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 .
Priority
This Application is a 371 of PCT/US2021/060923, filed Nov. 29, 2021, and claims domestic benefit of U.S. Provisional Application Nos. 63121753 and 63253843, filed Dec. 4, 2020 and Oct. 8, 2021 respectively. The effective filing date of claims 1, 2 and 8 is Dec. 4, 2020. The effective filing date of claims 3-7 is Nov. 29, 2021, as the provisional applications do not fully support the subject matter of these claims.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on Dec. 4, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1-15 and 23 are pending. Applicant’s election without traverse of Group I, claims 1-8, and the compound having the structure:
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,
in the reply filed on January 13, 2026 is acknowledged.
Claims 1-8 are currently active and subject to examination. Claims 9-15 and 23 are withdrawn.
Drawings
The drawings are not of sufficient quality to permit examination. Accordingly, replacement drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to this Office action. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action.
Applicant is given a shortened statutory period of TWO (2) MONTHS to submit new drawings in compliance with 37 CFR 1.81. Extensions of time may be obtained under the provisions of 37 CFR 1.136(a) but in no case can any extension carry the date for reply to this letter beyond the maximum period of SIX MONTHS set by statute (35 U.S.C. 133). Failure to timely submit replacement drawing sheets will result in ABANDONMENT of the application.
The drawing do not have sufficiently clear, dark and black lines to permit examination. The structures and labels in the following figures are blurred and not clearly discernable: Fig. 2e, Fig 10, Fig. 11, Fig. 15 and Fig. 18. The graphs and labels in the following figures are blurred and not possible to read: Fig. 12C, Fig. 13, and Fig. 16.
Claim Rejections – 35 USC § 112(b)
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 1-8 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is directed towards a compound of formula I wherein R1, R2, R3, and R4 “independently include any chemical moiety that permits the resulting compound to inhibit Mpro protease activity.” One of ordinary skill in the art cannot determine the metes and bounds of the claimed invention because the claim boundaries are defined entirely by a functional result rather than by chemical structure. A person of ordinary skill in the art, reading the claim cannot determine which compounds fall within the claim scope. The claim could encompass any structure capable of inhibiting Mpro. The functional limitation also lacks objective boundaries. The claim does not specify the degree of inhibition required and whether any detectable inhibition suffices. On the whole, claim 1 attempts to claim a result rather than an invention because the claim does not define a compound with identifiable structure features but rather uses the abstract concept of “compounds that inhibit Mpro”. Such purely functional claiming at the exact point of novelty, without meaningful structural limitations, renders the claim indefinite.
Notwithstanding the permissible instances, the use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear. Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255, 85 USPQ2d 1654, 1663 (Fed. Cir. 2008) (noting that the Supreme Court explained that a vice of functional claiming occurs "when the inventor is painstaking when he recites what has already been seen, and then uses conveniently functional language at the exact point of novelty") (quoting General Elec. Co. v. Wabash Appliance Corp., 304 U.S. 364, 371 (1938)); see also United Carbon Co. v. Binney & Smith Co., 317 U.S. 228, 234, 55 USPQ 381 (1942) (holding indefinite claims that recited substantially pure carbon black "in the form of commercially uniform, comparatively small, rounded smooth aggregates having a spongy or porous exterior"). Further, without reciting the particular structure, materials or steps that accomplish the function or achieve the result, all means or methods of resolving the problem may be encompassed by the claim. Ariad Pharmaceuticals., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353, 94 USPQ2d 1161, 1173 (Fed. Cir. 2010) (en banc). See also Datamize LLC v. Plumtree Software Inc., 417 F.3d 1342, 75 USPQ2d 1801 (Fed. Cir. 2005) where a claim directed to a software based system for creating a customized computer interface screen recited that the screen be "aesthetically pleasing," which is an intended result and does not provide a clear cut indication of scope because it imposed no structural limits on the screen. 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. For more information regarding the written description requirement and enablement requirement under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, see MPEP §§ 2161-2164.08(c). Examiners should keep in mind that whether or not the functional limitation complies with 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, is a different issue from whether the limitation is properly supported under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, or is distinguished over the prior art.
MPEP § 2173.05(g).
Claim 2 also uses similar functional language and is also indefinite for the reasons given above in the rejection of claim 1.
Claims 3-6 and 8 depend from claim 1 and do not resolve this ambiguity and are therefore also indefinite.
