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 .
Status of claims
Applicant’s response filed 6/25/2026 has been entered.
The specification has been amended.
Claims 16. 32 have been canceled.
Claims 29, 34, 36 have been amended.
In summary, claims 1-15, 17-31, 33-38 are pending and examined in this office action.
All previous objections and rejections not set forth below have been withdrawn in view of the applicant’s amendment and/or upon further consideration. See “Response to Arguments” at the end of office action.
The following rejections are repeated, modified and/or added for the reasons of record as set forth in the last Office action of 3/25/2026, and/or necessitated by the applicant’s amendments. The applicant’s arguments filed 6/25/2026 have been thoroughly considered but are not deemed fully persuasive.
Objection to the Specification
The specification is objected because:
In [0176], line 9, the “NCMA Deposit No. ____”, the blank line “____” should be a real deposit number. Line 10, “on____” should be a real date.
Appropriate corrections are required.
Claim Rejections - 35 USC § 112
Enablement/Lacking Deposit
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.
Claims 1-15, 17-31, 33-38 are rejected under 35 U.S.C. 112(a), as failing to comply with the enablement requirement. The claim(s) contains 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.
Claims are drawn to seed of triticale cultivar APT1415735, plant grown from the seed, as well as part, cell, progeny, modified seed and/or plant, and methods of using, the seed.
The triticale cultivar APT1415735 appears to be novel biological materials. Since the seed claimed is essential to the claimed invention, it must be obtainable by a repeatable 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. The specification does not disclose a repeatable 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.
In the specification ([0176]), “A deposit of the seed of triticale plant APT1415735 is and has been maintained by Northern Agri Brands, LLC, 205 9th Ave. S., Suite 205, Great Falls, Montana 59405, since prior to the filing date of this application. Access to this deposit will be available during the pendency of the application to the Commissioner of Patents and Trademarks and persons determined thereby to be entitled thereto upon request. Deposit will be made in a timely manner upon allowance of any claims in the application, whereby, the Applicant(s) will make available to the public, pursuant to 37 CPR 1.808(2), a deposit of at least 625 seeds of cultivar APT1415735 with the Provasoli-Guillard National Center for Marine Algae and Microbiota (NCMA), 60 Bigelow Drive, East Boothbay, ME 04544, USA, with NCMA Accession No. ____ . The seeds deposited with the NCMA on ____ will be taken from the same deposit maintained at Northern Agri Brands, LLC and described above. Additionally, Applicant(s) will meet all the requirements of 37 C.F.R. § 1.801 - 1.809, including providing an indication of the viability of the sample when the deposit is made. These deposits will be maintained in the NCMA depository, which is a public depository, for a period of 30 years, or 5 years after the most recent request, or for the enforceable life of the patent, whichever is longer, and will be replaced if it ever becomes nonviable during that period. Applicant has no authority to waive any restrictions imposed by law on the transfer of biological material or its transportation in commerce. Applicant does not waive any infringement of its rights granted under this patent or under the Plant Cultivar Protection Act (7 USC 2321 et seq.).”
However, there is no indication whether the seeds have actually been deposited under the Budapest Treaty nor an affirmation that the deposit will meet all of the requirements of 37 CFR 1.801-1.809, and has been accepted.
If the deposit has been made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by the applicants, or a statement by an attorney of record over his or her signature and registration number, or someone empowered to make such a statement, stating that the specific strain has been deposited under the Budapest Treaty and that the strain will be irrevocably and without restriction released to the public upon the issuance of a patent, and will be publicly available for the enforceable life of the patent, would satisfy the deposit requirement made herein.
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 C.F.R. 1.801-1.809 and MPEP 2402-2411.05, the applicants may provide assurance of compliance by statement, affidavit or declaration, or by someone empowered to make the same, 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 for the enforceable life of the patent in accordance with 37 CFR § 1.808(a)(2);
(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; and
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807).
In addition, the information set forth in 37 CFR 1.809(d) should be added to the specification. See 37 C.F.R. 1.801-1.809 for additional explanation of these requirements.
The applicant is required to amend the specification and the claims to include the deposit number.
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.
Claims 1-15, 17-31, 33-38 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 pre-AIA the applicant regards as the invention.
Claims recite blanks “____” after NCMA accession number, thus, are not complete. According to MPEP 2173, where possible, claims are to be complete in themselves.
In addition, the deposit of the representative seed of cultivar APT1415735 has not been made (as analyzed above).
Furthermore, the breeding history and parent lines of instant APT1415735 are not fully disclosed in the specification. Thus, the genetic background of instant APT1415735 is unknown.
Therefore, cultivar APT1415735 is not an art recognized or accepted term.
Dependent claims do not cure the deficiency.
Appropriate corrections and clarifications are required.
It is required to perfect the deposit, and amend the claims and the specification to include a real deposit number.
Lacking written description
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.
Claims 1-15, 17-31, 33-38 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The rejection is made because the specification fails to disclose the breeding history and parent lines of the instant triticale cultivar APT1415735.
