DETAILED ACTION
Notice of Pre-AIA or AIA Status
This Office action details a first action on the merits for the above reference application No. Claims 1-17, 20 and 24-28 are pending in this application. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/28/2024 was noted and the submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings were received on 02/28/2024. These drawings are acknowledged.
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 1-11, 13, 14, 24, and 27 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.
The claims are indefinite due the almost unlimited number of distinct alternative compounds encompassed by the various variations in the claimed formula. For example, if a claim defines a chemical compound using one or more Markush groups, and that claim encompasses a massive number of distinct alternative members, the claim may be indefinite under 35 U.S.C. 112(b) if one skilled in the art cannot determine its metes and bounds due to an inability to envision all of the compounds defined by the Markush group(s). In such a circumstance, a rejection of the claim for indefiniteness under 35 U.S.C. 112(b) is appropriate. See MPEP 2173.05(h) Alternative Limitations [R-01.2024].
Improper Markush Rejection
Claims 1-11, 13, 14, 24, and 27 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCP1980)
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 features and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of the components of the formulation 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:
The claims are directed to a compound of formula (IV) or a pharmaceutically acceptable salt thereof,
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. The compound formula (IV) encompass various substituents including, but not limited to the following: T= -NR4(CO)-, -NR4(SO2)-, and NR4(CH2)-, R4 is selected from the group consisting of H, C₁-₆ alkyl, 6-10 membered aryl, and 5-12 membered heteroaryl; the C₁-₆ alkyl, 6-10 membered aryl, or 5-12 membered heteroaryl is optionally substituted with one or more substituents P; A=
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455
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W is selected from the group consisting of 6-10 membered aryl and 5-12 membered heteroaryl; the 5-10 membered aryl or 5-12 membered heteroaryl is optionally substituted with one or more substituents P or is unsubstituted; the substituents P are selected from the group consisting of C₁-C₆ alkyl, halogen, deuterium, hydroxy, sulfhydryl, -NRR, oxo, thio, -C(O)Rₖ, -C(O)ORk, -S(O)Rk, -S(O)ORk, -S(O)(O)Rk, -S(O)(O)ORk, -C(S)Rk, nitro, cyano, C₁-C₆ alkoxy, C₁-C₆ alkylthioether group, C2-C₆ alkenyl, C2-C₆ alkynyl, 3- to 10-membered cycloalkyl, 3- to 10-membered heterocyclyl, 6- to 10-membered aryl, 5- to 10-membered heteroaryl, 8- to 12-membered fused cycloaryl, and 5- to 12-membered fused heteroaryl; Ri and Rj are each independently selected from the group consisting of a hydrogen atom, hydroxy, C₁-C₆ alkyl, and C₁-C₆ alkoxy; Rk is independently selected from the group consisting of a hydrogen atom, C₁-C₆ alkyl, C₁-C₆ haloalkyl, C₁-C₆ alkoxy, hydroxy, and -NRR,, wherein the alkyl, alkoxy, or haloalkyl is optionally substituted with one or more substituents selected from the group consisting of C₁-C₆ alkyl, halogen, hydrogen, sulfhydryl, -NR|R₁, oxo, thio, carboxyl, nitro, cyano, C₁-C₆ alkoxy, C₁-C₆ alkylthioether group, C₂-C₆ alkenyl, C₂-C₆ alkynyl, 3- to 10-membered cycloalkyl, 3- to 10-membered heterocyclyl, 6- to 10-membered aryl, and 5- to 10-membered heteroaryl; and R3 is a chelating agent selected from group consisting of:
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. It is duly noted that the above do not contain a common core but comprise a wide variety of structures, rings, variable repeating units and functional groups. Thus, there is no common core consistent with the structures above since the claims embrace species from various chemical classes.
Applicant attention is directed to the third paragraph of MPEP 803.02 which discloses: "Since the decisions in In re Weber, 580 F.2d 455, 198 USPQ 328 (CCPA 1978) and In re Haas, 580 F.2d 461, 198 USPQ 334 (CCPA 1978), it is improper for the Office to refuse to examine that which Applicants regard as their invention, unless the subject matter in a claim lacks unity of invention. In re Harnisch, 631 F.2d 716, 206 USPQ 300 (CCPA 1980); and Ex parte Hozumi, 3 USPQ2d 1059 (Bd. Pat. App.& Int. 1984). Broadly, unity of invention exists where compounds included within a Markush group (1)
share a common utility, and (2) share a substantial structural feature essential to that utility."
In the instant case, if it is asserted that the claims share a common utility, namely they are used in the formulation of independent claim 1, the genus does not share a substantial structural feature essential to the utility which is a feature that is essential to the activity/function of the claimed species. The only component that is probably consistent in the above individual groups is a carbon-carbon bond. As a result, such a grouping would be repugnant to scientific classification because the carbon-carbon bond alone is not responsible for the utility of the entire molecule. In addition, the wide variety of rings, structures and functional groups does not allow the genus to have an art recognized classification. Hence, the Markush grouping is improper.
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 CFR 41.31(a)(1) (emphasis provided).
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.
Claim Objections
Claims 12, 15-17, 20, 25, 26 and 28 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 are allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAGADISHWAR RAO SAMALA whose telephone number is (571)272-9927. The examiner can normally be reached Monday-Friday 9am-6pm.
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/J.R.S/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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