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 .
Priority
This application filed on 08/18/2023, is a U.S. National Stage Application, filed under 35 U.S.C. § 371, of International Application No. PCT/NL2022/050083 filed on 02/18/2022, which claims the priority to International Application No. PCT/NL2021/050109, filed 02/18/2021.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 01/09/2026, complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits, except where noted.
Status of claims
Applicant’s amendments and arguments filed on 04/10/2026 have been received and have been fully considered. Claims 35 and 39 were amended, claims 38, 40 and 50-52 were cancelled, and claims 1-34 were previously cancelled. Claims are 35-37, 39 and 41-49 are pending.
Claim interpretation
Examination requires claim terms first be construed in terms in the broadest reasonable manner during prosecution as is reasonably allowed in an effort to establish a clear record of what applicant intends to claim. See MPEP § 2111. Under a broadest reasonable interpretation, words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. See MPEP § 2111.01. It is also appropriate to look to how the claim term is used in the prior art, which includes prior art patents, published applications, trade publications, and dictionaries. MPEP § 2111.01 (III). However, specific embodiments of the specification cannot be imported into the claims, particularly where the subject claim limitation is broader than the embodiment. MPEP § 2111.01(II).
As provided in MPEP 2111.01.IV, “the only exceptions to giving the words in a claim their ordinary and customary meaning in the art is (1) when the applicant acts as their own lexicographer; and (2) when the applicant disavows or disclaims the full scope of a claim term in the specification. To act as their own lexicographer, the applicant must clearly set forth a special definition of a claim term in the specification that differs from the plain and ordinary meaning it would otherwise possess. CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366, 62 USPQ2d 1658, 1662 (Fed. Cir. 2002).” In the instant case, Applicant defines the term subject” as:
The term "subject" as used herein refers to humans suffering from or at risk for a certain disease or disorder. The term "subject" and "patient" herein are used interchangeably. [Pg. 5].
The specification attempts to provide a specific definition to the term “subject” that is “suffering from of at risk of any disease or disorder. Because the definition targets any disease or disorder, the term subject” is given its ordinary and customary meanings attributed by those of ordinary skill in the art. MPEP 2111.01.
Instant specification provides specific definition to the term “increased risk”:
“the term 'increased risk' has its conventional meaning and refers to a situation in a subject, preferably human, where in individuals, either male or female, have an LDL- cholesterol level above 2.6 mmol/1 (100,54 mg/dL), such that they are exposed at an increased risk of a cardiovascular event, compared to those with lower levels. [Pg. 5].
The specification, while providing specific definition to the term “increased risk”, the specification recites that the term gets its conventional meaning. Thus, under broadest reasonable interpretation, the term is given its ordinary and customary meanings attributed by those of ordinary skill in the art as described by EUPATI (European Patients Academy on Therapeutic Innovation), [“increased risk”. (01/2021). EUPATI. Retrieved from Internet Archive, website:
https://web.archive.org/web/20210104204248/https://toolbox.eupati.eu/resources/risk-factors-in-health-and-disease/].
Rejection Maintained/Slightly Modified in view of the Amendment
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
§ 102 Rejection over Ford
Claims 35-37, 39 and 41-49 remain rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by J. Ford et al. (WO 2017/023166 A1, 02/09/2017, “Ford” cited in the PTO-892 dated 01/12/2026).
Ford discloses a method of treatment of subjects suffering from hyperlipidemia or mixed dyslipidemia or having an increased risk for hyperlipidemia or mixed dyslipidemia comprising administering Compound A or a pharmaceutically acceptable salt thereof and ezetimibe or a pharmaceutically acceptable salt thereof. [Pg. 9, ln. 15-20, claim 31]. Ford discloses that the subject is particularly statin intolerant. [Pg. 6, ln. 22, Pg. 9, ln. 30].
Ford’s Compound A with the structure below, [Pg. 5, ln. 17], recited in the instant claims as obicetrapib:
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Ford discloses the ezetimibe, [Pg. 9, ln. 25]:
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Ford discloses in Example 2 a method of treating subjects suffering from or having an increased risk of hyperlipidemia by administering compound A together with ezetimibe. [Pg. 20, ln. 15].
