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 .
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-8, drawn to a method for treating diabetes in a subject by administering to the subject a composition comprising a GLP-1 RA and a ACAT inhibitor where the composition reduces plasma glucose levels in the subject during the treatment period to a greater extent compared to GLP-1 RA monotherapy, classified in A61P 3/10.
II. Claims 9-15, drawn to a pharmaceutical composition comprising a GLP-1 RA and a ACAT inhibitor where the composition reduces plasma glucose levels in the subject during the treatment period to a greater extent compared to GLP-1 RA monotherapy, classified in A61K 38/22.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the process for using the product as claimed can be practiced with another materially different product; for example, insulin. Therefore, Inventions I and II are independent and distinct.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
(a) the inventions have acquired a separate status in the art in view of their different classification;
(b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter;
(c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries).
There would be a serious search and/or examination burden because the inventions have acquired a separate status in the art in view of their different classification.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claims 1-15 are generic to the following disclosed patentably distinct species:
Species A: a single and specific composition including:
A single and specific GLP-1 RA (please see claims 1-2, 6, 9-10, and 14);
A single and specific ACAT inhibitor (please see claims 1, 3, 6, 9, 11, and 14); AND
Whether the GLP-1 RA and ACAT inhibitor are formed in the same formulation or formulated separately (please see claims 1, 4-5, 9, 12-13).
The species are independent or distinct because as disclosed the different species have mutually exclusive characteristics for each identified species. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
(a) the species or groupings of patentably indistinct species have acquired a separate status in the art in view of their different classification;
(b) the species or groupings of patentably indistinct species have acquired a separate status in the art due to their recognized divergent subject matter;
(c) the species or groupings require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries); and/or
(d) the species may raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
There is a serious search and/or examination burden because the species may raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species or a grouping of patentably indistinct species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the species to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with Jhongwoo Peck (representative for Applicants) on April 1, 2026, a provisional election was made without traverse to prosecute the invention of Group I, claims 1-8, and election of a composition comprising semaglutide as the GLP-1 RA and avasimibe as the ACAT inhibitor where the two agents are formulated separately for Species A. Affirmation of this election must be made by applicant in replying to this Office action. Claims 9-15 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Please note that in light of the Examiner’s search, whether the GLP-1 RA and ACAT inhibitor are formulated in the same formulation or formulated separately as a component of Species A is hereby removed.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Status of Claims
Claims 1-10 were originally filed on November 3, 2023.
The amendment received on November 18, 2024, amended claims 1, 7-10; and added new claims 11-15. The amendment received on November 28, 2024, amended claims 1 and 9. The amendment received on April 24, 2026, amended claims 2 and 8.
Claims 1-15 are currently pending and claims 1-8 are under consideration as claims 9-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse telephonically on April 1, 2026.
Priority
The present application claims the benefit under 35 U.S.C. 119(e) to U.S. Provisional Application No. 63/382,287 filed November 3, 2022. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Claim Interpretation
For purposes of applying prior art, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation set forth below, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 2111.01(IV), describing how Applicant may act as their own lexicographer).
For claim 1, with respect to the scope of “diabetes”, it is noted that the instant specification does not define what is encompassed by “diabetes”. As such, any form of species of diabetes is encompassed in claim 1 to be treated. There are many different types of diabetes including type 1 diabetes (T1D), type 2 diabetes (T2D), gestational diabetes, maturity onset diabetes of the young (MODY), neonatal diabetes, wolfram syndrome, latent autoimmune diabetes in adults (LADA), type 3c diabetes, steroid-induced diabetes, and cystic fibrosis diabetes (See, “Types of Diabetes”, available online at www.diabetes.org.uk/about-diabetes/types-of-diabetes, 3 pages (accessed on 4/4/26) at pg. 1, 2nd paragraph). Thus, the scope of claim 1 encompasses treating any of these types of diabetes. It is noted that a combination of a GLP-1 RA and an ACAT inhibitor are not currently known to treat all types of diabetes, but rather only T2D (See Dejgaard et al., Medical Research Archives 12:1-11 (2024) at abstract: teaching that GLP-1 RAs are established for the treatment of T2D but are not currently recommended for the treatment of people with T1D). However, since the scope of claim 1 requires that the composition reduces plasma glucose levels in a subject during the treatment period to a greater extent compared to GLP-1 RA monotherapy, and the composition has demonstrated reduction of plasma glucose levels (See instant, Figures 2F-G), the treatment of diabetes is limited to where the treatment results in a reduction of plasma glucose levels. Therefore, even though the claimed combination does not treat T1D by curing the diseased state, the scope of treatment is limited to a reduction of plasma glucose levels in a subject during the treatment period to a greater extent compared to GLP-1 RA monotherapy. Thus, the scope of claim 1 is enabled.
