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 1-2, 18, 19, 32, 33, 38, 54-56, 62, 64-72 are pending. Claims 3-17, 20-31, 34-37, 39-53, 57-61 and 63 have been cancelled.
Election/Restrictions
Applicant’s election of the invention of Group I, and the species of position 50,854,826 on chromosome 7 in the reply filed on 13 April 2026 is acknowledged. 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)).
Claims 19, 38 and 67 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species there being no allowable generic or linking claim. Claims 1-2, 18, 32, 33, 54-56, 62, 64-66 and 68-72 are hereby examined.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The specification is also objected to because Table 4 is incomplete.
Appropriate action is advised.
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 1-2, 18, 32, 33, 54-56, 62, 64-66 and 68-72 are 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 using a SNP at reference genome position 50,854,826 on chromosome 7, does not reasonably provide enablement for the selecting for plants having one or more modified cannabinoids 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 for selecting one or more Cannabis plants having any number of modified cannabinoids comprising detecting any number or combination of markers that indicate modified cannabinoids, wherein one or more or any combination of markers correlate to an increased ratio of the combination of total THC, CBD, CBG, THCV, CBDV, CBC and CBGV to the combination of total CBG and CBGV or an increased ratio of total THC and THCV to total CBG and CBGV or an increased ratio of total CBC to total CBG and CBGV, wherein the marker is a polymorphism at nucleotide position 50,854,826 on chromosome 7 and indicates the increased ratio of any of the aforementioned modified cannabinoids, and products produced from said plants.
Meanwhile, the specification teaches "cannabinoid type I" or "a type I cannabinoid" refers to Total THC:Total CBD ratios, or plants having said ratios, of greater than 3, that "cannabinoid type II" or "a type II cannabinoid" refers to Total THC:Total CBD ratios, or plants having said ratios, of between 0.33 and 3 and that "cannabinoid type Ill" or "a type Ill cannabinoid" refers to Total THC:Total CBD ratios, or plants having said ratios, of less than 0.33 (¶ 41-43).
The specification teaches that SEQ ID NO: 273 having SNP marker name 1422269_1 35398 with reference genome position 50,854,826 has a beneficial genotype of “A,X” or “B,X” that “modifies” levels of the combination of total CBG and CBGV or the total THC to CBG ratio or the total cannabinoids to CBG ratio (¶ 199 and p. Table 12 on p. 106; see also ¶ 126; see ¶ 201 and p. 114; see also ¶ 200 and p. 117).
However, the specification fails to teach or provide working examples, in fact, that the SNP at reference genome position 50,854,826 on chromosome 7 may predictably modify ratios of any possible cannabinoid in Cannabis plants as encompassed by instant claims 1, 2, 54, 55, 56, 62 and 64. In other words, the specification fails to teach that this marker alone is indicative of a Cannabis plant that may have an increase in any particular cannabinoid and at the same time be predictive of a Cannabis plant having a decrease in the same cannabinoid.
In addition, the specification fails to teach, in fact, whether the SNP at reference genome position 50,854,826 on chromosome 7 correlates to an increase or decrease in any particular cannabinoid. Rather, the specification merely teaches that the marker may correlate total varin content of anywhere from 0% to 11.8% and has a “beneficial genotype” (e.g., see Table 3 and 13, 19 and 22).
Moreover, one would not expect to predictably to use this particular marker on the one hand to select for plants having an increased level of THC content and on the other hand have an increase in other cannabinoids, for example, CBG.
This is because the skilled artisan readily appreciates that if THC levels are increased in a selected plant then there is less CBGA precursor for the production of CBD, CBC, CBG or other cannabinoids (Degenhardt et al, 2017, “The Biosynthesis of Cannabinoids” in Handbook of Cannabis and Related Pathologies, Chapter 2, p. 13-23, https://doi.org/10.1016/B978-0-12-800756-3.00002-8; see Figure 2.3). Thus, one would be unable to predictable use the marker as claimed to select for plants where levels of the combination of total CBG and CBGV or the total THC to CBG ratio or the total cannabinoids to CBG ratio are modified.
