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
Applicant’s amendments to claims 1, 4, 7-10,12,13 and 15-17 as well as cancellation of claims 19-20 in the reply filed on 11/13/2025 are acknowledged.
Claims 1-18 and SEQ ID NO:17 and 18 are examined on the merits.
2. The rejections and objections not recited in this action are withdrawn.
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.
3. Claims 2-3, 5-13 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.
In claims 2 and 10, the recitations “standard irrigation conditions”, “standard growth density conditions” and “standard salinity conditions” render the claims indefinite. It is unclear what is condition is considered as a standard condition. The metes and bounds are not clear.
In claim 5, the recitation “substantially similar photosynthetic efficiency” renders the claim indefinite. It is unclear what is considered to have substantially similar photosynthetic efficiency. The metes and bounds are not clear.
Applicants traverse in the paper filed 11/13/2025. Applicants’ arguments have been fully considered but were not found persuasive.
Applicants argue that it is not possible to recite specific numbers or even ranges given that each crop has its own requirement for irrigation conditions, growth density and soil salinity (response, page 8).
The Office contends that applicant’s argument is irrelevant. The fact that each crop may has its own requirement does not provide exemption to meet the requirement under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
Applicants further argue that a person of skill in the art who has several years of experience cultivating the crop of interest would be able to decide what irrigation conditions, growth density condition and soil salinity condition are for plants they grow (response, page 8).
The Office contends that individual person of skill in the art with several years of experience could come with different conclusions as to what the conditions should be as those decisions are subjective.
Written Description
4. Claims 1-18 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.
The claims are broadly drawn to a genetically altered plant with increased water use efficiency comprising one or more of the genetic alterations increase activity of Photosystem II Subunit S (PsbS) protein as compared to wild type (WT) that doesn’t have the alterations, and wherein the increased activity of the protein increases water use efficiency and wherein the genetically altered plant produced by introducing the genetical alteration to the plant cell, regenerating the plant cell into a genetically altered plantlet, growing the plantlet into the plant and selecting the genetically altered plant for increased water use efficiency; or does not increase ZEP/VDE protein as compared to the WT grown under the same conditions. However, the claims and the specification do not define or describe what is considered a wild type plant with respect to a PsbS protein, therefore an altered plant is also not described.
The specification only discloses tobacco plants that overexpress the PsbS of SEQ ID No: 17 or 18 to produce plants with increased water use efficiency, yet the claims are broadly drawn to a plant of any species that has any one or more genetic alterations that result in the increase in activity of PsbS and increases water use efficiency. The claims encompass the cultivation of a large genus of plants of any species and having unspecified alterations that result in an increase in PsbS activity and an increase in water use efficiency, yet only two species have been provided in the form of tobacco plants transformed with SEQ ID NO: 17 or 18. Still further, even for tobacco plant, the claimed genus is still not described. Further, the specification does not teach other ways to up-regulate activity of PsbS except for overexpressing the PsbS gene of SEQ ID No: 17 or 18. However, genes can be regulated in many other ways that are not described by the specification. For example, over-expression of a gene can be achieved by down-regulating the negative regulators of the gene. Likewise, up-regulation of a gene can also be achieved by up-regulating the positive regulators of the gene. The transcriptional factors could be among those regulators. Neither the specification or the prior art teaches other regulators for expression of PsbS gene even for tobacco, needless to say for any other plant species. The specification failed to correlates genetic structure to the function (i.e increased activity of PsbS gene, water use efficiency and/or without increased ZEP/VDE protein activity.
Further still, even for overexpression of PsbS gene, neither the specification or the prior art teaches PsbS gene that is at least 70% identical to SEQ ID NO:17/18. The specification fails to correlated conserved structure shared among the genus of proteins to the PsbS function.
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. Further, the court held that to adequately describe a claimed genus, Patent Owner must describe a representative number of species of the claimed genus, and that one of skill in the art should be able to “visualize or recognize the identity of the members of the genus”. Id.