Ford discloses that compound A is administered orally at 5 mg or 10 mg, [Pg. 18, ln. 10-12], and ezetimibe is administered at preferably 10 mg, [Pg. 17, 23], wherein Compound A and ezetimibe are administered orally. [Pg. 24, ln. 26]. Ford discloses that Compound A treatment alone decreased LDL-C and increased HDL-C, and it was remarkably found that when Compound A was combined with ezetimibe a further reduction in LDL-C was observed. [Pg. 25, ln. 13-20].
With regard to the new amendment to claim 35, Ford discloses that CETP inhibition, i.e., Compound A lowers the concentration of ApoB. [Pg. 3, ln. 17-21]. Ford discloses that the combination of Compound A and ezetimibe reduces LDL and lipoproteins e.g., ApoB. [Pg. 12, ln. 1-6]. Ford discloses that the efficacy assessment of the combination of Compound A and ezetimibe include measuring the concentration of apolipoprotein B, ApoB. [Pg. 18, ln. 19-20, ln. 33]. Ford discloses that ApoB measured 2 weeks prior to treatment, [Pg. 24, 15-21], and ApoB measured after 10 days of treatment. [Pg. 24, ln. 29-32]. While Ford discloses that the combination of Compound A and ezetimibe lowers LDL and ApoB, and that ApoB concentration has been measure prior and after the treatment with the combination of Compound A and ezetimibe in subjects suffering from or having an increased risk of hyperlipidemia, Ford is silent on the concentration of ApoB but otherwise teaches a substantially identical method as claimed. As such, it is reasonable to presume that the resulting concentration of ApoB is inherently reduced. The burden is on Applicant(s) to show that this property is different from those taught by the prior art and to establish patentable differences. See MPEP 2112.
Therefore, Ford anticipates claims 35-37, 39, and 41-44.
With regard to claims 45-48, Ford discloses that the combination of Compound A and ezetimibe more preferably formulated as an oral fixed dose combination, [Pg. 10, ln. 26-28], wherein the term 'fixed dose combination' refers to a combination of defined doses of Compound A and ezetimibe presented in a single dosage unit, a tablet or a capsule, and administered as such. [Pg. 7, ln. 32-34].
With regard to claim 49, Ford discloses that the combination of Compound A and ezetimibe used in a method of treatment of subjects suffering from cardiovascular diseases or having an increased risk for cardiovascular diseases. [Pg. 9, ln. 15-17]. Ford discloses that “the term 'increased risk' refers to a situation in a subject exposed at an increased risk of a cardiovascular event, compared to those with lower levels. [Pg. 7, ln. 7-10].
Response to arguments
Applicant argues:
Firstly, Examiner alleges that pg. 3, In. 17-21 of Ford, discloses that "Compound A lowers concentration of ApoB."2 The Examiner is incorrect. The referenced paragraph does not disclose Compound A lowering of ApoB, rather it teaches that CETP mediates the transfer of cholesteryl esters from HDL particles to ApoB-containing particles (i.e., atherogenic lipoproteins such as LDL), and that CETP inhibition may therefore decrease the cholesterol content of the atherogenic ApoB fraction. This is not the same as lowering the concentration of ApoB particles themselves (and indeed, it is well known that ApoB particles have variable cholesterol content, and that CVD risk markers such as LDL-C can be discordant with ApoB). Thus, it certainly does not teach CETP inhibition (much less Compound A) reduces ApoB concentration in the blood. Next, it is the Examiner's position that Ford discloses that the combination of Compound A (obicetrapib) and ezetimibe reduces LDL and ApoB. 3 Again, Applicant respectfully disagrees and puts forth that the Examiner has mischaracterized the reference. Applicant notes that the cited portion is not directed to the combination of obicetrapib and ezetimibe for the reduction of ApoB, rather, it teaches that polyunsaturated fatty acids (PUFAs) in combination with cholesterol absorption inhibitors and CETP inhibitors in a pharmaceutical composition, would make such a composition particularly suitable for treatment of subjects suffering from or having an increased risk for cardiovascular diseases, because PUFAs (not CETP-inhibitors) have a capacity to reduce lipoprotein concentrations. Specifically, Ford