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 .
Status of the Claims
Claims 1-20 are pending. Acknowledgment is made of Applicant’s amendments to the claims filed March 20th 2026 and addition of claims 19-20.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-4, 8, 13, 15, and 17, drawn to a guaianolide sesquiterpene lactone derivative of general formula (I) in the reply filed on March 20, 2026 is acknowledged. The traversal is directed to the species election and is addressed below.
The requirement is still deemed proper and is therefore made FINAL.
Claims 5-7, 9-12, 14, 16, and 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 20th, 2026.
Applicant's election with traverse of Compound 1, depicted below, in the reply filed on March 20th, 2026 is acknowledged.
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The traversal is on the ground(s) that compound 23 is This is not found persuasive because even though compound to compound 1, the structures of compounds 1 and 23 are nonetheless different. A search for compound 1 and applicable prior art would not likely apply to compound 23 and vice versa. Thus, a serious search burden exists for the distinct species because they require a different field of search.
The requirement is still deemed proper and is therefore made FINAL.
Claims 3-4, 15 and 17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on March 20th, 2026.
Claims 1-2, 8, and 13 are currently under examination as they relate to the elected species, Compound 1 of formula I.
Priority
This application is a CIP of PCT/CN2022/095243, filed May 26th, 2022, which claims foreign priority to CN202210573181.1, filed May 26th, 2022, and to CN202110588960.4, filed May 28th, 2021.
Claim Objections
Claim 1 is objected to because the phrase “Guaianolide sesquiterpene lactone derivatives” should read “A guaianolide sesquiterpene lactone derivative[[s]]”.
Claim 1 is further objected to because the phrase “R5 is methyl; and R6 is a hydroxyl” should read “R5 is methyl; 6 is [[a]] hydroxyl”.
Claims 2, 8, and 13 objected to because the phrase “the guaianolide sesquiterpene lactone derivatives” should read “the guaianolide sesquiterpene lactone derivative[[s]]” in each of these claims.
Appropriate correction is required.
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.
Claims 1-2, 8, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (US 2013/0109749 A1).
Regarding claims 1-2, Chen teaches compounds of the following formula (I) (claim 1):
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When the variables are chosen as highlighted, the following compound is obtained:
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This is the same compound as instantly elected Compound 1, except the cyclopropyl group has no stereochemistry defined.
Chen does not explicitly teach a compound wherein the cyclopropyl group has the same stereochemistry as instantly claimed.
MPEP 2144.09.II states: “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.).” It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to arrive at the elected compound with a reasonable expectation of success from the teachings of Chen. Moreover, the stereoisomer (racemate) of Chen is of sufficiently close structural similarity that there is a presumed expectation that such compound would possess similar properties.
Taken together, all this would result in instant Compound 1 of claims 1-2, with a reasonable expectation of success.
Regarding claims 8 and 13, Chen teaches a pharmaceutical composition for cancer treatment comprising an effective amount of a compound or salt thereof of formula (I) in combination with a pharmaceutically acceptable carrier (para [0032]).
Thus, it would have been obvious before the filing of the instant application to make a pharmaceutical composition of compounds from instant claims 1 and 2 since Chen teaches instant Compound 1 is a compound of their formula (I) and because compounds of their formula (I) are useful in pharmaceutical compositions for cancer treatment.
Conclusion
Claims 1-2, 8, and 13 are rejected.
No claims are allowed.
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/O.D.H./Examiner, Art Unit 1628 /Rayna Rodriguez/Primary Examiner, Art Unit 1628
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