DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
This office action is in response to the amendment filed 8/22/2025. As directed by the amendment, claims 1-21 have been amended. Claims 1-21 are pending in the instant application.
Applicant has amended the claims render the previous claim objections and 112 rejections moot; the previous claim objections and 112 rejections are withdrawn.
Response to Arguments
Applicant's arguments filed 8/22/2025 (hereinafter “Remarks”) have been fully considered but they are not persuasive.
Applicant argues on page 9 of Remarks that “The present claims are directed to a system that actively senses and controls both the heater plate and the heater wire at the same time in order to reduce condensate.”
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., that the heater plate and heater wire are sensed and controlled at the same time to reduce condensate) 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). However, even if these limitations were included in the instant claims, the prior art is concerned with the same functionality, and reducing condensation was a standard goal in respiratory humidifiers at the time of invention.
Applicant argues on page 9 of Remarks that the prior art “actively controls only one of the heater plate or heater wire, while merely passively controlling the other.”
The Examiner disagrees. Muller expressly discloses actively controlling/suppling power to both the heater plate and the heater wire, with Koch educating Muller to include a feedback loop for the patient end temperature as well as the chamber exit temperature. Therefore, the prior art continues to teach the claimed limitations as discussed in the updated rejections below.
Applicant argues on page 9 of Remarks that “Muller does not teach using flow rate in addition to the other parameters to determine a target temperature.”
This is incorrect. Muller expressly discloses using flow rate as claimed, see e.g. Muller paras [0035-36]: “calculates the set gas temperature at the outlet of the humidifier 19 from the gas flow…and from the ambient temperature” (emphasis added). Therefore, the rejections in view of Muller are maintained/updated below.
Applicant argues on page 9 of Remarks that “there is no disclosure in Muller about controlling patient-end temperature using ambient temperature and flow rate to set the patient end temp.”
This is incorrect. Muller discloses controlling patient-end temperature using ambient temperature and flow rate to set the patient end temp by setting the patient end temp to ~set gas temperature Tb of Muller para [0036], which is based on ambient temperature and flow rate, see e.g. Muller paras [0035-36] discussed above, in view of Muller para [0046] which states “the humidifier temperature [i.e. controlled to achieve set gas temperature Tb] must [be] approximately equal to the temperature of the administered gas [i.e. the target patient end temp],” and see also Muller para [0037] which states “the tube heating power substantially serves to compensate a temperature loss of the gas…as it flows to the nasal cannula,” and para [0037]: “tube heater control, too, is supplied with the gas flow measured by the volume flow sensor 24…and the ambient temperature measured by the ambient temperature sensor.” See also Muller paras [0044-51] for operation and temperature control of both the chamber and the tubing based on flow and ambient temperature, and note that, per page 24, lines 12-13 of the instant specification, the instant system is understood to function the same way, namely, the patient end target temperature is matched to the chamber exit target temperature, which is set based on ambient temperature and flow rate: “controller 8…is used to ensure that the temperature of the gases at the point of delivery substantially matches the target patient temperature of the gases as the chamber exit (the target patient temperature is the target dew point temperature at the chamber exit).” Therefore, the rejections in view of Muller are maintained/updated below.
Applicant argues on page 9 that Koch “doesn’t disclose determining a patient-end temperature sent point based on ambient temperature and flow rate.”
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Muller already discloses the contested limitation as discussed above and in the updated rejections below; Koch need not disclose it as well.
Applicant states on page 10 of Remarks that “the two different control system[s] of Muller and Koch can[not] be combined.”
Applicant has provided no objective evidence to support this assertion. Both Muller and Koch are concerned with automated control of respiratory humidifiers, and there is no indication that an artisan at the time of invention would have had any difficulty adding the nominal tube temperature control feedback loop of Koch into the system of Muller (which already has one feedback control loop) as discussed in the updated rejections below.
Applicant argues on page 10 of Remarks that neither reference “recognizes the need for active control of both the heater plate and the heater wire.”
