DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
2. This office action is responsive to the preliminary amendment filed on December 16, 2025. As directed by the amendment: claims 6 and 11 have been amended, claims 25-64 have been cancelled, and no claims have been added. Thus, claims 1-24 are presently pending in this application.
Drawings
3. The drawings are objected to because
Fig. 3 depicts spacing between oral cannulas (fig. 3, 334 and 340) as having a smaller space between them compared to the spacing between nasal cannulas (fig. 3, 322 and 328) which contradicts specification paragraph [0037] which states the spacing between oral cannulas is greater or equal to the spacing between nasal cannulas.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
4. The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
5. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
6. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “delivery device” in claim 1 lines 2, 3, 5, and 7 which is interpreted as a conserver according to specification paragraph [0027] or the like.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
7. 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.
8. Claims 18-24 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.
Regarding claim 18, the limitation “create a signal indicative of left-narial airflow, a signal indicative of right-narial airflow, a signal indicative of left-oral airflow, and a signal indicative of right-oral airflow” in lines 19-21 is unclear if the therapeutic gas delivery device is able to measure airflow or if sensors are used to detect airflow as suggested in the specification (see specification paragraph [0075] which states a right-narial sensor is used to produce a signal indicative of right-narial airflow). In the case the therapeutic delivery device is intended to be used, it is unclear what structure is being used to measure airflow.
Claim(s) 19-24 is/are rejected due to being dependent on a rejected claim.
Claim Rejections - 35 USC § 102
9. 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.
10. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
11. Claim(s) 1, 7, and 9 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Graetz et al. (US 5,617,846).
Regarding claim 1, Graetz discloses a method of providing therapeutic gas to a patient, the method (col. 1 lines 44-67) comprising:
sensing, by a delivery device, pre-apnea inhalations (col. 1, lines 47-51 states a baseline breathing resistance is first found which can be defined as pre-apnea inhalations);
refraining, by the delivery device, from providing therapeutic gas to the patient during the pre-apnea inhalations (col. 1, lines 55-60 states that the device is only activated if the breathing activity is affected by an apnea which inherently means during inhalations with a baseline resistance the device is inactive and thus refraining);
determining, by the delivery device, a presence of a sleep apnea event of the patient (col. 1, lines 58-62 state that an apnea can be detected by a change in breathing resistance); and then
delivering, by the delivery device, therapeutic gas to the patient for a plurality of post- apnea inhalations (col. 1, lines 56-58 states that the device is only active while the breathing activity is affected by an apnea, therefore the device stays on for as long as the apnea is affecting breathing during post-apnea event inhalations).
Regarding claim 7, Graetz discloses the method of claim 1 and further discloses: delivering therapeutic gas for the plurality of post- apnea inhalations further comprises delivering therapeutic in a continuous-flow mode (col. 4, lines 7-10 states that a continuous supply of respiratory gas is delivered while the measured pressure deviates from a base value) for a predetermined period of time (col. 4, lines 9-12 the predetermined time the continuous pressure is provided is for as long as the measured pressure deviates from a base pressure).
Regarding claim 9, Graetz discloses the method of claim 1 and further discloses: wherein, after the plurality of post-apnea inhalations, the method further comprises: ceasing delivery of therapeutic gas (col. 1, lines 56-58 states that the device is only active while the breathing activity is affected by an apnea, therefore once the apnea has been resolved the device inherently turns off); and then refraining from delivering therapeutic gas until a subsequent sleep apnea event (col. 1, lines 55-60 states that the device is only activated if the breathing activity is affected by an apnea which inherently means during inhalations with a baseline resistance the device is inactive and thus refraining); determining, by the delivery device, a presence of the subsequent sleep apnea event of the patient (col. 1, lines 58-62 state that an apnea can be detected by a change in breathing resistance); and then delivering, by the delivery device, therapeutic gas to the patient for a plurality of second post-apnea inhalations (col. 1, lines 56-58 states that the device is only active while the breathing activity is affected by an apnea, therefore the device stays on for as long as the apnea is affecting breathing during post-apnea inhalations).
Claim Rejections - 35 USC § 103
12. 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.
13. Claim(s) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Graetz in view of Adriance et al (US 2010/0168601).
Regarding claim 2, Graetz discloses the limitations of claim 1 and further discloses use of a breathing mask (fig. 1, 1). Graetz does not expressly state the use of a bifurcated oral sensing tubes.
