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 . The present application was filed on 09/18/2024.
Priority
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d) to application CN2024101119100 filed in PEOPLE'S REPUBLIC OF CHINA on 01/26/2024. However, the present application does not yet satisfy the formal requirements to establish entitlement to the benefit of the earlier foreign filing date. Specifically, the following items are required under 37 CFR 1.55 and MPEP § 214:
Certified Copy English Translation of Foreign Application: A certified copy of the foreign application (specification and drawings) upon which the priority claim is based must be submitted. If the foreign application is not in the English language, a verified English translation must also be provided.
Status of the Claims
Claims 1-6 are pending.
Claims 1-6 are examined herein.
Information Disclosure Statement
Acknowledgment is made of the information disclosure statement (IDS) submitted on 10/04/2024.
Specification
Sequence compliance
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 because sequences are set forth in the specification and drawings that lack sequence identifiers.
Any response to this office action that fails to meet all of these requirements will be considered non-responsive. The nature of the noncompliance with the requirements of 37 C.F. R. 1.821 through 1.825 did not preclude the examination of the application on the merits, the results of which are communicated below.
Nucleotide and/or Amino Acid Sequence Disclosures
Specific deficiency - Sequences appearing in the specification (page 7-8, paragraphs 0041, 0046) are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like) in accordance with 37 CFR 1.831(c).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
• A new sequence listing file.
Claim Objections
Claim 1 is objected to because of the following informalities:
In line 1, the incorrectly stated name of "Aromatica roxburghii" instead of "Anoectochilus roxburghii".
Appropriate correction is required.
Claim 5 is objected to because of the following informalities:
"promoting a reproductive growth" instead of "promoting reproductive growth"
"improving a seed vitality" instead of "improving seed vitality"
Claim 6 is objected to because of the following:
claim 6 is a methods claim, it must have positive, active steps. “Construction”, “transformation”, “cultivation”, and “a screening” are not positive, active steps.
Additionally, the claim sets forth a plurality of steps, yet each step of the claim is not separated by a line indentation, as it should (37 CFR 1.75(i)).
Appropriate correction of the above informalities is required. Any response to this office action that fails to meet all of these requirements will be considered non-responsive.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3 and 5 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon including products of nature, or an abstract idea) without significantly more. All dependent claims are included in these rejections unless they contain a limitation that overcomes the deficiencies of the parent claim from which they depend. The rationale for this determination is explained below.
The claims are drawn to HD-ZIP transcription factor ArHDZ19 of amino acid sequence as shown in SEQ ID NO: 2, a gene which encodes it, a recombinant expression vector comprising the gene, and “using” the gene.
The instantly claimed HD-ZIP transcription factor appears to be naturally occurring in the perennial herb Anoectochilus roxburghii; see Example 1. Likewise, the gene encoding the HD-ZIP transcription factor would also be naturally occurring; see Example 1. The broadly claimed recombinant expression vector does not provide any special structure and is thus indistinguishable from the naturally occurring gene (and accompanying regulatory sequences). Claim 3 only recites that the vector comprises the (naturally occurring) gene according to claim 2 and no other specific, non-naturally occurring structural features that would render it patent-eligible. The unspecified “use” of the gene as recited in claim 5 (without specific active method steps) does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed invention is directed to naturally-occurring process(es), cells, and organisms, with naturally occurring gene. The claimed gene, and proteins have the inherent properties that are recited in the claims. The judicial exception is not integrated into a practical application because the claimed invention is directed to naturally-occurring gene and processes. A claim that focuses on use of a natural principle must also include additional elements or steps to show that the inventor has practically applied, or added something significant to, the natural principle itself. Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __, 132 S.Ct. 1289,101 USPQ2d 1961 (2012), at 1966. To show integration, the additional elements or steps must relate to the natural principle in a significant way to impose a meaningful limit on the claim scope.
Thus, the claimed products are not patent-eligible pursuant to the Supreme Court decision in Ass'n. for Molecular Pathology v. Myriad Genetics (formerly v. USPTO), 653 F.3d 1329, 99 USPQ2d 1398 (Fed. Cir. 2011), cert. granted, judgment vacated and remanded to the Court of Appeals for the Federal Circuit, No. 11-725, 80 U.S.L.W. 3380, 2012 BL 72224 (U.S. Mar. 26, 2012), reversed, ---- S.Ct. ----, 106 USPQ2d 1972, 1974-75 (2013). The claimed invention does not rise to a level that is markedly different in structure from what exists in nature. See “The 2019 Revised Patent Subject Matter Eligibility Guidance”, issued January 7, 2019, available from the USPTO website at https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf.
