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 .
Applicant's election with traverse of Group I, claims 1-5 and elect SEQ ID NO:1 in the reply filed on May 26, 2026 is acknowledged. The traversal is on the ground(s) that no additional burden would be experienced by including claims 1-10. This is not found persuasive because there would be a search burden for the different process of making, product made, products and processes.
Claims 6-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 10, 2025 is considered by the examiner.
Priority
The present application filed on date claims benefit of U.S. Provisional Patent Application No. 63/558,768 filed on February 28, 2024.
Status of the Claims
Claims 6-17 are withdrawn; claims 1-5 will be examined on the merits.
Claim Rejections - 35 USC § 112
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 1-5 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Dependent claims are included in this rejection.
Claim 1, line 2, the recitation “stem cells” would refer to plant stem cells and mammal stem cells. The specification teaches Saccharum (sugarcane) plant stem cells in paragraphs [0015]-[0016], for example.
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 1, 4-5 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the term “promotor” in lines 4 and 7. The term “promotor” refers to a person or company that promotes something while the term “promoter” refers to a DNA sequence that initiates gene transcription.
Claim 4 recites the limitation “an amino acid sequence” of SEQ ID NO:6. It is unclear if the claim requires the whole sequence or only a fragment, for example a dimer. The phrase “an amino acid sequence” rather than “the amino acid sequence” encompasses the full length sequence or any portion of SEQ ID NO:6, the specific utility of which is unclear.
Claim 5 recites the limitation “an amino acid sequence” of SEQ ID NO:7. It is unclear if the claim requires the whole sequence or only a fragment, for example a dimer. The phrase “an amino acid sequence” rather than “the amino acid sequence” encompasses the full length sequence or any portion of SEQ ID NO:7, the specific utility of which is unclear.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al in view of Singletary et al (US 2005/0160494 A1), Knappe et al (The Plant Journal, 2003, 36, 411-420), Fettke et al (Trends in Plant Science 2015, Vol. 20, No. 8, 490-497, Frommer (US 2014/0359899 A1) and Troukhan et al (US 2009/0094717 A1).
The phrase “stem cells” will be interpreted as sugarcane stem cells.
The claims are broadly drawn to a construct for increasing fatty acid and/or oil synthesis in sugarcane stem cells comprising sugarcane Tonoplast Sugar Transporter (TST) promoter operably linked to nucleic acid encoding a plastidic phosphoenolypyruvate/phosphate translocator (PPT), where a second sugarcane TST promoter is operably linked to a nucleic acid encoding a tonoplast-localized hexose transporter protein (SWEET16).
Regarding claims 1, 3, Wang et al teach stem-specific promoters of TSTa (pTST2b-1P allele) and TST2b (including pTST2b-1A and pTST2b-1C alleles) in sugarcane (Saccharum spontaneum CP88-1762) and energy cane (S. UFCP 82-1655) (p. 1516 bridging p. 1517). Immature stage of sugarcane showed in Fig. 3a that TST1 and TST2b were expressed in older stem (p. 1520, col. 2, last para.); TST2a was not stem specific; and TST3a was low in the stem (p. 1520, col. 2, 1st full para.) The mature stage of sugarcane was similar to the immature stage of sugarcane (p. 1520, col. 2, 2nd full para.) TSTB2b at IN3 increased from 0.74 to 3.20 resulting in an increase sugar accumulation in mature plants (p. 1520 bridging 1521). Wang et al further teach in younger plant that the TST promoter construct, GUS signals were constitutively present in p35S:GUS plant (p. 1523, col. 2 and Fig. 6b). The GUS signals were mainly found in cortical cells and phloem cells of both pTST2b-1A:GUS and pTST2b-1C:GUS transgenic line (p. 1523, col. 2 and Fig. S4) (claim 3). The TST genes are involved in vacuolar sugar accumulation in Arabidopsis, sugar beet, tomato and apple (p. 1525, col. 1). Wang et al concluded, “Therefore, these promoter could also be used in many other species for stem-specific expression of other target genes unrelated to sugar accumulation (p. 1525, col. 1, 1st full para.)
Wang et al do not teach that the construct where the first TST is operably linked to nucleic acid encoding PPT and a second TST is operably linked to nucleic acid encoding tonoplast-localized hexose protein that are different from each other.
