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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR
1.17(e), was filed in this application after final rejection. Since this application is eligible for continued
examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the
finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's
submission filed on 07/11/2025 has been entered.
Examiner invites the applicant to call and schedule an interview at applicant’s convenience.
Priority
Acknowledgement is made of applicant’s claim for benefit under 35 U.S.C. 119(e). As such, the
effective filing date of Claims 1-20 and 23-24 is 10/17/2019.
Status of the Claims
Amendments dated 07/11/2025 have been entered.
Claims 21-22 and 25-37 are cancelled.
Claims 1-20 and 23-24 are pending.
Claims 1-19 and 24 are withdrawn from consideration as being directed to a non-elected invention.
Claims 20 and 23 are examined herein.
The rejections to Claims 20 and 22-23 under 35 U.S.C. 103 as being unpatentable over Virgili-Lopez et al. (Int. J. Mol. Sci. 2013, 14 (7), 13241-13265; IDS document dated 24 October 2023) in view of Parks et al. (US 20190040411 A1, published 02/07/2019), GenBank Accession XP_028207014.1 (dated 03/12/2019), and Froehlich et al. (The Plant Journal 68.5 (2011): 844-856; IDS Document dated 24 October 2023) have been withdrawn in view of Applicant’s remarks in the reply filed 07/11/2025 and Applicant’s cancellation of Claim 22.
Claim Interpretation
Claim 20 recites, in part, “a MeSH DNA sequence”, which is defined in the specification to be “…membrane-specific hydrophobic "MeSH targeting sequences" or interchangeably "MeSH Sequences" wherein MeSH targeting sequences are protein sequences that target a protein encoded by a N-transgene ("N-protein") to an Anchor Membrane.” (Specification, pg. 2, lines 13-16) Per the definition disclosed by Applicant, the broadest reasonable interpretation of “MeSH DNA sequences” encompasses DNA sequences that encode hydrophobic transmembrane domains (TMDs) capable of anchoring target genes of interest to plant cell membranes. For clarity of the record, plant cell membranes included in the scope of the claimed invention are the chloroplast outer membrane, chloroplast inner membrane, chloroplast thylakoid membrane, mitochondrial outer membrane, mitochondrial inner membrane, peroxisome membrane, plasma membrane, nuclear membrane, pre-lytic vacuolar membrane, protein storage vacuolar membrane, endosome membrane, vesicle membrane, cell wall, ER membrane and Golgi membrane (Specification, pg. 1, lines 24-28).
Claim Rejections - 35 USC § 112
Indefiniteness
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 20 and 23 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 20 recites the term “N-transgene” which renders the claim indefinite. The term “N-transgene” does not carry an art-recognized meaning and is not defined by the specification or the claims in such a way that one of ordinary skill in the art would be able to recognize the metes and bounds of the claimed invention. Since the term “N-transgene” is not known in the art, the use of said term does not carry an art-recognized limitation as to the specific characteristics associated with the transgenes that are included in the broad genus of “N-transgenes”. Additionally, when looking at Claim 20, Applicant narrows the claimed genus of “N-transgenes” to include all MTX, YVGO, or Monalysin transgenes known in the art. However, without a clear definition of the term “N-transgene” it is not clear if all MTX, all YVGO, or all Monalysin genes known in the art would be considered N-transgenes in the scope of the instant invention. As such, one of ordinary skill in the art would not be able to recognize the metes and bounds of the claimed invention.
Claim 23 depends from Claim 20 and is therefore rejected for the same reasons as given above.
Closest Prior Art
Claims 20 and 23 appear to be free of the prior art.
The closest prior art in regards to Claims 20 and 23 can be found in Virgili-Lopez et al. (Int. J. Mol. Sci. 2013, 14 (7), 13241-13265; IDS document dated 24 October 2023) in view of Parks et al. (US 20190040411 A1, published 02/07/2019), GenBank Accession XP_028207014.1 (dated 03/12/2019), and Froehlich et al. (The Plant Journal 68.5 (2011): 844-856; IDS Document dated 24 October 2023).
Regarding Claims 20 and 23, Virgili-Lopez et al. (herein referred to as Virgili-Lopez) teaches a method of accumulating higher amount of a target protein in transgenic plants, and more specifically an expression cassette comprising a hydrophobic transmembrane domain DNA sequence (MeSH DNA, See Claim Interpretation) (pgs. 13243-44, bridging paragraph) and a CaMV 35S promoter (pg. 13245, first paragraph) operably linked to a DNA sequence encoding a target protein of interest, wherein the expression cassette was expressed in a plant cell (Nicotiana tabacum) (pg. 13258, last paragraph). Virgili-Lopez teaches that the transmembrane domain within the expression cassette anchors the DNA sequence encoding a target protein of interest to the plant endoplasmic reticulum membrane (Anchoring Membrane), where the target DNA sequence was expressed, resulting in a large accumulation of target protein polymers encoded by the target DNA sequence in the ER lumen (Abstract; Figure 1; Figure 3). Virgili-Lopez teaches that targeting to the ER membrane results in relatively high stability and accumulation when compared to anchoring to other endomembrane. Virgili-Lopez also teaches that the methods of the present invention and the plant expression cassette introduced to the ER membrane of the plant cell are safe environment for the accumulation of many foreign proteins, avoids luminal post-translational modifications that occur downstream the ER along the secretory pathway, allows folding of cytosolic proteins in their native environment and at the same time escape proteasomal degradation, and is not limited to the model protein used in the present invention (pg. 13261, Conclusions).
