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 .
DETAILED ACTION
Status of Objections and Rejections
1. Applicant’s response filed January 9, 2026 is acknowledged. Claims 13, 15, 17, 20, 22-25, 29, 31-34, 36 and 38-42 are pending. Claims 1-12, 14, 16, 18, 19, 21, 26-28, 30, 35 and 37 are cancelled. Claims 23, 29, 31-34 and 36 are previously withdrawn as directed to non-elected inventions. Accordingly, claims 13, 15, 17, 20, 22, 24, 25 and 38-42 are examined on merits in the present Office action.
2. Objections to claims 15, 17, 20, 24 and 40 are withdrawn in light of claim amendments filed in the papers of January 9, 2025.
3. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
4. Rejection of claims 17, 20, 22, 24 and 25 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of claim amendments and arguments filed in the papers of January 9, 2025, and upon further consideration.
5. Rejection of claims 13, 15, 17, 20, 22, 25 and 38-42 under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter is withdrawn in light of claim amendments and arguments filed in the papers of January 9, 2025, and upon further consideration.
Claim Rejections - 35 USC § 112 (Written Description)
6. Claims 13, 15, 17, 20, 22, 24, 25 and 38-42 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 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(s), at the time the application was filed, had possession of the claimed invention for the reasons of record stated in the Office action mailed in the papers of July 9, 2025.
Applicant traverses the rejection in the papers filed January 9, 2025.
Applicant argues by stating as follows:
“The specification identifies multiple salinity resistance genes, including SOS1, NHX1, HKT1. See, for example, paragraphs [0029] and [0034]. Representative sequences and functional roles are also provided, showing that the Applicant contemplated multigene configurations. See, for example, paragraph [0034]. The specification explicitly describes root-specific promoters and enhancers, including cis-elements such as TAF- 1, TATA, E2F, G-BOX, or CAAT enhancer sequences, and hormone-responsive motifs (e.g., abscisic acid, auxin, gibberellin, and ethylene). See, for example, paragraphs [0030] through [0038] as well as Tables 1-5. Various sequences and promoters are also included, enabling the skilled person to identify and use these elements. Paragraph [0043] describes operably linking root-specific promoter or enhancer sequences to at least three salinity resistance genes for transfection. Example 1 describes transformation of plants using DNA molecules described in the specification for gene editing. Example 2, in one transfection method, describes generating embryogenic callus tissue for particle bombardment. Example 3 describes recovery of transformed plants after particle bombardment. And Example 4 describes identifying salt tolerant transformed plants by partially submerging the roots of the plantlets or a plant in salt media. A skilled artisan would reasonably recognize from the disclosure that the inventors contemplated the claimed invention. The specification provides not only detailed embodiments of the claimed plants and plant cells but also various sequences of promoters and enhancers. The specification further provides detailed explanation of how the recited components interact to achieve the claimed function. Moreover, once transformed plants or plant cells having genome modifications are generated, they are readily tested, absent undue experimentation, for an elevated threshold salinity compared to a plant of the same species without the genome modification (see, for example, Example 4).”
Applicant’s arguments have been considered but are not deemed persuasive.
1. Applicable Legal Standard (Post-Ariad)
The written description requirement of §112(a) is separate and distinct from enablement and requires that the specification reasonably convey to a person of ordinary skill in the art that the inventor had possession of the claimed invention at the time of filing. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc).
For claims directed to broad biological genera, possession must be demonstrated by:
(a) disclosure of a representative number of species, or
(b) disclosure of structural features common to the genus such that one skilled in the art can recognize the members of the genus.
Ariad, 598 F.3d at 1350; MPEP §2163. Functional language alone is insufficient where
the art is unpredictable. Id. at 1351.
It is noted, for the record, that any prior concerns regarding the clarity of the terms “promoter” or “enhancer” under 35 U.S.C. §112(b) have been withdrawn. The terms are recognized in the art as classes of regulatory DNA elements and, standing alone, are not indefinite. However, withdrawal of any §112(b) issue does not resolve the separate and distinct deficiency under §112(a). As made clear in Ariad, the written description requirement is not satisfied merely because a term is understood in the art. Rather, the specification must demonstrate that Applicant had possession of the full scope of the claimed genus, including the promoter or enhancer sequences recited in the claims.
