DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to a crystalline form III of a compound of formula 1, a pharmaceutically acceptable thereof of a solvate thereof; and monohydrate of N-((3S,5S)-1-((3S,4R)-1-(tert-butyl)-4-(4-chlorophenyl) pyrrolidine-3-carbonyl) pyrrolidine-3-yl)-N-((1s,4R)-4-methylcyclohexyl) isobutyramide hydrochloride as the species of crystalline form III of a compound of formula 1 has been maintained.
Claims 6-10, 12-15, 17-20, and 23-24 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim.
Expansion of Election of Species Requirement
A reasonable and comprehensive search of the elected species conducted by the Examiner determined that the prior art at the time of the present invention was such that it did not anticipate or render obvious the elected species of crystalline form III of a compound of formula 1. In light of this discovery, the search is expanded to the subject matter of the subgenus of the elected species, i.e., N-((3S,5S)-1-((3S,4R)-1-(tert-butyl)-4-(4-chlorophenyl) pyrrolidine-3-carbonyl) pyrrolidine-3-yl)-N-((1s,4R)-4-methylcyclohexyl) isobutyramide hydrochloride.
Status of Claims
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Acknowledgement is made of the receipt and entry of the amendment to the claims filed on July 23, 2026, wherein claim 1 is amended; and claims 2-24 are unchanged.
Claims 1-24 are pending.
Claims 6-10, 12-15, 17-20, and 23-24 remain withdrawn.
Claims 1-5, 11, 16 and 21-22 are under examination in accordance with the elected species along with the expanded species set forth in the Expansion of Election of Species Requirement section above.
Priority
The instant application 18/251,129 filed on April 28, 2023 is a 371 of PCT/KR2021/015473 filed
on October 29, 2021, which claims priority to, and the benefits of Foreign Application No.
KR10-2020-0142398 filed on October 29, 2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55, including a certified English language translation.
Action Summary
Claims 1-5, 11, 16 and 21-22 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 are withdrawn in view the amendments; However, upon further consideration, the rejection has been reapplied.
Claims 1-2, 11, 16, and 21-22 rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Kang et al. (WO 2021/091283 A1; cited in the IDS filed on April 28, 2023), as evidenced by Anderson (Academic Press, 2012: pp. 329-364) are withdrawn; However, upon further consideration, the rejection has been reapplied.
Claims 1-5, 11, 16, and 21-22 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 11 of copending Application No. 18/251,111; over claims 1-5 and 11 of copending Application No. 18/251,101; over claims 1-5 and 11 of copending Application No. 18/251,084; over claims 1-4 and 14-16 of copending Application No. 18/258,711; over claims 1-4, 11 and 14-16 of copending Application No. 18/258,717; over claims 1-4 and 13-19 of copending Application No. 18/258,730; over claims 1-4 and 9 of copending Application No. 18/558,142; over claims 1-4 and 12 of copending Application No. 18/558,148; over claims 1-3 and 12 of copending Application No. 18/558,351; over claims 1-5 and 17-18 of copending Application No. 18/557,866 are withdrawn; However, upon further consideration, the rejection has been reapplied.
Claims 1-5, 11, 16, and 21-22 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-7 of copending Application No. 18/258,705 (reference application) are withdrawn; However, upon further consideration, the rejection has been reapplied.
Claims 1-2, 11, 16, and 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 8-10, 13-17 of U.S. Patent No. 12,516,047 B2 (reference patent), as evidenced by Anderson (Academic Press, 2012: pp. 329-364) are withdrawn; However, upon further consideration, the rejection has been reapplied.
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.
Claims 1-5, 11, 16 and 21-22 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.
Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. In other words, possession of a claimed genus is not established merely by describing a desired result or literal recitation of the generic formula coupled with the desired characteristics. Rather, the specification must disclose either (1) a representative number of species falling within the scope of the claimed genus or (2) structural features common to the members of the genus coupled with their characteristics such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the entire genus. See MPEP 2163.
In the present case, instant amended claim 1 encompasses a broad genus of crystalline forms of compounds of formula (I), pharmaceutically acceptable salts or solvates thereof (collectively refer to therein as “crystalline form III”), and these compounds are characterized by an X-ray powder diffraction pattern having 5 or more characteristic peaks selected from the same list containing, at a minimum, 27 peaks instantly claimed, and that includes a wide variety of combinations. The claim also defines variable R1 of its formula (I) as “C2-C5 alkyl”, including straight-chain or branched C2 to C5 alkyl. Accordingly, the presently claimed genus is drawn to a multitude of compounds of crystalline form III, including free base forms, salts and solvates, results independently selected Markush R1 variables, characterized by a subset of the recited X-ray powder diffraction peaks (5 or more peaks) in any combination.
