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 .
DETAILED ACTION
This action is in response to a Request for Continued Examination received July 30th, 2026.
Status of Claims
Claims 1-4, 6-13, 15-16, 22, and 25 are pending in the instant application.
Claims 5, 14, 17-21, and 23-24 have been canceled.
Information Disclosure Statement
The Information Disclosure Statement received on July 30th, 2026 has been fully considered by the examiner, except where marked with a strikethrough.
Withdrawn Objections/Rejections
Applicant’s amendment is sufficient to overcome the objection to the Abstract. This objection is hereby withdrawn.
Applicant’s cancellation of Claims 17-21 and 23-24 renders the rejection thereof under 35 U.S.C. 112(a) moot. The rejection thereof is hereby withdrawn.
Applicant’s cancellation of Claims 14, 17-21, and 23-24 renders the rejection thereof on the ground of nonstatutory double patenting as being unpatentable over copending application 18/258,717 moot. The rejection thereof is withdrawn.
Claim Objections
Claim 22 is objected to because of the following informalities:
In the third line of the claim, the stereochemical label “1S” is erroneously presented as a lower-case “1s”.
Applicant is advised that should claim 16 be found allowable, claim 22 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The rejection of Claims 1-4, 6-13, 15-16, and 22 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is maintained because the specification, while being enabling for a crystalline form II of a compound of Formula 4, as recited at instant Claim 25, does not reasonably provide enablement for a crystalline form II of any compound of formula 1. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Pursuant to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required: (1) The breadth of the claims, (2) The nature of the invention, (3) The state of the prior art, (4) The level of one of ordinary skill, (5) The level of predictability in the art, (6) The amount of direction provided by the inventor, (7) The existence of working examples and (8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Applicant has traversed this rejection on the basis that the specification sufficiently enables a skilled artisan to arrive at the crystalline form II as instantly claimed, as noted at the last paragraph of Page 7 of the remarks filed July 30th, 2026. Further, Applicant asserts at the second paragraph of Page 8 of these remarks that the amended claim is drawn to a crystalline form II embracing a compound of Formula 1 wherein the R1 radical is limited to a single alkyl group, and that it is conventional in the pharmaceutical arts to prepare pharmaceutically acceptable salts and solvates of active ingredients. Finally, at the last paragraph of Page 8 of these remarks, Applicant states, “Applicant agrees in principal that X-ray powder diffraction data is useful in distinguishing distinct polymorphic forms; however, Applicant disagrees with the Examiner’s characterization. The Examiner is rendering as equivalent a selection of peaks with all of the peaks.”
The examiner does not find this argument persuasive.
As noted in the final rejection mailed March 30th, 2026, enablement is lacking because “crystalline form II” refers to the hydrate prepared via the method disclosed in the instant specification at Page 30, Paragraphs [00145-00147] with a powder XRD diffraction pattern characterized by the values listed at Page 31, Paragraph [00154] and also disclosed at Table 1 on Page 32 of the instant specification.
Instant Claim 1 is drawn to a crystalline form II. As noted above, crystalline form II refers to a single polymorph. Formula 1 is drawn to multiple compounds. R1 is not limited to a single alkyl group as Applicant has suggested, but is limited to “propyl”. The broadest reasonable interpretation of this limitation is defining R1 as either n-propyl or isopropyl. These are two distinct alkyl groups. Because crystalline form II is drawn to a hydrate of an HCl salt of formula 1 wherein R1 is isopropyl, defining R1 as n-propyl would result in a distinct compound and a distinct polymorph. While the polymorph of this compound may be characterized with an XRD diffraction pattern generating peaks that overlap with those of crystalline form II, this compound would still be a distinct polymorph, and therefore, not crystalline form II.
Similarly, because crystalline form II is defined as an HCl salt and hydrate of a compound of formula 1 in which R1 is isopropyl, other pharmaceutically acceptable salts or solvates of a compound of formula 1 will necessarily give rise to polymorphic forms that are distinct from crystalline form II.
In other words, crystalline form II, in light of the instant specification, is defined as a single polymorph of a hydrate of an HCl salt of a compound of formula 1 in which R1 is defined as isopropyl. The instant claims recite limitations allowing formula 1 to be defined as a compound, any number of pharmaceutically acceptable salts, or solvates thereof. Deviating from the selection of HCl as the pharmaceutically acceptable salt, water as the solvate, or R1 defined as isopropyl necessarily generates distinct polymorphs that can not be crystalline form II, which as defined in the instant specification, must possess all of the XRD diffraction peaks listed at instant Paragraph [00154] and at Table 1. “Crystalline form II” is a unique identifier defined by the instant specification as a single polymorph of a hydrate of an HCl salt of a compound of formula 1 in which R1 is isopropyl.
