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 .
Priority
Acknowledgment is made of applicant’s claim for priority to Application No. (65/507034) filed on the June 08, 2023.
Drawings
The drawings are objected to under 37 CFR 1.84(h)(5) because Figure 7 Graph 1 shows a duration of 00:00:54 but the graph is showing something different making it unclear what the graph is illustrating. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
In paragraph 0078, “ Accordingly, a deviation value may comprise a difference between a mean and a standard deviation of one or more one or more parameters, a difference between a median and an upper percentile value of one or more one or more parameters, an upper percentile value of one or more parameters, and/or another measure of variance.” Should read as –Accordingly, a deviation value may comprise a difference between a mean and a standard deviation of one or more parameters, a difference between a median and an upper percentile value of one or more parameters, an upper percentile value of one or more parameters, and/or another measure of variance.— because “one or more” is repeated twice in two different instincts.
Appropriate correction is required.
Claim Objections
Claims 4-7, 16, and 24 objected to because of the following informalities:
Regarding Claim 4, line 1, “further” should be added before “comprises”
Regrading Claim 5, line 2, “a predefined tolerance range” should read as “the predefined tolerance range”.
Regrading Claim 5, line 2, “a simulated” should read as “the simulated”.
Regrading Claim 5, line 2, “the corresponding ” should be added before “second predefined tolerance range”.
Regarding Claim 6, Examiner suggests the claim to read as “The method according to claim 1, wherein the one or more values outside of the predefined tolerance range for the one or more parameters are used to calculate a mean and a standard deviation and the deviation value is determined by the difference of the mean and the standard deviation.”
Regarding Claim 7, Examiner suggests the claim to read as “The method according to claim 1, wherein the one or more values outside of the predefined tolerance range for the one or more parameters are used to calculate a median and an upper percentile value and the deviation value is determined by the difference of the median and the upper percentile value.”
Regrading Claim 16, line 3, “a simulated” should read as “the simulated”.
Regrading Claim 16, line 5, “a physiologic” should read as “the physiologic”.
Regrading Claim 24, line 1, a comma should be added after “claim 23”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-24 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 1 recites the limitation "said values" in line 8 and "the predefined tolerance ranges" in line 9. There is insufficient antecedent basis for these limitations in the claim. Examiner is interpreting the claim and suggests to amend claim 1 to read as
“A method for determining a physiological effectiveness of a positive airway pressure device or determining a physiologic versus a simulated use of a positive airway pressure device, the method comprising:
obtaining one or more parameters recorded by the positive airway pressure machine;
determining whether one or more parameters are within expected physiologic range for each parameter;
identifying the simulated use when a deviation value is determined from a value outside of a predefined tolerance range for the one or more parameters; and
identifying the physiologic use when all of the values of the one or more parameters or a predetermined number of the value of the one or more parameters are within the predefined tolerance range.”
Claim 5 recites the limitation "at least the first deviation value and the second deviation value" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of the Office Action, Examiner is interpretating that the claim was depended off of claim 4 that teaches the first and second deviation values.
Claims 8-10 recites the limitation “the upper percentile” in line 1. There is insufficient antecedent basis for this limitation in the claim. Examiner is unsure what limitation is directed towards.
Claim 16 recites the limitation "at least two parameters" in line 1. There is insufficient antecedent basis for this limitation in the claim. For the purpose of the Office Action, Examiner is interpretating that the claims were depended off of claim 3.
Claim 17 recites the limitation recites the limitation " a simulated use and said values" in line 10 and "a physiologic use" in line 12. There is insufficient antecedent basis for these limitations in the claim. Examiner is interpreting the claim and suggests to amend claim 17 to read as
“A system configured to determine a physiological effectiveness of a positive airway pressure device or determining a physiologic versus a simulated use of a positive airway pressure device, the system comprising:
one or more processors; and
one or more memory storages, wherein the one or more memory storages have stored thereon, or the system is configured to receive, one or more parameters obtained by the positive airway pressure machine,
wherein the one or more processors are configured to perform the following:
determine values for the one or more parameters;
identify a simulated use when a deviation value is determined from a value outside of a predefined tolerance range for the one or more parameters, and identify the physiologic use when all of the values of the one or more parameters or a predetermined number of the value of the one or more parameters are within the predefined tolerance range.”
Claim 23 recites the limitation recites the limitation "said values" in line 6 and “the predefined tolerance range" in line 12. There is insufficient antecedent basis for these limitations in the claim. Examiner suggests to amend claim 23 to read as
“A method for determining an effectiveness of use of a positive airway pressure machine, the method comprising:
obtaining one or more parameters recorded by the positive airway pressure machine;
determining whether one or more parameters are within an expected physiologic range for each parameter;
identifying ineffective use when a deviation value determined from a value outside of a predefined tolerance range for the one or more parameters, and
identifying effective use when all of the values of the one or more parameters or a predetermined number of the value of the one or more parameters are within the predefined tolerance range.”
