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 .
Applicant's election with traverse of Group II, claims 14-20 in the reply filed on 11 November 2025 is acknowledged. (Though, it is unclear why since the claims of Group I (1-13) appear to be the same as claims 1-13 in previous Application 15/654834).
The traversal is on the ground(s) that there would not be a serious search burden to examine the inventions together. This is not found persuasive because as set forth in the election/restriction requirement. Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply: the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries); the prior art applicable to one invention would not likely be applicable to another invention; the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention.
Claims 14-20 are presented for examination on the merits.
Double Patenting
Claim 14-20 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.
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 14-20 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 recites the limitation "the nicotine content" in line 1. Applicant does not claim a nicotine containing plant material or recite any other instance of nicotine, so it is not clear what nicotine content is being removed. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gerardi et al. (US2014/0343254), in view of Mua (US2014/0271952).
Gerardi teaches homogenizing tobacco leaves to provide a green juice (homogenizing tobacco leaves to provide a green juice (which reads on receiving a plant-derived, protein enriched material comprising RuBisCO, F2 fraction proteins, or a combination thereof, wherein the material further comprises undesirable nicotine, since this is inherent to tobacco leaves), adjusting the pH to 10.5 with sodium hydroxide (which reads on step b or claim 14 and the limitations of claim 15), filtering with 500, but that a 10kDa provides higher percentages of F2 protein and wherein the fraction is concentrated to give a RuBisCO protein containing retentate (comprising about 75-85% protein by weight) and stored.
Mua further teaches that the permeate is cooled to 8o C. and processed on a 1 kDa reverse osmosis filter using tangential flow filtration and washed with the glycine solution and concentrated to give a F2 fraction protein-enriched tobacco-derived material (comprising about 30-40% F2 protein, although higher percentages, e.g., 65% have been obtained using alternate filtration methods, e.g., using 10 kDa and/or 20 kDa filters in place of the 1 kDa filter) (See e.g. Example 4, paragraphs 0085-0086).
Gerardi further teaches that the protein-enriched material can be kept at a pH of about 9.5-10 to maintain the protein solubility and ensure free base nicotine permeability. Gerardi further teaches that the filtrate was freeze dried and provided less than 1ug/g nicotine (See e.g. Example 7, which encompasses the amount claimed in claim 20). Gerardi further teaches that the protein solution can be heated between about room temperature and about 100o C. or between about room temperature and about 80oC. (e.g., between about 50oC. and about 70oC., such as at about 60oC.) (See e.g. para 0048, which encompasses the temperature claimed in claim 17).
Gerardi does not teach hydrogen peroxide or heating the solution before, during or both before and during the mixing step of c.
Mua teaches the same process steps of Gerardi: homogenizing tobacco leaves to provide a green juice (which reads on receiving a plant-derived, protein enriched material comprising RuBisCO, F2 fraction proteins, or a combination thereof, wherein the material further comprises undesirable nicotine, since this is inherent to tobacco leaves), adjusting the pH to 10.5 with sodium hydroxide (which reads on step b or claim 14 and the limitations of claim 15), filtering with 500, but that a 10kDa provides higher percentages of F2 protein and wherein the fraction is concentrated to give a RuBisCO protein containing retentate (comprising about 75-85% protein by weight) and stored. Mua further teaches that the permeate is cooled to 8oC and processed on a 1 kDa reverse osmosis filter using tangential flow filtration and washed with the glycine solution and concentrated to give a F2 fraction protein-enriched tobacco- derived material (comprising about 30-40% F2 protein, although higher percentages, e.g., 65% have been obtained using alternate filtration methods, e.g., using 10 kDa and/or 20 kDa filters in place of the 1 kDa filter) (See e.g. Example 4, paragraphs 0118-0119). Mua further teaches that the protein-enriched material can be used directly, but that the material can be thermally treated and this can be conducted before or after any of the processes described herein. Mua further teaches that tobacco material can be thermally processed by mixing the tobacco material, water, and an hydrogen peroxide to form a moist tobacco mixture; and heating the moist tobacco mixture at a temperature of at least about 60oC. to form a heat-treated tobacco mixture. (See e.g. para 0089). Mua further teaches that the filter can have a pore size of between 1 um and 1kDa (See e.g. claim 11) and can be spray dried (See e.g. claim 16).
It would have been obvious to one of ordinary skill in the art to prepare a nicotine reduced plant- derived protein-enriched material because at the time the invention was made, it was known that a nicotine reduced protein-enriched material could be obtained by the instantly claimed method steps as clearly taught by both Gerardi and Mua. A person of ordinary skill in the art would have understood to modify the method by mixing the base treated mixture with hydrogen peroxide and to heat the material because Mua teaches that the protein-enriched material can be thermally treated with hydrogen peroxide and then heated and Gerardi teaches that the material can be heated at a temperature that encompasses the claimed range. A person of ordinary skill in the art would have understood add hydrogen peroxide to the base treated mixture to provide a more effective method for obtaining protein-rich material with lower nicotine, since the methods taught by Gerardi and Mua result in the same material and have the samemethod steps. A person of ordinary skill in the art would have understood to adjust the temperature to heat the protein containing material based upon the beneficial teachings of Gerardi and Mua. The skilled artisan in the art would have understood to include and adjust the temperature of the material with expectation of success. A person of ordinary skill in the art would have understood to use hydrogen peroxide to further process the protein-containing material and to include this step in the process taught by Gerardi since the method steps taught by both Gerardi and Mua are the same and the product taught by both is the same. Therefore, the skilled artisan would have been motivated to use hydrogen peroxide and to heat the protein containing material to the instantly claimed temperature range based upon the beneficial teachings of Gerardi and Mua.
From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Terry McKelvey can be reached at 5712720775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUSSELL G FIEBIG/ Examiner, Art Unit 1655
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