DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions. 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 14 May, 2026 has been entered.
Election/Restrictions
Applicant elected group II (method of making) with traverse in the reply filed on 25 April, 2024. The traversal was found unpersuasive, and the election/restriction requirement made final in the office action of 24 May, 2024.
Claims Status
Claims 1-10 and 12-19 are pending.
Claims 9 and 19 have been amended.
Claims 1-8 and 12-15 have been withdrawn due to an election/restriction requirement.
Withdrawn Rejections
The rejection of claims 9, 10 and 16-20 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Dhoot et al (US 20060078323) in view of Peter et al (Powder Technol. (2010) 199 p165-175) is hereby withdrawn due to amendment.
The provisional rejection of claims 9-11 and 16-20 on the ground of nonstatutory double patenting as being unpatentable over claim 15 of copending Application No. 18/578,485 in view of Kikuta et al (Drug Develop. Indust. Pharm. (1994) 20(3) p343-355), and Peter et al (Powder Technol. (2010) 199 p165-175) is hereby withdrawn due to amendment.
The provisional rejection of claims 9-11, 16, 18, and 19 on the ground of nonstatutory double patenting as being unpatentable over claims 30 and 45-49 of copending Application No. 17/424,537 (US20220072493) in view of Kikuta et al (Drug Develop. Indust. Pharm. (1994) 20(3) p343-355) is hereby withdrawn due to amendment.
The rejection of claims 9-11 and 16-20 on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 6 of U.S. Patent No. 10,335,369 in view of Hess et al (Europ. J. Pharmaceut. Sci. (2005) 25 p307-312) is hereby withdrawn due to amendment.
The rejection of claims 9-11 and 16-20 on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-9, and 12 of U.S. Patent No. 11,123,296 in view of Hess et al (Europ. J. Pharmaceut. Sci. (2005) 25 p307-312) is hereby withdrawn due to amendment.
New Rejections
Claim Rejections - 35 USC § 112(b)
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.
first rejection
Claims 9, 10 and 16-19 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.
Claim 9 and claims dependent on it is a method of making a pharmaceutical composition. However, the only pharmaceutical mentioned in the claims uses the verb “providing.” There is no limitation of mixing or anything that would include the pharmaceutical in the formulation. This mismatch makes it unclear what limitations (beyond the identity) of the pharmaceutical are required for the claims.
second rejection
Claims 9, 10 and 16-19 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.
Claim 9 and claims dependent on it requires that the pharmaceutically active ingredient consists of a specific GLP-1 inhibitor. It is not clear if the consists of language modifies the active ingredient or the GLP-1 inhibitor. In other words, it is not clear if the claim is limited to a single pharmaceutical ingredient (the GLP-1 analog), or it must contain the GLP-1 analog without any additions to the structure (such as the prodrug formulation of Lau et al (US 12,616,739)
Claim Rejections - 35 USC § 103
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.
Claims 9, 10 and 16-19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Steinert et al (Am. J. Clin. Nutr. (2010) 92 p810-817) in view of Dhoot et al (US 20060078623, previously cited), Peter et al (Powder Technol. (2010) 199 p165-175, previously cited), and Lau et al (US 20090156478) with evidentiary support from Kikuta et al (Drug Develop. Indust. Pharm. (1994) 20(3) p343-355, previously cited) and Vanarase et al (Powder Technol. (2011) 208 p26-36, previously cited).
Steinert et al discuss oral administration of GLP-1 (title). With SNAC, this drug can be administered orally with a pharmacodynamic profile consistent with other administration routes (p810, 2nd column, 1st paragraph). The effects are also similar to other administration routes (p813, 2nd column, 3d paragraph).
The difference between this reference and the examined claims is that this reference does not discuss the mixing method, nor the GLP-1 analog claimed.
Dhoot et al discuss microparticles for oral dosing of pharmaceuticals (paragraph 4), such as GLP-1 (paragraph 56). Example 7 describes 5g of SNAC mixed with 0.5g of magnesium stearate, which was then pressed into granules and coated with heparin (paragraph 275). Dhoot et al does not describe how long the material was mixed, leading to two scenarios:
The material was mixed for at least 5 min (20 min for claim 10). Under this scenario, Dhoot et al meets the claim limitations
The material was mixed for less than 5 min (20 min for claim 10). Under this scenario, Dhoot et al does not meet the claim limitations, but the claims are obvious as equivalent to the same material mixed for the required amount of time but less efficiently.
