DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of group I, claims 1 – 5 in the reply filed on September 5, 2025 is acknowledged.
Claims 1 – 19 are pending; claims 6 – 19 are withdrawn as being drawn to non-elected subject matter; claims 1 – 5 have been considered on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 9, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 – 5 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 – 3 are drawn to any variant of Helicoverpa zea wherein the H. zea is resistant to Vip3Aa. Claim 4 is drawn to the variant of H. zea wherein it has one or more nucleic acid variations while claim 5 requires the variations to be single nucleotide polymorphism. These claims are considered genus claims that encompass a wide array of H. zea variants. The specification fails to set forth a representative number of examples in order to reasonably verify possession of such a potentially enormous number of variants. Rather, the specification discloses seven strains of H. zea selected for resistance to Vip3Aa over 33 generations (example 1), crossing 5 strains to create heterozygous strains with resistance and susceptibility to Vip3Aa, wherein resulting larvae are scored for resistance and prepared for DNA sequencing (example 2). The specification fails to identify any single or specific variant having the claimed activity and no variants having “one or more nucleic acid variations” or a “single nucleotide polymorphism.”
The MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that the claims are broad generics, with respect to all variants of H. zea with any nucleic acid variation or any single nucleotide polymorphism that might result from natural selection, natural breeding, specific selective breeding or genetic manipulation of a strain.
The instant disclosure fails to identify a single variant having any single or specific nucleic acid variation or single nucleotide polymorphism. The possible variations of H. zea are limitless with potentially millions of types of strains let alone any variation thereof. Furthermore, claims 1 – 3 recite a composition of H. zea wherein the only limitations are interpreted as functional language, e.g., is resistant to Vip3Aa. A claim term is functional when it recites a feature by what it does rather than by what it is. Without reciting the particular structure, materials or steps that accomplish the function or achieve the result, all means or methods of resolving the problem may be encompassed by the claim. In this instance, unlimited functional claim limitations that extend to all means or methods of achieving the claimed function is not adequately supported by the written description. MPEP 2173.05(g). Although claims 4 and 5 recite that the H. zea has nucleic acid variations or single nucleotide polymorphisms compared to a wild type, the specification fails to describe any variation or polymorphism within any strain of H. zea.
The purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by them. A patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention. Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations" and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." The specification lacks sufficient variety of species of H. zea variants to reflect this variance in the genus since the specification does not provide any examples of such a genus of variants. Accordingly, the specification fails to provide adequate written description for the genus of “a variant of H. zea” and does not reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed had possession of the entire scope of the claimed invention Moreover, the specification neither describes the complete structure of a representative number of species, nor describes a representative number of species in terms of partial structure and relevant identifying characteristics. Absent of such teachings and guidance as to the structure and function of these variants, the specification does not describe the claimed variants, nucleic acid variations or single nucleotide polymorphisms in such full, clear, concise and exact terms so as to indicate that Applicant had possession of these variants at the time of filing of the present application.
Thus, the written description requirement has not been satisfied.
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 4 – 5 are 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.
Claims 4 – 5 are drawn to a composition comprising H. zea, however are rendered indefinite because it is unclear if the nucleic acid variations or nucleotide polymorphisms are tied to the claimed function only, or if they can represent variations in any gene or function. Clarification is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 – 3 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a Helicoverpa zea organism without significantly more.
Step 1: Yes, the claims are drawn to a Vip3Aa resistant H. zea variant which is a composition of matter.
Step 2A Prong 1: Yes, the claims are drawn to a Vip3Aa resistant H. zea, which is product of nature. The specification indicates the variants are obtained by selectively breeding H. zea for Vip3Aa resistance, however the prior art shows that H. zea with a Vip3Aa resistance ratio of 588-fold relative to susceptible populations is found in nature (See Yang et al., 2020, abstract).
Step 2A Prong 2: No, the claims do not recite any additional elements that integrate the product of nature into a practical application.
Step 2B: No, the claims do not recite any additional elements that amount to significantly more than the product of nature.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1 – 4 are rejected under 35 U.S.C. 102a1 as being anticipated by Yang et al. (2020, IDS filed 05.09.2024, NPL #8).
Regarding claims 1 – 3, Yang teaches Helicoverpa zea populations (compositions) that are resistant to Vip3Aa (abstract) and have an LC50 value that is 588-fold compared to susceptible strains (table 2, p.4, Results).
Regarding claim 4, Yang teaches the resistance is tied to an allelic variation (abstract, p.3-4).
The reference anticipates the claimed subject matter.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
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/RUTH A DAVIS/Primary Examiner, Art Unit 1699