DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn.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, and constitute the complete set presently being applied to the instant application.
Response to Arguments
Applicant's arguments filed 9/17/2025 have been fully considered but they are not persuasive.
35 U.S.C. 103
Applicants have argued that Bahr fails to meet the limitation “no more than 2 times the height of the tablet after step (d)”. However, Bahr teaches that for the experiments performed, the selected tablet tooling produced a standard convex round tablet with a cup depth of 0.79mm. In other words, the height of the tablet produced is 0.79mm. Two times the height of the final tablet is therefore 0.79mm*2 = 1.58mm. As stated previously, the tablet cylinder height during precompression was 4.16 mm and the tablet cylinder height during main compression was 1.86 mm. Assuming the tablet cylinder height during main compression represents the pre-compressed tablet height after the pre-compression step, the pre-compression step taught by Bahr does not exceed two times the height of the tablet after step (d), 1.58mm. Therefore, Bahr does indeed teach the limitation “no more than 2 times the height of the tablet after step (d).”
Double patenting
The Applicants request that the double patenting rejections be held in abeyance is noted but they are maintained herein.
Claim Status
Claims 1-12 and 14-15 are pending. Claims 1-11 and 14 have been withdrawn. Claim 13 was previously cancelled.
Priority
The instant application is a CON of 15958236, filed 4/20/2018, which is a CON of 14409021, filed 12/18/2014, which is the 371 national stage entry of PCT/EP2013/062751, filed 6/19/2013, which claims priority to the provisional application 61662456, filed 6/21/2012, and the foreign application EP12172739.0, filed 6/20/2012. The priority date of 6/20/2012 is acknowledged.
Information Disclosure Statement
The IDS submitted on 9/17/2025 is being considered.
Maintained - 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 12 and 15 are rejected under 35 U.S.C. 103(a) as being unpatentable over Sauerberg (US 2013/0345134, effectively filed 12/20/10), cited on the IDS, and Bahr (Bahr MN, “A Design of Experiments for Tablet Compression,” Pharmaceutical Technology Europe 23 (9) 72-81 (2011)).
Sauerberg discloses oral tablet formulations comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylate (SNAC) as a delivery agent (title; abstract; [0023]-[0024], [0043]-[0045]). The tablets comprise a granulate that may comprise the GLP-1 agonist and the delivery agent ([0045], [0047]). Sauerberg teaches semaglutide as the GLP-1 agonist and teaches monosodium N-8-(2-hydroxybenzoyl)amino)caprylate (SNAC) as the delivery agent ([0005], [0017], [0027], [0029], [0078], [0098]; Example 1).
Sauerberg teaches magnesium stearate as an excipient, used as a lubricant and/or glidant ([0032], [0037], [0101], [0111]). Sauerberg teaches that granules may be formed by dry granulation techniques in which the pharmaceutically active agent (i.e., the GLP-1 agonist) is compressed with the excipients to form relatively large moldings, for example slugs or ribbons, which are comminuted by grinding, and the ground (granulated) material serves as the tabletting material to be later compacted. Suitable equipment for dry granulation includes roller compaction equipment from Gerteis, such as Gerteis MINI-PACTOR ([0047]), which is the same dry granulation equipment described in the instant specification (see Pg 8, line 5). Sauerberg teaches blending the dry/dried tabletting material followed by compression of the blend into tablets ([0046], [0049]). Sauerberg teaches compression at a pressure of 4.4 kN or higher ([0129]).
Sauerberg does not teach performing a pre-compression step such that a tablet press reduces the blended granules to no more than 2 times the height of the tablet after the compression step.
Bahr discloses a series of experiments designed to evaluate the impact of five parameters on pharmaceutical tablet hardness and weight. The study used a Pharmatech MB015 intermediate bulk container (IBC) blender to prepare a blend consisting of microcrystalline cellulose as the bulk ingredient and magnesium stearate as a lubricant to improve flow behavior. Following the blending process, the powder mixture was dispensed into a hopper above a Fette 102i tablet press, which produced standard convex round tablets 7.5 mm in diameter and with a cup depth of 0.79mm. The five parameters tested include 1) turret speed, 2) feed-frame paddle speed, 3) tablet-cylinder height during pre-compression, 4) tablet-cylinder height during main compression, and 5) fill-cam height (Pg104, right column, paragraph 4 – Pg 106, left column, paragraph 3).
