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 .
Response to Amendment
The amendment filed 2026 June 3 is acknowledged. Newly amended claims 1, 7, 12, 16, 17, 20, and 21 are examined on the merits. The 35 U.S.C. 112 (a) written description is overcome because the ENPP1 inhibitor is amended to compounds with written description. The 35 U.S.C. 112(b) rejection is overcome because claims 2-6 are now cancelled.
Claims 24, 27, 32, and 36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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.
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 17, 20, and 21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification is enabling for stimulating an immune response or treating an infectious disease with a three-component composition of an ENPP1 inhibitor selected form compound 1 or 76, a vaccine, and a cyclic GMP-AMP synthase/ STING pathway agonist. and non-enabling for preventing an infectious disease with a three-component composition of an ENPP1 inhibitor selected form compound 1 or 76, a vaccine, and a cyclic GMP-AMP synthase/ STING pathway agonist. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
Consideration of the relevant factors sufficient to establish a prima facie case for lack of enablement is set forth herein below:
The nature of the invention and (2) the breadth of the claims:
The claims are drawn to a method of stimulating an immune response, treating an infectious disease, or preventing an infectious disease with a three-component composition of an ENPP1 inhibitor selected form compound 1 or 76, a vaccine, and a cyclic GMP-AMP synthase/ STING pathway agonist. Thus, the claims taken together with the specification imply that a three component of claim 1 can stimulate an immune response, treat an infectious disease, or prevent an infectious disease.
The state of the prior art and (4) the predictability or unpredictability of the art:
Avelleira (Anais Brasileiros de Dermatologia, 2006, 81(2), 111-126) describes that syphilis, an infectious disease is not preventable through medicinal means (page 122, column 1, last paragraph to column 2, paragraph 2).
The relative skill of those in the art:
Those of relative skill in the art are those with level of skill of the authors of the references cited to support the examiner’s position (MD’s, PhD’s, or those with advanced degrees and the requisite experience in prevention of an infectious disease).
The amount of direction or guidance presented and the presence or absence of working examples:
The specification has provided guidance for stimulating an immune response or treating an infectious disease with a three-component composition of an ENPP1 inhibitor selected form compound 1 or 76, a vaccine, and a cyclic GMP-AMP synthase/ STING pathway agonist.
The specification does not provide guidance for preventing an infectious disease with a three-component composition of an ENPP1 inhibitor selected form compound 1 or 76, a vaccine, and a cyclic GMP-AMP synthase/ STING pathway agonist.
The quantity of experimentation necessary:
Considering the state of the art as discussed by the references above, particularly with regards to preventing an infectious disease with a three-component composition of an ENPP1 inhibitor selected form compound 1 or 76, a vaccine, and a cyclic GMP-AMP synthase/ STING pathway agonist and the high unpredictability in the art as evidenced therein, and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims.
Conclusion
Claims 1, 7, 12, and 16 are allowed. Claims 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 not a three-component 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].
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/NOBLE E JARRELL/Primary Examiner, Art Unit 1699
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