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
This action is in response to the papers filed May 18, 2026.
Claim Amendments
Applicant’s amendment to the claims filed 05/18/2026 is acknowledged.
Claim 15 is amended.
Claims 1-20 are pending.
Claims 1-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Claims 15-20 are under examination.
Election/Restrictions
The following is a summary of the restriction/election requirements in the present application, as set forth in the Office action mailed 12/19/2024.
Applicant elected with traverse Invention II, drawn to an expression vector comprising a nucleic acid which inhibits, reduces, knocks-down or down-regulates 53BP1, and a kit comprising thereof, during a telephone conversation on 12/12/2024, as recorded in the interview summary mailed 12/19/2024 and affirmed in applicant’s reply filed 05/01/2025.
Accordingly, claims 1-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement, as noted above.
Priority
The instant application 17/580,219 was filed on 01/20/2022. This application is a continuation (CON) of international application PCT/US2020/042978 filed 07/22/2020, claiming priority based on U.S. Provisional Application No. 62/877,052 filed 07/22/2019.
Effective filing dates:
Sufficient written support for claims 15-20 is not found in U.S. Provisional Application No. 62/877,052. The provisional application describes “an agent which interferes with 53BP1” (claim 1), and “inhibition of 53BP1 during reprogramming” for iPS cell generation (pg. 16 of drawings). However, written support for an expression vector comprising a nucleic acid which inhibits, reduces, knock downs or down regulates 53BP1 expression, as claimed in claims 15-20, is not found in the provisional application. Further, providing a combination of a 53BP1 inhibitor and OSKM reprogramming factors is also not found in the provisional application. For these reasons, the effective filing date of claims 15-20 is found to be 07/22/2020 based on the filing date of international application PCT/US2020/042978.
Withdrawal of Prior Rejections/Objections
Rejections and/or objections not reiterated from the previous Office action mailed 02/25/2026 are hereby withdrawn. The following rejections and/or objections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application. In particular, the amendment to the claims filed on 05/18/2026 has overcome the prior rejections under 35 U.S.C. 112 set forth in the previous Office action.
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 15-20 rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0008161 A1 to D’Souza et al. (published: 01/14/2021; filed: 06/17/2020), which claims priority based on U.S. Provisional Application No. 62/862,539 filed 06/17/2019; in view of Qi et al. (2007) “The magic of four: induction of pluripotent stem cells from somatic cells by Oct4, Sox2, Myc and Klf4” Cell research, 17(7), 578-580.
This rejection is newly applied.
Please note that 53BP1 is also known as TP53BP1.
The teachings of US 2021/0008161 A1 to D’Souza et al. relied upon in this rejection find written support in U.S. Provisional Application No. 62/862,539 filed 06/17/2019.
D’Souza teaches increasing homology-directed repair (HDR) in a cell by contacting the cell with a 53BP1 inhibitor (par. 6). The 53BP1 inhibitor is encoded by a polynucleotide and delivered to a cell by a vector (e.g., par. 162-163).
D’Souza further teaches 53BP1 inhibitor is a siRNA targeting 53BP1 (par. 11). The siRNA targets 53BP1 mRNA, decreases or silences 53BP1 expression, and delivered using non-viral or viral delivery methods (par. 165). "[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom." In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968). See MPEP 2144.01. In this case, one of ordinary skill in the art would have reasonably inferred that delivery of the 53BP1-targeting siRNA by “viral delivery methods” (D’Souza, par. 165) would necessitate a recombinant viral genome comprising a nucleic acid sequence encoding the 53BP1-targeting siRNA.
See pages 2, 33-34 of U.S. Provisional Application No. 62/862,539 for written support regarding the above teachings.
For these reasons, D’Souza teaches of fairly suggests component (a) of the combination claimed in claim 15 (“an expression vector comprising a nucleic acid which inhibits, reduces, knock downs or down regulates 53BPI expression”).
D’Souza does not teach that component (a) is combined with component (b) of claim 15, i.e., “a component that promotes OSKM reprogramming of human somatic cells into human induced pluripotent ste[m] (iPS) cells.”
However, D’Souza does teach that the genetically-engineered cells are derived from induced pluripotent stem cells (iPSCs), which are reprogrammed from a somatic cell (par. 199). The iPSCs are obtained by transducing somatic cells with transcription factors that include OCT4, SOX2 and NANOG (par. 200). See page 46 of U.S. Provisional Application No. 62/862,539.
In addition, Qi is relevant prior art for disclosing that the expression of four transcription factors, OCT4, SOX2, KLF4 and cMYC (OSKM), are able to convert a somatic cell from a terminally differentiated state to an embryonic one, thereby generating the so-called iPSC. See pages 578-579; Figure 1.
In summary, D’Souza teaches increasing homology-directed repair in a cell by inhibiting 53BP1 expression, wherein the genetically-modified cell is an iPSC reprogrammed from a somatic cell using transcription factors. The transcription factors OCT4, SOX2, KLF4 and cMYC (OSKM) were known in the art to reprogram somatic cells into iPSCs, as taught by Qi.
