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 .
Status of the Application
Receipt of the Response and Amendment after Non-Final Office Action filed December 31, 2025 is acknowledged.
Applicant has overcome the following by virtue of amendment of the specification and claims: (1) the objection to the specification has been withdrawn; and (2) the objections to the claims have been withdrawn.
The status of the claims upon entry of the present amendments stands as follows:
Pending claims:
49-62
Withdrawn claims:
60-61
Previously canceled claims:
1-48
Newly canceled claims:
None
Amended claims:
49, 52, 55, 56, 58, 61
New claims:
None
Claims currently under consideration:
49-59, 62
Currently rejected claims:
49-59, 62
Allowed claims:
None
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 49-54 and 62 are rejected under 35 U.S.C. 103 as being unpatentable over Czarnik (US 2011/0046236 A1)(IDS Reference filed 11/14/2022) in view of Richter (DE 952441C)(IDS Reference filed 11/14/2022) and Haadsma (US 5,708,018 A)(IDS Reference filed 11/14/2022).
Regarding claims 49-52 and 62, Czarnik teaches a deuterated alcohol (i.e., a substitute to normal alcohol; Abstract) where the beverage base can be beer ([0051]) or alcopop ([0050]).
Czarnik does not teach the beverage comprising 5-methoxy-2-aminoindan or wherein the beverage is a beer substitute comprising up to 0.70 mg/mL of 5-methoxy-2-aminoindan or the beverage is an alcopop substitute comprising up to 0.60 mg/mL.
Regarding the beverage comprising 5-methoxy-2-aminoindan, Richter teaches of analgesically active 2-aminoindan compounds ([0001]) including 5-methoxy-2-aminoindan ([0004]) (claims 52 and 62). 5-methoxy-2-aminoindan corresponds to R1 of -O(C1-C8)alkyl (i.e., -OCH3)(claim 51); R2 of H (claim 51); R3 of H (claim 50); and R4 of H (claim 50).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the beverage of Czarnik with the addition of 5-methoxy-2-aminoindan taught by Richter. One of ordinary skill would have been motivated to make this modification because Czarnik teaches that it is known in the art deuterization results in a reduction is analgesic properties ([0011]). Therefore, one of ordinary skill would be motivated to add 5-methoxy-2-aminoindan because Richter teaches that the compound has analgesic properties ([0001]).
Although the cited prior art does not teach the amount of 5-methoxy-2-aminoindan to add to the beverage, Haadsma teaches of 2-aminoindan analogs (col. 1, lines 10-11) including 5-methoxy-2-aminoindan (col 6, line 52), and administering the 2-aminoindan analogs in a therapeutically effective amount orally (col. 4, lines 8-13). Therefore, one of ordinary skill in the art would have adjusted the amount of 5-methoxy-2-aminoindan during routine optimization to find the amount that results in the desired therapeutic amount to replace the analgesic effect that was lost by deuterizing the ethanol of Czarnik. MPEP §2144.05(II) states where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The claimed ranges would thus be obvious.
Regarding claim 53, Czarnik in view of Richter and Haadsma teach all elements of claim 49. Czarnik also teaches when the beverage is beer, it comprises between 0.25% and 15.0% alcohol ([0051]), which overlaps with the claimed range of “more than 0.01% by volume but less than 0.50% by volume”.
With respect to the overlapping ranges, MPEP §2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Regarding claim 54, Czarnik in view of Richter and Haadsma teach all elements of claim 49. Czarnik also teaches when the beverage is an alcopop, it comprises between 0.25% and 20.0% alcohol ([0050]), which overlaps with the claimed range of “more than 0.01% by volume but less than 1.00% by volume”.
With respect to the overlapping ranges, MPEP §2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Claims 55-59 are rejected under 35 U.S.C. 103 as being unpatentable over Czarnik (US 2011/0046236 A1)(IDS Reference filed 11/14/2022) in view of Richter (DE 952441C)(IDS Reference filed 11/14/2022).
