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 .
Priority
This application filed on 08/30/2023 is a U.S. National Stage filing under 35 U.S.C. Q 371 of International Application No. PCT/FI2022/050129, filed 02/28/2022, which claims the benefit of Finnish Application No. 20215215, filed 03/1/2021.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 06/10/2024 and 12/04/2025, complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits, except where noted.
Status of claims
The preliminary amendment filed on 08/30/2023, that amended claims 1-22 and added claims 23-35, is acknowledged. Claims 1-35 are pending.
Election/Restriction
Applicant’s response filed on 03/18/2026 to Restriction/Election Requirement filed on 12/18/2025, is acknowledged. Applicant elected without traverse Group I drawn to crystalline forms of 2-(isoindolin-2- ylmethyl)-5-((1-(methylsulfonyl)piperidin-4-yl)methoxy)-4H-pyran-4-one. Claims 1-13, 21, 24, 27, 30, and 33 read on the elected Group. Claims 14-20, 22-23, 25-26, 28-29, 31-32, and 34-35 of Groups II and III are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Pursuant to the Election of Species Requirement, Applicant respectively elected without traverse, crystalline form 5 of 2-(isoindolin-2- ylmethyl)-5-((1-(methylsulfonyl)piperidin-4-yl)methoxy)-4H-pyran-4-one for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Claims 11-13 and 33 read 1on the elected species.
Thus, claims 1-35 are pending with claims 1-10, 14-32 and 34-35 are withdrawn from further consideration, and claims 11-13 and 33 are under consideration.
Abstract
The Abstract of the disclosure is objected to because the Abstract recites “the present disclosure relates to …”. Applicant is reminded of the proper language and format for an abstract of the disclosure. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Rejections 35 U.S.C. 112(b)
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.
Claims 11-13 and 33 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.
Pursuant to 35 U.S.C. 112(b), the claim must apprise one of ordinary skill in the art of its scope so as to provide clear warning to others as to what constitutes infringement. MPEP 2173.02(II); Solomon v. Kimberly-Clark Corp., 216 F.3d 1372, 1379, 55 USPQ2d 1279, 1283 (Fed. Cir. 2000).
Claim 11 recites “A compound which is crystalline form 5 of 2-(isoindolin-2- ylmethyl)-5-((1-(methylsulfonyl)piperidin-4-yl)methoxy)-4H-pyran-4-one (I) having an X-ray powder diffraction pattern comprising peaks, expressed in degrees 2-theta (± 0.2), at 9.4, 10.0, 10.5, 11.6, 13.5, 15.2, 16.5 and 20.0. claims 12 and 13 further recite spectroscopic characterization.
The art teaches that compounds can exists in multiple crystalline forms, and the gold standard to distinguish these forms is through XRPD. The XRPD consider to be the fingerprint in determining and identifying the particular crystalline form. However, the instant specification describes form 5 by three different figures:
Figure 5 shows the X-ray powder diffraction pattern of the crystalline form 5 (water content 0.3-0.6) of compound (I).
Figure 6 shows the X-ray powder diffraction pattern of the crystalline form 5 (water content 0.3) of compound (I).
Figure 7 shows the X-ray powder diffraction pattern of the crystalline form 5 (water content 0.6) of compound (I).
Independent claim 11 recites crystalline form 5 without indicating the water content which resulted in confusion of which figure (figure 5, 6 or 7) represents the crystalline form of claim 11. In view of figures 5, 6 and 7, one of ordinary skill in the art would presume that crystal form 5 may comprises a hydrate and questions what hydrate forms are falling within the scope of the claim 11? One of ordinary skill would also question the relationship between the amount of water and crystalline forms formed. For example, which crystalline form would be formed if the water content is 0.7? the three figures are reproduced below for facile comparison:
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One of ordinary skill would presume that Applicant intends to define form 5 as a crystalline form that comprises the peaks recited in claim 12 regardless of the water content, however, ordinary skill would not know if water content of, for example, 0.2 or 0.7 would produce the same peaks recited in claim 12. It appears that the figures share most of the XRPD beaks, yet the three figures are distinct. Also, it’s unclear how figure 5 contains 0.3-0.6 water is dissimilar to the other figures 6 and 7 that contains 0.3 and 0.6, respectively. For example, one would expect figure 5 to comprise all the peaks of figure 6 and 7. Please note that figure 6 and 7 share a lot of similarity.
