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 1-12 and 17-26 are pending and examined. Claims 13-16 have been cancelled.
The objections to the claims are withdrawn in light of the amendments thereto.
The rejection of claims 1-26 under 35 U.S.C. 112(a) as containing 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skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention is withdrawn in light of Applicant’s reply dated 19 August 2025 (e.g., see p. 6).
Specification
The specification REMAINS objected for lacking a deposit date and a deposit number: on page 53 there are “_____”s instead of the required deposit date and NCMA Accession No. It is assumed that Applicant will provide the appropriate information in response to the instant Office action.
Appropriate action is advised.
Claim Rejections - 35 USC § 112
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 1-12 and 17-26 REMAIN 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.
Claims 1, 4, 6, 9, 12, 17-21 and 25 recite the limitation “KS12D03-1” which is an arbitrary designation that is not recognized in the art. Thus, one would not know what is or is not encompassed by the claims.
Claims 2, 3, 5, 7, 8, 22-24 and 26 are rejected for depending upon a rejected base claim and for failing to remedy the issues of indefiniteness.
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 1-12 and 17-26 REMAIN 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.
Instant claims 1-12 and 17-26 are broadly drawn a plant and seeds of wheat variety KS12D03-1, methods of crossing said variety, products produced from said variety, and wherein said variety further comprises a single locus conversion, seed that produces said plant, and a method of introducing a desired trait into wheat variety KS12D03-1 wherein the obtained backcross progeny comprise the trait and essentially all of the morphological and physiological characteristics of wheat variety KS12D03-1.
Applicant should note that MPEP 2402 provides that every patent must contain a written description of the invention sufficient to enable a person skilled in the art to which the invention pertains to make and use the invention. Where the invention involves a biological material and words alone cannot sufficiently describe how to make and use the invention in a reproducible manner, access to the biological material may be necessary for the satisfaction of the statutory requirements for patentability under 35 U.S.C. 112 [emphasis added].
However, as with other biological material deposited for purposes of patents for inventions under 35 U.S.C. 101, the deposit of plant material together with the written specification must enable those skilled in the art to make and use the claimed invention, in accordance with the requirements of 35 U.S.C. 112. See MPEP 2403.02.
However, MPEP 2163(I) also provides that "Compliance with the written description requirement is essentially a fact-based inquiry that will ‘necessarily vary depending on the nature of the invention claimed.’" Enzo Biochem, 323 F.3d at 963, 63 USPQ2d at 1613. An application specification may show actual reduction to practice by describing testing of the claimed invention or, in the case of biological materials, by specifically describing a deposit made in accordance with 37 CFR 1.801 et seq. See Enzo Biochem, 323 F.3d at 965, 63 USPQ2d at 1614 ( "reference in the specification to a deposit may also satisfy the written description requirement with respect to a claimed material" ); see also Deposit of Biological Materials for Patent Purposes, Final Rule, 54 FR 34,864 (August 22, 1989) ("The description must be sufficient to permit verification that the deposited biological material is in fact that disclosed. Once the patent issues, the description must be sufficient to aid in the resolution of questions of infringement." Id. at 34,880.).
Such a deposit is not a substitute for a written description of the claimed invention. The written description of the deposited material needs to be as complete as possible because the examination for patentability proceeds solely on the basis of the written description. See, e.g., In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985).
In the instant matter, the specification only provides a description of the traits of the variety but is silent and/or incomplete with respect to the breeding history of said variety. This breeding history is critical because it provides the genetics of the variety and, in turn, its corresponding traits. Thus, in the absence of a breeding history, the specification has failed to provide an adequate written description of the claimed variety.
To overcome this rejection, Applicant must amend the specification/drawing to provide the breeding history used to develop the instant variety or cultivar. When identifying the breeding history, applicant should identify any and all other potential names for all parental lines utilized in the development of the instant variety.
For example, if Applicant’s breeding history uses proprietary line names, applicant should notate in the specification all other names of the proprietary lines, especially publicly disclosed or patented line information.
Or, if the breeding history encompasses a locus conversion or a backcrossing process, Applicant should clearly indicate the recurrent parent and the donor plant and specifically name the trait or transgenic event that is being donated to the recurrent parent. If one of the parents is a backcross progeny or locus converted line of a publicly disclosed line, applicant should provide the breeding history of the parent line as well (i.e. grandparents).
Applicant is also reminded that they have a duty to disclose information material to patentability. Applicant should also notate the most similar plants which should include any other plants created using similar breeding history (such as siblings of the instant variety). This information can be submitted in an IDS with a notation of the relevancy to the instant application or as information submitted as described in MPEP 724 (e.g., trade secret, proprietary, and Protective Order).
Accordingly, the specification fails to provide an adequate written description to support the claimed genus of plants/seeds and methods of using said plants/seeds.
Response to Arguments
Applicant traverses the rejection of the claims because the breeding history is proprietary information not open to the public and that this information will be submitted pursuant to the guidance of MPEP 724.02 (Applicant reply dated 19 August 2025, p. 7, last ¶).
This argument is not persuasive for the reasons as set forth above. However, if proprietary lines were used to arrive at the instantly claimed wheat variety then the specification should reflect that proprietary lines were, in fact, used to arrive at the claimed wheat variety.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON DEVEAU-ROSEN whose telephone number is (571)272-2828. The examiner can normally be reached 7:30am - 4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, 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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/JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662