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 the crystalline or pharmaceutically acceptable solvate or hydrate thereof; and a pharmaceutical composition comprising said crystalline and at least one pharmaceutically acceptable excipient; and Crystalline Form I of N-(2,4,5-trifluoro-3-(3-morpholinoquinoxaline-6-carbonyl) phenyl) propane-1-sulfonamide as the elected crystalline species are maintained.
Claims 30-33 and 39 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim.
Status of Claims
Acknowledgement is made of the receipt and entry of the amendment to the claims filed on May 5, 2026, wherein claims 1, 3, 4, 10, 11, 13, 25, 30 are amended; claims 2, 5-9, 12, 13-24, 26-29 are cancelled; and claims 31-33 and 39 are unchanged; claims 34-38 and 40-65 are cancelled.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3-4, 10-11, 13, 25, 30-33 and 39 are pending.
Claims 30-33 and 39 remain withdrawn.
Claims 1, 3-4, 10-11, 13 and 25 are under examination in accordance with the elected invention and species.
Priority
The instant application 18/255,227 filed on May 31, 2023 is a 371 of PCT/US21/61375 filed
on December 1, 2021, which claims priority to, and the benefits of U.S. Provisional Application No.
63/120,588 filed on December 2, 2020.
Action Summary
Applicant’s amendment to the claims overcome each and every objection previously sets forth in the Non-Final Office Action mailed on February 6, 2026.
Claims 1, 3-4, 10-11, 13 and 15 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement are withdrawn in light of the claim amendments.
Claims 1, 3-4, and 13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention are withdrawn in light of the claim amendments.
Claim 11 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention are maintained.
Claims 1, 3, 10-11, 13 and 15 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhu et al. (US-2013/0053384 A1; cited in the IDS filed on February 9, 2024) are maintained, but revisited and modified in light of the claim amendments.
Claims 1, 3, 10-11, 13 and 15 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3 and 14 of U.S. Patent No. 10,561,652 B2 are maintained, but revisited and modified in light of the claim amendments.
Drawings
The drawings are objected to because of the following informalities:
Figure 2: the text and numerical numbers recites therein appears to be blurry and unreadable, e.g., “
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”; the numerical numbers on the x-axis and y-axis are also blurry and unreadable.
Figure 3: the numerical numbers on the y-axis appears to be blurry and unreadable, e.g., “
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”.
Figure 5: the text and numerical numbers recites therein appears to be blurry and unreadable, e.g., “
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”; the numerical numbers on the x-axis and y-axis are also blurry and unreadable.
Figure 7 and 9 : the numerical numbers on the x-axis and the y-axis appears to be blurry and unreadable.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1, 4, 10-11 and 13 are objected to because of the following informalities:
Regarding claim 1, the recitation of “Crystalline Form I” is grammatically incorrect, because said recitation is missing an proper article prior to a singular countable nouns (“Crystalline Form I”). Said singular countable noun requires an article “a”, and should read –A crystalline Form I--.
Regarding claims 4, 10-11 and 13, the claim(s) repeatedly missing a proper article (e.g., “the”) before the noun “[c]rystalline Form I”, which is a subject matter that have already been mentioned prior to said recitation, and that is grammatically incorrect.
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.
Claims 1, 3-4, 10-11, 13 and 25 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.
Instant claim 1 recites “[c]rystalline N-(2,4,5-trifluoro-3-(3-morpholinoquinoxaline-6-carbonyl)phenyl)propane-1-sulfonmnide (Compound A):
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or pharmaceutically acceptable solvate or hydrate thereof; wherein the Crystalline Form I is characterized by an X-ray powder diffraction pattern comprising peaks at 8.7 ± 0.2° 2-θ, 21.6 ± 0.2° 2-θ, and 24.4 ± 0.2° 2-θ, and at least one peak selected from 17.5 ± 0.2° 2-θ, 14.6 ± 0.2° 2-θ, and 19.3 ± 0.2° 2-θ, as measured by X-ray powder diffraction using an X-ray wavelength of 1.5406 Å”. In other words, instant claim broadly “pharmaceutically acceptable solvate or hydrate thereof”, the specification does not reasonably convey to one of ordinary skill in the art that Applicant was in possession of the full scope of the genus pharmaceutically acceptable solvate or hydrate of crystalline form I.