With respect to “treating”, it is noted that the instant specification defines “treating” as referring to methods of alleviating, abating or ameliorating a disease or condition symptoms, preventing additional symptoms, ameliorating or preventing the underlying metabolic causes of symptoms, inhibiting the disease or condition, arresting the development of the disease or condition, relieving the disease or condition, causing regression of the disease or condition, relieving a condition caused by the disease or condition, or stopping the symptoms of the disease or condition either prophylactically and/or therapeutically (See instant, pg. 7, 2nd paragraph). As such, the scope of the claimed method of treatment of diabetes encompasses prophylactically stopping symptoms of diabetes, preventing diabetes from occurring (i.e., preventing the underlying metabolic causes of symptoms), or ameliorating/relieving diabetes and diabetic symptoms. Since the instant specification does not define what is meant by “prevention”, the plain and ordinary meaning of the term applies. Merriam-Webster defines “prevent” as to keep from happening or existing (See Merriam-Webster, “Prevent”, Merriam-Webster, www.merriam-webster.com/dictionary/prevent, 9 pages (accessed on 7/15/25) at pg. 1). However, since claim 1 also requires that the composition reduces plasma glucose levels in the subject during the treatment period to a greater extent compared to GLP-1 RA monotherapy, the scope of claim 1 excludes 100% prevention because a treatment period would correspond to where the subject has elevated plasma glucose levels that need to be reduced. Thus, it is no longer possible to prevent any type of diabetes. Therefore, the Examiner is interpreting the scope of claim 1 as excluding 100% prevention of any type of diabetes.
With respect to a GLP-1 RA, it is noted that the instant specification defines a GLP-1 RA as a glucagon-like peptide 1 receptor agonist (See instant, pg. 6, 3rd paragraph). As such, the scope of claim 1 encompasses any compound, peptide, protein, nucleic acid, etc. that agonize the GLP-1 receptor. The instant specification teaches several species of GLP-1 RAs such as semaglutide, exenatide, liraglutide (See instant claim 2). Moreover, Jensen et al. teaches a large number of GLP-1 peptides defined as referring to a compound, which fully or partially activates the human GLP-1 receptor (See Jensen et al. US Patent No. 9,993,430 B2 at col. 10, 2nd paragraph). Jensen et al. cites several WIPO publications teachings GLP-1 peptides and analogues and also teaches a large list of GLP-1 peptides by listing the chemical names including GLP-1(7-37) (See Jensen, col. 10, 3rd paragraph to col. 16, 2nd paragraph). Moreover, Latif et al. a list of current GLP-1 RAs that are FDA approved for glycemic control such as dulaglutide, exenatide, liraglutide, lixisenatide, semaglutide, and tirzepatide (See Latif et al., “Compare and Contrast the Glucagon-Life Peptide-1 Receptor Agonists (GLP1RAs),” NCBI Bookshelf. StatPearls, 14 pages (last updated 2024) at pg. 2). As such, an ordinary skilled artisan would have put one in possession of the genus of GLP-1 RAs given the representative number species taught in the instant specification and in the art. Thus, an ordinary skilled artisan would conclude that the applicant was in possession of the claimed genus before the effective filing date of the instant application.
With respect to an ACAT inhibitor, it is noted that the instant specification defines an ACAT inhibitor as a small or large molecule that can inhibit ACAT activity (See instant, pg. 6, last paragraph). As such, the scope of claim 1 encompasses any compound, peptide, protein, nucleic acid, etc. that inhibit ACAT. The instant specification teaches several species of ACAT inhibitors including avasimibe, K-604, CI-976, and methanol extracts of Saururus chinensis root containing soucerneol B and manassantin B (See instant, claim 3). Kim et al. teaches active agents that can inhibit ACAT, either ACAT1, ACAT2, or both (See Kim et al., WO2018/093966 A1 at [0011]-[0012]). Kim et al. teaches a large number of ACAT inhibitors including small molecules such as avasimibe, CI-976, pactimibe, SKF-99085, NTE-122, etc.; an antibody such as a monoclonal antibody; and an inhibitory nucleic acid (See Kim, [0013], [00108]-[00120]). Moreover, Chang et al. teaches specific anti-ACAT1 antibodies including a monoclonal antibody and polyclonal antibodies in determining that ACAT1 plays a major catalytic role in the adult human liver, adrenal glands, macrophages, and kidneys (See Chang et al., J. Biol. Chem. 275:28083-28092 (2000) at abstract; pg. 28085, col. 2, 2nd-3rd paragraphs). As such, an ordinary skilled artisan would have put one in possession of the genus of ACAT inhibitors given the representative number species taught in the instant specification and in the art. Thus, an ordinary skilled artisan would conclude that the applicant was in possession of the claimed genus before the effective filing date of the instant application.
