0DETAILED 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 .
Applicant’s arguments, filed 07/27/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Status
Claims 23, 26, and 27 are pending and under examination.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 23, 26, and 27 stand rejected under 35 U.S.C. 103 as being unpatentable over Horn Moller et al (WO 2019038412 A1).
Horn Moller et al discloses pharmaceutical compositions comprising semaglutide comprising no more than 0.1 wt% phenol (abs), with embodiments comprising 0.5 mg/ml semaglutide, no phenol, and 6.3 mg/ml sodium chloride (example 3, table 6 comp. no. 25). The composition of the invention is in the form of a liquid pharmaceutical composition (pg. 1 ln 16-17). The compositions is for parenteral administration (pg. 4 ln 19). Isotonic agents may be included, including sodium chloride, in a concentration from 8 mg/ml to 50 mg/ml (pg. 7 embodiment 13, pg. 3 ln 26-27). The compositions are used for the method of treating diabetes or obesity (pg. 5).
Regarding claim 23, it would have been obvious to adjust the amount of sodium chloride in the embodiment recited above in amounts suitable for isotonic agents, such as adjusting the amounts up to 8 mg/ml to 50 mg/ml, as taught by Horn Moller et al, overlapping the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claim 26, where Horn Moller et al disclose the compositions are suitable for parenteral administration, the intended use limitation of a parenteral composition is met.
Regarding claims 27, it would have been obvious to administer the composition made obvious above by Horn Moller et al to a subject in need thereof for treating diabetes and obesity, as taught by Horn Moller et al.
Response to Arguments
Applicants assert Horn Moller does not qualify for prior art under 35 U.S.C. 102(a)(2) in view of the exemptions set forth in 35 U.S.C. 102(b)(2)(C). Applicants assert the Applicant of the instant application and Horn Moller is Novo Nordisk A/S and is excluded from prior art and unavailable for obviousness determination.
Respectfully, this argument is not persuasive. Horn Moller et al (WO 2019038412 A1) was published 02/28/2019, and was therefore available to the public before the effective filing date of the claimed invention, qualifying as 102(a)(1) art, where the common ownership exemption does not apply. Accordingly, the claims stand rejected for the same reasons above and of record.
Claims 23, 26, and 27 stand rejected under 35 U.S.C. 103 as being unpatentable over Reedtz-Runge et al (US 20150011462 A1).
Reedtz-Runge et al teaches compositions comprising 20-60 nmol/ml GLP-1 derivatives, 70-145 mM sodium chloride, 50 mM sodium phosphate (buffer), 0.05% Tween 80, with a pH of 7.4 (¶ 600). The GLP-1 derivatives include semaglutide (¶ 7). The following amounts were calculated from the molar concentrations above: GLP-1 derivatives from 0.082-0.245 mg/mL and sodium chloride from 4.1-8.5 mg/mL. The GLP-1 derivative may be included in a suitable concentration, such as from 0.1 mg/mL to 100 mg/mL (¶¶ 155-159). The pharmaceutical composition may comprise a preservative, selected from phenol, etc. (¶ 142). Examples of formulations include liquid formulations (¶ 138). The composition can be in the form of an injection (¶ 601), for parenteral administration (¶ 164). The composition is used for the treatment of diabetes, obesity, Alzheimer’s disease, and cardiovascular diseases, by administration to a subject in need thereof (¶ 18, claim 12).
Regarding claim 23, it would have been obvious to formulate the composition as a liquid composition, as taught by Reedtz-Runge et al, such as for purposes of formulating an injectable composition.
Regarding semaglutide of claim 23, it would have been obvious to select semaglutide as the GLP-1 derivatives, as motivated by Reedtz-Runge et al. Further, it would have been obvious to include semaglutide in amounts taught to be suitable of GLP-1 derivatives, such as 0.082-0.245 mg/mL, overlapping the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding the phenol content of claim 23, there appears to be no phenol included in the embodiment cited above, thereby meeting the claimed limitation.
