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
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application No. 63/060,714, 63/070,335, 63/093,844, 63/114,021, 63/130,443, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. A claim by claim analysis indicated a lack of support for the NMRs in the listed applications. Thus claims 1, 2, 3, 4, 23, 24, 25, 26, 28, 29, 31 received a priority date of 08/04/2021. The spectra of claims 5-8 found support in the priority document with the filing date of 08/26/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/12/2023 is being considered by the examiner.
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 1- 8, 23-26, 28-29, 31 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.
The term “substantially” in claims 1- 8, 23-26, 28-29, 31 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification simply states [0044]: "A crystal form of Fezolinetant referred to herein as being characterized by graphical data "as depicted in" or "as substantially depicted in" a Figure will thus be understood to include any crystal forms of Fezolinetant characterized with the graphical data having such small variations, as are well known to the skilled person, in comparison with the Figure". However, it is not clear what one would consider 'small variations' as small variations could be taken to mean different degrees to different people of ordinary skill in the art.
The term “about” in claims 24 and 25 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Since the specification gives no specific definition for the range to be included in the term ‘about’ the scope of the claim is indefinite for the (w/w).
Regarding claim 31, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. For example it is unclear if the scope of the claimed menopausal symptoms are limited to night sweats and sleep or mood disturbances or can be any menopausal symptom. See MPEP § 2173.05(d).
Claims 1- 8, 23-26, 28-29, 31 are rejected for being indefinite because of point (v) because it is unclear what the scope of the spectrum claimed would be because it is not clear what are the characteristic chemical shift differences, what peaks they are between and if any of the numbers listed could be the shift for any of the other numbers.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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(s) 1, 5, 23, 24, 25, 26, 28, 29, 31 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by KOJIMA (KOJIMA et al., US2021094955A1, effectively filing date 2017-10-13).
The reference KOJIMA teaches FEZOLINETANT [Chem 1, page 1, Compound A] and “ A pharmaceutically acceptable salt of (4-fluorophenyl)[(8R)-8-methyl-3-(3-methyl-1,2,4-thiadiazol-5-yl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]methanone”(reference claim 1). The reference teaches “A crystal of the salt according to claim 3”(reference claim 9) and “The crystal according to claim 13, wherein in a powder X-ray diffraction using Cu as a radiation source, the crystal has peaks at 2θ(°) of 6.2, 10.9, 12.5, 14.0, 15.3, 16.3, 18.7, 19.5, 21.3 and 24.1” (reference claim 14). The reference also teaches “The crystal according to claim 13, wherein in a powder X-ray diffraction using Cu as a radiation source, the crystal has peaks at 2θ(°) of 7.1, 10.0, 15.2, 16.7, 17.6, 18.5, 19.7, 23.5, 24.2, and 25.3”(reference claim 15) and “Furthermore, the present invention also includes various hydrates and solvates of the salt of Compound A, and crystal polymorphic substances thereof”[0016]. Since there is no specific definition of ‘substantially’ given the peaks of the reference can be considered substantially the same as figure 1 and figure 2. This anticipates claims 1, 5, 23, 24, 25.
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The reference also teaches “ A pharmaceutical composition comprising the salt according to claim 1 and a pharmaceutically acceptable excipient” (reference claim 25). This anticipates claim 26, 28, 29.
The reference also teaches “A method for treating a disease associated with an NK3 receptor, the method comprising administering an effective amount of the salt according to claim 1 to a subject”(reference claim 30) and “It is known that Compound A has the chemical structure below, and is known to be useful as a neurokinin 3 (NK3) receptor antagonist against NK3 receptor related diseases such as depression, anxiety, psychosis, schizophrenia, psychotic disorders, bipolar disorder, cognitive disorder, Parkinson's disease, Alzheimer's disease, attention deficit hyperactivity disorder (ADHD), pain, convulsions, obesity, inflammatory disease such as irritable bowel syndrome (IBS) and inflammatory bowel disorder, emesis, pre-eclampsia, chronic obstructive pulmonary disease, asthma, airway-related diseases such as airway hyperreactivity, bronchoconstriction, and cough, urinary incontinence, reproduction disorders, contraception and sex hormone-dependent diseases (examples of the sex hormone-dependent disease include, but are not limited to, benign prostatic hyperplasia (BPH), prostatic hyperplasia, metastatic prostatic carcinoma, testicular cancer, breast cancer, ovarian cancer, androgen-dependent acne, male pattern baldness, endometriosis, abnormal puberty, uterine fibrosis, uterine fibroid, uterine leiomyoma, hormone-dependent cancer, hyperandrogenism, hirsutism, virilization, polycystic ovary syndrome (PCOS), premenstrual dysphoric disorder (PMDD), HAIR-AN syndrome (hyperandrogenism, insulin resistance, and acanthosis nigricans ), ovarian hyperthecosis (HAIR-AN with hyperplasia of luteinized theca cells, in ovarian stroma), other manifestations of high intraovarian androgen concentrations (such as follicular maturation arrest, atresia, anovulation, dysmenorrhea, dysfunctional uterine bleeding, and infertility), androgen producing tumors (virilizing ovarian or adrenal tumors), menorrhagia, and adenomyosis), and hot flash (Patent Document 1 and Non-Patent Document 1)” This anticipates claim 31.
Conclusion
Claims 1- 8, 23-26, 28-29, 31 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISON AZAR SALAMATIAN whose telephone number is (703)756-4584. The examiner can normally be reached Mon-Thurs 7:30am-5pm EST Friday 7:30-4pm EST (every other Friday off).
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/A.A.S./Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627