DETAILED 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 .
Status of Application, Amendments, And/Or Claims
Claims 1-21 are pending and under consideration.
Priority
The instant application is a CON of US Application No. 18/208,485 filed on 1/30/2024, now abandoned, which is CON of US Application No. 17/736,116 filed on 5/4/2022 and the application is CON of PCT/EP2020/081087 filed on 11/5/2020. EP19207501.8 filed on 11/6/2019 and EP 20186623.3 filed 7/20/2020 do not disclose a method of treating Alzheimer’s Disease. Therefore, the instant application gets the priority of 11/5/2020.
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in US20180360918A1on 11/06/2019, and EP20186623.3 filed on 7/20/2020. It is noted, however, that applicant has not filed a certified copy of the US20180360918A1 and EP20186623.3 applications as required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statements (IDSs) filed on 1/30/2024, 8/12/2024, 2/27/2025 and 3/7/2025 have been considered.
Title
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The title recites “GLP-1 RECEPTOR AGONISTS IN DEMENTIA”. The following title, for example, is suggested: A method of treating Alzheimer’s Disease or like that.
Claim Rejections - 35 USC § 102
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)(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.
Claim(s) 1-3 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zimmer et al. (IDS, US Pub. No. 2019/0142905).
The instantly claimed invention is broadly drawn to a method for treating Alzheimer's disease, comprising administering semaglutide to a subject in need thereof (claim 1), wherein the subject has dementia (claim 2) wherein the semaglutide is the sole pharmaceutically active ingredient administered to the subject (claim 3).
Zimmer et al. teach a pharmaceutical composition for treating Alzheimer’s Disease (claim 4) and dementia with Lewy bodies, frontotemporal dementia (claim 4). They teach that the composition comprises a GLP-1 analog, wherein the analog is semaglutide (claim 2). Therefore, the instantly claimed invention is implicitly or explicitly anticipated by the prior art.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention 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 35 U.S.C. 103 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.
Claim(s) 1-4, 9-10, 14-15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Gejl et al. (Frontiers in Aging Neuroscience 8 (article 108): 1-10, 2016 in view of Zimmer et al (US Pub. No. 20190142905), and Jensen (US Pat. No.10,335,462) as evidenced by Batista et al. (IDS of 2/27/2025; CNS Drugs (33: 209-223, 2019).
The instantly claimed invention is broadly drawn to a method for treating Alzheimer's disease, comprising administering semaglutide 5to a subject in need thereof (claim 1), wherein the subject has mild cognitive impairment or mild dementia (claim 2)10, wherein the semaglutide is the sole pharmaceutically active ingredient administered to the subject (claim 3), wherein the semaglutide is administered subcutaneously (claim 4, 10, 15 and 19), wherein the subject has mild cognitive impairment (claim 9), the method of claim 2, wherein the subject has mild dementia (claim14).
Gejl et al teach treating Alzheimer's disease in a patient in need thereof comprising administering a GLP-1 analog, Liraglutide for six months. Liraglutide is a GLP-1 receptor agonist. (pg. 2, left col.). They teach that the composition is administered subcutaneously using a pre-filled injection pens (see Title, page 2, right column). They teach that subjects have Alzheimer’s disease with MMSE score of 18-21 (Table 1). They teach that the in AD model mouse, Liraglutide stimulates neuronal proliferation, improves learning, reduces plaque formation and Aβ synthesis (pg. 2, left col.). They teach in a human study the effect of liraglutide administration results in reduction of Aβ deposition, and improvement in cognition (Discussion). They teach that the 26 wk study of Liraglutide treatment resulted in decline of CMRglc that reflects disease progression, as observed in the placebo group. They do not teach administering semaglutide.
Zimmer et al teach treating a neurodegenerative or cognitive disease using a GLP-1 analog selected from semaglutide, liraglutide, albiglutide or dulaglutide. Therefore, these GLP-1 analogs are functionally equivalent and can be used for treating Alzheimer’s disease, wherein the subject has cognitive impairment or dementia.
Jensen teaches that semaglutide when compared with liraglutide, semaglutide lowered HbA1c better than liraglutide (see (Col. 23, lines18+) and Fig. 1). Therefore, one skilled in the art would have used semaglutide for treating Alzheimer’s disease and its associated dementia or cognitive impairments.
