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 .
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
Claim 19 is objected to because of the following informalities:
in claim 19, line 15: “receiving” should be “receive”; and
in claim 19, line 44: “(b)” should be inserted before “output human-perceptible notifications”.
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 orientation” in line 14 and “the particular orientation” in lines 30 and 33-34, but it is not clear if this recitation is the same as, related to, or different from “an orientation of the person” of claim 1, line 7. If they are the same, consistent terminology should be used. If they are different, their relationship should be made clear.
Claim 1 recites “(a) comparing the respiratory data with (i) a respiratory rate protocol termination threshold value or (ii) a respiratory rate position removal threshold value different than the respiratory rate protocol termination threshold value” in lines 18-20, but it is not clear if the respiratory rate protocol termination threshold value is required by the method. The conjunction “or” between (i) and (ii) suggests that the respiratory rate protocol termination threshold value is simply an alternative while the expression “different than the respiratory rate protocol termination threshold value” suggests that its presence in the claim is required. If the respiratory rate protocol termination threshold value is required, it is not clear if both alternatives (i) and (ii) are required for the claimed method or if only one of the alternatives (i) and (ii) is required by the claimed method. These issues render claim 1 indefinite.
Claim 1 recites “(b) comparing the oxygen saturation data with (i) an oxygen saturation protocol termination threshold value or (ii) an oxygen saturation position removal threshold value different than the oxygen saturation protocol termination threshold value” in lines 21-24, but it is not clear if the oxygen saturation protocol termination threshold value is required by the method. The conjunction “or” between (i) and (ii) suggests that the oxygen saturation protocol termination threshold value is simply an alternative while the expression “different than the oxygen saturation protocol termination threshold value” suggests that its presence in the claim is required. If the oxygen saturation protocol termination threshold value is required, it is not clear if both alternatives (i) and (ii) are required for the claimed method or if only one of the alternatives (i) and (ii) is required by the claimed method. These issues render claim 1 indefinite.
Claim 1 recites:
“receiving physiological sensor data associated with a particular orientation of the person, the physiological sensor data indicating at least one of (a) respiratory data, (b) heart rate data, or (c) oxygen saturation data of the person;
analyzing the physiological sensor data, including at least one of:
(a) comparing the respiratory data with (i) a respiratory rate protocol termination threshold value or (ii) a respiratory rate position removal threshold value different than the respiratory rate protocol termination threshold value; or
(b) comparing the oxygen saturation data with (i) an oxygen saturation protocol termination threshold value or (ii) an oxygen saturation position removal threshold value different than the oxygen saturation protocol termination threshold value; and
based at least on the analysis of the physiological sensor data, either:
(a) automatically terminating the proning protocol for the person if the respiratory data exceeds the respiratory rate protocol termination threshold value or the oxygen saturation data exceeds the oxygen saturation protocol termination threshold value, and outputting a message indicating the termination of the proning protocol; or
(b) automatically removing the particular orientation from the proning protocol for the person if the respiratory data exceeds the respiratory rate position removal threshold value or the oxygen saturation data exceeds the oxygen saturation position removal threshold value, and outputting a message indicating the removal of the particular orientation from the proning protocol”
in lines 14-34 that renders the claim indefinite. The indefinite issues are enumerated in the following paragraphs.
First, the receiving physiological sensor data (the receiving step) has at least one of (a) respiratory data, (b) heart rate data, or (c) oxygen saturation data of the person. The analyzing the physiological sensor data (the analyzing step) has two alternatives: the analyzing option (a) and the analyzing option (b). The output based at least on the analysis of the physiological sensor data has two alternatives: the output option (a) and the output option (b).
Second, the receiving step, the analyzing step, and the output options (a) and (b) are written such that any of following combinations is contemplated (assuming both alternatives (i) and (ii) are required in the analyzing step option (a) and both alternatives (i) and (ii) are required in the analyzing step option (b)):
Entry
Data from the Receiving Step
The Analyzing Step Option
The Output Option
A
respiratory data
(a)
(a)
B
respiratory data
(a)
(b)
C
respiratory data
(b)
(a)
D
respiratory data
(b)
(b)
E
heart rate data
(a)
(a)
F
heart rate data
(a)
(b)
G
heart rate data
(b)
(a)
H
heart rate data
(b)
(b)
I
oxygen saturation data
(a)
(a)
J
oxygen saturation data
(a)
(b)
K
oxygen saturation data
(b)
(a)
L
oxygen saturation data
(b)
(b)
Third, the entries A, B, K, and L do not render the claim indefinite since data from the receiving step matches the data used in the analyzing step option and the output option. However, entries C-J render the claim indefinite since it is not clear how the data from the receiving step can be used in the analyzing step option and the output option since the data in the receiving step does not match the data used in the analyzing step option and the output option.