Bahr explains that tablet-cylinder height during pre-compression represents how low the compression roller is set to force the tablet punches through the precompression zone to tamp down the powder and compact the blend slightly before main compression occurs. Bahr teaches that the purpose of precompression is to remove entrapped air from the filled tablet-die cavity, which aids the main compression step in producing a robust tablet. For this experimental parameter, initial limits of 2-4 mm were set (Pg 106, left column, paragraph 2; Pg 108, Table 1). For tablet-cylinder heigh during main compression, initial limits of 2-3 mm were set (Pg 106, left column, paragraph 3; Pg 108, Table 1).
After several rounds of experimentation and data analysis, Bahr conducted a series of optimization experiments with the aim to target a hardness of 7kP and a weight of 190 mg (Pg 114, right column, first paragraph underneath “Optimization study and discussion of response”). Out of the 8 experiments performed, two runs met both desired hardness and weight as shown in Table VII (Pg 115). Number 7 is one such combination of parameters that produced the desired hardness and weight, wherein the tablet cylinder height during precompression was 4.16 mm and the tablet cylinder height during main compression was 1.86 mm.
Thus, regarding claims 12 and 15, it would have been prima facie obvious to one of ordinary skill in the art to incorporate the teachings of Bahr into the method taught by Sauerberg and perform a precompression step with a tablet press, wherein the tableting composition comprises a salt of NAC, such as sodium NAC, magnesium stearate, and semaglutide. One would be motivated to do so with a reasonable expectation of success in order to remove entrapped air from the filled tablet-die cavity prior to the compression step, thereby producing a more robust tablet. Consequently, one of ordinary skill in the art would have recognized that applying the known technique of Bahr would have resulted in an improvement of the method taught by Sauerberg, thus resulting in the instant invention.
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 obviousness-type 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); and 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 12 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 9,278,123 B2 (US ‘123) in view of Sauerberg (US 2013/0345134, effectively filed 12/20/10). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 1 of US ‘123 recites a solid composition for oral administration comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid, wherein the amount of said salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid is in the range of 0.8-1.3 mmol, and the GLP-1 agonist is N-epsilon26-2-(2-2-[2-(2-2-(S)-4-carboxy-4-(17-carboxyheptadecanoylamino) butyry laminol ethoxyethoxy)acetylaminol ethoxyethoxy) acetyl Aib8, Arg34 GLP-1 (7-37).
Dependent claims include wherein said composition is in the form of a tablet (claim 2); the amount of the GLP-1 agonist is in the range of 5 to 20 mg (claim 3); said salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid is selected from the group consisting of the sodium salt, potassium salt and calcium salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid (claim 4); the composition according to claim 4, wherein the amount of the GLP-1 agonist is in the range of 5 to 20 mg (claim 5); the composition according to claim 4, wherein said salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid is sodium N-(8-(2-hydroxybenzoyl)amino)caprylic acid (SNAC; claim 6); the composition according to claim 6, wherein the amount of the GLP-1 agonist is in the range of 5 to 20 mg (claim 7).
Claim 8 recites a method for the treatment of type II diabetes or obesity comprising administering a composition according to claim 1 to a patient in need thereof.
Claim 9 recites a solid composition for oral administration comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid, wherein the amount of said GLP-1 agonists is in the range of from 5 to 20 mg, and the GLP-2 agonist is N-epsilon26-2-(2-2-[2-(2-2-(S)-4-carboxy-4-(17-carboxyheptadecanoylamino) butyry laminol ethoxyethoxy)acetylaminol ethoxyethoxy) acetyl Aib8, Arg34 GLP-1 (7-37).
Dependent claims include wherein said salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid is selected from the group consisting of the sodium salt, potassium salt and calcium salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid (claim 10); the composition according to claim 10, wherein said salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid is sodium N-(8-(2-hydroxybenzoyl)amino)caprylic acid (SNAC; claim 11); the composition according to claim 11, wherein the amount of SNAC is in the range of 250 mg to 400 mg (claim 12); the composition according to claim 11, wherein the amount of SNAC is 300 mg (claim 13); the composition according to claim 9, wherein said composition is in the form of a tablet (claim 14).