See MPEP Section 2163, where it is taught that
[T]he claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function. A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.
Also, see Vas-Cath Inc. v. Mahurkar 1991 (CAFC) 19 USPQ2d 1111, 1115, which teaches that the purpose of written description is for the purpose of warning an innocent purchaser, or other person using a machine, of his infringement of the patent and at the same time, of taking from the inventor the means of practicing upon the credulity or the fears of other persons, by pretending that his invention is more than what it really is, or different from ostensible objects, that the patentee is required to distinguish his invention in his specification.
Therefore, given the lack of written description in the specification with regard to the structural and physical characteristics of the claimed compositions, one skilled in the art would not have been in possession of the genus claimed at the time this application was filed.
Applicants traverse in the paper filed 11/13/2025. Applicants’ arguments have been fully considered but were not found persuasive.
Applicants argue that the specification has demonstrated strong, linear correlation between expression of PsbS and enhanced water use efficiency such that one of skill in the art could readily follow to practice the invention in a wide range of crops (response, page 12).
The Office contends that a modified plant with increased expression of PsbS is not adequately described for the reason stated in the rejection. Particularly, it is well known in the art that genes can be regulated in many other ways that are not described by the specification. For example, over-expression of a gene can be achieved by down-regulating the negative regulators of the gene. Likewise, up-regulation of a gene can also be achieved by up-regulating the positive regulators of the gene. The transcriptional factors could be among those regulators. Neither the specification or the prior art teaches other regulators for expression of PsbS gene even for tobacco, needless to say for any other plant species. The specification failed to correlates genetic structure to the function (i.e increased activity of PsbS gene, water use efficiency and/or without increased ZEP/VDE protein activity.
Applicants argue that in view of the known and conserved function of PsbS and extensive disclosure in the specification regarding PsbS sequences, one of skill in the art recognize that the inventor had possession of the claimed invention (response, page 12).
The Office contends that the variants of SEQ ID NO:17/18 are not adequately described in that specification fails to correlated conserved structure shared among the genus of proteins to the PsbS function.
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) 1-11, 14-16 remain rejected under 35 U.S.C. 102(a)1) as being anticipated by Hieber et al (2004, Plant Cell Physiol 45(1): 92-102 in IDS) in evidence of Genbank Accession No. OAP16209 (2016).
. The claims are drawn to a genetically altered plant with increased water use efficiency comprising providing a plant with genetic alteration wherein the genetic alteration increases activity of Photosystem II Subunit S (PsbS) protein as compared to wild type (WT) that doesn’t have the alterations, and the altered plant shows increased water use efficiency and biomass as compared to the WT grown under the same conditions and wherein the genetically altered plant produced by introducing the genetical alteration to the plant cell, regenerating the plant cell into a genetically altered plantlet, growing the plantlet into the plant and selecting the genetically altered plant for increased water use efficiency; wherein the condition is lower irrigation conditions than standard irrigation condition; or wherein increased PsbS activity provides the genetically altered plant with higher yield; or wherein there is no increase in VDE protein, and there is not reduced KEA3 as compared to a wild type plant; or wherein the increased activity is increased expression; or wherein the increased expression is due to expression of a heterologous PsbS protein; or wherein the nucleic acid sequence encoding the PsbS protein is operably linked to a promoter such as CaMV35S promoter and stably integrated into the genome of the plant; or the heterologous PsbS protein comprises a protein with at least 70% identity to SEQ ID NO:17 or 18; or wherein the heterologous PsbS protein comprises a glutamate at positions 149 and 255 of SEQ ID NO:21; or wherein the PsbS protein is localized to a thylakoid membrane of a chloroplast.