Response to Arguments
Applicant’s arguments, see Response, filed 4/24/26, with respect to the 112(b) rejection have been fully considered and are persuasive. The rejection of claim 2 as reciting a trademark/trade name has been withdrawn.
Applicant’s arguments, see Response, filed 4/24/26, with respect to the obviousness-type double patenting rejection have been fully considered and are persuasive. The rejection of claims 1-8 as being unpatentable over claims 1-12 of copending Application No. 19/346,447 (Kim et al. US 2026/0091010 A1) in view of Kim WO 2018/093966 A1 published on May 24, 2018 has been withdrawn. Please note that the rejection has been withdrawn in light of Applicant’s argument, i.e., the ‘447 claimed invention is directed to suppressing post-treatment rebound effects whereas the instant invention is directed to therapeutic efficacy during the treatment period.
Maintained/Modified Rejections Necessitated by Amendments
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 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 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
103 - KSR Examples of 'Rationales' Supporting a Conclusion of Obviousness(Consistent with the "Functional Approach" of Graham)
Further regarding 35 USC 103(a) rejections, the Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) (KSR) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
Also, a reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976).
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Kim WO 2018/093966 A1 published on May 24, 2018 (cited in the Action mailed on 4/22/26), in view of Milluzzo et al., Explor. Med. 3:173-180 (April 2022) (cited in the Action mailed on 4/22/26). Please note that the rejection has been updated in light of Applicants’ arguments; namely, amendments to claim 8.
For claims 1-6 and 8, with respect to a method for treating diabetes and reducing body weight in a subject in need thereof by administering to the subject a composition comprising a GLP-1 RA such as semaglutide and an ACAT inhibitor such as avasimibe as recited in instant claims 1-3, 6 and 8; and with respect to where the GLP-1 RA and ACAT inhibitor are formed in the same formulation or are formulated separately but administered at the same time or sequentially as recited in instant claims 4-5:
‘966 teaches methods of treating a subject for obesity or T2D using a combination therapy comprising an ACAT inhibitor and at least one additional active agent in a regimen for the treatment of the metabolic disease (e.g., overweight, obesity, diabetes, T2D or related diseases) (See ‘966, [0085], [00143]). ‘966 defines “a combination therapy” as the administration of a therapeutically effective amount of an ACAT inhibitor with at least one additional active agent, as part of a specific treatment regimen intended to provide a beneficial effects from the co-action of the active agents in the regimen (See ‘966, [00143]). The at least one additional active agent can be a therapeutic agent (See ‘966, [00144]). Thus, the teachings of ‘966 suggest a method for treating diabetes or reducing body weight in a subject in need thereof by administering a combination therapy of a therapeutically effective amount of an ACAT inhibitor and an additional therapeutic agent as recited in instant claims 1 and 8.
Regarding the ACAT inhibitor being avasimibe, ‘966 defines an ACAT inhibitor as an agent that inhibits ACAT enzymatic activity and/or expression (See ‘966, [00102]). ACAT inhibitors can be an antibody or fragment thereof, peptides, polypeptides or fragments thereof, small molecules, and an inhibitory nucleic acid (See ‘966, [00102]). An example of a small molecule ACAT inhibitor is avasimibe (See ‘966, [0085], [00108]). Avasimibe is a non-selective small molecule inhibitor or both ACAT1 and ACAT2 (See ‘966, [00109]). ACAT inhibitors provide a therapeutic benefit of decreasing, suppressing, reducing or ameliorating one or more signs or symptoms of obesity and/or T2D including weight of adipose tissue and/or liver, blood glucose, insulin, and whole body weight in the subjects as compared to subjects not receiving treatment with the ACAT inhibitor (See ‘966, [0085], [00111]). Therefore, the teachings of ‘966 satisfy the claim limitation with respect to where the ACAT inhibitor is avasimibe as recited in instant claims 3 and 6.
Regarding the additional therapeutic agent being a GLP-1 RA such as semaglutide, as discussed supra, ‘966 teaches methods of treating a subject for obesity or T2D using a combination therapy comprising an ACAT inhibitor and at least one additional active agent in a regimen for the treatment of the metabolic disease (e.g., overweight, obesity, diabetes, T2D or related diseases) (See ‘966, [0085], [00143]). Moreover, ‘966 teaches that the ACAT inhibitor can be coadministered with an anti-obesity agent (See ‘966, [0055], [0082]) as discussed below. However, ‘966 does not expressly teach that the additional active agent or anti-obesity agent is semaglutide.
