DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. The Applicant’s submission filed on 7/14/2026 has been entered.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 1 and 19 are objected to because of the following informalities:
in claim 1, line 11: “and” should be inserted before “(b)”; and
in claim 19, line 22: “and” should be inserted before “(b)”.
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 1-2, 4, 6-7, 9, 13, 19, and 21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “a particular body position of the set of body positions” in lines 24-25, but it is not clear if this recitation is the same as, related to, or different from “a prone position” of claim 1, line 10, “at least one other position” of claim 1, lines 10-11, or “a current body position” of claim 1, line 17. The relationship among these recitations should be made clear.
Claim 1 recites a period after “the target position for the person” in line 50. It is not clear if the end of the claim takes place at the period and the rest of the text is a typographical error of if the period should be a comma. Clarification is required.
Claims 2, 4, 6-7, 9, and 13 are rejected by virtue of their dependence from claim 1.
Claim 4 recites “a processor” in line 3, but it is not clear if this recitation is the same as, related to, or different from “a processor” in claim 1, line 9. If they are the same, “a processor” in claim 4 should be “the processor”. If they are different, their relationship should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements).
Claim 7 recites “an application” in line 4, but it is not clear if this recitation is the same as, related to, or different from “a proning user application” in claim 1, lines 8-9. If they are the same, “an application” in claim 7 should be “the proning user application”. If they are different, their relationship should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements).
Claim 9 recites “(a) a minimum duration spent in the prone position or (b) a maximum duration spent out of the prone position” in lines 1-3, but it is not clear if this recitation is the same as, related to, or different from “orientation-based rules or parameters to encourage time spent in the prone position” in claim 1, lines 11-12. The relationship between these recitations should be made clear.
Claim 19 recites “the wearable sensor” in line 13, but it is not clear if this recitation is the same as, related to, or different from “a wearable sensor device” in line 3. If they are the same, “the wearable sensor” in line 13 should be “the wearable sensor device”. If they are different, their relationship should be made clear. Also, if they are different, there is insufficient antecedent basis for “the wearable sensor” in claim 19.
Claim 19 recites “a particular orientation” in lines 14-15, but it is not clear if this recitation is the same as, related to, or different from “the person’s orientation” of claim 19, line 6. If they are the same, consistent terminology should be used. If they are different, their relationship should be made clear.
Claim 19 recites “the particular body position” in lines 49-52, which is indefinite. First, it is not clear if this recitation is the same as, related to, or different from “a particular orientation of the person” in lines 14-15. Second, it is not clear if this recitation is the same as, related to, or different from “a prone position and at least one other position” in lines 22. The relationship among these references should be made clear.
Claim 21 is rejected by virtue of its dependence from claim 19.
Claim 21 recites “(a) a minimum duration spent in the prone position or (b) a maximum duration spent out of the prone position” in lines 2-3, but it is not clear if this recitation is the same as, related to, or different from “orientation-based rules or parameters to encourage time spent in the prone position” in claim 19, lines 22-23. The relationship between these recitations should be made clear.
Allowable Subject Matter
Claims 1-2, 4, 6-7, 9, 13, 19, and 21 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter.
U.S. Patent Application Publication No. 2018/0103874 (Lee)(previously cited) teaches that the respiration rate may be monitored so as to identify respiratory distress or dysfunction and to assess the patient’s overall health condition (paragraphs 0013, 0027-0028, 0082, 0098, 0101, and 0123 of Lee). U.S. Patent Application Publication No. 2011/0263950 (Larson)(previously cited) teaches that, when patients with congestive heart failure (CHF) lie flat, they can develop respiratory distress that manifests as an increased respiratory rate. In particular, patients with CHF can’t handle the extra fluid load that occurs when lying supine, hence they get short of breath when lying flat. Similarly, patients with morbid obesity or obstructive sleep apnea can develop respiratory distress when they lie flat since the extra weight due to fat around the chest and neck can increase the work of breathing. Larson also teaches that patient’s breathing patterns can change based on the postural changes in these cases. Larson then teaches the use of an accelerometer placed on the patient so as to measure both the patient’s position/orientation and respiratory rate. When the sensing system detects changes in respiratory rate that are associated with changes in position/orientation, caregivers can be notified and further workup initiated (paragraphs 0106-0107 of Larson). These changes in respiratory rate are compared thresholds that define a normal range (paragraphs 0058 and 0102 of Larson) with abnormal rates or magnitudes falling outside the normal range (paragraph 0063 of Larson). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the accelerometer of Lee to measure the respiratory rate, to detect the changes in the respiratory rate that are associated with the times during or changing into the supine position, compare them against the thresholds of a normal range, and to notify caregivers if there are detected changes in the respiratory rate associated with the times during or changing into the supine position are falling outside the normal range for this condition so that the caregiver may initiate a turn for the patient with CHF to prevent or alleviate respiratory distress.
