DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “humified” in line 5. This should read “humidified”.
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 7-8 and 13 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 7 recites “an electro-mechanical valve”. It is unclear if this is an additional electro-mechanical valve or if applicant is attempting to refer back to the valve introduced in claim 6.
Claim 8 is rejected due to its dependency on claim 7.
Claim 13 recites “normally seal”. This is unclear because it is unclear if normal is when the device is turned off or if normal is when the device is running normally.
Claim Interpretation
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.
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.
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: “blocking member” in claim 21.
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 § 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 1-5, 10-11, 17-20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Payton et al. (US 2008/0190427 A1) in view of Seakins et al. (US 2001/0050080 A1).
Regarding claim 1, Payton discloses: A respiratory treatment apparatus (figure 1) configured to reduce conduit rainout attributable to a breathable supply of humidified gas generated by the respiratory treatment apparatus (abstract), the apparatus comprising:
a flow generator (15) comprising a blower (15) and configured to generate a flow of breathable gas for the breathable supply of humified gas [0073], the flow generator further configured to couple to a breathable gas conduit (3) for a patient interface (20) for delivering the breathable supply of humidified gas to an airway of a patient [0068];
a humidifier (8) configured to humidify the flow of breathable gas [0069]; and
a controller (9) configured to control operation of the flow generator in a shutdown procedure to generate a flow of air through the breathable gas conduit for a period of time at a completion of a treatment session (drying mode: [0082]-[0086].
Payton is not explicit in that the flow in the shutdown procedure is a dry flow of air but Payton states humidity in gases are decreased [0084].
Seakins teaches a respiratory apparatus (abstract) wherein a flow bypasses the humidifier (see figures 5, 6) [0071] via a flow bypass tube (27, and upper pathway shown in figure 6) and valve (30, 26) [0072].
It would be obvious to have incorporated a flow bypass and valve as taught by Seakins for the benefit of supplying gases at varying levels of relative humidity and temperature [0070]. This modification would allow the device of Payton to deliver a dry flow through the bypass tube as opposed to cooling the water in the humidification chamber as set forth in [0084] of Payton.
Regarding claim 2, Payton as modified discloses a diverter (26, 30 of Seakins) configured to divert the flow of breathable gas from traversing through the humidifier ([0072] of Seakins).
Regarding claim 3, Payton as modified discloses wherein the diverter comprises a valve [0072].
Regarding claim 4, Payton as modified discloses wherein the diverter comprises a manual valve [0072].
Regarding claim 5, Payton as modified discloses wherein the manual valve is coupled to a bypass conduit configured for bypassing the humidifier [0072] (figures 5-6).
Regarding claim 10, Payton further discloses wherein the patient interface comprises a mask [0014].
Regarding claim 11, Payton further discloses wherein the patient interface comprises a nasal cannula [0014].
Regarding claim 17, Payton further discloses wherein the respiratory treatment apparatus is configured to provide a positive airway pressure therapy [0002].
Regarding claim 18, Payton further discloses wherein wherein the respiratory treatment apparatus is configured to provide a high flow therapy (high flow rates as per [0008] [0013] [0015]).
Regarding claim 19, Payton does not explicitly disclose wherein the respiratory treatment apparatus is a ventilator.
Seakins teaches it is known to provide gas flow with a ventilator [0058].
Therefore it would have been obvious to have modified Payton wherein the respiratory treatment apparatus is a ventilator as taught by Seakins for the benefit of creating intermittent flow patterns to provide breaths to a patient [0058].
Regarding claim 20, Payton disclsoes: A respiratory apparatus (figure 1) comprising a flow generator (15) coupled to a humidifier (8) and an air delivery conduit (3) coupled to an outlet of the humidifier at a first end and coupled to a patient interface (20) at the opposing end (see figure 1), the respiratory apparatus further comprising a controller (9) configured to control operation of the flow generator in a shutdown procedure (drying mode) to generate a flow of air through the air delivery conduit for a period of time at a completion of a treatment session [0082]-[0086].
Payton is not explicit in that the flow in the shutdown procedure is a dry flow of air but Payton states humidity in gases are decreased [0084].
Seakins teaches a respiratory apparatus (abstract) wherein a flow bypasses the humidifier (see figures 5, 6) [0071] via a flow bypass tube (27, and upper pathway shown in figure 6) and valve (30, 26) [0072].
It would be obvious to have incorporated a flow bypass and valve as taught by Seakins for the benefit of supplying gases at varying levels of relative humidity and temperature [0070]. This modification would allow the device of Payton to deliver a dry flow through the bypass tube as opposed to cooling the water in the humidification chamber as set forth in [0084] of Payton.
Claims 6-9 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Payton et al. (US 2008/0190427 A1) in view of Seakins et al. (US 2001/0050080 A1) in further view of Schroeder et al. (US 5,664,563 A).
Regarding claim 6, Payton as modified discloses wherein the diverter comprises an automatic valve coupled to and controlled by the controller [0072].
Payton as modified is not explicit in that the automatic valve is an electro-mechanical valve.
Schroeder teaches a ventilation system (abstract) and teaches it is known to use electro-mechanical valves (col. 2, lines 56-62).