Claim 2 recites the limitations "R5, R6, X, Y, Z, 8, #" in lines 1-2. There is insufficient antecedent basis for these limitations in the claim.
Regarding claim 2, it is unclear what the phrase “if one or both are present” refers to.
Regarding claim 2, the phrase "e.g." renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 3, the phrase "e.g." renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 4, the phrase "e.g." renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 7 is also indefinite because it references Tables and Figures.
Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).
MPEP § 2173.05(s).
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.”
Claims 1-6 and 8 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 written description requirement is distinct from the enablement requirement; this was first pointed out by the court in In re Ruschig, 379 F.2d 990, 154 USPQ 118 (CCPA 1967), and clarified in Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 19 USPQ2d 1111 (Fed. Cir. 1991). The issue of whether the claimed subject matter is adequately supported/described by the specification, is a question of fact. Id. at 1563, 19 USPQ2d at Il 16.
When considering whether the claimed subject matter complies with the written description requirement, Applicants' disclosure should be read in light of the knowledge possessed by those skilled in the art.
"[T]he disclosure in question must be read in light of the knowledge possessed by those skilled in the art, and that knowledge can be established by affidavits of fact composed by an expert, and by referencing to patents and publications available to the public... "
In re Lange, 644 F.2d 856, 863, 209 USPQ 288, 294 (CCPA 1981). see also, In re Alton, 76
F.3d 1168, 37 USPQ2d 1578 (Fed. Cir. 1996).
Applicants enjoy the presumption that their patent application is valid and all statements contained therein are accurate; it is the PTO's burden to demonstrate why any of Applicants claims should be rejected or why any of Applicant's statements should be doubted.
"it is incumbent upon the Patent Office, whenever a rejection... is made, to explain why it doubts the truth or accuracy of any statement in a supporting disclosure and to back up assertions of its own with acceptable evidence or reasoning which is inconsistent with the contested statement. Otherwise, there would be no need for the applicant to go to the trouble and expense of supporting his presumptively accurate disclosure. "
In re Marzocchi, 439 F.2d 220, 224, 169 USPQ 367, 370 (CCPA 1971). The court has made it clear that such challenges apply to written description rejections:
"we are of the opinion that the PTO has the initial burden of presenting evidence or reasons why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims."
In re Wertheim, 191 USPQ 90, 97 (CCPA 1976).
If successful in presenting such evidence and argument, the burden then shifts to the Applicant to provide evidence that would convince one to the contrary that the disclosure as a whole provides written description support for the claimed subject matter.
The Claimed Invention
The Applicant’s invention is directed towards a compound of Formula I:
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, including pharmaceutically acceptable salts, solvates, and/or prodrugs thereof, wherein each of R1, R2, R3, and R4 independently include any chemical moiety that permits the resulting compound to inhibit Mpro protease activity. Claim 2 further recites additional variables, R5, R6, X, Y, Z, * and #, along with R1, R2, R3 and R4, that independently include any chemical moiety that permits the compound to treat, ameliorate and/or prevent a viral infection. Claims 3-6 define a structure for each of R1, R2, R3, and R4, respectively, but still allow the other three moieties not defined by that claim to be any chemical moiety that permits the resulting compound to inhibit Mpro protease activity. Claim 8 is directed towards a pharmaceutical composition comprising the compound of claim 1.
The Supporting Disclosure
In the background of the invention, the Applicant describes that the c is a chemical target for the treatment of COVID-19 (Specification, p. 1-2). The Applicant teaches that inhibitors of Mpro are known in the art (id.).
In the summary of the invention, the Applicant states that the present invention is directed towards Mpro inhibitors that were developed through structure-based drug design (id. at 2). The Applicant describes that a preferred embodiment of the invention, compounds encompassed within formula I are provided:
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(Formula I), including pharmaceutically acceptable salts, solvates, and/or prodrugs thereof (id. at 3). The Applicant states that Formula I is not limited to a particular moiety for R1, R2, R3, and R4, and includes any chemical moiety that permits the resulting compound to inhibit Mpro activity (id.). Another embodiment defines R1, R2, R3, and R4, includes any chemical moiety that permits the compound to treat, ameliorate and/or prevent a viral infection (id. at 4).
The Applicant then provides embodiments which encompass particular structures for R1, R2, R3, and R4 (id. at 3-7). The Applicant does describe particular compounds in Table 1 which have activity against Mpro protease. For example:
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(id. at 7).
