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 .
Claims and Previous Objections/Rejections Status
Claims 45,47-51,53-55 and 58-75 are pending in the application. Claims 1-7,10,11,14-31 and 46 are cancelled in the amendment filed 2/2/26.
Any objections and/or rejections from previous office actions that have not been reiterated in this office action are obviated.
The terminal disclaimer filed 2/2/26 was approved on 3/2/26.
Modified Grounds of Rejection Necessitated by the Amendment
Response to Arguments
Applicant's arguments filed 2/2/26 have been fully considered but they are not persuasive.
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.
Claim(s) 45,47-51,53-55 and 58-75 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yanze et al. (Drug Dev. Indust. Pharm. 26(11), 1167-1176) (2000)), as evidenced by Hands-on Activity 2013 (Summary) in view of Lieberman, H.A. et al. Pharmaceutical Dosage Forms: Tablets Volume 1, Second Edition. New York: Marcel Dekker, Inc. 1989 and Effer-K® (Dailymed 5/12) and in further view of So et al. (US 4,760,138), Bakan et al. (US 9,561,241B1) and Baker (US 2016/0367442A1) as stated in the office action mailed 10/2/25 but modified to include Rasor et al. (US 7,748,379B2) and Niinimaa et al. (Respir. Physiol. 1981, 43, 69-75).
With regards to the amendment to include inhaling the CO2 through the mouth and exhaling through the nose to maintain more CO2 within the mouth for a subsequent inhalation of the instant claims, Rasor et al. (US 7,748,379B2) discloses the method of delivery carbon dioxide to patients for therapeutic therapy (abstract; column 5, lines 48-63).
The carbon dioxide is directed into the patient’s mouth and allowed to exit through either or both nostrils (column 6, lines 12-45, especially lines 43-45; column 11, lines 20-22; column 19, Transmucosal Treatment). The inhalation of carbon dioxide occurs through the mouth with exit through the nose while the breath is held (column 11, lines 20-22) to bathe the mucous membranes (abstract).
Niinimaa et al. (Respir. Physiol. 1981, 43, 69-75) discloses the examination of oronasal distribution of respiratory airflow in 30 healthy adult via nasal airflow measurements (abstract). Subjects included normal augmenters switching from nasal to oronasal breathing, mouth breathers habitually breathing oranasally, nose breathers persistently breathing though the nose only and a subject showing no consistent nose/mouth breathing pattern (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the carbon dioxide released from the effervescent tablets of Yanze et al. is inhaled by a human subject upon dissolution and/or upon drinking as raising a drinking vessel
comprising an effervescent tablet to the mouth will allow for oral inhalation.
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention for human subjects to inhale the carbon dioxide via the mouth and exhale through the nose to bathe the mucous membrane in carbon dioxide as taught by Rasor et al. for the advantage of therapeutic treatment and because different human subjects have various breathing patterns that include no consistent nose/mouth breathing pattern, as taught by Niinimaa et al. that predictably includes inhaling through the mouth and exhaling through the nose prior to subsequent inhalation.
Response to Arguments
Applicant's arguments filed 2/2/2/26 have been fully considered but they are not persuasive.
Applicant asserts that independent claim 45 was amended herein to recite a method for delivering CO2 to a human that comprises (a) placing a composition into a container for drinking comprising a drinking liquid, (b) inhaling the CO2 from the container through the mouth, and (c) exhaling through the nose to maintain more CO2 within the mouth for a subsequent inhalation. At no point does the combination of cited references teach or suggest such a method for delivering CO2 to a human. In fact, the combination of cited reference does not teach or suggest (a) placing a composition into a container for drinking comprising a drinking liquid, where at least 90 percent of the composition consists of an acid in dry form and a carbonate in dry form, (b) inhaling the CO2 from the container through the mouth, and (c) exhaling through the nose to maintain more CO2 within the mouth for a subsequent inhalation.
The reference of Yanze et al. was used to teach of effervescent tablets comprising anhydrous citric acid powder and sodium bicarbonate and adding the effervescent tablets to a beaker containing 200 mL of distilled water.
The reference of Yanze et al. further teaches of formulation A which comprises 43.2g AcAmcp,
56.8g SBCmcp, 1g PEGvfp and 3 g SBvfp which yields 104 g total. The 4 g PEGvfp and SBvfp of the tablet composition is 3.84% of the total tablet composition which leaves 96% of the citric acid and sodium bicarbonate of the remaining total tablet composition and encompasses the at least about 90% and/or at least about 95% acid and carbonate of the instant claims.
The reference of Effer-K® (Dailymed 5/12) was used to teach of dissolving effervescent tablets in cold or ice water before drinking, the dosage and administration for patient, precautions for patients,
use in pregnancy, use in children and is therefore drawn to human use.
The reference of Rasor et al. teaches of the method of delivery carbon dioxide to patients by directed carbon dioxide into the patient’s mouth and allowing it to exit through either or both nostrils for therapeutic delivery as well as that stated above.
The reference of Niinimaa et al. teaches that some human subject show no consistent nose/mouth breathing pattern.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the carbon dioxide released from the effervescent tablets of Yanze et al. is inhaled by a human subject upon dissolution and/or upon drinking as raising a drinking vessel comprising an effervescent tablet to the mouth will allow for oral inhalation.
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention for human subjects to inhale the carbon dioxide via the mouth and exhale through the nose to bathe the mucous membrane in carbon dioxide as taught by Rasor et al. for the advantage of therapeutic treatment and because different human subjects have various breathing patterns that include no consistent nose/mouth breathing pattern, as taught by Niinimaa et al. that predictably includes inhaling through the mouth and exhaling through the nose prior to subsequent
inhalation.
The instant claims do not provide for a length of time for maintaining more carbon dioxide within the mouth prior to subsequent inhalation and therefore, it would have been predictable to one of ordinary skill in the art that the time between inhalation via the mouth and exhalation via the nose, as taught by Rasor et al. provides for an amount of carbon dioxide in the mouth of the human subject prior to subsequent inhalation.
New Grounds of Rejection/Objection Due to the Amendment
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.
Claim 75 is 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.
Claim 75 recites the limitation "said pill" in line 2. The instant claim 45 was amended to delete the recitation of “a pill.” There is insufficient antecedent basis for this limitation in the claim.
Conclusion
No claims are allowed at this time.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA JEAN PERREIRA whose telephone number is (571)272-1354. The examiner can normally be reached M9-3, T9-3, W9-3, Th9-2, F9-2.
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/MELISSA J PERREIRA/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618