DETAILED ACTION
Notice of Pre-AIA or AIA Status
The inventor or joint inventor should note that the instant invention, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-15 are pending in the instant invention.
Status of Priority
This invention is a Continuation-In-Part (CIP) of US Application No. 17/410,965, filed August 24, 2021 and now US 11,629,148, which is a Continuation (CON) of International Application No. PCT/CN2021/112352, filed August 12, 2021, which is a Continuation (CON) of International Application No. PCT/CN2020/076231, filed February 21, 2020, which claims priority under 35 U.S.C. § 119(a-d) to: a) CN 202010818212.6, filed August 14, 2020; b) CN 201910877661.5, filed September 17, 2019; and c) CN 201910137984.0, filed February 25, 2019.
Restrictions / Election of Species
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The inventor’s or joint inventor’s provisional election of the following, without traverse, in the reply filed on October 28, 2025, is acknowledged: a) Group II - claims 1-7 and 9-11; and b) solid form of a pharmaceutically acceptable salt of (S)-(2-(6-(2-ethyl-5-fluoro-4-hydroxyphenyl)-1H-indazol-3-yl)-4,6-dihydropyrrolo[3,4-d]imidazol-5(1H)-yl)(3-hydroxy-pyrrolidin-1-yl)methanone of formula (I) - p. 64, shown to the right below, and hereafter referred to as crystal form B of (S)-(2-(6-(2-ethyl-5-fluoro-4-hydroxyphenyl)-1H-indazol-3-yl)-4,6-dihydropyrrolo-[3,4-d]imidazol-5(1H)-yl)(3-hydroxypyrrolidin-1-yl)methanone
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methanesulfonate. Claims 1-7 and 9-11 read on the elected species. Affirmation of this election must be made by the inventor or joint inventor in replying to this Office action.
Similarly, the inventor or joint inventor should further note that the requirement is still deemed proper and is therefore made FINAL.
Likewise, the inventor or joint inventor should further note that the elected species, shown to the right above, was found to be free of the prior art.
Moreover, the inventor or joint inventor should further note that claims 8 and 12-15 were withdrawn from further consideration, pursuant to 37 CFR 1.142(b), as being drawn to a nonelected or cancelled invention, there being no allowable generic or linking claim.
Thus, a first Office action and prosecution on the merits of claims 1-7 and 9-11 is contained within.
Specification Objection - Disclosure
The inventor or joint inventor is advised to format the specification according to 37 CFR 1.77(c). Revisions should particularly address bold-type, underline, and/or upper case formatting. Appropriate correction may be required.
Specification Objection - Title
The inventor or joint inventor is reminded of the proper content of the title of the invention.
The title of the invention should be brief, but technically accurate and descriptive and should contain fewer than 500 characters. See 37 CFR 1.72(a) and MPEP § 606.
The title of the invention is not technically accurate and descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. In the revised title, the examiner suggests additionally identifying the solid form of a pharmaceutically acceptable salt of (S)-(2-(6-(2-ethyl-5-fluoro-4-hydroxyphenyl)-1H-indazol-3-yl)-4,6-dihydropyrrolo[3,4-d]imidazol-5(1H)-yl)(3-hydroxypyrrolidin-1-yl)methanone of the formula (I).
