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 .
Election/Restrictions and Claim Status
Applicant’s election without traverse of Group 1 in the reply filed on 8/7/26 is acknowledged.
Claims 21 and 24-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/7/26.
Applicant’s election of compound 1 (see page 5 of the specification) in the reply filed on 8/7/26 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)).
The elected species is such that R1 and R2 are D and R3-R17 are H so claims 16-19 are drawn to non-elected species.
Claims 16-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 was made without traverse in the reply filed on 8/7/26.
Claims 1-13 have been canceled.
Claims 14-15, 20 and 22-23 are being examined.
Priority
The priority information is found in the filing receipt of 9/11/24. It is noted that the foreign priority document of record is not in the English language.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/10/24 has been considered by the examiner.
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.
Claims 14-15 and 22-23 are 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.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated:
“To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”). Thus, an applicant complies with the written description requirement “by describing the invention, with all its claimed limitations, not that which makes it obvious,” and by using “such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention.” Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below.
Further, to provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include: a) the scope of the invention; b) actual reduction to practice; c) disclosure of drawings or structural chemical formulas; d) relevant identifying characteristics including complete structure, partial structure, physical and/or chemical properties, and structure/function correlation; e) method of making the claimed compounds; f) level of skill and knowledge in the art; and g) predictability in the art.
(1) Scope of the invention/Partial structure/disclosure of drawings:
Claim 14 recites prodrugs and isomers and claims 15 and 22-23 incorporate such scope.
The term isomer encompasses any type of isomer. For example a structural isomer can have the atoms arranged in any configuration (A-B-C is an isomer of C-A-B).
The term prodrug encompasses any type of prodrug.
None of the examples appear to be drawn to prodrugs or structural isomers.
Claim 20 is not included in this rejection since it is interpreted as being drawn to specific compounds or salts thereof.
(2) Level of skill and knowledge in the art/predictability in the art:
The level of skill in the art is high.
Nice et al. (US 2007/0099917) teach that with respect to prodrugs that one substituent may be successfully deployed with a particular class of compounds but the same approach on a different class may be ineffective (section 0008) and that seemingly minor modifications in order to accommodate a prodrug may cause the compound to be ineffective (section 0009).
(3) Physical and/or chemical properties and (4) Functional characteristics:
Claim 14 recites prodrugs and isomers and claims 15 and 22-23 incorporate such scope.
The term isomer encompasses any type of isomer. For example a structural isomer can have the atoms arranged in any configuration (A-B-C is an isomer of C-A-B).
The term prodrug encompasses any type of prodrug.
None of the examples appear to be drawn to prodrugs or structural isomers.
There is no specific disclosed correlation between structure and function (the word prodrug implies a function) particularly related to what structures are adequate to result in the prodrugs for example. One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus and that there is a lack of the predictability in the art thus that the applicant was not in possession of the claimed genus.
(5) Method of making the claimed invention/actual reduction to practice:
The specification (beginning on page 19) describes synthetic strategies. However, mere synthesis of a compound does not show that it would be a prodrug or structural isomer.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”) Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
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.
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.
Claim(s) 14-15, 20 and 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Macchiagodena et al. (as cited with IDS of 4/10/24; ‘Macchiagodena’) in view of Dampalla et al. (‘Postinfection treatment with a protease inhibitor increases survival of mice with a fatal SARS-CoV-2 infection’ PNAS v118(29) July 1 2021, pages 1-8; ‘Dampalla’).
The first page of Macchiagodena states that the article was available online 5 October 2021.
Macchiagodena teach that PF-07321332 (figure 1) is an antiviral agent for SARS-CoV-2 exhibiting nanomolar affinity (page 1 paragraph connecting columns 1-2).
Macchiagodena does not teach a deuterated version as claimed.
