CTNF 18/950,522 CTNF 77007 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claims 17-22, pending in this application, are examined. Copending Applications Applicants must bring to the attention of the Examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications, which are "material to patentability" of the application in question. MPEP 2001.06(b). See Dayco Products Inc. v. Total Containment Inc., 66 USPQ2d 1801 (CA FC 2003). Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 17-22 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. Claim 17 is indefinite because where and how the “testing for markers” of step b are accomplished. The step is incomplete. In addition, since the preamble requires “transforming a plant” and the last step (step d) recites “transforming cells”, the claimed method is incomplete. Therefore, clarification is required to more clearly define the metes and bound of the claim. Dependent claims 18-22 do not obviate the rejection. Claim 19 is indefinite in the recitation of “a sequence corresponding to SEQ ID NO: 7” because the term “corresponding to” in the context of nucleic acid is referred to certain enumerated position relative to a particular nucleotide sequence. See paragraph [0025] of the specification. However, claim 19 does not refer to any specific nucleotide at a position in SEQ ID NO: 7. Clarification is required to more clearly define the metes and bounds of the claim. Claim Rejections - 35 USC § 112 07-30-01 AIA 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. 07-31-01 Claims 17-22 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. The claims are drawn to a method of transforming a plant, comprising: obtaining a plurality of plant lines; testing for markers indicative of NA cytoplasm; selecting at least one line from the plurality of plant lines wherein the selected lines possess markers for NA cytoplasm; and transforming cells derived from the at least one selected line; wherein the test detects a G nucleotide at a position that corresponds to position 11 of mitochondrial DNA sequence SEQ ID NO: 7, wherein the test for markers indicative of NA cytoplasm detects the presence of a sequence corresponding to SEQ ID NO: 7 and comprises forward primer SEQ ID NO: 5 and reverse primer SEQ ID NO: 6, or comprises probe SEQ ID NO: 7 and/or probe SEQ ID NO: 8, wherein the probes are differentially labeled with fluorophores. The specification describes identification of the primer and probe sets SEQ ID NO: 1-4 from maize to distinguish between CMS and normal cytoplasm, and SEQ ID NO: 5-8 from maize for distinguishing between Normal A and Normal B cytoplasm. The specification also describes a method testing maize plant lines for markers indicative of NA cytoplasm using primers/probes of SEQ ID NO: 5-8, wherein the testing detects at G at a position that corresponds to position 11 of SEQ ID NO: 7 and selecting at least one line for transformation( Example 1, Tables 2-3). The specification further describes a method of improving transformation efficiency of recalcitrant maize by transfer of pollen from maize plant with NA cytoplasm, by crossing NA transformable line by a heterozygous ig1 individual , and PCR genotyping to identify heterozygous carriers and self-pollinated to create a NA version of the ig1 stock; resultant F2 plants were PCR genotyped and homozygous mutant ig1 plants were pollinated by Line 13; identified haploid was pollinated by Line 13 recurrent. However, transformation tests of the NB to NA have failed (Example 2). The specification fails to describe a representative species of plant lines that can be transformed by transfer of NA cytotype, and a representative species of markers for NA cytoplasm that can be employed in the claimed methods. The description provided in the specification is limited to maize plants and the use of SEQ ID NO: 5-8 as probes/primers to distinguish between NA and NB maize lines. No representative species of markers specific for NA cytoplasm in a representative plant lines, in order to increase transformability of the plant lines, are disclosed in the specification or known in the prior art. The state of the prior art as evidenced by Salvo et al ( The Plant genome (2018), 11(2)) teach that friable embryonic and regenerable cultures have been used in most of crop transformation protocols, however, this genotype-dependent culture response has limited functional genomic research, and biotechnological approaches to improve crop transformation. Salvo et al teach the limited studies are available on genes and gene networks controlling differential embryogenic and regenerable response in tissue culture for improving crop transformation efficiency and the existing gaps in knowledge on the genetic factors affecting plant regeneration of embryogenesis in maize and other crop species. The disclosed SEQ ID NO: 5-8 are probes and primer sequences, according to the sequence listing, and it is unclear how the primers and probes can be an indicative of NA cytoplasm in plant lines other than maize. The specification does not disclose a single marker indicative for the NA cytoplasm in exemplified or non-exemplified plant. Therefore, the method of transforming a maize plans by identifying and selecting a maize line comprising NA cytoplasm using primers/probes of SEQ ID NO: 5-8 specific for NA cytoplasm cannot be extrapolated to a method that employs a genus of plant lines and a genus of markers specific to NA cytoplasm, for increased transformability. MPEP 2163 and related case laws state that the written description requirement may be satisfied through sufficient description of a representative number of species by disclosing relevant and identifying characteristics such as structural or other physical and/or chemical properties, by disclosing functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the invention as claimed. See E/i Lilly,119 F.3d at 1568, 43 USPQ2d at 1406. The Federal Circuit court stated that a written description of an invention "requires a precise definition, such as by structure, formula [or} chemical name, of the claimed subject matter sufficient to distinguish it from other material". University of California v. Eli Lilly and Co., 43 USPQ2d 1398 (Fed. Cir. 1997). The court also stated "naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of is not a description of that material". Id. Further, the court stated that to adequately describe a claimed genus, Applicant must describe a representative number of the species of the claimed genus, and that one of skill in the art should be able to "visualize or recognize the identity of members of the genus". Id. Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it"). "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 1612. It is true that functionally defined claims can meet the written description requirement if a reasonable structure-function correlation is established, whether by the inventor as described in the specification or known in the art at the time of the filing date” (AbbVie, 759 F.3d at 1298, reiterating Enzo Biochem, Inc., 323 F.3d at 964)(emphasis added). However, in the instant application, there is insufficient evidence of such an established structure-function correlation. Therefore, since the specification has not described a representative species of plant lines amenable to NA cytotype for increased transformability or a representative species of markers/primer and probes indicative of NA cytoplasm, the claimed method that employs said plant lines and markers specific for NA cytoplasm is similarly not adequately described. Therefore, the specification fails to sufficiently describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize that Applicant was in possession of the invention as broadly claimed at the time of filing. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA 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. Considering objective evidence present in the application indicating obviousness or nonobviousness. 07-20-02-aia AIA 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. 07-21-aia AIA Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Zuo et al (US 20080078003, Applicant’s IDS) in view of Allen et al (Genetics (2007) 177:1173-1192, Applicant’s IDS) . The claim is drawn to a method of transforming a plant, comprising: obtaining a plurality of plant lines; testing for markers indicative of NA cytoplasm; selecting at least one line from the plurality of plant lines wherein the selected lines possess markers for NA cytoplasm; and transforming cells derived from the at least one selected line. Claim 1 do not recite any specific markers. Zuo-Yu et al teach a method of producing maize plants for enhancing transformability, and markers to track the enhanced transformability, the method comprising selecting maize plants as maternal parent from a population of Hi-II plant lines with good transformability, introgressing the genome of maize plants with increased transformability into the genome of plants of an elite maize line with low transformability, and tracking the enhanced transformability with markers ([0004, 0067, and 0130]. Zuo-Yu et al specifically teach crossing the plants of maize line PHWWD having increased transformability as the female parent with plants of maize line PH09B lacking the enhanced transformability as the male parent [0131], and obtaining F1 progeny seed produced on the female parent plant [0070]. Zuo-Yu et al teach that the transformation efficiency rate of the progeny produced from the cross may be increased by fifty-fold beyond the transformation efficiency of the parental line. Zuo-Yu et al disclose the availability of maize inbred lines Hi-II, A188 or H99 having increased transformability that can be used in the disclosed breeding methods. While A188 is a known NA cytoplasm maize line and inherently comprises markers specific for NA cytotype, Zuo-Yu et al do not explicitly teach a maize plant comprising normal A (NA) cytoplasm. Allen et al teach a maize plant comprising a normal (NA) cytoplasm and that it is the cytoplasm present in most of maize lines used to transform maize (page 1173). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the method of increasing of transformation efficiency of maize taught by Zuo-Yu et al by incorporating the maize plant comprising Normal A (NA) cytoplasm and/or (NB) as taught by Allen, given the maize plants with NA cytoplasm is the preferred cytotype found in most of the maize lines used to transform maize as taught by Allen et al (last paragraph, 2nd column on page 1173). Thus, the teachings of the cited prior art in the obviousness rejection above provide the requisite teachings and motivations with a clear, reasonable expectation. The cited prior art meets the criteria set forth in Graham. Therefore, for all the reasons discussed above, the claimed invention is a prima facie obvious. Conclusion No claim is allowed. Contact Information Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEDINA AHMED IBRAHIM whose telephone number is (571)272-0797. The examiner can normally be reached Monday-Friday, 9:00 - 6:00. 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, BRATISLAV STANKOVIC can be reached at 571-270-0305. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent- center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. MEDINA AHMED. IBRAHIM Primary Examiner Art Unit 1662 /MEDINA A IBRAHIM/Primary Examiner, Art Unit 1662 Application/Control Number: 18/950,522 Page 2 Art Unit: 1662 Application/Control Number: 18/950,522 Page 3 Art Unit: 1662 Application/Control Number: 18/950,522 Page 4 Art Unit: 1662 Application/Control Number: 18/950,522 Page 5 Art Unit: 1662 Application/Control Number: 18/950,522 Page 6 Art Unit: 1662 Application/Control Number: 18/950,522 Page 7 Art Unit: 1662 Application/Control Number: 18/950,522 Page 8 Art Unit: 1662 Application/Control Number: 18/950,522 Page 9 Art Unit: 1662 Application/Control Number: 18/950,522 Page 10 Art Unit: 1662 Application/Control Number: 18/950,522 Page 11 Art Unit: 1662
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