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 .
This office action is in response to amendment filed on 8/28/25. Claims 94,97,99,102-105,113 are amended. Claims 95-96,98,100-101,106-112 are cancelled and claims 114-115 are added. Claims 94,97,99,102-105,113-115 are pending.
The previous 112 second paragraph and 102 rejections are withdrawn due to the amendment.
Claim Rejections - 35 USC § 112
Claims 97,99,105,113,115 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.
In claim 97, the limitation “ does not substantially or completely extract pyrones and dicarbonyl compounds to be extracted at the second extraction” is not supported by the original disclosure. Applicant does not point to the support in the specification. The only disclosure pertaining to pyrones and dicarbonyl is at the bottom of page 16 which only discloses “ pyrones and dicarbonyl compounds are efficiently extracted early on with minimal residual levels present in the marc and the highest levels in extract A”. There is no disclosure defining what would constitute “ does not substantially or completely extract pyrones and dicarbonyl. The recitation “ does not substantially extract” indicates that the compounds are not extracted which would contradict the disclosure of “ efficiently extracted early on”. The recitation of “ does not completely extract pyrones and dicarbony” is not disclosed in the specification. It cannot be determined if the disclosure on page 16 is the same the limitation recited in claim 97. In claim 99, the limitation “ wherein the lipid soluble fraction includes pyrones and dicarbonyl compounds” is not disclosed in the specification. In claim 105, the limitation “ wherein the method utilized an SCCO2 extraction process to extract the pyrones and dicarbonyl compounds” is not supported by the original disclosure. Page 16 discloses that “ pyrones and dicarbonyl compounds are efficiently extracted early on” but there is no disclosure that SCCO2 is used . In claim 113, the limitation “ pyrones having molecular weight of 376,404 and/or 432 and dicarbonyl compound having molecular weight of 406 and 434 “ is not disclosed in the specification. The limitation “ wherein the mixture of active compounds is a lipid soluble fraction that is substantially or completely devoid of vanillin” is not disclosed in the specification.
Claims 97,105,113,115 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.
In claim 97, the limitation “ does not substantially or completely extract pyrones and dicarbonyl compounds” is vague and indefinite because it’s unclear how much of the compounds can be extracted to be considered as “ does not substantially extract or completely extract”. The same problem is noted for the limitation “ is substantially spent of vanillin, vanillic acid, p-hydroxybenzaldehyde and p-hydroxybenzoic acid”. It’s unclear how much of the compound is allowed to be in the first marc to be considered substantially spent.
In claim 105, the limitation “ substantially 35% by weight ethanol” is vague and indefinite because it’s unclear what is meant by “ substantially 35%”; is it 35% or not 35%. What does substantially 35% indicate?
In claim 113, the limitation molecular weight of 376,404,432,406,434 is vague and indefinite because it’s not clear what the numbers indicate because there is no unit to the numbers; 376 what? The limitation “ substantially devoid of vanillin” is vague and indefinite because it’s unclear how much of vanillin is allowed in the fraction to be considered “ substantially devoid”.
In claim 115, the limitation of “substantially spent” has the same problem as claim 113.
The new 112 rejections are necessitated by amendment.
Claim Rejections - 35 USC § 103
Claim(s) 94,97,99,102-105,113-115 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maestro ( 2007/0071710) in view of Clark ( 2013/0064946).
For claims 94,105 Maestro discloses an extraction process comprising a first extraction on a feedstock of Vanilla planifolia pod to obtain a first extract and residue and a second extraction step on the residue to produce a second extract. The first extraction is a solvent extraction in which the solvent can be chosen from methanol, ethanol, etc.. ( see paragraphs 0035, 0103-0108)
For claims 97,114,115 Maestro discloses the residue vanilla ground material is extracted a second time to obtain a second extracted fraction. Thus, it’s obvious the first extraction does not completely extract the compound present in the vanilla material. Since Maestro discloses extracting the same materials as the claimed method, it’s obviously inherently that the same compounds are present. Furthermore, Maestro discloses the extract of vanilla consists of liposoluble fraction comprising dicarbonyl compounds and pyranones. Since vanillin is extracted from the vanilla beans, it’s obviously inherent the residue is substantially spent of vanillin( see paragraphs 0022-0025,0103-0108)
For claim 99, the vanilla oleoresin extract obtained in Maestro is again extracted to yield liposoluble fraction of vanilla. Thus, the second extraction comprises extracting lipid soluble fraction from the residue ( marc). Since Maestro discloses extracting the same materials as the claimed method, it’s obviously inherently that the same compounds are present. Furthermore, Maestro discloses the extract of vanilla consists of liposoluble fraction comprising dicarbonyl compounds and pyranones. ( see also paragraphs 0114-0118)
For claim 102, Maestro discloses a third extraction step. ( see paragraph 0114-0118)
For claim 113, Maestro discloses formulation comprising the active compound obtained from the extraction method. Maestro discloses the extract of vanilla consists of liposoluble fraction comprising dicarbonyl compounds and pyranones. Maestro does not disclose the present of vanillin in the liposoluble fraction. As to the molecular weight, the numbers are indefinite as explained in the 112 rejection above. In any event, Maestro discloses the same compounds; thus, it’s expected the compounds have molecular weight within the ranges claimed. ( see paragraphs 0022-0031)
Maestro does not disclose the super critical CO2 extraction as in claim 94, third extraction removing compound from second marc as in claim 103, SCCO2 extraction as in claims 104,105 and the concentration of ethanol as in claim 105.
