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
1. Claims 25-31 are pending and under examination to the extent of the elected species of SEQ ID NO:128.
Claims 32-43 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 31, 2025.
Restrictions/Elections
2. The Office acknowledges receipt of Applicant’s restriction election filed February 27, 2025. Applicant elects Group I, claims 25-31, and the species of SEQ ID NO:128. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Therefore, claims 32-43 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention(s), there being no allowable generic or linking claim.
However, method claims may be rejoined in accordance with In re Ochiai when
allowability is indicated.
The requirement is deemed proper and is made FINAL.
Priority
3. This application is a 371 of Internation Application No. PCT/US2021/051535 filed September 22, 2021. The Office acknowledges receipt of Applicant’s domestic priority documents Provisional Application No. 63/081,900 filed on September 22, 2020 and Provisional Application No. 63/188,354 filed on May 13, 2021.
Information Disclosure Statement
4. The information disclosure statement (IDS) submitted on March 22, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered to the extent of the English translations provided.
Specification
5. The disclosure of the specification is objected to because of the following:
[0016], ln. 1 contains a typographical error; a word appears to be missing in the phrase “provided is nucleic acid molecule”. It is recommended Applicant amend the phrase to correct the incorrect subject-verb agreement.
[0044], ln. 1 contains a grammatical error; “SEQ ID NO:95 show” should be amended to “SEQ ID NO:95 shows” for proper subject-verb agreement.
p. 048 contains a typographical error; “Cannabis” should be italicized in the title of Example 3. It is standard in the art to italicize the formal names of genes, genus, and species. Likewise, “CBDAS” should be italicized in the title of Example 5 on p. 50.
Appropriate correction is required.
Claim Objections
6. Claims 25-31 are objected to because of the following:
Claim 25 contains a typographical and/or grammatical error. “THCAS” and “CBCAS” should be italicized wherein “THCAS” and “CBCAS” refer to a gene name. It is standard in the art to italicize formal names when referring to genes, species, and genera. See, also: claims 26-28.
Dependent claims are included.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
7. 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.
8. Claims 25-31 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.
The metes and bounds of claim 25 are indefinite because lns. 3-6 contain grammatical and syntactical errors that obscure the intended recitation of the claim. In particular, the phrase “and being between 20 and 30 nucleotides in length which is substantially identical” is unclear and confusing, as discussed further below. It is suggested Applicant amend the claim to use language more similar to that found in paragraph [0014]. See, also: claim 26, lns. 2-3; claim 27, lns. 2-3; and claim 28, lns. 2-3, which have similar issues.
The metes and bounds of claim 25 are indefinite because it is unclear if it the first nucleotide sequence (ln. 4), the first polyribonucleotide sequence (ln. 4), or both are substantially identical to the complement or reverse complement of a Cannabis THCAS/CBCAS gene of SEQ ID NO:1. It is similarly unclear if the first nucleotide sequence (ln. 4), the first polynucleotide sequence (ln. 4), or both are between 20 and 30 nucleotides in length. The presence of multiple reasonable interpretations renders the claims indefinite.
The metes and bounds of claim 25 are indefinite because it is unclear if the second nucleotide sequence (ln. 7), the second polyribonucleotide sequence (ln. 7), or both are substantially the reverse complement of the first nucleotide sequence. The presence of multiple reasonable interpretations renders the claims indefinite.
Dependent claims are included.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
9. 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.
10. Claims 25-28 and 30-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boudko et al. (US-2018/0258439-A1, published 09/13/2018 (Applicant’s IDS)).
Regarding claim 25, Boudko teaches a nucleic acid molecule comprising at least one polynucleotide operably linked to a plant promoter that functions in a Cannabis plant[0007] (see: Abstract; Claims 1-3), wherein the polynucleotide encodes a hairpin RNA (hpRNA) molecule[0026], [0028], [0064], [0129], [0198], [0318], [0320], and wherein the hpRNA molecule comprises: a first nucleotide sequence encoding a first polyribonucleotide, wherein the first nucleotide sequence is between 20 and 30 nucleotides in length and is substantially identical to the complement or reverse complement of a Cannabis THCAS gene of Applicant’s SEQ ID NO:1[0320], and a second nucleotide sequence encoding a sense polyribonucleotide in the hpRNA molecule that is substantially the reverse complement of the first nucleotide sequence[0320] (see: Claims 1-7; Figures 3-5; Sequence Listing: SEQ ID NO:72), wherein the first and second nucleotide sequence are separated in the polynucleotide by a nucleotide sequence that encodes a loop structure in the hpRNA molecule[0028], [0064], [0129] .
