DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The instant application is a 371 National Stage Entry of PCT/US2021/061284 filed on November 30, 2021 which claims priority to foreign application No. 63/120,109 filed on December 1, 2020.
Status of Claims
Acknowledgement is made of original (1-5, 16, 19), amended (6-15, 17-18), claims filed on May 31, 2023. Claims 1-19 are pending in instant application.
Information Disclosure Statement
The information disclosure statement filed on May 31, 2023 and December 19, 2023 have been considered.
Claim Interpretation
Prior art disclosing a utility of treating SARS-CoV-2 is understood to also be treating COVID-19 (see instant spec. at p. 2 ¶[0006]).
Claim Objections
Claim 5 is objected to because of the following informalities:
Claim 5 recites “wherein is A is”, but should read “wherein A is”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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, 16 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 recites “Ra”, but does not define what Ra can be structurally. For the purposes of applying art, Ra is understood to be H or alkyl, since claim 2 defines A as -N(H)t-butyl, reading on Ra as H, and the specification exemplifies Ra as H or alkyl (see instant spec. at p. 3 line 19).
Claim 16 refers to a table. MPEP 2173.05(s) states:
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).
Claim 16 recites Table 1. Appropriate correction is required. For purposes of applying prior art, claim 16 is presumed to be an attempt to incorporate by reference Table 1.
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.
Claims 1-2, 10, 11, 14, 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Westberg et. al.1
Regarding compounds of Formula X, Westberg teaches ML1000 and ML1100 (see Westberg at Figure 4), inhibitors of the coronavirus main protease capable of inhibiting SARSCov2 viral replication (see Westberg at Abstract).
Instant Formula X
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92
167
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Westberg ML1000
Westberg ML1100
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242
536
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241
526
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Westberg ML1000 reads on instant Formula X when A is N(Ra)-alkyl specifically Ra is H and the alkyl is tert-butyl (see instant claim 2), m is 2, and the two R1s are taken together to form a substituted cycloalkyl (see instant claim 10) specifically
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96
106
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, R2 is
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64
65
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, R3a is amido specifically C(=O)NH2 (see instant claim 11), R4 is methyl, and both R4a are methyl (see instant claim 14). Westberg ML1000 is also recited in the instant specification Table 1 (see p. 79 first entry) (see instant claim 16).
Westberg ML1100 reads on instant Formula X when A is N(Ra)-alkyl specifically Ra is H and the alkyl is tert-butyl (see instant claim 2), m is 2, and the two R1s are taken together to form an unsubstituted cycloalkyl cycloalkyl (see instant claim 10) specifically
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90
91
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, R2 is
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media_image5.png
64
65
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, R3a is amido specifically C(=O)NH2 (see instant claim 11), R4 is methyl, and both R4a are methyl (see instant claim 14).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 15, 17-19 are rejected under 35 U.S.C. 103 as being obvious over Westberg et. al.2 as applied to claims 1-2, 10, 11, 14, above.
Recall Westberg teaches anticipatory compounds of instant Formula X.
Regarding a method of treating COVID-19, Westberg teaches ML1000 and ML1100 (see Westberg at Figure 4), inhibitors of the coronavirus main protease capable of inhibiting SARSCov2 viral replication (see Westberg at Abstract).
The prior art differs from the instant claims as follows: While Westberg teaches compounds that inhibit SARSCov2, Westberg does not specify i) a pharmaceutical composition ii) administering to a patient or iii) a species wherein R4a is H.
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Regarding a pharmaceutical composition and administering to a patient, one skilled in the art would recognize that a compound capable of inhibiting SARSCov2 viral replication could be formulated in a composition comprising a carrier and administered in therapeutically effective amounts to a patient infected with SARSCov2 for treatment (see MPEP ¶ 2144.07), thus using the compound for its intended purpose.
Regarding R4a is H, Westberg teaches species where R4a is methyl. It is generally noted that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Druey, 319 F.2d 237, 138 U.S.P.Q. 39 (C.C. P.A. 1963). Per MPEP § 2144.08(II)(A)(4)(c), the closer the physical and/or chemical similarities between the claimed species or subgenus and any exemplary species or subgenus disclosed in the prior art, the greater the expectation that the claimed subject matter will function in an equivalent manner to the genus. In addition or in the alternative, per MPEP § 2144.09(I)-(II), “[a] prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities” because “[c]ompounds which are…homologs…are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties” (see, e.g., MPEP § 2144.09(I)-(II)), and the Court has stated that “[i]f a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” KSR, 127 S.Ct. at 1740. Here, the prior art teaches highly similar structural compounds differing only by methyl -(CH2)- of the instantly claimed invention, wherein such compounds have the same, exact utility as the instantly claimed compounds; accordingly, an artisan would readily appreciate that such compounds could be utilized in the treatment of COVID-19, exactly as taught and suggested in view of the prior art.
Allowable Subject Matter
Claims 3-9, 12-13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and the typographical error in claim 5 fixed.
Conclusion
Claims 1-2, 10-11, 14--19 are rejected.
Claims 3-9, 12-13 are objected to.
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/S.R./Examiner, Art Unit 1627
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
1 Westberg et. al. "Rational design of a new class of protease inhibitors for the potential treatment of coronavirus diseases" bioRxiv, 2020, DOI: 10.1101/2020.09.15.275891. Published September 16, 2020.
2 Westberg et. al. "Rational design of a new class of protease inhibitors for the potential treatment of coronavirus diseases" bioRxiv, 2020, DOI: 10.1101/2020.09.15.275891. Published September 16, 2020.