The Examiner disagrees. Muller expressly discloses actively controlling/suppling power to both the heater plate and the heater wire, with Koch educating Muller to include a feedback loop for the patient end temperature as well as the chamber exit temperature. Therefore, the prior art continues to teach the claimed limitations as discussed in the updated rejections below.
Applicant argues on page 10 of Remarks that the combination of Muller and Koch “amounts to nothing more than hindsight reconstruction.”
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Muller discloses all of the instant limitations except a second feedback loop for the patient end temperature, and Koch demonstrates that it was known in the respiratory humidifier art before the effective filing date of the claimed invention to include a feedback loop for the patient end temperature. Therefore, the rejection does not rely on hindsight reasoning, because it only combines known elements to provide the predictable results discussed in the updated rejections below, i.e. two feedback loops to confirm/ensure that both the chamber exit and the patient end are reaching the intended temperature.
Applicant argues on page 10 of Remarks that “neither reference recognizes the control complexity that is required nor do they address any type of solution for actively controlling both the heater p[l]ate an[d] heater wire.”
The Examiner is confused as to what “control complexity” Applicant is referring, and the Examiner disagrees that Muller and Kock do not address “a solution” as claimed, since Muller discloses all of the claimed elements except a patient end sensor and patient end temperature feedback loop and Koch teaches a patient end sensor and patient end temperature feedback loop, and the combination provides the predictable results discussed in the updated rejections below, i.e. two feedback loops to confirm/ensure that both the chamber exit and the patient end are reaching the intended temperature.
Claim Objections
Claims 1-3, 14, 15 and 17-21 are objected to because of the following informalities:
Claim 1, lines 5-6 should read “configured to passe heated and humidified and exit
Claims 1 and 17, the sixth-to-last and third-to-last lines of each claim [four instances total] should read “control[s] power provided to” for clearer antecedent basis in the dependent claims
Claims 1 and 17, the last two lines of each claim [two instances total] should read “the target patient end temperature” because they are clearly referring to that of the fourth-to-last line of each claim
Claims 2, 3, 18 and 19, line 3 of each claim [four instances total] should read “flow rate” for continuity of language/terms through the claims
Claim 2, line 5, and claim 3, line 3, should read “is configured to adjust
Claim 14, line 7 should read “to determine the
Claim 15, lines 3-4 should read “determine the target chamber temperature or the target patient end temperature” because they are clearly referring to those of claim 1
Claim 17, the sixth-to-last line should read “exit temperature” for continuity of language/terms through the claims
Claim 18, line 5 should read “the power” because it is understood to be referring to that of claim 17, sixth-to-last line
Claims 20 and 21, line 2 of each claim [two instances total] should read “the target patient end temperature” because the claims are understood to be referring to the patient end temperature that is calculated rather than measured
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.
Claims 1-21 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 claims 1 and 17 (and thus their dependent claims), the independent claims recite “determine a target chamber temperature based on ambient temperature and flow rate” and “a measured exit temperature,” wherein it is unclear in the claims whether “ambient temperature” is different from the third temperature measured by the ambient temperature sensor or is the same value, whether “flow rate” is referring to the flow rate measured by the flow sensor or a different value, and whether “[a] measured exit temp[erature]” is different from the second temperature relating to the flow of gases exiting the humidifier or the same value. As best understood, for purposes of examination, they are all the latter interpretation, such that Applicant could address this rejection by amending claims 1 and 17 to read “determine a target chamber temperature based on the third temperature and the flow rate” and “[the second temperature” and “determine a target patient end temperature based on thethird temperature”.
Regarding claims 1 and 17 (and thus their dependent claims), the second-to-last line of each of the independent claims also recites “the difference between measured temperature and [the] target patient end temperature,” wherein “the difference” lacks antecedent basis, and it is unclear in the claims which temperature is to be considered “measured temperature,” since claim 1 recites three measured temperatures and claim 17 does not recited any measured temperatures. As best understood, for purposes of examination, “measured temperature” in this context is intended to refer to the first (patient end) temperature, such that Applicant could address this rejection by amending claims 1 and 17 to read “a difference between the first temperature and the target patient end temperature.”