Although the specification expressly set forth formula (I) and provides definition for the R1 variable, pharmaceutically acceptable salt and solvate, the disclosure does not reasonably convey to one of ordinary skill in the art that applicant had possession of the full scope of formula (I) genus, or salt or solvate thereof characterized by the same X-ray powder diffraction pattern with 5 or more claimed characteristic peaks. Particularly, the specification as-filed only describes a single representative species of crystalline form III, and that is a hydrate of N-((3S,5S)-1-((3S,4R)-1-(tert-butyl)-4-(4-chlorophenyl) pyrrolidine-3-carbonyl)-5-(morpholine-4-carbonyl) pyrrolidin-3-yl)-N-((1s,4R)-4-methylcyclohexyl)isobutyramide hydrochloride having the structure of:
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(see e.g., Example 1 at paragraph [00139]-[00142]) and characterized by having a powder XRD diffraction pattern peaks disclosed in Table 1 and Figure 4. Thus, the working examples of the specification are concentrated in particular crystalline form III species in Example 1, and said species has isopropyl as R1.
While applicant is in possession of crystalline form III of a hydrate of N-((3S,5S)-1-((3S,4R)-1-(tert-butyl)-4-(4-chlorophenyl)pyrrolidine-3-carbonyl)-5-(morpholine-4-carbonyl)pyrrolidin-3-yl)-N-((1s,4R)-4-methylcyclohexyl)isobutyramide hydrochloride with an X-ray powder diffraction pattern as shown in Fig. 4 and Table 1, the specification does not identify any other representative species of crystalline form III of compounds of formula 1, salt or solvate thereof employing other R1 variables, nor does it identify other representative species characterized by an X-ray powder diffraction pattern having 5 or more characteristic peaks. In other words, the disclosure does not provide representative species spanning across the structural variation of R1, nor does it identify common characteristic diffraction peaks sufficient to establish possession of the entire claimed genus. One of ordinary skill in the art would have understood that X-ray powder diffraction pattern acts as a unique fingerprint because every crystalline substance has a distinct internal atomic arrangement; and compounds do not share the exact same set of X-ray powder diffraction pattern. Thus, the X-ray diffraction pattern of a single species of compound encompassed by claim 1 (see Example 1 at paragraph [00139]-[00142]) does not reasonably represent the full genus of compounds exhibiting the X-ray diffraction peaks in its claimed scope. Accordingly, one of ordinary skill in the art would not reasonably conclude from the specification that Applicant were in possession of the entire scope of the genera coupled with X-ray powder diffraction pattern selected from the same list presently recited in the claims.
Therefore, claims 1-5, 11, 16 and 21-22 fail to satisfy the written description requirement under 35 U.S.C. 112(a).
Response to Arguments
Applicant's arguments filed on July 17, 2026 with respect to the rejection of claims 1-5, 11, 16 and 21-22 remain 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 have been fully considered but they are not persuasive.
Applicant amends claim 1 from the recitation of “has 3 or more characteristic peaks” to the recitation of “5 or more characteristic peaks”, and that changes the scope of the claims; therefore, the rejection of record has been revisited and modified in view of the claim amendments.
In Summary, applicant states without acquiescing to the rejection and solely to advance prosecution, Applicant amends claim 1 to be drawn to a crystalline form III of a compound of formula 1, a pharmaceutically acceptable salt thereof, or a solvate thereof, wherein the X-ray powder diffraction (XRPD) pattern has 5 or more characteristic peaks, and wherein R1 is C2-C5 alkyl. Applicant argues that such amendment is sufficient to overcome the rejection of record.
In response, Applicant’s arguments are not found persuasive for the reasons set forth below:
First, the rejection is not based upon an assertion that applicant is not in possession of crystalline form III of hydrate of N-((3S,5S)-1-((3S,4R)-1-(tert-butyl)-4-(4-chlorophenyl)pyrrolidine-3-carbonyl)-5-(morpholine-4-carbonyl)pyrrolidin-3-yl)-N-((1S,4R)-4-methylcyclohexyl)isobutyramide hydrochloride disclosed at paragraph [00139]-[00142] and Table 1 of the specification; Rather, the rejection is directed to the substantial broader scope of claim 1, and the fact that the claimed genus shares the same X-ray powder diffraction pattern.
As noted in the rejection, the claims are drawn to a genus of crystalline compounds, salts, or hydrates thereof coupled with an X-ray diffraction pattern having 5 or more characteristic peaks selected from the same list containing, at a minimum, 27 peaks instantly claimed, and that includes a wide variety of combinations; However, the application as-filed only describes a singular crystalline form (crystalline form III of hydrate of N-((3S,5S)-1-((3S,4R)-1-(tert-butyl)-4-(4-chlorophenyl)pyrrolidine-3-carbonyl)-5-(morpholine-4-carbonyl)pyrrolidin-3-yl)-N-((1S,4R)-4-methylcyclohexyl)isobutyramide hydrochloride at paragraph [00139]-[00142] and Table 1 of the specification). A person skilled in the art would have understood that an X-ray powder diffraction pattern represents a unique fingerprint that is specific to a particular crystalline arrangement of the molecule, and reasonably recognized that different crystalline compounds encompassed by the formula (I) will have different X-ray powder diffraction patterns (XRPD). Thus, that specific, single crystal form III disclosed by the applicant in Example 1 is not representative of the claimed genus, which embraced different compound species of formula I composed of different R1 variables within the present Markush definition, and different pharmaceutically acceptable salts and solvates thereof. There is lack of written basis supporting that the full scope of the compounds of formula (I), salts or solvates embraced by claim 1 will all have 5 or more of the claimed peaks. Accordingly, the disclosure of that singular crystalline form does not reasonably convey to one of ordinary skill in the art that applicant truly envisioned the whole range.
