DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/1/2025 has been entered.
Response to Amendment
This office action is in response to the amendment filed 8/1/2025. As directed by the amendment, claims 79, 87, 89, 104, 105 and 109 have been amended, and claim 86 has been cancelled. As such, claims 79-84, 87-89 and 104-112 are pending in the instant application.
Applicant has amended the claims to address the previous objections thereto, which are hereby withdrawn.
Applicant has not removed the new matter from claims 79 and 89; the rejections under 35 USC 112(a)/first paragraph are maintained below.
Applicant has not amended claim 89 in a way that sufficiently addresses the previous rejection thereof under 35 USC 112(b)/second paragraph, which is updated below.
Applicant has amended claim 109 to address the previous rejection thereof under 35 USC 112(b)/second paragraph, which is hereby withdrawn.
Response to Arguments
Applicant's arguments filed 8/1/2025 (hereinafter “Remarks”) have been fully considered but they are not persuasive.
Regarding the rejection of claim 79 (and thus its dependents) under 35 USC 112(a)/first paragraph, Applicant argues on page 5 of Remarks that paras [0223-227] and [0232-233] of the specification as originally filed support the limitation previously added to claim 79 (see 112(a) section maintained below) because “[t]hose paragraphs describe that a user can set a desired expiratory relief level, but the system will have pre-programmed limits which will automatically limit the user settings if needed based on effectiveness and safety.”
While the specification as originally filed (including those paragraphs referenced by Applicant) does disclose min/max threshold settings (e.g. “pre-programmed limits based on effectiveness and safety”) that are utilized for negative feedback during operation/therapy, the specification as originally filed makes no mention of the controller being configured to “determine prior to therapy initiation, whether the user input to decrease an expiratory relief level is available based on a comparison with a minimum flow rate threshold selected to ensure effectiveness and safety of the high-flow therapy” (emphasis added), that is, there is no disclosure regarding a pre-operational/pre-therapy step, particularly one configured to be performed by the controller, where a user input is compared to a threshold as claimed and determined to be “available.” Therefore, the Examiner maintains that this previously-added subject matter is new matter.
Regarding the rejection of claim 89 under 35 USC 112(a)/first paragraph, Applicant argues on page 5 of Remarks that the amendment to claim 89 finds support “in the same paragraph noted above with regard to claims [sic] 79”.
The Examiner again emphasizes that the claimed expiratory relief levels are disclosed as positive feedback parameters (see e.g. instant para [0220]), while the claimed attenuation is negative feedback (see e.g. instant para [0223]), such that “negative feedback…based on selected expiratory relief levels” as recited by claim 89 is not understood to be supported by the specification as originally filed because this is an undisclosed (and unclear) mixing of two different types of feedback. Applicant could address this 112(a) rejection by amending claim 89 to read “based on the minimum flow rate threshold”, but it is noted that the 112(b) of claim 89 would still remain as discussed in the 112 section below.
Applicant argues on page 6 of Remarks that Kazufuku “is a pressure controlled device…the pressure is controlled either to overshoot or understood…flow delivered to the patient is completely uncontrolled…evident in the graph 1 of Fig. 2.”
The Examiner disagrees with Applicant’s mischaracterization of Kazufuku: the device of Kazufuku is not “a pressure controlled device” where “flow delivered to the patient is completely uncontrolled.” The device of Kazufuku is explicitly described as having “a flow rate control unit configured to control an air flow rate,” see e.g. Kazufuku para [0064]. Moreover, it is noted that Kazufuku para [0064] also discusses how it was well known in the art before the effective filing date of the claimed invention that both flow and pressure are standard, interrelated and interchangeable control parameters, such that even if Kazufuku had disclosed a pressure controlled device, modifying it to be a flow controlled device would have been an obvious matter of design choice that would provide the predictable result of an alternative standard means for controlling positive pressure therapy. As such, Applicant’s arguments are unconvincing and the rejections in view of Kazufuku are maintained below.