However, Adriance teaches of a combined cannula and temperature sensing device for detecting breathing of a patient (see abstract) which has bifurcated oral sensing tubes (fig. 20, oral tubes 54, 54’).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the breathing mask of Graetz with the cannula and its control program as taught by Adriance as a simple substitution of one known element for another to obtain a predictable result of connecting to the patient to deliver therapeutic gas.
Regarding claim 3, the modified method of Graetz reads on the limitations of claim 2 and further reads on sensing by way of the cannula further comprises sensing by way of the cannula comprising narial sensing tubes that are bifurcated (Adriance fig. 20, nasal prongs 38 and nasal temperature sensors 6 and 8).
Regarding claim 4, the modified method of Graetz reads on the limitations of claim 1 and further reads on delivering therapeutic gas to at least one of the nares and the mouth (Adriance fig. 20, includes oral tubes 54 and 54’ and nasal prongs 38 which can deliver the gas due to their communicating with the internal flow chamber 47, see [0092]).
14. Claim(s) 5-6 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Graetz in view of Richard (US 2010/0313898).
Regarding claim 5, the method of Graetz reads on the limitations of claim 1 and further reads on during the sleep apnea event, delivering a continuous supply of respiratory gas (Graetz col. 4, lines 7-10) to at least one of the nares and the mouth (col. 2, lines 60-61 state that breathing mask 1 can be over a patient’s nose), but does not disclose the delivery of therapeutic gas in a plurality of pulses.
However, Richard discloses the use of pulses when delivering a gas to a subject in need when they are sleeping ([0009]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the continuous flow of gas of Graetz with gas pulses as taught by Richard as a simple substitution of one known element for another to obtain a predictable result of assisting breathing (Richard [0009]) while the patient is asleep.
Regarding claim 6, the modified method of Graetz reads on the limitations of claim 5 and further reads on providing therapeutic gas in a plurality of pulses (Richard [0040] states that a bolus of gas can be delivered in pulses with a controlled timing) which can consider various factors such as the subject’s breathing cycle (Richard [0010] states that a plurality of pulses can be delivered in accordance with a determined breathing cycle). The modified method of Graetz does not expressly state that the pulses are delivered at a rate of two pulses per second or greater.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the timing of the provided gas pulses of the modified method of Graetz to be delivered at 2 per second or greater, for the purpose of providing a pulsed delivery that meets the needs of the subject (Richard [0010]), and since it has been held that where the general conditions of a claim are discloses in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, Applicant has not provided criticality that a pulse rate of 2 or more per second provides an advantage, is used for a particular purpose, or solves a stated problem beyond stating that the conserver can provide pulses at a rate of two pulses per second or greater r between three to six pulses, see the paragraph [0051] in the specification. Further, it appears the modified method of Graetz would perform equally well with the recited pulse speed in providing therapeutic gas to the patient to limit sleep apnea events. See MPEP 2144.05(II).
Regarding claim 8, the method of Graetz reads on the limitations of claim 1 and further reads on delivering a continuous supply of respiratory gas (Graetz col. 4, lines 7-10), but does not expressly disclose that the respiratory gas is delivered as a bolus.
However, Richard discloses the use of a bolus during each of the plurality of post-apnea inhalations ([0036] states a bolus of gas can be delivered in a series of pulses, and [0009] states upon sensing inhalation a pulse of gas can be delivered).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the continuous flow of gas of Graetz with a gas bolus as taught by Richard as a simple substitution of one known element for another to obtain a predictable result of assisting breathing (Richard [0009]) while the patient is asleep.
15. Claim(s) 10-13, 15, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Graetz in view of Adriance and Aylsworth et al. (US 2017/0203062).
Regarding claim 10, Graetz discloses a therapeutic gas delivery device (fig. 1) comprising:
A controller (fig. 1, control regulating device 4);
A source-house connection (fig. 1, connection between gas source 2 and breathing tube 8), and a first nose connection (col. 2, lines 60-61 state that breathing mask 1 can be over a patient’s nose). Graetz further discloses the use of sensors for measuring pressure (col. 2, lines 64-66) and the controller being configured to intake sensor data to determine the presence of sleep apnea (col. 1, lines 58-62 state that an apnea can be detected by a change in breathing resistance), refrain, in the absence of sleep apnea, from delivering therapeutic gas (col. 1, lines 55-60 states that the device is only activated if the breathing activity is affected by an apnea which inherently means during inhalations with a baseline resistance the device is inactive and thus refraining), and command, during a plurality of subsequent inhalations after the presence of sleep apnea is detected, to deliver therapeutic gas (col. 1, lines 56-58 states that the device is active while the breathing activity is affected by an apnea, therefore the device stays on for as long as the apnea is affecting breathing during post-apnea inhalations). Graetz does not disclose the use of a first mouth connection, a second mouth connection, a first narial sensor, a first valve, a first mouth sensor, a second valve, a second valve, a second mouth sensor, and a third valve.