In the instant case, the claims encompass any root-specific promoter or enhancer sequence, including sequences defined by: (a) minimal length (e.g., at least 10, 20, or 30 nucleotides), (b) relative genomic position, (c) hormone responsiveness, or sequence identity to SEQ ID NO: 53.
While such elements may be conceptually understood, the specification fails to disclose: a representative number of promoter or enhancer species within the claimed scope, or structural features common to the claimed genus that correlate with root-specific regulatory activity. Accordingly, the deficiency is not one of claim clarity, but rather a failure of the specification to reasonably convey possession of the broadly claimed promoter and enhancer genus at the time of filing. See Ariad, 598 F.3d at 1350–51; MPEP §2163.
2. The Amended Claims Remain Overly Broad and Functionally Defined
It is noted that the amended independent claim 13 is directed to an engineered plant or plant cell comprising: (i) genome modifications, (ii) enhancing root-specific expression,, (iii) of at least three salinity resistance genes, (iv) using at least three promoter or enhancer insertions. Despite amendment, the claim remains a genus defined primarily by function, with scope far exceeding the disclosure.
(a) “Salinity resistance genes”
The claims encompass any salinity resistance genes, including but not limited to SOS1, NHX1, and HKT1, from any plant species.
The specification, however, discloses only three rice genes, identified by GenBank accession numbers. No structural description, sequence disclosure, or functional data are provided for: (i) homologs from other species, (ii) allelic variants or paralogs, or (iii) modified or engineered versions. Merely identifying gene names or functional categories does not establish possession of the genus. Ariad, 598 F.3d at 1350; Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568 (Fed. Cir. 1997).
Applicant has not identified any structural features common to the claimed salinity resistance genes, nor has Applicant disclosed a representative number of species sufficient to support the breadth of the claims.
(b) “Root-specific promoter or enhancer sequences”
The claims encompass: (i) any promoter or enhancer, (ii) operably linked to the genes, (iii) positioned within 50–500 nucleotides of an ORF, as short as 10 nucleotides, or (iv) having ≥95% identity to SEQ ID NO: 53.
None of synthetic enhancer sequences, including elected SEQ ID NO: 53 and do not describe: (i) which nucleotides are required for regulatory activity, (ii) which positions tolerate variation,(iii) how sequence identity correlates with function, or (iii) how minimal sequence lengths retain enhancer or promoter activity. The disclosure does not identify common structural characteristics sufficient to define the claimed genus of promoter or enhancer sequences. Given the high unpredictability of regulatory sequence function, functional characterization alone is insufficient. Ariad, 598 F.3d at 1351; MPEP §2163.
(c) Multigene, root-specific genome modification
The claims require at least three distinct genome insertions conferring enhanced root-specific expression of multiple genes. The specification does not describe a single plant or plant cell having: (i) three salinity resistance genes, (ii) each operably linked to a root-specific promoter or enhancer, (iii) integrated into the genome, (iv) resulting in enhanced root-specific expression or salinity tolerance.
As discussed in previous Office action, Examples 1–4 describe prophetic methods and screening approaches, not actual engineered plants demonstrating the claimed invention. A description of a research plan or methods for achieving a result does not establish possession. Ariad, 598 F.3d at 1352.
3. Enablement Arguments Are Not Persuasive
Applicant argues that a skilled artisan could make and test the claimed plants without undue experimentation. This argument relates to enablement, not written description.
The written description requirement asks whether the inventor had possession, not whether the invention could be made. Ariad, 598 F.3d at 1352. Enablement cannot cure a lack of written description.
4. Lack of Representative Species or Genus-Defining Features
In view of the breadth of the claims, disclosure of: (i) three rice genes, and (b) a single untested synthetic enhancer, does not constitute a representative number of species, nor does it identify genus-defining structural features for: salinity resistance genes, root-specific promoters or enhancers, or multigene genome-modified plants.
Accordingly, one of ordinary skill in the art would not recognize that Applicant was in possession of the claimed genus at the time of filing. The amended claims remain broader than the supporting disclosure and are defined primarily by functional result rather than structure in an unpredictable art. The specification fails to demonstrate possession of the full scope of the claimed invention.
