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 .
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-26, drawn to a pharmaceutical composition comprising: a) a therapeutically effective amount of obicetrapib, or a pharmaceutically acceptable salt thereof; and b) a therapeutically effective amount of at least one SGLT2 inhibitor, or a pharmaceutically acceptable salt thereof.
Group II, claim(s) 55, 57, and 87, drawn to a method of treating or preventing a metabolic disorder, comprising administering to a subject having or at risk of developing a metabolic disorder a therapeutically effective amount of a pharmaceutical composition according to claim 1.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of a pharmaceutical composition comprising: a) a therapeutically effective amount of obicetrapib, or a pharmaceutically acceptable salt thereof; and b) a therapeutically effective amount of at least one SGLT2 inhibitor, or a pharmaceutically acceptable salt thereof, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Ganapati (US20180362570A1, Published 12/20/2018). Ganapati teaches derivatives of the oxidized form and the reduced form of nicotinamide riboside (NR) and nicotinic acid riboside (NAR) and pharmaceutical compositions thereof (paragraph [0059]). Ganapati also teaches one or more NR/NAR derivatives described herein are used in combination with one or more antihyperlipidemic agents to treat such as a metabolic disorder (e.g., type 2 diabetes) (paragraph [0229]), wherein the antihyperlipidemic agent can be cholesterylester transfer protein (CETP) inhibitors such as AMG 899 (TA-8995) (i.e., obicetrapib) (paragraph [0239]). Ganapati further teaches that the one or more NR/NAR derivatives disclosed herein are used in combination with one or more antidiabetic agents to treat diabetes (e.g., type 1 or type 2), or a disorder associated therewith (paragraph [0220]), wherein the antidiabetic agents can be sodium-glucose transport protein 2 (SGLT2) inhibitors, including canagliflozin (also inhibits SGLT1), dapagliflozin, empagliflozin, ertugliflozin (paragraph [0226]). It would have been obvious to one of ordinary skill in the art to have both obicetrapib and at least one SGLT2 inhibitors in Ganapati’s pharmaceutical composition because Ganapati teaches one or more NR/NAR derivatives described herein are used in combination with one or more antihyperlipidemic agents such as obicetrapib and antidiabetic agents such as at least one SGLT2 inhibitors which both are used to treat diabetes. See MPEP 2144.06(I).
During a telephone conversation with Kelly Ndubuka on 06/03/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-26. Affirmation of this election must be made by applicant in replying to this Office action. Claims 55, 57, and 87 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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 the claims
Claims 27-54 were cancelled in a previous communication. Claims 1-26, 55, 57 and 87 are pending. Claims 55, 57, and 87 have been withdrawn.
Claims 1-26 are currently under examination.
Information Disclosure Statement
Initialed and dated copies of Applicants’ information disclosure statements (IDS) filed on
06/28/2024 and 01/09/2026 are attached to the instant Office action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 23 is objected to because of the following informalities: Claim 23 has a table present listing the components and their amounts % by weight. Amending the claim for the table to be written out in text form would be remedial. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 23-25 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 23 does not end with a period and as such the claim is not definitively limited only to the limitations expressly recited in the claim. See MPEP 608.01(m).
Claims depending from rejected claims have also been rejected because they incorporate
all of the limitations of the claims from which they depend, but fail to resolve the indefiniteness
concerns outlined above.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, and 3-26 are rejected under 35 U.S.C. 103 as being unpatentable over Ganapati (US20180362570A1, Published 12/20/2018).
Applicant’s invention
The Applicants claims are drawn to a pharmaceutical composition comprising: a) a therapeutically effective amount of obicetrapib, or a pharmaceutically acceptable salt thereof; and b) a therapeutically effective amount of at least one SGLT2 inhibitor, or a pharmaceutically acceptable salt thereof.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 1, and 3-8, Ganapati teaches derivatives of the oxidized form and the reduced form of nicotinamide riboside (NR) and nicotinic acid riboside (NAR) and pharmaceutical compositions thereof (paragraph [0059]). Ganapati also teaches one or more NR/NAR derivatives described herein are used in combination with one or more antihyperlipidemic agents to treat such as a metabolic disorder (e.g., type 2 diabetes) (paragraph [0229]), wherein the antihyperlipidemic agent can be cholesterylester transfer protein (CETP) inhibitors such as AMG 899 (TA-8995) (i.e., obicetrapib) (paragraph [0239]). Ganapati further teaches that the one or more NR/NAR derivatives disclosed herein are used in combination with one or more antidiabetic agents to treat diabetes (e.g., type 1 or type 2), or a disorder associated therewith (paragraph [0220]), wherein the antidiabetic agents can be sodium-glucose transport protein 2 (SGLT2) inhibitors, including canagliflozin (also inhibits SGLT1), dapagliflozin, empagliflozin, ertugliflozin (paragraph [0226]).