However, regarding the sensors and mouth connections, Adriance teaches of a combined cannula and temperature sensing device for detecting breathing of a patient (see abstract) which has bifurcated oral sensing tubes (fig. 20, oral tubes 54, 54’).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the breathing mask of Graetz with the cannula and its control program as taught by Adriance as a simple substitution of one known element for another to obtain a predictable result of connecting to the patient to deliver therapeutic gas.
Further, regarding the valves coupled between the source and each nose or mouth connection, Aylsworth teaches of multiple valves (fig. 1, valves 22, 24, and 26) for individually controlling gas flow in each particular delivery path ([0095]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide each flow path of the modified device of Graetz with the valves and the control program as taught by Aylsworth for the purpose of detecting blockages or delivery problems and redirecting delivery to a different orifice to ensure the prescribed volume is provided (Aylsworth [0095]).
Therefore, the modified device of Graetz reads on a first nose connection (Adriance fig. 20, left nasal prong 38), a first mouth connection (Adriance fig. 20, oral airflow pressure sensing prong 54), and a second mouth connection (Adriance fig. 20, oral airflow pressure sensing prong 54’);
a first narial sensor electrically coupled to the controller and fluidly coupled to the first nose connection (Adriance fig. 20, first temperature sensor 6 is coupled to nasal prong 38 and is intended to be connected to a controller to measure and model breathing patterns, see [0020]), the first narial sensor configured to create a first signal indicative of narial airflow (Adriance [0020] states that temperature sensor data is sent to the controller to determine apnea);
a first valve electrically coupled to the controller (Aylsworth fig. 1, valves 22, 24, and 26 are connected to a processor 12 which uses a digital to analog converter 18) and configured to fluidly couple the source-hose connection to the first nose connection (Aylsworth fig. 1, the valves are between the gas source 10 and the nasal/oral connections 23, 25, and 27);
a first mouth sensor electrically coupled to the controller and fluidly coupled to the first mouth connection (Adriance fig. 20, oral airflow pressure sensing prong 54 can detect changes in pressure, see [0096], and [0020] states that pressure data is accounted for by the controller), the first mouth sensor configured to create a first signal indicative of oral airflow (Adriance [0020] states that pressure data is accounted for by the controller to detect apnea);
a second valve electrically coupled to the controller (Aylsworth fig. 1, valves 22, 24, and 26 are connected to a processor 12 which uses a digital to analog converter 18) and configured to fluidly couple the source-hose connection to the first mouth connection (Aylsworth fig. 1, the valves are between the gas source 10 and the nasal/oral connections 23, 25, and 27);
a second mouth sensor electrically coupled to the controller and fluidly coupled to the second mouth connection (Adriance fig. 20, oral airflow pressure sensing prong 54’ can detect changes in pressure, see [0096], and [0020] states that pressure data is accounted for by the controller), the second mouth sensor configured to create a second signal indicative of oral airflow (Adriance [0020] states that pressure data is accounted for by the controller to detect apnea);
a third valve electrically coupled to the controller (Aylsworth fig. 1, valves 22, 24, and 26 are connected to a processor 12 which uses a digital to analog converter 18) and configured to fluidly couple the source-hose connection to the second mouth connection (Aylsworth fig. 1, the valves are between the gas source 10 and the nasal/oral connections 23, 25, and 27);
the controller is configured to: read at least one of the first signal indicative of narial airflow, the first signal indicative of oral airflow, and second signal indicative of oral airflow (Adriance [0020] states that the sensors send data to the controller);
Regarding claim 11, the modified device of Graetz reads on the limitations of claim 10 and further reads on a second nose connection (Adriance fig. 20, right nasal prong 38); a second narial sensor electrically coupled to the controller and fluidly coupled to the second nose connection (Adriance fig. 20, second temperature sensor 8 is coupled to nasal prong 38 and is intended to be connected to a controller to measure and model breathing patterns, see [0020]), the second narial sensor configured to create a second signal indicative of narial airflow (Adriance [0020] states that temperature sensor data is sent to the controller to determine apnea); a fourth valve electrically coupled to the controller and configured to fluidly couple the source-hose connection to the second nose connection (Aylsworth [0095] provides each flow path with a valve); wherein when the controller reads, the controller is further configured to read at least the second signal indicative of narial airflow (Adriance [0020] states that the sensors send data to the controller); wherein when the controller commands, the controller is further configured to command at least the fourth valve to deliver therapeutic gas (Aylsworth [0095] states that each valve is controlled for each particular gas path).