One of ordinary skill in the art used the XRPD figure to identify the claimed crystalline form 5 as XRPD consider the art standard in determining and identifying the particular crystalline form. In the instant case, since there are three figures and claims that directed to crystal form 5 without reciting the water content, one of ordinary skill in the art would not be able to apprise the scope of the claims. Claim 11 is unclear. A claim limitation which is considered indefinite cannot be disregarded. MPEP § 2143.03(I).
Dependent claims 12-13 and 33 are indefinite due to their dependence on a rejected claim and lacking any limitations that cure the ambiguities resulting from the parent claim(s).
For compact prosecution and for the purpose of applying prior art, the crystalline form 5 is as the crystalline form that defined by Figure 5 and its interpreted as crystalline form that contain small amount of water between 0.3-0.6.
Claim Rejections - 35 USC § 103
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 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.
§ 103 Rejection over Belle in view of Barth and Morissette
Claims 11-13 and 33 are rejected under 35 U.S.C. 103 as being obvious over D. Belle, et al. (US PG Pub 2019/0359601 A1, 11/28/2019 “Belle” cited in the IDS dated 06/10/2024) in view of Oksala, R., et al. "ODM-208, a novel CYP11A1-inhibitor as a therapeutic approach for the treatment of castration-resistant prostate cancer." Annals of Oncology 28 (2017): v8, “Oksala” cited in the PTO-892), W. Barth et al. (US Patent No. 4,432,987A, 02/21/1984, “Barth”, cited in the PTO-892) and S. Morissette, et al. Advanced Drug Delivery Reviews, Volume 56, Issue 3, 2004, Pages 275-300, “Morissette” cited in the PTO-892).
This application currently names joint inventors and assignee. 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.
Belle teaches CYP11A1 inhibitors of formula (I) for use as medicaments in the treatment of steroid hormone dependent conditions and diseases where CYP11A1 inhibition is desired, wherein the diseases include breast cancer and prostate cancer [0007]. Belle teaches compound 185 as species of formula (I) (the claimed compound), [page 96, comp. 185]:
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Belle discloses that the compound is purified by crystallization. [page [1020], [1034], [1046]]. Belle discloses the preparation of compound 185 (the claimed compound), wherein the compound isolated as a solid. [page 56, [1015]].
However, Belle does not specifically recite the crystalline form 5 of compound 185 or the spectroscopic characterization. Also, one of ordinary skill in the art need to select compound 185 from Belle’s list of CYP11A1 inhibitors.
Oksala teaches that ODM-208 is a novel, oral, non-steroidal and selective inhibitor of CYP11A1 enzyme and suppresses the synthesis of all steroid hormones and precursors. ODM-208 2 is the same compound as Belle’s compound 185 and the claimed compound. Oksala teaches that ODM-208 inhibited adrenal and testicular hormone production. Oksala teaches ODM-208 inhibited tumor growth in the androgen dependent VCaP cells. Oksala teaches ODM-208 potently inhibits CYP11A1 enzyme and formation of pregnenolone and testosterone with low nM concentrations in vitro. Oksala teaches that in prostate cancer model, ODM-208 significantly inhibited tumor growth.
In the same art area of pharmaceutical preparations and their use in treating disease, Barth teaches the following:
“[c]rystalline forms of compounds are ordinarily preferable to the non-crystalline forms thereof. The crystalline materials have superior stability, appearance and handling characteristics when compared to their amorphous counterparts. For pharmaceutical use crystalline compounds are especially advantageous in manufacturing procedures and in formation and use of acceptable dosage forms such as solutions, suspensions, elixirs, tablets, capsules and various pharmaceutically elegant preparations required by the medical and pharmaceutical professions.” [Pg. 2, col. 1, ln. 60- col. 2, ln. 2].
Morissette teaches an automated high-throughput crystallization to form polymorphs, salts, co-crystals and solvate forms of pharmaceuticals [Title, abstract]. The prior art describes the successful application of the automated high-throughput technique to several known pharmaceuticals and details how thousands of crystallization conditions can be performed in parallel, computer analyzed and then used to produce the polymorphic forms of a given pharmaceutical [Page 296, para. 2].
At the time of invention, one of ordinary skill in the art would have been motivated to specifically pick compound 185 from Belle’s CYP11A1 inhibitors of formula (I) for preparing crystalline forms. One of ordinary skill in the art would have been motivated to do so with reasonable expectation of success because Belle teaches that the CYP11A1 inhibitors of formula (I) directed to the treatment of a disease related to CYP11A1 inhibition, particularly, prostate cancer, and Oksala teaches that compound ODM-208 (Belle’s compound 185) is a potent and selective inhibitor of CYP11A1 enzyme for treating prostate cancer and inhibiting adrenal and testicular hormone production. Oksala also teaches the potency of ODM-208 in inhibiting tumor growth in the androgen dependent VCaP cells and in prostate cancer model with low nM concentrations.