In the present case, the specification only described two crystalline species of Compound A, specifically, a crystalline form I in Example 2 and Fig. 1; and a crystalline form II in Example 3 and Fig. 4. It is further noted that paragraph [092] of specification expressly describes the crystalline form I is anhydrous, non-solvated and non-hydrated form. The disclosure fails to identify any particular species of pharmaceutically acceptable solvate or hydrate of crystalline form I, aside from a broad recitation in the specification that any solvates, such as hydrates (including monohydrate and hemihydrates), formed by the interaction of a solvent and the compound are contemplate for use in the claimed invention (see paragraph [108] of the specification). The disclosure fails to describe any representative solvate or hydrate species spanning across the claimed genus or synthetic preparation thereof. To the extent that the pharmaceutically acceptable solvate or hydrate of crystalline form I of compound A as claimed in claim 1 is referring to solvate or hydrate of said crystalline form having the same X-ray diffraction pattern as claimed (see “wherein” clause in line 4-7 in claim 1), the disclosure provides no guidance identifying which solvate or hydrate of crystalline form I can retain the same X-ray diffraction pattern claimed. In sum, the mere boiler plate reference to “pharmaceutically acceptable solvate or hydrate thereof” does not provide adequate blaze marks to the vast genus encompassed by the claims. While applicant is in possession of crystalline form I of Compound A characterized by the X-ray powder diffraction pattern instantly claimed, applicant is not in possession of the full scope of pharmaceutically acceptable solvate or hydrate of crystalline Form I of compound A.
Regarding claim 2, to the extent that “the crystalline form” recites in the phrase of “the crystalline form is further characterized by” in line 2-3 is taken to include the pharmaceutically acceptable solvate or hydrate of crystalline Form I of compound A, the specification fails to describe any representative solvate or hydrate species with one or more of the characteristics claimed. Applicant also provide no guidance identifying which solvate or hydrate of crystalline form I has the characteristic(s) claimed, nor provide guidance for preparing said solvate or hydrate form. Therefore, the specification does not reasonably convey to one of ordinary skill in the art that Applicant was in possession of the full scope of the genus pharmaceutically acceptable solvate or hydrate of crystalline form I with the characteristics instantly claimed.
Regarding claims 4 and 13, to the extent that each of these X-ray powder diffraction patterns recites therein is intending to include peak positions in addition to the peaks required by the X-ray powder diffraction pattern of claim 1, the specification fails to identify a crystalline form I of compound A having more than one peaks at the same peak position (e.g., 8.7 ± 0.2 °C). Therefore, it does not reasonably convey to one of ordinary skill in the art that Applicant was in possession of the full scope of the genus crystalline form I of compound A with an X-ray powder diffraction pattern comprising peak positions in addition to the peaks of claim 1.
Regarding “[a] pharmaceutical composition comprising the crystalline Form I of N-(2,4,5-trifluoro-3-(3-morpholinoquinoxaline-6-carbonyl)phenyl)propane-1-sulfonamide of claim 1, and at least one pharmaceutically acceptable excipient” as claimed in claim 25, the specification does not reasonably convey to one of ordinary skill in the art that Applicant was in possession of the full genus of pharmaceutical composition comprising the claimed crystalline Form I of N-(2,4,5-trifluoro-3-(3-morpholinoquinoxaline-6-carbonyl)phenyl)propane-1-sulfonamide and at least one pharmaceutically acceptable excipient. The disclosure fails to identify any particular pharmaceutical composition species spanning across the claimed genus such that the at least one pharmaceutically acceptable excipient contains therein does not alter the polymorph behavior of the crystalline form I instantly claimed, and the crystalline Form I contains therein retain the same X-ray powder diffraction pattern. The disclosure also fails to describe the synthetic preparation or representative examples thereof. The mere boiler plate reference to “a pharmaceutical composition” does not provide adequate blaze mark to the vast genus encompassed by the claims. The specification does not reasonably convey to one of ordinary skill in the art that Applicant was in the possession of the full scope of the claimed pharmaceutical composition.
