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 1-17 remain pending.
Claims 1-17 remain rejected.
Response to Applicant Arguments - Specification
In response to Applicant’s arguments and amendments to the specification dated 06/09/2026 the objections to the specification of record are withdrawn.
Response to Applicant Arguments - Indefiniteness
In response to Applicant’s arguments and amendments to the specification dated 06/09/2026 the indefiniteness rejections of record are withdrawn. However, the information provided in the specification to overcome this grounds of rejection necessitates new obviousness rejections.
Response to Applicant Arguments – Written Description
In response to Applicant’s arguments and amendments to the specification dated 06/09/2026 the written description rejections of record are withdrawn.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-17 are newly rejected under 35 U.S.C. 103 as being unpatentable over Delheimer, US 2019/0289808 A1, Published September 26, 2019 in view of EFSA Panel on Genetically Modified Organisms (GMO). EFSA Journal 9.5 (2011): 2147.
Claim 1 is drawn to plants, plant parts, or seeds of soybean variety CL2042637. Soybean variety CL2042637 was produced using a backcross method to introduce the A5547-127 transgenic event into recurrent parent CW1660237 (Specification-06/09/2026, Page 45, Lines 17-22). The specification describes backcross breeding as follows:
“In backcross breeding a genetic allele or loci is often transferred into a desirable homozygous recurrent parent. The trait from the donor parent is tracked into the recurrent parent. The resultant plant is bred to be essentially the same as the recurrent parent, with the same physiology and morphological characteristics as the recurrent part, with the new desired allele or loci” (Specification, Page 3, Lines 24-28).
Given the breeding history and the definition of backcross breeding in conjunction with the language of the claim it is clear that the claims are drawn to plants, plant parts and seeds of soybean variety CW1660237 further comprising a single additional transgenic event A5547-127 which was introduced into the variety by backcrossing.
With respect to claim 1, Delheimer teaches soybean variety CW1660237, the recurrent parent of the instantly claimed variety (Delheimer, Page 23, Paragraph 0195-Page 24, Paragraph 0199 including Tables 17-18).
Further, Delheimer teaches introducing one or more traits into the variety through backcrossing (Delheimer, Page 8, Paragraph 0094), where the trait is a transgenic event conferring tolerance to glufosinate (Delheimer, Page 8, Paragraph 0095). Delheimer even teaches glufosinate tolerance event A5547-35 (Delheimer, Page 8, Paragraph 0095).
With respect to claim 1, Delheimer does not teach soybean plants of variety CW1660237 further comprising the A5547-127 transgenic event conferring glufosinate tolerance.
With respect to claim 1, EFSA Panel on Genetically Modified Organisms (GMO) teaches the soybean A5547-127 transgenic event (EFSA Panel, Pages 1-2, Abstract; EFSA Panel, Page 9, First Full Paragraph). Further, EFSA Panel teaches that “soybean A5547-127 is not different from its conventional counterpart (A5547), except for the newly expressed protein (PAT). The safety assessment of the PAT protein and the soybean A5547-127 identified no concerns regarding potential toxicity and allergenicity. A feeding study on broiler chickens confirmed that seeds of soybean A5547-127 are as nutritional as seeds of the conventional counterpart.” and further that “the information available for soybean A5547-127 addresses the scientific comments raised by the Member States and that the soybean A5547-127, as described in this application, is as safe as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of its intended uses” (EFSA Panel, Pages 1-2, Abstract).
Given the teachings of Delheimer and EFSA Panel at the time of filing the ordinary artisan would have found it obvious to modify the CW1660237 soybean of Delheimer to add an additional gene conferring glufosinate tolerance as taught by Delheimer where the additional transgenic event is the A5547-127 soybean event of EFSA Panel. This would have been obvious because Delheimer teaches CW`6601237 further comprising a transgenic event conferring glufosinate tolerance and teaches that these events can be introduced through backcrossing and because EFSA Panel teaches a safe, effective glufosinate tolerance event that has been approved for use by the EFSA Panel and in addition to conferring glufosinate tolerance has proven to have other desirable qualities including no potential toxicity or allergenicity concerns, comparable nutritional value to a non-transgenic counterpart and high safety. As such the ordinary artisan would have found it obvious to combine these references.
