Status of the Application
This Office Action is in response to the Amendment and Remarks filed 16 March 2026.
The rejection of claims 2-7 under 35 U.S.C. 103 is withdrawn in view of Applicant’s arguments, pages 15-17 of the Remarks.
Claim Objections
Claims 1 and 2 are objected to because of the following informalities:
At claim 1, line 2, “the plant being” should read -- the cultivar having been --.
At claim 2, line 3, “King” should not be capitalized for consistency with the other claims and the Specification.
Appropriate correction is required.
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 1-7 and 10-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Applicant claims hemp cultivar ‘Cherry King’ obtained by open pollination, and progeny and extracts thereof.
Applicant teaches that hemp cultivar ‘Cherry king’ was produced by using hemp cultivar ‘Cherry Wine’ as the seed parent in an open pollination method. Applicant teaches 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 teaches 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 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.
In re Wands, 858F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988) lists eight considerations for determining whether or not undue experimentation would be necessary to practice an invention. These factors are: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples of the invention, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of the art, and the breadth of the claims.
It doesn’t appear that Applicant has taught a repeatable method of making and using hemp cultivar ‘Cherry King’, and the deposited seed do not appear to be capable of producing/growing a plant of hemp cultivar ‘Cherry King’. As addressed above, hemp cultivar ‘Cherry King’ was produced by open pollination of hemp cultivar ‘Cherry Wing’ which itself was selected from an outcross breeding method. It does not appear that the deposit enables the claimed invention, and it would have required undue trial and error experimentation to make and use the invention as claimed.
In Wyeth v. Abbott Laboratories, 107 USPQ2d 1273, at 1276-1277 (Fed. Cir. 2013), the court teaches that, the specification…discloses only a starting point for further iterative research in an unpredictable and poorly understood field, the resulting need to engage in a systematic screening process for each of the many rapamycin candidate compounds is excessive experimentation. The court thus held that there is no genuine dispute that practicing the full scope of the claims, measured at the filing date, required undue experimentation.
Applicant argues that growing feminized seeds and then selecting and vegetatively propagating the resultant plants that exhibit the Cherry king phenotype (using the Table 6 morphological and Tables 7 and 8 cannabinoid benchmarks as selection criteria) is a defined, reproducible process, the deposit in combination with the written description is fully enabled (page 7, 5th paragraph of the Remarks).
Applicant’s arguments are not found to be persuasive. The CW21-5 plant line was named ‘Cherry king’. Table 6 teaches a limited number of morphological characteristics of ‘Cherry king’ most of which would be highly influenced by growth conditions as would the cannabinoid content taught in Table 7. Further, it is unclear what portion of the deposited feminized seed would produce a plant with similar phenotypical and chemotypical characteristics as ‘Cherry king’. Instant Tables 6 and 7 demonstrate that seed progeny of ‘Cherry wine’ from which ‘Cherry king’ was derived have high levels of variability. The nature of the instant invention is that individual Cannabis sativa plants have distinct phenotypical and chemotypical characteristics that are not predictable.
The Lim Declaration filed under 37 CFR 1.132 on 16 March 2026 has been fully considered. The Lim Declaration begins with the statement “The Cherry King cannabis cultivar is maintained through asexual propagation rather than seed reproduction in order to preserve the genetic identity of the cultivar”. The Lim Declaration appears to contradict the assertion that hemp cultivar Cherry king can be selected from the deposited feminized seed without undue trial and error experimentation. Even beginning with ‘Cherry wine’, the evidence in instant Tables 6 and 7 would suggest undue trial and error experimentation to reproduce ‘Cherry king’. Where the specification discloses only a starting point for further iterative research in an unpredictable and poorly understood field and offers no guidance or predictions about particular substitutions to be made, and where there is a need to engage in a systematic screening process for each of the candidate compounds, experimentation is considered to be excessive. See Wyeth v. Abbott Laboratories, Nos 12-1223-1224 (Fed. Cir. 2013).
It is the Examiner’s opinion that Applicant needs to deposit regenerable plant tissue that can predictably regenerate a plant of cultivar ‘Cherry king’.
Claims 1-7 and 10-13 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.
Applicant claims hemp cultivar ‘Cherry king’ obtained by open pollination using hemp cultivar ‘Cherry wine’, and progeny and extracts thereof.