Applicant have not explained or pointed to specific support in the specification that adequately describe a representative number of species of the claimed genus. Considering the unpredictability in the field of pharmaceutical crystalline forms and since it is well known in the art that small changes in structure can cause large changes in the X-ray powder diffraction, it is not readily apparent that the data provided in the specification as-filed can be expanded or generalized to the claimed genus. Therefore, the rejection is reapplied, revisited and modified in view of the amendments.
Claim 11 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling to the extent that the claims encompass solid pharmaceutical compositions comprising a specifically disclosed crystalline form III, i.e., a hydrate of N-((3S,5S)-1-((3S,4R)-1-(tert-butyl)-4-(4-chlorophenyl)pyrrolidine-3-carbonyl)-5-(morpholine-4-carbonyl)pyrrolidin-3-yl)-N-((1s,4R)-4-methylcyclohexyl)isobutyramide hydrochloride, and a pharmaceutically acceptable carrier under formulation and processing conditions that do not materially alter the disclosed crystalline form, does not reasonably provide enablement for full scope of the claim. 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.
In the present case, claim 11 is directed to pharmaceutical composition comprising the crystalline form III of claim 1 and a pharmaceutically acceptable carrier. Claim 1, from which claim 11 ultimately derives its crystalline-form limitation, broadly encompass crystalline form III of a compound of formula 1 without restricting the crystalline material to a particular chemical structure, formulation, carrier, or formulation conditions.
The specification demonstrates hydrate of N-((3S,5S)-1-((3S,4R)-1-(tert-butyl)-4-(4-chlorophenyl)pyrrolidine-3-carbonyl)-5-(morpholine-4-carbonyl)pyrrolidin-3-yl)-N-((1S,4R)-4-methylcyclohexyl)isobutyramide hydrochloride is capable of existing in a particular solid-state crystal form, referred to therein as crystalline form III; and that the solid-state crystal form obtained is dependent upon the conditions under which N-((3S,5S)-1-((3S,4R)-1-(tert-butyl)-4-(4-chlorophenyl)pyrrolidine-3-carbonyl)-5-(morpholine-4-carbonyl)pyrrolidin-3-yl)-N-((1S,4R)-4-methylcyclohexyl)isobutyramide hydrochloride is processed. For example, the specification discloses the claimed crystalline form III can be obtained by dissolving N-((3S,5S)-1-((3S,4R)-1-(tert-butyl)-4-(4-chlorophenyl)pyrrolidine-3-carbonyl)-5-(morpholine-4-carbonyl)pyrrolidin-3-yl)-N-((1S,4R)-4-methylcyclohexyl)isobutyramide in 1 mL of EtOAc and 0.15 mL of distilled water at 60°C, and then cooled to 3°C for 25 hours; whereas the same crystal cannot be obtained by dissolving the same compound in 1 mL of EtOAc at room temperature. Thus, Applicant’s own disclosure establishes that the solid-state crystal form of compound of formula (I) is sensitive to its physicochemical environment and its processing history.
The specification provides general disclosure concerning pharmaceutical compositions and identifies numerous pharmaceutically acceptable carriers, and conventional dosage forms (see e.g., [0075]-[0080]). However, these teachings do not provide representative experimental pharmaceutical formulations demonstrating that the claimed crystalline form III of compound of formula 1 is maintained when combined across the full scope of pharmaceutically acceptable carriers encompassed by claim 11.
The concern is supported by the state of the pharmaceutical solid-state art. Sood et al. (Ther Deliv, 2015. Vol. 6(6): 721-740) teaches that excipients and formulation variables are used to modify stability and physiochemical properties of dosage forms and importantly, that excipients may influence the crystal structure of solid and may modify the rate and direction of crystal growth. Thus, the effect of incorporating a crystalline active pharmaceutical ingredient into a formulation is not necessarily neutral. Sood et al. further teaches that crystal habit may influence pharmacokinetic properties of a dosage form (see e.g., abstract).
Censi et al. (Molecules 2015, 20, 18759-18776) similarly teaches that crystalline polymorphs having the same chemical composition possess different internal crystal structures and, consequently, can possess different physiochemical properties because of their different lattice structures and/or molecular conformations (see e.g., p. 18761, last paragraph). Censi et al. further teaches that polymorphic forms may differ in properties including melting point, density, stability, and solubility, and that particular excipients and technological processes may promote solid-state transitions. Censi et al. additionally explains that solid-state transformation must be monitored during formulation, manufacture and storage to ensure reproducible pharmaceutical performance (see e.g., p. 18762-18763).
