Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
The amendments to the claims filed April 28, 2023 are acknowledged and entered. Claims 1-13 are pending.
Priority
This application is a 371 of PCT/KR2021/015475, filed October 29, 2021, which claims priority to KR 10-2020-0142400, filed October 29, 2020.
Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which applicant may become aware of in the specification.
Information Disclosure Statement
Acknowledgement is made of the Information Disclosure Statements filed on April 28, 2023 and February 20, 2024. All references have been considered except where marked with a strikethrough.
Claim Rejections - 35 USC § 112a
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.
Claims 1-4 and 6-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to crystalline form IV of Formula I, a salt thereof, or a solvate thereof wherein R1 is C2-C5 alkyl and wherein the crystalline compound is characterized by three or more X-ray powder diffraction (XRPD) peaks selected
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However, the instant specification only describes one crystalline compound which corresponds to a hydrate of Formula I wherein R1 is an isopropyl group ( Comparative Example 1, Preparation of crystalline form IV of hydrate of N(( 3S,5S)-1-((3S,4R)-1-(tert-butyl)-4-(4-5 chlorophenyl)pyrrolidine-3-carbonyl)-5-(morpholine-4-carbonyl)pyrrolidin-3-yl)-N-((1s,4R)-4- methylcyclohexyl)isobutyramide hydrochloride [00139]-[00149]; pictured below for convenience). Moreover, the specification teaches that each of the XRPD peaks recited in claim 1 correspond to this crystalline compound of Formula I wherein R1 is an isopropyl group (see Table 1).
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The specification discloses no other crystalline forms of Formula I, solvates thereof, or salts thereof wherein R1 is any group other than isopropyl. The field of chemistry, and especially crystallization of chemical compounds, is highly unpredictable and accurate prediction of which compounds are crystalline cannot be made based on chemical structure alone. Nor is it possible to predict the exact XRPD peaks of a compound based on chemical structure alone as is presently being claimed. A person skilled in the art for instance could not say that Formula I wherein R1 is any group other than isopropyl is crystalline nor could they say that the entire genus that is claimed will have the claimed peaks.
To satisfy the written-description requirement, the specification must describe every element of the claimed invention in sufficient detail so that one of ordinary skill in the art would recognize that the inventor possessed the claimed invention at the time of filing. Vas-Cath, 935 F.3d at 1563; see also Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 [41 USPQ2d 1961] (Fed. Cir. 1997) (patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention”); In re Gosteli, 872 F.2d 1008, 1012 [10 USPQ2d 1614] (Fed. Cir. 1989) (“the description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed”). Thus, an applicant complies with the written-description requirement “by describing the invention, with all its claimed limitations, not that which makes it obvious,” and by using “such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention.” Lockwood, 107 F.3d at 1572.
According to the MPEP §2163 I. A. “the issue of a lack of adequate written description may arise even for an original claim when an aspect of the claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the applicant had possession of the claimed invention. The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional in the art or known to one of ordinary skill in the art.”
Moreover, MPEP §2163 II 3 i) provides that “for inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession….Conception does not occur unless one has a mental picture of the structure of the chemical, or is able to define it by its method of preparation, its physical or chemical properties, or whatever characteristics sufficiently distinguish it. It is not sufficient to define it solely by its principal biological property, e.g., encoding human erythropoietin, because an alleged conception having no more specificity than that is simply a wish to know the identity of any material with that biological property. We hold that when an inventor is unable to envision the detailed constitution of a gene so as to distinguish it from other materials, as well as a method for obtaining it, conception has not been achieved until reduction to practice has occurred, i.e., until after the gene has been isolated.” (citations omitted)). In such instances the alleged conception fails not merely because the field is unpredictable or because of the general uncertainty surrounding experimental sciences, but because the conception is incomplete due to factual uncertainty that undermines the specificity of the inventor’s idea of the invention. Burroughs Wellcome Co. v. Barr Labs. Inc., 40 F.3d 1223, 1229, 32 USPQ2d 1915, 1920 (Fed. Cir. 1994). Reduction to practice in effect provides the only evidence to corroborate conception (and therefore possession) of the invention”. In the present case, it is the crystalline structure of Formula I, salt thereof, or solvates thereof wherein R1 is any group other than isopropyl that cannot be predicted. A person skilled in the art cannot say with specificity that Formula I, a salt thereof, or solvates thereof wherein R1 is any group other than isopropyl will be crystalline and have the claimed XRPD peaks because the art is unpredictable.