Regarding claims 2 and 18, it is unclear how a temperature can “comprise” another temperature. As best understood, for purposes of examination, claims 2 and 18 will be considered to read “the target chamber temperature is the target temperature at the exit port”.
Regarding claims 5, 8 and 9 [three instances total], line 2 of each claim recites “the target patient end temperature or the target patient end temperature,” which is confusing because it redundantly recites “the target patient end temperature” while including the term “or.” As best understood, for purposes of examination, claims 5, 8 and 9 will be considered to read “the target chamber temperature or the target patient end temperature.”
Regarding claims 8, 9 and 21, it is unclear how a temperature can “comprise” a humidity, as these are different physical parameters/values, and claim 9 appears repetitive by saying that the target temperatures comprise target temperatures. As best understood, for purposes of examination, claims 8, 9 and 21 will be interpreted as reading “is configured to provide a target absolute/relative humidity” as appropriate [with no redundant comprising of temperatures in claim 9].
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 16 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 1 has been amended to recite that the target patient end temperature is determined based on the ambient temperature, which, as best understood as discussed in the 112(b) section above, corresponds to the third temperature. Therefore, claim 16 is no longer understood to further limit claim 1, because “data related to the third temperature” is understood to be the determined ambient/third temperature. [If the data refers to something else, Applicant is welcome to point out support in the specification as originally filed.] Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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 negatived 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-4, 7, 9, 10, 14 and 16-21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Muller (WO 2007/121736 A2; hereinafter “Muller", wherein the national stage PGPub, US 2010/0132707 A1, will be referenced in the rejection below as an English translation of the WIPO document) in view of Koch (US 2008/0190426 A1; hereinafter “Koch”).
Regarding claims 1, 16 and 17, Muller discloses a breathing assistance system (Fig. 1) configured to deliver a stream of gases for therapeutic purposes and method of operating the same under a controller thereof (paras [0001-0003]), comprising:
a humidifier (humidifier unit 3) including an inlet port (on the left of the humidifier housing 41 in Fig. 1) and an exit port (on the right of the humidifier housing 41 in Fig. 1), the humidifier configured to receive a flow of gases (see arrow to the left of the humidifier 3, near label 12 in Fig. 1) from a gases source (compressor unit 2) via the inlet port and hold and heat a volume of water (within reservoir 20 via heating 18), the flow of gases passing through the humidifier, becoming heated and humidified, and exiting the humidifier (see arrow to the right of the humidifier 3 in Fig. 1) via the exit port (Fig. 1; paras [0028-30]);
a delivery conduit (to the right of the humidifier 3 in Fig. 1) configured to receive the flow of gases from the exit port for delivery to a user via an interface (the prongs of nasal cannula 27), the delivery conduit including a heater wire (heating wire 26) configured to heat the flow of gases within the delivery conduit (Fig. 1; para [0031]);
an exit port temperature sensor (temperature sensor 23) configured to measure/determining a second temperature (actual gas temperature measured by the gas temperature sensor 23) relating to the flow of gases exiting the humidifier (Fig. 1; paras [0035-36]);
an ambient temperature sensor (ambient temperature sensor 25) adapted to measure/determining a third temperature (ambient temperature Tu measured by the ambient temperature sensor) relating to the flow of gases before the flow of gases enters the humidifier (Fig. 1; paras [0029] and [0035-36]);
a flow sensor (volume flow sensor 24) configured to measure a flow rate (gas flow measured by the volume flow sensor 24) of the flow of gases (Fig. 1; paras [0029] and [0035-37]); and
a controller (humidifier electronics 13, comprising means for determining set gas temperature function 35, gas temperature controller 26 and tube heater control 39) configured to/implementing control algorithms to:
determine a target chamber temperature (set gas temperature Tb, para [0036]) based on ambient temperature and flow rate, and to control power to a heater plate (humidifier heating power Pb setting) based on a difference between a measured exit temperature and the target chamber temperature (see Figs. 2-4, Fig. 9 and para [0044]; calculates the set gas temperature at the outlet of the humidifier 19 from the gas flow…and from the ambient temperature…controller 36 is supplied with the set gas temperature…and the actual gas temperature [at the humidifier exit]…controls the humidifier heating power Pb…in such a way that the set gas temperature and the actual gas temperature best possible coincide with each other, paras [0035-36], which infers an algorithm for implementing said control/adjustment),
the controller further configured to determine a target patient end temperature (~set gas temperature Tb, para [0036], in view of para [0046] which states “the humidifier temperature must [be] approximately equal to the temperature of the administered gas,” and see also para [0037] which states “the tube heating power substantially serves to compensate a temperature loss of the gas…as it flows to the nasal cannula”) based on the ambient/third temperature and the flow rate (tube heater control, too, is supplied with the gas flow measured by the volume flow sensor 24…and the ambient temperature measured by the ambient temperature sensor, para [0037]), and control power to the heater wire in the delivery conduit (tube heating power Ps setting) (see Figs. 5-7, Fig. 9 and para [0044]; tube heater control 39, which controls the tube heating power, para [0037], which infers an algorithm for implementing said control/adjustment; the tube heating power Ps is likewise adjusted in dependence on the adjusted gas flow…and the measured ambient temperature, para [0044]).
While Muller teaches feedback control of the exit temperature based on a comparison of the actual exit temperature to the set exit temperature as discussed above (para [0036]), Muller does not explicitly disclose a similar feedback control loop for the temperature of the administered gas (see para [0037]), such that Muller is silent regarding a patient end temperature sensor adapted to measure a first temperature relating to the flow of gases at or close to the user;
the controller configured to/implementing a control algorithm to control the power to the heater wire based on, as best understood, the difference between [the] measured [first] temperature and [the] target patient end temperature. However, Koch demonstrates that it was well known in the respiratory humidifier art at the time of invention for a respiratory humidifier system (Fig. 1) to include a patient end temperature sensor (temperature sensor 19) adapted to measure a first temperature relating to said flow of gases at or close to said user (Fig. 1; respiration temperature Ty of the respiration gas 10 is determined by the temperature sensor 19, para [0035]);
the controller (control device 15) configured to/implementing a control algorithm to control the power to the heater wire based on the difference between [the] measured [first] temperature and [the] target patient end temperature ([t]o ensure that the temperature of the outgoing gas up to the [user] reaches the desired value [i.e. the target patient end temp], the temperature of the outgoing gas [i.e. the actual/first temp] can be determined at the proximal end of the inspiration tube, para [0011]; heating of the inspiration tube 7 is controlled correspondingly, paras [0034-35]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of invention to modify the system/method of Muller to comprise a patient end temperature sensor adapted to measure a first temperature relating to said flow of gases at or close to said user, the controller configured to/implementing a control algorithm to control the power to the heater wire based on the difference between [the] measured [first] temperature and [the] target patient end temperature as taught by Koch, thus providing a standard feedback control loop for the conduit heater of Muller that is similar to the feedback control loop for the humidifier heater of Muller, in order to ensure/verify that the gas temperature actually being delivered to the patient end coincides with the target patient end gas temperature (e.g. by increasing the temperature of the heating conduit if the patient end temperature reads a little too low, or vice versa) (Muller, para [0036]); Koch, para [0035]).