Regarding claims 9-11, Ganapati teaches that the one or more NR/NAR derivatives disclosed herein are used in combination with one or more antidiabetic agents to treat diabetes (e.g., type 1 or type 2), or a disorder associated therewith, wherein the antidiabetic agents can be a biguanide (e.g., metformin) (paragraph [0220]), or dipeptidyl peptidase 4 (DPP-4) inhibitors such as linagliptin (paragraph [0225]).
Regarding claims 12-17 and 23, Ganapati teaches administering a therapeutically effective amount of at least one other therapeutic agent selected from antidiabetics, antihyperlipidemic agents, and combinations thereof (claim 51). Ganapati also teaches the term “therapeutically effective amount” refers to an amount of an agent that, when administered to a subject, is sufficient to prevent, reduce the risk of developing, delay the onset of, slow the progression of or cause regression of the medical condition being treated, or to alleviate to some extent the medical condition or one or more symptoms or complications of that condition, at least in some fraction of the subjects taking that agent. The term “therapeutically effective amount” also refers to an amount of an agent that is sufficient to elicit the biological or medical response (paragraph [0045]).
Regarding claims 18 and 24-25, Ganapati teaches pharmaceutically acceptable excipients and carriers include pharmaceutically acceptable substances, materials and vehicles. Non-limiting examples of types of excipients include liquid and solid fillers, diluents, lubricants, glidants, disintegration agents (paragraph [0137]).
Regarding claims 19-22, Ganapati teaches tablets can contain one or more NR/NAR derivatives in admixture with, e.g., a filler or inert diluent (e.g., calcium phosphate, lactose, or microcrystalline cellulose), and a disintegrating agent (e.g., crospovidone, croscarmellose sodium or colloidal silica) (paragraph [0141]). Ganapati also teaches lubricating agents or glidant such as e.g., stearic acid, magnesium stearate, talc or silicon dioxide (paragraph [0141]).
Regarding claim 26, Ganapati teaches a pharmaceutical composition can be presented in unit dosage form as a single dose wherein all active and inactive ingredients are combined in a suitable system, wherein representative examples of a unit dosage form include a tablet, capsule or pill for oral administration, and a single-use pen comprising a pre-filled syringe, a needle and a needle cover for parenteral (e.g., intravenous, subcutaneous or intramuscular) injection of the drug (paragraph [013]).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Ganapati does not disclose a single embodiment or example where every limitation
recited in the instant claims is taught.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
The claims are considered prima facie obvious to one of ordinary skill in the art at the
time of filing because Ganapati teaches all of the claimed elements. With regards to having a pharmaceutical composition comprising both obicetrapib and at least one SGLT2 inhibitor, it would have been obvious to one of ordinary skill in the art to have both obicetrapib and at least one SGLT2 inhibitors in Ganapati’s pharmaceutical composition. One would have understood in view of Ganapati that one or more NR/NAR derivatives described herein are used in combination with one or more antihyperlipidemic agents to treat such as a metabolic disorder (e.g., type 2 diabetes) (paragraph [0229]), wherein the antihyperlipidemic agent can be cholesterylester transfer protein (CETP) inhibitors such as AMG 899 (TA-8995) (i.e., obicetrapib) (paragraph [0239]). Ganapati further teaches that the one or more NR/NAR derivatives disclosed herein are used in combination with one or more antidiabetic agents to treat diabetes (e.g., type 1 or type 2), or a disorder associated therewith (paragraph [0220]), wherein the antidiabetic agents can be sodium-glucose transport protein 2 (SGLT2) inhibitors, including canagliflozin (also inhibits SGLT1), dapagliflozin, empagliflozin, ertugliflozin (paragraph [0226]). It would have been obvious to one of ordinary skill in the art to have both obicetrapib and at least one SGLT2 inhibitors in Ganapati’s pharmaceutical composition because Ganapati teaches one or more NR/NAR derivatives described herein are used in combination with one or more antihyperlipidemic agents such as obicetrapib and antidiabetic agents such as at least one SGLT2 inhibitors which both are used to treat diabetes. See MPEP 2144.06(I).
