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 .
Specification
The Specification is objected to because page 1 is missing a reference to the Application(s) to which the instant Application claims priority to. Appropriate correction is required.
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.
Claims 1-4, 8, 14-15, 19, 20, 25, 26, 30, 33, 34, 42, 43, 87, 88 and 132 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.
At claim 1b, “wherein the siRNA sequence increases the likelihood that silencing of the genetic construct will lead to silencing of the plant host factor sequence” is indefinite. The limitation appears to be directed to a desired result but does not set forth the metes and bounds of the siRNA sequence.
Claim 34 is indefinite because a transgenic plant cannot be both in the subfamily Papilionoideae and Poaceae or Malvaceae. Further, Glycine is a genus and not a species. Hence, it is unclear what the metes and bounds of the claim are.
At claim 88, line 3, “a genetic construct according to claim 1” is indefinite, it should read -- the genetic construct --.
Claim 132 is indefinite because the claim is directed to a desired result of the method of claim 88 and does not appear to further limit any element of the method of claim 88. Hence, the metes and bounds of the claim are unclear.
Those claims not specifically addressed are also indefinite because they depend from claim 1.
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 1-4, 8, 14-15, 19, 20, 25, 26, 30, 33, 34, 42, 43, 87, 88 and 132 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 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.
Applicant claims a genetic construct comprising an siRNA sequence, wherein the siRNA sequence increases the likelihood that silencing of the genetic construct will lead to silencing of the plant host factor sequence.
Applicant describes a retrotransposon-based system comprising an siRNA sequence in a host factor gene, fragment thereof or sequence “homologous” thereto (see Fig. 8).
Applicant does not describe the structure of the siRNA sequence other than by a possible function, especially given “increases the likelihood” does not describe a structure/function relationship but a desired outcome.
Hence, it is unclear that Applicant was in possession of the invention as broadly claimed.
See Ex parte Kubin, 83 USPQ2d 1410 (Bd. Pat. App. & Int. 2007) at pg 1417:
[Appellants] … have not described what domains of those sequences are correlated with the required binding to CD48, and thus have not described which of NAIL's amino acids can be varied and still maintain binding. Thus, under Lilly and its progeny, their Specification would not have shown possession of a sufficient number of sequences falling within their potentially large genus to establish possession of their claimed genus. Cf. Enzo, 323 F.3d at 964, 63 USPQ2d at 1612 ("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, 43 USPQ2d at 1406 ("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").
With respect to Appellants’ reliance on hypothetical Example 14 in the Office's Synopsis, "[c]ompliance with the written description requirement is essentially a fact-based inquiry that will ‘necessarily vary depending on the nature of the invention claimed.’" Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991) (quoting In re DiLeone, 436 F.2d 1404, 1405, 168 USPQ 592, 593 (CCPA 1971)), quoted with approval in Enzo, 323 F.3d at 963, 63 USPQ2d at 1612. While the Written Description Guidelines and the hypothetical examples in the Office's Synopsis can be helpful in understanding how to apply the relevant law (as it existed in 2001 when the Guidelines were adopted), they do not create a rigid test.
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) 1-3, 8, 14-16, 19, 20, 25, 26, 33, 34, 42, 43, 87, 88 and 132 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sakai et al (US 2021/0054404).
Sakai et al discloses a genetic construct (a recombinant DNA construct, Para. [0004]) comprising: a) a plant host factor sequence (a recombinant DNA construct comprising the following: ... a second polynucleotide encoding a polynucleotide guided polypeptide, Para. [0004]; the polynucleotide guided polypeptide may be ... Argonaute, Para. [0014]; wherein Argonaute is a host factor sequence, according to Para. [0101] of the instant disclosure) operably linked to a genetic cargo sequence comprising a gene of interest (a recombinant DNA construct comprising the following: ...a second polynucleotide encoding a polynucleotide guided polypeptide, Para. [0004]; the eighth polynucleotide may encode at least one selected from the group consisting of: an herbicide tolerance protein, a pesticidal protein, Para. [0008]; the polynucleotide-guided polypeptide may be ...Argonaute, Para. [0014]; expression cassette for use in transformation (e.g, into an organelle) may be constructed using, for example, a Cry sequence, Para. [0383]); and b) an siRNA sequence (wherein the eighth polynucleotide may encode ...a pesticidal protein ...a siRNA ...and any combination thereof, Para. [0008]). Further, in regards to the limitation relating to "wherein the siRNA sequence increases the likelihood that silencing of the genetic construct will lead to silencing of the plant host factor sequence," a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to distinguish the claimed invention from the prior art. If the prior art is capable of performing the intended use, it meets the claim.
