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
RESPONSE TO ELECTION/RESTRICTION
Applicant's election with traverse of acromegaly as the elected species in the reply filed on 6/11/2026 is acknowledged. The traversal is on the ground(s) that the diseases share a common etiology as being dependent on SSTR2 activity. Not necessarily agreeing with the aforementioned statement, the species requirement is hereby withdrawn.
An action on the merits of claims 67-80 is contained herein.
Priority
This application is a continuation of U.S. Patent Application No. 18/468,414 filed
September 15, 2023, which is a continuation of U.S. Patent Application No. 17/116,728 filed December 9, 2020, now Abandoned, which is a continuation of U.S. Patent Application No.16/592,595 filed October 3, 2019, now U.S Patent No. 10,889,561, issued January 12, 2021,which is a continuation of U.S. Patent Application No. 16/249,729 filed January 16, 2019, now U.S. Patent No. 10,464,918, issued November 5, 2019, which claims the benefit of U.S.Provisional Patent Application No. 62/618,538 filed on January 17, 2018.
Information Disclosure Statement
The examiner has considered the references cited in the information disclosure statement filed of record. References which do not contain a publication year have not been considered.
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 67-80 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 10,464,918. Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed compounds are disclosed in U.S. Patent No. 10,464,918. It appears that the instantly claimed invention is completely embraced the disclosure of U.S. Patent No. 10,464,918. At column 12, lines 15, the compounds are used in the treatment of acromegaly. At column 55, lines 45-59, the composition dosage is taught. At column 79, see Example A-3 and A-4 for the oral forms. Claim 1 is reproduced below:
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.
Claims 67-80 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 11,414,397. Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed compounds are disclosed in U.S. Patent No. ‘397 (see col. 343, claim 17, example 2-2, col. 243, lines 33-41 for HCl salt) and its method of use as recited in the instant claims (see col. 9, lines 30-40).
Claims 67-80 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 10,597,377. Although the claims at issue are not identical, they are not patentably distinct for the reasons set forth in U.S. Patent No. 11,414,397 (more particularly the suggestion of employing the HCl salt in the claimed method).
Claims 67-80 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 10,875,839. Although the claims at issue are not identical, they are not patentably distinct for the reasons set forth in U.S. Patent No. 11,414,397 (more particularly the suggestion of employing the HCl salt in the claimed method).
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)(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.
Claims 67-80 are rejected under 35 U.S.C. 102(a)(2) as being anticipated over Zhao et al. [U.S Patent No. 10,597,377-mentioned in IDS].
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
The instantly claimed invention is taught. At column 260, lines 54-56, see the units for oral administration. At column 263, lines 48-60, see the guidance for dosing administration. The reference teaches the typical range of 0.01mg -2000 mg per day for adult human treatment. At column 341, see claim 4. The claim is reproduced below:
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and HCl salts recited at col. 237, lines 35-41.
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(see claim 6 for neuroendocrine tumor treatment as well).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E MCDOWELL whose telephone number is (571)270-5755. The examiner can normally be reached on 8:30-6 MF.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN E MCDOWELL/Primary Examiner, Art Unit 1624
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