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 .
Claim Status
Claims 1-2, 7-15 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 1-2 and 7-8 are currently active and subject to examination. Claims 9-15 and 23 are withdrawn.
Claim Objections
Claim7 objected to because of the following informalities: many of the structures are not drawn with sufficiently clear and dark lines for legibility. Appropriate correction is required.
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.
Withdrawn Rejections – Overcome by Amendment
The rejection of claims 1 and 7-8 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn.
The rejection of claim(s) 1-7 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) is withdrawn.
The rejection of claim(s) 1-8 under 35 U.S.C. 102(a)(2) as being anticipated by Arnold et al. (US 2022/0380347 A1) is withdrawn.
The rejection of claim(s) 1-6 and 8 under 35 U.S.C. 102(a)(2) as being anticipated by Zavoronkovs et al. (US 2023/0174488 A1) is withdrawn.
The above rejections were overcome by Applicant’s amendments to the claims.
Claim Rejections – 35 USC § 112(b) – Previously Presented
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.”
The rejection of claims 2 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.
Response to Arguments
The Applicant argues that the amendment of claim 1 obviates the rejection (Remarks, p. 19). This argument was fully considered but it not persuasive. While claim 1 now recites specific Markush members, claim 2 is defined purely on functional terms. It is unclear how claim 2 further limits claim 1 because claim 1 is supposed to encompass viral protease inhibitors to treat viral infection.
Reiterated Rejection
Claim 2 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 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 treat, ameliorate, and/or prevent viral infection. 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 viral infections. The functional limitation also lacks objective boundaries. On the whole, claim 2 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 which treat or prevent viral infection 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 Rejections – 35 USC § 112(a) – Previously Presented
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.”
The rejection of claims 1-2 and 8 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 is maintained. 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.
Response to Arguments
The Applicant argues that amended claim 1 now includes substituents which structurally define the genus (Remarks, p. 20). These arguments were fully considered but are not persuasive. The genus is still so expansive that it includes compounds which may or may not have the claimed therapeutic activity. For example, each one of R1, R2, R3 and R4 may be hydrogen, or they may be a large heterocyclic group. One of ordinary skill in the art would not expect a compound in which each of R1, R2, R3 and R4 are hydrogen to have the same activity as a compound in which R1 is benzyl, R2 is pyridinyl, R3 is phenyl-phenyl, and R4 is a 5 membered heterocycle.
Reiterated Rejection.
The rejection of claims 1-2 and 8 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 is maintained. 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 are hydrogen or a number of structurally distinct groups. Claim 2 further recites additional variables, R1, R2, R3 and R4 independently include any chemical moiety that permits the compound to treat, ameliorate and/or prevent a viral infection. 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. 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.
While claim 1 was amended to limit each substituent of R1, R2, R3, and R4 individually, claim 1 is still very broad 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. The claimed invention covers the prior art compound of Glatzel et al. (ChemComm, 2010, 46, 4517–4519), which is disclosed as a monomer for building a hydrogel but not a viral protease inhibitor:
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Glatzel, Scheme 1, p. 4517.
Claim Rejections – 35 USC § 112(a) – New Grounds of Rejection Necessitated by Amendment
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.”
New Matter Rejection
Claims 1-2 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. This is a new matter rejection.
Claim 1 was amended to contain an exclusionary proviso/ negative limitation:
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This limitation is not supported by the specification. The specification includes such compounds (for example, compound JUN9-6-4). The proviso must have support in the original specification and it does not:
Any negative limitation or exclusionary proviso must have basis in the original disclosure. If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims. See In re Johnson, 558 F.2d 1008, 1019, 194 USPQ 187, 196 (CCPA 1977) ("[the] specification, having described the whole, necessarily described the part remaining."). See also Ex parte Grasselli, 231 USPQ 393 (Bd. App. 1983), aff’d mem., 738 F.2d 453 (Fed. Cir. 1984). In describing alternative features, the applicant need not articulate advantages or disadvantages of each feature in order to later exclude the alternative features. See Inphi Corporation v. Netlist, Inc., 805 F.3d 1350, 1356-57, 116 USPQ2d 2006, 2010-11 (Fed. Cir. 2015). The mere absence of a positive recitation is not basis for an exclusion. However, a lack of literal basis in the specification for a negative limitation may not be sufficient to establish a prima facie case for lack of descriptive support. Ex parte Parks, 30 USPQ2d 1234, 1236 (Bd. Pat. App. & Inter. 1993). "Rather, as with positive limitations, the disclosure must only 'reasonably convey[] to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.'... While silence will not generally suffice to support a negative claim limitation, there may be circumstances in which it can be established that a skilled artisan would understand a negative limitation to necessarily be present in a disclosure." Novartis Pharms. Corp. v. Accord Healthcare, Inc., 38 F.4th 1013, 2022 USPQ2d 569 (Fed. Cir. 2022) (quoting Ariad Pharm. Inc. v. Eli Lilly & Co., 589 F.3d 1336, 1351, 94 USPQ2d 1161, 1172). Any claim containing a negative limitation which does not have basis in the original disclosure should be rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. See MPEP § 2163 - § 2163.07(b) for a discussion of the written description requirement of 35 U.S.C. 112(a) and pre-AIA 35 U.S.C. 112, first paragraph.