Batista et al. teach that long-acting GLP-1 analogs marketed for treatment of type 2 diabetes mellitus have been tested and have shown encouraging protective actions in experimental models of AD and PD as well as in initial clinical trials (abstract). They teach that Liraglutide and lixisenatide show long-term potentiation and reduction in amyloid plaque load in the cortex of APPswePS1E9mice (page 213, left col.). It is noted that Zhang et al. (IDS, Neuropeptide, 71: 70-80, 2018) teaches that semaglutide shows better result than liraglutide in neuroprotective effect in Parkinson’s disease model. Zhang et al. is applied to support the state of the art and not as a prior art. Batista et al. teach that clinical trials with dual and triple receptor agonists (GIP- GLP-1; GIP-GLP-1-glucagon) show better neuroprotective effects than a GLP-1 RA (pg. 216, left col: Dual and Triple Ras in the treatment of Neurodegenerative Diseases).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use semaglutide to replace liraglutide as taught by Jensen et al in using a GLP-1 analog as taught by Zimmer and as evidenced by Batista et al and in treating Alzheimer’s disease and its associated dementia and cognitive impairment using a subcutaneous administration as taught by Gejl et al. Additionally, one would have been motivated to do so because Jensen teaches that semaglutide reduces HbA1c better than liraglutide (Fig. 1). Further, one would have a reasonable expectation of success in treating Alzheimer’s and its associated cognitive impairment and dementia by administering semaglutide subcutaneously because Zhang et al. teach that semaglutide show better neuroprotection than liraglutide or lixisenatide . Therefore, the instantly claimed invention would have been obvious over the combined teachings of the prior art.
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Gejl et al. (Frontiers in Aging Neuroscience 8 (article 108): 1-10, 2016 in view of Zimmer et al (US Pub. No. 20190142905), Jensen (US Pat. No.10,335,462) as evidence by Batista et al.as applied to claims 1-4, 9-10, 14-15, and 19 above, and further in view of Talbot et al (IDS, US Pub. No. 20170112897).
The invention of claim 7 is further drawn to method of claim 1 comprising treating Alzheimer's disease, comprising administering semaglutide 5to a subject in need thereof, wherein the administration of semaglutide is administering for at least for 12 months.
The teachings of Gejl et al. Zimmer et al., Jensen and Batista et al. are summarized above. Neither Gejl et al., Zimmer et al., Jensen not Batista et al teaches administration of semaglutide for at least a period of 12 months.
It is noted that claim 7 is an intended use of semaglutide for future 12 months or longer and does not have a patentable weight.
Talbot et al. teach that treatment for brain insulin resistance associated diseases including Alzheimer’s disease by 5 year by incretin receptor agonist could reduce cases by 57% [0005]. They teach that brain insulin resistance associated disease is mild cognitive impairments and AD associated dementia [0007]. They teach a composition for treating mild cognitive impairment and AD associated dementia can be administered to a subject in need thereof for 1-5 months or 1-5 years.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to administer a composition for treating Alzheimer’s disease and its associated disorders (e.g., dementia or cognitive impairments) for at least 1-5 years as taught by Talbot et al., by administering semaglutide as taught by Gejl et al in view of Zimmer et al., Jensen and Batista et al. Additionally, one would have been motivated to do so because Talbot et al teach that the administration of an incretin receptor agonist for about 5 years can reduce AD and its associated cognitive impairment and dementia by about 57% [0005]. Further, one would have a reasonable expectation of success in treating Alzheimer’s and its associated cognitive impairment and dementia by administering semaglutide subcutaneously because Jensen teaches that semaglutide reduces HbA1c and body weight better than liraglutide and Gejl et al teaching Alzheimer’s disease by a GLP-1 receptor agonist. Therefore, the instantly claimed invention would have been obvious over the combined teachings of the prior art.
Claim(s) 1-3, 5-6, 8-9, 11-14, 16-18 and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Gejl et al.,(Frontiers in Aging Neuroscience 8 (article 108): 1-10, 2016) in view of Zimmer et al (US Pub. No. 20190142905), Jensen (US Pat. No.10,335,462),Batista et al. (IDS of 2/27/2025; CNS Drugs (33: 209-223, 2019) and Sauerburg et al. (US Pat. No.10,960,052, CON of US application No. 13/994,262 filed on 12/1/6/2011, now US Pat. No. 9,278,123).
The instant invention is broadly drawn to a method for treating Alzheimer's disease, comprising administering semaglutide 5to a subject in need thereof (claim 1), wherein the semaglutide is administered orally (claims 5,11,16, 20), wherein semaglutide tablet comprises a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid (claim 6, 12,17,21) and wherein the salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid is sodium salt N-(8-(2-hydroxybenzoyl)amino)caprylate (claims 8,13, 18 and 22).