With regards to the limitations of the amounts of obicetrapib, SGLT2 inhibitors, diluents, disintegrants, one or more additional additives of claims 12-17 and 23, it would have been obvious to optimize the amounts of obicetrapib, SGLT2 inhibitors, diluents, disintegrants, one or more additional additives of Ganapati’s pharmaceutical composition. One would have understood in view of Ganapati that administering a therapeutically effective amount of at least one other therapeutic agent selected from antidiabetics, antihyperlipidemic agents, and combinations thereof (claim 51). Ganapati also teaches the term “therapeutically effective amount” refers to an amount of an agent that, when administered to a subject, is sufficient to prevent, reduce the risk of developing, delay the onset of, slow the progression of or cause regression of the medical condition being treated, or to alleviate to some extent the medical condition or one or more symptoms or complications of that condition, at least in some fraction of the subjects taking that agent. The term “therapeutically effective amount” also refers to an amount of an agent that is sufficient to elicit the biological or medical response (paragraph [0045]). Therefore it would have been obvious to one of ordinary skill in the art to optimize the amounts of obicetrapib, SGLT2 inhibitors, diluents, disintegrants, one or more additional additives of Ganapati’s pharmaceutical composition by routine experimentation to obtain the desired results as taught in Ganapati. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 (II). In addition, according to the MPEP, “It is to be presumed also that skilled workers would as a matter of course, if they do not immediately obtain desired results, make certain experiments and adaptations, within the skill of the competent worker.” (MPEP 716.07).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Ganapati (US20180362570A1, Published 12/20/2018) in view of Gupta et al. (Molecules, Published July 14,2018; 23(7):1719).
Applicant’s invention
Ganapati renders obvious all the limitations of instant claim 1. Applicants instant claim 2 further adds the limitation wherein the obicetrapib is a calcium salt.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claim 2, Ganapati teaches derivatives of the oxidized form and the reduced form of nicotinamide riboside (NR) and nicotinic acid riboside (NAR) and pharmaceutical compositions thereof (paragraph [0059]). Ganapati also teaches one or more NR/NAR derivatives described herein are used in combination with one or more antihyperlipidemic agents to treat such as a metabolic disorder (e.g., type 2 diabetes) (paragraph [0229]), wherein the antihyperlipidemic agent can be cholesterylester transfer protein (CETP) inhibitors such as AMG 899 (TA-8995) (i.e., obicetrapib) (paragraph [0239]).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Ganapati does not teach wherein the obicetrapib is a calcium salt. However this deficiency is cured by Gupta et al.
Gupta teaches the physicochemical and biological properties of active pharmaceutical ingredients (APIs) are greatly affected by their salt forms. The choice of a particular salt formulation is based on numerous factors such as API chemistry, intended dosage form, pharmacokinetics, and pharmacodynamics. The appropriate salt can improve the overall therapeutic and pharmaceutical effects of an API (abstract). Gupta also teaches in table 1, a list of currently available counterions such as calcium (Introduction section, table 1). Gupta further teaches salt formation approaches have widely been utilized to increase solubility, and therefore, the dissolution rate of a drug. It is one of the most common methods to increase the solubility of weakly acidic and basic drugs. Hydrochloride, mesylate, hydrobromide, acetate, and fumarate are the most common counterions that are used for basic chemical entities in the past 20 years while sodium, calcium, and potassium continue to be the most common counterions for weakly acidic drugs. Increases in aqueous solubility have been achieved by most of these counterions (Section 2.8 Solubility and Dissolution Rate)
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have obicetrapib as a calcium salt in Ganapati’s pharmaceutical composition. Ganapati teaches one or more NR/NAR derivatives described herein are used in combination with one or more antihyperlipidemic agents to treat such as a metabolic disorder (e.g., type 2 diabetes) (paragraph [0229]), wherein the antihyperlipidemic agent can be cholesterylester transfer protein (CETP) inhibitors such as AMG 899 (TA-8995) (i.e., obicetrapib) (paragraph [0239]). The artisan of ordinary skill would have been motivated to have obicetrapib as a calcium salt because Gupta teaches the appropriate salt can improve the overall therapeutic and pharmaceutical effects of an API (abstract). Gupta also teaches in table 1, a list of currently available counterions such as calcium (Introduction section, table 1). Gupta further teaches salt formation approaches have widely been utilized to increase solubility, and therefore, the dissolution rate of a drug. It is one of the most common methods to increase the solubility of weakly acidic and basic drugs. Sodium, calcium, and potassium continue to be the most common counterions for weakly acidic drugs. Increases in aqueous solubility have been achieved by most of these counterions (Section 2.8 Solubility and Dissolution Rate). The skilled artisan would have had a reasonable expectation of success because Ganapati teaches a pharmaceutical composition comprising obicetrapib which is an antihyperlipidemic agent (i.e., API) and Gupta teaches that salt formation approaches have widely been utilized to increase solubility, and therefore, the dissolution rate of a drug, wherein sodium, calcium, and potassium continue to be the most common counterions for weakly acidic drugs (i.e., obicetrapib is a weakly acidic drug) (Section 2.8 Solubility and Dissolution Rate).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AFUA BAMFOAA BOATENG whose telephone number is (703)756-1358. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571) 272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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AFUA BAMFOAA BOATENGExaminer, Art Unit 1617
/KATHERINE PEEBLES/Primary Examiner, Art Unit 1617
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