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 .
Receipt of Applicant’s Amendment filed July 14, 2026.
Response to Amendment
Claims 26 and 45 have been amended. Claims 1-25 have been previously canceled. Claims 26-45 are pending and are provided to be examined upon their merits.
Response to Arguments
Applicant’s arguments with respect to claims 26-45 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. A response is provided below in bold where appropriate.
Applicant argues 35 USC §112(b), starting pg. 9 of Remarks:
Response to the Office Action
Applicants address the rejections pertaining to the claim amendments first.
Response to Rejection (2)
Claims 26-45 stand rejected under 35 U.S.C. § 112(b) as allegedly being indefinite. The rejection asserts two specific bases. First, the rejection alleges that the term "degree" in independent claim 26 is a relative term that is not defined by the claim and for which the specification does not provide a standard for ascertaining the requisite degree (Office Action at pages 8-9). Second, the rejection alleges that, because claim 26 also recites that "the specified respiration pattern can be partially adapted to the real respiration pattern of the patient," it is unclear whether "the user" or "the specified respiration pattern" is the entity that synchronizes (Office Action at page 9).
Without acquiescing in the underlying observations, and solely in order to advance prosecution, claim 26 has been amended in three respects, each of which addresses the Examiner's observations and each of which is fully supported by the instant specification as originally filed.
Withdrawn based on the claim amendments. However, the amendments have resulted in a new rejection.
First, the language "in a manner dependent on a degree to which the actual ventilation parameter differs from the setpoint ventilation parameter" has been replaced with "in a manner dependent on a deviation of the actual ventilation parameter from the setpoint ventilation parameter," thereby removing the term "degree" to which the Examiner has taken exception. The use of the term "deviation" is fully supported by the instant specification as originally filed (see, e.g., page 18, lines 25-26: "red light to be projected if the respiration deviates from the setpoint value to too great a degree"; paragraph [0061] of the published application) and is, in any event, recognized by one of ordinary skill in the art as a quantitative measure of the difference between an actual value and a setpoint value of the same parameter.
Second, and as a further measure responsive to the Examiner's observations, the recitation that the specified respiration pattern "can be partially adapted to the real respiration pattern of the patient" has been amended to recite that the specified respiration pattern "is partially adapted to the real respiration pattern of the patient to a defined extent." This additional language is taken from the instant specification at page 20, lines 4-5 (paragraph [0062] of the published application) and provides a clear, structural anchor by which the partial adaptation of the specified respiration pattern is bounded.
Respectfully, partially adapted to a defined extent is indefinite as there is no standard or limitation as to partially adapted to a defined extent. This could be anything.
Third, the language "in a way which makes it easier for the user to synchronize its respiration with the specified respiration pattern" has been replaced with "in order to make it easier for the user to synchronize the user's respiration with the specified respiration pattern," thereby (i) tracking substantially the language of the instant specification at page 20, lines 5-7 (paragraph [0062] of the published application) and (ii) clarifying, through replacement of the antecedent-ambiguous pronoun "its" with "the user's," that it is the user, and not the specified respiration pattern, that synchronizes the user's respiration with the specified respiration pattern.
The amendments are believed to address each and every basis for indefiniteness identified by the Examiner at pages 8-9 of the Office Action. Applicants therefore respectfully submit that the instant rejection under 35 U.S.C. § 112(b) is now moot, and withdrawal of this rejection is respectfully requested.
The prior rejection has been withdrawn but the amendments have caused a new rejection. It is indefinite as to the specified pattern partially adapted to a pattern to a defined extent. If the basis of this is in order to make it easier for the user to synchronize the user’s respiration with the respiration pattern, make it easier is subjective depending on the patient.
Applicant argues 35 USC §112(d), pg. 11 of Remarks:
Response to Rejection (3)
Claim 45 stands rejected under 35 U.S.C. § 112(d) on the asserted basis that, in light of the amendments to claim 26 entered with the Request for Continued Examination, claim 45 "recites limitations that are included in independent Claim 26" and therefore allegedly does not further limit the subject matter of claim 26 (Office Action at page 9-10).
Applicants respectfully submit that claim 45, even as currently of record following the Request for Continued Examination, in fact further limits claim 26 in at least two respects: (i) claim 45 requires the method to be configured as a relaxation or sleep-inducing aid during use of the ventilator, thereby selecting one alternative of the broader "and/or" recitation in claim 26 ("relaxation or sleep-inducing aid during use of the ventilator and/or learning aid for the use of the ventilator"); and (ii) claim 45 requires that at least one stored and settable respiration pattern be specified by the ventilator, thereby selecting the combined-and alternative from the broader "stored and/or settable" recitation in claim 26. Selection of a particular alternative from a recited "and/or" group is a narrowing of scope and constitutes a further limitation under 35 U.S.C. § 112(d).
Without acquiescing in the Examiner's observation, however, and solely in order to advance prosecution, claim 45 has additionally been amended to recite that "an assimilation of the specified respiration pattern with the real respiration pattern of the patient takes place at least once per breath." This additional limitation is taken verbatim from the instant specification at page 20, lines 11-13 (paragraph [0062] of the published application) and is further supported at page 28, line 30 through page 29, line 2 (paragraph [0091] of the published application). The additional limitation unambiguously further limits the subject matter of claim 26.
Withdrawn based on the claim amendment.
Applicant argues 35 USC §101, starting pg. 12 of Remarks:
Response to Rejection (1)
Claims 26-45 stand rejected under 35 U.S.C. § 101 as allegedly being directed to an abstract idea ("certain methods of organizing human activity," specifically "managing personal behavior including following teaching and rules or instructions"; and "mental processes") without significantly more. Applicants respectfully disagree with the Examiner's assessment and traverse this rejection.
Step 2A, Prong One - The Amended Claims Do Not "Recite" the Identified Judicial Exception
As amended, claim 26 is directed to a method for assisting a user of a ventilator in which a mobile terminal is coupled to the ventilator for data exchange, data registered on the ventilator (including a ventilation parameter acquired by the ventilator) are transmitted to the terminal, the data are evaluated to provide a user information item, and the user information item is output by the terminal. The method is configured as a relaxation or sleep-inducing aid during use of the ventilator and/or as a learning aid for the use of the ventilator, in which the ventilator itself specifies a stored and/or settable respiration pattern, a setpoint ventilation parameter required for the respiration pattern is set, the specified respiration pattern is output by the terminal, an actual ventilation parameter of the user is acquired by one or more sensors, and - critically - the specified respiration pattern is itself partially adapted to the real respiration pattern of the patient in dependence on how strongly the actual ventilation parameter differs from the setpoint ventilation parameter, in order to make it easier for the user to synchronize the user's respiration with the specified respiration pattern.
The claimed method is anchored, end-to-end, in the operation of a specific physical machine (the ventilator) in cooperation with another specific physical machine (the mobile terminal). It requires sensor-acquired data, real-time signal-dependent adaptation of a pattern that is output by the terminal, and a particular cooperative relationship between the ventilator, the terminal and the sensors. Such a method is not properly characterized as "managing personal behavior" or as "following teaching and rules or instructions," any more than a method for operating an industrial machine on the basis of sensor feedback is properly characterized as "managing the operator's behavior." Nor is the claimed method a "mental process." The claim recites operations, namely sensor-based acquisition of ventilation parameters, transmission of registered data between two devices, machine-driven specification and dynamic adaptation of a respiration pattern, and machine output of that pattern, that cannot be "practically performed in the human mind," as required by MPEP § 2106.04(a)(2)(III)(B). See also CyberSource Corp. V. Retail Decisions, Inc., 654 F.3d 1366, 1376 (Fed. Cir. 2011) (mental-process exclusion limited to steps that "can be performed in the human mind, or by a human using a pen and paper").
The system is interacting with a person by teaching and having the user follow rules/instructions.
Step 2A, Prong Two - Even Assuming Arguendo That the Claim Recites a Judicial Exception, It Integrates Any Such Exception Into a Practical Application
Even assuming, arguendo, that the foregoing operations could be considered to "recite" an abstract idea, the amended claim plainly integrates any such alleged abstract idea into a practical application, for at least the reasons set forth below.
First, the claim recites the use of, and a specific configuration of, a particular machine. See MPEP § 2106.05(b). The claimed method is performed using a ventilator (a particular medical machine) coupled to a mobile terminal comprising a control algorithm, and one or more sensors that acquire an actual ventilation parameter from the user. The ventilator specifies a respiration pattern (stored and/or settable); the terminal outputs that pattern; and the pattern is adapted, in real time, dependent on a deviation of the actual ventilation parameter from the setpoint ventilation parameter that the ventilator has set for that pattern. The cooperative arrangement of these specific machines, and the data flows between them, is integral to - not incidental to - the claimed method. See Thales Visionix Inc. V. United States, 850 F.3d 1343, 1349 (Fed. Cir. 2017) (claims directed to a particular configuration of sensors and a mathematical relationship between them held patent-eligible at Step 2A).
Respectfully, the pattern adapted in real time is taught and claimed at a high level of generality. It is also provided to teach a user to synchronize their respiration to a specified pattern. This is managing personal behavior.
Second, the claim improves the functioning of the ventilator/terminal system as a particular technology. See MPEP § 2106.05(a). Conventionally, a respiration pattern presented to a patient as a relaxation, sleep-inducing or learning aid is presented as a fixed, predefined cadence (e.g., 10 breaths per minute with a 1:2 inhalation-to-exhalation ratio). As the instant specification explains (at page 28, lines 25 through page 29, line 2), such a fixed presentation would inevitably drift out of phase with the user's actual respiration, defeating the purpose of the aid. The amended claim resolves that technical problem by specifying that the ventilator-specified respiration pattern is itself partially adapted, in dependence on how strongly the sensor-acquired actual ventilation parameter differs from the setpoint, so that the displayed pattern "picks up" the user's current respiration and nudges it toward the setpoint pattern. This is an improvement to the technical functioning of the ventilator/terminal system, which is analogous to McRO, Inc. V. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1315 (Fed. Cir. 2016) (specific automated rules improving a technological process), and to Enfish, LLC V. Microsoft Corp., 822 F.3d 1327, 1336 (Fed. Cir. 2016) (claims directed to a specific improvement to the way computers operate held patent-eligible).
There is no indication the device itself is improved. This is using existing devices at a high level to make it easier for a user to synchronize their respiration pattern. Further, there is no adjustment or control of a ventilator, only an output of a pattern by a terminal and, the terminal and/or ventilator provides user information for evaluation or assistance. A mobile terminal or ventilator providing a user information is teaching.
Third, the claim does not "monopolize" any alleged abstract idea. The amended claim is narrowly tailored to a specific cooperative configuration of a ventilator, a mobile terminal, and one or more sensors, performing a specific sensor-driven adaptation of a specified respiration pattern. The Examiner has not identified any plausible field-preemption concern, and none exists on the present record.
Preemption is not a two-way test for eligibility. Preemptive claims are not statutory, however, the opposite cannot be said.
Fourth, the additional elements of the claim, including the sensor(s), the setpoint, and the sensor-driven adaptation of the specified respiration pattern, are not the kind of "insignificant extra-solution activity" the Examiner posits. See Diamond V. Diehr, 450 U.S. 175, 187 (1981) (process is patent-eligible where additional steps "transform[ ] the process into an inventive application" of any underlying judicial exception). The claim, taken as a whole, does not merely "apply" an abstract idea using a generic computer; it specifies how a particular machine system operates to achieve a specific technological result.
The above cited Diamond V. Diehr controlled a physical device. Applicant is not claiming control of a physical device.
Step 2B - The Claim Recites Significantly More
For at least the reasons set forth above, the amended claim is patent-eligible at Step 2A. Should the Examiner nonetheless reach Step 2B, Applicants respectfully submit that the recited combination, namely a ventilator that specifies a stored and/or settable respiration pattern; a mobile terminal that outputs the specified pattern; one or more sensors that acquire an actual ventilation parameter; and a closed-loop adaptation of the specified respiration pattern dependent on a deviation of the actual ventilation parameter from the setpoint, is not "well-understood, routine, or conventional" ("WURC") and constitutes significantly more than any alleged abstract idea. See Berkheimer V. HP Inc., 881 F.3d 1360, 1369 (Fed. Cir. 2018) (WURC determination is a question of fact that must be supported by evidence in the record); see also USPTO Memorandum on Berkheimer (April 19, 2018). The Examiner has identified no evidence (in the form of an express statement in the specification, a published court decision, or a publication demonstrating well-understood, routine and conventional nature of the combination) to support a Step 2B finding of WURC as to the recited combination, as required by MPEP § 2106.05(d).
The rejection is not based on well-understood, routine and conventional.
From MPEP 2106.07(a) III…
“When performing the analysis at Step 2A Prong One, it is sufficient for the examiner to provide a reasoned rationale that identifies the judicial exception recited in the claim and explains why it is considered a judicial exception (e.g., that the claim limitation(s)falls within one of the abstract idea groupings). Therefore, there is no requirement for the examiner to rely on evidence, such as publications or an affidavit or declaration under
37 CFR 1.104(d)(2) (mpep-9020-appx-r.html#d0e322249), to find that a claim recites a judicial exception. Cf. Affinity Labs of Tex., LLC v. Amazon.com Inc., 838 F.3d 1266, 1271-72, 120 USPQ2d 1210, 1214-15 (Fed. Cir. 2016) (affirming district court decision that identified an abstract idea in the claims without relying on evidence); OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1362-64, 115 USPQ2d 1090, 1092-94 (Fed. Cir. 2015) (same); Content Extraction &Transmission LLC v. Wells Fargo Bank,
N.A., 776 F.3d 1343, 1347, 113 USPQ2d 1354, 1357-58 (Fed. Cir. 2014) (same). At Step 2A Prong Two or Step 2B, there is no requirement for evidence to support a finding that the exception is not integrated into a practical application or that the additional elements do not amount to significantly more than the exception unless the examiner asserts that additional limitations are well-understood, routine, conventional activities in Step 2B.
Therefore, Berkheimer is not relevant.
In view of at least the foregoing, the rejection of claims 26-45 under 35 U.S.C. § 101 lacks merit and should be withdrawn, which action is respectfully requested.
The rejection is respectfully maintained but modified for the claim amendments. The use of alternative language “and/or” allows for many of the steps to be performed by a mobile terminal (smartphone, tablet, etc.). There is also no teaching of controlling a machine as in the Diamond case cited above.
Applicant argues 35 USC §103, starting pg. 16 of Remarks:
Response to Rejection (4)
Claims 26-45 stand rejected under 35 U.S.C. § 103 as allegedly being unpatentable over KENNEDY in view of HUDSON, further in view of YOUNES. The rejection acknowledges that KENNEDY and HUDSON, as previously combined, do not teach or suggest the recited adaptation of the specified respiration pattern dependent on a deviation of the actual ventilation parameter from the setpoint ventilation parameter in order to make it easier for the user to synchronize the user's respiration with the specified respiration pattern, a deficiency for which the Examiner now relies on YOUNES (see Office Action at pages 27-28).
