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. 119(e) 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. 63/584,045, 63/640,903, 63/678,839, 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 structures of claims 1, 3, 7, 24 , 26, 29, 31, 8-9, 11-12, 15, 17-18, 20, 106-112 in PRO 63/584,045 due to a lack of requirement for formula (I) having different Rd and Rd*. Thus a date of 05/01/2024 was used for priority for these claims. A claim by claim analysis indicated a lack of support for the structures of claims 22, 33, 35, 37, 38, 39, 42, 82, 87, 91, 96, 98-100 in PRO 63/640,903, such as the rings of ring B or A, or the optionally substituted 3-6-memebered ring fused to ring A. Thus a date of 08/02/2024 was used for priority for these claims. A claim by claim analysis indicated a lack of support for the structures of claims 40, 45, 102-103 in PRO 63/678,839, such as the specific ring A structures or the compounds of claims 102-103. Thus a date of 09/18/2024 was used for priority for these claims.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: SUBSTITUTED AMINE COMPOUNDS FOR MRGPRX2 MODULATION.
The disclosure is objected to because it contains an embedded hyperlink (see page 271) and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Applicant is reminded of the proper content of an abstract of the disclosure.
In chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., “The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics.” Exemplification of a species could be illustrative of members of the class. For processes, the type of reaction, reagents and process conditions should be stated, generally illustrated by a single example unless variations are necessary.
Claim Objections
Claim 1 is objected to because of the following informalities: there should be an . Appropriate correction is required.
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.
Claim 45 is 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 scope of claim 45 is indefinite because it depends from claims 1-42, however, the scope of the structures is indefinite because several of these claims have been canceled.
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)(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.
Claim(s) 1, 12, 15, 17. 18, 20, 22, 26, 29, 31, 33, 35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN (STN, REGISTRY CAS 2733726-86-6, 17 Nov 2021).
The reference STN REGISTRY CAS 2733726-86-6 teaches the following compound, wherein Xh*=O, Z2=CH2, Xh=CH2, Xg=CH, n**=0, Rd=H, Rd*=CH3, L2=C(O), Ring A =5-membered heteroarylene, R*= H, n*=1, L1= C(Rc)(Rc*) and one of Re or Re* and R * taken together with the atoms to which they are bonded form an optionally substituted 3- to 6-membered ring fused to Ring A, B=5-membered heteroaryl, B=6-memembered aryl, R=H, n=1.
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261
365
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This anticipates claims 1, 12, 15, 17. 18, 20, 22, 26, 29, 31, 33, 35.
Claim(s) 1, 3, 11-12, 15, 18, 20, 22, 24, 26, 29, 31, 45 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN (STN, REGISTRY CAS 1604197-97-8, 13 May 2014).
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256
485
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The reference STN REGISTRY CAS 1604197-97-8 teaches the following compound, wherein Xh*=NH, Z2=CH2, Xh=CH2, Xg=N, n**=0, Re=halo, Rd=H, Rd*=C3 alkyl, L2=C(O), Ring A =5-membered heteroarylene, R*= H, n*=1, L1= CH2, B=6-membered aryl, R=C1 alkoxy, n=1
This anticipates claims 1, 3, 11-12, 15, 18, 20, 22, 24, 26, 29, 31, 45.
Claim(s) 1, 7, 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN (STN, REGISTRY CAS 2212368-15-3, 15 Apr 2018).
The reference STN REGISTRY CAS 2212368-15-3 teaches the following compound, wherein Xh*=O, Z2=CH2, Xh=CH2, Xg=CH, n**=0, Rd=H, Rd*=CH3, L2=C(O), Ring A =5-membered heteroarylene, R*= H, n*=1, L1= CH2, B=5-membered heteroaryl, R=C0 alkyl aryl, n=1.
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397
519
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This anticipates claims 1 , 7, 17.
Claim(s) 1, 3, 7, 8, 9, 11, 12, 15, 17, 18, 20, 22, 24, 26, 29, 45, 106, 107, 108, 109-112 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by SHEN (SHEN et al., WO 2025130765 A1, effective filing date 2023-12-18).
The reference Shen teaches the following compound(page 119), wherein Xh*=(CRe)2, Re=F, Z2=
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174
239
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, Xj=CH, Xe=NH, Xf=C=O, n^=0, Xh=CH2, Xg=N, n**=0, Re=halo, Rd=H, Rd*=C1 alkyl, L2=C(O), Ring A =5-membered heteroarylene, R*= H, n*=1, L1= O, B=6-membered aryl, R=halo, n=1
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114
659
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105
581
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144
707
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This anticipates claims 1, 3, 7, 8, 9, 11, 12, 15, 17, 18, 20, 22, 24, 26, 29, 45.
The reference also teaches “Pharmaceutical composition: As used herein, the term “pharmaceutical composition” refers to an active agent, formulated together with one or more pharmaceutically acceptable carriers. In some embodiments, an active agent is present in unit dose amount appropriate for administration in a therapeutic regimen that shows a statistically significant probability of achieving a predetermined therapeutic effect when administered to a relevant population. In some embodiments, pharmaceutical compositions may be specially formulated for administration in solid or liquid form, including those adapted for the following: oral administration, for example, drenches (aqueous or non-aqueous solutions or suspensions) , tablets, e.g., those targeted for buccal, sublingual, and systemic absorption, boluses, powders, granules, pastes for application to the tongue; parenteral administration, for example, by subcutaneous, intramuscular, intravenous or epidural injection as, for example, a sterile solution or suspension, or sustained-release formulation; topical application, for example, as a cream, ointment, or a controlled-release patch or spray applied to the skin, lungs, or oral cavity; intravaginally or intrarectally, for example, as a pessary, cream, or foam; sublingually; ocularly; transdermally; or nasally, pulmonary, and to other mucosal surfaces.
Pharmaceutically acceptable: As used herein, the phrase “pharmaceutically acceptable” refers to those compounds, materials, compositions and/or dosage forms which are, within the scope of sound medical judgment, suitable for use in contact with the tissues of human beings and animals without excessive toxicity, irritation, allergic response, or other problem or complication, commensurate with a reasonable benefit/risk ratio.
Pharmaceutically acceptable carrier: As used herein, the term “pharmaceutically acceptable carrier” means a pharmaceutically-acceptable material, composition or vehicle, such as a liquid or solid filler, diluent, excipient, or solvent encapsulating material, involved in carrying or transporting the subject compound from one organ, or portion of the body, to another organ, or portion of the body” (page 11).
This anticipates claim 106.
The reference also teaches (page 188):
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This anticipates claims 107, 109-112.
The reference also teaches “Activation of MRGPRX2 by basic secretagogues, neurokinin peptides, host defense peptides, and small molecules has been reported to lead to mast cell degranulation via an IgE-independent pathway”(page 1).
This anticipates claim 108.
Allowable Subject Matter
Claims 99-100 and 102-103 are allowed.
Claims 37-40, 42, 82, 87, 91, 96, 98 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 1, 3, 7, 8, 9, 11, 12, 15, 17, 18, 20, 22, 24, 26, 29, 31, 33, 35, 45, 106, 107, 108, 109-112 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISON AZAR HASTINGS 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.A.H./ Examiner, Art Unit 1627
/Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627
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