With respect to claim 1, the combination teaches or suggests a method of treating Covid-19 or other respiratory illness in a person (the preamble merely provides an intended use that does not impact the method steps that follow. Alternatively, Larson teaches that patients with CHF suffer from orthopnea (paragraph 0107 of Larson) and it would have been obvious to use the method on such a patient suffering from orthopnea so as to prevent serious respiratory disfunction), the method comprising:
receiving orientation-related sensor data generated by at least one orientation-related sensor provided in a wearable sensor device secured to the person or to an article worn by the person (receiving sensor data from the wearable accelerometer in the wireless sensor 102; paragraphs 0011, 0013, 0016, 0018, 0027, and 0071-0072 of Lee; paragraphs 0106-0107 of Larson);
executing a proning user application by a processor to manage a proning protocol for the person, the proning protocol defining (a) a set of body positions including a prone position and at least one other position (b) orientation-based rules or parameters to encourage time spent in the prone position; and
wherein executing the proning user application by the processor to manage the proning protocol for the person includes:
automatically determining a current body position, from the set of body positions defined by the proning protocol, based on the orientation-related sensor data (the determining of orientation over time; paragraphs 0011-0012, 0014, 0020, 0022, 0025, 0029, 0082, 0090, and 0149-0153 of Lee);
automatically comparing a time spent in the current body position to a threshold time, and when the time spent in the current body position exceeds the threshold time, automatically selecting a target position from the set of body positions defined by the proning protocol and generating a repositioning notification indicating the selected target position (the comparison of the time when the patient remains in a particular orientation (including those times in the prone position and those times in positions other than prone) to a duration prescribed by a clinician according to a repositioning protocol; outputting the visual notification that the patient has exceeded the maximum time between patient turns (including those times in the prone position and those times in positions other than prone); paragraphs 0020, 0029, 0090, 0149-0150, 0152, and 0176 of Lee); and
receiving physiological sensor data associated with a particular body position of the set of body positions defined by the proning protocol, the physiological sensor data indicating at least one of (a) respiratory data, (b) heart rate data, or (c) oxygen saturation data of the person (receiving sensor data for the respiratory rate from the wearable accelerometer in the wireless sensor 102; paragraphs 0011, 0013, 0016, 0018, 0027, and 0071-0072 of Lee; paragraphs 0106-0107 of Larson).
The combination teaches the determination to turn the patient with CHF away from the supine position when the respiratory rate exceeds the threshold of the normal range. However, the combination does not teach or suggest “wherein executing the proning user application by the processor to manage the proning protocol for the person includes…automatically comparing the physiological sensor data with a stored position removal threshold value, and if the physiological sensor data exceeds the stored position removal threshold value, automatically removing the particular body position from the set of body positions defined by the proning protocol; wherein as a result of removing the particular body position from the set of body positions defined by the proning protocol, the particular body position is excluded from being subsequently selected as the target position for the person. and outputting a message indicating the removal of the particular body position from the set of body positions defined by the proning protocol” along with the other features of claim 1.
U.S. Patent Application Publication No. 2022/0167880 (Addison) teaches a video-based patient monitoring method includes: determining a patient's position; comparing the patient's position to a list of prohibited patient positions; and when the patient's position matches a patient position on the list of prohibited patient positions, initiating an alarm (paragraph 0009 of Addison).
