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 .
Status of the Claims
Claims 1-10 are currently pending.
Information Disclosure Statement
No information disclosure statement (IDS) has been submitted in this application.
Objections
A naming inconsistency is found in the use of the terms wfzp-2A, wfzp-D, ttbh-a1, ttfzp-2A and ttfzp-2 at paragraph [0005] of the specification. All other reference to these terms, in both the specification and the claims use, WFZP-2A, WFZP-2B and WFZP-2D and are fully capitalized. The general convention on naming genes depends on the species under examination. For example, in humans, gene symbols use all upper-case letter while mouse/rat genes use an initial capital followed by remaining lowercase. Typically, these designations are italicized, for example BRAC1 in humans and Braca1 in mice. It is unclear if the different use of upper- and lower-case gene designations are intended to indicate the isolation of these genes from disparity sources or merely an inconsistency. In some instances, the convention is for capitalized names to refer amino acids or protein, where all lower cases indicates nucleic acids. Correction and or explanation is required.
Claim interpretation
Prior to analysis of the art, the claims must be construed. As noted in MPEP 2111, citing Phillips v. AWH Corp., 415 F.3d l303, 75 USPQ2d l321 (Fed. Cir. 2005), "During patent examination, the pending claims must be 'given their broadest reasonable interpretation consistent with the specification. "
As pointed out, in, In re Mott, 190 U.S.P.Q. 536 (CCPA 1975), "Claims must be given broadest reasonable construction their language will permit in ex parte prosecution, and applicant who uses broad language runs the risk that others may be able to support the same claim with a different disclosure."
The terms “biomaterial,” “wheat genetic breeding” and “engineered cells” are used in the instant applications and are afforded the broadest reasonable interpretation. The specification does not define “biomaterial” but states at [007], biomaterial includes the genes for regulating the spike-branched traits of the wheat as described above. A dictionary definition describes plant biomaterial as a natural or synthetic substance obtained from or derived from a plant.
The term “wheat genetic breeding” is similarly not defined in the specification of the instant application. At [037] states: for example, situations of the genes for regulating the spike-branched traits of the wheat can be detected through the primer pairs before breeding, to select a target parent. For another example, the conserved domain of the WFZP genes in the wheat is modified by using a gene editing technology, to achieve regulation of the spike-branched traits of the wheat. Alternatively, the gene editing germplasm resource of applicants can be used to introduce mutated traits, which can be selected based on specific situations.
The term “engineered cells” is not defined in the specification. In biology, the common definition of an engineered cell comprises cells in which the adding, deleting, or altering DNA sequences. Thus, encompassed by this term are all mutations, variation, and modification imposed on a cell. In this regard an engineered cell includes a cell found in vivo have a variant trait.
Non-Prior art Rejections
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.
Claim 10 is 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 10 is indefinite in claiming a “wheat germplasm resource” with an “edited” FRIZZY PANICLE (WFZP) gene. A “resource” can comprise a multitude of different material including a database along with specific germplasms. Similarly, an “edited gene” does not clearly set forth if the editing is genetic or merely textual in nature, for example, introgressing a known gene into a novel species would encompass editing the gene as the location and environment of the gene would be affected by the introgression. The recitation of FRIZZY PANICLE (WFZP) is both vague and indefinite in that it is not clear if the text in brackets is intended as a species or further limitation of the FRIZZY PANICLE gene or a mere abbreviation. Correction and clarification are required.
35 USC 112(a)
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 1-2, 4-5 and 10 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 claims 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 not supported by an adequate written description because the specification does not reasonably convey to those of skill that the applicant was in possession of the invention as claimed.
Regarding claim 1-2, 4-5 and 10, the limitations of which broadly cover any gene for regulating spike-branched trait in wheat (comprising at least one of TtFZP-1A…), the specification only describe one specific variant from three specific wheat variety. These claims represent a genus of variants but only provide evidence concerning a limited number of species. The specification describes TtFZP-1A and TtFZP-2b obtained from wheat varieties GAN-A631, GAN-A1582 and DW1 and discloses specific mutations in the AP2/ERF domain. Furthermore, the use of both upper- and lower-case gene naming does not support evidence of a complete and proper written description. At paragraph [0005] of the specification, it is noted, “In the wheat, researched genes include wfzp-2A, wfzp-D, ttbh-a1, ttfzp-2A and ttfzp-2B.” while at paragraph [0006] “in the disclosure, WFZP-2A, WFZP-2B and WFZP-2D are found to jointly regulate formation of RS, MRS and FRS traits of a wheat.” Since capitalization of a gene is considered genus designation as discussed above under Objections, it is not clear if these are the same gene(s) or are genes derived from different sources. See, for context, BRACA1 vs Braca1 discussion above.