Further, Claim 2 is drawn to any of six distinct pharmaceutically acceptable salts. Each of these salts would produce a distinct crystalline form with a unique XRPD that is distinct from that of crystalline form II.
Claim 3 is drawn to a solvate of the crystalline form II. As noted above, crystalline form II is drawn to a hydrate of an HCl salt of the compound of formula 1. Different solvates of a compound of formula 1 would give rise to unique polymorphs that are not form II.
Claim 4 is drawn to a hydrate of crystalline form II. As noted above, crystalline form II is a drawn to a hydrate of an HCl salt of the compound of formula 1. Claim 4 could be drawn to crystalline forms that are hydrates of other pharmaceutically acceptable salts of a compound of formula 1.
For clarity of the record, the Wands factors previously considered are revisited below.
Nature of the invention:
The invention is drawn to a crystalline form II of a compound having the formula:
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Wherein R1 is propyl.
Breadth of the invention:
The scope of the claimed invention is narrow, as it is drawn to a single polymorph that is crystalline form II, defined by a specific X-ray powder diffraction pattern.
State of the prior art and predictability in the art:
With respect to X-ray diffraction patterns, Thakral et. al. (“Applications of Powder X-Ray Diffraction in Small Molecule Pharmaceuticals: Achievements and Aspirations”, Journal of Pharmaceutical Sciences, 107, 2969-2982, 2018; cited in final rejection mailed March 30th, 2026; hereinafter referred to as Thakral) represents the state of the prior art.
At Page 2973, the first paragraph under “Identification and Quantifiaction of API”, Thakral teaches “The X-ray powder diffraction pattern of every crystalline form of a compound is unique and can be used for identification.”
The instant claims are drawn to a single crystalline from II of a compound of formula 1, representative of multiple compounds due to the variability of R1, and multiple pharmaceutically acceptable salts and/or solvates thereof. It is counter to what is known in the art as taught by Thakral for a single crystalline form II of a compound to characterize a multitude of polymorphs by a single X-ray powder diffraction pattern.
Level of ordinary skill in the art:
An ordinary artisan in the area of drug development would have experience in synthesizing chemical compounds for particular activities. The synthesis of new drug candidates, while complex, is routine in the art. The process of finding new drugs that have in vitro activity against a particular biological target (i.e., receptor, enzyme, etc.) is well known. Additionally, while high throughput screening assays can be employed, developing a therapeutic method, as claimed, prior to synthesizing and testing compounds is generally not well-known or routine, given the complexity of certain biological systems.
The amount of direction provided and working examples:
At Page 29, Paragraphs [001401]-[00143] of the instant specification, a procedure for the preparation of an amorphous hydrochloride salt of a compound of formula 1, specifically N-((3S,5S)-1-((3S,4R)-1-(tert-butyl)-4-(4-chlorophenyl)pyrrolidine-3-carbonyl)-5-morpholine-4-carbonyl)pyrrolidine-3-yl)-N-((1S,4R)-4-methylcyclohexyl)isobutyraide hydrochloride is sufficiently disclosed.
At Page 30, Paragraphs [00145-00147], a procedure for the preparation of crystalline form II of a hydrate of this salt is sufficiently disclosed.
At Pages 31-32, Paragraphs [00151-00155] of the instant specification, the method for obtaining a powder XRD diffraction pattern and the results thereof are sufficiently disclosed.
To this end, “crystalline form II” refers to the hydrate prepared via the method disclosed at Page 30, Paragraphs [00145-00147] with a powder XRD diffraction pattern characterized byt he values listed at Page 31, Paragraph [00154] (also disclosed at Table 1 on Page 32 of the instant specification).
Therefore, the specification is sufficiently enabled for a crystalline form II, as noted above, characterized by the hydrate prepared via the method disclosed at Page 30, Paragraphs [00145-00147] with a powder XRD diffraction pattern characterized by the values listed at Page 31, Paragraph [00154], but is not enabled for a crystalline form II of a compound, wherein the crystalline compound is of formula 1, pharmaceutically acceptable salts or solvates thereof other than the disclosed hydrate described above.
