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 office action is in response to applicant’s filing on December 8, 2023.
Status of Claims
Claim 1 is currently pending and are the subject of this office action.
Claim 1 is presently under examination.
Priority
The present application is a CON of 17/834,667 (ABN), which is a CON of 15/750,318 filed on 02/05/2018 (ABN), which is a 371 of PCT/US2016/045721 filed on 08/05/2016, and claims priority to provisional application No. 62/201,788 filed on 08/06/2015.
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.
Claim 1 is 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
Claim 1 recites a group of compounds defined by their biological properties: “a reagent that downregulates or reduces TFAM, TRAP-1, PPRC-1 or ESSRA”.
M.P.E.P. #2163 states: “An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention….one must define a compound by ‘whatever characteristics sufficiently distinguish it’. A lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process”.
A description of a chemical genus will usually comprise a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the members of the genus, which features constitute substantial portion of the genus. See Univ. of California vs. Eli Lilly, 43 USPQ 2d 1398, 1406 (Fed. Cir. 1997). This is analogous to enablement of a genus under section 112 first, by showing enablement of a representative number of species within the genus. A chemical genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. If the genus has a substantial variance, the disclosure must describe a sufficient number of species to reflect the variation within that genus.
Applicant has failed to show that he was in possession of most of the diverse compounds encompassed by “reagents that downregulates or reduces TFAM, TRAP-1, PPRC-1 or ESSRA”. Applicant discloses that phenformin, gamitrinib, siRNA or antibodies qualify as “reagents that downregulates or reduces TFAM, TRAP-1, PPRC-1 or ESSRA”.
The prior art does not teach which “reagents downregulate or reduce TFAM, TRAP-1, PPRC-1 or ESSRA”.
Given the broad scope of the claimed subject matter, Applicant has not provided sufficient written description that would allow the skilled in the art to recognize all the compounds that qualify as “reagents that downregulates or reduces TFAM, TRAP-1, PPRC-1 or ESSRA” as claimed.
In summary, the skilled in the art will not know which compounds, besides phenformin and Gamitrinib qualify as “reagents that downregulates or reduces TFAM, TRAP-1, PPRC-1 or ESSRA”.
Claim Rejections - 35 USC § 102
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 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 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 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yuan et. al. (PNAS (2013) 110:18226-18231).
For claim 1, Yuan teaches (See abstract) a composition comprising: DMSO in carboxymethylcellulose (i.e., a pharmaceutical composition, see page 18231 under Animal Studies), PLX4720 (a MAPK inhibitor, see instant specification on page 2, line 34) and Phenformin (a reagent that downregulates or reduces TFAM, TRAP-1, PPRC1 or ESSRA, see specification page 2, line 33).
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARCOS L SZNAIDMAN/Primary Examiner, Art Unit 1628
June 11, 2024.