The following title is suggested: SOLID FORMS OF PHARMACEUTICALLY ACCEPTABLE SALTS OF (S)-(2-(6-(2-ETHYL-5-FLUORO-4-HYDROXYPHENYL)-1H-INDAZOL-3-YL)-4,6-DIHYDROPYRROLO[3,4-d]IMIDAZOL-5(1H)-YL)(3-HYDROXYPYRROLIDIN-1-YL)METHANONE AS JAK INHIBITORS.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: for clarity, precision, compliance with the Requirement for Restriction/Election of Species, mailed on September 3, 2025, and to avoid issues under 35 U.S.C. § 112(a) and/or 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation:
A crystal form of a pharmaceutically acceptable salt of a compound of formula (I):
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(I)
wherein the crystal form of the pharmaceutically acceptable salt of the compound of formula (I) is selected from the group consisting of:
(1) the crystal form A of the benzenesulfonate salt of the compound of formula (I) characterized by an X-ray powder diffraction (XRPD) pattern comprising at least one characteristic peak at a diffraction angle (º2q) selected from the group consisting of 5.82º ± 0.10º, 6.74º ± 0.10º, 11.85º ± 0.10º, and 16.38º ± 0.10º;
(2) the crystal form B of the benzenesulfonate salt of the compound of formula (I) characterized by an X-ray powder diffraction (XRPD) pattern comprising at least one characteristic peak at a diffraction angle (º2q) selected from the group consisting of 4.93º ± 0.10º, 5.63º ± 0.10º, 9.02º ± 0.10º, 10.89º ± 0.10º, 14.84º ± 0.10º, 17.55º ± 0.10º, 18.84º ± 0.10º, 23.12º ± 0.10º, 25.55º ± 0.10º, and 26.14º ± 0.10º;
(3) the crystal form A of the citrate salt of the compound of formula (I) characterized by an X-ray powder diffraction (XRPD) pattern comprising at least one characteristic peak at a diffraction angle (º2q) selected from the group consisting of 4.85º ± 0.10º, 6.42º ± 0.10º, 14.63º ± 0.10º, 17.12º ± 0.10º, 20.75º ± 0.10º, and 25.34º ± 0.10º;
(4) the crystal form B of the citrate salt of the compound of formula (I) characterized by an X-ray powder diffraction (XRPD) pattern comprising at least one characteristic peak at a diffraction angle (º2q) selected from the group consisting of 4.96º ± 0.10º, 7.67º ± 0.10º, 10.20º ± 0.10º, 11.04º ± 0.10º, 14.73º ± 0.10º, 19.23º ± 0.10º, 22.86º ± 0.10º, 23.54º ± 0.10º, 24.28º ± 0.10º, and 25.08º ± 0.10º;
(5) the crystal form A of the fumarate salt of the compound of formula (I) characterized by an X-ray powder diffraction (XRPD) pattern comprising at least one characteristic peak at a diffraction angle (º2q) selected from the group consisting of 4.96º ± 0.10º, 7.66º ± 0.10º, 10.21º ± 0.10º, 11.06º ± 0.10º, 14.74º ± 0.10º, 16.11º ± 0.10º, 22.87º ± 0.10º, and 25.10º ± 0.10º;
(6) the crystal form A of the hydrochloride salt of the compound of formula (I) characterized by an X-ray powder diffraction (XRPD) pattern comprising at least one characteristic peak at a diffraction angle (º2q) selected from the group consisting of 8.05º ± 0.10º, 17.11º ± 0.10º, 18.02º ± 0.10º, 20.84º ± 0.10º, 21.09º ± 0.10º, 22.77º ± 0.10º, and 23.14º ± 0.10º;
(7) the crystal form A of the maleate salt of the compound of formula (I) characterized by an X-ray powder diffraction (XRPD) pattern comprising at least one characteristic peak at a diffraction angle (º2q) selected from the group consisting of 4.55º ± 0.10º, 8.78º ± 0.10º, 12.69º ± 0.10º, 13.96º ± 0.10º, 16.62º ± 0.10º, 17.61º ± 0.10º, 18.32º ± 0.10º, 25.39º ± 0.10º, and 26.53º ± 0.10º;
(8) the crystal form B of the methanesulfonate salt of the compound of formula (I) characterized by an X-ray powder diffraction (XRPD) pattern comprising at least one characteristic peak at a diffraction angle (º2q) selected from the group consisting of 5.91º ± 0.10º, 9.22º ± 0.10º, 15.83º ± 0.10º, 17.73º ± 0.10º, 19.02º ± 0.10º, and 25.01º ± 0.10º;
(9) the crystal form A of the mucolate salt of the compound of formula (I) characterized by an X-ray powder diffraction (XRPD) pattern comprising at least one characteristic peak at a diffraction angle (º2q) selected from the group consisting of 4.98º ± 0.10º, 10.22º ± 0.10º, 11.07º ± 0.10º, 14.75º ± 0.10º, 14.94º ± 0.10º, 16.13º ± 0.10º, 19.65º ± 0.10º, and 30.79º ± 0.10º;
(10) the crystal form A of the phosphate salt of the compound of formula (I) characterized by an X-ray powder diffraction (XRPD) pattern comprising at least one characteristic peak at a diffraction angle (º2q) selected from the group consisting of 5.29º ± 0.10º, 7.47º ± 0.10º, 10.61º ± 0.10º, 19.16º ± 0.10º, and 21.32º ± 0.10º;
(11) the crystal form A of the tartrate salt of the compound of formula (I) characterized by an X-ray powder diffraction (XRPD) pattern comprising at least one characteristic peak at a diffraction angle (º2q) selected from the group consisting of 7.90º ± 0.10º, 8.69º ± 0.10º, 13.12º ± 0.10º, 13.43º ± 0.10º, 18.11º ± 0.10º, 21.28º ± 0.10º, and 22.90º ± 0.10º; and
(12) the crystal form A of the p-toluenesulfonate salt of the compound of formula (I) characterized by an X-ray powder diffraction (XRPD) pattern comprising at least one characteristic peak at a diffraction angle (º2q) selected from the group consisting of 5.90º ± 0.10º, 9.34º ± 0.10º, 14.87º ± 0.10º, 15.33º ± 0.10º, 17.88º ± 0.10º, 18.76º ± 0.10º, 19.71º ± 0.10º, and 24.26º ± 0.10º.
