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 .
Priority
This application is a CON of 16/602,652 (11/15/2019 ABN)
16/602,652 has PRO 62/810,212 (02/25/2019)
16/602,652 has PRO 62/797,666 (01/28/2019)
16/602,652 has PRO 62/796,811 (01/25/2019)
16/602,652 has PRO 62/917,463 (12/07/2018).
Information Disclosure
An IDS was not filed in this application. Applicant is reminded of the duty of disclosure as per 37 CFR 1.56 and detailed in MPEP § 2000.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed 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 Schwope et al. (Anal Bioanal Chem (2011) 401:1273–1283).
Schwope teaches CBD-d3 (Table 1) which anticipates the claim.
Claims 16-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gant et al. (US20100125094).
Gant teaches the following compounds which anticipate the claims ([0021], Claim 7):
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Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 and 16-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature (law of nature or natural phenomenon) without significantly more. Subject matter eligibility guidance from MPEP 2106 requires considering the following steps:
Step 1: the claims are to products of deuterated forms of CBD and nicotine. (Step 1: Yes).
Step 2A, prong one: the claims recite a nature-based product, thus the markedly different characteristics analysis is used to determine if the nature-based product is a product of nature exception. MPEP 2106.04(c)(I). As disclosed by the cited prior art above, the compounds of the claims are naturally occurring and would be deuterated according to the conditions of plant growth. Therefore, the naturally occurring counterpart is the compound as it occurs in nature in the corresponding plants growing in water either with natural abundance deuterium or in D2O which would naturally incorporate the deuterium into the molecule. Upon comparing the claimed product to the naturally occurring counterpart the comparison shows there are no differences in chemical structure or any other aspect or characteristic.
Step 2A, prong two: : This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. The claims do not recite language which integrates the exception into a practical application – the claims are to the molecules alone. (Step 2A: Yes).
This part of the eligibility analysis evaluates whether the claim as a whole amounts to
significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05. As discussed with respect to Step 2A Prong Two, the claim does not recite any additional element beyond the judicial exception. Thus, the claims lack an inventive concept (Step 2B: NO). The claim is not eligible.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at (571) 270-5293. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626