DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 16 April 2026 has been entered.
Claim 12 is pending.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The objection to claim 12 is withdrawn in light of Applicant’s amendment to the claim.
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 the second paragraph of 35 U.S.C. 112:
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.
Claim 12 is 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 that the inventor or a joint inventor, or for pre-AIA the applicant, regards as the invention.
Due to Applicant’s amendment of the claim, the rejection is modified from the rejection set forth in the Office action mailed 16 January 2026. Applicant’s arguments filed 16 April 2026 have been fully considered but they are not persuasive.
Claim 12 is indefinite in its recitation of “comprising crossing a first parent Helianthus plant‘SUR67-1’, wherein representative plant tissue of hybrid Helianthus plant ‘SUR67-1’ is deposited … under NCMA No. ____”.
It is unclear what hybrid Helianthus plant ‘SUR67-1’ is and what will be deposited.
Interspecific Helianthus plant SUR67-1 was produced from a cross of female parent interspecific hybrid H. annuus x H. argophyllus HELAC0001 with male parent H. debilis plant HELAB0103-2V (example 1).
In the response filed 3 August 2023 to the Request for Information under 37 CFR 1.105, Applicant stated that H. annuus x H. argophyllus HELAC0001 is a heterozygous F1 hybrid, one plant of which was used as the female parent in the cross to make SUR67-1 (response to f, on pg 4) and that HELAB0103-2V is a homozygous inbred plant (response to g, on pg 5).
Gametes produced from inbred parent HELAB0103-2V will each be genetically identical. When hybrid parent HELAC0001 produces gametes, crossing over occurs and each of the gametes get a different portion of each of the H. annuus and H. argophyllus parent genomes; each gamete will be different genetically. When HELAB0103-2V and HELAC0001 are crossed, each progeny will get the same set of chromosomes from inbred parent HELAB0103-2V and each will get a different set of chromosomes from hybrid parent HELAC0001. The resulting progeny are a genus of plants with a mixture of genotypes.
It is not clear if “SUR67-1” refers to a single plant selection from this genus of progeny or if refers to this genus of progeny as a whole. The specification is not clear what SUR67-1 is (example 1). In the response filed 3 August 2023 to the Request for Information under 37 CFR 1.105, Applicant merely said that “SUR67-1 is a heterozygous F1 hybrid” (response to e, on pg 4); however, this would be true whether “SUR67-1” refers to a single plant or a genus of plants.
The seed deposit referenced in the specification further muddies this. The “SEED DEPOSIT DETAILS” on pg 7 of the specification states
Seed of the variety Helianthus Interspecific Hybrid SUR67-1 (4A994) made from H. annuus x H. argophyllus x H. debilis is deposited under the terms of the Budapest Treaty American Type Culture Collection (ATCC) Patent Depository, 10801 University Blvd., Manassas, VA 20110. The ATCC number of the deposit is PTA-125012.
In the response filed 3 August 2023 to the Request for Information under 37 CFR 1.105, Applicant admitted that seed of SUR67-1 was not deposited; what was deposited was a “backcross generation (to HELAB0103-2V) seeds” (response to d, on pg 4), presumably because “SUR67-1 is a vegetative sterile F1 hybrid plant” (response to d, on pg 4) that is propagated vegetatively (response to e, on pg 4).
Thus, “representative plant tissue of hybrid Helianthus plant ‘SUR67-1’ is deposited under NCMA No. ____” is indefinite as it is not clear what plant tissue is being deposited. Are the cuttings from a plant of a single heterozygous genotype, are the cuttings from a mixture of plants, each with a different of heterozygous genotype, are the cuttings from a plant single heterozygous genotype grown from a seed deposited as PTA-125012, or are the cuttings from a mixture of plants grown from seeds deposited as PTA-125012?
Further, if “SUR67-1” refers to a genus of plants, each of a different genotype, it is unclear how many plants of this genus are needed to be representative of “SUR67-1” and thus how many genetically different vegetative tissues must be deposited to represent SUR67-1.
Response to Arguments
Applicant urges that a vegetative cutting of variety ‘SUR67-1’ will be deposited (response pg 1).
This is not found persuasive. This does not answer whether the cutting is from a plant of a single heterozygous genotype or if what is being deposited is cuttings from a mixture of heterozygous genotypes produced by crossing H. annuus x H. argophyllus HELAC0001with H. debilis HELAB0103-2V or if what is being deposited is cuttings from a plant or plants grown from a seed or seeds deposited as PTA-125012.