Regarding claim 26, in addition to the teachings discussed above, the first nucleotide sequence taught by Boudko comprises at least 12 contiguous nucleotides of the complement or reverse complement of Applicant’s SEQ ID NO:1 (see: Claim 6; Sequence Listing: SEQ ID NO:72).
Regarding claim 27, in addition to the teachings discussed above, the first nucleotide sequence taught by Boudko comprises at least 12 contiguous nucleotides of the complement or reverse complement of Applicant’s SEQ ID NO:17 (see: Claim 6; Sequence Listing: SEQ ID NO:41).
Regarding claim 28, in addition to the teachings discussed above, the first nucleotide sequence taught by Boudko comprises at least 12 contiguous nucleotides of the complement or reverse complement of Applicant’s SEQ ID NO:28 (see: Claim 6; Sequence Listing: SEQ ID NO:3).
Regarding claim 30, in addition to the teachings discussed above, the polynucleotide taught by Boudko does not comprise 8 or more contiguous nucleotides of SEQ ID NO:103 (see: Claim 6; Sequence Listing: SEQ ID NO:3).
Regarding claim 31, in addition to the teachings discussed above, Boudko teaches a vector configured to express the recited nucleic acid molecule[0022], [0029], [0318-0321].
Accordingly, the claimed invention is anticipated by the prior art.
Claim Rejections - 35 USC § 103
11. 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.
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.
12. Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Boudko et al. (US-2018/0258439-A1, published 09/13/2018 (Applicant’s IDS)) as applied to claims 25-28 and 30-31 above.
The teachings of Boudko are as discussed above in the rejection of the claims under 35 U.S.C. 102(a)(1).
Regarding claim 29, in addition to the teachings discussed above, Boudko teaches a polynucleotide sequence that encodes a hairpin RNA molecule that inhibits expression of THCAS[0026], [0028], [0064], [0129], [0198], [0318], [0320] (see: Claims 1-7; Figures 3-5; Sequence Listing: SEQ ID NOs:3, 41, and 72).
Boudko does not teach SEQ ID NO:128.
However, the hairpin RNA molecule taught by Boudko comprises polynucleotide sequences that complement and target the THCAS gene of Applicant’s SEQ ID NO:1. The generation of hairpin RNAs, other RNAi silencing constructs, and methods of knocking out or silencing gene expression are routine in the art as demonstrated by both Boudko[0014], [0082], [0169-0180], [0183-0204] and Applicant’s disclosure [0119-0139]. One of ordinary skill in the art would expect, absent a claim of unexpected results, that any two gene-silencing hairpin RNAs that target the same gene would result in the same effect (i.e., a reduction in the expression of said gene) even if the sequence of those two hairpin RNAs were distinct. It would have been obvious to one of ordinary skill in the art at the time the invention was filed, to have produced a nucleic acid molecule encoding an hpRNA comprising sequences that are reverse complementary, from any subsequence from the THCAS gene of Boudko, to target the THCAS gene in Cannabis, including an hpRNA that is identical to instant SEQ ID NO: 28. One would have been motivated to do so, as all such hpRNAs based on sequences from the THCAS gene would inhibit the THCAS gene, and be considered functional equivalents. Applicant provides no evidence or claim that a hairpin RNA construct comprising SEQ ID NO:128 would provide any surprising or unexpected results when compared to the effects of the hairpin construct taught by Boudko. Thus, the claimed construct and its effect are rendered obvious in view of the teachings of Boudko. See MPEP 716.02.
Accordingly, one of ordinary skill in the art would have been motivated to produce the claimed invention with a reasonable expectation of success and without any surprising results.
Conclusion
13. No claim is allowed.
Examiner’s Contact Information
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEQUANTARIUS JAVON SPEED whose telephone number is (703)756-4779. The examiner can normally be reached M-F; 9AM-5PM ET.
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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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/DEQUANTARIUS JAVON SPEED/Junior Examiner, Art Unit 1663 /Amjad Abraham/SPE, Art Unit 1663