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 1, claims 1-11, 16, and 21, and species election 1. iPS cells and 2. an insertion site on chromosome 13q12.12 between nucleotides -24,083,331 - 24,083,332 bp from the P-terminus in the reply filed on 05/13/2025 is acknowledged.
Claims 7 and 8 require cells other than the elected iPS cells, therefore, are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, claims 12-15 and 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 05/13/2025.
The Official Action mailed 13 June 2025 partially withdrew the species election, only as it pertains to the insertion site.
Applicant has amended claims 9 and 10 to read as method claims, thus, a different statutory category than that of the elected invention.
Therefore, claims 9 and 10 are considered Group IV.
The new groups are as follows:
Group I, claims 1, 5-8, 11, and 21, drawn to a mammalian cell and pharmaceutical composition comprising said cell.
Group II, claims 12-15 drawn to a method of producing a transgenic cell.
Group III, claims 17-20, drawn to a nucleic acid molecule.
Group IV, claims 9 and 10, drawn to a method of using a transgenic cell.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I-II and IV lack unity of invention because even though the inventions of these groups require the technical feature of a cell with a genetic modification within the SPATA13 gene on chromosome 13q12.12, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Bourbia et al. (Mammalian Genome (2019) 30:54-62, published 04/24/2019 (of record)). Bourbia et al. teach a spermatogenesis-associated protein 13 (Spata13) knockout mouse line using CRISPR-mediated deletion of an exon containing the GTPase domain common to multiple isoforms (Abstract). This reads as a genetic modification within the SPATA13 gene. Bourbia et al. does not teach where the gene is located on chromosome 13q12.12. Not all mammals share the same location of the spermatogenesis-associated protein 13 gene and this gene is located on chromosome 14 in mice. Furthermore, the gene as indicated in the claim is in all capital letters indicating it is a human gene. However, it would have been obvious to one skilled in the art to employ a mouse model because mice have a high degree of genetic similarity to humans, with many genes performing the same functions in both species, making mouse biology a good proxy for studying human biology to obtain predictable results.
Groups (I, II, and IV) and III lack unity of invention because the groups do not share the same or corresponding technical feature. Groups I, II, and IV require the technical feature of a cell with a genetic modification within the SPATA13 gene on chromosome 13q12.12 and Group III require a nucleic acid molecule.
Therefore, claims 9-10, 12-15, and 17-20 are withdrawn from consideration as being directed to a nonelected invention and claims 7-8 are withdrawn from consideration as being directed to a nonelected species. See 37 CFR 1.142(b) and MPEP § 821.03.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Status
Claims 1, 9-10, and 21 have been amended, claims 7-10, 12-15, and 17-20 have been withdrawn, claims 2-4 and 16 have been cancelled, and claims 1, 5-6, 11, and 21 have been examined on their merits.
Withdrawn Rejections/Objections
The objection to claim 16 has been withdrawn because Applicant cancelled the claim.
The rejections under 35 U.S.C. 112(b) are withdrawn due to the amendments to the claims.
The rejections under 35 U.S.C. 112(d) of claim 4 is withdrawn because Applicant cancelled the claim.
The rejections under 35 U.S.C. 102 are withdrawn due to the amendments to the claims.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5-6, 11, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Ostertag et al. (WO 2010/124200, of record).
This is a new rejection, necessitated by applicants amendments to the claims. A response to Applicant’s traversal follows the rejection below.
Regarding claims 1 and 5-6, Ostertag et al. teach genetic modifications to rat (mammalian) pluripotent cells, such as induced pluripotent stem (iPS) cells (claims 5 and 6), specifically genetic modifications to tumor suppressor genes (Abstract and para. [0069]). Ostertag et al. teach these modified tumor-suppressor genes include Spata13 (para. [0068]). This reads as a cell comprising a genetic modification within the SPATA13 gene and wherein the cells is not CTX0E03.
