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
The instant application, filed 10/11/2024, is the national stage entry of PCT/IB2023/053789, filed 04/13/2023, which claims priority to U.S. Provisional Patent Application No. 63/330,377, filed on 04/13/2022. Receipt is acknowledged of certified copies of papers required by 37 CFR § 1.55.
Information Disclosure Statement
The Information Disclosure Statement received 10/11/2024 is acknowledged and found to be in compliance with the provisions of 37 CFR § 1.97. Accordingly, the Information Disclosure Statement has been considered.
Status of Claims
Claims 1-14 were originally presented on 10/11/2024. Applicant’s preliminary amendments to the claims also received on 10/11/2024 are acknowledged and entered. Claims 3-9, 11, and 14 are amended, claims 15-23 are added, and claims 10, 12, and 13 are canceled.
Accordingly, claims 1-9, 11 and 14-23 are pending.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-8 and 18-23 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 1 recites:
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Instant claim 1.
Claim 1 claims the subject matter of a crystalline Form 7 of Mavacamten. It states that this Form 7 is crystalline and has X-ray powder diffraction (“XRPD”) pattern peaks at 5.9, 9.7 and 17.7 2θ ±0.2⁰. It does not claim “amorphous” Form 7 of Mavacamten, or any other Form of Mavacamten. Under 35 U.S.C. 112(d), every claim that depends upon claim 1 must limit its subject matter.
Once the subject matter of crystalline Form 7 of Mavacamten is invoked in claim 1, all of properties of crystalline Form 7 of Mavacamten are simultaneously present. This includes:
All of its characteristic peaks as determined by its XRPD pattern, as shown in Fig. 1.
Its crystalline nature, meaning that it is not amorphous. Crystalline and amorphous forms are explicitly distinguished in the Specification at 4, paragraph [0022]. This paragraph is the only place in the Specification where the word “amorphous” even appears, and it is used once to distinguish “a crystal form” from “an amorphous form”.
Its property as being “polymorphically pure”, meaning that only crystalline Form 7 is present. This is explained in the Specification, which states 12 times, “No polymorphic conversion”.
Its property as being anhydrous. This is explained in the Specification at 5, paragraph [0023], and shown in Example 2, Specification at 12-13, Table 1.
The claim does not claim the subject matter of a composition comprising crystalline Form 7 of Mavacamten and other polymorphs and/or amorphous forms. In fact, it cannot. The Specification discloses “a crystalline polymorph of Mavacamten”. See Specification at 2, paragraph [0008]. The crystalline polymorph of Mavacamten disclosed in the Specification is designated Form 7. See Specification at 6, paragraph [0032] (“The present disclosure includes a crystalline polymorph of Mavacamten, designated Form 7.”).
The Specification provides a Figure:
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The crystalline Form 7 of Mavacamten is what is claimed in claim 1, and nothing else.
Claims 2-8 and 18-23 still claim crystalline Form 7 irrespective of the number of peaks used to “characterize” the crystalline Form 7 of Mavacamten (claims 2-5), or its inherent properties as being “anhydrous” (claim 6), “polymorphically pure” (claims 7 and 18-20), and crystalline (claims 8 and 21-23).
Claims 2-8 and 18-23 therefore claim identical subject matter – the identical crystalline Form 7 of Mavacamten. Accordingly, claims 2-8 and 18-23 indeed fail to specify a further limitation of the subject matter claimed.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102(a)(2)
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)(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 1-9, 11 and 14-23 Anticipated by WO’599
Claim(s) 1-9, 11 and 14-23 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO’599.1
WO’599 discloses the identical polymorphic form that Applicant alleges to have discovered. Every peak that Applicant observes in its XRPD pattern matches within experimental error the “crystalline form VI of mavacamten” disclosed in WO’599. As admitted in the Instant Specification at 4, paragraph [0022], XRPD provides a “fingerprint” of a crystal form. Fingerprints are unique. XRPD may exhibit variations in peak intensities and positions. Id. Irrespective of these variations, “the skilled person would readily be capable of comparing the graphical data in the Figures herein with graphical data generated for an unknown crystal form and confirm whether the two sets of graphical data are characterizing the same crystal form or two different crystal forms.” Id.
