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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/2/2026 has been entered.
Priority
The present application is a continuation of application number 16/624,398, which claims priority to provisional application 62/526,181, filed 06/28/2017.
Status of the Claims
Claims 49-65 are pending and under current examination. Claims 1-48 are cancelled.
Withdrawn Claim Rejections
All double patenting rejections pertaining to co-pending application no. 18/080,346 are withdrawn in view of the terminal disclaimer filed 2/2/2026 and approved 3/2/2026.
All rejections pertaining to claims 33-48 are moot because the claims are cancelled in the amendments to the claims filed 2/6/2026.
All rejections not reiterated have been withdrawn.
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 49-65 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.
The term “improving cognitive performance” in claim 49 is a relative term which renders the claim indefinite. The term “improving cognitive performance” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification provides no guidance for what the term performance entails and what a baseline is that improvement should be measured against.
Claims 62-65 recite the limitation "the method of claim 49, wherein said coating comprises…" in line 1. There is insufficient antecedent basis for this limitation in the claims.
Regarding claims 50-61, claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the indefiniteness concerns outlined above.
Response to Arguments
Applicant's arguments filed 2/2/26 have been fully considered but they are not persuasive.
On page 5, Applicant argues that the amended claim 49 recites a method for improving cognitive performance of a human during a right shift of an oxygen-hemoglobin dissociation curve. However, the amended claims do not address the indefiniteness concerns regarding the relative term “improving cognitive performance” or the antecedent basis concerns as described in the 35 U.S.C. 112(b) rejection above, therefore the rejection is maintained.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 49-53, 55, and 57-60 are rejected under 35 U.S.C. 103 as being unpatentable over Stella (U.S. Patent Application 2014/0371174, publication date: 12/18/2014, of record) in view of Van Dorp et. al. (Aviation, Space and Environmental Medicine, pg. 666-672, publication year: 2007, cited in the IDS filed 10/18/2022).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claim 49, Stella teaches a chewable dosage form that may contain calcium carbonate, sodium bicarbonate, and an acid [0070]. The acid and effervescent agent present in the chewable dosage can react in the oral cavity to form carbon dioxide [0068]. Stella also teaches that the tablet is for use or consumption by humans [0029].
Regarding claims 50 and 51, Stella teaches that the acid present in the composition may be citric acid, tartaric acid, malic acid, or ascorbic acid [0070].
Regarding claim 52, Stella teaches a chewable dosage form that may contain calcium carbonate, sodium bicarbonate, and an acid [0070].
Regarding claim 53, Stella teaches that the bicarbonate present in the composition may be sodium bicarbonate or potassium bicarbonate [0065].
Regarding claims 55, 58 and 59, Stella teaches a chewable dosage form that may contain calcium carbonate at 10-70%, sodium bicarbonate at 1-20%, and an acid at 1-15% [0070] and that the carbon dioxide evolves from the tablet when it is exposed to water [0088].
Regarding claim 57, Stella teaches that the acid present in the composition may be ascorbic acid [0070] and that the bicarbonate present in the composition may be sodium bicarbonate [0065].
Regarding claim 60, Stella teaches a chewable dosage form [0060].
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claim 49, Stella does not teach that the carbon dioxide released by the composition is for inhalation or a used in a method for improving cognitive performance. However, this deficiency is cured by van Dorp.
Van Dorp teaches that inhaled carbon dioxide during hypoxia improves cognitive performance and that the inhaled CO2 may also have reversed the hypocapnia-induced impairment of brain metabolic function and may have reversed an alkalosis-induced leftward shift of the oxyhemoglobin-dissociation curve. The increase in end-tidal CO2 going from poikilocapnic hypoxia to isocapnic hypoxia was sufficient to cause a mild rightward shift of the oxygen dissociation curve, which will further increase the release of oxygen form hemoglobin during hypoxia, and thus increase oxygenation of the brain (pg. 671, Discussion).
Regarding claims 55, 58 and 59, Stella does not teach that the carbonate or acid is present in the composition in dry form.