Imagine that the 5.5 grams of material of example 7 of Dhoot et al are vigorously mixed by hand in a beaker with a glass rod. This will take a relatively short amount of time to completely mix. Now imagine a similar scenario, but on a multikilogram scale, using a trough, and the same glass rod. Under this situation, it will take much longer to achieve the same level of homogeneity as the first scenario, but the product will be the same. As evidenced by Kikuta et al, the degree or rate of lubricant distribution during the mixing operation depends on, among other things, the batch of magnesium stearate, the scale, and type of mixer used (p353, 2nd paragraph), supporting the equivalence of less efficient mixing being equivalent. Thus, the product is identical to the first scenario, and meets the claim limitations as to mixing time.
Alternatively, if a flow system with a continuous powder mixer is used (such as that of Vanarase et al, abstract) for mixing lubricant with other materials (p26, 2nd column, 2nd paragraph), mixing will occur from the time the system is turned on until the system is shut down, such as for maintenance or changing the material mixed for a different product. Note that the system of Vanarase et al worked on a scale of kg/hr (table 1, p28, 1st column, bottom of page); it seems unlikely that such a system will be run for only a few min at a time. This reference discusses mixing SNAC with a lubricant for pharmaceutical formulations.
Peter et al discuss a model for describing roller compaction (title). This is the best known dry granulation method that has the advantages of being a continuous process, requiring small GMP area, with a relatively large throughput, can handle powders that flow poorly or are heat or solvent sensitive, and requires low amounts of energy, making it the most economical granulation method (p165, 1st column, 1st paragraph). Note that this is in the context of tablets (p165, 2nd column, 1st paragraph). This reference discusses the advantages of roller compaction.
Lau et al discuss acylated GLP-1 analogs (title). These analogs have longer pharmacological lifetime (paragraph 12), allowing for less frequent dosing (paragraph 9). Among the analogs discussed is the same analog of the examined claims (paragraph 123). Oral administration is contemplated (paragraph 170).
Therefore, it would be obvious to mix the materials of Steinert et al with the process of Dhoot et al, as a substitution of one element (the process of Steinert et al) for another (the process of Dhoot et al) yielding expected results (pharmaceutical formulation). As Dhoot et al explicitly mentions GLP-1 as a compound that can be formulated with their methods, an artisan in this field would attempt this process with a reasonable expectation of success.
Furthermore, it would be obvious to submit the material to roller compaction to form granules, as this is the most economical method of doing so, according to Peter et al. As this is a well known technique, an artisan in this field would attempt this process with a reasonable expectation of success.
Finally, it would be obvious to use the GLP-1 analog of Lau et al in the formulation, to allow for longer plasma lifetime and less frequent dosing, as mentioned by Lau et al. As that reference mentions oral dosing, an artisan in this field would attempt this substitution with a reasonable expectation of success.
Steinert et al mention mixing GLP-1 analogs with SNAC to allow oral dosing. Dhoot et al mix SNAC with a lubricant, with the mixing time either the same as the examined claims or equivalent. While the concentration is different than claimed, differences in concentration are not considered a patentable distinction absent secondary considerations (MPEP 2144.05(II)). Thus, the combination of references renders obvious claims 9 and 10.
Dhoot et al does not mention roller compacting, rendering obvious claim 17.
The lubricant is magnesium stearate, rendering obvious claim 18.
Peter et al discusses roller compacting, rendering obvious claims 16 and 19.
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.
first rejection
Claims 9-11 and 16-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of copending Application No. 18/578,485 in view of Kikuta et al (Drug Develop. Indust. Pharm. (1994) 20(3) p343-355), Peter et al (Powder Technol. (2010) 199 p165-175), and Lau et al (US 20090156478).
Competing claim 1 describes a method of manufacturing a solid pharmaceutical composition, comprising blending or mixing SNAC with a lubricant, optionally with an active pharmaceutical agent and other excipients, optionally followed by granulating the material.
