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 statements submitted on 05/14/2025 has been considered by the examiner.
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Claims 10-12, 19-20, 22-27 are withdrawn from further consideration pursuant to 37 CFR1.142(b) as being drawn to a nonelected Group II-IV or based on the elected species, there being no allowable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 As a result claims 9, 18 are withdrawn.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 1-5, 7, 10-13, 17-29, and 31-32 are pending. Claims 1, 5, 7, 17-18 are amended. Claims 6, 8-9, 14-16, and 30 are canceled. Claims 10-12, 18-20, 22-27 are withdrawn. Claims 31-32 are new.
Claims 1-5, 7, 13, 17, 21, 28-29, and 31-32 are being examined on the merits in this office action.
Claim Rejections - Withdrawn
The rejection of claims 1-4, 6, 16-17 21, and 28-29 under 35 U.S.C. 102(a)(1) as being anticipated by Richardson et al. (US20120252728A1 – hereinafter “Richardson”) is withdrawn in view of the claim amendments.
The rejection of claims 5, 13-15, and 30 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 (WO1999047161A1 – hereinafter “Goke”) is withdrawn in view of the claim amendments.
The rejection of claims 7 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) is withdrawn in view of the claim amendments.
Claim Rejections - 35 USC § 103 – New
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 1-5, 13, 17, 21, 28-29, and 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Richardson et al. (US20120252728A1 – hereinafter “Richardson”) in view of Raun et al. (US20070082844A1 – hereinafter “Raun”) and Goke et al. (WO1999047161A1 – hereinafter “Goke”).
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, or immediately before a meal or at mealtime [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]. Richardson teaches that the administration of the instant peptide, did not cause any side effects such as nausea and vomiting [0083-0086, 0140, 0186-0187]. Examiner notes that this teaching of Richardson reads on the limitation “wherein the administration does not result in a side effect lasting longer than 2.5-3 hours.
Ricardson teaches that the instant peptide is administered before a meal but does not explicitly teach that the instant peptide is administered 60 min or less prior to a meal.
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 1 hour, 30 min, or 15 min before a meal [0056]. Raun teaches that the method decreases food intake [0008, 0015, 0033]. Examiner notes that from the teachings of Raun, GLP-1 agonists are known to be administered 1 hour or less before a meal and thus one of ordinary skill in the art would be motivated to administer the peptide of Richardson 1 hour or less before a meal.
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. The disclosures render obvious 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], which reads on nasally.
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 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 claim 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]. Examiner 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].
Regarding claims 31-32, Richardson teaches the composition for subcutaneous injection [0095, 0156, 0161].
Claims 7 is rejected under 35 U.S.C. 103 as being unpatentable over Richardson et al. (US20120252728A1 – hereinafter “Richardson”) in view of Raun et al. (US20070082844A1 – hereinafter “Raun”) and Goke et al. (WO1999047161A1 – hereinafter “Goke”) 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 the GLP-1 agonist is cheaper for patients and for preventing side effects. 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.
Response to Amendment
The Affidavit under 37 CFR 1.132 filed 05/26/2026 is insufficient to overcome the rejection of claims 1-5, 7, 13, 17, 21, 28-29, and 31-32 based upon 35 U.S.C. 103 as set forth in the last Office action because the cited references render obvious the claimed invention. Applicant argues that they surprisingly discovered that ROSE-010 can maintain a lower level of hunger until 6.5 hours and that the side effects are resolved within 2.5-3 hours (Page 2-5 of affidavit). Applicant argues that they did not expect that Rose-010 administered 10-60 minutes before a meal would provide hunger suppressing effect and avoid long lasting side effects associated with long acting GLP-1 agonists (Page 5 of affidavit). Applicant argues that Raun uses liraglutide which is a long lasting GLP-1 agonist and different from ROSE-010 and thus would not expect that ROSE-010 can be administered 10-60 minutes before a meal and would suppress hunger and would avoid log lasting side effects (Page 5-6 of affidavit). Applicant argues that Goke teaches GLP-1 (7-36) which has a very short plasma half-life and thus cannot provide a hunger suppressing effect and few side effects (Page 6 of affidavit). Applicant argues that EASO is discussing managing side effects for semaglutide and thus cannot provide a hunger suppressing effect and few side effects (Page 7 of affidavit).
