Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1-3 and 5-12 are pending and examined. Claims 4 and 13-40 have been cancelled.
The rejection of claim(s) 1, 2 and 5-12 under 35 U.S.C. 102(a)(1) as being anticipated by Cogan et al (WO 2020/093104 A1) is withdrawn in light of the amendments to the claims.
Election/Restrictions
Applicant elected the invention of Group I directed to claims 1-3, 5-12 and 40 in the reply filed on 17 April 2025. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election was treated as an election without traverse (MPEP § 818.01(a)).
Claim Objections
The objections to the claims are withdrawn in light of the amendments.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3 and 5-12 REMAIN rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being arguably enabling for specific Cannabis lines with up to 6.68 total THCV content, does not reasonably provide enablement for making and/or using the broad genus of Cannabis plants as claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make/use the invention commensurate in scope with these claims.
In In re Wands (8 USPQ2d 1400 (CAFC 1988)), the CAFC considered the issue of enablement in molecular biology. The CAFC summarized eight factors to be considered in a determination of "undue experimentation". These factors include: (a) the quantity of experimentation; (b) the amount of guidance presented; (c) the presence or absence of working examples; (d) the nature of the invention; (e) the state of the prior art; (f) the predictability of the prior art; (g) the breadth of the claims; and (h) the relative skill in the art. The factors are analyzed in turn for the instant case as follows:
Here, the claims are drawn broadly to a Cannabis plant comprising a THCV amount of between 6 and 7%, a seed of said plant, a tissue culture of cells or a protoplast produced therefrom, a plant regenerated from said tissue culture, a plant produced by growing said seed, an F1 hybrid seed produced by crossing said plant with another plant and a plant produced from said seed, a method of generating a product comprising the use of said plant, and a product produced from the plant.
Meanwhile, the specification teaches that unidentified Cannabis plants having elevated THCV levels were sourced and obtained and crosses were conducted to further increase said levels (¶ 0162). The specification teaches two unidentified strains having 5.58 and 5.22 total THCV (see Table 1). The specification further prophetically suggests that two cultivars may be used to produce offspring with at least 11.60 and 10.51% total THCV (¶ 016 and 0167).
However, the specification fails to teach, in fact, the parental varieties used to obtain the THCV content as claimed and fails to teach, in fact, plants comprising the THCV content as claimed (e.g., see Tables 1 and 2 of the instant specification).
These teachings and guidance are critical in light of the state of the art, which teaches that when the primary cannabinoid is THCV, a level of 6.49% is considered high (e.g. see “Jack the Ripper” strain as evidenced by Rahn, 2015, “What is THCV and what the benefits of this cannabinoid?” published 03 February 2015; https://www.leafly.com/; see also Strain Reviews, 2018, “Strain Report – The Ripper Effect” published on 11 April 2018; http://weedworld.co.uk).
Therefore, in light of the vague breeding history, the failure of the specification to predictably teach producing plants with the THCV content as claimed, and the state of the art which teaches that a high THCV content is considered above 5%, the skilled artisan would resort to undue trial and error experimentation to predictably make the plants as broadly claimed, which is tantamount to impermissible excessive and undue experimentation.
Response to Arguments
Applicant traverses the rejection of the claims in light of the amendments thereto (Applicant reply dated 07 October 2025, p. 5, penultimate ¶).
This argument is not persuasive for the reasons as set forth above: the vague breeding history, the failure of the specification to predictably teach producing plants with the THCV content as claimed and the state of the art which teaches that a high THCV content is considered above 5% all of which would lead the skilled artisan to resort to undue trial and error experimentation to predictably make the plants as broadly claimed, which is tantamount to impermissible excessive and undue experimentation.
Moreover, Applicant’s own disclosure demonstrates that not all cultivars predictably yield the THCV content as claimed demonstrating that it is a particular genetic background that yields the THCV content as claimed (e.g., see cultivar 20VLDY-1002-3 which fails to reach the THCV content as claimed).
Claims 1-3 and 5-12 REMAIN rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Instant claims 1-3 and 5-12 are broadly drawn to a Cannabis plant comprising a THCV amount of between 6 and 7%, a seed of said plant, a tissue culture of cells or a protoplast produced therefrom, a plant regenerated from said tissue culture, a plant produced by growing said seed, an F1 hybrid seed produced by crossing said plant with another plant and a plant produced from said seed, a method of generating a product comprising the use of said plant, and a product produced from the plant.