Regarding claims 2 and 18, Muller in view of Koch teaches the breathing assistance system and method as claimed in claims 1 and 17, wherein Muller further discloses wherein the target chamber temperature (set gas temperature Tb) relates to a target temperature (set gas temperature Tb) at said exit port for a given flow level (calculates the set gas temperature at the outlet of the humidifier 19 from the gas flow, para [0035]), the target chamber temperature comprises[/is] said target temperature at said exit port (para [0035]), and said controller adjusts said power provided to the humidifier to match the second temperature with the target temperature at said exit port (gas temperature controller 36 controls the humidifier heating power Pb supplied to the humidifier heating 18 in such a way that the set gas temperature and the actual gas temperature best possibly coincide with each other, para [0036]).
Regarding claims 3 and 19, Muller in view of Koch teaches the breathing assistance system and method as claimed in claims 1 and 17, wherein modified Muller further discloses/teaches wherein the target patient end temperature relates to a target temperature at the interface (temperature of the administered gas, Muller paras [0045-47]; the gas temperature at the outlet of the nasal cannula, Muller para [0049]; see also Muller paras [0013], [0016], [0037]) for a given flow level (tube heater control, too, is supplied with the gas flow measured by the volume flow sensor 24, Muller para [0037]; the tube heating power Ps is likewise adjusted in dependence on the adjusted gas flow, Muller para [0044]), and the controller adjusts the power provided to the heater wire to match the first temperature with the target temperature at the interface (as discussed above regarding claims 1 and 17, Muller as modified in view of Koch includes feedback control based on the patient end temperature similar to the feedback control based on the humidifier outlet temperature discussed in Muller para [0036], such that the patient end feedback control adjusts the wire power to ensure that the patient end temperature matches the desired temperature for the patient end gas, similar to the control described in Muller para [0036] and as discussed above regarding claims 1, 2, 17 and 18).
Regarding claims 4 and 20, Muller in view of Koch teaches the breathing assistance system and method as claimed in claims 1 and 17, wherein Muller further discloses/teaches wherein the controller is configured to determine/the determining [at least one of] the target chamber temperature [or the [target] patient end temperature is] based at least in part on pre-determined data, e.g. a rule-based system loaded in a memory of said controller, a mathematical formula loaded in the memory, or a look-up table loaded in the memory (Muller Figs. 2-7; paras [0034-37], [0045-46] and [0054-57]).
Regarding claim 7, Muller in view of Koch teaches the breathing assistance system as claimed in claim 1, wherein Muller further discloses wherein at least one of a target temperature at the interface or a target temperature at the exit port is in the range of 31 - 39°C (Muller Figs. 2-4; paras [0047] and [0049]).
Regarding claims 9 and 21, Muller in view of Koch teaches the breathing assistance system and method as claimed in claims 1 and 17, wherein Muller further discloses wherein the target chamber end temperature of the target patient end temperature, as best understood, is configured to provide a relative humidity (the humidifier [outlet] temperature must approximately equal to the [patient end] temperature of the administered gas so as to obtain a relative humidity of 80%, Muller para [0046]).
Regarding claim 10, Muller in view of Koch teaches the breathing assistance system as claimed in claim 1, wherein Muller further discloses one or more user controls (gas flow generator 28) configured to enable the user to set a desired user-set flow rate of gases (Muller Fig. 1; rotary pulse generators…[b]y means of the gas flow generator 28 a gas flow between 10 l per minute and 20 l per minute can be adjusted, Muller para [0034]; see also paras [0042-43]).