Regarding claim 2, Singletary et al teach alteration of oil traits in plants by modifying the lipid and starch metabolism in plants [0026] where the first promoter is an LTP2 promoter and the second promoter is OLE promoter which are different from each other (Example 6 at [0249]-[0255], patent claim 27). Patent claim 11 describes the first promoter is operably linked to sequence encoding said polypeptide having LEC1 activity and second promoter operably linked to sequence that is capable of inhibiting expression of function of AGP1, AGP2 or combination thereof [0074]. The type of kind of promoter used to drive expression of the operably linked nucleotide sequence is an expression or function of the gene of interest that is increased or inhibited [0086]. The promoter may be selected based on the desired results [0128].
It would have been obvious to combine Singletary et al having a first promoter and a second promoter that is different from the first with Wang et al stem specific promoters, TSTa and TST2b from sugarcane and energy cane for increasing oil in stems. Wang et al states, “A large suite of stem-specific promoters would allow more options for bioengineering and increase the possibility of stacking together a few genes with stem-specific promoter should drive high and specific expression pattern” (p. 1516, col. 2, lines 4-7). The increase in oils in the stem would result in high production of oils for biodiesel and jet fuel (Wang et al p. 1515 bridging p. 1516). Singletary et al teach that any promoter may be utilized as long as it is functional in plant and that the choice of promoter would depend on the desired alteration in oil phenotype [0093]. The person of ordinary skill in the art would have found it obvious to combine these elements because Kinney et al teach that two promoter were operably linked with nucleic acid. The person of ordinary skill in the art would further have predicted that the combination would have increase fatty acid and/or oils in sugarcane stem cells.
Wang et al and Kinney et al do not teach that the first TST is operably linked nucleic acid encoding PPT.
Regarding claim 1(i), Knappe et al teach two functional PPT genes in Arabidopsis.
Wang et al, Kinney et al and Knappe et al do not teach the second TST is operably linked to a nucleic acid encoding a tonoplast-localized hexose transporter protein.
Regarding claim 1(ii), Fettke et al teach tonoplast localized SWEET16 (p. 494, col. 2). The SWEET 16 gene is mainly expressed in vascular tissue but the protein encodes is capable of transporting sucrose, glucose and fructose (p. 494, col. 2).
It would have been obvious to combine Wang et al with Knappe et al because PPT is known in the art and it would have been obvious to combine Wang et al with Knappe et al. In addition, Fettke et al teach SWEET16 which is known in the art. The person of ordinary skill in the art would have found it obvious to combine these together to link the promoter with the protein. Singletary teach that the choice of promoter will depend on the desired alteration in oil. The person of ordinary skill in the art would have further have predicted that the combination would increase fatty acid and/or oil synthesis in sugarcane stem cells because Wang et al teach, “identifying gene promoter that are specific to maturing stem, which can then be fused to the transgene for this enhanced oil synthesis” (p. 1516, col. 1, lines 5-8).
It would have been obvious to one of ordinary skill in the art before the effective filing date, to employ the first sugarcane TST promoter and second sugarcane TST promoter comprising a nucleotide sequence selected from the group of SEQ ID Nos:1-5. Wang et al teach TST2b direct p35SGUS gene expression in Arabidopsis stem. One would have had a reasonable expectation of success given that Wang et al showed oil accumulation in stems of sugarcane and energy cane and that swapping out one promoter for another promoter is routine in the art, commonly practiced by the skilled artisan and merely a design choice. Furthermore, one would expect an even higher production of oil than that obtained using the 35S promoter. A construct for increasing fatty acid and/or oil would provide an alternative source for biofuel.
Wang et al, Singletary et al, Fettke et al and Knappe et al do not teach that the PPT protein has an amino acid sequence of SEQ ID NO:6.
Regarding claim 4, Troukhan et al (US 2009/0094717 A1) teach 100% sequence identity with SEQ ID NO:6 of instant application.
RESULT 1
US-12-286-964-8626
(NOTE: this sequence has 2 duplicates in the database searched.