U.S. Patent Application Publication No. 2009/0250070 (Pfeifer) teaches an operating unit with a selection device for selecting at least one desired and/or at least one prohibited rotational position of the body of the person about the longitudinal axis of the body; a comparator device for comparing the current rotational position and the at least one desired and/or at least one prohibited rotational position and emitting a corresponding position signal; and a control device which can be set to actuate an actuator device to supply a predeterminable stimulus pattern to the body in response to the position signal if the position signal shows that the current rotational position does not correspond to the at least one desired rotational position and/or corresponds to at least the one prohibited rotational position (abstract and paragraphs 0019-0025 of Pfeifer).
U.S. Patent Application Publication No. 2014/0257057 (Reis Cunha) teaches that, for patients with “forbidden” contact areas, a device allows alerting that the patient is being place in a position previously defined as inadequate for the patient's particular condition (e.g.: the doctor determines that a patient must not be placed under his left side, in case anyone puts him, inadvertently in that position, an alarm will sound)(paragraph 0061 of Reis Cunha).
However, each of Addison, Pfeifer, and Reis Cunha (either alone, in combination with each other, or in combination with Lee and Larson) does not teach or suggest “wherein executing the proning user application by the processor to manage the proning protocol for the person includes…automatically comparing the physiological sensor data with a stored position removal threshold value, and if the physiological sensor data exceeds the stored position removal threshold value, automatically removing the particular body position from the set of body positions defined by the proning protocol; wherein as a result of removing the particular body position from the set of body positions defined by the proning protocol, the particular body position is excluded from being subsequently selected as the target position for the person. and outputting a message indicating the removal of the particular body position from the set of body positions defined by the proning protocol” along with the other features of claim 1.
Claims 2, 4, 6-7, 9, and 13 are allowable by virtue of their dependence from claim 1.
With respect to claim 19, the combination of Lee and Larson teaches or suggests a system for treating Covid-19 or other respiratory illness in a person (the preamble merely provides an intended use that does not impact the structural elements that follow. Alternatively, Larson teaches that patients with CHF suffer from orthopnea (paragraph 0107 of Larson) and it would have been obvious to use the method on such a patient suffering from orthopnea so as to prevent serious respiratory disfunction), the system comprising :
a wearable sensor device (the wireless sensor 102; paragraphs 0011, 0013, 0016, 0018, 0027, and 0071-0072 of Lee; paragraphs 0106-0107 of Larson) configured to be secured to the person or to an article worn by the person, the wearable sensor device including:
at least one orientation-related sensor (the wearable accelerometer in the wireless sensor 102; paragraphs 0011, 0013, 0016, 0018, 0027, and 0071-0072 of Lee; paragraphs 0106-0107 of Larson) configured to generate orientation-related sensor data indicative of the person's orientation; and
a wireless transmitter (the wireless transceiver in the wireless sensor 102; paragraphs 0011, and 0071-0073 of Lee) configured to wireless transmit orientation data including the generated orientation-related sensor data or data derived from the generated orientation-related sensor data;
a mobile device (the patient monitor 106 is a portable device, thus making it a mobile device (paragraph 0079 of Lee)) separate from the wearable sensor device and including:
a wireless receiver (the receiver in the patient monitor 106; paragraphs 0011 and 0079 of Lee) configured to: receive the orientation data transmitted by the wireless transmitter of the wearable sensor; and receive physiological sensor data associated with a particular orientation of the person, the physiological sensor data indicating at least one of (a) respiratory data (the respiratory rate) or (b) oxygen saturation data of the person;
a mobile device processor (the processor in the patient monitor 106; paragraphs 0011-0012, 0071, 0079, 0090, 0195 of Lee) configured to: manage a proning protocol for the person, the proning protocol defining (a) a set of body positions including a prone position and at least one other position (b) orientation-based rules or parameters to encourage time spent in the prone position; and wherein managing the proning protocol for the person includes:
determining a current body position, from the set of body positions defined by the proning protocol, based on the orientation-related sensor data (the determining of orientation over time; paragraphs 0011-0012, 0014, 0020, 0022, 0025, 0029, 0082, 0090, and 0149-0153 of Lee);
comparing a time spent in the current body position to a threshold time, and when the time spent in the current body position exceeds the threshold time, selecting a target position from the set of body positions defined by the proning protocol and generating a repositioning notification indicating the selected target position (the comparison of the time when the patient remains in a particular orientation (including those times in the prone position and those times in positions other than prone) to a duration prescribed by a clinician according to a repositioning protocol; outputting the visual notification that the patient has exceeded the maximum time between patient turns (including those times in the prone position and those times in positions other than prone); paragraphs 0020, 0029, 0090, 0149-0150, 0152, and 0176 of Lee).
