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 without traverse of Group I, encompassed by claims 1, 5, 17, 18, 37, 39, 51, 54, 55, 58, 67, 71, 79, 81, 87, and 103 in the reply filed on January 23, 2026 is acknowledged. Further, Applicant elects the species (Example 967 on page 879 of the Specification) of:
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The species election was made without traverse. The single compound species has been searched and found free of the prior art of record. Search and examination has been expanded to the full scope of formula (I).
Examiner notes that while claims 39 and 54 are encompassed by elected Group I, in the claim set filed on January 23, 2026, Applicant annotated these claims as “Withdrawn, Currently Amended”. Therefore, claims 1, 5, 17, 18, 37, 51, 55, 58, 67, 71, 79, 81, 87, and 103 are examined herein. Claims 39, 54, 88, 104, 105, and 110 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or withdrawn.
Priority
The instant application claims priority to U.S. Provisional Patent Application No. 63/370,629 filed on August 05, 2022, U.S. Provisional Patent Application No. 63/375,522 filed on September 13, 2022, U.S. Provisional Patent Application No. 63/476,359 filed on December 20, 2022, U.S. Provisional Patent Application No. 63/482,750 filed on February 1, 2023, U.S. Provisional Patent Application No. 63/486,156 filed on February 21, 2023, and U.S. Provisional Patent Application No. 63/508,350 filed on June 15, 2023.
However, the limitations of the instant claims are not adequately supported or enabled in the manner provided by 35. U.S.C. 112(a) or pre-AIA U.S.C. 112, first paragraph by 63/370,629, 63/375,522, 63/476,359, 63/482,750, 63/486,156, or 63/508,350. In claim 1 of the instant application, in the description of L2, it ends with “or -(C1-6 alkyl)S(O)2-(C1-6 alkyl)-“. This unit is not claimed in the provisional applications and no support is found for it in the specifications. In a similar manner, in the limitation of X6 and X7, it reads “each X6 and X7 is independently N, CH, or CF”. The CF variable is not claimed or present in the provisional applications, and no support for it can be found in the provisional applications, whether the A ring is present or not. Last, in the limitation of R3a, it claims “4- to 10- membered heterocyclyl”. The earliest provisional application to provide support for this limitation is 63/476,359, filed on December 22, 2022, as written in the claims. Prior to ‘359 provisional, the limitation read “5- to 10-membered heterocyclyl” and lacked support for a 4-membered heterocyclyl in any of the earlier filed specifications and claims. Therefore, because the -(C1-6 alkyl)S(O)2-(C1-6 alkyl)- limitation of L2 and CF limitation of X6 and X7 first find support in the instant application, claim 1, and all of its dependent claims 5, 17, 18, 37, 51, 55, 58, 67, 71, 79, 81, 87, and 103 which do not resolve the issues, of the instant application have been awarded the effective filing date of the instant application, filed August 04, 2023.
Application and Claims Status
Applicant’s amendments filed on January 23, 2026 are acknowledged and entered.
Claims 1, 5, 17, 18, 37, 39, 51, 54, 55, 58, 67, 71, 79, 81, 87, 88, 103-105, and 110 were pending. In the amendment as filed on January 23, 2026, applicants have amended claims 5, 17, 18, 37, 39, 51, 54, 55, 58, 67, 71, 79, 81, 87, 88, 103-105, and 110; cancelled no claims; withdrew claims 39, 54, 88, 104, 105, and 110; and added no new claims. Therefore, claims 1, 5, 17, 18, 37, 51, 55, 58, 67, 71, 79, 81, 87, and 103 are currently pending. The present claims are amended to correct the claim numbering so that the original numbering of the claims is preserved throughout prosecution. Additionally, the present specification is amended in order to correct a typographical error and correctly show a corresponding chemical structure.
Information Disclosure Statement
The information disclosure statements (IDS) filed on March 1, 2024, July 9, 2025, and January 23, 2026 are in compliance with the provisions of 37 CFR 1.97. All references have been considered except where marked with a strikethrough. Signed copies of Form 1449 are included with this Office Action.