Hieber et al teach a method comprising transforming a tobacco plant with a Arabidopsis PsbS coding sequence operably linked to a 35S promoter, wherein there is not an increase in VDE protein (page 94, Fig. 2). Hieber et al teach no significant difference between PsbS overexpressing plant and wild type (page 95, Table 1) for photochemical parameters. Arabidopsis PsbS protein is at least 71% identical to instant SEQ ID NO:17(see alignment below). The stable transgenic plant of Hieber et al. would inherently comprise Arabidopsis PsbS coding sequence operably linked to a 35S promoter integrated into the genome. The Arabidopsis PsbS protein also contains a glutamate at positions 149 and 255 of SEQ ID NO:21.
Although Hieber et al do not teach an increase in water use efficiency as shown under the condition is lower irrigation conditions than standard irrigation condition in the plant such feature would have been inherently exhibited by the transgenic tobacco plant of Hieber et al. Although Hieber et al do not teach the PsbS protein is localized to a thylakoid membrane of a chloroplast, those features would have been inherently exhibited by the heterologous expressed Arabidopsis PsbS protein of Hieber et al.
Genbank Accession No. OAP16209 vs. SEQ ID NO:17
Sequence ID: Query_2695945Length: 274Number of Matches: 1
Range 1: 1 to 274GraphicsNext MatchPrevious Match
Alignment statistics for match #1
Score
Expect
Method
Identities
Positives
Gaps
307 bits(787)
2e-110
Compositional matrix adjust.
197/276(71%)
214/276(77%)
14/276(5%)
Query 1 MAQTMLLTSGVTAGHFLRNKSPLAQ---PKVHHLFLSGNSPVALPSRRQSFVP------L 51
MAQTMLLT+ LRNK PL + PK F + P+ PS S +
Sbjct 1 MAQTMLLTANAKVD--LRNKEPLVERLKPKPLSSFFLPSLPLKYPSASSSSSSHFTSTTV 58
Query 52 ALFKPKTKAAPKKVEKPKSKVE-DGIFGTSGGIGFTKANELFVGRVAMIGFAASLLGEAL 110
ALFK K KA KKV + DGIFGTSGGIGFTK NELFVGRVAMIGFAASLLGEA+
Sbjct 59 ALFKSKAKAPAKKVVPKPKEKVEDGIFGTSGGIGFTKQNELFVGRVAMIGFAASLLGEAI 118
Query 111 TGKGILAQLNLETGIPIYEAEPLLLFFILFTLLGAIGALGDRGKFVDD--PPTGLEKAVI 168
TGKGILAQLNLETGIPIYEAEPLLLFFILF LLGAIGALGDRGKF+DD P TGL+KAVI
Sbjct 119 TGKGILAQLNLETGIPIYEAEPLLLFFILFNLLGAIGALGDRGKFIDDPVPATGLDKAVI 178
Query 169 PPGKNVRSALGLKEQGPLFGFTKANELFVGRLAQLGIAFSLIGEIITGKGALAQLNIETG 228
PPGK +SALGL E GPLFGFTKANELFVGRLAQLGIAFS+IGEIITGKGALAQLN ETG
Sbjct 179 PPGKGFKSALGLSEGGPLFGFTKANELFVGRLAQLGIAFSIIGEIITGKGALAQLNFETG 238
Query 229 IPIQDIEPLVLLNVAFFFFAAINPGNGKFITDDGEE 264
+PI +IEPL+L N+ FFF AAINPG GKF+TD+ EE
Sbjct 239 VPINEIEPLLLFNIVFFFVAAINPGTGKFVTDEEEE 274
Applicants traverse in the paper filed 11/13/2025. Applicants’ arguments have been fully considered but were not found persuasive.
Applicants argue that Hieber does not teach the genetically altered plant produced by introducing the genetical alteration to the plant cell, regenerating the plant cell into a genetically altered plantlet, growing the plantlet into the plant and selecting the genetically altered plant for increased water use efficiency (response, page 14).
The Office contends that Hieber are not required to use the same method to produce the modified plant as claimed as long as they share the same genetical structure. Applicants are reminded that instant claims are directed to product rather than a method.
Applicants argue that the office does not provide rationale to explain why the limitation for increased water use efficiency, let along the limitation for increased biomass, as recited would necessarily flow from Hieber (response, page 15).
