DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/29/2026 has been entered.
Response to Amendment
This office action is in response to the amendment filed 1/29/2026. As directed by the amendment, claims 1-5, 7-9 and 14-21 have been amended. Claims 1-21 are pending in the instant application.
Applicant has amended the claims to address most of the previous objections thereto; any previous objection not maintained below has been withdrawn.
Applicant has amended the claims to address most of the previous rejections under 35 USC 112(b)/second paragraph; any previous rejection under 35 USC 112(b)/second paragraph not maintained below has been withdrawn.
Applicant has not amended claim 16 to be properly further limiting; the rejection of claim 16 under 35 USC 112(d)/fourth paragraph is updated below.
Response to Arguments
Applicant's arguments filed 1/29/206 (hereinafter “Remarks”) have been fully considered but they are not persuasive.
Applicant argues on page 8 of Remarks that the claims recite “a system and method in which two different algorithms are used to determine respective heater plate and heater wire power requirements…the Office Action appears to [be] applying an overly broad interpretation that effectively reads the limitations out of the claims.”
The Examiner fails to see what limitations were “effectively read of out the claims.” The previous rejections and those updated below specifically address each of the claim limitations (copy and pasted in bold), as best understood in view of the specification as originally filed.
Applicant argues on page 8 of Remarks that, in contrast/opposite to Miller, the claims “recite different concurrent algorithms based on different parameters for controlling each of the heater plate and the heater wire.”
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 algorithms are based on different parameters) 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). Indeed, the Examiner respectfully notes that the instant claims require the algorithms to be based on the same parameters: “a first control algorithm comprising determining a target chamber temperature based on the ambient temperature and the flow rate…a second different control algorithm comprising determining a target patient end temperature based on the ambient temperature and the flow rate.” She also notes that there is nothing in the claims that requires the target chamber temperature and the target patient end temperature to have different values, and indeed, as discussed in the 112(a) second below, the specification as originally filed discusses the target chamber temperature and the target patient end temperature as having the same value. Muller discloses determining a target chamber temperature based on flow rate and ambient temperature, which also determines the target patient end temperature, i.e. the target patient end temperature is also set on these parameters [as similarly described on pages 24-25 of the instant specification, which is understood to be the support for the instantly claimed subject matter, see 112(a/b) discussions below]. Muller discloses controlling heater plate power to target the target chamber temperature, including using a feedback control loop for the heater plate power based on measured exit port temperature, and Muller teaches controlling conduit heater wire power to target the target patient end temperature, with Koch educating Muller to include a patient end sensor to provide a similar feedback control loop for the heater wire power based on the measured patient end temperature. Therefore, in as far as the instant specification supports two control algorithms as claimed, the prior art teaches two control algorithms as claimed.
Applicant argues on page 9 of Remarks that “[n]o distinction is drawn in the algorithms [of Muller]…teaches that the temperature of the gases delivered…is the same as the temperature of gases exiting the humification chamber…no disclosure of two separate set point calculations…only disclosures a single set point – which is the chamber outlet set point.”
The Examiner disagrees. Muller separately describes and labels a gas temperature controller 36 for controlling the heater plate and a tube heater control 39 for controlling the conduit heater (Fig. 1); therefore, Muller does draw a distinction between two control “algorithms,” because the controller 36 implements one algorithm (for powering the heater plate) and the control 39 implements a second algorithm (for powering the conduit heater), where the controls/the elements controlled thereby are different, such that the algorithms implemented are “different.” And 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., two separate set point calculations) 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). Moreover, even though “two separate set point calculations” are not recited in the instant claims (the claims only require “determination” of target temperatures; they do not say they are separately “calculated”), nor are two separate set point calculations supported by the specification as originally filed, Muller does teach “two separate set point calculations,” in as far as Muller teaches that “the 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” (Muller para [0037]), i.e. the control 39 is not just forwarded the result of the chamber set point determination of Muller paras [0035-36]; rather, it is provided with the same data and taught to arrive at (inferred by calculating from the provided sensor data) the same value for the target patient end temperature as the target chamber (exit) temperature (as discussed in the art rejections below) for concurrent control of the conduit heater. Therefore, the prior art teaches the claimed limitations as discussed in the rejections maintained/updated below.
Applicant argues on page 9 of Remarks that “Koch does not teach using two different control algorithms for each of the heater plate and the heater wire.”
