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 .
According to a preliminary amendment filed on Sep. 26, 2023, the applicants have amended claims 1, 3, 5-7, 9-13, 15 and 17-20.
Claims 1-20 are pending in the application.
Claim Rejections - 35 USC § 112
4. 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 6-7 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 6 recites the broad recitation vitamin E, and the claim also recites (alpha-tocopherol) which is the narrower statement of the range/limitation.
In the present instance, claim 7 recites the broad recitation coenzyme Q-10, and the claim also recites (ubiquinone) which is the narrower statement of the range/limitation.
In the present instance, claim 7 recites the broad recitation B, and the claim also recites (thiamine, riboflavin, niacin, pyridoxine, cobalamin) which is the narrower statement of the range/limitation.
In the present instance, claim 7 recites the broad recitation vitamin C, and the claim also recites (ascorbic acid) which is the narrower statement of the range/limitation.
In the present instance, claim 7 recites the broad recitation vitamin E, and the claim also recites (alpha-tocopherol) which is the narrower statement of the range/limitation.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 102
(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 1 is rejected under 35 U.S.C. 102(a) (1) as being anticipated by Martins (PLoS one).
Martin discloses preventing experimental malaria by plasmodium berghei ANKA. The combination of L-arginine, BH4 and nor NOHA disclosed in figures 1B, 1C and 1D (see page 4) by Martin anticipates the instant claim when arginase inhibitor is represented by nor NOHA in the instant claim.
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.
9. 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.
10. Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Tratsiakovich (Int. J. of Cardiol) in view of Kovamees (PLoS one).
Tratsiakovich teaches combination of L-arginine and BH4 protects the heart from ischemia-reperfusion injury. Tratsiakovich meets all the limitations of instant claim except that it does not teach addition of arginase inhibitor for treating ischemia-reperfusion injury. However, Kovamees teaches treating ischemia-reperfusion injury by arginase inhibitor, nor NOHA. Therefore, it would have been obvious to one skilled in the art to treat ischemia-reperfusion injury by combination of L-arginine, BH4 and arginase inhibitor in order to have a synergistic effect with reasonable expectation of success.
Allowable Subject Matter
11. Claims 2-5 and 8-12 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.
12. Claims 13-20 are allowed.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARANJIT AULAKH whose telephone number is (571)272-0678. The examiner can normally be reached Monday-Friday 7:00-3:30.
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, Clinton A Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARANJIT AULAKH/ Primary Examiner, Art Unit 1621
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