The Federal Circuit has clarified the application of the written description
requirement to inventions in the field of biotechnology. See University of California v. Eli
Lilly and Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). In summary,
the court stated that a written description of an invention requires a precise definition, one
that defines the structural features of the chemical genus that distinguishes it from other
chemical structures. A 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. The court goes on to say,
"A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNAs, defined by nucleotide sequence, falling within the scope of the genus or of a recitation of structural features common to members of the genus, which features constitute a substantial portion of the genus." See University of California v. Eli Lilly and Co., 119 F.3d 1559; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997).
Thus, under Lilly and its progeny, the Specification does not show possession of a
sufficient number of sequences falling within their potentially large genus to establish
possession of their claimed genus. See Cf Enzo, 323 F.3d at 964 ("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, ("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"); see also Kubin, 83 USPQ2d at 1416-17.
Also see in re Curtis (69 USPQ2d 1274 (Fed. Cir.2004), where the court held that
there was sufficient evidence to indicate that one of ordinary skill in the art could not
predict the operability of other species other that the single one disclosed in the
specification. The court held that a disclosure naming a single species can support a claim
to a genus that includes that species if a person of ordinary skill in the art, reading the
initial disclosure, would "instantly recall" additional species of the genus already "stored" in
the minds, but if other members of the genus would not "naturally occur" to a person of
ordinary skill upon reading the disclosure, then unpredictability in performance of species
other than specifically enumerated defeats claims to the genus.
Therefore, it is further maintained that given the lack of written description in the
specification with regard to the structural and functional characteristics of the claimed
compositions, it is not clear that Applicant was in possession of the claimed genus at the
time this application was filed.
Accordingly, it is maintained that there is lack of adequate description to inform a
skilled artisan that applicant was in possession of the claimed invention at the time of
filing. See Written Description guidelines published in Federal Register/Vol.66, No.
4/Friday, January 5, 2001/Notices; p. 1099-1111.
Accordingly, the rejection is maintained.
Claim Rejections - 35 USC § 103
7A. Claim(s) 13, 15, 17, 20, 22, 25 and 38-42 remain rejected under 35 U.S.C. 103 as being unpatentable over Ono et al. (EP 3409105A1, published December 5, 2018, IDS) and further in view of Hossain et al. (Plant biotechnology, 23:275-281, 2006, IDS) and Wu et al. (CN102242119, Published November 16, 2011) for the reasons of record stated in the Office action mailed in the papers of July 9, 2025.
Ono et al. teach a method of overexpressing one or more of SOS1-3, NHX1 and HKT1 salt tolerant genes in plants to improve salt tolerance under salt stress conditions. The salt tolerant plants (transgenic) are obtained by transforming plant cells or plants with expression cassette(s) comprising a promoter (heterologous or native) operably linked to a coding sequence encoding one or more of SOS1-3, NHX1 and HKT1 salt tolerant proteins. The reference further teaches that said plant can be for example, rice, (monocot), brassica (dicot). The reference further teaches obtaining transgenic seeds (plant part) expressing said one or more of SOS1-3, NHX1 and HKT1 salt tolerant genes. The reference also teaches that said transformed plant cells are regenerated to obtain transgenic plants transformed with said expression cassette(s). See in particular, paragraphs [0012], [0029-[0031], claim 1, 8-13, examples 2, 1, 3-7.
Ono et al. do not teach overexpressing SOS1-3, NHX1 and HKT1 salt tolerant genes using root-specific promoter(s).
Hossain et al. teach root specific overexpression of Na+/H+ antiporter gene in a plant increases its salt tolerance and seed yield under salt stress conditions. Hossain et al. teach a method of overexpressing Na+/H+ antiporter salt tolerant gene in a plants improve salt tolerance under salt stress conditions. The salt tolerant plants (transgenic) are obtained by transforming plant cells or plants with an expression cassette comprising a root-specific promoter (heterologous, adh) operably linked to a coding sequence encoding Na+/H+ antiporter salt tolerant protein. The reference further teaches obtaining transgenic seeds (plant part) expressing said Na+/H+ antiporter salt tolerant protein. The reference also teaches that said transformed plant cells are regenerated to obtain transgenic plants transformed with said expression cassette. See in particular, abstract, Figures 1-5; materials & method (pages 276-277); results (pages 277-279) and discussion (pages 279-280).
Wu et al. teach a method of obtaining stress tolerant plants (rice) by overexpressing exogenous genes encoding stress tolerant protein using a root specific promoter obtained from rice.
