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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/07/2025 has been entered.
Status of the Claims
Claims 2, 8-12, and 19 are canceled.
Claims 1, 3-7, 13-18, and 20-25 are pending.
Claims 1, 3-7, 13-18, and 20-25 are rejected.
Priority
Application No. 17/860,013 filed on 07/07/2022 claims priority to provisional Application No. 63/219,743 filed on 07/08/2021.
Claim Objections
Claims 22-25 are objected to because of the following informalities: The claims each conclude with two periods. Applicant should amend the claims by deleting one period from each claim. Appropriate correction is required.
Claim Rejections - 35 USC § 112
Indefiniteness
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 21-25 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.
Claims 21-25 recite increasing a transformation rate by 1, 2, 3, 4, or 4.5 fold prior to the steps of culturing and co-cultivating the Cannabis sativa cotyledon. However, itis unclear what the increased transformation rate is being compared against. Additionally, the referenced culturing step is found in claim 1 and utilizes an Agrobacterium transformation method, therefore it is unclear how the transformation rate is increased prior to the culturing step which includes the transformation step. For purposes of examination, the claims are reasonably interpreted as increasing a transformation rate by 1, 2, 3, 4, or 4.5 fold as compared to any other transformation method. This interpretation does not relieve Applicant of the duty to amend and address the recited deficiencies.
Claim Rejections - 35 USC § 103
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 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.
Claims 1, 3-7, 13-18, and 20-25 are rejected under 35 U.S.C. 103 as being unpatentable over Choudry (PCT Patent Application Publication No. WO-2021067645-A1), Hinchee (US Patent No. US-5416011-A1), Preil (Preil, W. (2005). General introduction: a personal reflection on the use of liquid media for in vitro culture. In Liquid culture systems for in vitro plant propagation (pp. 1-18). Dordrecht: Springer Netherlands), Zarei (Zarei, A., Behdarvandi, B., Tavakouli Dinani, E., & Maccarone, J. (2021). Cannabis sativa L. photoautotrophic micropropagation: A powerful tool for industrial scale in vitro propagation. In Vitro Cellular & Developmental Biology-Plant, 57(6), 932-941) and Andre (Andre, C. M., Hausman, J. F., & Guerriero, G. (2016). Cannabis sativa: the plant of the thousand and one molecules. Frontiers in plant science, 7, 19).
Claim 1 is drawn to a method for improved transformation and shoot induction of Cannabis sativa, the method comprising: culturing a Cannabis sativa cotyledon explant utilizing an Agrobacterium transformation method, and co-cultivating the Cannabis sativa cotyledon explant with Agrobacterium; and excluding liquid media from the transformation method.
Claim 3 is drawn to the method of claim 1, further comprising using a regeneration method.
Claim 4 is drawn to the method of claim 3, wherein the regeneration method does not include liquid media.
Claim 5 is drawn to the method of claim 1, further comprising rubbing a surface of the Cannabis sativa cotyledon explant against a lawn of the Agrobacterium.
Claim 6 is drawn to the method of claim 5, further comprising: Ensuring a proximal region of the Cannabis sativa cotyledon explant with the lawn of the Agrobacterium is not in contact with media during co- cultivation.
Claim 7 is drawn to the method of claim 1, wherein the transformation method is biotic transformation method.
Claim 13 is drawn to the method of claim 1, further comprising rubbing a surface of the Cannabis cotyledon explant against an Agrobacterium coated tool.
Claim 14 is drawn to the method of claim 1, further comprising the Cannabis cotyledon explant regenerating a shoot.
Claim 15 is drawn to the method of claim 1, further comprising the Cannabis cotyledon explant regenerating a shoot on a proximal adaxial surface of the Cannabis cotyledon explant.
Claim 16 is drawn to the method of claim 1, further comprising the Cannabis cotyledon explant regenerating a shoot after 15 days on a solid media.
Claim 17 is drawn to the method of claim 1, further comprising the Cannabis cotyledon explant regenerating a shoot on a proximal adaxial surface of the Cannabis cotyledon explant after 15 days on a solid media.
Claim 18 is drawn to the method of claim 1, further comprising the Cannabis cotyledon explant regenerating a plurality of shoots after 15 days on a solid media.