Applicant argues on pages 6-7 of Remarks that “Poormand is an invasive ventilation system…PHOSITA would not look at the teachings of Poormand when trying to modify Kazufuku, as these are completely different therapies with very different contexts and patient considerations.”
The Examiner disagrees with Applicant’s characterization of Poormand, as well as with their assertion that Poormand and Kazufuku are “completely different therapies.” Poormand para [0049] explicitly discusses non-invasive patient interfaces in addition to invasive ones, and Poormand and Kazufuku are both squarely in the field of respiratory therapy involving the delivery of positive pressure/flow, such there is no reason why an artisan would not have looked to Poormand to educate Kazufuku regarding hard-stop/operational min (and max) thresholds for delivering therapeutic gases as discussed in the art rejection maintained below, because the general concept of having hard-stop thresholds is applicable regardless of the type of patient interface, in order to predictably protect the patient from selecting flow/pressure values that are dangerous and/or ineffective. As such, Applicant’s arguments are unconvincing and the rejections in view of Kazufuku and Poormand are maintained below.
Applicant argues on page 7 of Remarks that “[t]he pressure delivered to the patient [in Kane] is the controlled parameter…flow delivered…is simply a function of the pressure and is not the target parameter…to control the pressure, the flow has to be variable…[f]low is not the target itself.”
The Examiner disagrees on multiple points. First, the Examiner disagrees with Applicant’s mischaracterization of Kane: Kane explicitly states “controlling a flow and/or pressure of fluid to be delivered to a patient” in e.g. para [0036] (see also e.g. para [0054] which indicates that “target peak flow” can be used as a variable, and para [0066]: “causes the pressure generator system to adjust the pressure or the rate of flow”), such that Kane expressly teaches flow as a suitable parameter to be controlled/targeted. Second, 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). Even if Kane did not disclose controlling flow (which it does), the base reference of Kazufuku already discloses controlling flow, as discussed above, such that the contested limitation is already provided for by the base reference. Moreover, as evidenced by both Kazufuku and Kane, flow and pressure control were well known to be interchangeable before the effective filing date of the claimed invention, such that stipulating one or the other would not be a point of novelty or non-obviousness. As such, Applicant’s arguments are unconvincing and the rejections in view of Kazufuku and Kane are maintained below.
Applicant states on page 7 of Remarks that “While it is possible for a PHOSITA to combine the teachings of Kane and Kazufuku being both pressure based control systems, a PHOSITA would not add the teachings of Poormand, as it is directed to an invasive ventilator.”
The Examiner once again disagrees with Applicant’s mischaracterization of the prior art. As discussed above, Kazufuku and Kane both explicitly disclose flow-based control, and Poormand teaches non-invasive interfaces, such that Applicant’s grounds for argument are unsubstantiated, and the Examiner maintains that all of the prior art is in the same field with which Applicant was concerned, namely, respiratory therapy involving the delivery of positive pressure/flow, such that combining teachings from said field would have been no problem for PHOSITA before the effective filing date of the claimed invention. As such, Applicant’s arguments are unconvincing and the rejections in view of Kazufuku, Poormand and Kane are maintained below.
Applicant argues on page 7 of Remarks that “PHOSITA would also not combine Burgess with Kazufuku and Kane, as Burgess is a flow controlled system which applies high flow therapy…provides a specific flow rate and holds that flow rate, while Kazufuku and Kane attempt to deliver a specific pressure to the patient…Kazufuku and Kane are directed to controlling the delivered pressure and fail to provide any teaches [sic] regarding controlling the delivered flow…Burgess is not combinable with Kazufuku, Kane.”