Applicants respectfully disagree with the Examiner's assessment and traverse this rejection.
It is recalled that, as amended, independent claim 26 is directed to a method for assisting a user of a ventilator that is configured as a relaxation or sleep-inducing aid during use of the ventilator and/or as a learning aid for the use of the ventilator, in which the ventilator specifies at least one stored and/or settable respiration pattern for which at least one setpoint ventilation parameter required for the respiration pattern is set; the specified respiration pattern is output by the terminal; at least one actual ventilation parameter of the user is acquired by one or more sensors; and the respiration pattern is itself adapted in a manner dependent on a deviation of the actual ventilation parameter from the setpoint ventilation parameter, such that the specified respiration pattern is partially adapted to the real respiration pattern of the patient to a defined extent, in order to make it easier for the user to synchronize the user's respiration with the specified respiration pattern.
In other words, the amended claim is directed to a closed-loop biofeedback configuration in which the ventilator presents a guided respiration pattern through the mobile terminal (for example, as a relaxation or sleep-inducing aid) and that guided pattern itself is partially adapted, in real time and in dependence on the sensor-measured deviation of the actual ventilation parameter from the setpoint, so that the user can more readily synchronize the user's own respiration with the guided pattern presented through the terminal.
Closed-loop biofeedback is not claimed.
Synchronize is intended use language and given no patentable weight.
The respiration pattern adapted in a manner dependent on a deviation of the actual parameter from the setpoint is contingent language, so adapted may never happen. This is given no patentable weight.
YOUNES Does Not Teach or Suggest the Recited Sensor-Dependent Adaptation of the Specified Respiration Pattern Output by the Terminal
Respectfully, Younes does not have to teach anything as Applicant’s synchronize is intended use language and contingent on a deviation happening.
Examiner will provide other prior art to further teach the amendments.
YOUNES is directed to the entirely different problem of synchrony between the inflation and exhalation phases delivered by a mechanical ventilator and the patient's spontaneous respiratory cycle. See YOUNES, Abstract; T [0003] ("Failure of patient and ventilator to cycle off at substantially the same time results in non-synchrony "); T [0012] ("It is an object of the present invention to provide a method for the ongoing automatic adjustment of cycling-off time ..."). "). YOUNES' solution to that problem, as cited by the Examiner, is to automatically adjust the ventilator's mechanical cycling-off time so that the machine matches the patient's spontaneous cycling-off time. YOUNES, 1 [0012]; see also 1 [0046] et seq.
YOUNES does not teach or suggest the recited subject matter of amended claim 26 for at least the following reasons.
First, YOUNES is silent on outputting any respiration pattern through a mobile terminal as a relaxation, sleep-inducing, or learning aid. YOUNES is concerned with the internal mechanical timing of a ventilator. The Examiner has identified no passage of YOUNES that even suggests presenting a guided respiration pattern through a mobile terminal for the user to follow, much less that the method is configured "as a relaxation or sleep-inducing aid" and/or "as a learning aid" as expressly recited in amended claim 26.
Applicant is reminded of piecemeal analysis…
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).
Younes was only used to teach synchronize.
Second, YOUNES adapts a different aspect. The amended claim requires that "the respiration pattern" specified by the ventilator and output by the terminal, i.e., the pattern that is presented to the user to follow, be partially adapted to the real respiration pattern of the patient to a defined extent. YOUNES, by contrast, adapts the ventilator's mechanical cycling-off time to the patient's real respiration. The direction of accommodation in YOUNES is fundamentally opposite to that recited in claim 26: in YOUNES, the machine accommodates to the patient (during the delivery of mechanical ventilation); in the claimed method, a guided respiration pattern presented to the user via the terminal is partially adapted toward the user's actual respiration in order to make it easier for the user to voluntarily synchronize the user's respiration with the (still ventilator-specified) pattern, in a biofeedback / relaxation / learning context, see, e.g., page 28, line 17 through page 29, line 2 of the instant specification, corresponding to paragraphs [0090]-[0091] of the published application.
Younes was only used to teach synchronize. The combined prior art teaches the above.
For example, from Hudson…
"The display screens may assist in helping a patient set up their CPAP (or other medical) system in, for example, their own home. The display screens may provide reassurance to a patient who is trying respiratory pressure therapy (e.g., CPAP therapy) for the first time. The display screens and associated programming may be used to provide an interactive process that allows a user to control aspects of the setup and acclimatization process. The programming and display screens may provide feedback (e.g., in real-time with provision of therapy) to the patient. The programming and display screens may provide advice and/or instructions to assist patients in addressing (or avoiding) one or more potential problems with their therapy." [0069]
Third, the Examiner has provided no articulated reasoning, with a rational underpinning, as to why one of ordinary skill in the art would have been motivated to combine YOUNES'S teaching regarding cycling-off-time adjustment in a mechanical ventilator with the smart-inhaler / health-analysis features of KENNEDY and the CPAP acclimatization features of HUDSON to arrive at the very different cooperative arrangement recited in amended claim 26. The Office Action recites (at page 27) only that "YOUNES teaches non-synchrony is an extremely common problem and it would be obvious to somehow reduce or fix this problem." That is precisely the kind of "mere conclusory statement" that the Federal Circuit and the U.S. Supreme Court have held cannot sustain an obviousness rejection. See In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006), quoted with approval in KSR Int'l Co. V. Teleflex Inc., 550 U.S. 398, 418 (2007) ("rejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness"); see also Transocean Offshore Deepwater Drilling, Inc. V. Maersk Contractors USA, Inc., 617 F.3d 1296, 1303 (Fed. Cir. 2010).
See pgs. 27-28 where motivation was provided. Further, Younes teaches non-synchrony is a problem.
Fourth, even if the cited passages of YOUNES were combined with KENNEDY and HUDSON exactly as the Examiner proposes, the combination would still fail to teach or suggest the recited sensor-dependent adaptation of the specified respiration pattern that is output by the terminal, as opposed to mere internal mechanical adjustment of a ventilator's inflation/exhalation timing. The Examiner has not identified any passage of KENNEDY, HUDSON or YOUNES (individually or in combination) that teaches partial adaptation of a guided respiration pattern presented to the user via a mobile terminal, to a defined extent, in order to make it easier for the user to synchronize the user's respiration with the (partially adapted) presented pattern.
Applicant’s “sensor-dependent adaptation” is not claimed. The adaptation depends on a deviation of the actual ventilation parameter from the setpoint ventilation parameter. The prior art teaches feedback.
Kennedy et al. teaches:
Sensors…
“A flow rate sensor 4274 in accordance with the present technology may be based on a differential pressure transducer, for example, an SDP600 Series differential pressure transducer from SENSIRION. In one form, a signal representing a flow rate from the flow rate sensor 4274 is received by the central controller 4230.” [0077]
“Connected devices such as the RPT 4000 in FIG. 4A are capable of storing and sending varying levels of data. For example, the central controller 4230 in FIG. 4C may send data to the external source 4286. Such data may include the data gathered by the sensors of the RPT 4000, such as the flow rate sensor 4272 or pressure sensor 4272, data generated by the algorithms of the pre-processing module 4310, or data generated by the algorithms of the therapy engine module 4320. Alternatively, devices such as the headbox 2000 in FIG. 7A may include sensors as described above that may provide additional data. Such data may be combined for analysis by algorithms that generate yet more data.” [0204]
Hudson et al. teaches:
Feedback to patients…
“The display screens may assist in helping a patient set up their CPAP (or other medical) system in, for example, their own home. The display screens may provide reassurance to a patient who is trying respiratory pressure therapy (e.g., CPAP therapy) for the first time. The display screens and associated programming may be used to provide an interactive process that allows a user to control aspects of the setup and acclimatization process. The programming and display screens may provide feedback (e.g., in real-time with provision of therapy) to the patient. The programming and display screens may provide advice and/or instructions to assist patients in addressing (or avoiding) one or more potential problems with their therapy.” [0069]
The Recitation "In Order To Make It Easier For The User To Synchronize The User's Respiration With The Specified Respiration Pattern" Is Limiting and Cannot Be Given "No Patentable Weight"
The Office Action takes the position (at page 21) that "No Patentable Weight is given to intended use language of 'makes it easier for the user to synchronize its respiration with the respiration pattern' as synchronize may never happen." Applicants respectfully disagree.
The cited recitation (as amended: "in order to make it easier for the user to synchronize the user's respiration with the specified respiration pattern") is not a free-floating statement of intended use. It is structurally tied to the immediately preceding active step ("the respiration pattern is adapted in a manner dependent on a deviation of the actual ventilation parameter from the setpoint ventilation parameter, such that the specified respiration pattern is partially adapted to the real respiration pattern of the patient to a defined extent"), and it specifies the functional purpose for which that partial adaptation is performed. As such, the recitation is properly given patentable weight under MPEP § 2111.04, because it describes how and toward what end the partial adaptation of the specified respiration pattern is to be carried out. See Griffin v. Bertina, 285 F.3d 1029, 1033 (Fed. Cir. 2002) ("wherein" clauses giving "meaning and purpose to the manipulative steps" are limiting); Hoffer V. Microsoft Corp., 405 F.3d 1326, 1329-30 (Fed. Cir. 2005) (per curiam). The Examiner's contrary position, namely that the recitation may be disregarded because synchronization "may never happen," improperly conflates the limitation (i.e., what the claimed adaptation is configured to do) with infringement (i.e., whether a particular user's respiration in fact ends up synchronized).
Respectfully, the active verb “synchronizing” is not used, and “to synchronize” is not the same. However, this is now compounded by using contingent language of “dependent on a deviation”.
In view of at least the foregoing, KENNEDY, HUDSON and YOUNES, individually or in combination, neither teach nor suggest each and every limitation of amended claim 26. The rejection of claim 26 under 35 U.S.C. § 103 therefore lacks merit and should be withdrawn, which action is respectfully requested.
The rejection is respectfully maintained but modified based on the claim amendments.
Claims 27-45
Each of claims 27-44 ultimately depends from claim 26 and is patentable for at least the reasons set forth above with respect to claim 26. Claim 45, as amended, includes the additional limitation that the assimilation of the specified respiration pattern to the real respiration pattern of the patient is carried out at least once per breath. Applicants respectfully submit that none of KENNEDY, HUDSON or YOUNES, individually or in combination, teaches or suggests this additional limitation in the context of the recited cooperative arrangement of the ventilator, mobile terminal, sensor(s) and specified respiration pattern. The cited passages of KENNEDY (e.g., 11 [0182], [0190], [0084]) and HUDSON (e.g., " [0017], [0020], [0035], [0069], [0074], [0094]), and the cited passages of YOUNES, do not teach or suggest the per-breath partial assimilation of a guided, terminal-output respiration pattern in the manner recited in amended claim 45.
Withdrawal of the rejection of dependent claims 27-45 under 35 U.S.C. § 103 is therefore also respectfully requested.
The rejection is respectfully maintained but modified based on the claim amendments.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 26-45 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 26-45 are either directed to a method, which is a statutory category of invention. (Step 1: YES).
The Examiner has identified method Claim 26 as the claim that represents the claimed invention for analysis.
Claim 26 recites the limitations of:
A method for assisting a user of a ventilator, wherein the method comprises:
- coupling at least one mobile terminal, which comprises at least one control algorithm, to the ventilator for data exchange between the ventilator and the terminal;
- transmitting data registered on the ventilator to the terminal, the registered data comprising at least one ventilation parameter acquired by the ventilator;
- evaluating the transmitted data on the terminal and/or on the ventilator, and/or by means of a processor device that communicates with the terminal or with the ventilator, to provide at least one user information item such that the user, irrespective of its medical expertise, is provided with an evaluation and/or assistance based at least partially on a ventilation parameter;
- outputting the user information item by means of the terminal;
and wherein
the method is configured as a relaxation or sleep-inducing aid during use of the ventilator and/or a learning aid for the use of the ventilator, and
wherein at least one stored and/or settable respiration pattern is specified by the ventilator, and
wherein at least one setpoint ventilation parameter required for the respiration pattern is set, and
wherein the specified respiration pattern is output by the terminal, and
wherein at least one actual ventilation parameter of the user is acquired by one or more sensors, and
wherein the respiration pattern is adapted in a manner dependent on
a deviation of the actual ventilation parameter from the setpoint ventilation parameter, such that the specified respiration pattern is partially adapted to the real respiration pattern of the patient to a defined extent, in order to make it easier for the user to synchronize the user’s respiration with the respiration pattern.
These above limitations, under their broadest reasonable interpretation, cover performance of the limitation as certain methods of organizing human activity. The claim recites elements, in non-bold above, which covers performance of the limitation as managing personal behavior including following teaching and rules or instructions (e.g., provide user information with an evaluation and/or assistance). Evaluating transmitted data to provide at least one user information item such that the user is provided with an evaluation and/or assistance (teaching), outputting the user information (teaching), configured as a relaxation or sleep-inducing aid during use or learning aid for the use of the ventilator (managing personal behavior and teaching), wherein the one and/or settable respiration pattern is specified (teaching), wherein the setpoint ventilation parameter required for the respiration pattern is set (following rules/instructions), wherein the respiration pattern is output by the terminal (teaching), wherein the respiration pattern is adapted dependent on a deviation of the actual ventilation parameter from the from the setpoint ventilation parameter such that the specified pattern is partially adapted to the real respiration pattern to make it easier for the user to synchronize the user’s respiration with the respiration pattern (teaching and following rules/instructions). If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation as managing personal behavior, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea. Therefore, claim 26 is abstract. (Step 2A-Prong 1: YES. The claims are abstract)
Applicant’s use of alternative language “and/or” does not require use of the ventilator for evaluating, therefore the mobile terminal can be providing instructions to the user. In as much as the claim is transmitting data to a terminal (therefore, terminal is collecting data), evaluating the data, and outputting (providing) a result, the claims are also abstract under Mental Processes grouping of abstract ideas (see MPEP 2106.04(a)(2) III A where collecting data, analyzing it, and displaying certain results were abstract). See MPEP 2106.04(a)(2) III C, where using a generic computer or in a computer environment was not enough to make abstract claims statutory.
