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 with traverse of Claims 1-4, 8, 10-13, 17, 21 and 23 in the reply filed on 3/18/2024 is acknowledged. The traversal is on the ground(s) that allegedly the Examiner has not demonstrated there would be a serious burden on the Examiner if the species were examined together. This is NOT found persuasive because a reference to chewing tobacco or moist snuff would not necessarily anticipate nor render obvious a smokeable cigarette or cigar. Thus, there is indeed a serious burden on the Examiner which involve completely different searches and considerations. In fact, the examiner had to find completely different prior art to meet “moist snuff”.
Thus, claims 19, 20, 22 and 24 are withdrawn from further consideration by the Examiner as being drawn to non-elected inventions.
The requirement is still deemed proper and is therefore made FINAL.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Claims 1-4, 8, 10-13, 17, 21 and 23 are 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.
The phrase, “wherein the composition of matter comprises the oi! mixed with the tobacco leaves such that the isolated cannabinoid is present in the composition of matter in an amount of between 0.1 wt. % to 20.0 wt. % relative to the weight of the tobacco leaves” is confusing since it is not clear what the amount of “isolated cannabinoid” (which is already confusing since it is not clear what happened to the “extracted cannabinoid”) is referring to since the “isolated cannabinoid” is being referred to in reference to the weight of the “tobacco leaves” and NOT the overall composition of matter. Therefore, it is a confusing term. This is not understood since it is not clear if the composition of matter is the point of reference or the “tobacco leaves” or the “isolated cannabinoid”. And whatever happened to the “extracted cannabinoid” ? is that the same thing as the “isolated cannabinoid” ?
Applicant argues that allegedly the tobacco leaves are the primary component of the composition but this is NOT true since one does not know how much oil or tobacco leaves are in the composition. Without knowing how much the oil and the tobacco leaves are in the total composition makes it impossible to quantify the context of the amount of isolated cannabinoids in the oil and does not to help quantify anything in the overall composition. Applicant further argues about isolation and extraction of the cannabinoids in the oil but this is confusing since are the cannabinoids isolated or extracted ? Correction and/or explanation is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-4, 8, 10-13, 17, 21 and 23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The claims are directed to a composition of matter comprising tobacco leaves and an oil comprising an isolated cannabinoid that has been isolated from cannabis plant material. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
See MPEP 2106.07.
Effective January 7, 2019, subject matter eligibility determinations under 35 U.S.C. § 101 follow the procedure explained in the Federal Register notice titled 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No.4, 50-57), which is found at: https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf. Applicants are kindly asked to review this guidance as well as MPEP 2106.
The statutory categories of invention under 35 U.S.C. 101 are processes, machines, manufactures, and compositions of matter. However, certain members of these categories constitute judicial exceptions, i.e., the courts have determined that these entities are not patentable subject matter. These judicial exceptions include abstract ideas, laws of nature, and natural phenomena. The Office released guidance on December 16, 2014 for the examination of claims reciting natural products under 35 U.S.C. 101 in light of the recent Supreme Court decisions in Association for Molecular Pathology v. Myriad Genetics, Inc. (569 U.S. ___, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013)) and Mayo Collaborative Services v. Prometheus Laboratories (566 U.S. ___, 132 S. Ct. 1289, 101 USPQ2d 1961 (2012)), Diamond v. Chakrabarty, 447 U.S. 303 (1980)) and Funk Brothers Seed Co. v. Kalo Inoculant Co. - 333 U.S. 127 (1948)). (inter alia). See eg. MPEP 2106.04(b)
The Supreme Court has explained that the judicial exceptions reflect the Court’s view that abstract ideas, laws of nature, and natural phenomena are "the basic tools of scientific and technological work", and are thus excluded from patentability because "monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it." Alice Corp., 134 S. Ct. at 2354, 110 USPQ2d at 1980 (quoting Myriad, 133 S. Ct. at 2116, 106 USPQ2d at 1978 and Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012)). The Supreme Court’s concern that drives this "exclusionary principle" is pre-emption. Alice Corp., 134 S. Ct. at 2354, 110 USPQ2d at 1980. The Court has held that a claim may not preempt abstract ideas, laws of nature, or natural phenomena; i.e., one may not patent every "substantial practical application" of an abstract idea, law of nature, or natural phenomenon, even if the judicial exception is narrow.
While preemption is the concern underlying the judicial exceptions, it is not a standalone test for determining eligibility. Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1052, 119 USPQ2d 1370, 1376 (Fed. Cir. 2016). Instead, questions of preemption are inherent in and resolved by the two-part framework from Alice Corp. and Mayo (the Alice/Mayo test referred to by the Office as Steps 2A and 2B). It is necessary to evaluate eligibility using the Alice/Mayo test, because while a preemptive claim may be ineligible, the absence of complete preemption does not demonstrate that a claim is eligible.
Products of Nature: When a law of nature or natural phenomenon is claimed as a physical product, the courts have often referred to the exception as a "product of nature". Products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena. See Myriad 133 S. Ct. at 2116-17, 106 USPQ2d at 1979 (claims to isolated DNA held ineligible because they "claim naturally occurring phenomena" and are "squarely within the law of nature exception"); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948) (claims to bacterial mixtures held ineligible as "manifestations of laws of nature" and "phenomena of nature"). Step 2A of the Office’s eligibility analysis uses the terms "law of nature" and "natural phenomenon" as inclusive of "products of nature".
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It is important to keep in mind that product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart. Instead, the key to the eligibility of all non-naturally occurring products is whether they possess markedly different characteristics from any naturally occurring counterpart.
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When a claim recites a nature-based product limitation, examiners use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A. Nature-based products, as used herein, include both eligible and ineligible products and merely refer to the types of products subject to the markedly different characteristics analysis used to identify product of nature exceptions.
