DETAILED ACTION
Notice of 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 in the reply filed on 1/28/2026 is acknowledged. The requirement is still deemed proper and is therefore made FINAL.
Claims 84-95 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant’s election without further specifying traverse of a single species in the reply filed on 1/28/2026 is also acknowledged.
The elected species read upon claims 65-71. Claims 72-83 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
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.
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 65-70 are rejected under 35 U.S.C. 103(a) as being unpatentable over Snyder et al (US 2018/0296574) in view of Hedley et al (US 2018/0311224) and Benjamin et al (US 2016/0015816).
Claim 65 is drawn to a granule composition comprising:
granules consisting essentially of:
abiraterone acetate,
niraparib tosylate monohydrate, and
a pharmaceutically acceptable carrier;
wherein the pharmaceutically acceptable carrier comprises:
a wetting agent that is sodium lauryl sulfate;
a disintegrant that is crospovidone;
a diluent (more specifically, lactose (claim 68)); and
further comprising a glidant, lubricant, and binder (claim 66), more specifically, wherein:
the glidant is colloidal anhydrous silica (claim 69);
the lubricant is magnesium stearate (claim 70); and
the binder is lactose (claim 68) and HPMC.
Snyder et al teach “pharmaceutical compositions comprising... niraparib, abiraterone acetate, and prednisone” (Paragraph 0011), wherein “[t]he compositions... may be in a form suitable for oral use, for example, as... granules” (Paragraph 0047), wherein “the niraparib [and] abiraterone acetate may be administered in a first dosage form, while the prednisone is administered to the patient in a second, separate dosage form” (Paragraph 0039). As further taught by Snyder et al, the “granules... provide the active ingredients in admixture with a dispersing or wetting agent, suspending agent and one or more preservatives” and, optionally, “[a]dditional excipients” (Paragraph 0052).
Accordingly, it would have been prima facie obvious to formulate a composition comprising granules comprising abiraterone acetate, niraparib and a pharmaceutical carrier(s).
However, the granule composition taught by Snyder et al differs from the instantly claimed invention in that:
(a) Snyder et al teach the inclusion of niraparib as opposed to niraparib tosylate monohydrate; and
(b) Snyder et al do not specifically disclose any embodiments of granules and, in particular, granules comprising:
the wetting agent sodium lauryl sulfate;
the disintegrant crospovidone;
the diluent is lactose;
the glidant colloidal anhydrous silica;
the lubricant magnesium stearate; and
the binder is lactose and HPMC.
Yet, as to (a): Hedley et al, teaching “methods of administering a PARP inhibitor to a cancer patient” (Abstract) wherein “[i]n certain embodiments, the agent is niraparib or a salt or derivative thereof” (Paragraph 0009), further teach that “the term ‘niraparib’ means any free base compound... a salt form... or a solvated or hydrated form there... individually referred to as ‘niraparib free base’, ‘niraparib tosylate’, and ‘niraparib tosylate monohydrate’, respectively” (Paragraph 0119).
Accordingly, based further on Hedley et al, it would have been prima facie obvious to utilize niraparib tosylate monohydrate in place of niraparib in the granules of Snyder et al. The simple substitution a known niraparib equivalent for niraparib is prima facie obvious.
And, as to (b): Benjamin et al, describing “solid compositions... for the oral delivery of a drug” (Paragraph 0008), more specifically “a solid composition that comprises granules” (Paragraph 0063), specifically disclose granules comprising, as pharmaceutical excipients, sodium lauryl sulfate, crospovidone, lactose, magnesium stearate, and HMPC (Paragraph 0108, Example 7 and Paragraph 0112, Example 11) wherein “[i]n some embodiments of the invention, the solid composition further comprises at least one additional pharmaceutical ingredient” (Paragraph 0054) “such as colloidal silica” (Paragraph 0055), further disclosing “Cabosil, fumed silica, available from Cabot of Tuscola, Ill, USA” (Paragraph 0096) which entails colloidal anhydrous silica.