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). As discussed above, the base reference of Muller already teaches using two different control algorithms, one for each of the heater plate and the heater wire; Koch is not relied on in this regard. Koch is relied on to demonstrate the obviousness of including a patient end sensor for feedback control of a conduit heater, which thus educates the second control algorithm of Muller to arrive at the instant claim limitations as discussed in the updated rejections below.
Applicant argues on page 9 of Remarks that “Koch does not teach…each algorithm has a different target temperature for different locations in the system.”
First, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a different target temperature for different locations in the system) 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). There is nothing in the claims that requires the target chamber temperature and the target patient end temperature to have different values, and indeed, as discussed above and in the 112(a) second below, the specification as originally filed explicitly discusses the target chamber temperature and the target patient end temperature as having the same value. Second, even if the instant claims did require different values for the exit port temperature and the patient end temperature (although not supported in combination with two different algorithms as claimed), offsetting the patient end temperature from the chamber exit temperature was already known and thus obvious in the art at the time of invention, as demonstrated by previously-cited McPhee (see e.g. McPhee paras [0177-179]).
Applicant argues on page 9 of Remarks that “Muller and Koch in combination do not disclose two different concurrent algorithms using two set points (chamber outlet set point and patient end set point) using ambient temp and flow rate. Conflating Muller and Koch is nothing more than hindsight reconstruction, lacking any suggestion or motivation mix and match features of each reference.”
The Examiner disagrees that Muller and Kock do not disclose the amended limitations; see the updated rejections below. And 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). Both Muller and Koch provide ample suggestions for the inclusion of sensor feedback control loops, as discussed in the maintained/updated rejections, as well-known means for ensuring that a target temperature at a given location is actually achieved, with Koch educating Miller to include a patient end temperature sensor for conduit heater feedback loop as claimed.
Applicant argues on page 9 that “the objectives of Muller (to use the same algorithm for both heater plate and heater wire) are entirely different than the objectives of Koch. There is no rational[e] to…manipulate the single algorithm of Muller into two different algorithms, it is contrary to the operation of Muller.”
The Examiner disagrees with this mischaracterization of Muller. There is no “objective” by Muller to “use the same algorithm for both heater plate and heater wire.” Muller clearly describes and separately labels a gas temperature controller 36 for controlling the heater plate and a tube heater control 39 for controlling the conduit heater (Fig. 1), which would thus operate two (different target) algorithms, one implemented by the controller 36 and another implemented by control 39. There is no reason why the feedback loop for the conduit heater taught by Koch could not be integrated into the system of Muller, i.e. in the same way Muller already integrates a feedback loop for the chamber, and the Examiner fails to see how integration of such an additional feedback loop would be “contrary to the operation of Miller,” as the modified system would still operate to deliver heated, humidified air at a target temperature to a user.
Applicant argues on page 9 of Remarks that “The Office Action…attempts to shifts its burden of proof to the Applicant…[b]ut the Office Action has failed to establish why a person of skill in the art having Muller's teachings that the a [sic] single control algorithm for both the heater plate and the heater wire would apply a separate algorithm.”
The Office maintains that Applicant has provided no objective proof that an artisan at the time of invention would have been unable to integrate the additional sensor feedback control loop taught by Koch into Muller to arrive at the claimed invention, and she again contests Applicant’s mischaracterization of Muller of “a single control algorithm,” since Muller clearly discloses separate controls/controllers for the heater plate and conduit heater wire, as discussed above and in the updated rejections below.
Applicant argues on page 9 of Remarks that “Koch fails to teach any algorithms that use ambient temperature…a person of skill…would not be able combine the teachings…to arrive at two different separate algorithms which both use ambient temperature.”
In response to applicant's argument that Koch’s conduit heater control does not utilize ambient temperature, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). 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). The base reference of Muller already discloses using ambient temperature when determining the power requirements for/target temperatures to be achieved by both the heater plate and the heater wire as discussed in the rejections maintained below; Koch is not relied on in this regard. Koch is relied on to demonstrate the obviousness of including a patient end sensor for feedback control of a conduit heater, which thus educates the second control algorithm of Muller (already based on ambient temperature) to arrive at the instant claim limitations as discussed in the updated rejections below.
No separate arguments are made regarding the dependent claims. The rejections of the dependent claims are maintained/updated as appropriate below.
Claim Objections
Claims 3, 20 and 21 are objected to because of the following informalities:
Claim 3, line 3, should read “is configured to adjust
Claim 20, lines 1-2 should read “determining
Claim 21, lines 1-2 should read “wherein
Appropriate correction is required.