The specification describes that unidentified Cannabis plants having elevated THCV levels were sourced and obtained and crosses were conducted to further increase said levels (¶ 0162). The specification describes two unidentified strains having 5.58 and 5.22 total THCV (see Table 1). The specification further prophetically suggests that two cultivars may be used to produce offspring with at least 11.60 and 10.51% total THCV (¶ 016 and 0167).
The written description requirement may be satisfied through sufficient description of a representative number of species by disclosing relevant and identifying characteristics such as structural or other physical and/or chemical properties, by disclosing functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the invention as claimed. See Eli Lilly,119 F.3d at 1568, 43 USPQ2d at 1406.
Here, the specification fails to describe a representative number of species from the genus of Cannabis plants as broadly claimed that comprise, in fact, the THCV range as claimed. Moreover, the specification fails to describe, in fact, the parental varieties used to obtain the THCV content as claimed and fails to describe, in fact, plants comprising the THCV content as claimed (e.g., see Tables 1 and 2 of the instant specification).
This description is paramount in light of the state of the art, which describes that when the primary cannabinoid is THCV, a level of 6.49% is considered high (e.g. see “Jack the Ripper” strain as evidenced by Rahn, 2015, “What is THCV and what the benefits of this cannabinoid?” published 03 February 2015; https://www.leafly.com/; see also Strain Reviews, 2018, “Strain Report – The Ripper Effect” published on 11 April 2018; http://weedworld.co.uk).
MPEP 2402 provides that every patent must contain a written description of the invention sufficient to enable a person skilled in the art to which the invention pertains to make and use the invention. Where the invention involves a biological material and words alone cannot sufficiently describe how to make and use the invention in a reproducible manner, access to the biological material may be necessary for the satisfaction of the statutory requirements for patentability under 35 U.S.C. 112 [emphasis added].
As with other biological material deposited for purposes of patents for inventions under 35 U.S.C. 101, the deposit of plant material together with the written specification must enable those skilled in the art to make and use the claimed invention, in accordance with the requirements of 35 U.S.C. 112. See MPEP 2403.02.
However, MPEP 2163(I) also provides that "Compliance with the written description requirement is essentially a fact-based inquiry that will ‘necessarily vary depending on the nature of the invention claimed.’" Enzo Biochem, 323 F.3d at 963, 63 USPQ2d at 1613. An application specification may show actual reduction to practice by describing testing of the claimed invention or, in the case of biological materials, by specifically describing a deposit made in accordance with 37 CFR 1.801 et seq. See Enzo Biochem, 323 F.3d at 965, 63 USPQ2d at 1614 ( "reference in the specification to a deposit may also satisfy the written description requirement with respect to a claimed material" ); see also Deposit of Biological Materials for Patent Purposes, Final Rule, 54 FR 34,864 (August 22, 1989) ("The description must be sufficient to permit verification that the deposited biological material is in fact that disclosed. Once the patent issues, the description must be sufficient to aid in the resolution of questions of infringement." Id. at 34,880.).
Such a deposit is not a substitute for a written description of the claimed invention. The written description of the deposited material needs to be as complete as possible because the examination for patentability proceeds solely on the basis of the written description. See, e.g., In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985).
In the instant matter, the specification only provides a description of a limited number of cannabinoid profiles for a few varieties but is silent and/or incomplete with respect to the breeding history of said varieties. This breeding history is critical because it provides the genetics of the variety and, in turn, its corresponding traits. Thus, in the absence of a breeding history, the specification has failed to provide an adequate written description of the claimed variety.
To overcome this rejection, Applicant must amend the specification/drawing to provide the breeding history used to develop the instant variety or cultivar. When identifying the breeding history, applicant should identify any and all other potential names for all parental lines utilized in the development of the instant variety.
For example, if Applicant’s breeding history uses proprietary line names, applicant should notate in the specification all other names of the proprietary lines, especially publicly disclosed or patented line information.