Within the specification, “specific operative embodiments or examples of the invention must be set forth. Examples and description should be of sufficient scope to justify the scope of the claims.” Markush claims must be provided with support in the disclosure for each member of the Markush group. Where the constitution and formula of a chemical compound is stated only as a probability or speculation, the disclosure is not sufficient to support claims identifying the compound by such composition or formula. See MPEP 608.01(p).
MPEP § 2164.01(a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F. 2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here that Applicant is not enabled for making these compounds.
The rejection of Claims 12-13 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement is maintained. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Pursuant to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required: (1) The breadth of the claims, (2) The nature of the invention, (3) The state of the prior art, (4) The level of one of ordinary skill, (5) The level of predictability in the art, (6) The amount of direction provided by the inventor, (7) The existence of working examples and (8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Applicant has traversed this rejection, stating at Page 9 of the remarks filed July 30th, 2026, that “the specification equips the skilled artisan with the requisite tools to arrive at a pharmaceutical composition comprising crystalline form II and a pharmaceutically acceptable carrier which is useful in treating obesity based on Formula 1’s melanocortin-4-receptor activity.”
The examiner does not find this argument persuasive.
As noted in the final rejection mailed March 30th, 2026, Applicant has provided no evidence of a crystalline form II having any melanocortin-4-receptor activity. For clarity of the record, the Wands factors previously evaluated are revisited below.
Nature of the invention:
The invention is drawn to a method for agonizing the function of a melanocortin-4 receptor and for treating obesity.
Breadth of the invention:
The scope of the claimed invention is limited, as it is drawn to agonism of melanocortin-4 receptor and treatment of obesity.
State of the prior art and predictability in the art:
With respect to agonism of melanocortin-4 receptor, Kang et. al. (US 2022/0289731 A1; cited on Applicant’s Information Disclosure Statement filed February 20th, 2024; cited in final rejection mailed March 30th, 2026; hereinafter referred to as Kang) represents the state of the prior art.
At Page 9, Kang teaches the following hydrochloride salt as Example 1:
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This is a compound of Formula 1, as recited at instant Claim 1, and is in the anhydrate of the compound of Formula 4, as recited at instant Claim 25.
At Pages 14-15, Tables 1-4, Kang sufficiently discloses data demonstrating Example 1 as an agonist of the melanocortin-4 receptor. At Page 17, Paragraph [0175], Kang teaches administration of Example 1 resulted in significant weight loss in a mouse obesity model.
The instant application is drawn to administration of crystalline form II, a polymorph of Example 1. With respect to predictability of polymorphs of active pharmaceutical ingredients (APIs), Thakral represents the state of the prior art.
At Page 2969, Second Paragraph, Thakral teaches “Polymorphs can show a wide range of physical and chemical properties, including different melting points and spectral properties. Polymorphs can also exhibit different solubility, density, hardness and crystal shape. Control of polymorphism is specifically important in cases where changing the polymorph can affect bulk properties, dissolution rate, bioavailability, hygroscopicity, and chemical or physical stability of a drug.”
Therefore, in view of Thakral, the pharmaceutical properties of the amorphous salt of Example 1, taught by Kang, as noted above, does not predictably correspond to the polymorph of crystalline form II demonstrating the same pharmaceutical properties.
The amount of direction provided and working examples:
No examples have been provided in the instant specification to provide enabling disclosure of administration of the crystalline form II for agonizing the function of a melanocortin-4 receptor or for the treatment of obesity.
Quantity of experimentation needed to use the invention based on the content of the disclosure:
The quantity of experimentation needed is undue experimentation. A person having ordinary skill in the art would need to identify and/or develop methods to evaluate the efficacy of a crystalline form II in agonizing the function of melanocortin-4 receptor and/or treating obesity.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specifcation, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation.
Genentech Inc. v Novo Nordisk A/S (CAFC) 42 USPQ2d 1001 states that “a patent is nota hunting license. It is not a reward for search, but compensation for its successful conclusion” and “patent protection is granted in return for enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
Therefore in view of the Wands factors and in re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person having ordinary skill in the art would have to engage in undue experimentation to determine the efficacy of administration of a crystalline form II in agonizing the function of melanocortin-4 receptor and/or treating obesity.
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.
Claim 11 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2021/091283 A1 (cited on Applicant’s Information Disclosure Statement received April 28th, 2023; priority date of November 7th, 2019; hereinafter referred to as WO ‘283).