The Markedly Different Characteristics Analysis
The markedly different characteristics analysis is part of Step 2A, because the courts use this analysis to identify product of nature exceptions. If the claim includes a nature-based product that has markedly different characteristics, then the claim does not recite a product of nature exception and is eligible. If the claim includes a nature-based product that does not exhibit markedly different characteristics from its closest naturally occurring counterpart in its natural state, then the claim is directed to a "product of nature" exception (Step 2A: YES), and requires further analysis in Step 2B to determine whether any additional elements in the claim add significantly more to the exception.
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Nature-based Product Claim Analysis
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Where the claim is to a nature-based product by itself, the markedly different characteristics analysis should be applied to the entire product.
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Where the claim is to a nature-based product produced by combining multiple components, the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts. Where the claim is to a nature-based product in combination with non-nature based elements, the markedly different characteristics analysis should be applied only to the nature-based product limitation. For a product-by-process claims, the analysis turns on whether the nature-based product in the claim has markedly different characteristics from its naturally occurring counterpart.
The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties, and are evaluated based on what is recited in the claim on a case-by-case basis. If the analysis indicates that a nature-based product limitation does not exhibit markedly different characteristics, then that limitation is a product of nature exception. If the analysis indicates that a nature-based product limitation does have markedly different characteristics, then that limitation is not a product of nature exception.
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Because the markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state, the first step in the analysis is to select the appropriate counterpart(s) to the nature-based product.
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When there are multiple counterparts to the nature-based product, the comparison should be made to the closest naturally occurring counterpart. When the nature-based product is a combination produced from multiple components, the closest counterpart may be the individual nature-based components of the combination. Because there is no counterpart mixture in nature, the closest counterparts to the claimed mixture are the individual components of the mixture, i.e., each naturally occurring species by itself. See, e.g., Funk Bros., 333 U.S. at 130, 76 USPQ at 281 (comparing claimed mixture of bacterial species to each species as it occurs in nature).
Markedly changed characteristics can include structural, functional, chemical changes. In order to show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart. Myriad, 133 S. Ct. at 2111, 106 USPQ2d at 1974-75. Thus, in order to be markedly different, applicant must have caused the claimed product to possess at least one characteristic that is different from that of the counterpart.
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If there is no change in any characteristic, the claimed product lacks markedly different characteristics, and is a product of nature exception.
The claims are drawn to a composition of matter for consumption by a human comprising: tobacco leaves; and
an oil comprising an isolated cannabinoid that has been isolated from cannabis plant material, wherein the oil is mixed with the tobacco leaves such that the isolated cannabinoid is present in an amount of between 0.1 to 20.0 weight percent of the tobacco leaves, wherein the isolated cannabinoid is selected from the group consisting of tetrahydrocannabinol, cannabidiol and mixtures thereof, wherein the composition of matter is in a form suitable for incorporation into smokeable cigarettes, cigars, chewing tobacco, and moist snuff; and wherein the composition of matter, when consumed, reduces at least one harmful effect associated with use of tobacco leaves lacking the isolated cannabinoid which is not markedly different from its closest naturally-occurring counterpart because there is no indication that their combination, amounts or preparation has caused the nature-based product to have any characteristics that are markedly different from the closest naturally-occurring product and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The rationale for this determination is explained below:
Step 1: Determine if the claims are directed to one of the four statutory categories of patentable subject matter identified by 35 U.S.C. 101: a process, machine, manufacture or composition of matter. YES, the claims are directed to a composition of matter (i.e., a composition of matter comprising tobacco leaves and an oil comprising an isolated cannabinoid that has been isolated from cannabis plant material), which is a statutory category within at least one of the four categories of patent eligible subject matter.
Step 2A: PRONG ONE: Evaluate whether the claim recites a Judicial Exception
(e.g., law of nature, natural phenomenon, or an abstract idea). YES, the claims are product claims reciting something that appears to be a nature-based product (i.e., a composition of matter comprising tobacco leaves and an oil comprising an isolated cannabinoid that has been isolated from cannabis plant material which is not markedly different from the closest naturally-occurring counterpart (i.e., the individual nature-based products).
Note: with respect to extracts of natural products such as tobacco leaves, oil and THC or CBD, the closest naturally-occurring counterpart is always the same compounds found in the extract, present in the non-isolated form in the source plant material. Extracts that are made simply by separating the extracted components from the non-extracted components, is a partitioning process that absent any specific chemical modification, merely separates the compounds leaving their activities unchanged (as is evidenced by the instantly claimed invention).
Ingredients recited in the claims are natural products that would occur naturally; thus, the claims involve the use of judicial exceptions. There is no indication in the record of any markedly different characteristics (either structural or functional) of the composition as broadly claimed. For example, there is no evidence of record of a structural difference between the extract(s) in the claimed composition and that of their nature-based counterparts. Consequently, the claimed compositions are structurally the same as their closest naturally- occurring counterparts.
Nor is there any difference in functional characteristics. To show a marked difference, the characteristic(s) must be changed as compared it closest natural-occurring counterpart. Furthermore, inherent or innate characteristics of the naturally occurring counterpart cannot show a marked difference. Likewise, differences in the characteristics that came about or were produced independently of any effort or influence by Applicant cannot show a marked difference.
The recitation of specific amounts of the ingredients does not affect this analysis because it is well known and routine in the art to mix specific amounts of active ingredients with additional ingredients. The same holds true for whether the composition is a cosmetic, pharmaceutical or food composition since there is nothing which imparts a markedly different characteristic on the composition. In this case, there is only a composition of matter comprising tobacco leaves, an oil containing an isolated cannabinoid and isolated THC or isolated CBD. Therefore, the claim is not meaningfully limited and does not amount to significantly more than each product of nature by itself. Finally, the claimed composition is like the novel bacterial mixture of Funk Brothers, which was held ineligible because each species of bacteria in the mixture continued to have “the same effect it always had”, i.e., it lacked markedly different characteristics. Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948), discussed in Myriad Genetics, 133 S. Ct. at 2117. While not discussed in the opinion, it is noted that several of the claims held ineligible in Funk Brothers recited specific amounts of the bacterial species in the mixture, e.g., claims 6, 7 and 13. Funk Brothers, 333 U.S. at 128 n.1.