MPEP § 2173.05(I).
Claims 2 and 8 depend from claim 1 and are therefore rejected on the same basis.
Claim Rejections – 35 USC § 112(d) – New Grounds of Rejection Necessitated by Amendment
The following is a quotation of 35 U.S.C. 112(d):
“(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.”
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
“Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.”
Claim 7 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 7 includes substituents which are not included in claim 1. For example, the following compound is not a compound of claim 1:
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Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections – 35 USC § 102 – Previously Presented
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.”
The rejection of claims 1-2 and 7 under 35 U.S.C. 102(a)(1) as being anticipated by Kitamura et al. (BioRxiv, Dec. 20, 2020, p. 1-31) is maintained.
The effective filing date of claims 1-2 and 7 is Nov. 29, 2021 because the claims include substituents and compounds not disclosed in the priority documents.
Claims 1-2 were amended to include the subject matter of cancelled claims 3-7 and are therefore rejected on the same grounds as previously presented.
Response to Arguments
The Applicant argues that the amended claims are now fully supported by the priority documents and that the Examiner did not identify any specific embodiment within the scope of the claims that both lacks support in the Dec. 4, 2020 provisional application and is disclosed in Kitamura (Remarks, p. 21). These arguments were fully considered but are not persuasive. The amended claims still include substituents which are not supported by either priority document and specific embodiments from Kitamura falling within the scope of the claims were presented in the prior office action, which still fall within the scope of the claims. A claim can only have a single priority date and that priority date is the date in which every limitation in the claim is supported (MPEP § 211). For example, amended claim 1 allows R1 to be:
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The priority documents only disclose the following for R1:
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63/121,753, Spec, p. 3-4;
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63/253,843, Spec., p. 4.
As can be seen from the above lists, claim 1 is not fully supported by the priority document. Several compounds of claim 7 are also not supported by the priority documents. The Applicant is advised to review every claimed embodiment against the priority document if the claims are amended if the Applicant would like benefit of the priority documents. Not every embodiment which is not supported is shown above by the Examiner.
Reiterated Rejection
The rejection of claims 1-2 and 7 under 35 U.S.C. 102(a)(1) as being anticipated by Kitamura et al. (BioRxiv, Dec. 20, 2020, p. 1-31) is maintained.
The effective filing date of claims 1-2 and 7 is Nov. 29, 2021 because the claims include substituents and compounds not disclosed in the priority documents.
Claim 1 is directed towards a compound of formula I:
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,
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Kitamura teaches Mpro inhibitors of formula I wherein R1-R4 is as in the above:
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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 1 is anticipated.
Claim 2 depends from claim 1, wherein each of R1, R2, R3, and R4 independently independently include any chemical moiety that permits the resulting compound to treat, ameliorate, and/or prevent viral infection. Kitamura teaches that the compound inhibit Mpro protease activity for the treatment of viral infections: “These promising results highlight the translational potential of Mpro inhibitors as potent SARS-CoV-2 antivirals and validate Mpro as an antiviral drug target for coronaviruses.” (p. 3). Therefore, claim 2 is anticipated.
Claim 7 is directed towards the compound of Claim 1, wherein said compound is selected from:
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As shown in the rejection of claim 1, Kitamura teaches these compounds.
Therefore, claim 7 is anticipated.
Claim Rejections – 35 USC § 102 – New grounds of rejection necessitated by amendment
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 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Glatzel et al. (ChemComm, 2010, 46, 4517–4519).
Claim 1 is directed towards a compound of Formula I:
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. Glatzel teaches a compound of formula I:
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Glatzel, Scheme 1, p. 4517.
As in formula I of claim 1, R1 is H, R2 is H, R3 is H and R4 is
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. Therefore, claim 1 is anticipated.
Claim(s) 1-2 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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. Mescar teaches compounds of formula (I). For example, compounds 46 and 48:
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618
502
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St. John, Spec., col. 27-28.
Therefore, claim 1 is anticipated.
Claim 2 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 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.
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.
Conclusion
No claim is found to be allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/HEATHER DAHLIN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