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Instant Claim 11 is drawn to a pharmaceutical composition comprising the crystalline form II of claim 1 and a pharmaceutically acceptable carrier. In solution, polymorphs lose the distinguishing polymorphic properties of the crystalline form. Therefore, Claim 11 is drawn broadly to a pharmaceutical composition comprising a compound of formula 1 and a pharmaceutically acceptable carrier.
At Page 35, Claim 4, WO ‘283 teaches the compound N-((3S,5S)-1-((3S,4R)-1-(tert-butyl)-4-(4-chlorophenyl)pyrrolidine-3-carbonyl)-5-(morpholine-4-carbonyl)pyrrolidine-3-yl)-N-((1s,4R)-4-methylcyclohexyl)isobutyramide. This is a compound of formula 1 as recited at instant Claim 1 when R1 is isopropyl. Further, at Page 6, Claim 7, WO ‘238 teaches a pharmaceutical composition comprising this compound and a pharmaceutically acceptable carrier. Therefore, Claim 11 is anticipated by WO ‘238.
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.
The provisional rejection of Claim 6 on the ground of nonstatutory double patenting as being unpatentable over claim 5 of copending Application No. 18/258,711 (reference application) is maintained.
Applicant traverses the rejection at Page 9 of the remarks filed July 30th, 2026 on the basis that the reference application has a priority date of December 22nd, 2020, after the filing date of the instant application, and therefore the later-filed application can not be a valid nonstatutory double patenting reference.
The examiner does not find this argument persuasive.
Per MPEP 804, I., B., 1., (i)., “If a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent.”
This is not the only rejection remaining, and therefore, is maintained. For clarity of the record, the merits of this rejection are revisited below:
Although the claims at issue are not identical, they are not patentably distinct form each other because they are both drawn to a method of preparing a crystalline form of a compound of Formula 1:
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Although nominally, the claims are drawn to methods of preparing distinct crystalline forms of a compound of Formula 1, the methods of preparation are identical, as both Claim 6 in the instant application and Claim 5 in the reference application are drawn to preparing a mixed solution by dissolving a compound of Formula 1 in a crystallization solvent and obtaining crystals from the mixed solution. Per MPEP 2112.01, I., “Where the claimed and prior art products are identical or substantially identical ins tructure or composition, or are produced by identical or substantialled 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).”
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The provisional rejection of Claim 6 on the ground of nonstatutory double patenting as being unpatentable over claim 6 of copending Application No. 18/258,730 (reference application) is maintained.
Applicant traverses the rejection at Page 9 of the remarks filed July 30th, 2026 on the basis that the reference application has a priority date of December 22nd, 2020, after the filing date of the instant application, and therefore the later-filed application can not be a valid nonstatutory double patenting reference.
The examiner does not find this argument persuasive.
Per MPEP 804, I., B., 1., (i)., “If a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent.”
This is not the only rejection remaining, and therefore, is maintained. For clarity of the record, the merits of this rejection are revisited below:
Although the claims at issue are not identical, they are not patentably distinct form each other because they are both drawn to a method of preparing a crystalline form of a compound of Formula 1:
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Although nominally, the claims are drawn to methods of preparing distinct crystalline forms of a compound of Formula 1, the methods of preparation are identical, as both Claim 6 in the instant application and Claim 5 in the reference application are drawn to preparing a mixed solution by dissolving a compound of Formula 1 in a crystallization solvent and obtaining crystals from the mixed solution. Per MPEP 2112.01, I., “Where the claimed and prior art products are identical or substantially identical ins tructure or composition, or are produced by identical or substantialled 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).”
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The provisional rejection of Claims 1-4, 6-13, 15-16, 22, and 25 on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 11-16 of copending Application No. 18/258,717 (reference application) is maintained.
Applicant traverses the rejection at Page 9 of the remarks filed July 30th, 2026 on the basis that the reference application has a priority date of December 22nd, 2020, after the filing date of the instant application, and therefore the later-filed application can not be a valid nonstatutory double patenting reference.
The examiner does not find this argument persuasive.
Per MPEP 804, I., B., 1., (i)., “If a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent.”
This is not the only rejection remaining, and therefore, is maintained. For clarity of the record, the merits of this rejection are revisited below:
Although the claims at issue are not identical, they are not patentably distinct from each other because they are both drawn to a crystalline Form II of a compound of Formula 1, wherein Formula 1 is
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Instantly, R1 is propyl, reading on the limitation of the reference application defining R1 as C2-C5 alkyl.
