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 of Group I, claims 1-6 and the species compound 108110 of claim 2 in the reply filed on December 16, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 7-24 are withdrawn from consideration.
Note that compounds, corresponding compositions, a method of use and a process of making that are of the same scope are considered to form a single inventive concept under PCT Rule 13.1, 37 CFR 1.475(d). The claims are not so linked as to form a single inventive concept.
The specification identifies compound 108110 as the compound depicted as Figure 2 in the first Sheet of the drawings.
PNG
media_image1.png
315
241
media_image1.png
Greyscale
.
Claims 1, 3 and 5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter because art was found on the elected species.
Claim Rejections - 35 USC § 102
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.
Claims 2 and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Palese et al. (WO 2014/031571). The claims read on the teachings of the reference of the compound ON108110, which corresponds to the elected species, for treating viral infection (see paragraph [0011]). The claims read on the treatment or inhibition of viral infection or inhibition the replication of negative-sense, single-stranded RNA viruses, such as influenza virus, vesicular stomatitis virus (VSV), and Newcastle disease virus (NDV), see Examples 3, 4 and 6 in pages 45-47.
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 2 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 enablement requirement. The claim contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention.
The specification does not enable any physician skilled in the art of medicine, to use the invention commensurate in scope with these claims. The factors to be considered in making an enablement rejection have been summarized below.
In evaluating the enablement question, several factors are to be considered. Note In re Wands, 8 USPQ2d 1400 and Ex parte Forman, 230 USPQ 546. The factors include: 1) The nature of the invention, 2) the state of the prior art, 3) the predictability or lack thereof in the art, 4) the amount of direction or guidance present, 5) the presence or absence of working examples, 6) the breadth of the claims, and 7) the quantity of experimentation needed.
1) The nature of the invention: The claim is drawn to a method for treating RNA virus infection or a disease associated therewith.
2) The state of the prior art: There are no known compounds that can treat RNA virus infection generally or a disease associated therewith generally.
3) The predictability or lack thereof in the art: Applicants have not provided any competent evidence or disclosed tests that are highly predictive for the pharmaceutical use for treating any or all condition of the instant compound. Pharmacological activity in general is a very unpredictable area. Note that in cases involving physiological activity such as the instant case, “the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved”. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
4) The amount of direction or guidance present and 5) the presence or absence of working examples: The specification has no working examples to show treating any or all RNA virus infections or diseases associated therewith. The state of the art is unpredictable.
6) The breadth of the claims: The instant claims embrace treating any and all RNA virus infections and diseases associated therewith. The physician clearly must know what RNA virus infections or associated diseases are intended to be treated. The skilled artisan should know what diseases and what symptoms are to be treated. In this case, Applicants have not provided what is diseases are associated with RNA virus infections, 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.
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.
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.”
7) The quantity of experimentation needed would be an undue burden to one skilled in the pharmaceutical arts since there is inadequate guidance given to the skilled artisan, regarding the pharmaceutical use, for the reasons stated above.
Thus, factors such as “sufficient working examples”, “the level of skill in the art” and “predictability”, etc. have been demonstrated to be sufficiently lacking in the instant case for the instant method claims. In view of the breadth of the claims, the chemical nature of the invention, the unpredictability of enzyme-inhibitor interactions in general, and the lack of working examples regarding the activity of the claimed compounds towards treating the variety of diseases of the instant claims, one having ordinary skill in the art would have to undergo an undue amount of experimentation to use the instantly claimed invention commensurate in scope with the claims.
The instant compounds are disclosed to have kinase inhibitory activity and it is recited that the instant compounds are therefore useful in treating any or all diseases stated above for which applicants provide no competent evidence. It appears that the applicants are asserting that the embraced compounds because of their mode of action as kinase inhibitor would be useful for all sorts of RNA viral infections and diseases associated therewith. However, Applicants have not provided any competent evidence that the instantly disclosed test of inhibition of SARS-CoV-2 Replication (page 44) is highly predictive for all the uses disclosed and embraced by the claim language for the intended host.
The search for anti-viral compounds has been slow indeed. The record is filled with new compounds that were highly touted only to show no benefit in human efficacy clinical trials. The approaches that have been fruitful take advantage of precisely defined molecular features of the virus and have resulted in effective therapy for herpes and AIDS. It is optimistic in the extreme to believe that given the history of anti-viral research that an agent will be effective on such a diverse class of viruses that share physical but not molecular features. The rejected claims call for the treatment of viruses generally. 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 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. Amantadine has some effect on Influenza A but is ineffective against Influenza B or C. Foscavir is effective against HSV-1 and HSV-2 but ineffective against VZV. All three viruses are herpes viruses. Acyclovir, the most widely used agent for herpes is not effective against virus corneal epithelial herpes. AZT, part of the widely used treatment for HIV is not effective against DNA containing viruses. 5-FU, applied topically is effective against the human papilloma virus but has no effect against RNA viruses systemically or topically. Rabies has been known for hundreds of years. It is treated with a specific vaccine, which of course is ineffective against any other species of virus. No small molecule treatment of rabies is known. This lack of general efficacy in the antiviral arts means that a clinician is required to identify the species of viruses causing the disease before beginning treatment. This is in sharp contrast to the situation with bacteria.
MPEP §2164.01(a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was ‘filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here and undue experimentation will be required to practice Applicants’ invention.
Allowable Subject Matter
Claim 6 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.
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.
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, Jeffrey H. Murray can be reached at 571-272-9023. 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.
March 19, 2026
/BRUCK KIFLE/Primary Examiner, Art Unit 1624