Applicant is also reminded that they have a duty to disclose information material to patentability. Applicant should also notate the most similar plants which should include any other plants created using similar breeding history (such as siblings of the instant variety). This information can be submitted in an IDS with a notation of the relevancy to the instant application or as information submitted as described in MPEP 724 (e.g., trade secret, proprietary, and Protective Order).
Therefore, in light of the enormous breadth of the claims which are directed to any Cannabis plant having any genetic makeup, the failure of the specification to describe a representative number of species from the genus of plants that in fact have the THCV content as claimed and the state of the art, the skilled practitioner would not be of the opinion that Applicant was in possession of the plants, progeny, products and methods as broadly claimed.
Response to Arguments
Applicant traverses the rejection of the claims because the specification has reduced to practice cultivar 21VLP5-1-18 (Applicant reply dated 07 October 2025, p. 6, ¶ 1 and 2).
This argument is not persuasive because the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ( "[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted).").
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus.").
The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]." See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) ("[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated."). "A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004) (Claims directed to PTFE dental floss with a friction-enhancing coating were not supported by a disclosure of a microcrystalline wax coating where there was no evidence in the disclosure or anywhere else in the record showing applicant conveyed that any other coating was suitable for a PTFE dental floss.)
The Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 "merely by clearly describing one embodiment of the thing claimed." LizardTech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1346, 76 USPQ2d 1731, 1733 (Fed. Cir. 2005). The issue is whether a person skilled in the art would understand inventor to have invented, and been in possession of, the invention as broadly claimed. In LizardTech, claims to a generic method of making a seamless discrete wavelet transformation (DWT) were held invalid under 35 U.S.C. 112, first paragraph, because the specification taught only one particular method for making a seamless DWT and there was no evidence that the specification contemplated a more generic method. Id.; see also Tronzo v. Biomet, 156 F.3d at 1159, 47 USPQ2d at 1833 (Fed. Cir. 1998)(holding that the disclosure of a species in a parent application did not provide adequate written description support for claims to a genus in a child application where the specification taught against other species).
Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the inventor was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed.
For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation."
Such correlations may be established "by the inventor as described in the specification," or they may be "known in the art at the time of the filing date." See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014) (Holding that claims to all human antibodies that bind IL-12 with a particular binding affinity rate constant (i.e., koff) were not adequately supported by a specification describing only a single type of human antibody having the claimed features because the disclosed antibody was not representative of other types of antibodies in the claimed genus, as demonstrated by the fact that other disclosed antibodies had different types of heavy and light chains, and shared only a 50% sequence similarity in their variable regions with the disclosed antibodies.).
If a representative number of adequately described species are not disclosed for a genus, the claim to that genus must be rejected as lacking adequate written description under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. See MPEP 2163(II)(A)(3)(a)
Here, the claims are enormously broad as they are directed to any Cannabis plant having any genetic makeup yet the specification only describes a single cultivar with a specific genotype comprising the THCV content as claimed. As such, the skilled artisan would not believe that Applicant was in possession of the plants as broadly claimed.
In addition, Applicant has failed to provide the breeding history of the claimed variety which is critical to satisfy the written description requirement as outlined supra.
Finally, Applicant’s own disclosure demonstrates that not all cultivars are able to yield the THCV content as claimed indicating that it is a particular genetic background that yields the THCV content as claimed (e.g., see cultivar 20VLDY-1002-3 which fails to yield the THCV content as claimed).
Claim Rejections - 35 USC § 102/103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 1 and 2 REMAIN rejected under 35 U.S.C. 102(a)(1) as being anticipated by the Cannabis hybrid “Jack the Ripper” as evidenced by Rahn (2015, “What is THCV and what the benefits of this cannabinoid?” published 03 February 2015; https://www.leafly.com/) and Strain Reviews (2018, “Strain Report – The Ripper Effect” published on 11 April 2018; http://weedworld.co.uk) or in the alternative are NOW rejected under 35 U.S.C. 103 as being unpatentable over the Cannabis hybrid “Jack the Ripper” as evidenced by Rahn.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Instant claims 1 and 2 are drawn broadly drawn to a Cannabis plant comprising a THCV amount of between 6.68%.
