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 .
Claims 1-20, filed 3/28/24, are currently pending.
Information Disclosure Statement
The information disclosure statement filed 5/20/24 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because non-patent literature references 4-5 and 8-9 do not have a date listed on the IDS. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Specification
The disclosure is objected to because of the following informalities:
Reference number 100 on page 8, line 2 is suggested to be changed to 110 for consistency. Appropriate correction is required.
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 12 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 12 recites “substantially zero” however it is unclear what is included in the scope of this language.
Claim Rejections - 35 USC § 102
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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4-11 and 15-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Colbaugh et al. (2019/0183417).
Regarding claim 1, in fig. 1 Colbaugh discloses a method for delivering air to a patient throughout the patient's respiratory cycle [0016], the method comprising: providing a positive airway pressure system (via pressure generator 140), the system including a flow generator 140 and conduit 182 having an outlet configured to connect to a patient's respiratory system (outlet connected to interface appliance 184); applying an inspiratory positive airway pressure through the outlet during an inspiration phase of the patient's respiratory cycle [0019]; and applying an expiratory positive airway pressure through the outlet during an expiration phase of the patient's respiratory cycle [0019]; wherein the inspiratory positive airway pressure is less than the expiratory positive airway pressure [0019].
Regarding claim 4, Colbaugh discloses that the positive airway pressure system includes a computer with a processor 110 for executing instructions stored in a memory 130 component to modulate air flow through the outlet such that the expiratory positive airway pressure is greater than the inspiratory positive airway pressure [0004][0025].
Regarding claim 5, Colbaugh discloses that the patient sets the inspiratory positive airway pressure (via user interface 120 [0026]).
Regarding claim 6, Colbaugh discloses that the patient sets the expiratory positive airway pressure (via user interface 120 [0026]).
Regarding claim 7, Colbaugh discloses that the method further comprising setting a maximum inspiratory positive airway pressure (recommended IPAP level [0042]) and a maximum expiratory positive airway pressure (recommended EPAP level [0042]); wherein the patient sets the inspiratory positive airway pressure at or below the maximum inspiratory positive airway pressure [0042][0026].
Regarding claim 8, Colbaugh discloses that the patient sets the expiratory positive airway pressure at or below the maximum expiratory positive airway pressure [0004][0038].
Regarding claim 9, Colbaugh discloses that the inspiratory positive airway pressure is lower when the patient falls asleep and gradually increases (the IPAP changes throughout the sleep period of a patient and therefore an increase occurs as needed [0053]).
Regarding claim 10, Colbaugh discloses that the inspiratory positive airway pressure is determined based on a patient parameter [0028][0041].
Regarding claim 11, Colbaugh discloses that the inspiratory positive airway pressure is determined based on an ambient condition [0028-0030].
Regarding claim 15, in fig. 1 Colbaugh discloses positive airway pressure system comprising: a flow generator 140; a conduit 182 operably connected to the flow generator, the conduit having an outlet configured to connect to a patient's respiratory system (outlet connected to interface appliance 184); wherein the flow generator provides an inspiratory positive airway pressure through the outlet during an inspiration phase of the patient's respiratory cycle [0019] and an expiratory positive airway pressure through the outlet during an expiration phase of the patient's respiratory cycle [0019]; and wherein the inspiratory positive airway pressure is less than the expiratory positive airway pressure [0019].
Regarding claim 16, Colbaugh discloses that the positive airway pressure system further includes an air flow resistor (humidifier [0018]) to reduce air flow through the outlet during the inspiration phase of the patient's respiratory cycle thereby providing that the expiratory positive airway pressure is greater than the inspiratory positive airway pressure (since Colbaugh already teaches providing an inspiratory positive airway pressure greater than an expiratory positive airway pressure).
Regarding claim 17, Colbaugh discloses that the air flow resistor additionally functions as a bacterial filter, humidifier [0018], heat and moisture exchanger, or nebulizer.
Regarding claim 18, Colbaugh discloses that a portion of the conduit is configured to function as the air flow resistor (the conduit portion that extends through humidifier [0018], or a portion of the conduit 182 due to friction).