Specification - Disclosure
For clarity, on page 93, the 3rd compound in row 2 should be labeled as “Isomer 2” if it is the corresponding isomer to that which is labeled “Isomer 1”.
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.
Claim Objections - Minor Informalities
Claim 1 is objected to because of the following informalities:
The limitation for R1 recites the -CN substituent twice.
The limitations of R1a, R4a, R4b, R3a, R3b recite -S(O)(NH)(C1-6 alkyl). The current parentheses suggest that attached directly to the sulfur are the following three species: O, NH, and (C1-6 alkyl). The examiner wonders if applicant actually wishes to recite -S(O)NH(C1-6 alkyl) without the NH in parentheses.
The limitation of R1a recites -N(C1-6 alkyl)(S(O)(C1-6alkyl). The examiner wonders if the applicant wants an open-ended parenthesis around the Sulfur.
The limitation of R1b is currently written as “CO2H,-O(C1-6 alkyl)” and should be corrected to “-CO2H, -O(C1-6 alkyl)” , where there is a “-“ before the “CO2H” unit and a space separating “-CO2H,” from “-O(C1-6 alkyl)”
In the limitation of R1b, there is an unnecessary space between the parenthesis and C6 as in “-NHC(O)( C6aryl).”
In the limitations of R4a and R3a, applicant writes “-NH2,-O(C1-6 alkyl),” where there should be a space between the two enumerated items.
The applicant recites “X1 is S, N, or C(Rx1),” and it should read “-S-, -N-, or -C(Rx1)=” This is repeated in the limitations for X2 and X3.
Appropriate correction is required.
Claim Rejections – Improper Markush Grouping
Claims 1, 5, 17, 18, 37, 51, 55, 58, 67, 71, 79, 81, 87, and 103 are rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature.
A Markush claim contains an “improper Markush grouping” if: (1) the species of the Markush group do not share a “single structural similarity,” or (2) the species do not share a common use. Members of a Markush group share a "single structural similarity” when they belong to the same recognized physical or chemical class or to the same recognized physical or chemical class or to the same art-recognized class. Members of a Markush group share a common use when they are disclosed in the Specification or known in the art to be functionally equivalent (see Federal Register, Vol. 76, No. 27, Wednesday, February 9, 2011, p. 7166, left and middle columns, bridging paragraph). If (1) or (2) apply to a Markush grouping, a rejection under the judicially approved “improper Markush grouping” doctrine is proper.
The members of the improper Markush grouping do not share a substantial feature and/or a common use that flows from the substantial structural feature for the following reasons:
The variable is defined as seen below:
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There are no required structural features in common such that each member of formula (I) would have at least one structural feature, which feature is essential to the activity/function of the claimed compound. One would not expect all of these compounds to be alternatively usable. The heterocyclic ring systems depicted above represent a sampling of the numerous and various core structures of the compound of formula (I) as recited in claim 1. However, these core structures exhibit no discernible structural similarity. The fused 5,6- and fused 6,6-ring systems are all different, as well as the aromatic left-hand side with affixed A ring. Furthermore, the Markush group of formula (I) contains a plethora of nested variables for L1, L2, L3, R1, R3, and ring A. Clearly, no ‘‘single structural similarity’’ can be seen. In the absence of evidence to the contrary, all compounds within the metes and bounds of the extraordinarily large Markush grouping of the instant claims cannot be individually envisioned and each expected to be functionally equivalent.
Since the dependent claims 5, 17, 18, 37, 51, 55, 58, 67, 71, 79, 81, 87, and 103 do not resolve the improper Markush grouping, they are similarly rejected.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. § 134 and 37 CFR41.31 (a) (1) (emphasis provided).
Claim Rejections - 35 USC § 112(a)
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.
