DETAILED ACTION
The Amendment filed August 13, 2025 has been entered.
Claims 4-7 and 25-28 are cancelled.
Claims 1, 16, 20, 23, 24, 29, 34 and 35 are currently amended.
Claims 36-38 are new.
Claims 1-3, 8-24, 29-35 and 36-38 are pending.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
All previous objections and rejections not set forth below have been withdrawn.
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 .
Request for Information under 37 CFR § 1.105
Applicant’s response to the Request for Information under 37 CFR § 1.105 has been received and considered.
Withdrawn Objections
The objection to the specification is withdrawn in light of Applicant’s response.
The objection to claims 4, 5, 12, 18, 19 and 25 is withdrawn in light of Applicant’s response.
The objection to claim 24 is withdrawn in light of the amendment of claim 24.
Withdrawn Claim Rejections
The rejection of claims 1-3, 5-11, 16, 23, 25-29 and 35 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in light of the amendment of the claims.
The rejection of claims 1-35 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35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement is withdrawn in light of Applicant’s response.
The rejection of claims 4, 5, 6, 7, 10, 12, 18, 21, 24, 25, 29, 30 and 31, and ALL CLAIMS DEPENDENT THEREON, 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the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention is withdrawn in light of the cancellation of claims 4-7 and 25, and in light of Applicant’s response.
The rejection of claims 25-28 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the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention is withdrawn in light of the cancellation of the claims.
The rejection of claim 28 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 is withdrawn in light of the cancellation of the claim.
The rejection of claim 29, and claim 30 dependent thereon, 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 is withdrawn in light of the amendment of claim 29.
The rejection of claim 34 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is withdrawn in light of the amendment of the claim.
The rejection of claims 1-3, 5-11, 16, 23 and 35 under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over, Cooper (2014, dissertation entitled “Improving End-use Quality in Hard Winter Wheat Through Glutenin Allele Combinations and Genomic Selection’, Colorado State University, Department of Soil and Crop Sciences) is withdrawn in light of the amendment of claim 1, and in light of the cancellation of claims 5-7.
The rejection of claims 25-28 under 35 U.S.C. 103 as being unpatentable over Cooper (2014, dissertation entitled “Improving End-use Quality in Hard Winter Wheat Through Glutenin Allele Combinations and Genomic Selection”, Colorado State University, Department of Soil and Crop Sciences) in view of Ward et a/ (Patent No. US 8,309,830 B2) is withdrawn in light of the cancellation of the claims.
The rejection of claims 1, 2, 3, 8, 9 and 11 of this application as being patentably indistinct from claims 1, 2, 3, 8, 9 and 11 of Application Nos. 18/174,388 and 18/174,421 is withdrawn in light of the amendment of claim 1.
Claim Rejections - 35 USC § 112
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.
Claim 16 as currently amended is 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. THIS IS A NEW MATTER REJECTION. Claim 16 as currently amended is drawn to a wheat plant regenerated from the tissue culture of claim 15, wherein the regenerated wheat plant is not a somaclonal variant. A wheat plant regenerated from a tissue culture produced from a part of a plant of wheat variety OK15MASBx7 ARS 8-29 wherein the regenerated plant is not a somaclonal variant does not find support in the specification as filed, and thus constitutes new matter. In order to overcome the rejection, it is suggested that claim 16 be amended to indicate that the regenerated wheat plant expresses all of the morphological and physiological characteristics of a plant grown from the wheat seed designated OK15MASBx7 ARS 8-29. Support for such an amendment may be found in paragraph [0008] at pages 2-3 of the specification.
New claims 37 and 38 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.
New claim 37 is drawn to a progeny HRW wheat plant produced by the method of claim 36.
New claim 38 is drawn to the progeny HRW wheat plant of claim 37, wherein the plant has an overexpression of the wheat Bx7subunit (Bx7oe).
New claim 36 is drawn to a method of producing a Hard Red Winter (HRW) wheat plant having increased dough strength, the method comprising crossing the plant of claim 1 with a second HRW wheat plant to produce a progeny HRW wheat plant, wherein the progeny HRW wheat plant has increased dough strength as compared to a typical HRW wheat variety.
Claim 1 as currently amended is drawn to a commercially elite Hard Red Winter (HRW) wheat variety having increased dough strength, as compared to typical HRW wheat varieties, wherein the variety is wheat variety OK15MASBx7 ARS 8-29, wherein a representative sample of seed of said variety has been deposited under NCMA Accession No. _____.
The specification teaches that wheat variety OK15MASBx7 ARS 8-29 was made from a cross between an unspecified commercially available HRW variety and an unspecified proprietary hard white winter variety comprising the Bx7 overexpression subunit Bx7oe (¶ 0037).
The specification describes that success was already demonstrated in producing Glu-B1al-elevated dough strength in hard white cultivars, but reluctance has prevailed in distributing Glu-B1al beyond hard white wheat into the predominant market class of the U.S. Great Plains, HRW wheat (¶ 0032).