Therefore, in light of the breadth of the claims, the failure of the specification to teach, in fact, the cannabinoid levels associated with the SNP at reference genome position 50,854,826 on chromosome 7 alone or in combination with any other marker, the lack of working examples, and the state of the art as addressed supra, the skilled practitioner would be unable to predictable practice the methods as claimed or produce the plants and products as claimed without resorting to impermissible undue trial and error experimentation.
Claims 1-2, 18, 32, 33, 54-56, 62, 64-66 and 68-72 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.
Instant claims 1-2, 18, 32, 33, 54-56, 62, 64-66 and 68-72 are broadly drawn to a method for selecting one or more Cannabis plants having any number of modified cannabinoids comprising detecting any number or combination of markers that indicate modified cannabinoids, wherein one or more or any combination of markers correlate to an increased ratio of the combination of total THC, CBD, CBG, THCV, CBDV, CBC and CBGV to the combination of total CBG and CBGV or an increased ratio of total THC and THCV to total CBG and CBGV or an increased ratio of total CBC to total CBG and CBGV, wherein the marker is a polymorphism at nucleotide position 50,854,826 on chromosome 7 and indicates the increased ratio of any of the aforementioned modified cannabinoids, and products produced from said plants.
Meanwhile, the specification describes "cannabinoid type I" or "a type I cannabinoid" refers to Total THC:Total CBD ratios, or plants having said ratios, of greater than 3, that "cannabinoid type II" or "a type II cannabinoid" refers to Total THC:Total CBD ratios, or plants having said ratios, of between 0.33 and 3 and that "cannabinoid type Ill" or "a type Ill cannabinoid" refers to Total THC:Total CBD ratios, or plants having said ratios, of less than 0.33 (¶ 41-43).
The specification describes that SEQ ID NO: 273 having SNP marker name 1422269_1 35398 with reference genome position 50,854,826 has a beneficial genotype of “A,X” or “B,X” that “modifies” levels of the combination of total CBG and CBGV or the total THC to CBG ratio or the total cannabinoids to CBG ratio (¶ 199 and p. Table 12 on p. 106; see also ¶ 126; see ¶ 201 and p. 114; see also ¶ 200 and p. 117).
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.
Here the specification fails to describe or provide working examples, in fact, that the SNP at reference genome position 50,854,826 on chromosome 7 may predictably modify ratios of any possible cannabinoid in Cannabis plants as encompassed by instant claims 1, 2, 54, 55, 56, 62 and 64. In other words, the specification fails to describe that this marker alone is indicative of a Cannabis plant that may have an increase in any particular cannabinoid and at the same time be predictive of a Cannabis plant having a decrease in the same cannabinoid.
In addition, the specification fails to describe, in fact, whether the SNP at reference genome position 50,854,826 on chromosome 7 correlates to an increase or decrease in any particular cannabinoid. Rather, the specification merely describes that the marker may correlate to total varin content of anywhere from 0% to 11.8% or has a “beneficial genotype” that confers a modified cannabinoid phenotype (e.g., see Table 3 and 13, 19 and 22).
Moreover, one would not expect to predictably to use this particular marker on the one hand to select for plants having an increased level of THC content and on the other hand have an increased content of CBG.
For example, the skilled artisan readily appreciates that if THC levels are increased in a selected plant then there is less CBGA precursor for the production of CBD, CBC, CBG or other cannabinoids (Degenhardt et al, 2017, see Figure 2.3). Thus, one would not be of the opinion that Applicant possesses the marker as claimed to select for plants where levels of the combination of total CBG and CBGV or the total THC to CBG ratio or the total cannabinoids to CBG ratio are modified.
Regarding claim 2, the limitation “progeny” plants encompasses the F2 filial generation and beyond yet the specification has failed to describe any additional “progeny” plants produced by the method.
With each subsequent outcrossing two a different Cannabis plant the progeny produced by the method will retain less of the genetics of the starting material comprising the markers required to yield a modified cannabinoid profile. As a result, one would be unable to distinguish between an F2 progeny and beyond produced from the claimed methods and plants derived from other crosses.
