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
Claims 202-213 and 216-233 are pending. Claims 1-201, 214 and 215 have been cancelled. Claims 202-212 and 217-221 have been withdrawn from consideration. Claims 213, 216 and 222-233 are hereby examined.
The rejection of claim(s) 213 under 35 U.S.C. 102(a)(2) as being anticipated by Barrera et al (Pub. No. US 2024/0049666 A1) is withdrawn in light of the amendments as Barrera et al pertains to the PRR37 gene on chromosome 1 of Cannabis.
The rejection of claim(s) 213 under 35 U.S.C. 102(a)(2) as being anticipated by Barrera et al (Pub. No. US 2024/0130311 A1) is withdrawn in light of the amendments as Barrera et al pertains to the PRR37 gene on chromosome 1 of Cannabis.
The rejection of claims 213, 214, 216 and 222 under 35 U.S.C. 103 as being unpatentable over Barrera et al (Pub. No. US 2024/0049666 A1) in view of Nakamichi et al (2020, Bioscience, Biotechnology, and Biochemistry, 84(5):970-979) and McKernan (Pub. No. US 2016/0177404 A1) is withdrawn as Barrera et al pertains to the PRR37 gene on chromosome 1 of Cannabis.
Election/Restrictions
Applicant elected without traverse the invention of Group II directed to claims 213-216 in the reply filed on 22 December 2025. Claims 202-212 and 217-221 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Specification
The objection to the drawings for including nucleotide and/or amino acid sequences appearing in the drawings not identified by sequence identifiers is withdrawn in light of the amendments.
The objection to the specification for including nucleotide and/or amino acid sequences not identified by sequence identifiers is withdrawn in light of the amendments.
Claim Objections
The objection to claim 213 is withdrawn in light of the amendments.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
The claimed invention as encompassed by claims 213, 216 and 222 REMAIN directed to a natural phenomenon without significantly more, and claims 223-233 are NOW directed to a natural phenomenon without significantly more.
Claim(s) 213, 216 and 222-233 recite(s) a method for identifying a trait in a Cannabis plant comprising obtaining nucleic acids to determine the presence or absence of a variation as indicator of the trait at a polymorphic site within a low-recombination region or an allele in linkage disequilibrium with the polymorphic site in said region and is thus considered a natural phenomenon as the method merely correlates variation with location in the Cannabis genome.
This judicial exception (JE) is not integrated into a practical application because obtaining and testing for this naturally occurring phenomenon does not add any meaningful limitation to the presence or absence of said naturally occurring phenomenon.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the JE. In light of the absence of a practical application and additional elements to amount to significantly more than the JE the instant method precludes anyone that is skilled in the art from obtaining and testing nucleic acids in a Cannabis plant for the presence or absence of variations at polymorphic sites or alleles in linkage disequilibrium in low-recombination regions.
Response to Arguments
Applicant traverses the rejection in light of the amendments which recite steps of physically obtaining nucleic acids and testing them which is a practical application that is significantly more than the judicial exception (Applicant reply dated 06 July 2026, p. 11, last ¶).
This argument is not persuasive because the issue is not merely whether the JE is integrated into a practical application, but is also whether the claim recites additional elements that amount to significantly more than the JE.
Here, the JE is not considered to be integrated into a practical application because obtaining and testing nucleic acids that is an indicator of the trait does not, in fact, use the JE in a manner that imposes a meaningful limit of the JE. In other words, obtaining and testing nucleic acids does nothing more than generally link the use of the JE to molecular biology assays and are a nominal and insignificant relationship to the exception that does not apply or use the JE in any way.
Assuming even arguendo that the claims recite a practical application, the claims fails to recite additional elements that are sufficient to amount to significantly more than the claimed JE. Here, the inventive concept is that a gene in Cannabis is responsible for autoflowering. However, none of the claims are directed to using this concept in any meaningful way that amounts to more than the JE as addressed above.
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 213, 216 and 222-233 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 213 recite the limitation wherein the low-recombination region is an “approximately” 20 megabase region. The metes and bounds of the claim are indefinite because the limitation is subjective and not defined by the specification such that one would not know the location of the region.
The issue is compounded by the fact that claim does not provide a reference position in the chromosome for where the region is located, and because the limitation “between about” means that the region can be found in a position that ranges from more less than 40 megabases to greater than 60 megabases.
Claim 213 also recites the limitation is a carrier of “a trait” for day length neutral phenotype. Here, the specification fails to define the limitation “trait”. Because the specification fails to define “trait”, the limitation is understood to mean something measurable, for example, a phenotype.