This judicial exception is not integrated into a practical application. In particular, the claim only recites: ventilator, mobile terminal, processor, sensors. The computer hardware (mobile terminal, processor) is recited at a high-level of generality (i.e., as a generic processor performing a generic computer function) such that it amounts no more than mere instructions to apply the exception using a generic computer component. The ventilator appears to be a generic ventilator (pg. 1, lines 10-13 of the specification), being applied to perform functions at a high level of generality. Coupling a mobile terminal to a ventilator for data exchange is claimed at a high level of generality and appears to be insignificant extra solution activity (e.g. transmitting and receiving data), and not the subject or focus of the invention. The respiration pattern is adapted in a manner dependent on a degree to which the actual ventilation parameter differs from the setpoint ventilation parameter and makes it easier for the user to synchronize its respiration is recited at a high level and without specificity as to how the respiration pattern is adapted. Further, a user synchronize is teaching a user and following rules or instructions and would be abstract. Make it easier to synchronize the user’s respiration is an effect or result that may or may not happen. Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Therefore claim 26 is directed to an abstract idea without a practical application. (Step 2A-Prong 2: NO. The additional claimed elements are not integrated into a practical application)
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because, when considered separately and as an ordered combination, it does not add significantly more (also known as an “inventive concept”) to the exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a computer hardware amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Steps such as acquired (receiving) and transmitting are steps that are considered insignificant extra solution activity and mere instructions to apply the exception using general computer components (see MPEP 2106.05(d), II). Thus claim 26 is not patent eligible. (Step 2B: NO. The claims do not provide significantly more)
Dependent claims 27-45 further define the abstract idea that is present in the independent claim 26 and thus correspond to Certain Methods of Organizing Human Activity and Mental Processes and hence are abstract for the reasons presented above. The dependent claims do not include any additional elements that integrate the abstract idea into a practical application or are sufficient to amount to significantly more than the judicial exception when considered both individually and as an ordered combination. Claim 31 recites report generated for a caregiver, therefore, this is also abstract under managing interactions between people (Certain Methods of Organizing Human Activity). Claim 27, 32, 33, 36, and 43-45 also recite terminal, which is a computer being applied to perform a judicial exception and not enough. Claim 27 recites an auxiliary unit, which is something undefined that may be various things (see pg. 4, lines 6-16). Claims 27, 29, 31, 38, 43, and 45 recite a generic ventilator, also applied at a high level of generality to perform abstract steps. Claim 33, 37-39 recite mask, which appears to be software for an input interface. Claim 29 recites mask, which itself is used in the alternative, and where it’s use is being evaluated for leak-tightness at a high level of generality. Claims 35 and 45 recite sensors, which appear to be generic sensors for acquiring data. Therefore, the claims 27-45 are directed to an abstract idea. Thus, the claims 26-45 are not patent-eligible.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 26-45 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 26 recites “a deviation of the actual ventilation parameter from the setpoint ventilation parameter, such that the specified respiration pattern is partially adapted to the real respiration pattern of the patient to a defined extent, in order to make it easier for the user to synchronize the user’s respiration with the respiration pattern” where it is indefinite as to respiration pattern is partially adapted… to a defined extent as to what the extent is (i.e., what is the definition that defines the extent). For examination purposes, this is interpreted as some type of range limit.
Claims 27-45 are rejected as they depend from independent claim 26.
Examiner Request
The Applicant is requested to indicate where in the specification there is support for amendments to claims should Applicant amend. The purpose of this is to reduce potential 35 U.S.C. §112(a) or §112 1st paragraph issues that can arise when claims are amended without support in the specification. The Examiner thanks the Applicant in advance.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 26-45 are rejected under 35 U.S.C. 103 as being unpatentable over Pub. No. US 2022/0020488 to Kennedy et al. in view of Pub. No. US 2020/0121873 to Hudson et al. and in view of Pub. No. US 2009/0194110 to Poon et al.
Regarding claim 26
A method for assisting a user of a ventilator, wherein the method comprises:
- coupling at least one mobile terminal, which comprises at least one control algorithm, to the ventilator for data exchange between the ventilator and the terminal;
Kennedy et al. teaches:
Communication technologies (coupling) with smartphone (mobile terminal) and Internet of Medical Things (IoMT)…
“Chronic disease management (CDM) applications and services exist to track chronic conditions. One example is the Twine service which was recently acquired by FitBit. Further, telehealth services exist to monitor people at home using wired and wireless sensors and cellular data connections. There is a trend toward technology solutions and increasing acceptance for older people with a higher prevalence of sleep-disordered breathing and co-morbid conditions. Such solutions may include smartphone applications, continuous positive airway pressure (CPAP) usage applications, wearable activity monitors, Internet of Medical things (IoMT), artificial intelligence (AI), and communication technologies such as Wi-Fi, Bluetooth, 4G, and 5G.” [0006]
“FIG. 1A shows a system including a patient 1000 wearing a patient interface 3000, in the form of nasal pillows, receiving a supply of air at positive pressure from a respiratory pressure therapy (RPT) device 4000. In this example, the respiratory pressure therapy device may include a PAP device, a non-invasive ventilation (NIV) device, or an adaptive support ventilation (ASV) device. Of course, other devices may also perform the functions of the RPT device 4000 described herein. Air from the RPT device 4000 is humidified in a humidifier 5000, and passes along an air circuit 4170 to the patient 1000. A bed partner 1100 is also shown. The patient 1000 is sleeping in a supine sleeping position. A health analysis system collects data from the RPT device 4000 used by the patient 1000” [0030]
Fig. 1A, ref. 110, 4000, where the smartphone is coupled to the respiratory device (ventilator)…
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See Control below.
- transmitting data registered on the ventilator to the terminal, the registered data comprising at least one ventilation parameter acquired by the ventilator;
Fig. 8B, ref. 4000 and 110, where RPT (respiratory pressure therapy) device is transmitting and receiving data to Patient computing device (terminal)…
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Data transmitted from RPT device to mobile computing device…
“Data from additional sensors, such as those on a body-mounted health monitoring device 120 worn by the patient 1000, may be collected. The body-mounted health monitoring device 120 may be smart wearable clothing, smart watch, or a smart device, in order to capture data in a low impact manner continuously from the patient 1000. For example, the health monitoring device 120 may include one or more sensors such as an audio sensor, a heart rate sensor, a respiratory sensor, a ECG sensor, a photoplethysmography (PPG) sensor, an infrared sensor, an activity sensor, a radio frequency sensor, a SONAR sensor, an optical sensor, doppler radar motion sensors, a thermometer, or impedance, piezoelectric, photoelectric, or strain gauge type sensors. This data can be fused with other data sources collected during the day or data collected during certain periods of time, such as from operating the RPT device 4000. Data may be sent to the mobile computing device 110 that may be in communication with the RPT device 4000. Alternatively, data from the additional sensors on the health monitoring device 120 may be directly sent to the RPT device 4000. Data from the health monitoring device 120, RPT device 4000, or mobile computing device 110 may be transmitted to the cloud 140.” [0165]
One example of forgot to operate (parameter) therapy device and RPT pushed notification to remind (transmitted parameter) to the patient device…
“Another example scenario may be if a patient has forgotten to operate their therapy device. A push notification may be sent to a smart device such as the mobile device 110 to remind the patient. Another example scenario may be if a consumable such as a filter, oxygen tank, or a battery has been depleted, preventing use of the device. The system 100 may then provide communication to a supply system to drop-ship a replacement consumable directly to the patient, or provide delivery of the consumable to a pharmacy for patient pickup or to a technician for installation at the patient location.” [0180]
- evaluating the transmitted data on the terminal and/or on the ventilator, and/or by means of a processor device that communicates with the terminal or with the ventilator, to provide at least one user information item such that the user, irrespective of its medical expertise, is provided with an evaluation and/or assistance based at least partially on a ventilation parameter;
[Applicant’s use of alternative language “or” only requires prior art teaching one of the alternatives. (MPEP 2111.04 II)]
Determine health condition of patient (evaluating) transmitted data
“The respiratory pressure therapy device 4000 includes a transmitter and an air control device to provide respiratory therapy to the patient 1000. As will be explained, the respiratory pressure therapy device 4000 collects operational data and transmits the collected operational data to the remote health data analysis engine 130. The health data analysis engine 130 receives the collected data from the respiratory therapy device 4000 to determine a health condition of the patient 1000 based on the collected data. The engine 130 may also receive and add other relevant data from a patient information database 150, the health monitoring device 120, and the mobile device 110. External databases, such as a database 160 may also provide additional data for the analysis of the health condition. For example, the database 160 may include “big data” from other respiratory pressure therapy devices and corresponding patients. The database 160 may also store relevant external data from other sources such as environmental data, scientific data, and demographic data. External devices such as a workstation 170, accessible by a health care provider, may be connected to the health analysis engine 130, as will be explained below.” [0160]
Collecting COPD and respiration data and determine and measure (evaluating) how baseline level of respiration rate evolves over time, pressure relief, etc. (information)…
“The collected data may be used to determine respiration changes for the tracking of changes in conditions, such as COPD (e.g., higher than normal breathing rate/tachypnea). The collection of respiration data over time may determine how base (e.g., an average “baseline” level) respiration rate evolves over time. The collection of respiration data may also be used to measure expiration, expiratory pressure relief (EPR) back-off time during expiration (e.g., as configured and delivered by the RPT), overall inspiration time and amplitude, and breath-hold time (time before next cycle). Such disease analysis may include tracking worsening disease conditions. The collected data may be analyzed to detect worsening Asthma, pollen allergy, common cold, or respiratory infections. For example, lung impedance may be monitored to detect changes in lung condition over time. Other increases in patient airway resistance may be indicative of the worsening conditions. For example, COPD and Asthma are diseases in which airway narrowing occurs and thus exhibit an increase in airway resistance, which can be detected or estimated.” [0190]
Displaying data on a [user] mobile device, where data is compared to others, a baseline, etc…
“The patient input data may include subjective feedback on how the patient is feeling, whether the patient feels fatigued, and the level of sleepiness. The data may be used to determine the quality of sleep for the patient. This may be a comparison to a personal baseline for the patient, linked to weather data, a comparison to an average sleeper of their age and gender (aiming to be better than average), or a comparison to an average of a person with the same chronic conditions and or disease progression. As explained above, the baseline may be one determined from a normative patient population relative to the patient. Such data may be displayed in an application executed by the mobile device 110. Such data may also be made available on a work station 170 for a health care professional.” [0197]
Examples of evaluate medication or treatment in general or ask patient sit up (assistance)…
“A similar procedure may be used to evaluate medication or treatment in general for the patient. The medication amount or frequency of dosing may be adjusted automatically if the patient has medication delivery via a platform integrated with the RPT device 4000. Such a delivery platform may include a drug reservoir. For example, the drug reservoir may be used in conjunction with a patch for daytime delivery (thus saving power and medication contained in the patch. The RPT device 4000 may thus control the drug reservoir to administer the medication while the RPT device 4000 is in use (typically at night). Thus, a platform for medication delivery is realized with routine delivery of medication or exceptional delivery of medication based on a triggering event. Based on clinical review and approval, certain medications such as bronchodilators, anti-inflammatories, and antibiotics may be delivered to the patient. These may be delivered while the patient is awake and wearing a patient interface. Delivery of such medications may be made by pressing a button. This delivery may be combined with oxygen delivery, for example. For a person that is detected as having an asthma attack, instead of the RPT device 4000 increasing the pressure (which could worsen the situation), the system 100 can offer the patient the ability to request (or automatically) deliver a relief dosage via the patient interface or the mobile device 110, and activate a breathing program to help calm the patient. The mobile device 110 may include an application that communicates additional instructions to the patient. For example, an application may also ask the patient to sit upright and may contact emergency services or another health care provider. Similarly, medication may be offered for patients having (or predicated to have) COPD exacerbations or CHF decompensations. Other medications, such as nasal decongestants, may treat an upper airway infection related to the common cold or influenza (e.g., to try to prevent this deteriorating into an exacerbation). Other devices that administer medication may be communicatively integrated with the RPT device 4000. For example, medication may be delivered via a smart inhaler, a combination monitor accessory attached to an inhaler such as those offered by Propeller Health, or other smart-connected metered medication delivery system/devices, that may communicate the occurrence of dosages of medication inhaled by the patient 1000 and other data.” [0182]
- outputting the user information item by means of the terminal;
Example of mobile device (terminal) delivers (outputting) instructions (user information) to the patient…
“A similar procedure may be used to evaluate medication or treatment in general for the patient. The medication amount or frequency of dosing may be adjusted automatically if the patient has medication delivery via a platform integrated with the RPT device 4000. Such a delivery platform may include a drug reservoir. For example, the drug reservoir may be used in conjunction with a patch for daytime delivery (thus saving power and medication contained in the patch. The RPT device 4000 may thus control the drug reservoir to administer the medication while the RPT device 4000 is in use (typically at night). Thus, a platform for medication delivery is realized with routine delivery of medication or exceptional delivery of medication based on a triggering event. Based on clinical review and approval, certain medications such as bronchodilators, anti-inflammatories, and antibiotics may be delivered to the patient. These may be delivered while the patient is awake and wearing a patient interface. Delivery of such medications may be made by pressing a button. This delivery may be combined with oxygen delivery, for example. For a person that is detected as having an asthma attack, instead of the RPT device 4000 increasing the pressure (which could worsen the situation), the system 100 can offer the patient the ability to request (or automatically) deliver a relief dosage via the patient interface or the mobile device 110, and activate a breathing program to help calm the patient. The mobile device 110 may include an application that communicates additional instructions to the patient. For example, an application may also ask the patient to sit upright and may contact emergency services or another health care provider. Similarly, medication may be offered for patients having (or predicated to have) COPD exacerbations or CHF decompensations. Other medications, such as nasal decongestants, may treat an upper airway infection related to the common cold or influenza (e.g., to try to prevent this deteriorating into an exacerbation). Other devices that administer medication may be communicatively integrated with the RPT device 4000. For example, medication may be delivered via a smart inhaler, a combination monitor accessory attached to an inhaler such as those offered by Propeller Health, or other smart-connected metered medication delivery system/devices, that may communicate the occurrence of dosages of medication inhaled by the patient 1000 and other data.” [0182]
and wherein
the method is configured as a relaxation or sleep-inducing aid during use of the ventilator and/or a learning aid for the use of the ventilator, and
[Applicant’s use of alternative language “or” only requires prior art teaching one of the alternatives. (MPEP 2111.04 II)]
Activate a breathing program to calm (relax) the patient and additional instructions (learning aid) such as sit upright…
“… This delivery may be combined with oxygen delivery, for example. For a person that is detected as having an asthma attack, instead of the RPT device 4000 increasing the pressure (which could worsen the situation), the system 100 can offer the patient the ability to request (or automatically) deliver a relief dosage via the patient interface or the mobile device 110, and activate a breathing program to help calm the patient. The mobile device 110 may include an application that communicates additional instructions to the patient. For example, an application may also ask the patient to sit upright and may contact emergency services or another health care provider. Similarly, medication may be offered for patients having (or predicated to have) COPD exacerbations or CHF decompensations. Other medications, such as nasal decongestants, may treat an upper airway infection related to the common cold or influenza (e.g., to try to prevent this deteriorating into an exacerbation). Other devices that administer medication may be communicatively integrated with the RPT device 4000. For example, medication may be delivered via a smart inhaler, a combination monitor accessory attached to an inhaler such as those offered by Propeller Health, or other smart-connected metered medication delivery system/devices, that may communicate the occurrence of dosages of medication inhaled by the patient 1000 and other data.” [0182]
wherein at least one stored and/or settable respiration pattern is specified by the ventilator, and
{
From Applicant’s specification on respiration pattern…
“… The respiration pattern particularly preferably defines when and/or for how long inhalation should be performed. In addition or alternatively, the respiration pattern may define when and/or for how long exhalation should be performed. In particular, for this purpose, in each case one visual and/or acoustic and/or haptic signal for the inhalation and/or exhalation is output in time-controlled fashion, as a user information item, by way of the terminal. For this purpose, the user information item is in particular configured as described above. It is particularly preferable if the projection device and/or the display device is used for this purpose.” (pg. 21, lines 1-12)
}
Collected (stored) data over time that is respiration data including breath-hold time (respiration pattern)…
“The collected data may be used to determine respiration changes for the tracking of changes in conditions, such as COPD (e.g., higher than normal breathing rate/tachypnea). The collection of respiration data over time may determine how base (e.g., an average “baseline” level) respiration rate evolves over time. The collection of respiration data may also be used to measure expiration, expiratory pressure relief (EPR) back-off time during expiration (e.g., as configured and delivered by the RPT), overall inspiration time and amplitude, and breath-hold time (time before next cycle). Such disease analysis may include tracking worsening disease conditions. The collected data may be analyzed to detect worsening Asthma, pollen allergy, common cold, or respiratory infections. For example, lung impedance may be monitored to detect changes in lung condition over time. Other increases in patient airway resistance may be indicative of the worsening conditions. For example, COPD and Asthma are diseases in which airway narrowing occurs and thus exhibit an increase in airway resistance, which can be detected or estimated.” [0190]
Where collected data is collected (stored) by RPT device…
“Internal sensors such as the flow rate sensor 4274, a pressure sensor 4272, and a motor speed transducer 4276 may be coupled to the central controller 4230 in FIG. 4C. An optional internal audio sensor 4278 may be embedded in the interface 3000 in FIG. 1 to detect specific patient air sounds. An optional external audio sensor 4279 such as a microphone may be located on the exterior of the RPT device 4000, the interface 3000, or the humidifier 5000 to collect additional audio data. Additional sensors such as a heart rate sensor, an ECG sensor (providing cardiac fiducial parameters, of which peaks could be processed to estimate heart rate, detect arrhythmias and so forth), a pulse oximeter (SpO2) sensor (providing heart rate, oxygen saturation, and potential an estimate of blood pressure from pulse transit time), a blood pressure sensor, a room-temperature sensor, a contact or non-contact body temperature sensor, a room humidity sensor, a proximity sensor, a gesture sensor, a touch sensor, a gas sensor, an air quality sensor, a particulate sensor, an accelerometer, a gyroscope, a tilt sensor, other acoustic sensors such as passive or active SONAR, an ultrasonic sensor, a radio frequency sensor, an accelerometer, a light intensity sensor, a LIDAR sensor, an infrared sensor (passive, transmissive, or reflective), carbon dioxide sensor, a carbon monoxide sensor, or a chemical sensor, may be connected to the central controller 4230 via an external port. Data from such additional sensors may also be collected by the central controller 4230. Data from the sensors 4272, 4274, 4276, 4278, and 4279 may be collected by central controller 4230 on a periodic basis. Such data generally relates to the operational state of the RPT device 4000.” [0084]
See Settable Respiration Pattern below.