Wu et al. teach root specific overexpression of exogenous gene encoding stress tolerant protein in a plant (rice) increases its salt tolerance under salt stress conditions. The transgenic plants are obtained by transforming plant cells or plants with an expression cassette comprising a root-specific promoter (SEQ ID NO: 1 from rice) operably linked to a coding sequence encoding exogenous protein of interest, including the one that imparts salt stress tolerance. The reference further teaches obtaining transgenic seeds (plant part) expressing said protein. The reference also teaches that said transformed plant cells are regenerated to obtain transgenic plants transformed with said expression cassette.
The promoter taught in the reference has TATA box and ERF (ethylene hormone responsive factor) elements that respond to hormone ethylene to regulate expression of said exogenous gene sequence of interest. The complete analysis of cis acting elements (including ERF etc.) of the promoter taught by Wu et al. is attached with the reference. It may be noted that such element(s) are at least 10, 20 nucleotides in length. See in particular, abstract, Tables 1-8; SEQ ID NO: 1, Figures 1-15, claims, and the entire translated document.
Given (a) Ono et al. teach that overexpressing salt tolerant genes like SOS1-3, NHX1 and HKT1 in a transgenic plant environment results in imparting salt tolerance/resistance upon growing plants under elevated salt stress conditions, and (b) Hossain et al. and Wu et al. teach that overexpressing stress (salt) tolerant genes from a root-specific promoter having enhancers (as taught by Wu et a.) increases salt tolerance or resistance capability in a transgenic plant environment, it would have been obvious and within the scope of an ordinary skill in the art prior to earliest filing date of the claimed invention to have combined the teachings of cited prior art to overexpress multiple (e.g. 3 or more) salt tolerant genes in a plant for the purpose of obtaining salt tolerant or resistant plants that can thrive under very high salt environment without impacting yield or biomass of the plant. Obviously overexpressing previously well characterized multiple (3 or more as a design choice) salt tolerant genes in a plant would have been primary motivation to do so without any unexpected or surprising results, and thus arrive at the Applicant’s claimed invention with a reasonable expectation of success.
Thus, the claimed invention as a whole was prima facie obvious over the combined teachings of the prior art.
7B. Applicant’s arguments & Response to Applicant’s arguments:
Applicant traverses the rejection in the papers filed January 9, 2025.
Applicant argues by stating as follows:
“Ono, at best, teaches overexpressing salt-tolerance genes (e.g., SOS1-3, NHX1, HKT1) under promoters but does not disclose: simultaneous expression of at least three distinct salinity resistance genes in a single plant or a coordinated use of multiple root-specific promoters or enhancers. To remedy Ono, the Office relies on Hossain and Wu.Hossain, however, teaches root-specific expression of a single Na+/H+ antiporter gene, but does not suggest: a multigene strategy or integration of multiple root-specific regulatory elements for different genes. Wu similarly describes root-specific expression of one exogenous gene under a promoter with cis-elements (ERF, TATA box) but does not: teach or suggest combining multiple salinity resistance genes as claimed. None of these references, alone or in combination, disclose or suggest the claimed structural design of multiple salinity resistance genes each operably linked to distinct root-specific promoters or enhancers. Still further, Ono, Hossain, and Wu, alone or taken together, provide no teaching or reasonable expectation of success for combining three or more salinity resistance genes much less coordinating root- specific expression across multiple genes. A skilled worker would not be motivated to undertake designing such a plant without a reasonable expectation of success.”
Applicant’s arguments are carefully considered but are deemed to be unpersusaive for the following reasons;
1. Alleged Failure to Teach “Multiple” Salinity Resistance Genes
Applicant argues that Ono et al. do not disclose simultaneous expression of three salinity resistance genes under root-specific control. This argument is not persuasive.
Ono et al. expressly disclose overexpression of multiple salt tolerance genes, including SOS family members, NHX1, and HKT1, and teach that such genes may be used individually or in combination to improve salt tolerance (see Ono, claims 1, 4–12). The selection of three or more such genes represents a numerical optimization and design choice, which is considered obvious where the art recognizes the benefit of combining known elements for their predictable functions (see MPEP §2144.05, In re Aller).