Claim 9 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 8. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Regarding amended claims 1 and 17 (and thus their dependent claims), the specification as originally filed is not understood to disclose a “first control algorithm” and “second different control algorithm” as claimed, much less where the controller is configured to “determine and implement both…concurrently during a therapeutic treatment session.” First, regarding control algorithms, while the specification as originally filed does disclose first and second different control algorithms, these are described in conjunction with whether or not the system is experiencing high convective heat loss, and they alternatively control the control output (which controls both the heater plate and the conduit heater wire), see e.g. page 8, line 27-page 9, line 5, and page 28 of the instant specification, i.e. they are not implemented concurrently, and they are pre-loaded, i.e. not “determined…during a therapeutic treatment session.” Second, in as far as control for a target temperature is concerned, page 20 of the specification as originally filed describes determining a target chamber exit temperature based on a pre-loaded algorithm or formulae (again, not one “determined” by the controller during a therapeutic session), and page 24 of the specification as originally filed further describes that, “[t]he reading from the patient end temperature sensor 15 is fed back to the controller 8 and is used to ensure that the temperature of the gases at the point of delivery [i.e. the patient end temperature] substantially matches the target patient temperature of the gases at the chamber exit [i.e. the exit port temperature],” using “a predetermined data set [to adjust] the power to the heater plate, or the conduit heater wire, or both, using this data,” i.e. both the heater plate and conduit heater wire are controlled to target the same temperature, which is determined from a single given algorithm/formula based on flow rate and ambient temperature as described on page 20 of the specification as originally filed (and adjusted if the patient end temperature cannot be maintained, see page 34, lines 18-23, of the specification as originally filed). This is understanding is reinforced on page 25 of the specification as originally filed, which states, “The controller 8 adjusts the power output of the heater plate, or the heater wire, or both, to match the measured chamber exit temperature (or patient end temperature) with the ‘ideal’ temperature retrieved from the data set in the memory of the controller.” [Note: page 25, lines 24-26, does describe an alternative variation where the exit temperature does not match the patient end temperature, but specific control algorithm(s) for this embodiment are not described.] Therefore, while the specification as originally filed supports power to the heater plate and power to the conduit heater wire being separately delivered, the control over both deliveries functions to operate the heater plate and conduit heater wire to achieve the same target temperature (at two different locations), where said target temperature is determined using a single/shared pre-determined algorithm/formula, not two different algorithms determined during a treatment session as amended.
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 claim 1 (and thus its dependent claims), it is unclear how control algorithms are to be “determined” by a controller “during a therapeutic treatment session.” Is the controller writing programs while it operates? Perhaps Applicant intended claim 1 to be interpreted as “utilize”? And regarding claims 1 and 17 (and thus their dependent claims), what does it mean for a control algorithm to be “different” from another, particularly since the specification as originally filed does not use the claimed terms in the claimed context as discussed in the 112(a) section above? If two different heating elements in a system are being controlled, is their control by two “different algorithms,” even if the target is the same value, because there is control going to two different places? Applicant’s arguments on page 8 of Remarks appear to support the interpretation of a “control algorithm” as anything that determines a power requirement for a heater element, such that determining a heating requirement for one heating element would constitute a “different algorithm” from determining the heating requirement for a second heating element, even if the heating elements are intended to ensure the same gas temperature value. As best understood, in view of the instant disclosure (see 112(a) discussion above regarding what is supported by the specification as originally filed), a controller that determines both a target exit temperature and a target patient end temperature (which can be the same temperature value, as instantly disclosed) based on ambient temperature and flow rate and controls/control of power to a heater plate as well as power to conduit heater wire (considered to be “different control algorithms” because one branch of the control is for the heater plate and the other is for the conduit heater wire, i.e. the control is of different elements, especially when using two separate feedback loops as taught by the prior art as discussed in the art rejection below) using sensor data indicating the exit temperature and the patient end temperature to maintain said target exit temperature/target patient end temperature reads on the instant claims.
Claim 2 recites the limitation "the target temperature at said exit port" in the last two lines. There is insufficient antecedent basis for this limitation in the claim. As best understood, for purpose of examination, the claim will be considered to read “the target chamber temperature
Claim 3 recites the limitation "the target temperature at the interface" in the last two lines. There is insufficient antecedent basis for this limitation in the claim. As best understood, for purpose of examination, the claim will be considered to read “the target patient end temperature
Regarding claims 8, 9 and 21, it is unclear how a temperature can “comprise” a dew point. As best understood, for purposes of examination, claims 8, 9 and 21 will be interpreted as reading “is”.