See complete list at the end of this report)
Sequence 8626, US/12286964
Publication No. US20090094717A1
GENERAL INFORMATION
APPLICANT: Maxim Troukhan
APPLICANT: Peter Mascia
TITLE OF INVENTION: NUCLEOTIDE SEQUENCES AND CORRESPONDING POLYPEPTIDES CONFERRING
TITLE OF INVENTION: MODULATED PLANT CHARACTERISTICS
FILE REFERENCE: 2750-1716PUS2
CURRENT APPLICATION NUMBER: US/12/286,964
CURRENT FILING DATE: 2008-12-01
PRIOR APPLICATION NUMBER: 60/997,507
PRIOR FILING DATE:
PRIOR FILING DATE: 2007-10-03
NUMBER OF SEQ ID NOS: 21783
SEQ ID NO 8626
LENGTH: 397
TYPE: PRT
ORGANISM: Sorghum bicolor
FEATURE:
NAME/KEY: misc_feature
OTHER INFORMATION: Ceres ANNOT ID no. 6091348
FEATURE:
NAME/KEY: misc_feature
LOCATION: (240)..(386)
OTHER INFORMATION: Pfam Id: TPT
Pfam Desc: Triose-phosphate Transporter family
FEATURE:
NAME/KEY: misc_feature
LOCATION: (1)..(396)
OTHER INFORMATION: NCBI GI: 13991929
NCBI Desc: phosphoenolpyruvate/phosphate translocator [oryza
sativa]
FEATURE:
NAME/KEY: misc_feature
LOCATION: (1)..(396)
OTHER INFORMATION: NCBI GI: 1778147
NCBI Desc: phosphate/phosphoenolpyruvate translocator precursor
FEATURE:
NAME/KEY: misc_feature
LOCATION: (1)..(395)
OTHER INFORMATION: NCBI GI: 1778149
NCBI Desc: phosphate/phosphoenolpyruvate translocator precursor
FEATURE:
NAME/KEY: misc_feature
LOCATION: (1)..(396)
OTHER INFORMATION: NCBI GI: 1778143
NCBI Desc: phosphate/phosphoenolpyruvate translocator precursor
FEATURE:
NAME/KEY: misc_feature
LOCATION: (30)..(396)
OTHER INFORMATION: NCBI GI: 1778145
NCBI Desc: phosphate/phosphoenolpyruvate translocator precursor
FEATURE:
NAME/KEY: misc_feature
OTHER INFORMATION: The sequence is a functional homolog of SEQ ID NO. 360 in the
11/188,298 US application
FEATURE:
NAME/KEY: misc_feature
OTHER INFORMATION: The sequence is a functional homolog of SEQ ID NO. 484 in the
11/188,298 US application
Query Match 100.0%; Score 2004; Length 397;
Best Local Similarity 100.0%;
Matches 397; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MQSAAAFRPCPAGAGAGAGQLVSRNPSRGPLLPVPARPLRVVVSAATTRALGLGRLRLSA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MQSAAAFRPCPAGAGAGAGQLVSRNPSRGPLLPVPARPLRVVVSAATTRALGLGRLRLSA 60
Qy 61 SPDDRSGQRQVSCGAAGDAVAAPSAEEGGGFMKTLWLGSLFGLWYLFNIYFNIYNKQVLK 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 SPDDRSGQRQVSCGAAGDAVAAPSAEEGGGFMKTLWLGSLFGLWYLFNIYFNIYNKQVLK 120
Qy 121 VFPYPINITEAQFAVGSVVSLFFWTTGIIKRPKISGAQLAAILPLAIVHTMGNLFTNMSL 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 VFPYPINITEAQFAVGSVVSLFFWTTGIIKRPKISGAQLAAILPLAIVHTMGNLFTNMSL 180
Qy 181 GKVAVSFTHTIKAMEPFFSVLLSAIFLGEFPTVWVVASLLPIVGGVALASLTEASFNWIG 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 GKVAVSFTHTIKAMEPFFSVLLSAIFLGEFPTVWVVASLLPIVGGVALASLTEASFNWIG 240
Qy 241 FWSAMASNVTFQSRNVLSKKLMVKKEESLDNLNLFSIITVMSFFVLAPVTFFTEGVKITP 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 FWSAMASNVTFQSRNVLSKKLMVKKEESLDNLNLFSIITVMSFFVLAPVTFFTEGVKITP 300
Qy 301 TFLQSAGLNVNQVLTRSLLAGLCFHAYQQVSYMILAMVSPVTHSVGNCVKRVVVIVTSVL 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 TFLQSAGLNVNQVLTRSLLAGLCFHAYQQVSYMILAMVSPVTHSVGNCVKRVVVIVTSVL 360
Qy 361 FFRTPVSPINSLGTAIA LAGVFLYSQLKRLKPKPKTP 397
|||||||||||||||||||||||||||||||||||||
Db 361 FFRTPVSPINSLGTAIA LAGVFLYSQLKRLKPKPKTP 397
Wang et al, Singletary et al, Knappe et al, Fettke et al and Troukhan et al do not teach that the tonoplast-localized hexose transporter protein has an amino acid sequence of SEQ ID NO:7.
Regarding claim 5, Frommer teach 100% sequence identity of SEQ ID NO:7 of instant application.