35 USC 112 (a) states that “The specification shall contain a written description of the invention”. In evaluating written description, the threshold question is what is “an adequate written description”. This is question of fact that is evaluated by the factfinder (examiner). MPEP 2163.04 clearly states that “The inquiry into whether the description requirement is met must be determined on a case-by-case basis and is a question of fact. In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976).”
The instant invention is a new triticale cultivar APT1415735. Accordingly, the examiner will evaluate what is an adequate written description for new tomato lines. In reviewing this question of fact, the examiner analyzed how plant lines are evaluated in the public domain. The review concluded that generally the minimum requirements for an adequate description of a new plant cultivar has a trait table and genetic information (via a breeding history). In reviewing applicant’s specification there is a phenotypic description as is seen in table 1 (in [0053]). However, there are no accompanying breeding history and parent lines in the specification.
The examiner noticed that in the amended specification of 6/25/2025 (between [0051]-[0052]), “APT1415735 is derived from a cross made in 2002 with the pedigree Trical 2700 (PVPO # 009300122) and a second proprietary and not publicly available triticale line.”
Thus, the disclosure of the breeding history and parent lines is partial not full. Only one of the parents is disclosed. The “a second proprietary and not publicly available triticale line” is modifiable and changeable. If the line is not published, at the very least, an internal or experimental name should be provided and disclosed in the specification.
Because the specification lacks a breeding history and parent lines, and breeding history is part of the minimum description of a plant cultivar 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 Cultivar Protection (PVP) applications. That information is used to “determine if development is sufficient to consider the cultivar new” (See “Applying for a Plant Cultivar 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 cultivar. (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 cultivar. 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. Haun et al. (Plant Physiology, Feb. 2011, Vol. 155, pp. 645-655 (Y)) 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., J. Exp. Bot., Vol. 66, No. 11, pp. 5429-5440, 2015 (Z), p. 5430, left column, 1st full paragraph, and right column, 2nd full paragraph). 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 written description. 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 and parent lines are 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 cultivar.
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.
Furthermore, a breeding history particularly parent lines is essential to search siblings of instant plant to determine if there is/are any double patenting(s).
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, the applicant must amend the specification/drawing to provide the breeding history used to develop the instant cultivar. When identifying the breeding history, the 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 the applicant’s breeding history uses proprietary cultivar names, the 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, the 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, the applicant should provide the breeding history of the parent line as well (i.e., grandparents). The 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.
The applicant is reminded that they have a duty to disclose information material to patentability. The 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).
Remarks
In the amended specification of 6/25/2025 (between [0051]-[0052]), “APT1415735 is derived from a cross made in 2002 with the pedigree Trical 2700 (PVPO # 009300122) and a second proprietary and not publicly available triticale line.”
Thus, the disclosure of the breeding history and parent lines is partial not full. Only one of the parents is disclosed. The “a second proprietary and not publicly available triticale line” is modifiable and changeable. If the line is not published, at the very least, an internal or experimental name should be provided and disclosed in the specification.
By name search, triticale cultivar APT1415735 (or other name 456672168) has no prior art in patent, patent application or NPL.
One of the parents Trical 2700, was disclosed by Crop Science Report in 1995 (PDF attached).
However, the breeding history and parent lines of APT1415735 are not fully disclosed in the specification, the second parent is not disclosed. Thus, the written description is lacking. Once the breeding history and parent lines of APT1415735 are fully disclosed, the examiner will perform new search for prior art and/or sibling(s) and potential double patenting.
Response to Arguments
The Objections to the Specification, Rejections Under 35 U.S.C. § 112 Enablement/Lacking Deposit, Indefiniteness, and Written Description for lacking Breeding History, stand.
The deposit still has not been made and accepted. The specification and claims have not been amended accordingly to include the deposit information.
In addition, the rejection is not the only remaining rejection.
Regarding the rejection for lacking Breeding History, the applicant argues that specification at paragraphs [0051]-[0052] to provide additional breeding history information. Regarding names of parental lines utilized in the development of the instant variety, Applicant submits that one of the parental lines is a proprietary line developed by Applicant and is not publicly known by any other names or disclosed in a patent. Therefore, Applicant respectfully
submits that the internal designations or codes used for the proprietary parental line is not required to be disclosed in the specification at least because, as discussed above, these designations were assigned only for internal purposes and such information would not provide any relevant information to one of ordinary skill in the art.
The argument is fully considered but not deemed to be persuasive.
As analyzed above, the disclosure of the breeding history and parent lines is partial not full. Only one of the parents is disclosed. The “a second proprietary and not publicly available triticale line” is modifiable and changeable.
If the line is not published, at the very least, an internal or experimental name should be provided and disclosed in the specification.
In summary, 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. In this case, without a disclosure in the specification, any person skilled in the art cannot even see the description.
Regarding the Written Description – Other to Claims 12, 16, 30, 32, 34, and 36
The rejections are withdrawn in view of the amendments and/or cancelations of the claims.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). The applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Contact information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WAYNE ZHONG whose telephone number is (571)270-0311. The examiner can normally be reached 8:30am to 5:00pm EST.
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 on 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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/Wayne Zhong/
Primary Examiner, Art Unit 1662
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