DETAILED ACTION
The amendment filed on 10/6/25 has been received and considered. By this amendment, Claims 22-24, 28-29, and 31 are amended. Claims 43-48 are added.
Response to Arguments
Applicant’s arguments with respect to claim(s) 22-36 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.
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.
Claim(s) 22-23, 28, 30-36, and 43-44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barbut et al. (PG Pub. 2013/0274651) in view of Ackerman et al. (PG Pub. 2014/0316485).
Regarding Claim 22, Barbut discloses providing external respiratory support to the subject (see air in optional lumen; par. 43); providing gas flow to a nasal cavity (see nitric oxide in lumen 114; par. 43) via a nasal stimulator (see catheter 100; par. 43). Barbut discloses electrically stimulating the cortex (see par. 55), but does not explicitly disclose an electrode supported on the nasal stimulator. Ackerman discloses a similar nasal stimulator (see stimulator 100) providing gas flow to a nasal cavity via a nasal stimulator (see chemical agents via gas; par. 138) and delivering an electrical current from an electrode (see electrodes 110 and 112; par. 6 and 53) supported on the nasal stimulator (see par. 217; Fig. 1A). It would have been obvious to one of ordinary skill in the art at the time of the invention to incorporate electrical stimulation onto Barbut’s device because Ackerman teaches it can helps modulate blood flow (see par. 227) and combining different modes of treatment can be synergistic (see par. 138).
Regarding Claim 23, Barbut discloses wherein electrical stimulation, gas flow, or both are delivered in synchrony with the external respiratory support (see claim 6).
Regarding Claim 28, Barbut discloses delivering positive pressure ventilation via a tracheal endoscope, and the nasal stimulator is positioned within a nasal cavity of the subject (see par. 38).
Regarding Claim 30, Barbut further discloses wherein gas that is used to generate the gas flow does not enter lungs of the subject (see par. 7).
Regarding Claim 31, Barbut discloses wherein the nasal stimulator is placed within a nasal cavity of the subject (see par. 43), wherein the nasal stimulator includes a gas outlet (see nitric oxide orifices 124/424; Fig. 1 and 4), a gas inlet (see inlet 114/414), and an occlusion device (see device 428); and inflating the occlusion device (see par. 42); and releasing a gas (see Nitric oxide) flowing from the gas outlet to the gas inlet (see par. 43).
Regarding Claim 32, Barbut further discloses wherein inflating the occlusion device includes forming an air-tight seal between the nasal cavity and the nasal stimulator (see par. 38).
Regarding Claim 33, Barbut further discloses a second occlusion device (see device 426), and the method further comprises inflating the second occlusion device thereby forming a second air-tight seal between the nasal cavity and the nasal stimulator.
Regarding Claim 34, the examiner considers the space between two occlusion devices would necessarily form a sealed-off length of a nasal passage since both ends are blocked.
Regarding Claim 35, Barbut discloses wherein the gas flowing from the gas outlet to the gas inlet is within the sealed-off length of the nasal passage (see Fig. 4).
Regarding Claim 36, Ackerman discloses wherein the nasal nerve includes: an olfactory bulb receptor; a maxillary branch of a trigeminal nerve; a mandibular branch of a trigeminal nerve; an afferent nerve connected to an olfactory bulb receptor, a maxillary branch of a trigeminal nerve, or a mandibular branch of a trigeminal nerve; an afferent nerve of a nasal-bronchial reflex; an efferent nerve connected to an olfactory bulb receptor, a maxillary branch of a trigeminal nerve, or a mandibular branch of a trigeminal nerve; or a combination thereof (see par. 212, 215 and 226).
Regarding Claims 43-44, Barbut discloses the nasal stimulator comprises an occlusion device (see occlusion device 226; par. 44 and Fig. 2). Ackerman discloses an equivalent occlusion device (see portions 176 and 178; par. 86) and the electrode is supported on the occlusion device (see electrodes 110 and 112; Fig. 6A). The examiner considers it would have been obvious to one of ordinary skill in the art at the time of the invention to place the electrodes on the occlusion portions for maximal contact with the tissue (see par. 8). The examiner considers the prongs are necessarily occlusive because they block the nasal passageway to some degree.
Claim(s) 24-25, 27, and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barbut et al. (PG Pub. 2013/0274651) and Ackerman et al. (PG Pub. 2014/0316485) in view of Cipollone et al. (PG Pub. 2011/0094518).
Regarding Claim 24, Barbut discloses external respiratory support (see air in optional lumen; par. 43), but does not disclose a mechanical ventilator. Ackerman discloses providing gas flow and delivering an electrical current to stimulate a nasal nerve (see par. 99), but also does not disclose a mechanical ventilator. Cipollone discloses wherein the external respiratory support is provided via a mechanical ventilator (see par. 11), and the nasal nerve is stimulated during a breath assisted by the mechanical ventilator (see par. 87 and 138). It would have been obvious to one of ordinary skill in the art at the time of the invention to deliver the gas during a mechanical ventilator breath because Cipollone teaches the coinciding of these two creates a clinically efficacious effect on the lung and airways (see par. 85).
Regarding Claim 25, Cipollone further discloses wherein the gas flow to the nasal cavity is greater during an inspiration phase of the breath assisted by the mechanical ventilator compared to an expiration phase of the breath (see par. 131 and Fig. 30J). It would have been obvious to one of ordinary skill in the art at the time of the invention to provide more flow during inspiration because Cipollone teaches it would be efficacious in some clinical applications (see par. 131).
Regarding Claim 27, modified Ackerman discloses wherein stimulating a nasal nerve modulates the activity of: a brain stem; a cortical respiratory area; a respiratory motor cortex; a prefrontal cortex; a nasal-bronchial reflex; a hypothalamus; a trigeminal nerve (see par. 212); a facial nerve; a suprachiasmatic nucleus; or a combination thereof.
Regarding Claim 29, Cippolone further discloses wherein stimulating the nasal nerve increases a compliance of a lung or an airway (see par. 127). It would have been obvious to one of ordinary skill in the art at the time of the invention to increase airway compliance because that is in indication of clinical efficacy (see par. 127).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barbut et al. (PG Pub. 2013/0274651) and Ackerman et al. (PG Pub. 2014/0316485) in view of Cipollone et al. (PG Pub. 2011/0094518), and further in view of Evans et al. (PG Pub. 2019/0001127).
Regarding Claim 26, Barbut and Cippolone do not disclose effects on the hippocampus. Evans discloses a mechanical ventilation system wherein stimulating a nasal nerve (see par. 32, 73 and 95) during a breath assisted by the mechanical ventilator stimulates hippocampus neurogenesis, mitigates hippocampus neuroinflammation, or both (see par. 20). It would have been obvious to one of ordinary skill in the art at the time of the invention to stimulate the hippocampus because Evans teaches it mitigates the degree of apoptosis in the hippocampus and thereby increases dopamine (see par. 20).
Allowable Subject Matter
Claims 45-48 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Ackerman discloses a gas outlet (see ports 3516 and 3518), the gas flow is provided from the gas outlet (see par. 138; Fig. 35A), but does not disclose the electrode is placed transverse to the gas outlet. Ackerman also does not disclose generating an electric field between the electrodes. The other prior art of record does not disclose this combination either.
Simon (PG Pub. 20100010564) discloses inserting an electrode through a nasal cavity (see par. 16) and generating an electric field (see par. 46), but it is not between two electrodes in each respective nostril.
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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/N.P/Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792