Appropriate correction is required. See MPEP § 2173.02.
Claim 2 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation(s):
16. The crystal form according to claim 1, wherein the crystal form is crystal form A of the benzenesulfonate salt of the compound of formula (I) characterized by an X-ray powder diffraction (XRPD) pattern comprising at least one characteristic peak at a diffraction angle (º2q) selected from the group consisting of 5.82º ± 0.10º, 6.74º ± 0.10º, 11.85º ± 0.10º, and 16.38º ± 0.10º.
17. The crystal form according to claim 16, wherein the crystal form is further characterized by an X-ray powder diffraction (XRPD) pattern comprising at least one additional characteristic peak at a diffraction angle (º2q) selected from the group consisting of 19.46º ± 0.10º and 20.20º ± 0.10º.
Appropriate correction is required. See MPEP § 2173.02.
Claim 3 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation(s):
18. The crystal form according to claim 1, wherein the crystal form is crystal form B of the benzenesulfonate salt of the compound of formula (I) characterized by an X-ray powder diffraction (XRPD) pattern comprising at least one characteristic peak at a diffraction angle (º2q) selected from the group consisting of 4.93º ± 0.10º, 5.63º ± 0.10º, 9.02º ± 0.10º, 10.89º ± 0.10º, 14.84º ± 0.10º, 17.55º ± 0.10º, 18.84º ± 0.10º, 23.12º ± 0.10º, 25.55º ± 0.10º, and 26.14º ± 0.10º.
19. The crystal form according to claim 18, wherein the crystal form is further characterized by an X-ray powder diffraction (XRPD) pattern comprising at least one additional characteristic peak at a diffraction angle (º2q) selected from the group consisting of 10.30º ± 0.10º, 11.43º ± 0.10º, 14.23º ± 0.10º, 17.04º ± 0.10º, 19.66º ± 0.10º, 20.24º ± 0.10º, 22.71º ± 0.10º, and 24.91º ± 0.10º.
Appropriate correction is required. See MPEP § 2173.02.
Claim 4 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation(s):
20. The crystal form according to claim 1, wherein the crystal form is crystal form A of the citrate salt of the compound of formula (I) characterized by an X-ray powder diffraction (XRPD) pattern comprising at least one characteristic peak at a diffraction angle (º2q) selected from the group consisting of 4.85º ± 0.10º, 6.42º ± 0.10º, 14.63º ± 0.10º, 17.12º ± 0.10º, 20.75º ± 0.10º, and 25.34º ± 0.10º.
21. The crystal form according to claim 20, wherein the crystal form is further characterized by an X-ray powder diffraction (XRPD) pattern comprising at least one additional characteristic peak at a diffraction angle (º2q) selected from the group consisting of 7.64º ± 0.10º, 15.40º ± 0.10º, 18.12º ± 0.10º, 18.84º ± 0.10º, and 19.37º ± 0.10º.
Appropriate correction is required. See MPEP § 2173.02.
Claim 5 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation(s):
22. The crystal form according to claim 1, wherein the crystal form is crystal form B of the citrate salt of the compound of formula (I) characterized by an X-ray powder diffraction (XRPD) pattern comprising at least one characteristic peak at a diffraction angle (º2q) selected from the group consisting of 4.96º ± 0.10º, 7.67º ± 0.10º, 10.20º ± 0.10º, 11.04º ± 0.10º, 14.73º ± 0.10º, 19.23º ± 0.10º, 22.86º ± 0.10º, 23.54º ± 0.10º, 24.28º ± 0.10º, and 25.08º ± 0.10º.