Although the XRPD characteristic peaks recited in each application’s respective Claim 1 are not identical, at least 10 characteristic peaks are within the margin of error (±0.2o [Symbol font/0x71]) of the recited peaks. For example, the instantly recited peaks in Claim 1 of 7.77±0.2o, 9.82±0.2o-, 11.37±0.2o-, 12.35±0.2o-, 15.17±0.2o-, 15.88±0.2o-, 16.75±0.2o-, 18.33±0.2o-, 19.64±0.2o-, and 25.07±0.2o- overlap with 10 peaks recited in the reference application’s Claim 1. Therefore, the claims are not patentably distinct, as they are both drawn to a crystalline form of a compound of Formula 1 with at least 10 overlapping characteristic peaks observed in the XRPD pattern
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 11 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of copending Application No. 18/251,074 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to a common pharmaceutical composition.
Claim 10 of the reference application is drawn to a pharmaceutical composition of a compound of formula 1 and a pharmaceutically acceptable carrier. Formula 1 of Claim 1 of the reference application reads on Formula 1 as recited at instant Claim 1 when R1 is defined as propyl. Instant Claim 11 is drawn to a pharmaceutical composition comprising the crystalline form II of claim 1 and a pharmaceutically acceptable carrier. In solution, polymorphs lose the distinguishing polymorphic properties of the crystalline form. Therefore, Claim 11 is drawn broadly to a pharmaceutical composition comprising a compound of formula 1 and a pharmaceutically acceptable carrier.
Taken together, instant Claim 11 and Claim 10 of the reference application are not patentably distinct, as they are drawn to pharmaceutical compositions comprising the same compound and a pharmaceutically acceptable carrier. The pharmaceutical composition as recited at instant Claim 11 does not retain the properties of the polymorph form II in solution.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 11 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of copending Application No. 18/558,142 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to a common pharmaceutical composition.
Claim 9 of the reference application is drawn to a pharmaceutical composition of a compound of formula 1 and a pharmaceutically acceptable carrier. Formula 1 of Claim 1 of the reference application reads on Formula 1 as recited at instant Claim 1 when R1 is defined as propyl. Instant Claim 11 is drawn to a pharmaceutical composition comprising the crystalline form II of claim 1 and a pharmaceutically acceptable carrier. In solution, polymorphs lose the distinguishing polymorphic properties of the crystalline form. Therefore, Claim 11 is drawn broadly to a pharmaceutical composition comprising a compound of formula 1 and a pharmaceutically acceptable carrier.
Taken together, instant Claim 11 and Claim 9 of the reference application are not patentably distinct, as they are drawn to pharmaceutical compositions comprising the same compound and a pharmaceutically acceptable carrier. The pharmaceutical composition as recited at instant Claim 11 does not retain the properties of the polymorph form II in solution.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 11 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of copending Application No. 18/557,866 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to a common pharmaceutical composition.
Claim 17 of the reference application is drawn to a pharmaceutical composition of a compound of formula 1 and a pharmaceutically acceptable carrier. Formula 1 of Claim 1 of the reference application reads on Formula 1 as recited at instant Claim 1 when R1 is defined as propyl. Instant Claim 11 is drawn to a pharmaceutical composition comprising the crystalline form II of claim 1 and a pharmaceutically acceptable carrier. In solution, polymorphs lose the distinguishing polymorphic properties of the crystalline form. Therefore, Claim 11 is drawn broadly to a pharmaceutical composition comprising a compound of formula 1 and a pharmaceutically acceptable carrier.
Taken together, instant Claim 11 and Claim 17 of the reference application are not patentably distinct, as they are drawn to pharmaceutical compositions comprising the same compound and a pharmaceutically acceptable carrier. The pharmaceutical composition as recited at instant Claim 11 does not retain the properties of the polymorph form II in solution.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 11 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of copending Application No. 18/558,351 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to a common pharmaceutical composition.
Claim 12 of the reference application is drawn to a pharmaceutical composition of a compound of formula 1 and a pharmaceutically acceptable carrier. Formula 1 of Claim 1 of the reference application reads on Formula 1 as recited at instant Claim 1 when R1 is defined as propyl. Instant Claim 11 is drawn to a pharmaceutical composition comprising the crystalline form II of claim 1 and a pharmaceutically acceptable carrier. In solution, polymorphs lose the distinguishing polymorphic properties of the crystalline form. Therefore, Claim 11 is drawn broadly to a pharmaceutical composition comprising a compound of formula 1 and a pharmaceutically acceptable carrier.