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claim 49, it would have been prima facie obvious to one of ordinary skill in the art of filing that the carbon dioxide released by the tablet embraced by Stella may also be inhaled by the subject. One would have understood that the carbon dioxide released into the mouth by the tablet embraced by Stella is suitable for inhalation because it is released directly into the mouth where it may be readily inhaled. The artisan of ordinary skill would have had reasonable expectation of success because the composition of the instant claims and that embraced by Stella both release carbon dioxide directly into the mouth of the patient after reaction between the acid and carbonate present in the composition. See MPEP 2144.07.
Furthermore, it would have been prima facie obvious to one of ordinary skill in the art of filing that the carbon dioxide released by the composition of Stella may be used in a method of improving cognitive function. One would have understood in view of van Dorp that inhaled CO2 may reverse the hypocapnia-induced impairment of brain metabolic function and may also reverse an alkalosis-induced leftward shift of the oxyhemoglobin-dissociation curve, thus contributing to an improvement in cognitive performance during poikilocapnic and isocapnic hypoxia (pg. 671, Discussion). It would have been obvious that the carbon dioxide released by the composition of Stella may also improve cognitive performance. One of ordinary skill in the art of filing would have been motivated to use the composition of Stella in a method of improving cognitive performance in order to provide a source of carbon dioxide directly into the mouth for inhalation. The artisan of ordinary skill in the art of filing would have had reasonable expectation of success because van Dorp teaches that inhaled CO2 may improve cognitive performance and cause a mild rightward shift of the oxygen dissociation curve, which will further increase the release of oxygen form hemoglobin during hypoxia, and thus increase oxygenation of the brain (pg. 671, Discussion).
Regarding claims 55, 58, and 59, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing that the carbonate and acid present in the tablet embraced by Stella are in dry form. One would have understood in view of Stella that the tablet comprised of acid and a carbonate releases carbon dioxide when exposed to water [0088]. It would have been obvious to one of ordinary skill in the art of filing that the carbonate and acid present in the composition embraced by Stella are in dry form. One of ordinary skill would have been motivated to include the carbonate in dry form in order to avoid release of carbon dioxide from the tablet prior to placing the tablet into the mouth of the patient. The artisan of ordinary skill would have had reasonable expectation of success because Stella teaches that the effervescent tablet releases carbon dioxide when exposed to water.
Claim 54 is rejected under 35 U.S.C. 103 as being unpatentable over Stella (U.S. Patent Application 2014/0371174, publication date: 12/18/2014, of record) in view of Van Dorp et. al. (Aviation, Space and Environmental Medicine, pg. 666-672, publication year: 2007, cited in the IDS filed 10/18/2022), as applied to claims 49-53, 55, and 57-60 above, and further in view of Chem Europe (Magnesium Carbonate, available online 2/19/2014, of record).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Stella, in view of van Dorp, teaches the relevant limitations of claim 49 as described above. Stella also teaches that magnesium carbonate may be present in the composition [0059].
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Stella does not teach that magnesium bicarbonate may be present in the composition. However, this deficiency is cured by Chem Europe.
Chem Europe teaches that when magnesium bicarbonate is dried, it decomposes into hydrated magnesium carbonate. Magnesium carbonate may then react with acid to release carbon dioxide (pg. 1, Reactions).
Finding of a Prima Facia Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing that magnesium bicarbonate cannot exist in a solid effervescent tablet and must be present as magnesium carbonate. One would have understood in view of Chem Europe that when magnesium bicarbonate is dried, as it would be to form the tablet embraced by the instant claims, it degrades into hydrated magnesium carbonate. It would have been obvious that any magnesium bicarbonate included in the composition embraced Stella would degrade into magnesium carbonate after drying to form the effervescent tablet. One would have been motivated to include magnesium carbonate in the composition because it reacts with acid to form carbon dioxide. The artisan of ordinary skill would have had reasonable expectation of success because Chem Europe teaches that magnesium carbonate releases carbon dioxide when reacting with acid.
Claim 56 is rejected under 35 U.S.C. 103 as being unpatentable over Stella (U.S. Patent Application 2014/0371174, publication date: 12/18/2014, of record) in view of Van Dorp et. al. (Aviation, Space and Environmental Medicine, pg. 666-672, publication year: 2007, cited in the IDS filed 10/18/2022), as applied to claims 49-53, 55, and 57-60 above, and further in view of Bonuccelli (Hands on Activity: Reaction Exposed: The Big Chill, available online 3/14/2017, of record).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Stella teaches the relevant limitations of claim 49 as described above. Stella also teaches that the acid and effervescent agent in the composition can react in the oral cavity to form carbon dioxide [0068].