Regarding claim 12, the modified device of Graetz reads on the limitations of claim 10 and further reads on the controller is further configured to, after a determination of the presence of sleep apnea and before an immediately subsequent inhalation (Graetz col. 1, lines 56-58 states that the device is active while the breathing activity is affected by an apnea, therefore the device will turn on upon detecting an apnea and provide gas for affected inhalations), command at least one of the first, second, and third valves to deliver therapeutic gas to their respective connections (Aylsworth [0095] states that each valve is controlled for each particular gas path).
Regarding claim 13, the modified device of Graetz reads on the limitations of claim 12 and further reads on the delivered gas meets the needs of the subject (Graetz col. 1, lines 56-58 states that the device is active while the breathing activity is affected by an apnea, therefore the device stays on for as long as the apnea is affecting breathing during post-apnea event inhalations). The modified device of Graetz does not explicitly state that delivery of gas is for a length of a previous sleep apnea event, three seconds, or greater than half a duration of a previous inhalation.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the duration of the gas delivery of the device of Graetz to be a length of a previous sleep apnea event, three seconds, or greater than half a duration of a previous inhalation, for the purpose of providing gas delivery that treats the apnea, and since it has been held that where the general conditions of a claim are discloses in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, Applicant has not provided criticality that the specified duration of gas delivery provides an advantage, is used for a particular purpose, or solves a stated problem beyond stating that gas is provided for a predetermined duration, see the paragraph [0049] in the specification which states that gas is delivered for a predetermined duration, an example of which is 3 seconds. Further, it appears the device of Graetz would perform equally well with the recited duration of respiratory gas being a length of a previous sleep apnea event, three seconds, or greater than half a duration of a previous inhalation. See MPEP 2144.05(II).
Regarding claim 15, the modified device of Graetz reads on the limitations of claim 10 and further reads on the controller configured to, during the plurality of subsequent inhalations, command at least one of the first, second, and third valves (Aylsworth [0095] teaches using a valve for each flow path) to deliver therapeutic gas to their respective connections in a continuous-flow mode (Graetz col. 4, lines 7-10 states that a continuous supply of respiratory gas is delivered while the measured pressure deviates from a base value).
Regarding claim 17, the modified device of Graetz reads on the limitations of claim 10 and further reads on the controller configured to, after the plurality of subsequent inhalations: cease delivery of therapeutic gas (Graetz col. 1, lines 56-58 states that the device is only active while the breathing activity is affected by an apnea, therefore once the apnea has been resolved the device inherently turns off); and refrain from delivery of therapeutic gas until a subsequent sleep apnea event (Graetz col. 1, lines 55-60 states that the device is only activated if the breathing activity is affected by an apnea which inherently means during inhalations with a baseline resistance the device is inactive and thus refraining); and then during a plurality of second subsequent inhalations after the presence of sleep apnea is detected, command at least one of the first, second, and third valves (Aylsworth [0095] teaches using a valve for each flow path) to deliver therapeutic gas to their respective connections (Graetz col. 1, lines 56-58 states that the device is active while the breathing activity is affected by an apnea, therefore, subsequent apneas can also be treated).
16. Claim(s) 14 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Graetz in view of Adriance and Aylsworth as applied to claim 10 above, and further in view of Richard.
Regarding claim 14, the modified device of Graetz reads on the limitations of claim 10 and further reads on the controller configured to, after a determination of the presence of sleep apnea and provide gas before the plurality of subsequent inhalations (Graetz col. 1, lines 56-58 states that the device is active while the breathing activity is affected by an apnea, therefore the device stays on for as long as the apnea is affecting breathing during subsequent inhalations), and the first, second, and third valves (Aylsworth [0095] teaches using a valve for each flow path). The modified device of Graetz does not read on pulsing at least one of the first, second, and third valves to deliver pulses of therapeutic gas to their respective connections.