Taken together, instant Claim 11 and Claim 12 of the reference application are not patentably distinct, as they are drawn to pharmaceutical compositions comprising the same compound and a pharmaceutically acceptable carrier. The pharmaceutical composition as recited at instant Claim 11 does not retain the properties of the polymorph form II in solution.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 11 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of copending Application No. 18/257,705 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to a common pharmaceutical composition.
Claim 11 of the reference application is drawn to a pharmaceutical composition of a compound of formula 1 and a pharmaceutically acceptable carrier. Formula 1 of Claim 1 of the reference application reads on Formula 1 as recited at instant Claim 1 when R1 is defined as propyl. Instant Claim 11 is drawn to a pharmaceutical composition comprising the crystalline form II of claim 1 and a pharmaceutically acceptable carrier. In solution, polymorphs lose the distinguishing polymorphic properties of the crystalline form. Therefore, Claim 11 is drawn broadly to a pharmaceutical composition comprising a compound of formula 1 and a pharmaceutically acceptable carrier.
Taken together, instant Claim 11 and Claim 11 of the reference application are not patentably distinct, as they are drawn to pharmaceutical compositions comprising the same compound and a pharmaceutically acceptable carrier. The pharmaceutical composition as recited at instant Claim 11 does not retain the properties of the polymorph form II in solution.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 11 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of copending Application No. 18/251,111 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to a common pharmaceutical composition.
Claim 11 of the reference application is drawn to a pharmaceutical composition of a compound of formula 1 and a pharmaceutically acceptable carrier. Formula 1 of Claim 1 of the reference application reads on Formula 1 as recited at instant Claim 1 when R1 is defined as propyl. Instant Claim 11 is drawn to a pharmaceutical composition comprising the crystalline form II of claim 1 and a pharmaceutically acceptable carrier. In solution, polymorphs lose the distinguishing polymorphic properties of the crystalline form. Therefore, Claim 11 is drawn broadly to a pharmaceutical composition comprising a compound of formula 1 and a pharmaceutically acceptable carrier.
Taken together, instant Claim 11 and Claim 11 of the reference application are not patentably distinct, as they are drawn to pharmaceutical compositions comprising the same compound and a pharmaceutically acceptable carrier. The pharmaceutical composition as recited at instant Claim 11 does not retain the properties of the polymorph form II in solution.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 11 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of copending Application No. 18/251,129 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to a common pharmaceutical composition.
Claim 11 of the reference application is drawn to a pharmaceutical composition of a compound of formula 1 and a pharmaceutically acceptable carrier. Formula 1 of Claim 1 of the reference application reads on Formula 1 as recited at instant Claim 1 when R1 is defined as propyl. Instant Claim 11 is drawn to a pharmaceutical composition comprising the crystalline form II of claim 1 and a pharmaceutically acceptable carrier. In solution, polymorphs lose the distinguishing polymorphic properties of the crystalline form. Therefore, Claim 11 is drawn broadly to a pharmaceutical composition comprising a compound of formula 1 and a pharmaceutically acceptable carrier.
Taken together, instant Claim 11 and Claim 11 of the reference application are not patentably distinct, as they are drawn to pharmaceutical compositions comprising the same compound and a pharmaceutically acceptable carrier. The pharmaceutical composition as recited at instant Claim 11 does not retain the properties of the polymorph form II in solution.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 11 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of copending Application No. 18/251,084 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to a common pharmaceutical composition.
Claim 11 of the reference application is drawn to a pharmaceutical composition of a compound of formula 1 and a pharmaceutically acceptable carrier. Formula 1 of Claim 1 of the reference application reads on Formula 1 as recited at instant Claim 1 when R1 is defined as propyl. Instant Claim 11 is drawn to a pharmaceutical composition comprising the crystalline form II of claim 1 and a pharmaceutically acceptable carrier. In solution, polymorphs lose the distinguishing polymorphic properties of the crystalline form. Therefore, Claim 11 is drawn broadly to a pharmaceutical composition comprising a compound of formula 1 and a pharmaceutically acceptable carrier.
Taken together, instant Claim 11 and Claim 11 of the reference application are not patentably distinct, as they are drawn to pharmaceutical compositions comprising the same compound and a pharmaceutically acceptable carrier. The pharmaceutical composition as recited at instant Claim 11 does not retain the properties of the polymorph form II in solution.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-4, 6-13, 15-16, 22, and 25 are rejected.
No claim is allowed.
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/D.J.B./ /BRENDA L COLEMAN/ Examiner, Art Unit 1624 Primary Examiner, Art Unit 1624
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