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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/18/2026 has been entered.
Status of the Claims
Claims 91-111 are currently pending. Claims 91-92, 96, 104, and 108 are currently amended. Claim 111 is newly added. Claims 91-109 and 111 are currently rejected. Claim 110 is currently withdrawn.
Response to Arguments
Applicant's arguments filed 02/18/2026 have been fully considered but they are not persuasive.
Applicant argues that Massardier fails to disclose the claim limitations of “cause the pressure source to increase airflow into a sealed nasal passage” and points to the specification [0074] which reads in part “the device senses palate closure during a swallow using nasal cavity back-pressure and preforms a brief, high flow puff of air” and [0043] which notes both a “low flow mode” and a “high flow mode” wherein “The pressure source may be configured to apply a further elevated pressure”. Specifically, Applicant states the following:
Massardier cannot disclose a pressure source configured to "apply airflow into a sealed nasal passage" as well as a controller configured to "cause the pressure source to increase airflow into a sealed nasal passage," as in the instant claims, as amended.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a “low flow mode” with a non-zero flow and a “high flow mode”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In this case, the pressure source meets the functional limitation of applying airflow into a sealed nasal passage, and the controller meets the limitation of causing the pressure source to increase airflow into a sealed nasal passage. The claim language does not necessarily define more than one level of non-zero airflow provided by the pressure source and/or controller.
Additionally, as described in Massardier [0069-0071] and with reference to Massardier figs. 4-6, the pressure source 8/12/35/37 as currently mapped to the claim and applies a first pressure in the configuration of fig. 5 (air flows from pump 8 to patient’s nose), and a second, higher pressure in the configuration of fig. 6 (air flows from both pump 8 and reservoir 12 to patient’s nose).
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 93-95 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.
Claim 93 recites the limitation “a liquid container” on line 2. Claims 91 and 92, from which claim 93 depends, introduced “a container” (claim 91 line 3) and recited “the container” (claim 92 lines 1-2) respectively. it is unclear whether “a liquid container” in claim 93 is meant to refer back to the “container” of claims 91 and 92 (in which case the limitation in claim 93 should be changed to “the container”), or whether “a liquid container” in claim 93 is meant to introduce a new, separate container (in which case the claim language should be altered to clarify the difference between “a container” and “a liquid container”). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claims 94-95 are rejected for being dependent upon a claim rejected under 112b, since dependent claims inherit the deficiencies of the claims on which they depend.
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.
Claim(s) 91-96, 103-105, 108-109, and 111 is/are rejected under 35 U.S.C. 103 as obvious over Massardier et al (US 20130178716 A1; hereafter Massardier) in view of Aquarian (US 4153170 A; hereafter Aquarian).
Regarding claim 91, Massardier discloses a system for opening an eustachian tube of a subject ([0016] a device is proposed automatically to apply a pneumatic overpressure phase, of a value of between 5 and 100 hPa in the Eustachian tube and/or in the nasal fossae of a human being through at least one nostril at the moment of swallowing), the system comprising:
a container (Examiner notes that although a container is not explicitly described in Massardier, the “sip of water” noted in [0012] must implicitly be contained/held in order to be sipped) dimensioned to contain or hold a swallow inducer (sip of water noted in [0012]; as understood from Applicant’s specification pg. 9 para. 3);
a nasal passage seal (nostril plug 1, fig. 1, [0038]);
a pressure source (gas generator 8, reservoir 12, electrovalves 35 and 37, and connective tubings shown in fig. 4 and described in [0065]) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to apply airflow into a sealed nasal passage (Examiner notes that since the gas generator as noted in [0065] provides air at a pressure, the gas generator 8 would be able to satisfy this functional limitation.) ([0070] pump 8 delivers an airflow through second electrovalve 37 into patient’s nose);
a sensor (pressure sensor 41, fig. 4, [0067]) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to detect a parameter indicative of a swallow resultant palate closure ([0071] when the patient swallows, pressure in the flexible pipe 5 increases, first pressure sensor 41 continuously measures the pressure in the flexible pipe 5; Examiner notes that this satisfies the functional limitation.);
and a controller (CPU 30, fig. 4, [0067]) operably coupled to the pressure source (8/12/35/37) and the sensor (41) ([0067] CPU 30 is connected to the pressure sensors 41 and 42, [0071] CPU 30 activates valves which allow pump 8 to supply the reservoir 12),
wherein the controller (CPU 30, fig. 4) is configured to cause the pressure source (8/12/35/37) to increase airflow ([0071] when pressure is high than pre-set value air is delivered both from reservoir 12 and pump 8 simultaneously, thus delivering increased airflow) into a sealed nasal passage upon detection by the sensor (first pressure sensor 41) of the parameter indicative of a swallow resultant palate closure ([0071] when pressure monitored by first pressure sensor 41 is higher than a threshold indicating that the patient is swallowing, the CPU 30 triggers delivery of air from reservoir 12 to nostril plug 1, pump/gas generator 8 supplies air to reservoir 12).