RESULT 1
US-14-363-480-141
(NOTE: this sequence has 2 duplicates in the database searched.
See complete list at the end of this report)
Sequence 141, US/14363480
Publication No. US20140359899A1
GENERAL INFORMATION
APPLICANT: Carnegie Institution of Washington
APPLICANT: Frommer, Wolf
TITLE OF INVENTION: SUCROSE TRANSPORTERS AND METHODS OF GENERATING PATHOGEN-RESISTANT
TITLE OF INVENTION: PLANTS
FILE REFERENCE: 056100-5087-US
CURRENT APPLICATION NUMBER: US/14/363,480
CURRENT FILING DATE: 2014-06-06
PRIOR APPLICATION NUMBER: PCT/US2012/068746
PRIOR FILING DATE: 2012-12-10
PRIOR APPLICATION NUMBER: US 61/568,493
PRIOR FILING DATE: 2011-12-08
NUMBER OF SEQ ID NOS: 180
SEQ ID NO 141
LENGTH: 329
TYPE: PRT
ORGANISM: Sorghum bicolor
Query Match 100.0%; Score 1668; Length 329;
Best Local Similarity 100.0%;
Matches 329; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MTTPSFLVGIAGNVISILVFASPIATFRRIVRNKSTGDFTWLPYVTTLLSTSLWTFYGLL 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MTTPSFLVGIAGNVISILVFASPIATFRRIVRNKSTGDFTWLPYVTTLLSTSLWTFYGLL 60
Qy 61 KPKGLLVVTVNGAGAALEAVYVTLYLVYAPRETKAKMGKLVLAVNVGFLAVVVAVALLAL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 KPKGLLVVTVNGAGAALEAVYVTLYLVYAPRETKAKMGKLVLAVNVGFLAVVVAVALLAL 120
Qy 121 HGGARLDAVGLLCAAITIGMYAAPLGSMRTVVKTRSVEYMPFSLSFFLFLNGGVWSVYSL 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 HGGARLDAVGLLCAAITIGMYAAPLGSMRTVVKTRSVEYMPFSLSFFLFLNGGVWSVYSL 180
Qy 181 LVRDYFIGVPNAVGFVLGTAQLVLYLAFRNKAAERKDDDDEKEAAAAAPSSGDEEEGLAH 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 LVRDYFIGVPNAVGFVLGTAQLVLYLAFRNKAAERKDDDDEKEAAAAAPSSGDEEEGLAH 240
Qy 241 LMGPPQVEMEMTAQQRGRLRLHKGQSLPKPPTGGPLSSSSSSSPHHGFGSIIKSLSATPV 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 LMGPPQVEMEMTAQQRGRLRLHKGQSLPKPPTGGPLSSSSSSSPHHGFGSIIKSLSATPV 300
Qy 301 ELHSVLYQHGLGRGRFEPVKKDDVDATNH 329
|||||||||||||||||||||||||||||
Db 301 ELHSVLYQHGLGRGRFEPVKKDDVDATNH 329
At the time the invention was made, it would have been obvious to one of ordinary skill in the art to combine the teachings of Wang et al, Singletary et al, Knappe et al, Fettke et al, Troukhan et al, Frommer, Troukhan et al to have construct for increasing fatty acid and/or oil synthesis in sugarcane stem cells because Wang et al teach two promoters, TSTa and TST2b from sugarcane. Singletary et at teach a first promoter and second promoter. Knappe et al teach two functional PPT genes in Arabidopsis. Fettke et al teach tonoplast localized SWEET16. Troukhan et al teach SEQ ID NO:6 in the instant application which is well known in the art. Frommer teaches SEQ ID NO:7 in the instant which is well known in the art. One would have been motivated to increase the amount of fatty acid in stem cells for an economically way of producing biofuel in large scale. One would have had a reasonable expectation of success in a construct for increasing fatty acid and/or oil synthesis in sugarcane stem cells because Wang et al teach that mature sugarcane stems showed increase in TST2b. Wang et al further teach that qPCR analysis proved that TSP gene expression levels were at immature and mature stem cells of sugarcane, notably TST1 and TST2b (p. 1516, col. 2, last para.) High production of oil accumulation in stems would provide an alternative way to utilize a way to produce biodiesel and jet fuel.
Thus, the invention, as a whole, would clearly prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Conclusion
Claims 1-5 are not allowed.
Correspondence
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/June Hwu/
Primary Examiner, Art Unit 1661
Prosecution Insights