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 .
DETAILED ACTION
Filing Receipt and Priority
The filing receipt mailed 09/23/2024 states that the instant application is a 371 of PCT/US2022/075678, filed 08/30/2022.
The PCT document supports the instant claims. Therefore, the instant application has an effective filing date of 08/30/2022.
Information Disclosure Statement
The information disclosure statement submitted 02/29/2024 and 07/21/2026 have been considered.
Restriction/Species Election
Applicant’s election of Compound 216 in the remarks submitted 05/26/2026 is acknowledged. At examiner’s discretion, search and examination has been broadened to include compounds wherein the general formula (I) is the following:
Ring A is a 6-membered heteroatom ring containing nitrogen (N),
X5 is -N(H)-,
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is pyrimidine.
Claims 15 and 20-24 are withdrawn being drawn to a non-elected invention.
Rejections
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.
Improper Markush
Claims 1-9, 13-14 are rejected on the 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). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping in claim 1 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons.
Applicant has elected the following compound, compound 216.
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Claim 1 is drawn to general formula I, shown below.
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The general formula (I) includes compounds that drastically different from the compound elected and from compounds where Ring A is a single ring and X5 is –N(H)-. As an example, Table 6 of the instant disclosure gives a compound of general formula shown below.
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The compounds listed in Table 6 do not share a structural similarity with the compound claimed or even from compounds where Ring A is a single heterocycle, X5 is -N(H)-, and the second ring system is a 6-membered heteroaryl.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Indefinite Limitation
Claims 1-9, 11, and 13 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 includes a wherein clause defining Z, shown below.
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However, this wherein clause is nested within a conditional limitation (“if Ring a is…). Therefore, technically, all other instances of Z are undefined as the wherein clause only applies to conditions in bullet (a).
For the purpose of examination, it is understood that the definition of Z in bullet (a) applies to all instances of Z.
As claims 2-9, 11, and 13 are dependent on claim 1, they are also rejected.
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) 1-9 and 11 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Cohen (WO2013174780, of the record).
Cohen on p. 100 discloses the following compound.
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The above compound embraces the instant claims.
Additionally, there are many compounds that embrace the instant claims disclosed in Cohen, of which the following are included.
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At least the compounds above embrace the claims.
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.
KSR Rationales
Claim(s) 1-9, 11, and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cohen (WO2013174780, of the record).
Discussion of Cohen from the 102 rejection above is incorporated here.
Cohen does not explicitly disclose compounds of claim 13 or compositions comprising compounds of general formula I, as in claim 1.
However, Cohen teaches compounds 97 and 108, shown below.
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The combination of these two compounds makes claim 13 obvious as one of ordinary skill in the art would find it obvious to modify compound 97 to include the R5 moiety of compound 108. One of ordinary skill in the art would find it obvious to modify the compound as the teaching of the alternative R5 moiety is effectively teaching that two moieties as alternatives of each other.
Regarding claim 14, Cohen contemplates compositions comprising compounds and a pharmaceutically acceptable carrier, diluent, or excipient (p. 68, l. 31-33).
Cohen teaches compound 97 that can be modified to include the R5 moiety of compound 108, which would embrace the limitations of claim 13.
Therefore, it would have been prima facie obvious at the time of the effective filing date for one of ordinary skill in the art to have modified compound 97 via the R5 moiety of compound 108 to arrive at the instant claims. One of ordinary skill would be motivated to make the modification as it would have been obvious to try as the R5 moiety of 108 is taught as an alternative with a similar effect.
Allowable Subject Matter
Claims 12 and 35 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.
Conclusion
No claims allowed.
Allowable subject matter has been indicated.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LUISALBERTO GONZALEZ/Examiner, Art Unit 1624
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