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 .
Election/Restrictions
Applicant’s election without traverse of group II, claims 6-7, 9-12, 15, 17-18 and 20-21 in the reply filed on 05/23/2026 is acknowledged.
Claims 1, 3, 5-7, 9-12, 15, 17-18, 20-23, 26-28, and 30 are pending.
Claims 1, 3, 5, 22-23, 26-28 and 30 are withdrawn from consideration as being directed to the non-elected invention.
claims 6-7, 9-12, 15, 17-18 and 20-21 are examined.
Copending Applications
Applicants must bring to the attention of the Examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications, which are "material to patentability" of the application in question. MPEP 2001.06(b). See Dayco Products Inc. v. Total Containment Inc., 66 USPQ2d 1801 (CA FC 2003).
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the instant specification is objected to because of the use of legal phraseology “said” plant. 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 6-7, 9-12, 15, 17-18 and 20-21 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 6 is indefinite in the recitation of “functional variant” and “functional fragment” , which are not defined in the specification and are open to individual interpretations. The terms “orthologue” and “homologue” are not defined in the specification and it is unclear how closely related it has to be considered as “orthologue” or “homologue” of SEQ ID NO: 1-3. The metes and bounds of the claims are unclear.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 6 recites the broad recitation “modulate”, and the claim also recites “or decrease” which is the narrower statement of the range/limitation. Claims 7, 15, 17 and 20 recite the broad recitation “modulated”, and the claim also recites “or decreased” which is the narrower statement of the range/limitation The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Dependent claims 9-12, 18 and 21 do not obviate the rejection, therefore are included in the rejection.
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 6-7, 9-12, 15, 17-18 and 20-21 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 claims are broadly drawn to a genus of tobacco plants or a propagation material, harvested leaf or cut harvested leaf or parts thereof, tobacco cells or cell culture: i) having been modified to modulate or decrease the activity or expression of a protein kinase polypeptide which: a) comprises an amino acid sequence as set out in SEQ ID No. 3; or a functional variant or functional fragment or orthologue of SEQ ID No. 3; or a sequence which has at least 80% identity to SEQ ID No. 3; or a homologue of SEQ ID No. 3; or b) is encoded by a nucleotide sequence as set out in SEQ ID No. 1 or 2; or a functional variant or functional fragment or orthologue of SEQ ID No. 1 or 2; or a nucleic acid sequence which has at least 80% identity to SEQ ID No. 1 or 2; or a homologue of SEQ ID No. 1 or 2; and (ii) comprising decreased alkaloid and or TSNA precursor content in comparison to an unmodified plant or unmodified cell or cell culture; wherein the one or more alkaloids include nicotine, nornicotine, PON, anabasine, myosmine and anatbine is modulated or decreased. The claims are also drawn to a cured tobacco material or a tobacco industry product made from the tobacco plant or part thereof or harvested leaf of the tobacco plant or a processed leaf obtained by processing the tobacco plant or part thereof, said cured tobacco material comprising the modulated or decreased activity or expression of the kinase polypeptide or decrease alkaloid and/or TSNA precursor content as compared to a cut tobacco material made from an unmodified tobacco plant or part thereof; and a tobacco blend comprising said cured tobacco material.
The specification describes transient overexpression of Nitab4.5 0005880g0020.1 (the coding sequence of SEQ ID NO: 2) causing an increase in the content of particular alkaloids nicotine, nornicotine, anabasins, myosmine or anatabine and PON in the leaves of the nicotiana plant (Fig. 1 Example 1) . The results show that Nitab4.5 0005880g0020.1 is a position regulator of alkaloid content in tobacco leaves. The nucleotide sequence of SEQ ID NO: 2 is a genomic sequence encoding the protein of SEQ ID NO: 3.
The specification fails to describe a representative number of species of the genus of “an amino acid sequence as set out” in SEQ ID NO: 3, “functional variant, “functional fragment”, “orthologue”, “a homologue” (not defined in the specification) of SEQ ID NO: 3, “a nucleotide sequence as set out” in SEQ ID NO: 1 or 2, “functional variant, “functional fragment”, “orthologue”, “a homologue” (not defined in the specification) of SEQ ID NO: 1 or 2; or the genus of sequences having at least 80% identity to SEQ ID NO: 1, 2 or 3. These are genus claims.