The Examiner disagrees on multiple points. First, the Examiner disagrees with Applicant’s mischaracterization of Burgess: Burgess does not “provide[] a specific flow rate and hold[] that flow rate,” rather, Burgess explicitly teaches varying flow depending on respiratory cycle (Fig. 7), using both positive and negative feedback (paras [0100-101], i.e. as instantly disclosed/claimed. Second, as discussed at length above, Kazufuku and Kane both disclose flow-based control, such that there is no issue with combining these disclosures with Burgess’s teaching of a particular type of flow/interface (i.e. high flow/non-sealed cannula). As such, Applicant’s arguments are unconvincing and the rejections in view of Kazufuku, Kane and Burgess are maintained below.
Applicant argues on page 7 of Remarks that “PHOSITA…would not combine Burgess with the teachings of Poormand as Poormand is an invasive ventilator… Burgess is from a very different field and involves different patient contexts…attempting to add the teachings of Poormand may cause harm to a conscious patient.”
The Examiner disagrees. As has been discussed above, Poormand is not limited to “an invasive ventilator,” Burgess is from the same field as all of the references, i.e. the field of respiratory therapy involving the delivery of positive pressure/flow, and Applicant has provided no logical reasoning to support their baseless assertion that “attempting to add the teachings of Poormand may cause harm to a conscious patient.” Indeed, the Examiner fails to see how ensuring that a minimum level of flow/pressure required for therapeutic effectiveness (and a maximum level to prevent barotrauma) would “cause harm to a patient,” given that these thresholds are explicitly for preventing harm.
Applicant argues on page 7 of Remarks that “[t]he Office Action also fails provided any credible reasoning as to why the teachings cited in the Office Action would be specifically chosen and combined…no credible reason to combine teachings of very different and unrelated therapies like pressure therapy, invasive therapy and flow therapy. A PHOSITA would not combine these teachings.”
The Examiner heartily disagrees. Not only are the prior art references not “very different and unrelated therapies,” because they are all respiratory therapies involving the delivery of positive pressure/flow, but explicit reasoning was provided on page 9 of the Office Action mailed 2/10/2025 (and is maintained below), that is, Poormand teaches utilizing hard-stop thresholds, Kane teaches setting thresholds based on a percentage above/below a desired/controlled parameter, and Burgess teaches attenuation based on a comparison to thresholds, such that combining the concepts to arrive a system with attenuation based on hard-stop thresholds determined via percentage as claimed would have been obvious to an artisan before the effective filing date of the claimed invention in order to provide the predictable results of ensuring that the patient-altered settings of Kazufuku do not result in min (or max) flows that are insufficient (or could cause barotrauma) by bounding the patient-altered/alterable settings with hard-stop/operational min (and max) thresholds determined based on percentages from a selected flow rate. The Examiner asserts that an artisan would have had no difficulty combining these concepts, as they are clearly described by the prior art and readily applicable to the system of Kazufuku.
Applicant argues on page 8 of Remarks that “[t]he graph of Kazufuku shows the flow is not the control parameter and is not reduced by a specific amount.”
The Examiner once again disagrees with Applicant’s mischaracterization of Kazufuku. Fig. 2 of Kazufuku clearly has flow as the Y-axis, describes flow as the control parameter (see discussions above) and shows the flow as reduced by a specific amount (at M1 or L1 versus H1).
Applicant argues on page 8 that “limitation (a)…is not disclosed…[t]he Office Action points to Poormand for a teaching of whether a default setting is available…Poormand does not disclose at its paragraph [0058] the concept of checking if the user input for expiratory relief is available in comparison for a minimum flow rate threshold to ensure effective therapy is delivered“ (emphasis Applicant’s).
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). Poormand para [0058] teaches the concept of ensuring that patient-altered settings do not fall outside of an acceptable, pre-set range, and indicating when/if a patient selection is outside the acceptable range (i.e. not available) before beginning therapy. This is combined with the base reference of Kazufuku, which discloses patient-altered settings, i.e. similar to the manual overrides of Poormand, and Kane, which teaches providing variable IPAP/EPAP settings (i.e. similar to Kazufuku Fig. 2) with a (maximum or) minimum threshold selected to ensure effectiveness and safety of the therapy, the (maximum or) minimum threshold comprising a percentage (above or) below a selected pressure/flow. Therefore, it is the combination of references that arrives at the contested limitation, as maintained in the art rejections below.