The specification does not disclose that the WFZP is a conserved region that can define the genus claimed, there is no evidence providing a functional definition of what controls the branched trait, there is no structure (specific nucleic acid sequences) to correlate the function beyond the single mutations and there is no description of any range of variation from any functional variants. The claims are directed to all allelic variants across all wheat varieties, including all wild type sequences, mutant variations, natural variation and those created synthetically that are useful to regulate spike-branched trait in wheat. There is simply insufficient teaching to support a broad generic claim which is supported by a disclosure of only a single or limited number of species unless there is some evidence that the disclosed species are representative of the entire genus. See MPEP § 2163.02.
Claims 6-8 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.
The limitation “performing wheat genetic breeding” as recited in claim 6, performed by using primer pairs in claim 7, performed by using biomaterial in claim 8, is not adequately supported by the specification. The terms “wheat genetic breeding” is broad and encompasses traditional crossing methods, such as manual cross pollination and selfing or backcrossing to generate inbred populations and genetic recombination. Additionally modern techniques include genomic selection (GS) and molecular markers assisted selection (MAS) to develop new varieties with improved traits, by manipulating genes are encompassed within the claims. It is not clear if an understanding of gene function in both tetraploid and hexaploidy genetic backgrounds serve as compounding factors requiring special breeding techniques. As noted in LizardTech Inc. v. Earth Resource Mapping Inc., 424 F.3d 1336, 1345, 76 USPQ2d 1724, 1732 (Fed. Cir. 2005) to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification"). As stated by the Federal Circuit, "[a]lthough many original claims will satisfy the written description requirement, certain claims may not." Id. at 1349, 94 USPQ2d at 1170-71; see also Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F... 35 U.S.C. 112 "merely by clearly describing one embodiment of the thing claimed." The issue is whether a person skilled in the art would understand the inventor to have invented, and been in possession of, the invention as broadly claimed.
Claims 1-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the genes WFZP-AF, limited to SEQ ID NO: 1, and WFZP-AR limited to SEQ ID NO: 2; WFZP-BF limited to SEQ ID NO: 3, and WFZP-BR limited to SEQ ID NO: 4; WFZP-DF limited to SEQ ID NO: 5, and WFZP- limited to SEQ ID NO: 6; WFZP-BF2 limited to SEQ ID NO: 7, and WFZP-BR2 limited to SEQ ID NO: 8; WFZP-AF2 limited to SEQ ID NO: 9, and WFZP-AR2 limited to SEQ ID NO: 10; and WFZP-DF2 limited to SEQ ID NO: 11, and WFZP-DR2, does not reasonably provide enablement for other genes and variants of these genes which regulate spike-branched traits in wheat. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims. See In re Wands, 858 f.2d 731 (Fed Cir 1988). In this analysis, the Wands factors listed below, are considered.
A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In view of the Wands factors, the claims are considered to be extremely broad by encompassing all wheat varieties while the predictability is considered low, see paragraph [0053] which explains that different mutations produced different phenotypes and [0068] that mutations in both the structural gene and the promoter regions combine to make results unpredictable. The direction provided by the specification is minimal at best encompassing “using” breeding techniques, etc. The list of working examples of how to use these techniques is lacking and the quantity of experimentation required here is extensive. The set of primer described have not been shown to work with a variety of wheat cultivars and the effects on tetraploid vs hexaploidy wheat compounds the quantity of experiments.
Accordingly, claims 1-10 are only enabled for specific genes, primer and varieties and nothing more.
Biological Deposit
Claims 1, 4, 5, 6, 8-10 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 claims 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.
Under 35 USC 112(a), a deposit of biological material may satisfy the statutory requirements for enablement where the inability to make and use an invention based on the description found in the specification, and the absence of readily available material alone, is not sufficient to enable a person of skill in the art make and use the invention. Deposits may be made under the Budapest Treaty or under US practice.
The claims required the genes for regulating spike-branched traits of wheat comprising at least one of TtFZP-2A, 2B, WFZP-2A, 2B and WFZP-2D. However, what comprises the metes and bounds of each designated gene, and its status of being known and readily available to a person of skill in the art, is not established in the specification or the prior art. Since the material is not both known and readily a deposit of biological material may provide enablement.
