DETAILED ACTION
Status of Application
The Examiner acknowledges receipt of the amendments filed on 12/16/2025 wherein claim7 has been amended and claims 8 and 9 have been cancelled.
Claims 7, 10 and 11 are presented for examination on the merits. The following rejections are made.
Response to Applicants’ Arguments
Applicant’s amendments filed 12/13/2025 overcome the rejection of claims 7-11 made by the Examiner under 35 USC 112. This rejection is withdrawn.
Applicant’s arguments filed 12/13/2025 regarding the rejection of claims 7, 10 and 11 made by the Examiner under 35 USC 103 over Chang et al. (J Agri Food Chem, 2013, 61, 11016-11024) in view of Jang et al. (KR 102082106) and Srinivasan et al. (Current Res Food Sci I, 2019, 8-16) have been fully considered but they are not found persuasive and is MAINTAINED for the reasons of record in the office action mailed on 7/17/2025.
In regards to the 103 rejection, Applicant asserts the following:
A) there would be no reasonable expectation for success that the rejection would provide a method of treating hangover as both Chang and Jang fail to describe how extraction method affects average molecular weight of the polysaccharide let along the average molecular weight of the polysaccharide in various ethanol extracts. Moreover, the results of the present method are unexpected.
In response to A, the claims are ‘comprising’ claims and are thus open to unrecited elements. See MPEP 2111.03. Thus, so long as the method claimed is described, the prior art is applicable. In the present case, the maintained rejection describes a method of enhancing alcohol dehydrogenase activity by administering a composition of noni juice (and polysaccharides). More specifically, Chang’s noni juice is made by separating the solids of the juice via a mesh screen, centrifuging and then pasteurizing. The resulting juice contains phenolic acids and polysaccharides to which the bioactivity (enhanced alcohol metabolism) of the juice is attributed. It is taught that the polysaccharides can be isolated via precipitation with 95% ethanol. The method of Chang provides different dosages of the noni juice and extracted polysaccharides with a first group (1X) being administered 5 mL of the juice containing 107.08 mg of the polysaccharides, a second group (2X) administered 10 mL of the juice containing 214.15 mg of polysaccharide and a third group administered 15 mL of the juice containing 321.22 mg polysaccharide. Figure 3 A demonstrates that the activity of the 3X treatment group caused the largest increase in alcohol dehydrogenase. Figure 3C demonstrates that the 3X treatment group caused the greatest decrease in the relative expression of CYP2E1 (an enzyme which produces reactive oxygen species in alcohol metabolism). Regardless, all treatment groups showed improved alcohol clearance via alcohol and acetaldehyde dehydrogenase relative to control.
As the polysaccharides of noni juice are soluble in water and in essentially pure ethanol and it would reasonably follow that they would be present in mixtures of the two (an aqueous ethanol solution). To this end, Jang teaches that noni fruit extract for use in foods and health products can be extracted via 10-95% ethanol solution. One of ordinary skill in the art would expect the intervening fractions between pure water and 95% ethanol/5% water to be similarly capable of extracting polysaccharides from noni juice. Jang teaches that the ethanolic extract includes polysaccharides of 10 kDa (which overlaps with that claimed). Modifying Chang’s extract to be a 10-20% ethanol extract as taught by Jang would have been an obvious modification as the result would be a noni fruit extract similar to that described by the primary teaching. So long as the extract contains the polysaccharide bioactives, the extract should be capable of enhancing alcohol metabolism when consumed.
Regarding the unexpected results pointed to by Applicant, the Examiner is not persuaded as the claims are not commensurate in scope with that described. For instance, the administration of a polysaccharide having an average molecular weight between 8-10 kDa only requires the presence of said polysaccharide. The source of the polysaccharide, whether from the juice, aqueous extract or ethanol extract is immaterial. Chang’s juice would include such a polysaccharide as would Jang’s as both are directed to noni juice extracts where Jang’s extract includes overlapping ethanolic extracts. The administration of the compositions having such a polysaccharide would yield the desired outcome of treating hangover.
Figure 13 appears to show a fraction having improved alcohol dehydrogenase activity relative to other fractions. The Examiner acknowledges that this may demonstrate an unexpected outcome, however, this fraction is not currently the focus of the claimed invention.
Maintained Rejections, of Record
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.
Claims 7, 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al. (J Agri Food Chem, 2013, 61, 11016-11024; of record) in view of Jang et al. (KR 102082106; translation provided) and Srinivasan et al. (Current Res Food Sci I, 2019, 8-16).
Chang is directed to the use of noni juice as a composition for accelerating alcohol clearance from a subject post alcohol consumption via increased hepatic alcohol dehydrogenase (ADH) and acetaldehyde dehydrogenase (ALDH) activity (see abstract and Figure 3). Figure 3 demonstrates that administration of the noni juice composition enhances activity of alcohol dehydrogenase and aldehyde dehydrogenase whereas page 11021 indicates that the noni juice reduces concentration of blood alcohol and acetaldehyde (“supplementation increase ADH and ALDH activities”) (see instant claim 10). It is taught that noni juice comprises a mixture of polysaccharides, polyphenols and trace minerals (see abstract). Moreover, the ‘noni juice” of Chang is understood as overlapping with a “none fruit extract” as recited by the instant claims and is broadly applicable to “a food composition or a health functional food composition” as recited by instant claim 11. Chang states that the noni juice applied to enhance ADH and ALDH activity includes ‘crude polysaccharides’ which are precipitated via ethanolic extraction using 95% ethanol (see page 11017).
Chang fails to teach the method as including a polysaccharide having an average molecular weight of 8-10 kDa and the extract as being extracted with 10% ethanol.
Jang, similar to Chang, is directed a method of preparing a noni fruit extract for use in pharmaceutical and health foods (see abstract) to provide immune enhancing benefits. Jang teaches that their noni fruit extract is produced via extraction using a solution comprising from 10-95% ethanol (see page 3) (see claim 7). The extracts resulting from the process contains polysaccharides having a molecular weight of 10kDa or more (see page 4) which are taught to have immune enhancing activity. Thus, as the prior art recognizes that ethanolic extracts (e.g. 10%, 95%) of noni fruit would include polysaccharides having similar molecular weights to that specified by the claims, it would have been obvious to expect the noni juice of Chang to comprise them despite being unrecognized as such.
Chang (and Jang) fails to teach their method as being used to treat a hangover in a subject in need thereof.
Srinivasan is directed to the influence of food that increases ADH and ALDH activity on hangover. It is taught that alcohol consumption leads to hangover and that hangover may be alleviated by altering the rate of alcohol metabolism and facilitating elimination of acetaldehyde by affecting the activity of ADH and ALDH enzymes (see abstract). Srinivasan teaches that increasing ADH and ALDH activity can act to mitigate hangover and its symptoms (see page 15). Thus, it would have been obvious to modify Chang’s method such that in addition to mitigating the damage of alcohol consumption via enhanced ADH and ALDH activity, one would desire to expand the method so as to encompass treating hangover as taught by Srinivasan. Because the activity of ADH and ALDH are taught to increase clearance of ethanol and acetaldehyde from the body, the two main components associated with hangover, expanding Chang’s method to further encompass treating hangover would have been an obvious and desirable modification. See MPEP 2143(I)(A) which states that combining prior art elements according to known methods to yield predictable results is supportive of obviousness.
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Conclusion
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 extension fee 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 KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE A PURDY/Primary Examiner, Art Unit 1611