DETAILED ACTION
Examiner acknowledges receipt of the reply filed 2/20/2026, in response to the non-final office action mailed 10/22/2025.
Claims 1-10 and 12-16 are pending. Claim 11 has been cancelled.
Claims 1-9, 15, and 16 remain withdrawn from further prosecution for the reasons made of record.
Claims 10 and 12-14 are being examined on the merits in this office 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 .
Specification- withdrawn
The objection to the abstract is withdrawn in view of the amendment filed 2/20/2026.
Claim Rejections - 35 USC § 112- withdrawn
The rejection of claim 11 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of the amendment filed 2/20/2026.
Claim Rejections - 35 USC § 102- withdrawn
The rejection of claims 10-12 under 35 U.S.C. 102(a)(1) as being anticipated by Beglinger et al. (Clin. Pharma. Therap. 84:468-474 (2008)- previously cited), is withdrawn in view of the amendment filed 2/20/2026.
The rejection of claims 10-14 under 35 U.S.C. 102(a)(1) as being anticipated by Sauerberg et al (U.S. 2013/0345134- previously cited), is withdrawn in view of the amendment filed 2/20/2026.
The rejection of claims 10-14 under 35 U.S.C. 102(a)(2) as being anticipated by Sauerberg et al (U.S. 20240277817- correlates with Appl. No. 18643038, ODP rejection), is withdrawn in view of the amendment filed 2/20/2026.
Double Patenting- withdrawn
The rejection of claims 10-12 on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 9278123 (hereinafter referred to as “the ‘123 patent”) is withdrawn in view of the amendment filed 2/20/2026.
The rejection of claims 10-14 on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 -19 of U.S. Patent No. 9278123 (hereinafter referred to as “the ‘123 patent”), in view of Johansson (Int’l J Pharma 21:307-315 (1984)), is withdrawn in view of the amendment filed 2/20/2026.
The rejection of claims 10-14 on the ground of non-statutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,086,047 (hereinafter “the ‘047 patent”) in view of Johansson (Int’l J Pharma 21:307-315 (1984)), is withdrawn in view of the amendment filed 2/20/2026.
The rejection of claims 10-14 on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10960052 (hereinafter referred to as “the ‘052 patent”), is withdrawn in view of the amendment filed 2/20/2026.
The rejection of claims 10-14 on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11382957 (hereinafter referred to as “the ‘957 patent”), is withdrawn in view of the amendment filed 2/20/2026.
The rejection of claims 10-14 on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18643038 (hereinafter referred to as “the ‘038 application”), is withdrawn in view of the amendment filed 2/20/2026.
Response to Arguments
Applicant's arguments and amendment filed 2/20/2026 with respect to the above rejections have been fully considered and are persuasive. The rejections have been withdrawn.
Applicant's arguments and amendment filed 2/20/2026 have been fully considered but they are not persuasive with respect to the maintained rejections.
Upon further consideration of the claims and claim scope, new objection and rejections are set forth herein.
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.
Claim Interpretation
Claims 10 and 12-14 are construed as product-by-process claims.
Claim 10 recites: A tablet obtained by the process comprising: a) spray-drying a feed solution comprising the GLP-1 peptide and a feed solution solvent, wherein the pH of the feed solution is in the range of about 5 to about 10, in order to obtain the GLP-1 peptide as a powder; and b) compressing the obtained powder of the GLP-1 peptide into a tablet; wherein the tablet comprises a salt of N-(-(2-hydroxybenzoyl)amino caprylic acid that is at least 90 percent (w/w) of the total amount of excipients in the tablet.
M.P.E.P. § 2113 reads, “Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps.”
“Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979)
The use of 35 U.S.C. §§ 102 and 103 rejections for product-by-process claims has been approved by the courts. “[T]he lack of physical description in a product-by-process claim makes determination of the patentability of the claim more difficult, since in spite of the fact that the claim may recite only process limitations, it is the patentability of the product claimed and not of the recited process steps which must be established. We are therefore of the opinion that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Once a product appearing to be substantially identical is found and an art rejection made, the burden shifts to the applicant to show an unobvious difference. In this case, given the broadest reasonable claim interpretation, claim 10 is construed as a tablet comprising a GLP-1 peptide and 90% (w/w) N-(8-(2-hydroxybenzoyl)amino) caprylic acid of the total amount of excipients in the tablet. Dependent claims 12-14 are construed as reciting further elements of the tablet comprising a GLP-1 peptide, per claim 10.