Massardier is silent to a container dimensioned to contain or hold the swallow inducer.
Aquarian, in the art of weaning device for children, teaches a container (bottle B, fig. 3) dimensioned to contain or hold a swallow inducer (liquid L, fig. 3 shows that bottle B contains/holds liquid L) (col. 4 ln. 19-27 infant lips make contact with nipple; col. 2 ln. 4-15 child uses straw in the nipple and a vacuum is produced via suction causing the fluid to flow).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Massardier to include the liquid container of Aquarian with the system of Massardier, because Massardier notes that [0008] children make up the vast majority of patients with Eustachian tube dysfunction and [0009] reflex reactions to a pressure stimulus using an appropriate device are helpful to rehabilitate the Eustachian tube. Massardier notes taking a sip of water in [0012] but does not provide any details on the vessel from which the water is sipped. Since Aquarian teaches a drinking vessel designed for use by children, one would have been motivated to use the liquid container and mouthpiece of Aquarian with the nasal pressure system of Massardier.
Regarding claim 92, Massardier modified by Aquarian discloses the system according to Claim 91, as described above, including wherein the container (Aquarian: bottle B, fig. 3) is in fluidic communication with a mouthpiece (Aquarian: nipple 11 and straw 13, fig. 3; col. 2 ln. 62-67 straw 13 extends through nipple 11 and is attached to bottle B which contains liquid L) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function) to be orally contacted by the subject (Aquarian: Examiner notes that the nipple 11 and straw 13 could be contacted by the subject, so this structure satisfies the functional limitation; col. 4 ln. 19-27 infant lips make contact with nipple; col. 2 ln. 4-15 child uses straw in the nipple and a vacuum is produced via suction causing the fluid to flow).
Regarding claim 93, Massardier modified by Aquarian discloses the system according to Claim 92, as described above, including wherein the mouthpiece (Aquarian: nipple 11 and straw 13, fig. 3 is configured such that fluid (Aquarian: liquid L, fig. 3) is drawn from a liquid container (see 112b interpretation above) (Aquarian: bottle B, fig. 3) by the subject (Aquarian: col. 2 ln. 4-15 child uses straw in the nipple and a vacuum is produced via suction causing the fluid to flow).
Regarding claim 94, Massardier modified by Aquarian discloses the system according to Claim 93, as described above, including wherein the mouthpiece (Aquarian: nipple 11 and straw 13, fig. 3) comprises a straw (Aquarian: straw 13, fig. 3).
Regarding claim 95, Massardier modified by Aquarian discloses the system according to Claim 93, as described above, including wherein the mouthpiece (Aquarian: nipple 11 and straw 13, fig. 3) comprises a nipple (Aquarian: nipple 11, fig. 3).
Regarding claim 96, Massardier modified by Aquarian discloses the system according to Claim 92, as described above, including wherein the container (Aquarian: bottle B, fig. 3) and the mouthpiece (Aquarian: nipple 11 and straw 13, fig. 3) are configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) as a standalone, functional liquid delivery device (Aquarian: see fig. 3, note that in col. 2 ln. 4-15 the use of the device shown in fig. 3 is disclosed for use as a weaning device and thus this liquid container / bottle B with the attached mouthpiece 11/13 could be used as a standalone liquid delivery device).
Regarding claim 103, Massardier modified by Aquarian discloses the system according to Claim 91, as described above. Massardier further discloses wherein the sensor comprises a pressure sensor (sensor is pressure sensor 41, fig. 4, [0071] pressure sensor 41 monitors pressure in flexible tube 5 as noted in 102 rejection of claim 91 above).
Regarding claim 105, Massardier modified by Aquarian discloses the system according to Claim 91, as described above. Massardier also discloses wherein the system further comprises a communications module (means for transferring 34, fig. 4; [0064] transfer means transfer measured pressure vales and transfer means consist in a system bus enabling connection to a network and/or in wireless communication means such as Bluetooth.RTM., WI-FI.RTM., Zigbee.RTM., etc.).
