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 .
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.
Current Status of 18/486,889
This office action is in response to the amended claims on 04/05/2024.
Claims 1,5-9 and 56-60 are currently amended.
Claims 1,5-9 and 56-60 are examined in this office action.
Priority
The effective filing date is 10/13/2022 since the instant claims find support in provisional application no. 63/379,391.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 01/04/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Objections to Specification
The specification , on page 108, paragraph [00558] contains hyperlink “[https://clinicaltrials.gov/ ct2/results?term=chimeric+antigen+receptors&pg= 1].” Reference incorporated by hyperlinks or other form of browser executable code is not permitted.
Please delete hyperlink from the specification to render-moot this objection.
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 7 and 60 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 claim 7 is a relative term which renders these claims 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. As drafted, the term “substantially” renders the metes and bounds of claims 7 undefined (hence rendering claims 7 indefinite) since the artisan has no idea by which objective standard “substantially” should be measured.
Claim 60 recites the limitation of the phrase “including…” The examiner does not know if the phrase “including” further limits the embodiments in the claim or list the different embodiments of the claims. Moreover, the reader does not know if the limitations following “including” are merely exemplary or are required limitations of the claim. As drafted, the term “including” renders the metes and bounds of claim 60 undefined hence rendering claim 60 indefinite. Please delete all occurrences of “including” and either delete: 1) the broad limitations immediately preceding “including” or 2) the limitations immediately following “including”.
Claims 60 contains numerous occurrences of limitations within parentheticals. For example, “ … glomerulonephritis (with and without nephrotic syndrome, optionally including idiopathic nephrotic syndrome or minal change nephropathy),…” ; “… asthma (allergic, non-allergic, mild, moderate, severe, bronchitis, or exercise-induced),…” and ; “… COPD (reduction of damage, airways inflammation, bronchial hyperreactivity, remodeling or disease progression) …”. Claims are not allowed to have limitations within parentheticals since the readers does not know whether the limitation within the parentheticals are merely exemplary or a required limitation of the claim. Only abbreviations are allowed in parentheticals for example “Cryopyrin Associated Periodic Syndrome (CAPS)”. Thus, parentheticals of claim 60 renders metes and bounds of claim 60 undefined hence rendering 60 indefinite. Please remove all occurrences of limitations within parentheticals within this claim to render moot the rejection.
Conclusion
Claims 1, 5-6 and 56-59 are allowed.
Claims 7 and 60 are rejected.
Examiner did not find prior art for independent claim 1.
Zheng et. al (US 11685750 B2) discloses crystal form of compound
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(claim 1) where the salt is different from the instant claim where the salt is
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. Artisan skilled in the art would not be able to envision an obvious modification or rationale to use different acid, therefore Zheng et.al. is a close art not a prior art.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625