Claim 24 recites the limitation recites the limitation "said values" in line 9. There is insufficient antecedent basis for these limitations in the claim. Examiner is interpreting the claim and suggests to amend claim 24 to read as
“A system configured to perform the method according to claim 23, for determining an effectiveness of use of a positive airway pressure machine, the system comprising:
one or more processors; and
one or more memory storages, wherein the one or more memory storages have stored thereon, or the system is configured to receive, one or more parameters obtained by the positive airway pressure machine, wherein the one or more processors are configured to perform the following:
determine values for the one or more parameters;
identify an ineffective use when a deviation value is determined from a values of the one or more parameters to be outside of a predefined tolerance range, and
identify an effective use when all of the values of the one or more parameters are inside the predefined tolerance range.”
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 1, 17 and 23 and its dependencies claims 2-16, 18-22, and 24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The claim recite a system two of the statutory categories; therefore, the claims pass step 1 of the eligibility analysis. For step 2A, the claim(s) are directed to a method and a system for determining a physiological effectiveness of a positive airway pressure device or determining a physiologic versus a simulated use of a positive airway pressure device. The claims recite an abstract idea in the form of obtaining one or more parameters recorded by the positive airway pressure machine; determining whether one or more parameters are within expected physiologic range for each parameter; identifying simulated use when a deviation value is determined from said values to be outside the predefined tolerance range, and identifying physiologic use when the all of said values or a predetermined number of said values are inside the predefined tolerance ranges. This represents a mental processes because it can equivalently be done by a person simply observing parameters and identifying a certain use if the parameters are either inside the predefined range or outside the predefined tolerance range are actions that a person could do purely in the mind. If a claim recites a limitation, which under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas.
Using Claim 1, 17, and 23, as a representative example the abstract idea is defined by the elements of:
Claim 1:
A method for determining a physiological effectiveness of a positive airway pressure device or determining a physiologic versus a simulated use of a positive airway pressure device, the method comprising:
obtaining one or more parameters recorded by the positive airway pressure machine;
determining whether one or more parameters are within expected physiologic range for each parameter;
identifying simulated use when a deviation value is determined from said values to be outside the predefined tolerance range, and
identifying physiologic use when the all of said values or a predetermined number of said values are inside the predefined tolerance ranges.
Claim 17:
A system configured to determine a physiological effectiveness of a positive airway pressure device or determining a physiologic versus a simulated use of a positive airway pressure device, the system comprising:
one or more processors; and one or more memory storages,
wherein the one or more memory storages have stored thereon, or the system is configured to receive, one or more parameters obtained by the positive airway pressure machine, wherein the one or more processors are configured to perform the following:
determine values for the one or more parameters;
identify a simulated use when a deviation value is determined from said values to be outside a predefined tolerance range,
and identify a physiologic use when the value is inside the predefined tolerance range.
Claim 23
A method for determining an effectiveness of use of a positive airway pressure machine, the method comprising:
obtaining one or more parameters recorded by the positive airway pressure machine;
determining whether one or more parameters are within expected physiologic range for each parameter;
identifying ineffective use when a deviation value is determined from said values to be outside the predefined tolerance range, and
identifying effective use when the all said values or a predetermined number of said values are inside the predefined tolerance ranges.
The above bolded limitations recite the method of obtaining one or more parameters recorded by the positive airway pressure machine; determining whether one or more parameters are within expected physiologic range for each parameter; identifying simulated use when a deviation value is determined from said values to be outside the predefined tolerance range, and identifying physiologic use when the all of said values or a predetermined number of said values are inside the predefined tolerance ranges, that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. The process of obtaining one or more parameters, determining whether one or more parameters are within expected physiologic range for each parameter; and identifying simulated use or physiologic use when a deviation value is determined from said values to be outside/inside the predefined tolerance range can be carried out in a person’s mind. This is further defining the abstract idea. Furthermore, this is a process known to be capable of being performed by people mentally, and not limited to be carried out via computer for automation. People (patients or doctor or caregivers) are capable of looking at data calculating a certain parameter and determine simulated or physiologic by seeing if it is within a predefined tolerance range or not through observations. This is further defining mental process in the form of observations, evaluations, judgments, and opinions. This is considered longstanding practice that is the focus of the (patent ineligible) claimed invention and is further defining the abstract idea. The mere nominal recitation of “the positive airway machine”, “memory storage” or “processors” does not take the claim out of the group of mental processes.
