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 the species wherein X is N; Y is CHR5, Z is NR1; R1 is CH3; R2 is phenyl substituted with Rx; R3 is H; R4 is CH2CF3; R4a is H; R5 is H; R6 is H; R7 is H; R8 is H; R9 is H; and Rx is CH3 in the reply filed on November 11, 2025 is acknowledged.
The elected species was not found and is allowable. He search and examination was expanded to embrace compounds wherein X is N; Y is CHR5, Z is NR1; R2 is aryl or cycloalkyl (optionally substituted); along with the full scope of the remaining variables in the tricyclic ring system (i.e., no additional ring fusions). This subgenus is free from prior art.
Subject matter not embraced by this subgenus is withdrawn from consideration as being drawn to non-elected subject matter.
Improper Markush Rejection
Claims 1-16 are rejected under a judicially created doctrine as being drawn to an improper Markush group, that is, the claims lack unity of invention. The variables X, Y, Z and the various “R” groups forming additional ring fusions are defined in such a way that they keep changing the core of the compound that determines the classification. By changing these values, several patentably distinct and independent compounds are claimed. In order to have unity of invention the compounds must have “a community of chemical or physical characteristics” which justify their inclusion in a common group, and that such inclusion is not repugnant to principles of scientific classification” In re JONES (CCPA) 74 USPQ 149 (see footnote 2). The structural formula in claim 1 does not have a significant structural feature that is shared by all of its alternatives which is inventive. The structure has only a pyridine ring as common. This feature is not inventive. In fact, the elected tricyclic ring system is not inventive (see Taoda et al. (WO 2019/230858), pages 4, formula (I) and page 17). Instantly claimed compounds embraced claim 1 are so diverse in nature that a prior art anticipating a claim with respect to one member under 35 USC 102 would not render obvious the same claim under 35 USC 103. This is evidentiary of patentably distinct and independent inventions.
Limiting the claims to the group above that has been searched would overcome this rejection.
Claim Rejections - 35 USC § 112
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 1-16 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.
i) The term “heteroaryl” is indefinite because it is not known how many atoms are present, how many and what kind of heteroatoms are involved, what size ring is intended and how many rings are present.
ii) The term “heterocyclyl” is indefinite because it is not known how many atoms make up the ring, which atoms are present and what kind of a ring (monocyclic, bicyclic, spiro, fused, bridged, saturated, etc.) is intended.
iii) In claim 10, “an effective amount” of the compound according to claim 1 for the composition to work as intended. Appropriate correction is required.
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 11, 12, 14 and 16 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 treating influenza, does not reasonably provide enablement for treating a disease caused by a virus having a cap-dependent endonuclease, a method for inhibiting cap-dependent endonuclease in a virus or preventing influenza. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The how to use portion of the statute has not been addressed. This means that Applicants must teach the skilled practitioner, in this case a physician, how to treat a given subject. The physician clearly must know what diseases and what symptoms are to be treated. In this case, Applicants have not provided what is being treated by claim 11, who the subject is, how one can identify said subject (i.e. how one can identify a subject in need), given no specific dose, given no specific dosing regimen, given no specific route of administration, and do not specify what diseases or symptom they intend to treat.
Regarding claim 12, this claim would read inhibition of cap-dependent endonuclease in any virus or in asymptomatic mammals. The specification fails to teach any benefit to be gained from such actions. Is extensive experimentation required on the part of a potential infringer to determine if his use of Applicants' inhibitor falls within the limitations of applicants' claim? In re Kirk and Petrow, 153 USPQ 48 (CCPA 1967).
As the Supreme Court said in Brenner v. Manson, 148 USPQ at 696: “a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.” As U.S. Court of Customs and Patent Appeals stated In re Diedrich 138 USPQ at 130, quoting with approval from the decision of the board: “We do not believe that it was the intention of the statutes to require the Patent Office, the courts, or the public to play the sort of guessing game that might be involved if an applicant could satisfy the requirements of the statutes by indicating the usefulness of a claimed compound in terms of possible use so general as to be meaningless and then, after his research or that of his competitors has definitely ascertained an actual use for the compound, adducing evidence intended to show that a particular specific use would have been obvious to men skilled in the particular art to which this use relates.”
Patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. Tossing out the mere germ of an idea does not constitute enabling disclosure. Genentech Inc. v. Novo Nordisk 42 USPQ2d 1001.
Regarding claim 11, the claim is directed to treating any disease caused by any virus having a cap-dependent endonuclease. The claimed utility is an extraordinary one in that it is not limited to the viruses disclosed in the specification but rather asserts that administration of these compounds is effective against complex of viral infections.
Despite the colossal amount of research, since viruses were first identified as infective agents no one has found an agent that is effective against all viruses. Under such circumstances, it is proper for the PTO to require evidence that such an unprecedented feat has actually been accomplished, In re Ferens, 163 USPQ 609. No such evidence has been presented in this case. The failure of skilled scientists to achieve a goal is substantial evidence that achieving such a goal is beyond the skill of practitioners in that art, Genentech vs Novo Nordisk, 42 USPQ2nd 1001, 1006.
The situation with viruses may be contrasted with that for bacterial infections. Certain agents, especially tetracycline and β-lactams are routinely found effective against a broad range of bacteria species. Thus, antibiotic activity against a single gram-positive species means that activity against all Gram-positive bacteria. The clinician uses this knowledge to prescribe a penicillin without determining which bacterium is responsible for the infection.
A far different situation prevails for viruses. Commonly an antiviral agent will be effective against a single species but not effective against other viruses in the same genus. What few antiviral agents exist are effective against only a limited range of viruses.
The same situation prevails with the prevention of viral diseases by vaccines, which is generally how prevention is achieved. No compound is known that can prevent influenza. This is generally achieved using vaccines. The specification lacks guidance to offer the clinician in the use of Applicants' compounds for the prevention of influenzas.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRUCK KIFLE whose telephone number is (571)272-0668. The examiner can normally be reached 8 AM - 6 PM, M-F.
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November 24, 2025
/BRUCK KIFLE/Primary Examiner, Art Unit 1624