It would have been obvious to have modified Payton to include an electro-mechanical valve as the automatic valve as this is a well known valve in the art for controlling flow (col. 2, lines 56-62).
Regarding claim 7, Payton as modified discloses wherein the diverter (modified 26 30 of Seakins) comprises an electro-mechanical valve (as modified above with Schroeder for claim 6) comprises a three-port valve (see three ports on valve of Seakins in figures 5-6).
Regarding claim 8, Payton as modified discloses wherein the three-port valve (26 30 of Seakins as modified by Schroeder) is coupled to a bypass conduit configured for bypassing the humidifier (see figures 5-6 of Seakins).
Regarding claim 9, Payton as modified discloses wherein the electro-mechanical valve (modified 26 30 of Seakins) is coupled to a bypass conduit configured for bypassing the humidifier (see figures 5-6 of Seakins).
Claims 12-14 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Payton et al. (US 2008/0190427 A1) in view of Seakins et al. (US 2001/0050080 A1) in further view of Hely et al. (US 5,896,857) or in the alternative unpatentable over Payton et al. (US 2008/0190427 A1) in view of Seakins et al. (US 2001/0050080 A1) in view of Hely et al. (US 5,896,857 A) in further view of Pujol (US 2007/0132117 A1).
Regarding claim 12, Payton as modified does not explicitly disclose a vapor barrier in a channel between an input aperture of the breathable gas conduit and an output aperture of the breathable gas conduit (between input and output of conduit 3), the vapor barrier operable to selectively permit and prevent vapor to pass from the input aperture to the output aperture.
However, Hely discloses a vapor barrier (valve within 14: 24, 39, 36, 38) (col. 3, lines 17-24; col. 5, lines 1-3 indicates the valve material is engineered polymer or thermoplastic and absent a reason the material of the valve blocks airflow but allows vapor to move therethrough in the prior art (which would be a special property) it is the examiner's position that one of ordinary skill in the art would find it inherent that since Hely blocks airflow, the valve in Hely also blocks vapor considering water vapor is a larger molecule than air; the common understanding of a valve closing is that it blocks against entry or passage as set forth in merriamwebster.com) in a channel between an input aperture (where 12 connects to 10) of the breathable gas conduit and an output aperture (where 12 connects to 16) of the breathable gas conduit (between input and output of conduit 12), the vapor barrier operable to selectively permit and prevent vapor to pass from the input aperture to the output aperture (col. 4, lines 28-52; valve within 14 closes selectively when there is insufficient airflow being generated and when valve within 14 closes, vapor is prevented from passing from 16 to the input aperture which is where 12 connects to 10; figures 3a-4 and valve within 14 opens when there is sufficient flow col. 3, lines 47-48).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Payton to include a vapor barrier in a channel between an input aperture of the breathable gas conduit and an output aperture of the breathable gas conduit (between input and output of conduit 3), the vapor barrier operable to selectively permit and prevent vapor to pass from the input aperture to the output aperture as taught by Hely for the benefit of allowing a user to breathe atmospheric air when there is insufficient flow (col. 4, lines 44-46).
In the alternative to the valve of Hely being a vapor barrier as set forth above, the valve of Hely is not explicitly a vapor barrier that blocks vapor when closed.
However, Pujol teaches that it is known to provide valves (160; 266) in respiratory systems (abstract) wherein the valve is a vapor barrier that blocks vapor when it is closed [0058] [0062] (abstract).
Thus it would have been obvious to one having ordinary skill in the art before the invention was made to have modified Hely's valve to be a vapor barrier as taught by Pujol for the benefit of preventing the backflow of moisture [0062] (abstract). The examiner also notes that Hely indicates that the system can be used with humidified gas (col. 5, lines 44-46).
Regarding claim 13, Payton as modified further discloses wherein the vapor barrier is configured to normally seal (when there is insufficient flow) the channel to prevent vapor passing from the input aperture to the output aperture (Hely: col. 4, lines 28-52; valve within 14 closes selectively when there is insufficient airflow being generated and when valve within 14 closes, vapor is prevented from passing from 16 to the input aperture which is where 12 connects to 10).
Regarding claim 14, Payton as modified further discloses wherein the breathable gas conduit further comprises an atmosphere access port (Hely: 30), and wherein the vapor barrier is further configured to cover the atmosphere access port when the vapor barrier permits vapor to pass from the input aperture to the output aperture (Hely: figures 3a-3).
Claims 15-16 and 21 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Payton et al. (US 2008/0190427 A1) in view of Seakins et al. (US 2001/0050080 A1) in further view of Hely et al. (US 5,896,857).
Regarding claim 15, Payton as modified does not explicitly disclose a rainout valve adapted to be coupled to an outlet of the humidifier and configured to block transfer of humidified gas from flowing through the rainout valve in an absence of a pressurized flow travelling through the humidifier and to the outlet.