The specification describes that wide differences occurred among lines for dough strength, even though all lines descended from single plants homozygous for the Glu-B1al allele (emphasis added). Thus breeding for uniformity in dough strength is much more complicated that simply selecting for Bx7oe, as Bx7oe alone does not guarantee increased dough strength (¶ 0035).
Because the method used to produce the claimed plants allows for the use of any unspecified second HRW wheat plant to produce a progeny HRW wheat plant and uses the open claim language of “comprising” that allows for the use of additional unspecified materials and method steps, and because the claimed plants are not required to retain any of the characteristics of the parental wheat variety OK15MASBx7 ARS 8-29 with the sole exception of the wheat Bx7subunit (Bx7oe) in claim 38, claims 37 and 38 encompass a vast genus of plants that need not comprise the necessary genes to yield plants HRW varieties having increased dough strength as broadly encompassed by the claims and which the specification has failed to describe. Rather, the specification has provided a description of a single species: the deposited variety OK15MASBx7 ARS 8-29.
A description of this genus of plants is essential in light of the instant disclosure: that wide differences occurred among lines for dough strength, even though all lines descended from single plants homozygous for the Glu-B1al allele (emphasis added). Thus breeding for uniformity in dough strength is much more complicated that simply selecting for Bx7oe, as Bx7oe alone does not guarantee increased dough strength (¶ 0035).
Thus, the skilled practitioner would not be led to believe that Applicant was in possession of the genus of plants as encompassed by the claims.
Here, the rejected claims are considered “reach through” claims in which the specification has described a starting material and/or at least one method step, however, they have not described the beginning or resulting product that they are claiming, where the genus of products and products that can be produced by the recited method steps and materials is so large that one of skill in the art is not able to envision the members of the genus. (See Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004)).
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.
Claim 35 is 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.
Claim 35 as currently amended is drawn to an F1 progeny wheat plant produced by the method of claim 34.
Claim 34 as currently amended is drawn to the method of claim 33, wherein the plant breeding technique is one or more of backcrossing, marker assisted breeding, pedigree breeding, selfing, outcrossing, haploid production, doubled haploid production, or transformation.
Claim 33 is drawn to a method of producing a progeny wheat plant comprising applying plant breeding techniques to the plant of claim 12 or an F1 hybrid thereof to yield said progeny wheat plant.
Claim 12 is drawn to a plant of wheat variety OK15DMASBx7 ARS 8-29, wherein a representative sample of seed of said variety has been deposited under NCMA Accession No. _____.
Claim 35 is indefinite because it is not clear how an F1 progeny is produced by the method of claim 34, since the method of claim 34 as it depends from claim 33 results only in the production of a progeny wheat plant, and since the method of claim 33 allows for the application of breeding techniques to an F1 hybrid of the plant of claim 12.
In order to advance prosecution, it is suggested that 1) claim 33 be amended to remove the limitation "or an F1 hybrid thereof", and 2) that claim 35 be amended to recite "A progeny wheat plant produced by the method of claim 34, wherein the progeny wheat plant is an F1 wheat plant".
Claim Rejections - 35 USC § 102/103
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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.
New claims 37 and 38 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over, Cooper (2014, dissertation entitled “Improving End-use Quality in Hard Winter Wheat Through Glutenin Allele Combinations and Genomic Selection’, Colorado State University, Department of Soil and Crop Sciences).
New claim 37 is drawn to a progeny HRW wheat plant produced by the method of claim 36.
New claim 38 is drawn to the progeny HRW wheat plant of claim 37, wherein the plant has an overexpression of the wheat Bx7subunit (Bx7oe).
New claim 36 is drawn to a method of producing a Hard Red Winter (HRW) wheat plant having increased dough strength, the method comprising crossing the plant of claim 1 with a second HRW wheat plant to produce a progeny HRW wheat plant, wherein the progeny HRW wheat plant has increased dough strength as compared to a typical HRW wheat variety.
Claim 1 as currently amended is drawn to a commercially elite Hard Red Winter (HRW) wheat variety having increased dough strength, as compared to typical HRW wheat varieties, wherein the variety is wheat variety OK15MASBx7 ARS 8-29, wherein a representative sample of seed of said variety has been deposited under NCMA Accession No. _____.
Because the method used to produce the claimed plants allows for the use of any unspecified second HRW wheat plant to produce a progeny HRW wheat plant and uses the open claim language of “comprising” that allows for the use of additional unspecified materials and method steps, and because the claimed plants are not required to retain any of the characteristics of the parental wheat variety OK15MASBx7 ARS 8-29 with the sole exception of the wheat Bx7subunit (Bx7oe) in claim 38, claims 37 and 38 encompass a vast genus of plants that need not comprise the necessary genes to yield plants HRW varieties having increased dough strength as broadly encompassed by the claims. Thus, any prior art that discloses HRW plants with increased dough strength, including a wheat plant that overexpresses the wheat Bx7subunit (Bx7oe), would necessarily anticipate and/or render the instant claims obvious.