This judicial exception is not integrated into a practical application (2nd prong of eligibility test for step 2A) because the additional elements of the claim amount to the use of “memory storage” which is used for extra solution data gathering. The use of “the positive airway machine” are field of use and/or extra solution activity these are merely being used as a tool to execute the abstract idea, see MPEP 2106.05(f). In addition, the use of “processor” has limitations that are not indicative of integration into a practical application because they are being recited at a high-level of generality as shown in US 20170182267 A1 (para. 0148) (i.e., as a generic processor performing a generic computer function of communicating data between users) such that they amount no more than mere instructions to apply the exception using a generic computer component. This is indicative of the fact that the claim has not integrated the abstract idea into a practical application and therefore the claim is found to be directed to the abstract idea identified by the examiner.
Likewise, the rationale set forth for the 2nd prong of the eligibility test above for claim 1, 17, and 23 is also applicable to Claim 2-16, 18-22, and 24. In regards to Claims 2-3 and 16, 18, the applicant is reciting elements that further limit the claims to include wherein the one/two or more parameters comprise one or more of maximum pressure, minimum pressure, delivered pressure, respiratory rate, minute ventilation, tidal volume, inspiratory time, inspiratory pressure, peak inspiratory pressure, and expiratory pressure; and wherein at least two or more parameters are assessed for values that are outside the corresponding tolerance ranges, wherein the step of identifying a simulated use when one or more of the at least two or more parameters have values outside the corresponding predefined tolerance ranges, and wherein the step of identifying a physiologic use when each of the at least two or more parameters have values inside of the corresponding predefined tolerance ranges. This is further defining the abstract idea identified by the examiner. No new additional elements were introduced in these claims, therefore, the same rationale set forth for the 2nd prong of the eligibility test above for claim 1 and 17 can be applied to the following claims. Examiner further considers these claim limitations as pre-solution activity because it is collecting the reference data that is used to make the abstract determination and data gathering is indicative of not amounting to significantly more when considered as a whole. See MPEP 2106(g).
In regards to Claims 4-5, the applicant is reciting elements that further limit the claims to include wherein the deviation value comprises at least a first deviation value and a second deviation value, and wherein the predefined tolerance range comprises at least a first predefined tolerance range corresponding to the first deviation value and a second predefined tolerance range corresponding to the second deviation value. Also, the claims include wherein the step of identifying simulated use when the deviation value is outside a predefined tolerance range comprises identifying a simulated use when one or more of at least the first deviation value and the second deviation value are outside of the corresponding first predefined tolerance range and second predefined tolerance range. This is further defining the abstract idea identified by the examiner. No new additional elements were introduced in these claims, therefore, the same rationale set forth for the 2nd prong of the eligibility test above for claim 1 can be applied to the following claims. Examiner further considers these claim limitations as pre-solution activity because it is collecting the reference data that is used to make the abstract determination and data gathering is indicative of not amounting to significantly more when considered as a whole. See MPEP 2106(g).
In regards to Claims 6-12, the applicant is reciting elements that further limit the claims to include wherein the deviation value comprises a difference between a mean and a standard deviation or a median and an upper percentile value of the one or more parameters; wherein the upper percentile value comprises a number between 80th percentile to a 99th , 90th , or 95th percentile value; wherein the one or more parameters comprise time series data; determining an initial usage value based on the one or more parameters, and determining a corrected usage value taking into account said identifying physiologic use and said identifying the simulated use. This is further defining the abstract idea identified by the examiner. No new additional elements were introduced in these claims, therefore, the same rationale set forth for the 2nd prong of the eligibility test above for claim 1 can be applied to the following claims. Examiner further considers these claim limitations as pre-solution activity because it is collecting the reference data that is used to make the abstract determination and data gathering is indicative of not amounting to significantly more when considered as a whole. See MPEP 2106(g).
In regards to Claims 13-15 and 20, the applicant is reciting elements that further limit the claims to include collecting one or more parameters using the positive airway pressure machine, : determining the predefined tolerance range based on a sleep fingerprint of a target subject; and /or determining whether the one or more parameters correspond to a “sleep fingerprint” of a target subject. This is further defining the abstract idea identified by the examiner. No new additional elements were introduced in these claims, therefore, the same rationale set forth for the 2nd prong of the eligibility test above for claim 1 and 17 can be applied to the following claims. Examiner further considers these claim limitations as pre-solution activity because it is collecting the reference data that is used to make the abstract determination and data gathering is indicative of not amounting to significantly more when considered as a whole. See MPEP 2106(g).