Maintained Rejections
Claim Rejections - 35 USC § 102- maintained
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Please see the above details relating to claim interpretation for product-by-process claims which applies to the following rejections.
Claims 10 and 12-14 remain/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jensen et al (U.S. 2018/0235888- previously cited). This correlates with issued U.S. Patent No. 11033499 in the ODP rejection. The rejection is maintained from the office action mailed 10/22/2025, but has been amended to reflect claims filed 2/20/2026.
Jensen et al teach a tablet comprising a GLP-1 peptide and a delivery agent, such as salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid [NAC] (abstract, paras. [0055]-[0070], claims 1-4). The GLP-1 peptide include semaglutide (e.g., claim 5, Example 1). SNAC can be 90% (w/w) of the tablet (e.g., cols. 17, 20, 24, claim 5).
Accordingly, the limitations of claim 10 is satisfied.
Regarding claim 12, Jensen et al teach the salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid is sodium [SNAC] (abstract, paras. [0055]-[0070], claims 1-4).
Regarding claims 13 and 14, the tablets further comprise a pharmaceutically acceptable excipient such as a lubricant, a binder, or filler (paras. [0026]-[0031], [0098], Example 1; claims 6, 7). Table 1 teaches tablet formulations comprising semaglutide [GLP-1 peptide], SNAC, povidone [binder], microcrystalline cellulose [filler], and magnesium stearate [lubricant].
Response to Arguments
Applicant traversed the rejection at o. 6 of the reply filed 2/20/2026. Applicant asserts the amendment of clam filed, as filed 2/20/2026 overcomes the instant rejection.
Examiner has reviewed and considered Applicants argument but is not persuaded.
As noted in the instant rejection, Jensen et al teach the limitation 90% (w/w) SNAC in the tablet. Please see the comments above relating to product-by-process claim limitations.
Claim(s) 10 and 12-14 remain/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bjerregaard et al (U.S. 20210275458- previously cited; correlates with Appl. No. 17/320436, ODP rejection). The earliest effective filing date is 6/20/2012. The rejection is maintained from the office action mailed 10/22/2025, but has been amended to reflect claims filed 2/20/2026.
The applied reference has a common applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Bjerregaard et al teach a tablet comprising a GLP-1 peptide and a delivery agent, such as salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid [SNAC] (abstract, paras. [0052]-[0070], claims 1 and 4). The tablets can comprise 90% (w/w) of a salt of NAC (e.g., paras [0072], [0110], [0155], claim 5). The GLP-1 peptide include semaglutide (e.g., claim 3, Example 1). The tablets further comprise a pharmaceutically acceptable excipient such as a lubricant, a binder, or filler (paras. [0026]-[0031], [0098], Example 1; claims 6, 7). Table 1 teaches tablet formulations comprising semaglutide [GLP-1 peptide], SNAC, povidone [binder], microcrystalline cellulose [filler], and magnesium stearate [lubricant].
Accordingly, the limitations of claims 10 and 12-14 are satisfied.
Response to Arguments
Applicant traversed the rejection at o. 6 of the reply filed 2/20/2026. Applicant asserts the amendment of clam filed, as filed 2/20/2026 overcomes the instant rejection.
Examiner has reviewed and considered Applicants argument but is not persuaded.
As noted in the instant rejection, Bjerregaard et al teach the limitation 90% (w/w) salt of NAC in the tablet. Please see the comments above relating to product-by-process claim limitations.
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.
Please see the above details relating to claim interpretation for product-by-process claims which applies to the following rejections.
Claims 10 and 12-14 remain/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11033499 (hereinafter referred to as “the ‘499 patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because for the following reasons. The rejection is maintained from the office action mailed 10/22/2025, but has been amended to reflect claims filed 2/20/2026.