The skilled person would compare the XRPD peaks of the “crystalline form VI of mavacamten” disclosed in WO’599 to those now claimed and conclude they already characterized the same crystal form that Applicant alleges to have discovered, i.e., instant “crystalline Form 7”.
See WO’599 at 21, which teaches “crystalline form VI of mavacamten”:
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WO’599 at 21.
See Applicant’s Instant Figure 1:
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Instant Figure 1.
See also, WO’599 at 14-15, which teaches:
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WO’599 at 14-15.
Accordingly, claims 1-8 and 18-23 are anticipated by WO’599.
Claim 9 recites:
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Claim 9.
WO’599 at 24 – 25, claims 1 and 7-15, teach:
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WO’599 at 24-25.
Accordingly, claim 9 is anticipated by WO’599.
Claim 11 recites:
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Claim 11.
WO’599 at 15-17 teaches pharmaceutical compositions. At 16, it teaches the process for preparing such pharmaceutical compositions comprising selecting any of the described embodiments, such as the crystalline form of mavacamten instantly claimed, and combining it with at least one pharmaceutically acceptable excipient through processed known in the art, such as by blending. See, e.g., WO’599 at 16:
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WO’599 at 16.
Accordingly, claim 11 is anticipated by WO’599.
Claim 15 recites:
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Claim 15.
WO’599 at 16 teaches:
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WO’599 at 16.
Accordingly, claim 15 is anticipated by WO’599.
Claims 16-17 recite:
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Claims 16-17.
WO’599 at 17 teaches:
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WO’599 at 17.
Accordingly, claims 16-17 are anticipated by WO’599.
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.
Claim 1-9, 11 and 14-23 were obvious over WO’599
Claim(s) 1-9, 11 and 14-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO’599.2
The rejections of claims 1-9, 11 and 14-23 under 35 U.S.C. 102(a)(2) as being anticipated by WO’599 is fully incorporated herein.
WO’599 discloses the identical polymorphic form that Applicant alleges to have discovered. Because polymorphic form was known to exist, any chemist of ordinary skill in the art would have a reasonable expectation of success in preparing it. Any difference between the explicit wording of the instant claims and the subject matter disclosed in WO’599 represents preferences in selection of “characteristic” peaks of the same polymorphic form, and experimental error, which would be observed from routine experimentation working within the teachings of WO’599.
Accordingly, claims 1-9, 11 and 14-23 were obvious at the time of filing.
Prior Art Cited but not Applied
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
U.S. Patent No. 12,258,320 B2, hereinafter “US’320”, is directed to other polymorphs of mavacamten. Both US’320 and the instant Application are commonly owned and share inventors. The experimental section is identical. Compare Instant Specification at 11, paragraph [0069], and US’320 at col. 11 (same instrument, silicon internal standard, etc.). Claim 1 of US’320 at col. 13 explains that the abnormally large peak at high 2θ belongs to a silicon impurity/standard. This region was therefore not considered reliable, and it was excluded from the claims of US’320.
See US’320 at claim 1:
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US’320 at claim 1.
See also, US’320 at FIG. 1:
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US’320 at FIG. 1.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christopher Evan Redwood whose telephone number is (571) 272-8882. The examiner can normally be reached Monday - Friday 6:15 AM - 4:45 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S. Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.E.R./ Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/ Supervisory Patent Examiner, Art Unit 1629
1 BRAUN DORIS, et al., “CRYSTALLINE FORMS OF MAVACAMTEN FOR THE TREATMENT OF HCM”, International Publication No. WO 2022189599 A1, published 2022-09-15, priority to 2021-03-12, SANDOZ AG Applicant, hereinafter “WO’599”.
2 Same reference used in the section regarding anticipation.
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