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 only describes hemp cultivar ‘Cherry king’ by how it was produced and by a limited number of morphological characteristics in Table 6 and CBD content in Table 7. Further, the deposited seed do not appear to describe hemp cultivar ‘Cherry King’. Applicant also does not describe the claimed “progeny”, “F1 hemp plant”, mutant plant, “hempseed oil”, “seed protein” or the compositions comprising an extract of hemp cultivar ‘Cherry King’ other than by a possible method of making. The requirement for a specific identification is consistent with the description requirement of the first paragraph of 35 U.S.C. 112, and to provide an antecedent basis for the biological material which either has been or will be deposited before the patent is granted. 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. 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., Ex parte Hibberd, 227 USPQ 443, 447 (Bd. Pat. App. & Int. 1985), 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985). See also 54 Fed. Reg. at 34,880.
Hence, it is unclear that Applicant was in possession of the invention as broadly claims. See University of Rochester v. G.D. Searle & Co., 68 USPQ2d 1424, 1433 (DC WNY 2003) which teaches knowing the "starting point" is not enough; that is little more than a research plan. The court held that the disclosure of screening assays and general classes of compounds was not adequate to describe compounds having the desired activity: without disclosure of which peptides, polynucleotides, or small organic molecules have the desired characteristic, the claims failed to meet the description requirement of § 112.
Applicant argues that for biological inventions, the combination of a sufficient written characterization and a Budapest Treaty deposit satisfies this standard, citing Ex parte Hibberd, 227 USPQ 443 (Bd. Pat. App. & Inter. 1985); MPEP §§ 2163, 2402 (page 11 of the Remarks).
Applicant’s argument is not found persuasive. Ex parte Hibberd states that plants, seeds and tissue cultures are patentable subject matter under 35 USC 101, not exclusively under 35 USC 161 or Plant Variety Protection Act. The issue at hand is that the deposit of feminized seed does not adequately describe hemp cultivar ‘Cherry king’ because it is unclear that one could grow hemp cultivar ‘Cherry king’ from the deposited seed. This is further supported by the Lim Declaration filed under 37 CFR 1.132 on 16 March 2026 as discussed above.
Applicant argues that these downstream plant forms (progeny plant, feminized seed and F1 hybrid) remain genetically derived from the Cherry king cultivar and therefore inherently retain the defining genetic background and cannabinoid biosynthetic characteristics of the deposited Cherry King plant. Applicant argues that the specification reasonably conveys to a person skilled in the art that the inventors were in possession of plant material derived from the Cherry King cultivar and its biologically related variants at the time of filing (page 12 of the Remarks).
Applicant’s argument is not found persuasive because ‘Cherry king’ is described as a seed progeny of ‘Cherry wine’ produced by open (uncontrolled) pollination. Haddad (PP35,171 P2) describes reciprocal crosses between ‘Cherry wine’ and ‘The Wife’ (column 2, lines 30-35), and that said crosses produced “segregating progeny” (column 3, lines 1-2) which would indicate that ‘Cherry wine’ itself is not a homozygous inbred line. Given these facts, Applicant has not adequately described progeny of ‘Cherry king’ and the art would suggest F1 progeny of ‘Cherry king’ would be widely segregating. Hence, Applicant has not adequately described the claimed progeny/F1 progeny of ‘Cherry king’ sufficiently to distinguish them from other hemp cultivars. See Vas-Cath Inc. v. Mahurkar 1991 (CA FC) 19 USPQ2d 1111, 1115, which teaches that the purpose of the written description is for the purpose of warning an innocent purchaser, or other person using a machine, of his infringement of the patent; and at the same time, of taking from the inventor the means of practicing upon the credulity or the fears of other persons, by pretending that his invention is more than what it really is, or different from its ostensible objects, that the patentee is required to distinguish his invention in his specification.
Applicant argues that the specification at pages 10-13 provides detailed descriptions of functional health food compositions, pharmaceutical compositions, antimicrobial compositions, and cosmetic compositions, including formulation forms, carrier components, and dosage guidance. Applicant argues that each of claims 10-13 is expressly limited to compositions comprising "an extract of the hemp cultivar Cherry king plant according to claim 1." Applicant argues that because claim 1 specifically defines Cherry King by both its unique genetic origin and its deposit under Accession Number KACC 88007BP, any composition falling within claims 10-13 must be derived from Cherry King specifically---not from hemp plants generally. Applicant argues that the specification fully characterizes Cherry king through its cannabinoid profile (Tables 7-8), its biological activities (Example 3, FIGS. 6A-7), and its cultivation characteristics (Table 5), demonstrating that the inventors were in possession of each claimed composition. Applicant argues that amended claim 12 now expressly requires that the antimicrobial composition extract exhibits antimicrobial activity against Escherichia coli, a specific functional limitation directly and fully supported by Example 3 and FIG. 7 of the specification (pages 12-13 of the Remarks).
