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 application is the national stage entry of PCT/US2022/024290, filed 11 April 2022; claims benefit of provisional application 63/298,836, filed 12 Jan 2022; claims benefit of provisional application 63/288,163, filed 10 Dec 2021; claims benefit of provisional application 63/210,246, filed 14 June 2021; claims benefit of provisional application 63/175,673, filed 16 April 2021; and claims benefit of provisional application 63/173,354, filed 09 April 2021.
Claims 1-12, 19, 30, 41, 50, 61, 76-81, 94-96, 98, and 118-123 are pending in the current application. Claims 12, 19, 30, 41, 50, 77-81, 95-96, 98, and 118-123, drawn to non-elected species, are withdrawn. Claims 1-11, 61, 76, and 94 are examined on the merits herein.
Election/Restrictions
Applicant’s election of species of compound administered to be a 4’-β-D-thioribonucleoside and the viral infection treated to be a Coronaviridae virus in the reply filed on 20 May 2026 is acknowledged.
In view of the teachings of Gunaga et al. (Current Medicinal Chemistry, 2004, 11, 2585-2637, cited in PTO-892) cited further below to teach obvious variants, search and examination has expanded to encompass the 4’-β-D-thioribonucleosides.
Claims 12, 19, 30, 41, 50, 77-81, 95-96, 98, and 118-123 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election of species was made in the reply filed on 20 May 2026.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - Sequences appearing in the specification are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like) in accordance with 37 CFR 1.831(c).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
In this case the specification as published at paragraphs 357, 368-370, and 389 lists nucleotide sequences that are not identified by sequence identifiers.
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 61 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 61 recites “the compound is co-administered with one or more additional active compounds selected from the group consisting of … and agents of distinct or unknown mechanism.” (emphasis added)
The recitation of “agents of distinct or unknown mechanism” is interpreted as a functional limitation, reciting a feature "“by what it does rather than by what it is” (e.g., as evidenced by its specific structure or specific ingredients). In re Swinehart, 439 F.2d 210, 212, 169 USPQ 226, 229 (CCPA 1971)." See MPEP 2173.05(g), further providing 'Unlimited functional claim limitations that extend to all means or methods of resolving a problem may not be adequately supported by the written description or may not be commensurate in scope with the enabling disclosure, both of which are required by 35 U.S.C. 112(a) and pre-AIA 35 U.S.C. 112, first paragraph. In re Hyatt, 708 F.2d 712, 714, 218 USPQ 195, 197 (Fed. Cir. 1983); Ariad, 598 F.3d at 1340, 94 USPQ2d at 1167. For instance, a single means claim covering every conceivable means for achieving the stated result was held to be invalid under 35 U.S.C. 112, first paragraph because the court recognized that the specification, which disclosed only those means known to the inventor, was not commensurate in scope with the claim. Hyatt, 708 F.2d at 714-715, 218 USPQ at 197."'
In this case the claimed method recites the agents of distinct or unknown mechanism as active agents co-administered with the compound of Formula (A) or (A1), and the written description of such active agents does not adequately support this functional claim language extending to all active agents, known or unknown. The specification, which discloses only those means known to the inventor, is not commensurate in scope with the claim, which specifically covers agents of unknown mechanism. Further, the scope of the claim would reasonably cover unknown agents which have a distinct mechanism. Therefore the description in the specification is not commensurate in scope with the claim.
Claims 1-11, 61, 76, and 94 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 Coronaviridae infection comprising administering a treatment amount of a compound of Formula (A) or Formula (A1), does not reasonably provide enablement for preventing a Coronaviridae infection comprising administering a preventative amount of a compound of Formula (A) or Formula (A1). 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 Applicant’s attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
(1) The nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
Nature of the invention: A method for treating or preventing a Coronaviridae, Flaviviridae, Picornaviridae, Bunyaviridae, or Togaviridae infection, comprising administering a treatment or preventative amount of a compound of Formula (A) or Formula (A1) to a patient in need of treatment or prevention thereof.
The state of the prior art: Pradhan et al. (Archives of Medical Research, 2020, 51, p363-374, cited in PTO-892) teaches the state of the art regarding interventions for COVID-19 prevention, or prevention of a Coronaviridae infection. Pradhan et al. teaches the current unavailability of an effective antiviral drug, and that implementation of effective preventive measures such as a suitable selection of surface disinfectants, appropriate hand sanitization, and empowering personal protective equipment (PPE), is the only option left to counteract CoVID-19 (page 363, abstract). In comparison to the other microbial infections (bacterial and fungal), developing an antiviral therapy is always a tough assignment to the scientific community. The primary reasons are the highly complex structural ambiguity and inability to identify the viral targets that make the process more complicated to design a selective and effective antiviral therapy. Currently, the unavailability of effective antiviral drug therapy in the global market worsens the situation to a greater extent (page 364, right column).