Cooper discloses that subunits Bx7OE at the Glu-B7 locus have been shown to enhance dough strength over the common Bx7+By8 subunits, is an overexpression of Bx7, is associated with dough quality parameters, is found in hard white wheat, and that despite being identified as sources as dough strength there is little known about the influence in hard red winter wheat germplasm (p. 3; see also p. 20).
Cooper discloses using Ripper hard red winter wheat as a recurrent parent in a cross with the donor parent Glenlea carrying the Bx7OE subunit and that is contributed to increasing dough strength (p. 22, last ¶; see also p. 29, ¶ 1; see iii, ¶ 1). Mixing properties were obtained with a mixograph to measure mixing stability and products (i.e. dough) produced from the aforementioned plants (e.g., see p. 24 ¶ 2; p. 28).
Accordingly, the claimed invention is anticipated by, or in the alternative, is obvious in view of the prior art. See In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985), which teaches that a product-by-process claim may be properly rejected over prior art teaching the same product produced by a different process, if the process of making the product fails to distinguish the two products.
Since the Patent Office does not have the facilities to examine and compare the plant of Applicant’s with that of the prior art, the burden of proof is upon the Applicant to show an unobvious distinction between the claimed plant and the plant of the prior art. See In re Best, 562F.2d 1252, 195 USPQ 430 (CCPA 1977).
Nonstatutory 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 10, 12-24 and 29-35 remain provisionally rejected, and claims 1-3, 8-9, 11 and 36-38 are provisionally rejected, on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 8-24 and 29-35 of copending Application No. 18/174,388 and copending Application No. 18/174,346 (reference applications). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 1-3, 8-24 and 29-38 of the instant application are drawn to HRW varieties with increased dough strength and wheat variety OK15MASBx7 ARS 8-29, plants, seeds and products produced therefrom, and methods of using said plants.
Claims 1-3, 8-24 and 29-35 of the reference applications are drawn to HRW varieties with increased dough strength and wheat varieties OK15MASBx7 ARS 8-20 and OK15DMASBx7 ARS 6-8, plants, seeds and products produced therefrom, and methods of using said plants.
The varieties OK15DMASBx7 ARS 6-8, OK15MASBx7 ARS 8-20 and OK15MASBx7 ARS 8-29 appear to have been produced using the same or a similar method, a cross between an unspecified proprietary HRW variety or an unidentified commercially available HRW variety, and an unspecified proprietary hard white winter variety comprising the Bx7 overexpression subunit Bx7oe.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to arrive at the variety as claimed because the reference applications also teach varieties from the same or similar parents producing produce products having increased dough strength.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed August 13, 2025, 2025 have been fully considered but they are not persuasive.
Applicant maintains that MPEP § 804(B)(1) explicitly provides that in evaluating whether the invention defined in a claim of an application would have been anticipated by or is an obvious variation of the invention defined in the claim of a patent or copending application, “no part of the reference patent or application may be used as if it were prior art.”, and Applicant asserts that the outstanding rejections are improper because the Examiner gleamed the information regarding the parentage of OK15MASBx7 ARS 8-20 and OK15DMASBx7 ARS 6-8 from the specifications of ‘388 and ‘346, respectively. Applicant also maintains that because these applications, along with the instant application, were all filed the same day, the applications cannot be used as prior art against the instant application. Applicant further maintains that the claims of ‘388 and ‘346 do not teach or suggest wheat variety OK15MASBx7 ARS 8-29.
Applicant's arguments are not persuasive.
Applicant's arguments are not persuasive because the copending applications need not qualify as prior art for the purpose of making a nonstatutory double patenting rejection over the claims of the instant application. The issue is whether the claims in the reference applications render obvious the claims of the instant application. Further, MPEP section 804(B)(1) also provides that the specification may be used to formulate a nonstatutory double patenting rejection, in that that one is not precluded from all use of the reference patent or application disclosure to understand the meaning of the reference claims. Here, the reference applications and the instant application each claim a HRW wheat variety with increased dough strength due in part to the wheat Bx7 subunit. Additionally, the instantly claimed wheat variety, OK15MASBx7 ARS 8-29, and the varieties claimed in the copending applications, OK15MASBx7 ARS 8-20 and OK15DMASBx7 ARS 6-8, appear to have been produced using the same or a similar method. The claims in the reference applications and the claims of the instant application are therefore obvious over each other due to the shared genotypic and phenotypic qualities that are common to the claimed varieties.
With respect to Applicant’s allusion that the rejection is improper because the reference applications and the instant application were all filed on the same day, this not persuasive because a shared common filing date does not preclude a nonstatutory double patenting rejection. In this regard Applicant is referred to MPEP 804 I.B.1.(b)(ii) regarding suggestions for overcoming provisional nonstatutory double patenting rejections where the application under examination has the same patent term filing date as the reference applications.
Conclusion
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.
Remarks
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CYNTHIA E COLLINS whose telephone number is (571)272-0794. The examiner can normally be reached M-F 8:30 am - 5:00 pm.
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/CYNTHIA E COLLINS/Primary Examiner, Art Unit 1662