Applicant argues on page 8 of Remarks that “it is not clear to the Applicant which prior art reference the Office Action relies on for the teaching of this limitation [(b)]…has not met a prima facie burden of showing that the prior art discloses attenuating the patient specified flow rate reduction (e.g. adjustment based on the minim flow rate thresholds)…Kane only describes setting the maximum IPAP possible as a percentage of the min IPAP”.
The Examiner respectfully notes that the teachings of Burgess were clearly associated with the contested limitation, as discussed on page 9 of the Office Action mailed on 2/10/2025 and maintained below, by explicitly stating: “Burgess further demonstrates that it was known in the respiratory therapy art before the effective filing date of the claimed invention for a controller to attenuate adjusting of flow (suppress the change to the control signal, para [0096]) based on comparing a flow rate threshold with a flow rate measured by one or more sensors (magnitude of the patient’s inhale or exhale exceeds a threshold level, para [0096]; paras [0099-101] and [0105]).” She also disagrees that a prima facie case has not been made. Kazufuku’s disclosure of flow adjustment based on a selected level of expiratory relief is modified by Poormand’s teaching of a need for hard-stop thresholds, Kane’s teaching of setting thresholds based on percentages, and Burgess’s teaching to attenuate (i.e. to utilize negative feedback in addition to positive feedback) control of respiratory device flow based on comparisons to associated thresholds, in order to provide the predictable results discussed on pages 9-10 of the Office Action mailed 2/10/2025 and maintained below. As such, Applicant’s arguments are unconvincing, a prima facie case has been made, and the rejections in view of Kazufuku, Poormand, Kane and Burgess are maintained below.
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 79-84, 87-89 and 104-112 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 claim 79 (and thus its dependent claims 80-84, 86-89 and 104-112), the specification as originally filed makes no mention of the controller being configured to “determine prior to therapy initiation, whether the user input to decrease an expiratory relief level is available based on a comparison with a minimum flow rate threshold selected to ensure effectiveness and safety of the high-flow therapy.” Therefore, this subject matter is new matter.
Regarding claim 89, the specification as originally filed only describes the negative feedback as being based on min/max thresholds that are based on a selected flow rate, see e.g. instant paras [0016], [0158] and [0222-223], not “based on selected expiratory relief levels” (which are positive feedback terms, see discussion below) as now claimed. Therefore, amended claim 89 contains new matter. Applicant could address this rejection by amending claim 89 to read “based on the minimum flow rate threshold”.
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 79-84, 87-89 and 104-112 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 79 (and thus its dependent claims), claim 79 recites the limitation "the user input to decrease" in lines 13-14. There is insufficient antecedent basis for this limitation in the claim because lines 10-11 recite “a user input…to increase or decrease” (emphasis added), i.e. “input to…decrease” is presented as an alternative/possibility, not necessarily a positively recited element, rendering it unclear whether the scope of the claim includes an increase, which does not require the limitations regarding the decrease, without a decrease with the associated limitations, or whether the decrease is required. To address this rejection, Applicant could amend claim 79, lines 10-11 to read “a user input…to
Regarding claim 89, it is unclear how a negative feedback can be based on selected expiratory relief (ER) levels (or how “selected ER levels” (plural) relate to claim 79, since claim 79 is only concerned with decreasing/selecting an ER level), since, as best understood from paras [0200-225] and [0231] of the instant specification, the disclosed ER levels are positive feedback terms. Moreover, the specification as originally filed indicates that the disclosed negative feedback is an attenuation based on min/max thresholds, see e.g. instant paras [0014-16], and claim 79 has been amended to recite an attenuation based on a min threshold, such that it is unclear what is the “negative feedback” that is being “further…appl[ied]” (emphasis added) in claim 89, since the negative feedback disclosed by the specification as originally filed is the attenuation already recited amended claim 79. As best understood, for purposes of examination, the negative feedback of claim 89 is not a “further…app[lication]”, rather, it is the attenuation of claim 79, which then raises a concern regarding whether claim 89 is properly further limiting, because attenuation is a type of negative feedback, i.e. claim 79 recites a narrow limitation and claim 89 recites a broader scope of that same limitation. Applicant could cancel claim 89 to address this rejection.