Regarding the sodium chloride content of claim 23, it would have been obvious to formulate the composition made obvious above with sodium chloride ranging from 4.1-8.5 mg/mL, as taught by Reedtz-Runge et al, overlapping the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claim 26, it would have been obvious to formulate the compositions in a form suitable for parenteral administration, as taught by Reedtz-Runge et al, thereby reading on a parenteral composition.
Regarding claim 27, it would have been obvious to use the composition for the method of treating diabetes, obesity, Alzheimer’s disease, and cardiovascular diseases, by administering the composition to a subject in need thereof, as taught by Reedtz-Runge et al.
Response to Arguments
Applicants assert Reedtz-Runge does not qualify for prior art under 35 U.S.C. 102(a)(2) in view of the exemptions set forth in 35 U.S.C. 102(b)(2)(C). Applicants assert the Applicant of the instant application and Reedtz-Runge is Novo Nordisk A/S and is excluded from prior art and unavailable for obviousness determination.
Respectfully, this argument is not persuasive. Reedtz-Runge et al (US 20150011462 A1) was published 01/08/2015, and was therefore available to the public before the effective filing date of the claimed invention, qualifying as 102(a)(1) art, where the common ownership exemption does not apply. Accordingly, the claims stand rejected for the same reasons above and of record.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 23, 26, and 27 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/226,405 (reference application), hereinafter referred to as ‘405, in view of Reedtz-Runge et al (US 20150011462 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘405 discloses a liquid pharmaceutic composition comprising semaglutide, contains no phenol, and further comprises one or more excipients selected from a buffer or an isotonic agent. Semaglutide is 0.5-10 mg/ml of the composition. Sodium chloride is 8.25 mg/mL and 6.3 mg/mL (claims 21, 22).
‘405 does not disclose the method of treating those conditions of instant claim 27.
Reedtz-Runge et al are discussed above.
It would have been obvious to use the composition made obvious above for the treatment of diabetes, obesity, Alzheimer’s disease, and/or cardiovascular diseases, as motivated by Reedtz-Runge et al, where both are drawn to liquid compositions comprising semaglutide.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The following are rejected for the same reasons for comprising a composition comprising semaglutide, in view of Reedtz-Runge et al (US 20150011462 A1):
Copending application no. 18/427,270, while disclosing a liquid pharmaceutical composition comprising semaglutide from 0.01-10.0 mg/mL and an isotonic agent, sodium chloride and its amounts are not disclosed. It would have been obvious to include sodium chloride in amounts taught by Reedtz-Runge et al, as the isotonic agent, where both are directed to liquid pharmaceutical compositions comprising semaglutide and an isotonic agent.
Copending application no. 17/799,700, while disclosing a semaglutide formulation comprising semaglutide comprising sodium chloride, the claims do not disclose the amount of semaglutide and sodium chloride instant claimed, nor the method of treating those conditions of the instant claims. It would have been obvious to include semaglutide and sodium chloride in known amounts suitable for semaglutide formulations, as taught by Reedtz-Runge et al. It would have been obvious to administer the formulations for the treatment of those conditions of the instant claims, as motivated by Reedtz-Runge et al.
Copending application no. 19/026,842 (newly published), while disclosing a medical device comprising an aqueous semaglutide formulation comprising semaglutide in a concentration of 0.1-10 mg/mL and a tonicity agent, including sodium chloride from 5.0-7.0 mg/mL, the claims do not disclose a method of treating those conditions of the instant claims. It would have been obvious to administer the semaglutide formulation of ‘842 for the method of treating of diabetes, obesity, Alzheimer’s disease, and cardiovascular diseases, by administering the composition to a subject in need thereof, as taught by Reedtz-Runge et al, where both are directed to semaglutide formulations.
Copending application no. 19/423,120, while disclosing a medical device comprising an aqueous semaglutide formulation comprising semaglutide in a concentration of 0.1-10 mg/mL and a tonicity agent, including sodium chloride at 6.4 mg/mL, the claims do not disclose the concentration of sodium chloride as instantly claimed, nor a method of treating those conditions of the instant claims. It would have been obvious to include known amounts of sodium chloride suitable for isotonic agents, such as those taught by Reedtz-Runge et al. Further, it would have been obvious to administer the semaglutide formulation of ‘842 for the method of treating of diabetes, obesity, Alzheimer’s disease, and cardiovascular diseases, by administering the composition to a subject in need thereof, as taught by Reedtz-Runge et al, where both are directed to semaglutide formulations.
