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 .
DETAILED ACTION
Claims 25-35 and 46-56 are currently pending in the instant application. Applicants have amended claims 26, 28, 30 and 32-35, canceled claims 1-24 and 36-45 and added new claims 46-56 in an amendment filed on January 31, 2025. Claims 25-35 and 46-56 are rejected in this Office Action.
I. Priority
The instant application is a CON of 18/621,972, filed on March 29, 2024 PAT 12,145,916 which claims benefit of US Provisional Application 63/493,500, filed on March 31, 2023.
II. Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 31, 2025 and March 18, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
III. Rejections
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.
Claims 25-29 and 30-35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Raga, et al. (US 8,207,197). The instant invention claims
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44
545
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The Raga, et al. reference teaches a crystalline form of
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92
397
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that has a X-ray powder diffraction pattern with peaks at 11.2°, 15.4°, 16.3°, 16.9°, 17.8°, 19.9°, 20.7°, 21.0°, 21.8°, 22.6°, 24.5°, 24,6°, 25,0°, 25.5°, 26.3°, 28.3°, 30.3°, 34.1°, 35.8°, 40.0°, 46.0° ± 0.2°. Claim 25 is drawn to a Form II polymorph of pitolisant hydrochloride which Applicants have defined in the specification as the following
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47
704
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which the prior art’s crystalline form reads on. This crystalline form anticipates the crystalline form of the instant invention, wherein the x-ray diffraction pattern peaks are listed above.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 25-35 and 46-56 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,145,916. Although the conflicting claims are not identical, they are not patentably distinct from each other because:
Applicants claim
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700
754
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895
754
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474
748
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Determining the Scope and Content of the Issued Patent
Claim 1 of the issued patent claims
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780
441
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283
478
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Ascertaining the Differences Between the Instant Application and the Issued Patent
The instant application claims are drawn to a Form II polymorph of pitolisant hydrochloride with no peaks listed whereas the issued patent is drawn to a crystalline form of pitolisant hydrochloride with peaks listed which is defined as “Form II” in the specification. “Form II” is being claimed in both the instant application and the issued patent.
Finding Prima Facie Obviousness
Form II is being claimed in both the instant application and the issued patent. Therefore, one of ordinary skill in the art would be motivated to prepare and claim the polymorphic form in the issued patent again in the instant application for the same utility of treating a sleep disorder. As a result, the claims are rejected under obviousness-type double patenting.
IV. Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Shawquia Jackson whose telephone number is 571-272-9043. The examiner can normally be reached from 7:00 AM-3:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Adam Milligan can be reached on 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/SHAWQUIA JACKSON/Primary Examiner, Art Unit 1626