Ostertag et al. do not teach to the location on the chromosome, specifically 13q12.12, however, it would have been obvious to one of ordinary skill in the art to make a genetic modification at a precise location on the gene of interest with a reasonable expectation of success because this technique is well-known to one of ordinary skill. This specific location is understood to be the location of the SPATA13 gene in the human genome. Ostertag et al. is editing rat cells and the Spata13 gene is not located on chromosome 13 in rats. However, it would have been obvious to one skilled in the art to employ a rat model because rats have a high degree of genetic similarity to humans, with many genes performing the same functions in both species, making rat biology a good proxy for studying human biology to obtain predictable results. Additionally, it would have been obvious to one of ordinary skill in the art to make a genetic modification at a precise location on the gene of interest with a reasonable expectation of success because this technique is well-known to one of ordinary skill. One would have been motivated to modify the SPATA13 gene because it is a known mammalian tumor-suppressor gene and Ostertag et al. teach several methods for precise genetic modifications, which are all well-known techniques in the art.
Regarding the limitations directed to the cell is a human cell, wherein the genetic modification is an inserted integrated transgene, Ostertag et al. teach insertional mutagens for making mutant cells and organisms involving integration of one or more polypeptide sequence (transgene) into the genome of a cell or organism (para. [0081]). Ostertag et al. teach the insertional mutagenic polynucleotides are designed to mutate one or more endogenous genes when the polynucleotides integrate into the genome of the cell (para. [0081]). Ostertag et al. teach a retrovirus may be used for insertional genetic modification and the retroviral vector can carry a transgene (para. [0086]). An insertional genetic modification reads as an inserted integrated transgene, as retroviral vectors stably integrate transgenes. Ostertag et al. teach mutagenesis through recombination of a cassette into the genome may be carried out by Serine and Tyrosine recombinase with the addition of an insertion cassette, the cassette can contain a transgene (para. [0088]).
Therefore, the teachings of Ostertag et al. render obvious the limitations of claim 1.
Regarding claim 11, Ostertag et al. teach the tumor-suppressor gene is mutated in a pluripotent cell, then these genetically modified pluripotent cells are microinjected into a recipient blastocyst or into the rete testis of a recipient animal (para. [00172]). The genetically modified cell being injected reads as a pharmaceutical composition comprising the genetically modified cell.
Regarding claim 21, Ostertag et al. is silent to the specific insertion site, specifically on chromosome 13q12.12 within an intron of the SPATA13. This is understood to be the location of the SPATA13 gene in the human genome. Ostertag et al. is editing rat cells and the Spata13 gene is not located on chromosome 13 in rats. However, it would have been obvious to one skilled in the art to employ a rat model because rats have a high degree of genetic similarity to humans, with many genes performing the same functions in both species, making rat biology a good proxy for studying human biology to obtain predictable results. Additionally, it would have been obvious to one of ordinary skill in the art to make a genetic modification at a precise location on the gene of interest with a reasonable expectation of success because this technique is well-known to one of ordinary skill. One would have been motivated to modify the SPATA13 gene because it is a known mammalian tumor-suppressor gene and Ostertag et al. teach several methods for precise genetic modifications, which are all well-known techniques in the art. Any of the disclosed species of insertion location would be obvious based on the prior art.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Response to traversal
Applicant’s arguments, see pp. 5-6 of the response (Sections II-IV), filed 12 November 2025, with respect to the 112 and 102 rejections have been fully considered and are persuasive. The 112 and 102 rejections of claims 1, 5-6, 11, and 21 have been withdrawn.
Applicant’s arguments, see pp. 7-9, filed 12 November 2025, with respect to the rejection(s) of claim(s) 1-6, 9-11, 16, and 21 under 103 have been fully considered and are not persuasive. The original rejection has been withdrawn due to the amendments to claim 1, and the new grounds of rejection are a modified version of the original rejection in order to address the amendments to the claims. The new ground(s) of rejection is still made in view of Ostertag et al.
In response to applicant's argument directed to nonobviousness over Ostertag, Section V, pp. 7-8 of the response, that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the purpose and the approach of the transgene integration) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Regarding the argument that site-specific integration techniques were generally available does not render obvious the claimed subject matter; the rejection above contains reasonable expectations of predictable results, motivations, and reasonable expectations of success. Therefore, this argument is not persuasive.
In response to applicant's argument directed to nonobviousness over Ostertag, Section V, p. 9, of the response, that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., stable transgene expression without adverse effects on endogenous genetic regulation) are not recited in the rejected claim(s). The limitations of claim 1 are interpreted as any transgene, which is made obvious according to the teachings of Ostertag. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/N.A.H./Examiner, Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631