Response to Arguments
First, Applicants assert the Examiner impermissibly treats the OTDP as a rejection under 35 U.S.C 103 and does not explain why the claimed inventions of the cited references themselves would have been modified to arrive at Applicant’s claimed formulation. Applicants assert the Examiner’s recitations that it “would have been obvious” to incorporate the teachings of Reedtz-Runge into the reference claims is a conventional obviousness rejection rather than whether the pending claims are patentably distinct.
Second, Applicants assert the rejection over the claims of copending Application no. 18/226,405 illustrates this deficiency, where Applicants assert the rejection does not explain why the skilled artisan would have modified the claimed invention of ‘405 to arrive at the claimed composition. Applicants assert the Examiner provides no analysis regarding the pending 0.0-0.1 wt% phenol despite the reference claims affirmatively requiring that the composition contain no phenol.
First, respectfully, this argument is not persuasive. To determine whether or not the application is an obvious variant of an invention claimed, the examiner should determine whether those differences render the claims patentably distinct using an anticipation analysis and/or an obviousness analysis. See MPEP 804 II.B. Any secondary reference used to support an obviousness analysis for a nonstatutory double patenting rejection must be prior art. See MPEP 804 II.B.3. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). An obviousness analysis is required when the examined claim is not anticipated by the reference claim. Thus, Applicants’ argument that the Examiner’s recitation that it “would have been obvious” is impermissible in nonstatutory double patenting rejections Is not persuasive as the MPEP is clear that obviousness analysis is required for nonstatutory double patenting rejections.
Second, respectfully, this argument is not persuasive. As recited above, the claims of ‘405 disclose a liquid pharmaceutic composition comprising semaglutide, contains no phenol, and further comprises one or more excipients selected from a buffer or an isotonic agent. Semaglutide is 0.5-10 mg/ml of the composition. Sodium chloride is 8.25 mg/mL (claim 21). Accordingly, the amount of semaglutide falls within the claimed ranges, the limitation of no phenol falls within the scope of the amount of phenol instantly claimed which recites down to 0.0% w/w phenol, and 8.25 mg/mL sodium chloride falls within the claimed range for sodium chloride. As such, the claims of ‘405 are not patentably distinct from the instant claims for the reasons set forth above.
Claims 23, 26, and 27 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/426,412 (reference application), hereinafter referred to as ‘412, in view of Reedtz-Runge et al (US 20150011462 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘412 discloses a method for treating Alzheimer’s disease comprising administering semaglutide to a subject in need thereof, wherein the semaglutide is administered subcutaneously.
‘412 does not disclose the inclusion of sodium chloride or its amounts nor the amount of semaglutide instantly claimed.
It would have been obvious to include known components that are taught to be suitable for liquid pharmaceutical compositions comprising semaglutide that are known to treat Alzheimer’s disease, such as sodium chloride, as taught by Reedtz-Runge et al above and for the same reasons.
It would have been obvious to adjust the amount of the components to those taught to be suitable by Reedtz-Runge et al, where both are drawn to liquid compositions comprising semaglutide.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The following are rejected for the same reasons for comprising a composition comprising semaglutide, in view of Reedtz-Runge et al (US 20150011462 A1):
Copending Application No. 19/423,120, while disclosing a method of treating obesity or overweight in a subject comprising administering a subcutaneous injection comprising 0.05-5.0 mg semaglutide, the reference does not teach specific concentration in mg/mL semaglutide, nor the inclusion of sodium chloride. It would have been obvious to include known concentrations of semaglutide known for subcutaneous injections and further include sodium chloride in known amounts for the same reasons discussed above by Reedtz-Runge et al.
Response to Arguments
Applicants assert the Examiner does not explain why the claimed sodium chloride range of 8.0-9.5 mg/mL would have been an obvious variation of the specifically claimed sodium chloride concentrations. Additionally, Applicants assert the claims of ‘412 contain no limitations directed to a pharmaceutical formulation, liquid compositions, sodium chloride, phenol, excipients, or semaglutide concentration and asserts the Examiner does not explain why the claimed composition would have been obvious.