Claim Interpretation
The user input for controlling an expiratory relief level of claim 79 being “configured to allow adjusting…based in part on a cycle of the patient inspiration and expiration” is understood in light of the instant specification at e.g. paras [0208], [0220] and [0225] to mean that the user input describes a level of positive feedback to be implemented in the exhalation phase of a breath.
The relative term “high flow” of claim 79 is understood in light of instant para [0185] to mean flow that meets or exceeds peak inspiratory demand.
Claim 79, lines 12-13, recites “the user input configured to be received from a therapy recipient.” The identity of the user is considered intended use; any system that allows the instantly-claimed input from a user will be considered to meet the instant limitation, because any user is fully capable of being “a therapy recipient.”
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claim(s) 79, 80, 82, 84, 87-89 and 104-112 are rejected under 35 U.S.C. 103 as being unpatentable over Kazufuku (WO 2018/025950 A1; hereinafter “Kazufuku,” wherein PGPub US 2021/0128851 A1 is cited in the rejection below as an English translation of the WIPO document) in view of Poormand (US 2016/0256659 A1; hereinafter “Poormand”), Kane et al. (US 2012/0298108 A1; hereinafter “Kane”), and Burgess et al. (WO 2017/200394 A1; hereinafter “Burgess”).
Regarding claims 79, 87 and 88, Kazufuku discloses a respiratory system (conventional respiratory assistance device (CPAP) 1) (Figs. 1A and 8) for delivering a respiratory therapy to a patient (para [0003]), the system configured to adjust a flow rate of gases (controls a flow rate from the air blower, abstract, paras [0073] and [0079]) delivered to the patient according to patient inspiration and expiration (Figs. 2, 9B-C; para [0004]), the system comprising:
a flow generator (air blower 120) with a motor for generating a gases flow (paras [0059] and [0073], wherein a blower whose revolutions are controlled inherently possesses a motor for effecting said revolutions); and
a controller (control unit 2) in electrical communication (via sensor I/F 110) with one or more sensors (flow rate sensor and pressure sensor) (paras [0059] and [0079]); the controller programmed with software (program…executed by the CPU, para [0056]) which, when operated, causes the controller to:
display, on a user interface (display section 100) of the respiratory system, an expiratory relief level setting (undershoot (US) value), the setting comprising a plurality of different expiratory relief levels (numbers/US levels displayed in the selection screen 50) (Figs. 5 and 6C; paras [0017], [0047], [0058] and [0103]);
prior to therapy initiation, receive a user input via the user interface to increase or decrease an expiratory relief level, the user input configured to be received from a therapy recipient (Figs. 3-5 and 7; paras [0027], [0065-67], [0071], [0079], [0084], [0089-99] and [0103]);
determine a cycle of patient inspiration and expiration based on the one or more sensors (para [0081]); and
adjust the flow rate based on the user input, wherein the user input is configured to allow adjusting of the flow rate based in part on a cycle of the patient inspiration and expiration (Figs. 9B-C; paras [0050], [0065-67], [0084], [0096-99]).