The teachings of Sood et al. and Censi et al. are relied upon not to establish that every pharmaceutically acceptable carrier necessarily converts the claimed crystalline form III into a different crystalline form. Rather, these teachings are used as evidence that the effect of pharmaceutically acceptable carriers and formulation condition upon crystalline form cannot reasonably be presumed to be invariant across the broad scope encompassed by the claim. Accordingly, while the specification enables preparation and characterization of crystalline form III of the compound of Formula (I) (i.e., hydrate of N-((3S,5S)-1-((3S,4R)-1-(tert-butyl)-4-(4-chlorophenyl)pyrrolidine-3-carbonyl)-5-(morpholine-4-carbonyl)pyrrolidin-3-yl)-N-((1S,4R)-4-methylcyclohexyl)isobutyramide hydrochloride) and generally teaches that those materials may be formulated into pharmaceutical compositions, the disclosure does not provide sufficient representative examples, formulation-specific solid-state characterization, or a general applicable technical principle by which a person of ordinary skill could determine, without undue experimentation, which of the numerous carriers, carrier concentrations, processing conditions, and dosage forms would preserve the requisite crystalline material throughout preparation of the claimed pharmaceutical composition.
I. Legal Standard
The enablement requirement of 35 U.S.C. 112(a) requires the specification to teach a person of
ordinary skill in the art how to make and use the claimed invention without undue experimentation. Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: (1) the nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and, (8) the quantity of experimentation necessary. No single factor is dispositive, and the factors must be weighed together. MPEP 2164.01(a). All of the Wands factors have been considered and discussed below:
Factor 1: Breadth of the claims
In the present case, claim 11 is drawn to a broad genus of pharmaceutical composition. Said claim is not restricted to a particular carrier, nor restricted to a particular class of carrier, amount of carriers, dosage form, manufacturing process, or formulation condition. Claim 1, from which claim 11 ultimately derives its crystalline-form limitation, and that also broadly encompasses crystalline forms of the compound of formula 1. Said claim 1 permits multiple independently selected structural variables within formula 1. Particularly, formula 1 permits R1 to be selected from C2-C5 alkyl, including straight chain or branched alkyl. The claim therefore encompasses pharmaceutical composition employing essentially any pharmaceutically acceptable carrier(s) with the claim language. The breadth of possible combination of compound of formula (I) (with independent selected Markush variable), carriers, amount of carriers, processing conditions is therefore substantial.
Factor 2: Nature of the invention
The claimed subject matter concerns pharmaceutical compositions containing the crystalline form III of the compound of formula 1 as active pharmaceutically active ingredient. Applicant’s own specification establishes that the crystalline form III of the compound of formula 1, characterized by having particular characteristics peaks in the X-ray powder diffraction pattern (see e.g., Table 1 and Figure 4), is prepared using a particular compound of formula 1 (N-((3S,5S)-1-((3S,4R)-1-(tert-butyl)-4-(4-chlorophenyl)pyrrolidine-3-carbonyl)-5-(morpholine-4-carbonyl)pyrrolidin-3-yl)-N-((1S,4R)-4-methylcyclohexyl)isobutyramide) and processing method (see e.g., Example 1 in [00139]-[00142]). The specification further established said compound of formula 1 (N-((3S,5S)-1-((3S,4R)-1-(tert-butyl)-4-(4-chlorophenyl)pyrrolidine-3-carbonyl)-5-(morpholine-4-carbonyl)pyrrolidin-3-yl)-N-((1S,4R)-4-methylcyclohexyl)isobutyramide) when undergoes a different processing method, such as dissolving said compound in 1 mL of EtOAc at room temperatures, cannot arrive at the same crystalline form (see e.g., page 17, Example 4 and Example 7), and that includes crystalline form H with different X-ray powder diffraction pattern (see e.g., Comparative Example 1 in [00143]-[00144]). Therefore, the nature of the invention is not merely mixing an arbitrary species of compound of formula 1 or a pharmaceutically acceptable salt or solvate thereof with an inert carriers, but depends upon the preservation of the crystalline material within a pharmaceutical composition concerns solid-state interactions and formulation conditions.
Factor 3: State of the prior art
The state of the art establishes that polymorphism and solid-state transformation are recognized concerns in pharmaceutical development. Sood et al. (Ther Deliv, 2015. Vol. 6(6): 721-740) teaches that excipients and formulation variables can influence crystal structure and crystal growth. Censi et al. (Molecules 2015, 20, 18759-18776) teaches chemical composition of crystalline polymorphs possess different physiochemical properties, and the excipients and technological processes can influence solid-state transitions. Accordingly, the state of the art establishes that formulation components cannot universally be presumed to have no effect upon the crystalline state of an active pharmaceutical ingredient.
Factor 4: Level of ordinary skill
A person of ordinary skill in the art would have possessed substantial knowledge concerning pharmaceutical formulation, polymorphism, crystallization, and conventional analytical techniques, such as XRPD and DSC. Such a person would also know conventional synthetic transformation and would be capable of preparing many analogs within the claimed formula and modifying synthetic route.
This factor weighs in Applicant’s favor to the extent that the skilled artisan would have known how to synthesize structurally related analogs, and formulate and characterize individual compositions. However, a high level of skill does not provide a predictive teaching identifying which of the variable within the present Markush definition can arrive a crystalline form with the claimed characteristics; and also does not provide predictive teachings identify which combination of the compound of formula 1, and members of the broad universe of pharmaceutically acceptable carriers encompassed by the claim will preserve a particular crystalline lattice under the numerous processing and storage conditions encompassed by the claims. Rather, the skilled artisan’s knowledge provides the means for experimentally determining the resulting solid-state.
