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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1, 2, 10, 11, 18, 21, 22, 25-27 and 30 in the reply filed on 18 June 2026 is acknowledged.
Claims 28-29, 31, 33-34, 36-38, 40-41, 43-45, 48, 51-52, 56-57, 59, 62-63 and 65-66 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 18 June 2026.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Specification
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the applicant’s use.
The disclosure is objected to because of the following informalities: The sequence listing on pages 50-56 is objected to because it fails to comply with 37 CFR 1.831(a) which must be a separate part of the disclosure.
Appropriate correction is required.
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 2, 10, 11, 18 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.
At claim 2, the limitations “ltp3/8K12”, “FLA7”, “FLA12”, “FLA9”, “FLA11” and “FLA17” appear to be arbitrary designations for a promoter. The Specification teaches a nucleotide sequence for FLA7 and FLA12 at SEQ ID Nos. 29 and 30, respectively. The Specification does not teach the promoter from a cotton fiber-specific gene designated FLA9, FLA11 or FLA17. Hence, the metes and bounds of the claim are unclear. Claims 10, 11 and 18 are similarly indefinite because they do not teach the metes and bounds of said limitation either.
At claims 10(b) and 18, the limitations cDOPA5GT, DODA1, CYP76AD1, CYP76AD6, amilGFP, amilCP, eforRED, igiA, igiD or igiB renders the claim indefinite because the metes and bounds of the limitations are unclear. It is unclear what parts of the pigment producing genes the limitations encompass This issue is found in claim 11 as well, which merely states what organism the pigment producing genes can be found.
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, 2, 10, 11, 18, 21, 22, 25-27 and 30 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.
Applicant claims a nucleic acid construct comprising a cotton fibre-specific promoter “capable” of driving expression during two or more fibre development stages. Applicant claims where said promoter is ltp3/8K12 or from a cotton fibre-specific gene “FLA7”, “FLA12”, “FLA9”, “FLA11” and “FLA17”. Applicant claims wherein the pigment producing gene coding sequence is cDOPA5GT, DODA1, CYP76AD1, CYP76AD6, amilGFP, amilCP, eforRED, igiA, igiD or igiB. Applicant claims said construct comprising a nucleotide sequence having 90% identity to any of instant SEQ ID NO: 1, 3, 5, 7, 9 or 11. Finally, Applicant claims a method comprising transforming a cotton plant cell with said nucleic acid construct.
Applicant describes using a ltp3/8K12 (SEQ ID NO: 15) to produce a nucleic acid construct comprising a nucleotide sequence encoding DODA1 (SEQ ID NO: 3), CYP76AD1 (SEQ ID NO: 5) and cDOPA5GT (SEQ ID NO:2) in vector pMM2009 in Table 1 on page 57, and a method of transforming a cotton cell to produce a cotton plant that produces purple cotton fibres.
Applicant does not describe promoters from a cotton fibre-specific gene “FLA7”, “FLA12”, “FLA9”, “FLA11” and “FLA17” other than by function. Applicant does not describe pigment producing gene coding sequences cDOPA5GT, DODA1, CYP76AD1, CYP76AD6, amilGFP, amilCP, eforRED, igiA, igiD or igiB other than by function as a whole. Applicant does not describe a structure/function relationship of a cotton fibre-specific promoter capable of driving expression of a nucleotide sequence during two or more fibre development stages (instant claim 1) or driving expression…at a level that is “sufficient” to produce pigment that is present in cotton fibre at ³ 40 DPA (instant claim 26).
Hence, it is unclear that Applicant was in possession of the invention as broadly claimed.
See Ex parte Kubin, 83 USPQ2d 1410 (Bd. Pat. App. & Int. 2007) at pg 1417:
[Appellants] … have not described what domains of those sequences are correlated with the required binding to CD48, and thus have not described which of NAIL's amino acids can be varied and still maintain binding. Thus, under Lilly and its progeny, their Specification would not have shown possession of a sufficient number of sequences falling within their potentially large genus to establish possession of their claimed genus. Cf. Enzo, 323 F.3d at 964, 63 USPQ2d at 1612 ("if the functional characteristic of … binding to [CD48] were coupled with a disclosed correlation between that function and a structure that is sufficiently known or disclosed," the written description requirement may be met).