Scope of Enablement - Compounds
Claims 1, 5, 17, 18, 37, 51, 55, 58, 67, 71, 79, 81, 87, and 103 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 the following:
A compound having a structure of formula (I) (as recited in Claim 1)
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or a pharmaceutical composition comprising a compound having a structure represented by Formula I (as recited in claim 1), where:
X6 and X7 are CH or N;
Z, X1, X2, and X3, X5, m, n, R2, R3, Rx1, Rx2, Rx3, and ring B are as recited in claim 1;
X4 is C only when ring A is present
X4 is as recited in claim 1, when ring A is absent;
L1 is a bond, -O-, or -O(C1-6 alkyl)-;
R1 is as recited in claim 58;
R1a is C1-6 alkyl, C1-6 alkoxy, halogen, C3-8 cycloalkyl, 4- to 10-membered heterocyclyl, C6 aryl, 5- to 10-membered heteroaryl, oxo, -OH, -CN, -NH2 -C(O)NH2, -C(O)NH(C1-6 alkyl), -C(O)N(C1-6 alkyl)2, -S(O)2(C1-6 alkyl), or S(O)2NH2;
R1b is C1-6 alkyl, C1-6 haloalkyl, halogen, oxo, -OH, -NH2, or S(O)2C1-6 alkyl;
L2 is as recited in claim 79;
R5 is H, -CN, -OR5a, -NR5a2, C(O)NR5a2, -NR5aC(O)R5a, C3-6 cycloalkyl, C6 aryl, 5- to 6--membered heterocyclyl, or 5- to 10-membered heteroaryl;
R5a is H or C1-6 alkyl;
R5b is halogen, -CN, or C1-3 alkyl;
LX4 and LX5 are a bond;
Rx4 and Rx5 are hydrogen, halogen, hydroxy, -CN, C1-6 alkyl, C2-6 alkynyl, C1-6 alkoxy, C3-6 cycloalkyl, -O(C1-6 alkyl), -NH2, -NH(C1-6 alkyl), -N(C1-6 alkyl)2, 4- to 10-membered heterocyclyl, C6 aryl, or 5- to 10-membered heteroaryl;
R4a is C1-6 alkyl, C1-6 haloalkyl, halogen, -C(O)NH2, -C(O)NH(C1-6 alkyl), -OH, -CN, -NH2, or C3-6 cycloalkyl;
L3 is a bond or -C(O)-;
R3 is halogen, hydroxy, -CN, C1-6 alkyl, C2-6 alkynyl, C1-6 alkoxy, C3-8 cycloalkyl, 4- to 10-membered heterocyclyl, C6 aryl, 5- to 10-membered heteroaryl, -NH2, -NH(C1-6 alkyl), or -N(C1-6 alkyl)2;
R3a is C1-6 alkyl, C1-6 haloalkyl, halogen, -C(O)(C1-C6 alkyl), C3-6 cycloalkyl, oxo, -OH, -CN, -NH2, -NHC(O)(C1-6 alkyl), -O(C1-6 alkyl), -S(O)2(C1-6 alkyl), or 4- to 5-membered heterocyclyl;
R3b is C1-6 alkyl, C1-6 haloalkyl, C3-6 cycloalkyl, halogen, oxo, -OH, or -NH2;
does not reasonably provide enablement for elements that are outside the scope of the enabling elements listed above. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
To be enabling, the specification of the patent application must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fd. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996). As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is "undue", not "experimentation".
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors:
1- the quantity of experimentation necessary,
2- the amount of direction or guidance provided,
3- the presence or absence of working examples,
4- the nature of the invention,
5- the state of the prior art,
6- the relative skill of those in the art,
7- the predictability of the art, and
8- the breadth of the claims
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
The nature of the invention:
The nature of the invention relates to compounds of formula (I) in claim 1. Such compounds are useful for treating a viral infection in a subject. This invention is also directed to compositions comprising said compounds.
Predictability of the art:
However, the hypothetical compounds in claim 1 would be unpredictable in terms of one skilled in the art being able to synthesize every possible compound claimed in instant claim 1. 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).
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.
