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 with traverse of Group I, claims 1-10, in the reply filed on 07/16/2026 is acknowledged. The traversal is on the ground(s) that the commonly shared technical feature is a relation between cell senescence state and CPEB4 expression level. This is not found persuasive because senescence state of the cell is not relevant at all to at least methods of claims 1-10.
The requirement is still deemed proper and is therefore made FINAL.
Claims 11-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/16/2026.
Claim Rejections - 35 USC § 112
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 1-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for reducing senescence in muscle stem cells by increasing CPEB4 expression, does not reasonably provide enablement for reducing senescence in any type of cell by increasing CPEB4 activity. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The claimed invention is not supported by an enabling disclosure taking into account the Wands factors. In re Wands, 858/F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988). In re Wands lists a number of factors for determining whether or not undue experimentation would be required by one skilled in the art to make and/or use the invention. These factors are: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples of the invention, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of the art, and the breadth of the claim.
Claims are broadly drawn to methods of rejuvenation/reduction of senescence of any cell by increasing expression or activity of CPEB4.
Instant claims encompass increasing expression or activity in any possible type of cell by increasing expression or activity of CPEB4.
Instant specification teaches that increasing expression of CPEB4 in muscle stem cells by (SCs) leads to reduced senescence of such cells (see paragraph [0138]). Such expression is increased by administering adenoviral vector encoding CPEB4 to such cells (see Example 6). There is nothing in specification concerning increasing activity of CPEB4 in the cells. There are no agents described that would carry out such action. Specification suggests identifying such CPEB4 activators (see paragraph [0095-0098]), but does not provide examples of even one of such compound. Further, there are no examples in specification of reducing senescence in any other type of cells than muscle stem cells.
There is no prior art describing reducing senescence in any type of cell by increasing expression or activity of CPEB4 in such cell.
The guidance provided in the specification is limited to increasing expression of CPEB4 in one type of cell to reduce senescence.
In the absence of guidance, undue trial and error experimentation would have been required by one skilled in the art at the time invention was made to reduce senescence of any cell by increasing activity of CPEB4 in such cells as instantly claimed. Given the breadth of the claims, unpredictability of the art and lack of guidance of the specification, as discussed above, undue experimentation would be required by one skilled in the art to make and use the claimed invention commensurate in scope with the claims.
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 9-10 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.
Claim 9 recites the limitation "the expression vector" in the first line. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination it will be considered that claim 9 depends on claim 5, but appropriate correction is required.
Claim 10 is rejected based on its dependency on claim 9.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 3, 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mendez et al (WO 2017/153606, September 2017, cited from IDS).
Concerning claims 1, 3 and 7 Mendez disclose methods of overexpressing CPEB4 in HPDE cell by administering lentiviral vector into the cell (see bridging paragraph between pages 30 and 31). The limitation “for rejuvenating a cell” in the preamble of claim 1 is of intended use and therefore is not given patentable weight. It is inherent that lentiviral vector expressing CPEB4 comprises nucleic acid encoding CPEB4, anticipating claim 3. It is inherent that the method is performed ex vivo, anticipating claim 7.
Claim(s) 1, 3, 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yuan et al (CN 103705920, April 2014, cited from IDS, citations are from machine translation).
Concerning claims 1, 3 and 7 Yuan disclose method of expressing CPEB4 ex vivo in a cell by introducing expression vector in such cell (see paragraphs [4-5]). The limitation “for rejuvenating a cell” in the preamble of claim 1 is of intended use and therefore is not given patentable weight. It is inherent that expression vector expressing CPEB4 comprises nucleic acid encoding CPEB4, anticipating claim 3.
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.
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.
Claim(s) 1, 3-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yuan et al, above, as applied to claims 1, 3, 7, and in further view of Brown et al (US 2016/0237438, August 2016).
Teachings of Yuan are discussed above. Yuan further teach that CPEB4-expressing vector can be used as a vaccine for cancer treatment (see Abstract).
Yuan do not teach that the cell expressing CPEB4 is within a human body, or vector administration by intravenous injection.
Brown teach administration of expression vectors by intravenous injection (see paragraph [0488]).
It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to administer vector taught by Yuan to a human by intravenous injection as taught by Brown, arriving at instant invention. One of the ordinary skill in the art would be motivated to do so, because Yuan teach that the expression vector can be used as a vaccine for cancer treatment, motivating one of the art to administer such vector to a human. Such administration can be done by intravenous injection as taught by Brown.
Conclusion
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/EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637
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