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
This application was filed 05/14/2025 and has PRO 63/648,006 filed on 05/15/2024.
Information Disclosure Statement
The information disclosure statement filed 05/14/2025 fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
Election/Restrictions
Claims 10-12, 19-20, 22-27 are withdrawn from further consideration pursuant to 37 CFR1.142(b) as being drawn to a nonelected Group II-IV or based on the elected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/24/2025. Applicant’s election without traverse of Group I drawn to a method of treating, in the reply filed on 11/24/2025 is acknowledged.
Applicant further elects the species of:
(1) subcutaneous administration as the single administering mode species from claims 4 and
22;
(2) 30 minutes prior to 1 meal as the time period species from claims 5-6 and 23-24;
(3) 100 micrograms as the single dose species from claims 2-3 and 19-21;
(4) vomiting and nausea (as a combination) as the single species of the side effects from
claims 13-15 and 30;
(5) once a day as the single species of administration frequency from claims 7-9, 16-18 and
25-27.
(6) the subject having BMI of no less than 27 and no greater than 35 as the single specific
subject species from claims 28-29.
As a result claims 9, 18 are withdrawn.
Claim Status
Claims 1-30 are pending. Claims 13-14, 16-18, 21, 28-29 are amended. Claims 9-12, 18-20, 22-27 are withdrawn.
Claims 1-8, 13-17, 21, 28-30 are being examined on the merits in this office action.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claims 1-4, 6, 16-17 21, and 28-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Richardson et al. (US20120252728A1 – hereinafter “Richardson”).
Regarding claim 1, Richardson teaches a pharmaceutical composition comprising GLP-1 analog having the amino acid sequence of SEQ ID NO: 1 [0007], which is identical to the instant SEQ ID NO: 1. Richardson teaches a method of treating obesity comprising administering the composition [0009, 0021, 0053, 0064, 0080], that obesity is typically assessed by BMI (body mass index) with BMI of greater than 30 kg/m2 [0064], that the GLP-1 can be administered in proximity to the beginning of a meal or snack [0089] or can be administered before a meal [0085, 0095, 0138]. Richardson teaches that the method reduce food consumption, inhibit food intake in the patient, decrease or suppress appetite, and/or control body weight [0097]. The disclosures anticipate claim 1.
Regarding claims 2-3, Richardson teaches that the GLP-1 is administered at dosages from about 50 μg to about 300 μg [0022, 0052].
Regarding claim 4, Richardson teaches the composition for subcutaneous injection [0094-0095, 0156, 0161], and inhalation through the nose [0072].
Regarding claim 6, Richardson teaches that the GLP-1 can be administered several times per day, such as before the meals [0138] and can also be administered between meals and daily as needed and can be administered once, twice, three or four times a day [0132]. Examiner notes that the disclosure reads on administration several times before a meal.
Regarding claims 16-17, Richardson teaches that the GLP-1 is administered once a day [0137-0138].
Regarding claims 21, Richardson teaches that the GLP-1 is administered at dosages from about 50 μg to about 300 μg [0022]. Examine notes that the teaches of Richardson encompass the instant dose range.
Regarding claims 28, Richardson teaches that the GLP-1 is administered to a female subject [0161].
Regarding claims 29, Richardson teaches the method of treating obesity comprising administering the composition [0009, 0021, 0053, 0064, 0080], that obesity is typically assessed by BMI (body mass index) with BMI of greater than 30 kg/m2 [0064].
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5, 13-15, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Richardson et al. (US20120252728A1 – hereinafter “Richardson”) as applied to claim 1 above, and further in view of Raun et al. (US20070082844A1 – hereinafter “Raun”) and Goke et al. (WO1999047161A1 – hereinafter “Goke”).
The teachings of Richardson are disclosed above and incorporated herein by reference.
Richardson does not teach the time prior to administering the GLP-1 as recited in claim 5.