Regarding claim 14, Muller in view of Koch teaches the breathing assistance system as claimed in claim 1, wherein Muller further discloses/teaches wherein the humidifier comprises a humidifier chamber (reservoir 20) including a heater base (bottom of housing 41) (Muller Fig. 1), and the breathing assistance system further comprises:
a heater plate (humidifier heating 18) adapted to heat contents of the humidifier chamber by providing energy to the heater base (Muller Fig. 1; para [0030]); and
a heater plate temperature sensor (humidifier temperature sensor 22) adapted to measure a fourth temperature relating to the heater plate (temperature measured by the humidifier temperature sensor 22, Muller para [0056]), the controller further configured to determine the target chamber temperature by assessing the second, third, and fourth temperatures and the flow rate and adjusting at least power provided to the heater plate to match the second temperature to a target temperature at the exit port (calculates the set gas temperature at the outlet of the humidifier 19 from the gas flow…and from the ambient temperature…controller 36 is supplied with the set gas temperature…and the actual gas temperature…controls the humidifier heating power Pb…in such a way that the set gas temperature and the actual gas temperature best possible coincide with each other, Muller paras [0035-36]; [f]rom the…temperature measured by the humidifier temperature sensor 22 conclusions can be drawn to the liquid temperature TF…can be used as actual value in a control loop…the conducted gas has approximately the liquid temperature TF at the outlet of the humidifier, Muller paras [0057-58]; wherein, given the stated relationship of the heater plate temperature and the outlet temperature, an artisan at the time of invention would have reasonably inferred that the control loop of Muller para [0057] is that of the heater plate/adjustment of the heater plate power, and that said humidifier heater temperature is used in another standard feedback loop similar to the control described in Muller para [0036], all to ensure that a target exit temperature for the gases is determined and reached).
Claims 5, 6 and 8 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Muller in view of Koch as applied to claims 1 and 17 above, and further in view of McPhee (US 2002/0129815 A1; hereinafter “McPhee”).
Regarding claim 5, 6 and 8, Muller in view of Koch teaches the breathing assistance system as claimed in claim 1, wherein Muller teaches achieving a desired relative humidity at the humidifier outlet/patient end (para [0046]) and wherein Muller teaches a saturated set gas temperature (para [0049]), but Muller is silent regarding wherein the target [chamber] temperature or the target patient end temperature is further based on a user-set target dew point temperature that relates to an absolute humidity level of substantially 44mg H20 / liter of air, or, as best understood, is configured to provide a target absolute humidity. However, McPhee teaches that it was well known in the respiratory humidifier art at the time of invention for a respiratory humidifier to be controlled to achieve a user-set target dew point temperature that relates to an absolute humidity level of substantially 44mg H2O/liter of air/provides a target absolute humidity (optimal temperature may be about 37 °C and the optimal humidity value about 44 mg H2O per liter, para [0148]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of invention for the system of modified Muller to include wherein the target [chamber] temperature or the target patient end temperature comprises a user-set target dew point temperature that relates to an absolute humidity level of substantially 44mg H20 / liter of air/provides a target absolute humidity as taught by McPhee, in order to allow the system/target temperatures to be set to provide an optimal humidity value and temperature to an intubated patient (McPhee, para [0148]).
Claims 11-13 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Muller in view of Koch as applied to claim 1 above, and further in view of Applicant’s Admitted Prior Art (page 1, line 32-page 2, line 4; hereinafter “Applicant’s APA”) and Farbarik (US 2008/0078248 A1; hereinafter “Farbarik”) (and as evidenced by Schroeder et al. (US 5,664,563; hereinafter “Schroeder”)).
