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 .
Claim Status
1. Claims 1-11 are pending and under examination on the merits.
Claims 12-19 are withdrawn as being directed to a none-elected invention. Election was made without traverse in the reply filed September 23, 2025.
Information Disclosure Statement
2. No Information Disclosure Statement has been received for consideration by the Office. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
3. The specification is objected to because of the following:
The disclosure is objected to because [0057] contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Correction and/or clarification is required.
Claim Rejections - 35 USC § 112(a)
4. 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.
Written Description
5. Claims 1-11 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 claims contain 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 inventors, at the time the application was filed, had possession of the claimed invention.
The independent claims are broadly directed to an expression vector comprising a heterologous nucleic acid encoding a sorgoleone transporter having at least 75% sequence identity to SEQ ID NO:1 (claim 1) and a transgenic plant expressing such a vector (claim 10).
The Specification describes the identification of an ABC subfamily G protein required for secretion of sorgoleone from Sorghum bicolor root hairs (see: Example 1, pp. 27-38)[0104], wherein said protein comprises SEQ ID NO:1 and is encoded by SEQ ID NO:2[0108]. Applicant further discloses the production of transgenic S. bicolor and Arabidosis thaliana plants overexpressing SEQ ID NO:1, as encoded by SEQ ID NO:2, under the control of the S. bicolor root hair-specific DES3 gene promoter (see: Example 2, pp.38-39)[0108].
The limitation of “at least 75% sequence identity” to SEQ ID NO:1/SEQ ID NO:2 lacks adequate written description for the following reasons.
Applicant does describe any sequence comprising a sorgoleone transporter having only 75% sequence identity to SEQ ID NO:1 nor any nucleotide sequence having only 75% sequence identity to SEQ ID NO:2 and encoding a sorgoleone transporter. While one skilled in the art can produce a population of sequences having at least 75% sequence identity to SEQ ID NO:1/SEQ ID NO:2, one skilled in the art cannot predict which sequence(s) within said population would result in a functional sorgoleone transporter.
The polypeptide sequence set forth in SEQ ID NO:1 represents an ABCG-type sorgoleone transporter consisting of 1281 amino acids. The 75% sequence identity scope encompasses amino acid sequences obtained from any species as long as said sequence retains sorgoleone transport activity, yet no structural feature that defines said activity has been described. Thus, the claims encompass polypeptides having as many as 320 amino acid substitutions, insertions, and/or deletions at any position. Even a single substitution at any of the 1281 amino acid positions would result in 191281 different amino acid sequences. The nucleotide sequence set forth in SEQ ID NO:2 encodes SEQ ID NO:1 and consists of 3846 nucleotides. The 75% sequence identity claim scope encompasses nucleotide sequences having as many as 961 nucleic acid substitutions, insertions, and/or deletions at any position; a single substitution at any of the 3846 positions would result in 33846 different nucleotide sequences. It is unclear if sequences comprising only 961 amino acids from SEQ ID NO:1 would form a functional sorgoleone transporter. For example, Conrath (US-2024/0384288-A1, published 11/21/2024 (A)) discloses a coumarin transporter (SEQ ID NO:4) having 76% sequence identity to instant SEQ ID NO:1, but provides no indication as to whether said transporter also functions in sorgoleone transport (see attached STIC search results). Therefore, sorgoleone transporters having only 75% sequence identity to SEQ ID NO:1 and nucleotide sequences having only 75% sequence identity to SEQ ID NO:2 lack adequate written description.
The state of the prior art does not teach the structure or sequence of an ABCG-type sorgoleone transporter or protein domains responsible and/or sufficient for said activity. Applicant does not describe features, structures, or regions within the sequence of SEQ ID NO:1 that are sufficient and/or required for the claimed sorgoleone transport activity. The disclosure of SEQ ID NO:1 is not representative of other sorgoleone transporter sequences. Thus, there are insufficient relevant identifying characteristics to allow one skilled in the art to predictably determine which sequences, within the 75% sequence identity scope of the claims, comprise a functional sorgoleone transporter.
The Federal Circuit has clarified that the written description of an invention "requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials." University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). The court also concluded that "naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material." Id. Further, the court held that to adequately describe a claimed genus, Patent Owner must describe a representative number of the species of the claimed genus, and that one of skill in the art should be able to "visualize or recognize the identity of the members of the genus." Id.
“Functional” terminology may be used “when the art has established a correlation between structure and function” but “merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing one has invented a genus and not just a species.” Ariad Pharmaceuticals Inc. v. Eli Lilly & Co., 598 F3d 1336, 94 USPQ2d 1161, 1171 (Fed Cir. 2010). Since there is only functional sorgoleone transporter sequence taught by Applicant and no correlation between structure and function has been established by either Applicant or the prior art, there is no correlation between the members of a genus of sequences having 75% sequence identity to SEQ ID NO:1/SEQ ID NO:2. Thus, since there is no correlation between structure and function across the entire genus, functional language should not be used to define a genus. Rather, structure should be used, including the core sequence required for said function.
Applicant fails to disclose a representative number of species within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. Similarly, Applicant has not described functional sequences having only 75% sequence identity to SEQ ID NO:1 or SEQ ID NO:2 and form or encoding sorgoleone transporters. Thus, Applicant has not described a sufficiently representative number of species or characteristics to define the claimed genus. Accordingly, there is lack of adequate written description to inform a skilled artisan that Applicant was in possession of the claimed invention at the time of filing.