discloses that PUFAs "have a specific capacity against triglyceride rich lipoproteins, remnant cholesterol, and small dense LDL, whereas CETP-inhibitors have no or little effect against triglyceride rich lipoprotein and remnant cholesterol. Separately, Examiner alleges: "Ford discloses that the efficacy assessment of the combination of Compound A and ezetimibe include measuring the concentration of Apolipoprotein B. Applicant again disagrees with Examiner assessment of the reference. The cited disclosure is actually directed to a double-blind randomized study of subjects receiving compound A monotherapy, statin monotherapy, or placebo. This study is specifically limited to Compound A and statin therapy. It does not in any way reference ezetimibe, Compound A in combination with ezetimibe, and definitely not Compound A in combination with ezetimibe for lowering of ApoB in statin intolerant subjects suffering from or at risk of hyperlipidemia or dyslipidemia. Finally, Applicant also respectfully disagrees with the Examiner's assessment of Example 2: "...Ford is silent on the concentration of ApoB but otherwise teaches a substantially identical method as claimed. As such it is reasonable to presume that the resulting concentration of ApoB is inherently reduced. Applicant notes that these paragraphs do not provide ApoB measuring but methods for measuring HDL levels using the phosphotungstate/MgCl2 method that selectively precipitates ApoB containing particles leaving the HDL particles in the supernatant. This is an ApoB- containing particle removal process, where the end result is a HDL containing supernatant for quantification. Therefore, Ford does not in-fact teach lowering of ApoB concentration in the blood of a subject suffering from or having an increased risk of hyperlipidemia or mixed dyslipidemia by administering a combination of Compound A and ezetimibe.
Examiner response:
Applicant’s major argument is that Ford does not teach “reducing apolipoprotein B (ApoB) concentration in the blood.” Applicant’s arguments have been fully considered but they are not persuasive for the following reasons: Ford’s invention is directed to combination of CETP inhibitor, Compound A and a cholesterol absorption inhibitor, ezetimibe for treatment of subjects suffering from or having an increased risk for cardiovascular diseases, in particular hyperlipidemia or mixed dyslipidemia. [Abstract]. Ford teaches that ezetimibe effectively reduces the amount of cholesterol that is delivered back to the liver. This latter effect increases hepatic LDL-receptor activity and thereby increases clearance of circulating LDL-C. Thus, the net result is a reduction in circulating LDL-C particles, note that decreasing LDL-C leads to a decrease in ApoB. Ezetimibe as a mono-therapy has been shown to moderately reduce LDL-C levels in patients, i.e. a reduction of less than 20% when compared to placebo, in patients with hypercholesterolemia for statin intolerant patients [page 2]. Ezetimibe also increases in HDL-C levels. Inhibition of CETP reduces LDL-C and elevates HDL-C levels. CETP mediates the transfer of cholesteryl esters from HDL to apolipoprotein B (ApoB)-containing particles (mainly LDL and VLDL) in exchange for triglycerides (TG), thereby decreasing the cholesterol content in HDL in favor of that in VLDL and LDL. Hence, CETP inhibition retains cholesteryl esters in HDL-C and decreases the cholesterol content of the atherogenic ApoB fraction [page 3]. Note that it’s known that every VLDL or LDL particle contains exactly one molecule of ApoB, which means that any reduction in VLDL or LDL would necessarily result in reduction in ApoB. It has further been shown in hamster studies that combining Compound A with ezetimibe, gives a further advantageous effect with respect to the lowering of the LDL-C concentration in blood. It has further been found that when Compound A is used in combination with ezetimibe, the LDL-C concentration decreases more than one would have expected. Furthermore, the use of Compound A in combination with ezetimibe also resulted in an increase of HDL-C [page 6]. Compound A significantly increase the HDL-C concentration and significantly lower the LDL-C concentration. Surprisingly combining Compound A with ezetimibe, gives