Thus, there is no evidence of record to indicate that the claimed product is markedly different, structurally, chemically, functionally, then its closest naturally occurring counterpart.
PRONG TWO: Evaluate whether the judicial exception is integrated into a practical application. The claims are directed to a composition, not its practical use such as a particular treatment or prophylaxis for a disease or medical condition.
Thus, the cited claims are directed to a judicial exception to patentable subject matter.
Step 2b: Determine whether the claim directed to a judicial exception provides an inventive concept. For example, the claims may recite additional elements that amount to significantly more than the judicial exception. In the instant case, NO, the claims are directed to an extract composition without any other components that could add significantly more to the exception. No other specific limitations other than what is well-understood, routine and conventional in the field at a high level of generality have been added to the claimed nature-based product (e.g., addition of well-known ingredients).
Thus, the claimed composition is not eligible subject matter under current 35 USC 101 standards. See MPEP 2106.07.
Applicant argues that allegedly there is no naturally occurring counterpart. While this is noted, the standard is whether combining the three components (a composition of matter comprising tobacco leaves, an oil containing an isolated cannabinoid and isolated THC or isolated CBD) creates a markedly different characteristic which it does not. Applicant goes on to argue that allegedly the naturally occurring substances (applicant here is admitting they are naturally occurring) are physically joined together into a non-natural structure and the property of reduced harmful effects is markedly different from properties of the cannabinoid (THC or CBD), oil or the tobacco in nature. While this is noted, it is also noted that simply combining the components does not create a markedly different characteristic since the cannabinoid in an oil directly mixed with the tobacco leaves is just that, ingredients combined.
Applicant argues that allegedly the individual components are not naturally occurring substances. They state that isolated THC is for example, a hand of man.
Next, applicant argues that allegedly the claimed invention recites substances that are isolated and are physically joined together into a non-natural structure and the property of reduced harmful effects is markedly different from properties of either the cannabis material or the tobacco in nature.
While this is noted, this is not a markedly different characteristic since the claimed invention is basically tobacco leaves, isolated THC or CBD and in the form for use in reducing irritation associated with tobacco product use, providing anti-inflammatory relief or reducing inflammatory response associated with tobacco product use, providing pain relief, reducing carcinogenicity associated with tobacco product use, reducing mouth discomfort associated with tobacco product use, and a combination thereof.
Applicant argues that allegedly each of the individual components are not naturally occurring substances. For example, at least the claimed oil containing an isolated cannabinoid is not a naturally occurring substance, according to applicant. More specifically, an oil containing an isolated form of a cannabinoid, which is extracted and isolated from other cannabis plant material, as now more clearly claimed, does not exist in nature and rather requires human intervention, according to applicant. Furthermore, the claim language recited by amended independent claims 1 and 10 includes that the oil containing the isolated cannabinoid is mixed with the tobacco leaves such that the isolated cannabinoid is present in the composition of matter or tobacco product at between 0.1% to 20.0% by weight of the tobacco leaves, which does not exist in nature and/or without human intervention, according to applicant.
While this is noted, the test is if a markedly different characteristic was created or not, not whether the composition exists in nature.
Furthermore, the claimed invention recites substances that are isolated and are physically joined together into a non-natural structure and the property of reduced harmful effects is markedly different from properties of either the cannabis material or the tobacco in nature, according to applicant. That is, when the claim is analyzed as a whole, each claim is focused on the assembly of components that together form a product for which there is no naturally occurring counterpart, according to applicant. Unlike Myriad, the present claimed invention is not directed solely to an isolated naturally occurring product, according to applicant. See Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013). Rather, the claimed formulation includes a combination of tobacco leaves and an oil containing the isolated cannabinoid and mixed with the tobacco leaves such that the isolated cannabinoid is present in the composition of matter or tobacco product at between 0.1% to 20.0% by weight, according to applicant.
Once again, while this is noted there is no markedly different characteristic created by mixing tobacco leaves with an oil containing an isolated cannabinoid which is extracted and isolated from other cannabis plant material.
Applicant argues that allegedly the claims recite an “isolated cannabinoid” which is isolated from cannabis and then formulated with tobacco leaves in specific proportions.
While this is noted, it is not clear how adding tobacco leaves and the “isolated cannabinoid” creates a markedly different characteristic. In other words, there is NO markedly different characteristic.
Applicant argues that allegedly the markedly different characteristic is that the claimed combination has a reduced harmful effect associated with use of tobacco leaves (e.g. reduced irritations, anti-inflammatory, and reduced carcinogenicity).
No evidence of this has been provided on the record only statements by applicant.
Applicant further argues that this combination is not found in nature by so what? The test is when the components are put together is there in fact a markedly different characteristic created ?
Next applicant argues that allegedly the fact that the cannabinoids are isolated creates a markedly different characteristic which it does not. This is simply NOT true.
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 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 1-4, 8, 10-13, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/030369 (Knudsen) in view of Sumner et al.
WO teaches “e-cigarettes” that contain an oil with tobacco and THC and/or CBD, see abstract, pages 1, 10-12, 19, 21, 22, 24-26, 28, 34, 35, 37, 39, the claims. The “CBD extract” in WO is clearly an isolated cannabinoid since when extraction is performed the CBD is being isolated from the rest of the cannabis extract. Note that the composition containing an oil with tobacco and THC and/or CBD is placed in a device which is known as an “e-cigarette”. Note that tobacco, THC and/or CBD are all together along with an oil. As shown on page 43, 0.1 mg to 50 mg is used for both the CBD/THC and the tobacco, see specifically claim 14. Note that a 1:1 ratio of CBD/THC to tobacco can be used, see page 24. As shown in claim 39 of WO, THC and CBD are noted as being isolated from cannabis sativa. Note that “e-cigarettes” still read on “smokable cigarettes” because whether the cigarettes are smoked or vaped is the same thing since a “smoke” is produced. Note also that in claim 1 of the instant case, “to effectively reduce the harmful effects of tobacco use” is intended use language that carries no patentable weight since it does not further limit the composition in any way.