Regarding claim 108, Massardier modified by Aquarian discloses the system according to Claim 91, as described above. Massardier further discloses wherein the pressure source (8/12/35/37) comprises an air pump (pump 8 and reservoir 12, fig. 4) and the controller (CPU 30, fig. 4) is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to cause the air pump (8/12) ([0067] CPU 30 is connected to the pressure sensors 41 and 42, [0071] CPU 30 activates valves which allow pump 8 and reservoir 12 to apply air to patient’s nose) to apply an increased airflow rate ([0016] device automatically applies a pneumatic overpressure phase) upon detection by the sensor of the parameter indicative of a swallow resultant palate closure ([0016] overpressure phase is applied at the moment of swallowing; [0071] CPU 30 receives reading from pressure sensor 41 and after a threshold is reached opens a valve so that air is delivered to the nostril plug 1 from reservoir 12 (which is filled by pump 8) and pump 8).
Regarding claim 109, Massardier modified by Aquarian discloses the system according to Claim 91, as described above. Massardier further discloses whereby the pressure sensor ([0067] pressure sensor 41 connected to CPU 30) monitors whether nasal pressurization therapy successfully occurred ([0067] CPU 30 compares measured pressure values to pre-set pressure values to ensure that the swallowing action is correctly performed during the pressure stimulus).
Regarding claim 111, Massardier modified by Aquarian discloses the system according to claim 91, as described above, including wherein the container (Aquarian: bottle B, fig. 3) comprises a mouthpiece (Aquarian: nipple 11 and straw 13, fig. 3; col. 2 ln. 62-67 straw 13 extends through nipple 11 and is attached to bottle B which contains liquid L).
Claim(s) 97-102 and 106-107 is/are rejected under 35 U.S.C. 103 as being obvious over Massardier modified by Aquarian and further in view of Gusky et al (US 20160095996 A1; hereafter Gusky).
Regarding claim 97, Massardier modified by Aquarian discloses the system according to claim 91, as described above.
Massardier is silent to the nasal passage seal being extra nostril.
Gusky, in the field of nasal interfaces, teaches wherein the nasal passage seal (soft pad portion 200, fig. 2A) comprises an extra-nostril seal (upper surface 210 of wings 218 of nasal pad 200, fig. 2A [0081] upper surfaces 210 may seal around the user’s nostrils).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the under the nose-mask of Massardier to have the soft pad portion 200 including the extra-nostril seal of Gusky because both deal with nasal seals. One would have been motivated to make the modification because the seal being external to the nostril would likely be more comfortable to the patient, and the seal would not need to match the internal nostril size of the patient since the seal goes around the nostril instead of inside it.
Regarding claim 98, Massardier modified by Aquarian and Gusky discloses the system according to claim 97, as described above, including wherein the extra-nostril seal (upper surface 210, fig. 2A) is an under the nose mask (see fig. 2A of Gusky, note [0086] the holes 216 in the upper surfaces 210 let air into and out of a user's nostrils; this indicates that the mask is positioned under the nose such that the holds 216 can engage with the nostrils of the patient).
Regarding claim 99, Massardier modified by Aquarian and Gusky discloses the system according to claim 98, as described above, including wherein the under the nose mask (upper surface 210, see claim 98 the extra-nostril seal is an under the nose mask) comprises flaps (wings 218, fig. 2A) for aligning the under the nose mask with the nose of the subject ([0081] mechanical pressure of the upper surfaces 210 of wings 218 are held against the user’s nose to form a seal; [0080] airflow holes 216 are positioned such that when the wings 218 are sealed to the user’s nose the holes 216 are located near the user’s nostrils).
Regarding claim 100, Massardier modified by Aquarian and Gusky discloses the system according to claim 99, as described above, including the under the nose mask is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) so that a shape of a proximal section of the under the nose mask deforms to seal the nasal passage (Examiner notes that the upper surface 210 of wings 218 of nasal pad 200, as shown in fig. 2A do make up a proximal section of the nose mask and as noted in [0081] upper surfaces 210 seals around the user’s nostrils. Additionally, see [0088] wings 218 may be adjusted with respect to a user’s nostril allowing flexible positioning and [0080] soft pad portion 200 including wings 218 with upper surfaces 210 may be made of a silicon pad and be unitary in nature).
Regarding claim 101, Massardier modified by Aquarian and Gusky discloses the system according to claim 99, as described above.
Massardier is silent to a flexible element.