Sakai et al discloses wherein the host factor sequence is a
host factor gene, a fragment thereof, or a sequence homologous thereto (a recombinant DNA construct comprising the following: ...a second polynucleotide encoding a polynucleotide guided polypeptide, Para. [0004]; the polynucleotide-guided polypeptide may be ...Argonaute, Para. [0014] wherein Argonaute is a host factor sequence, according to Para. [0101] of the instant disclosure).
Sakai et al discloses wherein the host factor is involved in host plant fecundity, survival, or gene silencing (a recombinant DNA construct comprising the following: ...a second polynucleotide encoding a polynucleotide guided polypeptide, Para. [0004]; the polynucleotide guided polypeptide may be ...Argonaute, Para. [0014]; wherein Argonaute is gene silencing, see Paras. [0100]-[0101] of the instant disclosure).
Sakai et al discloses wherein the gene of interest is a gene endogenous to the host plant cell (target gene may be endogenous ...to a target cell (e.g., plant), Para. [0303]).
Regarding the limitation in instant claim 14, “wherein increased expression of the gene of interest in the host plant improves a growing parameter, a production parameter, or a biophysical parameter of the host plant," a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to distinguish the claimed invention from the prior art. If the prior art is capable of performing the intended use, it meets the claim.
Sakai et al discloses wherein the genetic cargo comprises genes for the production of a biomolecule (RNA or DNA viral based systems can be used to target specific cells and trafficking the viral payload to an organelle of the cell, Para. [0511]; a nucleotide sequence that has been optimized for increased expression in plants, particularly for increased expression in plants or in one or more plants of interest. Para. [0344]).
Sakai et al discloses wherein the genetic cargo comprises genes for the production of a biomolecule, wherein the biomolecule is a nucleic acid (RNA or DNA viral based systems can be used to target specific cells and trafficking the viral payload to an organelle of the cell, Para. [0511]; a nucleotide sequence that has been optimized for increased expression in plants, particularly for increased expression in plants or in one or more plants of interest. Para. [0344]).
Sakai et al discloses wherein the siRNA sequence is integrated into the host factor sequence (a recombinant DNA construct comprising the following: ...a second polynucleotide encoding a polynucleotide guided polypeptide, Para. [0004]; the ... polynucleotide may encode at least one selected from the group consisting of: an herbicide tolerance protein, a pesticidal protein, Para. [0008]; the polynucleotide-guided polypeptide may be ...Argonaute, Para. [0014]; wherein the eighth polynucleotide may encode ...a pesticidal protein ...a siRNA ...and any combination thereof, Para. [0008]; the site-specific endonuclease system ... is used to introduce one or more heterologous donor polynucleotides encoding a dsRNA, a siRNA, and/or a miRNA, Para. [0698]).
Sakai et al discloses wherein the construct comprises a promoter (the fourth polynucleotide is operably linked to a promoter that is functional, Para. [0004]). Sakai et al discloses wherein the construct comprises a promoter, and wherein the promoter is an inducible promoter, a constitutive promoter, a tissue-specific promoter, or a tissue-preferred promoter (the host/vector system utilized, any of a number of suitable transcription and translation control elements, including constitutive and inducible promoters, Para. [0518]).
Sakai et al discloses a transgenic plant, plant part, or plant cell comprising the genetic construct ("Suppression DNA construct" can be a recombinant DNA construct which when transformed or stably integrated into the genome of the plant, can result in "silencing" of a target gene (e.g., in a plant), disclosure of a transgenic plant also discloses a method of making same. The target gene may be endogenous or transgenic to a target cell (e.g., plant), Para. [0303]).
Sakai et al discloses the transgenic plant, plant part, or plant cell of instant claim 33, wherein the plant, plant part, or plant cell is an agronomic crop plant, plant part, or plant cell ("Suppression DNA construct" can be a recombinant DNA construct which when transformed or stably integrated into the genome of the plant, can result in "silencing" of a target gene (e.g., in a plant). The target gene may be endogenous or transgenic to a target cell (e.g., plant), Para. [0303]; [a]ny plant can be used, including monocot and dicot plants. Examples of monocot plants that can be used include, but are not limited to, corn, Para. [0585]).
Sakai et al discloses a vector comprising the construct (a nucleotide sequence encoding one or more compositions of the disclosure can be a recombinant expression vector, Para. [0506]). Regarding Claim 43, Sakai et al discloses the vector of instant claim 42, wherein the vector is a viral vector ([v]iral vector delivery systems, Para. [0509]).