Rahn discloses the high THCV Cannabis plant Jack the Ripper (p. 3) which is known to have greater than 5% THCV content and has been recorded to have a THCV content of 6.49% (e.g., see Strain Reviews, p. 5 and 6).
Here, the Office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same, material, structural and functional characteristics of the claimed product.
In the absence of evidence to the contrary, the burden is on the Applicant to provide that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Failure of those skilled in the art to contemporaneously recognize an inherent property, function or ingredient of a prior art reference does not preclude a finding of anticipation, Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1349, 51 USPQ2d 1943, 1948 (Fed. Cir. 1999).
Therefore, a Cannabis plant comprising a THCV amount of between 5 and 25% is anticipated by the Cannabis plant “Jack the Ripper”.
In the alternative, prior to the effective filing date of the instant invention it would have been prima facie obvious to arrive at a THCV content of 6.68%, and with a reasonable expectation of success, because Jack the Ripper displays a THCV content of 6.49% which is virtually indistinguishable from that as claimed.
One would be motivated to arrive at this particular content because Rahn teaches the various positive effects and benefits of said plant such as acting as an appetite suppressant or stimulating bone growth.
Applicant should note that any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (differences in sedative and anticholinergic effects between prior art and claimed antidepressants were not unexpected ). In In re Waymouth, 499 F.2d 1273, 1276, 182 USPQ 290, 293 (CCPA 1974), the court held that unexpected results for a claimed range as compared with the range disclosed in the prior art had been shown by a demonstration of "a marked improvement, over the results achieved under other ratios, as to be classified as a difference in kind, rather than one of degree." See MPEP 716.02
"A greater than expected result is an evidentiary factor pertinent to the legal conclusion of obviousness ... of the claims at issue." In re Corkill, 711 F.2d 1496, 226 USPQ 1005 (Fed. Cir. 1985). In Corkhill, the claimed combination showed an additive result when a diminished result would have been expected. This result was persuasive of nonobviousness even though the result was equal to that of one component alone. Evidence of a greater than expected result may also be shown by demonstrating an effect which is greater than the sum of each of the effects taken separately (i.e., demonstrating "synergism"). Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989).
However, a greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected . Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. Ex parte The NutraSweet Co., 19 USPQ2d 1586 (Bd. Pat. App. & Inter. 1991). see MPEP 716.02(a)(I).
Evidence of unobvious or unexpected advantageous properties, such as superiority in a property the claimed compound shares with the prior art, can rebut prima facie obviousness. "Evidence that a compound is unexpectedly superior in one of a spectrum of common properties . . . can be enough to rebut a prima facie case of obviousness." No set number of examples of superiority is required. In re Chupp, 816 F.2d 643, 646, 2 USPQ2d 1437, 1439 (Fed. Cir. 1987) whereas presence of a property not possessed by the prior art is evidence of nonobviousness. In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) and absence of property which a claimed invention would have been expected to possess based on the teachings of the prior art is evidence of unobviousness. Ex parte Mead Johnson & Co., 227 USPQ 78 (Bd. Pat. App. & Inter. 1985) See MPEP 716.02(a)(II) and (III).
The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength "are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration."); Ex parte C, 27 USPQ2d 1492 (Bd. Pat. App. & Inter. 1992).
Applicant has the burden of explaining the proferred data: "[A]ppellants have the burden of explaining the data in any declaration they proffer as evidence of non-obviousness." Ex parte Ishizaka, 24 USPQ2d 1621, 1624 (Bd. Pat. App. & Inter. 1992). Evidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). See MPEP 716.02(b)(I)-(III).
However, whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). See MPEP 716.02(d)(I).
Here, if there is assumed to be a difference of 0.19% THCV content between Jack the Ripper and the instantly claimed plant then it is not of statistical and practical significance such that the instantly claimed plant is obvious and unpatentable over Jack the Ripper.
Response to Arguments
Applicant traverses the rejection of the claims because there is a 0.19% difference between Jack the Ripper and the instantly claimed Cannabis plant (Applicant reply dated 07 October 2025, p. 7, ¶ 1-3).
Applicant’s argument are not persuasive because claim 1 clearly falls within the purview of the Cannabis strain Jack the Ripper. Regarding claim 2, the Office notes that it does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same, material, structural and functional characteristics of the claimed product.