Claim 25 is rejected 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. The claim(s) contains 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.
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. All of the Wands factors have been considered and discussed below:
(1, 5) The breadth of the claims and the Nature of the Invention: As stated in MPEP 2164.05(a), “[t]he initial inquiry” for determining whether the Specification is enabling “is into the nature of the invention, i.e., the subject matter to which the claimed invention pertains.”
In the present case, instant claim 25 recites “[a] pharmaceutical composition comprising the crystalline Form I of N-(2,4,5-trifluoro-3-(3-morpholinoquinoxaline-6-carbonyl)phenyl)propane-1-sulfonamide of claim 1, and at least one pharmaceutically acceptable excipient”; and instant claim 1 is drawn to Crystalline Form I of N-(2,4,5-trifluoro-3-(3-morpholinoquinoxaline-6-carbonyl)phenyl)propane-1-sulfonamide or pharmaceutically acceptable solvate or hydrate thereof, wherein the Crystalline Form I is characterized by an X-ray powder diffraction pattern comprising peaks at 8.7 ± 0.2° 2-θ, 21.6 ± 0.2° 2-θ, and 24.4 ± 0.2° 2-θ, and at least one peak selected from 17.5 ± 0.2° 2-θ, 14.6 ± 0.2° 2-θ, and 19.3 ± 0.2° 2-θ, as measured by X-ray powder diffraction using an X-ray wavelength of 1.5406 Å.
Therefore, the breadth of the claims covers a full genus of composition, comprising the crystalline Form I of N-(2,4,5-trifluoro-3-(3-morpholinoquinoxaline-6-carbonyl)phenyl)propane-1-sulfonamide with the claimed X-ray powder diffraction pattern in combination with at least one of any pharmaceutically acceptable excipient; and that encompass a broad API concentration ranges, multiple excipients classes and alternatives with broad concentration ranges, and numerous potential formulations.
(2, 3, 4) The state of the prior art, the level of skill in the art, and the predictability or lack
thereof in the art: As stated in MPEP 2164.05(a), “[t]he state of the prior art is what one skilled in the
art would have known, at the time the application was filed, about the subject matter to which the
claimed invention pertains” and, as stated in MPEP 2164.05(b), “[t]he relative skill of those in the art
refers to the skill of those in the art in relation to the subject matter to which the claimed invention
pertains at the time the application was filed.”
According to Tim (Journal of Chemical and Pharmaceutical Research, 2024, 16(5): 9-10), one skilled in the art would have known that polymorphs significantly affect solubility, dissolution rate, stability, and bioavailability; different polymorphs of the same compound can exhibit different pharmaceutical behavior, despite identical chemical composition (see e.g., p. 9, 1st paragraph). One skilled in the art would have also known that polymorphs forms are sensitive to formulation conditions, including excipients selection, processing conditions, and storage; Polymorphs may undergo phase transitions, recrystallization, and conversion to less stable forms during storage or manufacturing processes (see e.g., p. 9, 2nd paragraph and p. 10, 2nd paragraph). In other words, the crystal polymorph in the composition is highly sensitive to formulation variables. While the level of skilled in the art with respect to forming a pharmaceutical composition would have been high, there is lack of predictability surrounding polymorph behavior in manufacturing the claimed genus of compositions.