The Office contends that the plant of Hieber comprises the same genetical structure as that claimed, therefore without additional unrecited limitations to further define the claimed plant, the plant of Hieber would inherently exhibit the features such as increased water use efficiency and increased biomass possessed by instant claims.
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 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 1-18 remain rejected under 35 U.S.C. 103 as being unpatentable over Hieber et al (Plant Cell Physiol 45(1): 92-102 in IDS) further in view of Genbank Accession No. OAP16209 (2016).
Claims 1-11 and 14-16 are discussed above.
The claims 12-13 and 17-18 further contain limitations that wherein increased expression is due to overexpression of an endogenous PsbS protein; or wherein the plant part is a leaf; or the plant is not a tobacco plant; or the tissue culture produced from the protoplast or cells from the genetically altered plant wherein the protoplast or cell are produced from a plant part such as leaf and wherein the genetically altered tissue culture includes the genetic alteration; or wherein the overexpression is achieved by gene editing technique such as CRISPR/Cas.
The teachings of Hieber et al. are discussed above.
Hieber et al do not teach that wherein increased expression is due to overexpression of an endogenous PsbS protein; or wherein overexpression of the endogenous PsbS protein was achieved using a gene editing technique such as CRISPR/Cas to introduce more or more genetic alteration that increase the activity; or wherein the plant part is a leaf; or the plant is not a tobacco plant; or the tissue culture produced from the protoplast or cells from the genetically altered plant wherein the protoplast or cell are produced from a plant part such as leaf and wherein the genetically altered tissue culture includes the genetic alteration.
Although Hieber et al do not teach tissue culture per se, such tissue culture would obviously produced from the transgenic plant cell such as leaf of Hieber et al. for further transformation application. The regenerated plant would also have been obvious produced from the tissue culture to obtain transgenic plant with additional transgene.
Given the recognition of those of ordinary skill in the art of the value of transforming a tobacco plant with a PsbS coding sequence, it would have been obvious to transform other plant species such as Arabidoposis. to confirm the result of Hieber et al. The modified method would result in a transgenic Arabidopsis plant overexpression it endogenous PsbS gene. Although Hieber et al do not teach overexpression of the endogenous PsbS protein was achieved using a gene editing technique such as CRISPR/Cas to introduce more or more genetic alteration that increase the activity, as gene modification method is well known in the art and thus is merely regarded as a obvious design choice. Thus, the claimed invention would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art, especially in the absence of evidence to the contrary.
Applicants traverse in the paper filed 11/13/2025. Applicants’ arguments have been fully considered but were not found persuasive.
Applicants present similar argument as above. Therefore for the reason as discussed above, the rejection is maintained.
RESULT 1
AZO31782
(NOTE: this sequence has 4 duplicates in the database searched.
See complete list at the end of this report)
ID AZO31782 standard; protein; 277 AA.
XX
AC AZO31782;
XX
DT 08-DEC-2011 (first entry)
XX
DE Agronomic trait enhancing protein homolog SEQ:11689.
XX
KW agriculture; cold tolerance; crop improvement; plant; plant breeding;
KW transgenic plant; BOND_PC; chloroplast photosystem II 22 kDa component;
KW GO9765; GO16020.
XX
OS Nicotiana benthamiana.
OS xx.
XX
CC PN US2011252501-A1.
XX
CC PD 13-OCT-2011.
XX
CC PF 17-AUG-2007; 2007US-00893915.
XX
PR 17-AUG-2006; 2006US-0838415P.
XX
CC PA (MONS ) MONSANTO TECHNOLOGY LLC.