One of ordinary skill in the art would have been motivated to prepare crystalline form 5 of the Belle potent CYP11A1 inhibitor, compound 185 because Barth teaches that crystalline forms are preferred over non-crystalline forms; have superior stability; are preferred in formulation of dosage forms; and are advantageous in manufacturing procedures. [page 2, col. 1, ln. 60- col. 2, ln. 2].
One of ordinary skill in the art practicing the Belle’s pharmaceutical compound 185 would form a crystalline form in accordance with the specific teaching of Belle. Utilizing the routine “High-throughput salt selection” taught by Morissette [page 285-287] one of ordinary skill in the art would arrive at the claimed invention. Specifically, because Belle teaches that compound 185 form solid and purified by crystallization. Thus, one of ordinary skill in the art would have a reasonable expectation of success in arriving at the claimed invention.
In the instant case one of ordinary skill in the art would have a reasonable expectation of success in following the teaching of Belle and utilizing the well-known and routine automated high-throughput screening described by Morissette arrive at the claimed invention because such acts are conventional and routine in the art. One of ordinary skill in the art would be expected to apply methods within their technical grasp (such as automated high-throughput screening) to improve that which is already known in the art. The Supreme Court stated in KSR “if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person's skill.” KSR Intern. Co. v. Teleflex Inc., 127 S.Ct. 1727, 1731 (2007). Here, the use of an automated system to screen a pharmaceutical salt for crystallization is well known and specifically taught by Morissette. Therefore, the method is within the technical grasp of those of ordinary skill in the art and it would be obvious to one of ordinary skill in the art to use the same method and apply it to the Belle’s compound.
Regarding the spectroscopic characterization of the obvious product, such properties are inherent in the product (MPEP 2112.02: "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.). In this case, one of ordinary skill in the art would have reasonably considered producing the crystalline salt form 5 which would inherently show the same spectroscopic parameters as are in the claim. "[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, or ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same." In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977).
Thus, claims 11-13 are rejected as prima facie obvious.
With regard to claim 33, Belle teaches a pharmaceutical composition comprising a compound of formula (I) together with a pharmaceutically acceptable carrier [0089], wherein the composition formulated in dosage forms e.g., tablets, granules or capsules. [0718].
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.
Non-Statutory Double Patenting over US Patent No. 10717726B2
Claims 11-13 and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 14, 21, 22, 23, 24, 27 and 35 of US Patent No. 10717726B2 (US20190359601A1) in view of Oksala, R., et al. Annals of Oncology 28 (2017): v8, “Oksala” cited in the PTO-892), W. Barth et al. (US Patent No. 4,432,987A, 02/21/1984, “Barth”, cited in the PTO-892) and S. Morissette, et al. Advanced Drug Delivery Reviews, Volume 56, Issue 3, 2004, Pages 275-300, “Morissette” cited in the PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims 11-13 and 33 recites “a compound which is crystalline form 5 of 2-(isoindolin-2- ylmethyl)-5-((1-(methylsulfonyl)piperidin-4-yl)methoxy)-4H-pyran-4-one (I) having an X-ray powder diffraction pattern comprising peaks, expressed in degrees 2-theta (± 0.2), at 9.4, 10.0, 10.5, 11.6, 13.5, 15.2, 16.5 and 20.0.” and pharmaceutical dosage form comprising the compound of claim 11.
US Patent No. 10717726B2 recites a compound of formula (I), and claim 27 recites the claimed compound as species of formula (I) (claim 27, 11th compound). Claim 35 recites pharmaceutical composition comprising a compound according to claim 1 and a pharmaceutically acceptable carrier. The pharmaceutical composition is described as dosage form, e.g., tablets, granules, capsules [col. 38, ln. 19-23]. US Patent No. 10717726B2 does not specifically recite the crystalline form 5 of claim 27 compound or the spectroscopic characterization. Also, one of ordinary skill in the art need to select compound of claim 27 from US Patent No. 10717726B2 list of CYP11A1 inhibitors.
Oksala, Barth and Morissette teach as discussed above, pages 8-9.
The obviousness rationale is similar to the rationale in the obviousness Rejection above, pages 9-10.