Because dependent claims 2-9 and 11 do not limit the scope of the “at least 75% sequence identity” recitations, they also lack adequate written description. Accordingly, there is lack of adequate written description to inform a skilled artisan that Applicant was in possession of the claimed invention at the time of filing.
Enablement
6. Claims 1-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for SEQ ID NOs:1-2, does not reasonably provide enablement for sequences sharing only 75% sequence identity with SEQ ID NO:1 or SEQ ID NO:2. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to produce the invention commensurate in scope with these claims.
When determining whether a claimed invention complies with the enablement requirement, factors to consider include: “(1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.” Id.
Applicant’s disclosure is as set forth above.
The claimed invention is not enabled for the following reasons.
The scope of amino acid sequences having 75% identity to SEQ ID NO:1 encompasses any sequence modification, including insertions, deletions, and/or substitutions, of up to 320 amino acids as long as said sequence forms a functional sorgoleone transporter. Applicant provides only one working example of a functional sorgoleone transporter amino acid sequence (i.e., SEQ ID NO:1)[0104], one working example of the nucleotide sequence encoding said transporter (i.e., SEQ ID NO:2)[0108], and two working examples of transgenic plants transformed with SEQ ID NO:2 (i.e., S. bicolor and A. thaliana; see: Example 2, pp. 38-39). The Office notes that while Applicant describes the transformation of SEQ ID NO:2 into either plant species, Applicant does not describe or confirm the expression of SEQ ID NO:2 in said transgenic S. bicolor or said transgenic A. thaliana.
Applicant provides no guidance as to which amino acid(s) or region(s) of SEQ ID NO:1 must be conserved to retain sorgoleone transport activity. While one skilled in the art can readily isolate, modify, transform, and/or express virtually any protein, no guidance is provided with regard to how to identify which regions of SEQ ID NO:1 are required or sufficient for the claimed sorgoleone transport activity. The state of the art fails to remedy this deficiency and does not provide any structures or sequences, within SEQ ID NO:1, sufficient for conferring sorgoleone transport activity. As such, it is difficult for one of ordinary skill in the art to predict which sequences, within the 75% sequence identity scope of the claims, represent functional sorgoleone transporters or the nucleotide sequences encoding said transporters. Furthermore, the state of the art teaches that protein biochemistry is one of the most unpredictable areas of biotechnology. For example, substitution of Tyr-38 with Phe or Trp did not abolish protein activity while replacement of Tyr-38 with other amino acids severely reduced or abolished protein activity (Lazar et al., Molecular and Cellular Biology. 1989; 9(2):860-864 (U); Abstract; p. 860, “Detection and biological activity of yeast-secreted proteins of mutant TGF-a.”); similarly, deletion of the N-terminus of TDP-43 results in the formation of abnormal protein inclusions (Nonaka et al., Human Molecular Genetics. 2009; 18(18):3353-3364 (V)); Abstract). Together, these examples teach that even a single amino acid change can unpredictably alter the function of polypeptide variants. As such, it is difficult to predict or determine which sequences will form or encode functional sorgoleone transporters. Because Applicant provides no guidance as to how to readily identify sequences representing or encoding functional sorgoleone transporters, one of ordinary skill in the art would not be able to predict which sequences are required or sufficient to produce the instant invention without engaging in extensive and undue experimentation. Thus, sequences having only 75% sequence identity to SEQ ID NO:1 or SEQ ID NO:2 are not predictably functional, and so are not enabled.
In making this determination, the Office has weighed each of the Wands factors. The breadth of the claims is to an expression vector comprising a sorgoleone transporter having at least 75% sequence identity to SEQ ID NO:1 and to a plant containing such an expression vector. The nature of the invention comprises a gene encoding a sorgoleone transporter and the transporter encoded therein. The level of one of ordinary skill in the plant biotechnology art is high. The state of the prior art does not teach the structure of sorgoleone transporters. Applicant discloses no working examples sequences having only 75% sequence identity to SEQ ID NO:1 or SEQ ID NO:2. Given these difficulties, notwithstanding a relatively high level of ordinary skill of those in the art, the amount of experimentation would likely be extensive and undue.
Weighing all of the Wands factors based on the totality of the record as discussed above, the Office determines that it would require undue experimentation for a person of ordinary skill in the art to make and use the invention as claimed.
Because dependent claims 2-9 and 11 do not limit the scope of the “at least 75% sequence identity” recitations, they also are not enabled.
Conclusion
7. No claim is allowed.
8. The closest prior art, Turgeman et al., (US-2019/0345511-A1, published 11/14/2019 (B)), teaches an expression vector[0028], [0091] (see: claims 64-65, 77-78; Example 5) comprising a promoter and a heterologous polynucleotide, wherein the polynucleotide encodes an S. biocolor amino acid sequence having at least 75% sequence identity to SEQ ID NO:1, and wherein the promoter is operably linked to the heterologous polynucleotide. Turgeman does not teach sorgoleone and sorgoleone transporters.
Examiner’s Contact Information
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEQUANTARIUS JAVON SPEED whose telephone number is (703)756-4779. The examiner can normally be reached M-F; 9AM-5PM ET.
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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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/DEQUANTARIUS JAVON SPEED/Junior Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663