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Stella does not teach that the reaction between the acid and the effervescent agent to release carbon dioxide is endothermic. However, this deficiency is cured by Bonuccelli.
Bonuccelli teaches that when sodium bicarbonate and citric acid are in the presence of water, the reaction to form carbon dioxide is an endothermic reaction (pg. 1, Summary).
Finding of a Prima Facia Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing that the reaction between the acid and effervescent agent to release carbon dioxide in the tablet embraced by Stella is endothermic. One would have understood in view of Bonuccelli that the reaction of sodium bicarbonate and a weak acid, such as citric acid, to release carbon dioxide, is an endothermic reaction. It would have been obvious to one of ordinary skill in the art of filing that the reaction that occurs between the acid and effervescent agent in the tablet embraced by Stella is also endothermic. See MPEP 2144.02.
Claims 61, 62, 64 and 65 are rejected under 35 U.S.C. 103 as being unpatentable over Stella (U.S. Patent Application 2014/0371174, publication date: 12/18/2014, of record) in view of Van Dorp et. al. (Aviation, Space and Environmental Medicine, pg. 666-672, publication year: 2007, cited in the IDS filed 10/18/2022), as applied to claims 49-53, 55, and 57-60 above, and further in view of Lieberman, et. al. (Pharmaceutical Dosage Forms, Volume 1, publication year: 1989, cited in the IDS filed 12/17/2024, of record).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 61, 62, 64, and 65, Stella, in view of van Dorp, teaches the relevant limitations of claim 49 above. Stella also teaches that the composition may be a tablet [0044].
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claim 61, Stella does not teach that the tablet comprises a coating. However, this deficiency is cured by Lieberman.
Lieberman teaches that coatings on a tablet may cover a bitter substance or conceal an unpleasant or mottled appearance (pg. 247, I. Compression Coating). Compression coatings may also serve to help sustain release of the active substance and slow down disintegration and dissolution of the tablet (pg. 248, I. Compression Coating, third paragraph).
Regarding claim 62, Stella does not teach shellac or polyvinyl pyrrolidone as a coating for the tablet. However, this deficiency is cured by Lieberman
Lieberman teaches that effervescent tablets may be encapsulated using polyvinyl pyrrolidone (pg. 305, last paragraph) and shellac (pg. 372, last paragraph).
Regarding claim 64, Stella does not teach a cellulose acetate phthalate coating on the effervescent tablet. However, this deficiency is cured by Lieberman.
Lieberman teaches that effervescent tablets may use enteric coatings such as cellulose acetate phthalate (pg. 286, third paragraph).
Regarding claim 65, Stella does not teach an acrylate polymer as a coating on the tablet composition. However, this deficiency is cured by Lieberman.
Lieberman teaches that methacrylic acid polymers may be used for coatings on effervescent tablets (pg. 305, last paragraph).
Finding of a Prima Facia Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claim 61, it would have been prima facie obvious to one of ordinary skill in the art of filing to include a coating on the tablet embraced by Stella. One would have understood in view of Stella that the acid present in the composition can give the tablet a sour or chalky taste depending on the composition of carbonate and acid present in the tablet [0014]. It would have been obvious to one of ordinary skill in the art that a coating described by Lieberman may be used to mask any potential unpleasant taste of the tablet embraced by Stella. One of ordinary skill would have been motivated to use a coating in order to improve the taste of the tablet embraced by Stella. The artisan of ordinary skill would have had reasonable expectation of success because Lieberman teaches that a coating may be used to mask an unpleasant taste of a tablet.