However, Richard discloses the use of pulses when delivering a gas to a subject in need when they are sleeping ([0009]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the continuous flow of gas of Graetz with gas pulses as taught by Richard as a simple substitution of one known element for another to obtain a predictable result of assisting breathing (Richard [0009]) while the patient is asleep. This can be accomplished using the valves (Aylsworth [0095] teaches using a valve for each flow path).
Regarding claim 16, the modified device of Graetz reads on the limitations of claim 10 and further reads on the controller configured to, during the plurality of subsequent inhalations (Graetz col. 1, lines 56-58 states that the device is active while the breathing activity is affected by an apnea, therefore the device stays on for as long as the apnea is affecting breathing during the subsequent inhalations), command at least one of the first, second, and third valves (Aylsworth [0095] teaches using a valve for each flow path) to deliver therapeutic gas to their respective connections. The modified device of Graetz does not read on providing gas in a bolus-flow mode.
However, Richard discloses the use of a bolus during each of the plurality of post-apnea inhalations ([0038] states that gas can be delivered as a bolus, and [0009] states upon sensing inhalation a pulse of gas can be delivered).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the continuous flow of gas of Graetz with a gas bolus as taught by Richard as a simple substitution of one known element for another to obtain a predictable result of assisting breathing (Richard [0009]) while the patient is asleep.
17. Claim(s) 18-20, 22, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Graetz in view of Adriance.
Regarding claim 18, Graetz discloses a therapeutic gas delivery system (fig. 1) comprising:
A source of therapeutic gas (fig. 1, gas source 2);
A source-house connection (fig. 1, connection between gas source 2 and breathing tube 8), and a first nose connection (col. 2, lines 60-61 state that breathing mask 1 can be over a patient’s nose). Graetz further discloses the use of sensors for measuring pressure (col. 2, lines 64-66) and the controller being configured to intake sensor data to determine the presence of sleep apnea (col. 1, lines 58-62 state that an apnea can be detected by a change in breathing resistance), refrain, in the absence of sleep apnea, from delivering therapeutic gas (col. 1, lines 55-60 states that the device is only activated if the breathing activity is affected by an apnea which inherently means during inhalations with a baseline resistance the device is inactive and thus refraining), and deliver therapeutic gas during a plurality of post-apnea inhalations after the presence of sleep apnea is detected (col. 1, lines 56-58 states that the device is only active while the breathing activity is affected by an apnea, therefore the device stays on for as long as the apnea is affecting breathing during post-apnea inhalations). Graetz does not disclose a cannula comprising a left narial prong and tube, a right narial prong and tube isolated from the left narial tube, a first spacing between the left and right narial prongs, a left oral prong and tube, a right oral prong and tube isolated from the left oral tube, a second spacing between the left and right oral prongs that is greater than the first spacing, a second nose connect, a first mouth connection, and a second mouth connection.
However, Adriance teaches of a combined cannula and temperature sensing device for detecting breathing of a patient (see abstract) which has bifurcated oral sensing tubes (fig. 20, oral tubes 54, 54’).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the breathing mask of Graetz with the cannula and its control program as taught by Adriance as a simple substitution of one known element for another to obtain a predictable result of connecting to the patient to deliver therapeutic gas.