23. The crystal form according to claim 22, wherein the crystal form is further characterized by an X-ray powder diffraction (XRPD) pattern comprising at least one additional characteristic peak at a diffraction angle (º2q) selected from the group consisting of 12.42º ± 0.10º, 16.09º ± 0.10º, 17.55º ± 0.10º, and 27.91º ± 0.10º.
Appropriate correction is required. See MPEP § 2173.02.
Claim 6 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation(s):
24. The crystal form according to claim 1, wherein the crystal form is crystal form A of the fumarate salt of the compound of formula (I) characterized by an X-ray powder diffraction (XRPD) pattern comprising at least one characteristic peak at a diffraction angle (º2q) selected from the group consisting of 4.96º ± 0.10º, 7.66º ± 0.10º, 10.21º ± 0.10º, 11.06º ± 0.10º, 14.74º ± 0.10º, 16.11º ± 0.10º, 22.87º ± 0.10º, and 25.10º ± 0.10º.
25. The crystal form according to claim 24, wherein the crystal form is further characterized by an X-ray powder diffraction (XRPD) pattern comprising at least one additional characteristic peak at a diffraction angle (º2q) selected from the group consisting of 12.44º ± 0.10º, 19.25º ± 0.10º, 23.54º ± 0.10º, 24.27º ± 0.10º, and 25.37º ± 0.10º.
Appropriate correction is required. See MPEP § 2173.02.
Claim 7 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation(s):
26. The crystal form according to claim 1, wherein the crystal form is crystal form A of the hydrochloride salt of the compound of formula (I) characterized by an X-ray powder diffraction (XRPD) pattern comprising at least one characteristic peak at a diffraction angle (º2q) selected from the group consisting of 8.05º ± 0.10º, 17.11º ± 0.10º, 18.02º ± 0.10º, 20.84º ± 0.10º, 21.09º ± 0.10º, 22.77º ± 0.10º, and 23.14º ± 0.10º.
27. The crystal form according to claim 26, wherein the crystal form is further characterized by an X-ray powder diffraction (XRPD) pattern comprising at least one additional characteristic peak at a diffraction angle (º2q) selected from the group consisting of 15.04º ± 0.10º, 20.44º ± 0.10º, and 22.07º ± 0.10º.
28. The crystal form according to claim 1, wherein the crystal form A of the maleate salt of the compound of formula (I) characterized by an X-ray powder diffraction (XRPD) pattern comprising at least one characteristic peak at a diffraction angle (º2q) selected from the group consisting of 4.55º ± 0.10º, 8.78º ± 0.10º, 12.69º ± 0.10º, 13.96º ± 0.10º, 16.62º ± 0.10º, 17.61º ± 0.10º, 18.32º ± 0.10º, 25.39º ± 0.10º, and 26.53º ± 0.10º.
29. The crystal form according to claim 28, wherein the crystal form is further characterized by an X-ray powder diffraction (XRPD) pattern comprising at least one additional characteristic peak at a diffraction angle (º2q) selected from the group consisting of 13.74º ± 0.10º and 21.72º ± 0.10º.
30. The crystal form according to claim 1, wherein the crystal form is crystal form B of the methanesulfonate salt of the compound of formula (I) characterized by an X-ray powder diffraction (XRPD) pattern comprising at least one characteristic peak at a diffraction angle (º2q) selected from the group consisting of 5.91º ± 0.10º, 9.22º ± 0.10º, 15.83º ± 0.10º, 17.73º ± 0.10º, 19.02º ± 0.10º, and 25.01º ± 0.10º.
31. The crystal form according to claim 30, wherein the crystal form is further characterized by an X-ray powder diffraction (XRPD) pattern comprising at least one additional characteristic peak at a diffraction angle (º2q) selected from the group consisting of 20.61º ± 0.10º, 21.36º ± 0.10º, and 23.18º ± 0.10º.
