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
Claim Status
Claims 1-20 are pending. Claim 20 has been added. Claims 1 and 14 have been amended. In the response to the restriction requirement, Applicants elected Group I and compound 22a.
Applicants elected species (i.e. compound 22a) was deemed to be free of the prior art.
Claim Rejections - 35 USC § 112
The rejection of claims 1-5 and 7-10 under 35 USC 112(b) is withdrawn in view of the amendments to the claims.
Improper Markush
Claims 1-11 and 20 are rejected under the judicially created basis of improper Markush group of alternatives. See 76 Fed. Reg. 7164-7166 (Feb. 9, 2011); In re Harnish, 631 F.2d 716m 721-22 (CCPA 1980); Ex parte Hosuzmi, 3 USPQ2d 1059m 1060 (Bd. Pat. App. & Int. 1984). For a Markush grouping to be proper the species of the Markush group must share a ‘‘single structural similarity” and must share a common use. Members of a Markush group share a "single structural similarity" when they belong to the same recognized physical or chemical class or to the same art recognized class. Here, the claimed compounds do not share a "single structural similarity.” The template portion of the claimed compound contains different molecules that do not belong to the same recognized physical or chemical class and do not belong to the same art recognized class. For instance, the structural requirements of SH (variable Z) are completely different from S-trityl. Similarly, variable Y comprises unrelated molecules (i.e. these molecules do not belong to the same art recognized class). Variable B comprises an a-amino acid and a b-amino acid backbone, which, once again, do not belong to the same art recognized class. The different compounds encompassed by the claims do not belong to the same recognized physical or chemical class and do not belong to the same art recognized class.
Response to Arguments
Applicant’s arguments filed on 8/10/2026 have been fully considered but they are not persuasive.
Applicant argues that “[a]ccording to In re Harnisch, the structure of the compound as a whole must be considered for structural similarity with each listed substituent (rather than just comparing the substituents to each other in each group). The common structural features are that the amanitin precursor compound includes a cyclic moiety containing an indole ring, the cyclic moiety including a specific number of amino acids, and two lower alkyl linkers. Also, all compounds regardless of substituents have the common use of being adapted to form amanitin toxin compounds. Thus, according to In re Harnisch the present claims are directed to proper Markush Groups”.
Applicant’s arguments are not persuasive because the instantly claimed compounds do not share a common structure.
Claim 1 recites “X is either (-(-indole-S-) or (-S-indole-)-) with the indole being an unsubstituted or hydroxyl-, halogen-, halogenated carbon-, alkynyl-, olefin-, cyano-, protected carboxylate and/or carboxyamide-substituted indole, wherein optionally the sulphur atom of X can be subsequently oxidized”.
A substituted indole is different than a substituted indole. Therefore, in contrary to Applicant’s arguments, the instantly claimed compounds do not share a common structure.
With respect to Applicant’s arguments regarding “a common use”, The MPEP 2117 states that “[A] Markush claim may be rejected under judicially approved "improper Markush grouping" principles when the claim contains an improper grouping of alternatively useable members. A Markush claim contains an "improper Markush grouping" if either: (1) the members of the Markush group do not share a "single structural similarity" or (2) the members do not share a common use. Supplementary Guidelines at 7166 (citing In re Harnisch, 631 F.2d 716, 721-22, 206 USPQ 300, 305 (CCPA 1980))”.
In the instant case, as discussed above, the members of the Markush group do not share a "single structural similarity".
Therefore, the claims are properly rejected under the judicially created basis of improper Markush group of alternatives.
For the reasons stated above the rejection is maintained.
Claim Rejections - 35 USC § 102
The rejection of claims 1-4 and 7-10 under 35 U.S.C. 102(a)(1) as being anticipated by Lokey et al. is withdrawn in view of Applicant’s arguments.
Claim Rejections - 35 USC § 103
The rejection of claims 1-5 and 7-10 under 35 U.S.C. 103 as being unpatentable over Lokey et al. is withdrawn in view of Applicant’s arguments.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658
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