wherein at least one setpoint ventilation parameter required for the respiration pattern is set, and
A target flow rate (setpoint ventilation parameter) is entered (set)…
“In other forms of respiratory therapy, the pressure of the flow of air is not controlled as it is for respiratory pressure therapy. Rather, the central controller 4230 controls the pressure generator 4140 to deliver a flow of air whose device flow rate Qd is controlled to a treatment or target flow rate Qtgt. Such forms are generally grouped under the heading of flow therapy. In flow therapy, the treatment flow rate Qtgt may be a constant value that is hard-coded or manually entered to the RPT device 4000. If the treatment flow rate Qtgt is sufficient to exceed the patient's peak inspiratory flow rate, the therapy is generally referred to as high flow therapy (HFT). Alternatively, the treatment flow rate may be a profile Qtgt(t) that varies over the respiratory cycle.” [0158]
Another example of inputs include breathing rate (ventilation parameter setpoint)…
“… The system learns changes in breathing rate and or heart rate variability during different stages of sleep, and the relationship with movements of the patient. Knowledge of sleep stage patterns can be used to adapt the therapy settings in order to optimize deep and REM sleep, maximize overall sleep time, and reduce awakenings and light sleep. Demographic data such as age and gender information for may be input into a machine learning model to determine the sleep stage. Inputs may include age, gender, estimated movement intensity, duration, and patterns of activity, heart rate, heart rate variability, breathing rate, breathing rate variability, normalized breathing rate variability, and breathing signal waveform shape (inspiration, expiration pauses) to a sleep staging analysis blocks for the machine learning model.” [0188]
See Settable Respiration Pattern below.
wherein the specified respiration pattern is output by the terminal, and
Respiratory data may be transmitted (output) to the cloud from the mobile device (terminal)…
“Data from additional sensors, such as those on a body-mounted health monitoring device 120 worn by the patient 1000, may be collected. The body-mounted health monitoring device 120 may be smart wearable clothing, smart watch, or a smart device, in order to capture data in a low impact manner continuously from the patient 1000. For example, the health monitoring device 120 may include one or more sensors such as an audio sensor, a heart rate sensor, a respiratory sensor, a ECG sensor, a photoplethysmography (PPG) sensor, an infrared sensor, an activity sensor, a radio frequency sensor, a SONAR sensor, an optical sensor, doppler radar motion sensors, a thermometer, or impedance, piezoelectric, photoelectric, or strain gauge type sensors. This data can be fused with other data sources collected during the day or data collected during certain periods of time, such as from operating the RPT device 4000. Data may be sent to the mobile computing device 110 that may be in communication with the RPT device 4000. Alternatively, data from the additional sensors on the health monitoring device 120 may be directly sent to the RPT device 4000. Data from the health monitoring device 120, RPT device 4000, or mobile computing device 110 may be transmitted to the cloud 140.” [0165]
wherein at least one actual ventilation parameter of the user is acquired by one or more sensors, and
{
From Applicant’s specification…
“In particular, defined (in the control algorithm) ventilation parameters are taken into consideration for the provision of the user information item. Here, it is possible and preferred that those defined ventilation parameters which are not available for the evaluation and/or which have not been or cannot be provided by the ventilator are substituted and/or supplemented by (subjective and/or objective) additional information items. In particular, the additional information items required for this purpose are purposely interrogated by way of the input mask. The input mask is in particular correspondingly adapted for this purpose. This allows a considerable improvement in the evaluation and assistance. In particular, the control algorithm has stored in it which additional information items are necessary for substitution or supplementation.” [0047]
The ventilator somehow acquires actual ventilation parameter of the user.
Ventilation parameter can be a respiratory frequency…
“In a likewise preferred and advantageous refinement, it is provided that the user information item indicates at least one measure for the degree to which an actual value of a ventilation parameter (presently) acquired (by sensor means) by the ventilator for the respiration of the user differs from a setpoint value of the ventilation parameter that is stored (in the ventilator). As ventilation parameter, it is for example possible for the respiratory frequency or other suitable ventilation parameters to be provided. The measure may be depicted for example by way of corresponding colors or tones or the like. It is for example possible for green light to be projected if the respiration corresponds particularly closely to the setpoint values, and for red light to be projected if the respiration deviates from the setpoint value to too great a degree.” [0059]
The actual ventilation parameter can be a persons respiratory frequency and acquired by the sensors (of the ventilator).
}
Collection of respiration data and measure pressure, time (therefore actual ventilation parameters)…
“The collected data may be used to determine respiration changes for the tracking of changes in conditions, such as COPD (e.g., higher than normal breathing rate/tachypnea). The collection of respiration data over time may determine how base (e.g., an average “baseline” level) respiration rate evolves over time. The collection of respiration data may also be used to measure expiration, expiratory pressure relief (EPR) back-off time during expiration (e.g., as configured and delivered by the RPT), overall inspiration time and amplitude, and breath-hold time (time before next cycle). Such disease analysis may include tracking worsening disease conditions. The collected data may be analyzed to detect worsening Asthma, pollen allergy, common cold, or respiratory infections. For example, lung impedance may be monitored to detect changes in lung condition over time. Other increases in patient airway resistance may be indicative of the worsening conditions. For example, COPD and Asthma are diseases in which airway narrowing occurs and thus exhibit an increase in airway resistance, which can be detected or estimated.” [0190]
Treatment device (ventilator) with sensor…
“In one example, a patient treatment device is provided, including a controller, a sensor, a memory, and a transmitter, wherein the sensor is configured to collect data from a patient, and the collected data is stored in the memory, the collected data including low resolution data and high resolution data; and wherein the transmitter is controlled by the controller to send either low or high resolution data to an external system, the high resolution data being transmitted based on the occurrence of an event detected based on the low resolution data.” [0023]
wherein the respiration pattern is adapted in a manner dependent on
a deviation of the actual ventilation parameter from the setpoint ventilation parameter, such that the specified respiration pattern is partially adapted to the real respiration pattern of the patient to a defined extent, in order to make it easier for the user to synchronize the user’s respiration with the respiration pattern.
[No Patentable Weight is given to contingent language of “wherein the respiration pattern is adapted in a manner dependent on a deviation of the actual ventilation parameter from the setpoint ventilation parameter, such that the specified respiration pattern is partially adapted to the real respiration pattern of the patient to a defined extent,…” as dependent on a deviation may never happen.]
[No Patentable Weight is given to intended use language of “in order to make it easier for the user to synchronize the user’s respiration with the respiration pattern” as synchronize is not required to happen.]
“makes it easier for the user to synchronize its respiration with the respiration pattern” as synchronize may never happen.]
Controlling a flow rate (ventilation parameter)…
“In other forms of respiratory therapy, the pressure of the flow of air is not controlled as it is for respiratory pressure therapy. Rather, the central controller 4230 controls the pressure generator 4140 to deliver a flow of air whose device flow rate Qd is controlled to a treatment or target flow rate Qtgt. Such forms are generally grouped under the heading of flow therapy. In flow therapy, the treatment flow rate Qtgt may be a constant value that is hard-coded or manually entered to the RPT device 4000. If the treatment flow rate Qtgt is sufficient to exceed the patient's peak inspiratory flow rate, the therapy is generally referred to as high flow therapy (HFT). Alternatively, the treatment flow rate may be a profile Qtgt(t) that varies over the respiratory cycle.” [0158]
See Settable Respiration Pattern below.
See Synchronize below.
Control Algorithm
Kennedy et al. teaches mobile device interacting with RTP (ventilator). They do not directly teach control algorithm.
Hudson et al. also in the business of interacting
Ventilation systems…
“The technology described herein relates techniques for assisting or guiding patients in setting up medical devices. More particularly, the technology described herein relates to techniques for setting up and using medical devices, such as CPAP and other ventilation systems, that are used in a home environment.” [0002]
Control functionality (algorithm) of CPAP (ventilator) system…
“At 502, the process begins when the test drive application (or process within an already running application) is started. For example, a patient may launch an app on their mobile phone for the test drive application. Alternatively, the patient may begin the test drive process from within an already running application on their mobile device. As discussed herein, the patient may have setup their mobile phone (or other computing device) to communicate with CPAP system 106 and/or components thereof. Such communication may allow computing device 104 to control functionality of CPAP system 106 (such as when positive air pressure is supplied and the pressure level it is supplied at).” [012]
“In certain examples, a test drive CPAP therapy is provided that allows for a patient to control therapy aspects from their own mobile phone (or other computing device). The therapy may start out low and allow a patient to control when pressure is increased (e.g., the patient may increase pressure at their own pace).” [0159]
It would have been obvious to one of ordinary skill in the art at the time of filing to include in the method and system of Kennedy et al. the ability to use control functionality as taught by Hudson et al. since the claimed invention is merely a combination of old elements and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable. Further motivation is provided by Hudson who teaches the advantages of using a mobile device to control ventilator device. Kennedy benefits as they also use a mobile device to interact with a ventilator.
Store
Kennedy et al. teaches therapy. They do no specifically teach store therapeutic objective.
Hudson et al. also in the business of therapy teaches:
Computer system that provides therapy to patient…
“In certain examples, a computer system (e.g., a mobile device such as a smart phone) is provided that wirelessly communicates with a therapy device (e.g., a device that provides CPAP therapy) that provides therapy for a patient. The computer system may be programmed to provide a series of linked instruction displays that guide a user through setting up and/or using one or more components (e.g., a flow generator, a patient interface, etc. . . . ) that are used to provide CPAP therapy.” [0006] Inherent with computer system programmed to provide therapy is storing the therapy.
Computer system to control CPAP-related therapy…
“The computer system may include programmed functionality that is used to control how CPAP-related therapy may be provided to a patient. This functionality may act as a test drive of sorts that allows a user to experience CPAP therapy through guided instructions and illustrations that are presented to the user on, for example, their own mobile phone. The programmed functionality may include a series of display screens that provide informational notices to a patient. Explanations of CPAP and control of the positive air pressure may also be provided. In certain examples, the display screens, and associated programmed functionality, may show the air pressure being increased in a stepwise manner. The increase may require the user to expressly control when pressure is increased (e.g., the pressure only increases in response to the user pressing an increase pressure button) and/or have the user expressly control when pressure stops increasing (e.g., the pressure will automatically increase unless the user presses a “stop” button).” [0007]
Controlling CPAP pressure (therapy)…
“Subsequent display screens 320, 322, and 324 show increases in the provided pressure in a stepwise manner (e.g., 5, then 6, then 7, etc. . . . ). In certain examples, each stepwise increase may be controlled by the computing device 104 sending a new instruction to the CPAP system 106 to increase the pressure. In certain examples, the CPAP system 106 may automatically stepwise increase the pressure and report to the computing device (e.g., via the wireless communication link) the current pressure. In other words, in some instances the computing device “controls” the pressure increases performed by the CPAP system. Alternatively, or in addition, the CPAP system (or flow generator thereof) “controls” the pressure increases and reports the pressure level back to the computing device for display thereon (e.g., as part of display screens 320, 322, 324, etc. . . . )” [0105]
Prescription information used to increase value (pressure therapy)….
“In certain examples, the time period for the individual stepwise increases may be set by the patient. In certain examples, the time period for the stepwise increase is set to a default value that may be configured based on, for example, the prescription information of the patient, the patient, characteristics of the patient (e.g., height, weight, etc. . . . ), the type of CPAP components being used, and the like.” [0107]
Where prescription data loaded (stored) in local memory…
“At 504, prescription data is acquired. In certain examples, this data is loaded from local memory of the computing device 104. In certain examples, this data is acquired from a remote computing resource (e.g., a server or the like). The prescription data may be used to present informational displays at 506 that are contextually relevant to the patient to which the prescription data pertains. The presentation of such information may occur using animation, audio, video, images, text, or any combination thereof. The presentation may include a description of the test drive process and the role of each component in the patient CPAP system.” [0123]
It would have been obvious to one of ordinary skill in the art at the time of filing to include in the method and system of Kennedy et al. the ability to store therapeutic objective as taught by Hudson et al. since the claimed invention is merely a combination of old elements and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable. Further motivation is provided by Hudson who teaches the advantages of a computer to instruct and guide users on use of respiratory devices such as CPAP devices. Kennedy benefits as they also provide therapy to users.