Clark discloses that supercritical fluid extraction is a known extraction method for selectively extracting one material from a solid or liquid. Supercritical fluids have a significant capacity to dissolve substances. The ability of a supercritical fluid for selectively dissolving a substance during extraction process is influenced by the specific conditions of pressure and temperature within the supercritical fluid regions at which the extraction is performed. By selecting a supercritical solvent with proper critical temperature, the extraction process may be conducted at a relatively low temperature, thus minimizing and possibly avoiding denaturation or decomposition of heat-liable compounds and loss of volatile components. Because of the ability to remove substantially all of the extraction fluid from the material extracted, SFE is often a preferred alternative to liquid extraction using organic solvents. Supercritical CO2 extraction is known in food processing industry. ( see paragraphs 0003-0013)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use SCCO2 extraction as taught in Clark in the second and third extraction steps in the Maestro process when desiring to remove more selective compounds from the material being extracted. One would have been motivated to use SCCO2 for better result of more completely removing extraction fluid and minimizing decomposition and loss of volatile components. Clark teaches that the conditions of the SCCO2 extraction can be changed to target different substances. Thus, it would have been obvious to one of ordinary skill in the art to change the condition of each extraction step depending on the substances targeted. Such parameter can readily be determined by one of ordinary skill in the art. It would have been obvious to change the concentration of alcohol depending on the degree of the extraction desired. Generally, difference in concentration does not support patentability is absence of showing of criticality or unexpected result. It would have been obvious to repeat extraction on the residue after second extraction when desiring to ensure complete removal of wanted compounds before discarding the used material.
Response to Arguments
Applicant's arguments filed 8/28/25 have been fully considered but they are not persuasive.
` In the response, applicant argues that Maestro is satisfied with the 31% yield of vanilla oleoresin from the two combined ethanol extraction. Applicant asserts that in the industry, a 31% extractive yield from ground vanilla pod would be considered high. The person of ordinary skill in the art would not be motivated to try any further extraction such as using supercritical carbon dioxide since it would be recognized that the marc was effectively already spent of all extractable compounds. This argument is not persuasive. Maestro discloses the yield is 31%. There is no disclosure that the yield is high or satisfactory. Applicant has not submitted any evidence to show that a yield of 31% is so high that one would not be motivated to make change to extraction process to obtain a higher yield. If there is known alternative that gives improvement to a process, one skill in the art would have been motivated to incorporate such teaching to optimize the process and thus give better end result. Applicant further argues that using the office action’s logic, the ordinary skilled person would need to purposely substitute the advantageous molecular distillation step for a supercritical carbon dioxide extraction step which was not suggested by Maestro. This argument is not persuasive. The molecular distillation step is a post extraction step on the liposoluble fraction. The step is not part of the extraction process. The claimed language doesn’t exclude additional step. There is no suggestion to substitute the molecular distillation step with the supercritical carbon dioxide extraction. It’s suggested to incorporate the SCCO2 in the extraction processing. Applicant argues the rejection is based on hindsight. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case, the motivation to incorporate a SCCO2 step is not gleaned from applicant’s disclosure. Clark teaches the benefits of using SCCO2 extraction. One skilled in the art would have been motivated to incorporate the teaching to obtain the benefits disclosed in Clark.
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.
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November 7, 2025
/LIEN T TRAN/Primary Examiner, Art Unit 1793