Gusky further teaches wherein the under the nose mask comprises a flexible element (bellows 220, fig. 2A, [0084]) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to allow the under the nose mask to rotate ([0084] bellows 220 may provide flexibility in height of the nasal interface and the angle at which the upper surfaces 210 reside with respect to a user's nostrils).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to further include the bellows 220 of Gusky with the system of Massardier because the bellows would allow for more flexible, comfortable, and secure positioning of the mask against the user’s face.
Regarding claim 102, Massardier modified by Aquarian and Gusky discloses the system according to claim 98, as described above.
Massardier is silent to the mask having a single hole engaging both nostrils.
Gusky further teaches wherein the under the nose mask comprises a single hole configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to engage both nostrils of the subject ([0086] A single opening (not shown) intended to be co-extensive with the position of both of a typical user's nostrils may also be used. The hole or holes 216 may have a cross section optimized for low pressure losses and low noise from the airflow through the holes.).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to use the embodiment of Massardier having a single hole to modify the invention of Gusky because having one hole engaging both nostrils would simplify the design of the device and make manufacturing easier, since there would only be a need for one hole in the center of the nose piece instead of two holes spaced apart by a specific amount which may vary from patient to patient.
Regarding claim 106, Massardier modified by Aquarian discloses the system according to claim 91, as described above.
Massardier is silent to an aligner.
Gusky teaches wherein the system further comprises an aligner (wings 218, fig. 2A; [0081] mechanical pressure of the upper surfaces 210 of wings 218 are held against the user’s nose to form a seal; [0080] airflow holes 216 are positioned such that when the wings 218 are sealed to the user’s nose the holes 216 are located near the user’s nostrils).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the system of Massardier to include the wings 218 of Gusky since both deal with nasal seals and the upper surface 210 of the wings of Gusky would provide a more comfortable, adaptable seal than fitted nostril pieces placed a specific distance apart.
Regarding claim 107, Massardier modified by Aquarian and Gusky discloses the system according to claim 106, as described above, including wherein the aligner (wings 218, fig. 2A) is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to ensure proper alignment of the nasal passage seal and the mouth of the subject (Examiner notes that since the wings 218 would serve to appropriately seal against the nose and position the hole 216 in the appropriate location near the nostrils, the wings 218 help to align the device with the nostrils of the patient and thus also with the mouth of the subject, since the nostrils and mouth are generally positioned in a predictable way on the human face. For instance, the wings 218 would ensure placement of the nasal passage seal above the mouth of the subject.).
Claim(s) 104 is/are rejected under 35 U.S.C. 103 as being obvious over Massardier modified by Aquarian and further in view of White et al (US 20170296767 A1; hereafter White).
Regarding claim 104, Massardier modified by Aquarian discloses the system according to Claim 91, as described above.
Massardier modified by Aquarian is silent to the system further comprising an accelerometer operably connected to the controller.
White, directed to a method and apparatus for controlled delivery of gas to a patient, teaches wherein a system further comprises an accelerometer (accelerometer 46 optionally included with mask 31 noted in [0225]) operably connected to the controller (controller 1; [0228] Body position could be detected using the accelerometers 46 communicating with the controller 1 attached to the body and head of the user.).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the system of Massardier modified by Aquarian to include the accelerometer as taught by White since White also deals with pressurized air delivery through nasal passages. One would have been motivated to make the modification because, as noted by White [0228], the accelerometer 46 could be used to detect the body position of the user, and thus could provide data on the posture of the user during treatment, indicating or ensuring an appropriate patient posture for effective treatment.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
White et al (US 20170296767 A1) - fig. 6, [0150], a low pressure is applied as a baseline and then a higher treatment pressure is applied during a treatment phase. (Examiner notes that White is relied upon above, but not fig. 6 or [0150] and thus these particularly relevant passages are noted here for the record)
Djupesland et al (US 20150144129 A1) - fig. 2a shows a nasal administration device with a mouthpiece and a nosepiece, spec describes swallowing a drug and adjusting the intranasal pressure during drug administration, [0450] notes that increased pressure in the nasal cavity during oral drug delivery is beneficial
Rasmussen (US 6565517 B1) - fig. 1 shows a system which covers the nose and mouth and, as noted in col. 6 ln. 61-col. 7 ln. 3, an external pressure source can be connected to increase pressure while the patient swallows.
Garde - (US 20120209089 A1) - [0028] and [0029] discuss control module 34 which controls the pressure generator 14 to adjust a parameter of pressurized flow to a patient while swallowing, see fig. 1
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 04/30/2026
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