The difference between the competing claims and the examined claims is that the competing claims does not specify the mixing time, nor does it describe the lubricant or roller compaction.
Kikuta et al discuss the effect of mixing time on the lubricating properties of magnesium stearate (title) using 0.1, 0.3, and 0.5% in their experiments (p346, 4th paragraph). The reference states that the degree or rate of lubricant distribution during the mixing operation depends on, among other things, the batch of magnesium stearate, the scale, and type of mixer used (p353, 2nd paragraph). This means that there are scenarios with inefficient mixing that will meet the time requirements of the examined claims merely to mix the material.
Peter et al discuss a model for describing roller compaction (title). This is the best known dry granulation method that has the advantages of being a continuous process, requiring small GMP area, with a relatively large throughput, can handle powders that flow poorly or are heat or solvent sensitive, and requires low amounts of energy, making it the most economical granulation method (p165, 1st column, 1st paragraph). Note that this is in the context of tablets (p165, 2nd column, 1st paragraph). This reference discusses the advantages of roller compaction.
Lau et al discuss acylated GLP-1 analogs (title). These analogs have longer pharmacological lifetime (paragraph 12), allowing for less frequent dosing (paragraph 9). Among the analogs discussed is the same analog of the examined claims (paragraph 123). Oral administration is contemplated (paragraph 170).
Therefore, it would be obvious to use a roller compaction method to granulate the material, as this is the most economical method of granulation, as described by Peter et al. As this is a well known technique, an artisan in this field would attempt this process with a reasonable expectation of success.
Furthermore, it would be obvious to use the GLP-1 analog of Lau et al, as a substitution of one known element (the unspecified pharmaceutical agent of the competing claims) with another (the pharmaceutical agent of Lau et al) yielding expected results.
This is a provisional nonstatutory double patenting rejection.
second rejection
Claims 9-11, 16, 18, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 30 and 45-49 of copending Application No. 17/424,537 (US20220072493) in view of Kikuta et al (Drug Develop. Indust. Pharm. (1994) 20(3) p343-355).
Competing claim 30 describes a method of producing ribbons or granules of hydroxybenzoyl amino caprylate using a roller compactor. Competing claim 45 specifies that the caprylate is the sodium salt (i.e. SNAC), and there is a lubricant mixed in it before compaction. Competing claims 46-49 specify a pharmaceutical agent, specifically, a GLP-1 agonist, the lubricant is magnesium stearate, and that the GLP-1 agonist is semaglutide (the same peptide as the examined claims).
The difference between the competing claims and the examined claims is that the competing claims does not specify the mixing time.
Kikuta et al discuss the effect of mixing time on the lubricating properties of magnesium stearate (title), using 0.1, 0.3, and 0.5% in their experiments (p346, 4th paragraph). The reference states that the degree or rate of lubricant distribution during the mixing operation depends on, among other things, the batch of magnesium stearate, the scale, and type of mixer used (p353, 2nd paragraph). This means that there are scenarios with inefficient mixing that will meet the time requirements of the examined claims merely to mix the material.
This is a provisional nonstatutory double patenting rejection.
third rejection
Claims 9-11 and 16-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 6 of U.S. Patent No. 10,335,369 in view of Hess et al (Europ. J. Pharmaceut. Sci. (2005) 25 p307-312) and Lau et al (US 20090156478).
Competing claim 1 is identical to examined claim 9, save that the competing claim does not specify the salt used. Competing claim 2 is almost identical with examined claim 10. Competing claim 3 specifies that the lubricant is at least 0.25% by weight, while competing claim 6 specifies that the lubricant is magnesium stearate.
The difference between the competing claims and the examined claims is that the competing claims do not specify the sodium salt of the permeation enhancer.
Hess et al look at the mechanism by which SNAC improves intestinal permeability (title). This reference uses the sodium salt of the material of the competing claims.
Lau et al discuss acylated GLP-1 analogs (title). These analogs have longer pharmacological lifetime (paragraph 12), allowing for less frequent dosing (paragraph 9). Among the analogs discussed is the same analog of the examined claims (paragraph 123). Oral administration is contemplated (paragraph 170).
