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 .
Specification
The disclosure is objected to because of the following informalities: The Specification comprises a single Table on page 1, but no Table 2. The label “Table 1:” should be deleted and “cyclodextrin structures” should be capitalized. In paragraph [0002] “Table 1” should be replaced with “the table”.
Appropriate correction is required.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Czap (US 2019/0046598) in view of Pate et al (U.S. 5,977,180) and Chwalisz et al (US 2001/0056068) and in further view of Ghasemi et al (2007 BHY International)
The instant claims are directed to a method for treating or preventing a nitric oxide deficiency or a disease which can be treated or prevented by increasing endogenous nitric oxide levels in a mammal by orally administering a composition comprising an anandamide and a cyclodextrin carrier with a cyclodextrin degrading enzyme. Applicant claims said method wherein the composition further comprises L-arginine or a citrulline.
Czap teaches a method of treating a disease in a mammal using a cyclodextrin inclusion complex delivery vehicle (claim 1) comparing a salivary or microbial amylase (claim 6 and 7) wherein the cyclodextrin in gamma cyclodextrin (claim 21). Czap teaches said method wherein the delivery vehicle comprises a drug and a pharmaceutically acceptable carrier (claim 13). Czap teaches said delivery vehicle can comprise L-arginine (claim 43). Czap teaches that the delivery vehicle can be administered orally (claim 41). Czap teaches that one of ordinary skill in the instant art would use common general knowledge to modify the teachings therein on page 6, paragraph [0057].
Czap does not teach a method of orally administering anandamide or an analogue thereof as a guest molecule in a cyclodextrin inclusion complex formulation.
Pate et al teach a method of treating intraocular hypertension using a composition comprising anandamide analogues and a cyclodextrin (Abstract). Pate et al teach a wide variety of anandamide analogues at columns 3 and 4. Pate et al teach that a gamma cyclodextrin can be used at column 4, lines 52-65. Pate et al teach that a viscosity enhancing agent like hydroxypropylmethyl cellulose can be used in the composition at column 11, lines 57-59. Pate et al teach that arachidonyl ethanolamine (an anandamide analogue) is known to bind the cannabinoid receptor at column 1, lines 58-60. Pate et al teach that there is an advantage to using a cyclodextrin to deliver an anandamide at column 2.
Chwalisz et al teach control, management, treatment and prevention of conditions related to nitric oxide deficiency such as hypertension by administering to a mammal an effective amount of citrulline or a citrulline analogue at claim 3 and 21, and that the composition can further contain L-arginine at claim 23.
Ghasemi et al teach that anandamide increases the production of nitric oxide and can be useful in the treatment of erectile dysfunction.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant claims to modify the teachings of Czap using the teachings of Pate et al to produce a cyclodextrin inclusion complex formulation comprising anandamide or an analogue thereof and a cyclodextrin degrading enzyme. Both Czap and Pate et al teach using gamma cyclodextrin (instant claim 20). Ghasemi et al teaches that anandamide and analogues thereof can increase endogenous nitric oxide levels in a mammal, and Chwalisz et al teach that citrulline and analogues thereof in combination with L-arginine can be also used to increase endogenous nitric oxide levels in a mammal. Hence, the invention of instant claims 1-9 and 17 are obvious in view of these two references. Selection of an anandamide analogue and/or citrulline analogue (instant claims 6-10) would have been a design choice as suggested by both Pate et al and Chwalisz et al. The pharmaceutically acceptable carrier calcium laurate (instant claim 18) would have been a design choice also. Pate et al had suggested including hydroxypropylmethylcellulose (instant claims 13 and 14) would have been a desired addition to the composition even if Applicant’s reason is different from that of the prior art. Finally, measuring nitrous oxide levels in the subject mammal to be treated would have been obvious given the teachings of Chwalisz et al and Ghasemi et al.
Given the teachings of the prior art, one of ordinary skill in the art would have been motivated in modifying the teachings of Czap to use the taught cyclodextrin inclusion complex formulation to administer anandamide or an analogue thereof for the purposes of increasing endogenous nitric oxide levels in a mammal, especially given the teachings of Ghasemi et al.
Given the teachings of Czap and Pate et al, one of ordinary skill in the art would have had a reasonable expectation of success in modifying the prior art to arrive at the method of the instant claims.
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.
Claim 12 is 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.
Claim does not appear to properly further limit claim 4 upon which it depends, and it is unclear if the “characterized” method step is limited to administering citrulline or a citrulline analogue. Hence, the metes and bounds of the claim are unclear.
Conclusion
No claims of allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID H KRUSE whose telephone number is (571) 272-0799. The examiner can normally be reached Monday-Friday 7AM-3:30PM.
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/David H Kruse/
Primary Examiner, Art Unit 1663