Therefore, the metes and bounds of the claim are indefinite because it is not clear what is meant by the variation indicates the plant is a carrier of a phenotype for a phenotype. Instead, one of skill in the art would understand that the variation indicates the plant has the day length neutral phenotype, or that the variation indicates the plant is a carrier an allele for day length neutral phenotype.
Finally, the metes and bounds of the claim are indefinite because it is not clear if the claim is meant to encompass identifying “a” (i.e., more than one trait), or, if the claim is meant to encompass a method for only identifying the trait of a day length neutral phenotype.
Claims 216 and 222-233 are rejected for depending upon a rejected base claim and for failing to remedy the issues of indefiniteness.
Claims 213, 222, 223 and 233 are rejected under 35 U.S.C. 112, 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(s), at the time the application was filed, had possession of the claimed invention. THIS IS A NEW MATTER REJECTION.
37 CFR 1.118 (a) provides that "No amendment shall introduce new matter into the disclosure of an application after the filing date of the application".
In the instant case, the claims have been amended to include limitations that were not previously claimed, and adequate support for the newly claimed limitations are not found in the disclosure.
For instance, claim 213 has been amended to include the limitation where the region is an “approximately” 20 megabase region.
While the specification uses the term “approximately”, it is not used in relation to where the low-recombination region is found in chromosome 5. Furthermore, the specification has been thoroughly searched and support for “approximately” cannot be found.
Applicant is invited to point to the specification where support can be found. THIS IS A NEW MATTER REJECTION.
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 213, 216 and 222 REMAIN rejected, and claims 223-233 are NOW rejected, under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method to detect SEQ ID NO: 146, does not reasonably provide enablement for a method to test the genus of variations in polymorphic sites as broadly claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
In In re Wands (8 USPQ2d 1400 (CAFC 1988)), the CAFC considered the issue of enablement in molecular biology. The CAFC summarized eight factors to be considered in a determination of "undue experimentation". These factors include: (a) the quantity of experimentation; (b) the amount of guidance presented; (c) the presence or absence of working examples; (d) the nature of the invention; (e) the state of the prior art; (f) the predictability of the prior art; (g) the breadth of the claims; and (h) the relative skill in the art. The factors are analyzed in turn for the instant case as follows:
Here, the claims are broadly drawn to a method comprising identifying a trait comprising obtaining and testing nucleic acids from a Cannabis plant to determine the presence or absence of a variation at any conceivable polymorphic site within a low-recombination region in the Cannabis genome or an allele in linkage disequilibrium with the polymorphic site within the low-recombination region and the variation indicates the plant is a carrier of a “trait” for day length neutral phenotype, wherein the low recombination region is in an “approximately” 20 megabase region in chromosome 5 (CM010796.2) between about 40 megabases to about 60 megabases and wherein the polymorphic site is a PRR7 gene.
Meanwhile, the specification teaches that PRR7 expression decreases in photoperiod plants upon transition to flowering while its expression remains constant in autoflowering plants (e.g., see p. 13 and Figure 5). The specification teaches a cross between a photosensitive plant MOT19P06/Tangerine Dream and an autoflowering plant BAT1804/Blue Dream Auto (p. 33).
The specification suggests the genetic underpinning of the autoflowering trait is located in a 20 MB region that has undergone very little recombination with photosensitive genotypes and that further crossing experiments provided evidence for a significantly reduced linkage region with a minimum size of about 0.75 Mb to a maximum size of about 2.5 Mb within the 20 Mb region (p. 36; see also p. 37, ¶ 1).
The specification teaches that of 1172 genes located in a 20 MB low recombination region in chromosome CM010796.2 a subset of 14 genes were identified as actively expressed in both autoflowering and photoperiod sensitive plants with PRR7 located within 0.75 MB and 2.5 MB linkage regions (p. 41, last ¶ bridging p. 42).
PRR7 is homologous to Arabidopsis PRR7 and is known to be involved in the circadian clock and with mutant flowering phenotypes (p. 42, ¶ 1). Non-functional PRR7 gene in Cannabis display the same autoflowering phenotype as Arabidopsis PRR7 mutants (p. 45, last ¶).
The specification teaches the predicted mutational effects on PRR7 protein is severe strongly indicating non-functional PRR7 protein is causative of day length neutral phenotype (p. 44, last ¶). These mutants display similar phenotypes as compared to Arabidopsis PRR7 mutants and that its early downregulation suggests it as a likely candidate for controlling flowering time (p. 45 ¶ 1; see also p. 48, last ¶; p. 51, last ¶). The specification teaches no other clock genes have been identified in the linkage region and no mutations have been identified in other clock genes such that PRR7 likely regulates other clock genes and represses flowering (p. 51, last ¶).