Settable Respiration Pattern
The combined references setup and pattern.
Hudson et al. also in the business of setup and pattern further teaches:
Example of communicating to flow generator (therefore, output by terminal) for first and second pressure level (respiration pattern)…
“Another aspect of the present technology comprises in response to determination that a leak is present based on sensor data obtained during the increase of the supply of breathable gas from a first pressure level to a second pressure level, causing, via wireless communication, the flow generator to hold at a pressure level at which the leak was detected.” [0017]
“In one form of the present technology, the pressure level at which the breathable gas is supplied to the patient is increased in response to a determination that no leak is present. In an aspect of the present technology, the increase is automatically performed. In another aspect, the increase is performed in response to user provided input.” [0020]
Acclimatizing the user to the therapy and operating the device so patient receives correct therapy (make it easier for patient to synchronize with specified pattern)…
“In certain examples, techniques and systems for facilitating the setup, acclimatization, and/or use of a medical system that may be, for example, used in a home setting are provided. In certain examples, a guided setup process may be provided through a computer system such as a mobile device (e.g., a smart phone) of the patient. The guided process may provide instructions to patients for the setup of components of a medical system. An example of a medical system includes a respiratory therapy system that may include a patient interface component (e.g., a mask), an air conduit, a flow generator (e.g., a Respiratory Pressure Therapy Device (RPT device)), a humidifier, etc. The guided process may instruct a user on setting up each component of the system for proper use. The guided process may assist in acclimatizing the user to the therapy provided by the medical device. The guided process may assist in addressing issues (e.g., a leak) that arise during use of the medical device. In certain examples, the computer system may be programmed to assist a patient in tracking progress for therapy of the patient over a period of time (e.g., hours, days, weeks, months, etc. . . . ). In certain examples, the guided setup process may act to increase the confidence that a patient has in setting up and/or operating the medical device(s) (e.g., a CPAP system or other respiratory therapy system) so as to receive the correct therapy for the patient.” [0035]
Real-time feedback with therapy (synchronization) for setup and acclimatization process…
“The display screens may assist in helping a patient set up their CPAP (or other medical) system in, for example, their own home. The display screens may provide reassurance to a patient who is trying respiratory pressure therapy (e.g., CPAP therapy) for the first time. The display screens and associated programming may be used to provide an interactive process that allows a user to control aspects of the setup and acclimatization process. The programming and display screens may provide feedback (e.g., in real-time with provision of therapy) to the patient. The programming and display screens may provide advice and/or instructions to assist patients in addressing (or avoiding) one or more potential problems with their therapy.” [0069]
“Part of the setting up of the CPAP system may include prompting the patient to load their prescription information into the computing device 104. In certain examples, the prescription for the patient may be used to customize the setup instructions that are provided to the patient. For example, the setup for a nasal mask that is prescribed to one patient may be different than the setup instructions provided to a second patient that is prescribed a full face mask.” [0074]
“In certain examples, finishing a setup of a component and/or a given display screen may be logged to a data file or the like. In certain examples, the data of a patient's progress in the setup of the equipment may be transmitted to a remote computing device. This may allow remote users (e.g., medical or customer support personnel) to verify that the setup for a given component has been completed. In certain examples, data from the CPAP system 104 (and/or components thereof) may be retrieved for each of the components that is set up and additionally logged. For example, the patient interface and/or air conduit may be structured to electronically determine that one has been correctly installed with the other. Data of such a determination may be transmitted to the computing device 104 for storage in association with a given setup process (e.g., FIG. 2C) and/or a specific step in that process (e.g., a step in the process that is associated with display screen 234). Such recorded data may be transmitted to remote computing systems (e.g., 622 in FIG. 6) for storage therein.” [0094]
It would have been obvious to one of ordinary skill in the art at the time of filing to include in the method and system of the combined references the ability to further set respiration patterns as taught by Hudson et al. since the claimed invention is merely a combination of old elements and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable. Further motivation is provided by Hudson who teaches more details setting respiration patterns. The combined references benefit by the additional features as they improve control of the respirator devices.
Synchronize
The combined references teach respiration pattern. They do not teach synchronize.
Poon et al. also in the business of respiration pattern teaches:
Ventilator synchrony is a major concern…
“Patient-ventilator synchrony is a major concern in critical care and is influenced by phasic lung-volume feedback control of the respiratory rhythm Routine clinical application of positive end-expiratory pressure (PEEP) introduces a tonic input which, if unopposed, might disrupt respiratory-ventilator entrainment through sustained activation of the vagally-mediated Hering-Breuer reflex.” [0004]
Entrain to the ventilator and preset limit with patient entrainment…
“An entrainment-based mechanical ventilator may be initially set to approximate the patient's spontaneous respiratory frequency, enabling the patient to entrain to the ventilator if the ventilator frequency matches the patient's spontaneous breathing frequency or is within a reasonable range from it. If the preset frequency of the ventilator is set too high or too low from the spontaneous frequency, the patient will fall out of phase and "fight" the ventilator. The ventilator phase relative to the patient's breathing effort indicates the difference between the ventilator frequency and spontaneous frequency. Based on the phase difference, a closed-loop control mechanism may continuously adjust the ventilator frequency to match the patient breathing frequency until the phase shift is within a preset limit. Patient-ventilator entrainment will occur when the ventilator frequency is within a certain range from the patient breathing frequency.” (Abstract)
Entrainment allows synchronize with ventilator…
“Entrainment is an important physiologic phenomenon of potential clinical significance in that it allows the spontaneous, barring voluntary, respiratory rhythm to synchronize with the ventilator naturally without any external triggering device necessary…” [0051]
Ventilator settings within range (defined extent) of patient’s respiration, and ventilator adjusts to within a range of patients respiration so patient can entrain (synchronize) with the ventilator…
“The ventilator 500 settings are initially set to match the patient's respiration. If the ventilator 500 is operating at the same level as the patient's respiration or is within a reasonable range from it, the patient should be able to entrain to the ventilator. Under conditions where the ventilator 500 is operating at higher or lower levels comparing to the patient's respiration, the patient will fall out of phase. The ventilator phase relative to the patient's breathing effort is calculated 545 as a function of the difference between the ventilator and the patient's respiration. Based on the phase difference, a closed-loop control mechanism 550 automatically adjusts the frequency of the pressure generating mechanism 510 to the patient's respiration. Patient-ventilator entrainment will occur when the ventilator 500 is operating at a level within a certain range of the patient's respiration.” [0055]
It would have been obvious to one of ordinary skill in the art at the time of filing to include in the method and system of the combined references the ability to synchronize respiration patterns as taught by Poon et al. since the claimed invention is merely a combination of old elements and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable. Further motivation is provided by Poon et al. who teaches the health effects of not synchronizing and the benefits of a ventilator being within a range of a patient’s breathing frequency so they can entrain on the ventilator pattern.
more details setting respiration pattern.
Regarding claim 27
The method of claim 26, wherein data are additionally transmitted from the terminal to the ventilator, the data being compiled locally by the terminal and/or by an auxiliary unit.
[Applicant’s use of alternative language “or” only requires prior art teaching one of the alternatives. (MPEP 2111.04 II)]
Kennedy et al. teaches:
Deliver relief dosage via (from) patient mobile device (terminal) to the RPT device (ventilator)…
“A similar procedure may be used to evaluate medication or treatment in general for the patient. The medication amount or frequency of dosing may be adjusted automatically if the patient has medication delivery via a platform integrated with the RPT device 4000. Such a delivery platform may include a drug reservoir. For example, the drug reservoir may be used in conjunction with a patch for daytime delivery (thus saving power and medication contained in the patch. The RPT device 4000 may thus control the drug reservoir to administer the medication while the RPT device 4000 is in use (typically at night). Thus, a platform for medication delivery is realized with routine delivery of medication or exceptional delivery of medication based on a triggering event. Based on clinical review and approval, certain medications such as bronchodilators, anti-inflammatories, and antibiotics may be delivered to the patient. These may be delivered while the patient is awake and wearing a patient interface. Delivery of such medications may be made by pressing a button. This delivery may be combined with oxygen delivery, for example. For a person that is detected as having an asthma attack, instead of the RPT device 4000 increasing the pressure (which could worsen the situation), the system 100 can offer the patient the ability to request (or automatically) deliver a relief dosage via the patient interface or the mobile device 110, and activate a breathing program to help calm the patient. The mobile device 110 may include an application that communicates additional instructions to the patient. For example, an application may also ask the patient to sit upright and may contact emergency services or another health care provider. Similarly, medication may be offered for patients having (or predicated to have) COPD exacerbations or CHF decompensations. Other medications, such as nasal decongestants, may treat an upper airway infection related to the common cold or influenza (e.g., to try to prevent this deteriorating into an exacerbation). Other devices that administer medication may be communicatively integrated with the RPT device 4000. For example, medication may be delivered via a smart inhaler, a combination monitor accessory attached to an inhaler such as those offered by Propeller Health, or other smart-connected metered medication delivery system/devices, that may communicate the occurrence of dosages of medication inhaled by the patient 1000 and other data.” [0182]
Regarding claim 28
The method of claim 26, wherein for providing the user information item at least one stored therapeutic objective is taken into consideration.
Kennedy et al. teaches:
One example of adjust amount or frequency of medication (take in consideration therapeutic objective), where it could be done at night (therefore information is stored)…
“A similar procedure may be used to evaluate medication or treatment in general for the patient. The medication amount or frequency of dosing may be adjusted automatically if the patient has medication delivery via a platform integrated with the RPT device 4000. Such a delivery platform may include a drug reservoir. For example, the drug reservoir may be used in conjunction with a patch for daytime delivery (thus saving power and medication contained in the patch. The RPT device 4000 may thus control the drug reservoir to administer the medication while the RPT device 4000 is in use (typically at night). Thus, a platform for medication delivery is realized with routine delivery of medication or exceptional delivery of medication based on a triggering event. Based on clinical review and approval, certain medications such as bronchodilators, anti-inflammatories, and antibiotics may be delivered to the patient. These may be delivered while the patient is awake and wearing a patient interface. Delivery of such medications may be made by pressing a button. This delivery may be combined with oxygen delivery, for example. For a person that is detected as having an asthma attack, instead of the RPT device 4000 increasing the pressure (which could worsen the situation), the system 100 can offer the patient the ability to request (or automatically) deliver a relief dosage via the patient interface or the mobile device 110, and activate a breathing program to help calm the patient. The mobile device 110 may include an application that communicates additional instructions to the patient. For example, an application may also ask the patient to sit upright and may contact emergency services or another health care provider. Similarly, medication may be offered for patients having (or predicated to have) COPD exacerbations or CHF decompensations. Other medications, such as nasal decongestants, may treat an upper airway infection related to the common cold or influenza (e.g., to try to prevent this deteriorating into an exacerbation). Other devices that administer medication may be communicatively integrated with the RPT device 4000. For example, medication may be delivered via a smart inhaler, a combination monitor accessory attached to an inhaler such as those offered by Propeller Health, or other smart-connected metered medication delivery system/devices, that may communicate the occurrence of dosages of medication inhaled by the patient 1000 and other data.” [0182]
Regarding claim 29
The method of claim 26, wherein the evaluation evaluates a therapy behavior and wherein, for this purpose, a duration and/or intensity of a therapeutic use of the ventilator are evaluated and/or wherein the evaluation comprises at least one statement relating to mask leak-tightness.
[Applicant’s use of alternative language “or” only requires prior art teaching one of the alternatives. (MPEP 2111.04 II)]
Kennedy et al. teaches:
Example of compliance rules and duration and deemed compliant (evaluates) therapeutic use…
“For example, the HCP server process 432 or a similar process on the data server 412 may provide compliance analysis based on the use of the RPT 4000 in accordance with compliance rules that specify the required RPT usage over a compliance period, such as thirty (30) days, in terms of a minimum duration of device usage per session, such as four hours, for some minimum number of days, e.g. 21, within the compliance period. A session is deemed compliant if its duration exceeds the minimum duration. The usage data post-processing may determine whether the most recent session is a compliant session by comparing the usage duration with the minimum duration from the compliance rule. The result of such post-processing is compliance data, such as a Boolean compliance variable, that forms part of the usage data. A further example of multi-session usage data is a count of compliant sessions since the start of RPT therapy. The summary data post-processing may determine whether the most recent time period is a compliant session by comparing the usage time with the minimum duration from the compliance rule. Such compliance data may be used by a health care provider to tailor therapy that may include the inhaler and other mechanisms. Other actors such as payors may use the compliance data to determine whether reimbursement may be made to a patient.” [0213]
“Respiration data can be processed to track inspiration and expiration values, to estimate respiration rate, determine any apneas or hypopneas, determine snoring duration, intensity and type, and trends over different timescales. Machine parameters, such as mask leak or vent leak, can be tracked over time as will be explained below. Gas content in expired breath can be analyzed to detect unusual content, as well as an analysis of chemicals in the environment (e.g., tobacco smoke, scented laundry detergent, etc.). An estimate of dyspnea can be generated based on breathing rate, breathing curve (indicate of faster and shallower breathing), cardiac changes, such as palpitations and potentially change in cardiac output, and may include user subjective feedback on a feeling of difficulty breathing or feeling smothered. Changes in sleep architecture, such as an increase in wake time, and/or more fragmented sleep (number of arousal or awakenings, and duration of each), can also be captured. Any of these parameters may be compared to global or personalized trigger levels.” [0178]
Regarding claim 30
The method of claim 26, wherein the evaluation comprises a points system and/or a grading system and/or a system with graphical symbols, and wherein at least one previous evaluation and/or at least one objective created by the user is taken into consideration in the evaluation.