Level of skill in the art:
An ordinary artisan in the area of drug development would have experience in synthesizing and screening chemical compounds for particular activities, such as a medical doctor or chemist. Screening of new drug candidates, while complex, is routine in the art. The process of finding new drugs that have in vitro activity against a particular biological target, (i.e., receptor, enzyme, etc.) is well known. Additionally, while high throughput screening assays can often be employed, developing a therapeutic method, as claimed, is generally not well-known or routine, given the complexity of certain biological systems.
The breadth of the claims:
The scope of the claims involves compounds of formula (I), shown below.
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Claim 1 is very broad in the number of variables and the options of substituents for each variable. There is an extremely large amount of hypothetical compounds included in claim 1.
The amount of direction provided, the presence or absence of working examples, and the quantity of experimentation necessary:
The specification provides the analytical and biological data of 1102 compounds, with the synthetic procedures for model compounds. Synthesis methods are not taught in the specification to provide for the aforementioned variables to include all of the possible substituents listed in the claims. For example, there are no working examples of a compound of formula (I) wherein, when the A ring is present, X4 is N and X6 and X7 and CF. As another example, there are no instances where the L2-R5 variables are such that L2 is -(C1-6 alkyl)C(O)N(H)- and R5 is a 5- to 10-membered heterocycle further substituted with R5b, which can be -OCF2H, as defined in claim 1. It would be expected that the varying ring sizes (ring A, ring B, and rings defined in R1, R3, and R5) and heteroatoms in the rings would change the reactivity of the compounds, and therefore may require alternate synthesis methods. It would require one skilled in the art, such as a chemist, to perform thousands of reactions to determine which compounds of formula (I) can be prepared and would likely require synthesis methods other than those provided in the specification. This is undue experimentation given the limited guidance and direction provided by Applicants.
Accordingly, the instant claims do not comply with the enablement requirement of 35 U.S.C. 112(a), since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
Claims 5, 17, 18, 37, 51, 55, 58, 67, 71, 79, 81, 87, and 103, which are dependent on claim 1, are also rejected for further requiring and/or reciting elements that are outside the scope of the enabling elements listed above.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 18, 37, 51, 55, 58, 67, 71, 79, 87, and 103 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Taoda et al. (WO 2023/042879 A1, published March 23, 2023)(hereinafter “Taoda”). Because the effective filing date of the instant application has been adjusted to August 04, 2023, this is a 102(a)(1) rejection (see Priority section within Office Action).
Taoda discloses the following general formula and teaches, as an example, compound I-0168, shown below:
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Compound I-0168 is disclosed in WO 2023/042879 A1, page 146, para 0213, and this same species can be found in priority document Application No. 2021-152086 on page 53, para 0173. This compound is embraced by instant formula (I), wherein A ring is absent, X1 through X8 are all carbon, LX4 is a bond, Rx4 is C1-6 alkyl (here, methyl), Z is O, L2 is C1-6 alkyl (here, methyl), R5 is C6 aryl, R5b is CN and halogen (here, Cl), RX2 is C1-3 alkoxy (here, methoxy), B ring is a C6-10 aryl (here, phenyl), R2 is hydrogen, L1 is a bond, R1 is CN and a halogen (here, Cl), and m is 2. Because the effective filing date of the instant application has been adjusted to August 04, 2023, this is a 102(a)(1) rejection.
Note: The anticipation rejection is just a sampling of the prior art found within the reference against the compounds and compositions of the compounds of formula (I) as claimed herein. The prior art reference teaches many species that read on instant formula (I) but the overall analysis is the same.
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 1, 5, 17, 18, 37, 51, 55, 58, 67, 71, 79, 81, 87, and 103 are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1, 14, 27 and 28 of U.S. Patent No. 12,091,420 B2. Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons given below.
The compounds or pharmaceutically acceptable salts thereof claimed in U.S. Patent No. 12,091,420 B2 fit within the scope of the compounds, or pharmaceutically acceptable salts thereof, encompassed by Formula (I) in instant claim 1. Both references disclose that the compounds are useful in the treatment of viral infections, for example, coronaviridae infections (see abstracts). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention through routine experimentation to arrive at a compound and pharmaceutical composition thereof of the instant claims in view of the reference with a reasonable expectation of success. The motivation would have been to find an optimal pharmaceutical compound which could be used for the quoted purpose. Thus, a prima facie case of obviousness has been established.
