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 .
Election/Restrictions
Applicant’s election without traverse of baked goods (claims 17-34) in the reply filed on 2/27/2026 is acknowledged.
Therefore, claims 35 and 36 are withdrawn from further consideration by the Examiner as being drawn to non-elected inventions.
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 28 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 28 depends on a claim which does not exist.
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 17-34 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/123475 in view of Serna-Loaiza et al.
WO teaches that cannabis is heated to form a distillate which would meet part ii) of claim 17 since distillation will raise the temperature in the cannabis enough to decarboxylate the cannabis. Note that these claims are product by process claims, thus as long as the process in WO would make the claimed composition, the same exact steps do not have to be disclosed in WO. Note also stirring in vitamin E with the cannabis. It is also noted that cannabis in and of itself contains oils thus meeting the lipid limitation since cannabis oil is a lipid. Note that cannabis oil would be a plant derived lipid (oil). Note also the formation of cannabis oil extracts, see abstract, paragraphs 9-11, 14, 17, 39, 47, 56-57. Note winterization in paragraph 39. Note the solvents in paragraphs 56 and 57. The solvent can be ethanol, see paragraph 56. Note girl scout cookies in paragraph 205, table 8. Note butter in paragraph 149. Note in paragraphs 163-164, toothpaste, chewing gum, lozenges, solutions, syrups.
Serna-Loaiza teaches that pressurized extractions of cannabis are known to be extracted at low pressures, see abstract.
The amounts of solvent, cannabis, pressures, temperatures, etc. are met since these claims are product by process claims and clearly it would have been well within the purview of the ordinary artisan in an effort to optimize the desired results to produce the claimed composition. Clearly these parameters are result effective variables.
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.
Note that compositions including chewing gums, lozenges, etc. are produced, thus it would have been obvious to produce a food product, edibles, drinks and alcoholic beverages.
C. Changes in Sequence of Adding Ingredients
Ex parte Rubin , 128 USPQ 440 (Bd. App. 1959) (Prior art reference disclosing a
process of making a laminated sheet wherein a base sheet is first coated with a metallic film and thereafter impregnated with a thermosetting material was held to render prima facie obvious claims directed to a process of making a laminated sheet by reversing the order of the prior art process steps.). See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.).
Note also that the steps to make the claimed composition can be done in a different order to arrive at the claimed composition.
Applicant argues that allegedly WO 2016/123475 discloses the distillation of cannabis to form a distillate, which may result in the decarboxylation of cannabis. However, it does not disclose the specific method steps outlined in the amended claims, particularly the use of specific solvents, pressures, temperatures, or the precise incorporation of vitamin E into cannabis oil.
There is NO requirement for vitamin E to be in the claimed product. The references do not have to teach the same steps as claimed since this is a product by process claim and as long as the same product is formed as is claimed it meets the clamed invention.
Applicant argues that allegedly while the prior art describes general distillation processes, it does not provide the detailed conditions or parameters required for the Applicant’s claimed method. Applicant argues that the specific combination of steps in the amended claims is neither disclosed nor suggested by WO 2016/123475.
Additionally, while the rejection notes that cannabis contains oils, which are lipids, the prior art does not specifically address the process of extracting or utilizing these oils in the claimed method according to applicant. Although cannabis oil may be classified as a lipid, the process of extracting it and combining it with vitamin E, as outlined in the amended claims, is neither disclosed nor suggested in WO 2016/123475 according to applicant.
Note that there is NO requirement in any of the claims for vitamin E.
Serna-Loaiza, discusses the pressurized extraction of cannabis at low pressures according to applicant. However, Serna-Loaiza neither teaches nor suggests the specific process steps now claimed, including the precise extraction conditions, solvent selection, temperatures, and pressures according to applicant. Additionally, it does not disclose the stirring or incorporation of vitamin E into cannabis oil (which was not claimed). While Serna-Loaiza mentions low-pressure extraction techniques, it does not provide a clear teaching of the specific process combination, including the role of cannabis oil as a lipid or the incorporation of vitamin E under the claimed conditions according to applicant. Accordingly, Serna-Loaiza neither anticipates nor renders obvious the amended method according to applicant. The amended claims are directed to a specific combination of process steps, solvents, temperatures, pressures, and mixing conditions, none of which are disclosed or suggested by the prior art according to applicant. While an ordinarily skilled artisan may optimize individual parameters, such optimization would not inherently lead to the specific combination of steps and conditions now claimed according to applicant. The inclusion of vitamin E and the precise utilization of cannabis oil, as specified in the amended claims, represents a non-obvious method that is not anticipated by the prior art according to applicant.
Once again, the specifically claimed product by process is just that a product and NOT a process being claimed. Note that hemp oil is the same thing as cannabis oil. Applicant admits on the record that cannabis contains oils thus the requirement of hemp oil is met by the teachings to cannabis. The claimed decarboxylation is met for the above reasons and since the claims are product by process they will inherently be met since the cannabis in WO is decarboxylated. Further, “wherein the decarboxylation is carried out in a multi-step heating process in which the plant material is first heated to a first temperature for a first time period to evaporate off retained water and allow for uniform heating of the plant material: and second the temperature is increased to a second temperature for a second time period until at least 95% conversion of the acid cannabinoids to their neutral form”, is so broad on its face and is confusing to what it actually means. A “first time period” is never defined nor is the temperature to which applicant claims the cannabis has to be heated to, to carboxylate the cannabis.
Note girl scout cookies in paragraph 205, table 8. Note butter in paragraph 149. Note in paragraphs 163-164, toothpaste, chewing gum, lozenges, solutions, syrups. Clearly syrups can be seen as a type of sauce.
The Rumpf declaration has been carefully considered, but clearly the butter tested and the resulting product being tested by “ten adult participants” is a small group and the results of this group is very relative and subjective since everyone has a different taste palate and the results are thus not definitive. Cannabis taste and cannabis smell are relative and subjective since smells and tastes vary from person to person and 10 people is a very small group of data to rely on.
Therefore, the “sensory study” is relative and subjective from person to person and no definitive answers can be made or yielded since everyone’s perception of smell and taste are completely different from one another. “Perceived cannabis aroma” once again is completely relative and subjective from person to person that no quantitative results can be determined. The same is true for “consumer perception standpoint”.
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
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