Respectfully, this argument is not persuasive. As recited above, where the claims of ‘412 are directed to a method of treating Alzheimer’s disease comprising administering semaglutide to a subject, wherein the semaglutide is administered subcutaneously (i.e., a liquid semaglutide formulation), it would have been obvious to include known components taught to be suitable for liquid pharmaceutical compositions comprising semaglutide that were known to treat Alzheimer’s disease, such the isotonic agent sodium chloride. Further, as discussed above, it would have been obvious to include known amounts of the components, including the amount semaglutide and sodium chloride, as taught by Reedtz-Runge et al above, where the claims of ‘412 and Reedtz-Runge et al are both directed to liquid formulations comprising semaglutide that are suitable for treating Alzheimer’s disease. Additionally, where no phenol is claimed, the limitation of 0.0-0.1% w/w phenol is met. Therefore, the claims of ‘412 are not patentably distinct from the instant claims.
Claims 23, 26, and 27 stand rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11,752,198 B2, hereinafter referred to as ‘198, in view of Reedtz-Runge et al (US 20150011462 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘198 discloses a liquid pharmaceutical composition comprising semaglutide, contains no phenol, further comprises one or more excipients selected from a buffer or an isotonic agent, and wherein the semaglutide is from 0.01-10.0 mg/ml. The composition can be used for parenteral administration. ‘198 discloses a method of treating diabetes and obesity comprising administering a therapeutically effective amount to a subject.
‘198 does not disclose sodium chloride as the isotonic agent.
It would have been obvious to include sodium chloride (isotonic agent), as taught by Reedtz-Runge et al, where both are drawn to compositions comprising semaglutide that comprise isotonic agents.
The following are rejected for the same reasons in view of Reedtz-Runge et al (US 20150011462 A1):
U.S. Patent No. 10888605 B2, while disclosing a liquid pharmaceutical composition comprising 0.5-5.0 mg/mL semaglutide, phenol at no more than 0.1 mg/mL, and sodium chloride for treating diabetes and obesity, the claims do not disclose the amount of sodium chloride. It would have been obvious to include known amounts of sodium chloride suitable for semaglutide formulations, such as those taught by Reedtz-Runge et al above.
U.S. Patent No. 12527844 B2 (newly published), while disclosing an aqueous semaglutide formulation comprising semaglutide in a concentration of 0.1-10 mg/mL, water, a tonicity agent selected from sodium chloride, etc., the claims do not disclose the concentration of sodium chloride as instantly claimed, wherein the composition is a parenteral composition specifically, nor the method of claim 27. It would have been obvious to include known amounts of the isotonicity agent sodium chloride suitable for liquid semaglutide formulations, such as 4.1-8.5 mg/mL as taught by Reedtz-Runge, overlapping the claimed range. Where the compositions of ‘844 are aqueous formulations of semaglutide, it would have been obvious to formulate the compositions for parenteral administration, which were known to be suitable for liquid semaglutide compositions, as taught by Reedtz-Runge et al for the same reasons discussed above. Regarding the method, it would have been obvious to use the composition made obvious above for the treatment of diabetes, obesity, Alzheimer’s disease, and/or cardiovascular diseases, as motivated by Reedtz-Runge et al, where both are drawn to liquid compositions comprising semaglutide. There appears to be no phenol claimed by ‘844, thereby falling within the claimed range.
Claims 23, 26, and 27 stand rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 12,029,779 B2, hereinafter referred to as ‘779, in view of Reedtz-Runge et al (US 20150011462 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘779 discloses a method for reducing the body weight of a subject comprising administering semaglutide subcutaneously, wherein the subject suffers from obesity, diabetes, etc.
‘779 does not disclose the inclusion of sodium chloride or its amounts, nor the amount of semaglutide instantly claimed.
It would have been obvious to include known components that are taught to be suitable for pharmaceutical compositions comprising semaglutide that are known to treat subjects who suffer from obesity and diabetes, such as sodium chloride, as taught by Reedtz-Runge et al above and for the same reasons.