32. The crystal form according to claim 1, wherein the crystal form is crystal form A of the mucolate salt of the compound of formula (I) characterized by an X-ray powder diffraction (XRPD) pattern comprising at least one characteristic peak at a diffraction angle (º2q) selected from the group consisting of 4.98º ± 0.10º, 10.22º ± 0.10º, 11.07º ± 0.10º, 14.75º ± 0.10º, 14.94º ± 0.10º, 16.13º ± 0.10º, 19.65º ± 0.10º, and 30.79º ± 0.10º.
33. The crystal form according to claim 32, wherein the crystal form is further characterized by an X-ray powder diffraction (XRPD) pattern comprising at least one additional characteristic peak at a diffraction angle (º2q) selected from the group consisting of 7.69º ± 0.10º, 21.51º ± 0.10º, and 22.92º ± 0.10º.
34. The crystal form according to claim 1, wherein the crystal form is crystal form A of the phosphate salt of the compound of formula (I) characterized by an X-ray powder diffraction (XRPD) pattern comprising at least one characteristic peak at a diffraction angle (º2q) selected from the group consisting of 5.29º ± 0.10º, 7.47º ± 0.10º, 10.61º ± 0.10º, 19.16º ± 0.10º, and 21.32º ± 0.10º.
35. The crystal form according to claim 34, wherein the crystal form is further characterized by an X-ray powder diffraction (XRPD) pattern comprising at least one additional characteristic peak at a diffraction angle (º2q) selected from the group consisting of 15.94º ± 0.10º, 16.77º ± 0.10º, 18.68º ± 0.10º, and 25.36º ± 0.10º.
36. The crystal form according to claim 1, wherein the crystal form is crystal form A of the tartrate salt of the compound of formula (I) characterized by an X-ray powder diffraction (XRPD) pattern comprising at least one characteristic peak at a diffraction angle (º2q) selected from the group consisting of 7.90º ± 0.10º, 8.69º ± 0.10º, 13.12º ± 0.10º, 13.43º ± 0.10º, 18.11º ± 0.10º, 21.28º ± 0.10º, and 22.90º ± 0.10º.
37. The crystal form according to claim 36, wherein the crystal form is further characterized by an X-ray powder diffraction (XRPD) pattern comprising at least one additional characteristic peak at a diffraction angle (º2q) selected from the group consisting of 15.08º ± 0.10º, 17.17º ± 0.10º, 17.44º ± 0.10º, 19.40º ± 0.10º, 20.74º ± 0.10º, 24.15º ± 0.10º, and 24.95º ± 0.10º.
38. The crystal form according to claim 1, wherein the crystal form is crystal form A of the p-toluenesulfonate salt of the compound of formula (I) characterized by an X-ray powder diffraction (XRPD) pattern comprising at least one characteristic peak at a diffraction angle (º2q) selected from the group consisting of 5.90º ± 0.10º, 9.34º ± 0.10º, 14.87º ± 0.10º, 15.33º ± 0.10º, 17.88º ± 0.10º, 18.76º ± 0.10º, 19.71º ± 0.10º, and 24.26º ± 0.10º.
39. The crystal form according to claim 38, wherein the crystal form is further characterized by an X-ray powder diffraction (XRPD) pattern comprising at least one additional characteristic peak at a diffraction angle (º2q) selected from the group consisting of 12.99º ± 0.10º, 16.10º ± 0.10º, 19.34º ± 0.10º, 20.39º ± 0.10º, and 24.99º ± 0.10º.
Appropriate correction is required. See MPEP § 2173.02.
Claim 9 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
A pharmaceutical composition comprising at least one pharmaceutically acceptable carrier, adjuvant, or excipient and the crystal form according to claim 1.
Appropriate correction is required. See MPEP § 2173.02.
Claim 10 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation(s):
10. The pharmaceutical composition according to claim 9, wherein the pharmaceutical composition is formulated as a dispersion.
40. The pharmaceutical composition according to claim 10, wherein the dispersion comprises a pharmaceutically acceptable medium.
41. The pharmaceutical composition according to claim 40, wherein the pharmaceutically acceptable medium disperses the crystal form according to claim 1.
Appropriate correction is required. See MPEP § 2173.02.
Claim 11 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation(s):
11. The pharmaceutical composition according to claim 9, wherein the pharmaceutical composition is formulated as a solution.
42. The pharmaceutical composition according to claim 11, wherein the solution comprises a pharmaceutically acceptable solvent.
43. The pharmaceutical composition according to claim 42, wherein the pharmaceutically acceptable solvent dissolves the crystal form according to claim 1.