Therefore, it would be obvious to use the sodium salt of the material of the competing claims, as a simple substitution of one known element (the unspecified salt of the competing claims) with another (the sodium salt of Hess et al) yielding expected results (intestinal permeation). As this material is commonly used for this purpose, an artisan in this field would attempt this substitution with a reasonable expectation of success.
Furthermore, it would be obvious to mix the finished product of the competing claims with the pharmaceutical of Lau et al, to produce a pharmaceutical formulation. As Lau et al discusses oral administration, an artisan in this field would attempt this addition with a reasonable expectation of success.
fourth rejection
Claims 9-11 and 16-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-9, and 12 of U.S. Patent No. 11,123,296 in view of Hess et al (Europ. J. Pharmaceut. Sci. (2005) 25 p307-312) and Lau et al (US 20090156478).
Competing claim 1 is identical to examined claim 9, save that the competing claim does not specify the salt used and does not list an optional roller compaction step. Competing claim 2 is almost identical with examined claim 10. Competing claim 3 specifies that the lubricant is at least 0.25% by weight, while competing claim 6 specifies that the lubricant is magnesium stearate. Competing claims 7-9 and 12 differ from competing claims 1-3 and 6 only in that a roller compaction step is required.
The difference between the competing claims and the examined claims is that the competing claims do not specify the sodium salt of the permeation enhancer.
Hess et al look at the mechanism by which SNAC improves intestinal permeability (title). This reference uses the sodium salt of the material of the competing claims.
Lau et al discuss acylated GLP-1 analogs (title). These analogs have longer pharmacological lifetime (paragraph 12), allowing for less frequent dosing (paragraph 9). Among the analogs discussed is the same analog of the examined claims (paragraph 123). Oral administration is contemplated (paragraph 170).
Therefore, it would be obvious to use the sodium salt of the material of the competing claims, as a simple substitution of one known element (the unspecified salt of the competing claims) with another (the sodium salt of Hess et al) yielding expected results (intestinal permeation). As this material is commonly used for this purpose, an artisan in this field would attempt this substitution with a reasonable expectation of success.
Furthermore, it would be obvious to mix the finished product of the competing claims with the pharmaceutical of Lau et al, to produce a pharmaceutical formulation. As Lau et al discusses oral administration, an artisan in this field would attempt this addition with a reasonable expectation of success.
fifth rejection
Claims 9-11 and 16-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 42 of copending Application No. 19/312,400 in view of Dhoot et al (US 20060078623, previously cited) and Peter et al (Powder Technol. (2010) 199 p165-175).
Competing claim 42 describes a method of weight management, comprising administering semaglutide, the same therapeutic of the examined claims.
The difference between the competing claims and the examined claims is that the competing claims do not discuss formulating the therapeutic.
Dhoot et al discuss microparticles for oral dosing of pharmaceuticals (paragraph 4), such as GLP-1 (paragraph 56). Example 7 describes 5g of SNAC mixed with 0.5g of magnesium stearate, which was then pressed into granules and coated with heparin (paragraph 275). Dhoot et al does not describe how long the material was mixed, leading to two scenarios:
The material was mixed for at least 5 min (20 min for claim 10). Under this scenario, Dhoot et al meets the mixing claim limitations
The material was mixed for less than 5 min (20 min for claim 10). Under this scenario, Dhoot et al does not meet the claim limitations, but the claims are obvious as equivalent to the same material mixed for the required amount of time but less efficiently.
Imagine that the 5.5 grams of material of example 7 of Dhoot et al are vigorously mixed by hand in a beaker with a glass rod. This will take a relatively short amount of time to completely mix. Now imagine a similar scenario, but on a multikilogram scale, using a trough, and the same glass rod. Under this situation, it will take much longer to achieve the same level of homogeneity as the first scenario, but the product will be the same. As evidenced by Kikuta et al, the degree or rate of lubricant distribution during the mixing operation depends on, among other things, the batch of magnesium stearate, the scale, and type of mixer used (p353, 2nd paragraph), supporting the equivalence of less efficient mixing being equivalent. Thus, the product is identical to the first scenario, and meets the claim limitations as to mixing time.
Alternatively, if a flow system with a continuous powder mixer is used for mixing lubricant with other materials (p26, 2nd column, 2nd paragraph), mixing will occur from the time the system is turned on until the system is shut down, such as for maintenance or changing the material mixed for a different product. This reference discusses mixing SNAC with a lubricant for pharmaceutical formulations.
