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 .
Election/Restrictions
Applicant's election with traverse of Group II, claims 46, 47, 49, 50 and 61 after Applicant’s amendments to the claims, in the reply filed on 24 July 2025 is acknowledged. The traversal is essentially moot as Applicant has cancelled non-elected claims except claim 62. The Examiner has rejoined claim 62 to the elected invention. Applicant argues that the claims of Group I (cancelled) and II (elected) contain significant overlapping technical features and it is submitted that it would not constitute an undue burden to examine both Groups of claims (page 5 of the response).
The requirement is still deemed proper and is therefore made FINAL.
Specification
The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
The disclosure is objected to because of the following informalities: The Specification appears to have translation errors. For example, on page 1, paragraph 0004, Nicotiana umbratica is referred to as “an annual grass” which is factually incorrect.
Appropriate correction is required.
Information Disclosure Statement
The listing of references on pages 4-5 of the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claim 62 is objected to because of the following informalities: At line 3, “tomentose” is misspelled. Appropriate correction is required.
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 46, 47, 49, 50 and 61-63 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 composition comprising an extract obtained from an F1 hybrid plant between Nicotiana umbratica and N. tomentosa, or a portion thereof. Applicant defines “extract” as including but not limited to refined oil or a particular component or the like (page 20, paragraph 0069).
Applicant describes producing an F1 hybrid between Nicotiana umbratica (seed parent) and N. tomentosa (pollen parent) in Example 1 on pages 24-26. Applicant describes a comparison of a limited number of characteristics between said F1 hybrid and “control variety 2” defined on page 24 of the Specification as an F1 hybrid between Nicotiana umbratica and N. kawakamii. Applicant describes a very limited number of components of a composition comprising an extract obtained from F1 hybrid in Figure 7.
Applicant does not describe the very broad genus of F1 hybrids between Nicotiana umbratica and N. tomentosa used to produce the claimed composition comprising an extract. This is especially true of the multitude of characteristics recited in instant claim 46 (which appear to be directed to desired outcomes).
Hence, it is unclear that Applicant was in possession of the invention as broadly claimed. In particular, the F1 hybrid plant from which the claimed composition comprising an extract is only describe by a method of making. The decision in AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc. 111 USPQ2d 1780 (Fed. Cir. 2014) seems to be germane to the instant case. In Abbvie, an analogy is drawn between a claimed genus and a plot of land (see pages 1789-1791). Using this analogy, the Court offered that “[I]f the disclosed species only abide in a corner of the genus, one has not described the genus sufficiently to show that the inventor invented, or had possession of, the genus. He only described a portion of it.” Similar to the analogy drawn in Abbvie, in the case of Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 94 USPQ2d 1161 (Fed. Cir. 2010), the court (at page 1171) offered: [M]erely drawing a fence around the outer limits of purposed genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.
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 46, 47, 49, 50 and 61-63 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.
The term “smaller” or “improved” or “yield…increases” or “resistance…improved” in claim 46 is a relative term which renders the claim indefinite. The terms are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As shown in instant Figures 2 and 3, the variation within the encompass genus of compared plants does not clearly delineate the F1 hybrid plant or portion thereof from the plant it is compared to. Hence, the metes and bounds of the claim is unclear.
Because an F1 hybrid between Nicotiana umbratica and N. kawakamii would vary in a substantial number of characteristics. The Specifcation appears to define “control 1” as an F1 hybrid between Nicotiana umbratica and N. kawakamii and “control 2” as a plant of N. umbratical on pages 22-23, paragraph 0082. An F1 hybrid between Nicotiana umbratica and N. kawakamii is taught in U.S. Patent 11,533,885 and characteristics thereof. Instant Figure 4 teaches a comparison between an F1 hybrid between Nicotiana umbratica and N. tomentosa and an F1 hybrid between Nicotiana umbratica and N. kawakamii (control 1) of the number of flowers per plant, the ‘885 patent teaches the average number of flowers per plant of an F1 hybrid between Nicotiana umbratica and N. kawakamii in Figure 4, but the number per plant of an F1 hybrid between Nicotiana umbratica and N. kawakamii in the ‘885 Patent is substantially larger than the control 1 number of flowers per plant in instant Figure 4. Consequently, the comparisons are highly relative and highly variable between F1 hybrid plants whether it be a F1 hybrid from which the instantly claimed composition is produced or the control 1 F1 hybrid to which comparisons are being made. Hence, it is unclear what the metes and bounds of the claim are.
The Examiner notes that the Specification further seems to define an F1 hybrid between Nicotiana umbratica and N. kawakamii as “control variety 2” on page 24, paragraph 0091.
Those claims which depend from claim 46 are similarly indefinite because they do not obviate the indefiniteness of the claim(s) upon which they depend.
Claim 62 is indefinite because at line 1, “an extract” is unclear if it is directed to a different “extract” or to the “extract” comprised in the composition of claim 46. At line 3, “the F1 hybrid” lacks proper antecedent basis because claim 46 is directed to a composition and not an F1 hybrid. Hence, the metes and bounds of the claim are unclear.
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) 46, 47, 49, 50, 61 and 63 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shinozaki et al (1991, Agric. Biol. Chem., 55(3): 751-756).
See In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985), which teaches that a product-by-process claim may be properly rejectable over prior art teaching the same product produced by a different process, if the process of making the product fails to distinguish the two products.
Shinozaki et al disclose a composition comprising an extract of Nicotiana umbratical including methylhexanoic acid (instant claim 61) in Table IV on page 753. Shinozaki et al disclose an agricultural chemical composition (instant claims 47 and 50) in Table VII on page 755 useful for control of barnyard grass growth (see also the abstract on page 751). The limitation “a product” at instant claims 49 and 63, for example, is given its broadest reasonable interpretation. The composition Shinozaki et al disclose would appear to meet the definition of “a product” (page 752, left column, last full paragraph) because it is a composition in solution form (instant claim 47) comprising an extract and 0.01% Tween 80. Hence, Shinozaki et al had previously disclosed the claimed invention.
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) 62 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zaitlin et al (US 20060236433 A1, October 19, 2006) in view of Subhashini et al (1974 Cytologia 39: 403-409).
Applicant claims a method for producing a composition containing an extract comprising extracting a tobacco plant-derived material from an F1 hybrid between Nicotiana umbratica and N. tomentosa.
Zaitlin et al teach a method of producing interspecific F1 Nicotiana hybrids for producing a plant-made pharmaceutical at claim 17. Zaitlin et al teach that the limitation “Nicotiana” includes N. tomentosa and N. umbratica on page 3, paragraph 0033.
Zaitlin et al does not reduce to practice a specific F1 hybrid between N. umbratica and N. tomentosa.
Subhashini et al teaches interspecific hybrids between N. umbratica and a second species N. paniculata as the male parent. Subhashini et al teaches that N. umbratica will cross freely with a second 2n=24 species as a male parent.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant claim to use the teachings of Zaitlin et al to make an F1 interspecific hybrid between Nicotiana umbratica and N. tomentosa for the purpose of producing an extract from said F1 interspecific hybrid. Subhashini et al teaches that N. umbratical will readily cross with an 2n=24 Nicotiana species like N. tomentosa, it would have been obvious to substitute the N. paniculata used by Subhashini et al with an N. tomentosa as suggested by Zaitlin et al. Given the teachings of Subhashini et al, one of ordinary skill in the art would have had a reasonable expectation of success in crossing Nicotiana umbratica and N. tomentosa.
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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