Status of the Application
This Office Action is in response to the Amendment and Remarks filed 20 October 2025.
The objections to the Specification are withdrawn in view of Applicant’s amendments.
The objections to claims 4, 6 and 9 are withdrawn in view of Applicant’s amendments to the claims.
The rejection of claims 6 and 13 under 35 U.S.C. 112(b) is withdrawn in view of Applicant’s amendments to said claims.
The Examiner notes that Applicant’s response filed 20 October 2025 failed to address the Request for Information under 37 CFR 1.105 in the Office Action mailed 20 June 2025. Failure to address the request for information will be held as non-responsive to this Office action.
Specification
The amendment filed 20 October 2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: The amendment to paragraph [0075] to replace “crossbreeding” to “inbreeding” is New Matter because there was no accompanying declaration by an Inventor or the Assignee that attests that there was an error in the Specification as originally filed.
Applicant is required to cancel the new matter in the reply to this Office Action.
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 3, 12 and 14 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.
The Examiner acknowledges Applicant’s deletion of “essentially all” in the instant claims. The problem created is that the phrase now reads “has physiological and morphological characteristics of”, it is unclear what physiological and morphological characteristics the phrase encompasses. Hence, the metes and bounds of the claims remain unclear.
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 1-20 remain and claims 21-24 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 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.
The invention appears to employ novel plants. Since the plant 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 the plant is not so obtainable or available, the requirements of 35 USC § 112 may be satisfied by a deposit of the plant. A deposit of 650 seeds of each of the claimed embodiments is considered sufficient to ensure public availability. The specification does not disclose a repeatable process to obtain the plant and it is not apparent if the plant is readily available to the public. It is noted that Applicants have deposited seeds of the plants but there is no indication in the specification as to public availability.
(a) If a deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by 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 instant invention has been deposited and accepted, and will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
(b) If a 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 and MPEP 2402-2411.05, Applicant 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:
(i) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(ii) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent in accordance with 37 CFR § 1.808(a)(2);
(iii) 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 effective life of the patent, whichever is longer;
(iv) a test of the viability of the biological material at the time of deposit (see 37 CFR § 1.807); and,
(v) the deposit will be replaced if it should ever become inviable.
Applicant argues that they have submitted a deposit statement rendering the rejection moot on page 9 of the Remarks.
Applicant’s argument is not found persuasive because the Examiner can find no evidence of a deposit statement in the response filed 20 October 2025. The Examiner does acknowledge Applicant’s filing of copies of the Budapest Treaty Deposit receipts. The rejection is maintained for the reasons of record.
Claims 3, 10-15 and 17 remain and claims 21-24 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.
At claims 3, 12 and 14, Applicant does not describe all of the physiological and/or morphological characteristics, hence Applicant has failed to adequately describe the claimed sunflower or claimed method. The requirement for a specific identification is consistent with the description requirement of the first paragraph of 35 U.S.C. 112, and to provide an antecedent basis for the biological material which either has been or will be deposited before the patent is granted. 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. Such a deposit is not a substitute for a written description of the claimed invention. 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.
Claims 10, 11, 13 and 15 lack adequate written description because it is unclear if each of the recited sunflower varieties are inbred lines and thus have a defined genomic makeup. New claims 21-24 are also dependent from the method of claim 9. The Specification on page 21 describes the deposited lines as being the result of crossbreeding and selection (lines 24-25), Applicant is silent as to what breeding steps were used to produce the deposited lines subsequent to 2007 in 2012-2016. The issue of New Matter in the Specification is addressed above. Hence, Applicant does not adequately describe the claimed derived sunflower seed and plant to which the instant claims are directed.
Claims 17 lacks adequate written description because the method of claim 16 is directed to introducing random mutations that confer “at least one new characteristic” but the claimed method of making fails to adequately describe the product produced.
Hence, it is unclear that Applicant was in possession of the invention as broadly claimed.
Applicant argues that certain claims have been amended as discussed during the interview (of 1 October 2025) on page 9 of the Remarks.
This argument is not found persuasive given the issue of New Matter discussed above. Further, written description of the “mutant” of claim 17 would not be overcome by clarifying whether the deposited sunflower lines are indeed inbred and not crossbred. The Examiner notes that if the deposited lines are inbred, the method of claim 9 would produce first generation selfed progeny and F1 hybrid progeny, both of which would be adequately described if Applicant overcomes the following rejection.
Claims 1-20 remain and claims 21-24 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 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 and 2, Applicants claims a new sunflower plant variety. 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 exact breeding history used to produce each of the claimed plant varieties and the names of the parental lines used.
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 and starting materials used 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 as discussed during the interview, Applicant has amended paragraph [0075] to clarify "the progeny lines resulting from crossing with these sunflower lines were repeatedly subjected to inbreeding and selection." (page 10 of the Remarks).
Applicant’s amendment to the Specification does not overcome the instant rejection because it does not provide any information about how the individual sunflower varieties were made, how they are related to each other or how to distinguish the claimed sunflower varieties from other sunflowers with a horizontal flower head attitude. Hence, the rejection is maintained for the reasons of record.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 8, 10, 11, 18 and 19 remain and claims 21 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Benson et al (U.S. Patent 8,558,094).
On page 11 of the instant Specification Applicant states that “the progeny line may be directly or indirectly obtained, obtainable, or derived from the deposited line or a progeny line thereof by selfing and/or cross-pollination, or may be derived from a parental line obtained from the deposited line using a traditional breeding method such as selfing and/or cross-pollination”.
Based on Applicant’s definition of “progeny”, the Examiner interprets the limitation as being directed to a sunflower plant or part thereof, in particular a Helianthus annuus plant or plant part.
At instant claim 8, the microspore and egg cell of the progeny sunflower plant of claim 6 would include cells with predominantly the second parental plant, and because the progeny would be heterologous the microspore and egg cell would not necessarily comprise the recited SNP#.
The issue of how the specific sunflower varieties were made remains. At instant claim 9, a method of producing a sunflower seed, the claim is not specific as to which sunflower plant is the female parent and which is the male parent. Based on the specification, lines Takii23 and Takii28 would necessarily have to be the female parental line in the method of claim 9, but the remaining could be either parent.
Benson et al teach sunflower OID687R which is taught to have a horizontal head attitude (Table 1, column 10). Benson et al teach pollen, and ovule and a tissue culture therefrom at claims 3, 4 and 7, as well as a sunflower regenerated therefrom at claim 8. The instant claims would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant claims because said claims do not recite any physiological or morphological characteristics that would distinguish the claimed parts and/or progeny from that taught in the prior art. Given the teachings of Benson et al, one of ordinary skill in the art would have had a reasonable expectation of success, and the fact that the parts and progeny were claimed and deposited the teachings of Benson et al would have been fully enabled.
Applicant argues that Benson fails to teach or suggest each and every element of claims. As discussed during the interview, Benson fails to teach or suggest that "the part includes at least 50% of alleles of the parent sunflower plant" as set forth in the claims. Applicant argues that Benson does not teach or suggest each and every element of the present claims (page 10 of the Remarks).
Applicant’s argument is not found persuasive. The issue of homozygosity/heterozygosity of the deposited sunflower lines remains. Hence, the claimed produced sunflower seed and plant would have been obvious over the teachings of Benson et al.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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