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 1, 2, 8, 10, 12, 14, 15, 28-31 are rejected under 35 U.S.C. 103 as being unpatentable over JP 4146225 in view of CN 1686230 and Morita et al.
JP teaches that cannabis sativa buds (herbal extract) are known to be extracted with ethanol and distilled to produce cannabis oil, see paragraphs 2, 3, 16, 19, 20, 28, 34, 46. Note in the abstract that the solvent (ethanol) is removed.
JP does not explicitly state that the dehydrating is for at least about 72 hours and that vitamin E is used along with the cannabis oil.
CN teaches that cannabis oil is known to be dried, distilled, filtered, etc. Note drying for 24 hours, page 3.
Morita teaches that alpha tocopherol ameliorates acute lung injury, i. e. inhalation injury, see abstract.
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.
Therefore, to dry for 72 hours is prima facie obvious to one having ordinary skill in the art since clearly CN teaches to dry for 24 hours and to dry for longer is clearly a results effective variable which is obvious to use in an effort to optimize the desired results.
Therefore, to use vitamin E (alpha-tocopherol) is prima facie obvious since clearly Morita teaches that alpha tocopherol is known to be used in inhalation to ameliorate acute lung injury which is clearly a results effective variable which is obvious to use in an effort to optimize the desired results.
The amounts claimed by applicant are clearly result effective variables, therefore it would have been obvious to use the claimed amounts in an effort to optimize the desired results.
Applicant argues that amended claim 1 is patentable over JP 4146225 in view of CN 1686230 at least because none of the cited references, either singly or in combination, discloses or suggests mixing a quantity of a-tocopherol with a cannabis oil extract, as required by amended claim 1.
Claims 2, 8, 10, and 12-15 are also patentable over JP 4146225 in view of CN 1686230 for at least the reason that these claims depend from and include all the elements of claim 1 and recite additional elements of particular advantage and utility according to applicant.
The fact of the matter is that clearly the rejection has now been amended to meet the Vitamin E requirement in the claims.
Whether the alpha tocopherol is from soybean or sunflower does not change the fact that the compound is the compound, namely alpha tocopherol no matter where it comes from.
MPEP 2111.03 states:
“For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising." See, e.g., PPG, 156 F.3d at 1355, 48 USPQ2d at 1355 ("PPG could have defined the scope of the phrase consisting essentially of' for purposes of its patent by making clear in its specification what it regarded as constituting a material change in the basic and novel characteristics of the invention."). See also > AK Steel Corp. v. Sollac, 344 F.3d 1234, 1240-41,68 USPQ2d 1280, 1283-84 (Fed. Cir. 2003) (Applicant's statement in the specification that "silicon contents in the coating metal should not exceed about 0.5% by weight" along with a discussion of the deleterious effects of silicon provided basis to conclude that silicon in excess of 0.5% by weight would materially alter the basic and novel properties of the invention. Thus, "consisting essentially of" as recited in the preamble was interpreted to permit no more than 0.5% by weight of silicon in the aluminum coating)”.
Thus, the claims can still be interpreted as reading, "comprising". Thus, the claims are not limited in any way by the "consisting essentially of" language.
Clearly since JP teaches that the composition is used for inhalation, it would have been obvious to include vitamin E since Vitamin E is well known to be used in inhalation to ameliorate acute lung injury which is clearly a results effective variable which is obvious to use in an effort to optimize the desired results.
Applicant alleges that JP teaches that there are disadvantages to using ethanol. The fact of the matter is that ethanol is clearly listed as a solvent to be used. The claims use “comprising” thus ethanol is clearly contemplated to be used with the CO2, see paragraph 34 and the claims.
Next, applicant alleges that CN fails to teach dehydrating or purging a distillate under conditions sufficient to remove residual solvent. Clearly this is taught as is evident in paragraph 31 of CN.
Next, applicant argues that allegedly Morita teaches post trauma administration of vitamin E to burn victims. The claims only require the addition of vitamin E for ANY purpose, thus making applicant’s arguments moot. This argument has already been addressed on the record. There is NO requirement in the claims for the Vitamin E to adjust viscosity as applicant asserts.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
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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MICHAEL V. MELLER
Primary Examiner
Art Unit 1655
/MICHAEL V MELLER/ Primary Examiner, Art Unit 1655
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