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 of Claims 1, 2, 4-7, 15-18, 20, 22-28, 39 in the reply filed on 12/13/2023 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Therefore, claims 8-14, 19, 21, 29-38 (as noted by Applicant in their recent claim set) are withdrawn from further consideration as being drawn to a non-elected invention.
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, 2, 5-7, 15-18, 20, and 22, 24, 26-28 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 cell culture comprising:
a) a liquid based plant cell culture medium; and
b) friable Cannabis callus cells derived from Cannabis leaves. 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 cell culture comprising:
a) a liquid based plant cell culture medium; and
b) friable Cannabis callus cells derived from Cannabis leaves;
wherein the cell culture is grown under a constant exposure of PAR at a rate of about 0.5 moles of photons per day; and exposure to UVB and UVA at an intensity of approximately 500 lumens; such that the concentration of cannabinoids ranges from 0.01% (g/mL) to about 5% (g/mL), or
wherein, the cell culture is grown under a constant exposure of PAR at a rate of about 0.5 moles of photons per day; and alternating 1 hr exposure to UVA and UVB at an intensity greater than or equal to 1200 lumens but less than 2000 lumens, followed by 1 hr of no exposure to UVA and UVB; such that the concentration of cannabinoids ranges from about 20% (g/mL) to about 50% (g/mL) 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 cell culture comprising:
a) a liquid based plant cell culture medium; and
b) friable Cannabis callus cells derived from Cannabis leaves), 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 cell culture comprising:
a) a liquid based plant cell culture medium; and
b) friable Cannabis callus cells derived from Cannabis leaves) 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 cannabis callus cells, 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 “friable cannabis callus cells”. 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 friable cannabis callus cells 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 controlled content of cannabinoids in the cannabis callus cells found in nature. Applicant argues that their cannabis callus cells contain a controlled content of cannabinoids of 5%-60 %. While this is noted, it is also noted that there is no art recognized term for “controlled”. What exactly does that mean ? Further, it is not clear if the “controlled” amount of cannabinoids is in the cannabis callus cells or the cell culture overall. The specification indicates that the “tissue culture” contains the “controlled” cannabinoids, but applicant claims the “controlled” amount in terms of cannabis callus cells. Thus, it is not clear on the record what the “controlled” content of cannabinoids is in relation to and thus has no art recognized meaning. Further, Hemphill does NOT ever state that the callus cells grown by the methods provided in Hemphill do not produce any detectable cannabinoids. In fact, Hemphill clearly indicates that cannabis strains have a HIGH concentration of THC in the flower parts of drug 152, see page 455. Thus, there is no markedly different characteristic.
Applicant now argues that allegedly according to the newly submitted Whitton Declaration filed 4/19/2024, “a natural callus occurs when a plant is injured and is a swelling formed by the immune response of the plant. This type of callus is heavily lignified. The friable callus cells of the instant application do not exist in nature and have to be induced in tissue culture settings or mimicked by artificial manipulation of gene expression. These calluses do not contain lignin and do not have the ability to fight infections.”
While this is noted, there is no support in the specification for such a statement of the callus not being heavily lignified nor is the friable callus in the claims stated as “not lignified”.
Applicant next argues that allegedly the THC levels are higher in their samples then that of a donor plant. Dr. Whitton’s declaration asserts than his THC levels are higher than the donor plant but it is also noted that the claims, claim a wide range of 0.01 % to 5% and 5% to 50 % of cannabinoids (which is not specific to THC). In other words, the amounts claimed of cannabinoids still reads on that of Hemphill for example, thus there is no markedly different characteristic.