Furthermore, MPEP states in §2163 II 3 ii) “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.” In the instant case, the description of a single crystalline species of Formula I is not sufficient to show possession of the entire genus that is claimed.
According to the MPEP §2163.02 Standard for Determining Compliance With the Written Description Requirement,
“The courts have described the essential question to be addressed in a description requirement issue in a variety of ways. An objective standard for determining compliance with the written description requirement is, “does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed". In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon “reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter". Ralston Purina Co. v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)).”
This case was filed before Applicants had a clear idea of which compounds of Formula I, solvates thereof, or salt thereof, are crystalline.
Applicants are reminded of what the U.S. Court of Appeals Federal Circuit wrote in University of California v. Eli Lilly and Co. 43 USPQ2d 1398, "In claims involving chemical materials, generic formulae usually indicate with specificity what the generic claims encompass. One skilled in the art can distinguish such a formula from others and can identify many of the species that the claims encompass. Accordingly, such a formula is normally an adequate description of the claimed genus." "A definition by function, as we have previously indicated, does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is.” See Fiers, 984 F.2d at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen). "It is only a definition of a useful result rather than a definition of what achieves that result." "The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.")".
Therefore, the full breadth of the claim fails to meet the written description provision of 35 U.S.C. §112, first paragraph. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision.
Claim 12-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating obesity and erectile dysfunction does not reasonably provide enablement for
General treatment or prevention of diabetes;
General treatment or prevention of inflammation; or
A method of generally agonizing the function of melanocortin-4 receptor in a subject
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. In the instant case, agonizing the function of melanocortin-4 receptor in a subject appears to be a method treating disease; however, agonizing the function of melanocortin-4 receptor is not recognized as a general strategy for disease treatment as is claimed. Similarly, agonizing the function of melanocortin-4 receptor is not recognized as a general treatment of inflammation or diabetes. Applicant’s disclosure is only enabling for the treatment of conditions which Applicant has demonstrated may be treated by the instant compound, and of specific conditions which the art is aware can be treated by agonizing the function of melanocortin-4 receptor and for which Applicant has written support. Case law is clear on this point. In an unpredictable art, such as drug therapy to treat disease, models may be used for enablement only if there is a well-established correlation between the assay and clinical efficacy. Applicants have not demonstrated nor have they alleged there is any correlation between the reported activity and clinical efficacy against all diseases included in the scope of the claims. Accordingly, a person skilled in the art could not practice the full scope of the invention without undue and unreasonable experimentation.
As a general rule, enablement must be commensurate with the scope of claim language.MPEP 2164.08 states, "The Federal Circuit has repeatedly held that "the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation." In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)" (emphasis added). The "make and use the full scope of the invention without undue experimentation" language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc., 75 USPQ2d 1865, and Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: "A lack of enablement for the full scope of a claim, however, is a legitimate rejection." The principle was explicitly affirmed most recently in Liebel-Flarsheim Co. v. Medrad, Inc., 481 F.3d 1371, 82 USPQ2d 1113; Auto. Tech. Int'l, Inc. v. BMWofN. Am., Inc., 501 F.3d 1274, 84 USPQ2d 1108 (Fed. Cir. 2007), Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 84 U.S.P.Q.2d 1705 (Fed. Cir. 2007), and Sitrick v. Dreamworks, LLC, 516 F.3d 993, 85 USPQ2d 1826 (Fed. Cir. 2008).
In evaluating the enablement question, several factors are to be considered. Note In re Wands, 8 USPQ2d 1400 and Ex parte Forman, 230 USPQ 546. The factors include: 1) The nature of the invention, 2) the state of the prior art, 3) the predictability or lack thereof in the art, 4) the amount of direction or guidance present, 5) the presence or absence of working examples, 6) the breadth of the claims, and 7) the quantity of experimentation needed. The determination that “undue experimentation” would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the above noted factual considerations.
The nature of the invention & breadth of claims:
Claim 1 is drawn to a crystalline form IV of a compound of formula 1, a pharmaceutically acceptable salt thereof, or a solvate thereof. The specification teaches formula I is an agonist of melanocortin-4 receptor (see [0011]).
