Status of the Application
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4 August 2026 has been entered.
Claims 1-3, 5-7 and 10-13 have been cancelled. Claim 4 has been rewritten as independent.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
At lines 1-2, “the feminized seed” lacks proper antecedent basis in the claim.
At line 3, “the Cherry wine parent plant” lacks proper antecedent basis in the claim.
At claim 4, line 3, the limitation “the Cherry wine parent plant” renders the claim indefinite. The sole designation of a plant by its breeding line name or number is arbitrary and creates ambiguity in the claims. For example, the plant disclosed in this application could be designated by some other arbitrary means, or the assignment of the breeding line name could be arbitrarily changed to designate another plant. If either event occurs, one’s ability to determine the metes and bounds of the claim would be impaired. See In re Hammack, 427 F .2d 1378, 1382; 166 USPQ 204, 208 (CCPA 1970). Amendment of the claim to refer to the deposit accession number of the claimed breeding line would obviate this rejection.
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.
Claim 4 is 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.
Applicant claims hempseed oil and/or a seed protein “derived” from a feminized seed produced from an undefined Cannabis sativa cultivar having a CBD content greater than that of the Cherry wine parent plant.
Applicant describes hemp cultivar ‘Cherry King’ as being produced by using hemp cultivar ‘Cherry Wine’ as the seed parent in an open pollination method. Applicant describes that the “plant” deposited under Accession Number KACC 88007BP appears to be “feminized seeds” taken from hemp cultivar ‘Cherry King’ on page 7, 4th paragraph of the Specification. Table 3 on page 18 of the instant Speciation describes that hemp cultivar ‘Cherry Wine’ is the result of a cross between a Cannabis sativa subsp. sativa and s Cannabis sativa subsp. indica. These facts would appear to mean that hemp cultivar ‘Cherry King’ is an outcrossed plant (which is confirmed in Table 6 on page 22 of the instant Specification). Hence, any seed taken from hemp cultivar ‘Cherry King’ would be widely variable and highly genetically segregating.
Applicant does not appear to describe the genus of “a Cannabis sativa cultivar” other than by the functional limitation “having a CBD content greater than that of the Cherry wine parent plant”, from which the claimed hempseed oil and/or seed protein are derived. Further, given the fact that CBD content of a Cannabis sativa plant can vary greatly in different environments one cannot adequately describe “CBD content greater than”, as shown in Campbell (US 11,666,016) for variety ‘AF14b15-21’ in table 6 at column 38.
Hence, it is unclear that applicant was in possession of the invention as broadly claimed.
The decision in AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc. 111 USPQ2d 1780 (Fed. Cir. 2014) seems to be germane to the instant case. In Abbvie, an analogy is drawn between a claimed genus and a plot of land (see pages 1789-1791). Using this analogy, the Court offered that “[I]f the disclosed species only abide in a corner of the genus, one has not described the genus sufficiently to show that the inventor invented, or had possession of, the genus. He only described a portion of it.” Similar to the analogy drawn in Abbvie, in the case of Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 94 USPQ2d 1161 (Fed. Cir. 2010), the court (at page 1171) offered: [M]erely drawing a fence around the outer limits of purposed genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.
Applicant argues that feminized seed produced from a Cannabis sativa cultivar characterized by a CBD content greater than that of the Cherry wine parent plant grown under identical cultivation conditions, a comparative characteristic of the source cultivar that is expressly described throughout the Specification, including the Summary and Detailed Description, and further supported by the cannabinoid analyses shown in FIGS. 3A-3D and Tables 7-8 (page 3 of the Remarks).
Applicant’s arguments are not found persuasive because the seed from which the claimed hempseed oil and/or seed protein is only described by it’s CBD content relative to Cherry wine.
Claim Rejections - 35 USC § 102
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.
Claim(s) 4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Campbell (U.S. 11,666,016).
Applicant claims hempseed oil and/or a seed protein “derived” from a feminized seed produced from an undefined Cannabis sativa cultivar having a CBD content greater than that of the Cherry wine parent plant. Applicant only discloses an average CBD percentage of ‘Cherry wine’ in Table 3 on page 18 and Table 8 on page 25. Table 3 states 0.3% and Table 8 states about 2.51%.
Campbell discloses hemp cultivar ‘AF14b15-21’ at Table 1, columns 10-19 having high CBD content like hemp cultivar ‘Cherry King’ of the instant invention. Campbell discloses producing a variety of products from hemp cultivar ‘AF14b15-21’ including liquid forms and cosmetic products at column 9, lines 30-35. Campbell discloses a hemp oil extract at column 43, lines 50-51. Campbell discloses the CBD content of variety ‘AF14b15-21’ in table 6 at column 38. The CBD content of variety ‘AF14b15-21’ ranges from 4.6% to 7.81% w/w of dried inflorescence. Hence, Campbell had previously disclosed the claimed invention.
See In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985), which teaches that a product-by-process claim may be properly rejectable over prior art teaching the same product produced by a different process, if the process of making the product fails to distinguish the two products.
Applicant argues that the claim recites a source cultivar characterized by a specific comparative cannabinoid profile. Applicant argues that Campbell contains no disclosure establishing that its products possess the claimed CBD compositional relationship (page 4 of the Remarks).
Applicant’s arguments are not found persuasive. The instant Application teaches a CBD content of ‘Cherry wine’ in Tables 3 and 8 as a percentage. The Examiner has directly compared the disclosed percent CBD content in the prior art cultivar which does appear to meet the claim limitations. Further, claim 4 refers to “a Cannabis sativa cultivar” but does not distinguish what cultivar the claim is directed to.
Conclusion
Claim 4 is rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID H KRUSE whose telephone number is (571) 272-0799. The examiner can normally be reached Monday-Friday 7AM-3:30PM.
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/David H Kruse/
Primary Examiner, Art Unit 1663
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