If applicants chose to make a deposit, they are directed to 37 CFR 1.801-1.809. Under 37 CFR 1.807, a) A deposit of biological material that is capable of self-replication either directly or indirectly must be viable at the time of deposit and during the term of deposit. Viability may be tested by the depository. The test must conclude only that the deposited material is capable of reproduction. No evidence is necessarily required regarding the ability of the deposited material to perform any function described in the patent application.
(b) A viability statement for each deposit of a biological material defined in paragraph (a) of this section not made under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure must be filed in the application and must contain:
(1) The name and address of the depository;
(2) The name and address of the depositor;
(3) The date of deposit;
(4) The identity of the deposit and the accession number given by the depository;
(5) The date of the viability test;
(6) The procedures used to obtain a sample if the test is not done by the depository; and
(7) A statement that the deposit is capable of reproduction.
(c) If a viability test indicates that the deposit is not viable upon receipt, or the examiner cannot, for scientific or other valid reasons, accept the statement of viability received from the applicant, the examiner shall proceed as if no deposit has been made. The examiner will accept the conclusion set forth in a viability statement issued by a depository recognized under § 1.803(a). [Emphasis added].
US patent applications comprising a biological deposit in addition to adherence to the Budapest Treaty, must further comply with 37 C.F.R. 1.808 (a) in which a person in position to assert that the deposit was made under conditions that assure that:
(1) Access to the deposit will be available during pendency of the patent application making reference to the deposit to one determined by the Director to be entitled thereto under § 1.14 and 35 U.S.C. 122, and
(2) Subject to paragraph (b) of this section, all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent.
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.
Eligibility is considered in light of MPEP 2106 III, which incorporates the 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG) published on January 17, 2019 (84 Fed. Reg. 50) and is clarified in the October 2019 Update.
Claims 1 and 4-9 are rejected under 35 U.S.C 101 because the claimed invention is directed to a judicial exception without significantly more. The claims are directed to a composition of matter, specifically to naturally occurring DNA sequences designated as genes TtFZP-2A, TtFZP-2B, WFZP-2A, WFZP-2B and WFZP-2D and therefore constitute a judicial exception and are not patentable under 35 USC 101.
The specification discloses that the recited genes were isolate from naturally occurring wheat plants varieties GAN-A631, GAN-A1582 and DW1 [0061-0068]. The specification and the claims recited that the genes are located on chromosome 2AS, 2BS and 2 and there is no indication that the indicated isolated genes differ structurally from the naturally occurring genes. The Supreme Court in Association for Molecular Pathology v. Myriad Genetics (569 US 576 (2013) held that naturally occurring DNA segments are a product of nature and not patent eligible merely because it has been isolated. The claims do not integrate the judicial exception into a practical application as the claims are directed to the isolated genes per se. There is no recitation of a particular use or function beyond their naturally occurring function. There does not appear to be any structural modification or changes to the genes nor are their unconventional combinations of these elements with others. The genes are claimed in isolation, are used for their natural regulatory function which does not institute an integration into a practical application under Step 2A prong 2 of the 2019 Revised Patent Subject Matter Eligibility Guidance.
Under step 2B, the claims do not include additional elements that amount to significantly more than the judicial exception. The specification describes the routine and conventional use of molecular biological methods to identify and isolate the genes. Under Mayo Collaborative Services v. Prometheus Laboratories, Inc, 566 US 22 (2012) a discovery of a naturally occurring phenomenon does not render the phenomenon patent -eligible even if the discovery is novel and groundbreaking.
As can be seen in the MPEP 2106 III Figure, eligibility analysis requires one to address the following questions: (i) Step 1 - Is the claim directed to one of the four statutory categories (i.e., process, machine, manufacture or composition of matter); (ii) Step 2A - Is the claim directed to a judicial exception (i.e., a natural phenomenon, law of nature or abstract idea); and (iii) Step 2B - does the claim recite additional elements that amount to significantly more than the judicial exception. In addition, as can be seen in the MPEP 2106.04 Il Figure, Step 2A is a two-prong inquiry, with Prong One asking whether the claims recite a judicial exception (i.e., an abstract idea, natural phenomenon or law of nature) and Prong Two asking whether the claims recite additional elements that integrate the judicial exception into a practical application.