The teachings of Gejl et al., Zimmer et al., Jensen and Batista et al. are summarized above. Neither Gejl et al., Zimmer et al., Jensen nor Batista et al. teach administering semaglutide orally, wherein semaglutide in a tablet formulation comprises a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid (claim 6, 12,17,21) and wherein the salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid is sodium salt N-(8-(2-hydroxybenzoyl)amino)caprylate.
Sauerburg et al. teaches a solid oral formulation comprising semaglutide and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid (abstract). They teach that the formulation is in the form of a tablet (col. 12, lines 22+). They teach that the tablet formulation is to administer orally (col.19, lines 34). They teach that semaglutide composition comprises a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid (see claim 14) and wherein the salt of a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid is sodium salt of N-(8-(2-hydroxybenzoyl)amino)caprylate (SNAC) (claim 15).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to administer a solid formulation of semaglutide and SNAC orally as taught by Sauerburg et al for treating Alzheimer’s disease and its associated dementia and cognition impairment as taught by Gejl et al. in view Zimmer et al, Jensen and Batista et al. Additionally, one would have been motivated to do so because oral administration of a medicine is preferred by patients as compared to subcutaneous or intravenous injections and patients are more in compliance with oral regimen than i.v. or subcutaneous administration. Further, one would have a reasonable expectation of success in using oral semaglutide tablets in an effective amount for a long time because Jensen teaches treating Alzheimer’s disease for a period of 1-5 years to improve the disease associated dementia and cognition impairment (as discussed above). Therefore, the instant invention would have been obvious to a skill in the art over the combined teachings of the prior art.
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.
Claims 1-4, 9-10, 14-15, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 27-29 of U.S. Patent No. 12,539,326. Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed invention comprising a method for treating Alzheimer's disease, comprising administering semaglutide 5to a subject in need thereof (claim 1), wherein the subject has mild cognitive impairment or mild dementia (claim 2)10, wherein the semaglutide is the sole pharmaceutically active ingredient administered to the subject (claim 3), wherein the semaglutide is administered subcutaneously (claim 4, 10, 15 and 19), wherein the subject has mild cognitive impairment (claim 9), the method of claim 2, wherein the subject has mild dementia are taught by claims 1-4 and 27-29 of U.S. Patent No. 12,539,326. The instantly claimed invention does not require a specific dosage, a range of pH, or buffer which is required by the claims of US Pat. No. 12,539,326.
Claim1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 27-29 of U.S. Patent No. 12,539,326 in view of Sauerburg et al. (US Pat. No.10,960,052). Claims 1-4 and 27-29 of U.S. Patent No. 12,539,326 teach a method for treating Alzheimer's disease, comprising administering semaglutide 5to a subject in need thereof, wherein the subject has mild cognitive impairment or mild dementia10, wherein the semaglutide is the sole pharmaceutically active ingredient administered subcutaneously to the subject. U.S. Patent No. 12,539,326 does not teach a method of administering orally, wherein the semaglutide tablet comprises N-(8-(2-hydroxybenzoyl)amino)caprylic acid. It is noted that claim 7 is an intended use of semaglutide for future 12 months or longer and does not have a patentable weight.
Sauerburg et al. teaches a solid oral formulation comprising semaglutide and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid (abstract). They teach that the formulation is in the form of a tablet (col. 12, lines 22+). They teach that the tablet formulation is to administer orally (col.19, lines 34). They teach that semaglutide composition comprises a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid (see claim 14) and wherein the salt of a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid is sodium salt of N-(8-(2-hydroxybenzoyl)amino)caprylate (SNAC) (claim 15). Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to administer a solid formulation of semaglutide and SNAC orally as taught by Sauerburg et al for treating Alzheimer’s disease and its associated dementia and cognition impairment as taught by U.S. Patent No. 12,539,326. Additionally, one would have been motivated to do so because oral administration of a medicine is preferred by patients as compared to subcutaneous administration and patients are in higher compliance. Further, one would have a reasonable expectation of success in using oral semaglutide tablets in an effective amount for a long time because oral tablets comprising SNAC has routinely been used to deliver other GLP-1 analogs (see US20180360918A1 (IDS)).
Conclusion
No claim is allowed.
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/GYAN CHANDRA/Primary Examiner, Art Unit 1674
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