2. Root-Specific Promoters Are Properly Supplied by Hossain and Wu
Hossain et al. and Wu et al. teach that root-specific expression of salt-tolerance genes improves salt tolerance and yield. The application of a known root-specific promoter to known salt-tolerance genes represents a simple substitution of one known promoter for another, yielding predictable results (see MPEP §2143.01(V)). Applicant’s argument that the references disclose only single-gene expression is unavailing. The law does not require that the prior art expressly disclose the exact claimed combination, but only that it would have been obvious to combine known elements to achieve a predictable result (KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398).
3. Motivation to Combine Is Clearly Articulated
The motivation to combine arises directly from the art: (i) Ono teaches that salt tolerance can be enhanced by overexpressing salt-resistance genes, and (ii) Hossain and Wu teach that root-specific expression improves salt stress performance. It would have been obvious to a person of ordinary skill in the art to express multiple known salt-tolerance genes under root-specific promoters to maximize salt exclusion and sequestration at the root level, thereby improving overall plant performance. This rationale satisfies MPEP §2143 and does not rely on hindsight.
4. Reasonable Expectation of Success Exists
Applicant argues that there would be no reasonable expectation of success due to pathway complexity. This argument is not persuasive. Each of the genes (SOS1, NHX1, HKT1) was well characterized prior to Applicant’s filing date, and each was independently known to improve salt tolerance. Combining such genes to enhance the same trait would have been expected to provide at least additive benefits. Absolute predictability is not required (see MPEP §2143.02).
It is further important to note that KSR forecloses the argument that a specific teaching,
suggestion or motivation is required to support a finding of obviousness. See the recent Board
decision Ex parte Smith, -- USPQ2d --, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing
KSR, 82 USPQ2d at 1396). As indicated above, that obviousness does not require an absolute certainty of success but merely a reasonable expectation thereof, so long as the motivation or suggestion to combine the teaching of the cited references is known or disclosed in the prior art and is obvious to one skilled in the art and this is sufficient to establish a prima facie case of obviousness. In this case, it would have been obvious and within the scope of an ordinary skill in the art to have arrived at the instantly claimed invention with a reasonable expectation of success and without any surprising results by using the combined teachings of Ono et al., Hossain et al., and Hossain et al. as discussed above.
8A. Claim(s) 13, 15, 17, 20, 22, 25 and 38-42 remain rejected under 35 U.S.C. 103 as being unpatentable over Yue et al. (Journal of Plant Physiology, 169:255-261,2012), Apse et al. (Science, 285:1256-1258, August 1999) and Wang et al. (Scientific Reports, 8:(16585):1-12, 2018), and further in view of Hossain et al. (Plant biotechnology, 23:275-281, 2006, IDS) and Wu et al. (CN102242119, Published November 16, 2011) for the reasons of record stated in the Office action mailed in the papers of July 9, 2025.
Yue et al. teach a method of overexpressing SOS1 salt tolerant gene in a tobacco (a dicot) plant to improve salt tolerance under salt stress conditions. The salt tolerant plants (transgenic) are obtained by transforming plant cells or plants with expression cassette(s) comprising a promoter (heterologous) operably linked to a coding sequence encoding SOS1 salt tolerant protein. The reference further teaches obtaining transgenic seeds (plant part) expressing said SOS1 salt tolerant gene. The reference also teaches that said transformed plant cells are regenerated to obtain transgenic plants transformed with said expression cassette(s). See in particular, abstract, materials and method, figures 1-6, results & discussion, pages 256-260.
Apse et al. teach a method of overexpressing NHX1 salt tolerant gene in Arabidopsis (a dicot) plant to improve salt tolerance under salt stress conditions. The salt tolerant plants (transgenic) are obtained by transforming plant cells or plants with expression cassette(s) comprising a promoter (heterologous) operably linked to a coding sequence encoding NHX1 salt tolerant protein. The reference further teaches obtaining transgenic seeds (plant part) expressing said HKT1 salt tolerant gene. The reference also teaches that said transformed plant cells are regenerated to obtain transgenic plants transformed with said expression cassette(s). See in particular, abstract, figures 1-4, pages 1256-1258
Wang et al. teach a method of overexpressing HKT1 salt tolerant gene in a tobacco (a dicot) plant to improve salt tolerance under salt stress conditions. The salt tolerant plants (transgenic) are obtained by transforming plant cells or plants with expression cassette(s) comprising a promoter (heterologous) operably linked to a coding sequence encoding HKT1 salt tolerant protein. The reference further teaches obtaining transgenic seeds (plant part) expressing said HKT1 salt tolerant gene. The reference also teaches that said transformed plant cells are regenerated to obtain transgenic plants transformed with said expression cassette(s). See in particular, abstract, methods, figures 1-10, table 1, results & discussion, pages 1-10.