Regarding claim 10, claims 1, 3, and 5 of the ‘499 patent are drawn to a tablet comprising a GLP-1 peptide (e.g., semaglutide) and 90% (w/w) of a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid (NAC).
Regarding claim 12, the tablets comprise sodium N-(8-(2-hydroxybenzoyl)amino)caprylate (SNAC) (claims 4 and 12 of the ‘499 patent).
Regarding claims 13 and 14, the tablets may further comprise a pharmaceutically acceptable excipient such as a binder, a filler, or a lubricant (claims 6, 7, and 13 of the ‘499 patent).
Response to Arguments
Applicant did not address this rejection in the reply filed 2/20/2026.
Claims 10 and 12-14 remain/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 9993430 (hereinafter referred to as “the ‘430 patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because for the following reasons. The rejection is maintained from the office action mailed 10/22/2025, but has been amended to reflect claims filed 2/20/2026.
Regarding claim 10, claim 1 of the ‘430 patent is drawn to a tablet comprising a GLP-1 agonist (e.g., semaglutide) and at least 50% (w/w) a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid (NAC). Claim 3 of the ‘430 patent recites that the tablet comprises at least 60% (w/w) salt of NAC. Col. 17, ll. 10-15; col. 20, ll. 31-33, and col., ll. 24, ll. 23-25 disclose that the salt of NAC can comprise 90% w/w of the tablet.
“[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 reference application, species of the instant claims encompassed by the claims of the reference application are disclosed in the specification of the reference application, and thus the instant claims are not patentably distinct from the claims of the reference application.
Regarding claim 12, the tablets comprise sodium N-(8-(2-hydroxybenzoyl)amino)caprylate (SNAC) (claims 4 of the ‘430 patent).
Regarding claims 13 and 14, the tablets further comprise a pharmaceutically acceptable excipient such as a binder, filler or lubricant (claims 5 and 6 of the ‘430 patent).
Response to Arguments
Applicant did not address this rejection in the reply filed 2/20/2026.
Claims 10 and 12-14 remain/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 17320436 (hereinafter referred to as “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 10/22/2025, but has been amended to reflect claims filed 2/20/2026.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claim 10, claims 1, 3, and 5 of the ‘436 application are drawn to tablet comprising GLP-1 peptide (e.g., semaglutide) and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid (NAC). The salt of NAC can be 90% (w/w) of the tablet (claim 5 of the ‘436 patent).
Regarding claim 12, the tablets further comprise sodium N-(8-(2-hydroxybenzoyl)amino)caprylate (SNAC) (claim 4 of the ‘436 application).
Regarding claims 13 and 14, the tablets further comprise a pharmaceutically acceptable excipient such as a binder, filler or lubricant (claim 7 of the ‘436 patent).
Response to Arguments
Applicant did not address this rejection in the reply filed 2/20/2026.
New Objection and Rejections
Claim Objections- New objection
Claims 10 and 12 are objected to because of the following informalities:
Claims 10 and 12 should be amended to recite: N-(8-(2-hydroxybenzoyl)amino) caprylic acid .
Appropriate correction is required.
Claim Rejections - 35 USC § 112- New
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 10 and 12-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. This is a new rejection necessitated by the amendment filed 2/20/2026.
Claim 10 recites the limitations “the GLP-1”, "the pH", “the range”, and “the total amount”. There is insufficient antecedent basis for the limitations in the claim.
Because claims 12-14 depend from indefinite claim 10 and do not clarify the point of confusion, they must also be rejected under 35 U.S.C. 112(b).
Claim Rejections - 35 USC § 102 - new
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Please see the above details relating to claim interpretation for product-by-process claims which applies to the following rejections.
Claims 10 and 12-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jensen et al (Patent No. 9993430; hereinafter referred to as “the ‘430 patent”). This is a new rejection necessitated by the amendment filed 2/20/2026.
Regarding claim 10, the ‘430 patent discloses a tablet comprising a GLP-1 agonist (e.g., semaglutide) and 90% (w/w) a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid (NAC) w/w of the tablet, e.g., Col. 17, ll. 10-15; col. 20, ll. 31-33, and col., ll. 24, ll. 23-25.
