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 .
Claim Status
Claims 1-20 are pending and examined on the merits.
Specification
Paragraph 0195 of Specification filed 23 February 2024 is objected to because of the following informalities: There are Xs where access information should be. 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.
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 pre-AIA the applicant regards as the invention.
All the claims directly or indirectly recite “variety.” Paragraph 114 is captured below. It is unclear what the metes and bounds of “substantially homozygous” is. It also states that the lines can be “a locus conversion, a mutation… or a somaclonal variant.” When this is coupled with paragraph 194, which states that “a” should be read to mean “at least one,” it raises the question as to what if any characteristics define the instantly claimed “variety.” Given this, the metes and bounds of the claims cannot be determined.
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Claims 4 and 13 recite “otherwise comprises all of the physiological and morphological characteristics of soybean variety 5PDAG73.” Given the expansive definition of “variety” it is unclear what the characteristics of soybean variety 5PDAG73 are.
Lack of Written Description
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.
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 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are broadly drawn to products comprising or methods using soybean variety 5PDAG73.
The claimed genus includes a broad and undefined scope of products and methods given the indefinite nature of the claims which imparted by the definition of the word “variety” provided in the specification.
The value of any descriptions provided in the specification are unclear, because although Table 1 provides “Variety Description Information,” none of the described traits appear to be required for a plant to be soybean variety 5PDAG73 given the definition of the word “variety” in the instant specification.
These descriptions are insufficient, because they have provided to way for a person of ordinary skill in the art to discern the instantly claimed variety from other materials. While Applicant may contest that molecular markers could be used to compare the deposited seeds to another variety, this fact does not matter, because the definition of “variety” provided is so expansive, any other variety could be argued to be soybean variety 5PDAG73.
As such, the claims are rejected for lacking adequate written description.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kyle et al (US 8546658 B1), and further in view of Sprague et al, November 2021 (https://www.canr.msu.edu/weeds/extension/2022-Weed-Control-Guide/2022%20E-434%20Palmer%20&%20Waterhemp.pdf).
The instantly claimed soybean variety is a locus conversion of the patented variety XB38AL11. A stacked locus comprising 2,4-D, glyphosate, and glufosinate resistance genes were added to the genome of XB38AL11 and the locus comprising the independent glyphosate resistance gene was removed. These steps were executed by outcrossing followed by backcrossing methods.
Kyle teaches inbred soybean variety XB38AL11. They also claim locus conversions of XB38AL11 as well as associated methods including modifying herbicide resistance (claims 4, 12, 13). Kyle also teaches that herbicide transgenes that can be included in the XB38AL11 genome include 2,4D, glyphosate, and glufosinate resistance genes (columns 15, 19-20).
Kyle does not teach adding a stacked locus of 2,4D, glyphosate, and glufosinate resistance genes to the genome of XB38AL11.
Sprague teaches that the Enlist E3 trait stack comprising 2,4-D, glyphosate, and glufosinate resistance genes in soybean allow for effective control of multi-herbicide resistant Palmer amaranth and waterhemp.
At the times of filing, it would have been prima facie obvious for a person of ordinary skill in the art to make a locus conversion of XB38AL11 to include the Enlist E3 trait stack for better management of multi-herbicide resistant weeds. Further, it would have been obvious for a person of ordinary skill in the art to segregate away independent glyphosate resistance gene during backcrossing as its presence was not useful as a glyphosate resistance gene is already present in the trait stack. As such, claims 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kyle et al further in view of Sprague et al.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 8546658 B1 in view of Sprague et al, November 2021 (https://www.canr.msu.edu/weeds/extension/2022-Weed-Control-Guide/2022%20E-434%20Palmer%20&%20Waterhemp.pdf).
The patented and instant claims cover very similar subject matter but differ in that the patented variety XB38AL11 and instant variety 5PDAG73 differ functionally only by presence of 2,4-D and glufosinate resistance traits being present in the instant variety.
Sprague teaches that the Enlist E3 trait stack comprising 2,4-D, glyphosate, and glufosinate resistance genes in soybean allow for effective control of multi-herbicide resistant Palmer amaranth and waterhemp.
It would have been obvious to modify the patented subject matter by integrating 2,4-D, glyphosate, and glufosinate resistance genes into the genome of XB38AL11 to address the issue of herbicide resistance genes as taught by Sprague.
Please note that many claims are not limited to just the deposited variety, but include much broader scopes including locus conversion claims. These claims have subject matter that directly overlaps and do not even need the teachings of Sprague to be obvious over one another.
Deposit of Biological Material
This application requires public availability of specific biological material to make and use the claimed invention. A rejection under the appropriate sections of 35 USC 112 would have been made but for (1) evidence that the material is both known and readily available; (2) applicant’s statement paragraph 0195 of the Specification filed on 23 February 2024 indicating that an acceptable deposit of the specific biological material in compliance with the requirements under 37 CFR 1.801-1.809 will be made with a recognized IDA, at or before the payment of the issue fee, in the event that the application should be determined to be allowable; or (3) an acceptable deposit of the specific biological material in compliance with the requirements under 37 CFR 1.801-1.809 has already been made. Because viability testing of all deposits is required before they can be considered to meet the requirements of 37 CFR 1.801-1.809, applicants are advised to perfect the deposit as early as is possible, and before the payment of the issue fee. Failure to perfect a deposit by the date of payment of the issue fee may result in abandonment of the application for failure to prosecute.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW R KEOGH whose telephone number is (571)272-2960. The examiner can normally be reached M-Th 7-4:30, half day on Fridays.
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, 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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/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663