Claim 20 is drawn to the method of claim 1, further comprising the Cannabis cotyledon explant regenerating a shoot on a proximal adaxial surface of the Cannabis cotyledon explant after 3 days of co-cultivation with the Agrobacterium.
Claim 21 is drawn to the method of claim 1, further comprising increasing a transformation rate by 1 fold prior to the steps of culturing and co-cultivating the Cannabis sativa cotyledon.
Claim 22 is drawn to the method of claim 1, further comprising increasing a transformation rate by 2 fold prior to the steps of culturing and co-cultivating the Cannabis sativa cotyledon.
Claim 23 is drawn to the method of claim 1, further comprising increasing a transformation rate by 3 fold prior to the steps of culturing and co-cultivating the Cannabis sativa cotyledon.
Claim 24 is drawn to the method of claim 1, further comprising increasing a transformation rate by 4 fold prior to the steps of culturing and co-cultivating the Cannabis sativa cotyledon.
Claim 25 is drawn to the method of claim 1, further comprising increasing a transformation rate by 4.5 fold prior to the steps of culturing and co-cultivating the Cannabis sativa cotyledon.
Regarding claim 1, Choudhry teaches a Cannabis transformation and regeneration method (Example 4, ¶0676-0690), which is reasonably interpreted as the species Cannabis sativa from Choudhry’s repeated reference to the recited species throughout the document (¶0497-0498, 0504, 0510, 0514, 0517, Tables 2-5, Fig. 7A, claim 159 of Choudhry). Choudry teaches culturing a Cannabis cotyledon explant using an Agrobacterium transformation method, and co-cultivating the explants with Agrobacterium (¶0680-0682).
Regarding claim 3, Choudhry teaches the method further comprises a regeneration method (¶0683-0690).
Regarding claim 4, Choudhry teaches the cotyledon co-culture/ regeneration medium uses 8 g/ L of Agar (¶0683-0690) (i.e. wherein the regeneration method does not include liquid media).
Regarding claim 7, Choudhry teaches the transformation method is an Agrobacterium transformation method (¶0679-0680) (i.e. wherein the transformation method is a biotic transformation method).
Regarding claims 14-18, Choudhry teaches the first round of selection is 15 days on regeneration media that comprises 8 g/ L of Agar (¶0683-0690), and for cotyledon explants the callus may be formed in the proximal side, and shoots may be visible (0684-0685) (i.e. the cotyledon explant regenerating a shoot and also regenerating a plurality of shoots after 15 days on solid media). Choudhry teaches the shoots may regenerate from the proximal side, and also teaches in Figs. 16 b-c the shoots appear from the adaxial side of the explant (¶0685 and Fig. 16 b-c) (i.e. regenerating a shoot on a proximal adaxial surface of the Cannabis cotyledon explant after 15 days on solid media).
Regarding claim 20, Choudhry teaches the method includes co-cultivating the explants with Agrobacterium for 3 days (¶0682), then Choudhry teaches the shoots may regenerate from the proximal side, and also teaches in Figs. 16 b-c the shoots appear from the adaxial side of the explant (¶0685 and Fig. 16 b-c) (i.e. the Cannabis cotyledon explant regenerating a shoot on a proximal adaxial surface of the Cannabis cotyledon explant after 3 days of co-cultivation with the Agrobacterium).
However, Choudhry does not explicitly teach:
excluding liquid media from the transformation method (remaining limitation of claim 1).
The method of claim 1, further comprising rubbing a surface of the Cannabis sativa cotyledon explant against a lawn of the Agrobacterium (claim 5).
The method of claim 5, further comprising: ensuring a proximal adaxial region of the Cannabis sativa cotyledon explant with the lawn of the Agrobacterium is not in contact with media during co-cultivation (claim 6).
The method of claim 1, further comprising rubbing a surface of the Cannabis cotyledon explant against an Agrobacterium coated tool (claim 13).
The method of claim 1, further comprising increasing a transformation rate by 1 fold (claim 21).