advantageous effect with respect to the lowering of the LDL-C concentration in blood. In other words, when Compound A is used in combination with ezetimibe, the LDL-C concentration decreases more than one would have expected [page 8-9]. In Example 2, Ford tested the combination of Compound A with ezetimibe on hamsters and measures the LDL-cholesterol and HDL-cholesterol using phosphotungstate/MgCl2 apolipoprotein B-lipoproteins precipitation method. Note that the ApoB precipitation method allows for measuring VLDL and LDL with ApoB containing lipoproteins LDL and VLDL precipitated out of the solution whereas HDL stayed solubilized in the solution. Ford summaries the results as “From the preclinical study described above it has become clear that Compound A treatment alone decreased LDL-C and increased HDL-C. It was further observed that ezetimibe treatment alone resulted only in a decreased LDL-C. However, it was remarkably found that when Compound A was combined with ezetimibe a further reduction in LDL-C was observed. [page 21 and 24-25]. Note that Ford uses precipitated ApoB to measure the HDL and LDL, and since the measurement resulted in reduction in LDL, it is reasonable to presume that the resulting concentration of ApoB is inherently reduced. The burden is on Applicant(s) to show that this property is different from those taught by the prior art and to establish patentable differences. See MPEP 2112. Note that Ford teaches the same combination of Compound A and ezetimibe at the same amount as claimed for treating the same condition as claimed by reducing LDL (and necessary ApoB as discussed above). As provided in MPEP 2112.01 I “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.).
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.
Double Patenting over USPN 11642344 B2
Claims 35-37, 39, and 41-49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of USPN 11,642,344 B2 (cited in the PTO-892 dated 01/12/2026) in view of J. Ford et al. (WO 2017/023166 A1, 02/09/2017, “Ford” cited in the PTO-892 dated 01/12/2026). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims 35-37, 39 and 41-49 recite: a method of reducing apolipoprotein B (ApoB) concentration in the blood of a subject suffering from or having an increased risk for hyperlipidemia or mixed dyslipidemia, the method comprising administering to the subject an oral dose of between 1 to 10 mg of obicetrapib per day and between 5 to 20 mg of ezetimibe per day, wherein the subject is partially or completely intolerant to statins, wherein LDL-C concentration in the blood of the subject is reduced, wherein the reduction of LDL-C levels by the combination of obicetrapib and ezetimibe is no less than the LDL-C reduction by the same dose of obicetrapib administered as monotherapy, wherein obicetrapib and ezetimibe are administered in a single oral dosage form in the form of capsule or tablet, wherein the method reduces the risk for major adverse cardiovascular events.
USPN 11,642,344 B2 claims a method of treating a subject suffering from or having an increased risk for cardiovascular diseases, the method comprising administering to said subject in need thereof an effective dosage amount of a compound of the formula A (obicetrapib) or a pharmaceutically acceptable salt thereof, wherein the effective dosage amount of said Compound A to be administered to said subject is 1-25 mg daily, wherein said effective dosage amount of said compound A to be administered to the subject in need thereof is 5 mg or 10 mg daily, wherein the effective dosage amount of said compound A to be administered to the subject in need thereof is 5 mg daily, wherein the effective dosage amount of said compound A to be administered to the subject in need thereof is 10 mg daily, wherein said cardiovascular diseases are selected from hyperlipidemia or mixed dyslipidemia, wherein said effective dosage amount of said compound A to be administered to the subject in need thereof is 5 mg or 10 mg daily in a solid oral dosage form or liquid oral dosage form, wherein said solid oral dosage form is a tablet, wherein said solid oral dosage form is a capsule.
USPN 11,642,344 B2 does not recite that the method includes administering ezetimibe and resulted in reducing ApoB concentration in the blood.