Factor 5: Predictability or unpredictability of the art
Although persons of ordinary skill possessed conventional methods for synthesizing compound of formula 1, preparing pharmaceutical formulations and characterizing solid-state forms, the evidence does not establish that the effect of the broad range of carrier(s), carrier(s) concentrations, processing conditions, and dosage forms encompassed by the claim on the crystalline state of compound of formula 1 could reliably extrapolated across the full scope of the claims.
Applicant’s own specification demonstrates that the identical species of compound of formula 1 (N-((3S,5S)-1-((3S,4R)-1-(tert-butyl)-4-(4-chlorophenyl)pyrrolidine-3-carbonyl)-5-(morpholine-4-carbonyl)pyrrolidin-3-yl)-N-((1S,4R)-4-methylcyclohexyl)isobutyramide) can exist in crystalline forms other than the crystalline form III disclosed in Example 1, and that form depends on its physiochemical environment and processing condition. In view of Sood’s teachings that excipients may influence crystal structure and crystal growth behavior and Censi’s teachings that formulation components and technological processes may facilitate solid-state transitions, even though individual formulations could be prepared and evaluated using routine techniques, the specification does not provide a generally applicable predictive principle permitting the skilled artisan to identify operative embodiments throughout the full breadth claimed without the need for substantial empirical formulation and solid-state characterization.
Factor 6: Amount of guidance or direction provided in the specification
The specification provides substantial general guidance regarding pharmaceutical
dosage forms, routes of administration, dosing ranges, and pharmaceutically acceptable carriers. However, the specification does not provide corresponding guidance identifying which carrier(s) or classes thereof preserve the claimed crystalline material; which carrier(s) or processing condition induce conversion to another polymorph, solvate or amorphous material; permissible concentrations of the respective carrier(s) for preservation of the crystalline state; or a general predictive relationship between carrier(s) identity and maintenance of the claimed crystalline lattice. Therefore, while the specification teaches the skilled artisan numerous materials that may be selected, it does not provide sufficient direction concerning which selections will produce pharmaceutical compositions retaining the crystalline subject matter required by the claims.
Factor 7: Existence of working examples
The specification contains working examples concerning preparation and solid-state characterization of crystalline form III of compound of formula 1, i.e., hydrate of N-((3S,5S)-1-((3S,4R)-1-(tert-butyl)-4-(4-chlorophenyl)pyrrolidine-3-carbonyl)-5-(morpholine-4-carbonyl)pyrrolidin-3-yl)-N-((1S,4R)-4-methylcyclohexyl)isobutyramide hydrochloride (see e.g., paragraph [00139]-[00142] and [00145]-[00150]). Said example establish enablement of hydrate of N-((3S,5S)-1-((3S,4R)-1-(tert-butyl)-4-(4-chlorophenyl)pyrrolidine-3-carbonyl)-5-(morpholine-4-carbonyl)pyrrolidin-3-yl)-N-((1S,4R)-4-methylcyclohexyl)isobutyramide hydrochloride. However, no representative working pharmaceutical-composition examples have been identified demonstrating retention of the claimed crystalline material across the broad range of carrier(s) and dosage forms. The rejection therefore does not take the position that Applicant has enabled no embodiment. Rather, the concern is that the demonstrated embodiments and general formulation disclosure are not reasonably commensurate with the substantially broader claimed scope.
Factor 8: Quantity of experimentation necessary.
To practice the full scope of claim 11 while ensuring that the composition contains the required crystalline form III of compound of formula 1, a person of ordinary skill would have to select among the numerous R1 variables within the present Markush definition to arrive at the compound of formula 1, and then further select among the numerous encompassed carrier(s), carrier(s) concentrations, and formulation processes to prepare the respective compositions; and then determine experimentally whether the crystalline state of compound of formula 1 is retained or transformed. Such determination would reasonably require solid-state characterization, e.g., XRPD, DSC, and/or other appropriate analytical testing across materially different formulations and processing conditions.
While each individual characterization technique may have been conventional, the issue is not whether XPRD and DSC was difficult to perform. Rather, the issue is the extent of empirical formulation and characterization required to identify operative embodiments throughout the broad scope of claim 11 in the absence of a disclosed predictive principle identifying which formulation conditions preserve the claimed crystalline state. The necessity to proceed through the claimed scope by formulation, testing and solid-state characterization weighs toward undue experimentation.
Conclusion
Upon consideration of Wand factors as a whole, the breadth of claim 11, the polymorphic nature of compound of formula 1 demonstrated by Applicant’s own specification, the recognized ability of carriers and formulation variables to influence crystal structure and solid-state transitions, the absence of representative pharmaceutical-composition examples reasonably commensurate with the breadth claimed, and the quantity of empirical formulation and the solid-state characterization required to establish that the specification does not enable the full scope of clam 11 without undue experimentation.