Regarding claim 12, the tablets comprise sodium N-(8-(2-hydroxybenzoyl)amino)caprylate (SNAC) (e.g., abstract, cols. 17, 20, 24, Ex 1; claim 4).
Regarding claims 13 and 14, the compositions further comprise a pharmaceutically acceptable excipient such as a binder, filler or lubricant (e.g., cols. 20-21, 24-25; claims 5-6).
Claims 10 and 12-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nielsen et al (U.S. 20160067184). This is a new rejection necessitated by the amendment filed 2/20/2026.
Regarding claim 10, Nielsen et al teach a composition contains 1-100 mg GLP-1 peptide (e.g., semaglutide), 100-500 mg or 50-90%(w/w) SNAC, microcrystalline cellulose, povidone, and magnesium stearate (para. [0101], 44-49; claims 1, 4, 6, 11-14, and 17). SNAC is 50-90%(w/w) of the total weight of the composition (para [0074]). The composition is in the form of a tablet (e.g., paras [0075], [0086]-[0089]. The GLP-1 peptide is semaglutide (e.g., paras [0010], [0101], 44-49, claim 12).
Accordingly, the limitations of claims 10 and 12-14 are satisfied.
Claim(s) 10 and 12-14 remain/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Pedersen et al (U.S. Patent No. 11833248- cited in ODP rejection). See also child U.S. Patent No. 12396953. The earliest effective filing date is 2/02/2018. This is a new rejection necessitated by the amendment filed 2/20/2026.
The applied reference has a common applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Pedersen et al teach a pharmaceutical composition comprising semaglutide [GLP-1 peptide], magnesium stearate, and sodium N-(8-(2-hydroxybenzoyl)amino)caprylate (SNAC), wherein the pharmaceutical composition comprises 2-5 mg of the magnesium stearate [lubricant] per 100 mg of the SNAC, and wherein the SNAC constitutes at least 95% of the excipients of the composition (claim 6). The delivery agent/absorption enhancer [SNAC] constitutes at least 90%, such as at least 95% w/w of the excipients of the composition (col. 2). The pharmaceutical composition can be a tablet (e.g., cols. 2, 15, Examples 1 and 4).
Accordingly, the limitations of claims 10 and 12-14 are satisfied.
Double Patenting- new
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.
Please see the above details relating to claim interpretation for product-by-process claims which applies to the following rejections.
Claims 10 and 12-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11833248 (hereinafter referred to as “the ‘248 patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because for the following reasons. This is a new rejection necessitated by the amendment filed 2/20/2026.
Regarding claim 10, claim 6 of the ’248 patent is drawn to a pharmaceutical composition comprising semaglutide [reads on GLP-1 peptide], magnesium stearate, and sodium N-(8-(2-hydroxybenzoyl)amino)caprylate (SNAC), wherein the pharmaceutical composition comprises 2-5 mg of the magnesium stearate per 100 mg of the SNAC, and wherein the SNAC constitutes at least 95% of the excipients of the composition. The specification discloses that the pharmaceutical composition can be a tablet (e.g., cols. 2, 15, Examples 1 and 4). “[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 reference application, species of the instant claims encompassed by the claims of the reference application are disclosed in the specification of the reference application, and thus the instant claims are not patentably distinct from the claims of the reference application.
Regarding claim 12, claims 1 and 6 of the ’248 patent recite sodium N-(8-(2-hydroxybenzoyl)amino)caprylate (SNAC).
Regarding claims 13 and 14, claims 1 and 6 of the ’248 patent recite magnesium stearate [lubricant].
Claims 10 and 12-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-56 of U.S. Patent No. 12396953 (hereinafter referred to as “the ‘953 patent”). This is a child of US Pat No. 11833248, the ‘248 patent. Although the claims at issue are not identical, they are not patentably distinct from each other because for the following reasons. This is a new rejection necessitated by the amendment filed 2/20/2026.