Applicant’s arguments are not found to be persuasive. The compositions at claims 10, 11 and 13 only recite where the extract is from and not what the extract actually is. At claims 12, the extract is only described by its function “antimicrobial activity against Escherichia coli” but does not describe any specific structure or structures that produce the claimed function. Hence, the claims as a whole lack adequate written description. This also applies to claims 4 and 7 directed to hempseed oil or a seed protein derived from a seed. See MPEP § 2163 which states that the claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function. A biomolecule described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 4, 7 and 10-13 remain rejected under 35 U.S.C. 102(a)(2) as being anticipated by Campbell (U.S. Patent 11,666,016).
Applicant claims extracts/products produced from hemp cultivar ‘Cherry King’. 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.
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. The compositions of instant claims 10-13 recite intended uses of the compositions but do not compositionally distinguish the claimed compositions from the compositions disclosed by Campbell. Further, Applicant provides no evidence that an extract of hemp cultivar ‘AF14b15-21’ would not be able to exhibit antimicrobial activity against Eschericha coli as required by instant claim 12. 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). Hence, Campbell had previously disclosed the claimed invention.
Applicant argues that claims 10, 11, and 13 each expressly require "an extract of the hemp cultivar Cherry king plant according to claim 1." Applicant argues that because claim 1 defines Cherry King as a specific cultivar with higher cannabinoid content than its Cherry wine seed parent and as deposited under Accession Number KACC 88007BP, the claimed extract necessarily possesses the unique phytochemical characteristics of Cherry king including the specific cannabinoid composition documented in Tables 7-8 of the specification. Applicant argues that Cherry king produces CBD at 53.078±0.242 g/m3 (the highest of all 16 CW21 lines) with a distinctive high-CBD, low-THC chemotype demonstrated in FIGS. 3A-3D. Applicant argues that Campbell discloses hemp cultivar 'AF14b15-21,' which is a different cultivar with a different and separately characterized cannabinoid profile. Applicant argues that under the Atlantic Thermoplastics/Thorpe framework, where products derived from structurally distinct source plants have different phytochemical profiles, the Thorpe product-by-process doctrine does not render the claims unpatentable. Applicant argues that because Cherry king and AF14b15-21 are different cultivars with different documented phytochemical profiles, an extract of Cherry king is structurally different from any extract of Campbell's AF14b15-21 (pages 13-14 of the Remarks).
Applicant’s arguments are not found persuasive because Applicant is arguing limitations not found in the claims. Applicant has not shown any distinguishing characteristic(s) of protein of hemp cultivar ‘Cherry king’ of the instant invention at instant claims 4 and 7. The “extract” at claims 10-13 is not limited and would clearly include isolated cannabinoids or CBDs useful in a functional health food composition, pharmaceutical composition, antimicrobial composition or cosmetic composition.
The instant Specification on page 10 defines “extract” as follows:
The term "extract" used in this specification generally has a meaning that is commonly known in the pertinent art as a crude extract, but, in a broad sense, it also encompasses fractions that are obtained by further fractionating the extract. In other words, the extract includes not only those obtained using the aforementioned extraction solvents but also those obtained by applying additional purification processes. For instance, fractions obtained by additionally performing various purification processes such as passing the aforementioned extract through an ultrafiltration membrane having certain molecular weight cut-off or separations performed by various chromatography techniques (designed for separation based on size, charge, hydrophobicity, or affinity) are also included in the extract of the present invention.
Hence, clearly the limitation “extract” is directed to a product-by-process and the instantly rejected claims fail to distinguish and “extract” of hemp cultivar ‘Cherry king’ from the hemp cultivar of the prior art.
With respect to amended claim 12 (antimicrobial composition), Applicant argues that the amendment now expressly requires that the composition extract "exhibits antimicrobial activity against Escherichia coli." Campbell does not disclose, teach, or suggest an antimicrobial composition derived from a hemp cultivar extract having demonstrated antimicrobial activity against E. coli. Applicant argues that Example 3 and FIG. 7 of the specification establish that Cherry king extract exhibits antimicrobial activity against E. coli. Applicant argues that Campbell's disclosure of hemp oil, liquid forms, and cosmetic products contains no disclosure of antimicrobial activity against E. coli for any hemp extract. This functional limitation - tied to the unique phytochemical properties of Cherry king is independently sufficient to overcome the anticipation rejection for claim 12 (page 14, 3rd paragraph of the Remarks).
Applicant’s arguments are not found persuasive. 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). Applicant provides not substantive evidence that an extract from hemp cultivar ‘AF14b15-21’ would not have antimicrobial activity against Escherichia coli.
Conclusion
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.
No claims are allowed.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached on (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/David H Kruse/
Primary Examiner, Art Unit 1663