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 30-33, 35, 40, 41, 43, 51, 52, 56, 59, 63, 75, 76, 79, 80, 82, 83 and 88 are pending in the application. Claims 30-33, 35, 40, 41, 43, 51, 52, 56, 59, 63, 75, 76, 79, 80, 82, 83 and 88 are rejected.
Priority
This application is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/US2022/026920, filed on April 29, 2022, which claims benefit of Provisional Application No. 63/298,601, filed on January 11, 2022, which claims benefit of Provisional Application Nos. 63/289,520 and 63/289,506, filed on December 14, 2021, which claims benefit of Provisional Application No. 63/285,812, filed on December 3, 2021, which claims benefit of Provisional Application No. 63/239,096, filed on August 31, 2021, which claims benefit of Provisional Application No. 63/210,810, filed on June 15, 2021, which claims benefit of Provisional Application No. 63/197,025, filed on June 4, 2021, which claims benefit of Provisional Application No. 63/181,743, filed on April 29, 2021.
Information Disclosure Statement
The Information Disclosure Statement(s) (IDS) filed on October 15, 2024 are in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the Examiner has considered the IDS documents and signed copies of the 1449 forms are attached.
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.
(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 30-33, 35, 40, 41, 52, 56, 59, 63, 75, 76, 79, 80, 83 and 88 are rejected under 35 U.S.C. § 102(a)(1) and 35 U.S.C. § 102(a)(2) as being anticipated by Kanes et al. (U.S. PGPub. No. 2020/0113917 A1; April 16, 2020).
Regarding instant claims 30, 59, 63 and 88, Kanes et al. teach “Compound 1” in paragraph [0016] (shown below) which corresponds to the instantly claimed Compound (1).
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Kanes et al. further teach the following in paragraph [0109]:
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Note: the instant specification (paragraph [0018]) defines major depressive disorder with “elevated anxiety” as being characterized by a Hamilton Rating Scale for Depression (HAM-D) Anxiety/Somatization subscale score of 7 or greater, prior to the administration of Compound (1).
Regarding instant claim 31, Kanes et al. teach a pharmaceutically acceptable salt of the prior art “Compound 1.” See e.g., paragraph [0006].
Regarding instant claims 32, 33, 35, 59, 63, 75 and 76, Kanes et al. teach “the subject is administered about 30 mg of Compound 1 once a day during the 2 week period (or about 14 days).” See e.g., paragraph [0009].
Regarding instant claims 40 and 79, Kanes et al. teach administering Compound 1 to a subject orally. See e.g., paragraph [0057].
Regarding instant claims 41 and 80, Kanes et al. teach “Compound 1 is administered with food.” See e.g., paragraph [0022].
Regarding instant claims 52 and 83, Kanes et al. teach the following in paragraph [0153]:
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Regarding instant claim 56, Kanes et al. teach “the reduction in depression-related symptoms is characterized by a reduction in HAM-D score from baseline.” See e.g., paragraph [0026].
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.
Claims 43, 51 and 82 are rejected under 35 U.S.C. § 103 as being unpatentable over Kanes et al. (U.S. PGPub. No. 2020/0113917 A1; April 16, 2020) in view of Watson et al. (PCT Publication No. WO 2018/039378 A1; March 1, 2018)
Determining the scope and contents of the prior art (See MPEP § 2141.01)
Kanes et al. teach “Compound 1” in paragraph [0016] (shown below) which corresponds to the instantly claimed Compound (1).
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Kanes et al. further teach the following in paragraph [0109]:
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Ascertainment of the differences between the prior art and the claims (See MPEP § 2141.02)
Regarding instant claim 43, Kanes et al. does not teach crystalline Compound 1. However, Watson et al., in the same field of endeavor, teach crystalline “Compound 1” in paragraph [0006] (reproduced below), wherein “Compound 1” corresponds to both the “Compound 1” of Kanes et al. and the instantly claimed Compound (1).
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Watson et al. further teach polymorph Form A of “Compound 1” having the following 2Ɵ (degrees) values that coincide with the XRPD pattern peak limitations recited in instant claim 43:
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Regarding instant claims 51 and 82, Kanes et al. does not specifically teach the subject is treatment naïve. The limitation “treatment naïve” is defined in the instant specification in paragraph [00139] (reproduced below).
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Kanes et al. does, however, teach “[s]ubject was willing to delay start of any antidepressant, anxiolytic, insomnia, psychostimulant, or presecription opioid regimens until after study completion.” See e.g., paragraph [0226].
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claim 43, it would, therefore, have been obvious to a person of ordinary skill in the art to utilize a crystalline form of the instantly claimed Compound (1) in the treatment of a patient with postpartum depression (PDD). Considering that both Kanes et al. and Watson et al. teach the instantly claimed Compound (1) in relation to the treatment of postpartum depression (PDD), it would be within the ability of a skilled artisan to administer either the crystalline form of Compound (1), as taught by Watson et al., or the non-crystalline form of Compound (1), as taught by Kanes et al. to a PDD patient. See e.g., paragraph [0109] of Kanes et al. and paragraph [00199] of Watson et al. MPEP § 2144(II) states:
An “obvious to try” rationale may support a conclusion that a claim would have been obvious where one skilled in the art is choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. “[A] person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.” KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007).
Therefore, at least in the interest of administering Compound (1) having various physical parameters, a skilled artisan would have been motivated to employ the instantly claimed method.
Regarding instant claims 51 and 82, it would, therefore, have been obvious to administer Compound (1) to subjects suffering from PDD, including those that are treatment naïve. At least in the interest of studying the effects of Compound (1) in a wider patient population and to obtain baseline data, a person of ordinary skill would have been motivated to employ the instantly claimed methods.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
The analysis employed for an obviousness-type double patenting rejection parallels the analysis for a determination of obviousness under 35 U.S.C. § 103. 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.
Claims 30-33, 35, 40, 41, 43, 51, 52, 56, 59, 63, 75, 76, 79, 80, 82, 83 and 88 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending U.S. Application No. 19/407,758 (‘758) as evidenced by Gauld et al. (Progress in Neuro-psychopharmacology and Biological Psychiatry, 2023, 121(110671): 1-5). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘758 are drawn towards methods of treating major depressive disorder- a type of which is postpartum depression as evidenced by Gauld et al. [e.g., see page 1 which states “[p]ostpartum depression (PPD) is defined as a major depressive disorder”]- comprising administering the instantly claimed Compound (1). In addition, claims 16-19 of ‘758 recite HAM-D score requirements that read on the instantly claimed expression “elevated anxiety” as defined in paragraph [0018] of the instant specification.
Conclusion
No claims are allowed.
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/D.M.S./Examiner, Art Unit 1626
/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626
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