(6, 7, 8) The amount of guidance given, the presence of working example and the quantitation
of experimentation required:
In view of all of the foregoing, at the time the invention was made, it would have required undue experimentation to practice the entire scope of the claimed invention. In this case, the specification does not disclose any representative species of pharmaceutical composition in the working example. Based on the limited disclosure provide, one skilled in the art could not reasonably predict which of the hundreds or thousands of pharmaceutically acceptable excipient encompassed by the claims can be incorporated without altering the polymorph behavior of the crystalline form I instantly claimed. Additionally, one could not reasonably predict which amount of additional pharmaceutically acceptable excipient can be added to the pharmaceutical composition without changing the polymorphs forms. Therefore, the quantity of experimentation necessary to carry out the entire scope of the claimed invention is high, because it would require extensive formulation screening to determine stable and effective pharmaceutical compositions. Given the sensitivity of polymorphic forms to formulation conditions and the lack of guidance in the specification, a person of ordinary skill in the art would be required to engage in undue experimentation to practice the full scope of the pharmaceutical composition instantly claimed.
Accordingly, the entire scope of pharmaceutical composition instantly claimed is not enabled by the instant specification.
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.
Claim 11 remain rejected, and claims 1, 3-4, 10-11, 13 and 25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the claim is drawn to a specific crystalline Form I of N-(2,4,5-trifluoro-3-(3-morpholinoquinoxaline-6-carbonyl)phenyl)propane-1-sulfonamide (Compound A) or pharmaceutically acceptable solvate or hydrate thereof; and further recites the wherein clause (see “wherein the Crystalline Form I is…” in line 4-7) that introduced the X-ray powder diffraction pattern (XRPD) of the crystalline form I. In other words, the recited “wherein” clause only modifies “Crystalline from I” and not the recited solvate or hydrate form; therefore, the claim can lead to various interpretations, for example, the claim can be interpreted such that (i) the XRPD applies only to the crystalline form I, and then separately encompasses any pharmaceutically acceptable solvate or hydrate of compound A, regardless of its XRPD; or (ii) the applicant intended the solvate or hydrate form to be crystalline form I. To the extent that applicant is referring to the second scenario (ii) noted above, the claim does not expressly reflect the solvate or hydrate form is crystalline form I having the X-ray powder diffraction pattern instantly claimed. In view of the foregoing, one cannot reasonably determine the metes and bounds of the crystalline form, and cannot reasonably determine which interpretation applies. Accordingly, claims 3-4, 10-11, 13 and 25 are rejected base on their dependency on a rejected base claim. In order to advance prosecution, the Examiner is examining the claim to the extent that the first scenario (i) applies.
Regarding claim 3,
“the crystalline form” in the phrase of “the crystalline form is further characterized by” line 2-3 renders the claim indefinite as it can leads to various interpretation, because it is not clear which “crystalline form” is being referred to by the applicant. It is respectfully noted that the claimed invention is drawn to “[c]rystalline Form I of N-(2,4,5-trifluoro-3-(3-morpholinoquinoxaline-6-carbonyl)phenyl)propane-1-sulfonamide (Compound A)… or pharmaceutically acceptable solvate or hydrate thereof”. In other words, the claim can be interpreted such that the crystalline form is the solvate of crystalline form I, crystalline form I or the hydrate of crystalline form; and therefore, it is not clear which crystalline form is further characterized. The lack of clarity renders the claim indefinite, because one cannot reasonably determine which interpretation applies.
