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 .
This is the first action on the merits.
Claims 15-20 are pending and under examination. Claims 15-20 are new claims.
Priority
Applicant's claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) (PROVISIONAL) or 119(a) (FOREIGN) or under 35 U.S.C. 120 (CONT/CIP), 121(DIV), or 365(c) (WO) is acknowledged. The present claims receive the benefit of the foreign priority filing date of February 11, 2020 based on the translation received on October 14, 2025.
Claim Objections
The objection of claims 2-14 because of the following informalities: the term “Claim” is withdrawn based on the cancellation of said claims.
The objection of claim 1 because of the term “and” should added between the terms “arylalkoxy” and “heteroarylalkylalkoxy” in the definition of the variables R5, R6 and R7, is withdrawn based on the cancellation of said claim.
Claim 15 is objected to because of the following informalities: the “and” term at the end of lines 5 and 7 should be removed. Moreover, the “;” after the term “heteroalkylalkoxy” in lines 6 and 8 should also be removed. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: the “and” term should be added between the last two groups in the definition of R3. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: the subformulas shown below in the definition of R4 should indicate a point of attachment with “*.”
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Appropriate correction is required.
Claim 17 is objected to because of the following informalities: the comma after the term “medicine” should be removed. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The rejection of claims 1-14 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the definition of R1, is withdrawn based on the cancellation of said claims.
The rejection of claims 1-14 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the term “adduct,” is withdrawn based on the cancellation of said claims.
The rejection of claims 4-7, 13 and 14 under 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for not being further limiting is withdrawn based on the cancellation of said claims.
The rejection of claims 9 and 10 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-IA), first paragraph, because the specification, while being enabling for a method for treating a disease caused by coronavirus, picornavirus, enterovirus and norovirus, does not reasonably provide enablement for a method for treating all RNA viruses, generally, is withdrawn based on the cancellation of said claims.
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 15-20 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 pre-AIA the applicant regards as the invention.
The word “adduct” in claims 15 is vague. An adduct is a substance or compound obtained from, or regarded as derived from another substance or compound. What are these “adducts?” Are the “adducts” covered by the scope of the compounds in claim 15? Thus, claims 15 and 17-20 are indefinite.
To overcome the rejection, the term may be removed from the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 15 recites the broad recitation “a salt,” and the claim also recites “pharmaceutically acceptable salt” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
To overcome the rejection, the term “salt” may be removed from line 3.
Regarding claim 16, the phrase “antiviral active agent” lacks antecedent basis.
To overcome the rejection, the phrase may be amended to “antiviral agent.”
Further in claim 16, the following compounds lack antecedent basis with regards to the phenyl ring at R3.
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To overcome the rejection, the claim may be amended into an independent claim.
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 18 and 19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-IA), first paragraph, because the specification, while being enabling for a method for treating a disease caused by coronavirus, picornavirus, enterovirus and norovirus, does not reasonably provide enablement for a method for treating all RNA viruses, generally. 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.
Pursuant to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. Some experimentation is not fatal; the issue is whether the amount of experimentation is “undue”; see In re Vaeck, 20 USPQ2d 1438, 1444.
The analysis is as follows:
(A) Breadth of claims.
(a) Scope of the compounds. The instant claims encompass millions of compounds that are embraced by the formula in claim 1 with a variety of substituents at eight different positions.
(b) Scope of the diseases covered. The instant claims are drawn to a method of treating a disease, see claim 9, and more specifically a disease caused by an RNA virus, see claim 18. The scope is broad because all RNA viruses are not the same.
RNA viral infections are caused by viruses whose genetic material is RNA, not DNA. These viruses can cause a variety of diseases, some of which are very serious. Their RNA genome can be single-stranded (ssRNA) or double-stranded (dsRNA). Examples of infections caused by RNA viruses are respiratory viruses (for example, influenza, coronaviruses (including SARS-CoV-2, causing COVID-19), respiratory syncytial virus (RSV), Vector-borne viruses (for example, Dengue virus, West Nile virus and Zika virus); other RNA viruses (for example, Hepatitis C virus (HCV), HIV, Ebola virus, polio, measles and rabies).
(B) The nature of the invention and predictability in the art: The invention is directed toward medicine and is therefore physiological in nature. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
(C) Direction or Guidance: That provided is very limited. The dosage range information, found on page 13 of the Specification points to US 10189810 for guidance, which is generic.
(D) State of the Prior Art: These compounds are substituted 3-amino-2-oxopyridin-1(2H)-yl)-3-cyclohexylpropanamide scaffold with a particular substitution. So far as the examiner is aware, no substituted 3-amino-2-oxopyridin-1(2H)-yl)-3-cyclohexylpropanamides of this kind have been used for treating all RNA viral infections.
(E) Working Examples: The invention is drawn to a method of treating RNA viral infections. On pages 10-25 of the Specification and the drawings there are several antviral assays with mice with RHCDSIe and pharmokinetic data, see Table 3.
(F) Skill of those in the art: The viral infections listed under Scope of diseases above cannot be treated generally by any one drug. These are all different viral infections, which occur at different locations in the body and by different viruses. Claim 9 is drawn to a method of treating a disease, generally, claim 18 is drawn to a method of treating a disease caused by an RNA virus, generally.
Challenges in treating RNA viral infections is that RNA viruses have high mutation rates, which allows them to evolve and evade immune responses and develop resistance to antiviral treatments. Some RNA viruses can persist in the host even after the infection is cleared, leading to chronic diseases.
Treatment options are antiviral medications. Some medications are available to treat specific RNA viral infections, such as influenza antivirals and medications for hepatitis C. Gardasil®, a vaccine which is currently marketed to prevent HPV, only protects against HPV strains 16, 11, 18 and 6, which is the majority of the strains which cause cervical cancer, but is not all the strains.
Furthermore, despite intensive efforts, pharmaceutical science has been unable to find a way of getting a compound to be effective for the treatment of viral infections generally. 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.
(G) The quantity of experimentation needed: Owing especially to factors A, C, E and F, the amount of experimentation is expected to be high.
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.
To overcome the rejection, the claims may be limited to those RNA viruses noted as being enabled in the rejection.
Claim Rejections - 35 USC § 102
The rejection of claim(s) 1-14 under 35 U.S.C. 102(a)(1) as being anticipated by Ullrich et al. (Bioorganic and Medicinal Chemistry Letters, 2020, 30(17), 127377, 1-8, published online on July 2, 2020), is withdrawn based on the translation of the foreign priority document.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNA MOORE whose telephone number is (571)272-9046. The examiner can normally be reached Monday - Friday, 10:00 am to 7:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUSANNA MOORE/Primary Examiner, Art Unit 1624