Status of the Application
This Office Action is in response to the Amendment and Remarks filed 10 September 2025.
The objection to the Specification is withdrawn in view of Applicant’s amendment.
The objection to claim 15 is withdrawn in view of Applicant’s amendment.
The rejection of claims 1-4 and 8-21 under 35 USC 112(b) is withdrawn in view of Applicant’s amendments to the claims.
The rejection under 35 USC 112(a) for lack of enablement of the deposited seed is withdrawn in view of Applicant’s response.
Claim Rejections - 35 USC § 112
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 5, 8, 9, 10, 12, 14, 17 and 19-21 remain 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 5 is drawn to a wheat plant having “essentially all” of the traits of the deposited line and an additional trait. Because the deposited line has a defined genome, it cannot have an additional trait unless said trait is introduced into the plant. Therefore, the plant as encompassed by claim 5 fails to further limit the claim from which it depends as it is broader in scope. 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.
While Applicant reiterates the rejection on page 1, last paragraph, of the Remarks, Applicant presents no specific arguments to why the rejection is not proper. Hence, the rejection is maintained for the reasons of record.
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 5-7 remain 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.
Because the Specification defines “gene converted (conversion) includes random mutations the limitations “additional trait” and “converted seed” of claims 5 and 7 respectively read of random events. Hence, the metes and bounds of the claims are unclear.
Applicant argues that claims 2 and 7 have been amended to recited “wheat line” on page 2, 1st paragraph of the Remarks, but while this addresses the vagaries of “variety” the instant claims still read on a random mutation read in light of the Specification. Hence, the rejection is maintained for the reasons of record.
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 1-21 remain 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 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 variety. Specifically, in claims 1, 2 and 7, applicant claims a new wheat variety R14000248#58. A plant variety 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 plant variety.
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). 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). 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. (See Haun 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. (See 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. (See Großkinsky 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).
Applicant argues that the written description requirement has been satisfied for the claimed wheat line R14000248#58. Applicant argues that the claims at issue recite a plant, plant part or seed of wheat line R14000248#58, that has been deposited under ATCC Accession Number PTA-127507. Applicant argues that the specification provides a phenotypic description of the claimed wheat line R14000248#58 (for example, tables 1-8 of the instant specification). Applicant argues that the biological deposit provides the genotypic information of the claimed wheat line R14000248#58 (page 3, 2nd paragraph of the Remarks).
Applicant argues 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 (Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc)) that written description is about demonstrating possession and that proper remedy for obtaining information to facilitate examination is a Rule 105 request as the USPTO has historically done (page 4, 1st paragraph of the Remarks).
Applicant’s argument is not found to be fully persuasive. To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention at the time of filing. Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345, 54 USPQ2d 1915, 1917 (Fed. Cir. 2000) ("The purpose of [the written description requirement] is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification") (see MPEP 2161.01(I)). It is the Examiner’s opinion that without a description of the breeding history of the claimed invention, the Examiner cannot determine whether the claimed invention is novel and nonobvious or whether the invention is an obvious derivation of what was known in the art before the effective filing date of the instantly claimed invention.
Applicant argues that the genetic make-up of the claimed wheat line is described in the specification via a seed deposit under the terms of the Budapest Treaty. Applicant cites Enzo Biochem, Inc. v Gen-Prove Inc., 323 F.3d 956, 956 (Fed. Cir. 2002) which holds "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 (page 4 of the Remarks).
Applicant’s argument is not found persuasive because Applicant appears to be capable of describing how the instant invention was made. Enzo Biochem, Inc. actually states that [a] reference in specification to deposit of biological material in public depository, which makes its contents accessible to public when it is not otherwise available in written form, constitutes adequate written description of deposited material sufficient to comply with the written description requirement. Unlike Enzo where the inventor had not described the nucleotide sequences inserted into the plasmids contained in the deposited bacteria, Applicant would appear to be fully capable of describing the parental plants and breeding method(s) used to produce the claimed wheat line R14000248#58.
Applicant argues that predicating a written description rejection for a utility patent on the distinct requirements of a plant patent in particularly inapt because plant patents are subject to a relaxed standard under 34 U.S.C. 112(a) and do not provide the additional disclosure of a deposit (page 5, 1st paragraph of the Remarks). Applicant argues that examination of a PVP application for an EDV is the same as for any other variety, which does not include consideration of a breeding history under the UPOV convention (page 6, 2nd paragraph of the Remarks).
Applicant’s arguments are not found to be fully persuasive. 35 U.S.C. 162 states No plant patent shall be declared invalid for noncompliance with section 112 if the description is as complete as is reasonably possible. MPEP 1605 states that “The specification should also include the origin or parentage and the genus and species designation of the plant variety sought to be patented.”, while plant patents do not have an enablement requirement, they do have a written description requirement. Further, Plant Variety Certificate of Protection application does include “Exhibit A: Origin and Breeding History provides information about parentage, breeding methodology, and is used to determine if development is sufficient to consider the variety new. Also includes statements on the variety’s uniformity and stability.” A plant’s breeding history is an art standard disclosure that provides important information about a “new” plant variety.
Applicant’s arguments concerning Ex Parte C is noted, the Examiner notes that the Specification in Ex Parte C does actually describe what parental lines were used and what breeding method was used to produce the claimed soybean variety. In fact, the Board acknowledged in the decision that the Specification “also names the parent plants used to obtain the claimed cross”, a fact that the instant Specification lacks.
Applicant argues that the USPTO has a well-established practice of using Rule 105 requests to obtain breeding histories for plant variety applications, rather than rejecting the application under 35 U.S.C. § 112(a) for lacking such information. Applicant indicates a willingness to comply with a Rule 105 request and respectfully request the Examiner to follow the well-established practice of using Rule 105 requests to obtain breeding histories for plant variety applications (pages 8-9 of the Remarks).
Applicant’s argument is noted but is not persuasive. In the instant Application Applicant provides no description of how the instant invention was made. See Vas-Cath Inc. v. Mahurkar 1991 (CA FC) 19 USPQ2d 1111, 1115, which teaches that the purpose of the written description is for the purpose of warning an innocent purchaser, or other person using a machine, of his infringement of the patent; and at the same time, of taking from the inventor the means of practicing upon the credulity or the fears of other persons, by pretending that his invention is more than what it really is, or different from its ostensible objects, that the patentee is required to distinguish his invention in his 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.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID H KRUSE whose telephone number is (571) 272-0799. The examiner can normally be reached Monday-Friday 7AM-3:30PM.
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, Amjad Abraham can be reached on (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/David H Kruse/
Primary Examiner, Art Unit 1663