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
This Application claims foreign priority to PCT/CN2021/095205, filed May 21, 2021, in the People’s Republic of China, and is a CON of PCT/EP2022/063377, filed May 18, 2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on Feb. 12, 2026 and May 7, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1-18, 20-21 and 27-28 are currently pending and subject to examination.
Claim Rejections – 35 USC § 112(b)
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 18 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 18 recites the broad recitation “unsubstituted or substituted heterocycle”, and the claim also recites “particularly ring B is selected from azetidinyl, pyrrolidinyl, and azaspiro[3.3]heptanyl”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Examples are properly set forth in the specification and not in the claims:
Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph should be made. The examiner should analyze whether the metes and bounds of the claim are clearly set forth. Note that the mere use of the phrase "such as" or "for example" in a claim does not by itself render the claim indefinite.
Examples of claim language which have been held to be indefinite because the intended scope of the claim was unclear are:
(A) "R is halogen, for example, chlorine";
(B) "material such as rock wool or asbestos" Ex parte Hall, 83 USPQ 38 (Bd. App. 1949);
(C) "lighter hydrocarbons, such, for example, as the vapors or gas produced" Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949);
(D) "normal operating conditions such as while in the container of a proportioner" Ex parte Steigerwald, 131 USPQ 74 (Bd. App. 1961); and
(E) "coke, brick, or like material". Ex parte Caldwell, 1906 C.D. 58 (Comm’r Pat. 1906).
MPEP § 2173.05(d).
Claim 18 is also indefinite because the formulae (XXXII) and (VII) have R10 but R10 is not defined by the claim. Furthermore, it is unclear if “the compound of Formula (XXIV), R7-Q” means that the compound of formula (XXIV) has the structure R7-Q.
Claim 27 is indefinite because it is unclear if the second instances “autoimmune disease and inflammatory disease” and “cancer” refer back to the instances of these terms in the preamble. Consider adding “the” before these terms. The same problem arises with the phrase “which method” because it is not clear if this is referring back to the method of the preamble. Consider revising to “the method comprising” or “wherein the method comprises”.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
“Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”
Claim 21 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claim(s) recite(s) a method for inhibition of PDHK1, the method comprises administering a therapeutically effective amount of a compound as defined in claim 1. This judicial exception is not integrated into a practical application because the claim is not applied to effect a particular treatment or prophylaxis for a disease or medical condition. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim does not require that the compound is administered to a subject in need of treatment of a particular disease or medical condition and does not recite any additional elements.
Step 1: YES. The claim is directed towards a process, a statutory category.
Step 2A, Prong 1: YES. The claim is directed towards a judicial exception because it is directed towards observing natural phenomenon, the activity of the enzyme PDHK1.
Step 2A, Prong 2: NO. The claim does not recite additional elements that integrate the judicial exception into a practical application because it does not recite a particular disease or medical condition.
STEP 2B: NO. the claim does not amount to significantly more than the judicial exception because it does not require that the drug is administered to a patient in need of treatment or prophylaxis for a particular disease or medical condition and does not recite any additional elements.
The claim reads on the basic tools of scientific or technological work, e.g. administering the compound to an animal model and observing the result. The claim does not require that the method is used to effect treatment or prophylaxis for a particular medical condition.
Allowable Subject Matter
Claims 1-17, 20 and 28 are allowable subject matter.
The following is a statement of reasons for the indication of allowable subject matter: The present application is directed towards compounds of formula (I) as inhibitors of pyruvate dehydrogenase kinase for the treatment of inflammatory diseases and cancer:
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192
189
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.
An exemplary compound of formula (I) is:
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216
124
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(Specification, p. 37).
Oxoindoline compounds are known in the art for the treatment of cancer. For example, Chen et al. (WO2008034736 A2) (of record, IDS Feb. 12, 2026) teaches oxoindoline derivatives of the formula I:
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128
269
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(Chen, Specification, p. 1).
An exemplary compound of Chen’s formula I is:
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126
181
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(Id., p. 64).
This compound differs from instant formula I in that R2 is alkyl-aryl and not alkyl and the compound lacks NH-R1 as required by the present claims. These modifications are not taught or suggested by the prior art. Chen teaches that R6 is aryl or heteroaryl, V is hydrogen or halogen and X is selected from hydrogen, halogen, cyano, lower alkyl, lower alkenyl, lower alkynyl, lower alkoxy, nitro, methyl sulfonyl, sulfonamide and cyclopropyl.
Conclusion
Claims 1-17, 20 and 28 are allowable subject matter.
Claims 18, 21, and 28 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HEATHER DAHLIN whose telephone number is (571)270-0436. The examiner can normally be reached 9-5.
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/HEATHER DAHLIN/Examiner, Art Unit 1629