The term “an amino acid sequence” of SEQ ID NO: 3 or “a nucleotide sequence” of SEQ ID NO: 1 or 2 in broadest reasonable interpretation encompasses not only SEQ ID NO: 1-3 but any fragment within SEQ ID NO: 1-3. “an” and “a” read on “any two/dipeptide” or “two nucleotides”.
The Federal Circuit court stated that a written description of an invention "requires a precise definition, such as by structure, formula [or} chemical name, of the claimed subject matter sufficient to distinguish it from other material". University of California v. Eli Lilly and Co., 43 USPQ2d 1398 (Fed. Cir. 1997). The court also stated "naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of is not a description of that material". Id. Further, the court stated that to adequately describe a claimed genus, Applicant must describe a representative number of the species of the claimed genus, and that one of skill in the art should be able to "visualize or recognize the identity of members of the genus". Id.
Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it").
The court stated that a written description of an invention requires a precise definition, one that defines the structural features of the chemical genus that distinguishes it from other chemical structures.
In the instant case, the genus of claimed polypeptides and encoded nucleotide sequences are extremely large, structurally and functionally variable genus. The specification provides no information beyond the description of the nucleotide sequences of SEQ ID NO: 1 or 2 encoding the polypeptide sequence having the amino acid sequence of SEQ ID NO: 3, and tobacco plants, parts thereof and cells or propagation material expressing said SEQ ID NO: 2 encoded by SEQ ID NO: 1 or 2.
The specification has not described a representative species of nucleic acid sequences of the genus claimed. Furthermore, the specification fails to describe structural features common to members of the claimed genus of sequences. Therefore, the specification has not met either of the two elements of the written description requirement as set forth in the court's decision in Eli Lilly, and has not shown her/his possession of the claimed genus at the time of the application.
Since the specification fails to adequacy describe the sequences as broadly claimed, tobacco plants or a propagation material, harvested leaf or cut harvested leaf or parts thereof, tobacco cells or cell culture comprising said sequences are similarly not described.
Therefore, the specification fails to sufficiently describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize that Applicant was in possession of the invention as broadly claimed at the time of filing.
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.
Claims 6-7, 9-12, 17-18, and 20-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Frederick et al (US 2015/0173319 A1).
Frederick et al teach modified tobacco plants, parts, cells, a harvested leaf thereof having modulated or reduced amount of at least one or more alkaloids or tobacco specific nitrosamine (TSNA) in the leaves relative to the leaves of non-modified tobacco plants; cured leaf from said tobacco plants having reduced amount of at least one tobacco specific nitrosamine (TSNA). See paragraph [0006]. Frederick et al also teach hybrid plants bred from said tobacco plants, and seeds (propagation material) from the modified tobacco plant with reduced alkaloids. At paragraph [0023], Frederick et al teach that the alkaloids include nicotine, nornicotine, anabasine, myosmine, and anatabine. At paragraph [0096], Frederick et al teach tobacco products with reduced-alkaloid tobacco or reduced TSNA.
Given the lack of clear definition of “functional variant, “functional fragment”, “orthologue”, “a homologue” (not defined in the specification) of SEQ ID NO: 3, “functional variant, “functional fragment”, “orthologue”, “a homologue” in the specification; and the use of the terms “an amino acid sequence” as set forth in SEQ ID NO: 3 and “a nucleotide sequence” as set out” in SEQ ID NO: 1 or 2 (see the 112(b) rejection above), the claims are anticipated by Frederick et al.
Conclusion
No claim is allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEDINA AHMED IBRAHIM whose telephone number is (571)272-0797. The examiner can normally be reached Monday-Friday, 9:00 - 6:00.
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MEDINA AHMED. IBRAHIM
Primary Examiner
Art Unit 1662
/MEDINA A IBRAHIM/ Primary Examiner, Art Unit 1662
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