Fourth, the receiving step, the analyzing step, and the output options (a) and (b) are also written such that any of following combinations is contemplated (assuming both alternatives (i) and (ii) are required in the analyzing step option (a) and both alternatives (i) and (ii) are required in the analyzing step option (b)):
Entry
Data from the Receiving Step
The Analyzing Step Option
The Output Option
AZ
respiratory data, heart rate data
(a)
(a)
BZ
respiratory data, heart rate data
(a)
(b)
CZ
respiratory data, heart rate data
(b)
(a)
DZ
respiratory data, heart rate data
(b)
(b)
EZ
respiratory data, oxygen saturation data
(a)
(a)
FZ
respiratory data, oxygen saturation data
(a)
(b)
GZ
respiratory data, oxygen saturation data
(b)
(a)
HZ
respiratory data, oxygen saturation data
(b)
(b)
IZ
heart rate data, oxygen saturation data
(a)
(a)
JZ
heart rate data, oxygen saturation data
(a)
(b)
KZ
heart rate data, oxygen saturation data
(b)
(a)
LZ
heart rate data, oxygen saturation data
(b)
(b)
MZ
respiratory data, heart rate data, oxygen saturation data
(a)
(a)
NZ
respiratory data, heart rate data, oxygen saturation data
(a)
(b)
OZ
respiratory data, heart rate data, oxygen saturation data
(b)
(a)
PZ
respiratory data, heart rate data, oxygen saturation data
(b)
(b)
QZ
respiratory data, heart rate data
(a),(b)
(a)
RZ
respiratory data, heart rate data
(a), (b)
(b)
SZ
respiratory data, oxygen saturation data
(a),(b)
(a)
TZ
respiratory data, oxygen saturation data
(a), (b)
(b)
UZ
heart rate data, oxygen saturation data
(a),(b)
(a)
VZ
heart rate data, oxygen saturation data
(a), (b)
(b)
WZ
respiratory data, heart rate data, oxygen saturation data
(a),(b)
(a)
XZ
respiratory data, heart rate data, oxygen saturation data
(a), (b)
(b)
Fifth, the entries SZ and TZ do not render the claim indefinite since data from the receiving step matches the data used in the analyzing step option and the output option. However, the entries AZ-RZ and UZ-XZ render the claim indefinite since it is not clear how the data from the receiving step can be used in the analyzing step option and the output option since the data in the receiving step does not match the data used in the analyzing step option and the output option.
Sixth, assuming both alternatives (i) and (ii) are not required in the analyzing step option (a) and both alternatives (i) and (ii) are not required in the analyzing step option (b), the indefiniteness issues become compounded since alternative (i) of the analyzing step option (a) and alternative (i) of the analyzing step option (b) produce results unusable by output option (b), thus rendering any entry relying on output option (b) in conjunction with alternative (i) of the analyzing step option (a) and/or alternative (i) of the analyzing step option (b) indefinite. Further, alternative (ii) of the analyzing step option (a) and alternative (ii) of the analyzing step option (b) produce results unusable by output option (a), thus rendering any entry relying on output option (a) in conjunction with alternative (ii) of the analyzing step option (a) and/or alternative (ii) of the analyzing step option (b) indefinite.
These above issues render claim 1 indefinite.
Claims 2, 4, 6-7, 9, and 13 are rejected by virtue of their dependence from claim 1.
Claim 19 recites “the wearable sensor” in lines 13-14, but it is not clear if this recitation is the same as, related to, or different from “a wearable sensor device” in line 4. If they are the same, “the wearable sensor” in lines 13-14 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 15-16 and “the particular orientation” in lines 39 and 45-46, 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 7. If they are the same, consistent terminology should be used. If they are different, their relationship should be made clear.
Claim 19 recites “an orientation of the person” in line 19, 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 7 and/or “a particular orientation” in lines 15-16. Clarification is required.
