DETAILED ACTION
Examiner acknowledges receipt of the reply filed 10/13/2025, a reply to the nonfinal office action mailed 5/22/2025.
Claims 1-3 and 5-14 are pending and being examined on the merits in this office action. Claim 4 has been cancelled.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 112- withdrawn
The rejection of claims 4 and 12 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of the amendment filed 10/13/2025.
Claim Rejections - 35 USC § 103- withdrawn
The rejection of claims 1-14 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Beglinger et al. (Clin. Pharma. Therap. 84:468-474 (2008)- cited in IDS filed 4/23/2024), and further in view of Lau et al. (U.S. 2009/0156478, published 06/18/2009- cited in IDS filed 4/23/2024), as evidenced by Semaglutide (ChemSpider, accessed 5/19/2025 at URL chemspider.com/Chemical-Structure.34985066.html, pp. 1-3), and Johansson (Int’l J Pharma 21:307-315 (1984)- previously cited), is withdrawn in view of the amendment filed 10/13/2025.
Response to Arguments
Applicant's amendment and arguments filed 10/13/2025 have been fully considered and are persuasive with regard to the above rejections. Therefore, the rejections have been withdrawn.
Applicant's arguments filed 10/13/2025 have been fully considered but they are not persuasive with regard to the maintained ODP rejections.
An action on the merits is set forth herein.
Specification
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Double Patenting- maintained
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 1-3 and 5-14 remain/are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 9,993,430 (hereinafter “the ‘430 patent”). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons. The rejection is maintained from the office action mailed 5/22/2025, but has been amended to reflect claims filed 10/13/2025.
Regarding instant claims 1 and 2, independent claim 1 of the ‘430 patent recites a tablet [reads on solid oral composition] comprising a granulate wherein said granulate comprises i) no more than 15% (w/w) semaglutide [GLP-1 receptor agonist], and ii) at least 50% (w/w) salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid (NAC), and wherein said tablet has a) a bulk density of at least 1.0 g/cm3, b) a median pore diameter of no more than 1.5 μm, c) a maximum pore diameter of no more than 4 μm, d) a crushing strength of at least 50 N, and e) a disintegration time of 12-18 minutes for a tablet with a total weight of 300-500 mg comprising at least 60% (w/w) salt of NAC. Claim 5 of the ‘430 patent recites a tablet of claim 1 wherein said tablet comprises an intragranular and an extragranular part, wherein said extragranular part comprises a lubricant and optionally a filler. Claim 6 of the ‘430 patent recites a tablet according to claim 1, wherein said tablet comprises a) a granulate comprising i) 1-15% (w/w) semaglutide, ii) 55-85% (w/w) salt of NAC, and iii) 1-20% (w/w) binder; b) 10-35% (w/w) filler; and c) 0.5-3% (w/w) lubricant. claim 6 of the ‘430 patent recites 55-85% (w/w) salt of NAC. Claim 8 recites that the tablet is for oral administration.
Regarding claim 3, claims 4 and 10 of the ‘430 patent teach that the salt of NAC is monosodium NAC (SNAC).
The‘430 patent states at col. 5, ll. 34-40 that lubricants include magnesium stearate. “[The specification] may be used to learn the meaning of terms and interpreting the coverage of a claim." In re Basell Poliolefine Italia S.P.A., 89 USPQ2d 1030, 1036 (Fed. Cir. 2008). Thus, even though the instant claims recite specificities not explicitly recited by the claims of the ‘430 patent, species of the instant claims encompassed by the claims of the ‘430 patent are disclosed in the specification of the ‘430 patent, and thus the instant claims are not patentably distinct from the claims of the reference application. Accordingly, claims 10-12 are obvious variants of claims 1-6 and 10 of the ‘430 patent.
Regarding claims 5-9, 13 and 14, it is considered routine for an artisan to determine the appropriate amounts of semaglutide and NAC.
Accordingly, the entire scope of the instant claims is rendered obvious as it is concerned to result in an obvious variant of the ‘430 patent claims.
Response to Arguments
Applicant did not address this rejection in the reply filed 10/13/2025.
Claims 1-3 and 5-14 remain/are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-10 and 12-16 of U.S. Patent No. 11033499 (hereinafter “the ‘499 patent”). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons. The rejection is maintained from the office action mailed 5/22/2025, but has been amended to reflect claims filed 10/13/2025.
Regarding instant claims 1 and 2, independent claim 1 of the ‘499 patent recites tablet [reads on solid oral composition] comprising a granulate, wherein said granulate comprises: i) no more than 15% (w/w) GLP-1 peptide, wherein the GLP-1 peptide is a peptide; and ii) at least 50% (w/w) salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid (NAC); wherein said tablet has a) a bulk density of at least 1.0 g/cm3; b) a median pore diameter of no more than 1.5 μm; and c) a feature selected from the group consisting of a maximum pore diameter of no more than 4 μm, a crushing strength of 50-400 N, and a disintegration time of 22 minutes or less. Claim 3 of the ‘499 patent recites that the GLP-1 peptide is semaglutide. Claim 6 of the ‘499 patent recites a tablet of claim 1 wherein said tablet comprises an intragranular and an extragranular part, wherein said extragranular part comprises a lubricant. Claim 5 of the ‘499 patent recites the amount of the salt of NAC is 50-90% (w/w). Claim 7 of the ‘499 patent recites 55-85% (w/w) salt of NAC. Claim 9 recites that the tablet is for oral administration.
Regarding claim 3, claims 4 and 12 of the ‘499 patent teach that the salt of NAC is monosodium NAC (SNAC).