Regarding claim 55, Czarnik teaches a deuterated alcohol (i.e., a substitute to normal alcohol; Abstract) where the beverage base can be beer ([0051]), wine ([0052]), or other ingredients including water, fruit juice, and/or soda ([0078]).
Czarnik does not teach the beverage comprising 5-methoxy-2-aminoindan.
Regarding the beverage comprising 5-methoxy-2-aminoindan, Richter teaches of analgesically active 2-aminoindan compounds ([0001]) including 5-methoxy-2-aminoindan ([0004]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the beverage of Czarnik with the addition of 5-methoxy-2-aminoindan taught by Richter. One of ordinary skill would have been motivated to make this modification because Czarnik teaches that it is known in the art deuterization results in a reduction is analgesic properties. Therefore, one of ordinary skill would be motivated to add 5-methoxy-2-aminoindan because Richter teaches that the compound has analgesic properties.
Regarding claim 56, Czarnik teaches a deuterated alcohol (i.e., a substitute to normal alcohol; Abstract) where the beverage base can be wine ([0052]).
Czarnik does not teach the beverage comprising 5-methoxy-2-aminoindan.
Regarding the beverage comprising 5-methoxy-2-aminoindan, Richter teaches of analgesically active 2-aminoindan compounds ([0001]) including 5-methoxy-2-aminoindan ([0004]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the beverage of Czarnik with the addition of 5-methoxy-2-aminoindan taught by Richter. One of ordinary skill would have been motivated to make this modification because Czarnik teaches that it is known in the art deuterization results in a reduction is analgesic properties. Therefore, one of ordinary skill would be motivated to add 5-methoxy-2-aminoindan because Richter teaches that the compound has analgesic properties.
Regarding claim 57, Czarnik in view of Richter teach all elements of claim 56. Czarnik also teaches that when the beverage is wine, it typically comprises between 0.25% and 15.0% alcohol ([0052]), which overlaps with the claimed range of “more than 0.01% by volume but less than 5.0% by volume”.
With respect to the overlapping ranges, MPEP §2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Regarding claim 58, Czarnik teaches a deuterated alcohol (i.e., a substitute to normal alcohol; Abstract) where the beverage base can be soju ([0059]), which is a spirit ([0046]).
Czarnik does not teach the beverage comprising 5-methoxy-2-aminoindan.
Regarding the beverage comprising 5-methoxy-2-aminoindan, Richter teaches of analgesically active 2-aminoindan compounds ([0001]) including 5-methoxy-2-aminoindan ([0004]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the beverage of Czarnik with the addition of 5-methoxy-2-aminoindan taught by Richter. One of ordinary skill would have been motivated to make this modification because Czarnik teaches that it is known in the art deuterization results in a reduction is analgesic properties. Therefore, one of ordinary skill would be motivated to add 5-methoxy-2-aminoindan because Richter teaches that the compound has analgesic properties.
Regarding claim 59, Czarnik in view of Richter teach all elements of claim 56. Czarnik also teaches that when the beverage is soju (i.e., a spirit), it comprises between 0.25% to 50.0% alcohol ([0059]), which overlaps with the claimed range of “more than 0.01% by volume but less than 15% by volume”.
Response to Arguments
Specification: Applicant has overcome the objections to the specification based on amendments to the Specification. Accordingly, the objections have been withdrawn.
Claim Objections: Applicant has overcome the objections to the claims based on amendments in the Claims. Accordingly, the objections have been withdrawn.
Claim Rejections – 35 U.S.C. §103 of claims 49-54 and 62 over Czarnik, Richter, and Haadsma: Applicant’s arguments filed December 31, 2025 have been fully considered but they are not persuasive.
Applicant argued that one of ordinary skill would not have been motivated to modify and combine the teachings of Czarnik, Richter, and Haadsma. Applicant argued that Czarnik does not suggest any deficiency that would motivate a POSA to seek out additional additives and that Czarnik only teaches that analgesic properties are reduced when deuterating morphine (Remarks, p. 13, ¶ 3- p. 14, ¶ 2).