Regarding claim 18, it is unclear to which of the two algorithms of claim 17 “the control algorithm” of line 2 refers. As best understood, for purposes of examination, claim 18 will be considered to read “the first control algorithm”.
Regarding claim 19, it is unclear to which of the two algorithms of claim 17 “the control algorithm” of line 2 refers. As best understood, for purposes of examination, claim 19 will be considered to read “the second different control algorithm”.
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 recites that the target patient end temperature is determined based on the ambient temperature. Therefore, claim 16 does not properly further limit claim 1, because if the “data” of claim 16 refers to something other than the ambient temperature, then it is broader than claim 1, and if it does not refer to something other than the ambient temperature, then it is a redundant limitation. 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, 10, 14 and 16-20 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 control of 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 configured to pass through the humidifier, become heated and humidified, and exit 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 an exit port 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 an ambient 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 36 and tube heater control 39) configured to, as best understood, determine/utilize/implementing:
a first control algorithm (implemented by controller 36 directing control of the heater plate power) comprising determining/which determines a target chamber temperature (set gas temperature Tb, para [0036]) based on the ambient temperature and the flow rate, and to control power provided to a heater plate (humidifier heating power Pb setting) based on a difference between the exit port 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),
a second different control algorithm (implemented by control 39 directing control of the heater wire power) comprising determining/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 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 provided 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]);
wherein the controller is configured to, as best understood, determine/utilize and implement both the first and second control algorithms concurrently during a therapeutic treatment session in order to reduce condensate (adjust the heating power of the humidifier and/or the tube heating power…so as to…prevent condensation, para [0011]; see also paras [0013], [0016], [0037], [0044-52], [0061-62]).
While Muller teaches feedback control (within the first algorithm) 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 (within the second algorithm) 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 patient end temperature relating to the flow of gases at or close to the user;
the controller configured to/implementing the second different control algorithm to control the power to the heater wire based on the difference between the patient end 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 patient end 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 patient end 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 patient end temperature relating to said flow of gases at or close to said user, the controller configured to/implementing the second control algorithm to control the power to the heater wire based on the difference between the patient end 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 said controller/implementing, as best understood, the first control algorithm is further configured to adjust/comprises controlling the power provided to the heater plate in order to match the exit port temperature to, as best understood, the target [chamber] temperature (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 teaches wherein the controller adjusts/implementing, as best understood, the second control algorithm comprises adjusting the power provided to the heater wire to match the patient end temperature to, as best understood, the target [patient end] temperature (as discussed above regarding claims 1 and 17, Muller as modified in view of Koch includes feedback control of the heater wire power based on the patient end temperature similar to the feedback control of the heater plate based on the humidifier outlet temperature discussed in Muller para [0036], such that the patient end/heater wire feedback control adjusts the heater 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 further configured to determine/the determining [at least one of] the target chamber 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 a range of 31 - 39°C (Muller Figs. 2-4; paras [0047] and [0049]).
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 heater plate 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 exit port temperature, ambient temperature, and heater plate temperature and the flow rate and adjusting at least power provided to the heater plate to match the exit port 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, 8, 9 and 21 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, 8, 9 and 21, Muller in view of Koch teaches the breathing assistance system as claimed in claim 1 and method as claimed in claim 17, 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 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 a target dew point. 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/is a target dew point (optimal temperature may be about 37 °C and the optimal humidity value about 44 mg H2O per liter, para [0148], where the dew point temperature of an absolutely humidity 44 mg H2O/l is 37 °C, and see also McPhee para [0160], which discusses targeting an optimal dewpoint). 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 patient end temperature comprises a user-set target dew point temperature that relates to an absolute humidity level of substantially 44mg H2O/liter of air/is a target dew point 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, i.e. fully saturated air at body temperature (McPhee, paras [0148] and [0160]).
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 ambient gas up to the desired delivery humidity and/or temperature level.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHRYN E DITMER whose telephone number is (571)270-5178. The examiner can normally be reached M 7:30a-3:30p, Tu-Th 8a-2p, F 7:30-11:30a ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at 571-270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHRYN E DITMER/Primary Examiner, Art Unit 3785