Milluzzo et al. teaches that semaglutide is a GLP-1 RA molecule approved for the treatment of both T2D and obesity (See Milluzzo, abstract). Semaglutide has a greater impact on HbA1c reduction compared to other GLP-1 RAs and is the first molecule of this class available in oral formulation for T2D therapy representing a useful option for subjects and physicians less prone to start an injective drug (See Milluzzo, abstract). Semaglutide, similarly to other GLP-1 RAs, offers beneficial effects on cardiovascular, renal, and liver protection, making this molecule an advantageous choice in the therapeutic management of “diabesity” (coexistence of both diabetes and obesity) and its co-morbidity (See Milluzzo, abstract). As such, the teachings of Milluzzo et al. demonstrate that semaglutide is a superior GLP-1 RA for the treatment of both diabetes and obesity. Thus, when combined with the ‘966 teachings, the teachings of Milluzzo et al. suggest substituting semaglutide as the additional active agent or anti-obesity agent to be co-administered with an ACAT inhibitor such as avasimibe.
Regarding the combination therapy being a composition, and where the GLP-1 RA and ACAT inhibitor are formed in the same formulation or are formulated separately but administered at the same time or sequentially, it is noted that the instant specification defines a “composition” as encompassing a product comprising the compound, salt, diastereomer, enantiomer, racemate, hydrate, solvate, or a pharmaceutical combination thereof in a therapeutically effective amount, as well as any other product which results, directly or indirectly, from claimed compound, salt, diastereomer, enantiomer, racemate, hydrate, solvate, or a pharmaceutical combination (See instant pg. 12, 1st paragraph). As such, the instant composition constitutes where the GLP-1 RA and ACAT inhibitor are part of a pharmaceutical combination. The instant specification also defines a “pharmaceutical combination” as a product that results from the mixing or combining of more than one therapeutically active ingredients (See instant, pg. 12, 3rd paragraph).
‘966 teaches that combinations of agents or composition can be administered either concomitantly (e.g., as a mixture) thereby constituting the agents being formulated together in the same formulation, separately but simultaneously (e.g., via separate intravenous lines) or sequentially (e.g., one agent is administered first followed by administration of the second agent) (See ‘966, [0055], [00149]). The combined administrations contemplates co-administration, using separate formulations or a single pharmaceutical formulation, and consecutive administration in either order, wherein preferably there is a time period while both (or all) active agents simultaneously exert their biological activities (See ‘966, [0055], [00150]). Thus, the teachings of ‘966 satisfy the claim limitations of a composition that is a pharmaceutical combination where the ACAT inhibitor is either formulated in the same composition as the GLP-1 RA or where the two agents are formulated separately but administered at the same time or sequentially as recited in instant claims 1 and 4-5.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the teachings of ‘966 and co-administer a therapeutically effective amount of a composition comprising avasimibe as an ACAT inhibitor and semaglutide as an additional active agent or anti-obesity agent to a subject in order to treat diabetes and reduce the subject’s body weight. One of ordinary skill in the art at the time the invention was made would have been motivated to do so because semaglutide was known to be a superior GLP-1 RA for the treatment of both diabetes and obesity as taught by Milluzzo et al. One of ordinary skill in the art at the time the invention was made would have had a reasonable expectation of success given that the combination therapy of ‘966 comprised co-administering a therapeutically effective amount of avasimibe as an ACAT inhibitor and an additional active agent useful for the treatment of a metabolic disease such as overweight, obesity, diabetes, T2D or related diseases or an anti-obesity agent to a subject in need thereof. Therefore, substituting semaglutide as the additional active agent or anti-obesity agent would support the treatment of T2D and reduce the subject’s body weight by constituting the simple substitution of one known element for another to obtain predictable results and/or some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention pursuant to KSR.