Thus, in the absence of evidence to the contrary and the fact that there is only a difference of 0.19% in THCV content between Jack the Ripper and the instantly claimed variety it is presumed that Jack the Ripper comprises the THCV content as claimed, especially in light of the fact there are no stated differences in the genetics between the two plants.
Even, assuming arguendo that there is a 0.19% difference, it is not of statistical and practical significance such that the instantly claimed plant is obvious and unpatentable over Jack the Ripper.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 3 and 5-12 REMAIN rejected under 35 U.S.C. 103 as being unpatentable over the Cannabis hybrid “Jack the Ripper” as evidenced by Rahn (2015, “What is THCV and what the benefits of this cannabinoid?” published 03 February 2015; https://www.leafly.com/) and Strain Reviews (2018, “Strain Report – The Ripper Effect” published on 11 April 2018; http://weedworld.co.uk) and in view of Cogan et al (WO 2020/093104 A).
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Instant claims 1, 3 and 5-12 are broadly drawn to a Cannabis plant comprising a THCV amount of between 6 and 7%, a seed of said plant, a tissue culture of cells or a protoplast produced therefrom, a plant regenerated from said tissue culture, a plant produced by growing said seed, an F1 hybrid seed produced by crossing said plant with another plant and a plant produced from said seed, a method of generating a product comprising the use of said plant, and a product produced from the plant.
Rahn teaches the high THCV Cannabis plant Jack the Ripper (p. 3) which is known to have greater than 5% THCV content and has been recorded to have a THCV content of 6.49% (e.g., see Strain Reviews, p. 5 and 6).
Rahn teaches the various positive effects and benefits of said plant such as acting as an appetite suppressant or stimulating bone growth (p. 2).
Thus, while Rahn teaches the plant as instantly claimed, the issue is whether one of ordinary skill in the art would have used this plant in crosses or produced tissue cultures or protoplasts therefrom to regenerate plants or to produce products from said plants.
To this point, Cogan et al teaches a cannabis plant wherein the plant comprises a THCV amount of between 5 and 25%, a seed of the said cannabis plant, a cannabis plant or part thereof including at least one cell of said plant produced by growing said seed, an F1 hybrid seed produced by crossing said cannabis plant with a different cannabis plant, an F1 hybrid plant grown from the said seed or a plant part thereof wherein the plant part comprises at least one cell of the F1 hybrid plant, a tissue culture of cells produced from said cannabis plant, a cannabis plant generated from said tissue culture and a protoplast produced from the said cannabis plant (e.g., see claims 1, 15, 21-29, 32-34; see also Examples and Tables 8-12).
Therefore, prior to the effective filing date of the instant invention it would have been prima facie obvious to one of ordinary skill in the art to use the Jack the Ripper in crosses, or to produce tissue cultures or protoplasts therefrom to regenerate plants, or to produce products from said plants because Cogan et al clearly teaches, suggests and provides motivation for doing so using high THCV Cannabis plants.
One would have a reasonable expectation of success in doing so because both Rahn and Cogan et al teach the production of Cannabis plants with greater than 5% THCV content, and because Cogan et al provides the well-known teachings for producing hybrids, crosses, making tissue cultures or protoplasts, and for producing products from plants.
In this way one would propagate a plant with high THCV, or, could use said plant in crosses to make new plants with tailored cannabinoid profiles for end use products.
Response to Arguments
Applicant traverses the rejection of the claims because the references fails to teach a THCV content between 6% and 7% and in particular a THCV content of 6.68% (Applicant reply dated 07 October 2025, p. 7, penultimate and last ¶).
First, this argument is not persuasive because the prior art need not teach all elements of the claims as they are not rejected for being anticipated under 35 U.S.C. 102. Moreover, claim 2 which is directed to a 6.68% THCV content, is not included in the rejection of the claims.
Second, this argument is not persuasive because Rahn clearly teaches the THCV content as encompassed by claim 1 and because Rahn teaches the benefits of producing plants with high THCV contents.
Conclusion
No claim is allowed.
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 JASON DEVEAU-ROSEN whose telephone number is (571)272-2828. The examiner can normally be reached 7:30am - 4pm.
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/JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662