However, aside from teaching a method to determine the presence of a limited number of variations at polymorphic sites in a particular low-recombination region, the specification fails to teach the methods as broadly claimed wherein any variation in an approximately 20 megabase region as claimed or that the variation indicates the plant is a carrier of a “trait” for day length neutral phenotype.
Here, the claims encompass testing a vast genus of nucleic acids and “traits” for day length neutral phenotype yet the specification only teaches a limited number of variations at polymorphic sites and on a particular chromosome and in a particular region of said chromosome.
This guidance is critical in light of the state of the art: Leckie et al teach that Arabidopsis prr7 single mutants have a slight effect on flowering time and do no significantly disrupt the circadian rhythms of CCA1 and that it is a splice mutation in csPRR37 that causes autoflowering (2024, The Plant Journal, 118:2020-2036; p. 2030, col. 1, last ¶ bridging col. 2; see also p. 2021, col. 1, last ¶ bridging col. 2).
Here, the claims encompass genes other than PRR7 yet the art teaches even this gene may not indicate a day length neutral phenotype. Therefore, and aside from testing for PRR7, the skilled artisan would be unable to predictably use the methods as claimed to determine the presence or absence of other variations at other polymorphic sites as broadly claimed and that may indicate the plant is a carrier of a “trait” for day length neutral phenotype.
Thus, in light of the breadth of the claims, the lack of working examples, the lack of guidance and the state of the art, the skilled practitioner would be unable to predictably use the method as broadly claimed without resorting to impermissible undue trial and error experimentation.
Response to Arguments
Applicant traverses the rejection because the claims have been limited to the presence of the variation that indicates the plant has a day length neutral phenotype and that it would not be undue experimentation to do so (Applicant reply dated 06 July 2026, p. 12, last ¶).
This argument is not persuasive because the claims remain drawn to a vast genus of nucleic acids with variations which require undue trial and error experimentation to determine if these variations indicate the plant has day length neutral phenotype or is a carrier of a trait for day length neutral phenotype.
Claims 213, 216 and 222 REMAIN rejected, and claims 223-233 are NOW 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.
Claims 213, 214, 216 and 222-233 are broadly drawn to a method comprising testing nucleic acids from a Cannabis plant to determine the presence or absence of a variation at any conceivable polymorphic site within a low-recombination region in the Cannabis genome or an allele in linkage disequilibrium with the polymorphic site within the low-recombination region and the variation indicates the plant is a carrier of a “trait” for day length neutral phenotype, wherein the low recombination region is in chromosome CM010796.2 from about 40 megabases to about 42.5 megabases and wherein the polymorphic site is a PRR7 gene.
Meanwhile, the specification describes that PRR7 expression decreases in photoperiod plants upon transition to flowering while its expression remains constant in autoflowering plants (e.g., see p. 13 and Figure 5). The specification describes a cross between a photosensitive plant MOT19P06/Tangerine Dream and an autoflowering plant BAT1804/Blue Dream Auto (p. 33).
The specification suggests the genetic underpinning of the autoflowering trait is located in a 20 MB region that has undergone very little recombination with photosensitive genotypes and that further crossing experiments provided evidence for a significantly reduced linkage region with a minimum size of about 0.75 Mb to a maximum size of about 2.5 Mb within the 20 Mb region (p. 36; see also p. 37, ¶ 1).
The specification describes that of 1172 genes located in a 20 MB low recombination region in chromosome CM010796.2 a subset of 14 genes were identified as actively expressed in both autoflowering and photoperiod sensitive plants with PRR7 located within 0.75 MB and 2.5 MB linkage regions (p. 41, last ¶ bridging p. 42).
PRR7 is homologous to Arabidopsis PRR7 and is known to be involved in the circadian clock and with mutant flowering phenotypes (p. 42, ¶ 1). Non-functional PRR7 gene in Cannabis display the same autoflowering phenotype as Arabidopsis PRR7 mutants (p. 45, last ¶).
The specification describes the predicted mutational effects on PRR7 protein is severe strongly indicating non-functional PRR7 protein is causative of day length neutral phenotype (p. 44, last ¶). These mutants display similar phenotypes as compared to Arabidopsis PRR7 mutants and that its early downregulation suggests it as a likely candidate for controlling flowering time (p. 45 ¶ 1; see also p. 48, last ¶; p. 51, last ¶). The specification describes no other clock genes have been identified in the linkage region and no mutations have been identified in other clock genes such that PRR7 likely regulates other clock genes and represses flowering (p. 51, last ¶).
The written description requirement may be satisfied through sufficient description of a representative number of species by disclosing relevant and identifying characteristics such as structural or other physical and/or chemical properties, by disclosing functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the invention as claimed. See Eli Lilly,119 F.3d at 1568, 43 USPQ2d at 1406.