Claims 62 and 64 present a similar issue: products such an “edible” product would comprise a certain amount of THC and no genetic material of the plants produced by the method of claim 2. As such, the products of claims 62 and 64 would be indistinguishable from other products in the art, and the skilled artisan would be unaware if any other product infringed upon the products of the instant invention.
Therefore, in light of the breadth of the claims, the failure of the specification to describe, in fact, the cannabinoid levels associated with the SNP at reference genome position 50,854,826 on chromosome 7 alone or in combination with any other marker, the lack of working examples, and the state of the art as addressed supra, the skilled practitioner would not be of the opinion that Applicant possesses the method, plants and products as claimed.
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) 1, 2, 18, 32, 54, 55, 56, 62, 64 and 65 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Pauli et al (Pub. No. US 2020/0270623 A1).
Instant claims 1, 2, 18, 32, 54, 55, 56, 62, 64 and 65 are drawn to a method for selecting one or more Cannabis plants having one or more modified cannabinoids comprising obtaining nucleic acids, detecting one or more markers that indicate modified cannabinoids and selecting plants comprising said marker(s) for breeding purposes, wherein the method further comprises crossing said plant to produce F1 or additional progeny plants, wherein the modified cannabinoids correlate to the ratio of total CBC to the total THC, CBD, CBG,
Instant claims 1, 2, 18, 32, 54, 55, 56, 62, 64, 65 are drawn to a method for selecting one or more Cannabis plants having one or more modified cannabinoids comprising obtaining nucleic acids, detecting one or more markers that indicate modified cannabinoids and selecting plants comprising said marker(s) for breeding purposes, wherein the method further comprises crossing said plant to produce F1 or additional progeny plants, wherein the modified cannabinoids correlate to the ratio of total CBC to the total THC, CBD, CBG, THCV, CBDV, CBC and CBGV or correlate to an increased ratio of THC to other cannabinoids, wherein oligonucleotide probes are used for detecting, wherein the progeny comprise the modified cannabinoids, wherein the crossing is by selfing or backcrossing, an edible product produced from said progeny plant, and wherein the levels of THC or CBG are elevated.
Pauli et al claim a method for producing a cannabis cultivar comprising identifying paralogs of a cannabinoid synthase gene in two or more cultivars and crossbreeding them to have desired effects on cannabinoid production (claim 1) and wherein the identifying comprises PCR amplification (claim 4) and primers (claim 5) or molecular marker analysis where the molecular marker is a SNP (claims 14-16), plants and progeny produced therefrom (claims 18 and 19), and products produced therefrom such as CBDA and/or THCA (claim 25).
Pauli et al is directed to specific primers, probes and SNPs that amplify or identify unique regions within CBDA synthases responsible for and influence production of cannabinoids and CBDA (¶ 0006-0008 and ¶ 0011; see also ¶ 0041-0042; see ¶ 0068). The methods are advantageous for growing and using plants the produce known or desired cannabinoids for consistent and predictable therapeutic effect resulting from consumption (¶ 0080).
Therefore, a method for selecting one or more Cannabis plants having one or more modified cannabinoids comprising obtaining nucleic acids, detecting one or more markers that indicate modified cannabinoids and selecting plants comprising said marker(s) for breeding purposes, wherein the method further comprises crossing said plant to produce F1 or additional progeny plants, wherein the modified cannabinoids correlate to the ratio of total CBC to the total THC, CBD, CBG, THCV, CBDV, CBC and CBGV or correlate to an increased ratio of THC to other cannabinoids, wherein oligonucleotide probes are used for detecting, wherein the progeny comprise the modified cannabinoids, wherein the crossing is by selfing or backcrossing, an edible product produced from said progeny plant, and wherein the levels of THC or CBG are elevated is anticipated by Pauli et al.