The Examiner acknowledged that the specification enables preparation of the specifically disclosed crystalline form of the compound of formula (I) (hydrate of N-((3S,5S)-1-((3S,4R)-1-(tert-butyl)-4-(4-chlorophenyl)pyrrolidine-3-carbonyl)-5-(morpholine-4-carbonyl)pyrrolidin-3-yl)-N-((1S,4R)-4-methylcyclohexyl)isobutyramide hydrochloride) and provides sufficient general teachings to prepare at least certain pharmaceutical compositions containing such crystalline material. The rejection is therefore not based upon an assertion that the pharmaceutic compositions containing the compound of formula 1 cannot be made. Rather, the rejection is directed to the substantial broader scope of claim 11, which encompass the claimed crystalline material in combination with broadly unrestricted pharmaceutical acceptable carrier(s), without disclosure reasonably enabling preservation and use of the claimed crystalline state throughout that scope without undue experimentation.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-2, 11, 16, and 21-22 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kang et al. (WO 2021/091283 A1; cited in the IDS filed on April 28, 2023).
Kang et al. teaches a compound of Example 1, N-((3S,5S)-1-((3S,4R)-1-(tert-butyl)-4-(4-chlorophenyl)pyrrolidine-3-carbonyl)pyrrolidine-3-yl)-N-((1s,4R)-4-methylcyclohexyl)isobutyramide hydrochloride, having the structure of:
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is an exemplary compound of Formula I (see e.g., [155]-[156]). Kang et al. further teaches said compound of Example 1 was prepared as follows: N-((3S,5S)-1-((3S,4R)-1-(tert-butyl)-4-(4-chlorophenyl)pyrrolidine-3-carbonyl)-5-(morpholinc-4-carbonyl)pyrrolidin-3-yl)-N-((1s,4R)-4-mcthylcyclohcxyl)isobutyramide was dissolved in ethyl acetate, and a 2N hydrochloric acid ethyl acetate solution was slowly added; after stirring at room temperature for 30 minutes, the reaction solvent was concentrated under reduced pressure; and the resulting crude solid was purified by trituration using hexane and diethyl ether to obtain the title compound (see e.g., [173]). Kang et al. further teaches a pharmaceutical composition comprising the compound of Formula 1, or a pharmaceutically acceptable salt or isomer thereof as an active ingredient, together with a pharmaceutically acceptable carrier, wherein the compound is selected from: N-((3S,5S)-1-((3S,4R)-1-(tert-butyl)-4-(4-chlorophenyl)pyrrolidine-3-carbonyl)pyrrolidine-3-yl)-N-((1s,4R)-4-methylcyclohexyl)isobutyramide (see e.g., [69]; claims 4, 6-7).
In the present case, Kang et al. is silent regarding the limitation of “the X-ray powder diffraction pattern has 5 or more characteristic peaks selected from among peaks with the following diffraction angles (2θ values) of: 17.37±0.2°…, 24.66±0.2°, 25.52±0.2°”; However, Kang et al. expressly prepares the same stereochemically defined hydrochloride salt encompassed by Formula I and converts the compound to its hydrochloride salt by dissolving the compound in ethyl acetate, stirring the resulting solution, concentrating the solvent, and recovering the resulting product as a solid (see paragraph [173]). Significantly, the instant disclosure identifies ethyl acetate as a crystallization solvent suitable for preparing crystalline Form III and broadly describes preparation of Form III by dissolving a compound of Formula I in a crystallization solvent and obtain crystals from the resulting solution (see paragraph [0053]-[0059] of instant specification). Thus, Kang et al. does not merely disclose the same chemical compound or generically disclose hydrochloride salt thereof. Kang et al. actually prepares the same hydrochloride species through a solvent-based solid-forming process employing ethyl acetate, a crystallization solvent expressly disclosed by Applicant for preparing the presently claimed crystalline Form III. Accordingly, the identity of the species and the substantial correspondence between the manner in which Kang et al. obtains the solid and the manner disclosed by Applicant for obtaining Form III provide a reasonable basis for concluding that the solid product of Kang et al. inherently possesses the crystalline characteristics recited in claim 1, including at least five of the recited XRPD peaks.
Where the prior art product appears to be identical or substantially identical to the claimed product, the burden shifts to Applicant to establish that the prior art product does not necessarily or inherently possess the claimed characteristics.
Therefore, the claimed invention is being anticipated by Kang et al.
Response to Arguments
Applicant's arguments filed on June 8, 2026 with respect to the rejection of claims 1-2, 11, 16, and 21-22 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Kang et al. (WO 2021/091283 A1), as evidenced by Anderson, have been fully considered but they are not persuasive. It is respectfully noted that applicant has submitted a certified English language translation of the non-English language foreign application (Foreign priority document KR10-2020-0142398 filed on October 29, 2020) with a statement that the translation of the certified copy is accurate on July 28, 2026, which is after the mailing date of the Non-Final Office Action mailed on February 23, 2026. In view of said certified copies, Kang et al. is a prior art under 35 U.S.C. 102(a)(2) given that it was effectively filed before the effective filing date of the claimed invention.
In Summary, Applicant argues Kang et al. fails to anticipate the claimed invention, because the prior art is entirely silent about the 5 or more characteristic diffraction peaks instantly claimed. Applicant argues the Examiner fails to demonstrate all the claimed limitations are explicitly disclosed and/or inherent in the reference and fails to verify that the crystalline form II was indeed produced.