[Applicant’s use of alternative language “or” only requires prior art teaching one of the alternatives. (MPEP 2111.04 II)]
Kennedy et al. teaches:
Example of measure (point/grading system) and exceeded first threshold (previous evaluation)…
“The method 4500 starts at step 4520, at which the central controller 4230 compares the measure of the presence of apnea/hypopnea with a first threshold, and determines whether the measure of the presence of apnea/hypopnea has exceeded the first threshold for a predetermined period of time, indicating an apnea/hypopnea is occurring. If so, the method 4500 proceeds to step 4540; otherwise, the method 4500 proceeds to step 4530. At step 4540, the central controller 4230 compares the measure of airway patency with a second threshold. If the measure of airway patency exceeds the second threshold, indicating the airway is patent, the detected apnea/hypopnea is deemed central, and the method 4500 proceeds to step 4560; otherwise, the apnea/hypopnea is deemed obstructive, and the method 4500 proceeds to step 4550.” [0142]
Another example of compliance usage over compliance period (grading system)…
“For example, the HCP server process 432 or a similar process on the data server 412 may provide compliance analysis based on the use of the RPT 4000 in accordance with compliance rules that specify the required RPT usage over a compliance period, such as thirty (30) days, in terms of a minimum duration of device usage per session, such as four hours, for some minimum number of days, e.g. 21, within the compliance period. A session is deemed compliant if its duration exceeds the minimum duration. The usage data post-processing may determine whether the most recent session is a compliant session by comparing the usage duration with the minimum duration from the compliance rule. The result of such post-processing is compliance data, such as a Boolean compliance variable, that forms part of the usage data. A further example of multi-session usage data is a count of compliant sessions since the start of RPT therapy. The summary data post-processing may determine whether the most recent time period is a compliant session by comparing the usage time with the minimum duration from the compliance rule. Such compliance data may be used by a health care provider to tailor therapy that may include the inhaler and other mechanisms. Other actors such as payors may use the compliance data to determine whether reimbursement may be made to a patient.” [0213]
Example of reward, based on good health (evaluation)…
“Such triggering events may also indicate incorrect RPT device settings, an uncompliant user, blood pressure, asthma attack, and arrhythmias such as diabetes. Generally, an outcome is then determined by the analysis. The patient is notified, and the patient may take a recommended action. For example, the actions may include actions that may be communicated to the patient via the mobile device 110. For example, a message may be sent to the patient to check a bio-signal related to the event. The actions may also include a notification that indicates that medication is required, which the patient may already have in their possession. The event may be to prompt the patient for a current feeling or health condition. For example, the application on the mobile device 110 may ask a patient to input responses to inquiries such as “how do you feel” or other questions in relation to the current state of the patient. Such data may be collected from patient input to the application in the form of a slider or a numerical rating. Such subjective information may provide additional verification to cross-check collected objective data streams. The responses of the patient may therefore be used as a feedback mechanism to reduce risk of a false positive triggering event. The responses may also be compared to previous patient inputs. A change in one or some of these user reported issues (and increase in perceived quality of life such as increased alertness, ability to walk, or walk a longer distance, not feeling breathless, or clearing up a respiratory infection), along with an improvement in the analysis of the collected data may be captured by the system. An application on the mobile device 100 may also suggest that the patient consult a health care professional. The application may give the patient the underlying data generated from the health analysis engine 130. The application may provide the data to indicate good health, which can be used for rewards or incentives such as a health insurance discount. The patient may be provided coaching based on the granular data.” [0202]
Graphical Symbols
The combined references teach display with ventilator devices. They do not teach graphical symbols.
Hudson et al. also in the business of display teaches.
Graphical indictors…
“Both the setup machine and setup mask portions of the overall setup process may include graphical indicators that show the patient how far into the setup process the patient has proceeded. For example, in display screens 212-218, a series of dots are included in an upper portion of the various display screens that indicate how far along a patient is into the setup process for setting up the “machine” (e.g., the flow generator or RPT device). Display screen 212 is the first of four screens or steps and display screen 218 is the fourth of four.” [0077]
Example of picture, video, animation (graphics)…
“Upon pressing the continue button in display screen 302, display screen 304 may be displayed. Display screen 304 includes an explanation for the patient that may help to pre-empt panic and/or fear from arising when a patient first tries therapy (e.g., due to being supplied with positive air pressure). In certain examples, a picture, video, audio, or animation may accompany or replace the textual explanation.” [0099]
It would have been obvious to one of ordinary skill in the art at the time of filing to include in the method and system of the combined references the ability to use graphical symbols as taught by Hudson et al. since the claimed invention is merely a combination of old elements and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable. Further motivation is provided by Hudson who teaches the advantages of using such displays as an aide to instructing users on use of devices.
Regarding claim 31
The method of claim 26, wherein the assistance comprises at least one instruction for using the ventilator and/or at least one therapy explanation, and wherein, as assistance, at least one report is generated for a caregiver and/or consultation of a caregiver is recommended.
[Applicant’s use of alternative language “or” only requires prior art teaching one of the alternatives. (MPEP 2111.04 II)]
Kennedy et al. teaches:
Example of incorrect RPT (ventilator) device settings…
“Such triggering events may also indicate incorrect RPT device settings, an uncompliant user, blood pressure, asthma attack, and arrhythmias such as diabetes. Generally, an outcome is then determined by the analysis. The patient is notified, and the patient may take a recommended action. For example, the actions may include actions that may be communicated to the patient via the mobile device 110. For example, a message may be sent to the patient to check a bio-signal related to the event. The actions may also include a notification that indicates that medication is required, which the patient may already have in their possession. The event may be to prompt the patient for a current feeling or health condition. For example, the application on the mobile device 110 may ask a patient to input responses to inquiries such as “how do you feel” or other questions in relation to the current state of the patient. Such data may be collected from patient input to the application in the form of a slider or a numerical rating. Such subjective information may provide additional verification to cross-check collected objective data streams. The responses of the patient may therefore be used as a feedback mechanism to reduce risk of a false positive triggering event. The responses may also be compared to previous patient inputs. A change in one or some of these user reported issues (and increase in perceived quality of life such as increased alertness, ability to walk, or walk a longer distance, not feeling breathless, or clearing up a respiratory infection), along with an improvement in the analysis of the collected data may be captured by the system. An application on the mobile device 100 may also suggest that the patient consult a health care professional. The application may give the patient the underlying data generated from the health analysis engine 130. The application may provide the data to indicate good health, which can be used for rewards or incentives such as a health insurance discount. The patient may be provided coaching based on the granular data.” [0202]
Example of notifications or recommendations to nurse (caregiver) and reporting…
“In some implementations, the data server 412 is configured to communicate with the HCP server 416 to trigger notifications or action recommendations to an agent of the HCP such as a nurse, or to support reporting of various kinds. Details of actions carried out are stored by the data server 412 as part of the engagement data. The HCP server 416 hosts the HCP server process 432 that communicates with the analysis engine 130 and the applications on the mobile device 110.” [0212]
Instruction
Kennedy et al. teaches instructions. They do not literally teach instructions for using a ventilator.
Hudson et al. also in the business of input data teaches:
Fig. 2B, ref. 218 machine setup and example of instruction to connect tube to the machine…
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media_image3.png
271
636
media_image3.png
Greyscale
“Display screen 408 includes an instructional image asking the patient to determine if air is escaping. The patient may select either Yes or No. If No is selected, then display screen 412 may be displayed (display screen 410 may be skipped). If Yes is selected, then display screen 410 is displayed with instructions for the patient to adjust the straps of the mask. The patient may then recheck for leaks. If a leak is still detected then 406 may be displayed again and the further investigative option may be shown at display screen 412.” [0115]
It would have been obvious to one of ordinary skill in the art at the time of filing to include in the method and system of the combined references the ability to provide instructions to a mobile device as taught by Hudson et al. since the claimed invention is merely a combination of old elements and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable. Further motivation is provided by Hudson who teaches the advantages of using a mobile device to set up a ventilator device. Kennedy benefits as they also use a mobile device to interact with a ventilator, and would need to set up such a device.
Regarding claim 32
The method of claim 26, wherein, on the terminal, there is stored at least one function for a digital diary, by which the user can log its experiences with a therapy, and wherein the diary is taken into consideration for preparing the assistance.
Kennedy et al. teaches:
Logging (digital diary) of incident…
“In one form of the present technology, the central controller 4230 executes one or more methods 4340 for the detection of fault conditions. The fault conditions detected by the one or more methods 4340 may include at least one of the following:… Logging of the incident (digital diary)” [0113] – [0122]
Example of patient command via mobile device (terminal) to build up a health record (digital diary)…
“For example, one triggering event may be a request to build up health records for the user or patient that may be initiated by the patient 1000 or a caregiver. Such a command may be provided remotely via the mobile device 110 or a remote external device such as the workstation 170 in FIG. 1A. For example, the request to build up a health record may be made to establish a new baseline for the user, detect normal trends of the user to compare to longitudinal data in the future, or a request to access electronic health records. Alternatively, the baseline may be determined by adding the data from the patient to a baseline relating to a patient population of normative values for the type of patient.” [0176]
Example of data input through mobile device and various patient data…
“The collected data may be analyzed in the context of specific patient conditions that may be derived from data from other sources. Such data may include data input through an application running on the mobile device 110, or input from electronic health records on a database such as the database 160 in FIG. 1A. The patient-specific data may therefore include conditions a patient may have such as pre-existing issues, demographic details (BMI, age, gender), and geographic details (allergen risks due to pollen count, heat exhaustion due to outside temperature, air quality and oxygen quantity due to altitude), and medications associated with the patient.” [0196]
Regarding claim 33
The method of claim 26, wherein, on the terminal, there is displayed at least one input mask into which the user can input subjective and/or objective additional information items, and wherein the provision of the user information item is performed at least partially in a manner dependent on the additional information items.
[Applicant’s use of alternative language “or” only requires prior art teaching one of the alternatives. (MPEP 2111.04 II)]
Kennedy et al. teaches:
Data input through mobile device (input mask) with allergen risks, age (objective) items…
“The collected data may be analyzed in the context of specific patient conditions that may be derived from data from other sources. Such data may include data input through an application running on the mobile device 110, or input from electronic health records on a database such as the database 160 in FIG. 1A. The patient-specific data may therefore include conditions a patient may have such as pre-existing issues, demographic details (BMI, age, gender), and geographic details (allergen risks due to pollen count, heat exhaustion due to outside temperature, air quality and oxygen quantity due to altitude), and medications associated with the patient.” [0196]
Subjective data…
“The patient input data may include subjective feedback on how the patient is feeling, whether the patient feels fatigued, and the level of sleepiness. The data may be used to determine the quality of sleep for the patient. This may be a comparison to a personal baseline for the patient, linked to weather data, a comparison to an average sleeper of their age and gender (aiming to be better than average), or a comparison to an average of a person with the same chronic conditions and or disease progression. As explained above, the baseline may be one determined from a normative patient population relative to the patient. Such data may be displayed in an application executed by the mobile device 110. Such data may also be made available on a work station 170 for a health care professional.” [0197]
Regarding claim 34
The method of claim 33, wherein the additional information items are interrogated in a time-dependent manner and/or on the basis of a request by the user.
[Applicant’s use of alternative language “or” only requires prior art teaching one of the alternatives. (MPEP 2111.04 II)]
Kennedy et al. teaches:
Information based on request to build record…
“For example, one triggering event may be a request to build up health records for the user or patient that may be initiated by the patient 1000 or a caregiver. Such a command may be provided remotely via the mobile device 110 or a remote external device such as the workstation 170 in FIG. 1A. For example, the request to build up a health record may be made to establish a new baseline for the user, detect normal trends of the user to compare to longitudinal data in the future, or a request to access electronic health records. Alternatively, the baseline may be determined by adding the data from the patient to a baseline relating to a patient population of normative values for the type of patient.” [0176]
Example of sleep, therefore, time dependent manner…
“The patient input data may include subjective feedback on how the patient is feeling, whether the patient feels fatigued, and the level of sleepiness. The data may be used to determine the quality of sleep for the patient. This may be a comparison to a personal baseline for the patient, linked to weather data, a comparison to an average sleeper of their age and gender (aiming to be better than average), or a comparison to an average of a person with the same chronic conditions and or disease progression. As explained above, the baseline may be one determined from a normative patient population relative to the patient. Such data may be displayed in an application executed by the mobile device 110. Such data may also be made available on a work station 170 for a health care professional.” [0197]
Regarding claim 35
The method of claim 33, wherein the subjective additional information items are not acquired, and/or are not acquirable, by sensors, and comprise an occurrence of pressure points and/or leakages at respiration interfaces.
[Applicant’s use of alternative language “or” only requires prior art teaching one of the alternatives. (MPEP 2111.04 II)]
Kennedy et al. teaches:
“The flow data, motor speed, pressure and acoustic data from the example RPT device 4000 may be used to profile the characteristics of the RPT device 4000. As explained above, the sensors may be used to detect the flow generation from the motor, characteristics from the respiratory apparatus conduit such as the tube or hose to the mask, the mask or cannula fit, motor speed, and gas volumetric flow rate and outlet pressure (from a pressure transducer or a flow sensor). For example, this data may be used to identify accessories and parts such as mask type, tube or hose, number of hoses, and connectors. Data may be collected to determine any leaks that are indicative if the fit of the mask interface 3000 is within acceptable parameters. This may also be correlated to whether a patient is using a mask of the best size or type, or whether the mask specifically must be replaced due to ordinary wear and tear. The tube may act as an acoustic waveguide from the internal acoustic sensor 4278 in FIG. 2C. Data may be collected by the flow generator being run at a constant speed (to have largely flat sound data signal) or have a change introduced at a specific time.” [0184]
Subjective feedback input by patient….
“The patient input data may include subjective feedback on how the patient is feeling, whether the patient feels fatigued, and the level of sleepiness. The data may be used to determine the quality of sleep for the patient. This may be a comparison to a personal baseline for the patient, linked to weather data, a comparison to an average sleeper of their age and gender (aiming to be better than average), or a comparison to an average of a person with the same chronic conditions and or disease progression. As explained above, the baseline may be one determined from a normative patient population relative to the patient. Such data may be displayed in an application executed by the mobile device 110. Such data may also be made available on a work station 170 for a health care professional.” [0197]
Kennedy et al. teaches data indicative of leaks. They do not teach subjective information not acquired by sensors.
However, Kennedy also teaches:
Patient input to cross-check collected objective data streams….
“Such triggering events may also indicate incorrect RPT device settings, an uncompliant user, blood pressure, asthma attack, and arrhythmias such as diabetes. Generally, an outcome is then determined by the analysis. The patient is notified, and the patient may take a recommended action. For example, the actions may include actions that may be communicated to the patient via the mobile device 110. For example, a message may be sent to the patient to check a bio-signal related to the event. The actions may also include a notification that indicates that medication is required, which the patient may already have in their possession. The event may be to prompt the patient for a current feeling or health condition. For example, the application on the mobile device 110 may ask a patient to input responses to inquiries such as “how do you feel” or other questions in relation to the current state of the patient. Such data may be collected from patient input to the application in the form of a slider or a numerical rating. Such subjective information may provide additional verification to cross-check collected objective data streams. The responses of the patient may therefore be used as a feedback mechanism to reduce risk of a false positive triggering event. The responses may also be compared to previous patient inputs. A change in one or some of these user reported issues (and increase in perceived quality of life such as increased alertness, ability to walk, or walk a longer distance, not feeling breathless, or clearing up a respiratory infection), along with an improvement in the analysis of the collected data may be captured by the system. An application on the mobile device 100 may also suggest that the patient consult a health care professional. The application may give the patient the underlying data generated from the health analysis engine 130. The application may provide the data to indicate good health, which can be used for rewards or incentives such as a health insurance discount. The patient may be provided coaching based on the granular data.” [0202]
It would have been obvious to one of ordinary skill in the art at the time of filing to include in the leak detection method and system of Kennedy the ability to cross-check objective data such as leak data, also taught by Kennedy since the claimed invention is merely a combination of old elements and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable. Further motivation is provided by Kennedy who desires to reduce false positive triggering events and cross-checking by patient input of leak information would reduce such events.
