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 18/655,576
This office action is in response to the amended claims of 07/29/2024.
Claims 33-42 are new and are examined on merit.
Priority
The effective filing date is November 22, 2021.
Claim Interpretation
In claim 33 the phrase “ceasing administration of prednisone without dose reduction” is interpreted as stopping administration of prednisone to the subject before administering vamorolone.
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 07/29/2024. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 103
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.
Claims 33-42 are rejected under 35 U.S.C. 103 as being unpatentable over
McDonald CM et.al. (Efficacy and safety of vamorolone in Duchenne muscular dystrophy: An 18-month interim analysis of a non-randomized open-label extension study. PLoS Med. 2020 Sep 21.
In view of
Anisel et.al. “PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS” 7th edition, 1999.
1. Determining the scope and contents of the prior art.
The claims are directed to treating or reducing symptoms of Duchenne muscular dystrophy in human patients between age of 1 day and 18 years old where patients is being administered oral prednisone, and ceasing administration of prednisone and immediately beginning administration to the human patient with vamorolone
McDonald et.al teaches administering vamorolone in male human patient with Duchenne muscular dystrophy between ages of 4-7 years (page 14, discussion) (instant claims 33 and 37-38) improvements in some motor outcomes as compared with corticosteroid-naïve individuals over an 18-month treatment period in patient with fewer physician-reported adverse effect occurred with vamorolone than have been reported for treatment with prednisone (page 2, conclusion). McDonald further teaches dosage of vamorolone in the range of 2.0 to 6,0mg/kg/day (page 2 conclusion) (claims 33 and 34)
Anisel et.al. teaches dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50).
2. Ascertaining the differences between the prior art and the claims at issue.
Although McDonald teaches method of administering vamorolone in male human patient with Duchenne muscular dystrophy between ages of 4-7 years and treatment of Duchenne muscular dystrophy with prednisone. McDonald does not teaches ceasing of administering prednisone and immediately administration of vamorolone.
Although Anisel et.al. teaches dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area, Anisel et.al. does not teach the dosage of vomorolone for treatment of Duchenne muscular dystrophy.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who have sufficient background in developing treatment modality for Duchenne muscular dystrophy without developing adverse effect of prednisone.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person skilled in the art would be motivated to develop a method of treating or reducing the symptom of Duchenne muscular dystrophy with 6mg/kg/day dosage of vamorolone since vamorolone improves motor outcome and have less adverse effect on patients than prednisone (McDonald, conclusion). A person skilled in the art is expected to immediately administer vamorolone after ceasing administration of prednisone to avoid gap between treatment. Therefore, it is prima facia obvious to administer vamorolone to a patients immediately after ceasing administration of prednisone. Thus, teaching claim 33.
Regarding claims 39-42, McDonald is silent about how vamorolone is administered. Examiner interpret vamorolone is administered orally in solution or suspension. Thus, teaching claims 39-41
Similarly, Mcdonald is silent about flavoring agent of solution or suspension of vamorolone, examiner interpret this as a way to make the solution or suspension more palatable for oral consumption. Therefore, it would be obvious for a person skilled in the art to add flavoring agent to a solution or suspension of vamorolone. Thus teaching claim 42.
Claims 33-34 and 41 are directed to dosage of vamorolone (claims 33-34) and weight % of vamorolone in solution or suspension (claim 41). Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. For example, dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50). Generally, dosage will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. The specification does not indicate the dosage and frequency of the dosage to be 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) (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A).
Regarding the limitation of age of human patients (claims 33 and 35-37), examiner interpret this as common age of patient for treating or reducing the symptom of Duchenne muscular dystrophy.
Conclusion
No claims are allowable as written.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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