Dampalla teach treatments of SARS-CoV-2 (title and abstract). Dampalla teach that there are multiple potential advantages frequently accrued from the introduction of deuterium in a drug such as improved pharmacokinetics, reduction in toxicity and enhanced potency (page 5 first complete paragraph of column 2). Dampalla teach that higher mass of deuterium makes carbon-deuterium bonds more resistant to oxidative degradation (page 5 first complete paragraph of column 2). Dampalla recognizes combination treatments for SARS-CoV-2 (page 1 paragraph connecting columns 1-2). Dampalla teach synthesis of deuterated variants (page 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Macchiagodena because Macchiagodena teach that PF-07321332 (figure 1) is an antiviral agent for SARS-CoV-2 exhibiting nanomolar affinity (page 1 paragraph connecting columns 1-2) and Dampalla teach that there are multiple potential advantages frequently accrued from the introduction of deuterium in a drug such as improved pharmacokinetics, reduction in toxicity and enhanced potency (page 5 first complete paragraph of column 2). Thus, one would have been motivated to make deuterated versions of PF-07321332 at the finite number of possible positions on the compound. Since Dampalla recognizes combination treatments for SARS-CoV-2 (page 1 paragraph connecting columns 1-2) one would have been motivated to do so. One would have had a reasonable expectation of success since methods of synthesis were known.
In relation to the deuterated cyano compound of claims 14-15 and 20, Macchiagodena teach PF-07321332 (figure 1). When substituting hydrogen with deuterium as discussed above the resulting compounds read on the instant claims. One would have been motivated to substitute at the finite number of locations resulting in compounds as claimed.
In relation to the composition and carrier of claim 22, Dampalla recognizes combination treatments for SARS-CoV-2 (page 1 paragraph connecting columns 1-2) so one would have been motivated to prepare in an appropriate composition.
In relation to the further antiviral drug of claim 23, Dampalla recognizes combination treatments for SARS-CoV-2 (page 1 paragraph connecting columns 1-2).
Claim(s) 14-15, 20 and 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Owen et al. (WO 2021/250648, 12-2021; ‘Owen’).
Owen teach nitrile containing antiviral compounds (abstract). Owen specifically claims a particular compound (claim 5). The specification designates such compound E61 (page 42). Owen reports data related to such compound (page 293 and on pages 307-308). Owen teach compounds in a composition with a carrier (claim 17). Owen teach combination of drugs (pages 56-57 connecting paragraph and page 58).
Owen does not teach an example with a deuterated version of the compound as claimed.
Owen teach that substitution with deuterium can afford certain therapeutic advantages resulting from greater metabolic stability, for example increased in vivo half-life or reduced dosage requirements (page 56 first paragraph). In terms of the substitutions, Owen teach one or more atoms such as deuterium (page 55 last paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Owen because Owen teach that substitution with deuterium can afford certain therapeutic advantages resulting from greater metabolic stability, for example increased in vivo half-life or reduced dosage requirements (page 56 first paragraph). Since Owen specifically claims a particular compound (claim 5) and reports data related to such compound (page 293 and on pages 307-308) one would have been motivated to use such compound as the basis for the deuterium substitution. Since Owen teach one or more atom such as deuterium (page 55 last paragraph) one would have been motivated to do such. Since Owen teach in a composition with a carrier (claim 17) and teach combination of drugs (pages 56-57 connecting paragraph and page 58) one would have been motivated to do so. One would have had a reasonable expectation of success since Owen teach methods of preparing compounds (page 56 first paragraph).
In relation to the deuterated cyano compound of claims 14-15 and 20, Owen specifically claims a particular compound (claim 5). When substituting hydrogen with deuterium as discussed above the resulting compounds read on the instant claims. Since Owen teach one or more atoms such as deuterium for substitution (page 55 last paragraph) one would have been motivated to substitute at the finite number of locations.
In relation to the composition and carrier of claim 22, Owen teach in a composition with a carrier (claim 17).
In relation to the further antiviral drug of claim 23, Owen teach combination of drugs (pages 56-57 connecting paragraph and page 58).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 14-15, 20 and 22-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-23 of copending Application No. 18723921 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
18723921 recites a composition comprising a specific deuterated cyano compound (claim 11). 18723921 recites a composition comprising a deuterated cytidine compound (claim 11). 18723921 recites a composition comprising a carrier (claim 14).
In relation to the deuterated cyano compound of claims 14-15 and 20, 18723921 recites a composition comprising a specific deuterated cyano compound (claim 11) which is the first compound of instant claim 20.
In relation to the composition and carrier of claim 22, 18723921 recites a composition comprising a carrier (claim 14).
In relation to the further antiviral drug of claim 23, 18723921 recites a composition comprising a deuterated cytidine compound (claim 11).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD T NIEBAUER whose telephone number is (571)270-3059. The examiner can normally be reached M - F 6:30 - 2:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658
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