For claims 1 and 8, with respect to where the composition reduces plasma glucose levels in the subject during the treatment period to a greater extent compared to GLP-1 RA monotherapy as recited in instant claim 1; and with respect to where the composition further reduces body weight of the subject during the treatment period to a greater extent compared to GLP-1 RA monotherapy as recited in instant claim 8:
‘966 teaches that avasimibe suppressed blood glucose levels and food intake in a high-fat diet-induced obesity mouse model as depicted in Figure 21A (See ‘966, [0042]-[0043]; Figures 20A and 21A). Milluzzo et al. teaches that GLP-1 RAs are first-line drugs in the current multifactorial approach to T2D focused on both the improvement of glucose control and the mitigation of the dysmetabolic-related burden of target organs (See Milluzzo, pg. 173, last paragraph; pg. 176, 1st paragraph). Milluzzo et al. also teaches that GLP-1 RAs favor weight loss inducing satiety through central mechanisms (See Milluzzo, pg. 173, last paragraph; pg. 176, 1st paragraph). Thus, both avasimibe and semaglutide individually reduce plasma glucose levels and reduce body weight.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the teachings of ‘966 and Milluzzo et al. and administer to a subject avasimibe as an ACAT inhibitor in combination with semaglutide as a GLP-1 RA in order to reduce plasma glucose levels and reduce body weight in a subject with a reasonable expectation that such co-administration would result in the reduction of plasma glucose levels and body weight to a greater extent than semaglutide monotherapy. One of ordinary skill in the art at the time the invention was made would have been motivated to do so because administering avasimibe as an ACAT inhibitor alone or in combination with an additional therapeutic agent to a subject was known to reduce plasma glucose levels thereby treating T2D and reduce body weight as taught by ’966; and because administering semaglutide as a GLP-1 RA to a subject was known to reduce plasma glucose levels thereby treating T2D and reduce body weight as taught by Milluzzo et al. One of ordinary skill in the art at the time the invention was made would have had a reasonable expectation of success given that the ACAT inhibitor of ‘966 and the GLP-1 RA of Milluzzo et al. reduced plasma glucose levels in a subject suffering from T2D and reduce body weight in a subject in need thereof. Therefore, "it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose… [T]he idea of combining them flows logically from their having been individually taught in the prior art." (MPEP 2144.06). In re Susi, 58 CCPA 1074, 1079-80, 440 F.2d 442, 445, 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21, 279 F.2d 274, 276-77, 126 USPQ 186, 188 (1960). As the court explained in Crockett, the idea of combining them flows logically from their having been individually taught in prior art. Therefore, since each of the references teach agents that are effective in reducing plasma glucose levels and reduce body weight, it would have been obvious to combine the two agents with the expectation that such a combination would be effective in reducing plasma glucose levels and reduce body weight to a greater extent than semaglutide monotherapy. Thus, combining them flows logically from their having been individually taught in prior art.
For claim 7, with respect to where the method further comprises administering an additional composition that comprises an additional therapeutic agent:
As discussed supra for claim 1, ‘966 teaches a method of treating diabetes or reducing body weight in a subject by administering a combination therapy of an ACAT inhibitor with at least additional active agent where the additional active agent can be a therapeutic agent (See ‘966, [00143]-[00144]). ‘966 teaches that the additional therapeutic agent can be anti-inflammatory agents such as a corticosteroid drug, e.g., prednisolone acetate (See ‘966, [00145]). Alternatively, ‘966 defines “coadminister” as meaning that a composition described herein in administered at the same time, just prior to, or just after the administration of one or more additional therapies such as anti-obesity agent, e.g., leptin (See ‘966, [0055], [0082]). Given that ‘966 teaches that the ACAT inhibitor can be co-administered with at least one additional active agent, it would then follow that the methods taught by ‘966 satisfy the claim limitation with respect to where an ACAT inhibitor is coadministered with a GLP-1 RA and another anti-obesity agent and/or anti-inflammatory agent. Thus, the teachings of ‘966 satisfy the claim limitation as recited in instant claim 7.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 4/24/26 for claims 1-8 have been fully considered but they are not persuasive for the following reasons.
In response to Applicants’ first and second arguments, i.e., (1) the cited references fail to teach or suggest a key claim limitation – reducing plasma glucose levels to a greater extent than GLP-1 RA monotherapy, and (2) the claimed invention requires a superior effect beyond routine combination (See Applicant’s Response received on 4/24/26, pg. 7), they are found unpersuasive. Pursuant to MPEP 2144.06, it states that, "[it] is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious).
In the instant case, as discussed in the rejection supra, given that avasimibe as a ACAT inhibitor is administered to reduce body weight and to treat diabetes by reducing plasma glucose levels, and semaglutide is administered to reduce body weight and to treat diabetes by reducing plasma glucose levels thereby constituting compositions each of which is taught by the prior art to be useful for the same purpose, one of ordinary skill in the art would be motivated with a reasonable expectation of success to form a third composition to be used for the very same purpose. Plus, an intended function of the composition, i.e., reduces blood glucose levels and body weight to a greater extent compared to GLP-1 RA monotherapy, that necessarily occurs as a result of such administration would also be expected. The fact that the claimed invention is directed to a method of use instead of a product, and the fact that neither reference expressly teaches that a combination of both agents would reduce plasma glucose levels and body weight does not preclude the Kerkhoven rationale from rendering the claimed method obvious. Therefore, the Examiner has established a prima facie case of obviousness, and Applicants have not provided evidence rebutting that such a combination would have a negative effect on each ingredient. Thus, contrary to Applicant’s argument, an ordinary skilled artisan would be motivated with a reasonable expectation of success to administer a combination of avasimibe and semaglutide because both agents are known to be used for the same purpose thereby resulting in the same claimed effect without evidence commensurate in scope with unexpected results.
Moreover, pursuant to MPEP 2111.04(I), [c]laim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) "adapted to" or "adapted for" clauses;
(B) "wherein" clauses; and
(C) "whereby" clauses.