The relative skill of those in the art: The relative skill of those in the art is high.
The predictability or unpredictability of the art: Pradhan et al. teaching the highly complex structural ambiguity and inability to identify the viral targets that make the process to design a selective and effective antiviral therapy more complicated suggests the development of antiviral therapy for preventing a Coronaviridae infection is unpredictable. Therefore the claimed invention is unpredictable.
The Breadth of the claims: The scope of the claims specifically includes prevention of a Coronaviridae infection.
The amount of direction or guidance presented and The presence or absence of working examples: Working examples are provided for the virus yield inhibition of the SARS-CoV-2 virus at example 13.
Note that lack of working examples is a critical factor to be considered, especially in a case involving an unpredictable and undeveloped art such as preventing a Coronaviridae infection. See MPEP 2164.
The quantity of experimentation necessary: In order to practice the invention with the full range of all possible treatment methods beyond those known in the art, (such as treating a Coronaviridae infection) one skilled in the art would undertake a novel and extensive research program to show that the antiviral drug prevented a Coronaviridae infection. Because this research would have to be exhaustive, and because it would involve such a wide and unpredictable scope of Coronaviridae having different viral targets, it would constitute an undue and unpredictable experimental burden.
Genentech, 108 F.3d at 1366, states that, “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion.” And “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.”
Therefore, in view of the Wands factors, as discussed above, particularly the breadth of the claims, Applicants fail to provide information sufficient to practice the claimed invention for prevention of Coronaviridae infection.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-11, 61, 76, and 94 are rejected under 35 U.S.C. 103 as being unpatentable over Olsen et al. (US 2004/0259934, published 23 Dec 2004, cited in PTO-892) in view of Gunaga et al. (Current Medicinal Chemistry, 2004, 11, 2585-2637, cited in PTO-892).
Olsen et al. teaches infection by a Coronaviridae virus (e.g., a coronavirus) and/or illness due to a Coronaviridae virus are treated or protected against by administration of a therapeutically or prophylactically effective amount of certain nucleoside compounds and derivatives thereof (abstract). The nucleoside compounds and derivatives thereof administered are a compound of Formula I
PNG
media_image1.png
184
224
media_image1.png
Greyscale
where Z is O or S, R1 and R2 can be H or OH, R3 and R4 can be H or OH, R7 can be H, and R5 can be H, and where Q is
PNG
media_image2.png
174
466
media_image2.png
Greyscale
, where A can be N, R8 can be H, R9 can be amino, R10 can be H, R11 can be H, R12 can be amino, and W is O or S (page 1, paragraph 7 to page 2, paragraph 31). The invention includes administration of the compound of formula I in combination with one or more other agents useful for treating or prophylaxis of infection by a Coronaviridae virus, such as antiviral nucleosides ribavirin, levovirin, and viramidine (page 9, paragraphs 154-155), addressing limitations of claim 61.
Olsen et al. does not specifically disclose the method of treating an infection by a Coronaviridae virus comprising administering the elected species of compound (claim 1).
Gunaga et al. teaches 4’-thionucleosides, in which replacement of the 4’ oxygen by sulphur conferred resistance to nucleoside cleavage compared to the classical 4’-oxonucleoside. Antiviral activities of 2’-deoxy-4’-thionucleosides have been reported, and subsequent contributions by other authors enhanced its standing as an important class of antiviral agents (page 2585, abstract). The synthesis of 4’-β-D-thioribonucleosides is known in the art (page 2587, paragraph spanning left and right columns, and Scheme 2.3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Olsen et al. in view of Gunaga et al. in order to select the compound administered in the method of Olsen et al. to be a 4’-β-D-thioribonucleoside. One of ordinary skill in the art would have been motivated to combine Olsen et al. in view of Gunaga et al. with a reasonable expectation of success because Olsen et al. teaches the method of treatment of an infection by a Coronaviridae virus comprising administering a therapeutically or prophylactically effective amount of certain nucleoside compounds and derivatives, where the compounds are taught to encompass 4’-β-D-thioribonucleosides, and Gunaga et al. teaches 4’-thionucleosides are known as a class of antiviral agents, suggesting it would have been obvious to pick-and-choose the antiviral nucleoside compounds of Olsen et al. to be 4’-β-D-thioribonucleosides based on the guidance suggested by Gunaga et al.
Conclusion
No claim is found to be allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan S Lau whose telephone number is (571)270-3531. The examiner can normally be reached Monday-Friday 9a-5p Eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached at (571)270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN S LAU/ Primary Examiner, Art Unit 1693
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