Status of the Application
This Office Action is in response to the Amendment and Remarks filed 18 February 2026.
The rejection under 35 U.S.C. 102(a)(1) is withdrawn in view of Applicant’s amendments to the claims.
Specification
The disclosure remains 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 in Western Australia” (as presently amended) which is factually incorrect.
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, 63 and 64 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 method of producing a composition comprising extracting a tobacco plant-derived material obtained from an F1 hybrid plant between Nicotiana umbratica and N. tomentosa, or a portion thereof. Applicant has amended the claims to require that the extract comprises 1-isopropyl-5-(hydroxymethyl)-8-methyltricyclo[4.4.0.02,8]dec-4-ene and 4-methylhexanoic acid.
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.
Applicant argues that claim 46 has been amended (and new claim 64 recites) that the extract [produced] contains both of the components listed in [cancelled] claim 61 (page 8 of the Remarks).
Applicant argues that the F1 hybrid plant used in the claimed method now requires all of the recited characteristics (not just one of the recited characteristics), to include the limitations of [cancelled] claim 61 and to include the limitations of [cancelled] claim 62. Applicant argues that amended claim 46 [sic] addresses all of the issues raised by the Examiner (pages 8-9 of the Remarks).
Applicant’s arguments are not found to be persuasive. First Applicant describes an F1 hybrid between Nicotiana umbratica (seed parent) and N. tomentosa (pollen parent) and a few characteristics thereof, but does not describe any characteristics of a reciprocal F1 hybrid cross. Simply describing how to make an F1 hybrid does not necessarily describe the F1 hybrid itself. A method is not described if products used in the method are not described. See 64 Fed. Reg. 71427, 71428 (1999), comment No. 4.
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, 63 and 64 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 claims 46 and 64 are relative terms which renders the claims 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 Specification 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 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.
Applicant argues that the specification states that the number of flowers per plant (as compared with Nicotiana kawakamii) can vary depending on when the number of flowers per plant is measured (See paragraphs [0039] and [0040] per specification). Applicant argues that this characteristic has been amended in claim 46 to identify when the number of flowers is measured, based on paragraphs [0039] and [0040] of the specification. Applicant argues that new claim 64 does not recite the characteristic concerning the number of flowers per plant and therefore this new claim should not be subject to this rejection (page 9 of the Remarks).
Applicant’s arguments are not found to be persuasive because the limitations “improved”, “smaller”, “decreases” and “increases” are relative to a “control” wherein the “control” is highly variable. It is the example of an F1 hybrid between Nicotiana umbratica and N. kawakamii which demonstrates how variable the limitations and comparisons can be. Hence, the claims fail to set for the metes and bounds of 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) 46, 47, 49, 50, 63 and 64 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), Schinozaki et al (1991, Agric. Biol. Chem., 55(3): 751-756) and Mizutani et al (1997 Tetrahedron 53(34):11563-11568).
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.
Schinozaki et al teach that extracts of Nicotiana umbratica comprise methylhexanoic acid in Table IV on page 753. Schinozaki et al teaches agricultural compositions produced from N. umbratical are useful for control of barnyard grass growth (see the abstract on page 751).
Mizutani et al teach that N. umbratical produces the sesquiterpene 1-isopropyl-5-(hydroxymethyl)-8-methyltricyclo[4.4.0.02,8]dec-4-ene and that it has an oily citrus-like aroma.
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. Both Shinozaki et al and Mizutani et al teach that N. umbratica produces 1-isopropyl-5-(hydroxymethyl)-8-methyltricyclo[4.4.0.02,8]dec-4-ene and 4-methylhexanoic acid. It would be obvious to one of ordinary skill in the art that a hybrid of N. umbratica would produce 1-isopropyl-5-(hydroxymethyl)-8-methyltricyclo[4.4.0.02,8]dec-4-ene and 4-methylhexanoic acid and that extracts thereof would contain same. 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 and produce an extract containing 1-isopropyl-5-(hydroxymethyl)-8-methyltricyclo[4.4.0.02,8]dec-4-ene and 4-methylhexanoic acid.
Applicant argues that Zaitlin et al does not reduce to practice a specific F1 hybrid between N. umbratica and N. tomentosa and Zaitlin et al does not mention N. umbratical as one of the preferred Nicotina species (page 10 of the Remarks).
Applicant argues that the present invention in paragraph [0004] teaches that "Nicotiana umbratica has such a characteristically strong scent and is therefore considered to be preferable as a raw material for a tobacco product. However, a report on utilizing Nicotiana umbratica as a raw material for a tobacco product has not been found so far.” (page 10 of the Remarks).
Applicant argues that the present specification also teaches (asserts) that the different species of Nicotiana have different properties and cannot be easily substituted for each other with predictable results (page 10 of the Remarks).
Applicant’s arguments are not found persuasive because Zaitlin et al had suggested interspecific F1 Nicotiana hybrids for producing a plant-made pharmaceutical. Subhashini et al had taught that there would have been a reasonable expectation of success in producing an interspecific hybrid between N. umbratica and a second species that is 2n=24 which N. tomentosa is. The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
The Examiner notes that the instant rejection is new to address new limitations in the claims as presently amended.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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