Appropriate correction is required. See MPEP § 2173.02.
Claim Rejections - 35 U.S.C. § 112(b)
The following is a quotation of the second paragraph of 35 U.S.C. § 112:
(b) CONCLUSION. The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or joint inventor regards as the invention.
Claims 1, 3, 5 and 9-11 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that claim 1 recites the physicochemical property, A solid form of a pharmaceutically acceptable slat of a compound… of formula (I), in lines 1-6 of the claim.
Similarly, the inventor or joint inventor should further note that the aforementioned physicochemical property renders the instant invention ambiguous, vague, incoherent, opaque and/or otherwise unclear to the examiner and fails to meet the statutory requirements of 35 U.S.C. § 112(b), since the limitation merely states a physicochemical property (i.e. solid form) without providing any clarity regarding how the physicochemical property is imparted.
Likewise, the inventor or joint inventor should further note that the instantly recited solid form physicochemical property does not appear to emanate from and/or does not appear to be an inherent or salient property of the instantly recited pharmaceutically acceptable salts of (S)-(2-(6-(2-ethyl-5-fluoro-4-hydroxyphenyl)-1H-indazol-3-yl)-4,6-dihydropyrrolo[3,4-d]imidazol-5(1H)-yl)(3-hydroxypyrrolidin-1-yl)methanone of the formula (I).
Next, the inventor or joint inventor should further note that the examiner is uncertain whether the instantly recited pharmaceutically acceptable salts of (S)-(2-(6-(2-ethyl-5-fluoro-4-hydroxyphenyl)-1H-indazol-3-yl)-4,6-dihydropyrrolo[3,4-d]imidazol-5(1H)-yl)(3-hydroxy-pyrrolidin-1-yl)methanone of the formula (I) require an additional unrecited component to be admixed therewith, such as a stabilizer, bulking agent, solvent, or buffer, to impart the solid form physicochemical property.
Consequently, the inventor or joint inventor should further note that since the instantly recited pharmaceutically acceptable salts of (S)-(2-(6-(2-ethyl-5-fluoro-4-hydroxyphenyl)-1H-indazol-3-yl)-4,6-dihydropyrrolo[3,4-d]imidazol-5(1H)-yl)(3-hydroxypyrrolidin-1-yl)methanone of the formula (I) incorporate the aforementioned ambiguous, vague, incoherent, opaque and/or otherwise unclear solid form physicochemical property, the instantly recited pharmaceutically acceptable salts of (S)-(2-(6-(2-ethyl-5-fluoro-4-hydroxyphenyl)-1H-indazol-3-yl)-4,6-dihydro-pyrrolo[3,4-d]imidazol-5(1H)-yl)(3-hydroxypyrrolidin-1-yl)methanone of the formula (I) are rendered indefinite under 35 U.S.C. § 112(b), since one of ordinary skill in the art may not reasonably determine the metes and bounds of the instantly recited pharmaceutically acceptable salts of (S)-(2-(6-(2-ethyl-5-fluoro-4-hydroxyphenyl)-1H-indazol-3-yl)-4,6-dihydropyrrolo[3,4-d]imidazol-5(1H)-yl)(3-hydroxypyrrolidin-1-yl)methanone of the formula (I) due to an inability to establish the metes and bounds encompassed by the solid form physicochemical property.
Then, the inventor or joint inventor should further note that [A] claim which omits matter disclosed to be essential to the invention, as described in the specification or in other statements of record, may also be rejected under 35 U.S.C. § 112(a), as not enabling. {See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976); and MPEP § 2164.08(c)}.
Moreover, the inventor or joint inventor should further note that [C]laims which depend from indefinite claims are also indefinite. {See Ex parte Cordova, 10 USPQ 2d 1949, 1952 (PTO Bd. App. 1989)}.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 5 is further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that a broad limitation together with a narrow limitation that falls within the broad limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c), MPEP § 2173.05(h), and/or Eli Lilly & Co. v. Teva Parenteral Meds., 845 F.3d 1357, 1371, 121 USPQ2d 1277, 1287 (Fed. Cir. 2017).
Similarly, the inventor or joint inventor should further note that claim 5 recites the broad limitation, benzenesulfonate, citrate, fumarate, hydrochloride, maleate, methanesulfonate, mucinate, phosphate, L-tartrate, and p-tolunesulfonate, respectively, and the claim also recites maleate, methanesulfonate, and phosphate, respectively, which is the narrower statement of the limitation.
