DETAILED ACTION
The Amendment filed July 7, 2026 has been entered.
Claims 5-7, 16 and 22-29 are cancelled.
Claims 11 and 18-19 are currently amended.
Claims 1-4, 8-15 and 17-21 are pending.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
All previous objections and rejections not set forth below have been withdrawn.
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 .
Withdrawn Objection
The objection to claim 11 is withdrawn in light of the amendment of claim 11.
Withdrawn Claim Rejections
The rejection of claims 5 and 7, and all claims dependent thereon, 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the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention is withdrawn in light of the cancellation of claims 5 and 7.
The rejection of claims 18 and 19 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the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention is withdrawn in light of the amendment of claims 18 and 19.
The rejection of claims 5-6 under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Davies, U.S. Patent No. 9,265,220, issued Feb. 23, 2016 is withdrawn in light of the cancellation of claims 5 and 6.
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 1-4, 8-15 and 17-21 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 1-4, 8-15 and 17-21 are drawn to wheat A_08S0116-11, and methods of its use.
The instant Specification fails to satisfy the written description requirement of 35 U.S. Code § 112(a) because it does not provide a description sufficient to conduct an examination, including search of the prior art, nor does it provide enough description to be sufficient to aid in the resolution of questions of infringement.
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).
In the instant application, a full examination cannot be conducted because applicant failed to provide the breeding history for the instantly claimed plant. Specifically, applicant claims a wheat plant having the designation A_08S0116-11. A plant is defined by both its genetics (breeding history) and its traits. In the instant application, applicant has only provided a description of the plant traits as seen in the specification. The instant application is silent or incomplete as to the breeding history used to produce the claimed wheat plant having the designation A_08S0116-11.
The criticality of a breeding history in assessing the intellectual property rights of a plant is well recognized in the field of plant breeding. With regard to Plant Patents, MPEP 1605 states that a complete detailed description of a plant includes “the origin or parentage”. Other bodies that grant intellectual property protection for plant varieties require breeding information to evaluate whether protection should be granted to new varieties. 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” by the USDA reference to Exhibit A, www.ams.usda.gov/services/pvpo/application-help/apply). Additionally, 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 (See UPOV EDV Explanatory Notes 14 and 30, www.upov.int/edocs/expndocs/en/upov_exn_edv.pdf). While the USPTO, USDA, and UPOV have different laws governing intellectual property rights, all recognize that a breeding history is an essential part of adequate description of the plant sought to be protected.
The breeding history is also necessary to aid in the resolution of patent infringement by providing information necessary to determine whether differences in plants where genetic differences, differences caused by the environment, or differences within the accepted variation within a variety. 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) and Ex Parte McGowen- Board Decision in Application 14/996,093). 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.
Moreover, a specification devoid of a 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 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.
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 teaches that the assumption that elite cultivars are composed of relatively homogenous genetic pools is false. (Haun et al. The Composition and Origins of Genomic Variation among Individuals of the Soybean Reference Cultivar Williams 82. Plant Physiol. 2010 Nov 29;155(2):645–655, see page 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. (Haun Page 645 right column and Page 646 left column). In addition to genetic variation, environmental variation may lead to phenotypic variation within a cultivar. (Großkinsky et al. Plant phenomics and the need for physiological phenotyping across scales to narrow the genotype-to-phenotype knowledge gap. J. Exp. Bot. 2015 Sep;66(18):5429-40. Epub 2015 Jul 10, see page 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 at adequate describe a newly developed plant.
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 variety or 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 variety. For example, if applicant’s breeding history uses proprietary line names, applicant should notate in the specification all other names of the proprietary lines, especially publicly disclosed or patented line 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 is also 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 variety). 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).
Response to Arguments
Applicant's arguments filed July 7, 2026 have been fully considered but they are not persuasive.
Applicant traverses the rejection and asserts that the written description requirement has been satisfied for the claimed plant, plant part or seed of wheat A_08S0116-11. Applicant points out first that the specification provides a phenotypic description of the claimed wheat A 08S0116-11, and second, that the biological deposit provides the genotypic information of the claimed wheat A_08S0116-11. Applicant maintains that this demonstrates "possession" under Ariad of the claimed variety by providing the actual biological material along with its identifying characteristics. Applicant also maintains that the Examiner's position that breeding history is needed to conduct an examination, including search of the prior art, directly contradicts the Federal Circuit's holding in Ariad that written description is about demonstrating possession, and that the proper remedy for obtaining information to facilitate examination is a Rule 105 request, as the USPTO has historically done.
Applicant maintains that the genetic make-up of the claimed wheat A_08S0116-11 is described in the specification via a seed deposit under the terms of the Budapest Treaty, and Applicants further point to Enzo Biochem, Inc. v Gen-Prove Inc., 323 F.3d 956, 956 (Fed. Cir. 2002) which holds that "reference in the specification to a deposit in a public depository, which makes content available to the public when it is not otherwise available in written from, constitutes adequate description of the deposited material to sufficiently comply with the written description requirement of 112 1st paragraph.