In the detailed description of the invention, the Applicant describes certain embodiments and concepts pertaining to the invention, including descriptions of the compounds of Formula I as in the summary of the invention, compositions thereof, and methods for treating, preventing, and/or ameliorating the symptoms of a viral infection (id. at 22-34). The experimental section describes different assays employed by the Applicant to design inhibitors of Mpro (example I), analyze the activity of the compounds in inhibiting Mpro (example II), and assess binding to Mpro (examples III-IV).
The Written Description Requirement for Genus Claims
The MPEP states that the disclosure must support the full scope of the claimed genus:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ( "[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted).").
MPEP § 2161.01.
The State of the Art, Relevant facts and Applicants Lacking Disclosure
Inhibitors of Mpro falling within formula I are commonly known in the art. In claim 7, dependent on claim 1, the Applicant claims the compounds in Table 1, but Table 1 itself indicates that the claimed compounds are known in the art:
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(Specification at 7). As indicated by the Applicant, this inhibitor of Mpro, as well as other inhibitors, are taught by Jacobs et al. (J. Med. Chem, 2013, 56, 534-546) (of record, IDS cite no. 20):
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Jacobs, Fig. 6, p. 539.
The Applicant only describes a limited number of Mpro inhibitors of formula (I), which have varied potency for inhibition of Mpro activity (Table 1, Fig. 4, Fig. 10, Fig. 11, and Fig. 18). The Applicant does not demonstrate that the inventor was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. Inhibitors of Mpro need not be the compounds disclosed by the Applicant, and could include structurally related or unrelated compounds. For example, Jacobs teaches that both compound 16 above, of formula I, and a compound outside of the genus of formula I, are inhibitors of Mpro:
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Jacobs, Fig. 5, p. 538.
Regarding claims 4-6, while they limit each substituent of R1, R2, R3, and R4 individually, they still allow each of the other three substituents not listed to be any other substituent as in claim 1. As such, these claims do not significantly limit the scope of claim 1 and do not demonstrate that the inventor was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed.
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.”
Claim(s) 1-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jacobs et al. (J. Med. Chem, 2013, 56, 534-546) (of record, IDS cite no. 20).
Claim 1 is directed towards a compound of Formula I:
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, including pharmaceutically acceptable salts, solvates, and/or prodrugs thereof, wherein each of R1, R2, R3, and R4 independently include any chemical moiety that permits the resulting compound to inhibit Mpro protease activity.
Jacobs teaches compounds of formula I, wherein each of R1, R2, R3, and R4 are chemical moieties that permit the compound to inhibit Mpro (3CLpro) protease activity. For example:
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Jacobs, Fig. 6, p. 539.
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Jacobs, Table 1, p. 540.
Therefore, claim 1 is anticipated.
Claim 2 is directed towards the compound of claim 1, wherein each of R1, R2, R3, R4, R5, R6, X, Y Z, *, # if one or both are present, independently include any chemical moiety that permits the resulting compound to treat, ameliorate, and/or prevent viral infection.
Jacobs demonstrates a compound of formula I which can treat viral infection:
We next compared the EC50 of 16-(R) value to another noncovalent compound tested against SARS-CoV infected cells that targets the SARS-CoV papain-like protease (PLpro) known as GRL0617.47 Compound GRL0617 has an IC50 against the PLpro enzyme of 600 nM and an EC50 value of 14.5 μM against SARS infected Vero E6 cells.47 We next compared the EC50/IC50 ratios of the noncovalent compounds, 16-(R) and GRL0617, which are ∼8.7 and ∼24.1, respectively.
Jacobs, col. 2, p. 540;
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Jacobs, p. 541.
Therefore, claim 2 is anticipated.
Claims 3-7 read on the compounds disclosed by Jacobs. For example, compound 16 is a compound of formula I, wherein R1 is
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; R2 is
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, R3 is
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and R4 is
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. This compound is also shown in Table 1 (claim 7). Therefore, claims 3-7 are anticipated.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Arnold et al. (US 2022/0380347 A1) (PCT filed April 4, 2021, Provisional application No. 63/111,248, filed on Nov. 9, 2020, provisional application No. 63/067,666, filed on Aug. 19, 2020, provisional application No. 63/039, 290, filed on Jun. 15, 2020, provisional application No. 63/031,357, filed on May 28, 2020, provisional application No. 63/012,039, filed on Apr. 17, 2020).