As explained in the declaration of Dr. Peter Andrew Whitton dated April 19, 2024 (the “Whitton Declaration”, of record), “A natural callus occurs when a plant is injured and is a swelling formed by the immune response of the plant, according to applicant. This type of callus is heavily lignified, according to applicant. The friable callus cells of the instant application do not exist in nature and have to be induced in tissue culture settings or mimicked by artificial manipulation of gene expression, according to applicant. These calluses do not contain lignin and do not have the ability to fight infections”, according to applicant. As stated above, independent claims 1 and 27 are further amended to highlight this difference by reciting friable Cannabis callus cells derived from Cannabis leaves, according to applicant. In the Declaration, Dr. Whitton further points out that the current application is directed to enhancing the potential of naturally occurring cells to produce higher amounts of cannabinoids, over what is seen in nature, according to applicant. Providing supporting data in Table 1 of the Declaration (also reproduced here) he shows that his team, after extensive experimentation,” has successfully been able to produce levels of THC higher that those seen in the donor plant, according to applicant. As indicated by Dr. Whitton “our production team is able to obtain consistently higher amounts of THC using the disclosed light regime 2 than the donor plant cells, according to applicant. The THC levels were between 1.3-2.1 fold higher than the donor, according to applicant. Dr. Whitton further opines that “this is because the cultures only contain the THC producing cells and we have no lignin or cellulosic tissue that adds mass but not active ingredient”, according to applicant. This is in clear distinction from naturally occurring callus cells which do contain lignin or cellulosic tissue, according to applicant. As stated above, independent claims 1 and 27 are further amended to highlight this difference by reciting the concentration of cannabinoids ranges from about 20% (g/mL) to about 50% (g/mL), according to applicant. Thus, the friable callus cells of the instant application are structurally and functionally distinct from naturally occurring callus cells, according to applicant.
Applicant submits that the arguments and data put forth by Dr. Whitton, further in light of the amendments to claim 1 and 27, clearly distinguish the callus cells of the instant application form naturally occurring callus cells, according to applicant.
While all of this is noted, it is also noted that the combination of a liquid based plant cell culture medium; and
b) friable Cannabis callus cells derived from Cannabis leaves does NOT create a markedly different characteristic. The addition of the liquid based plant cell culture medium to the friable Cannabis callus cells derived from Cannabis leaves DO NOT change the friable Cannabis callus cells derived from Cannabis leaves and thus create a markedly different characteristic. The analysis is not whether the product is found in nature, but whether a markedly different characteristic has been created which is clearly NOT present.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 2, 5-7, 15-18, 20, and 22, 24, 26-28 are rejected under 35 U.S.C. 102 (a) (1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Hemphill et al.
Hemphill teaches a composition comprising cannabis callus cells cultured in a liquid based plant cell culture medium which appears to be identical to (and thus anticipate) the presently claimed liquid based plant cell culture medium; and
b) friable Cannabis callus cells derived from Cannabis leaves;
wherein the cell culture is grown under a constant exposure of PAR at a rate of about 0.5 moles of photons per day; and exposure to UVB and UVA at an intensity of approximately 500 lumens; such that the concentration of cannabinoids ranges from 0.01% (g/mL) to about 5% (g/mL), or
wherein, the cell culture is grown under a constant exposure of PAR at a rate of about 0.5 moles of photons per day; and alternating 1 hr exposure to UVA and UVB at an intensity intensity greater than or equal to 1200 lumens but less than 2000 lumens, followed by 1 hr of no exposure to UVA and UVB; such that the concentration of cannabinoids ranges from about 20% (g/mL) to about 50% (g/ml).
Consequently, the instantly claimed composition appears to be anticipated by the cited reference.
In the alternative, even if the claimed composition is not identical to the referenced extract composition with regard to some unidentified characteristics, the differences between that which is disclosed and that which is claimed are considered to be so slight that the referenced extract composition is likely to inherently possess the same characteristics of the claimed composition. Thus, the claimed composition would have been obvious to those of ordinary skill in the art within the meaning of USC 103. Further, if not anticipated, the result-effective adjustment of particular conventional working conditions (e.g., conventional temperatures, agitation of the composition, separation of phase, etc.) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the ordinary artisan.
Accordingly, the claimed invention as a whole was at least prima facie obvious, if not anticipated by the reference, especially in the absence of sufficient, clear, and convincing evidence to the contrary.