WO does NOT teach a THC:CBD ratio of 1:20. It teaches a ratio of 1:10, but clearly one having ordinary skill in the art at the time the invention was made would have been motivated to extend the ratio from THC/CBD of 1:10 to 1:20 since 1:1, 1:2, 1:3, 1:4, 1:5, 1:6, 1:7, 1:8; 1:9, and 1:10 are disclosed and contemplated by WO as very workable ranges and clearly one could simply continue the pattern out to a ratio of 1:20 in an effort to optimize the desired results.
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.
Thus, it clearly would have been obvious to one having ordinary skill in the art to use a ratio of THC/CBD of 1:20 instead of 1:10 in an effort to optimize the desired results. Clearly the ratio of THC/CBD is a results effective variable.
WO also does not teach that the tobacco is in leaf form and that they are cut, dried and cured.
Sumner teaches that drying and curing tobacco leaves actually develops and preserves the potential quality, flavor and aroma of the tobacco leaves. Curing is also noted as preserving the color of the tobacco leaves, see pages 1-4 of Sumner.
Thus, it would have been obvious to one having ordinary skill in the art at the time the invention was made to cut, dry and cure the tobacco leaves since Sumner teaches that drying and curing tobacco leaves actually develops and preserves the potential quality, flavor and aroma of the tobacco leaves. Curing is also noted as preserving the color of the tobacco leaves, see pages 1-4 of Sumner. Thus, clearly one of ordinary skill in the art at the time the invention was made would have been highly motivated to cut, dry and cure the tobacco leaves to yield such beneficial results as clearly taught in Sumner.
Applicant argues that allegedly WO fails to teach or suggest a composition of tobacco leaves (cut, dried and cured tobacco leaves) and an isolated cannabinoid in an oil that is directly mixed with the tobacco at between 0.1% to 20.0% by weight, let alone a tobacco product in the form of a smokeable cigarette, cigar, chewing tobacco or moist snuff. Applicant argues that WO teaches away from smokeable compositions stating, “although many compounds present in cannabis have beneficial effects, the normal intake of these compounds by smoking is highly harmful to the lungs, due to the smoking particles and the toxic gasses and the tar. The present invention solves this problem by delivering the ingredients without combustion. (p. 15, lines 9-14)”.
WO is stating right there on the record that it’s NOT combustible, but it’s still vaporized which can be seen as smoke, thus it’s still “smokeable”.
WO teaches formulations for passive inhalation for use in treating a number of diseases in the lungs and the brain, according to applicant. Modifying the compositions of WO by providing smokeable cigarettes, cigars, chewing tobacco or moist snuff would require changing the principle of operation of this reference, and/or render the compositions unsatisfactory for the treatment of lung and brain diseases according to applicant.
While this is noted, it is also noted that the vaporized composition in WO will still read on smokeable cigarettes because the vapor reads on smoke.
Next, applicant argues that allegedly Sumner does not cure the deficiency of WO to teach a smokeable cigarette, cigar, chewing tobacco or moist snuff composition of tobacco leaves and isolated cannabinoid, with the isolated cannabinoid being contained in an oil that is directly mixed with the tobacco leaves at between 0.1% to 20.0% by weight.
While this is noted, it is not agreed with for the above reasons.
It is also noted that “dried” in claim 10 makes no sense since if the tobacco is combined with the oil it is then NOT dried.
According to applicant, Knudsen does not teach or suggest a composition of matter comprising the combination of tobacco leaves and isolated cannabinoid that is contained in an oil directly mixed with the tobacco leaves at between 0.1% to 20.0% by weight of the tobacco. In contrast, Knudsen is directed to formulations for passive inhalation for use in treating a number of diseases number of diseases in the lungs and the brain, according to applicant. The only mention of tobacco is with respect to a terpene or other carrier which may be a tobacco extract or flavor, according to applicant. See, the Examples which remove the tobacco leaves using a cloth or the like, according to applicant. As such, Applicant submits that Knudsen is silent with respect to, and thereby does not teach or suggest, a composition comprising a combination of tobacco leaves and isolated cannabinoid and further does not teach or suggest that the isolated cannabinoid is contained in an oil directly mixed with the tobacco leaves at between 0.1% to 20.0% by weight of the tobacco leaves, according to applicant.
The Office Action cites to page 24 of Knudsen as allegedly corresponding to a 1:1 ratio of CBD/THC to tobacco, according to applicant. However, the claim language recites the isolated cannabinoid is contained in an oil directly mixed with the tobacco leaves at between 0.1% to 20.0% by weight of the tobacco leaves, and not a 1:1 ratio, according to applicant. Further, page 24 of Knudsen describes a ratio of extracts of CDB/THC/terpenes, with example terpenes being described as a tobacco extract, and a carrier such a peppermint oil, according to applicant. As such, the ratio described in Knudsen is not with respect to the isolated cannabinoid being mixed with tobacco leaves and as contained in a composition of matter as claimed, according to applicant. As noted above and in further support of Applicant’s position, Knudsen expressly teaches removing tobacco leaves from any composition of matter, according to applicant. Further, Knudsen does not teach or suggest that the composition of matter is configured to reduce the harmful effects of tobacco use and that the composition of matter is in a form suitable for incorporation into a tobacco product in the form of a smokeable cigarette, cigar, chewing tobacco or moist snuff, according to applicant. As noted above, Knudsen is directed to passive inhalation for use in treating a number of diseases number of diseases in the lungs and the brain and is silent with respect to reducing the harmful effects of tobacco use, according to applicant. Sumner is not cited for and does not cure the deficiencies of Knudsen, according to applicant. That is, Sumner does not teach or suggest a composition of matter comprising the combination of tobacco leaves and isolated cannabinoid that is contained in an oil directly mixed with the tobacco leaves at between 0.1% to 20.0% by weight of the tobacco, according to applicant. Further, Sumner does not teach or suggest that the composition of matter is configured to reduce the harmful effects of tobacco use and that the composition of matter is in a form suitable for incorporation into a tobacco product in the form of a smokeable cigarette, cigar, chewing tobacco or moist snuff, according to applicant. In contrast, Sumner is directed to a technique for drying and curing tobacco leaves, according to applicant.