Applicant urges that ‘SUR67-1’ has been described in US PP31819 (response pg 1).
This is not found persuasive. US PP31819 is not part of the instant specification. Although PP31819 and the instant application both claim priority to provisional 62/629,813, the description of SUR67-1 in PP31819 is not found in the provisional.
The description of a claimed invention cannot be found outside the specification.
Applicant urges that there are no genetic differences possible since no crosses are used to produce this vegetative material; it is unclear why the examiner refers to gametes and generations since no reproduction will be used to produce this material (response pg 1).
This is not found persuasive. The discussion of gametes and generations is necessary to explain the issue, which is that Applicant will not state what is being deposited as ‘SUR67-1’. The following are all possibilities based on the specification:
cuttings from a plant of a single heterozygous genotype from the cross of HELAB0103-2V and HELAC0001;
cuttings from a mixture of plants from the cross of HELAB0103-2V and HELAC0001, each plant with a different of heterozygous genotype;
cuttings from a plant single heterozygous genotype grown from a seed deposited as PTA-125012, i.e., seed producing by backcrossing a plant or a mixture of SUR67-1 plants to HELAB0103-2V, or
cuttings from a mixture of plants grown from seeds deposited as PTA-125012, i.e., mixture of seeds producing by backcrossing a plant or a mixture of SUR67-1 plants to HELAB0103-2V.
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Claim 12 is 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 contains subject matter that 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 repeated for the reasons of record as set forth in the Office action mailed 16 January 2026. Applicant’s arguments filed 16 April 2026 have been fully considered but they are not persuasive.
A. The claims require interspecific hybrid Helianthus SUR67-1 plant, wherein representative tissue sample will be deposited. The specification does not provide a sufficient description of SUR67-1.
The specification teaches that interspecific Helianthus plant SUR67-1 was produced from a cross of female parent interspecific hybrid H. annuus x H. argophyllus HELAC0001 with male parent H. debilis plant HELAB0103-2V (example 1).
In the response filed 3 August 2023 to the Request for Information under 37 CFR 1.105, Applicant stated that H. annuus x H. argophyllus HELAC0001 is a heterozygous F1 hybrid, one plant of which was used as the female parent in the cross to make SUR67-1 (response to f, on pg 4) and that HELAB0103-2V is a homozygous inbred plant (response to g, on pg 5).
Gametes produced from inbred parent HELAB0103-2V will each be genetically identical. However, when hybrid parent HELAC0001 produces gametes, crossing over occurs and each of the gametes get a different portion of each of the H. annuus and H. argophyllus parent genomes; each gamete will be different genetically. When HELAB0103-2V and HELAC0001 are crossed, each progeny will get the same set of chromosomes from inbred parent HELAB0103-2V and each will get a different set of chromosomes from hybrid parent HELAC0001. The resulting progeny are a genus of plants with a mixture of genotypes.
The specification does not state whether “SUR67-1” refers to a single plant selection from this genus of progeny or if refers to this genus of progeny as a whole.
The seed deposit referenced in the specification further muddies this. The “SEED DEPOSIT DETAILS” on pg 7 of the specification states
Seed of the variety Helianthus Interspecific Hybrid SUR67-1 (4A994) made from H. annuus x H. argophyllus x H. debilis is deposited under the terms of the Budapest Treaty American Type Culture Collection (ATCC) Patent Depository, 10801 University Blvd., Manassas, VA 20110. The ATCC number of the deposit is PTA-125012.
In the response filed 3 August 2023 to the Request for Information under 37 CFR 1.105, Applicant admitted that seed of SUR67-1 was not deposited; what was deposited was a “backcross generation (to HELAB0103-2V) seeds” (response to d, on pg 4), presumably because “SUR67-1 is a vegetative sterile F1 hybrid plant” (response to d, on pg 4) that is propagated vegetatively (response to e, on pg 4). Thus, even if “SUR67-1” refers to a single plant selection, what was deposited was a genus of plants that are not this single plant selection but apparently are also named “SUR67-1”.
The structural features that distinguish SUR67-1 from other H. annuus x H. argophyllus x H. debilis plants are not described in the specification.