The disclosures set forth above in the 102 Rejection over the same Ford et al. reference are herein incorporated by reference (pages 4-5 above).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of instantly claimed invention to combine ezetimibe with compound A (obicetrapib) in the method of treating a subject suffering from or having an increased risk for cardiovascular diseases, hyperlipidemia or mixed dyslipidemia, in view of the teachings of Ford. One of ordinary skill in the art would have been motivated to do so with reasonable expectation of success because Ford teaches a method of treating subjects suffering from hyperlipidemia or mixed dyslipidemia or having an increased risk for hyperlipidemia or mixed dyslipidemia by administering Compound A or a pharmaceutically acceptable salt thereof and ezetimibe or a pharmaceutically acceptable salt thereof for a subject particularly statin intolerant, wherein the combination of obicetrapib and ezetimibe remarkably further reduce LDL-C compared to obicetrapib alone. [Pg. 25, ln. 13-20].
With regard to claim 35 new amendment, Ford discloses that CETP inhibition, i.e., Compound A lowers the concentration of ApoB. [Pg. 3, ln. 17-21]. Ford discloses that the combination of Compound A and ezetimibe reduces LDL and lipoproteins e.g., ApoB. [Pg. 12, ln. 1-6]. Ford discloses that the efficacy assessment of the combination of Compound A and ezetimibe include measuring the concentration of apolipoprotein B, ApoB. [Pg. 18, ln. 19-20, ln. 33]. Ford discloses that ApoB measured 2 weeks prior to treatment, [Pg. 24, 15-21], and ApoB measured after 10 days of treatment. [Pg. 24, ln. 29-32]. While USPN 11,642,344 B2 and Ford discloses that the combination of Compound A and ezetimibe lowers LDL and ApoB, and that ApoB concentration has been measure prior and after the treatment with the combination of Compound A and ezetimibe in subjects suffering from or having an increased risk of hyperlipidemia, Ford is silent on the concentration of ApoB but otherwise teaches a substantially identical method as claimed. As such, it is reasonable to presume that the resulting concentration of ApoB is inherently reduced. The burden is on Applicant(s) to show that this property is different from those taught by the prior art and to establish patentable differences. See MPEP 2112. Therefore, instant claims 35-37, 39 and 41-49 are obvious over the combination of USPN 11,642,344 B2 and Ford.
Double Patenting over Copending Application No. 19/060,610
Claims 35-37, 39 and 41-49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13, 40, 41, and 45 of copending Application No. 19/060,610 (US PG-PUB 20250186442 A1 cited in the PTO-892 dated 01/12/2026). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims 35-37, 39 and 41-49 recite: a method of reducing apolipoprotein B (ApoB) concentration in the blood of a subject suffering from or having an increased risk for hyperlipidemia or mixed dyslipidemia, the method comprising administering to the subject an oral dose of between 1 to 10 mg of obicetrapib per day and between 5 to 20 mg of ezetimibe per day, wherein the subject is partially or completely intolerant to statins, wherein LDL-C concentration in the blood of the subject is reduced, wherein the reduction of LDL-C levels by the combination of obicetrapib and ezetimibe is no less than the LDL-C reduction by the same dose of obicetrapib administered as monotherapy, wherein obicetrapib and ezetimibe are administered in a single oral dosage form in the form of capsule or tablet, wherein the method reduces the risk for major adverse cardiovascular events.
Copending Application No. 19/060,610 recites in claims 1 and 13, a fixed dose pharmaceutical composition comprising a. obicetrapib or a pharmaceutically acceptable salt, solvate or co-crystal thereof; b. ezetimibe or a pharmaceutically acceptable salt, solvate or co-crystal thereof; and c. one or more pharmaceutically acceptable excipients, wherein the composition comprises 1 to 20 mg obicetrapib and 5 to 20 mg ezetimibe, preferably said composition comprises 5 mg obicetrapib and 10 mg ezetimibe or 10 mg obicetrapib and 10 mg ezetimibe, wherein the composition is tablet or capsule.