Likewise, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), pertaining to where broad language is followed by such as and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and consequently, not required, or (b) a required feature of the claim.
Moreover, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 6 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that a broad limitation together with a narrow limitation that falls within the broad limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c), MPEP § 2173.05(h), and/or Eli Lilly & Co. v. Teva Parenteral Meds., 845 F.3d 1357, 1371, 121 USPQ2d 1277, 1287 (Fed. Cir. 2017).
Similarly, the inventor or joint inventor should further note that claim 6 recites the broad limitation, benzenesulfonate, citrate, fumarate, hydrochloride, maleate, methanesulfonate, mucinate, phosphate, L-tartrate, and p-tolunesulfonate, respectively, and the claim also recites maleate, methanesulfonate, and phosphate, respectively, which is the narrower statement of the limitation.
Likewise, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), pertaining to where broad language is followed by such as and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and consequently, not required, or (b) a required feature of the claim.
Moreover, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 7 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that a broad limitation together with a narrow limitation that falls within the broad limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c), MPEP § 2173.05(h), and/or Eli Lilly & Co. v. Teva Parenteral Meds., 845 F.3d 1357, 1371, 121 USPQ2d 1277, 1287 (Fed. Cir. 2017).
Similarly, the inventor or joint inventor should further note that claim 7 recites the broad limitation, …having a powder X-ray diffraction pattern (XRPD) having one or more characteristic peaks at a diffraction angle (2q) selected from…, and the claim also recites …preferably having a powder X-ray diffraction pattern (XRPD) having one or more characteristic peaks at a diffraction angle (2q) selected from…, which is the narrower statement of the limitation.
Likewise, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), pertaining to where broad language is followed by such as and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and consequently, not required, or (b) a required feature of the claim.
Moreover, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claims 10 and 11 are further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that claim 10 recites the limitation, The pharmaceutical composition according to claim 9, which is in the form of a dispersion comprising a pharmaceutically acceptable dispersing medium and the solid form of the compound according to claim 1 dispersed in the dispersing medium, in lines 1-3 of the claim. There is insufficient antecedent basis, in claim 9, for this limitation, with respect to the pharmaceutical composition comprising a solid form of a pharmaceutically acceptable salt of (S)-(2-(6-(2-ethyl-5-fluoro-4-hydroxyphenyl)-1H-indazol-3-yl)-4,6-dihydropyrrolo[3,4-d]imidazol-5(1H)-yl)(3-hydroxy-pyrrolidin-1-yl)methanone of the formula (I). According to claim 1, a solid form is recited instead of a compound, with respect to the solid form of a pharmaceutically acceptable salt of (S)-(2-(6-(2-ethyl-5-fluoro-4-hydroxyphenyl)-1H-indazol-3-yl)-4,6-dihydropyrrolo[3,4-d]imidazol-5(1H)-yl)(3-hydroxypyrrolidin-1-yl)methanone of the formula (I).
Moreover, the inventor or joint inventor should further note that [C]laims which depend from indefinite claims are also indefinite. {See Ex parte Cordova, 10 USPQ 2d 1949, 1952 (PTO Bd. App. 1989)}.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim Rejections - Obviousness-type 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 obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined invention claim is not patentably distinct from the reference claims because the examined invention claim is either anticipated by, or would have been obvious over, the reference claims. {See 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); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969)}.
US Patent No. 11,629,148
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Consequently, at least claims 1, 3, 5 and 9-11 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over at least claim 11 of US Patent No. 11,629,148. Although the conflicting claims are not identical, they are not patentably distinct from each other because claim 11 in US 11,629,148 recites (S)-(2-(6-(2-ethyl-5-fluoro-4-hydroxyphenyl)-1H-indazol-3-yl)-4,6-dihydro-pyrrolo[3,4-d]imidazol-5(1H)-yl)(3-hydroxypyrrolidin-1-yl)-methanone, shown to the left, or a pharmaceutically acceptable salt thereof, which provides overlapping subject matter with respect to the instantly recited solid form of a pharmaceutically acceptable salt of (S)-(2-(6-(2-ethyl-5-fluoro-4-hydroxyphenyl)-1H-indazol-3-yl)-4,6-dihydropyrrolo[3,4-d]-imidazol-5(1H)-yl)(3-hydroxypyrrolidin-1-yl)methanone of the formula (I), shown to the right.