Claim 15 recites a method for treatment of type II diabetes or obesity comprising administering a composition according to claim 9 to a patient in need thereof.
Claim 16 recites a solid composition for oral administration comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid, wherein the amount of said salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid is in the range of 0.6-2.1 mmol, and the GLP-1 agonist is N-epsilon26-2-(2-2-[2-(2-2-(S)- 4-carboxy-4-(17-carboxyheptadecanoylamino) butyry laminol ethoxyethoxy)acetylaminol ethoxyethoxy) acetyl Aib8, Arg34 GLP-1 (7-37), wherein the amount of the GLP-1 agonist is in the range of 5 to 20 mg.
Dependent claims include wherein said salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid is selected from the group consisting of the sodium salt, potassium salt and calcium salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid (claim 17); the composition according to claim 17, wherein said salt of the N-(8-(2-hydroxybenzoyl)amino)caprylic acid is sodium N-(8-(2-hydroxybenzoyl)amino)caprylic acid (SNAC; claim 18); the composition according to claim 18, wherein said composition is in the form of a tablet (claim 19).
US ‘123 does not teach the addition of magnesium stearate to the solid composition.
As referenced above, Sauerberg teaches magnesium stearate as an excipient, used as a lubricant and/or glidant.
In light of these teachings, it would have been obvious to add magnesium stearate to the solid composition comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid. One of ordinary skill in the art would have been motivated to do so in order to improve powder flow. One would have had a reasonable expectation of success given that magnesium stearate had been added successfully to compositions comprising semaglutide and sodium NAC by others previously, such as Sauerberg.
The remaining difference between the two claim sets is that the US '123 claims recite a tablet comprising semaglutide and SNAC in certain amounts. However, it is considered routine for an artisan to determine the appropriate amounts (e.g., as recited in the US '123 claims). Thus the entire scope of the instant claims is rendered obvious as it is considered to result in an obvious variant of the US '123 claims.
Claims 12 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 9,993,430 B2 (US ‘430). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 1 of US ‘430 recites a tablet comprising a granulate wherein said granulate comprises i) no more than 15% (w/w) semaglutide, 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 1.0g/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.
Dependent claims include wherein said granulate comprises at least 60% (w/w) salt of NAC (claim 2); a tablet comprising a granulate according to claim 2, wherein said granulate comprises at least 60% (w/w) salt of NAC (claim 3); a tablet according to claim 1, wherein said salt of NAC is monosodium NAC (SNAC; claim 4); a tablet according to claim 1, wherein said tablet comprises an intragranular and an extragranular part, wherein said extragranular part comprises a lubricant and optionally a filler (claim 5); 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); a tablet according to claim 1, wherein said tablet does not contain a disintegrant (claim 7); a tablet according to claim 1, wherein said tablet is for oral administration (claim 8); a tablet according to claim 1, wherein said tablet was prepared by exerting a compression force of at least 5kN (claim 9); a tablet according to claim 6, wherein said salt of NAC is monosodium NAC (SNAC; claim 10).
The specification of US ‘430 discloses that lubricant can include magnesium stearate (Col. 5, lines 35-36).
The difference between the two claim sets is that the US '430 claims recite a tablet comprising semaglutide and SNAC in certain amounts and the tablet having certain properties. However, it is considered routine for an artisan to determine the appropriate amounts (e.g., as recited in the US '430 claims), and the properties recited in the US '430 claims are considered to result from the process recited in the instant claims, absent evidence to the contrary. Additionally, claim 9 of the US '430 claims recites a tablet prepared using the same compression force as instantly claimed. Thus the entire scope of the instant claims is rendered obvious as it is considered to result in an obvious variant of the US '430 claims.
Claims 12 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,086,047 B2 (US ‘047) in view of Sauerberg (US 2013/0345134, effectively filed 12/20/10). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 1 of US ‘047 recites a solid pharmaceutical composition for oral administration comprising: 0.5 to 2.5 µmol is N-epsilon26-2-(2-2-[2-(2-2-(S)-4-carboxy-4-(17-carboxyheptadecanoylamino) butyry laminol ethoxyethoxy)acetylaminol ethoxyethoxy) acetyl Aib8, Arg34 GLP-1 (7-37) and 0.8-1.3 mmol of a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid, wherein the solid pharmaceutical composition has surface eroding or co-release properties, and a disintegration time of 7-15 minutes.