The arguments presented above have been fully considered but are unpersuasive. Examiner notes that Richardson explicitly teaches the instant ROSE-010 and teaches a method of treating obesity comprising administering the composition comprising ROSE-010 and that the GLP-1 agonist can be administered in proximity to the beginning of a meal or snack [0089] or can be administered before a meal, or immediately before a meal or at mealtime [0085, 0095, 0138]. Examiner notes that one of ordinary skill in the art can infer from the teachings of Richardson that before a meal or immediately before a meal includes a time period of 60 minutes and less. Additionally, Examiner relied on the Raun reference to additionally disclose that GLP-1 agonists administered before a meal is usually done at 1 hour, 30 min, or 15 min before a meal. Thus, one of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in administering ROSE-010 at 1 hour, 30 min, or 15 min before a meal as taught by Raun.
Additionally, Examiner notes that Richardson teaches that the method reduced food consumption, inhibit food intake in the patient, decrease or suppress appetite, and/or control body weight [0097]. Thus, the teachings of Richardson disclose that ROSE-010 had a hunger suppressing effect. With regards to the reduction of side effects, Richardson teaches that that the administration of the instant peptide, did not cause any side effects such as nausea and vomiting [0083-0086, 0140, 0186-0187]. Examiner further notes that Richardson is administering the instant peptide, ROSE-010, to the patient population, and at the instant dose as recited in claim 2. Richardson teaches all the properties that Applicant claims are unexpected. Richardson teaches that the method reduced side effects, and that the method suppressed hunger, but does not explicitly disclose the duration in terms of hours the effects lasted. However, since Richardson teaches the administering the instant peptide (ROSE-010), to the patient population, and at the instant dose, and teaches that the method reduced side effects, and that the method suppressed hunger, Applicant discovery that lower level of hunger was maintained for 6.5 hours and side effects resolved in 3 hours, is simply the discovery of a previously unappreciated property of a prior art composition. Richardson already indicates that ROSE-010 has an effect of suppressing hunger and completely reducing the side effects of nausea and vomiting especially when administered nasally. Applicant has simply determined the duration of the side effects or the suppressing of hunger. Something old does not become patentable upon discover of a new property. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112 (I).
With regards to the arguments of Raun, Goke and EASO reference, Examiner notes that Applicant is arguing the references individually when the rejection is based on the combined teachings of Richardson, Raun and Goke. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to Applicant’s argument that Raun and Goke teach different GLP-1 agonists, Examiner notes that the Raun reference was used to further disclose that GLP-1 agonists administered before a meal, are known to be administered at 60 or less minutes as taught by Raun. Examiner notes that the primary reference, Richardson, already teaches that the instant peptide is administered before a meal or immediately before a meal. Additionally, Goke reference was used to teach the limitation of the decrease in calorie intake. Richardson, already teaches that the instant peptide helps to reduce food consumption [0097]. Further, the EASO reference was used to teach that GLP-1 agonists dose can be reduced gradually over weeks to reduce side effects. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Examiner maintains that when the teachings of the cited references are combined, the claimed invention is obvious.
Response to Arguments
Applicant's arguments filed 05/26/2026 have been fully considered but they are not persuasive.
Applicant makes the same arguments (Page 6-11 of Arguments) that were made in the Declaration filed 05/26/2026. These arguments have been addressed above and the response to the Arguments is incorporated herein. Thus, these arguments are considered and addressed above and are thus unpersuasive.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
/TARA L MARTINEZ/Primary Examiner, Art Unit 1654
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