Applicant clearly keeps arguing the same thing over and over which is that putting together the claimed product is not obvious but each component has been explained why it would have been included for the same purpose which does not have to be applicant’s purpose since these are product claims.
Applicant argues that allegedly Knudsen is directed to formulations for passive inhalation for use in treating a number of diseases in the lungs and the brain. Applicant states that the only mention of tobacco is with respect to a terpene or other carrier which may be a tobacco extract or flavor.
While this is noted, it is also noted that the claims are to a product and not to a method of using the product thus the arguments are moot.
In the very least if the tobacco leaves and the isolated cannabinoid were not in exactly the same exact composition in the reference (which is NOT being admitted) then it would have been obvious to one having ordinary skill in the art to combine them since as noted in the reference the components are known individually in the art for the same purpose.
Applicant has amended claim 1 to now read, “an isolated cannabinoid which is extracted and isolated from other cannabis plant material”. What is the “other cannabis plant material” that applicant is referring to ? It is simply NOT clear on the record what this (other cannabis plant material) actually means. Other than what ? A “cannabis plant material” is never anything other than itself. In fact, cannabis plant material is simply cannabis. Thus, the claim is confusing in its use of this term and therefore makes the claim broader since “isolated cannabinoid” could just read on any extracted cannabinoid from a simple water extraction of cannabis which is well known in the art. An oil and an isolated cannabinoid together read on a cannabis oil since a cannabis oil contains cannabinoids inherently since it comes from cannabis and the oil will extract a cannabinoid from the cannabis.
Applicant argues that allegedly WO does not teach or suggest a composition of matter or tobacco product comprising the combination of tobacco leaves and an oil containing an isolated cannabinoid, wherein the oil containing the isolated cannabinoid is mixed with the tobacco leaves such that the isolated cannabinoid is present at between 0.1% to 20.0% by weight of the tobacco. WO is directed to formulations for passive inhalation for use in treating a number of diseases in the lungs and the brain, according to applicant. The only mention of tobacco is with respect to a terpene or other carrier which may be a tobacco extract or flavor, according to applicant. See, the Examples which remove the tobacco leaves using a cloth or the like, according to applicant. As such, Applicant submits that WO does not teach or suggest a composition or tobacco product comprising a combination of tobacco leaves and an oil containing an isolated cannabinoid and further does not teach or suggest that the oil containing the isolated cannabinoid is mixed with the tobacco leaves such that the isolated cannabinoid is present in the composition of matter or tobacco product at between 0.1% to 20.0% by weight of the tobacco leaves.
This is NOT well taken. On pages 37-39 of WO it is made clear that the cannabinoid can be isolated from cannabis sativa and that the composition contains 0.1 mg to 50 mg which is clearly falls within the o,1 % to 20 % as claimed.
The Office Action cites to page 24 of WO as allegedly corresponding to a 1:1 ratio of CBD/THC to tobacco, according to applicant. However, the claim language recites the isolated cannabinoid being present at 0.1% to 20.0% by weight of the tobacco leaves, and not a 1:1 ratio, according to applicant. Further, page 24 of WO describes a ratio of extracts of CDB/THC/terpenes, with example terpenes being described as a tobacco extract, and a carrier such a peppermint oil, according to applicant. As such, the ratio described in WO is not with respect to the oil containing the isolated cannabinoid being mixed with tobacco leaves and the isolated cannabinoid being present in the composition of matter or tobacco product at between 0.1% to 20.0% by weight of the tobacco leaves as claimed, according to applicant.
As noted above, the amount of the “isolated cannabinoid” is so confusing since it is not clear if it is in reference to the amount of the composition of matter or the tobacco leaves.
WO expressly teaches removing tobacco leaves from any composition of matter or product, according to applicant. Further, WO does not teach or suggest that the composition of matter or tobacco product is configured to reduce the harmful effects of tobacco use and that the composition of matter is in a form suitable for incorporation into a tobacco product in the form of a smokeable cigarette, cigar, chewing tobacco or moist snuff, according to applicant. As noted above, WO is directed to passive inhalation for use in treating a number of diseases in the lungs and the brain and is silent with respect to reducing the harmful effects of tobacco use, according to applicant. In response to such previously presented arguments, page 15 of the Office Action submits that the reduced harmful effects is intended use and carries no patentable weight, according to applicant. However, Applicant respectfully submits that such language is a property of the composition of matter and the tobacco product, and that the claimed composition of matter and tobacco product are different than the composition and/or products of the cited references, and cannot be said to inherently provide the claimed property. M.P.E.P. § 2173.05(g) states that: “a functional limitation must be evaluated and considered, just like any other limitation of the claim, for what it fairly conveys to a person of ordinary skill in the pertinent art in the context in which it is used, according to applicant. A functional limitation is often used in association with an element, ingredient, or step of a process to define a particular capability or purpose that is served by the recited element, ingredient or step, according to applicant. Sumner is not cited for teaching and does not cure the deficiencies of Knudsen (WO), according to applicant. That is, Sumner does not teach or suggest a composition of matter or tobacco product comprising the combination of tobacco leaves and an oil containing an isolated cannabinoid that is mixed with the tobacco leaves such that the isolated cannabinoid is present in the composition of matter or tobacco product at between 0.1% to 20.0% by weight of the tobacco, according to applicant.