Yue et al., Apse et al., or Wang et al. do not teach overexpressing SOS1, NHX1 or HKT1 genes from a root-specific promoter.
Hossain et al. teach root specific overexpression of Na+/H+ antiporter gene in a plant increases its salt tolerance and seed yield under salt stress conditions. Hossain et al. teach a method of overexpressing Na+/H+ antiporter salt tolerant gene in a plants improve salt tolerance under salt stress conditions. The salt tolerant plants (transgenic) are obtained by transforming plant cells or plants with an expression cassette comprising a root-specific promoter (heterologous, adh) operably linked to a coding sequence encoding Na+/H+ antiporter salt tolerant protein. The reference further teaches obtaining transgenic seeds (plant part) expressing said Na+/H+ antiporter salt tolerant protein. The reference also teaches that said transformed plant cells are regenerated to obtain transgenic plants transformed with said expression cassette. See in particular, abstract, Figures 1-5; materials & method (pages 276-277); results (pages 277-279) and discussion (pages 279-280).
Wu et al. teach a method of obtaining stress tolerant plants (rice) by overexpressing exogenous genes encoding stress tolerant protein using a root specific promoter obtained from rice.
Wu et al. teach root specific overexpression of exogenous gene encoding stress tolerant protein in a plant (rice) increases its salt tolerance under salt stress conditions. The transgenic plants are obtained by transforming plant cells or plants with an expression cassette comprising a root-specific promoter (SEQ ID NO: 1 from rice) operably linked to a coding sequence encoding exogenous protein of interest, including the one that imparts salt stress tolerance. The reference further teaches obtaining transgenic seeds (plant part) expressing said protein. The reference also teaches that said transformed plant cells are regenerated to obtain transgenic plants transformed with said expression cassette.
The promoter taught in the reference has TATA box and ERF (ethylene hormone responsive factor) elements that respond to hormone ethylene to regulate expression of said exogenous gene sequence of interest. The complete analysis of cis acting elements (including ERF etc.) of the promoter taught by Wu et al. is attached with the reference. It may be noted that such element(s) are at least 10, 20 nucleotides in length. See in particular, abstract, Tables 1-8; SEQ ID NO: 1, Figures 1-15, claims, and the entire translated document.
Given (a) Yue et al. teach that overexpressing SOS1 protein encoding gene in a plant increases salt tolerance, (b) Apse et al. teach that overexpressing NHX1 protein encoding gene in a plant increases salt tolerance, and (c) Wang et al. . teach that overexpressing HKT1 protein encoding gene in a plant increases salt tolerance, it will be obvious and within the scope of an ordinary skill in the art to have overexpressed previously well characterized SOS1, NHX1 and HKT1 gene products in any economically important monocotyledonous (e.g. rice, wheat etc.) and/or dicotyledonous (soybean, Brassica etc.) plant species for the purpose of obtaining highly salt tolerant or salt resistant transgenic plants.
Given Hossain et al. and Wu et al. teach that overexpressing stress (salt) tolerant genes from a root-specific promoter having enhancers (as taught by Wu et al.) increases salt tolerance or resistance capability in a transgenic plant environment, it would have been obvious and within the scope of an ordinary skill in the art prior to earliest filing date of the claimed invention to have combined the teachings of cited prior art (Yue et al, Apse et al. and Wang et al.) to overexpress multiple salt tolerant genes in the same plant from any promoter, including a root-specific promoter of Hossain et al., and/or Wu et al., as a matter of design choice for the purpose of obtaining salt tolerant or resistant plants that can thrive under very high salt environment without impacting yield or biomass of the plant. Obviously overexpressing previously well characterized salt tolerant genes in a plant as asserted by Yue et al., Apse et al., and Wang et al.) would have been primary motivation to do so without any unexpected or surprising results, and thus arrive at the Applicant’s claimed invention with a reasonable expectation of success.
