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 1-41 are pending and examined.
Election/Restrictions
Applicant's election with traverse of the species of NWG5328 in the reply filed on 08 January 2026 is acknowledged. The traversal is on the ground(s) that the species do not require a different field of search and because it has not been shown that the species are not obvious variants of each other.
This is not found persuasive because the Office has explained why different searches are required and why the species are not obvious variants of one another.
As put forth in the Office action dated 10 November 2025 it was indicated that variety NWG5109 has increases in gamma-linolenic acid and stearidonic acid while variety NWG5107 has increased alpha-linolenic acid (see Examples 2, 3 and 4). Because the varieties as encompassed by the claims appear to have different genetic makeups different searches are required and the varieties are not obvious variants of one another.
The requirement is still deemed proper and is therefore made FINAL.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (e.g., see ¶ 0193). Applicant is required to delete all embedded hyperlinks and/or other forms 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 further objected to for failing to provide the deposit accession numbers and corresponding dates of the deposits.
Appropriate action is advised.
Claim Interpretation
The seed of claim 7 and the plant of claim 8 are interpreted to be of the F1 generation as the method claim from which they depend produces F1 hybrid seed. This also means that the plants as encompassed by claims 12, 14, 17 and 19 are limited to the F1 filial generation.
Claim Objections
Claim 9 part (d) recites the limitation “a” subsequent generation and should therefore use the definitive article when referring back to a previous claim. The limitation “a” should be replaced with the limitation --the--.
Claim 19 presents the same issue: the claim should recite --the-- value-added trait.
Appropriate action is advised.
Improper Markush Grouping
Claims 1, 2, 5, 9, 10, 20, 21 and 24 are rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature. The members of the improper Markush grouping do not share a substantial feature and/or a common use that flows from the substantial structural feature for the following reasons:
Variety NWG5109 has increases in gamma-linolenic acid and stearidonic acid while variety NWG5107 has increased alpha-linolenic acid (see Examples 2, 3 and 4) which indicates the claimed varieties have different structures/genetics and different uses that flow form said structures.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature.
This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. §134 and 37 CFR 41.31(a)(1) (emphasis provided).
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 1-41 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 1 recites the limitation “NWG5328” which is not an art recognized term that is arbitrary such that one would not know what is or is not encompassed by the claims.
Claims 2, 5, 9, 10, 20, 21 and 24 recite the same limitation and are rejected for the same reason as provided for claim 1.
Claim 24 is drawn to a method of producing a Cannabis plant with modified protein content by crossing a plant with a transgene conferring insect resistance to a second plant.
The metes and bounds of the claim are indefinite because it is not clear how the method produces a plant having modified protein content when the method requires using a plant comprising insect resistance.
Claims 3, 4, 6-8, 11-19, 22, 23 and 25-41 are rejected for depending upon a rejected base claim and for failing to remedy the issues of indefiniteness.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 28-33 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 28 is drawn to food or feed comprising the Cannabis variety NWG5328 wherein the food or feed product is oil or seed and wherein the Cannabis variety NWG5328 is combined with an excipient.
Here, claim 28 does not further limit the claim from which it depends because claim 27 is drawn to food or feed that is oil or seed and is not directed to Cannabis variety NWG5328.
Claims 29 and 30 present the same issue and are therefore rejected for the same reason as provided for claim 28.
Claims 31, 32 and 33 also present the same issue by reciting the limitation “extract” and are therefore rejected for the same reason as provided for claim 28. Namely, claim 27 is not drawn to an extract such that claims 31, 32 and 33 fail to further limit the claim from which they depend.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-41 are rejected under 35 U.S.C. 112(a) as containing 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.
The specification teaches that seeds were gamma irradiated but fails to teach what Cannabis strain was used (p. 71, ¶ 0232). Here, Since the seed claimed is essential to the claimed invention, it must be obtainable by a reproducible method set forth in the specification or otherwise be readily available to the public. If a seed is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112.
Here, the specification does not disclose a reproducible process to obtain the exact same seed in each occurrence and it is not apparent if such a seed is readily available to the public.
If the deposit of the seed is made under the terms of the Budapest Treaty, then an affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, stating the seed have been deposited under the Budapest Treaty and that the seed will be irrevocably, and without restriction or condition, released to the public upon the issuance of a patent would satisfy the deposit requirement made herein.
A minimum deposit of 625 seeds is considered sufficient in the ordinary case to assure availability through the period for which a deposit must be maintained.
If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 CFR 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number showing that
(a) during the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the enforceable life of the patent, whichever is longer;
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807); and
(e) the deposit will be replaced if it should ever become unviable.
Applicant has NOT deposited the seeds at the NCIMB in accordance with 37 CFR 1.801-1.809 by indicating all restrictions upon availability to the public will be irrevocably removed upon granting of the patent.
Applicant has also not indicated an intention to deposit the seeds in accordance with the Budapest Treaty, and by way of affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, stated that the seed will be irrevocably, and without restriction or condition, released to the public upon the issuance of a patent.