Raun teaches a method of treating obesity in a subject, the method comprising administering to said subject an effective amount of a GLP-1 agonist (claim 10, [0053]), wherein the GLP-1 is administered 4 hours, 3 hours, 2 hours, 1 hour, 30 min, or 15 min before a meal [0056]. Raun teaches that the method decreases food intake [0008, 0015, 0033].
Further, Goke teaches a method of suppressing human appetite comprising administering GLP-1 or its analogues (Page 3, line 9-21). Goke teaches that the method resulted in a decrease in calorie intake of 32% and a reduction of 35% food consumption (Page 15, line 1-5; Page 17, line 7-9; Page 20, line 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Richardson and administer GLP-1 at the times taught by Raun before a meal since Raun teaches that the method helped in a decrease of food intake [0008, 0015, 0033]. One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in modifying the teachings of Richardson with the teachings of Raun and Goke since Goke teaches that the method resulted in a decrease in calorie intake of 32% and a reduction of 35% food consumption (Page 15, line 1-5; Page 17, line 7-9; Page 20, line 4).
Additionally, one of ordinary skill in the art would have had a reasonable expectation of successfully combining the cited prior art teachings, because the cited references hail from the same field of endeavor, i.e. a method of treating weight loss or obesity comprising administering GLP-1 agonist resulting in suppressing appetite.
Regarding claim 5, Raun teaches a method of treating obesity in a subject, the method comprising administering to said subject an effective amount of a GLP-1 agonist (claim 10, [0053]), wherein the GLP-1 is administered 4 hours, 3 hours, 2 hours, 1 hour, 30 min, or 15 min before a meal [0056]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Richardson and administer GLP-1 at the times taught by Raun before a meal since Raun teaches that the method helped in a decrease of food intake [0008, 0015, 0033].
Regarding claim 13, Goke teaches a method of suppressing human appetite comprising administering GLP-1 or its analogues (Page 3, line 9-21). Goke teaches that the method resulted in a decrease in calorie intake of 32% and a reduction of 35% food consumption (Page 15, line 1-5; Page 17, line 7-9; Page 20, line 4). It would have been obvious to modify the teachings of Richardson with Goke and administer GLP-1 to suppress human appetite since Goke teaches that the method achieved a decrease in calorie intake of 32% and a reduction of 35% food consumption (Page 15, line 1-5; Page 17, line 7-9; Page 20, line 4).
Regarding claims 14-15, and 30, Richardson teaches the method does not induce unwanted adverse side effects such as profuse sweating, nausea and vomiting to the patient [0083, 0140].
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Richardson et al. (US20120252728A1 – hereinafter “Richardson”) as applied to claim 1 above, and further in view of EASO (https://easo.org/is-coming-off-semaglutide-slowly-the-key-to-preventing-weight-regain/ - published 05/11/2024).
The teachings of Richardson are disclosed above and incorporated herein by reference.
Richardson does not teach the reducing the dose of GLP-1 over time from the first administration as recited in claim 7.
EASO teaches Glucagon-like peptide-1 (GLP-1) receptor agonists such as semaglutide are highly effective at helping people lose weight, as well as reduce appetite and feelings of hunger, slow the release of food from the stomach and increase feelings of fullness after eating (Page 2, 3rd paragraph). EASO teaches tapering off or reduction of the GLP-1 dose gradually over weeks (Page 4, 1st and 2nd paragraph). EASO teaches that using lower doses of semaglutide is cheaper for patients, results in fewer side-effects and helps ensure that stocks of the drug go further (Page 4, line 1-2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Richardson and gradually reduce the dose of GLP-1 since EASO teaches that using lower doses of semaglutide is cheaper for patients. One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in reducing the GLP-1 dose gradually resulting in fewer side-effects (Page 4, line 1-2). The disclosures ender obvious claims 7-8.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mercy H. Sabila whose telephone number is (571)272-2562. The examiner can normally be reached Monday - Friday 5:00 am - 3:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. Garyu can be reached at (571)270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MERCY H SABILA/Examiner, Art Unit 1654
Prosecution Insights