Peter et al discuss a model for describing roller compaction (title). This is the best known dry granulation method that has the advantages of being a continuous process, requiring small GMP area, with a relatively large throughput, can handle powders that flow poorly or are heat or solvent sensitive, and requires low amounts of energy, making it the most economical granulation method (p165, 1st column, 1st paragraph). Note that this is in the context of tablets (p165, 2nd column, 1st paragraph). This reference discusses the advantages of roller compaction.
Therefore, it would be obvious to use the protocols of Dhoot et al, to allow for oral dosing of the semaglutide. As Dhoot et al discusses using GLP-1 analogs for this purpose, an artisan in this field would attempt this therapy with a reasonable expectation of success.
Furthermore, it would be obvious to submit the material to roller compaction to form granules, as this is the most economical method of doing so, according to Peter et al. As this is a well known technique, an artisan in this field would attempt this process with a reasonable expectation of success.
sixth rejection
Claims 9-11 and 16-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/378,410 in view of Dhoot et al (US 20060078623, previously cited) and Peter et al (Powder Technol. (2010) 199 p165-175).
Competing claim 1 describes a method comprising administering semaglutide, the same therapeutic of the examined claims.
The difference between the competing claims and the examined claims is that the competing claims do not discuss formulating the therapeutic.
Dhoot et al discuss microparticles for oral dosing of pharmaceuticals (paragraph 4), such as GLP-1 (paragraph 56). Example 7 describes 5g of SNAC mixed with 0.5g of magnesium stearate, which was then pressed into granules and coated with heparin (paragraph 275). Dhoot et al does not describe how long the material was mixed, leading to two scenarios:
The material was mixed for at least 5 min (20 min for claim 10). Under this scenario, Dhoot et al meets the mixing claim limitations
The material was mixed for less than 5 min (20 min for claim 10). Under this scenario, Dhoot et al does not meet the claim limitations, but the claims are obvious as equivalent to the same material mixed for the required amount of time but less efficiently.
Imagine that the 5.5 grams of material of example 7 of Dhoot et al are vigorously mixed by hand in a beaker with a glass rod. This will take a relatively short amount of time to completely mix. Now imagine a similar scenario, but on a multikilogram scale, using a trough, and the same glass rod. Under this situation, it will take much longer to achieve the same level of homogeneity as the first scenario, but the product will be the same. As evidenced by Kikuta et al, the degree or rate of lubricant distribution during the mixing operation depends on, among other things, the batch of magnesium stearate, the scale, and type of mixer used (p353, 2nd paragraph), supporting the equivalence of less efficient mixing being equivalent. Thus, the product is identical to the first scenario, and meets the claim limitations as to mixing time.
Alternatively, if a flow system with a continuous powder mixer is used for mixing lubricant with other materials (p26, 2nd column, 2nd paragraph), mixing will occur from the time the system is turned on until the system is shut down, such as for maintenance or changing the material mixed for a different product. This reference discusses mixing SNAC with a lubricant for pharmaceutical formulations.
Peter et al discuss a model for describing roller compaction (title). This is the best known dry granulation method that has the advantages of being a continuous process, requiring small GMP area, with a relatively large throughput, can handle powders that flow poorly or are heat or solvent sensitive, and requires low amounts of energy, making it the most economical granulation method (p165, 1st column, 1st paragraph). Note that this is in the context of tablets (p165, 2nd column, 1st paragraph). This reference discusses the advantages of roller compaction.
Therefore, it would be obvious to use the protocols of Dhoot et al, to allow for oral dosing of the semaglutide. As Dhoot et al discusses using GLP-1 analogs for this purpose, an artisan in this field would attempt this therapy with a reasonable expectation of success.
Furthermore, it would be obvious to submit the material to roller compaction to form granules, as this is the most economical method of doing so, according to Peter et al. As this is a well known technique, an artisan in this field would attempt this process with a reasonable expectation of success.
seventh rejection
Claims 9-11 and 16-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/422,732 in view of Dhoot et al (US 20060078623, previously cited) and Peter et al (Powder Technol. (2010) 199 p165-175).
