Status of the Application
This Office Action is in response to the Amendment and Remarks filed 17 October 2025.
Claim Objections
Claims 4 and 5 are objected to because of the following informalities: The phrase “claims 2” should be -- claim 2 --. Appropriate correction is required.
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 2-6 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 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.
Applicant claims an interspecific Helianthus plant made by crossing a Helianthus plant with another Helianthus plant from the pedigree of SUO22=SUL1 and the indeterminate phenotype is inherited from SUO22=SUL1 (claim 2 as presently amended). Applicant claims said determinant can be found in a plant grown from a deposited seed (claim 3). Applicant claims said interspecific Helianthus plant is made from H. annuus and H. argophyllus (claim 4) which is exemplified in the instant Specification.
Applicant describes crossing a commercial H. annuus variety ‘Junior’ with a proprietary inbred H. argophyllus line for making interspecific hybrids (see pages 12-13, Example 1). Applicant describes a single interspecific Helianthus plant variety produced by said crossing as SUO22=SUL1, also called Helianthus Interspecific Hybrid Yellow Dark Centre 70052828 seeds of which Applicant has deposited at the NCIMB (page 12, lines 6-9).
Applicant does not describe the very broad genus of interspecific Helianthus plants comprising a genetic determinant responsible for an indeterminate phenotype. Applicant does not describe a genetic determinant responsible for an indeterminate phenotype by structure. In particular, instant claim 2 is a product-by-process, a crossing using a Helianthus plant comprising “a genetic determinant responsible for an indeterminate phenotype” from the pedigree of the deposited SUO22=SUL1 line. The deposited seed only appears to represent a Helianthus plant with said genetic determinant, but is not limited to crossing using the deposited SUO22=SUL1 line.
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.
Applicant argues that Claim 2 is amended to clarify that the inderterminant phenotype is inherited from SU022=SUL1. Applicant argues that the plant from the pedigree of SU022=SUL1 can be obtained from the deposited seed. Applicant argues that a person of skill in the art would understand the description of the genus described in claims 2-6 in light of the deposited seed (page 3 of the Remarks).
Applicant’s arguments are not found persuasive. Applicant fails to describe the “genetic determinant responsible for an indeterminate phenotype” (instant claim 3) in order to distinguish the instantly claimed invention from other interspecific Helianthus plants having an indeterminate phenotype. The deposited seed appears to be “representative” of a claimed interspecific Helianthus plant comprising a genetic determinant responsible for an indeterminate phenotype used in the crossing step of claim 2. Further, the genetic determinant responsible for an indeterminate phenotype found in SUO22=SUL1 is only described by function. The description of interspecific Helianthus plant SUO22=SUL1 is insufficient to distinguish the claimed interspecific Helianthus plant where the genetic determinant is from SUO22=SUL1 or from another interspecific Helianthus plant that comprises a genetic determinant responsible for an indeterminate phenotype inherited from Helianthus argophyllus.
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.
In the instant case one skilled in the art could not distinguish a Helianthus plant from the pedigree of SUO22-SUL1 from a Helianthus from the pedigree of the plant(s) described by Terzik et al (2006) addressed below. See also, MPEP § 2163 which states that the claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function.
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.
Claim 2 remains 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.
At claim 2, line 2, the limitation “the pedigree of” lacks proper antecedent basis within the claim. Hence, the metes and bounds of the claim are unclear.
Applicant argues that claim 2 has been amended on page 3 of the Remarks.
This argument is not found persuasive because the amendment appears to be directed to the claimed “interspecific Helianthus plant” and not “a Helianthus plant from the pedigree of SUO22=SUL1”. Further, “the pedigree” is not defined in the claim as a whole. The rejection is maintained for the reasons of record.
Claim Rejections - 35 USC § 102/103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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) 2-6 remain/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Terzic et al (2006 HELIA 29(44): 87-94).
Instant claim 2 is directed to a product-by-process, as well as instant claim 3, wherein the “another Helianthus plant” made by a pedigree breeding method (claim 2) from Helianthus plant SUO22=SUL1. See In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985), which teaches that a product-by-process claim may be properly rejectable over prior art teaching the same product produced by a different process, if the process of making the product fails to distinguish the two products.
Terzic et al disclose an interspecific Helianthus plant produced by crossing H. annuus and H. argophyllus on page 91 and Table 2. The crosses disclosed are PHBC1 203A (annuus) with ARG1812 ts4 (argophyllus); PHBC1 202A with ARG1812 ts21; and PHBC1214A with ARG1805 ts18. The H. annuus lines PHBC1 203A and PHBC1 202A are disclosed as having minimal basil branching as illustrated in Figure 1 on page 88, that being a value of 1, and PHBC1 214A having a determinate no branching phenotype value of 0. All of the H. argophyllus lines have a fully branched phenotype value of 4. Terzic et al disclose interspecific F1 hybrids having a high level of branching (an indeterminate phenotype). Given the fact that the “genetic determinate” responsible for the “indeterminate phenotype” was inherited from the H. argophyllus lines, it would appear that the interspecific Helianthus plants disclosed by Terzic et al would inherently comprise the same genetic determinate as that found in plants grown from seed deposited under NCIMB Accession No. 42200 without evidence to the contrary. The Office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same, material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the Applicant to provide that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Terzic et al do not teach Helianthus plant SUO22=SUL1, seed deposited under NCIMB Accession No. 42200.
In the alternative, 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 over the teachings of Terzic et al because the instant seed deposited under NCIMB Accession No. 42200 were also produced by crossing and H. annuus with an H. argophyllus plant (Example 1 on page 13 of the instant Specification). Applicant does not teach any specific structure for “the genetic determinate” that would distinguish the claimed invention from the prior art given the fact that the interspecific Helianthus plants taught by Terzic et al comprise an indeterminate phenotype. Further, at instant claim 2, the “obtained from” would not have any distinguishing structural characteristic from the interspecific Helianthus plants taught by Terzic et al.
Applicant argues that claim 2 is amended. Applicant argues that 'Terzic' does not teach SU022=SUL1 obtained from the seed deposited under NCIMB Accession No. 42200. Applicant argues that 'Terzic' can't anticipate the claims 2-6 or serve as the basis for a prima facie obviousness rejection for claims 2-6 (page 3 of the Remarks).
Applicant’s argument is not found to be persuasive. As addressed above, Applicant has not described the “genetic determinant” in SUO22=SUL1 sufficiently to distinguish the claimed invention from the prior art. Because the “genetic determinant” in the interspecific Helianthus plants disclosed by Terzic et al produce the same function, an indeterminant phenotype, it would appear that the plants disclosed by Terzic et al anticipate or in the alternative render obvious the instant claims.
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.
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/David H Kruse/
Primary Examiner, Art Unit 1663