In regards to Claim 19, a new additional element of “positive airway device” which is routine and conditional using and “sensors” which is used for extra solution data gathering. The applicant is reciting elements that further limit the claims to include to record the one or more parameters using one or more sensors of the positive airway pressure machine and to communicate the one or more parameters to the one or more processors. This is further defining the abstract idea identified by the examiner. The same rationale set forth for the 2nd prong of the eligibility test above for claim 1 and 17 can be applied to the following claims. Examiner further considers these claim limitations as pre-solution activity because it is collecting the reference data that is used to make the abstract determination and data gathering is indicative of not amounting to significantly more when considered as a whole. See MPEP 2106(g).
In regards to Claims 21-22, the claim recites a new additional element of the claim amount to the use of “memory storage” which is used for extra solution data gathering. In addition, the use of “processor”, “computer system”, “computer-readable mediums”, which all have limitations that are not indicative of integration into a practical application because they are being recited at a high-level of generality as stated above. Also, the applicant is reciting elements that further limit the claims to include wherein the one or more memory storages have stored thereon executable instructions that when executed by the one or more processors configure the one or more processors to perform the method according to claim 1; or the one or more computer-readable mediums having stored thereon executable instructions that when executed by the one or more processors configure a computer system to perform the method according to claim 1.The same rationale set forth for the 2nd prong of the eligibility test above for claim 1 can be applied to the following claims. Examiner further considers these claim limitations as pre-solution activity because it is collecting the reference data that is used to make the abstract determination and data gathering is indicative of not amounting to significantly more when considered as a whole. See MPEP 2106(g).
In regards to Claims 24, the claim recites a new additional element of the claim amount to the use of “memory storage” which is used for extra solution data gathering. In addition, the use of “processor”, “system”, which all have limitations that are not indicative of integration into a practical application because they are being recited at a high-level of generality as stated above. Also, the applicant is reciting elements that further limit the claims to include receiving one or more parameters obtained by the positive airway pressure machine, wherein the one or more processors are configured to perform the following: determine values for the one or more parameters; identify an ineffective use/ effective use when a deviation value is determined from said values to be outside/inside a predefined tolerance range. The same rationale set forth for the 2nd prong of the eligibility test above for claim 23 can be applied to the following claims. Examiner further considers these claim limitations as pre-solution activity because it is collecting the reference data that is used to make the abstract determination and data gathering is indicative of not amounting to significantly more when considered as a whole. See MPEP 2106(g).
Claim 22 is additionally rejected under 101 because, it is not directed to a statutory category of a process, machine, manufacture or composition of matter. In addition, the claim recites a new additional element of “computer system” and “computer-readable mediums” which considered nothing more than a general link to a technological environment and generic computing devices to perform generic communicating functions such as storing data and instructions, transmitting and receiving data between computers. Examiner suggests amending the claim to add “non-transitory computer-readable storage medium”. For step 2B, the claim(s) do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they do not amount to more than simply instructing one to practice the abstract idea by using a computer to perform steps that define the abstract idea. This does not render the claims as being eligible. See MPEP 2106.05(f).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-5, 8-13, 16—19, 21, and 22-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shouldice (EP 3838138 A2).
Regarding Claim 1, Shouldice discloses a method for determining a physiological effectiveness of a positive airway pressure device or determining a physiologic versus a simulated use of a positive airway pressure device (para. 0054, 0078; Examiner notes: Shouldice teaches in some cases they may be integrated within a controller or processor of a treatment device, such as a respiratory pressure therapy device, that communicates with or coordinates with such a device for monitoring or treatment.), the method comprising:
obtaining one or more parameters recorded by the positive airway pressure machine (para. 0046, 0053-0054, 0077-0078; claim 97);
determining whether one or more parameters are within expected physiologic range for each parameter (para. 0045-0054; specifically para. 0046);
identifying a use when a deviation value is determined from said values to be outside the predefined tolerance range (para. 0187-0191; 0202; 216; Examiner notes: Shouldice teaches capable of detecting or identifying deviations from normal (healthy) signals based on a user-specific baseline, the detect a “trigger” and the trigger is identified when a value is outside the range), and
identifying a use when the all of said values or a predetermined number of said values are inside the predefined tolerance ranges (para. 0092-0098; Claim 1; abstract: Examiner notes: if it is within the range then it is “normal”).
Shouldice does not specifically disclose specifically a simulated and physiologic use is identified.