Regarding claim 62, it would have been prima facie obvious to one of ordinary skill in the art of filing to include polyvinyl pyrrolidone and shellac as the coating on the tablet embraced by Stella. One would have understood in view of Lieberman that a polyvinyl pyrrolidone coating provides a stabilizing effect to effervescent tablets (pg. 305, last paragraph) and that shellac can help to mask taste (pg. 372, B. Microencapsulation). It would have been obvious to utilize polyvinyl pyrrolidone and shellac as a coating on the tablet embraced by Stella. One of ordinary skill would have been motivated to use polyvinyl pyrrolidone and shellac in order to improve the stability or taste of the tablet. The artisan of ordinary skill would have had reasonable expectation of success because Lieberman teaches that polyvinyl pyrrolidone and shellac may be used as coatings on oral dosage tablets.
Regarding claim 64, it would have been prima facie obvious to one or ordinary skill in the art of filing to use a cellulose acetate phthalate coating on the tablet embraced by Stella. One would have understood in view of Lieberman that the enteric coating prevents dissolution of an effervescent tablet until it reaches the intestine. It would have been obvious to one of ordinary skill in the art of filing to use cellulose acetate phthalate as a coating on the effervescent tablet embraced by Stella. One of ordinary skill would have been motivated to use cellulose acetate phthalate as a coating on the tablet in order to prevent dissolution of the tablet in the stomach if swallowed. The artisan of ordinary skill would have had reasonable expectation of success because Lieberman teaches that cellulose acetate phthalate may be used as a coating on effervescent tablets.
Regarding claim 65, it would have been prima facie obvious to one of ordinary skill in the art of filing to include an acrylate polymer as the coating on the tablet embraced by Stella. One would have understood in view of Lieberman that methacrylic acid polymers provide a stabilizing effect to effervescent tablets (pg. 305, last paragraph). It would have been obvious to utilize methacrylic acid polymers as a coating on the tablet embraced by Stella. One of ordinary skill would have been motivated to use methacrylic acid polymers in order to improve the stability of the tablet. The artisan of ordinary skill would have had reasonable expectation of success because Lieberman teaches that methacrylic acid polymers be used as a coating on oral dosage tablets.
Claim 63 is rejected under 35 U.S.C. 103 as being unpatentable over Stella (U.S. Patent Application 2014/0371174, publication date: 12/18/2014, of record) in view of Van Dorp et. al. (Aviation, Space and Environmental Medicine, pg. 666-672, publication year: 2007, cited in the IDS filed 10/18/2022), as applied to claims 49-53, 55, and 57-60 above, and further in view of Lieberman, et. al. (Pharmaceutical Dosage Forms, Volume 1, publication year: 1989, cited in the IDS filed 12/17/2024, of record) and Nesbitt et. al. (International Journal of Pharmaceutics, pages 215-226; publication year: 1985, of record).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Stella, in view of van Dorp, teaches the relevant limitations of claim 49 above.
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Stella does not teach that the tablet may comprise a polyvinyl acetate phthalate coating. However, this deficiency is cured by Lieberman and Nesbitt.
Lieberman teaches that effervescent tablets may use enteric coatings (pg. 286, third paragraph) and Nesbitt teaches that polyvinyl acetate phthalate is an enteric coating (pg. 215, Summary).
Finding of a Prima Facia Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one or ordinary skill in the art of filing to use a polyvinyl acetate phthalate coating on the tablet embraced by Stella. One would have understood in view of Lieberman that an enteric coating prevents dissolution of an effervescent tablet until it reaches the intestine and in view of Nesbitt that polyvinyl acetate phthalate is an enteric coating. It would have been obvious to one of ordinary skill in the art of filing to use an enteric coating such as polyvinyl acetate phthalate as a coating on the effervescent tablet embraced by Stella. One of ordinary skill would have been motivated to use polyvinyl acetate phthalate as a coating on the tablet in order to prevent dissolution of the tablet in the stomach if swallowed. The artisan of ordinary skill would have had reasonable expectation of success because Lieberman teaches that enteric coatings may be used for effervescent tablets.
Response to Arguments
Applicant’s arguments with respect to the rejection of claims 49-65 under 35 U.S.C. 103 over Stella in view of Laffey, Harvey, Tanaka, Training Mask Review, Chem Europe, Bonuccelli, Liberman, and Nesbitt have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH ANNE MEYERS whose telephone number is (571)272-2271. The examiner can normally be reached Monday-Friday 8am-5pm ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
ELIZABETH ANNE MEYERSExaminer, Art Unit 1617
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614