Claim 19 recites “(a) comparing the respiratory data with (i) a respiratory rate protocol termination threshold value or (ii) a respiratory rate position removal threshold value different than the respiratory rate protocol termination threshold value” in lines 27-29, but it is not clear if the respiratory rate protocol termination threshold value is required by the method. The conjunction “or” between (i) and (ii) suggests that the respiratory rate protocol termination threshold value is simply an alternative while the expression “different than the respiratory rate protocol termination threshold value” suggests that its presence in the claim is required. If the respiratory rate protocol termination threshold value is required, it is not clear if both alternatives (i) and (ii) are required for the claimed method or if only one of the alternatives (i) and (ii) is required by the claimed method. These issues render claim 19 indefinite.
Claim 19 recites “(b) comparing the oxygen saturation data with (i) an oxygen saturation protocol termination threshold value or (ii) an oxygen saturation position removal threshold value different than the oxygen saturation protocol termination threshold value” in lines 30-33, but it is not clear if the oxygen saturation protocol termination threshold value is required by the method. The conjunction “or” between (i) and (ii) suggests that the oxygen saturation protocol termination threshold value is simply an alternative while the expression “different than the oxygen saturation protocol termination threshold value” suggests that its presence in the claim is required. If the oxygen saturation protocol termination threshold value is required, it is not clear if both alternatives (i) and (ii) are required for the claimed method or if only one of the alternatives (i) and (ii) is required by the claimed method. These issues render claim 19 indefinite.
Claim 19 recites:
“receiving physiological sensor data associated with a particular orientation of the person, the physiological sensor data indicating at least one of (a) respiratory data or (b) oxygen saturation data of the person…;
analyze the physiological sensor data, including at least one of:
(a) comparing the respiratory data with (i) a respiratory rate protocol termination threshold value or (ii) a respiratory rate position removal threshold value different than the respiratory rate protocol termination threshold value; or
(b) comparing the oxygen saturation data with (i) an oxygen saturation protocol termination threshold value or (ii) an oxygen saturation position removal threshold value different than the oxygen saturation protocol termination threshold value; and
based at least on the analysis of the physiological sensor data, either:
(a) automatically terminate the proning protocol for the person if the respiratory data exceeds the respiratory rate protocol termination threshold value or the oxygen saturation data exceeds the oxygen saturation protocol termination threshold value; or
(b) automatically remove the particular orientation from the proning protocol for the person if the respiratory data exceeds the respiratory rate position removal threshold value or the oxygen saturation data exceeds the oxygen saturation position removal threshold value…
output human-perceptible notifications regarding the termination of the proning protocol or indicating the removal of the particular orientation from the proning protocol”
in lines 15-46 that renders the claim indefinite. The indefinite issues are enumerated in the following paragraphs.
First, the receiving physiological sensor data (the receiving step) has at least one of (a) respiratory data or (b) oxygen saturation data of the person. The analyzing the physiological sensor data (the analyzing step) has two alternatives: the analyzing option (a) and the analyzing option (b). The output based at least on the analysis of the physiological sensor data has two alternatives: the output option (a) and the output option (b).
Second, the receiving step, the analyzing step, and the output options (a) and (b) are written such that any of following combinations is contemplated (assuming both alternatives (i) and (ii) are required in the analyzing step option (a) and both alternatives (i) and (ii) are required in the analyzing step option (b)):
Entry
Data from the Receiving Step
The Analyzing Step Option
The Output Option
AX
respiratory data
(a)
(a)
BX
respiratory data
(a)
(b)
CX
respiratory data
(b)
(a)
DX
respiratory data
(b)
(b)
EX
oxygen saturation data
(a)
(a)
FX
oxygen saturation data
(a)
(b)
GX
oxygen saturation data
(b)
(a)
HX
oxygen saturation data
(b)
(b)
Third, the entries AX, BX, GX, and HX do not render the claim indefinite since data from the receiving step matches the data used in the analyzing step option and the output option. However, entries CX-FX render the claim indefinite since it is not clear how the data from the receiving step can be used in the analyzing step option and the output option since the data in the receiving step does not match the data used in the analyzing step option and the output option.
