DETAILED ACTION
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 without traverse of Group I, claims 1-3, 5-6 and 8-9, in the reply filed on November 4, 2025 is acknowledged. Claims 10-12 are withdrawn from consideration.
Priority
The first paragraph of the Specification is provisionally objected to because the incorporation of essential material in the specification by reference to a foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference. The amendment must be accompanied by an affidavit or declaration executed by the applicant, or a practitioner representing the applicant, stating that the amendatory material consists of the same material incorporated by reference in the referencing application. See In re Hawkins, 486 F.2d 569, 179 USPQ 157 (CCPA 1973); In re Hawkins, 486 F.2d 579, 179 USPQ 163 (CCPA 1973); and In re Hawkins, 486 F.2d 577, 179 USPQ 167 (CCPA 1973). If the material is not considered by Applicant to be essential material, a statement on the record would obviate this objection (See MPEP 608.01(p)(I)).
Claim Objections
Claim 1 objected to because of the following informalities: a review of the specification suggests that “Inida” should be spelled “India”. See paragraph spanning pages 24-25, and paragraph 2 page 31, for example.
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, 5-6 and 8-9 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 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.
The claims are drawn to a hemp cultivar Pinkpepper (Cannabis sativa L. CV. Pinkpepper) plant obtained through artificial crossing between KHV2 genetic resource as a seed parent and Inida genetic resource as a pollen parent, the hemp cultivar Pinkpepper plant having a
higher content of cannabinoids than the seed parent and the pollen parent, the hemp cultivar Pinkpepper plant deposited under Accession Number KACC 88008BP, and its progeny.
The specification describes a hemp line designated 18-1 as having been developed using the germplasm of hemp cultivated for medicinal and hemp cloth purposes (page 20 and Table 2), with KHV2 genetic resource being the seed parent and India genetic resource being the pollen parent. The hemp line designated 18-1 was found to have a higher CBDA content in both leaves and inflorescence as compared to these parental lines, and was subsequently given the name Pinkpepper (cannabis sativa L. cv. Pinkpepper) (pages 20-25; page 31). The specification also discloses at page 7 that a hemp cultivar Pinkpepper (Cannabis sativa L. CV. Pinkpepper) was duly deposited with the Korean Agricultural Culture Collection (KACC) under the Access number of KACC 88008BP on May 26, 2023. The specification additionally describes an F1 progeny hemp plant obtained by crossing a Pinkpepper hemp plant and a Chungsam hemp plant as having inherited a mutation from the Pinkpepper hemp plant that can be detected with the an InDel4 marker (page 36).
The specification does not describe the genetic nature of the of the deposited seed. The specification also does not describe any other progeny plant derived from the hemp cultivar Pinkpepper. The specification additionally does not describe any mutant plant obtained by treating the hemp cultivar Pinkpepper plant with a mutagen.
The requirement for a specific identification of the claimed subject matter 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 the biological material disclosed. Once the patent issues, the description must be sufficient to aid in the resolution of questions of infringement. Such a biological 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). See also 54 Fed. Reg. at 34,880. Here, Applicant does not appear to be in possession of the invention as broadly claimed.
Claims 1-3, 5-6 and 8-9 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.
The claims are drawn to a hemp cultivar Pinkpepper (Cannabis sativa L. CV. Pinkpepper) plant obtained through artificial crossing between KHV2 genetic resource as a seed parent and Inida genetic resource as a pollen parent, the hemp cultivar Pinkpepper plant having a
higher content of cannabinoids than the seed parent and the pollen parent, the hemp cultivar Pinkpepper plant deposited under Accession Number KACC 88008BP, and its progeny.
The specification discloses a hemp line designated 18-1 that was developed using the germplasm of hemp that has been cultivated for medicinal and hemp cloth purposes (page 20 and Table 2) ,with KHV2 genetic resource being the seed parent and India genetic resource being the pollen parent. The hemp line designated 18-1 was found to have a higher CBDA content in both leaves and inflorescence as compared to these parental lines, and was subsequently given the name Pinkpepper (cannabis sativa L. cv. Pinkpepper) (pages 20-25; page 31). The specification also discloses at page 7 that a hemp cultivar Pinkpepper (Cannabis sativa L. CV. Pinkpepper) was duly deposited with the Korean Agricultural Culture Collection (KACC) under the Access number of KACC 88008BP on May 26, 2023. However, the genetic nature of the of the deposited seed is not discernable from the specification, or from the claims – see the rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, below. Accordingly, it is unclear whether the deposited seed constitute a repeatable method of making and using the hemp cultivar Pinkpepper plant of Claim 1, since only a genetically uniform seed deposit would repeatably ensure the production of plants with uniform genotypic and phenotypic characteristics. Absent such a deposit, it would require undue trial and error experimentation to make and use the claimed invention, since one skilled in the art would have to evaluate the characteristics of each individual hemp plant obtained through artificial crossing between KHV2 genetic resource as a seed parent and Inida genetic resource as a pollen parent n order to determine which hemp plants, if any, exhibit the desired spectrum of characteristics.
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 1, AND ALL CLAIMS DEPENDENT THEREON, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is drawn to a hemp cultivar Pinkpepper (Cannabis sativa L. CV. Pinkpepper) plant obtained through artificial crossing between KHV2 genetic resource as a seed parent and Inida genetic resource as a pollen parent, the hemp cultivar Pinkpepper plant having a
higher content of cannabinoids than the seed parent and the pollen parent, the hemp cultivar Pinkpepper plant deposited under Accession Number KACC 88008BP.
Claim 1 is indefinite because the composition being claimed is unclear. It is presumed that offspring plants obtained through artificial crossing between KHV2 genetic resource as a seed parent and Inida genetic resource as a pollen parent would be genetically and phenotypically different from each other. Accordingly, the language of the claim suggests that the seeds deposited under Accession Number KACC 88008BP may not be a genetically uniform population. Alternatively, if the seeds deposited under Accession Number KACC 88008BP are in fact a genetically uniform population, it is unclear whether claim is intended to be limited to the seeds deposited under Accession Number KACC 88008BP.
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 (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.
(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.
Claim(s) 2 and 9 are is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Reel. U.S. Patent No. 10,888,059, issued Jan. 12, 2021.
Claim 2 is drawn to a progeny plant derived from the hemp cultivar Pinkpepper plant of Claim 1. Because the progeny plant of claim 2 is not required to retain any of the genotypic and phenotypic characteristics of the hemp cultivar Pinkpepper plant of Claim 1, and may be derived from the hemp cultivar Pinkpepper plant of Claim 1 by any unspecified method using any number of genetic resources over the course of any number of generations, the progeny plant of claim 2 is anticipated by any prior art hemp cultivar.
Claim 9 is drawn to a mutant plant obtained by treating the hemp cultivar Pinkpepper plant of Claim 1 with mutagen. Because the mutant plant of claim 9 is not required to retain any of the genotypic and phenotypic characteristics of the hemp cultivar Pinkpepper plant of Claim 1, and may be obtained by treating the hemp cultivar Pinkpepper plant of Claim 1 with any unspecified mutagen using any unspecified method to any unspecified effect, the mutant plant of claim 9 is anticipated by any prior art hemp cultivar.
Reel teach a hemp plant cultivar designated LINDOREA. Accordingly, Reed anticipates claims 2 and 9.
Remarks
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CYNTHIA E COLLINS whose telephone number is (571)272-0794. The examiner can normally be reached M-F 8:30 am - 5:00 pm.
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/CYNTHIA E COLLINS/Primary Examiner, Art Unit 1662