The ‘499 patent states at col. 5, ll. 38-40 that lubricants include magnesium stearate. “[The specification] may be used to learn the meaning of terms and interpreting the coverage of a claim." In re Basell Poliolefine Italia S.P.A., 89 USPQ2d 1030, 1036 (Fed. Cir. 2008). Thus, even though the instant claims recite specificities not explicitly recited by the claims of the ‘499 patent, species of the instant claims encompassed by the claims of the ‘499 patent are disclosed in the specification of the ‘499 patent, and thus the instant claims are not patentably distinct from the claims of the reference application. Claim 5 of the ‘499 patent recites the tablet according to claim 1, wherein the granulate comprises i) 1-15% (w/w) GLP-1 peptide [semaglutide], ii) 55-85% (w/w) salt of NAC, and iii) 1-20% (w/w) binder; and wherein the tablet further comprises 10-35% (w/w) filler and 0.5-3% (w/w) lubricant [e.g., magnesium stearate]. Accordingly, claims 10-12 are obvious variants of claims 1 and 3-7 of the ‘499 patent.
Regarding claims 5-9, 13 and 14, it is considered routine for an artisan to determine the appropriate amounts of semaglutide and NAC.
Accordingly, the entire scope of the instant claims is rendered obvious as it is concerned to results in an obvious variant of the ‘499 patent claims.
Response to Arguments
Applicant did not address this rejection in the reply filed 10/13/2025.
Claims 1-3 and 5-14 remain/are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-10 of copending Application No. 17/320436 (hereinafter “the ‘436 application”). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons. The rejection is maintained from the office action mailed 5/22/2025, but has been amended to reflect claims filed 10/13/2025.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding instant claims 1 and 2, independent claim 1 of the ‘436 application recites a tablet [reads on solid oral composition] comprising a granulate comprising: i) no more than 15 % (w/w) GLP-1 peptide, and ii) at least 50%, 55%, or 60% (w/w) salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid (NAC). Claim 3 of the ‘436 application recites that the GLP-1 peptide is semaglutide. Claim 5 of the ‘436 application recites wherein the amount of said salt of NAC is 50-90 % (w/w), 55-85 % (w/w), or 70-80 % (w/w). Claim 6 of the ‘436 application recites wherein said tablet comprises an intragranular and an extragranular part, wherein said extragranular part comprises a lubricant. Claim 0 recites that the tablet is for oral administration.
Regarding claim 3, claim 4 of the ‘436 application teach that the salt of NAC is monosodium NAC (SNAC).
The ‘436 application states at p.6, ll. 33-35 that lubricants include magnesium stearate. “[The specification] may be used to learn the meaning of terms and interpreting the coverage of a claim." In re Basell Poliolefine Italia S.P.A., 89 USPQ2d 1030, 1036 (Fed. Cir. 2008). Thus, even though the instant claims recite specificities not explicitly recited by the claims of the ‘436 application, species of the instant claims encompassed by the claims of the ‘436 application are disclosed in the specification of the ‘436 application, and thus the instant claims are not patentably distinct from the claims of the reference application. Claim 7 of the ‘436 application recites tablet according to claim 1, wherein said tablet comprises a) a granulate comprising i) 1-15 % (w/w) GLP-1 peptide [semaglutide], ii) 55-85 % (w/w) salt of NAC, and iii) 1-20 % (w/w) binder; b) 10-35 % (w/w) filler; and c) 0.5-3 % (w/w) lubricant [e.g., magnesium stearate]. Accordingly, claims 10-12 are obvious variants of claims 1 and 3-7 of the ‘436 application.
Regarding claims 5-9, 13 and 14, it is considered routine for an artisan to determine the appropriate amounts of semaglutide and NAC.
Accordingly, the entire scope of the instant claims is rendered obvious as it is concerned to results in an obvious variant of the ‘436 application claims.
Response to Arguments
Applicant did not address this rejection in the reply filed 10/13/2025.
Closest Prior Art
Steinert et al (J Clin Pharma Therapeutics 86:644-650 (Dec 2009)- previously cited) teach tablets comprising the peptide GLP–1 (7–36 amide) and the delivery agent SNAC. Peptide tablets were prepared by mixing 2 mg of GLP–1 (7–36 amide) with 150 mg of SNAC.
Steinert et al. do not explicitly or implicitly teach tablets comprising semaglutide, SNAC, in further combination with a lubricant.
Beglinger et al. (Clin. Pharma. Therap. 84:468-474 (2008)- previously cited) teach pharmaceutical compositions of tablets comprising 0.5, 1.0, 2.0 or 4 mg GLP-1 (7-36 amide) and 200 mg sodium N-(8-(2-hydroxybenzoyl)amino)caprylate) (SNAC) (abstract; p. 471, para. 3 – p. 472, para. 1; p. 473, materials). The molecular weight of SNAC is 301.313369 g/mol. Thus, 200 mg of SNAC equates to 0.663 [.7] mmols. Beglinger et al. teach that the delivery agent SNAC is effective to transport the peptides across the intestinal epithelium (p. 472, para. 1). Thus, oral delivery of GLP-1 was shown to be a promising route of administration.
Beglinger et al. teaches tablets comprising 200 mg SNAC, but the reference does not teach the total weight of the tablet. Thus the w/w% of SNAC is not explicitly taught by Beglinger et al.
Beglinger et al. do not explicitly or implicitly teach tablets comprising semaglutide, in further combination with a lubricant, or the recited concentrations.
Conclusion
No claims are allowed.
Claims 1-3 and 5-14 are pending and are rejected.
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 KRISTINA M HELLMAN whose telephone number is (571)272-2836. The examiner can normally be reached M-F 9:00 am-5:30 pm.
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/KRISTINA M HELLMAN/Examiner, Art Unit 1654
/JULIE HA/Primary Examiner, Art Unit 1654
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