Regarding the remaining limitation of claim 1, in analogous art, Hinchee teaches Agrobacterium-mediated transformation of soybean cotyledon explants, and the transformation method directly applies the Agrobacterium to the cotyledon without the use of liquid media (Col. 7, lines 11-32) (i.e. the remaining limitation of claim 1 that is excluding liquid media from the transformation method).
Regarding claim 5, Hinchee also teaches using a bacteria loop to obtain Agrobacterium from a bacteria plate, and the loop is smeared on the cotyledon (Col. 7, lines 27-30) (i.e. reasonably interpreted as a collecting a lawn of Agrobacterium from the plate and rubbing the surface of the cotyledon explant against the lawn of Agrobacterium).
Regarding claim 6, Hinchee also teaches the inoculated cotyledon is positioned adaxial side up, and the petiole is positioned so it is not in contact with the medium, and the plates with the explants are wrapped and transferred 3-4 days later (Col. 7, lines 22-26 and 35-42, Fig. 3(b)) (i.e. if the cotyledon explant is adaxial side up and the petiolar region is not in contact with the media, the proximal adaxial region of the explant would also reasonably be interpreted to not be in contact with media during the co-cultivation period).
Regarding claim 13, Hinchee also teaches using a bacteria loop to obtain Agrobacterium from a bacteria plate, and the loop is smeared on the cotyledon (Col. 7, lines 27-30) (i.e. rubbing a surface of the cotyledon explant against an Agrobacterium coated tool).
Regarding claim 21, Hinchee teaches using a bacteria loop to obtain Agrobacterium from a bacteria plate, the loop is smeared on the cotyledon (Col. 7, lines 27-30), the cotyledon explants are positioned on the plate adaxial side up (Col. 7, lines 25-26), and the part of the explant away from the petiole is dug into the medium so the petiolar region is not in contact with the media (Col. 7, lines 35-39). Hinchee teaches this method has been found in many cases to obtain higher frequencies (referencing transformation frequencies from the inoculation method taught by Hinchee). Therefore, because higher transformation frequencies are obtained, and any increase in transformation frequency encompasses the range of increasing a transformation rate by 1 fold (i.e. 0%), Hinchee teaches further comprising increasing a transformation rate by 1 fold).
It would therefore have been obvious to a person of ordinary skill in the art to modify the invention of as taught by Choudhry to include the limitations of Hinchee to arrive at the instantly claimed method with a reasonable expectation of success because Choudhry teaches a method of Agrobacterium-mediated transformation and regeneration of Cannabis and Hinchee also teaches a method of Agrobacterium- mediated transformation for soybean plants rather than Cannabis, and one of ordinary skill in the art could incorporate the methods of Hinchee into the method of Choudhry without any special technical difficulties. One having ordinary skill in the art would have been motivated to combine the methods because Andre teaches Cannabis is a notoriously recalcitrant species (p. 10, 77), Zarei teaches Cannabis tissue-culture displays a high degree of plantlet hyperhydricity and low shoot proliferation (abstract, introduction, ¶1, conclusion, ¶1), and Preil teaches liquid cultures are known to cause detrimental issues such as hyperhydricity (vitrification) (p. 5, 74). Given this information that is well known in the art, it would be prima facie obvious to incorporate a “dry” transformation method taught by Hinchee into the Cannabis transformation method taught by Choudhry to avoid recalcitrance issues (including hyperhydricity of which Cannabis tissue-culture is susceptible to) that arise from the use of liquid cultures.
Claims 22-25 are also obvious because the result of increased transformation rate is an inherent outcome of the transformation method. Hinchee and Choudhry teach the method of claim 1 which claims 22-25 depend from), requiring culturing a Cannabis sativa cotyledon explant utilizing an Agrobacterium transformation method, and co- cultivating the Cannabis sativa cotyledon explant with Agrobacterium, and excluding liquid media from the transformation method. The instant specification provides evidence that applying the method of Hinchee to Cannabis plants increases the transformation rate of Cannabis cotyledon explants by 1 to 4.5 fold (0018 and Fig. 2). Therefore, the increases in transformation rate are inherent to the method taught by Hinchee when applied to Cannabis cotyledon explants in view of Applicant’s evidence, absent any evidence to the contrary.