Therefore, prior to the effective filing date of the instantly claimed invention, it would have been prima facie obvious to one of ordinary skill in the art to modify an expression vector encoding a nucleic acid which inhibits, reduces, knock downs or down regulates 53BPI expression, as found in D’Souza, by further including a component that promotes OSKM reprogramming of human somatic cells into human, as found in Qi, with a reasonable expectation of success because OSKM reprogramming of iPSCs into somatic cells provide a desirable source of genetically-engineered cells for the “correction of a disease resulting from a somatic genetic mutation” (D’Souza, par. 199), and such genetically-engineered cells are treated with a 53BP1 inhibitor in order to increase HDR. Accordingly, the two components, (a) and (b), possessed a combined utility in producing genetically-engineered cells for the correction of a disease resulting from a somatic genetic mutation in a patient in need thereof. For these reasons, one of ordinary skill in the art would have been motivated to combine an expression vector encoding a nucleic acid which inhibits, reduces, knock downs or down regulates 53BPI expression, as found in D’Souza, and a component that promotes OSKM reprogramming of human somatic cells into human, as found in Qi.
Claim 15 further recites that iPS cells demonstrate improved genomic stability, reprogramming efficiency, and quality relative to iPS cells that were not treated by 53BP1 inhibition. Claim scope is not limited by claim language that does not limit a claim to a particular structure. See, MPEP 2111.04. In this case, the recitation indicates a functional property or intended result of 53BP1 inhibition in iPS cells, i.e., improvement of genomic stability, reprogramming efficiency, and quality of the iPS cells. However, the recitation does not positively limit the claimed product, i.e., the combination of components (a) and (b), to a particular structure. A recitation of an intended use or functional property of the claimed invention must result in a structural difference between the claimed invention and the cited prior art in order to patentably distinguish the claimed invention from the cited prior art. If the prior art structure is capable of performing the intended use, or if the functional property naturally flows from the cited prior art structure, then the cited prior art reads on the intended use or functional property recitation. There is no requirement that the cited prior art expressly teach or suggest the intended use or functional property recitation. As set forth above, the claimed structure, i.e., the combination of components (a) and (b), would have been prima facie obvious over D’Souz and Qi combined. Further, D’Souza expressly recognizes that 53BP1 inhibition increases HDR in a cell (par. 6). Accordingly, the intended use or functional property recitation is not found to patentably distinguish the claimed invention from the prior art.
Regarding claim 16, as discussed above, D’Souza teaches that the nucleic acid is siRNA (par. 165).
Regarding claim 17, D’Souza teaches that the viral vector is a lentiviral vector, a retroviral vector or an adenoviral vector (e.g., par. 340). See also pages 89-90 of U.S. Provisional Application No. 62/862,539.
Regarding claim 18, providing the combination of components (a) and (b), as suggested by D’Souza and Qi combined (above), is minimally sufficient to provide the “kit” of claim 18, under the broadest reasonable interpretation, because both components are brought together for a combined utility, e.g., making genetically-engineered cells for the correction of a disease resulting from a somatic genetic mutation. Moreover, D’Souza teaches a “kit” comprising a container for the genetically-engineered cells (par. 89). See page 18 of U.S. Provisional Application No. 62/862,539. Accordingly, to the extent that a “kit” requires more than the combination, it would have been prima facie obvious to one of ordinary skill in the art to provide the combination in a “kit” in order to supply a container suitable for packaging and shipping to an end user of the product.
Claim 19 recites that the kit further comprises a somatic cell, a vector comprising four transcription factors OSKM, and media.
Regarding the somatic cell, as discussed above, both D’Souza and Qi disclose somatic cells for reprogramming into iPS cells.
Regarding the vector comprising four transcription factors OSKM, Qi discloses that the somatic cells are transduced with retroviral vectors containing the four transcription factors, OSKM. See page 579 and Figure 1. Accordingly, Qi teaches or fairly suggests an expression vector comprising four transcription factors, OSKM, as claimed.
Regarding the media, D’Souza teaches that the cells are provided in a media in vitro (e.g., par. 395). See page 105 of U.S. Provisional Application No. 62/862,539. Moreover, "in considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom." In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968). See MPEP 2144.01. In this case, one of ordinary skill in the art would have reasonably inferred that an in vitro process of reprogramming living cells (as in Qi, Figure 1) would necessitate media to contain said living cells.
Accordingly, for the same reasons provided above, it would have been prima facie obvious to one of ordinary skill in the art to further include in the kit a somatic cell, a vector comprising four transcription factors OSKM and media, in view of D’Souza and Qi combined, because these components possessed a combined utility, e.g., in producing genetically-engineered cells for the correction of a disease resulting from a somatic genetic mutation in a patient in need thereof.
Regarding claim 20, Qi discloses that the somatic cells are transduced with retroviral vectors containing the four transcription factors, OSKM. See page 579 and Figure 1. Accordingly, Qi teaches or fairly suggests an expression vector comprising four transcription factors, OSKM, as claimed.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES J GRABER whose telephone number is (571)270-3988. The examiner can normally be reached Monday-Thursday: 9:00 am - 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James D Schultz can be reached on (571)272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES JOSEPH GRABER/Examiner, Art Unit 1631
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