The combination teaches the determination to turn the patient with CHF away from the supine position when the respiratory rate exceeds the threshold of the normal range. However, the combination does not teach or suggest “comparing the physiological sensor data with a stored position removal threshold value, and if the physiological sensor data exceeds the stored position removal threshold value, automatically remove the particular body position from the set of body positions defined by the proning protocol; wherein as a result of removing the particular body position from the set of body positions defined by the proning protocol, the particular body position is excluded from being subsequently selected as the target position for the person; and an output device configured to …(b) output a human-perceptible notification indicating the removal of the particular body position from the set of body positions defined by the proning protocol” along with the other features of claim 19.
However, each of Addison, Pfeifer, and Reis Cunha (either alone, in combination with each other, or in combination with Lee and Larson) does not teach or suggest “comparing the physiological sensor data with a stored position removal threshold value, and if the physiological sensor data exceeds the stored position removal threshold value, automatically remove the particular body position from the set of body positions defined by the proning protocol; wherein as a result of removing the particular body position from the set of body positions defined by the proning protocol, the particular body position is excluded from being subsequently selected as the target position for the person; and an output device configured to …(b) output a human-perceptible notification indicating the removal of the particular body position from the set of body positions defined by the proning protocol” along with the other features of claim 19.
Claim 21 is allowable by virtue of its dependence from claim 19.
Lee teaches that the respiration rate may be monitored so as to identify respiratory distress or dysfunction and to assess the patient’s overall health condition (paragraphs 0013, 0027-0028, 0082, 0098, 0101, and 0123 of Lee). Larson teaches the use of an accelerometer placed on the patient so as to measure both the patient’s position/orientation and respiratory rate (paragraphs 0106-0107 of Larson). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to monitor respiration rate using the wearing accelerometer of Lee since it creates a more compact system and/or it is a simple substitution of one known element for another to obtain predictable results.
Lee teaches that the respiration rate may be monitored so as to identify respiratory distress or dysfunction and to assess the patient’s overall health condition (paragraphs 0013, 0027-0028, 0082, 0098, 0101, and 0123 of Lee). U.S. Patent Application Publication No. 2002/0104535 (Biondo)(previously cited) teaches that positioning of patients in a prone position results in improved oxygenation to the patient as opposed to a supine position. More particularly, it is believed that prone positioning reduces the occurrence of acute respiratory distress syndrome (ARDS)(paragraphs 0003 and 0105 of Biondo). Also, Biondo teaches that rotation between supine and prone positions avoids the formation of bed sores (paragraph 0003 of Biondo). U.S. Patent Application Publication No. 2009/0234240 (Kuenzler)(previously cited) teaches that an alert condition may be generated for ARDS based on the respiration rate being consistent with alert criteria including thresholds (paragraphs 0012-0013, 0034, 0040-0045, 0066-0067, 0069, 0073-0076, 0078-0080 and FIG. 1B of Kuenzler). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to monitor respiration rate and rotate the patient into the prone position in an alert condition for ARDS based on a comparison of the respiratory rate against thresholds so as to improve oxygenation to the patient.