Applicant further maintains that the Office has failed to provide to provide support for the position that written description under 35 U.S.C. § 112(a) requires the specification to disclose the breeding history, and disputes the references made in the non-final office action to Plant Patents, the Plant Variety Protection (PVP) applications and UPOV, because the statutory requirements for utility patents are different from the requirements for Plant Patents, the Plant Variety Protection (PVP) applications and UPOV.
Applicant also maintains that the citations of In Re Lundak, Ex Parte Cand Ex Parte McGowen fail to support the position of the Office Action. Applicant specifically notes that the issue in In Re Lundak centered on whether 35 U.S.C. 112 was satisfied if a deposit of the claimed cellular material to the ATCC depository was made 7 days after filing the patent application, whereas the instant application has fulfilled the deposit requirements. Applicant also points out that the Board in Ex Parte C reversed the rejection of the claimed soybean variety for lack of written description. Applicant further observes that the issue in Ex Parte McGowen is centered on whether the claimed cotton variety was obvious over the prior art, and that the case does not speak to written description.
Applicant reiterates that that the proper remedy for obtaining information to facilitate examination is a Rule 105 request, as the USPTO has historically done, rather than a written description rejection under 35 U.S.C. § 112(a). Applicant also indicates a willingness to comply with a Rule 105 request, and requests that this well-established practice be followed.
Applicant's arguments are not persuasive.
With respect to Applicant’s assertion that the claimed invention is described because "possession" has been demonstrated by providing a biological material along with its identifying characteristics, this is not persuasive because demonstrating possession of the claimed subject matter is not in itself sufficient to satisfy the written description requirement. See Enzo Biochem Inc. v. Gen-Probe Inc., 63 USPQ2d 1609, 1617:
Application of the
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written description requirement, however, is not subsumed by the “possession” inquiry. A showing of “possession” is ancillary to the statutory mandate that “[t]he specification shall contain a
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written description of the invention,” and that requirement is not met if, despite a showing of possession, the specification does not adequately describe the claimed invention. After all, as indicated above, one can show possession of an invention by means of an affidavit or declaration during prosecution, as one does in an interference or when one files an affidavit under 37 C.F.R. § 1.131 to antedate a reference. However, such a showing of possession alone does not cure the lack of a written description in the specification, as required by statute.
With respect to Applicant’s assertion that the genetic make-up of the claimed wheat A_08S0116-11 is described in the specification via a seed deposit under the terms of the Budapest Treaty, and that "reference in the specification to a deposit in a public depository, which makes content available to the public when it is not otherwise available in written from, constitutes adequate description of the deposited material to sufficiently comply with the written description requirement of 112 1st paragraph” (Enzo Biochem, Inc. v Gen-Prove Inc., 323 F.3d 956, 956 (Fed. Cir. 2002), this is not persuasive because the parental plants and breeding method(s) used to produce the claimed wheat A_08S0116-11 can be made available in written form.
With respect to Applicant’s objection to the references cited in the non-final office action (Plant Patents, the Plant Variety Protection (PVP) applications and UPOV), this is not persuasive because these references were cited to generally illustrate the criticality of a breeding history in assessing the intellectual property rights of a plant, since they all recognize breeding history as an essential part of an adequate description of a plant for which protection is sought, not withstanding the fact that the specific legal requirements that govern these rights differ from those that govern utility patents.
With respect to Applicant’s objection to the citations of In Re Lundak, Ex Parte Cand Ex Parte McGowen, this is not persuasive. Specifically, with respect to In Re Lundak, the fact that In Re Lundak centered on the timing of a deposit to satisfy the written description requirement does not negate the assertion that 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 Specifically, with respect to Ex Parte C, it is noted that the specification here did describe the parental lines and the breeding method used to produce the claimed soybean variety. Specifically, with respect to Ex Parte McGowen, it is noted that without the description of a breeding history, a complete comparison with the prior art could not have been possible, notwithstanding the fact that Ex Parte McGowen is centered on whether the claimed cotton variety was obvious over the prior art.
With respect to Applicant’s assertion that the proper remedy for obtaining information to facilitate examination is a Rule 105 request, as the USPTO has historically done, rather than a written description rejection under 35 U.S.C. § 112(a), this is not persuasive, because while the information obtained by the Office in a Rule 105 request can facilitate the examination of the application, this information cannot be used to support a description of the claimed subject matter, because it is not part of the specification.
Conclusion
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Remarks
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CYNTHIA E COLLINS whose telephone number is (571)272-0794. The examiner can normally be reached M-F 8:30 am - 5:00 pm.
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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/CYNTHIA E COLLINS/Primary Examiner, Art Unit 1662