a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, the claim recites “a combination thereof” that includes the broad recitation “a differential scanning calorimetry (DSC) thermogram comprising an endotherm in the range of about 180-190°C”, and also recites “a differential scanning calorimetry (DSC) thermogram comprising an endotherm with an onset of about 184°C and a peak of about 187°C” which is the narrower statement of the range/limitation; and also includes the broad recitation “an unchanged XRPD after storage at 40°C and 75% relative humidity (RH) for 6 months”, and also recites “an unchanged XRPD after storage at 25°C and 60% relative humidity (RH) for 6 months”, which is the narrower statement of the range/limitation. Therefore, to the extent that the combination is a combination of the broad recitation and the narrow recitation noted above, the claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 4, the recitation of “wherein Crystalline Form I is characterized by an X-ray powder diffraction pattern comprising at least five peaks selected from 8.7 ± 0.2° 2-θ, 21.6 ± 0.2° 2-θ, 24.4 ± 0.2° 2-θ, 17.5 ± 0.2° 2-θ, 14.6 ± 0.2° 2-θ, 19.3 ± 0.2° 2-θ, 23.1 ± 0.2° 2-θ, 16.0 ± 0.2° 2-θ and 25.7 ± 0.2° 2-θ, as measured by X-ray powder diffraction using an X-ray wavelength of 1.5406 Å” renders the claim indefinite because it leads to more than one interpretations. For example, the claim can be interpreted such that (i) the Crystalline Form I has at least five peaks selected from 8.7 ± 0.2° 2-θ, 21.6 ± 0.2° 2-θ, 24.4 ± 0.2° 2-θ, 17.5 ± 0.2° 2-θ, 14.6 ± 0.2° 2-θ, 19.3 ± 0.2° 2-θ, 23.1 ± 0.2° 2-θ, 16.0 ± 0.2° 2-θ and 25.7 ± 0.2° 2-θ, in addition to peaks as claimed in claim 1. In other words, the crystalline form I can have more than one peaks at 8.7 ± 0.2° 2-θ, 21.6 ± 0.2° 2-θ, and 24.4 ± 0.2° 2-θ, e.g., two or more peaks at the range of 8.7 ± 0.2° 2-θ; or (ii) the claim can be interpreted such that the Crystalline Form I has peaks at 8.7 ± 0.2° 2-θ, 21.6 ± 0.2° 2-θ, and 24.4 ± 0.2° 2-θ, and at least two peaks at 17.5 ± 0.2° 2-θ, 14.6 ± 0.2° 2-θ, and 19.3 ± 0.2° 2-θ, such that there is no more than one peaks at the same range, e.g., 8.7 ± 0.2° 2-θ. The lack of clarity renders the claim indefinite, because one cannot reasonably determine which interpretation applies.
Regarding claim 11, the term “substantially” recites in the phrase of “substantially the same” is a relative term which renders the claim(s) indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree. In the present case, the claim(s) and the specification do not clearly set forth what is considered to be substantially similar versus insubstantially similar. Therefore, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 13, the recitation of “wherein Crystalline Form I is characterized by an X-ray powder diffraction pattern comprising peaks at 8.7 ± 0.2° 2-θ, 21.6 ± 0.2° 2-θ, 24.4 ± 0.2° 2-θ, 17.5 ± 0.2° 2-θ, 14.6 ± 0.2° 2-θ, 19.3 ± 0.2° 2-θ, 23.1 ± 0.2° 2-θ, 16.0 ± 0.2° 2-θ and 25.7 ± 0.2° 2-θ, as measured by X-ray powder diffraction using an X-ray wavelength of 1.5406 Å” renders the claim indefinite because it leads to more than one interpretations. For example, the claim can be interpreted such that (i) the Crystalline Form I has peaks at 8.7 ± 0.2° 2-θ, 21.6 ± 0.2° 2-θ, 24.4 ± 0.2° 2-θ, 17.5 ± 0.2° 2-θ, 14.6 ± 0.2° 2-θ, 19.3 ± 0.2° 2-θ, 23.1 ± 0.2° 2-θ, 16.0 ± 0.2° 2-θ and 25.7 ± 0.2° 2-θ in addition to the peaks as claimed in claim 1; or (ii) the claim can be interpreted such that the Crystalline Form I has peaks at 8.7 ± 0.2° 2-θ, 21.6 ± 0.2° 2-θ, 24.4 ± 0.2° 2-θ, 17.5 ± 0.2° 2-θ, 14.6 ± 0.2° 2-θ, 19.3 ± 0.2° 2-θ, 23.1 ± 0.2° 2-θ, 16.0 ± 0.2° 2-θ and 25.7 ± 0.2° 2-θ, such that there is no more than one peaks at the same range, e.g., 8.7 ± 0.2° 2-θ. The lack of clarity renders the claim indefinite, because one cannot reasonably determine which interpretation applies.
Response to Arguments
Applicant's arguments filed on May 5, 2026 have been fully considered.