Competing claim 1 describes a method comprising administering semaglutide, the same therapeutic of the examined claims.
The difference between the competing claims and the examined claims is that the competing claims do not discuss formulating the therapeutic.
Dhoot et al discuss microparticles for oral dosing of pharmaceuticals (paragraph 4), such as GLP-1 (paragraph 56). Example 7 describes 5g of SNAC mixed with 0.5g of magnesium stearate, which was then pressed into granules and coated with heparin (paragraph 275). Dhoot et al does not describe how long the material was mixed, leading to two scenarios:
The material was mixed for at least 5 min (20 min for claim 10). Under this scenario, Dhoot et al meets the mixing claim limitations
The material was mixed for less than 5 min (20 min for claim 10). Under this scenario, Dhoot et al does not meet the claim limitations, but the claims are obvious as equivalent to the same material mixed for the required amount of time but less efficiently.
Imagine that the 5.5 grams of material of example 7 of Dhoot et al are vigorously mixed by hand in a beaker with a glass rod. This will take a relatively short amount of time to completely mix. Now imagine a similar scenario, but on a multikilogram scale, using a trough, and the same glass rod. Under this situation, it will take much longer to achieve the same level of homogeneity as the first scenario, but the product will be the same. As evidenced by Kikuta et al, the degree or rate of lubricant distribution during the mixing operation depends on, among other things, the batch of magnesium stearate, the scale, and type of mixer used (p353, 2nd paragraph), supporting the equivalence of less efficient mixing being equivalent. Thus, the product is identical to the first scenario, and meets the claim limitations as to mixing time.
Alternatively, if a flow system with a continuous powder mixer is used for mixing lubricant with other materials (p26, 2nd column, 2nd paragraph), mixing will occur from the time the system is turned on until the system is shut down, such as for maintenance or changing the material mixed for a different product. This reference discusses mixing SNAC with a lubricant for pharmaceutical formulations.
Peter et al discuss a model for describing roller compaction (title). This is the best known dry granulation method that has the advantages of being a continuous process, requiring small GMP area, with a relatively large throughput, can handle powders that flow poorly or are heat or solvent sensitive, and requires low amounts of energy, making it the most economical granulation method (p165, 1st column, 1st paragraph). Note that this is in the context of tablets (p165, 2nd column, 1st paragraph). This reference discusses the advantages of roller compaction.
Therefore, it would be obvious to use the protocols of Dhoot et al, to allow for oral dosing of the semaglutide. As Dhoot et al discusses using GLP-1 analogs for this purpose, an artisan in this field would attempt this therapy with a reasonable expectation of success.
Furthermore, it would be obvious to submit the material to roller compaction to form granules, as this is the most economical method of doing so, according to Peter et al. As this is a well known technique, an artisan in this field would attempt this process with a reasonable expectation of success.
eighth rejection
Claims 9-11 and 16-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, and 7 of copending Application No. 18/577,720 (US 20240335388 in view of Dhoot et al (US 20060078623, previously cited) and Peter et al (Powder Technol. (2010) 199 p165-175).
Competing claim 1 describes a tablet comprising SNAC and a pharmaceutical ingredient. Competing claim 4 specifies that the pharmaceutical ingredient is semaglutide, the same compound as the examined claims. Competing claims 5 and 7 require a lubricant, specifically, magnesium stearate.
The difference between the competing claims and the examined claims is that the competing claims do not discuss the method of formulating the therapeutic.
Dhoot et al discuss microparticles for oral dosing of pharmaceuticals (paragraph 4), such as GLP-1 (paragraph 56). Example 7 describes 5g of SNAC mixed with 0.5g of magnesium stearate, which was then pressed into granules and coated with heparin (paragraph 275). Dhoot et al does not describe how long the material was mixed, leading to two scenarios:
The material was mixed for at least 5 min (20 min for claim 10). Under this scenario, Dhoot et al meets the mixing claim limitations
The material was mixed for less than 5 min (20 min for claim 10). Under this scenario, Dhoot et al does not meet the claim limitations, but the claims are obvious as equivalent to the same material mixed for the required amount of time but less efficiently.
