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 .
DETAILED ACTION
Claim Status
Claims 1-2 and 4-12 are pending. Claims 7-12 have been added. Claim 3 has been canceled. Claims 1 and 5 have been amended. Claims 1-2 and 4-12 are being examined in this application.
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.
This rejection has been modified.
Claims 1-2 and 4-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10888605. Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same method.
With respect to claims 1 and 4, ‘605 teaches a method of treating diabetes (or obesity) comprising administering to a subject in need of such treatment a therapeutically effective amount of a composition comprising semaglutide, wherein said composition is for parenteral administration (claims 1 and 13-14), wherein said parenteral administration is subcutaneous administration (claim 8), and wherein said composition comprises 0.5 mg/ml-5.0 mg/ml semaglutide (claims 9-10).
It is noted that subjects with diabetes (or obesity) are in need of reducing body weight, and that subjects suffering from obesity are overweight. Therefore, administering semaglutide as claimed, would inherently reduce body weight in overweight patients.
Furthermore, ‘605 teaches that “[t]he invention relates to a method for treatment or prevention of overweight, optionally in the presence of at least one weight-related comorbidity” (column 3, lines 63-65). Please note that it is proper to turn to and rely on the disclosure of a patent application to ascertain what constitutes an obvious modification. This position is supported by the courts. See In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970).
With respect to claim 2, ‘605 teaches that the composition is administered once weekly (column 3, lines 62-63).
With respect to claims 5-6, ‘605 teaches that the invention relates to a method for treatment or prevention of overweight, optionally in the presence of at least one weight-related comorbidity, wherein the weight-related comorbidity is selected from the group consisting of hypertension, diabetes (such as type 2 diabetes), dyslipidaemia, high cholesterol, and obstructive sleep apnoea (para bridging columns 4-5).
With respect to claims 7 and 10, as discussed above, ‘605 teaches that composition comprises 0.5 mg/ml-5.0 mg/ml semaglutide (claims 9-10). A prima facie case of obviousness necessarily exists when the prior art range overlaps or touches a claimed range, such as in the instant rejection (MPEP § 2144.05).
With respect to claims 8 and 11, ‘605 teaches that the composition is administered once weekly (column 3, lines 62-63).
With respect to claims 9 and 12, ‘605 teaches that the subject suffers from obesity (claim 14).
Response to Arguments
Applicant’s arguments filed on 8/27/2026 have been fully considered but they are not persuasive.
Applicant argues that the claims of the '605 patent do not teach or suggest the claimed subject matter, particularly the dosage range of about 2.0 - 10.0 mg weekly, the dosage of about 2.4 mg weekly, or the dosage of 2.4 mg weekly.
Applicant’s arguments are not persuasive because, as discussed in the rejection above, ‘605 teaches the claimed dosage.
For the reasons stated above the rejection is maintained.
This rejection has been modified.
Claims 1-2 and 4-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11752198. Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same method.
With respect to claims 1 and 4, ‘198 teaches a method of treating diabetes (or obesity) comprising administering to a subject in need of such method a therapeutically effective amount of a pharmaceutical composition comprising semaglutide, wherein said composition is for parenteral administration (claims 1 and 7-8), wherein said parenteral administration is subcutaneous administration (claim 4), and wherein the concentration of semaglutide is selected from 0.5-10 mg/ml or 0.01-5 mg/ml (claim 2).
It is noted that subjects with diabetes (or obesity) are in need of reducing body weight, and that subjects suffering from obesity are overweight. Therefore, administering semaglutide as claimed, would inherently reduce body weight in overweight patients.
Furthermore, ‘605 teaches that “[t]he invention relates to a method for treatment or prevention of overweight, optionally in the presence of at least one weight-related comorbidity” (para bridging columns 4-5). Please note that it is proper to turn to and rely on the disclosure of a patent application to ascertain what constitutes an obvious modification. This position is supported by the courts. See In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970).
With respect to claim 2, ‘198 teaches that the composition is administered once weekly (column 3, lines 64-65). Please note that it is proper to turn to and rely on the disclosure of a patent application to ascertain what constitutes an obvious modification. This position is supported by the courts. See In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970).