If “SUR67-1” refers to a single plant selection, the structural features that distinguish SUR67-1 from other progeny of a cross between female parent H. annuus x H. argophyllus HELAC0001 and male parent H. debilis plant HELAB0103-2V are not described in the specification.
B. The specification does not describe SUR67-1 other than to show it has a larger flower diameter than its parents, a larger width under some growing conditions than its parents and a height that is intermediate between its parents, and that it has powdery mildew resistance (Table 1). The specification fails to describe if “SUR67-1” in Table 1 is an F1 plant of a single genotype, a mixture of F1 plants of a population of genotypes, a BC1F1 plant of a single genotype, a mixture of BC1F1 plants of a population of genotypes, a plant grown from a seed deposited as PTA-125012, or a mixture of plants grown from a mixture of seed deposited as PTA-125012.
Regardless, a description of flower diameter, width, and height relative to other plants and powdery mildew resistance is not a sufficient description. A deposit is not substitute for a description of a claimed invention.
The instant specification it does not provide a description sufficient to conduct an to conduct an examination, including search of the prior art
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.").”
The instant specification also fails to satisfy the written description because it does not provide enough description to be sufficient to aid in the resolution of questions of infringement.
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).
Hence, Applicant has not, in fact, described SUR67-1, and the specification fails to provide an adequate written description of the claimed invention.
Because SUR67-1 is not described, the method of the using plant is likewise not described, and the specification fails to provide an adequate written description of the claimed invention.
Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the claimed compositions, Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
Response to Arguments
Applicant urges that a deposit will be made to satisfy the written description requirement (response pg 1).
This is not found persuasive. A deposit where Applicant will not reveal what is in the deposit (vegetative material from a mixture of plants or vegetative material of a single plant, and the characteristics of what was deposited) does not meet the written description requirements. Written description also requires a description of the deposit.
Whether SUR67-1 is a genus of plants, each of a different genotype, or if it is a plant of a single heterozygous genotype, Applicant should provide support for that in the originally filed specification. If there is no support for the version of SUR67-1 that is in the deposit, then a deposit limiting SUR67-1 to that version of SUR67-1 would be new matter. Applicant should point to suppo0rt for the version of SUR67-1 that is in the deposit
Applicant urges that the response to the 105 request provided additional information for examination (response pg 1).
This is not found persuasive. As detailed in the rejection above, the response to the 105 request made it less clear as to what the deposit will be than before and raised more questions about the deposit. Applicant has not answered those questions even though answering those questions could obviate at least some of the rejections in this action.
Claim 12 is 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 contains subject matter that 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 rejection is modified from the rejection set forth in the Office action mailed 16 January 2026. Applicant’s arguments filed 16 April 2026 have been fully considered but they are not persuasive.
The claim requires a deposit of plant tissue of hybrid Helianthus variety SUR67-1.
It is noted that Applicant intends to deposit tissue of SUR67-1 at the NCMA, but there is no indication that the tissue has been deposited. Further, there is no affirmative statement in the specification that all restrictions upon availability to the public will be irrevocably removed upon granting of the patent.
It is not clear what plant tissue is being deposited, as detailed in the indefiniteness and written description rejections above and incorporated herein. It is not clear if the plant tissue from a plant of a single heterozygous genotype or if it is it plant tissue from a mixture of plants, each with a different of heterozygous genotype.
If the deposit of this tissue 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 that the tissue 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.
If the deposit is not been made under the Budapest Treaty, then in order to certify that the deposit, meets the requirements 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; and
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807).
In addition, the identifying information set forth in 37 CFR 1.809(d) should be added to the specification. See 37 CFR 1.801 - 1.809 [MPEP 2401-2411.05] for additional explanation of these requirements.
Response to Arguments
Applicant urges that a deposit will be made to satisfy the enablement requirement and makes a deposit statement (response pg 1-2).
This is not found persuasive because it is not clear what will be deposited, a plant tissue from a plant of a single heterozygous genotype or plant tissue from a mixture of plants, each with a different of heterozygous genotype? Since that is unknown, it cannot be determined if the deposit will satisfy the Enablement requirement.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anne R. Kubelik, Ph.D., whose telephone number is (571) 272-0801. The examiner can normally be reached Monday through Friday, 9:00 am - 5:00 pm Eastern.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham, can be reached at (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Anne Kubelik/Primary Examiner, Art Unit 1663
Prosecution Insights