DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The amendment filed December 26, 2025 has been received and entered. The text of those sections of Title 35, U.S. Code, not included in this action can be found in a prior Office action. Any rejection set forth in a previous Office action that is not specifically set forth below is withdrawn.
3. Claims 1-5, 8-10, 13-16, 20, 21, 23, 26, 29, and 31-34 are pending.
Election/Restrictions
4. In the reply filed on April 22, 2025, applicant elected Group I, claims 1-5, 8-10, 13-16, 20, and 32-34, an extraction solution comprising a mixture of water and DES (deep eutectic solvent) for species A, phenolic diterpenes and carnosic acid and/or its derivatives for species B, and betaine and levulinic acid for species C, without traverse.
5. Claims 2, 21, 23, 26, 29, and 31-34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 22, 2025.
6. Claims 1, 3-5, 8-10, 13-16, and 20 are examined on the merits in regards to the elected species.
Claim Rejections - 35 USC § 103
7. Claim(s) 1, 3-5, 8-10, 13, 16, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lavaud (US 2018/0055904) in view of Miyazaki (US 6,638,523) for the reasons set forth in the previous Office action.
All of applicant’s arguments regarding this ground of rejection have been fully considered but are not persuasive. Applicant argues:
In contrast to the method of Miyazaki, the eutectic extraction process described by Lavaud does not include a concentration step. This is because deep eutectic solvents cannot be evaporated or removed by conventional means, as they lack a practical boiling point. This characteristic makes it particularly challenging to precipitate the active compounds extracted in deep eutectic solvents. The purification strategy of Miyazaki, which relies on concentrating the extract before dilution to trigger precipitation, is fundamentally incompatible with the eutectic extraction process.
Establishing a prima facie case of obviousness requires showing that one of ordinary skill in the art would have had both an apparent reason or suggestion to modify the prior art and predictability or a reasonable expectation of success in doing SO. See KSR Int'l Co. V. Teleflex Inc., 550 U.S. 398, 418 (2007); In re Vaeck, 947 F.2d 488, 493 (Fed. Cir. 1991); "[o]bviousness requires more than a mere showing that the prior art includes separate references covering each separate limitation in a claim under examination." Unigene Labs., Inc. v. Apotex, Inc., 655 F.3d 1352, 1360 (Fed. Cir. 2011). Proof of obviousness requires a showing of at least a reasonable expectation of success from the perspective of a person of ordinary skill in the art. In re Vaeck, 947 F.2d 488, 493 (Fed. Cir. 1991); Life Techs., 224 F.3d at 1326. One having ordinary skill in the art would not be motivated to add the water precipitation step Miyazaki to the eutectic extraction method of Lavaud as eutectic extraction methods do not involve concentration of the extraction solution, and there is no reasonable expectation that adding water to an unconcentrated extraction solution comprising a DES would successfully result precipitation of targeted lipophilic, hydrophobic, oil soluble and/or non-water-soluble compounds from the biological material being extracted.
However, applicant’s arguments are not persuasive. Lavaud specifically teaches that the biological material is mixed with the Deep Eutectic solvent solution and filtered to obtain a liquid extract. The reference then teaches that the liquid extract can be purified such as by evaporation. The reference teaches that the purified extract may or may not contain the DES solution (see paragraphs 62 and 65). This is a concentration step. An artisan interested in purification of the components of interest in Lavaud, i.e. rosmarinic acid and carnosol, would logically look to the related prior art to determine what types of purifications for these compounds was known. Miyazaki demonstrates that water washing and precipitation were known to be useful in purifying these components. Thus, an artisan would have a reasonable expectation that the addition of the extraction steps taught by Miyazaki would be useful in further purifying the compounds of interest in Lavaud. Therefore, applicant’s claimed invention is considered to be an obvious modification of what was known in the art at the time of the invention.
8. Claim(s) 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lavaud (US 2018/0055904) in view of Miyazaki (US 6,638,523) as applied to claims 1, 3-5, 8-10, 13, 16, and 20 above, and further in view of Duan (ACS Sustainable Chem. Eng. (2016), vol. 4, pp. 2405-2411) for the reasons set forth in the previous Office action.
Applicant argues that Duan does not cure the deficiencies of the combination of Lavaud and Miyazaki. However, this rejection is still considered to be valid for the reasons discussed above. Therefore, applicant’s argument is not persuasive.
9. No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Susan Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 5:00pm.
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/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655