Applicant's arguments filed on May 5, 2026 with respect to the rejection of claim 11 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 have been fully considered but they are not persuasive.
In Summary, applicant argues the claim amendment removed the term “substantially”, and that overcomes the rejection of record.
In response, applicant’s argument is not found persuasive. It may well be true that applicant deletes the term “substantially” in other claims; However, amended claim 11 still positively recites the term “substantially”. Therefore, the rejection of claim 11 has been maintained for the reason of record.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 4, the recitation of “wherein Crystalline Form I is characterized by an X-ray powder diffraction pattern comprising at least five peaks selected from 8.7 ± 0.2° 2-θ, 21.6 ± 0.2° 2-θ, 24.4 ± 0.2° 2-θ, 17.5 ± 0.2° 2-θ, 14.6 ± 0.2° 2-θ, 19.3 ± 0.2° 2-θ, 23.1 ± 0.2° 2-θ, 16.0 ± 0.2° 2-θ and 25.7 ± 0.2° 2-θ, as measured by X-ray powder diffraction using an X-ray wavelength of 1.5406 Å” fails to include all the limitations of the claim upon which it depends, because claim 1 requires peaks to be present at 8.7 ± 0.2° 2-θ, 21.6 ± 0.2° 2-θ, 24.4 ± 0.2° 2-θ, and at least one peak to be present at 17.5 ± 0.2° 2-θ, 14.6 ± 0.2° 2-θ, or 19.3 ± 0.2° 2-θ. However, instant claim 4 does not require the peaks to be present at the positions as claimed in claim 1, and can be any positions selected from the 9 listed positions; and therefore, that fails to include all the limitations set forth in the claim it depends upon.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhu et al. (US-2013/0053384 A1; cited in the IDS filed on February 9, 2024).
To the extent that the X-ray powder diffraction pattern of claim 1 applies only to the crystalline form I of compound A, and the claim(s) separately encompasses any pharmaceutically acceptable solvate or hydrate of compound A regardless of its X-ray powder diffraction pattern, then the following rejection applies.
Zhu et al. teaches a compound of Example 6, N-(2,4,5-trifluoro-3-(3-morpholinoquinoxaline-6-carbonyl) phenyl) propane-1-sulfonamide, having the structure of:
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is a compound of Formula I useful for treating cancer, such as colon carcinoma (see e.g., [0470]; [0415]). Zhu et al. further teaches compounds of Formula I also include crystalline and amorphous forms of those compounds, including, for example, polymorphs, pseudopolymorphs, solvates (including hydrates), unsolvated polymorphs (anhydrates), conformational polymorphs, and amorphous forms of the compounds, as well as mixtures thereof (see e.g., [0146]).
In the present case, the fact that Zhu et al. teaches the compound of Example 6 includes solvates or hydrate forms, and that anticipates the claimed invention.
Regarding claims 3, the limitation(s) recites therein is drawn to the characteristics of the crystalline form. To the extent that “the crystalline form” is referring to solvates or hydrates of compound of Example 6, although Zhu et al. is silent regarding the characteristics of the solvates or hydrate forms, the solvates or hydrates form taught Zhu et al. would necessarily have the same characteristics.
Please note that the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicant’s claimed crystalline is different and, if so, to what extent, from that of the discussed reference.
Therefore, the claimed invention is being anticipated by Zhu et al.
Response to Arguments
Applicant's arguments filed on May 5, 2026 have been fully considered.
Applicant's arguments filed on May 5, 2026 with respect to the rejection of claims 1, 3, 10-11, 13 and 15 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhu et al. (US-2013/0053384 A1; cited in the IDS filed on February 9, 2024) have been fully considered but they are not persuasive.
Applicant amends claim 1 by adding the limitation of “wherein the Crystalline Form I is characterized by an X-ray powder diffraction pattern comprising peaks at 8.7 ± 0.2° 2-θ, 21.6 ± 0.2° 2-θ, and 24.4 ± 0.2° 2-θ, and at least one peak selected from 17.5 ± 0.2° 2-θ, 14.6 ± 0.2° 2-θ, and 19.3 ± 0.2° 2-θ, as measured by X-ray powder diffraction using an X-ray wavelength of 1.5406 Å”, and that changes the scope of the claims and necessitate a modification of the rejection of record.
