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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/17/2025 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Previously presented rejection of claims 1-6, 8-15, 17 and 18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention is maintained for reasons of record.
Applicants arguments focus on the following:
As amended the breadth is far narrower.
The claims are drawn to in vitro release conditions (not chemistry or unpredictable biological process).
The cited compounds share similar properties and therefore can be used formulated analogously.
The cited references support formulations have predictable use.
Amount of direction provided is extensive.
There are working examples.
Undue experimentation is not required.
The skill in the art is high.
Response.
Amendments and applications arguments are not persuasive.
Even though the base claim is limited to 12 combinations of the active ingredients, there are other factors in the claim as limitations for consideration of undue effort and predictable use. For example, consider the
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. This means each one of the 12, has the 25, 26,..74, or 75% variability to consider. That is 12 times 51 not
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. Likewise, d
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. Consider Applicant pointed out
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. At page 18
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or claim 5 for each
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As such the claims are broad when all the limitations are considered.
Applicant is encouraged to point out the working examples for the recited
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and
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possibilities as limited in the claims:
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Similarly, there is no disclosure or working examples for any and all
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.
That the release of acidic cannabinoids would be independent of the nature of coating with respect to pH just not make sense. The release of neutral cannabinoids and acidic cannabinoids would have similar release pattern is questionable. In this context Remarks
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is not persuasive. Applicant arguments under section State of the Art suggest that the claimed dosage forms are obvious routine variants. As to the predictable use, the argument that THCA can
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Is confusing at best, because Applicant argues in the context of Sanz that THCA and THC have
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Further these activity properties are not recited in the claims as limitations. In addition as previously pointed out (see page 5 chemical structures) the structural differences are not relating to ‘alkyl chains’. One of skill in the art would not expect the pictured compounds all to have
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similar physicochemical traits such as lipophilicity. It is one of commonsense physicochemical properties are the physical and chemical characteristics of a substance, such as its solubility, melting point, boiling point, density, and chemical stability. These properties are influenced by a molecule's chemical structure and govern how a substance behaves and interacts with its environment, playing a crucial role in fields like pharmaceuticals, environmental science, and materials science. For instance, they are used to predict toxicity, understand environmental fate, and design new materials. Asserting the compound with a carboxylic acid group would have same physicochemical trains as the other two is not persuasive.
Remarks at page 15 of 17
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Applicant is encouraged to point out these examples (as limited for cannabinoids as limited).
Applicant states at page 15/17 that
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It is not an assumption. The position taken is that the working examples for THC and CBN cannot be extended to the cannabinoids as limited by the claims. The
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for cannabinoids includes large number of possibilities.
Applicant is encouarged to provided support in the form a reference or disclosure in the specification that
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As admitted at specification page
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One of skill in the art would anticipate structurally different cannabionoids (as recited) would have different properties. As such in contrast to Applicants statement at the top of page 16/17, the specification is not enabling for the claims as limited.
Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001, states “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
Therefore Applicant statement that the
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Suggestion:
See MPEP 1204 Notice of Appeal [R-01.2024]. This suggestion takes into consideration that the
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From previous action:
The determination that "undue experimentation" would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the relevant factual considerations.
Enablement is considered in view of the Wands factors (MPEP 2164.01 (a)). These include: (1) breadth of the claims; (2) nature of the invention; (3) state of the prior art; (4) amount of direction provided by the inventor; (5) the level of predictability in the art; (6) the existence of working examples; (7) quantity of experimentation needed to make or use the invention based on the content of the disclosure; and (8) relative skill in the art.
All the factors have been considered with regard to the claims, with the most relevant factors discussed below:
The ‘invention’ is drawn to pulse-release dosage form comprising first cannabinoid API1 selected from delta-8- tetrahydrocannabinol or tetrahydrocannabinolic acid (THCA) and second cannabinoid API2 selected from cannabinolic acid A, cannabinol-C4, or cannabinol-C2.
It is not seen where in the specification enabling disclosure is found for
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None of the working examples is drawn to such a
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With the wide range of
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and the wide range
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undue effort would be needed to make and use Applicants' invention, to select the appropriate cannabinoid and dose as limited. In addition to this wide breadth, the cannabinoid compounds are structurally different and are anticipated to have different chemical and physical properties. Consider for example the delta-8 and delta-9 compounds. These compounds are structurally different (double bond isomers) and are known to have, related, but different pharmacological properties. For example see Jfirbe, Psychopharmacology (1981) 75:152-157 at column B, 153 (for chemical structures) and discussion of differences in pharmacological effects (based on structural differences) throughout, such as at page 154 column A lines 1-13; page 156 column A first full paragraph; page 155, Fig 3 and Table- 1. In addition, conversion of THCA to THC in vivo appears to be very limited, giving it only very slight efficacy as a prodrug for THC as taught by Sanz, Cannabis and Cannabinoid Research, Volume 1.1, 2016, 124-130, see for example, bottom of page 124 on to page 125:
“Since THCA-A does not seem to convert to THC in vivo and displays its own metabolic and elimination pathways, it was proposed as a marker capable of distinguishing between the use of Cannabis and prescription synthetic THC”.
This relates to the unpredictability with respect to dosage and release of instant first cannabinoid API1 selected.
Similar, unpredictability and need for undue effort with respect to API2 compounds is anticipated in view of the structural differences among these API2 compounds: (acid, C4 and C2):
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According to Sanz at bottom of page 126, column A “ Contrary to THC, THCA-A does not elicit psychoactive effects in humans and, perhaps for this reason, its
pharmacological value is often neglected”. As such the direction, guidance and working examples disclosed for different API1 and API2 cannabinoids cannot be extended or adopted for the instantly recited compounds and cannot be taken at face value for enabling for predictable use of the instantly recited API1 and API2 cannabinoids. Again, what is enabling for THC and CBN is irrelevant for the instantly recited API1 and API2 cannabinoidss for the intended use and per the conclusions of Sanz at page 129 column A. Also see Jain, Biomatter 1:1, 57-65; July/August/September 2011, which teaches the nuances in the recent technologies in pulsatile drug delivery systems. At page 58, Jian exemplifies differences in (A) sigmoidal release after lag time, (B) delayed release after lag time, (C) sustained release after lag time and (D) extended release without lag time. Further, as per Jain teaching, the predictable use of pulsative release depends on several factors. For example, the timing of release is controlled by the thickness of the coating and the amount of water-soluble polymer needed to achieve the pulsed release from oral dosage forms.
For these reasons, one skilled in the art would be faced with undue amount of research, to arrive at the dosage form as instantly recited.
The specification lacks disclosure sufficient to make and use the invention
MPEP 2164.01(a) states, “A conclusion of Iack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. ln re Wright, 999 F.2d 1557,1562, 27 USPQ 2d 1510, 1513 (Fed. Cir. 1993).'' That conclusion is clearly justified here. Thus, undue experimentation would be required to make and use Applicants' invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
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, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625