Non-Statutory Double Patenting over US Patent No. US11098032B2
Claims 11-13 and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2 and 10 of US Patent No. 11098032B2 in view of Oksala, R., et al. Annals of Oncology 28 (2017): v8, “Oksala” cited in the PTO-892), W. Barth et al. (US Patent No. 4,432,987A, 02/21/1984, “Barth”, cited in the PTO-892) and S. Morissette, et al. Advanced Drug Delivery Reviews, Volume 56, Issue 3, 2004, Pages 275-300, “Morissette” cited in the PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims 11-13 and 33 recites “a compound which is crystalline form 5 of 2-(isoindolin-2- ylmethyl)-5-((1-(methylsulfonyl)piperidin-4-yl)methoxy)-4H-pyran-4-one (I) having an X-ray powder diffraction pattern comprising peaks, expressed in degrees 2-theta (± 0.2), at 9.4, 10.0, 10.5, 11.6, 13.5, 15.2, 16.5 and 20.0.” and pharmaceutical dosage form comprising the compound of claim 11.
US Patent No. 11098032B2 recites a compound of formula (ID), and claim 2 recites the claimed compound as species of formula (ID) (claim 2, 3rd compound). Claim 10 recites pharmaceutical composition comprising a compound according to claim 1 and a pharmaceutically acceptable carrier. The pharmaceutical composition is described as dosage form, e.g., tablets, granules, capsules [col. 38, ln. 35-38]. US Patent No. 11098032B2 does not specifically recite the crystalline form 5 of claim 2 compound or the spectroscopic characterization. Also, one of ordinary skill in the art need to select compound of claim 2 from US Patent No. 11098032B2 list of CYP11A1 inhibitors.
Oksala, Barth and Morissette teach as discussed above, pages 8-9.
The obviousness rationale is similar to the rationale in the obviousness Rejection above, pages 9-10.
Non-Statutory Double Patenting over US Patent No. US12030871B2
Claims 11-13 and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 9 of US Patent No. 12030871B2 in view of Oksala, R., et al. "ODM-208, a novel CYP11A1-inhibitor as a therapeutic approach for the treatment of castration-resistant prostate cancer." Annals of Oncology 28 (2017): v8, “Oksala” cited in the PTO-892), W. Barth et al. (US Patent No. 4,432,987A, 02/21/1984, “Barth”, cited in the PTO-892) and S. Morissette, et al. Advanced Drug Delivery Reviews, Volume 56, Issue 3, 2004, Pages 275-300, “Morissette” cited in the PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims 11-13 and 33 recites “a compound which is crystalline form 5 of 2-(isoindolin-2- ylmethyl)-5-((1-(methylsulfonyl)piperidin-4-yl)methoxy)-4H-pyran-4-one (I) having an X-ray powder diffraction pattern comprising peaks, expressed in degrees 2-theta (± 0.2), at 9.4, 10.0, 10.5, 11.6, 13.5, 15.2, 16.5 and 20.0.” and pharmaceutical dosage form comprising the compound of claim 11.
US Patent No. 12030871B2 recites in claim 1 the claimed compound, 3rd compound. Claim 9 recites pharmaceutical composition comprising a compound according to claim 1 and a pharmaceutically acceptable carrier. The pharmaceutical composition is described as dosage form, e.g., tablets, granules, capsules [col. 39, ln. 3-6]. US Patent No. 12030871B2 does not specifically recite the crystalline form 5 of claim 2 compound or the spectroscopic characterization. Also, one of ordinary skill in the art need to select compound of claim 1 from US Patent No. 12030871B2 list of CYP11A1 inhibitors.
Oksala, Barth and Morissette teach as discussed above, pages 8-9.
The obviousness rationale is similar to the rationale in the obviousness Rejection above, pages 9-10.
Non-Statutory Double Patenting over copending Application No. 18/548,486
Claims 11-13 and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-43 of copending Application No 18/548,486 (US PG Pub 20240174654A1) in view of W. Barth et al. (US Patent No. 4,432,987A, 02/21/1984, “Barth”, cited in the PTO-892) and S. Morissette, et al. Advanced Drug Delivery Reviews, Volume 56, Issue 3, 2004, Pages 275-300, “Morissette” cited in the PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims 11-13 and 33 recites “a compound which is crystalline form 5 of 2-(isoindolin-2- ylmethyl)-5-((1-(methylsulfonyl)piperidin-4-yl)methoxy)-4H-pyran-4-one (I) having an X-ray powder diffraction pattern comprising peaks, expressed in degrees 2-theta (± 0.2), at 9.4, 10.0, 10.5, 11.6, 13.5, 15.2, 16.5 and 20.0.” and pharmaceutical dosage form comprising the compound of claim 11.
copending Application No 18/548,486 recites in the claims a process of preparation of compound of formula (IA), the claimed compound. copending Application No 18/548,486 does not specifically recite the crystalline form 5 of claim 1 compound or the spectroscopic characterization.