In Summary, applicant argues the claim amendment overcomes the rejection of record.
In response, applicant’s argument is not found persuasive. It may well be true that Zhu et al. fails to teach the X-ray powder diffraction pattern instantly claimed; However, it is respectfully noted that the instant claim also recites “pharmaceutically acceptable solvate or hydrate thereof”. To the extent that the wherein clause (see “wherein the Crystalline Form I is…” in line 4-7 of claim 1) of claim 1 only modifies the “Crystalline from I” of Compound A, and not the recited solvate or hydrate form, the claimed pharmaceutically acceptable solvate or hydrate of compound A reasonably encompass any solvate or hydrate forms regardless of its X-ray diffraction pattern. Therefore, the solvates or hydrates of compound of Example 6 disclosed by Zhu et al. still anticipates the claimed invention.
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 and 3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of U.S. Patent No. 10,561,652 B2.
To the extent that the X-ray powder diffraction pattern of claim 1 applies only to the crystalline form I of compound A, and the claim(s) separately encompasses any pharmaceutically acceptable solvate or hydrate of compound A regardless of its X-ray powder diffraction pattern, then the following rejection applies.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference patent are drawn to a compound, N-(2,4,5-trifluoro-3-(3-morpholinoquinoxaline-6-carbonyl) phenyl) propane-1-sulfonamide, or a pharmaceutically acceptable salt thereof (see e.g., claims 1 and 3).
The reference patent clearly teaches compounds of Formula I also include crystalline and solvates (including hydrates) of those compounds, and that anticipates the claimed invention. Although the claims of the reference patent is silent regarding the characteristics of the solvate or hydrate form(s); However, the claimed characteristics will inevitably flow from the teachings of Zhu et al., since the compound of the reference patent, N-(2,4,5-trifluoro-3-(3-morpholinoquinoxaline-6-carbonyl) phenyl) propane-1-sulfonamide, includes solvate or hydrate forms and the characteristics are inseparable from the compound.
Response to Arguments
Applicant's arguments filed on May 5, 2026 have been fully considered.
Applicant's arguments filed on May 5, 2026 with respect to the rejection of claims 1, 3, 10-11, 13 and 15 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3 and 14 of U.S. Patent No. 10,561,652 B2 have been fully considered but they are not persuasive.
Applicant amends claim 1 by adding the limitation of “wherein the Crystalline Form I is characterized by an X-ray powder diffraction pattern comprising peaks at 8.7 ± 0.2° 2-θ, 21.6 ± 0.2° 2-θ, and 24.4 ± 0.2° 2-θ, and at least one peak selected from 17.5 ± 0.2° 2-θ, 14.6 ± 0.2° 2-θ, and 19.3 ± 0.2° 2-θ, as measured by X-ray powder diffraction using an X-ray wavelength of 1.5406 Å”, and that changes the scope of the claims and necessitate a modification of the rejection of record.
In Summary, applicant argues the claim amendment overcomes the rejection of record.
In response, applicant’s argument is not found persuasive. It may well be true that the reference patent fails to teach the X-ray powder diffraction pattern instantly claimed; However, it is respectfully noted that the instant claim also recites “pharmaceutically acceptable solvate or hydrate thereof”. To the extent that the wherein clause (see “wherein the Crystalline Form I is…” in line 4-7 of claim 1) of claim 1 only modifies the “Crystalline from I” of Compound A, and not the recited solvate or hydrate form, the claimed pharmaceutically acceptable solvate or hydrate of compound A reasonably encompass any solvate or hydrate forms regardless of its X-ray diffraction pattern. Therefore, the solvates or hydrates form of N-(2,4,5-trifluoro-3-(3-morpholinoquinoxaline-6-carbonyl) phenyl) propane-1-sulfonamide taught by the reference patent still anticipates the claimed invention.
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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