The court has found that the determination of whether clauses such as “wherein” and “whereby" is a limitation in a claim is dependent on the specific facts of the case. If the “wherein" or “whereby” clause limits a process claim where the clause gives meaning and purpose to the manipulative steps, it should be given patentable weight. Griffin v. Bertina, 285 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002). However, the court also found (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” (emphasis added). In the instant case, the composition comprising a combination of avasimibe and semaglutide reducing plasma glucose levels and body weight to a greater extent compared to semaglutide alone would necessarily occur by the administration of the composition since each agent is known to individually reduce plasma glucose levels and body weight. In other words, such claimed effects are dependent upon the claimed manipulative step of administering the composition to a subject in need of treatment of diabetes. Since the cited references render obvious the claimed manipulative step as discussed supra, the intended result recited in the claimed wherein clauses would also be rendered obvious without evidence to the contrary. Therefore, contrary to Applicants’ arguments, it is unnecessary for the cited references to expressly demonstrate the claimed composition exhibits the claimed intended effects because the claimed intended effects are nothing more than inherent effects of the claimed manipulative step.
In response to Applicants’ third, fourth, and fifth arguments, i.e., (3) the experimental data demonstrate a synergistic, not additive, effect (See Applicant’s Response received on 4/24/26, pg. 7-9), (4) the synergistic effect overcomes the expected efficacy ceiling, and (5) the prior art provides no reasonable expectation of such a synergistic outcome (See Applicant’s Response received on 4/24/26, pg. 9), they are found unpersuasive. Pursuant to MPEP 716.02(a), “[a] greater than expected result is an evidentiary factor pertinent to the legal conclusion of obviousness ... of the claims at issue." In re Corkill, 711 F.2d 1496, 226 USPQ 1005 (Fed. Cir. 1985). Evidence of a greater than expected result may also be shown by demonstrating an effect which is greater than the sum of each of the effects taken separately (i.e., demonstrating “synergism"). Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). However, a greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected. Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. Ex parte The NutraSweet Co., 19 USPQ2d 1586 (Bd. Pat. App. & Inter. 1991). Moreover, the evidence relied upon should establish “that the differences in results are in fact unexpected and unobvious and of both statistical and practically significance.” Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength “are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration.”).
In the instant case, it is noted that Applicant asserts unexpected synergistic results with respect to the reduction in glucose levels. More specifically, Applicant points to Examples 2-5 and Figures 2F-2G as demonstrating that semaglutide monotherapy produces an approximate 40% reduction in glucose AUC, avasimibe monotherapy produces an approximate 15% reduction thereby corresponding to an additive reduction of approximately 55% whereas the combination produces an approximate 60% reduction (See Applicant’s Response received on 4/24/26, pg. 8). However, it is not readily apparent from Figures 2F-2G and the cited Examples how Applicant deduced an additive glucose AUC reduction of about 55%, but a combined glucose reduction of about 60%. Figure 2F depicts the glucose concentration, but there is no indication of the stated value reductions. In fact, it is not readily apparent that the combination statistically reduces glucose concentration relative to the vehicle, let alone, an additive glucose reduction except after 60 minutes post administration. But relative to semaglutide monotherapy, it is not readily apparent that the combination significantly reduced glucose concentration other than at 60 minutes post administration. Thus, Figure 2F does not clearly support Applicants assertion of unexpected synergistic results when avasimibe and semaglutide are administered together.
Regarding Figure 2G, it is acknowledged that the combination therapy significantly reduced glucose AUC relative to the vehicle and avasimibe monotherapy, but it is not readily apparent that the combination therapy significantly reduced glucose AUC relative to the semaglutide monotherapy. Similarly, there is no indication of an approximate 60% glucose AUC reduction relative to either monotherapy or the vehicle. Thus, Figure 2G does not clearly support Applicants assertion of unexpected synergistic results when avasimibe and semaglutide are administered together.
Regarding Examples 2-5, Table 1 depicts the plasma glucose levels for vehicle, avasimibe monotherapy, semaglutide monotherapy and the combination therapy (See published application, [0065]; Table 1). After four weeks of treatment, mice in the semaglutide and combination groups were sacrificed since their body weight had reached a plateau, but mice in the vehicle and avasimibe groups were sacrificed after an additional 16 days of treatment (See published application, [0065]). As shown in Table 1, the avasimibe group significantly reduced plasma glucose levels relative to the vehicle and the combination significantly reduced plasma glucose levels relative to the semaglutide monotherapy (See published application, [0067]; Table 1). Although the combination group resulted in lower plasma glucose levels relative to each monotherapy group, it is not readily apparent what the plasma glucose level would be would be of the two monotherapy groups, i.e., the additive effect, to compare to the combination therapy. As such, it is acknowledged that the combination therapy significantly reduced plasma glucose levels relative to the semaglutide monotherapy as depicted in Table 1, but it is not readily apparent that such a reduction is greater than an additive effect, i.e., synergistic. Therefore, without clarification including evidence that definitively demonstrates a synergistic reduction in plasma glucose levels, the claimed invention does not exhibit unexpected synergistic results.