However, aside from describing a method to determine the presence of a limited number of variations at polymorphic sites in a particular low-recombination region, the specification fails to describe determining the presence or absence of a representative number of species from the broad genus of any variant at any polymorphic site whatsoever.
Here, the claims encompass testing a vast genus of nucleic acids yet the specification only teaches a limited number of variations at polymorphic sites and on a particular chromosome and in a particular region of said chromosome. In fact, the methods as claimed would preclude virtually anyone from testing for variations at polymorphic sites in the Cannabis genome.
The Federal Circuit has clarified the application of the written description requirement. The court stated that a written description of an invention "requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials." University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997).
The court also concluded that "naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material." Id.
Further, the court held that to adequately describe a claimed genus, Patent Owner must describe a representative number of the species of the claimed genus, and that one of skill in the art should be able to "visualize or recognize the identity of the members of the genus." Id. See MPEP 2163.
Applicant should note that the written description requirement serves to warn an innocent purchaser of the infringement of a patent, and conversely requires the patentee to distinguish the invention in the disclosure, and thus prevents the inventor from practicing upon the credulity or fears of other persons or from pretending that the invention is more than what it is. see Vas-Cath Inc. v. Mahurkar 1991 (CA FC) 19 USPQ2d 1111, 1115.
Here, the instant specification has described a method to determine nucleic acid variations in particular genes rather than a method to test all variations in the Cannabis genome such that a skilled artisan would not be of the opinion that Applicant was in possession of methods as broadly claimed.
As such, these claims are “reach through” claims in which Applicant has only described a starting material and at least one method step, but has not described the resulting product such that the genus of products that can be produced by the recited method steps and materials is so large that one of skill in the art would not readily envision the members of the claimed genus. (See Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004)).
A description of a representative number of variants at polymorphic sites is critical in light of the state of the art: Leckie et al describe that prr7 single mutants have a slight effect on flowering time and do no significantly disrupt the circadian rhythms of CCA1 and that it is a splice mutation in csPRR37 that causes autoflowering (p. 2030, col. 1, last ¶ bridging col. 2; see also p. 2021, col. 1, last ¶ bridging col. 2).
Here, the claims encompass genes other than PRR7 yet the art teaches even this gene may not indicate a day length neutral phenotype. Therefore, and aside from testing for PRR7, the skilled artisan would not be of the opinion that Applicant possesses the methods as broadly claimed to determine the presence or absence of other variations at other polymorphic sites as broadly claimed and that may indicate the plant is a carrier of a “trait” for day length neutral phenotype.
Response to Arguments
Applicant traverses the rejection because the claims have been limited to the presence of the variation that indicates the plant has a day length neutral phenotype and that it would not be undue experimentation to do so (Applicant reply dated 06 July 2026, p. 12, last ¶).
This argument is not persuasive because the claims remain drawn to a vast genus of nucleic acids with variations which require undue trial and error experimentation to determine if these variations indicate the plant has day length neutral phenotype or is a carrier of a trait for day length neutral phenotype.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 213 REMAINS rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,002,546 B2 (referred to herein as ‘546). Although the claims at issue are not identical, they are not patentably distinct from each other because instant claim 213 is drawn to a method comprising testing nucleic acid from a Cannabis plant to determine the presence or absence of a variation at a polymorphic site within a low-recombination region in the plant or an allele in linkage disequilibrium with the polymorphic site within said region wherein the low recombination region is an approximately 20 megabase region in chromosome 5 (CM010796.2) between about 40 and 60 megabases wherein the presence of the variation indicates day length neutral phenotype or the plant is a carrier of a trait for said phenotype.
Meanwhile, ‘546 claims a method for producing a Cannabis plant having a day length neutral phenotype comprising testing nucleic acid to determine the presence or absence of an allele that is in linkage disequilibrium with a variation in a polymorphic site of the UPF2 gene (see claim 1).
Therefore, prior to the effective filing date of the instant invention it would have been prima facie obvious to one of ordinary skill in the art to arrive at the method as claimed because ‘546 claims a method which is a species within the genus of the instantly claimed methods.
Response to Arguments
Applicant traverses the rejection because of the amendments to the claims (Applicant reply dated 06 July 2026, p. 18).
This argument is not persuasive because the instant claim still encompasses identifying nucleic acids to determine the presence of a variation indicating day length neutral phenotype: UPF2 in claim 1 of ‘546 is a nucleic acid in a low recombination region that is in an approximately 20 megabase region in chromosome 5 (CM010796.2) between about 40 to 60 megabases and is indicative of a day length neutral phenotype.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662
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