With respect to claims 5-6, ‘198 teaches that the invention relates to a method for treatment or prevention of overweight, optionally in the presence of at least one weight-related comorbidity, wherein the weight-related comorbidity is selected from the group consisting of hypertension, diabetes (such as type 2 diabetes), dyslipidaemia, high cholesterol, and obstructive sleep apnoea (column 5, lines 1-16).
With respect to claims 7 and 10, as discussed above, ‘198 teaches that composition comprises 0.5-10 mg/ml or 0.01-5 mg/ml semaglutide (claim 2). A prima facie case of obviousness necessarily exists when the prior art range overlaps or touches a claimed range, such as in the instant rejection (MPEP § 2144.05).
With respect to claims 8 and 11, ‘198 teaches that the composition is administered once weekly (column 3, lines 64-65).
With respect to claims 9 and 12, ‘198 teaches that the subject suffers from obesity (claim 8).
Response to Arguments
Applicant’s arguments filed on 8/27/2026 have been fully considered but they are not persuasive.
Applicant argues that the claims of the '198 patent do not teach or suggest the claimed subject matter, particularly the dosage range of about 2.0 - 10.0 mg weekly, the dosage of about 2.4 mg weekly, or the dosage of 2.4 mg weekly.
Applicant’s arguments are not persuasive because, as discussed in the rejection above, ‘198 teaches the claimed dosage.
For the reasons stated above the rejection is maintained.
This rejection has been modified.
Claims 1-2 and 4-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12029779. Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same method.
With respect to claims 1, 7 and 10, ‘779 teaches a method for reducing body weight of a subject in need thereof, comprising administering semaglutide subcutaneously to the subject in an amount of about 2.4 mg weekly (claim 1), wherein the subject is overweight (claim 3), and wherein the subject has at least one weight-related comorbid condition (claim 12).
With respect to claims 2, 8 and 11, ‘779 teaches that the semaglutide is administered once weekly (claim 2).
With respect to claims 4, 9 and 12, ‘779 teaches that the subject suffers from obesity (claim 4).
With respect to claim 5, ‘779 teaches that the subject has at least one weight-related comorbid condition selected from the group consisting of hypertension, type 2 diabetes mellitus, dyslipidemia, sleep apnoea, and urine incontinence (claim 5).
With respect to claim 6, ‘779 teaches that the subject has type 2 diabetes mellitus (claim 6).
Response to Arguments
In the response filed on 8/27/2026 Applicant requested the rejections to be held in abeyance.
For this reason, the rejection is maintained.
This rejection has been modified.
Claims 1-2 and 4-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 12214017. Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same method.
With respect to claims 1 and 4, ‘017 teaches a method of treating diabetes (or obesity) comprising administering to a subject in need of such method a therapeutically effective amount of a pharmaceutical composition comprising semaglutide, wherein said composition is administered parenterally (claims 1 and 7-8), wherein said parenteral administration is subcutaneous administration (claim 4), and wherein the concentration of semaglutide is selected from 0.5-10 mg/ml or 0.01-5 mg/ml (claim 2).
It is noted that subjects with diabetes (or obesity) are in need of reducing body weight, and that subjects suffering from obesity are overweight. Therefore, administering semaglutide as claimed, would inherently reduce body weight in overweight patients.
Furthermore, ‘017 teaches that “[t]he invention relates to a method for treatment or prevention of overweight, optionally in the presence of at least one weight-related comorbidity” (column 5, lines 3-5). Please note that it is proper to turn to and rely on the disclosure of a patent application to ascertain what constitutes an obvious modification. This position is supported by the courts. See In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970).
With respect to claim 2, ‘017 teaches that the composition is administered once weekly (column 4, lines 1-2).
With respect to claims 5-6, ‘017 teaches that the invention relates to a method for treatment or prevention of overweight, optionally in the presence of at least one weight-related comorbidity, wherein the weight-related comorbidity is selected from the group consisting of hypertension, diabetes (such as type 2 diabetes), dyslipidaemia, high cholesterol, and obstructive sleep apnoea (column 5, lines 2-20).