In response, Applicant’s argument that Kang et al. does not expressly disclose the recited XRPD peaks has been considered but is not found persuasive. The rejection does not rely upon an express XRPD characterization by Kang et al. Rather, Kang et al. expressly prepares the same hydrochloride species encompassed by claim 1 by dissolving the corresponding compound in ethyl acetate, adding hydrochloric acid in ethyl acetate, and recovering the resulting product as a solid following concentration of the solvent (see paragraph [173]). The instant disclosure identifies ethyl acetate as a crystallization solvent for preparing crystalline Form III and broadly describes preparation of Form III by dissolving a compound of Formula I in a crystallization solvent and obtaining crystal from the resulting solution.
Thus, there is a reasonable factual and technical basis for concluding that the solid product actually produced by Kang et al. inherently possesses the claimed crystalline characteristics. The fact that Kang et al. did not recognize or expressly report these characteristics by XRPD does not establish that they are absent.
Therefore, the rejection is maintained but revisited and modified in view of the claim amendments.
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 1-5, 11, 16, and 21-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 11, 14-24 of copending Application No. 18/251,111; over claims 1-4, 11, 15-16, 22 and 25 of copending Application No. 18/251,101; over claims 1-5, 11, 14-20 of copending Application No. 18/251,084; over claims 1-4, 11, and 14-26 of copending Application No. 18/258,711; over claims 1-4, 11 and 14-26 of copending Application No. 18/258,717; over claims 1-4 and 9 of copending Application No. 18/558,142; and over claims 1-5, 12, and 15-24 of copending Application No. 18/558,351.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of the reference applications.
Each of the claims of the abovementioned reference application is drawn to a crystalline form of a compound of the claimed formula 1, a pharmaceutically acceptable salt thereof, or a solvate thereof. Each of the reference claims recite characteristics peaks in the X-ray powder diffraction pattern that overlap or lie inside the ranges instantly claimed. For instance, claim 1 of copending Application No. 18/251,111 is drawn to a crystalline form IV of a compound of the following formula 1, a pharmaceutically acceptable salt thereof, or a solvate thereof, said formula 1 includes N-((3S,5S)-1-((3S,4R)-1-(tert-butyl)-4-(4-chlorophenyl)pyrrolidine-3-carbonyl)pyrrolidine-3-yl)-N-((1s,4R)-4-methylcyclohexyl)isobutyramide. It is further noted that the crystalline form of the reference application contains at least 5 characteristics peaks that overlap or lie inside the ranges instantly claimed, for instance, the characteristics peaks at
9.69
±
0.2
°
(overlaps with the characteristic peak recites in the instant claim, 9.89±0.2°), 10.63 ± 0.2° (overlaps with the characteristic peak recites in the instant claim, 10.83 ± 0.2°), 12.72 ± 0.2° (overlaps with the characteristic peak recites in the instant claim, 12.92 ± 0.2°), 14.57 ± 0.2° (overlaps with the characteristic peak recites in the instant claim, 14.61 ± 0.2°), and 18.24 ± 0.2° (overlaps with the characteristic peak recites in the instant claim, 18.20 ± 0.2°) of the reference application overlaps with the peaks of instant application. The same is true for each of the above mentioned reference applications. In addition, the claims of each of the reference applications are also drawn to a pharmaceutical composition comprising the crystalline form and a pharmaceutically acceptable carrier.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-5, 11, 16 and 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 13 and 16-29 of U.S. Patent No. 12,703,683 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference patent is drawn to a crystalline form of a compound of the claimed formula 1, a pharmaceutically acceptable salt thereof, or a solvate thereof; and the recited characteristics peaks in the X-ray powder diffraction pattern overlaps or lie inside the ranges instantly claimed. For examples, the characteristics peaks at 17.465±0.1° (overlaps with the characteristic peak recites in the instant claim, 17.37±0.2°), 18.859 ± 0.1° (overlaps with the characteristic peak recites in the instant claim, 18.99 ± 0.2°), 19.333 ± 0.1° (overlaps with the characteristic peak recites in the instant claim, 19.34 ± 0.2°), 20.642 ± 0.1° (overlaps with the characteristic peak recites in the instant claim, 20.40 ± 0.2°), and 22.679 ± 0.1° (overlaps with the characteristic peak recites in the instant claim, 22.45 ± 0.2°) of the reference application overlaps with the peaks of instant application.
Response to Arguments
Applicant's arguments filed on July 23, 2026 with respect to the provisional rejection of claims 1-5, 11, 16, and 21-22 on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 11 of copending Application No. 18/251,111; over claims 1-5 and 11 of copending Application No. 18/251,101; over claims 1-5 and 11 of copending Application No. 18/251,084; over claims 1-4 and 14-16 of copending Application No. 18/258,711; over claims 1-4, 11 and 14-16 of copending Application No. 18/258,717; over claims 1-4 and 13-19 of copending Application No. 18/258,730; over claims 1-4 and 9 of copending Application No. 18/558,142; over claims 1-4 and 12 of copending Application No. 18/558,148; over claims 1-3 and 12 of copending Application No. 18/558,351; over claims 1-5 and 17-18 of copending Application No. 18/557,866 have been fully considered but they are not persuasive.
Applicant requests the double patenting rejections be held in abeyance until the identification of allowable subject matter.
In response, since Applicant did not put forth any arguments specifically against this obviousness-type double patenting rejection, the rejection has been reapplied for the same reasons of record and the reasons set forth herein in view of the amendments.
