).
Step 1: The claims are directed to the statutory categories of a process.
Step 2A, prong one: The claim recites a judicial exception.
Claim 1 recites a correlation of gene expression and presence of pluripotent stem cells. This phenotype-genotype correlation is a law of nature and natural phenomena (see MPEP 2106.04(b)).
Claims 1 additionally recites “analyzing” gene expression and “determining” pluripotency based upon the gene expression, which are abstract mental processes (see MPEP 2106.04(a)(2), subsection III). These active steps are performed within the mind.
Step 2A, prong two: The judicial exception is not integrated into a practical application.
Claims 1-8 recite extra-solution and data-gathering limitations for the judicial exceptions of law of nature/natural phenomena and mental process. These limitations generate the input data of the judicial exceptions, and/or are unrelated to the judicial exceptions.
Step 2B: The claim does not provide an inventive concept.
MPEP 2106.05(d)):
The courts have recognized the following laboratory techniques as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity:
i. Determining the level of a biomarker in blood by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017);
ii. Using polymerase chain reaction to amplify and detect DNA, Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377, 115 USPQ2d 1152, 1157 (Fed. Cir. 2015);
iii. Detecting DNA or enzymes in a sample, Sequenom, 788 F.3d at 1377-78, 115 USPQ2d at 1157); Cleveland Clinic Foundation 859 F.3d at 1362, 123 USPQ2d at 1088 (Fed. Cir. 2017);
iv. Immunizing a patient against a disease, Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1063, 100 USPQ2d 1492, 1497 (Fed. Cir. 2011);
v. Analyzing DNA to provide sequence information or detect allelic variants, Genetic Techs. Ltd., 818 F.3d at 1377, 118 USPQ2d at 1546;
vi. Freezing and thawing cells, Rapid Litig. Mgmt. 827 F.3d at 1051, 119 USPQ2d at 1375;
vii. Amplifying and sequencing nucleic acid sequences, University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 764, 113 USPQ2d 1241, 1247 (Fed. Cir. 2014); and
viii. Hybridizing a gene probe, Ambry Genetics, 774 F.3d at 764, 113 USPQ2d at 1247.
The claims are directed to well-understood, routine, and conventional activities in the life science arts recited at a high-level of generality. Additionally, gene expression level indicia of pluripotent stem cells are not inventive (see Slukvin et al. (2019; US 2019/0390168 A1; USPGP citation 2 in IDS filed 9/8/23) and Kim et al. (2020; US 10,533,177 B1; USPat citation 1 in IDS filed 9/8/23).
For the reasons set forth above, claims 1-8 are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 103
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.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Slukvin et al. (2019; US 2019/0390168 A1; USPGP citation 2 in IDS filed 9/8/23) in view of Kim et al. (2020; US 10,533,177 B1; USPat citation 1 in IDS filed 9/8/23).
(i) Slukvin et al. teaches limitations relevant to claims 1-8.
Relevant to claim 1, Slukvin et al. Abstract teaches “The invention relates to a method for detecting residual, undifferentiated pluripotent stem cells (PSCs) in a culture of cells differentiated from PSCs, the method comprising: … quantitating in the cultured cells expression of a marker of residual, undifferentiated PSCs… wherein lower marker expression in the culture of cells than marker expression in the reference culture of cells indicates absence of residual, undifferentiated PSCs in the cultured cells or presence of residual, undifferentiated PSCs in the cultured cells at a proportion lower than the known proportion of PSCs in the reference culture of cells.”
Relevant to claims 2-3, Slukvin et al. paragraph 0054 teaches “As used herein, ‘pluripotent stem cell’ or ‘PSC’ refers to a cell that has the ability to reproduce itself indefinitely, and to differentiate into any other cell type. There are two main types of pluripotent stem cell: embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs).”
Relevant to claim 4, Slukvin et al. Abstract teaches the samples of interest are “cultured cells” (or a cell mixture).
Relevant to claims 5-6, Slukvin et al. paragraph 0099 teaches “’Marker expression’ may be quantitated as protein or mRNA expression.”
Relevant to claims 7-8, Slukvin et al. paragraphs 0100-0101 teach techniques to detect marker gene expression.
(ii) Slukvin et al. is silent to specifics regarding SEQ ID NOs: 1-5 (claim 1). However, these limitations were known in the prior art and taught by Kim et al.
Relevant to claim 1, Kim et al. Table 3 teaches that SEQ ID NO. 384 is “upregulated during pluripotency reprogramming of primary skin fibroblasts.” Kim et al. SEQ ID NO. 384 contains 100% sequence identity to instantly claimed SEQ ID NO. 2 (see SEQ ID NO. 384 Alignment results; NPL citation U in PTO-892 filed 1/8/26). An excerpt is provided below for clarity:
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(iii) Although Slukvin et al. does not explicitly teach the Kim et al. SEQ ID NOs limitations, it would have been prima facie obvious to the skilled artisan. It is noted that Slukvin et al. and Kim et al. are analogous disclosures to the instant pluripotent stem cell field.
The skilled artisan would have been motivated to include the Kim et al. SEQ ID NOs within the Slukvin et al. methodology. Kim et al. Table 3 teaches that SEQ ID NO. 384 – which has 100% sequence identity to instantly claimed SEQ ID NO. 2 – is “upregulated during pluripotency reprogramming of primary skin fibroblasts.” Thus, the skilled artisan would be motivated to include the Kim et al. SEQ ID NO. 384 within the Slukvin et al. methodology because Kim et al. teaches that the SEQ ID NO. is associated with pluripotent stem cells.
The skilled artisan would have a reasonable expectation of success based on the disclosures of Slukvin et al. in view of Kim et al., as discussed in the preceding paragraphs.
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.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 19/468,774 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope. Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are broad and generic so as to encompass the claims of the copending application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/SARAH JANE KENNEDY/Examiner, Art Unit 1682
/WU CHENG W SHEN/Supervisory Patent Examiner, Art Unit 1682