With respect to claims 7 and 10, as discussed above, ‘017 teaches that composition comprises 0.5-10 mg/ml or 0.01-5 mg/ml semaglutide (claim 2). A prima facie case of obviousness necessarily exists when the prior art range overlaps or touches a claimed range, such as in the instant rejection (MPEP § 2144.05).
With respect to claims 8 and 11, ‘017 teaches that the composition is administered once weekly (column 4, lines 1-2).
With respect to claims 9 and 12, ‘198 teaches that the subject suffers from obesity (claim 8).
Response to Arguments
Applicant’s arguments filed on 8/27/2026 have been fully considered but they are not persuasive.
Applicant argues that the claims of the '017 patent do not teach or suggest the claimed subject matter, particularly the dosage range of about 2.0 - 10.0 mg weekly, the dosage of about 2.4 mg weekly, or the dosage of 2.4 mg weekly.
Applicant’s arguments are not persuasive because, as discussed in the rejection above, ‘017 teaches the claimed dosage.
For the reasons stated above the rejection is maintained.
This rejection has been modified.
Claims 1-2 and 4-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12295988. Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same method.
With respect to claims 1-2 and 5-6, ‘988 teaches a method for treating type 2 diabetes in a subject in need thereof, comprising administering semaglutide to the subject in an amount of 2.0 mg once weekly, wherein the semaglutide is administered subcutaneously (claim 1).
‘988 further teaches that the invention relates to a method for treatment or prevention of overweight, optionally in the presence of at least one weight-related comorbidity (column 5, lines 2-20). Please note that it is proper to turn to and rely on the disclosure of a patent application to ascertain what constitutes an obvious modification. This position is supported by the courts. See In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970).
It is noted that subjects with type 2 diabetes are in need of reducing body weight. Therefore, administering semaglutide as claimed, would inherently reduce body weight.
With respect to claim 4, ‘988 teaches that “[I]n some embodiments the present invention relates to a method for weight management. In some embodiments the weight management is chronic weight management. In some embodiments the said weight management is selected from the group consisting of: reducing body weight, treating and/or preventing obesity, treating and/or preventing overweight, and preventing weight gain (column 3, lines 41-49).
With respect to claims 7 and 10, ‘988 teaches that the amount of semaglutide is 2.4 mg weekly (column 5, lines 38-42).
With respect to claims 8 and 11, ‘017 teaches that the composition is administered once weekly (column 5, lines 43-45).
With respect to claims 9 and 12, ‘198 teaches that the subject suffers from obesity (column 1, lines 16-18; column 4, lines 16-22; column 5, line 31).
Response to Arguments
In the response filed on 8/27/2026 Applicant requested the rejections to be held in abeyance.
For this reason, the rejection is maintained.
This rejection has been modified.
Claims 1-2 and 4-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 12551536. Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same method.
With respect to claim 1, ‘536 teaches a method for reducing body weight of a subject in need thereof, comprising administering semaglutide subcutaneously to the subject in an amount of 2.0-10.0 mg weekly (claim 1), wherein the subject is overweight (claim 3), and wherein the subject has at least one weight-related comorbid condition (claim 5).
With respect to claim 2, ‘536 teaches that the semaglutide is administered once weekly (claim 2).
With respect to claim 4, ‘536 teaches that the subject suffers from obesity (claim 4).
With respect to claim 5, ‘536 teaches that the subject has at least one weight-related comorbid condition selected from the group consisting of hypertension, type 2 diabetes mellitus, dyslipidemia, sleep apnoea, and urine incontinence (claim 5).
With respect to claim 6, ‘536 teaches that the subject has type 2 diabetes mellitus (claim 6).
With respect to claims 7 and 10, as discussed above, ‘536 teaches that composition comprises 2.0-10.0 mg semaglutide (claim 1). A prima facie case of obviousness necessarily exists when the prior art range overlaps or touches a claimed range, such as in the instant rejection (MPEP § 2144.05).
With respect to claims 8 and 11, ‘536 teaches that the composition is administered once weekly (claim 2).
With respect to claims 9 and 12, ‘198 teaches that the subject suffers from obesity (claim 4).
Response to Arguments
In the response filed on 8/27/2026 Applicant requested the rejections to be held in abeyance.
For this reason, the rejection is maintained.
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 SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658