Claim 1 is directed towards a compound of Formula I:
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, including pharmaceutically acceptable salts, solvates, and/or prodrugs thereof, wherein each of R1, R2, R3, and R4 independently include any chemical moiety that permits the resulting compound to inhibit Mpro protease activity.
Arnold teaches compounds of Formula I, wherein each of R1, R2, R3, and R4 independently include any chemical moiety that permits the resulting compound to inhibit Mpro protease activity. Arnold teaches compounds of Formula I-B, which is equivalent to Formula I, to inhibit Mpro (3CL protease):
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Arnold, Specification, p. 2, paragraph [0010];
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Id., p. 1, paragraphs [0005-0006];
An exemplary species is:
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Id., p. 324, paragraph [0212].
Arnold teaches that this compound binds to Mpro to inhibit its protease activity:
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Arnold, Fig. 3.
“FIG. 3 depicts a 2D representation of predicted non-covalent interactions of (S)-N-(4-(tert-butyl)phenyl)-N-(1-(2-cyanopyridin-3-y1)-2-(cyclohexylamino)-2-oxoethyl)-1H-imidazole-5-carboxamide bound to COVID-19 Main Protease (PDB 6W63).” (Arnold, Specification, p. 4, paragraph 0021).
Therefore, claim 1 is anticipated.
Claim 2 is directed towards the compound of claim 1, wherein each of R1, R2, R3, R4, R5, R6, X, Y Z, *, # if one or both are present, independently include any chemical moiety that permits the resulting compound to treat, ameliorate, and/or prevent viral infection.
Arnold teaches that the compounds of the invention treat viral infections: “Also provided herein are methods of ameliorating or treating a viral infection in a patient in need thereof, comprising administering to the patient a therapeutically effective amount of any of the compounds described herein.” (Arnold, Specification, p. 4, paragraph [0016]).
Therefore, claim 2 is anticipated.
Claims 3-6 read on the compound N-(4-(tert-butyl)phenyl)-N-(1-(2-cyanopyridin-3-y1)-2-(cyclohexylamino)-2-oxoethyl)-1H-imidazole-5-carboxamide shown above. R1 is
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, R2 is
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, R3 is
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, and R4 is
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. Therefore, claims 3-6 are anticipated.
Claim 7 is directed towards the compound of Claim 1, wherein said compound is selected from the group of compounds recited in Table 1, Fig. 4, Fig. 10, Fig. 11, and/or Fig. 18.
Arnold teaches compounds found in these figures and tables. For example, Table 1 has the compound:
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(Instant Table 1). Arnold teaches this compound:
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(Arnold, Specification, p. 306).
Claim 8 is directed towards a pharmaceutical composition comprising a compound of claim 1. Arnold teaches pharmaceutical compositions comprising the compounds of the invention and a pharmaceutically acceptable carrier (Arnold, Specification, p. 320, paragraph [0175]). Therefore, claim 8 is anticipated.
Claims 3-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kitamura et al. (BioRxiv, Dec. 20, 2020, p. 1-31).
The effective filing date of claims 3-7 is Nov. 29, 2021 because claims 3-7 include substituents and compounds not disclosed in the priority documents.
Claim 3 is directed towards a compound of formula I:
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, of claim 1, wherein R1 is selected from the group
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Kitamura teaches Mpro inhibitors of formula I wherein R1 is the above. For example, in the following figure R1 is P3/4:
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Kitamura, Fig. 3, p. 9.
Specific compounds are shown in Fig. 4:
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Kitamura, Fig. 4, p. 11.
Therefore, claim 3 is anticipated.
Claim 4 is directed towards the compound of claim 1, wherein R2 is selected from the group
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As shown in the rejection of claim 3, Kitamura teaches compound of formula I wherein R2 is one or more of the above.
Therefore, claim 4 is anticipated.
Claim 5 is directed towards the compound of claim 1, wherein R3 is selected from the group
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As shown in the rejection of claim 3, Kitamura teaches compounds wherein R3 is one or more of the above.
Therefore, claim 5 is anticipated.
Claim 6 is directed towards the compound of claim 1, wherein R4 is selected from the group
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As shown in the rejection of claim 3, Kitamura teaches compound of formula I wherein R4 is one or more of the above.
Therefore, claim 6 is anticipated.