Thus, the claimed invention as a whole was prima facie obvious over the combined teachings of the prior art.
8B. Applicant’s arguments & Response to Applicant’s arguments:
Applicant traverses the rejection in the papers filed January 9, 2025.
Applicant argues by stating as follows:
“The combined references (i.e., Yue, Apse, Wang, Hossain and Wu) fail to teach or suggest the claimed multigene, root-specific design as claimed. Yue teaches overexpressing SOS1 in tobacco under a heterologous (non-tissue-specific) promoter- and, a single-gene approach. Apse teaches overexpressing NHX1 in Arabidopsis under a heterologous promoter-also single-gene and not tissue-specific. Wang et al. teaches overexpressing HKT1 in tobacco under a heterologous promoter-also a single-gene, without any multi-gene or root-specific control.
Hossain teaches root-specific expression of a single Na+/H' antiporter gene; it neither suggests stacking three different salinity genes nor orchestrating multiple root-specific promoters/enhancers across distinct loci. And Wu discloses one exogenous stress-tolerance gene under a single rice root-specific promoter (with cis elements such as ERF/TATA) but provides no teaching or motivation to engineer the claimed multi-gene system with at least three root-specific regulatory insertions that are operably linked to separate salinity-resistance genes. Even if each reference promotes salt tolerance by single-gene overexpression, the art provides no teaching or reason to construct a plant or plant cell as claimed. The cited references teach single-gene solutions and generic promoters; they do not recognize the need for root-localized control across multiple pathways or suggest that a multiplexed tissue-specific plant would outperform constitutive expression. Further, the "motivation" to constitutively overexpress a known gene does not motivate the specific claimed tissue-localized, multi-gene architecture. Thus, there is no articulated reason-from the art itself-to pursue the specific claimed plant or plant cell. Because the cited art-alone or in combination-does not teach or suggest the claimed coordinated, multi-gene, root-specific design; and because a skilled person would lack motivation and reasonable expectation of success to pursue it the claimed invention is nonobvious.”
Applicant’s arguments are carefully considered but are deemed to be unpersusaive for the following reasons;
1. Alleged “Impermissible Mosaic”
Applicant contends that combining Yue, Apse, and Wang constitutes an impermissible mosaic. This argument is not persuasive. The references are clearly analogous, all directed to improving plant salt tolerance through gene overexpression. Combining teachings from multiple references addressing the same problem is expressly permitted under MPEP §2145(X)(A).
2. Single-Gene References Support Multi-Gene Combination
While each reference discloses a single gene, the art collectively establishes that: (i) SOS1, NHX1, and HKT1 each independently improve salt tolerance; and (ii) Overexpression is a routine and successful strategy. It would have been obvious to combine these genes in a single plant to enhance salt tolerance through multiple known mechanisms. Such aggregation does not require explicit instruction in the prior art (In re Keller, 642 F.2d 413).
3. Root-Specific Expression Is a Predictable Optimization
Hossain and Wu teach that root-specific expression of stress-tolerance genes improves performance and yield. Applying this known strategy to other known salt-tolerance genes represents routine optimization, not invention (see MPEP §2144.05, In re Boesch).
4. Secondary Considerations Are Not Persuasive (MPEP §2141)
No comparative data or Rule 132 declaration has been provided to demonstrate results unexpected relative to the closest prior art. Attorney argument alone is insufficient (see MPEP §716.02). The prior art does not discourage multi-gene approaches or root-specific expression. The fact that prior studies used single genes does not constitute teaching away (see MPEP §2145(VIII)). Applicant has not provided objective evidence that others failed to solve the problem or that the claimed solution achieved commercial or industry recognition.
Accordingly, secondary considerations do not overcome the strong prima facie case of obviousness.
It is thus maintained that: (i) All claim limitations are taught or suggested by the cited references; (ii) The motivation to combine is explicitly supported by the art; (iii) A reasonable expectation of success exists; and No persuasive secondary considerations have been established.
Conclusions
9. Claims 13, 15, 17, 20, 22, 24, 25 and 38-42 remain rejected.
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VINOD KUMAR whose telephone number is (571)272-4445. The examiner can normally be reached on 8:30 am - 5.00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A. Abraham can be reached on (571) 270-7058 The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VINOD KUMAR/Primary Examiner, Art Unit 1663