Copending Application No. 19/060,610 specification recites the composition of the combination of obicetrapib and ezetimibe is for treatment of subjects requiring reduction in LDL cholesterol and/or an increase in HDL cholesterol, said subjects are suffering from or having hyperlipidemia or mixed dyslipidemia, heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD), wherein the said subjects are partially or completely intolerant to statins. [Pg. 33], wherein the combination reduces LDL-C plasma levels compared to methods based on therapy with obicetrapib, or a pharmaceutically acceptable salt, solvate or co-crystal thereof, alone, and reduces ApoB plasma levels. [Pg. 7, 43, 164].
MPEP 804 states: The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999) ("[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning."); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) ("Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings."). "The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’ " Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) (en banc) (quoting In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364, 70 USPQ2d 1827, 1830 (Fed. Cir. 2004); see also MPEP § 2111.01. Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because only "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
Moreover, Copending Application No. 19/060,610 recites in claim 40 a method of treatment of a subject requiring reduction in LDL cholesterol and/or an increase in HDL cholesterol, a subject with heterozygous familial hypercholesterolemia (HeFH) and/or subject with established atherosclerotic cardiovascular disease (ASCVD), wherein the method comprises administering a therapeutically effective dose of the pharmaceutical composition of claim 1 to a patient in need thereof. Copending Application No. 19/060,610 recites in claim 41 a method of treatment of subjects suffering from hyperlipidaemia or mixed dyslipidaemia, wherein the method comprises administering the pharmaceutical composition of anyone of the preceding claims claim 1 to a patient in need thereof. Copending Application No. 19/060,610 recites in claim 45 the composition of claim 1 for use in the treatment of subjects requiring additional lowering of low-density lipoprotein cholesterol. The new amendment of claim 35 is met by the combination of Copending Application No. 19/060,610 and Ford on a similar rationale as discussed on page 12 above. Therefore, Copending Application No. 19/060,610 and Ford meets the limitations of claims 35-37, 39 and 41-49.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Double Patenting over Copending Application No. 19/154,743
Claims 35-37, 39 and 41-49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of copending Application No. 19/154,743 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims 35-37, 39 and 41-49 recite: a method of reducing apolipoprotein B (ApoB) concentration in the blood of a subject suffering from or having an increased risk for hyperlipidemia or mixed dyslipidemia, the method comprising administering to the subject an oral dose of between 1 to 10 mg of obicetrapib per day and between 5 to 20 mg of ezetimibe per day, wherein the subject is partially or completely intolerant to statins, wherein LDL-C concentration in the blood of the subject is reduced, wherein the reduction of LDL-C levels by the combination of obicetrapib and ezetimibe is no less than the LDL-C reduction by the same dose of obicetrapib administered as monotherapy, wherein obicetrapib and ezetimibe are administered in a single oral dosage form in the form of capsule or tablet, wherein the method reduces the risk for major adverse cardiovascular events.
Copending Application No. 19/154,743 recites in claims 1-28, A fixed dose pharmaceutical composition comprising obicetrapib or a pharmaceutically acceptable salt, solvate or co-crystal thereof, ezetimibe or a pharmaceutically acceptable salt, solvate or co-crystal thereof, and, pharmaceutically acceptable excipients, for use in a method of synergistically lowering LDL-C plasma levels in a subject in need thereof, said method comprising the administration of the fixed dose pharmaceutical composition, wherein the subject is a subject suffering from mixed dyslipidemia, or established atherosclerotic cardiovascular disease (ASCVD), wherein the subject is a subject that is intolerant to statins and is unable to reach an LDL-C plasma level of < 70 mg/dL with ezetimibe alone, wherein said method results in a reduction of LDL-C plasma levels of at least 40%, from baseline, wherein baseline is defined as start of the treatment with obicetrapib and ezetimibe, wherein the method comprises the oral administration of obicetrapib at a daily dose of about 10 mg and the oral administration of ezetimibe at a daily dose of about 10 mg. Copending Application No. 19/154,743 defines “fixed dose” as single dosage unit (e.g. a tablet or a capsule) and administered as such [Pg. 9, ln. 12-14].