It would have been obvious to adjust the amount of the components, to those taught to be suitable by Reedtz-Runge et al, where both are drawn to compositions comprising semaglutide.
The following are rejected for the same reasons in view of Reedtz-Runge et al (US 20150011462 A1) as applied to each claim limitation:
U.S. Patent No. 9764003 B2, while disclosing a method for reducing body weight comprising administering a semaglutide formulation, the claims do not disclose the inclusion of sodium chloride or its amounts, nor the amount of semaglutide instantly claimed. It would have been obvious to include sodium chloride for the same reasons discussed above by Reedtz-Runge et al. It would have been obvious to adjust the amount of components, to those taught to be suitable by Reedtz-Runge et al, for the same reasons discussed above.
U.S. Patent No. 11478533 B2, while disclosing a method of treating NASH comprising administering about 1.0 mg/mL semaglutide subcutaneously, the claims do not disclose the inclusion of sodium chloride or its amounts, nor the amount of semaglutide instantly claimed. It would have been obvious to include sodium chloride for the same reasons discussed above by Reedtz-Runge et al. It would have been obvious to adjust the amount of components, to those taught to be suitable by Reedtz-Runge et al, for the same reasons discussed above.
U.S. Patent No. 10335462 B2, while disclosing a method for treating type 2 diabetes comprising administering semaglutide by subcutaneous injection, the claims do not disclose the inclusion of sodium chloride or its amounts, nor the amount of semaglutide instantly claimed. It would have been obvious to include sodium chloride for the same reasons discussed above by Reedtz-Runge et al. It would have been obvious to adjust the amount of components, to those taught to be suitable by Reedtz-Runge et al, for the same reasons discussed above.
Claims 23, 26, and 27 stand rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11,633,459 B2, hereinafter referred to as ‘459, in view of Reedtz-Runge et al (US 20150011462 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘459 disclose a pharmaceutical composition comprising semaglutide (claims 3-16), as well as a method of treating type II diabetes by administering an effective amount of the pharmaceutical composition to a subject in need thereof (claims 17-18).
The claims of ‘459 do not disclose a liquid composition comprising the concentration of semaglutide as instantly claimed, wherein the composition is a parenteral composition, nor the inclusion of sodium chloride.
Regarding the liquid composition, it would have been obvious to modify the claims of ‘459 by formulating the pharmaceutical compositions as a liquid pharmaceutical composition, where liquid pharmaceutical compositions of semaglutide were known from Reedtz-Runge et al.
Regarding the concentration of semaglutide, it would have been obvious to use known amounts of semaglutide suitable for liquid formulation of semaglutide, such as those of Reedtz-Runge et al above.
Regarding the parenteral composition, where the compositions of ‘459 are suitable for administration to a subject in need thereof, it would have been obvious to formulate the compositions for parenteral administration, which were known to be suitable for semaglutide compositions, as taught by Reedtz-Runge et al for the same reasons discussed above.
Regarding the inclusion of sodium chloride, it would have been obvious to further include known ingredients suitable for semaglutide compositions, such as the isotonic agent sodium chloride, as taught by Reedtz-Runge et al above.
The following are rejected for the same reasons in view of Reedtz-Runge et al (US 20150011462 A1) as applied to each claim limitation:
U.S. Patent No. 10,604,555 B2, while disclosing pharmaceutical compositions comprising semaglutide and methods of treating type II diabetes comprising administering the composition to a subject in need thereof, the claim of ‘555 do not disclose a liquid composition comprising the concentration of semaglutide as instantly claimed, wherein the composition is a parenteral composition, nor the inclusion of sodium chloride. It would have been obvious to modify the claims of ’555 for the same reasons discussed above by Reedtz-Runge et al.
Double Patenting - Withdrawn
The nonstatutory double patenting rejection over the claims of U.S. Patent No. 11,318,191 B2 has been obviated by the filing and acceptance of the terminal disclaimer dated 07/27/2026.
Conclusion
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 JOSHUA A ATKINSON whose telephone number is (571)270-0877. The examiner can normally be reached M-F: 9:00 AM - 5:00 PM + Flex.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOSHUA A ATKINSON/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