Imagine that the 5.5 grams of material of example 7 of Dhoot et al are vigorously mixed by hand in a beaker with a glass rod. This will take a relatively short amount of time to completely mix. Now imagine a similar scenario, but on a multikilogram scale, using a trough, and the same glass rod. Under this situation, it will take much longer to achieve the same level of homogeneity as the first scenario, but the product will be the same. As evidenced by Kikuta et al, the degree or rate of lubricant distribution during the mixing operation depends on, among other things, the batch of magnesium stearate, the scale, and type of mixer used (p353, 2nd paragraph), supporting the equivalence of less efficient mixing being equivalent. Thus, the product is identical to the first scenario, and meets the claim limitations as to mixing time.
Alternatively, if a flow system with a continuous powder mixer is used for mixing lubricant with other materials (p26, 2nd column, 2nd paragraph), mixing will occur from the time the system is turned on until the system is shut down, such as for maintenance or changing the material mixed for a different product. This reference discusses mixing SNAC with a lubricant for pharmaceutical formulations.
Peter et al discuss a model for describing roller compaction (title). This is the best known dry granulation method that has the advantages of being a continuous process, requiring small GMP area, with a relatively large throughput, can handle powders that flow poorly or are heat or solvent sensitive, and requires low amounts of energy, making it the most economical granulation method (p165, 1st column, 1st paragraph). Note that this is in the context of tablets (p165, 2nd column, 1st paragraph). This reference discusses the advantages of roller compaction.
Therefore, it would be obvious to use the protocols of Dhoot et al, as a substitution of one known element (the methodology of Dhoot et al) for another (the methodology of the competing claims) yielding expected results (a formulation). As Dhoot et al discusses using GLP-1 analogs for this purpose, an artisan in this field would attempt this therapy with a reasonable expectation of success.
Furthermore, it would be obvious to submit the material to roller compaction to form granules, as this is the most economical method of doing so, according to Peter et al. As this is a well known technique, an artisan in this field would attempt this process with a reasonable expectation of success.
ninth rejection
Claims 9-11 and 16-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,833,248 in view of Dhoot et al (US 20060078623, previously cited) and Peter et al (Powder Technol. (2010) 199 p165-175).
Competing claim 1 describes a formulation comprising SNAC, magnesium stearate, and semaglutide, the same therapeutic of the examined claims.
The difference between the competing claims and the examined claims is that the competing claims do not discuss formulating the therapeutic.
Dhoot et al discuss microparticles for oral dosing of pharmaceuticals (paragraph 4), such as GLP-1 (paragraph 56). Example 7 describes 5g of SNAC mixed with 0.5g of magnesium stearate, which was then pressed into granules and coated with heparin (paragraph 275). Dhoot et al does not describe how long the material was mixed, leading to two scenarios:
The material was mixed for at least 5 min (20 min for claim 10). Under this scenario, Dhoot et al meets the mixing claim limitations
The material was mixed for less than 5 min (20 min for claim 10). Under this scenario, Dhoot et al does not meet the claim limitations, but the claims are obvious as equivalent to the same material mixed for the required amount of time but less efficiently.
Imagine that the 5.5 grams of material of example 7 of Dhoot et al are vigorously mixed by hand in a beaker with a glass rod. This will take a relatively short amount of time to completely mix. Now imagine a similar scenario, but on a multikilogram scale, using a trough, and the same glass rod. Under this situation, it will take much longer to achieve the same level of homogeneity as the first scenario, but the product will be the same. As evidenced by Kikuta et al, the degree or rate of lubricant distribution during the mixing operation depends on, among other things, the batch of magnesium stearate, the scale, and type of mixer used (p353, 2nd paragraph), supporting the equivalence of less efficient mixing being equivalent. Thus, the product is identical to the first scenario, and meets the claim limitations as to mixing time.
Alternatively, if a flow system with a continuous powder mixer is used for mixing lubricant with other materials (p26, 2nd column, 2nd paragraph), mixing will occur from the time the system is turned on until the system is shut down, such as for maintenance or changing the material mixed for a different product. This reference discusses mixing SNAC with a lubricant for pharmaceutical formulations.