Amending the claims to recite the cDNA might help overcoming the rejection.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1-6 are rejected under 35 U.S.C. 112(b) 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. All dependent claims are included in these rejections unless they contain a limitation that overcomes the deficiencies of the parent claim from which they depend. See details below.
Within the claims, the abstract, and the specification, Applicant describes SEQ ID NO: 1 and SEQ ID NO: 2 as the gene for encoding the transcription factor ArHDZ19 of Anoectochilus roxburghii ‘Hongxia’ and the amino acid sequence of transcription factor ArHDZ19 of Anoectochilus roxburghii ‘Hongxia’, respectively. However, in the sequence listing file both SEQ ID NO: 1 and SEQ ID NO: 2 are listed as having a source where “organism = synthetic construct” (see Sequence listing file).
Thus, it is unclear where these sequences are sourced from. Were the sequences derived from some already existing synthetic construct? What are the origins of the sequences?
In the interest of compact prosecution, SEQ ID NO: 1 and SEQ ID NO: 2 are being interpreted to be the naturally occurring gene for encoding the transcription factor ArHDZ19 of Anoectochilus roxburghii ‘Hongxia’ and the amino acid sequence of transcription factor ArHDZ19 of Anoectochilus roxburghii ‘Hongxia’, respectively.
Claims 5 and 6 are additionally rejected under 35 U.S.C. 112(b) and are listed below for reference within this document.
Claim 5. A method for promoting a reproductive growth of the Anoectochilus roxburghii 'Hongxia' and improving a seed vitality, comprising using the encoding gene for encoding the HD-ZIP transcription factor ArHDZ19 of the Anoectochilus roxburghii 'Hongxia' according to claim 2.
Claim 6. The method according to claim 5, wherein the method comprises a construction of a recombinant expression vector comprising the encoding gene for encoding the HD-ZIP transcription factor ArHDZ19, a transformation of a plant host, and a cultivation and a screening of a transgenic plant.
In Claim 5, it is unclear what is encompassed by the relative phrase “seed vitality.” It is not known whether applicant is referring to seed germination, seed growth rate, seed survival, seed size, seed longevity, any combination thereof, or something else.
Additionally, the metes and bounds of “using” are unclear. In claim 5, it unclear what the target of the using is, it is not applied to the plant.
In the interest of compact prosecution, the claims are given the broadest reasonable interpretation that the Anoectochilus roxburghii 'Hongxia' plant was transformed with the “encoding gene for encoding the HD-ZIP transcription factor ArHDZ19” where any improvement of seed is an improvement of seed vitality.
Claim 6 is also rejected under 35 U.S.C. 112(b) as being indefinite because it is unclear what “a plant host” is being transformed with, what transgenic plant is being screened, and what the transgenic plant is being screened for; thus the claim never accomplishes what is recited in the preamble.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Parent claim 5 recites a method for promoting a reproductive growth of the Anoectochilus roxburghii 'Hongxia', a specific plant cultivar. Dependent claim 6 recites broadly "a plant host" and "a transgenic plant", which encompasses other plants that fall outside of the scope recited in claim 5 (i.e., Anoectochilus roxburghii 'Hongxia'). Thus, claim 6 fails to further limit the subject matter of claim 5.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
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.
Claims 1-6 are rejected under 35 U.S.C. 103 and is listed below for reference within this document.
An HD-ZIP transcription factor ArHDZ19 of [Anoectochilus roxburghii 'Hongxia'], comprising a polypeptide having the amino acid sequence as shown in SEQ ID NO: 2.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Chan (U.S. Patent Publication No. US9896695B2, assigned to UNIVERSIDAD NACIONAL DEL LITORAL, titled 'HAHB11 provides improved plant yield and tolerance to abiotic stress', published 2/20/2018) in view of Huang (Huang, Hui, et al. "Identification and characterization of HD-Zip genes reveals their roles in stresses responses and facultative crassulacean acid metabolism in Dendrobium catenatum." Scientia Horticulturae 285 (2021): 110058., published 3/5/2021) and NCBI Genbank accession XP_020698923.1 (cited in IDS, published 04/21/2019).
We interpret that the claim refers to the full length of the SEQ ID NO: 2.
Chan teaches
That homeodomain leucine zipper (HD-ZIP) proteins are a class of transcription factors characteristic of plants and key roles in specific biological processes in plants (col 1, lines 41-62).