Accordingly, Applicant needs to provide a signed statement indicating compliance with 37 CFR 1.801-1.809, the NCIMB Accession No. and evidence of deposit to overcome this rejection. Alternatively, Applicant may by way of affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, state that the seed will be irrevocably, and without restriction or condition, released to the public upon the issuance of a patent.
Compliance with this requirement may be held in abeyance until the application is otherwise in condition for an allowance.
Claims 1-41 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.
Claims 26-33, 39 and 40 are drawn to a food or feed composition comprising a plant part or extract of variety NWG5328, wherein the food or feed product comprises oil or is an extract or wherein a fiber product is produced from variety NWG5328.
Here, the specification fails to describe, in fact, any of the products as claimed. This description is critical because food or feed compositions comprising plant parts or extracts or oils or fiber products would be indistinguishable from these products produced from different Cannabis varieties.
For example, Schwabe et al describes that there are genetic inconsistencies within strains with most strains containing at least one genetic outlier and that there can be genetic variability among seeds from the same strain supplied from a single source indicating genotypic variability (2019, Journal of Cannabis Research, 1-16, see Abstract; see also p. 12, col. 1, last ¶).
Or see Xiang et al which describes that conventional methods for cannabis identification are inadequate in cases where the material has been processed till the sample lacks the morphologically distinct traits of cannabis plant material (2025, Genes,16:1-15; see p. 2, ¶ 3).
Thus, a food or feed comprising extracts, oils, THC, fiber, etc. would be indistinguishable from other foods or feeds comprising extracts, oils, THC, fiber, etc. as there is no way to identify their source.
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 merely described the deposited variety NWG5328 such that one would have no idea whatsoever if products produced from different Cannabis varieties other than variety NWG5328 would infringe upon the instantly claimed products.
Regarding the breeding history of the parental varieties used to arrive at the instantly claimed seeds and plants, it is noted that there is no accompanying breeding history in the specification. Because the specification lacks a breeding history and that breeding history is part of the minimum description of a plant variety the applicant has not fulfilled the requirement of 35 USC 112(a) to provide a written description in the specification. The office’s reasonable basis for challenging the adequacy of written description is informed by a review of the following:
With regard to Plant Patents, MPEP 1605 states that a complete detailed description of a plant includes “the origin or parentage”.
A breeding history, including information about parentage and breeding methodology, is part of the requirements of Plant Variety Protection (PVP) applications. That information is used to “determine if development is sufficient to consider the variety new” (See “Applying for a Plant Variety Certificate of Protection”, USDA, https://www.ams.usda.gov/services/pv po/application-help/apply, downloaded 05/01/2023, (U)).
The International Union for the Protection of New Varieties of Plants (UPOV) considers breeding history and methodology part of its evaluation of essentially derived plant varieties (UPOV, Explanatory Notes on Essentially Derived Varieties Under the 1991 Act of the UPOV Convention, April 6, 2017, See UPOV EDV Explanatory Notes 14 and 30 (V)).
Historically, the USPTO has considered breeding history information when determining the patentability of a new plant variety (See Ex Parte C (USPQ 2d 1492 (1992) (W) and Ex Parte McGowen Board Decision in Application 14/996,093, decided June 15, 2020 (X)). In both of these cases, there were many differences cited by the Applicant when comparing the prior art and the new plant variety. However, because the breeding history was available, these differences were deemed to be obvious and within the natural variation expected in a backcrossing breeding process. Without a breeding history in these cases, a complete comparison with the prior art could not have been possible.
As seen above in Ex Parte C and Ex Parte McGowan, a trait table is insufficient to differentiate varieties by itself. It has been long established that intracultivar heterogeneity exists in crop species (e.g., see Haun et al, Plant Physiology, 2011, 155, p. 645-655) teaches that the assumption that elite cultivars are composed of relatively homogenous genetic pools is false (p. 645, left column). Segregation, recombination, DNA transposition, epigenetic processes, and spontaneous mutations are some of the reasons elite cultivar populations will maintain some degree of plant-to-plant variation (p. 645, right column and p. 646, left column). In addition to genetic variation, environmental variation may lead to phenotypic variation within a cultivar (Großkinsky et al, 2015, J. Exp. Bot. 66(11), p. 5429-5440; see p. 5430, col. 1, ¶ 1 and col. 2, ¶ 2). In view of this variability, a breeding history is an essential and the least burdensome way to provide genetic information needed to adequately describe a newly developed plant.
The above factual evidence provides a reasonable basis that a breeding history is necessary to satisfy the written description requirement. With this information the examiner has met the initial burden of presenting by a preponderance of evidence why a person of ordinary skill in the art would not recognize in an applicant’s disclosure a description of the invention defined by the claims (See MPEP 2163.04). Please note, the citations above are not for legal authority, the legal authority relied upon by the examiner is the 35 USC 112(a) statute. The citations are presented to support the finding of fact that a breeding history is necessary to the adequate description of a plant.