Sakai et al discloses a method of delivering the genetic construct to a host plant cell ([a] method of delivery can involve contacting a target polynucleotide or introducing into a cell (or a population of cells) one or more nucleic acids comprising nucleotide sequences encoding the compositions of the disclosure. Sakai et al discloses that suitable nucleic acids comprising nucleotide sequences encoding the compositions of the disclosure can include expression vectors, Para. [0506]; enhance gene expression in a plant host, Para. [0345]).
Hence, Sakai et al had previously disclosed the invention as claimed.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 4 and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sakai et al (US 2021/0054404) in view of Chu et al (2021, RNA 27(9): 991-1003) and Bergquist et al (US 2010/0151518).
Applicant claims a genetic construct comprising one or more host factor exon sequences with or without siRNA inclusions. Applicant claims a genetic construct comprises independent promoters that act on each of the host factor sequence and the genetic cargo and wherein the promoters are differentially induced.
Sakai et al teaches a genetic construct (a recombinant DNA construct, Para. [0004]) comprising: a) a plant host factor sequence (a recombinant DNA construct comprising the following: ... a second polynucleotide encoding a polynucleotide guided polypeptide, Para. [0004]; the polynucleotide guided polypeptide may be ... Argonaute, Para. [0014]; wherein Argonaute is a host factor sequence, according to Para. [0101] of the instant disclosure) operably linked to a genetic cargo sequence comprising a gene of interest (a recombinant DNA construct comprising the following: ...a second polynucleotide encoding a polynucleotide guided polypeptide, Para. [0004]; the eighth polynucleotide may encode at least one selected from the group consisting of: an herbicide tolerance protein, a pesticidal protein, Para. [0008]; the polynucleotide-guided polypeptide may be ...Argonaute, Para. [0014]; expression cassette for use in transformation (e.g, into an organelle) may be constructed using, for example, a Cry sequence, Para. [0383]); and b) an siRNA sequence (wherein the eighth polynucleotide may encode ...a pesticidal protein ...a siRNA ...and any combination thereof, Para. [0008]). Further, in regards to the limitation relating to "wherein the siRNA sequence increases the likelihood that silencing of the genetic construct will lead to silencing of the plant host factor sequence," a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to distinguish the claimed invention from the prior art. If the prior art is capable of performing the intended use, it meets the claim.
Sakai et al does not explicitly teach further comprising one or more host factor exon sequences at a 5' and/or 3' UTR with or without siRNA inclusions to direct silencing. Sakai et al does not explicitly teach wherein the promoters are differentially induced.
Chu is in the field of Argonaute binding (Abstract) and teaches teaches further comprising one or more host factor exon sequences at a 5' and/or 3' UTR with or without siRNA inclusions to direct silencing ([t]he miRNA:AGO complex is generally assumed to recognize sequences within the 3′ -untranslated region (3′-UTR) of genes through complementary binding to a “seed sequence” at bases 2–8 of the miRNA, leading to repression of translation, Pg. 991, left-hand column, second paragraph, and right-hand column, first paragraph; exon > 3′ -UTR > 5′ UTR, Pg. 1001, right-hand column, bottom of page).
Bergquist is in the field of vectors (Title) and teaches promoters are differentially induced (subunits are operably linked to a first promoter and the beta subunit is operably linked to a second promoter, and wherein the first and second promoters are differentially induced, Para. [0011]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant claims to modify the teachings of Sakai et al using the teachings of either Chu et al or Bergquist et al. It would have been obvious to one of ordinary skill in the art before the priority date to modify Sakai et al with the teaching of Chu for the purpose of developing a regulatory mechanism that becomes important at critical points during development, response to environment change, or disease pathogenesis ((Chu, Pg. 1000, left-hand column, fourth paragraph). In addition, it would have been obvious to one of ordinary skill in the art before the priority date to modify Sakai et al with the teaching of Bergquist for the purpose of allowing expression from each promoter to be controlled independently of the other (Bergquist, Para. [0058]). The differences between the instantly rejected claims and the teachings of Sakai et al would have been obvious modifications of a well-established art (genetic construct) said modifications producing predictable results. The differences would have been a design choice by one of ordinary skill in the instant art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID H KRUSE whose telephone number is (571) 272-0799. The examiner can normally be reached Monday-Friday 7AM-3:30PM.
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/David H Kruse/
Primary Examiner, Art Unit 1663
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