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 .
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
The Petition filed 10 January 2024 was Dismissed in the decision mailed on 22 April 2024. Therefore, the drawings are objected to because they do not comply with 37 CFR 1.84.
Specification
The disclosure is objected to because of the following informalities: There is missing information in paragraph 0020.
Appropriate correction is required.
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.
Claims 1-8 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.
At claim 1, line 2 and claim 6, line 4, the blank/missing information renders the claim(s) indefinite because it is unclear what the metes and bounds of the claim are.
Claims 1, 2, 3 and 6 are indefinite because, “in Table 1” and “in Table 2” fail to set forth the metes and bounds of the claimed invention. Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993). Further, said tables list multiple profiles and it is unclear to which profile the limitation is directed.
Instant claim 1 is directed to a seed from a Cannabis plant designated ‘CK2015’, thus at claims 7 and 8, “the Cannabis plant, or plant part, tissue, or cell thereof” lacks proper antecedent basis in claim 1.
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 1-8 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 a seed from a Cannabis plant designated ‘CK2015’ said plant being obtained by crossing seed parent ‘White Walker OG’ with pollen parent ‘Blue Flame OG Pheno #22’ (page 2, paragraph 0011 of the Specification), and progeny and extracts thereof. Applicant does not teach whether either parent is an inbred or double haploid line, thus the Examiner presumes the parental lines themselves are outcrossed and not inbred.
Applicant teaches that Cannabis plant designated ‘CK2015’ was obtained by crossing seed parent ‘White Walker OG’ with pollen parent ‘Blue Flame OG Pheno #22’ (page 2, paragraph 0011 of the Specification). Applicant teaches that Cannabis plant designated ‘CK2015’ is asexually propagated by cuttings on page 2, paragraph 0013 of the Specification. Applicant further teaches that the cannabinoid and terpene profiles of Cannabis plant designated ‘CK2015’ is highly variable between plants as exemplified in Table 1 on page 7 and Table 2 on page 8. Hence, any seed taken from a Cannabis plant designated ‘CK2015’ 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 a Cannabis plant designated ‘CK2015’, and any deposited seed would not appear to be capable of producing/growing a plant of Cannabis plant designated ‘CK2015’. As addressed above, Cannabis plant designated ‘CK2015’ was produced by 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.
Claims 1-8 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.
Applicant claims a seed from Cannabis plant designated ‘CK2015’ said plant being obtained by crossing seed parent ‘White Walker OG’ with pollen parent ‘Blue Flame OG Pheno #22’ (page 2, paragraph 0011 of the Specification), and progeny and extracts thereof. Applicant does not describe whether either parent is an inbred or double haploid line, thus the Examiner presumes the parental lines themselves are outcrossed and not inbred.
Applicant describes that Cannabis plant designated ‘CK2015’ was obtained by crossing seed parent ‘White Walker OG’ with pollen parent ‘Blue Flame OG Pheno #22’ (page 2, paragraph 0011 of the Specification). Applicant describes that a Cannabis plant designated ‘CK2015’ is asexually propagated by cuttings on page 2, paragraph 0013 of the Specification. Applicant further describes that the cannabinoid and terpene profiles of a Cannabis plant designated ‘CK2015’ is highly variable between plants as exemplified in Table 1 on page 7 and Table 2 on page 8. Hence, any seed taken from a Cannabis plant designated ‘CK2015’ would be widely variable and highly genetically segregating.
Applicant only describes a Cannabis plant designated ‘CK2015’ by how it was produced and by a limited number of morphological characteristics in Table 1 and Table 2. Further, any deposited seed do not appear to describe a Cannabis plant designated ‘CK2015’.
Applicant also does not describe the claimed “descendant”, “plant descended from” or an extract of a Cannabis plant designated ‘CK2015’ 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., In re Lundak, 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.
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) 7 and 8 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Elkins et al (US 2021/0400895).
Applicant claims an extract made from a Cannabis plant designated ‘CK2015’ and a product made from or comprising said extract.
Elkins et al teach extracts from Cannabis plants on page 24 and Table 8 on pages 24-25. Elkins et al further teach extracts and uses thereof in the Abstract on page 1. Elkins et al teach an extract comprising a level of total THC and level of total CBG at a ratio from about 5:1 to about 50:1 at claim 42. The first column of instant Table 1 teaches an extract with a THC:CBG ratio of about 27.8:1 and thus would fall within the range taught in the prior art. The “product” of instant claim 8 is interpreted as an intended use of the “extract” because the extract can be used as a product.
The instant claims would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant claims because the extracts of a Cannabis plant designated ‘CK2015’ would not be distinguishable from extracts from other Cannabis plants having similar cannabinoid and terpene profiled. Given the teachings of Elkins et al, one of ordinary skill in the instant art would have had a reasonable expectation to produce extracts indistinguishable to those of a Cannabis plant designated ‘CK2015’ from other Cannabis plants.
Conclusion
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
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