The inventor or joint inventor should note that [T]he discovery of a previously unappreciated property of a prior art compound, or of a scientific explanation for the prior art’s functioning, does not render the old compound patentably new to the discoverer. {See Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999)}.
Similarly, the inventor or joint inventor should further note that [T]he claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. {See In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977); and In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004)}.
Likewise, the inventor or joint inventor should note that [W]hen the claim recites using an old compound and the use is directed to a result or property of that compound, then the claim is anticipated. {See In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978); and In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966)}.
Next, the inventor or joint inventor should further note that [P]roducts of identical chemical composition may not have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties the inventor or joint inventor discloses and/or claims are necessarily present. {See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)}.
Moreover, the inventor or joint inventor should further note that [I]t is obvious to add a carrier or solvent to an unpatentable compound. {See Ex parte Douros and Vanderweff, 163 USPQ 667, (BPAI 1968)}.
US Patent No. 12,180,215
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At least claims 1, 3, 5 and 9-11 are further rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over at least claim 18 of US Patent No. 12,180,215. Although the conflicting claims are not identical, they are not patentably distinct from each other because claim 18 in US 12,180,215 recites (S)-(2-(6-(2-ethyl-5-fluoro-4-hydroxyphenyl)-1H-indazol-3-yl)-4,6-dihydro-pyrrolo[3,4-d]imidazol-5(1H)-yl)(3-hydroxypyrrolidin-1-yl)-methanone, shown to the left, or a pharmaceutically acceptable salt thereof, which provides overlapping subject matter with respect to the instantly recited solid form of a pharmaceutically acceptable salt of (S)-(2-(6-(2-ethyl-5-fluoro-4-hydroxyphenyl)-1H-indazol-3-yl)-4,6-dihydropyrrolo[3,4-d]imidazol-5(1H)-yl)(3-hydroxypyrrolidin-1-yl)methanone of the formula (I), shown to the right below.
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The inventor or joint inventor should note that [T]he discovery of a previously unappreciated property of a prior art compound, or of a scientific explanation for the prior art’s functioning, does not render the old compound patentably new to the discoverer. {See Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999)}.
Similarly, the inventor or joint inventor should further note that [T]he claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. {See In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977); and In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004)}.
Likewise, the inventor or joint inventor should note that [W]hen the claim recites using an old compound and the use is directed to a result or property of that compound, then the claim is anticipated. {See In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978); and In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966)}.
Next, the inventor or joint inventor should further note that [P]roducts of identical chemical composition may not have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties the inventor or joint inventor discloses and/or claims are necessarily present. {See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)}.
Then, the inventor or joint inventor should further note that [I]t is obvious to add a carrier or solvent to an unpatentable compound. {See Ex parte Douros and Vanderweff, 163 USPQ 667, (BPAI 1968)}.
Moreover, the inventor or joint inventor should further note that a timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 37 CFR 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground, provided the conflicting invention or patent either is shown to be commonly owned with this invention, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Furthermore, the inventor or joint inventor should also note that the USPTO internet Web site contains terminal disclaimer forms which may be used, and the inventor or joint inventor is encouraged to visit http://www.uspto.gov/forms/, where (i) the filing date of the invention will determine what form should be used, and (ii) a web-based eTerminal Disclaimer may be filled out completely online using web-screens, respectively.
Also, the inventor or joint inventor should further note that an eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission.
Finally, for more information about eTerminal Disclaimers, the inventor or joint inventor should refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Allowable Subject Matter
No claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS M. WILLIS, whose telephone number is 571-270-5757. The examiner may normally be reached on Monday thru Thursday from 8:00-6:00 EST. The examiner is also available on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Jeffrey Murray, may be reached on 571-272-9023. The fax phone number for the organization where this invention or proceeding is assigned is 571-273-8300.
Information regarding the status of an invention may be obtained from Patent Center. For more information about Patent Center, see https://www.uspto.gov/patents/apply/patent-center. Should you have questions on access to Patent Center, contact the Patent Electronic Business Center (PEBC) at 866-217-9197 (toll-free) or ebc@uspto.gov.
/DOUGLAS M WILLIS/
Primary Examiner, Art Unit 1624