All of these arguments have been addressed above.
Further, Sumner does not teach or suggest that the composition of matter or tobacco product is configured to reduce the harmful effects of consumption of the composition of matter or tobacco product by a human as compared to tobacco use without the isolated cannabinoid and that the composition of matter or tobacco product is in a form suitable for incorporation into a tobacco product in the form of a smokeable cigarette, cigar, chewing tobacco or moist snuff, according to applicant. For the above reasons, this limitation is very confusing on its face and therefore carries no patentable weight. In contrast, Sumner is directed to a technique for drying and curing tobacco leaves, according to applicant. Applicant further submits that one of ordinary skill in the art would not be motivated to combine the alleged teaching of Knudsen with the alleged teaching of Sumner to arrive at the claimed invention. The Office Action’s alleged reason is rendered invalid because the proposed modification undermines: the principle of operation of the embodiment taught by the primary reference; and/or the stated purpose of the primary reference, according to applicant. M.P.E.P. § 2143.01 explains the long-standing principle that a § 103 rejection cannot be maintained when the asserted modification undermines the purpose of the primary reference or when an asserted combination would render the relied-upon embodiment of the primary reference inoperable, according to applicant. The primary purpose of WO is treatment of a number of diseases in the lungs and the brain using a passive inhaler to delivery various ingredients including cannabinoids, according to applicant. As acknowledged by page 20 of the Office Action, WO solves the problem of harm to lungs caused by smoking cannabinoids by delivering the ingredients without combustion via the use of a passive inhale, according to applicant. The Office Action is suggesting to modify the teachings of WO to form the claimed composition of matter in a form suitable for incorporation into smokeable cigarettes, cigars, chewing tobacco, and moist snuff, none of which include and/or appear to be suitable for a passive inhaler and at least the smokeable cigarettes and cigars including combustible forms, according to applicant. The proposed modification would thereby undermine the primary purposes of WO, according to applicant. Under M.P.E.P. § 2143.01, the rejections cannot be maintained, according to applicant.
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 argues that allegedly WO (Knudsen) does not teach an oil comprising an isolated cannabinoid…directly mixed with the tobacco leaves. This is clearly wrong since WO clearly teaches THC, CBD and tobacco extract (as a carrier) in an oil, see page 21.
It is noted on pages 21 and 28 that the inhaler device is capable of delivering the CBD as a vapor to the oral cavity or lungs when formulated with a carrier such as tobacco extract.
It is confusing to claim the amount of isolated cannabinoid in terms of its concentration in relation to the amount of tobacco leaves instead of it’s relation to the amount of the composition of matter.
On page 28 it is clearly shown that the amount of CBD extracts with carriers is 1-80 wt. % which means that the carrier (the tobacco extract) could easily be used from 1-wt. 20%, thus making the whole invention obvious.
Applicant argues that allegedly Sumner does not teach or suggest combining such traditionally cured tobacco with an isolated cannabinoid oil to produce the claimed composition comprising the isolated cannabinoid that is present at “0.1 wt. (%) to 20.0 wt. % relative to the weight of the tobacco leaves” for reducing harmful effects caused by tobacco alone (i.e., tobacco leaves lacking the isolated cannabinoid). According to applicant, Sumner is limited to standard curing processes and does not teach or suggest introducing an isolated cannabinoid oil at any time.
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).
This argument is of record and has already been addressed on the record.
It is noted that the claims now read on tobacco leaves, an oil and an isolated cannabinoid since the oil is NOT required to be CBD oil.
Please note that the “isolated cannabinoid” is clearly a results effective variable and thus as explained above it clearly would have been within the purview of the ordinary artisan to use the claimed amounts of 1-20% in an effort to optimize the desired results.
Applicant once again argues that Knudsen teaches or suggest tobacco leaves but as noted already on the record, this is why the rejection is a 35 USC 103 rejection and not a 35 USC 102 rejection.
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 next argues that the limitation of “wherein the oil is mixed with the tobacco leaves such that the isolated cannabinoid is present in an amount of between 0.1 to 20.0 wt% weight percent of the tobacco leaves” is allegedly not met. This has been addressed already on the record. It is also noted that while this limitation is in the claims it is still unclear how much oil and tobacco leaves are in the overall composition of matter. While it is noted that applicant is defining the invention in terms only of how much cannabinoid is in the leaves it is meaningless since one has no reference point since the amount of oil and leaves in the overall composition is not anywhere in the claims. In fact, none of the claims on the record ever quantify the amount of oil and leaves in the composition of matter.
Applicant continues to argue about the vaporizer portion of Knudsen but as already noted on the record, this is a combination rejection and the motivation to use the composition of Knudsen in a form as claimed has already been addressed on the record. It is noted that “e cigarettes” still read on smokable cigarettes as already noted on the record.
Claims 1-4, 8, 10-13, 17, 21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Goode, Jr. (US 2016/0165953) in view of Sumner et al.
Goode teaches snuff that contains an oil (spearmint oil, paragraph 42) with decarbolized THC (isolated THC) and tobacco, see abstract, paragraphs 3-5, 14, 36, 41, 42, 45, and the claims. The “decarbolized THC” in Goode is clearly an isolated cannabinoid since when the decarbolized reaction is performed the THC is being isolated from the rest of the cannabis extract. Note that the composition containing an oil with THC and tobacco can be placed in a pouch containing the snuff composition. Note that the dry weight of the “filling” (which the tobacco and the THC are a part of) can be used at 50 mg to 500 mg. Note also that in claim 1 of the instant case, “to effectively reduce the harmful effects of tobacco use” is intended use language that carries no patentable weight since it does not further limit the composition in any way.
Goode does not teach CBD or the use of the THC and the CBD at a ratio of 1:20, 1:20 to 20:1 or 1:1, THC:CBD, respectively.