Claim 12 depends from claim 1 and recites a method for agonizing the function of a melanocortin-4 receptor, comprising administering the crystalline form IV according to claims 1 to subject in need thereof.
Claim 13 depends from claim 12 and recites the method is for preventing or treating obesity, diabetes, inflammation, or erectile dysfunction.
The specification does not provide a definition of a “subject in need” of the claimed method; however, it appears the method is intended to be a treatment of disease (see Background Art, pages 1-5). No definition of which conditions are included in the scope of “inflammation” is provided. “Diabetes” is not defined and includes at least both type I and type II. The nature of the invention therefore includes a method of treating disease by agonism of MC4R, wherein the disease is obesity, erectile dysfunction, inflammation generally, diabetes generally, and any condition which may be associated with melanocortin-4 receptor (MC4R). The method is very broad.
The state of the prior art
The state of the prior art appears to be aware that agonism of MC4R is correlated with the treatment of erectile dysfunction and obesity. However, the state of the prior art is not aware of any single agent or single method which treats all a MC4R related diseases or conditions generally. Moreover, the only diseases that a person skilled in the art would recognize as treatable by instant formula I would be those diseases for which there is an established correlation between agonism of MC4R and treatment of the disease.
Regarding diabetes, the state of the prior art is aware that type I diabetes is treated by insulin. Bluestone et al (Nature 2010, 464(7293) 1293-1300) teaches type I diabetes is an autoimmune disorder. Once diagnosed patients require lifelong insulin treatment. The state of the prior art is not aware that an agonist of MC4R treats all forms of diabetes including type I diabetes.
Regarding inflammation, according the current state of the art there is no such an agent, which can treat inflammatory diseases generally. That is because inflammatory disorders are extremely varied in origin and nature of effect. Placha et al. (Pharmaceutics 2021, 13, 64) teaches inflammatory diseases for instance can be caused by stress or can arise from infection (Abstract), and that inflammation, the underlying cause of inflammatory disease, is complex and can vary depending on the condition (page 2, paragraph 2). Moreover, the origin and the nature of many inflammatory disorders are different one from the other and have different treatments. Placha et al. (Pharmaceutics 2021, 13, 64) for instance teaches conditions such as asthma, psoriasis and inflammatory bowel disease have varied treatment options that do not overlap (Scheme 1, page 6). The symptoms and nature of these diseases are also different one from the other. It can be shown that many of these inflammatory disorders have different origin and nature of effect. Many inflammatory disorders vary in how they affect the body and its functions. The symptoms and nature of inflammatory diseases are also different one from the other. Since the origin and nature of inflammatory disorders vary extremely one from the other, it is impossible to treat them in general as is being claimed.
As per prevention, the state of the prior art is not aware that any condition is prevented by administration of a MC4R agonist.
The Level of One of Ordinary Skill
The level of skill in the art is high. The artisan using the claimed invention would be a person with medical training such as a medical doctor or physician with an MD degree or the equivalent.
Predictability in the art
It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F. 2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. Pharmacological activity in general is a very unpredictable area. Note that in cases involving physiological activity such as the instant case, “the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved”. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
In terms of the law, MPEP 2107.03 states “evidence of pharmacological or other biological activity of a compound will be relevant to an asserted therapeutic use if there is a reasonable correlation between the activity in question and the asserted utility. Cross v. Iizuka, 753 F.2d 1040, 224 USPQ 739 (Fed. Cir. 1985); In re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980); Nelson v. Bowler, 626 F.2d 853, 206 USPQ 881 (CCPA 1980).” If correlation is lacking, it cannot be relied upon, Ex parte Powers, 220 USPQ 924; Rey-Bellet and Spiegelberg v. Engelhardt v. Schindler, 181 USPQ 453; Knapp v. Anderson, 177 USPQ 688. Indeed, the correlation must have been established “at the time the tests were performed”, Hoffman v. Klaus, 9 USPQ2d 1657.
Amount of guidance/working examples
Applicant teaches that the instant crystal form is an agonist of MC4R (see [0011]) and the state of the prior art is aware that compound with such activity may have use in treating obesity and erectile dysfunction.
