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 .
Application Transfer
The application has been transferred to Patent Examiner Yvette Tamukong in Art Unit 1662. Any inconvenience to Applicant(s) is regretted.
Priority
Acknowledgment is made of applicant’s claim for priority to U.S. Provisional Application No.63/137,952, filed January 15, 2021 through PCT/US2022/012494, filed January 14, 2022.
The effective filing date is January 15, 2021.
Elections/Restrictions
Applicant's election of Group I, claims 1-9 and 13-17 drawn to a method for producing cotton fiber by transgenic means, and of species (B) a gene for improvement and or modulation of cotton fiber along with the gene GhHD-1 in the reply filed on 11/25/2025 is acknowledged.
Because Applicants did not distinctly and specifically point out supposed errors in the restriction requirement, the election has been treated as an election without traverse. See MPEP § 818.03(a).
Claims 10-12 and 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being respectively drawn to a nonelected species and invention, there being no allowable generic or linking claim.
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).
Status of the Claims
Claims 1 is/are pending.
Claims 10-12 and 18-20 is/are withdrawn.
Claims 1-9 and 13-17 is/are examined herein.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 03/ are acknowledged and are being considered by the Examiner.
Claim Objections
Claim objected to because of the following informalities:
In line 3, a conjunction is used “and a CaMV 35S” when there should be none. A conjunction only belongs before the last element in a list.
In line 4, reads “an actin promoter, such a GhACT1” instead of “an actin promoter, such as GhACT1”
In line 5, a conjunction should precede the last element in a list.
Appropriate correction of the above informalities is required. Any response to this office action that fails to meet all of these requirements will be considered non-responsive.
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.
Claim(s) 1 rejected under 35 U.S.C. 112(b) 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. All dependent claims are included in these rejections unless they contain a limitation that overcomes the deficiencies of the parent claim from which they depend. See details below.
Claim 1 recites the phrase “modifying cotton cells such that they comprise at least one differently expressed gene…” It is uncertain what this phrase encompasses. Is modification letting the cotton cells regulate gene expression as occurs naturally (differently) in nature, is it introducing abiotic and/or biotic stresses that have downstream effects on gene regulation, transforming the cells with desirable gene(s), any combination of the above, or anything else? Claim 1 further recites “at least one differently expressed gene” without providing a comparative basis, and thus the meaning behind a “differently expressed gene” is unclear. Is the expression of the gene in the modified cotton cell compared to an unmodified cotton cell, another cotton cell variety, a cotton cel from a different cotton tissue, a different plant all together? What does differently mean? Is expression of the gene increasing or decreasing, longer shorter duration of expression, more or less intense, or more tissue specific or more constitutive, or perhaps making expression of the gene inducible?
In the interest of compact prosecution, the claims are nonetheless examined.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon including products of nature, or an abstract idea) without significantly more. All dependent claims are included in these rejections unless they contain a limitation that overcomes the deficiencies of the parent claim from which they depend. The rationale for this determination is explained below.
The claims are drawn to a method comprising:
modifying cotton cells such that they comprise a differently expressed gene that modulates cotton fiber development;
culturing the modified cotton cells in vitro; and
harvesting/removing cotton fiber from the cultured cells.
In cotton plants, cotton cells are modified such that genes that modulate cotton fiber development are “differently expressed” through the plant and at different developmental stages. Thus, this limitation is directed to naturally-occurring process(es), cells, and organisms, with naturally occurring genes.
Ovule culture (i.e., culturing modified cotton cells) is “unless otherwise indicated,… well known to those skilled in the art” (see col 14 lines 30-35 and col 30 of Yingru (Patent Publication No. US8049069B2, assigned to Commonwealth Scientific and Industrial Research Organization CSIRO, titled ‘Genes involved in plant fibre development’, published 11/01/2011)).
In the production of cotton, it is inherent that non fiber materials are separated from the fiber (i.e., harvesting cotton fiber from the cultured cells). Also, harvesting cotton fibers has been done for as long as humans began cultivating cotton. A claim that focuses on use of a natural principle must also include additional elements or steps to show that the inventor has practically applied, or added something significant to, the natural principle itself. Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __, 132 S.Ct. 1289,101 USPQ2d 1961 (2012), at 1966. Without disclosing a specific, novel, method of harvesting cotton fibers, this limitation is merely a well-understood, routine, conventional activity previously known to the industry, which is not sufficient to transform a judicial exception into a patent eligible invention.