Copending Application No. 19/154,743 teaches a method of using combination of obicetrapib and ezetimibe in treating subject suffering from mixed dyslipidemia and cardiovascular disease, wherein the subject is statins intolerant. Copending Application No. 19/154,743 is silent on the concentration of ApoB and on the reduction of LDL-C of the combination being no less than the reduction by obicetrapib monotherapy, but otherwise teaches a substantially identical method as claimed. As such, it is reasonable to presume that the resulting concentration of ApoB is inherently reduced, and LDL-C is inherently more than the reduction of the obicetrapib monotherapy. The burden is on Applicant(s) to show that this property is different from those taught by the prior art and to establish patentable differences. See MPEP 2112. Therefore, Copending Application No. 19/154,743 meets the limitations of claims 35-37, 39 and 41-49.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Double Patenting over Copending Application No. 18/346,342
Claims 35-37, 39 and 41-49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/346,342 (US20240010630A1 cited in the PTO-892 dated 01/12/2026, now U.S. Patent No. 12,006,305) in view of J. Ford et al. (WO 2017/023166 A1, 02/09/2017, “Ford” cited in the PTO-892 dated 01/12/2026). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims 35-37, 39 and 41-49 recite: a method of reducing apolipoprotein B (ApoB) concentration in the blood of a subject suffering from or having an increased risk for hyperlipidemia or mixed dyslipidemia, the method comprising administering to the subject an oral dose of between 1 to 10 mg of obicetrapib per day and between 5 to 20 mg of ezetimibe per day, wherein the subject is partially or completely intolerant to statins, wherein LDL-C concentration in the blood of the subject is reduced, wherein the reduction of LDL-C levels by the combination of obicetrapib and ezetimibe is no less than the LDL-C reduction by the same dose of obicetrapib administered as monotherapy, wherein obicetrapib and ezetimibe are administered in a single oral dosage form in the form of capsule or tablet, wherein the method reduces the risk for major adverse cardiovascular events.
Copending Application No. 18/346,342 recites in claim 1, Amorphous obicetrapib hemicalcium.
Copending Application No. 18/346,342 specification recites A method of treating a subject suffering from or having an increased risk of developing a cardiovascular disease, the method comprising administering a therapeutically effective amount of a [Pg. 77, [0371]]. The specification recites that obicetrapib, potent CETP- inhibitor, lower LDL-C and ApoB, wherein a strong association between low density lipoprotein-cholesterol (LDL-C) levels and cardiovascular disease (CVD) risk. [Pg. 1, [0002]-[0004]. MPEP 804 states: The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999) ("[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning."); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) ("Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings."). "The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’ " Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) (en banc) (quoting In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364, 70 USPQ2d 1827, 1830 (Fed. Cir. 2004); see also MPEP § 2111.01. Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because only "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
However, Copending Application No. 18/346,342 does not teach that the method includes administering ezetimibe.
The disclosures set forth above in the 102 Rejection over the same Ford et al. reference are herein incorporated by reference (pages 4-6 above).
The obviousness rationale is the same as the rationale of the obviousness Double Patenting on page 12.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant argues:
Double patenting rejection over U.S. Patent No. 11,642,344 in view of Ford. U.S. Patent No. 11,642,344 is commonly owned with the instant application; double patenting rejection over co-pending U.S. Application No. 19/060,610. U.S. Application No. 19/060,610 is commonly owned with the instant application; double patenting rejection over co-pending U.S. Application No. 19/154,743. U.S. Application No. 19/154,743 is commonly owned with the instant application; and double patenting rejection over U.S. Application No. 18/346,342 in view of Ford. Applicant points out that U.S. Application No. 18/346,342 is now U.S. Patent No. 12,006,305 and is commonly owned with the instant application. Following entry of the amendments directed herein, Applicant respectfully requests that Examiner reconsider these rejections.
Examiner response:
Applicant’s arguments have been fully considered but they are not persuasive for the same reasons discussed in the response to argument of the 102 rejection above.
Conclusion
Claims 35-37, 39 and 41-49 are rejected. No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/M.M.A./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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