Further, the ability to generate soybean plants of variety CW1660237 having glufosinate tolerance from a proven allele that has demonstrated effectiveness and safety would have been motivating to the ordinary artisan. This would have been motivating because adding this additional herbicide resistance gene allows glufosinate to be used to manage weeds in fields growing these soybeans allowing for higher yields by preventing competition for resources. This additional transgene would make for a more commercially desirable variety and therefore producing these plants by combining the two known prior art elements with predictable results would have been motivating to the ordinary artisan at the time of filing and claim 1 is rejected as obvious.
With respect to claim 2, Delheimer in view of EFSA Panel collectively teach all of the limitations of claim 1, see above.
Further, Delheimer teaches a cell of the plant of claim 1 (Delheimer, Page 27, Claim 2).
With respect to claim 3, Delheimer in view of EFSA Panel collectively teach all of the limitations of claim 1, see above.
Further, Delheimer teaches a soybean plant obtained by transforming the soybean plant of claim 1 (Delheimer, Page 27, Claim 3).
With respect to claim 4, Delheimer in view of EFSA Panel collectively teach all of the limitations of claim 3 taught above, see above.
Further, Delheimer teaches a seed of the soybean plant according to claim 3 (Delheimer, Page 27, Claim 4).
With respect to claim 5, Delheimer in view of EFSA Panel collectively teach all of the limitations of claim 1, see above.
Further, Delheimer teaches a method for producing a soybean seed, said method comprising crossing soybean plants and harvesting the resultant soybean seed, wherein at least one soybean plant is the soybean plant of claim 1 (Delheimer, Page 27, Claim 5).
With respect to claim 6, Delheimer in view of EFSA Panel collectively teach all of the limitations of claim 5 taught above, see above.
Further, Delheimer teaches a method further comprising the steps of:
crossing a plant grown from said resultant soybean seed with itself or a different soybean plant to produce a seed of a progeny plant of a subsequent generation;
growing a progeny plant of a subsequent generation from said seed of a progeny plant of a subsequent generation and crossing the progeny plant of a subsequent generation with itself or a second plant to produce a progeny plant of a further subsequent generation; and
repeating steps (a) and (b) using said progeny plant of a further subsequent generation from step (b) in place of the plant grown from said resultant soybean seed in step (a), wherein steps (a) and (b) are repeated with sufficient inbreeding to produce an inbred soybean plant derived from the claimed soybean variety (Delheimer, Page 27, Column 1, Claim 6).
With respect to claim 7, Delheimer in view of EFSA Panel collectively teach all of the limitations of claim 5 taught above, see above.
Further, Delheimer teaches an F1 soybean seed produced by the method of claim 5 (Delheimer, Page 27, Column 2, Claim 7).
With respect to claim 8, Delheimer in view of EFSA Panel collectively teach all of the limitations of claim 5 taught above, see above.
Further, Delheimer teaches an F1 soybean produced by the method of claim 5 wherein at least one of the soybean plants carries a heritable transgenic event (Delheimer, Page 27, Column 2, Claim 8).
With respect to claim 9, Delheimer in view of EFSA Panel collectively teach all of the limitations of claim 7 taught above, see above.
Further, Delheimer teaches an F1 soybean plant, or part thereof, produced by growing said seed of claim 7 (Delheimer, Page 27, Column 2, Claim 9).
With respect to claim 10, Delheimer in view of EFSA Panel collectively teach all of the limitations of claim 1 taught above, see above.
Further, Delheimer teaches a method for developing a second soybean plant through plant breeding, said method comprising applying plant breeding to said soybean plant, or parts thereof according to claim 1, wherein said plant breeding results in development of said second soybean plant (Delheimer, Page 27, Column 2, Claim 10).