With respect to claim 1, the combination teaches or suggests a method of treating Covid-19 or other respiratory illness in a person (the ARDS of Biondo), the method comprising:
receiving orientation-related sensor data generated by at least one orientation-related sensor provided in a wearable sensor device secured to the person or to an article worn by the person (receiving sensor data from the wearable accelerometer in the wireless sensor 102; paragraphs 0011, 0013, 0016, 0018, 0027, and 0071-0072 of Lee; paragraphs 0106-0107 of Larson);
executing a proning user application by a processor to manage a proning protocol for the person, the proning protocol defining (a) a set of body positions including a prone position and at least one other position (b) orientation-based rules or parameters to encourage time spent in the prone position; and
wherein executing the proning user application by the processor to manage the proning protocol for the person includes:
automatically determining a current body position, from the set of body positions defined by the proning protocol, based on the orientation-related sensor data (the determining of orientation over time; paragraphs 0011-0012, 0014, 0020, 0022, 0025, 0029, 0082, 0090, and 0149-0153 of Lee);
automatically comparing a time spent in the current body position to a threshold time, and when the time spent in the current body position exceeds the threshold time, automatically selecting a target position from the set of body positions defined by the proning protocol and generating a repositioning notification indicating the selected target position (the comparison of the time when the patient remains in a particular orientation (including those times in the prone position and those times in positions other than prone) to a duration prescribed by a clinician according to a repositioning protocol; outputting the visual notification that the patient has exceeded the maximum time between patient turns (including those times in the prone position and those times in positions other than prone); paragraphs 0020, 0029, 0090, 0149-0150, 0152, and 0176 of Lee);
receiving physiological sensor data associated with a particular body position of the set of body positions defined by the proning protocol, the physiological sensor data indicating at least one of (a) respiratory data, (b) heart rate data, or (c) oxygen saturation data of the person (receiving sensor data for the respiratory rate from the wearable accelerometer in the wireless sensor 102; paragraphs 0011, 0013, 0016, 0018, 0027, and 0071-0072 of Lee; paragraphs 0106-0107 of Larson).
The combination teaches the determination to turn the patient with ARDS away from the supine position (i.e., removing the supine position from the proning protocol) when the respiratory rate exceeds the threshold. However, the combination does not teach or suggest “wherein executing the proning user application by the processor to manage the proning protocol for the person includes…automatically comparing the physiological sensor data with a stored position removal threshold value, and if the physiological sensor data exceeds the stored position removal threshold value, automatically removing the particular body position from the set of body positions defined by the proning protocol; wherein as a result of removing the particular body position from the set of body positions defined by the proning protocol, the particular body position is excluded from being subsequently selected as the target position for the person. and outputting a message indicating the removal of the particular body position from the set of body positions defined by the proning protocol” along with the other features of claim 1.
However, each of Addison, Pfeifer, and Reis Cunha (either alone, in combination with each other, or the combination of Lee, Larson, Biondo, and Kuenzler) does not teach or suggest “wherein executing the proning user application by the processor to manage the proning protocol for the person includes…automatically comparing the physiological sensor data with a stored position removal threshold value, and if the physiological sensor data exceeds the stored position removal threshold value, automatically removing the particular body position from the set of body positions defined by the proning protocol; wherein as a result of removing the particular body position from the set of body positions defined by the proning protocol, the particular body position is excluded from being subsequently selected as the target position for the person. and outputting a message indicating the removal of the particular body position from the set of body positions defined by the proning protocol” along with the other features of claim 1.
Claims 2, 4, 6-7, 9, and 13 are allowable by virtue of their dependence from claim 1.