Please note that the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether the claimed extract differs and, if so, to what extent, from extract disclosed by the cited reference. Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the Applicants.
Please also note that “the patentability of a product does not depend upon its method of production. If the product in [a] product-by-process claim is the same as or obvious from a product of the prior art, [then] the claim is unpatentable even though the prior [art] product was made by a different process.” In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 218 USPQ 289, 292 (Fed. Cir. 1983).
The amount of time, intensity of the light, density of the cells, etc, are inherent since, they are parameters which (unless shown otherwise) have no effect on the final product since the claims are to the product and NOT to the method of use. The same conditions as claimed are used in Hemphill in absence of evidence to the contrary.
Applicant argues that allegedly there is no controlled content of cannabinoids in the cannabis callus cells. Applicant argues that their cannabis callus cells contain a controlled content of cannabinoids of 5%-60 %. While this is noted, it is also noted that there is no art recognized term for “controlled”. What exactly does that mean ? Further, it is not clear if the “controlled” amount of cannabinoids is in the cannabis callus cells or the cell culture overall. The specification indicates that the “tissue culture” contains the “controlled” cannabinoids, but applicant claims the “controlled” amount in terms of cannabis callus cells. Thus, it is not clear on the record what the “controlled” content of cannabinoids is in relation to and thus has no art recognized meaning. Further, Hemphill does NOT ever state that the callus cells grown by the methods provided in Hemphill do not produce any detectable cannabinoids. In fact, Hemphill clearly indicates that cannabis strains have a HIGH concentration of THC in the flower parts of drug 152, see page 455.
Applicant argues that allegedly Hemphill does not produce any major cannabinoids but as clearly stated above, Hemphill CLEARLY indicates that cannabis strains have a HIGH concentration of THC in the flower parts of drug 152, see page 455. Thus, this argument is moot.
The instant claims are product by process claims and are NOT method of producing the product claims. As long as the same product as claimed is yielded by Hemphill (which it is), then how it is made does not matter as long as the same product as claimed in the claims is taught in Hemphill (which it does).
Thus, the amended claims clearly indicate that the disclosed callus cells produce Cannabinoids, according to applicant. This is unlike the callus cells of Hemphill that fail to produce any major cannabinoids, according to applicant. Applicant reiterates remarks regarding Hemphill previously presented in Applicant’s Amendment in Response to Final Office Action submitted April 19, 2024, especially that the callus cells grown by the methods provided in Hemphill do not produce any detectable major Cannabinoids°, according to applicant. In his declaration, Dr. Whitton specifically points to the abstract, and paragraphs 4 and 5 on page 458, where Hemphill states: “Under these experimental conditions, no major cannabinoids were detected in callus extracts, although numerous unknown metabolites were present, according to applicant. Therefore, the callus cells of Hemphill are clearly distinguishable from the cells recited in the claims of the instant application, in that they actually produce major cannabinoids, according to applicant. A reference must disclose within the four corners of the document all of the limitations claimed but also all of the limitations arranged or combined in the same way as recited in the claim, or else it cannot anticipate under 35 U.S.C. §102, according to applicant. Applicant submits that Hemphill fails to disclose all of the limitations of Applicant’s claims, according to applicant.
While this is noted, it is also noted that clearly Hemphill does in fact teach that the “high concentration of delta 9 THC was found in the flower parts of drug 152 and the vegetative leaves of the Mexican strain”, thus the leaves themselves do in fact contain cannabinoids.
Claim Rejections - 35 USC § 103
Claims 1, 2, 5-7, 15-18, 20, and 22, 24, 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Hemphill et al.