The modified device of Graetz reads on:
a cannula comprising (Adriance fig. 20):
a left narial prong fluidly coupled to a distal end of a left narial tube (Adriance fig. 20, left nasal prong 38 is connected to gas supply/sensing tube 50);
a right narial prong fluidly coupled to a distal end of a right narial tube (Adriance fig. 20, right nasal prong 38 is connected to gas supply/sensing tube 52), the right narial tube fluidly isolated from the left narial tube (Adriance fig. 20, nasal prongs 38 are isolated via septum 48);
a left oral prong fluidly coupled to a distal end of a left oral tube (Adriance fig. 20, oral airflow pressure sensing prong 54 is connected to gas supply/sensing tube 56);
a right oral prong fluidly coupled to a distal end of a right oral tube (Adriance fig. 20, oral airflow pressure sensing prong 54’ is connected to gas supply/sensing tube 58), the right oral tube fluidly isolated from the left oral tube (Adriance fig. 20, prongs 54 and 54’ are separated via septum 48’);
a first nose connection coupled to the left narial tube, a second nose connection coupled to the right narial tube, a first mouth connection coupled to the left oral tube, and a second mouth connection coupled to the right oral tube (Adriance fig. 20, shows four distinct tubes 50, 52, 56, and 58 which inherently include connections to a gas generator), the therapeutic gas delivery device configured to:
create a signal indicative of left-narial airflow, a signal indicative of right-narial airflow, a signal indicative of left-oral airflow, and a signal indicative of right-oral airflow (Adriance fig. 20, temperature sensors 6 and 8 and pressure sensing oral prongs 54 and 54’ can be used to determine temperature and pressure data to help diagnose apneas, see [0020]);
determine a presence or absence of sleep apnea based at least one of the signal indicative of left-narial airflow, the signal indicative of right-narial airflow, the signal indicative of left-oral airflow, and the signal indicative of right-oral airflow (Adriance [0020] states that temperature and pressure data, that can be derived from nasal prongs and oral prongs, is used to diagnose apnea);
The modified device of Graetz states the oral sensing prongs (Adriance fig. 20, prongs 54 and 54’) are spaced apart from each other (Adriance [0097]) and can each distinctly sense airflow changes (Adriance [0101]), but does not expressly state that the spacing between the oral prongs is greater than the spacing between the nasal prongs.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the spacing between the oral sensing prongs to be larger than the spacing of the nasal sensing prongs of the modified device of Graetz as an obvious design choice which would not impact the function of the modified device of Graetz as there is no criticality to the spacing of the prongs (specification paragraph [0037] says in an example cases the oral prong spacing can be the same or greater than the nasal prong spacing) and the device would function to same in being able to detect airflow changes using either oral prong.
Regarding claim 19, the modified device of Graetz reads on the limitations of claim 18 and further reads on the therapeutic gas delivery device is configured to after a determination of the presence of sleep apnea and before post-apnea inhalation (Graetz col. 1, lines 56-58 states that the device is active while the breathing activity is affected by an apnea, therefore the device will turn on upon detecting an apnea and provide gas for affected inhalations), deliver therapeutic gas (Graetz col. 1, lines 56-58 states that respiratory gas is supplied) to at least one of the left narial prong, the right narial prong, the left oral prong, and the right oral prong (Adriance fig. 20, left nasal prong 38 connected to gas supply/sensing tube 50, right nasal prong 38 connected to gas supply/sensing tube 52, oral airflow pressure sensing prong 54, and oral airflow pressure sensing prong 54’ can deliver the gas).
Regarding claim 20, the modified device of Graetz reads on the limitations of claim 19 and further reads on the delivered gas meets the needs of the subject (Graetz col. 1, lines 56-58 states that the device is active while the breathing activity is affected by an apnea, therefore the device stays on for as long as the apnea is affecting breathing during post-apnea event inhalations). The modified device of Graetz does not explicitly state that delivery of gas is for a length of a previous sleep apnea event, three seconds, or greater than half a duration of a previous inhalation.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the duration of the gas delivery of the device of Graetz to be a length of a previous sleep apnea event, three seconds, or greater than half a duration of a previous inhalation, for the purpose of providing gas delivery that treats the apnea, and since it has been held that where the general conditions of a claim are discloses in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, Applicant has not provided criticality that the specified duration of gas delivery provides an advantage, is used for a particular purpose, or solves a stated problem beyond stating that gas is provided for a predetermined duration, see the paragraph [0049] in the specification which states that gas is delivered for a predetermined duration, an example of which is 3 seconds. Further, it appears the device of Graetz would perform equally well with the recited duration of respiratory gas being a length of a previous sleep apnea event, three seconds, or greater than half a duration of a previous inhalation. See MPEP 2144.05(II).
Regarding claim 22, the modified device of Graetz reads on the limitations of claim 18 and further reads on the therapeutic gas delivery device is configured to, during the post-apnea inhalations, deliver therapeutic gas to at least one of the prongs (Adriance fig. 20, left nasal prong 38 connected to gas supply/sensing tube 50, right nasal prong 38 connected to gas supply/sensing tube 52, oral airflow pressure sensing prong 54, and oral airflow pressure sensing prong 54’ can deliver the gas) in a continuous-flow mode (Graetz col. 4, lines 7-10 states that a continuous supply of respiratory gas is delivered while the measured pressure deviates from a base value).