However Shouldice does teach that the system is capable of detecting or identifying deviations from normal (healthy) signals based on a user-specific baseline, the detect a “trigger” and the trigger is identified when a value is outside the range, Examiner is reading that the simulated use is abnormal reading and when a treatment is instructed and it is automated response to the trigger or abnormal reading. Furthermore, one or more processors of the device may determine and/or communicate a treatment medication dosage or at least one parameter associated with a treatment program or a treatment session with a respiratory device, based on a trigger pattern and may adjust parameters (e.g., carry out dosage titration) of the treatment device within a safe window (para. 0056, 0083-0085, 107).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Shouldice to include specifically a simulated and physiologic use is identified as taught by Shouldice for the purpose of prevention of respiratory disorders and having one or more of improved comfort, cost, efficacy, ease of use and manufacturability (para. 0042). One would want the method to be able to determine a trigger or an abnormal event to be able to modify the positive airway device to what works best for the patient (para. 0076-0078).
Regarding Claim 2, Modified Shouldice discloses the method according to claim 1, wherein the one or more parameters comprise one or more of maximum pressure, minimum pressure, delivered pressure, respiratory rate, minute ventilation, tidal volume, inspiratory time, inspiratory pressure, peak inspiratory pressure, and expiratory pressure (para. 0045-0047).
Regarding Claim 3, Modified Shouldice discloses the method according to claim 1, wherein the one or more parameters comprise two or more of maximum pressure, minimum pressure, delivered pressure, respiratory rate, minute ventilation, tidal volume, inspiratory time, inspiratory pressure, peak inspiratory pressure, and expiratory pressure (para. 0045-0047).
Regarding Claim 4, Shouldice discloses the method according to claim 1,
Shouldice does not disclose specifically wherein the deviation value comprises at least a first deviation value and a second deviation value, and wherein the predefined tolerance range comprises at least a first predefined tolerance range corresponding to the first deviation value and a second predefined tolerance range corresponding to the second deviation value. However, Shouldice teaches capable of detecting or identifying deviations from normal (healthy) signals based on a user-specific baseline.
Therefore, it would be obvious to a person of ordinary skill in the art that the prior art teaches a first deviation value and a second deviation value defining the one end of a predefined tolerance range and the second value defining other end of that range, such there is established range against which the subsequent readings are evaluated. A reading falling outside the predefined tolerance range would necessarily be recognized as outside the expected normal “physiologic use” and the simulated “abnormal” reading can be identified. Thus, the claimed first and second deviation values are not distinct or unconventional parameters, but rather corresponding to the endpoints of the known range, with value outside those endpoints naturally indicating an abnormal condition.
Regarding Claim 5, Shouldice discloses the method according to claim 1
Shouldice does not disclose specifically wherein the step of identifying simulated use when the deviation value is outside a predefined tolerance range comprises identifying a simulated use when one or more of an at least the first deviation value and the second deviation value are outside of the corresponding first predefined tolerance range and second predefined tolerance range.
However, Shouldice teaches capable of detecting or identifying deviations from normal (healthy) signals based on a user-specific baseline.
Therefore, it would be obvious to a person of ordinary skill in the art that the prior art teaches a first deviation value and a second deviation value defining the one end of a predefined tolerance range and the second value defining other end of that range, such there is established range against which the subsequent readings are evaluated. A reading falling outside the predefined tolerance range would necessarily be recognized as outside the expected normal “physiologic use” and the simulated “abnormal” reading can be identified. Thus, the claimed first and second deviation values are not distinct or unconventional parameters, but rather corresponding to the endpoints of the known range, with value outside those endpoints naturally indicating an abnormal condition.
Regarding Claim 8, Modified Shouldice discloses the method according to claim 1, wherein the upper percentile value comprises a 90th percentile value (para. 0155).
Regarding Claim 9, Modified Shouldice method according to claim 1, wherein the upper percentile value comprises a 95th percentile value (para. 0155).
Regarding Claim 10, Modified Shouldice method according to claim 1, wherein the deviation value comprises an upper percentile value in a range of an 80th percentile to a 99th percentile (para. 0155).
Regarding Claim 11, Modified Shouldice method according to claim 1, wherein the one or more parameters comprise time series data (para. 0046; Examiner notes: “tracking”).
Regarding Claim 12, Shouldice method according to claim 1,
Shouldice does not specifically disclose further comprising: determining an initial usage value based on the one or more parameters, and determining a corrected usage value taking into account said identifying physiologic use and said identifying the simulated use.
However, Shouldice teaches the method may include controlling activation of an automated response based on the detection of the trigger pattern (para. 0056, para. 0107).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Shouldice to include the determining an initial usage value based on the one or more parameters, and determining a corrected usage value taking into account said identifying physiologic use and said identifying the simulated use as taught by Shouldice because the trigger pattern may be indicative of a probable event of exacerbation of the chronic condition (para. 0043, 0046).