The “DNA sequence encoding a target protein of interest” (HIV p24) that is comprised within the plant expression cassette taught by Virgili-Lopez is explicitly described as a model protein that is merely used in the methods of Virgili-Lopez as proof of concept to compare in vivo stability and final accumulation level of a foreign recombinant protein expressed in transgenic tobacco, by exploiting different membrane-anchoring strategies that lead to various localizations within the endomembrane system (pg. 13261, Conclusions). This disclosure puts one of ordinary skill in the art on notice that if a skilled artisan wanted to implement the method of Virgili-Lopez, the HIV p24 model protein is a replaceable/substitutable composition in the methods of Virgili-Lopez, wherein the model protein could be replaced with any known foreign gene of interest. However, Virgili-Lopez does not teach an embodiment of the invention where this is the case, much less an embodiment of the invention wherein the protein of interest is a pesticidal transgene.
Regarding Claim 20, Parks et al. (herein referred to as Parks) teaches DNA construct comprising a promoter that drives expression in a plant cell operably linked to a recombinant nucleic acid molecule comprising (a) a nucleotide sequence that encodes a polypeptide comprising an amino acid sequence, wherein several of the SEQ IDs listed are drawn to MTX pesticidal transgenes (Claim 10, Table 1, pgs. 3-76; SEQ ID NO: 3, 5, 6, 11, 13, 18, 19, 22, 29, 33, 42, 45, 47, 49, 54, 55, 57, 59, 63, 64, 66, 70, 73, 76, 77, 86, 88, 93, 95, 97, 101, 105, 108, 110, 112, 114, 115, 117, 126, 128, 129, 132, 133, 136, 139, 144, 146, 148, 149, 151, 153, 158, 161, 167, 170, 172, 174, 175, 182, 183, 194, 196, 201, 202, 211, 214, 219, 222, 227, 229, 235, 243, 251, 265, 272, 282, 285, 290, 291, 294, 304, 306, 310, 312, 314, 316, 320, 328, 329, 335, 337, 340, 342, 348, 350, 358, 360, 365, 367, 369, 378, 380, 382, and 384). Parks also teaches that the DNA construct is comprised within a vector (Claim 10), wherein a host cell contains the vector (Claim 13), and the host cell is a plant cell (Claim 14). Parks also teaches the integration of said vector into a host plant cell for a method of protecting a plant from an insect pest (Claim 21).
However, Virgili-Lopez and Parks do not teach the feature of Claim 20, wherein the MeSH DNA sequence encodes a protein comprising any one of SEQ ID NOs: 1, 3-83 or 288.
Regarding Claim 20, GenBank Accession XP_028207014.1 (dated 03/12/2019) teaches an STN8 serine/threonine-protein kinase transmembrane protein derived from Glycine soja that has 100% sequence identity and 100% query coverage relative to instant SEQ ID NO: 288.
Regarding Claim 20, Froehlich et al. (herein referred to as Froehlich) teaches that STN8 transmembrane proteins play a critical role in targeting integral membrane proteins to the thylakoid membrane (pg. 851, Table 6; STN8-WT), wherein STN8 localizes solely to the thylakoid fraction (pg. 852, left column, lines 1-2). Froehlich also teaches that different functional transmembrane proteins comprising a TMD domain can be substituted into expression cassettes to target different plant cell membranes [See Arc6 being expressed with 4 different transmembrane proteins in Table 6 (a)-(d) that localize to different plant cell membranes], and using the STN8 transmembrane protein to target protein accumulation in the thylakoid membrane is routine and well known in the art, with a reasonable expectation of success [pg. 851, See Table 6(c) where STN8 is stably expressed in the thylakoid membrane].
However, the combination of Virgili-Lopez et al. (Int. J. Mol. Sci. 2013, 14 (7), 13241-13265; IDS document dated 24 October 2023) in view of Parks et al. (US 20190040411 A1, published 02/07/2019), GenBank Accession XP_028207014.1 (dated 03/12/2019), and Froehlich et al. (The Plant Journal 68.5 (2011): 844-856; IDS Document dated 24 October 2023) does not teach or provide any motivation for transforming a plant with a DNA sequence that directs an expressed pesticidal N-transgene protein, nor does Virgili-Lopez teach SEQ ID NOs: 1, 3-83 or 288. Additionally, when reading Virgili-Lopez, one skilled in the art would not make the leap that a pesticidal N-transgene could be contemplated in Virgili-Lopez.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KELSEY L. MCWILLIAMS whose telephone number is (703)756-4704. The examiner can normally be reached M-F 08:00-17:30.
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/KELSEY L MCWILLIAMS/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663