To use CBD with THC is simply the choice of the artisan in an effort to optimize the desired results. CBD is a well known component of cannabis as THC is and is well known in the prior art to have beneficial effects to humans. Clearly one having ordinary skill in the art at the time the invention was made would have been motivated to use a ratio of THC/CBD of 1:10 to 1:20 since these are clearly result effective variables which can be used at different amounts in an effort to optimize the desired results.
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.
Thus, it clearly would have been obvious to one having ordinary skill in the art to use a ratio of THC/CBD of 1:20 to 1:10 in an effort to optimize the desired results. Clearly the ratio of THC/CBD is a result effective variable.
Goode also does not teach that the tobacco is in leaf form and that the tobacco is cut, dried and cured.
Sumner teaches that drying and curing tobacco leaves actually develops and preserves the potential quality, flavor and aroma of the tobacco leaves. Curing is also noted as preserving the color of the tobacco leaves, see pages 1-4 of Sumner.
Thus, it would have been obvious to one having ordinary skill in the art at the time the invention was made to cut, dry and cure the tobacco leaves since Sumner teaches that drying and curing tobacco leaves actually develops and preserves the potential quality, flavor and aroma of the tobacco leaves. Curing is also noted as preserving the color of the tobacco leaves, see pages 1-4 of Sumner. Thus, clearly one of ordinary skill in the art at the time the invention was made would have been highly motivated to cut, dry and cure the tobacco leaves to yield such beneficial results as clearly taught in Sumner. Note that tobacco is commonly made with tobacco leaves and to use tobacco leaves is clearly well within the purview of the ordinary artisan.
It is also noted that “dried” in claim 10 makes no sense since if the tobacco is combined with the oil it is then NOT dried.
Applicant argues that Goode, Jr does not teach or suggest a composition of matter comprising the combination of tobacco leaves and isolated cannabinoid that is contained in an oil directly mixed with the tobacco leaves at between 0.1% to 20.0% by weight of the tobacco. In contrast, Goode, Jr is directed to an oral pouch product having plant material inside an enclosure. While the cited portions of Goode, Jr describe that the plant material can include combinations of various materials including tobacco and marijuana, and stimulants can be added to the fiber threads, there is no teaching or suggestion of combining tobacco leaves with an isolated cannabinoid, let alone that the isolated cannabinoid that is contained in an oil directly mixed with the tobacco leaves at between 0.1% to 20.0% by weight of the tobacco, as claimed. As such, Applicant submits that Goode, Jr is silent with respect to, and thereby does not teach or suggest, a composition comprising a combination of tobacco leaves and isolated cannabinoid and further does not teach that the isolated cannabinoid is contained in an oil directly mixed with the tobacco leaves at between 0.1% to 20.0% by weight of the tobacco leaves. Further, Goode, Jr does not teach or suggest that the composition of matter is configured to reduce the harmful effects of tobacco use and that the composition of matter is in a form suitable for incorporation into a tobacco product in the form of a smokeable cigarette, cigar, chewing tobacco or moist snuff. ” Sumner is not cited for and does not cure the deficiencies of Goode, Jr. That 1s, Sumner does not teach or suggest a composition of matter comprising the combination of tobacco leaves and isolated cannabinoid that is contained in an oil directly mixed with the tobacco leaves at between 0.1% to 20.0% by weight of the tobacco. Further, Sumner does not teach or suggest that the composition of matter is configured to reduce the harmful effects of tobacco use and that the composition of matter is in a form suitable for incorporation into a tobacco product in the form of a smokeable cigarette, cigar, chewing tobacco or moist snuff. In contrast, Sumner is directed to a technique for drying and curing tobacco leaves.
While this is noted, it is also noted that the claims are to a product and not to a method of using the product thus the arguments are moot.
In the very least if the tobacco leaves and the isolated cannabinoid were not in exactly the same exact composition in the reference (which is NOT being admitted) then it would have been obvious to one having ordinary skill in the art to combine them since as noted in the reference the components are known individually in the art for the same purpose.
Applicant has amended claim 1 to now read, “an isolated cannabinoid which is extracted and isolated from other cannabis material”. What is the “other cannabis material” that applicant is referring to ? It is simply NOT clear on the record what this (other cannabis material) actually means. Other than what ? A “cannabis material” is never anything other than itself. In fact, cannabis material is simply cannabis. Thus, the claim is confusing in its use of this term and therefore makes the claim broader since “isolated cannabinoid” could just read on any extracted cannabinoid from a simple water extraction of cannabis which is well known in the art. An oil and an isolated cannabinoid together read on a cannabis oil since a cannabis oil contains cannabinoids inherently since it comes from cannabis and the oil will extract a cannabinoid from the cannabis.
Applicant argues that Goode, Jr does not teach or suggest a composition of matter comprising the combination of tobacco leaves and isolated cannabinoid that is contained in an oil directly mixed with the tobacco leaves at between 0.1% to 20.0% by weight of the tobacco. In contrast, Goode, Jr is directed to an oral pouch product having plant material inside an enclosure according to applicant. While the cited portions of Goode, Jr describe that the plant material can include combinations of various materials including tobacco and marijuana, and stimulants can be added to the fiber threads, there is no teaching or suggestion of combining tobacco leaves with an isolated cannabinoid, let alone that the isolated cannabinoid that is contained in an oil directly mixed with the tobacco leaves at between 0.1% to 20.0% by weight of the tobacco, as claimed according to applicant. As such, Applicant submits that Goode, Jr is silent with respect to, and thereby does not teach or suggest, a composition comprising a combination of tobacco leaves and isolated cannabinoid and further does not teach that the isolated cannabinoid is contained in an oil directly mixed with the tobacco leaves at between 0.1% to 20.0% by weight of the tobacco leaves. Further, Goode, Jr does not teach or suggest that the composition of matter is configured to reduce the harmful effects of tobacco use and that the composition of matter is in a form suitable for incorporation into a tobacco product in the form of a smokeable cigarette, cigar, chewing tobacco or moist snuff, according to applicant.