Regarding Claim 13, Modified Shouldice discloses method according to claim 1, further comprising: collecting one or more parameters using the positive airway pressure machine (para. 0046; RPT device parameters para. 0386-0388).
Regarding Claim 16, Modified Shouldice method according to claim 1, wherein at least two or more parameters (para. 0045-0047) are assessed for values that are outside the corresponding tolerance ranges (para. 0202), wherein the step of identifying a simulated use when one or more of the at least two or more parameters have values outside the corresponding predefined tolerance ranges, and wherein the step of identifying a physiologic use when each of the at least two or more parameters have values inside of the corresponding predefined tolerance ranges (para. 0187-0191; 0202; 216; Examiner notes: Shouldice teaches capable of detecting or identifying deviations from normal (healthy) signals based on a user-specific baseline, the detect a “trigger” and the trigger is identified when a value is outside the range, Examiner is reading that the simulated use is abnormal reading when a treatment is instructed and it is automated response to the trigger or abnormal reading. Furthermore, one or more processors of the device may determine and/or communicate a treatment medication dosage or at least one parameter associated with a treatment program or a treatment session with a respiratory device, based on a trigger pattern and may adjust parameters (e.g., carry out dosage titration) of the treatment device within a safe window).
Regarding Claim 17, Modified Shouldice discloses a system configured to determine a physiological effectiveness of a positive airway pressure device or determining a physiologic versus a simulated use of a positive airway pressure device (para. 0054, 0078; Examiner notes: Shouldice teaches in some cases they may be integrated within a controller or processor of a treatment device, such as a respiratory pressure therapy device, that communicates with or coordinates with such a device for monitoring or treatment),
the system comprising:
one or more processors (para. 0359; claim 8; 314); and
one or more memory storages (312) wherein the one or more memory storages have stored thereon, or the system is configured to receive, one or more parameters obtained by the positive airway pressure machine (para. 0046, 0053-0054, 0077-0078; claim 97), wherein the one or more processors are configured to perform the following (this limitation is functional):
determine values for the one or more parameters (para. 0045-0054; specifically para. 0046);
identify a use when a deviation value is determined from said values to be outside a predefined tolerance range, and identify a use when the value is inside a predefined tolerance range (para. 0092-0098, 0187-0191; 0202; 216; Examiner notes: Shouldice teaches capable of detecting or identifying deviations from normal (healthy) signals based on a user-specific baseline, the detect a “trigger” and the trigger is identified when a value is outside the range, Examiner is reading that the simulated use is abnormal reading).
Shouldice does not specifically disclose specifically a simulated and physiologic use is identified.
However Shouldice does teach that the system is capable of detecting or identifying deviations from normal (healthy) signals based on a user-specific baseline, the detect a “trigger” and the trigger is identified when a value is outside the range, Examiner is reading that the simulated use is abnormal reading and when a treatment is instructed and it is automated response to the trigger or abnormal reading. Furthermore, one or more processors of the device may determine and/or communicate a treatment medication dosage or at least one parameter associated with a treatment program or a treatment session with a respiratory device, based on a trigger pattern and may adjust parameters (e.g., carry out dosage titration) of the treatment device within a safe window (para. 0056, 0076, 0083-0085, 107).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Shouldice to include specifically a simulated and physiologic use is identified as taught by Shouldice for the purpose of prevention of respiratory disorders and having one or more of improved comfort, cost, efficacy, ease of use and manufacturability (para. 0042). One would want the method to be able to determine a trigger or an abnormal event to be able to modify the positive airway device to what works best for the patient (para. 0076-0078).
Regarding Claim 18, Modified Shouldice discloses the system according to claim 17, wherein the one or more parameters comprise one or more of maximum pressure, minimum pressure, delivered pressure, respiratory rate, minute ventilation, tidal volume, inspiratory time, inspiratory pressure, peak inspiratory pressure, and expiratory pressure (para. 0045-0047; 0359).
Regarding Claim 19, Modified Shouldice discloses the system according to claim 17, further comprising the positive airway pressure machine(para. 0054, 0078), the positive airway pressure machine configured to record the one or more parameters (para. 0045-0047) using one or more sensors of the positive airway pressure machine and to communicate the one or more parameters to the one or more processors (314; para. 0091-98).