XX
CC PI Abad M, Deng M, Duff S, Fernandes M, Gabbert KK, Alvarez JA;
CC PI Bennett KA, Castiglioni P, Deikman J, Fenner J, Ke D, Goldman BS;
CC PI Qi Q, Ruff TG, Thompason-Mize RL, Wu J, Adams TR, Bensen R;
CC PI Heard JE, Nelson DE, Bell E, Cerny RE, Chittoor-Vijayanath JM;
CC PI Fabbri BJ, Karunanandaa B, Ledeaux JR, Chen X, Galligan-Donnarummo M;
CC PI Hawkins DJ, Lee GJ, Patty O, Sanders RA, Savidge B, Val DL;
CC PI Zheng W, Savage TJ, Somaiah RM, Suma S, Sun J, Venkatesh T, Xu N;
CC PI Anuradha M, Augustine AC, Deeba F, Dhanalakshmi R, Madappa S;
CC PI Pranesh BS, Rajani MS, Ramamohan G, Sangeetha S, Shobha C;
CC PI Sudarshana P, Vidva KR, Venkatachalayya S;
XX
DR WPI; 2011-M86186/69.
DR PC:NCBI; gi84620804.
XX
CC PT New plant cell nucleus with stably integrated, recombinant DNA, useful
CC PT for developing transgenic plants with enhanced traits, e.g. enhanced cold
CC PT and heat tolerance, enhanced resistance to salt exposure, and enhanced
CC PT shade tolerance.
XX
CC PS Example 6; SEQ ID NO 11689; 70pp; English.
XX
CC The present invention relates to transgenic plant cells with recombinant
CC DNA for expression of proteins that are useful for imparting enhanced
CC agronomic trait(s) to transgenic crop plants and seeds. The recombinant
CC DNA comprises a promoter which is operably linked to a DNA encoding a
CC protein which comprises a Pfam domain module. The enhanced agronomic
CC trait of the transgenic crop plants are selected from: enhanced water use
CC efficiency, enhanced cold tolerance, increased yield, enhanced nitrogen
CC use efficiency, enhanced seed protein and enhanced seed oil. The present
CC sequence represents a recombinant DNA encoding protein homolog used for
CC production of transgenic plants with enhanced agronomic trait as
CC described in the invention.
CC
CC Revised record issued on 29-NOV-2011 : Enhanced with precomputed
CC information from BOND.
XX
SQ Sequence 277 AA;
Query Match 100.0%; Score 1380; Length 277;
Best Local Similarity 100.0%;
Matches 277; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MAQTMLLTANAKVDLRSKESLVERLKPKPLSSFFLPSLSLKYPSASSSSSSSSSHFTSTT 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MAQTMLLTANAKVDLRSKESLVERLKPKPLSSFFLPSLSLKYPSASSSSSSSSSHFTSTT 60
Qy 61 VALFKSKAKAPAKKVVPKPKEKVEDGIFGTSGGIGFTKQNELFVGRVAMIGFAASLLGEA 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 VALFKSKAKAPAKKVVPKPKEKVEDGIFGTSGGIGFTKQNELFVGRVAMIGFAASLLGEA 120
Qy 121 ITGKGILAQLNLETGIPIYEAEPLLLFFILFNLLGAIGALGDRGKFIDDPTPPTGLDKAV 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 ITGKGILAQLNLETGIPIYEAEPLLLFFILFNLLGAIGALGDRGKFIDDPTPPTGLDKAV 180
Qy 181 IPPGKGFKSALGLSEGGPLFGFTKANELFVGRLAQLGIAFSIIGEIITGKGALAQLNFET 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 IPPGKGFKSALGLSEGGPLFGFTKANELFVGRLAQLGIAFSIIGEIITGKGALAQLNFET 240
Qy 241 GVPINEIEPLLLFNIVFFFVAAINPGTGKFVTDEEEE 277
|||||||||||||||||||||||||||||||||||||
Db 241 GVPINEIEPLLLFNIVFFFVAAINPGTGKFVTDEEEE 277
Summary
Claims 1-18 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.Any inquiry concerning this communication or earlier communications from the examiner should be directed to LI ZHENG whose telephone number is (571)272-8031. The examiner can normally be reached Monday-Friday (9-5).
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 on 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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/LI ZHENG/Primary Examiner, Art Unit 1662
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