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 .
Claim Rejections - 35 USC § 103
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.
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.
Claims 17-36 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Kleidon et al. (US 2017/0172977).
Kleidon discloses a dosage form (see abstract) comprising: cannabidiol (Para. [0047]. The cannabinoids of the compositions disclosed can comprise cannabidiol-class compounds, including but not limited to cannabidiol (CBD)...); cannabidiolic acid (Para. [0047], ...cannabidiolic acid (CBDA)...); CBG type (CBG), cannabigerolic acid (Para. [(0047}; Para. [0043], Cannabinoids utilized in the compositions include but are not limited to...cannabigerolic acid (CBGA)...); A9-tetrahydrocannabinol (Para. [0047]; Para. [0050], The compositions of the present disclosure can comprise tetrahydrocannabinol (THC) as a type of cannabinoids. THC can comprise delta-9-THC, delta-8-THC, and combinations thereof); cannabichromene (Para. [0047]; Para. {0043}, ...cannabichromene-type (CBC)...); and one or more pharmaceutically acceptable additives, flavoring agents, surfactants, and adjuvants (Para. [0108], The compositions of the present disclosure can be administered in any oral dosage form, including liquid dosage forms (e.g., a suspension or slurry), and oral solid dosage forms (e.g., a tablet or bulk powder). Tablets can include tablets, caplets, capsules, soft gelatin capsules, and lozenges. Tablets can further comprise suitable binders, lubricants, diluents, disintegrating agents, colorants, flavoring agents, flow-inducing agents, and melting agents). Note administration for pain in paragraphs 97 and 116. Note essential oils such as Linalool; B-Caryophyllene; B-Myrcene; D-Limonene; Humulene; a-Pinene, paragraphs 12, 54, 66, 92. Note nerolidol at paragraph 85.
Kleidon discloses a pharmaceutical composition (Abstract; Para. (0015]) comprising hemp extract and a carrier (Para. [0058], The compositions of the present disclosure can be enriched in cannabidiol compounds compared to hemp oil. For example, a composition can comprise hemp oil and cannabidiol compounds from plant sources such as extracts (e.g., hemp extract) and essential oils; Para. (0111], The compositions of the present disclosure can be provided as a food composition in combination with a food carrier...), wherein the hemp extract comprises: cannabidio!, and cannabidiolic acid (Para. [0058]; Para. [0047], The cannabinoids of the compositions disclosed herein can comprise cannabidiol-class compounds, including but not limited to cannabidiol (CBD), cannabidiolic acid (CBDA)...).
Kleidon discloses the pharmaceutical composition of the claims for the treatment of pain. Kleidon further discloses where in hemp extract further comprises: cannabigerolic acid (Para. [0058]; Para. (0043), Cannabinoids utilized in the compositions disclosed herein include but are not limited to...cannabigerolic acid (CBGA)...); A9-tetrahydrocannabinol (Para. [0058]; Para. (0050), The compositions of the present disclosure can comprise tetrahydrocannabinol (THC) as a type of cannabinoids. THC can comprise delta-9-THC, delta-8-THC, and combinations thereof); and cannabichromene (Para. [0058]; Para. [0043], ...cannabichromene-type (CBC)...). Kleidon further discloses the cannabidiol and cannabidiolic acid (Para. [0058); Para. [0047].
It would have been obvious to prepare the liquid composition using an apparatus that dispenses the CBD, the CBG, the one or more additional cannabinoids, and the terpenes, in very precise, consistent amounts from less than 1 mg; and wherein the relative amounts of CBD and, if present, the THC, the CBG, the CBN, and the CBC are adjusted dynamically in response to patient feedback since these are all result effective variables.
Kleidon discloses a pharmaceutical composition (Abstract; Para. [0015]) comprising hemp extract and a carrier (Para. [0058), The compositions of the present disclosure can be enriched in cannabidiol compounds compared to hemp oil. For example, a composition can comprise hemp oil and cannabidiol compounds from plant sources such as extracts (e.g., hemp extract) and essential oils; Para. [0111], The compositions of the present disclosure can be provided as a food composition in combination with a food carrier...), wherein the hemp extract comprises: cannabidiol (Para. [0047], The cannabinoids of the compositions disclosed herein can comprise cannabidiol-class compounds, including but not limited to cannabidiol (CBD)...); cannabidiolic acid (Para. [0047], ...cannabidiolic acid (CBDA)...); cannabigerolic acid (Para. [0047]; Para. [0043], Cannabinoids utilized in the compositions disclosed herein include but are not limited to...cannabigerolic acid (CBGA)...); A9-tetrahydrocannabinol (Para. [0047]; Para. [0050],
MPEP 2144.05, subsection II.
II. ROUTINE OPTIMIZATION
A. Optimization Within Prior Art Conditions or Through Routine Experimentation
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is 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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("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) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.").
B. There Must Be an Articulated Rationale Supporting the Rejection
In order to properly support a rejection on the basis that an invention is the result of "routine optimization", the examiner must make findings of relevant facts, and present the underpinning reasoning in sufficient detail. The articulated rationale must include an explanation of why it would have been routine optimization to arrive at the claimed invention and why a person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range. See In re Stepan, 868 F.3d 1342, 1346, 123 USPQ2d 1838, 1841 (Fed. Cir. 2017). See also In re Van Os, 844 F.3d 1359,1361,121 USPQ2d 1209, 1211 (Fed. Cir. 2017 ("Absent some articulated rationale, a finding that a combination of prior art would have been ‘common sense’ or ‘intuitive’ is no different than merely stating the combination ‘would have been obvious.’"); Arendi S.A.R.L. v. Apple Inc., 832 F.3d 1355, 1362, 119 USPQ2d 1822 (Fed. Cir. 2016) ("[R]eferences to ‘common sense’ … cannot be used as a wholesale substitute for reasoned analysis and evidentiary support … .").
The Supreme Court has clarified that an "obvious to try" line of reasoning may properly support an obviousness rejection. In In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977), the CCPA held that a particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation, because "obvious to try" is not a valid rationale for an obviousness finding. However, in KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court held that "obvious to try" was a valid rationale for an obviousness finding, for example, when there is a "design need" or "market demand" and there are a "finite number" of solutions. 550 U.S. at 421 ("The same constricted analysis led the Court of Appeals to conclude, in error, that a patent claim cannot be proved obvious merely by showing that the combination of elements was ‘[o]bvious to try.’ ... When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under §103."). Thus, after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.
Claim 30 makes no sense since the composition cannot further comprise up titration or down titration therefore it carries no patentable weight.
To introduce or increase the THC in 1-10 mg/ml increments responsive to patient reported outcomes is obvious since clearly the THC is a results effective variable.
To dose about 0.1-1.0 mL once, twice or three times daily is obvious since this is clearly a results effective variable.
To prepare the composition and dispense by an apparatus configured to deliver each ingredient in very precise, consistent amounts from less than 1 mg and wherein the method reduces concurrent opioid consumption relative to baseline opioid use is obvious since clearly these are result effective variables.
The different amounts of the claimed components are well within the purview of the ordinary artisan to be optimized and achieved to yield the best possible results since the claimed components are clearly result effective variables in Kleidon.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL V MELLER whose telephone number is (571)272-0967. The examiner can normally be reached M-F 9 am-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MICHAEL V. MELLER
Primary Examiner
Art Unit 1655
/MICHAEL V MELLER/ Primary Examiner, Art Unit 1655