Regarding claim 19, Colbaugh discloses that the positive airway pressure system includes a computer with a processor 110 for executing instructions stored in a memory 130 component to modulate air flow through the outlet such that the expiratory positive airway pressure is greater than the inspiratory positive airway pressure [0004][0025].
Regarding claim 20, Colbaugh discloses that the system includes a patient interface 120 configured to allow the patient to set the inspiratory positive airway pressure [0026].
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.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Colbaugh, as applied to claim 1 above, in further view of Zdrojkowski et al. (5,878,743).
Regarding claim 2, Colbaugh is silent regarding that the positive airway pressure system further includes an air flow resistor to reduce air flow through the outlet during the inspiration phase of the patient's respiratory cycle thereby providing that the expiratory positive airway pressure is greater than the inspiratory positive airway pressure. However, in fig. 1and 7-8 Zdrojkowski teaches a positive airway pressure system further includes an air flow resistor 20 to reduce air flow through the outlet during the inspiration phase of the patient's respiratory cycle thereby providing that the expiratory positive airway pressure is greater than the inspiratory positive airway pressure (pressure sensitive flow control valve reduces airflow through the outlet, Col. 3, ll. 39-41). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Colbaugh’s conduit with the addition of an air flow resistor, for the purpose of preventing contaminants from entering the PAP unit when positive pressure is lost (Col. 1, ll. 54-57).
Regarding claim 3, the modified Colbaugh discloses that the air flow resistor (20, Zdrojkowski) is added to an existing positive airway pressure system configured to provide an inspiratory positive airway pressure greater than an expiratory positive airway pressure (since Colbaugh already teaches providing an inspiratory positive airway pressure greater than an expiratory positive airway pressure), the inclusion of the air flow resistor thereby modifying the operation of the existing positive airway pressure system (the addition of the air flow resister does modify the operation of the existing positive airway pressure system by increasing resistance and preventing backflow through the resistor).
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Colbaugh, as applied to claim 1 above, in further view of Hakim et al. (“Expiratory and inspiratory positive airway pressures in obstructure sleep apnea: how much pressure is necessary? A different point of view” 2015).
Regarding claim 12, Colbaugh is silent regarding that the inspiratory positive airway pressure is substantially zero. However, Hakim teaches an inspiratory positive airway pressure is substantially zero (Fig. 2, Page 135 second column, bottom half of page, starting at the first complete sentence). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Colbaugh’s inspiratory pressure with an inspiratory pressure of substantially zero, for the purpose of treating obstructive sleep apnea (abstract) and preventing upper airway collapse at the end of expiration (Page 135, right column).
Regarding claim 13, Colbaugh is silent regarding that the expiratory positive airway pressure is between 4 and 20 cm H20. However, Hakim teaches expiratory positive airway pressure is between 4 and 20 cm H20 (Fig. 2, Page 135 second column, bottom half of page, starting at the first complete sentence). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Colbaugh’s expiratory positive airway pressure with an expiratory positive airway pressure between 4 and 20 cm H20, for the purpose of treating obstructive sleep apnea (abstract) and preventing upper airway collapse at the end of expiration (Page 135, right column).
Regarding claim 14, Colbaugh is silent regarding that an average negative pressure provided by the patient during inspiration is determined and the inspiratory positive airway pressure is below the average negative pressure. However, Hakim teaches that an average negative pressure provided by the patient during inspiration is determined and the inspiratory positive airway pressure is below the average negative pressure (Fig. 2, upper right figure, Page 135 second column, bottom half of page, starting at the first complete sentence, 0 cmH2O of pressure is provided during inhalation and an average of negative 5 cmH2O (since the pressure starts at 0 and moves towards -10) is provided by the patient during inhalation). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Colbaugh’s inspiratory positive airway pressure to be below the average negative pressure, for the purpose of treating obstructive sleep apnea (abstract) and preventing upper airway collapse at the end of expiration (Page 135, right column).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Truitt et al. (6,915,705) directed towards a flow resistor with openings, O’Dea et al. (6,634,356) directed towards a CPAP controller and Colbaugh (6,987,444) directed towards limited flow respiratory therapy.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL T SIPPEL whose telephone number is (571)270-1481. The examiner can normally be reached M-F 9:00-5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at (571) 272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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