Kazufuku is silent regarding wherein the system is a high flow respiratory system comprising a non-sealed patient interface that comprises a non-sealed nasal cannula. However, Burgess demonstrates that it was well known in the respiratory therapy art before the effective filing date of the claimed invention for a positive pressure, positive feedback-controlled respiratory system to be a high flow respiratory system comprising a non-sealed patient interface that comprises a non-sealed nasal cannula (para [0037]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for the positive pressure, positive feedback-controlled respiratory system of Kazufuku to include wherein the system is a high flow respiratory system comprising a non-sealed patient interface that comprises a non-sealed nasal cannula as taught by Burgess, in order to provide the predictable result of a comfortable, known respiratory support system/user interface arrangement that reduces the volume of anatomical deadspace (Burgess, para [0037]) and thus the amount of rebreathing of expired gases.
Modified Kazufuku is silent regarding the controller configured to determine prior to therapy initiation, whether the user input to decrease an expiratory relief level is available based on a comparison with a minimum flow rate threshold selected to ensure effectiveness and safety of the therapy, the minimum flow rate threshold comprising a percentage above or below a selected flow rate; and further configured to attenuate the adjusting based on comparing the minimum flow rate threshold with minimum flow rate measured by the one or more sensors during therapy. However, Poormand teaches that it was well known in the respiratory therapy art before the effective filing date of the claimed invention to determine prior to therapy initiation, whether the user input to (increase or) decrease a default setting is available (within the clinically acceptable range) based on a comparison with a (maximum or) minimum setting threshold selected to ensure effectiveness and safety of the therapy (para [0058]), Kane teaches that it was well known in the respiratory therapy art before the effective filing date of the claimed invention to provide variable IPAP/EPAP settings with a (maximum or) minimum pressure threshold selected to ensure effectiveness and safety of the therapy, the (maximum or) minimum threshold comprising a percentage (above or) below a selected pressure (para [0064]), and Burgess further demonstrates that it was known in the respiratory therapy art before the effective filing date of the claimed invention for a controller to attenuate adjusting of flow (suppress the change to the control signal, para [0096]) based on comparing a flow rate threshold with a flow rate measured by one or more sensors (magnitude of the patient’s inhale or exhale exceeds a threshold level, para [0096]; paras [0099-101] and [0105]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Kazufuku to include wherein the controller is configured to determine prior to therapy initiation, whether the user input to decrease an expiratory relief level is available based on a comparison with a minimum flow rate threshold selected to ensure effectiveness and safety of the therapy, the minimum flow rate threshold comprising a percentage below a selected flow rate; and further configured to attenuate the adjusting based on comparing the minimum flow rate threshold with a minimum flow rate measured by the one or more sensors during therapy as taught by Poormand, Kane and Burgess, in order to provide the predictable results of ensuring that the patient-altered settings of Kazufuku (similar to the manual overrides of Poormand) do not result in min flow levels that fall below min flow levels that could cause insufficient airway splinting, by bounding/limiting the patient-altered settings with hard-stop/operational min (and max) thresholds, see Poormand para [0058] in view of the teachings of flow thresholds for attenuation discussed above with regards to Burgess, and the selection/establishment/calculation of appropriate min/max thresholds discussed above regarding Kane.
Regarding claim 80, Kazufuku in view of Poormand, Kane and Burgess teaches the system of Claim 79, wherein Kazufuku further discloses wherein the user input is configured to allow the adjusting of the flow rate based in part on a cycle of the patient inspiration and expiration by turning on and/or off expiratory relief, and/or adjusting a magnitude of the expiratory relief (Kazufuku para [0084]).
Regarding claim 82, Kazufuku in view of Poormand, Kane and Burgess teaches the system of Claim 79, wherein Kazufuku further discloses wherein the plurality of different expiratory relief levels comprise a range of numbers (Kazufuku Fig. 6C; para [0097]).
Regarding claim 84, Kazufuku in view of Poormand, Kane and Burgess teaches the system of Claim79, wherein Kazufuku further discloses wherein the user input is receivable via button(s) (keys 10, 20) on the user interface (Kazufuku Fig. 6A; para [0103]).