However, no experimental or other data is provided to show the instant compounds treat any other condition within the scope of the claims. The specification does not provide any guidance to one of ordinary skill in the art to extrapolate the compound activity (agonism of MC4R) to the treatment of all types of diseases claimed. Moreover, Applicant has provided no evidence that the claimed compounds prevent any condition. It is presumed “prevention” of the claimed disease would require a method of identifying those individuals who will develop the claimed diseases before they exhibit symptoms. There is no evidence of record that would guide the skilled clinician to identify those who have the potential of becoming afflicted. Nothing in the specification teaches how one skilled in the art identifies a subject who’s disease will be prevented.
As the Supreme Court said in Brenner v. Manson, 148 USPQ at 696: “a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.” As U.S. Court of Customs and Patent Appeals stated In re Diedrich 138 USPQ at 130, quoting with approval from the decision of the board: “We do not believe that it was the intention of the statutes to require the Patent Office, the courts, or the public to play the sort of guessing game that might be involved if an applicant could satisfy the requirements of the statutes by indicating the usefulness of a claimed compound in terms of possible use so general as to be meaningless and then, after his research or that of his competitors has definitely ascertained an actual use for the compound, adducing evidence intended to show that a particular specific use would have been obvious to men skilled in the particular art to which this use relates.
The quantity of experimentation needed:
MPEP 2164.01(a) states, "A conclusion of lack of enablement means that, based on theevidence 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)."
This conclusion is clearly justified here and one of ordinary skill in the art, even with high level of skill, would have to undergo an undue amount of experimentation to use the invention commensurate in scope with the claims.
Claim Rejections - 35 USC § 112b
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 11-12 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. [A] claim is indefinite when the boundaries of the protected subject matter are not clearly delineated and the scope is unclear (MPEP 2173.04). The following terms and/or phrases render the scope of the claims unclear because the specification does not provide a scope limiting definition of the phrase or term, or any direction for ascertaining the scope of the limitation indicated by the term or phrase. Accordingly, one skilled in the art could not ascertain the metes and bounds of the claimed invention.
In claim 11, “an effective amount” of the crystal form of claim 1 would be required to be present for the pharmaceutical composition to be effective. Insertion of the phrase “an effective amount” following “comprising” is suggested to indicate that what is intended.
Claim 12 recites the limitation “subject in need thereof”. This limitation is indefinite because the specification does not teach or provide any definition of which subjects are in need of agonizing the function of their melanocortin-4 receptor. Are these subjects suffering from any particular disease? Which conditions or diseases are subjects in need of the method suffering from? The metes and bounds of the invention cannot be ascertained because a person of skill in the art cannot say which subjects are in need of the invention. The claim would be more clear if amended to recite a method of treatment as well as specific conditions which are supported by the specification as filed.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18/558,351; or claims 1-14 of copending Application No. 18/558,148; or claims 1-19 of copending Application No. 18/557,866; or claims 1-11 of copending Application No. 18/558,142; or claims 1-19 of copending Application No. 18/258,730; or claims 1-16 of copending Application No. 18/258,717; or claims 1-16 of copending Application No. 18/258,711; or claims 1-13 of copending Application No. 18/251,129; or claims 1-13 of copending Application No. 18/251,084; or claims 1-13 of copending Application No. 18/251,101. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the reference claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Each of the claims of the abovementioned reference application is drawn to a crystalline form of instantly claimed Formula I. The reference claims anticipate the instant claims for that reason that each of the reference claims recites at least 3 X-ray powder diffraction peaks which overlap the instant claims. For example, claim 1 of reference Application No. 18/557,866 recites a crystalline form V of Formula I
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Of the reference peaks indicated above, the peaks at 12.22 ± 0.2, 12.58 ± 0.2 and 17.72 ± 0.2 overlap claim peaks 11.93 ± 0.2, 12.72 ± 0.2, and 17.65 ± 0.2 when considering the error of ± 0.2. The same is true for each of the abovementioned reference applications. Further, the claims of each of the reference applications are also drawn to pharmaceutical compositions and methods of use which overlap the claims. The instant claims are therefore anticipated by the claims of the reference applications.
Conclusion
Claims 1-13 are rejected.
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December 3, 2025
/K.S.M./Examiner, Art Unit 1624
/BRUCK KIFLE/Primary Examiner, Art Unit 1624