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 .
Continued Examination Under 37 CFR 1.114
The amendment filed 2023 July 24 containing claims 1-3 are examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2023 July 24 was submitted in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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(s) 1 and 3 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph due to lack of written description.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below.
In the instant case, claims 1 and 3 are drawn to an administration method of a chemotherapeutic drug that reduces or inhibits the growth of a solid or hematological tumor, comprising the anti-neoplastic of a chemotherapeutic drug, antineoplastic immunotherapy by reducing lactate dehydrogenase activity, and the modulation of immune cells activity by inhibiting lactate dehydrogenase activity,
(1) Level of skill and knowledge in the art:
TOPP (EP 2942629, published 2015 November 11) describes a combination chemotherapeutic method comprising blinatumomab and t-cell therapy in which lactate dehydrogenase activity is reduced (page 2, paragraphs [0007]-[0009]; page 10; para graph [0075] to page 17, paragraph [0104]).
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(2) Partial structure:
Examples 1-4 (page 8, line 27 to page 11, line 9) describes using stiripentol to treat a brain tumor, a solid tumor.
The MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that claim(s) 1 and 3 is/are broad and generic, with respect to combination chemotherapy comprising a chemotherapeutic drug and an immunotherapy in the treatment of a solid or blood tumor. The possible structural variations are limitless to any combination chemotherapy method comprising a chemotherapeutic drug and an immunotherapy in the treatment of a solid or blood tumor. Although the claims may recite some functional characteristics, the claims lack written description because there is no disclosure of a correlation between function and structure of the compounds beyond those compounds specifically disclosed in the examples in the specification. Moreover, the specification lack sufficient variety of species to reflect this variance in the genus. While having written description of the usage of stiripentol in the claimed method and compounds identified in the specification tables and/or examples, the specification does not provide sufficient descriptive support for the myriad of compounds embraced by the claims.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”) Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
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 1 and 3 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. The claims do not specify the metes and bounds of a chemotherapeutic agent to be used in the method. Without knowing the metes and bounds of the chemotherapeutic agent, it is unclear how the method recited in claims 1 and 3 can be practiced.
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 (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 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 and 3 is/are rejected under 35 U.S.C. 102(a0(1) as being anticipated by TOPP (EP 2942629, published 2015 November 11) describes a combination chemotherapeutic method of treating B-ALL comprising blinatumomab and t-cell therapy in which lactate dehydrogenase activity is reduced (page 2, paragraphs [0007]-[0009]; page 10; para graph [0075] to page 17, paragraph [0104]).
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Claim(s) 1 and 3 are is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by TURTLE (WO 2019232479, published 2019 December 5). Turtle describes a method of combination chemotherapeutic method of b-ALL using ibrutinib and CAR-T cells (abstract; page 9, lines 13-22; page 39, lines 14-30; page 40, lines 15 to page 44, line 20; page 75, line 10 to page 80, line 18; figures 21A-F).
Allowable Subject Matter
Claims 1 and 3 are not allowed.
Claim 2 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: TOPP (EP 2942629, published 2015 November 11) does not describe using stiripentol to treat cancer.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOBLE E JARRELL whose telephone number is (571)272-9077. The examiner can normally be reached 9:00 AM to 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NOBLE E JARRELL/Primary Examiner, Art Unit 1699