Dependent claims include wherein said salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid is selected from the group consisting of the sodium salt, potassium salt and calcium salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid (claim 2); the composition according to claim 2, wherein said salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid is sodium N-(8-(2-hydroxybenzoyl)amino)caprylic acid (SNAC; claim 3); the composition according to claim 3, wherein said composition is in the form of a tablet (claim 4); the composition according to claim 4, wherein said tablet has a weight between 300-5400mg (claim 5); the composition according to claim 2, wherein said salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid is selected from the group consisting of the potassium salt and calcium salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid (claim 6); the composition according to claim 2, wherein said composition is in the form of a tablet (claim 7); the composition according to claim 7, wherein said tablet has a weight between 300-500mg (claim 8); the composition according to claim 6, wherein said composition is in the form of a tablet (claim 9); and the composition according to claim 9, wherein said tablet has a weight between 300-500 mg (claim 10).
US ‘047 does not teach the addition of magnesium stearate to the solid composition.
As referenced above, Sauerberg teaches magnesium stearate as an excipient, used as a lubricant and/or glidant.
In light of these teachings, it would have been obvious to add magnesium stearate to the solid composition comprising GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid. One of ordinary skill in the art would have been motivated to do so in order to improve powder flow. One would have had a reasonable expectation of success given that magnesium stearate had been added successfully to compositions comprising semaglutide and sodium NAC by others previously, such as Sauerberg.
The remaining difference between the two claim sets is that the US '047 claims recite a tablet comprising semaglutide and SNAC in certain amounts. However, it is considered routine for an artisan to determine the appropriate amounts (e.g., as recited in the US '047 claims). Thus the entire scope of the instant claims is rendered obvious as it is considered to result in an obvious variant of the US '047 claims.
Claims 12 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,033,499 B2 (US ‘499). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 1 of US ‘499 recites a tablet 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 1.0g/cm3, b) a median pore diameter of no more than 1.5 µm, c) a feature selected from the group consisting of a maximum pore diameter of no more than 4 µm, a crushing strength of at least 50-400 N, and a disintegration time of 22 minutes for less.
Dependent claims include the tablet, wherein the GLP-1 peptide comprises a substituent comprising a fatty acid or a fatty diacid, of formula (X),
PNG
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wherein n is at least 13; and wherein said peptide optionally comprises one or more 8-amino-3,6-dioxaoctanoic acid (OEG; claim 2); the GLP-1 peptide is semaglutide (claim 3); the salt of NAC is monosodium NAC (SNAC; claim 4); the amount of salt of NAC is 50-90% (w/w) (claim 5); the tablet comprises an intragranular and an extragranular part, and wherein the extragranular part comprises a lubricant (claim 6); the granulate comprises i) 1-15% (w/w) GLP1- peptide, ii) 55-85% (w/w) salt of NAC, and iii) 1-20% (w/w) binder; wherein the tablet further comprises 10-35% (w/w) filler and 0.5-3% (w/w) lubricant (claim 7); the tablet dose not comprise a superdisintegrant (claim 8); the tablet is for oral administration (claim 9); the tablet is prepared by exerting a compression force in the range of 2-25 kN (claim 10); a method of treating type 2 diabetes or obesity comprising administering to a subject in need of such treatment a tablet according to claim 1 (claim 11); the tablet according to claim 4, wherein the SNAC is anhydrous SNAC monosodium salt (claim 12); the tablet according to claim 6, wherein the extragranular part further comprises a filler (claim 13); the tablet according to claim 1, 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 1.0g/cm3; b) a median pore diameter of no more than 1.5 µm; and c) a maximum pore diameter of no more than 4 µm (claim 14); the tablet according to claim 1, where said granulate comprises: i) no more than 15% (w/w) GLP-1 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 1.0g/cm3; b) a median pore diameter of no more than 1.5 µm; and c) a crushing strength of at least 50-400 N (claim 15); and the tablet according to claim 1, wherein said granulate comprises: i) no more than 15% (w/w) GLP-1 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 1.0g/cm3; b) a median pore diameter of no more than 1.5 µm; and c) a disintegration time of 22 minutes for less (claim 16).
