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 national stage entry of PCT/CN2022.070676, filed January 7, 2022.
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d) by application nos. PCTCN2021070898, PCTCN2021075582, PCTCN2021086638, and PCTCN2021103945 filed in the Chinese Patent Office on 1/8/2021, 2/5/2021, 4/12/2021, and 7/1/2021, respectively.
Information Disclosure Statement
4. The information disclosure statements (IDS) submitted on July 7, 2023 and November 24, 2025 were in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The IDS documents were considered. A signed copy of each form 1449 is enclosed herewith.
Election/Restrictions
5. Applicant's election without traverse of Group I in the reply filed on June 28, 2021 is acknowledged.
6. Applicant's election with traverse of Group I in the reply filed on November 24, 2025 is acknowledged. The traversal is on the ground(s) that the search and examination of multiple groups is not unduly burdensome to the Office. This is not found persuasive because the compounds of Groups II-VII are structurally divergent from Group I and from one another and the different structure searches are burdensome to the Office. For example, compounds of formula VIII of Claim 21 do not have a bridged ring at position R11. Withdrawn groups cannot be rejoined as the structural differences are burdensome to search and the claims lack unity of invention as discussed in the restriction requirement.
The requirement is still deemed proper and is therefore made FINAL.
Status of Claims
7. Claims 1-24, 26, 32-33, and 38 are pending in the instant application. Claims 21-24, 26, and 32-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention and species. Therefore, claims 1-20 and 38 read on an elected invention and species and are therefore under consideration in the instant application.
Claim Rejections – Improper Markush Group
8. The nonstatutory Markush grouping rejection is based on a judicially approved “improper Markush grouping” doctrine. Claims 1-20 and 38 are rejected on the judicially-created 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). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature.
A Markush claim contains an “improper Markush grouping” if: (1) The species of the Markush group do not share a single structural similarity,” or (2) the species do not 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 recognized physical or chemical class or to the same art-recognized class. Members of a Markush group share a common use when they are disclosed in the specification or known in the art to be functionally equivalent (see Federal Register, Vol. 76, No. 27, Wednesday, February 9, 2011, p. 7166, left and middle columns, bridging paragraph).
In the present case, at least (1) applies. It cannot be said that all members of the Markush group have a single structural similarity from which the activity flows. Specifically, the species of the Markush group do not share a “single structural similarity” because there are no required structural features within each compound of formula A such that each member of the group would have at least one structural feature, which feature is essential to the activity/function of the claimed compounds, in common.
In addition, at least (2) applies since each alternatively usable member of the Markush group does not share a common use. Rather, the specification discloses that the compounds are useful as KRAS G12D INHIBITOR AND DEGRADER; however, there is no common core in the compounds of formula A that are known as KRAS G12D INHIBITOR AND DEGRADER. It is suggested that applicant amend the claims to contain only proper Markush groupings to compounds sharing a single structural similarity and a common use, wherein the common use shared by the compounds is a result of the structural similarity essential to the function of the compounds.
The question of whether the lack of a specific statutory basis is a fatal flaw against a holding of an Improper Markush group was decided in In re Harnish, 206 USPQ 300, 305, where the court said, “…we think it should be clear from our actions in Weber and Haas II that we there recognized the possibility of such a thing as an "improper Markush grouping." We were and are aware that it does not have a specific statutory basis …” The court went on to reverse the rejection, (which had been made by the Board under Rule 196(b)) but not on the lack of a specific statutory basis but rather, “Clearly, they are all coumarin compounds which the board admitted to be "a single structural similarity." We hold, therefore, that the claimed compounds all belong to a subgenus, as defined by appellant, which is not repugnant to scientific classification. Under these circumstances we consider the claimed compounds to be part of a single invention so that there is unity of invention…” Thus, the rejection was overturned not because of any lack of a specific statutory basis, but because of the specific facts in the case. The Markush group was held proper in that case, as was the case also in Ex parte Price 150 USPQ 467, Ex parte Beck and Taylor, 119 USPQ 100, and Ex parte Della Bella and Chiarino 7 USPQ2d 1669. Cases where the Markush group was held improper include Ex Parte Palmer, 7 USPQ 11, In re Winnek, 73 USPQ 225, In re Ruzicka, 66 USPQ 226, Ex parte Hentrich, 57 USPQ 419, Ex parte Barnard, 135 USPQ 109, Ex parte Reid, 105 USPQ 251, Ex parte Sun and Huggins, 85 USPQ 516, In re Thompson and Tanner, 69 USPQ 148, In re Swenson, 56 USPQ 180, and In re Kingston, 65 USPQ 371. Note In re Milas 71 USPQ 212 in which the structural difference between vitamin A and D was sufficient to uphold the improper Markush rejection. Also see In re Winnek 73 USPQ 225 and In re Ruzicka 66 USPQ 226 in which structural differences were small and yet a similar holding was maintained. All these cases involved compounds in the pharmaceutical art known to be structure-sensitive. Of particular interest is Ex Parte Hozumi, 3 USPQ2d 1059, which reversed an improper Markush rejection “in view of the relatively large proportion of the structure of the compounds in the claimed class which is common to the entire class.” Here, by contrast, the amount in common is none, relative to the entire molecule.
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).
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.
9. Claim 38 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 pre-AIA the applicant regards as the invention.
The claim is indefinite because it makes express reference to the specification. The claim recites ‘compound is selected from Table 1, Table 2, and Table 6’ which are not present in the claims. According to MPEP 2173.05(s) “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).”
Conclusion
10. No claims allowed.
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/SAMANTHA L SHTERENGARTS/Primary Examiner, Art Unit 1623
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