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 amendment filed 1 June 2026 is acknowledged and has been entered.
Status of the claims
Claims 1-13 and 20 have been cancelled.
New claims 21-29 have been submitted.
Claims 14-19 and 21-29 are submitted for examination on the merits.
NOTE: The claims have been amended to include the intended result of the claimed method to reduce “undesirable taste, odor, or color characteristics”. Firstly, such a result is a consequence of the positively recited steps of the method and does not effectively limit the method per se. (see Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F. 3d 1373 (Fed. Cir. 2003) ( “clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.”). Thus, the claimed method is unchanged from that previously directed to a method of reducing nicotine content.
Alternatively, the claims have been amended to change the desired result for reducing nicotine to reducing “undesirable taste, odor, or color characteristics” which actually broadens the claim scope considerably. Though the method itself is unchanged, it Applicant intends for the intended result to be a limitation of the method the claims will have to be changed to reflect this changed scope, which has precipitated the new rejections.
Claim Rejections - 35 USC § 112
Claims 14-19, 21-23 and 28-29 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 14 is rendered vague and indefinite by the phrase “undesirable taste, odor, or color characteristics”. It is unclear what is “undesirable”, which is a highly subjective term. That is – how it one to determine if any particularly reduced taste, odor or color is “undesirable”? It is unclear how this phrase in meant to limit the claim, it at all, and how this differs from reducing nicotine content.
Appropriate clarification 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 14-19 and 21-29 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 a method of reducing nicotine content from plant-derived material from tobacco plant, does not reasonably provide enablement for a method of reducing any and all undesirable taste, odor or color characteristics from any and all plant species. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
See Genentech v. Novo Nordisk, 108 F. 3d 1361, 1366 “Patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. See Brenner v. Manson, 383 U.S. 519, 536, 86 S. Ct. 1033, 1042-43, 16 L. Ed. 2d 69, 148 USPQ 689, 696 (1966) (stating, in context of the utility requirement, that "a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.") Tossing out the mere germ of an idea does not constitute enabling disclosure. While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention.” In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970), held that "Inventor should be allowed to dominate future patentable inventions of others where those inventions were based in some way on his teachings, since such improvements while unobvious from his teachings, are still within his contribution, since improvement was made possible by his work; however, he must not be permitted to achieve this dominance by claims which are insufficiently supported and, hence, not in compliance with first paragraph of 35 U.S.C. 112; that paragraph requires that scope of claims must bear a reasonable correlation to scope of enablement provided by specification to persons of ordinary skill in the art; in cases involving predictable factors, such as mechanical or electrical elements, a single embodiment provides broad enablement in the sense that, once imagined, other embodiments can be made without difficulty and their performance characteristics predicted by resort to known scientific law; in cases involving unpredictable factors, such as most chemical reactions and physiological activity, scope of enablement varies inversely with degree of unpredictability of factors involved."
Undue experimentation would be required to practice the invention as claimed due to the quantity of experimentation necessary; limited amount of guidance and limited number of working examples provided in the specification; nature of the invention; state of the prior art; relative skill level of those in the art; predictability or unpredictability in the art; and breadth of the claims. In re Wands, 8USPQ2d 1400, 1404 (Fed. Cir. 1988).
Applicant’s claims are drawn to a method of a method of reducing undesirable taste, odor, or color characteristics in a plant-derived protein-enriched material. However, the specification provides only two examples, both of which employ tobacco plant and only one of which resulted in a significant decrease in odor and taste. The color changed from a dark brown/green to a light green color. That is – method 2, in which tobacco leaves are homogenized in a disintegrator and extracted with water. The liquid protein-containing extract thus obtained is a green juice having a pH of 8.4. This protein-containing extract is clarified first by passing the extract through a decanter.
The filtrate is concentrated on a 0.1 µm ceramic filter and washed 7 X with a buffer
(containing 3.0 mM NaHCO₃, 10.5 mM K₂CO₃, and 0.1% sodium metabisulfite). Once
washed, the retentate is concentrated and the retentate is pH adjusted to 10.0-10.5 by
addition of a 10N NaOH solution. The pH adjusted retentate is heated to 40°C ± 2°C.
Once at this temperature, the pH of the mixture is checked and readjusted if necessary to ensure a pH of 10.0-10.5. A solution of 34.5% hydrogen peroxide at 100 mL/L is added with very gentle stirring. The mixture is held at 40°C ± 2°C and mixed gently for 3-4 hours. After this time, the mixture is diluted 2 X with purified water and processed on a 10 nm ceramic filter. The retentate is concentrated and washed 7 X with purified water (pH ~7). The resulting mixture is washed 14 X with USP water and the material is
reconcentrated to the initial volume. The retentate is spray dried to provide a purified
protein-containing material.