Regarding claims 11-13, Muller in view of Koch teaches the breathing assistance system as claimed in claim 10, wherein Muller further discloses a source of pressurized of gas/gas flow (compressor 6) upstream of the humidifier (Fig. 1) and that blowers were known well known in the respiratory art before the time of invention (para [0006]), and wherein Muller further discloses one or more user controls (gas flow generator 28) configured to enable the user to set the desired user-set flow rate of gases (Muller Fig. 1; rotary pulse generators…[b]y means of the gas flow generator 28 a gas flow between 10 l per minute and 20 l per minute can be adjusted, Muller para [0034]; see also paras [0042-43]), but modified Muller is silent regarding a flow controller configured to receive the flow of gases from a remote central source, the flow controller located between the remote central source and the humidifier, the flow controller receiving the flow of gases and passing the flow of gases on to the humidifier via a gases connection path between the humidifier and the flow controller, wherein the flow controller further comprises a venturi adapted to mix the flow of gases from the remote central source with atmospheric gases before passing the flow of gases to the humidifier, or wherein the gases source comprises a blower configured to be fluidically connected to the humidifier, the blower including an adjustable, variable speed fan unit configured to deliver the flow of gases over a range of flow rates to the humidifier the controller configured to control power provided to the blower to produce the desired user-set flow rate. However, Applicant’s APA indicates that a step-down/modulator/entrainment unit and control such as that of claims 11-12 was “common” in the art at the time of invention, wherein Schroeder is provided as evidence to support this admission (Figs. 1-2; col. 4, lines 44-51), and Farbarik also teaches that it was known in the respiratory therapy art at the time of invention to include either a compressor as disclosed by Muller or a flow controller (one or more valves) (para [0029]) configured to receive a flow of gases from a remove central source (i.e. the source upstream of the line from the wall), the flow controller located between a remote central gases source and a patient device (Fig. 7 in view of para [0029]), the flow controller configured to receive the flow of gases and passing the flow of gases on to the patient device via a gases connection path between the patient interface and the flow controller (Fig. 7; para [0029]), or a blower configured to be fluidically connected to a patient device (Fig. 7; para [0029-30]), the blower comprising an adjustable, variable speed fan configured to deliver the flow of gases over a range of flow rates to the patient device (para [0030]), the controller configured to control power delivered to the blower to produce a desired flow rate (para [0030], wherein, in order to change the speed of the fan, the power must be increased or decreased). Therefore, it would have been obvious to one of ordinary skill in the art at the time of invention to substitute the pressure generator in the system of modified Muller with either a flow controller configured to receive the flow of gases from a remote central source, the flow controller located between the remote central source and the humidifier, the flow controller receiving the flow of gases and passing the flow of gases on to the humidifier via a gases connection path between the humidifier and the flow controller, wherein the flow controller further comprises a venturi adapted to mix the flow of gases from the remote central source with atmospheric gases before passing the flow of gases to the humidifier, or wherein the gases source comprises a blower configured to be fluidically connected to the humidifier, the blower including an adjustable, variable speed fan unit configured to deliver the flow of gases over a range of flow rates to the humidifier the controller configured to control power provided to the blower to produce the desired user-set flow rate as taught by Applicant’s APA and Farbarik (and evidenced by Schroeder), while maintaining the user controls configured to enable a user to set a desired user-set flow rate disclosed by Muller, in order to provide the expected/predictable result of using well-known means to produce the desired pressurized of gas/gas flow according to the availability of a given means.
Claim 15 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Muller in view of Koch as applied to claim 1 above, and further in view of Pujol et al. (US 2008/0308100 A1; hereinafter "Pujol").
Regarding claim 15, Muller in view of Koch teaches the breathing assistance system as claimed in claim 1, but modified Muller is silent regarding a humidity sensor configured to measure a humidity of atmospheric gases entering the humidifier, the controller configured to determine [the] target chamber temperature or [the] target patient end temperature based on data relating to the measured humidity. However, Pujol teaches that it was known in the respiratory humidifier art at the time of invention for a respiratory humidifier system to include not only an ambient temperature sensor as disclosed by Muller, but also a humidity sensor configured to measure a humidity of atmospheric gases entering the humidifier (Figs. 1, 4 and 5; monitor…ambient condition parameters……ambient humidity level…humidity sensor, para [0040]), said controller configured to determine target temperature-dependent system parameters based on data relating to the measured humidity (Figs. 1, 4 and 5; paras [0045-49] and [0052]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of invention for the system of modified Muller to further include a humidity sensor configured to measure a humidity of atmospheric gases entering the humidifier, the controller configured to determine the target chamber temperature or target patient end temperature based on data relating to the measured humidity as taught by Pujol, in order for the system to more accurately and/or efficiently control the delivered temperature and humidity (Pujol, paras [0046-49]), e.g. by supplying the exact amount of humidity/energy to the humidifier needed to bring the gas up to the desired delivery humidity and/or temperature level.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/KATHRYN E DITMER/Primary Examiner, Art Unit 3785
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