This argument has been considered. However, one of ordinary skill would have expected deuterated ethanol to have the same reduced analgesic effect as morphine. Evidence to support this is provided by Czarnik and Zambelli (Zambelli, Vanessa, et al. “Alcohol and analgesia: a fine wine getting better with age”, British Journal of Anaesthesia, Vol. 127, Issue 2, p. 181-184, published June 9, 2021 [accessed online February 5, 2026]). Czarnik teaches that the composition of the invention (i.e., the deuterated ethanol) leads to a slower formation of acetaldehyde ([0026]). Zambelli discloses that ethanol-induced analgesia occurs by acetate activating GABA, and that acetic acid come from the metabolization of acetaldehyde (p. 178, col. 1, ¶ 2-4). Thus, one of ordinary skill in the art would conclude that a reduced speed of the formation of acetaldehyde would result in a reduced analgesic effect in deuterated ethanol. The Examiner maintains that one of ordinary skill in the art would have included 5-methoxy-2-aminoindan in the product of Czarnik because of the reduced analgesic effect of deuterated alcohol. Additionally, although Czarnik does not suggest any deficiency, one of ordinary skill would recognize that the beverage of Czarnik is open to further improvements.
Applicant argued that Richter does not cure the deficiencies of Czarnik, and that one would not be motivated to apply Richter to such a beverage substitute just because it has analgesic effects (Remarks, p. 14, ¶ 3).
This argument has been considered. However, for the reasons stated above, the Examiner maintains that one of ordinary skill in the art would have included 5-methoxy-2-aminoindan in the product of Czarnik because of the reduced analgesic effect of deuterated alcohol.
Applicant additionally argued that the decision to add a compound of 5-methoxy-2-aminoindan to an alcoholic-beverage substitute can only be made by impermissible hindsight (Remarks, p. 14, ¶ 3- p. 15, ¶ 1).
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).
Applicant further argued that Haadsma does not cure the deficiencies of Czarnik or Richter and that the Examiner again relies on impermissible hindsight (Remarks, p. 15, ¶ 2-3).
One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Examiner maintains that Haadsma is adequate for all that is relied on in the present claim rejections, and the combination of references is adequate to deem the present claims obvious.
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).
Applicant argued that one of ordinary skill would not have had a reasonable expectation of success in arriving at the claimed subject matter (Remarks, p. 16, ¶ 1).
This argument has been considered. However, one of ordinary skill in the art would have had reasonable expectation of success combining the alcoholic beverage substitute of Czarnik with the 5-methoxy-2-aminoindan as taught by Richter to arrive at the claimed invention. There is nothing in prior art to suggest a lack of reasonable expectation of success would occur in combining the two products. Thus, one of ordinary skill would expect a reasonable expectation of success in creating an alcoholic beverage substitute with increased analgesic effects.
Applicant argued that dependent claims 50-54 and 62 are also not obvious (Remarks, p. 16, ¶ 2).
Applicant's arguments as related to claim 49 were determined to be unpersuasive as detailed previously herein. Examiner further maintains that the dependent claims are properly rejected in light of the cited combinations of prior art as described in the claim rejections.
Claim Rejections – 35 U.S.C. §103 of claims 55-59 over Czarnik and Richter: Applicant’s arguments filed December 31, 2025 have been fully considered but they are not persuasive.
Applicant argued that one of ordinary skill would not have arrived at the claimed inventions for the reasons discussed previously (Remarks, p. 17, ¶ 2-3).
This argument has been considered. However, claims 55-59 remain rejected as obvious in view of Czarnik and Richter for the reasons stated above with respect to claims 49-54 and 62.
The rejections of claims 49-62 have been maintained herein.
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 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 Amanda S Hawkins whose telephone number is (703)756-1530. The examiner can normally be reached Generally available M-Th 8:00a-5:00p, F 8:00-2:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emily Le can be reached at (571) 272-0903. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.S.H./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793