Regarding claim 89, Kazufuku in view of Poormand, Kane and Burgess teaches the system of Claim 79, wherein modified Kazufuku teaches a negative feedback (Burgess’s negative feedback 616) to the adjusting of the flow rate (Burgess Fig. 6A; paras [0094-101]) based on selected expiratory reliefs levels because different selected levels of relief will be closer or farther away from the min threshold and thus the degree of negative feedback will be varied depending on how close or far the threshold is (Burgess Fig. 6A; paras [0094-101]).
Regarding claim 104, Kazufuku in view of Poormand, Kane and Burgess teaches the system of Claim 85, wherein modified Kazufuku further teaches wherein the controller is further configured to cause to be displayed, on the user interface, a minimum flow rate threshold setting (e.g. Kazufuku Fig. 2, and see also Poormand para [0058]), because it would have been obvious to an artisan before the effective for the operational min/max thresholds to be displayed (along with the prescribed min/max as shown in Kazufuku Fig. 2) so that the user can visually assess if the flow is within the operating parameters, and receive a second user input to increase and/or decrease the minimum flow rate threshold (e.g. Kazufuku para [0029]), because it would have been obvious to an artisan before the effective filing date of the claimed invention for both of the operational min/max thresholds to be set in a manner similar to the prescribed min/max of Kazufuku.
Regarding claim 105, Kazufuku in view of Poormand, Kane and Burgess teaches the system of Claim 79, wherein modified Kazufuku further teaches wherein the controller is further configured to attenuate the adjusting (suppress the change to the control signal, Burgess para [0096]; limiting the positive feedback applied to the control signal to certain bounds, Burgess para [0097]) based on the user input/a positive feedback (Kazufuku’s undershoot (US) value/Burgess’s feedback 614) for providing expiratory relief (Kazufuku Fig. 2, para [0084]; Burgess paras [0094-95]) by a parameter (Burgess’s negative feedback 616) determined based in part on the minimum flow rate measured by the one or more sensors during the cycle of the patient inspiration and expiration (Burgess paras [0097-101] and see claim 79 discussion above).
Regarding claim 106, Kazufuku in view of Poormand, Kane and Burgess teaches the system of Claim 79, wherein Kazufuku further discloses wherein the flow rate configured to be adjusted by outputting a motor control signal (Kazufuku para [0099], wherein controlling the number of revolutions of the blower inherently requires the control unit to output a signal to the blower motor to control said revolutions).
Regarding claim 107, Kazufuku in view of Poormand, Kane and Burgess teaches the system of Claim 79, wherein Kazufuku further discloses wherein the adjusting comprises a decrease in the flow rate when the patient is expiring (Kazufuku Figs. 2 and 9B-C).
Regarding claim 108, Kazufuku in view of Poormand, Kane and Burgess teaches the system of Claim 79, wherein Kazufuku further discloses wherein the cycle of the patient inspiration and expiration is determined based on a second input (from the pressure sensor) received by the controller (para [0081]), and a first input (from the flow meter), the first and second inputs relating to a gases flow characteristic or performance of a component of the system (paras [0059], [0064] and [0081]), but modified Kazufuku is silent regarding wherein the cycle of the patient inspiration and expiration is determined based on the first input as well. However, Burgess demonstrates that it was known in the respiratory therapy art before the effective filing date of the claimed invention for a cycle of the patient inspiration and expiration to be determined based on both first/flow and second/pressure inputs (paras [0092-93]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Kazufuku to include wherein the cycle of the patient inspiration and expiration is determined based on the first input as well as further taught by Burgess, in order to provide the predictable result of utilizing extra sensor data to provide more detailed and/or accurate tracking of the breathing cycle.
Regarding claim 109, Kazufuku in view of Poormand, Kane and Burgess teaches the system of Claim 108, wherein modified Kazufuku further discloses wherein the first input corresponds to a flow rate from the one or more sensors (Kazufuku para [0073]; Burgess paras [0092-93]).
