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 .
Non-Final Rejection
The Status of Claims:
Claims 1-6 are pending.
Claims 1-6 are rejected.
DETAILED ACTION
1. Claims 1-6 are under consideration in this Office Action.
Priority
2. It is noted that this application is a 371 of PCT/JP2022/034601 09/15/2022,
which has priority documents, JAPAN JP2021-150271 09/15/2021 and JAPAN JP2022-128640 08/12/2022.
Drawings
3. The drawings filed on 8/16/24 were accepted by the examiner.
IDS
4. The IDS filed on 10/16/2025 & 8/16/24 were considered by the examiner.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-5 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 pre-AIA the applicant regards as the invention.
In claims 1-5, the phrase “an AMPA receptor antagonist
”is recited. This expression can be vague and indefinite because the terms can be read on the reach-through claim. A functional definition of a chemical compound ("reach-through" claim) covers all compounds possessing the activity or effect specified in the claim. It would be an undue burden to isolate and characterize all potential compounds, without any effective pointer to their identity or to test every known compound and every conceivable and undiscovered future compound for this activity to see if it falls within the scope of the claims. In effect, the applicant is attempting to patent what has not yet been invented. Therefore, an appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3 are rejected under 35 U.S.C. 102(a)(2) as being anticipated clearly by Kozachuk (US 6,191,117 B1).
Kozachuk discloses the methods of producing weight loss and treating obesity by using an antagonist of an AMPA receptor in the following:
1. A method for treating a human suffering from obesity comprising the steps of: administering to the human a compound whose mechanism
of action includes antagonism of the kainite and/or AMPA receptor. (see col. 8 , claim 1). This is inherently identical with the claims.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
6. Claims 1-4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Kozachuk (US 6,191,117 B1) in view of Krauss et al (Epilepsia, 55(7):1058–1068, 2014).
1. (Currently amended) A method of treating a subject having overweight or obesity, comprising administering a therapeutically effective amount of an AMPA receptor antagonist.
2. (Currently amended) The method according to claim 1,
[[for]] wherein the administration results in delaying, inhibiting, or arresting a development of overweight or obesity in a subject having overweight or obesity.
3. (Currently amended) The method according to claim 1, fer use wherein the administration results in reducing body weight in a subject having overweight or obesity.
4. (Currently amended) The method according to claim 1-, for use, wherein the administration results in reducing food intake in a subject having overweight or obesity.
6. (Currently amended) The method according to any one of claims 1 to 4 claim 1, wherein the AMPA receptor antagonist is perampanel.
Determination of the scope and content of the prior art
Kozachuk discloses the methods of producing weight loss and treating obesity by using an antagonist of an AMPA receptor in the following:
1. A method for treating a human suffering from obesity comprising the steps of: administering to the human a compound whose mechanism of action includes antagonism of the kainite and/or AMPA receptor. (see col. 8 , claim 1).
Kozachuk teaches that glutamate and its agonists act within the LH to elicit eating and thus participate of the LH in the regulation of eating behavior. LH injections of either glutamate, KA, AMPA, and NMDA elicit a strong dose-dependent eating response. Lateral hypothalamic NMDA blockade reduced the eating response to NMDA and suppressed both deprivation-induced eating and nocturnal eating. These results suggest that endogenous LH glutamate and the NMDA receptor are both involved in the regulation of natural eating, circadian factors, and eating behavior. Thus, NMDA receptors in the LH may participate in the long-term regulation of food intake and body weight control as in claim 4 (partially).
The current invention, however, differs from the prior art in that the use of an antagonist of an AMPA receptor being perampanel is unspecified in the prior art.
Krauss et al discloses a maximum perampanel daily dose of 10 or 12 mg/day
was reached by 1,122 patients (92.3%) (see page 1060, a section of Exposure , the right col, the second paragrraph).
Also, it teaches an increase in weight of >7% from baseline occurred in 460 (37.8%) of 1,216 patients across the perampanel treatment duration, and loss of >7% occurred in 134 (11.0%) of 1,216 patients. (see page 1065, the left col. at the bottom paragraph in the section of body weight).
Ascertainment of the difference between the prior art and the claims
1. The difference between the current application and the applied Kozachuk art is that the applied Kozachuk art does not expressly teach perampanel as an antagonist of an AMPA receptor. The deficiency of Kozachuk is cured by Krauss et al.
2. The difference between the current application and the applied Krauss et al art is that the Krauss et al does not mention directly the method of treating a subject having overweight or obesity by using perampanel as an antagonist of an AMPA receptor. The deficiency of Krauss et al is cured by Kozachuk.
Resolving the level of ordinary skill in the pertinent art.
Regarding the Claim 6, with respect to the lack of disclosing the use of perampanel as an antagonist of an AMPA receptor , the Krauss et al does mention that a loss of weight >7% occurred in 134 (11.0%) of 1,216 patients during the perampanel treatment period(see page 1065, the left col. at the bottom paragraph in the section of body weight). From this information, it is reasonable and feasible for the skilled artisan to make a decision for applying perampanel for the obesity treatment.
So, if the skilled artisan in the art had desired to use perampanel as an antagonist of an AMPA receptor for treating obesity , it would have been obvious to the ordinary skill in the art to be motivated to do so. This is because the skilled artisan in the art would expect such a manipulation to be within the purview of the skilled artisan in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Kozachuk expressly discloses the method of producing weight loss and treating obesity by using an antagonist of an AMPA receptor.
Although Kozachuk expressly discloses the use of an antagonist of an AMPA receptor being perampan for the method of treating obesity, the Krauss et al does mention that a loss of weight >7% occurred in 134 (11.0%) of 1,216 patients during the perampanel treatment period(see page 1065, the left col. at the bottom paragraph in the section of body weight). From this information, it is reasonable and feasible for the skilled artisan to make a decision for applying perampanel for the obesity treatment.
Both are closely related to each other with respect to using an antagonist of an AMPA receptor for the treatment of obesity (a general an antagonist of an AMPA receptor vs. a specific name of the antagonist of an AMPA receptor.
So, if the skilled artisan in the art had desired to use perampanel as an perampanel antagonist of an AMPA receptor for treating obesity, it would have been obvious to the ordinary skill in the art to be motivated to incorporate the Krauss’s specific name of perampanel into the Kozachuk method in order to enhance the overall treatment process.This is because the skilled artisan in the art would expect such a combined method to be feasible and successful as guidance as shown in the prior art.
Conclusion
Claims 1-6 are rejected.
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/TAYLOR V OH/Primary Examiner, Art Unit 1625 6/13/2026
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