Regarding claim 24, the modified device of Graetz reads on the limitations of claim 18 and further reads on the therapeutic gas delivery device is configured to, after the plurality of post-apnea inhalations: cease delivery of therapeutic gas (Graetz col. 1, lines 56-58 states that the device is only active while the breathing activity is affected by an apnea, therefore once the apnea has been resolved the device inherently turns off); refrain from delivery of therapeutic gas until a subsequent sleep apnea event (Graetz col. 1, lines 55-60 states that the device is only activated if the breathing activity is affected by an apnea which inherently means during inhalations with a baseline resistance the device is inactive and thus refraining); and then during a plurality of second post-apnea inhalations, deliver therapeutic gas (Graetz col. 1, lines 56-58 states that the device is active while the breathing activity is affected by an apnea, therefore, subsequent apneas can also be treated) to at least one of the prongs (Adriance fig. 20, left nasal prong 38 connected to gas supply/sensing tube 50, right nasal prong 38 connected to gas supply/sensing tube 52, oral airflow pressure sensing prong 54, and oral airflow pressure sensing prong 54’ can deliver the gas).
18. Claim(s) 21 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Graetz in view of Adriance as applied to claim 18 above, and further in view of Richard.
Regarding claim 21, the modified device of Graetz reads on the limitations of claim 18 and further reads on the therapeutic gas delivery device configured to, after a determination of the presence of sleep apnea and provide gas before post-apnea inhalations (Graetz col. 1, lines 56-58 states that the device is active while the breathing activity is affected by an apnea, therefore the device stays on for as long as the apnea is affecting breathing during the post-apnea inhalations) deliver gas to at least one of the prongs (Adriance fig. 20, left nasal prong 38 connected to gas supply/sensing tube 50, right nasal prong 38 connected to gas supply/sensing tube 52, oral airflow pressure sensing prong 54, and oral airflow pressure sensing prong 54’ can deliver the gas). The modified device of Graetz does not read on delivering therapeutic gas in pulses.
However, Richard discloses the use of pulses when delivering a gas to a subject in need when they are sleeping ([0009]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the continuous flow of gas of Graetz with gas pulses as taught by Richard as a simple substitution of one known element for another to obtain a predictable result of assisting breathing (Richard [0009]) while the patient is asleep.
Regarding claim 23, the modified device of Graetz reads on the limitations of claim 18 and further reads on the therapeutic gas delivery device configured to, during the plurality of post-apnea inhalations (Graetz col. 1, lines 56-58 states that the device is active while the breathing activity is affected by an apnea, therefore the device stays on for as long as the apnea is affecting breathing during the post-apnea inhalations) deliver gas to at least one of the prongs (Adriance fig. 20, left nasal prong 38 connected to gas supply/sensing tube 50, right nasal prong 38 connected to gas supply/sensing tube 52, oral airflow pressure sensing prong 54, and oral airflow pressure sensing prong 54’ can deliver the gas). The modified device of Graetz does not read on delivering the therapeutic gas in a bolus-flow mode.
However, Richard discloses the use of a bolus during each of the plurality of post-apnea inhalations ([0038] states that gas can be delivered as a bolus, and [0009] states upon sensing inhalation a pulse of gas can be delivered).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the continuous flow of gas of Graetz with a gas bolus as taught by Richard as a simple substitution of one known element for another to obtain a predictable result of assisting breathing (Richard [0009]) while the patient is asleep.
Response to Arguments
19. Applicant's arguments filed 12/16/2025 have been fully considered but they are not persuasive regarding the 112b rejections to claims 18-24. The rejection has been updated for clarity regarding the indefiniteness regarding what structures are detecting the narial flows.
Applicant’s arguments, see pages 10-14 of “Remarks”, filed 12/16/2025, drawn to the steps of Richard being used for a sleep study and not inhalations following an apnea event, with respect to the rejection(s) of claim(s) 1, 10 and 18 under 35 USC 102 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Graetz et al. (US 5,617,846).
Applicant’s arguments with respect to claim(s) 1, 10, 18, and dependent claims 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
20. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Aylsworth et al. (US 2005/0011523) discloses a system that only activates after a blockage or breathing disruption is detected. Aylsworth et al. (US 2005/0092321) discloses a system that uses multiple valves to control flow going to different output locations. Bruggeman et al. (US 2011/0245579) discloses a patient interface with two oral prongs. Schwaibold et al. (US 2016/0067434) discloses a breathing device that uses automated positive airway pressure to only provide pressure during respiratory problems.
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/THOMAS Z CHANG/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785