Although not directly relied upon for the above written description position, a complete written description additionally helps drive examination and help with infringement verification.
MPEP 2163 (I) states “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 ("As a general rule, the more information that is provided about a particular deposited biological material, the better the examiner will be able to compare the identity and characteristics of the deposited biological material with the prior art.").”
MPEP 2163(I) states “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." Id. at 34,880.)” (Quoting the Deposit of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 34,864 (August 22, 1989) at 34,880).
The breeding history aids in the resolution of patent infringement by providing information necessary to determine whether differences in the plants are genetic differences, differences caused by the environment, or differences within the accepted variation within a variety.
Moreover, a specification devoid of a complete breeding history hampers the public’s ability to resolve infringement analysis with plants already in the prior art as well as plants that have not yet been patented. Because the instant specification lacks the complete breeding history, the public will not be able to fully resolve questions of infringement.
Since the breeding history, including the parents, is not known to the public, the public could only rely on the phenotypes of the claimed plants for assessing potential infringement. Thus, an application that does not clearly describe the breeding history does not provide an adequate written description of the invention.
To overcome this rejection, Applicant must amend the specification/drawing to provide the breeding history used to develop the instant cultivar. When identifying the breeding history, Applicant should identify any and all other potential names for all parental lines utilized in the development of the instant cultivar and all other potential names for the claimed cultivar.
If Applicant’s breeding history uses proprietary cultivar names, Applicant should notate in the specification all other names of the proprietary cultivars, especially publicly disclosed or patented cultivar information. If the breeding history encompasses a locus conversion or a backcrossing process, Applicant should clearly indicate the recurrent parent and the donor plant and specifically name the trait or transgenic event that is being donated to the recurrent parent.
If one of the parents is a backcross progeny or locus converted line of a publicly disclosed line, Applicant should provide the breeding history of the parent line as well (i.e., grandparents). Applicant should identify the breeding method used, such as single seed descent, bulk method, backcross method, etc., and the filial generation in which the instant plant was chosen. Information pertaining to the homozygosity or heterozygosity of the parents as well as the instant plant should be set forth.
Applicant is reminded that they have a duty to disclose information material to patentability. Applicant should also notate the most similar plants which should include any other plants created using similar breeding history (such as siblings of the instant cultivar). If there any patent applications or patents in which sibs or parents of the instant plant are claimed, the serial numbers and names of the sibs or parents should be disclosed. This information can be submitted in an IDS with a notation of the relevancy to the instant application or as information submitted as described in MPEP 724 (e.g., trade secret, proprietary, and Protective Order).
35 USC 112(a) clearly states “The specification (emphasis added) shall contain a written description of the invention”. In the instant matter, the Specification fails to provide any breeding history. Moreover, the claims indicate Applicant intends to deposit seeds representative of the claimed cultivar.
Thus, the claims are not limited to the deposited seeds or plants grown therefrom. The claims are directed to a genus of corn plants and seeds that are genotypically and phenotypically different from the deposit, and have different traits from those disclosed in the specification.
Given these differences, the complete breeding history for producing the claimed cultivar, including all names for the parents and for the claimed cultivar, are material for patentability. A specification devoid of a complete breeding history hampers the public’s ability to fully resolve questions of infringement.
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.
Claim(s) 26-33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Devi et al (2019, Journal of Environmental Chemical Engineering, 7:1-10).
Claims 26-33 are drawn to a food or feed composition comprising a plant part or extract of variety NWG5328, wherein the food or feed product comprises oil or is an extract.
As noted supra, one of skill in the art would have no idea whatsoever if products produced from different Cannabis varieties other than variety NWG5328 would infringe upon the instantly claimed products.
Devi et al teach the isolation of fatty acids from Cannabis (see Abstract; see also p. 2, section 2.4). Devi et al teach these extracts and oils are used in food and feed compositions (p. 1, col. 1).
Therefore, because a food or feed composition comprising a plant part or extract of variety NWG5328, wherein the food or feed product comprises oil or is an extract or is indistinguishable from the compositions and products of Devi et al, Devi et al anticipates the claimed invention.
Claim(s) 39 and 40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pattnaik et al (2022, Chem. Eng. Technol., 45:962-970).
Claims 39 and 40 are drawn to a fiber product that is produced from variety NWG5328.
As noted supra, one of skill in the art would have no idea whatsoever if products produced from different Cannabis varieties other than variety NWG5328 would infringe upon the instantly claimed products.
Pattnaik et al disclose extracts and fibers produced from a Cannabis plant (see Abstract; see also p. 963, col. 2, ¶ 1; see also Table 1).
Therefore, because a fiber product that is produced from variety NWG5328 is indistinguishable from the products of Pattnaik et al, Pattnaik et al anticipates the claimed invention.
Conclusion
No claim is allowed.
Claims 1-25, 34-38 and 41 appear to be free of the prior art. However, a complete prior art search is not currently possible as the instant specification lacks a proper breeding history that discloses the parental varieties used to arrive at variety NWG5328.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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