Fourth, the receiving step, the analyzing step, and the output options (a) and (b) are also written such that any of following combinations is contemplated (assuming both alternatives (i) and (ii) are required in the analyzing step option (a) and both alternatives (i) and (ii) are required in the analyzing step option (b)):
Entry
Data from the Receiving Step
The Analyzing Step Option
The Output Option
AY
respiratory data, oxygen saturation data
(a)
(a)
BY
respiratory data, oxygen saturation data
(a)
(b)
CY
respiratory data, oxygen saturation data
(b)
(a)
DY
respiratory data, oxygen saturation data
(b)
(b)
EY
respiratory data, oxygen saturation data
(a),(b)
(a)
FY
respiratory data, oxygen saturation data
(a), (b)
(b)
Fifth, the entries EY and FY do not render the claim indefinite since data from the receiving step matches the data used in the analyzing step option and the output option. However, the entries AY-DY render the claim indefinite since it is not clear how the data from the receiving step can be used in the analyzing step option and the output option since the data in the receiving step does not match the data used in the analyzing step option and the output option.
Sixth, assuming both alternatives (i) and (ii) are not required in the analyzing step option (a) and both alternatives (i) and (ii) are not required in the analyzing step option (b), the indefiniteness issues become compounded since alternative (i) of the analyzing step option (a) and alternative (i) of the analyzing step option (b) produce results unusable by output option (b), thus rendering any entry relying on output option (b) in conjunction with alternative (i) of the analyzing step option (a) and/or alternative (i) of the analyzing step option (b) indefinite. Further, alternative (ii) of the analyzing step option (a) and alternative (ii) of the analyzing step option (b) produce results unusable by output option (a), thus rendering any entry relying on output option (a) in conjunction with alternative (ii) of the analyzing step option (a) and/or alternative (ii) of the analyzing step option (b) indefinite.
These above issues render claim 19 indefinite.
Claim 21 recites “The system of Claim 0” which does not exist. A claim that depends from a non-existent claim is indefinite since the metes and bounds of the claim cannot be ascertained. For the purposes of examination, claim 21 will be considered to depend from claim 19. As a result, claim 21 is also rejected by virtue of its interpreted dependence from claim 19.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 21 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourth paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 21 depends from claim 0, which is non-existent. A claim that depends from a non-existent claim is improper. For the purposes of examination, claim 21 will be considered to depend from claim 19.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 4, 6-7, 9, 13, 19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2018/0103874 (Lee)(previously cited), in view of U.S. Patent Application Publication No. 2011/0263950 (Larson)(previously cited).
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 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);
monitoring an orientation of the person over time based on the orientation-related sensor data (the monitoring or orientation over time; paragraphs 0011-0012, 0014, 0020, 0022, 0025, 0029, 0082, 0090, and 0149-0153 of Lee);
comparing the monitored orientation of the person to a defined proning protocol for the person, the proning protocol defining orientation-based rules or parameters to encourage time spent in a prone 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; paragraph 0020, 0029, 0090, 0149-0150, 0152, and 0176 of Lee); and
based on the comparison, outputting at least one visual or audible notification regarding the time spent in the prone position (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 orientation of 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), the physiological sensor data indicating at least one of (a) respiratory data (the respiratory rate), (b) heart rate data, or (c) oxygen saturation data of the person;
analyzing the physiological sensor data, including at least one of:
(a) comparing the respiratory data with (i) a respiratory rate protocol termination threshold value or (ii) a respiratory rate position removal threshold value different than the respiratory rate protocol termination threshold value (comparing the respiratory rate to the threshold of the normal range as suggested by Larson); or
(b) comparing the oxygen saturation data with (i) an oxygen saturation protocol termination threshold value or (ii) an oxygen saturation position removal threshold value different than the oxygen saturation protocol termination threshold value; and
based at least on the analysis of the physiological sensor data, either:
(a) automatically terminating the proning protocol for the person if the respiratory data exceeds the respiratory rate protocol termination threshold value or the oxygen saturation data exceeds the oxygen saturation protocol termination threshold value, and outputting a message indicating the termination of the proning protocol; or
(b) automatically removing the particular orientation from the proning protocol for the person if the respiratory data exceeds the respiratory rate position removal threshold value (the determination to turn the patient with CHF away from the supine position (i.e., removing the supine position from the proning protocol) when the respiratory rate exceeds the threshold of the normal range) or the oxygen saturation data exceeds the oxygen saturation position removal threshold value, and outputting a message indicating the removal of the particular orientation from the proning protocol (notifying the caregiver to turn the patient with CHF away from the supine position).