Prior Art
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4-6, 8 and 10 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Dobrovolskaya et al. (Plant Physiology January 2015, Vol 167, pp 189-199).
Dobrovolskaya et al. (2015) disclose a wheat germplasm comprising Frizzy Panicle (WFZP) gene described as having a trait comprising extra branching or supernumerary spikes emerging from rachis nodes due to a mutation in the Frizzy Panicle (WFZP) gene in wheat in which the spikelets are arranged as two opposite rows on the main axis, the rachis.
Regarding claims 1, 4 - 6, Dobrovolskaya et al. (2015) disclose the gene WFZP comprising a biomaterial as defined in the art, includes the genes for regulating the spike-branched traits of the wheat as described above. Furthermore, at page 198, repetitive marker-assisted backcrossing of the MRS donors with selected elite varieties with standard spike structure, using the WFZP markers described here, will rapidly lead to the development of new breeding lines with MRSs and improved genetic backgrounds and yield potential. Since the biomaterial of Dobrovolskaya et al. (2015) includes engineered cells (comprising mutants of WFZP) this aspect of the claimed invention is also taught. Accordingly, Dobrovolskaya et al. (2015) anticipates the claimed invention.
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.
Claims 1-3, 6-7 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Dobrovolskya et al. (BMC Plant Biology 2017, 17 (Suppl 2):252) in view of Lowe et al. (Nucleic Acids Research, Vol. 18, No. 7 1757)
Dobrovolskya (2017) et al. teach diploid and tetraploid wheat lines comprising mutant alleles of WHEAT FIZZY PANICLE (WFZP) gene that is shown to be determine the spiked branching in Tititcum monococcum is the result of wfzpA/BH-A1 mutation. At Table 1 is described primers used for WZFZP-A gene sequencing and genotyping. Dobrovolskya (2017) et al. do not teach wherein the primers used consists of the nucleotide of Seq ID no: 1 through 12, however, Dobrovolskya (2017) et al. clearly evidence that sequencing and genotyping of the gene controlling spiket formation in wheat and thus disclose that the gene sequence was knows in the art.
Lowe et al. teach a method for designing primers and evaluating their performance wherein Lowe et al. disclose a computer program for rapid selection of oligonucleotide primers for polymerase chain reaction, wherein the length of the primers designed to have specific size commensurate with the primers of Dobrovolskya (2017) et al. (paragraphs under subheading ‘computer program’ on page 1757-1758, abstract). Lowe et al. teach that all primers designed for over 10 gene products were experimentally tested and the results showed that all the amplification products specified by the primers are of the predicted size and also hybridize with the appropriate cDNA or internal oligonucleotide probe (see page 1759-1760, col. 2, paragraph 1, table 1).
It would be prima facie obvious to a person skilled in the art before the effective filing date of the invention to modify the method Dobrovolskaya (2017) et al. by designing a primer pair to amplify a nucleic acid region as taught by Lowe et al. to amplify method for detecting single nucleotide polymorphic regions or segments in chromosome 2 in the previous known wheat FRIZZY PANICLE WFZP gene. The ordinary person skilled in the art would have been motivated to combine the method of Dobrovolskaya (2017) et al. with the process of selecting primers of Lowe et al. and have a reasonable expectation to render primer selection obvious over the cited prior art. Further it would be obvious to modify the method of Dobrovolskya (2017) et al. with a method to design primers from the known sequence as taught by Lowe et al. to improve the specificity of primers for detecting target nucleic acid in a sample. The claimed primers are functional equivalents of the polynucleotide sequence taught by Dobrovolskya (2017) et al. because Lowe et al. explicitly taught that the primers are generated from a known sequence. Thus, using a computer program would specifically amplify the target sequence and all primers designed for over 10 gene products from known sequences were experimentally tested and the results showed that all the amplification products specified by the primers are of the predicted size also hybridizes with the appropriate cDNA or internal oligonucleotide probe (see page 1760, col. 2, paragraph 1). As noted in In re Aller, 105 USPQ 233 at 235, more particularly, [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation."
Routine optimization is not considered inventive and no evidence has been presented that the selection of hybridization conditions performed was other than routine, that the products resulting from the optimization have any unexpected properties, or that the results should be considered unexpected in any way as compared to the closest prior art and such a modification of the method is considered obvious over the cited prior art.
Conclusion
No Claim is allowed.
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/GARY BENZION/Supervisory Patent Examiner, Art Unit 1681