Peter et al discuss a model for describing roller compaction (title). This is the best known dry granulation method that has the advantages of being a continuous process, requiring small GMP area, with a relatively large throughput, can handle powders that flow poorly or are heat or solvent sensitive, and requires low amounts of energy, making it the most economical granulation method (p165, 1st column, 1st paragraph). Note that this is in the context of tablets (p165, 2nd column, 1st paragraph). This reference discusses the advantages of roller compaction.
Therefore, it would be obvious to use the protocols of Dhoot et al, as a substitution of one known element (the methodology of Dhoot et al) for another (the methodology of the competing claims) yielding expected results (a formulation). As Dhoot et al discusses using GLP-1 analogs for this purpose, an artisan in this field would attempt this therapy with a reasonable expectation of success.
Furthermore, it would be obvious to submit the material to roller compaction to form granules, as this is the most economical method of doing so, according to Peter et al. As this is a well known technique, an artisan in this field would attempt this process with a reasonable expectation of success.
tenth rejection
Claims 9-11 and 16-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,396,953 in view of Dhoot et al (US 20060078623, previously cited) and Peter et al (Powder Technol. (2010) 199 p165-175).
Competing claim 1 describes a formulation comprising SNAC, magnesium stearate, and semaglutide, the same therapeutic of the examined claims.
The difference between the competing claims and the examined claims is that the competing claims do not discuss formulating the therapeutic.
Dhoot et al discuss microparticles for oral dosing of pharmaceuticals (paragraph 4), such as GLP-1 (paragraph 56). Example 7 describes 5g of SNAC mixed with 0.5g of magnesium stearate, which was then pressed into granules and coated with heparin (paragraph 275). Dhoot et al does not describe how long the material was mixed, leading to two scenarios:
The material was mixed for at least 5 min (20 min for claim 10). Under this scenario, Dhoot et al meets the mixing claim limitations
The material was mixed for less than 5 min (20 min for claim 10). Under this scenario, Dhoot et al does not meet the claim limitations, but the claims are obvious as equivalent to the same material mixed for the required amount of time but less efficiently.
Imagine that the 5.5 grams of material of example 7 of Dhoot et al are vigorously mixed by hand in a beaker with a glass rod. This will take a relatively short amount of time to completely mix. Now imagine a similar scenario, but on a multikilogram scale, using a trough, and the same glass rod. Under this situation, it will take much longer to achieve the same level of homogeneity as the first scenario, but the product will be the same. As evidenced by Kikuta et al, the degree or rate of lubricant distribution during the mixing operation depends on, among other things, the batch of magnesium stearate, the scale, and type of mixer used (p353, 2nd paragraph), supporting the equivalence of less efficient mixing being equivalent. Thus, the product is identical to the first scenario, and meets the claim limitations as to mixing time.
Alternatively, if a flow system with a continuous powder mixer is used for mixing lubricant with other materials (p26, 2nd column, 2nd paragraph), mixing will occur from the time the system is turned on until the system is shut down, such as for maintenance or changing the material mixed for a different product. This reference discusses mixing SNAC with a lubricant for pharmaceutical formulations.
Peter et al discuss a model for describing roller compaction (title). This is the best known dry granulation method that has the advantages of being a continuous process, requiring small GMP area, with a relatively large throughput, can handle powders that flow poorly or are heat or solvent sensitive, and requires low amounts of energy, making it the most economical granulation method (p165, 1st column, 1st paragraph). Note that this is in the context of tablets (p165, 2nd column, 1st paragraph). This reference discusses the advantages of roller compaction.
Therefore, it would be obvious to use the protocols of Dhoot et al, as a substitution of one known element (the methodology of Dhoot et al) for another (the methodology of the competing claims) yielding expected results (a formulation). As Dhoot et al discusses using GLP-1 analogs for this purpose, an artisan in this field would attempt this therapy with a reasonable expectation of success.
Furthermore, it would be obvious to submit the material to roller compaction to form granules, as this is the most economical method of doing so, according to Peter et al. As this is a well known technique, an artisan in this field would attempt this process with a reasonable expectation of success.
Examiner’s Note
There are dozens of applications and patents describing the therapeutic of the examined claims, almost all of which are the basis of a valid double patenting rejection, such as the previous half dozen rejections. However, as these will follow the rejection under 35 USC 103, above, fairly closely, they will be overcome the same way as that rejection, and so are not described here.
Conclusion
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658
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