Regarding claim 110, Kazufuku in view of Poormand, Kane and Burgess teaches the system of Claim 108, wherein modified Kazufuku further discloses wherein the second input corresponds to a pressure of a gases flow from the one or more sensors, or a speed of a motor of the flow generator (Kazufuku para [0079]; Burgess paras [0092-93]).
Regarding claim 111, Kazufuku in view of Poormand, Kane and Burgess teaches the system of Claim 79, but Kazufuku is silent regarding wherein the adjusting is performed iteratively. However, Burgess demonstrates that it was known in the respiratory therapy art before the effective filing date of the claimed invention for the adjusting of a respirator setting to be performed iteratively (paras [0106] and [0114]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Kazufuku to include wherein the adjusting is performed iteratively as further taught by Burgess, in order to provide the predictable result of allowing the adjustment to be slowly optimized without exceeding the operational thresholds (see e.g. the discussion of claims 79/89/105 above).
Regarding claim 112, Kazufuku in view of Poormand, Kane and Burgess teaches the system of Claim 79, but Kazufuku is silent regarding wherein the one or more sensors comprise an ultrasonic transducer assembly or a heated temperature sensing element. However, Burgess demonstrates that it was well known in the respiratory therapy art before the effective filing date of the claimed invention for a flow sensor such as that of Kazufuku to comprise an ultrasonic transducer assembly or a heated temperature sensing element (Burgess para [0065]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Kazufuku to include wherein the flow sensor comprises an ultrasonic transducer assembly or a heated temperature sensing element as taught by Burgess, in order to provide the predictable result of a suitable flow sensor(s), particularly one that has better short-term or local accuracy and/or one with better average accuracy (Burgess, paras [0065-66]).
Claim(s) 81 is rejected under 35 U.S.C. 103 as being unpatentable over Kazufuku in view of Poormand, Kane and Burgess as applied to claim 79 above, and further in view of Lamprecht et al. (US 2016/0202853 A1; hereinafter “Lamprecht”).
Regarding claim 81, Kazufuku in view of Poormand, Kane and Burgess teaches the system of Claim 79, wherein Kazufuku discusses different levels as small or large (para [0084]), but Kazufuku does not explicitly disclose wherein the plurality of different expiratory relief levels comprise a plurality of categories including at least low and high expiratory relief levels. However, Lamprecht demonstrates that it was well known in the respiratory therapy art before the effective filing date of the claimed invention for a plurality of different expiratory relief levels (see the dots in Fig. 6, item 304) to comprise a plurality of categories including at least low and high expiratory relief levels (the three dots in Fig. 6, item 304 are understood to correspond to low, medium and high levels of expiratory relief). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Kazufuku to include wherein the plurality of different expiratory relief levels comprise a plurality of categories including at least low and high expiratory relief levels as suggested by Kazufuku and taught by Lamprecht, in order to provide the predictable result of general/more easily grasped terms for selecting an appropriate level, rather than the numerical graduations of Kazufuku.
Claim(s) 83 is rejected under 35 U.S.C. 103 as being unpatentable over Kazufuku in view of Poormand, Kane and Burgess as applied to claim 79 above, and further in view of White et al. (US 2016/0193438 A1; hereinafter “White”).
Regarding claim 83, Kazufuku in view of Poormand, Kane and Burgess teaches the system of Claim 79, but Kazufuku is silent regarding wherein the plurality of different expiratory relief levels comprise a sliding scale. However, White demonstrates that it was well known in the respiratory therapy art before the effective filing date of the claimed invention to utilize a sliding scale (Fig. 78) to select a value for a respirator flow setting (para [1041]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Kazufuku to include wherein the plurality of different expiratory relief levels comprise a sliding scale as taught by White, in order to provide the predictable result of more a granular means for selecting an appropriate level, rather than the numerical graduations of Kazufuku.
Conclusion
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/KATHRYN E DITMER/Primary Examiner, Art Unit 3785