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 .
Status of Claims
The amendments to the claims filed December 17, 2024 are acknowledged and entered. Claims 1-2, 7, 10, 14-15, 18-24, 28, 30-32, 34, 39 and 42 are pending.
Priority
This application claims benefit of 63/586,024, filed September 28, 2023.
Information Disclosure Statement
Acknowledgement is made of the Information Disclosure Statements filed on December 17, 2024; April 30, 2025; October 17, 2025; March 31, 2026 and September 15, 2026. All references have been considered except where marked with a strikethrough.
Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which applicant may become aware of in the specification.
Allowable Subject Matter
Claims 1-2, 7, 10, 14-15 and 19 and 21-24 are allowed.
Claims 18 and 20 would be allowable if rewritten to overcome the objection set forth herein.
The following is an examiner’s statement of reasons for allowance:
The claims are free of the prior art. The examiner performed a chemical structure as well as an inventor and classification search to identify any potential prior art. The Examiner was unable to identify any prior art which contained the limitations seen in the present application.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Claim Objections
Claims 18 and 20 are objected to for being drawn to an ion ( pictured below). The claims are incomplete because they do not depict the required kind and number of counter ions necessary to have a neutral compound. The claim should be amended to clarify counter ion number and type. Written support for such an amendment can be found in Example 2 from the specification as well as claim 1 which recites a compound or a pharmaceutically acceptable salt.
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Claim Rejections - 35 USC § 112a
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 28, 30-32, 34, 39 and 42 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 a method of treating a viral infection selected from the group consisting of RSV, MERS, Dengue, Zika, and SARS-CoV does not reasonably provide enablement for treating or preventing a viral infection 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.
Applicant teaches that the claimed compounds have activity against RSV, MERS, Dengue, Zika, and SARS-CoV (See Examples at page 92-98). However, RSV, MERS, Dengue, Zika, and SARS-CoV in no way are representative of the massive number of distinct viral infections embraced by the claims. Applicant’s disclosure is only enabling for the treatment of conditions which Applicant has demonstrated may be treated by the instant compound, and of conditions which the prior art is already aware may be treated by a compound with the disclosed activity and for which Applicant has written support. Case law is clear on this point. In an unpredictable art, such as drug therapy to treat disease, models may be used for enablement only if there is a reasonable correlation between the activity in question and the asserted utility. Given the guidance provided by Applicant, one skilled in the art would not be able to practice the full scope of the invention without undue experimentation.
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. The determination that “undue experimentation” would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the above noted factual considerations.
The nature of the invention & breadth of claims:
Claim 1 is drawn to a compound.
Claim 28 depends from claim 1 and recites a method of treating or preventing a viral infection in a human in need thereof, wherein the method comprises administering to the human the compound of claim 1. Claims 30-32, 34, 39 and 42 depend from claim 28 include the full scope of “viral infection” or recite a subset of viral infections and include “preventing”.
The specification does not provide a definition of viral infections embraced by the claim.
The nature of the invention is a method of treating or preventing viral infection. In view of the specification a person skilled in the art would understand viral infection to mean any human viral infection known in the art. The scope of the claims is thus very broad.
The state of the prior art
Siegel teaches virus families that infect humans consist of Adenoviridae, Arenaviridae, Astroviridae, Bornaviridae, Bunyaviridae, Caliciviridae, Circoviridae, Coronaviridae, Filoviridae, Flaviviridae, Hepadnaviridae, Hepeviridae, Herpesviridae, Orthomyxoviridae, Papillomaviridae, Polyomaviridae, Paramyxoviridae, Parvoviridae, Picornaviridae, Poxviridae, Reoviridae, Retroviridae, Rhabdoviridae, Togaviridae and unclassified delta (Table 201-2), and that these families represent many different forms of virus (Table 201-3). Coronavirus for instance embraces SARS coronavirus but also torovirus and other enteric coronaviruses (Table 201-3, Coronaviridae). Siegel teaches these viruses are distinct (Table 201-1).
The state of the prior art does not appear to be aware that any single agent treats or prevents all distinct forms of viral infection in humans as is presently claimed. The state of the prior art seems to be aware that different viral infections require different treatments as suggested by Tan et al. (medRxiv 2020, Ostavimir is ineffective against COVID-19: in silico assessment, in vitro and retrospective study)
who teaches Ostavimir is ineffective against COVID-19 (Title; Conclusion: We found that oseltamivir is ineffective against SARS-CoV-2 in vitro study and the clinical use of oseltamivir did not improve the patients’ symptoms and signs and did not slow the disease progression. Therefore, we consider that oseltamivir isn’t suitable for the treatment of COVID-19).
Moreover, the state of the prior art is aware that prevention of viral infections are achieved through the use of vaccines.
The Level of One of Ordinary Skill
The level of skill in the art is high. The artisan using the claimed invention would be a person with medical training such as a medical doctor or physician with an MD degree or the equivalent.
Predictability in the art
It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F. 2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. 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).
In terms of the law, MPEP 2107.03 states “evidence of pharmacological or other biological activity of a compound will be relevant to an asserted therapeutic use if there is a reasonable correlation between the activity in question and the asserted utility. Cross v. Iizuka, 753 F.2d 1040, 224 USPQ 739 (Fed. Cir. 1985); In re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980); Nelson v. Bowler, 626 F.2d 853, 206 USPQ 881 (CCPA 1980).” If correlation is lacking, it cannot be relied upon, Ex parte Powers, 220 USPQ 924; Rey-Bellet and Spiegelberg v. Engelhardt v. Schindler, 181 USPQ 453; Knapp v. Anderson, 177 USPQ 688. Indeed, the correlation must have been established “at the time the tests were performed”, Hoffman v. Klaus, 9 USPQ2d 1657.
Amount of guidance/working examples
Applicant provides in vitro data to show that the claimed compounds have activity against RSV, MERS, Dengue, Zika, and SARS-CoV, thus fairly suggesting the method may treat one of these viral infections.
However, no experimental or other data is provided to show the instant compound is useful for treating or preventing all human viral infections. The specification does not provide any guidance to one of ordinary skill in the art to extrapolate the in vitro data provided by Applicant to the treatment or prevention of many distinct viral infections included in the scope of the method. For instance, there is no evidence or statement provided that RSV, MERS, Dengue, Zika, and SARS-CoV are art recognized model systems of “viral infections” generally.
The quantity of experimentation needed:
MPEP 2164.01(a) states, "A conclusion of lack of enablement means that, based on theevidence 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 one skilled in the art could not practice the full scope of the claimed invention without undue experimentation.
Claim Rejections - 35 USC § 112b
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 39 is 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.
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 39 recites the broad recitation “SARS-CoV virus infection”, and the claim also recites “SARS-CoV-2 infection” 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN MARTIN whose telephone number is (571)270-0917. The examiner can normally be reached Monday - Friday 8 am - 5 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, 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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September 22, 2026
/K.S.M./Examiner, Art Unit 1624
/BRUCK KIFLE/Primary Examiner, Art Unit 1624
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