Regarding Claim 21, Modified Shouldice discloses a system configured to determine an effectiveness of use of a positive airway pressure machine (para. 0054, 0078), the system comprising: one or more processors(para. 0359; claim 8; 314); and one or more memory storages (312), wherein the one or more memory storages have stored thereon, or the system is configured to receive, one or more parameters obtained by the positive airway pressure machine (Examiner notes: this limitation is functional), wherein the one or more memory storages have stored thereon executable instructions that when executed by the one or more processors configure the one or more processors to perform the method according to claim 1 (para. 0092-0098; Claim 1; abstract: Examiner notes: if it is within the range then it is “normal”).
Regarding Claim 22, Modified Shouldice discloses one or more computer-readable mediums (para. 0055) having stored thereon executable instructions that when executed by the one or more processors (para. 0056-0057) configure a computer system to perform the method according to claim 1(This limitation is functional; the computer mediums works with the processor to determine/identify a trigger or abnormal reading that is outside the user baseline measurements).
Regarding Claim 23, Shouldice discloses a method for determining an effectiveness of use of a positive airway pressure machine(para. 00348), the method comprising: obtaining one or more parameters recorded by the positive airway pressure machine (para. 0046, 0053-0054, 0077-0078; claim 97); determining whether one or more parameters are within expected physiologic range for each parameter (para. 0045-0054; specifically para. 0046); identifying ineffective use when a deviation value is determined from said values to be outside the predefined tolerance range, and identifying effective use when the all said values or a predetermined number of said values are inside the predefined tolerance ranges (para. 0092-0098, 0187-0191; 0202; 216).
Shouldice does not specifically disclose specifically an ineffective and effective use is identified.
However Shouldice does teach that the system is capable of detecting or identifying deviations from normal (healthy) signals based on a user-specific baseline, the detect a “trigger” and the trigger is identified when a value is outside the range, Examiner is reading that the ineffective use is abnormal reading and when a treatment is instructed and it is automated response to the trigger or abnormal reading. Furthermore, one or more processors of the device may determine and/or communicate a treatment medication dosage or at least one parameter associated with a treatment program or a treatment session with a respiratory device, based on a trigger pattern and may adjust parameters (e.g., carry out dosage titration) of the treatment device within a safe window (para. 0056, 0083-0085, 107).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Shouldice to include specifically a ineffective and effective use is identified for the purpose of prevention of respiratory disorders having one or more of improved comfort, cost, efficacy, ease of use and manufacturability (para. 0042 One would want the method to be able to determine a trigger or an abnormal event to be able to modify the positive airway device to what works best for the patient (para. 0076-0078).
Regarding Claim 24, Modified Shouldice discloses a system configured to perform the method according to claim 23, for determining an effectiveness of use of a positive airway pressure machine, the system comprising:
one or more processors (314; para. 0056-0057); and
one or more memory storages (312), wherein the one or more memory storages have stored thereon, or the system is configured to receive, one or more parameters obtained by the positive airway pressure machine(para. 0038; This limitation is functional),
wherein the one or more processors are configured to perform the following:
determine values for the one or more parameters (para. 0045-0054; specifically para. 0046);
identify an ineffective use when a deviation value is determined from said values to be outside a predefined tolerance range, and identify an effective use when the value is inside the predefined tolerance range (para. 0092-0098, 0187-0191; 0202; 216; Examiner notes: Shouldice teaches capable of detecting or identifying deviations from normal (healthy) signals based on a user-specific baseline, the detect a “trigger” and the trigger is identified when a value is outside the range, Examiner is reading that the simulated use is abnormal reading).
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shouldice, as applied to claim 1, in view of Lain et al. (US 20120145152 A1), hereafter as Lian, and Osorio (US 20150080670 A1).
Regarding Claim 6, Modified Shouldice discloses the method according to claim 1, the deviation value (para. 0202).
Modified Shouldice does not specifically disclose that deviation value is calculated by difference between a mean and a standard deviation of the one or more parameters.
However, Lain teaches the condition index value may be calculated by various means, such as, for example, by use of mathematical equations, algorithms, formulas, and the like, that may take into consideration one or more of the values or derivatives of the values of the parameters that are being measured by the monitoring device (para. 0124 ) and the deviation values is commonly known to indicate status of the patient (para. 0121-124).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Shouldice to include the data of a mean and a standard deviation of the one or more parameters as taught by Lain for the purpose of indicating the patient's status, a need to analyze the various patient related parameters (data) that are collected on line, in real time, and provide the health care providers with a more comprehensive, comprehensible, meaningful, intuitive, clearer and useful information about the patient's status, such as, for example: stable, improving, deteriorating, as well as providing a depiction of the rate and change of the patient's status. Displaying of the condition-index-value trend may simplify the assessment of the changes in the condition of the patient as compared to assessing the patient condition based on the trend of the individual parameters (para. 0121-0125).
