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 October 27, 2025.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/27/2025 has been entered.
Claim Amendments
Applicant’s amendment to the claims filed 10/27/2025 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Claims 1-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.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Accordingly, claims 1-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 06/25/2025 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.
Applicant’s remarks filed 10/27/2025 have been carefully considered. The presented arguments are moot in view of applicant’s amendment to the claims and the new grounds of rejection set forth below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
This rejection is newly applied.
Claim 15, line 4, recites the limitation “the reprogramming factors.” There is insufficient antecedent basis for this limitation in the claim. Although the claim functionally describes a component (b) that “promotes OSKM reprogramming,” the claims do not previously recite a structural component of “reprogramming factors.” Generally, it is unclear, based on the claim construction, if “the reprogramming factors” necessarily refers to the transcription factors OCT4, SOX2, KLF4 and cMYC (OSKM), or some other combination of reprogramming factors, e.g., the transcription factors OCT4, SOX2, KLF4 and NS (OSKN).
For these reasons, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Dependent claims 16-20 are included in the basis of the rejection because they do not correct the deficiencies of the claim upon which they depend.
Claims 15-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
This rejection is newly applied.
Claim 15 recites a component (b) that promotes OSKM reprogramming of human somatic cells into human induced pluripotent stem (iPS) cells “demonstrating improved genomic stability, reprogramming efficiency and quality.” The term “improved” in claim 15 is a relative term which renders the claim indefinite. The term “improved” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In this case, it is unclear by which standard the claimed “improvement” is determined. For example, it is unclear whether the claimed iPS cells are “improved” relative to iPS cells which were not treated by 53BP1 inhibition, or whether the claimed iPS cells are “improved” relative to iPS cells generated by nuclear transfer (as opposed to the claimed OSKM reprogramming), or whether the iPS cells are improved relative to some other, undisclosed standard.
For these reasons, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Dependent claims 16-20 are included in the basis of the rejection because they do not correct the deficiencies of the claim upon which they depend.
Claims 15-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
This rejection is newly applied.
Claim 15 recites a combination comprising a component (b) that promotes OSKM reprogramming of human somatic cells into human induced pluripotent stem (iPS) cells “without causing overexpression of the reprogramming factors;” and dependent claim 19 recites the combination comprises “a vector comprising four transcription factors OCT4, SOX2, KLF4 and cMYC (OSKM).”
The scope of the claims is found to be indefinite because the plain language of the claims appear to be in conflict with one another. In this case, “a vector comprising four transcription factors OCT4, SOX2, KLF4 and cMYC (OSKM),” as claimed in claim 19, is a component that promotes OSKM reprogramming of human somatic cells into (iPS) cells by causing overexpression of the reprogramming factors OCT4, SOX2, KLF4 and cMYC (OSKM). Accordingly, dependent claim 19 appears to contradict claim 15, which recites that the component (b) promotes OSKM reprogramming “without causing overexpression of the reprogramming factors.” Therefore, the plain language of the claims is found to be internally inconsistent.
For these reasons, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Dependent claims 16-18, and 20 are included in the basis of the rejection because they do not correct the deficiencies of the claim upon which they depend.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 15-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This rejection is newly applied.
Claim 15 recites a combination comprising a component (b) that “promotes OSKM reprogramming of human somatic cells, without causing overexpression of the reprogramming factors, into human induced pluripotent stem (iPS) cells.”
Accordingly, the claims are directed to a structurally-undisclosed genus of components that is functionally-defined as promoting OSKM reprogramming of human somatic cells into iPS cells without causing overexpression of the reprogramming factors.
An adequate written description for a genus of components or agents that promote OSKM reprogramming, without causing overexpression of the reprogramming factors, as claimed, requires more than a mere statement that it is part of the invention. What is required is either (1) a description of a common core structure shared among the members (species) of the functionally described genus or (2) a disclosure of a representative number of species of the functionally described genus. It is not sufficient to define a genus of components or agents solely by its desired biological property, i.e. promoting OSKM reprogramming without overexpression of the reprogramming factors, because disclosure of no more than that, as in the instant case, is simply a wish to know the identity of any component or agent that is capable of achieving said desired biological property. Also, naming a type of material generically known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material. Thus, claiming all components that promote OSKM reprogramming absent overexpression of the reprogramming factors, without disclosing what means will do, or without disclosing a representative number of species, is not in compliance with the written description requirement.
The specification does not provide sufficient written description for a structurally-undisclosed, functionally-defined genus of components that promote OSKM reprogramming of human somatic cells into iPS cells without causing overexpression of the reprogramming factors, as claimed. The recitation “a component that promotes OSKM reprogramming of human somatic cells, without causing overexpression of the reprogramming factors, into human induced pluripotent stem (iPS) cells” is found to be subject matter not described in the original disclosure, i.e., new matter. The only agents that the specification describes as promoting OSKM reprogramming are nucleic acid vectors overexpressing the transcription factors OCT4, SOX2, KLF4 and cMYC (OSKM). See, e.g., pg. 1, 15, 24, and 30. The specification as originally filed does not describe a single component or agent that promotes OSKM reprogramming without causing overexpression of the reprogramming factors OCT4, SOX2, KLF4 and cMYC (OSKM).
Mah et al. (2011) “Molecular insights into reprogramming-initiation events mediated by the OSKM gene regulatory network” PloS one, 6(8), e24351, 17 pages, discloses that somatic cells can be reprogrammed into induced pluripotent stem cells by overexpression of OCT4, SOX2, KLF4 and c-MYC (OSKM). In particular, somatic cells (fibroblasts) were transduced with a viral vector encoding the OSKM reprogramming factors. See, e.g., Abstract.
Chia et al. (2017) “Genomic instability during reprogramming by nuclear transfer is DNA replication dependent” Nature cell biology, 19(4), 282-291, discloses that reprogramming of somatic cells into iPS cells may be achieved either by ectopic expression of transcription factors or nuclear transfer (NT), which is a process where the genome of a somatic cell is inserted into an enucleated oocyte. See, e.g., Abstract, pg. 282, and Figure 1(a).
Mah and Chia do not describe any agent that promotes OSKM reprogramming of a human somatic cell into an iPS cell without causing overexpression of the reprogramming factors OCT4, SOX2, KLF4 and c-MYC (OSKM), as instantly claimed.
Accordingly, this limited information is not deemed sufficient to reasonably convey to one skilled in the art that the applicant is in possession of the structurally-undisclosed genus of components that is functionally-defined as promoting OSKM reprogramming of human somatic cells into iPS cells without causing overexpression of the reprogramming factors, as instantly claimed, at the time the application was filed. Dependent claims 16-20 are included in the basis of the rejection because they do not correct the deficiencies of the claim upon which they depend.
Conclusion
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