Accordingly, based further on Benjamin et al, it would have been prima facie obvious to formulate the granules of Snyder et al utilizing sodium lauryl sulfate, crospovidone, lactose, colloidal anhydrous silica, and magnesium stearate, and HMPC as pharmaceutical excipients. The picking and choosing of known pharmaceutical excipients (which are known to be useful in formulating granules in oral compositions) for formulating granules in oral compositions is prima facie obvious.
In view of all of the foregoing, claims 65-70 are rejected as prima facie obvious.
Claim 71 is rejected under 35 U.S.C. 103(a) as being unpatentable over Snyder et al (US 2018/0296574) in view of Hedley et al (US 2018/0311224) and Benjamin et al (US 2016/0015816) as applied to claims 65-70 above, in further view of De Simone et al (J Drug Deliv Sci Tech 513-520, 2019).
Claim 71 is drawn to the composition of claim 66, wherein the binder is HPMC 2910 15 mPa.s.
As discussed above, Snyder et al in view of Hedley et al and Benjamin et al teach a granule composition of claim 66 comprising HPMC as a binder.
However, Benjamin et al further disclose “HPMC (METHOCEL E3 LV, USP, Dow Chemical Co., Midland, Mich., USA)” (Paragraph 0102) – having a viscosity of about 3 mPa.s – as opposed to HPMC 2910 15 mPa.s as recited by claim 71.
Yet, as stated by MPEP 2144.05, “[g]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical” (see also In re Aller (220 F.2d 454 (CCPA): “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation…” Indeed, as further discussed by the court, “[s]uch experimentation is no more than the application of the expected skill of the [ordinarily skilled artisan] and failure to perform such experiments would, in our opinion, show a want of the expected skill”; see also In re Peterson, 315 F.3d at 1325 (Fed. Cir. 2005): “[t]he normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages” and “[o]nly if the ‘results of optimizing a variable’ are ‘unexpectedly good’ can a patent be obtained for the claimed critical range” (quoting In re Antonie (559 F.2d 618 (CCPA 1977))).
In the instant case, the viscosity of HPMC as a binder in granules is clearly a result-effective variable as taught by De Simone et al, stating that “HPMC is one of the most important hydrophilic ingredients used in hydrogel matrices preparation (tablets or granules)” (Abstract) and “HMPC concentration and its viscosity grade... are the most important formulation variables to modulate the drug release profile from the HPMC-based matrices according to the therapeutic needs” (Page 513, Column 2).
Accordingly, it would have been customary for an artisan of ordinary skill in the art to select a specific HPMC having a desired viscosity to function as a binder in the granules of the prior art “according to the therapeutic needs”.
As such, claim 71 is also rejected as prima facie obvious.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 65-71 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 17/998,198.
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘198 claims are drawn to methods of treating prostate cancer, comprising administering “a pharmaceutical formulation comprising abiraterone acetate and niraparib tosylate monohydrate” (claim 59) wherein the Specification further discloses granule dosage forms comprising the instantly claimed pharmaceutical excipients (Paragraph 0129).
It would have been obvious to formulate the granule dosage forms of the ‘198 application in order to carry out the method recited by the claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 65-71 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 17/998,202.
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘202 claims are drawn to methods of treating prostate cancer, comprising administering “a pharmaceutical formulation comprising abiraterone acetate and niraparib tosylate monohydrate” (claim 40) wherein the Specification further discloses granule dosage forms comprising the instantly claimed pharmaceutical excipients (Paragraph 0278).
It would have been obvious to formulate the granule dosage forms of the ‘202 application in order to carry out the method recited by the claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 65-71 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 18/833,519.
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘519 claims are drawn to methods administering “a drug product comprising a two-drug combination of... niraparib and... abiraterone acetate” (claim 14), more specifically niraparib tosylate monohydrate (claim 23) as granules comprising each of the recited pharmaceutically acceptable excipients (claim 25).
It would have been obvious to formulate the granule dosage forms of the ‘519 application in order to carry out the method recited by the claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/CRAIG D RICCI/Primary Examiner, Art Unit 1611