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 .
Status of the Claims
Claims 1-13 are pending in the application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/9/2026 has been considered by the examiner.
Claim Rejections - 35 USC § 112(a), Scope of Enablement
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 8-13 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 a method of administering the requisite components in a treatment method, does not reasonably provide enablement for (1) identifying side effects referenced in the preamble of claim 8 for comparison purposes and (2) treatment of cancer or senescence induction across a population of cells as broad as claimed as in claims 9, 10, and 12. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to identify side effects or cells in particular to be considered met from the administration of VS in co-administration methods, nor does the specification enable one to identify a cell population or cancer population commensurate in scope with these claims.
Claim Rejections - 35 USC § 112(b)
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 8-11 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 8 recites the limitation "the disease" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claims 9-11 require all limitations of claim 8 and are also rejected here.
Appropriate clarification is required.
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.
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0001014A1 (“Ghaderi”).
The instant claims are drawn to methods of administering vanadyl sulfate to a subject in need thereof, as further specified in the claims.
Ghaderi teaches methods of treating a health condition comprising administering vanadyl sulfate to a subject in need thereof to a mammal, preferably a human being (see [0076], [0650], [0651]). Ghaderi teaches health conditions which may be cellular senescence ([0156], [0537]) among conditions which may be treated and further specifies age-related senescent cell treatment (see [0156])(limitations of claims 2, 5, and 9) as well as administration of active agents in combination with therapeutic medicinal treatments, reasonably suggesting treatment of senescent cells made to be senescent by the same or another process as age (limitation of claim 3) as well as explicitly teaching an additional therapy (limitation of claim 8). Cancer is among the health conditions which may be treated (see [0142])(limitation of claims 10 and 12). Senescent associated secretory phenotype (SASP) are among physiological conditions treated (see [1503])(limitation of claim 4). Regarding claim 6, Ghaderi teaches cardiovascular disease among conditions to be treated (see [0156]). Regarding claim 7, the steps of the claimed method are addressed above in regard to claim 1, and where claim 7 describes effects of performing the claimed steps, it is the examiner’s position that the effects of performing these steps are inseparable from the claimed process such that Ghaderi renders obvious the content of claim 7. Regarding claims 11 and 13, Ghader teaches radiation damage among conditions which may be treated (see [0411]) and generally teaches chemotherapeutic and/or immunotherapeutic scope (see [0336]).
Ghaderi teaches methods for inducing biological mimicry in a mammal for the prevention of various diseases and in so doing teaches a method comprising the stepwise administration of administering vanadyl sulfate to a subject in need thereof. Ghaderi specifies cancer treatments and/or treatment of senescent cells. While Ghaderi appears to teach this process to meet the effects recited in the preamble of each of claims 1, 8, and 12, because Ghaderi does not explicitly link the claimed purposes and/or effects to the claimed method steps, this rejection is made using obviousness rationale. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to administer vanadyl sulfate to a patient having senescent cells and/or cancer cells, and to do so in combination and/or conjunction with additional therapies specified by Ghaderi in a treatment method. One would have been motivated to do so based on Ghaderi’s disclosure as a whole considered for what it reasonably would have suggested to the ordinary artisan since Ghaderi specifies that the claimed method steps provide favorable physiological advantages (e.g., immune, genetic, and cellular) (see [0002]) and wherein Ghader specifies vanadyl sulfate among active agents for inhibiting certain cathepsins and specifically cathepsin S (see [0698]).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AUDREA B CONIGLIO whose telephone number is (571)270-1336. The examiner can normally be reached Monday - Thursday 7:00 a.m. - 5:30 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 5712720616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AUDREA B CONIGLIO/Primary Examiner, Art Unit 1617
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