Modified Shouldice does not specifically describe that deviation value is calculated by difference between a mean and a standard deviation of the one or more parameters.
However, Osorio teaches deviation value is calculated by difference between a mean and a standard deviation of the one or more parameters (para. 0061) is used to compare normal parameter reading to an extreme and the status or risk can be determined by comparing the change/deviation between a mean of value (para. 0061).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Shouldice to include calculating the difference between a mean and a standard deviation of the one or more parameters as taught by Osorio for the purpose of determining values for classification of events that may be chosen as needed to improve performance and to determine outliers/extremes (para. 0061).
Regarding Claim 7, Modified Shouldice discloses the method according to claim 1, the deviation value (para. 0202).
Modified Shouldice does not disclose that the deviation value comprises a difference between a median and an upper percentile value of the one or more parameters.
However, Lain teaches the condition index value may be calculated by various means, such as, for example, by use of mathematical equations, algorithms, formulas, and the like, that may take into consideration one or more of the values or derivatives of the values of the parameters that are being measured by the monitoring device (para. 0124 ) and the deviation values is commonly known to indicate status of the patient (para. 0121-124).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Shouldice to include the data of a a median and an upper percentile value of the one or more parameters as taught by Lain for the purpose of indicating the patient's status, a need to analyze the various patient related parameters (data) that are collected on line, in real time, and provide the health care providers with a more comprehensive, comprehensible, meaningful, intuitive, clearer and useful information about the patient's status, such as, for example: stable, improving, deteriorating, as well as providing a depiction of the rate and change of the patient's status. Displaying of the condition-index-value trend may simplify the assessment of the changes in the condition of the patient as compared to assessing the patient condition based on the trend of the individual parameters (para. 0121-0125).
Modified Shouldice does not specifically describe that deviation value is calculated by difference between a median and an upper percentile value of the one or more parameters.
However, Osorio teaches deviation value is calculated by difference between a median and an upper percentile value of the one or more parameters (para. 0061) is used to compare normal parameter reading to an extreme and the status or risk can be determined by comparing the change/deviation between a mean of value (para. 0061).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Shouldice to include calculating the difference between a median and an upper percentile value of the one or more parameters as taught by Osorio for the purpose of determining values for classification of events that may be chosen as needed to improve performance and to determine outliers/extremes (para. 0061).
Claim(s) 14-15 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shouldice, as applied to claim 1 and 17, in view of McDarby (US 10660563 B2).
Regarding Claim 14, Shouldice discloses method according to claim 1,
Shouldice does not disclose specifically further comprising: determining the predefined tolerance range based on a sleep fingerprint of a target subject.
However, McDarby teaches determining the predefined tolerance range based on a sleep fingerprint of a target subject (Col. 6 lines 59-Col. 7 lines 19).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Shouldice to include the determining the predefined tolerance range based on a sleep fingerprint of a target subject as taught by McDarby for the purpose of determining control settings for a ventilator or other respiratory related events by analysis of stored data such as from any of the sensors described herein (Col. 10 lines 10-14).
Regarding Claim 15, Shouldice discloses method according to claim 1,
Shouldice does not specifically disclose further comprising: determining whether the one or more parameters correspond to a “sleep fingerprint” of a target subject.
However, McDarby teaches determining whether the one or more parameters correspond to a “sleep fingerprint” of a target subject (Col. 6 lines 59-Col. 7 lines 19; Col. 10 lines 10-14).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Shouldice to include determining whether the one or more parameters correspond to a “sleep fingerprint” of a target subject as taught by McDarby for the purpose of determining control settings for a ventilator or other respiratory related events by analysis of stored data such as from any of the sensors described herein (Col. 10 lines 10-14).
Regarding Claim 20, Shouldice discloses the system according to claim 17,
Shouldice does not specifically disclose further comprising a sleep study device configured to record a sleep fingerprint of a target subject and communicate the sleep fingerprint to the one or more processors.
However, McDarby teaches further comprising a sleep study device configured to record a sleep fingerprint of a target subject and communicate the sleep fingerprint to the one or more processors (Col. 6 lines 59-Col. 7 lines 19; Col. 10 lines 10-14).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Shouldice to include further comprising a sleep study device configured to record a sleep fingerprint of a target subject and communicate the sleep fingerprint to the one or more processors as taught by McDarby for the purpose of determining control settings for a ventilator or other respiratory related events by analysis of stored data such as from any of the sensors described herein (Col. 10 lines 10-14).
Conclusion
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MAAP A. ELLABIB
Examiner
Art Unit 3785
/M.A.E./ Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
Prosecution Insights