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 .
Status of Claims
Claims 1-20 are under examination on the merits.
Interpretations
According to the instant specification, a plant part includes at least one cell of the plant from which the part was obtained (paragraph [0075]). This definition has been used in the examination of claims 2, 15 & 19.
Claim 18 requires a soybean plant expressing all the physiological and morphological characteristics of the soybean plant of claim 2. For purposes of examination, claim 18 has been interpreted as requiring that the soybean plant expressing all the physiological and morphological characteristics is a plant of the soybean variety 5PBDP31.
Specification
The disclosure is objected to because of the following informalities:
The specification uses “XXXX” as a placeholder for the accession number for the deposit of seeds of Soybean Variety 5PBDP31 and “[date]” as a placeholder for the date of deposit (paragraph [0192]). The specification should be amended with the correct accession number and date.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Indefiniteness
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 1-20 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. All dependent claims are included in the rejections below.
Claims 1-20 are indefinite due to the “XXXX” present in claim 1 (line 2), claim 4 (line 3), claim 18 (line 3) and claim 19 (line 3). The “XXXX” are intended as placeholders for the accession number which is not yet presented by the Applicant to the office. Without an accession number, “XXXX” leave the claims indefinite as it is unknown which deposit will be linked to the instant soybean variety PBDP31.
The failure to provide a deposit also renders the recitation of the soybean variety name “PBDP31” indefinite as the variety has no meaning without its linkage to a deposit.
Claim 15 recites “the seed, plant, plant part, or plant cell of claim 1” in line 2. There is insufficient antecedent basis for this limitation in the claims. Claim 1 is drawn to a plant or a seed, not a plant cell or any plant part. Dependent claim 16 is likewise indefinite.
Enablement
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 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 claims all require seed of Soybean Variety 5PBDP31.
Since the seed claimed 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.
The specification does not disclose a repeatable process to obtain the exact same seed in each occurrence and it is not apparent if such a seed is readily available to the public.
If a seed is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112. So long as the number of seeds deposited complies with the requirements of the IDA where the deposit is made, the USPTO considers such a compliant submission as satisfying the rules under 37 CFR 1.801 through 1.809.
It is noted that Applicant intends to deposit seeds for Soybean Variety 5PBDP31 at the NCMA (paragraph [0192]), but there is no indication that the seeds have 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.
If the deposit of these seeds is made and accepted 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 seeds 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 has not been made and accepted 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.
Written Description
Claims 13-14, 16 & 19-20 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.
A. Claim 16 is drawn to a modified soybean variety produced by the method of claim 15 wherein the variety comprises the genome edit and otherwise comprises all of the physiological and morphological characteristics of soybean variety 5PBDP31 when grown under the same environmental conditions.
The specification describes that genome editing may target one or more than one locus producing modified plants with one or more variations compared to variety 5PBDP31 (paragraph [0145]). The modified variety may have all or "essentially all" of the morphological and physiological or phenotypic characteristics of the variety, in otherwise all of the characteristics other than an occasional variant trait which might arise (paragraph [0146]).
In Azurity Pharms., Inc. v. Alkem Lab’ys Ltd, No. CV 19-2100-LPS, 2021 WL 5332406 (D. Del. Nov. 16, 2021), the parties disputed the term “a buffer,” which appears in three related patents. The claim granted by the U.S. Patent and Trademark Office (USPTO) generally follows this format: A formulation, consisting essentially of (i) enalapril or a pharmaceutically acceptable salt or solvate thereof; (ii) a buffer; (iii) a preservative that is sodium citrate; and (iv) water. The issue is whether “a buffer” should mean only one buffer or at least one buffer.
The court highlighted a general principle that the word “a” or “an” means “one or more” unless a patentee clearly intends to limit “a” or “an” to “one” in the specification, the claims, or the prosecution history. The court also noted that this general rule often applies to open-ended claims or partially opened claims characterized by “consisting essentially of.”
Because there is no upper limit of loci that may be edited in modified plants produced by genome editing provided by the instant specification, claim 16 broadly encompasses a genus of soybean varieties comprising any number of genome edits relative to soybean variety 5PBDP31. The claims require that the variety otherwise comprise all the physiological and morphological characteristics of soybean variety 5PBDP31 when grown under the same environmental conditions, but because an unlimited number of genome edits are encompassed by the claim, affecting any number of traits and any region of the genome, these plant varieties may have all or none of the physiological or morphological traits described in Table 1.