Thus, the claimed invention(s) is/are not patent-eligible for being directed to a natural law such as the existence of specific naturally occurring differently expressed gene that modulate cotton fiber development with the addition of laboratory techniques and that are recognized as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner.
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 1-9 and 13-17 are rejected under 35 U.S.C. 103 as being unpatentable over Yingru (U.S. Patent Publication No. US8049069B2, assigned to Commonwealth Scientific and Industrial Research Organization CSIRO, titled ‘Genes involved in plant fibre development’, published 11/01/2011) in view of Shan (Shan, CM. et al. Control of cotton fibre elongation by a homeodomain transcription factor GhHOX3. Nat Commun 5, 5519 (2014). https://doi.org/10.1038/ncomms6519, published 11/21/2014) and Kim (cited in IDS; Hee Jin Kim, and Barbara A. Triplett, Cotton Fiber Growth in Planta and in Vitro. Models for Plant Cell Elongation and Cell Wall Biogenesis, Plant Physiology, Volume 127, Issue 4, December 2001, Pages 1361–1366, https://doi.org/10.1104/pp.010724, published 12/01/2001).
Claim 1 is drawn to a method comprising:
modifying cotton cells such that they comprise a differently expressed gene that modulates cotton fiber development;
culturing the modified cotton cells in vitro; and
harvesting/removing cotton fiber from the cultured cells.
Merriam-Webster dictionary defines “harvest” as meaning “to remove or extract (something, such as living cells, tissues, or organs) from culture (see culture entry 1 sense 5) or from a living or recently deceased body especially for transplanting.”
Yingru teaches:
“A method of increasing fibre initiation and/or elongation in a fibre producing plant [i.e., cotton cells] comprising introducing into the plant a nucleotide sequence [i.e., modifying cotton cells] encoding a polypeptide” (claim 1).
The method “such that production of the polypeptide is increased [in modified cotton cells] when compared to a wild-type [cotton cells]” (i.e., modifying cotton cells such that they comprise at least one differently expressed gene)(claim 1).
The method wherein “the nucleotide sequence [is] set forth in SEQID NO:38” and is the coding region of GhMyb25-like clone which is characterized as a “fibre initiation gene” (i.e., said differently expressed gene modulates cotton fiber development) (claim 1; col 34, lines 40-45: col 4, table 5),
“Cotton ovule culture…(Beasley and Ting, 1973)” (i.e., culturing cotton cells in vitro) (Example 2, cols 30)
That “cotton fibres develop only from the epidermal cells of the outer integument of ovules”(col 33 lines 34-42) such that “fibres being removed [from ovules]” ( col 12 lines 50-56) is the harvesting of cotton fiber from the epidermal cells.
“Laser capture microdissection (LCM)… to isolate fibre… from… ovules” (i.e., harvesting cotton fiber from the cells) (col 44 lines 10-16).
Yingru does not explicitly teach culturing cotton cells in vitro.
However, Shan teaches control of cotton fibre elongation (entire document; see Title, Abstract, for example). Shan, while “uncover[ing] a new molecular mechanism underlying the role of [Gibberellic acid] in promoting cotton fibre elongation”(page 4, Discussion), teaches:
production of cotton fiber with wild type and transformed cotton plants (methods page 6) (i.e., modifying cotton cells…) where a differentially expressed gene “GhHOX3 regulates cotton fibre elongation” (page 2 col 2) (i.e., modulates cotton fiber development).
ovule culture (methods page 7 cols 1-2) and that fibres were collected by scraping the ovule in liquid nitrogen including cultured ovules (methods page 6 col 1, Figure 2) (i.e., harvesting cotton fiber from the cultured cells).
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Kim teaches cotton fiber growth in planta and in vitro (entire document; see Title, Abstract, for example).
Kim teaches:
Advantages of cotton fiber development in vitro
“a culture method for cotton ovules was perfected three decades ago” (page 1363 col 1; see partial snippet of figure 1 besides).
that “ovule cultures have obvious advantages over whole plants” and that “early comparison suggested substantial similarity between the fibers produced in planta and in vitro” (page 1363 col 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the filing of the claimed invention to combine and to modify the teachings of Yingru and Shan with that of Kim to culture the modified cotton cells of Yingru and Shan and harvest the cotton fibers directly from the cultured modified cells as they respectively did for obtained wildtype and cultured wildtype ovules (i.e., cotton cells). One would have been motivated to this because cotton fiber is “important contributor to world economies”(Yingru col 1 lines 25-28) and “ovule cultures have obvious advantages over whole plants” including less agricultural land use requirement and that compared to “in vitro fibers continue to divide for [more days than fibers produced in vivo]” (Kim, page 1363 col 2 and page 1364 col 1 para 2)
Regarding claim 2, which depends from claim 1, Shan teaches “fibres were collected by scraping the ovule” (i.e., cotton fiber harvested directly from the cultured cells) (page 6, col 1, para 1).