Without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 ("definition by function … does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is").
With respect to Appellants’ reliance on hypothetical Example 14 in the Office's Synopsis, "[c]ompliance with the written description requirement is essentially a fact-based inquiry that will ‘necessarily vary depending on the nature of the invention claimed.’" Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991) (quoting In re DiLeone, 436 F.2d 1404, 1405, 168 USPQ 592, 593 (CCPA 1971)), quoted with approval in Enzo, 323 F.3d at 963, 63 USPQ2d at 1612. While the Written Description Guidelines and the hypothetical examples in the Office's Synopsis can be helpful in understanding how to apply the relevant law (as it existed in 2001 when the Guidelines were adopted), they do not create a rigid test.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 2, 10, 21, 26, 27 and 30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McBride et al (US 7,732,678).
McBride et al disclose a nucleic acid construct comprising a nucleotide sequence encoding a cotton fibre-specific promoter, a transit peptide (signal peptide of instant claim 21) and pigment encoding sequence at claims 1, 2 and 6. McBride et al disclose that the pigment encoding sequence is non-native at claims 15 and 16 directed to a bacterial tyrA gene whose encoded enzyme produces melanin. McBride et al disclose a method of transforming a cotton cell and regeneration of a transgenic cotton plant and harvesting fibre from the regenerated cotton plant at Example 9, columns 21-22. Hence McBride et al had previously disclosed the claimed invention.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 11, 18, 22, 25, is/are rejected under 35 U.S.C. 103 as being unpatentable over McBride et al (US 7,732,678) in view of Aharoni et al (US 2018/0261801) and in further view of Huang et al (2008, Physiologia Plantarum 134:348-359).
McBride et al teaches a nucleic acid construct comprising a nucleotide sequence encoding a cotton fibre-specific promoter, a transit peptide (signal peptide of instant claim 21) and pigment encoding sequence at claims 1, 2 and 6. McBride et al teach that the pigment encoding sequence is non-native at claims 15 and 16 directed to a bacterial tyrA gene whose encoded enzyme produces melanin.
McBride et al do not teach where in the nucleic acid construct encodes a pigment producing gene that produces a betalain, betacyanin or betaxanthin. McBride et al do not teach that the signal peptide is a barley a-amylase signal sequence or a cotton fasciclin-like arabinogalatin signal peptide.
Aharoni et al teach transforming a plant cell with a nucleic acid construct encoding a CYP76AD6 (instant SEQ ID NO: 7) and a DODA1 (instant SEQ ID NO: 4) encoding pigment producing enzyme(s) in the Abstract and claims 8, 39 and 52 to produce betalains. Aharoni et al teach that the promoter selection would be a design choice at claim 7.
Huang et al teach cotton fasciclin-like arabinogalatan proteins and genes that are involved in fiber development. Huang et al teach the signal peptide regions in Figure 1 on page 353.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant claims to modify the teachings of McBride et al using the teachings of Aharoni et al to express pigment producing genes to produce betacyanins in a plant cell. The choice of promoters a signal peptides would have been a design choice as suggested by Aharoni et al and Huang et al had previously taught cotton FLA signal peptide coding sequences. Hence, the combinations as claims would have been obvious to one of ordinary skill in the art before the effective filing date of the instant claims. Given the teachings of McBride et al in expressing pigment producing genes in the fibre of a transgenic cotton plant, one of ordinary skill in the art would have had a reasonable expectation of success.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID H KRUSE whose telephone number is (571) 272-0799. The examiner can normally be reached Monday-Friday 7AM-3:30PM.
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/David H Kruse/
Primary Examiner, Art Unit 1663
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