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 .
Claim Status
Claims 1-52 were filed in the instant application. A Preliminary Amendment, filed June 4, 2024, canceled claims 2-4, 6-18, 23-24, 26, 29, 34-41, 43, 47, 49, and 51-52. The same amendment amended claims 1, 5, 19, 21, 22, 25, 27-28, 30-31, 33, 42, 44, 48, and 50. The same amendment introduced new claim 53. Consequently, claims 1, 5, 19-22, 25, 27-28, 30-33, 42, 44-46, 48, 50, and 53 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1, 5, and 19-22) in the reply filed on February 18, 2026 is acknowledged. Applicant’s election without traverse of the specific species of voruciclib malonate crystal form with diffraction pattern as recited in claim 21 in the reply filed on February 18, 2026 is acknowledged.
Claims 25, 27-28, 30-33, 42, 44-46, 48, 50, and 53 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 18, 2026.
Claim 22 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 18, 2026.
Consequently, claims 1, 5, and 19-21 are under consideration to the extent that the voruciclib malonate crystal form has the diffraction pattern as recited in claim 21.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on February 9, 2024 and June 30, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 19, and 21 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Duncan (WO2020/210760, published 10/15/2020, priority to April 11, 2019, IDS reference filed February 9, 2024).
It is noted that Duncan is being applied as of its publication date 10/15/2020 under 102(a)(1) and as of its earliest effectively filed date of 4/11/2019 under 102(a)(2).
With respect to Duncan applied under 102(a)(2), the applied reference has a common applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Duncan teaches crystalline solid forms of voruciclib, both as a free base and as a salt, compositions containing voruciclib, and methods for treating conditions/disorders by administering said pharmaceutical compositions. In particular, the prior art recites the pharmaceutical composition comprising a solid form of voruciclib that may be voruciclib malonate (paragraph [00400]). This solid form is “in the range from… approximately 0.001% to approximately 40%” in relation to the overall formulation, as in instant claim 1 (paragraph [00400] - [00402]). The composition taught by Duncan may also be in the form of a tablet (paragraph [00409]), as in instant claim 19. Further, Duncan teaches a crystal form of voruciclib malonate “characterized by an X-ray powder diffraction pattern including one or more peaks selected from 7.30° ± 0.2°, 13.58° ± 0.2°, 14.06° ± 0.2°, 15.18° ± 0.2°, 15.66° ± 0.2°, 17.50° ± 0.2°, 18.94° ± 0.2°, 19.54° ± 0.2°, 22.22° ± 0.2°, 23.38° ± 0.2°, 24.10° ± 0.2°, 24.98° ± 0.2°, 25.94° ± 0.2°, 27.26° ± 0.2°, 28.50° ± 0.2°, and 32.82° ± 0.2°” which aligns exactly with instant claim 21 (paragraph [004]).Therefore, claims 1, 19 and 21 are rejected.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5,19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Duncan (WO2020/210760, published 10/15/2020, priority to April 11, 2019, IDS reference filed February 9, 2024.)
With respect to claims 1, 19 and 21, it is noted that "[A] disclosure that anticipates under § 102 also renders the claim invalid under § 103, for `anticipation is the epitome of obviousness.'" Connell v. Sears, Roebuck Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983) (quoting In re Fracalossi, 681 F.2d 792 (Cust. Pat.App. 1982).
With respect to claim 5 , the teachings of Duncan have been described supra. Further, Duncan teaches the inclusion of various excipients such as granulating agents, lubricants, glidants, binders, and disintegrating agents (paragraph [00411]). Among the specific additives named is microcrystalline cellulose. The solid form may comprise a disintegrant in “about 0.5 to about 15 weight percent” such as microcrystalline cellulose in that amount (paragraph [00414]), overlapping with instant claim 5 (see MPEP 2144.05).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Duncan (WO2020/210760, published 10/15/2020, priority to April 11, 2019, IDS reference filed February 9, 2024) as applied to claims 1, 5,19 and 21, and further in view of Agarwal (US20160136132A1).
Duncan has been described supra. However, Duncan does not teach a film coating for the tablet formulation previously described. This deficiency is made up for by Agarwal.
Agarwal teaches a pharmaceutical composition wherein a cyclin dependent kinase (CDK) inhibitor is used for the treatment of melanoma. The CDK inhibitor used is voruciclib (paragraph [0060]), or salt form of voruciclib including voruciclib malonate (paragraph [0058]). Agarwal further teaches that this composition may be in the form of a film-coated tablet, which is disclosed to provide a benefit of preventing dissolution for a predictable period of time (paragraph [0146]).
As the active ingredient is exactly the same as that taught by Duncan, it would be prima facie obvious in light of Duncan in view of Agarwal to coat the tablet form as described by Duncan with a film coating such as that taught by Agarwal to offer the benefit of preventing dissolution for a predictable period of time. Therefore, claim 20 is rejected.
Claims 1, 5, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Agarwal (US20160136132A1) in view of Siddiqui-Jain (WO2020117988A1).