However, assuming arguendo, that the specification definitively demonstrates that the combination therapy exhibits s synergistic reduction in plasma glucose levels relative to each monotherapy, the claimed invention is not commensurate in scope with the unexpected results. Pursuant to MPEP 716.02(d), whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.” In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. See MPEP 716.02(d). The Federal Circuit has recognized where Applicants have provided comparative tests with the prior art and the claimed invention. See MPEP 716.02(d). In the instant case, Applicant’s unexpected results are limited to two specific embodiments; namely, Cohort 1: avasimibe at a dosage of 10 mg/kg as the ACAT inhibitor and semaglutide at a dosage of 0.04 mg/kg as the GLP-1 RA; and Cohort 2: avasimibe at a dosage of 20 mg/kg as the ACAT inhibitor and semaglutide at a dosage of 0.04 mg/kg as the GLP-1 RA (See published application, [0055]). As such, the dosage of avasimibe ranged from 10 to 20 mg/kg whereas the semaglutide dosage remained constant. However, it is not readily apparent which cohort Table 1 represents. It is noted that the specification indicates that the low dose avasimibe treatment alone led to only marginal body weight loss compared to the previous findings where a 24% reduction in body weight was achieved (See published application, [0065]). Although this effect is in reference to body weight and not glucose levels, it would be expected that the low dose avasimibe would similarly only reduce glucose levels marginally. However, the claimed invention does not recite any dosage or amount administered of either agents. Furthermore, the evidence in the specification is limited to one species of ACAT inhibitor and one species of GLP-1 RA. It is also being presumed that the two agents were administered at the same time (i.e., not in the same formulation), but the specification does not definitively indicate the timing of administration. Without evidence demonstrating the unexpected results for more than one species at more than one dosage/amount, the unexpected results cannot be extrapolated to extend to the instantly claimed genera. Thus, even if the claimed invention exhibits unexpected synergistic results, the scope of the claimed invention is not commensurate in scope with the evidence provided in the specification.
Additionally, pursuant to MPEP 716.02(c)(II), expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof." In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967). It is noted that Applicant’s assertion that the total additive glucose level reduction being about 55% and the combined therapy glucose level reduction being about 60% does not per se statistically equate to significant unexpected synergistic result. The reduction in glucose levels are indicated as “about” an integer. “About” encompasses variability. Presuming a 10% variability amount (note: the instant specification defines “about” as within 10% of a stated value (see instant, pg. 5, last paragraph)), the total additive glucose level reduction would range from 50 to 60%, and the combined therapy glucose level reduction would range from 54 to 66%. As such, when considering the glucose level reduction ranges, the combination therapy compared to the additive therapy is not significantly distinct. Thus, without further clarification, Applicant’s identified glucose level reduction percentage for the combination therapy would not exhibit unexpected synergistic results, but rather would be expected.
Furthermore, with respect to Applicant’s assertion that it is well recognized in drug development that once a primary agent achieves a substantial effect, it becomes increasingly difficult to achieve further reductions due to diminishing returns or an efficacy ceiling (See Applicant’s Response received on 4/24/26, pg. 9), this argument is merely the argument of counsel and is unsupported by evidence or declarations of those skilled in the art. Attorney argument is not evidence unless it is an admission, in which case, an examiner may use the admission in making a rejection. See M.P.E.P. § 2129 and § 2144.03 for a discussion of admissions as prior art. Counsel's arguments cannot take the place of objective evidence. In re Schulze, 145 USPQ 716 (CCPA 1965); In re Cole, 140 USPQ 230 (CCPA 1964); and especially In re Langer, 183 USPQ 288 (CCPA 1974). See M.P.E.P. § 716.01(c) for examples of attorney statements that are not evidence and that must be supported by an appropriate affidavit or declaration.