With respect to claim 19, the combination teaches or suggests a system for treating Covid-19 or other respiratory illness in a person (the ARDS of Biondo), the system comprising:
a wearable sensor device (the wireless sensor 102; paragraphs 0011, 0013, 0016, 0018, 0027, and 0071-0072 of Lee; paragraphs 0106-0107 of Larson) configured to be secured to the person or to an article worn by the person, the wearable sensor device including:
at least one orientation-related sensor (the wearable accelerometer in the wireless sensor 102; paragraphs 0011, 0013, 0016, 0018, 0027, and 0071-0072 of Lee; paragraphs 0106-0107 of Larson) configured to generate orientation-related sensor data indicative of the person's orientation; and
a wireless transmitter (the wireless transceiver in the wireless sensor 102; paragraphs 0011, and 0071-0073 of Lee) configured to wireless transmit orientation data including the generated orientation-related sensor data or data derived from the generated orientation-related sensor data;
a mobile device (the patient monitor 106 is a portable device, thus making it a mobile device (paragraph 0079 of Lee)) separate from the wearable sensor device and including:
a wireless receiver (the receiver in the patient monitor 106; paragraphs 0011 and 0079 of Lee) configured to: receive the orientation data transmitted by the wireless transmitter of the wearable sensor; and receive physiological sensor data associated with a particular orientation of the person, the physiological sensor data indicating at least one of (a) respiratory data (the respiratory rate) or (b) oxygen saturation data of the person;
a mobile device processor (the processor in the patient monitor 106; paragraphs 0011-0012, 0071, 0079, 0090, 0195 of Lee) configured to: manage a proning protocol for the person, the proning protocol defining (a) a set of body positions including a prone position and at least one other position (b) orientation-based rules or parameters to encourage time spent in the prone position; and wherein managing the proning protocol for the person includes:
determining a current body position, from the set of body positions defined by the proning protocol, based on the orientation-related sensor data (the determining of orientation over time; paragraphs 0011-0012, 0014, 0020, 0022, 0025, 0029, 0082, 0090, and 0149-0153 of Lee);
comparing a time spent in the current body position to a threshold time, and when the time spent in the current body position exceeds the threshold time, selecting a target position from the set of body positions defined by the proning protocol and generating a repositioning notification indicating the selected target position (the comparison of the time when the patient remains in a particular orientation (including those times in the prone position and those times in positions other than prone) to a duration prescribed by a clinician according to a repositioning protocol; outputting the visual notification that the patient has exceeded the maximum time between patient turns (including those times in the prone position and those times in positions other than prone); paragraphs 0020, 0029, 0090, 0149-0150, 0152, and 0176 of Lee).
The combination teaches the determination to turn the patient with ARDS away from the supine position (i.e., removing the supine position from the proning protocol) when the respiratory rate exceeds the threshold. However, the combination does not teach or suggest “comparing the physiological sensor data with a stored position removal threshold value, and if the physiological sensor data exceeds the stored position removal threshold value, automatically remove the particular body position from the set of body positions defined by the proning protocol; wherein as a result of removing the particular body position from the set of body positions defined by the proning protocol, the particular body position is excluded from being subsequently selected as the target position for the person; and an output device configured to …(b) output a human-perceptible notification indicating the removal of the particular body position from the set of body positions defined by the proning protocol” along with the other features of claim 19.
However, each of Addison, Pfeifer, and Reis Cunha (either alone, in combination with each other, or the combination of Lee, Larson, Biondo, and Kuenzler) does not teach or suggest “comparing the physiological sensor data with a stored position removal threshold value, and if the physiological sensor data exceeds the stored position removal threshold value, automatically remove the particular body position from the set of body positions defined by the proning protocol; wherein as a result of removing the particular body position from the set of body positions defined by the proning protocol, the particular body position is excluded from being subsequently selected as the target position for the person; and an output device configured to …(b) output a human-perceptible notification indicating the removal of the particular body position from the set of body positions defined by the proning protocol” along with the other features of claim 19.
Claim 21 is allowable by virtue of its dependence from claim 19.
Response to Arguments
The Applicant’s arguments filed on 6/23/2026 have been fully considered.
Claim objection
In view of the claim amendments filed on 6/23/2026, the previous claim objections have been withdrawn. There are new grounds of claim objections.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
In view of the claim amendments filed on 6/23/2026, the previous claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, have been withdrawn with the exception to the rejection of claim 19. With respect to claim 19, the Applicant did not address, by amendment or argument, the indefiniteness issue with respect to the recitation “the wearable sensor” in claim 19, line 13. Also, the Applicant did not address, by amendment or argument, the indefiniteness issue with respect to the recitation “a particular orientation” in claim 19, lines 14-15. The Examiner cannot find a reason to withdraw the rejections.
There are new grounds of claim rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourth paragraph
In view of the claim amendments filed on 6/23/2026, the previous claim rejections under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourth paragraph, have been withdrawn.
Prior art rejections
In view of the claim amendments filed on 6/23/2026, the previous prior art rejections have been withdrawn.
Conclusion
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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