Leak Determination Not By Sensor
The combined references teach leak.
Hudson et al. also in the business of leak teaches:
Determination of leak by a user…
“In one form of the present technology, the computing device that is used to communicate with the CPAP system and components thereof may be formed out of multiple computing devices. One computing device may be a mobile device or personal computer in the home a patient and other may be a remotely located computer system (e.g., a cloud-based computer system) that communicates with the in-home patient computing device. In an aspect of the present technology, the determination of a leak in the delivery of air flow to the patient may be made on the remotely located computer system. In an aspect of the present technology, the determination of a leak is automatically performed. In an aspect of the present technology, a leak determination is made in response to a user input provided to the in-home patient computing device to request that a leak be checked for.” [0019]
It would have been obvious to one of ordinary skill in the art at the time of filing to include in the leak detection method and system of the combined references the ability for a user to determine a leak as taught by Hudson et al. since the claimed invention is merely a combination of old elements and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable. Further motivation is provided by Hudson who teaches users can determine leaks and Kennedy who teaches the need to prevent false positives and having a user cross-check for leaks would be useful in this effort.
Regarding claim 36
The method of claim 33, wherein the objective additional information items are provided at least partially by the terminal and health applications of the terminal can be accessed for this purpose, and/or wherein the objective additional information items are health parameters measured by the user itself.
[Applicant’s use of alternative language “or” only requires prior art teaching one of the alternatives. (MPEP 2111.04 II)]
Kennedy et al. teaches:
Patient input to cross-check collected objective data streams….
“Such triggering events may also indicate incorrect RPT device settings, an uncompliant user, blood pressure, asthma attack, and arrhythmias such as diabetes. Generally, an outcome is then determined by the analysis. The patient is notified, and the patient may take a recommended action. For example, the actions may include actions that may be communicated to the patient via the mobile device 110. For example, a message may be sent to the patient to check a bio-signal related to the event. The actions may also include a notification that indicates that medication is required, which the patient may already have in their possession. The event may be to prompt the patient for a current feeling or health condition. For example, the application on the mobile device 110 may ask a patient to input responses to inquiries such as “how do you feel” or other questions in relation to the current state of the patient. Such data may be collected from patient input to the application in the form of a slider or a numerical rating. Such subjective information may provide additional verification to cross-check collected objective data streams. The responses of the patient may therefore be used as a feedback mechanism to reduce risk of a false positive triggering event. The responses may also be compared to previous patient inputs. A change in one or some of these user reported issues (and increase in perceived quality of life such as increased alertness, ability to walk, or walk a longer distance, not feeling breathless, or clearing up a respiratory infection), along with an improvement in the analysis of the collected data may be captured by the system. An application on the mobile device 100 may also suggest that the patient consult a health care professional. The application may give the patient the underlying data generated from the health analysis engine 130. The application may provide the data to indicate good health, which can be used for rewards or incentives such as a health insurance discount. The patient may be provided coaching based on the granular data.” [0202]
Regarding claim 37
The method of claim 33, wherein the input mask comprises at least one questionnaire with a multiplicity of stored questions.
Kennedy et al. teaches:
Mobile device application for input responses (input mask) with questions, which are passed on an event, therefore, the questions would be stored…
“Such triggering events may also indicate incorrect RPT device settings, an uncompliant user, blood pressure, asthma attack, and arrhythmias such as diabetes. Generally, an outcome is then determined by the analysis. The patient is notified, and the patient may take a recommended action. For example, the actions may include actions that may be communicated to the patient via the mobile device 110. For example, a message may be sent to the patient to check a bio-signal related to the event. The actions may also include a notification that indicates that medication is required, which the patient may already have in their possession. The event may be to prompt the patient for a current feeling or health condition. For example, the application on the mobile device 110 may ask a patient to input responses to inquiries such as “how do you feel” or other questions in relation to the current state of the patient. Such data may be collected from patient input to the application in the form of a slider or a numerical rating. Such subjective information may provide additional verification to cross-check collected objective data streams. The responses of the patient may therefore be used as a feedback mechanism to reduce risk of a false positive triggering event. The responses may also be compared to previous patient inputs. A change in one or some of these user reported issues (and increase in perceived quality of life such as increased alertness, ability to walk, or walk a longer distance, not feeling breathless, or clearing up a respiratory infection), along with an improvement in the analysis of the collected data may be captured by the system. An application on the mobile device 100 may also suggest that the patient consult a health care professional. The application may give the patient the underlying data generated from the health analysis engine 130. The application may provide the data to indicate good health, which can be used for rewards or incentives such as a health insurance discount. The patient may be provided coaching based on the granular data.” [0202] Inherent with inquiries (questions) for events are stored questions.
Regarding claim 38
The method of claim 33, wherein the input mask is created and/or adapted in a manner dependent at least on a ventilation parameter acquired by the ventilator and/or on a previously provided user information item and/or on at least one user input.
[Applicant’s use of alternative language “or” only requires prior art teaching one of the alternatives. (MPEP 2111.04 II)]
Kennedy et al. teaches:
Application questions based on triggering event from RPT…
“Such triggering events may also indicate incorrect RPT device settings, an uncompliant user, blood pressure, asthma attack, and arrhythmias such as diabetes. Generally, an outcome is then determined by the analysis. The patient is notified, and the patient may take a recommended action. For example, the actions may include actions that may be communicated to the patient via the mobile device 110. For example, a message may be sent to the patient to check a bio-signal related to the event. The actions may also include a notification that indicates that medication is required, which the patient may already have in their possession. The event may be to prompt the patient for a current feeling or health condition. For example, the application on the mobile device 110 may ask a patient to input responses to inquiries such as “how do you feel” or other questions in relation to the current state of the patient. Such data may be collected from patient input to the application in the form of a slider or a numerical rating. Such subjective information may provide additional verification to cross-check collected objective data streams. The responses of the patient may therefore be used as a feedback mechanism to reduce risk of a false positive triggering event. The responses may also be compared to previous patient inputs. A change in one or some of these user reported issues (and increase in perceived quality of life such as increased alertness, ability to walk, or walk a longer distance, not feeling breathless, or clearing up a respiratory infection), along with an improvement in the analysis of the collected data may be captured by the system. An application on the mobile device 100 may also suggest that the patient consult a health care professional. The application may give the patient the underlying data generated from the health analysis engine 130. The application may provide the data to indicate good health, which can be used for rewards or incentives such as a health insurance discount. The patient may be provided coaching based on the granular data.” [0202]
Regarding claim 39
The method of claim 33, wherein defined ventilation parameters are taken into consideration for providing the user information item, and wherein those defined ventilation parameters which are not available for the evaluation are supplemented by additional information items, and wherein the additional information items required for this purpose are purposely interrogated by way of the input mask.
[Applicant’s use of alternative language “or” only requires prior art teaching one of the alternatives. (MPEP 2111.04 II)]
Kennedy et al. teaches:
Example of cardiac signals (supplemented additional information) from mask….
“An example respiratory pressure therapy device may monitor and collect operational data such as the motor voltage, RPM, air flow, and mask leak. The example respiratory pressure therapy device may also monitor and collect physiological data via cardiac signals derived from a microphone in or near the tube, from the mask signal, from an optical sensor near or on the face (such as in the mask), from electrodes (in or on the mask, headgear), from a connected patch with electrical or optical sensing, from a smart watch, bracelet, or ring. Gas analysis could be at the mask or sampled in the tubing or device. Sweat analysis could be at the mask. Data could also be integrated from other devices, such as a smart inhaler, used by the patient.” [0053]
Example of patient with mobile device (substitute) based on asthma attack (ventilation parameters), where user with mobile device delivers (therefore, via input mask) relief dosage…
“A similar procedure may be used to evaluate medication or treatment in general for the patient. The medication amount or frequency of dosing may be adjusted automatically if the patient has medication delivery via a platform integrated with the RPT device 4000. Such a delivery platform may include a drug reservoir. For example, the drug reservoir may be used in conjunction with a patch for daytime delivery (thus saving power and medication contained in the patch. The RPT device 4000 may thus control the drug reservoir to administer the medication while the RPT device 4000 is in use (typically at night). Thus, a platform for medication delivery is realized with routine delivery of medication or exceptional delivery of medication based on a triggering event. Based on clinical review and approval, certain medications such as bronchodilators, anti-inflammatories, and antibiotics may be delivered to the patient. These may be delivered while the patient is awake and wearing a patient interface. Delivery of such medications may be made by pressing a button. This delivery may be combined with oxygen delivery, for example. For a person that is detected as having an asthma attack, instead of the RPT device 4000 increasing the pressure (which could worsen the situation), the system 100 can offer the patient the ability to request (or automatically) deliver a relief dosage via the patient interface or the mobile device 110, and activate a breathing program to help calm the patient. The mobile device 110 may include an application that communicates additional instructions to the patient. For example, an application may also ask the patient to sit upright and may contact emergency services or another health care provider. Similarly, medication may be offered for patients having (or predicated to have) COPD exacerbations or CHF decompensations. Other medications, such as nasal decongestants, may treat an upper airway infection related to the common cold or influenza (e.g., to try to prevent this deteriorating into an exacerbation). Other devices that administer medication may be communicatively integrated with the RPT device 4000. For example, medication may be delivered via a smart inhaler, a combination monitor accessory attached to an inhaler such as those offered by Propeller Health, or other smart-connected metered medication delivery system/devices, that may communicate the occurrence of dosages of medication inhaled by the patient 1000 and other data.” [0182]
Regarding claim 40
The method of claim 33, wherein ventilation parameters used for the provision of the user information item are selected at least partially in a manner dependent on the additional information items.
Kennedy et al. teaches:
Subjective data and linked to (dependent on) weather, comparison (additional) data…
“The patient input data may include subjective feedback on how the patient is feeling, whether the patient feels fatigued, and the level of sleepiness. The data may be used to determine the quality of sleep for the patient. This may be a comparison to a personal baseline for the patient, linked to weather data, a comparison to an average sleeper of their age and gender (aiming to be better than average), or a comparison to an average of a person with the same chronic conditions and or disease progression. As explained above, the baseline may be one determined from a normative patient population relative to the patient. Such data may be displayed in an application executed by the mobile device 110. Such data may also be made available on a work station 170 for a health care professional.” [0197]
Regarding claim 41
The method of claim 33, wherein provision of the user information item is performed interactively, and wherein the user information item is graphically depicted for this purpose, and wherein further user inputs are possible while the user information item is being depicted, and wherein the user information item is dynamically adapted by way of such inputs.
[Applicant’s use of alternative language “or” only requires prior art teaching one of the alternatives. (MPEP 2111.04 II)]
Kennedy et al. teaches:
Subjective feedback by patient input and comparison linked to weather, etc. (therefore dynamically adapted to inputs)…
“The patient input data may include subjective feedback on how the patient is feeling, whether the patient feels fatigued, and the level of sleepiness. The data may be used to determine the quality of sleep for the patient. This may be a comparison to a personal baseline for the patient, linked to weather data, a comparison to an average sleeper of their age and gender (aiming to be better than average), or a comparison to an average of a person with the same chronic conditions and or disease progression. As explained above, the baseline may be one determined from a normative patient population relative to the patient. Such data may be displayed in an application executed by the mobile device 110. Such data may also be made available on a work station 170 for a health care professional.” [0197]
Graphically
Kennedy et al. teaches input data. They do not teach graphically.
Hudson et al. also in the business of input data teaches:
Fig. 4, ref. 408 and “Test Drive” with graphical display…
PNG
media_image4.png
258
337
media_image4.png
Greyscale
“Display screen 408 includes an instructional image asking the patient to determine if air is escaping. The patient may select either Yes or No. If No is selected, then display screen 412 may be displayed (display screen 410 may be skipped). If Yes is selected, then display screen 410 is displayed with instructions for the patient to adjust the straps of the mask. The patient may then recheck for leaks. If a leak is still detected then 406 may be displayed again and the further investigative option may be shown at display screen 412.” [0115]
It would have been obvious to one of ordinary skill in the art at the time of filing to include in the method and system of the combined references the ability to provide graphical display on a mobile device as taught by Hudson et al. since the claimed invention is merely a combination of old elements and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable. Further motivation is provided by Hudson who teaches the advantages of using graphics on a mobile device for instructions to set up a ventilator device. Kennedy benefits as they also use a mobile device to interact with a ventilator, and would need to set up such a device.
Regarding claim 42
The method of claim 26, wherein the user information item is created on the basis of a request by the user, wherein a time period of a multiplicity of therapy hours and/or of a multiplicity of therapy days is taken into consideration for providing the user information item.
[Applicant’s use of alternative language “or” only requires prior art teaching one of the alternatives. (MPEP 2111.04 II)]
Kennedy et al. teaches:
Example of collecting fused data such as when operating the RPT (ventilator) device…
“Data from additional sensors, such as those on a body-mounted health monitoring device 120 worn by the patient 1000, may be collected. The body-mounted health monitoring device 120 may be smart wearable clothing, smart watch, or a smart device, in order to capture data in a low impact manner continuously from the patient 1000. For example, the health monitoring device 120 may include one or more sensors such as an audio sensor, a heart rate sensor, a respiratory sensor, a ECG sensor, a photoplethysmography (PPG) sensor, an infrared sensor, an activity sensor, a radio frequency sensor, a SONAR sensor, an optical sensor, doppler radar motion sensors, a thermometer, or impedance, piezoelectric, photoelectric, or strain gauge type sensors. This data can be fused with other data sources collected during the day or data collected during certain periods of time, such as from operating the RPT device 4000. Data may be sent to the mobile computing device 110 that may be in communication with the RPT device 4000. Alternatively, data from the additional sensors on the health monitoring device 120 may be directly sent to the RPT device 4000. Data from the health monitoring device 120, RPT device 4000, or mobile computing device 110 may be transmitted to the cloud 140.” [0165]
Duration RPT (therapy) of session in hours and days to meet compliance rules (compliance taken into consideration)…
“For example, the HCP server process 432 or a similar process on the data server 412 may provide compliance analysis based on the use of the RPT 4000 in accordance with compliance rules that specify the required RPT usage over a compliance period, such as thirty (30) days, in terms of a minimum duration of device usage per session, such as four hours, for some minimum number of days, e.g. 21, within the compliance period. A session is deemed compliant if its duration exceeds the minimum duration. The usage data post-processing may determine whether the most recent session is a compliant session by comparing the usage duration with the minimum duration from the compliance rule. The result of such post-processing is compliance data, such as a Boolean compliance variable, that forms part of the usage data. A further example of multi-session usage data is a count of compliant sessions since the start of RPT therapy. The summary data post-processing may determine whether the most recent time period is a compliant session by comparing the usage time with the minimum duration from the compliance rule. Such compliance data may be used by a health care provider to tailor therapy that may include the inhaler and other mechanisms. Other actors such as payors may use the compliance data to determine whether reimbursement may be made to a patient.” [0213]
The combined reference teach therapy. They also teach hours and days. They do not teach request by the user.
