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 .
All previous objections and rejections not reiterated herein were overcome by claim amendments and arguments, filed May 6th, 2026, have been fully considered and found persuasive. As such all objections and rejections not reiterated herein have been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4, and 7 – 9 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.
Claim 4 recites, “The crystalline (3S,5R,8R,9S,10S,l3R,l4S,l 7R)-14-hydroxy-10,13-dimethyl-17-(2-oxo-2H-pyran-5-yl)hexadecahydro-1H-cyclopenta[a]phenanthren-3-yl piperazine-1-carboxylate maleate of claim 3.” However, dependent claim 4 depends from claim 3, which is canceled. Claim 4 therefore lacks any antecedent basis for its limitations. See MPEP 2173.05(e). “If the base claim has been canceled, a claim which is directly or indirectly dependent thereon should be rejected as incomplete.” MPEP 608.01(n)(V). Claims 7 – 9 are included in the rejection because all three claims depend from claim 4, which further depends on cancelled claim 3.
Double Patenting
Applicant’s arguments and claim amendments, see page 8 paragraph 2, filed May 6th, 2026 nonstatutory double patenting (NSDP) rejections of examined claims 2, 27, and 31 – 33, with respect to claims 1, 4, and 7 – 9 of U.S. Patent No. US 8334376 B2 to Qian (Qian’376; cited on the IDS dated December 13th, 2023), claims 1, 12, and 15 – 18 of U.S. Patent No. US 10912784 B2 to Qian (Qian’784; cited on the IDS dated December 13th, 2023), claims 1 – 2, 12, and 17 – 18 of U.S. Patent No. US 10179141 B2 to Qian (Qian’141; cited on the IDS dated December 13th, 2023), claims 1 – 9, 20, and 23 – 24 of U.S. Patent No. US 9814735 B2 Qian (Qian’735; cited on the IDS dated December 13th, 2023), and over claims 1, 4, and 9 of U.S. Patent No. US 8993550 B2 to Qian (Qian’550; cited on the IDS dated December 13th, 2023) have been fully considered and are persuasive. The (NSDP) rejections of examined claims 2, 27, and 31 – 33 have been withdrawn.
Discussion of the prior art
The closet prior art of International Publication Number WO 2011/085641 A1 to Qian (herein after Qian’641; cited on the IDS dated December 13th, 2023) teaches chemical entities that are bufalin derivatives and pharmaceutical compositions (abstract). Qian’641 teaches compounds of Formula I
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and pharmaceutically acceptable salts thereof (page 1 paragraph 005). More specifically, Qian’641 teaches compound I-e of structure
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(page 19 paragraph 080). Additionally, Qian’641 teaches that compounds of Formula I, that includes compound I-e, also include crystalline and amorphous forms of those compounds, including, for example, polymorphs, pseudopolymorphs, solvates (including hydrates), unsolvated polymorphs (including anhydrates), conformational polymorphs, and amorphous forms of the compounds, as well as mixtures thereof (page 15 paragraph 053). Furthermore, Qian’641 teaches that pharmaceutically acceptable salt includes salts with an organic acid, such as maleate (page 16 paragraph 063).
However, the prior art of Qian’641 fails to teach a crystalline structure wherein the crystalline form is Crystalline Form I, which is characterized by an X-ray powder diffraction pattern further comprises peaks at 13 .8 ± 0.2° 2-θ, 19.5 ± 0.2° 2-θ, and 10.3 ± 0.2° 2-R and at least one peak selected from 25.9 ± 0.2° 2-θ, 20.6 ± 0.2° 2-θ. and 14.8 ± 0.2° 2-θ, as measured by X-ray powder diffraction using an X-ray wavelength of 1.54179 Å (claim 2), and a method of preparing crystalline form I (claim 42). Moreover, while the state of the prior art teaches the generic recrystallization steps for generically forming an acid salt and precipitate; the prior art fails to teach a method specifically for preparing crystalline form I and crystalline form II as both forms are defined. Thus the prior art of Qian’641 fails to anticipate and render obvious the method of claims 2, 27, 31 – 33, and 42. Thus claims 2, 27, 31 – 33, and 42 are free of the prior art and are allowable.
Conclusion
Claims 4, and 7 – 9 are rejected. Claims 2, 27, 31 – 33, and 42 are allowable.
` Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAWANNA S WHITE whose telephone number is (703)756-4687. The examiner can normally be reached 7:00 am - 5:00 pm [EST] M - Th.
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/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627
/JULIET C SWITZER/Primary Examiner, Art Unit 1682
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