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 without traverse of group I in the reply filed on 2025 October 23 is acknowledged. Claim 1-2, 5-7, 12, 16, 17, 20, 21, 24, 27, 32, and 36 are pending in the examined application. Due to the election without traverse, claims 1-2, 5-7, 12, 16, 17, 20, and 21 are examined on the merits.
Claims 24, 27, 32, and 36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2025 October 23.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 2022 December 16 and 2025 October 27 were submitted in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are considered by the examiner.
Claim Objections
Claims 2, 3, and 5 are objected to because of the following informalities: in formula (VI), variables Z1-Z4 and R1-R5 are present. In the body of the claim, variables Z1-Z4 are recited. For consistency, the body of the claim should recite variables Z1-Z4 and R1-R5 Appropriate correction is required.
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) 1-2, 5-7, 12, 16, 17, 20, and 21 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 them.
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 1-2, 5-7, 12, 16, 17, 20, 21 are drawn to a three component composition comprising an ectonucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1) inhibitor; a vaccine; and a cyclic GMP-AMP synthase (cGAS)/stimulator of interferon genes (STING) pathway agonist.
(1) Level of skill and knowledge in the art:
GALLATIN (WO 2019191504, published 2019 October 3, cited in IDS) describes various ENPP1 inhibitors (page 56, paragraph [0136] to page 60, paragraph [0148]).
(2) Partial structure:
A subgenus of formula (VI) describes ENPP1 inhibitors of the examined application. This formula specifies that a phosphorous-containing compound with two rings directly connected to each other is an ENPP1 inhibitor.
PNG
media_image1.png
516
572
media_image1.png
Greyscale
(3) Physical and/or chemical properties and (4) Functional characteristics:
NMR properties of a properties of a compound encompassed by a subgenus of formula (VI) are described (specification, pages 81, lines 7-19).
(5) Method of making the claimed invention:
Example 1 (specification, page 80, lines 7-10) describes a representative synthesis of preparing a compound encompassed by a subgenus of formula (VI).
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) 1-2, 5-7, 12, 16, 17, 20, and 21 is/are broad and generic, with respect to all possible compounds encompassed by the claims. The possible structural variations are limitless to any three component composition comprising an ectonucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1) inhibitor, a vaccine, and a cyclic GMP-AMP synthase (cGAS)/stimulator of interferon genes (STING) pathway agonist.
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 compositions identified in the specification tables and/or examples, the specification does not provide sufficient descriptive support for the myriad of compositions 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.
Claim 2, 3, 5, and 6 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.
Claims 2, 3, and 5 recite a formula containing variables Z1-Z4 and R1-R5 and the body text recites variables Z1-Z4 and R1-R5. There is insufficient antecedent basis for the limitations Z1-Z4 and R1-R5 in the claims because the structural formula recites variables Z1-Z4 and R1-R5.
In claim 6, tables 1 and 2 of the specification (pages 33-42) are referenced.
MPEP 2173.05(s) states the following:
Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).
Reference characters corresponding to elements recited in the detailed description and the drawings may be used in conjunction with the recitation of the same element or group of elements in the claims. Generally, the presence or absence of such reference characters does not affect the scope of a claim. See MPEP § 608.01(m) for information pertaining to the treatment of reference characters in a claim.
When this teaching is applied to claim 6, the compounds of tables 1 and 2 should be explicitly recited in the claim because the specification can be amended and the scope of the encompassed compounds then changes. Claim 6 is unclear for this reason.
Allowable Subject Matter
Claims 1-2, 5-7, 12, 16, 17, 20, and 21 are not allowed.
The following is a statement of reasons for the indication of allowable subject matter: GALLATIN (WO 2019046778, published 2019 March 7) described ENPP1 inhibitors but no three part composition containing an ENPP1 inhibitor, a vaccine, and a cyclic GMP-AMP synthase (cGAS)/stimulator of interferon genes (STING) pathway agonist (abstract; page 122, paragraph [0331]-[0337].
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.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NOBLE E JARRELL/Primary Examiner, Art Unit 1699