The specification of US ‘499 discloses that lubricant can include magnesium stearate (Col. 5, lines 35-36).
The difference between the two claim sets is that the US '499 claims recite a tablet comprising semaglutide and SNAC in certain amounts, the tablet having certain properties. However, it is considered routine for an artisan to determine the appropriate amounts (e.g., as recited in the US '499 claims), and the properties recited in the US '499 claims are considered to result from the process recited in the instant claims, absent evidence to the contrary. Thus the entire scope of the instant claims is rendered obvious as it is considered to result in an obvious variant of the US '499 claims.
Claims 12 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,382,957 B2 (US ‘957). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 1 of US ‘957 recites a solid composition for oral administration comprising a GLP-1 agonist, a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid, and at least one excipient selected from the group consisting of a lubricant, binder, and filler; wherein the GLP-1 agonist is semaglutide; and wherein the composition comprises at least 60% (w/w/) of the salt N-(8-(2-hydroxybenzoyl)amino)caprylic acid. Dependent claims include wherein the composition is in the form of a tablet (claim 2); the salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid is sodium N-(8-(2-hydroxybenzoyl)amino)caprylic acid (SNAC; claim 3); the amount of the salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid is in the range of 0.6-2.1 mmol (claim 4); the amount of the semaglutide is in the range of 0.01 mg to 100mg (claim 5); the amount of the semaglutide is in the range of 0.01 to 25 µmol (claim 6); the lubricant is magnesium stearate (claim 7); the binder is povidone (claim 8); and the filler is microcrystalline cellulose (claim 9).
The difference between the two claim sets is that the US ‘957 claims recite a tablet comprising semaglutide and SNAC in certain amounts. However, it is considered routine for an artisan to determine the appropriate amounts (e.g., as recited in the US '957 claims). Thus the entire scope of the instant claims is rendered obvious as it is considered to result in an obvious variant of the US '957 claims.
Claims 12 and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18/643,038 (‘038, reference application; claim set filed 10/13/2025). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 1 of copending Application No. ‘038 recites a solid composition for oral administration comprising semaglutide, a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid, and a lubricant, wherein the salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid is at least 60% (w/w) of the solid composition. Dependent claims include wherein the composition is in the form of a tablet (claim 2); the salt N-(8-(2-hydroxybenzoyl)amino)caprylic acid is sodium of N-(8-(2-hydroxybenzoyl)amino)caprylic acid (SNAC; claim 3); the composition comprises at least 60% (w/w) of the salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid (claim 4); the semaglutide is in an amount in the range of 0.01 mg to 100mg (claim 5); the semaglutide is in an amount in the range of 1 to 20 mg (claim 6); the semaglutide is in an amount in the range of 5 to 15 mg (claim 7); the salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid is in an amount in the range of 0.6 to 2.1 mmol (claim 8); the semaglutide is in an amount in the range of 0.01 to 25 µmol (claim 9); the lubricant is magnesium stearate (claim 10); the salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid is sodium N-(8-(2-hydroxybenzoyl)amino)caprylic acid and the lubricant is magnesium stearate (claim 11); the composition according to claim 11, wherein the composition comprises at least 60% (w/w) of the SNAC (claim 12); the composition according to claim 12, wherein the semaglutide is in an amount in the range of 1 to 20 mg (claim 13); the composition according to claim 13, wherein the amount of the semaglutide is in the range of 5 to 15 mg (claim 14).
The difference between the two claim sets is that the copending Application No. ‘038 claims recite a tablet comprising semaglutide and SNAC in certain amounts. However, it is considered routine for an artisan to determine the appropriate amounts (e.g., as recited in the copending Application No. ‘038 claims). Thus the entire scope of the instant claims is rendered obvious as it is considered to result in an obvious variant of copending Application No. ‘038 claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sara E Konopelski Snavely whose telephone number is (571)272-1841. The examiner can normally be reached Monday - Friday 9-6pm EST.
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, Melissa L Fisher can be reached at 571-270-7430. 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.
/SARA E KONOPELSKI SNAVELY/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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