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 1, 2, 18, 32, 54, 55, 56, 62, 64 and 65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 6-10 of U.S. Patent No. 11,920,187 B1 (referred to herein as ‘187). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims 1, 2, 18, 32, 54, 55, 56, 62, 64, 65 are drawn to a method for selecting one or more Cannabis plants having one or more modified cannabinoids comprising obtaining nucleic acids, detecting one or more markers that indicate modified cannabinoids and selecting plants comprising said marker(s) for breeding purposes, wherein the method further comprises crossing said plant to produce F1 or additional progeny plants, wherein the modified cannabinoids correlate to the ratio of total CBC to the total THC, CBD, CBG, THCV, CBDV, CBC and CBGV or correlate to an increased ratio of THC to other cannabinoids, wherein oligonucleotide probes are used for detecting, wherein the progeny comprise the modified cannabinoids, wherein the crossing is by selfing or backcrossing, an edible product produced from said progeny plant, and wherein the levels of THC or CBG are elevated.
‘187 claims a method for selecting one or more Cannabis plants having modified varin activity, the method comprising: i) crossing a Cannabis plant having modified varin activity with another Cannabis plant to produce one or more F1 Cannabis progeny plants; (ii) obtaining a nucleic acid sample from the one or more F1 Cannabis progeny plants or their germplasm; (iii) screening the nucleic acids to detect one or more polymorphisms that are genetically linked to a varin activity trait loci, wherein the one or more polymorphisms comprise a polymorphism in the reference allele of the Abacus Cannabis CsaAba2 reference genome on chromosome 4 relative to position 72,717,623; 72,413,830; 72,330,901; 73,591,604; 72,070,492; 74,886,331; 72,386,361; 72,500,945; 72,692,194; 80,090,345; 80,115,357; 80,028,174; 80,051,232; or 80,072,595; or a polymorphism in the reference allele of the Abacus Cannabis reference genome version CsaAba2 on chromosome 7 relative to position 62,019,912; 62,034,938; 62,231,000; 62,387,493; 62,647,527; 62,737,982; 62,742,884; 62,747,249; 62,761,203; 62,767,237; 62,792,364; 62,815,617; 62,850,589; 62,866,162; 62,870,580; 62,941,027; 62,971,551; 62,979,814; or 62,993,205; (iv) selecting the one or more F1 Cannabis progeny plants comprising the one or more polymorphisms that are genetically linked to a varin activity trait loci; and (v) crossing the selected F1 Cannabis progeny plants to produce at least one additional progeny plant comprising the modified varin activity (claim 1) wherein the modified varin activity correlates to modified tetrahydrocannabivarin (THCV), tetrahydrocannabivarinic acid (THCVA), cannabidivarin (CBDV), cannabidivarinic acid (CBDVA), cannabigerivarin (CBGV), or cannabigerivarinic acid (CBGVA) levels (claim 2) wherein the selecting comprises marker assisted selection (claim 3) wherein the detecting comprises use of an oligonucleotide probe (claim 4) wherein the crossing comprises selfing, sibling crossing, or backcrossing (claim 6) wherein the selfing, sibling crossing, or backcrossing comprises marker-assisted selection (claim 7) wherein the selfing, sibling crossing, or backcrossing comprises marker-assisted selection for at least two generations (claim 8) and wherein the at least one additional progeny plant comprising the indicated modified varin activity is an F2-F7 progeny plant (claim 9) and wherein the modified varin activity is an increase in THCV, CBGV, and/or CBDV levels (claim 10).
Therefore, prior to the effective filling date of the instant invention it would have been prima facie obvious to one of ordinary skill in the art to arrive at the methods, products and plants as claimed because they generically encompass the specific methods that are claimed in ‘187. One would have found it obvious to arrive at the plants and products as claimed because the methods of ‘187 result in an increase in cannabinoid content.
Conclusion
No claim is allowed.
The closest prior art is that which is referenced above yet does not reasonably teach, suggest or provide motivation for a SNP at reference genome position 50,854,826 on chromosome 7 or wherein the marker comprises a polymorphism at position 26 of SEQ ID NO: 273.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON DEVEAU-ROSEN whose telephone number is (571)272-2828. The examiner can normally be reached 7:30am - 4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bratislav Stankovic can be reached at (571)270-0305. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662
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