Hudson also in the business of therapy teaches:
Guided setup instructing a user (therefore, user requests) for proper use including tracking progress over a period of hours, days, etc…
“In certain examples, techniques and systems for facilitating the setup, acclimatization, and/or use of a medical system that may be, for example, used in a home setting are provided. In certain examples, a guided setup process may be provided through a computer system such as a mobile device (e.g., a smart phone) of the patient. The guided process may provide instructions to patients for the setup of components of a medical system. An example of a medical system includes a respiratory therapy system that may include a patient interface component (e.g., a mask), an air conduit, a flow generator (e.g., a Respiratory Pressure Therapy Device (RPT device)), a humidifier, etc. The guided process may instruct a user on setting up each component of the system for proper use. The guided process may assist in acclimatizing the user to the therapy provided by the medical device. The guided process may assist in addressing issues (e.g., a leak) that arise during use of the medical device. In certain examples, the computer system may be programmed to assist a patient in tracking progress for therapy of the patient over a period of time (e.g., hours, days, weeks, months, etc. . . . ). In certain examples, the guided setup process may act to increase the confidence that a patient has in setting up and/or operating the medical device(s) (e.g., a CPAP system or other respiratory therapy system) so as to receive the correct therapy for the patient.” [0035]
It would have been obvious to one of ordinary skill in the art at the time of filing to include in the method and system of the combined references the ability for a user to request information as taught by Hudson et al. since the claimed invention is merely a combination of old elements and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable. Further motivation is provided by Hudson who teaches the advantages of tracking progress and Kennedy who teaches the need for compliance.
Regarding claim 43
The method of claim 26, wherein provision of the user information item is performed during an ongoing therapy, wherein, during the ongoing therapy, data are transmitted continuously from the ventilator to the terminal and the user information item is thus continuously updated, wherein the user information item is updated upon a respiratory event.
Kennedy et al. teaches:
Data collected with RPT (ventilator) device operating, (therefore, continuously), where data is sent to mobile device (terminal)…
“Data from additional sensors, such as those on a body-mounted health monitoring device 120 worn by the patient 1000, may be collected. The body-mounted health monitoring device 120 may be smart wearable clothing, smart watch, or a smart device, in order to capture data in a low impact manner continuously from the patient 1000. For example, the health monitoring device 120 may include one or more sensors such as an audio sensor, a heart rate sensor, a respiratory sensor, a ECG sensor, a photoplethysmography (PPG) sensor, an infrared sensor, an activity sensor, a radio frequency sensor, a SONAR sensor, an optical sensor, doppler radar motion sensors, a thermometer, or impedance, piezoelectric, photoelectric, or strain gauge type sensors. This data can be fused with other data sources collected during the day or data collected during certain periods of time, such as from operating the RPT device 4000. Data may be sent to the mobile computing device 110 that may be in communication with the RPT device 4000. Alternatively, data from the additional sensors on the health monitoring device 120 may be directly sent to the RPT device 4000. Data from the health monitoring device 120, RPT device 4000, or mobile computing device 110 may be transmitted to the cloud 140.” [0165]
Regarding claim 44
The method of claim 26, wherein the user information item is projected by at least one projection device of the terminal into the surroundings, such that the user information item can be visually perceived even without directly viewing the terminal.
[Applicant’s use of alternative language “or” only requires prior art teaching one of the alternatives. (MPEP 2111.04 II)]
Kennedy et al. teaches:
Example of output device that is visual or audio…
“An output device 4290 in accordance with the present technology may take the form of one or more of a visual, audio and haptic unit. A visual display may be a Liquid Crystal Display (LCD) or Light Emitting Diode (LED) display.” [0097]
The combined references teach display. They do not teach projector.
Hudson et al. also in the business of display teaches:
Projector external to computing device, therefore, not viewing a terminal…
“In some examples, the display device 616 may be a Liquid Crystal Display (LCD) display, Light Emitting Diode (LED) display, or other type of display device. In examples where the display device 616 is a component of the computing device 600 (e.g., the computing device and the display device are included in a unified housing of, for example, a mobile or tablet device), the display device 616 may be a touchscreen display (e.g., using capacitive or resistive technology to sense a touch) or non-touchscreen display. In examples where the display device 616 is connected to the computing device 600 (e.g., is external to the computing device 600 and communicates with the computing device 600 via a wire and/or via wireless communication technology), the display device 616 is, for example, an external monitor, projector, television, display screen, etc.” [0153]
It would have been obvious to one of ordinary skill in the art at the time of filing to include in the method and system of the combined references the ability to use a projector as taught by Hudson et al. since the claimed invention is merely a combination of old elements and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable. Further motivation is provided by Hudson who teaches computers with the ability to use different display devices for providing information. Kennedy benefits as they also use computer devices to display information.
Regarding claim 45
The method of claim 26, wherein the method is configured as a relaxation or sleep-inducing aid during use of the ventilator, and wherein at least one stored and settable respiration pattern is specified by the ventilator, and wherein an assimilation of the specified respiration pattern with the real respiration pattern of the patient takes place at least once per breath.
[Applicant’s use of alternative language “or” only requires prior art teaching one of the alternatives. (MPEP 2111.04 II)]
{
From Applicant’s specification on “assimilation”…
“In particular, here, it is also the case that the specified respiration pattern is partially adapted to the real respiration pattern of the patient to a defined extent in order to make it easier for the user to synchronize their respiration with the specified respiration pattern. The user can thus, by observing the user information item, monitor whether their respiration corresponds to the respiration pattern whilst the respiration pattern is simultaneously also adapted (slightly) to the user's respiration pattern. An assimilation of the specified respiration pattern with the real respiration pattern of the user takes place in particular at least once per breath.” (pg. 20, lines 2-13)
Therefore, assimilation is interpreted as the breathing and specified respiration moving towards each other.
}
Kennedy et al. teaches:
Activate a breathing program to calm (relax) the patient and additional instructions (learning aid) such as sit upright…
“… This delivery may be combined with oxygen delivery, for example. For a person that is detected as having an asthma attack, instead of the RPT device 4000 increasing the pressure (which could worsen the situation), the system 100 can offer the patient the ability to request (or automatically) deliver a relief dosage via the patient interface or the mobile device 110, and activate a breathing program to help calm the patient. The mobile device 110 may include an application that communicates additional instructions to the patient. For example, an application may also ask the patient to sit upright and may contact emergency services or another health care provider. Similarly, medication may be offered for patients having (or predicated to have) COPD exacerbations or CHF decompensations. Other medications, such as nasal decongestants, may treat an upper airway infection related to the common cold or influenza (e.g., to try to prevent this deteriorating into an exacerbation). Other devices that administer medication may be communicatively integrated with the RPT device 4000. For example, medication may be delivered via a smart inhaler, a combination monitor accessory attached to an inhaler such as those offered by Propeller Health, or other smart-connected metered medication delivery system/devices, that may communicate the occurrence of dosages of medication inhaled by the patient 1000 and other data.” [0182]
Collected (stored) data over time that is respiration data including breath-hold time (respiration pattern)…
“The collected data may be used to determine respiration changes for the tracking of changes in conditions, such as COPD (e.g., higher than normal breathing rate/tachypnea). The collection of respiration data over time may determine how base (e.g., an average “baseline” level) respiration rate evolves over time. The collection of respiration data may also be used to measure expiration, expiratory pressure relief (EPR) back-off time during expiration (e.g., as configured and delivered by the RPT), overall inspiration time and amplitude, and breath-hold time (time before next cycle). Such disease analysis may include tracking worsening disease conditions. The collected data may be analyzed to detect worsening Asthma, pollen allergy, common cold, or respiratory infections. For example, lung impedance may be monitored to detect changes in lung condition over time. Other increases in patient airway resistance may be indicative of the worsening conditions. For example, COPD and Asthma are diseases in which airway narrowing occurs and thus exhibit an increase in airway resistance, which can be detected or estimated.” [0190]
Where collected data is collected (stored) by RPT device…
“Internal sensors such as the flow rate sensor 4274, a pressure sensor 4272, and a motor speed transducer 4276 may be coupled to the central controller 4230 in FIG. 4C. An optional internal audio sensor 4278 may be embedded in the interface 3000 in FIG. 1 to detect specific patient air sounds. An optional external audio sensor 4279 such as a microphone may be located on the exterior of the RPT device 4000, the interface 3000, or the humidifier 5000 to collect additional audio data. Additional sensors such as a heart rate sensor, an ECG sensor (providing cardiac fiducial parameters, of which peaks could be processed to estimate heart rate, detect arrhythmias and so forth), a pulse oximeter (SpO2) sensor (providing heart rate, oxygen saturation, and potential an estimate of blood pressure from pulse transit time), a blood pressure sensor, a room-temperature sensor, a contact or non-contact body temperature sensor, a room humidity sensor, a proximity sensor, a gesture sensor, a touch sensor, a gas sensor, an air quality sensor, a particulate sensor, an accelerometer, a gyroscope, a tilt sensor, other acoustic sensors such as passive or active SONAR, an ultrasonic sensor, a radio frequency sensor, an accelerometer, a light intensity sensor, a LIDAR sensor, an infrared sensor (passive, transmissive, or reflective), carbon dioxide sensor, a carbon monoxide sensor, or a chemical sensor, may be connected to the central controller 4230 via an external port. Data from such additional sensors may also be collected by the central controller 4230. Data from the sensors 4272, 4274, 4276, 4278, and 4279 may be collected by central controller 4230 on a periodic basis. Such data generally relates to the operational state of the RPT device 4000.” [0084]
Settable Respiration Pattern
The combined references setup and pattern.
Hudson et al. also in the business of setup and pattern further teaches:
Example of communicating to flow generator (therefore, output by terminal) for first and second pressure level (respiration pattern)…
“Another aspect of the present technology comprises in response to determination that a leak is present based on sensor data obtained during the increase of the supply of breathable gas from a first pressure level to a second pressure level, causing, via wireless communication, the flow generator to hold at a pressure level at which the leak was detected.” [0017]
“In one form of the present technology, the pressure level at which the breathable gas is supplied to the patient is increased in response to a determination that no leak is present. In an aspect of the present technology, the increase is automatically performed. In another aspect, the increase is performed in response to user provided input.” [0020]
Acclimatizing the user to the therapy and operating the device so patient receives correct therapy (make it easier for patient to synchronize with specified pattern)…
“In certain examples, techniques and systems for facilitating the setup, acclimatization, and/or use of a medical system that may be, for example, used in a home setting are provided. In certain examples, a guided setup process may be provided through a computer system such as a mobile device (e.g., a smart phone) of the patient. The guided process may provide instructions to patients for the setup of components of a medical system. An example of a medical system includes a respiratory therapy system that may include a patient interface component (e.g., a mask), an air conduit, a flow generator (e.g., a Respiratory Pressure Therapy Device (RPT device)), a humidifier, etc. The guided process may instruct a user on setting up each component of the system for proper use. The guided process may assist in acclimatizing the user to the therapy provided by the medical device. The guided process may assist in addressing issues (e.g., a leak) that arise during use of the medical device. In certain examples, the computer system may be programmed to assist a patient in tracking progress for therapy of the patient over a period of time (e.g., hours, days, weeks, months, etc. . . . ). In certain examples, the guided setup process may act to increase the confidence that a patient has in setting up and/or operating the medical device(s) (e.g., a CPAP system or other respiratory therapy system) so as to receive the correct therapy for the patient.” [0035]
Real-time feedback with therapy (synchronization) for setup and acclimatization process…
“The display screens may assist in helping a patient set up their CPAP (or other medical) system in, for example, their own home. The display screens may provide reassurance to a patient who is trying respiratory pressure therapy (e.g., CPAP therapy) for the first time. The display screens and associated programming may be used to provide an interactive process that allows a user to control aspects of the setup and acclimatization process. The programming and display screens may provide feedback (e.g., in real-time with provision of therapy) to the patient. The programming and display screens may provide advice and/or instructions to assist patients in addressing (or avoiding) one or more potential problems with their therapy.” [0069]
“Part of the setting up of the CPAP system may include prompting the patient to load their prescription information into the computing device 104. In certain examples, the prescription for the patient may be used to customize the setup instructions that are provided to the patient. For example, the setup for a nasal mask that is prescribed to one patient may be different than the setup instructions provided to a second patient that is prescribed a full face mask.” [0074]
“In certain examples, finishing a setup of a component and/or a given display screen may be logged to a data file or the like. In certain examples, the data of a patient's progress in the setup of the equipment may be transmitted to a remote computing device. This may allow remote users (e.g., medical or customer support personnel) to verify that the setup for a given component has been completed. In certain examples, data from the CPAP system 104 (and/or components thereof) may be retrieved for each of the components that is set up and additionally logged. For example, the patient interface and/or air conduit may be structured to electronically determine that one has been correctly installed with the other. Data of such a determination may be transmitted to the computing device 104 for storage in association with a given setup process (e.g., FIG. 2C) and/or a specific step in that process (e.g., a step in the process that is associated with display screen 234). Such recorded data may be transmitted to remote computing systems (e.g., 622 in FIG. 6) for storage therein.” [0094]
It would have been obvious to one of ordinary skill in the art at the time of filing to include in the method and system of the combined references the ability to further set respiration patterns as taught by Hudson et al. since the claimed invention is merely a combination of old elements and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable. Further motivation is provided by Hudson who teaches more details setting respiration patterns. The combined references benefit by the additional features as they improve control of the respirator devices.
Assimilation
The combined references teach ventilator. They do not teach assimilation.
Poon et al. also in the business of ventilator teaches:
Entrain (assimilation) to the ventilator…
“An entrainment-based mechanical ventilator may be initially set to approximate the patient's spontaneous respiratory frequency, enabling the patient to entrain to the ventilator if the ventilator frequency matches the patient's spontaneous breathing frequency or is within a reasonable range from it. If the preset frequency of the ventilator is set too high or too low from the spontaneous frequency, the patient will fall out of phase and "fight" the ventilator. The ventilator phase relative to the patient's breathing effort indicates the difference between the ventilator frequency and spontaneous frequency. Based on the phase difference, a closed-loop control mechanism may continuously adjust the ventilator frequency to match the patient breathing frequency until the phase shift is within a preset limit. Patient-ventilator entrainment will occur when the ventilator frequency is within a certain range from the patient breathing frequency.” (Abstract)
It would have been obvious to one of ordinary skill in the art at the time of filing to include in the method and system of the combined references the ability to assimilate breathing with simulator as taught by Poon et al. since the claimed invention is merely a combination of old elements and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable. Further motivation is provided by Poon et al. who teaches the problem of patients falling out of phase with a ventilator. Patients health benefits by using the same frequency of breathing as the ventilator.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/KENNETH BARTLEY/Primary Examiner, Art Unit 3684
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