With respect to the requisite expectation of success, pursuant to MPEP 2143.02(I), the reasonable expectation of success requirement refers to "the likelihood of success" in combining or modifying prior art disclosures to meet the limitations of the claimed invention. See Elekta Ltd. v. ZAP Surgical Sys., Inc., 81 F.4th 1368, 1375, 2023 USPQ2d 1100 (Fed. Cir. 2023) and Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367, 119 USPQ2d 1171, 1176 (Fed. Cir. 2016). Conclusive proof of efficacy is not required to show a reasonable expectation of success. Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1333, 128 USPQ2d 1001, 1018 (Fed. Cir. 2018) ("This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness." (citing to Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014); PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1364 (Fed. Cir. 2007); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367–68 (Fed. Cir. 2007) (reasoning that "the expectation of success need only be reasonable, not absolute")). Furthermore, pursuant to MPEP 2143.02(II), obviousness does not require absolute predictability, however, at least some degree of predictability is required. Evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness. In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). In the instant case, as discussed supra, there is a prima facie case of obviousness when two agents are combined for the same purpose including where each agent reduces blood glucose levels. Applicants provide no evidence that an ordinary skilled artisan would not have a reasonable expectation of success in co-administering both agents for such purpose, and in particular, an additive effect. Therefore, contrary to Applicant’s argument, there is a reasonable expectation of success, without evidence to the contrary, that the combination therapy would result in greater efficacy than each of the monotherapies individually, i.e., an additive effect.
In response to Applicant’s sixth argument, i.e., additional mechanistic evidence further supports non-obviousness (See Applicant’s Response received on 4/24/26, pg. 9-10), it is found unpersuasive. It is noted that the features upon which applicant relies (i.e., the combination induces a pronounced shift in adipocyte size distribution toward smaller adipocytes) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In the instant case, Applicants point to Figure 3G and paragraphs [0075]-[0078] (note: presuming Applicants mean [0065]-[0068]) to support their argument. Although the claimed invention does not currently recite that the combination induces a pronounced shift in adipocyte size distribution toward smaller adipocytes, it is noted that each monotherapy also induced a pronounced shift in adipocyte size distribution toward smaller adipocytes relative to the vehicle (See instant, Figure 3G). Presumably, the indicated statistical significance is relative to the vehicle. It is further noted in Example 5, that there was no significant changes in adipocyte size distribution detected in the combination group (See published application, [0069]). Collectively, the findings indicate that the combination treatment reduced fat mass in DIO mice, partially due to avasimibe-induced reduction in fat cell size (See published application, [0069]). Thus, even if the claimed invention recites that the combination therapy induces a pronounced shift in adipocyte size distribution toward smaller adipocytes, such a limitation would not per se render the claimed invention nonobvious, especially since it has not been searched.
Accordingly, the rejection of claims 1-8 is maintained as Applicants’ arguments are found unpersuasive.
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 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,257,217 B2. Please note that the rejection has been updated in light of Applicants’ arguments; namely, amendments to claim 8. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘217 claims:
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(‘217 claims 1, 5-6, 11-12, and 14-18 corresponding to issued claims 1, 4-5, and 9-16, respectively). As such, the ‘217 claimed invention encompasses treating diabetes and reducing body weight in a subject by co-administering a composition comprising avasimibe and an additional therapeutic agent such as a GLP-1 RA, e.g., exenatide, liraglutide or albiglutide, and/or an additional ACAT inhibitor and/or an anti-obesity drug such as leptin where the agents can be administered in the same formulation (i.e., ‘217 claim 9 recites that the composition further comprises at least one addl. active agent) or separately or simultaneously as recited in instant claims 1-8.
For claims 1 and 8, with respect to reducing plasma glucose levels and body weight during the treatment period to a greater extent compared to GLP-1 RA monotherapy, although ‘217 does not claim this limitation, since ‘217 claims the co-administration of an ACAT inhibitor and a GLP-1 RA (See ‘217 claims 12-13) thereby constituting the same manipulative step, the result of such combination therapy would inherently result in reduced plasma glucose levels and body weight during the treatment period to a greater extent compared to GLP-1 RA monotherapy, especially given that there are no specific parameters such as concentration or dosage of the agents needed to achieve the instantly claimed result. Thus, ‘217 claims 12-13 inherently encompass where the combination of the two agents reduce plasma glucose levels and body weight in the subject during the treatment period to a greater extent compared to GLP-1 RA monotherapy.
Therefore, the ‘217 claimed invention is not patentably distinct from the instantly claimed invention.
Response to Arguments
Applicant's arguments filed 4/24/26 for claims 1-8 have been fully considered but they are not persuasive for the reasons set forth in response to the 103 rejection supra. It is noted that Applicant asserts that the because the double patenting rejection relies on the same disclosure as Kim and because the present claims are patentably distinct over Kim for the reasons asserted in response to the 103 rejection, the double patenting rejection would similarly be overcome (See Applicant’s Response received on 4/24/26, pg. 11). Thus, Applicant’s attention is directed to the “Response to Arguments” section supra for the 103 rejection, which are incorporated herewith.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEA D' AMBROSIO whose telephone number is (571)270-1216. The examiner can normally be reached M-F 11:00 to 8:00 pm.
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/THEA D' AMBROSIO/Primary Examiner, Art Unit 1654
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