With respect to claim 11, Delheimer in view of EFSA Panel collectively teach all of the limitations of claim 1, see above.
Further, Delheimer teaches a method of producing a soybean plant comprising a desired trait, the method comprising introducing a single transgene or locus conferring the desired trait into the soybean plant of claim 1 (Delheimer, Page 27, Column 2, Claim 11).
With respect to claim 12, Delheimer in view of EFSA Panel collectively teach all of the limitations of claim 11 taught above, see above.
Further, Delheimer teaches methods wherein the desired trait is selected from the group consisting of male sterility, herbicide tolerance, insect resistance, nematode resistance, pest resistance, disease resistance, fungal resistance, modified fatty acid metabolism, modified carbohydrate metabolism, drought tolerance, abiotic stress tolerance, a site-specific recombination site, and modified nutrient deficiency tolerances (Delheimer, Page 27, Column 2, Claim 12).
With respect to claim 13, Delheimer in view of EFSA Panel collectively teach all of the limitations of claim 11 taught above, see above.
Further, Delheimer teaches a plant produced by the method of claim 11, wherein the plant has the desired trait and all of the morphological and physiological characteristics of the claimed soybean variety other than those characteristics altered by said transgene or locus when grown in the same location and in the same environment (Delheimer, Page 27, Column 2, Claim 13).
With respect to claim 14, Delheimer in view of EFSA Panel collectively teach all of the limitations of claim 1, see above.
Further, Delheimer teaches a method of introducing a single locus conversion into a soybean plant, wherein the method comprises:
crossing the plant of claim 1 with a plant of another soybean variety that comprises the single locus to produce F1 progeny plants;
selecting one or more F1 progeny plants from step (a) to produce selected progeny plants;
selfing selected progeny plants of step (b) or crossing the selected progeny plants of step (b) with the claimed plants to produce later generation selected progeny plants;
crossing or further selecting for later generation selected progeny plants that have the single locus and physiological and morphological characteristics of the claimed soybean variety to produce selected next later generation progeny plants; and optionally
repeating crossing or selection of later generation progeny plants to produce progeny plants that comprise the single locus and all of the physiological and morphological characteristics of said single locus and of the claimed soybean variety when grown in the same location and in the same environment (Delheimer, Pages 27-28, Claim 14).
With respect to claim 15, Delheimer in view of EFSA Panel collectively teach all of the limitations of claim 14 taught above, see above.
Further, Delheimer teaches a plant produced by the method of claim 14 or a selfed progeny thereof, wherein the plant or selfed progeny thereof comprises said single locus and otherwise comprises all of the physiological and morphological characteristics of the claimed soybean variety (Delheimer, Page 28, Column 1, Claim 15).
With respect to claim 16, Delheimer in view of EFSA Panel collectively teach all of the limitations of claim 1, see above.
Further, Delheimer teaches a method of producing a commodity plant product, said method comprising obtaining the plant of claim 1 or a part thereof and producing said commodity plant product comprising the protein concentrate, protein isolate, soybean hulls, meal, flour, or oil from said plant or said part thereof (Delheimer, Page 28, Column 2, Claim 16).
With respect to claim 17, Delheimer in view of EFSA Panel collectively teach all of the limitations of claim 13 taught above, see above.
Further, Delheimer teaches a seed that produces the plant of claim 13 (Delheimer, Page 28, Column 2, Claim 17).
Therefore, given the obviousness analysis with respect to claim 1 above and further that Delheimer has claims that are identical to the instant claims with the exception of the name of the variety and as such teaches all of the limitations of those claims, claims 2-17 are rejected as obvious under Delheimer in view of EFSA Panel.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN JAMES SULLIVAN whose telephone number is (571)272-0561. The examiner can normally be reached 7:30 to 5:00.
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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//BRIAN JAMES SULLIVAN/ Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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