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 8-10, 12 and 124-139 are rejected under 35 U.S.C. 103 as being unpatentable over KR 20110125429 (of record) in view of WO 2017/025712 (of record) and Kleidon et al. (US 2017/0172977-of record) and as evidenced by “VIVVITALS” (of record).
KR teaches that a hemp seed extract (which is a hemp extract) is used to treat diabetes in “patients”, see pages 2, 3, abstract. Note that the extract is used at 0.01 to 150 mg/kg, see page 6. Note that the composition can be administered to people and to mouse undifferentiated adipocytes, see page 10. Note on page 17 of the instant specification that the patient can be a human, rabbit, horse, cat, dog, mice, etc. Note that the suppository bases can be cocoa butter or laurin butter, see page 6. Claim 138 reads on just about anything since anything can be considered to be pharmaceutically acceptable additives or flavoring agents.
Note on page 17 of the instant specification that the patient can be a human, rabbit, horse, cat, dog, mice, etc.
Applicant argues that allegedly KR discloses using hemp oil for preventing or treating diabetes and obesity. Hemp oil (hemp seed oil) is oil obtained from hemp seeds as described in Example 1 of KR, according to applicant. Typically, hemp seed oil does not contain cannabinoids unless it has been contaminated with parts from the rest of the plant, according to applicant. See Exhibit A submitted herewith describing the differences between hemp seed oil and hemp extract, according to applicant. Applicant argues that KR does not teach or suggest a method of treating diabetes, lung cancer, inflammatory bowel disease, dermatological condition, seizures or obsessive behaviors in a veterinary subject in need thereof comprising administering to the subject a therapeutically effective amount of hemp extract.
While this is noted, it is also noted that “hemp seed oil” is a type of “hemp extract” since anything that is extracted from hemp is seen chemically as a “hemp extract”.
Whether a (for example, hot water) extract of coffee beans (coffee plant) is from the beans or another part of the coffee plant, the extract from coffee in and of itself is a coffee extract by definition and chemically since it is from a coffee plant.
VIVVITALS teaches that hemp seeds inherently contain lecithin in them, see entire document, especially page 2.
It would have been obvious for one having ordinary skill in the art to use the composition of KR on a canine, feline, bovine, porcine or equine since clearly KR uses the extract on mouse cells so clearly one of ordinary skill in the art has considered veterinary use. To extend that use to a dog or cat for example, would have been well within the purview of the ordinary artisan in an effort to optimize the desired results. Clearly if one can use the extract to treat diabetes on a mouse or human, one can also then use that extract to treat diabetes in a dog or cat.
New claims 124-137 claim that the hemp extract contains CBD and CBDA at a ratio of 0.1:1 to about 1:0.1. Please note that this reads on a 1:1 ratio which is clearly obvious to do in the prior art since using equal parts of something to form the whole is clearly obvious to perform.
KR teaches that a hemp seed extract is used to treat diabetes in “patients” but fails to explicitly disclose wherein the ratio of cannabidiol to cannabidiolic acid is about 0.1:1 to about 1:0.1 in the hemp extract.
However, GW is in the field of cannabinoids (GW Abstract) and teaches a ratio of cannabidiol to cannabidiolic acid that is about 0.6:1 to about 1:0.6 (GW Para. [0041], where CBDA is used in combination with CBD ratios of between 9:1 to 1:9 (CBDA:CBD) which are preferred. The ranges of ratios include 8:2 to 2:8 (CBDA:CBD), 7:3 to 3:7 (CBDA:CBD), 6:4 to 4:6 (CBDA:CBD),; and 1:1 (CBDA:CBD) and any ranges there in between).
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the composition of KR with the teaching of GW for the purpose of including the cannabidiol and cannabidiolic acid in a proportion for treating epilepsy (GW Para. [0041]; Para. [0035)). Note that preventing diabetes or obesity reads on anyone.
KR discloses the pharmaceutical composition of the claims.
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.
Clearly the amounts used of the cannabinoids are result effective variables and to use them in the claimed amounts is obvious in an effort to optimize the desired results of the invention.
Note the carrier being hemp seed oil is clearly taught in KR, see paragraphs 2, 3.
Note that Kleidon et al. (US 2017/0172977) discloses a dosage form (see abstract) comprising: 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] which teaches that such cannabinoids are commonly found in a hemp extract, see paragraph 44.
Applicant argues that hemp seed oil does not contain cannabinoids or terpenes but this is not true as is evidenced by Kleidon which teaches that cannabinoids used in the invention come from hemp seeds, see paragraph 44. Terpenes are also taught in paragraph 54. Clearly an extract can be seen as isolated since a hemp extract was isolated from a hemp plant reads on an extract by definition, see entire disclosure, especially paragraphs 44, 59.
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).
Applicant is attacking GW by saying that it does not apply, but the applicant cannot argue against individual references when the rejection is based on a combination of references.
Therefore, the rejection is maintained for the reasons of record and for the above reasons.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 8-10, 12, 124-139 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 132, 170-172, 175, 176, 178 of copending Application No. 17/045,945 since 17/045,945 treats pain and clearly an animal with diseases/disorders in this case would experience pain. Note that both applications use a composition of cannabinoids and terpenes that are isolated from a hemp plant.
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MICHAEL V. MELLER
Primary Examiner
Art Unit 1655
/MICHAEL V MELLER/ Primary Examiner, Art Unit 1655
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