The form in Goode is clearly configured to reduce the harmful effects of tobacco use and that the composition of matter is in a form suitable for incorporation into a tobacco product in the form of a smokeable cigarette, cigar, chewing tobacco or moist snuff.
As noted, Goode clearly teaches the claimed invention and an oil which can be cannabis or spearmint as taught in Goode.
THC (isolated cannabinoid) and tobacco are clearly taught together in Goode, see paragraph 14. When the oils of paragraph 36 are added in, clearly the finally product claimed will be yielded. The claimed invention is a composition as it is claimed itself and not to the method of making it thus as long as the final product has an oil, isolated cannabinoid and a tobacco leaf it, it reads on the claimed invention.
Applicant argues that allegedly Goode, Jr does not teach or suggest a composition of matter or tobacco product comprising the combination of tobacco leaves and an oil containing an isolated cannabinoid mixed with the tobacco leaves such that the isolated cannabinoid is present at between 0.1% to 20.0% by weight of the tobacco, according to applicant. In contrast, Goode, Jr is directed to an oral pouch product having plant material inside an enclosure, according to applicant. While the cited portions of Goode, Jr describe that the plant material can include combinations of various materials including tobacco and marijuana (cannabis), and stimulants can be added to the fiber threads, there is no teaching or suggestion of combination of tobacco leaves with an oil containing an isolated cannabinoid, let alone that the oil containing the isolated cannabinoid being mixed with the tobacco leaves such that the isolated cannabinoid is present at between 0.1% to 20.0% by weight of the tobacco, as claimed, according to applicant. Further, Goode, Jr does not teach or suggest that the composition of matter or tobacco product is configured to reduce the harmful effects of tobacco use and that the composition of matter or tobacco product is in a form suitable for incorporation into a tobacco product in the form of a smokeable cigarette, cigar, chewing tobacco or moist snuff, according to applicant. For at least the reasons provided above, Applicant respectfully submits that such language is a property of the composition of matter and tobacco product, and that the claimed composition of matter and tobacco product are different than the composition and/or products of the cited references, and cannot be said to inherently provide the claimed property, according to applicant.
While this is noted, it is also noted that Goode teaches snuff that contains an oil (spearmint oil, paragraph 42) with THC and tobacco, see abstract, paragraphs 3-5, 14, 36, 41, 42, 45, and the claims. Note that the composition containing an oil with THC and tobacco can be placed in a pouch containing the snuff composition. Note that the dry weight of the “filling” (which the tobacco and the THC are a part of) can be used at 50 mg to 500 mg. Note also that in claim 1 of the instant case, “to effectively reduce the harmful effects of tobacco use” is intended use language that carries no patentable weight since it does not further limit the composition in any way.
Sumner is not cited for teaching and does not cure the deficiencies of Goode, Jr., according to applicant. That is, Sumner does not teach or suggest a composition of matter or tobacco product comprising the combination of tobacco leaves and an oil containing an isolated cannabinoid that is mixed with the tobacco leaves such that the isolated cannabinoid is present at between 0.1% to 20.0% by weight of the tobacco, according to applicant. Further, Sumner does not teach or suggest that the composition of matter or tobacco product is configured to reduce the harmful effects of consumption of the composition of matter or tobacco product by a human as compared to tobacco use without the isolated cannabinoid and that the composition of matter or tobacco product is in a form suitable for incorporation into a tobacco product in the form of a smokeable cigarette, cigar, chewing tobacco or moist snuff, according to applicant. In contrast, Sumner is directed to a technique for drying and curing tobacco leaves, according to applicant.
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 argues that allegedly Goode, Jr. does not teach an oil comprising an isolated cannabinoid…directly mixed with the tobacco leaves. This is clearly wrong since Goode clearly teaches tobacco (obvious to get from leaves since the leaves are most commonly used), marijuana, decarbolyzed THC in an oil, see abstract, the claims, paragraphs 14,36, 41, etc. Clearly it is taught to use the claimed amounts.
It is confusing to claim the amount of isolated cannabinoid in terms of its concentration in relation to the amount of tobacco leaves instead of its relation to the amount of the entire composition of matter.
In paragraph 36 it is clearly shown that the amount of decarboyzed THC and tobacco and oils is 0.1-10 % by weight.
Applicant argues that allegedly Sumner does not teach or suggest combining such traditionally cured tobacco with an isolated cannabinoid oil to produce the claimed composition comprising the isolated cannabinoid that is present at “0.1 wt. (%) to 20.0 wt. % relative to the weight of the tobacco leaves” for reducing harmful effects caused by tobacco alone (i.e., tobacco leaves lacking the isolated cannabinoid). According to applicant, Sumner is limited to standard curing processes and does not teach or suggest introducing an isolated cannabinoid oil at any time.
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).
This argument is of record and has already been addressed on the record.
It is noted that the claims now read on tobacco leaves, an oil and an isolated cannabinoid since the oil is NOT required to be CBD oil.
Please note that the “isolated cannabinoid” is clearly a results effective variable and thus as explained above it clearly would have been within the purview of the ordinary artisan to use the claimed amounts of 1-20% in an effort to optimize the desired results.
Applicant argues that allegedly the claimed concentrations of isolated THC and CBD are not taught by the references but this has already been addressed on the record.
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 next argues that the limitation of “wherein the oil is mixed with the tobacco leaves such that the isolated cannabinoid is present in an amount of between 0.1 to 20.0 wt% weight percent of the tobacco leaves” is allegedly not met. This has been addressed already on the record. It is also noted that while this limitation is in the claims it is still unclear how much oil and tobacco leaves are in the overall composition of matter. While it is noted that applicant is defining the invention in terms only of how much cannabinoid is in the leaves it is meaningless since one has no reference point since the amount of oil and leaves in the overall composition is not anywhere in the claims. In fact, none of the claims on the record ever quantify the amount of oil and leaves in the composition of matter.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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