Claims 1, 5, 17, 18, 37, 51, 55, 58, 67, 71, 79, 81, and 87 are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 1 of U.S. Patent No. 12,410,183 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the method of treating or preventing a viral infection using compounds of of reference patent ‘183 independent claims 1-25 overlap in claimed matter with at least claim 1 of the instant application.
In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See also Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008);Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
Here, the twelve compounds used in the method claims of reference patent fit within the scope of formula (I) recited in instant claim 1. Although the instant application does not claim a method of use, the disclosure of the application (page 202, para 0303), recites that the disclosure “provides a method of treating or preventing a viral infection in a subject (e.g. human) in need thereof, the method comprising administering to the subject a compound described herein” and (page 26, para 0058) recites “the present disclosure provides compounds that are inhibitors of the SARS-CoV-2 main protease. In some embodiments, the disclosure provides compounds of Formula (I) as described herein, and/or pharmaceutically acceptable salt(s) thereof.”
The ordinary artisan would recognize as obvious that determination of whether “a method of treating or preventing a viral infection in a subject," is present, per step (a) of the instant claims, is implicit in the patented claim in view of Sun Pharmaceutical Industries, LTD. v. Eli Lilly and Company which states the following: “Similarly, in Pfizer, the earlier patent claimed several compounds and the specification disclosed their use in treating inflammation and inflammation-associated disorders. 518 F.3d at 1363 & n.9; see 5,563,165 (“’165 patent”), at [57], col.1 11.11-14, col.3 11.3-27. The later patent then claimed a method of using these compounds for treating inflammation, inflammation-associated disorders, and specific inflammation-associated disorders, including arthritis, pain, and fever. Pfizer, 518 F.3d at 1363 & n.9; see U.S. Patent No. 5,760,068 (“’068 patent”) col.97 1.49- col. 108 1.29. After rejecting the patentee’s objection to our consideration of the specification of the earlier patent, we determined that the later patent “merely claims a particular use described in the [earlier] patent of the claimed compositions of the [earlier] patent.” Pfizer, 518 F.3d at 1363 & n.8. As such, we concluded that the asserted claims of the later patent were not “patentably distinct” from the claims of the earlier patent, and thus the later patent was invalid for obviousness-type double patenting. Id. at 1368.
Claims 1 and 5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 1 of co-pending Application No. 19/045,761 in view of Silverman. The instant application teaches compounds of the structure below (Formula II):
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where X1 is “S, N, or C(Rx1)” and “X2 is S, N, or C(Rx2)”. It does not teach that X1 or X2 are oxygen. Silverman teaches oxygen and sulfur are classical isosteres of each other when used as ring equivalents. The skilled artisan would have expected success in substituting sulfur for oxygen in the instant application because the instant application teaches compounds of Formula II, which include a ring equivalent sulfur, and Silverman teaches sulfur and oxygen are classical isosteres of each other. The skilled artisan could have substituted one compound for another because Silverman teaches that sulfur and oxygen are classical isosteres. The person of ordinary skill in the art would have found it obvious to make the substitution because ordinary skilled artisans would have predicted that changing a ring sulfur to a ring oxygen would make isosterically equivalent molecules in order to arrive at the compounds in co-pending ‘761.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Examiner Comments
The examiner puts on the record WO 2022/224223 A1 (published October 27th, 2022, effectively filed April 23, 2021). The reference document discloses the synthetic intermediate (page 276, lines 6 – 15), in the synthesis of rac-3-(isoquinolin-4-yl)-1-(4- methoxybenzyl)-6-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan-2-yl)quinazoline-2,4(1H,3H)-dione, shown below:
PNG
media_image10.png
233
380
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Greyscale
The reference compound reads on all limitations of instant formula (I), except that the reference compound has a 5-membered heterocycle at ring B, whereas the instant claims require an aromatic group at this position.
Conclusion
All claims are rejected.
No claims are allowed.
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/L.A.B./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624