Regarding claim 3 , which depends from claim 2, Shan teaches “expression levels of GhHOX3 and two downstream genes in ovule (O) and/or fibre (F), which were taken from GhHOX3-silenced line 5–8 and the [wildtype] cotton at 2 DPA and cultured in vitro with addition of the hormone GA3 (1 mM) for 6 days” Figure 2 caption). Ascertaining transcript levels in fibers of cultured ovules inherently requires harvesting the fibers from the cultured epidermal cells, for example by scraping of the cultured ovules which does not include growing a cotton plant (i.e., cotton fiber is harvested from the cells without growing a cotton plant).
Regarding claim 4, which depends from claim 3, Yingru and Shan both teach differentially expressed genes selected for modulation of cotton fiber development (Yingru, col 2 lines 17-31 and FIG. 1 ; Shan, page 2 col 1 to page 3 col 1).
Regarding claim 5, which depends from claim 4, Yingru and Shan both teach the differentially expressed genes are transgenes (Yingru, col 46 line 49 to col 47 line 67; Shan, page 3, col 1, “Strikingly, compared with the wild-type, fibre length was increased up to 20% in the 35S::GhHOX3g lines in which GhHOX3 expression was elevated”).
Regarding claim 6 and 7, Yingru teaches that “the coding sequence of a gene of the invention may be operably linked to a promoter” and that “the promoter may be expressed constitutively throughout the plant, for example, a Subterranean clover stunt virus promoter (S7: WO96/06932)”( Example 13) (i.e., transgene is operably connected toa promoter). Further, Yingru teaches that promoters can be chosen based on desired expression pattern (col 24-col 25 line 37).
Regarding claim 8, which depends from claim 6, Shan “used the 35S promoter to drive the cDNA and transferred the constructs into G. hirsutum” both teach (i.e., modifying cotton cells comprising introducing the transgene and promoter via transformation) (page 2, col 1).
Regarding claims 9 and 13-14, Shan teaches that “compared with the wild-type, fibre length was increased up to 20% in the 35S::GhHOX3g lines in which GhHOX3 expression was elevated” (i.e., GhHOX3 was expressed at a higher level compared with a cotton cell prior to modifying, gene selected for modulation of cotton fiber development, differently expressed gene increases cotton fiber length) (page 2 col 2 to 3 col 1). Also see Yingru’s claims 1-8.
Regarding claim 15, which depends from claim 13, Yingru teaches the “over-expression of genes in a fibre producing plant such as cotton” using “the coding sequence of a gene of [Yingru’s] invention” of which GhHD1 is one (SEQ ID NOs: 1, 17-18, Example 2, Example 13).
Regarding claims 16 and 17, Yingru and Shan respectively teach collection of ovules (i.e., cotton cells) from the flowers and bolls of cotton plants (Yingru, col 30, lines 7-15; Shan, page 7, col 1, para 4).
References Cited but not Applied
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kasukabe (cited in IDS; U.S. Patent Publication No. 6563021B1, assigned to Toyobo Co Ltd and Texas Tech University TTU, titled ‘Production of cotton fiber with improved fiber characteristics’, published 05/03/2003) teaches:
"a method for inducing specific genes expression in a cotton plant to produce cotton fibers with improved fiber characteristics by treatment with a brassinosteroid, and a cotton plant produced by this method; as well as
a novel gene capable of changing the degree of its expression found in the ovules of a cotton plant treated with a brassinosteroid, a gene capable of hybridizing with this novel gene, a recombinant plasmid containing this novel gene,
a transformant containing this recombinant plasmid" (i.e., modifying cotton cells such that the comprise at least one differently expressed gene that modulates cotton fiber development),
"another method, [wherein] an ovule culture is prepared from a cotton plant of the genus Gossypium in a brassinosteroid-containing liquid medium"(i.e., culturing modified cotton cells in vitro) (abstract).
Conclusion
Claims 1-9 and 13-17 are rejected.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YVETTE B TAMUKONG whose telephone number is (571)272-1040. The examiner can normally be reached M-Th 8-5 EST.
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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.
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/YVETTE BIH TAMUKONG/ Examiner, Art Unit 1662
/BRATISLAV STANKOVIC/ Supervisory Patent Examiner, Art Units 1661 & 1662