Agarwal teaches a pharmaceutical composition comprising a cyclin dependent kinase (CDK) inhibitor or a salt thereof in combination with at least one anticancer agent. The CDK inhibitor used in this composition is voruciclib, or salt thereof for formulation purposes, including the malonate form (paragraph [0058]). Salt forms such as malonate forms are known in the art to Agarwal, and Agarwal teaches that this composition may be in the form of a tablet, and may be coated with a film coating (paragraph [0146]), as claimed in instant claims 19-20.
Agarwal does not teach the amount of voruciclib malonate in the formulation, nor does it teach the amount of excipient that may be included in the formulation. This deficiency is made up for by Siddiqui-Jain.
Siddiqui-Jain teaches a crystalline form of a CDK inhibitor. Siddiqui-Jain teaches this CDK inhibitor in a specific pharmaceutical composition, wherein the CDK inhibitor or salt form thereof is present in “about 0.5 weight percent to about 11.25 weight percent” (claim 28). Further, Siddiqui-Jain teaches the inclusion of excipients such as colloidal silicon dioxide in about 1 weight % of the overall composition (Siddiqui-Jain, claims 37-38), as well as magnesium stearate in about 1 weight % of the overall composition (Siddiqui-Jain, claims 40-41).
It would be prima facie obvious in light of Agarwal and Siddiqui-Jain before the effective filing date of the claimed invention to have produced a pharmaceutical composition comprising the CDK inhibitor voruciclib, including salt forms such as voruciclib malonate as taught by Agarwal in an amount of about 0.5 weight percent to about 11.25 weight percent as taught by Siddiqui-Jain) because both Agarwal and Siddiqui-Jain teach CDK inhibitors, and Siddiqui-Jain further teaches an effective amount in a pharmaceutical composition is 0.5 weight percent to about 11.25 weight percent. Combining the two references would yield voruciclib malonate in an amount between about 0.5 wt% and about 11.25 wt%, which overlaps with instant claim 1 (see MPEP 2144.05). Further, the two references would yield the inclusion of magnesium stearate in about 1%, and/or colloidal silicon dioxide in about 1%, both of which overlap with instant claim 5 (see MPEP 2144.05). Both references also teach these CDK inhibitor compositions in a tablet form, and Agarwal further notes that the tablet may also be coated with a film coating to resist dissolution (paragraph [0146]), aligning with instant claims 19-20. Based on the teachings of Agarwal and Siddiqui-Jain, claims 1, 5, and 19-20 are rejected.
In light of Agarwal in view of Siddiqui-Jain, claims 1, 5, and 19-20 would have been prima facie obvious.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Agarwal and Siddiqui-Jain as applied to claims 1, 5, and 19-20 above, and further in view of Sivakumar (US Patent No. 8,563,596 B2, IDS reference filed February 9, 2024).
Neither Agarwal nor Siddiqui-Jain teaches an X-ray powder diffraction pattern derived from the crystal form of voruciclib comprising one or more peaks selected from 7.30° ± 0.2°, 13.58° ± 0.2°, 14.06° ± 0.2°, 15.18° ± 0.2°, 15.66° ± 0.2°, 17.50° ± 0.2°, 18.94° ± 0.2°, 19.54° ± 0.2°, 22.22° ± 0.2°, 23.38° ± 0.2°, 24.10° ± 0.2°, 24.98° ± 0.2°, 25.94° ± 0.2°, 27.26° ± 0.2°, 28.50° ± 0.2°, and 32.82° ± 0.2°.
This deficiency regarding claim 21 is made up for by Sivakumar.
Sivakumar teaches enantiomerically pure compounds for treatment of proliferative disorders, such as voruciclib. Sivakumar discloses a crystal form of voruciclib (col. 6 line 23-34 and example 44). It is disclosed that this is done to determine the presence of polymorphs and for their analysis by various techniques including NMR spectroscopy, powder X-ray diffraction, and others (col. 6 line 34). This crystal form is the same as the instantly claimed crystal form. As a product and its properties are inseparable, the crystal form of Sivakumar inherently possesses the property of being characterized by an X-ray powder diffraction pattern comprising at least one of the peaks in the instant claim.
It would be prima facie obvious to crystalize the salt form of voruciclib for analysis by various techniques based on the teachings of Sivakumar, including the malonate salt of voruciclib as taught by Agarwal. As the structures of voruciclib, and the salt form voruciclib malonate, are identical between Agarwal and Sivakumar, it follows that voruciclib malonate crystals will necessarily contain at least one X-ray powder diffraction pattern peak that aligns with the instant claim 21. Therefore, claim 21 is rejected. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
In light of Agarwal, Siddiqui-Jain, and Sivakumar, claim 21 would have been prima facie obvious based on the evidence of the references.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW RYAN BURKE whose telephone number is (571)272-8949. The examiner can normally be reached Mon-Fri. 8am-5pm.
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/MATTHEW RYAN BURKE/Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619
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