DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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 the Application
2. Claims 1-20 are pending.
3. Claims 1-20 are examined herein.
Claim Rejections - 35 USC § 112(b)
4. 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.
5. Claims 5, 6, 7, 16, and 17 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.
In claim 5, it is unclear what the phrase “further comprising crossing the plant of soybean variety 01094723 with a second, nonisogenic plant” means. Claim 5 depends from claim 4, which recites a step of crossing the plant soybean variety 01094723. It is thus unclear whether the method step of claim 5 refers to a cross that is different from the one recited in claim 4. Given that claims 6, 7, 16, and 17 depend from claim 5 and fail to recite additional limitations overcoming its indefiniteness, they are indefinite as well.
Claim Rejections - 35 USC § 103
6. 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.
7. Claims 1-20 are rejected under 35 U.S.C. 103 as being obvious over Owen (US Patent 10,973,195) in view of De Beuckeleer (US Patent 8,017,756).
The claims are directed to soybean variety 01094723, methods of using said variety, and F1 hybrid seeds and plants derived therefrom. From the breeding history on page 6 of the specificaiton, it appears that the donor parent EI5114A1-T1LNN was used to introduce a locus conversion into the recurrent parent EI4717C2-C0DNN.
Owen teaches soybean variety 01073325, which is a synonym for EI4717C2-C0DNN, methods of breeding said variety, F1 hybrid seeds and plants therefrom as well as a locus conversion, wherein a trait is introgressed such as event A5547-127 and backcrossed to the recurrent parent. Owen teaches a plant produced by transformation, including herbicide tolerance (see claims 10-14).
Owen teaches as follows: “In one embodiment, the soybean plant is defined as further comprising the single locus conversion and otherwise capable of expressing all of the morphological and physiological characteristics of the soybean variety 01073325. In particular embodiments of the invention, the single locus conversion may comprise a transgenic gene which has been introduced by genetic transformation into the soybean variety 01073325 or a progenitor thereof. In still other embodiments of the invention, the single conversion may comprise a dominant or recessive allele. The locus conversion may confer potentially any trait upon the single locus converted plant, including herbicide resistance, insect resistance, resistance to bacterial, fungal, or viral disease, male fertility or sterility, and improved nutritional quality. In certain embodiments, a potential locus conversion that confers herbicide resistance may confer resistance to herbicides such as … glufosinate” (coll. 2, lines 13-40). From Table 1 of Owen, it appears that the instantly claimed variety differs from that of Owen by the presence of the glufosinate resistance transgenic event A5547-127.
Owen does not teach using variety EI5114A1-T1LNN as a donor parent and does not expressly teach introgressing transgenic event A5547-127 into soybean variety 01073325.
De Beuckeleer teaches soybean plants with the A5547-127 event, which confers glufosinate tolerance without otherwise compromising agronomic performance (column 25, lines 1-36; column 26, lines 34-42).
At the time of filing, it would have been prima facie obvious to one of ordinary skill in the art to introduce the A5547-127 event of De Beuckeleer into cultivar of Owen by backcrossing. It would have been also obvious to self the resultant plant or cross it with another soybean, obtaining an F1 progeny, or use the resultant plant in the methods taught by Owen.
One of ordinary skill in the art would have been motivated to do so because the presence of the event would confer glufosinate tolerance to EI5114A1-T1LNN, which would expand the spectrum of herbicides that could be used for weed control. One would have been specifically motivated to select event A5547-127 given that the event does not compromise agronomic performance, as taught by De Beuckeleer. Moreover, Owen expressly suggests introducing glufosinate resistance into the plant. Given the routine nature of the methods involved, one would have had reasonable expectation of success.
With regard to the qualitative traits other than the presence of event A5547-127, the traits of the instantly claimed soybean variety appear to mirror those of the variety of Owen. The difference in value in the relative maturity, 4.8 for the instant variety and 4.7 for the variety of Owen, would not have been unexpected. It is understood that said numeric value is an averages, and the teachings of Owen do not include any statistical information, such as standard deviation. Moreover, one of ordinary skill in the art would understand that during backcrossing, some degree of variability with regard to physiological and morphological characteristics is to be expected. For example, it is well-known in the art that the introduction of a trait via backcrossing could result in additional traits introduces as a results of linkage drag (See Fehr (ed.). in Principles of Cultivar Development (1987) Vol. 1: Theory and Technique, pp. 360-376; Table 28-2). At the same time, the Examiner has no way of determining the characteristics of the donor parent used to obtain the instantly claimed variety.
Barring any evidence of the above differences being unexpected and of practical significance, expected trait variability in the context of a breeding program, including specifically, wherein a transgenic event is introduced via backcrossing, will not make a plant that is prima facie obvious in view of the prior art patentably distinct from the plant of the instant invention. See MPEP 716.02(b). This is also consistent with the Patent Trial and Appeal Board’s decisions in Ex parte C (27 USPQ2d 1492) and Ex parte McGowen (Appeal 2019-006060).
In Ex parte C, where, as here, the issue was introducing, via backcrossing, a known trait from a donor plant into a known recurrent parent, the Board stated as follows regarding the differences between the claimed variety and the variety of the prior art: “We have reviewed the data and the declaration but are unpersuaded of patentability because there is nothing of record which explains why the differences between the claimed variety and a rot resistant variety such as ‘Pella 86’ are so significant and unexpected that they should weigh more heavily than the numerous similarities between the claimed variety and the varieties of the cited prior art. We remind appellant that in submitting evidence asserted to establish differences and/or unobvious results sufficient to dissipate a prima facie case of obviousness, there is a burden on the patent applicant to establish not only that the differences in results achieved are in fact “unexpected and unobvious” but also to establish that the differences are of practical significance. … We note, for instance, that it may not be unexpected that the claimed cross is shorter than ‘Pella 86.’” 27 USPQ2d 1492, 1497.
For the above reasons, and barring evidence to the contrary, the differences between the cultivar obtained by introducing event A5547-127 into the cultivar of Owen and the instantly claimed cultivar would not have been unexpected.
Double Patenting
8. 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
9. Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of application 17/987,934. Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to soybean varieties that appear to be siblings, given that they share the same parentage and breeding history, and have nearly identical morphological and physiological characteristics.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Deposit of Biological Material
10. 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 on page 44 of the specification 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
11. No claims are allowed.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MYKOLA V KOVALENKO whose telephone number is (571)272-6921. The examiner can normally be reached on Mon.-Fri. 9:00-5:30 PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SHUBO (JOE) ZHOU can be reached on (571)272-0724. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MYKOLA V. KOVALENKO/Primary Examiner, Art Unit 1662