Claim 1 is drawn to a cell culture comprising:
a) a liquid based plant cell culture medium; and
b) friable Cannabis callus cells derived from Cannabis leaves;
wherein the cell culture is grown under a constant exposure of PAR at a rate of about 0.5 moles of photons per day; and exposure to UVB and UVA at an intensity of approximately 500 lumens; such that the concentration of cannabinoids ranges from 0.01% (g/mL) to about 5% (g/mL), or
wherein, the cell culture is grown under a constant exposure of PAR at a rate of about 0.5 moles of photons per day; and alternating 1 hr exposure to UVA and UVB at an intensity greater than or equal to 1200 lumens but less than 2000 lumens, followed by 1 hr of no exposure to UVA and UVB; such that the concentration of cannabinoids ranges from about 20% (g/mL) to about 50% (g/mL).
Hemphill teaches that cannabis callus cells are cultured as claimed and exposed to light as claimed, see pages 453, 454, and 458.
Since the claims are drawn to a product by process, it is also noted that as long as the product is met by the reference, then the final product composition as claimed will be made obvious by the reference. In this case, it is submitted that the final product as claimed is taught in Hemphill at the indicated pages.
In the event it is seen that the cannabis cell suspension culture of Hemphill would not have all of the characteristics as claimed (which is NOT being admitted) then it would have been obvious for one having ordinary skill in the art to use the steps as claimed in the claims to produce the claimed composition since each of these steps is merely growing a culture of cells tissue culture of cannabis in a liquid media, while controlling the amount of light (which reads on less or more or darkness), collecting and drying the cells after growing them in a cell suspension culture to form the claimed phytocannabinoid containing dried cell composition which clearly Hemphill teaches in the noted areas of the reference.
C. Changes in Sequence of Adding Ingredients
Ex parte Rubin , 128 USPQ 440 (Bd. App. 1959) (Prior art reference disclosing a
process of making a laminated sheet wherein a base sheet is first coated with a metallic film and thereafter impregnated with a thermosetting material was held to render prima facie obvious claims directed to a process of making a laminated sheet by reversing the order of the prior art process steps.). See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.).
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, the claimed composition is in the very least obvious to one having ordinary skill in the art since the claims are to the product and as long as the final product as claimed is also taught by the reference (Hemphill) then clearly the claimed invention is taught by Hemphill.
Note that in claims 16 and 17, that these are types of measurements which are so broad they read on many different possibilities which through routine experimentation one of ordinary skill in the art could easily reproduce and be motivated to do so. For example, claim 16 states, “wherein the cell suspension culture comprises a volume ranging from about 1 mL to about 60 mLs, from about 40 mL to about 100 mLs, or from about 90 mLs to about 3 Ls or more”. It is noted, that the amounts go from broad to extremely broad such as 90 milliters to 3 liters, which reads on 90 milliters to 3,000 milliters ! That is on its face, extremely broad.
As for claim 17, on its face once again, makes NO sense. In claim 16, the above amounts are stated. In claim 17, it recites, “wherein the cell suspension culture comprises a volume ranging from about 100 Ls to about 5000 Ls or more”. So in claim 16, we went from a high of 3 liters for the volume of the cell suspension culture to in claim 17, 100 liters to about 5000 liters or more for the volume of the cell suspension culture. How can applicant define the volume of the cell suspension culture in such opposing ways ?
The amount of time, intensity of the light, density of the cells, etc, are inherent since, they are parameters which (unless shown otherwise) have no effect on the final product since the claims are to the product and NOT to the method of use. The same conditions as claimed are used in Hemphill in absence of evidence to the contrary.
Applicant argues that allegedly there is no controlled content of cannabinoids in the cannabis callus cells. Applicant argues that their cannabis callus cells contain a controlled content of cannabinoids of 5%-60 %. While this is noted, it is also noted that there is no art recognized term for “controlled”. What exactly does that mean ? Further, it is not clear if the “controlled” amount of cannabinoids is in the cannabis callus cells or the cell culture overall. The specification indicates that the “tissue culture” contains the “controlled” cannabinoids, but applicant claims the “controlled” amount in terms of cannabis callus cells. Thus, it is not clear on the record what the “controlled” content of cannabinoids is in relation to and thus has no art recognized meaning. Further, Hemphill does NOT ever state that the callus cells grown by the methods provided in Hemphill do not produce any detectable cannabinoids. In fact, Hemphill clearly indicates that cannabis strains have a HIGH concentration of THC in the flower parts of drug 152, see page 455.