Claim 7 is directed towards the compound of Claim 1, wherein said compound is selected from the group of compounds recited in Table 1, Fig. 4, Fig. 10, Fig. 11, and/or Fig. 18.
Fig. 4 teaches the same compounds as in Fig. 4 of Kitamura.
Therefore, claim 7 is anticipated.
Claim(s) 1-6 and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by St. John & Mesecar (US 9,975,885 B2).
Claim 1 is directed towards a compound of Formula I:
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, including pharmaceutically acceptable salts, solvates, and/or prodrugs thereof, wherein each of R1, R2, R3, and R4 independently include any chemical moiety that permits the resulting compound to inhibit Mpro protease activity.
St. John teaches compounds of Formula I wherein each of R1, R2, R3, and R4 independently include any chemical moiety that permits the resulting compound to inhibit Mpro protease (3CL protease) activity. For example:
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St. John, Specification, col. 10;
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St. John, Fig. 4A;
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St. John, Fig. 4B;
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St. John, Fig. 4C.
Therefore, claim 1 is anticipated.
Claim 2 is directed towards the compound of claim 1, wherein each of R1, R2, R3, R4, R5, R6, X, Y Z, *, # if one or both are present, independently include any chemical moiety that permits the resulting compound to treat, ameliorate, and/or prevent viral infection.
St. John teaches compounds of formula I for the treatment of viral infections:
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238
317
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St. John, Specification, col. 3.
Therefore, claim 2 is anticipated.
Claims 3-6 read on one or more compounds shown in the rejection of claim 1 and are therefore also anticipated.
Claim 8 is directed towards a pharmaceutical composition comprising the compound of claim 1. St. John teaches pharmaceutical compositions comprising the compound of claim 1:
In some embodiments, this invention pertains to a pharmaceutical composition comprising a compound disclosed herein, or a pharmaceutically acceptable salt thereof, together with one or more pharmaceutically acceptable carriers, diluents, and excipients.
St. John, Specification, col. 10, lines 36-41.
Therefore, claim 8 is anticipated.
Claim(s) 1-6 and 8 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zavoronkovs et al. (US 2023/0174488 A1) (Continuation of application No. PCT/CN2021/091093, filed on Apr. 29, 2021; Priority to Provisional application No. 63/017,878, filed on Apr. 30, 2020, provisional application No. 63/059,095, filed on Jul. 30, 2020, provisional application No. 63/112,087, filed on Nov. 10, 2020).
Claim 1 is directed towards a compound of Formula I:
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70
101
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, including pharmaceutically acceptable salts, solvates, and/or prodrugs thereof, wherein each of R1, R2, R3, and R4 independently include any chemical moiety that permits the resulting compound to inhibit Mpro protease activity.
Zavoronkovs teaches compounds of Formula I, wherein each of R1, R2, R3, and R4 independently include any chemical moiety that permits the resulting compound to inhibit Mpro protease activity. For example some representative compounds are shown below:
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459
570
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Zavoronkovs, Specification, p. 21;
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452
539
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Zavoronkovs, Specification, p. 22;
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555
499
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Zavoronkovs, Specification, p. 26;
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321
487
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Zavoronkovs, Specification, p. 39;
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337
514
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Zavoronkovs, Specification, p. 79;
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223
492
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Zavoronkovs, Specification, p. 92
Zavoronkovs demonstrates the SARS-CoV-2 Mpro inhibitory activity of these compounds in Example B-1 (Zavoronkovs, Specification, p. 143-144).
Claim 2 is directed towards the compound of claim 1, wherein each of R1, R2, R3, R4, R5, R6, X, Y Z, *, # if one or both are present, independently include any chemical moiety that permits the resulting compound to treat, ameliorate, and/or prevent viral infection.
Zavoronkovs teaches that the compounds of the invention treat or prevent SARS-CoV-2 infection (Zavoronkovs. Specification, p. 5, paragraph [0075]).
Therefore, claim 2 is anticipated.
Claims 3-6 read on one or more of the compounds shown in the rejection of claim 1 and are therefore also anticipated.
Claim 8 is directed towards a pharmaceutical composition comprising the compound of claim 1. Zavoronkovs teaches pharmaceutical compositions comprising the compound of claim 1 (Zavoronkovs, Specification, p. 5, paragraph [0074]). Therefore, claim 8 is anticipated.
Conclusion
No claim is found to be allowable.
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/HEATHER DAHLIN/Examiner, Art Unit 1629