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 .
Application Status
The preliminary amendment filed on 7/26/2024 is acknowledged. Claims 1-9, 11-16 and 19-22 are currently pending and under consideration.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements filed on 7/26/2024 and 9/09/2025 are acknowledged and have been considered except where lined through.
Drawings
The drawings are objected to because many of the “texts” of the drawings are illegible. For example, the text under the X-axis of figure 1, 2 and 3 are difficult to determine. Top graph of Figure 4, the annotations overlap. Figures 5-7 and 10-14 it is difficult to determine the annotations. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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, 11-15 and 19-22 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.
Regarding the claims, the term "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the term are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 9 and 11-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (WO2019205854A1, 2019-10-31, IDS, wherein US11440909 is used as the English Translation) in view of Stahl, P. H., & Wermuth, C. G. (Eds.). (2002). Pharmaceutical salts: Properties, selection and use. John wiley & sons and Carlson et al. (US20030124028).
Yang et al. teach 10H-phenothiazine derivatives capable of inhibiting ferroptosis having the structural formula (I)
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, wherein the derivatives, pharmaceutically acceptable salts thereof, crystal forms thereof or solvates thereof exhibit inhibitory effect on ferroptosis and therapeutic effect on a rat model of focal cerebral ischemia (abstract). Specifically, Yang et al. teach a compound having the structure
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referred to as compound A38 which is identical to the compounds within the instant claims, wherein compound A38 was chosen for the in vivo examples determining the inhibition rate of cerebral infarction and neurobehavioral assessments ( see Column 15 for structure and column 180, Example 7 for in vivo). Moreover, Yang et al. teach a method of treating stroke comprising administering a therapeutically effective amount of A38 or a pharmaceutically acceptable salt thereof, as well as, a pharmaceutical preparation comprising said compound and a pharmaceutically acceptable excipient (claims 14 and 19-20).
Yang et al. do not specifically teach that the pharmaceutically acceptable salt thereof is a hydrochloric acid salt or the method of preparing said hydrochloric acid salt.
Stahl and Wermuth teach that the hydrochloric acid salt of organic bases is the most widely used acid for formation of salts both for the isolation of synthetic intermediates and for the final pharmaceutical dosage form, wherein hydrochloric acid is conveniently used as the 36(%) solution in water (page 212, 8.1.1).
Calson teaches well known systems for automated high-throughput preparation and screening of salts and polymorphs of drug candidates:
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(Carlson Abstract). Carlson’s system specifically screens for salts and polymorphs using a variety of techniques and solvents including water, methanol, acetonitrile, MTBE, ethylene glycol, THF and DMSO (Claim 1, [0019],[0143]-[0144], [0157]-[0177], Fig. 29), heating/cooling, acids ([0014]-[0019], [0257]), seeding ([0131], [0141]) and isolating (claims 26-27).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the compound taught by Yang et al to include a hydrochloric salt in view of the teachings of Stahl and Wermuth and Carlson. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- Stahl and Wermuth teach that hydrochloric acid salt of organic bases is the most widely used acid for formation of salts both for the isolation of synthetic intermediates and for the final pharmaceutical dosage form.
Moreover, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to optimize the method of preparing said hydrochloric salt in view of the teachings Stahl and Wermuth and Carlson. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- Stahl and Wermuth teach that hydrochloric acid is conveniently used as the 36(%) solution in water (page 212, 8.1.1) and
-Carlson teaches well known systems for automated high-throughput preparation and screening of salts and polymorphs of drug candidates using a variety of different solvents.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) .
Conclusion
Therefore, No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BRANDON J. FETTEROLF, PHD
Primary Patent Examiner
Art Unit 1626
/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626
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