Response to Arguments
Applicant argues on p. 5 of remarks dated 11/07/2025 the
following arguments:
In the Final Office Action, claims 21-25 were rejected under 35 U.S.C. §112 as being indefinite. The Applicant has amended these claims to address the Examiner's rejections. Specifically, the increased transformation rate is defined relative to the processes of culturing and co-cultivating the Cannabis.
Accordingly, Applicant respectfully requests that the rejection under 35 U.S.C. §112 be withdrawn.
This argument has been fully considered and is found not persuasive for
the following reason(s):
It remains unclear what claims 21-25 are being compared to, e.g. if the transformation rate is increased by 1 (or 2, 3, 4, or 4.5) fold compared to any other transformation method or compared to a specific transformation method. The amendments also present additional 112(b) indefiniteness issues because it is unclear how the transformation rate could be increased prior to the step of co-culturing and co-cultivating the Cannabis sativa cotyledon when the co-culturing step encompasses the transformation step (see 112(b) rejection above). For these reasons, the claims remain rejected under 35 USC 112(b).
Applicant argues beginning on p. 5 of remarks dated 11/07/2025 the
following arguments:
In the Final Office Action, claims 1, 3-7, 13-18 and 20-25 were rejected under 35 U.S.C. § 103 as being obvious in light of Chaudhry (PCT Patent Application Publication No. WO-2021067645-A 1 ), in view of Hinchee (US Patent No. US-5416011-A), and further in view of Preil (Preil, W. (2005).
An asserted combination must teach or suggest each and every claim feature. SeeIn re Royka, 490 F.2d 981, 180 USPQ 580 (CCPA 1974) (to establish prima facie obviousness of a claimed invention, all the claim features must be taught or suggested by the prior art). It remains well-settled law that obviousness under 35 U.S.C. § 103(a) requires at least a suggestion of all of the features in a claim. See, e.g., In re Wada and Murphy, citing CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003) and In re Royka, 490 F.2d 981, 985 (CCPA 1974)). Because the cited documents fails to suggest or disclose at least one claim element for each of the pending claims, Applicant transverses these rejections.
In the Applicant's prior response, claim 1 was amended to include the limitation: "and excluding liquid media from the transformation method." In the Final Office Action, the Examiner did not cite any instance of the prior art references disclosing this limitation. In fact, the primary prior art reference, Chaudry, specifically provides multiple instances in which this limitation is taught away within the reference. In fact, there are multiple instances within the Chaudry specification in which liquid is used within the processes of transforming Cannabis. Nowhere do any of the references teach or suggest not using liquid media within the transformation method.
Accordingly, the Applicant respectfully requests that the rejection of the claims under 103 be withdrawn.
This argument has been fully considered and is found not persuasive for
the following reason(s):
Applicant argues the Examiner did not cite any instance of the prior art references disclosing the limitation of “excluding liquid media from the transformation method”. However, the reference of Hinchee was used to address this limitation by specifically teaching transforming (soybean) cotyledons by rubbing a bacterial loop against a bacterial plate then smearing the bacteria collected on the loop into the cotyledon explant. Thus, Hinchee teaches excluding liquid media from the transformation method. Motivations to combine the teachings are found in Andre, Preil, and Zarei who teach Cannabis is recalcitrant and susceptible to hyperhydricity which is detrimental to tissue culture and micropropagation, and use of liquid media can induce hyperhydricity (see 103 rejection above). Based on the motivations of Andre, Preil, and Zarei, one would be motivated to incorporate the known dry transformation method of Hinchee into the Cannabis transformation of Chaudry to avoid hyperhydricity that can be caused by use of liquid media.
Applicant also argues Chaudry teaches away from excluding liquid media from the transformation method. Although Chaudry’s methods are drawn to transformation using liquid media, Chaudry does not appear to teach away from this method anywhere in the reference. Applicant should point out specific examples and their locations within the reference if Applicant has identified instances of teaching away.
For the reasons above, Applicant’s argument is not found persuasive.
Conclusion
No claims are allowed.
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JESSICA N. STOCKDALE
Examiner
Art Unit 1663
/JESSICA NICOLE STOCKDALE/Examiner, Art Unit 1663
/CHARLES LOGSDON/Primary Examiner, Art Unit 1662