Regarding claim 10, claim 1 of the 953 patent is drawn to a pharmaceutical composition comprising semaglutide [GLP-1 peptide], sodium N-(8-(2-hydroxybenzoyl)amino)caprylic acid (SNAC), and magnesium stearate [lubricant], wherein the semaglutide is in an amount of 0.2 to 100 mg, wherein the pharmaceutical composition comprises 2-5 mg of the magnesium stearate per 100 mg of the SNAC; and wherein the SNAC constitutes at least 95% (w/w) of the excipients of the composition.
The specification discloses that the pharmaceutical composition can be a tablet (e.g., cols. 2, 15, Examples 1 and 4). “[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 reference application, species of the instant claims encompassed by the claims of the reference application are disclosed in the specification of the reference application, and thus the instant claims are not patentably distinct from the claims of the reference application.
Regarding claim 12, claims 1, 7-9, 11-13, 15-17, and 19-23 of the 953 patent recite sodium N-(8-(2-hydroxybenzoyl)amino)caprylate (SNAC).
Regarding claims 13 and 14, claims 1, 10-12, 14-16, and 18-26 of the 953 patent recite magnesium stearate [lubricant].
Claims 10 and 12-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 and 16 of copending Application No. 18577720 (hereinafter referred to as “the ‘720 application”). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons. This is a new rejection necessitated by the amendment filed 2/20/2026.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claim 10, claims 1, 3, and 5 of the ‘720 application are drawn to an
elongated oval-shaped compound cup tablet comprising sodium N-(8-(2-hydroxybenzoyl)amino)caprylate (SNAC) in a total amount of about 60 to 99.8% (w/w) and an active pharmaceutical ingredient (API) in an amount of 0.1-40 % (w/w), the tablet further comprising (a) a tablet height to width ratio of 0.9 or below; (b) a tablet height to cup depth ratio of above 4.3; (c) a minor major radius to width ratio of above 1.15; and (d) an index value of 0.67 or below. Claim 2 recites SNAC is present in a bout amount of about 75-99% weight based on the total weight of the tablet. Claim 4 recites that the API is semaglutide [reads on GLP-1 peptide]. Claim 9 of the ‘720 application recites 84-97% SNAC..
Regarding claim 12, the tablets further comprise sodium N-(8-(2-hydroxybenzoyl)amino)caprylate (SNAC) (claims 1, 2, and 9 of the ‘720 application).
Regarding claims 13 and 14, the tablets further comprise a pharmaceutically acceptable excipient such as a lubricant (claims 5-9 of the ‘720 patent).
Relevant Art Not Relied Upon
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). Beglinger et al. teach that the delivery agent SNAC is effective to transport the peptides across the intestinal epithelium (p. 472, para. 1). Beglinger et al. teach tablets comprising GLP-1 and the delivery agent sodium N-(8-(2-hydroxybenzoyl)amino)caprylate) (SNAC).
Beglinger et al. do not teach or suggest that the tablet comprises at least 90% (w/w) NAC.
Sauerberg et al (U.S. 2013/0345134- previously cited) teach solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid and their use in medicine (para. [0001]). The solid compositions encompass tablets (e.g., paras. [0043]-[0047-[0053]; claims 1-3). GLP-1 agonists include GLP-1(7-37), GLP-1(7-36)amide, exendin-4, semaglutide (e.g., paras. [0017], [0068], Ex 1, claims 8-11, Table 1). The tablets include a delivery agent such as sodium N-(8-(2-hydroxybenzoyl)amino)caprylate (SNAC) (paras. [0023]-[0032], Table 1, claims 1 and 3). The tablets further include povidone [binder], avicel PH 102 [microcrystalline cellulose; filler], and magnesium stearate [lubricant].
Sauerberg et al. do not teach or suggest that the tablet comprises at least 90% (w/w) NAC.
Conclusion
No claims are allowed.
Claims 1-10 and 12-16 are pending. Claims 1-9, 15, and 16 are withdrawn.
Claims 10 and 12-14 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/KRISTINA M HELLMAN/Examiner, Art Unit 1654
/JULIE HA/Primary Examiner, Art Unit 1654
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