HaHB11 is an HD-ZIP transcription factor (col 1-2).
That “amino acid substitutions may be made based on any characteristic known in the art, including the relative similarity or differences of the amino acid side-chain substituents, for example, their hydrophobicity, hydrophilicity, charge, size, and the like” and makes “conservative substitutions (i.e., substitution with an amino acid residue having similar properties)… in the amino acid sequence encoding the HaHB11 polypeptide” to create functionally equivalent or “biologically active” variants of the HaHB11 HD-ZIP transcription factor (col 24, lines 30-43).
A binary vector comprising the encoding gene of HD-ZIP HaHB11 polypeptide wherein the vector delivers and expresses polynucleotides in a plant, plant part, or plant cell (col 51).
“stably transforming a plant cell with a nucleic acid, expression cassette, or vector encoding an HaHB11 polypeptide” (col 6)
a transgenic plant stably transformed with an isolated nucleic acid encoding a polypeptide of a HD-ZIP protein, HaHB11 (col 55).
HaHB11 overexpressing plants exhibit approximately twice the yield of WT plants when measured by weight of seeds per plant (i.e., seed vitality)(col 9, Fig 31, col 59).
“Those skilled in the art will appreciate that both the homeodomain and leucine zipper motifs (HD-Zip) are functionally conserved and interchangeable among HD-Zip I proteins” (col 29).
Chan does not explicitly teach HD-ZIP transcription factor protein, comprising a polypeptide having the amino acid sequence as shown in instant SEQ ID NO: 2.
Huang teaches that it is known in the art that HD-ZIP proteins contain the homeodomain and leucine zipper motifs (HD-Zip) and that “the MEKHLA domain involved in light signaling and START domain with putative lipid-binding capability was also found in some HD-Zip proteins” (Introduction, page 1). Huang teaches that “Dendrobium catenatum is a well-known traditional Chinese medicinal herb with an extensive range of pharmacological properties and ornamental values” and cites that as a motivation to study the plant species (Introduction, page 2). Anoectochilus roxburghii 'Hongxia' and Dendrobium catenatum are both members of the Orchidaceae family. Huang teaches “identification and characterization of HD-ZIP genes” (title) by using preexisting datasets and publicly available tools (Materials and methods, page 3)ultimately identifying NCBI accession XM_020843265.2 as one of the HD-Zip genes in Dendrobium catenatum genome (page 2, table 1).
Huang does not explicitly teach HD-ZIP transcription factor protein, comprising a polypeptide having the amino acid sequence as shown in SEQ ID NO: 2.
NCBI accession XP_020698923.1 is the amino acid sequence of homeobox-leucine zipper protein HOX32 from the plant Dendrobium catenatum and is identical to the protein encoded by NCBI accession XM_020843265.2. Anoectochilus roxburghii 'Hongxia' and Dendrobium catenatum are both members of the Orchidaceae family. Multiple sequence alignment of XP_020698923.1 with Chan’s SEQ ID NO: 3(HaHB11 polypeptide) shows highly conserved amino acid residues (data not shown; COBALT: https://www.ncbi.nlm.nih.gov/tools/cobalt/cobalt.cgi) and shared conserved domains/motifs (NCBI Conserved Domain-search). XP_020698923.1 teaches 90.59% sequence identity with the amino acid sequence of the claimed HD-ZIP transcription factor ArHDZ19 as shown in SEQ ID NO: 2. Further, multiple sequence alignment of XP_020698923.1 and SEQ ID NO: 2 of the instant application indicates the amino acid residues are highly conserved (See below; COBALT: https://www.ncbi.nlm.nih.gov/tools/cobalt/cobalt.cgi)) with shared conserved domains, HD. ZIP, START, and MEKLA ( NCBI Conserved Domain-search: https://www.ncbi.nlm.nih.gov/Structure/bwrpsb/bwrpsb.cgi ). Thus, the 90.59% sequence identity between XP_020698923.1 and SEQ ID NO: 2 does not result in any functional differences, absent evidence to the contrary.
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Claim 2 is listed below for reference within this document.
An encoding gene for encoding the HD-ZIP transcription factor ArHDZ19 of the Anoectochilus roxburghii 'Hongxia'' according to claim 1, comprising the nucleotide sequence as shown in SEQ ID NO: 1.
We interpret that the claims refer to the full length of the SEQ ID NO: 1. Claim 2 depends from claim 1 and is drawn to the encoding gene for encoding the HD-ZIP transcription factor of claim 1.