Moreover, the Examiner noted that the copending application No. 18/258,730 is now an issued U.S. Patent No. 12,703,683 B2 published on August 11, 2026, which do not have the same claim numbers and language. Therefore, the rejection of record has also been reapplied in light of the issued patent for the reasons set forth herein.
Claims 1-5, 11, 16, and 21-22 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-10 and 15-17 of copending Application No. 18/258,705 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference application are drawn to a method that comprises a crystalline form of the compound of formula 1:
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having an X-ray powder diffraction pattern having characteristics peaks selected from among peaks that overlap or lie inside the ranges instantly claimed, and these peaks have the
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216
624
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. For instance, the characteristics peaks at 12.841±0.2° (overlaps with the characteristic peak recites in the instant claim, 12.92±0.2°), 10.5969 ± 0.2° (overlaps with the characteristic peak recites in the instant claim, 10.83 ± 0.2°), 15.5738 ± 0.2° (overlaps with the characteristic peak recites in the instant claim, 15.36 ± 0.2°), 17.305 ± 0.2° (overlaps with the characteristic peak recites in the instant claim, 17.37 ± 0.2°), and 18.364 ± 0.2° (overlaps with the characteristic peak recites in the instant claim, 18.20 ± 0.2°)
of the reference application overlaps with the peaks of instant application. The claims of the reference application also pertain to a pharmaceutical composition comprising the amorphous compound of formula I and a pharmaceutically acceptable carrier, in which said amorphous compound comprises the crystalline form; and therefore, the pharmaceutical composition comprises the crystalline compound instantly claimed.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed on July 23, 2026 with respect to the provisional rejection of claims 1-5, 11, 16, and 21-22 on the ground of nonstatutory double patenting as being unpatentable over claims 6-7 of copending Application No. 18/258,705 (reference application) have been fully considered but they are not persuasive.
Applicant requests the double patenting rejections be held in abeyance until the identification of allowable subject matter.
In response, since Applicant did not put forth any arguments specifically against this obviousness-type double patenting rejection, the rejection has been reapplied for the same reasons of record and the reasons set forth herein in view of the claim amendments.
Claims 1-2, 11, 16, and 21-22 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,516,047 B2 (reference patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference patent is drawn to a compound of Formula I, or a pharmaceutically acceptable salt thereof, wherein the compound is selected from N-((3S,5S)-1-((3S,4R)-1-(tert-butyl)-4-(4-chlorophenyl)pyrrolidine-3-carbonyl)pyrrolidine-3-yl)-N-((1s,4R)-4-methylcyclohexyl)isobutyramide and the pharmaceutically acceptable salt is the hydrochloric acid salt. The claims of the reference patent are also drawn to a pharmaceutical composition comprising said compound and a pharmaceutically acceptable carrier.
In the present case, the reference patent is silent regarding the limitation of “the X-ray powder diffraction pattern has 3 or more characteristic peaks selected from among peaks with the following diffraction angles (2θ values) of: 17.37±0.2°…, 24.66±0.2°, 25.52±0.2°”; However, the specification of the reference patent expressly disclosed the method of preparing the hydrochloric acid salt of compound of Formula I. Particularly, the reference patent expressly prepares the same stereochemically defined hydrochloride salt encompassed by Formula I and converts the compound to its hydrochloride salt by dissolving the compound in ethyl acetate, stirring the resulting solution, concentrating the solvent, and recovering the resulting product as a solid (see paragraph [173]). Significantly, the instant disclosure identifies ethyl acetate as a crystallization solvent suitable for preparing crystalline Form III and broadly describes preparation of Form III by dissolving a compound of Formula I in a crystallization solvent and obtain crystals from the resulting solution (see paragraph [0053]-[0059] of instant specification). Thus, the claims of reference patent do not merely disclose the same chemical compound or generically disclose hydrochloride salt thereof. The reference patent actually prepares the same hydrochloride species through a solvent-based solid-forming process employing ethyl acetate, a crystallization solvent expressly disclosed by Applicant for preparing the presently claimed crystalline Form III. Accordingly, the identity of the species and the substantial correspondence between the manner in which the reference patent obtains the solid and the manner disclosed by Applicant for obtaining Form III provide a reasonable basis for concluding that the solid product of reference patent inherently possesses the crystalline characteristics recited in claim 1, including at least five of the recited XRPD peaks.
Response to Arguments
Applicant's arguments filed on July 23, 2026 with respect to the rejection of claims 1-2, 11, 16, and 21-22 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 8-10, 13-17 of U.S. Patent No. 12,516,047 B2 (reference patent), as evidenced by Anderson (Academic Press, 2012: pp. 329-364) have been fully considered but they are not persuasive.
Applicant requests the double patenting rejections be held in abeyance until the identification of allowable subject matter.
In response, since Applicant did not put forth any arguments specifically against this obviousness-type double patenting rejection, the rejection has been reapplied for the same reasons of record and the reasons set forth herein in view of the claim amendments.
Conclusion
No claims are allowed.
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/CHIHYI LEE/Examiner, Art Unit 1628 /JEAN P CORNET/Primary Examiner, Art Unit 1628
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