Barth and Morissette teach as discussed above, pages 8-9.
The obviousness rationale is similar to the rationale in the obviousness Rejection above, pages 9-10.
With regard to claim 33, one of ordinary skill in the art would have been motivated to prepare the crystalline form taught by copending Application No 18/548,486, Barth and Morissette because copending Application No 18/548,486 recites that the compound of claim 1 is a pharmaceutical compound useful for the treatment of breast and prostate cancer [page 1, ln. 20-21], and Barth teaches that pharmaceutical use crystalline compounds are especially advantageous in manufacturing procedures and in formation and use of acceptable dosage forms such as tablets, capsules and various pharmaceutically elegant preparations required by the medical and pharmaceutical professions.” [Pg. 2, col. 1, ln. 60- col. 2, ln. 2].
Non-Statutory Double Patenting over copending Application No. 18/548,487
Claims 11-13 and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 17-24 of copending Application No. 18/548,487 (US PG Pub 20240158377A1) in view of Oksala, R., et al. Annals of Oncology 28 (2017): v8, “Oksala” cited in the PTO-892), W. Barth et al. (US Patent No. 4,432,987A, 02/21/1984, “Barth”, cited in the PTO-892) and S. Morissette, et al. Advanced Drug Delivery Reviews, Volume 56, Issue 3, 2004, Pages 275-300, “Morissette” cited in the PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims 11-13 and 33 recites “a compound which is crystalline form 5 of 2-(isoindolin-2- ylmethyl)-5-((1-(methylsulfonyl)piperidin-4-yl)methoxy)-4H-pyran-4-one (I) having an X-ray powder diffraction pattern comprising peaks, expressed in degrees 2-theta (± 0.2), at 9.4, 10.0, 10.5, 11.6, 13.5, 15.2, 16.5 and 20.0.” and pharmaceutical dosage form comprising the compound of claim 11.
Copending Application No. 18/548,487 recites in claim 1 a salt of 2-(isoindolin-2- ylmethyl)-5-((1-(methylsulfonyl)piperidin-4-yl)methoxy)-4H-pyran-4-one. Claims 17-20 recite methods of preparing the salt of the compound of claim 1. Claim 21-24 recites pharmaceutical composition comprising a compound according to claim 1 and one or more excipients, wherein the composition is a dosage form including tablet or capsule. Copending Application No. 18/548,487 recites the salt of the claimed compound, and does not specifically recite the crystalline form 5 of the compound or the spectroscopic characterization.
Oksala, Barth and Morissette teach as discussed above, pages 9-10.
Preparing the non-salt of copending Application No. 18/548,487 compound is obvious for the following reasons: Consistent with Sun Pharmaceutical Industries v. Eli Lilly and Col, 611 F. 3d 1381, 1387 (CAFC 2010), it is permissible to use a compound claim to reject a method of use claim where that method of use is disclosed in the specification of the application claiming the compound. According to the Sun Pharma. Court, “[i]t would shock one' s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. . .”. In the instant case, copending Application No. 18/548,487 recites in the instant specification that the compound of claim 1 is a pharmaceutical compound useful for the treatment of breast and prostate cancer [page 1, ln. 17-18]. Oksala teaches that compound ODM-208 (not the salt) is a potent and selective inhibitor of CYP11A1 enzyme for treating prostate cancer and inhibiting adrenal and testicular hormone production. Oksala also teaches the potency of ODM-208 in inhibiting tumor growth in the androgen dependent VCaP cells and in prostate cancer model with low nM concentrations. Thus, one of ordinary skill in the art would have been motivated to prepare the non-salt of copending Application No. 18/548,487 compound for treating prostate cancer.
The obviousness rationale for preparing the crystalline form 5 of the non-salt of copending Application No. 18/548,487 compound is similar to the rationale in the obviousness Rejection above, pages 9-10.
Conclusion
Claims 11-13 and 33 are rejected. No claim is allowed.
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/M.M.A./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
1 The response filed on 03/18/2026 indicates that claims 11-13, 21, 24 and 33 read on the elected species. The Examiner informed Attorney of record Megha Bhumralker that claims 21 and 24 do not read on the elected species, and only claims 11-13 and 33 reads on crystalline form 5. Attorney Megha Bhumralker agreed.
2 Compound ODM-208 structure is provided by PubChem: Opevesostat | C21H26N2O5S | CID 135151902 - PubChem
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