Regarding claim 2, Huang teaches that XM_020843265.2 encodes an HD-ZIP transcription factor. Aligned XM_020843265.2 shares 86.62% sequence identity with SEQ ID NO: 1 (i.e., an encoding gene for encoding the HD-ZIP transcription factor ArHDZ19). Chan teaches that “the degeneracy of the genetic code, which allows different nucleotide sequences to code for the same protein, is well known in the art” (col 27 line 59). Applicant has not shown any criticality of this nucleotide sequence.
Claims 3 and 4 are listed below for reference within this document.
A recombinant expression vector, comprising the encoding gene for encoding the HD-ZIP transcription factor ArHDZ19 of the Anoectochilus roxburghii 'Hongxia' according to claim 2.
The recombinant expression vector according to claim 3, wherein the recombinant expression vector is pHB-ArHDZ19.
Regarding claims 3 and 4, Chan teaches a binary vector comprising the coding sequence of the HD-ZIP polypeptide wherein the vector delivers and expresses polynucleotides in a plant, plant part, or plant cell (col 51) (i.e., a recombinant expression vector). Chan also teaches that exemplary binary vectors, their construction, and their use pertaining to the are known to those skilled in the art (col 49, lines 12-58). Thus, given the known status of XP_020698923.1, a person of ordinary skill in the art motivated to improve yield and stress tolerance of a plant as did Chan, would be motivated to construct a binary vector that encompasses the metes and bounds of the recombinant expression vector pHB-ArHDZ19 of claims 3 and 4.
Regarding claims 5 and 6, Chan teaches and claims a “method of increasing yield [(i.e., seed vitality)] and/or increasing tolerance of a plant to abiotic stress [(i.e., promoting reproductive growth)], the method comprising : (a) stably transforming a plant cell with an isolated nucleic acid encoding a polypeptide” of an HD-ZIP transcription factor or functional equivalents there of ( claim 8). Chan also teaches transformation [of a plant host, or parts and cells thereof], growing (i.e., cultivation) of WT and transgenic plants and cells, selection of transformed plants (i.e., screening of transgenic plants) cols 51- 56, Example 1).
Therefore, it would have been prima facie obvious and within the scope of an ordinary skill in the art at the time the invention was made to combine and modify the methods taught by Chan with compositions taught Huang and XP_020698923.1, and to transform a medicinally important plant with the nucleotide sequence encoding the polypeptide sequence as shown in XP_020698923.1 occurring upon the instant invention because:
Chan, an analogous art modifying plants via recombinant DNA technology for improved agronomic traits, teaches that “transgenic plants expressing [HD-ZIP transcription factor] HaHB11 exhibit larger rosettes and improved yield as compared with controls under normal growth conditions and conditions of abiotic stress” (col 2 line 21-30).
Dendrobium catenatum is a medicinally important plants of the Orchidaceae family like Anoectochilus roxburghii 'Hongxia'.
Huang teaches a method of identifying HD-ZIP transcription factors and identifies HD-ZIP transcription factors in Dendrobium catenatum that contain domains, HD. ZIP, START, and MEKLA including a gene that encode a polypeptide identical to XP_020698923.1.
XP_020698923.1 teaches an HD-ZIP transcription factor of an orchidaceous plant that shares 90.59% sequence identity and conserved residues with the amino acid sequence shown in SEQ ID NO: 2, and is functionally equivalent to the HD-ZIP transcription factor comprising the amino acid sequence shown in SEQ ID NO: 2.
Chan teaches transformation of a plant with the nucleotide sequences encoding an HD-ZIP transcription factor.
A person of ordinary skill in the art would have a reasonable expectation of success, because Chan also teaches that “any plant (or groupings of plants, for example, into a genus or higher order classification) can be employed in practicing the present invention including angiosperms or gymnosperms, monocots or dicots,” and “ornamentals” (col 20, line 48 to col 21, line 10), where Anoectochilus roxburghii 'Hongxia' is an angiosperm, a monocot, and an ornamental. One would have been motivated to this in order to promote growth and improve yield of the medicinally important plant Anoectochilus roxburghii as was done by Chan in the model plant.
Conclusion
Claims 1-6 are rejected.
Contact information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YVETTE B TAMUKONG whose telephone number is (571)272-1040. The examiner can normally be reached M-Th 730-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bratislav Stankovic can be reached at (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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/YVETTE BIH TAMUKONG/ Examiner, Art Unit 1662
/BRATISLAV STANKOVIC/ Supervisory Patent Examiner, Art Units 1661 & 1662