Therefore, Applicant has not described any structural features required by the genus of soybean varieties of the instant claims nor provided examples of soybean varieties over the full scope of the claimed genus. One of ordinary skill in the art would not conclude that Applicant was in possession of the full scope of soybean varieties produced by genome editing a seed, plant, plant part or plant cell of soybean variety 5PBDP31.
B. Claims 19-20 are drawn to a seed, plant, plant part or plant cell of soybean variety 5PBDP31, or a commodity plant product produced from the plant or seed, wherein the seed, plant, plant part or plant cell further comprises a single locus conversion. Claims 13-14 are drawn to a soybean plant produced by the method of claim 12, wherein the soybean plant comprises the locus conversion and otherwise comprises all of the physiological and morphological characteristics of soybean variety 5PBDP31 when grown under the same environmental conditions.
Claims 19 & 20 do not require that the soybean comprise all of the physiological and morphological characteristics of variety 5PBDP31. Because the instant specification does not limit “a” single locus conversion to one single locus conversion, claims 13 & 14 broadly require a seed, plant, plant part or plant cell of a soybean having one or more locus conversions relative to soybean variety 5PBDP31.
In Azurity Pharms., Inc. v. Alkem Lab’ys Ltd, No. CV 19-2100-LPS, 2021 WL 5332406 (D. Del. Nov. 16, 2021), the parties disputed the term “a buffer,” which appears in three related patents. The claim granted by the U.S. Patent and Trademark Office (USPTO) generally follows this format: A formulation, consisting essentially of (i) enalapril or a pharmaceutically acceptable salt or solvate thereof; (ii) a buffer; (iii) a preservative that is sodium citrate; and (iv) water. The issue is whether “a buffer” should mean only one buffer or at least one buffer.
The court highlighted a general principle that the word “a” or “an” means “one or more” unless a patentee clearly intends to limit “a” or “an” to “one” in the specification, the claims, or the prosecution history. The court also noted that this general rule often applies to open-ended claims or partially opened claims characterized by “consisting essentially of.”
The instant specification describes soybean variety 5PBDP31 as having the traits recited in Table 1 and a breeding history described in paragraph [0193]). The specification provides that encompassed soybean plants of the instant invention may comprise a single locus conversion in certain embodiments, but plants may comprise an occasional variant trait that might arise during backcrossing or direct introduction of a transgene or specific genetic modification (paragraph [0133]). The specification describes that backcross conversion methods may encompass transferring traits conferred by unlinked genes (paragraph [0136]). The specification describes how a single locus conversion may contain several transgene or modifications; at least one and less than ten locus conversions may be introduced into the plant by backcrossing (paragraph [0136]). However, although less than ten locus conversions may be introduced, the claims and the specification do not exclude plants comprising more than ten single locus conversions.
Thus, the genus of plants required by the claims encompass plants comprising any number of locus conversions and/or traits that vary from soybean variety 5PBDP31. The encompassed plants may have all or none of the physiological or morphological traits described in Table 1 which are physiological and morphological characteristics of soybean variety 5PBDP31. Because Applicant has not described a structural feature required by the genus of plants of the instant claims nor provided examples of plants over the full scope of the claimed genus, one of ordinary skill in the art would not conclude that Applicant was in possession of the full scope of seeds, plants, plant parts or plant cells of soybean variety 5PBDP31 further comprising a single locus conversion.
Language to limit the number of locus conversions encompassed (claims 13 & 14) or requiring that the seed, plant, plant part, or plant cell otherwise comprise all the physiological and morphological characteristics of soybean variety 5PBDP31 when grown under the same environmental conditions (claims 19 & 20) would overcome the Written Description rejections.
Conclusion
No claims are allowed.
The prior art does not teach a soybean variety with all the traits found in table 1 and a breeding history comprising the proprietary varieties used in the development of soybean variety 5PBDP31.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Victoria L DeLeo whose telephone number is (703)756-5998. The examiner can normally be reached M-F 8:00am-4pm EDT.
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, Bratislav Stankovic can be reached at (571) 270-0305. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VICTORIA L DELEO/Examiner, Art Unit 1662
/BRATISLAV STANKOVIC/Supervisory Patent Examiner, Art Units 1661 & 1662
