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 application, Application No. 63/105,477, 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 indicates that the several of the variables of claim 1 lack support from the PRO application, for example the variable p lacks support from the PRO application. Additionally, the compounds of claims 12, 16-17 and the methods of 25-26 lack support from the PRO application. Thus all claims were given a priority date of 10/26/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/25/2023 and 12/12/2024 are 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, 2, 9-11, 13, 14, 15, 16, 18-21, 25-26 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 scope of claims 1, 2, 9-11, 13, 14, 15, 16, 18-21, 25-26 is indefinite because the variables of ‘A’ from formula (I), and formula (I) are contradictory. The last variable of ‘A’ is a non-fused heteroaryl, however, formula (I) requires a fused heteroaryl as it is attached by two points. It is also unclear if the heteroaryl are limited to 5-membered heteroaryl or any heteroaryl for both variable ‘A’ and ‘Ar’. For the purposes of examination it was assumed that the heteroaryl had to be fused as indicated by the formula.
The scope of claims 1, 2, 9-11, 13, 14, 15, 16, 18-21, 25-26 is indefinite because of the phrase “and combinations thereof” it is unclear if the combinations are only meant to be several different ones can be used independently at the same time or that combinations of the variables can be substituted off each other in a chain. For example for variable G would combinations thereof include linking the groups OR and SR or any other groups.
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.
Claim(s) 1, 2, 9, 18-21, 25-26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by BILLICH(BILLICH et al., WO 2006/108671, 19 October 2006).
The reference BILLICH teaches the following compound(page 33, compound 24), wherein R1=R1’=H, X=O, A= fused 6-membered aryl, G=OR, R=C7 hydrocarbyl, n=1, Ar= 6-membered aryl, Z =C(O)(O)R, m=1, R=C1 hydrocarbyl. It meets the proviso because it is substituted at the indicated position with hydrogen, the broadest reasonable interpretation indicates no up or down on the attachment of the aryl group and the number of ‘n’ variable is not limited to 1. This anticipates claims 1, 2, 9.
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Since claim 9 is dependent on claim 2 and vii) is an optional selection and the compound of claim 9 is not required to be selected from vii) only that if the compound is selected from vii) than it must have G=OH means that claim 9 is also anticipated.
The reference BILLICH teaches “In another aspect the present invention provides a pharmaceutical composition comprising a compound of the present invention in association with at least one pharmaceutically acceptable excipient, e.g. appropriate carrier and/or diluent, e.g. including fillers, binders, disintegrators, flow conditioners, lubricants, sugars or sweeteners, fragrances, preservatives, stabilizers, wetting agents and/or emulsifiers, solubilizers, salts for regulating osmotic pressure and/or buffers” (page 19). This anticipates claim 18.
The reference BILLICH teaches “The present invention relates 3,4-dihydro-benzo[e][1,3]oxazin-2-ones, e.g. which are mediators of human macrophage migration inhibitory factor (MIF) activity” (Page 1) and “A compound of the present invention may be administered to larger mammals, for example humans, by similar modes of administration at similar dosages than conventionally used with other mediators, e.g. low molecular weight inhibitors, of MIF activity”(page 21). This anticipates claim 19.
The reference BILLICH teaches “Disorders, e.g. including diseases, mediated by MIF activity and which are prone to be successfully treated with MIF antagonists, e.g. with compounds of the present invention, include disorders, wherein the activity of MIF play a causal or contributory role. Such disorders (diseases) include but are not limited to disorders associated with inflammation e.g. including (chronic) inflammatory disorders, disorders related with the inflammation of the bronchi, e.g. including bronchitis, cervix, e.g. including cervicitis, conjunctiva, e.g. conjunctivitis, esophagus, e.g. esophagitis, heart muscle, e.g. myocarditis, rectum, e.g. proctitis, sclera, e.g. scleritis, gums, involving bone, pulmonary inflammation (alveolitis), airways, e.g. asthma, such as bronchial asthma, acute respiratory distress syndrome (ARDS), inflammatory skin disorders such as contact hypersensitivity, atopic dermatitis; fibrotic disease (e.g., pulmonary fibrosis), encephilitis, inflammatory osteolysis” (pages 13-14). This anticipates claims 20-21.
The reference BILLICH teaches “A compound of the present invention may be administered by any conventional route, for example enterally, e.g. including nasal, buccal, rectal, oral, administration; parenterally, e.g. including intravenous, intramuscular, subcutanous administration; or topically; e.g. including 25 epicutaneous, intranasal, intratracheal administration; via medical devices for local delivery…”(page 21). This anticipates claim 25 and 26.
Claim(s) 1 and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN(STN, Registry CAS 401464-33-3, 03/16/2002).
The reference STN teaches the following compound, X=CH2, R1=R1’=H, Ar= 6-membered aryl, Z=C(O)OR, R=H, m=1, A=fused 6-membered aryl, G=OR, R=C1 hydrocarbyl, n=2. This anticipates claims 1 and 13.
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Allowable Subject Matter
Claims 12 and 17 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, 2, 9-11, 13, 14, 15, 16, 18-21, 25-26 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
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