However, Hely discloses a rainout valve (valve within 14: 24, 39, 36, 38) configured to be coupled to an outlet of the humidifier (col. 1, lines 43-45; col. 2, lines 10-13; col. 5, lines 44-46; at least fluidly coupled) and configured to block transfer of humidifed gas from flowing through the rainout valve in an absence of a pressurized flow travelling through the humidifier and to the outlet (col. 4, lines 28-52; valve within 14 closes selectively when there is insufficient airflow being generated and when valve within 14 closes, humidified gas is prevented from passing from 16 to the input aperture which is where 12 connects to 10; figures 3a-4 and valve within 14 opens when there is sufficient flow col. 3, lines 47-48).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Payton to a rainout valve adapted to be coupled to an outlet of the humidifier and configured to block transfer of humidified gas from flowing through the rainout valve in an absence of a pressurized flow travelling through the humidifier and to the outlet as taught by Hely for the benefit of allowing a user to breathe atmospheric air when there is insufficient flow (col. 4, lines 44-46).
Regarding claim 16, Payton as modified does not explicitly disclose wherein the humidifier includes a blocking means coupled to an outlet of the humidifier to prevent humidified gas from leaving the humidifier when there is no pressurized flow through the humidifier.
However, Hely discloses a humidifier (col. 5, lines 44-46) and a blocking means (valve within 14: 24, 39, 36, 38) coupled to an outlet of the humidifier (col. 1, lines 43-45; col. 2, lines 10-13; col. 5, lines 44-46) to prevent humidified gas from leaving the humidifier when there is no pressurized flow through the humidifier (col. 4, lines 28-52; valve within 14 closes selectively when there is insufficient airflow being generated and when valve within 14 closes, humidified gas is prevented from passing from 16 to the input aperture which is where 12 connects to 10; figures 3a-4 and valve within 14 opens when there is sufficient flow col. 3, lines 47-48).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Payton wherein the humidifier includes a blocking means coupled to an outlet of the humidifier to prevent humidified gas from leaving the humidifier when there is no pressurized flow through the humidifier as taught by Hely for the benefit of allowing a user to breathe atmospheric air when there is insufficient flow (col. 4, lines 44-46).
Payton as modified does not explicitly disclose the humidifier including the blocking means.
However, Hely discloses multiple locations of the valve (col. 2, lines 10-13) and being integrated into the components in the system (see claims 5-6). Therefore, it would be obvious to incorporate the valve into the outlet of the humidifier as claimed in order to allow the patient to breathe in the event of insufficient airflow. As the humidifier is placed after the flow generator, it would be obvious to place it at the outlet of the humidifier as opposed or in addition to the outlet of the flow generator (col. 3, lines 16-24). Further, the examiner notes there are a finite number of places the valve can be placed in the system of Hely. One of ordinary skill in the art could have pursued these potential solutions/positions of the valve with a reasonable expectation of success. "A person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397. Therefore the placement of the valve at the outlet of the humidifier is obvious and this positioning would be “obvious to try”.
Regarding claim 21, Payton as modified does not explicitly disclose a valve arrangement adapted to adjustably obstruct an outlet of the humidifier, the valve arrangement comprising a first side adapted to couple to the humidifier outlet, a second side adapted to couple to the air delivery conduit; and a blocking member that is located between the first side and the second side and is configured to move between a first position and a second position, wherein in the absence of a force being applied through the valve, the blocking member is in the first position and obstructs access from the first side to the second side, and in a presence of a force being applied through the valve arrangement the blocking member is adapted to move to the second position to allow access from the first side to the second side.
However, Hely discloses a humidifier (col. 5, lines 44-46) and a valve arrangement (14) adapted to adjustably obstruct an outlet of the humidifier (col. 1, lines 43-45; col. 2, lines 10-13; col. 5, lines 44-46), the valve arrangement comprising a first side adapted to couple to the humidifier outlet (left end of 14 as shwon in figure 3a), a second side adapted to couple to the air delivery conduit (right end of figure 3a); and
a blocking member (24) that is located between the first side and the second side (see figure 3a) and is configured to move between a first position and a second position (figure 3a and 4a), wherein in the absence of a force being applied through the valve, the blocking member is in the first position and obstructs access from the first side to the second side (figure 4a), and in a presence of a force being applied through the valve arrangement the blocking member is adapted to move to the second position to allow access from the first side to the second side (figure 3a) (col. 4, lines 28-52; valve within 14 closes selectively when there is insufficient airflow being generated and valve within 14 opens when there is sufficient flow col. 3, lines 47-48).
It would have been obvious to one having ordinary skill in the art before the effective filing date to have modified Payton to include a valve arrangement adapted to adjustably obstruct an outlet of the humidifier, the valve arrangement comprising a first side adapted to couple to the humidifier outlet, a second side adapted to couple to the air delivery conduit; and a blocking member that is located between the first side and the second side and is configured to move between a first position and a second position, wherein in the absence of a force being applied through the valve, the blocking member is in the first position and obstructs access from the first side to the second side, and in a presence of a force being applied through the valve arrangement the blocking member is adapted to move to the second position to allow access from the first side to the second side as taught by Hely for the benefit of allowing a user to breathe atmospheric air when there is insufficient flow (col. 4, lines 44-46).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Moffett et a. (US 5,224,923)
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/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785