Regarding the extraction solvent used to obtain the claims product with anti-inflammatory properties, it is well known in the art that polarity of solvents plays a key role in determining the final product obtained by an extraction. However, because many phytochemicals remain undiscovered, the skilled artisan has to make his/her best educated guess as to what types of phytochemicals will be successfully extracted with a solvent of a particular polarity. Oftentimes, unless the constituents in a particular natural product extract have been well evaluated and documented in the literature, the skilled artisan must adhere to trial and error protocols in order to quantitatively determine phytochemical constituents present in samples obtained from respective extraction procedures. These procedures are common when, for example, a natural product or part thereof has been documented in the literature as possessing some medicinal quality. The skilled artisan will attempt numerous extraction protocols in an attempt to isolate particular ingredient(s) that have medicinal efficacy. Typically, beginning with the first crude extraction, it is a guess as to whether or not the extract will possess certain phytochemical constituents. For example, unpredictability with regard to natural extracts due to their highly complex nature has been well documented. Revilla et al. (J. Agric. Food Chem. (1998), vol. 46, pp. 4592-4597) showed that the slightest variations in polarity of solvent and reaction time upon grape extraction provided respective products with unique characteristic properties (See tables 1, 2, 4, 5, 6 and 7 in Revilla). In turn, each product would possess varying pharmacological properties based upon their respective methods of extraction.
The specification does not provide any specific guidance to show that any and all plant species can be employed by the method as claimed to reduce any and all undesirable taste, odor, or color characteristics. An artisan would have to test every potential extraction technique with the virtually limitless number of solvents as well as every species plant to determine if it is able to reduce undesirable taste, odor or color. This degree of experimentation clearly places an undue burden on the artisan of ordinary skill. The specification only provides testing data that the extract produced by the extraction procedures and variables disclosed in Method 2 could effectively decrease in odor and taste and change the color from a dark brown/green to a light green color. Given the wide range of possible resulting extracts that could potentially result from various extraction methods, the presence of a single example of an extract that decrease in odor and taste and change the color from a dark brown/green to a light green color. provides insufficient guidance to the person to practice the invention.
Claims 14-19 and 21-29 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the invention had possession, as of the filing date of the application, of the specific subject matter later claimed by him or her. The courts have stated:
“To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention.’ Lockwood v. American Airlines, Inc., 107 F. 3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F. 2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”). Thus, an applicant complies with the written description requirement “by describing the invention, with all its claimed limitations, no that which makes it obvious,” and by using “such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention.” Lockwood, 107 F. 3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient” MPEP § 2163.
Level of Skill and Knowledge in the Art:
The MPEP indicates:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
What constitutes a “representative number” is an inverse function of the skill and knowledge in the art. Satisfactory disclosure of a “representative number” depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly.
The specification provides only two examples, both of which employ tobacco plant and only one of which resulted in a significant decrease in odor and taste. The color changed from a dark brown/green to a light green color. That is – method 2. This disclosure is actually a very few number in comparison to the vast number of extracts which could be obtained from any species of plant with changed odor, taste or color.
Raskin et al. clearly establish the grave unpredictability of elucidating active ingredients from natural sources:
Multi-component botanical therapeutics also present unique challenges in identifying their active ingredients and in validating their clinical effects. Activity-guided fractionation and reconstitution experiments currently used to characterize compound interferences within a mixture are cumbersome and time consuming…..While chromatographic analysis is often employed to produce biochemical fingerprints used for product comparison…..in the absence of information about the identity of active ingredients, such analysis is hardly reliable, since chromatography provides an incomplete picture of the qualitative and quantitative comparison of a complex extract (p. 3426, col. 2 – p. 3427, col. 1) emphasis added.
Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed" (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed" (See Vas-Cath at page 1116).
Double Patenting
Claim 14-19 and 21-29 are directed to the same invention as that of claims 1-7 of commonly assigned U.S. Patent No. 11,805,805. Under 35 U.S.C. 101, more than one patent may not be issued on the same invention.
The USPTO may not institute a derivation proceeding in the absence of a timely filed petition. The U.S. Patent and Trademark Office normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). The applicant should amend or cancel claims such that the reference and the instant application no longer contain claims directed to the same invention.
Response to Arguments
Applicant’s amendments/arguments, with respect to the obviousness rejection have been fully considered and are persuasive. The 35 USC 103 rejection of the previous Office action has been withdrawn.
Applicant's amendments/arguments with respect to the 35 USC 101 have been fully considered but they are not persuasive.
Applicant asserts that the claims are amended and submits this rejection is moot in light of the amended claims. However, as stated above the amendment changing reducing nicotine content to reducing undesirable taste, odor, or color characteristics, does not effectively limit the claimed method, per se, which is the same method as that used to reduce nicotine content, which of course could be an undesirable taste, odor or color characteristic. The actual method steps (a)-(d) are identical.
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.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL G FIEBIG whose telephone number is (571)270-5366. The examiner can normally be reached M-F 8-4.
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/RUSSELL G FIEBIG/Examiner, Art Unit 1655
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