Clearly in this case, the cannabinoids are a result effective variable and to use routine optimization to maximize the yield of the cannabinoids is clearly obvious in an effort to optimize the desired results.
Applicant argues that allegedly Hemphill does not produce any major cannabinoids but as clearly stated above, Hemphill CLEARLY indicates that cannabis strains have a HIGH concentration of THC in the flower parts of drug 152, see page 455. Thus, this argument is moot.
While Dr. Whitton may state that in his opinion one could not have predicted that exposing cannabis callus to the light regimens provided in the instant application would have resulted in production of cannabinoids, it is very clear from Hemphill that a HIGH concentration of THC in the flower parts of drug 152 was indeed produced. Thus, cannabinoids were produced in Hemphill.
Cannabinoid profiles of bracts, anther-calyx complexes, and leaves of Cannabis strains is c Cannabinoid profiles of bracts, anther-calyx complexes, and leaves of Cannabis strains are completely different to the cannabinoid profile of the friable Cannabis callus cells derived from Cannabis leaves grown in cell culture as presently claimed, according to applicant. Additionally, there is no teaching or suggestion from Hemphill that provides the requisite motivation to lead one skilled in the art to arrive at the claimed cell culture comprising friable Cannabis callus cells derived from Cannabis leaves wherein growth conditions have been modified to maximize or minimize the concentration of cannabinoids within the friable Cannabis callus cells, much less the specific growth conditions comprising 1) a constant exposure of PAR at arate of about 0.5 moles of photons per day; and exposure to UVB and UVA at an intensity of approximately 500 lumens, or 2) a constant exposure of PAR at a rate of about 0.5 moles of photons per day; and alternating 1 hr exposure to UVA and UVB at an intensity greater than or equal to 1200 lumens but less than 2000 lumens, followed by 1 hr of no exposure to UVA and UVB as presently claimed, according to applicant. As stated by Dr. Whitton in the Whitton Declaration, “The use of light in cannabis tissue culture to control production was not guaranteed to work and was counter to conventional wisdom in the field [...].” The method taught by Hemphill states, “A set of cultures was maintained under a light cycle (12 hr at 7001 x - 12 hr dark) and another set under dark conditions, according to applicant. The callus growth yields were greater when grown in the dark than under light conditions, according to applicant.
Thus, Hemphill teaches against the use of light for production of callus by suggesting using dark conditions for callus growth, according to applicant.
While all of this is noted, high THC levels were indeed reported by Hemphill, see page 455. It is important to note that there is NO requirement in the claims for delta 9 THC levels.
The instant claims are product by process claims and are NOT method of producing the product claims. As long as the same product as claimed is yielded by Hemphill (which it is), then how it is made does not matter as long as the same product as claimed in the claims is taught in Hemphill (which it does).
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 2, 5-7, 15-18, 20, and 22, 24, 26-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. 11,477,953.
The method of obtaining the claimed composition of US 11,477,953 will yield the claimed composition since that is how it is claimed to produce the composition of claims of the instant claims.
Claims 1, 2, 5-7, 15-18, 20, and 22, 24, 26-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,477,791.
The method of obtaining the claimed composition of US 10,477,791 will yield the claimed composition since that is how it is claimed to produce the composition of claims of the instant claims.
Claims 1, 2, 5-7, 15-18, 20, and 22, 24, 26-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-44 of copending Application No. 16/806,955. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim liquid based medium to form a cell suspension culture comprising cultured Cannabis callus cells.
Claims 1, 2, 5-7, 15-18, 20, and 22, 24, 26-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 18/061,328. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim a cell suspension culture of Cannabis cells.
.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant has not filed the needed terminal disclaimers nor have they argued the rejections.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 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
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