With respect to claim 2, the combination teaches or suggests that the at least one orientation-related sensor provided in the wearable sensor device comprises at least one accelerometer (the wearable accelerometer in the wireless sensor 102; paragraphs 0011, 0013, 0016, 0018, 0027, and 0071-0072 of Lee; paragraphs 0106-0107 of Larson) and the orientation-related sensor data comprises acceleration data indicative of the orientation of the person (the data from the accelerometer).
With respect to claim 4, the combination teaches or suggests that receiving the orientation-related sensor data generated by at least one orientation-related sensor comprises receiving the orientation-related sensor data at a processor provided in a device separate from the wearable sensor device (the processor in the patient monitor 106 that performs the receiving is separate from the wearable sensor 102; paragraphs 0011-0012, 0071, 0079, 0090, 0195 of Lee).
With respect to claim 6, the combination teaches or suggests that the steps of (a) monitoring the orientation of the person over time based on the orientation-related sensor data, (b) comparing the monitored orientation of the person to the defined proning protocol, and (c) outputting the at least one visual or audible notification regarding the time spent in the prone position are performed by an application provided at the device separate from the wearable sensor device (the processor in the patient monitor 106 that performs the monitoring, comparing, and outputting is separate from the wearable sensor 102 (paragraphs 0011-0012, 0071, 0079, 0090, and 0195 of Lee); computer programs are used to implement these functions (paragraph 0223 of Lee)).
With respect to claim 7, the combination teaches or suggests communicating the orientation-related sensor data from the wearable sensor device to a mobile device; and monitoring, by an application hosted on the mobile device, the orientation of the person over time based on the orientation-related sensor data communicated by the wearable sensor device (the processor in the patient monitor 106 that performs the monitoring is separate from the wearable sensor 102 (paragraphs 0011-0012, 0071, 0079, 0090, 0195 of Lee); the patient monitor 106 is a portable device, thus making it a mobile device (paragraph 0079 of Lee); computer programs are used to implement these functions (paragraph 0223 of Lee)).
With respect to claim 9, the combination teaches or suggests that the proning protocol defines at least one of (a) a minimum duration spent in the prone position or (b) a maximum duration spent out of the prone position (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).
With respect to claim 13, the combination teaches or suggests that the physiological sensor data is generated by at least one physiological data sensor provided in the wearable sensor device (receiving sensor data from the wearable accelerometer in the wireless sensor 102; paragraphs 0011, 0013, 0016, 0018, 0027, and 0071-0072 of Lee).
With respect to claim 19, the combination 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 receiving 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:
monitor an orientation of the person over time based on the received orientation data (the monitoring or orientation over time; paragraphs 0011-0012, 0014, 0020, 0022, 0025, 0029, 0082, 0090, and 0149-0153 of Lee);
analyze the monitored orientation of the person with respect to a defined proning protocol for the person, the proning protocol defining orientation-based rules or parameters to encourage time spent in a prone 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; paragraph 0020, 0029, 0090, 0149-0150, 0152, and 0176 of Lee); and
generate notifications based on the analysis of the monitored orientation of the person with respect to the defined proning 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);
analyze the physiological sensor data, including at least one of:
(a) comparing the respiratory data with (i) a respiratory rate protocol termination threshold value or (ii) a respiratory rate position removal threshold value different than the respiratory rate protocol termination threshold value (comparing the respiratory rate to the threshold of the normal range as suggested by Larson); or
(b) comparing the oxygen saturation data with (i) an oxygen saturation protocol termination threshold value or (ii) an oxygen saturation position removal threshold value different than the oxygen saturation protocol termination threshold value; and
based at least on the analysis of the physiological sensor data, either:
(a) automatically terminate the proning protocol for the person if the respiratory data exceeds the respiratory rate protocol termination threshold value or the oxygen saturation data exceeds the oxygen saturation protocol termination threshold value; or
(b) automatically remove the particular orientation from the proning protocol for the person if the respiratory data exceeds the respiratory rate position removal threshold value (the determination to turn the patient with CHF away from the supine position (i.e., removing the supine position from the proning protocol) when the respiratory rate exceeds the threshold of the normal range) or the oxygen saturation data exceeds the oxygen saturation position removal threshold value;
an output device configured to (a) output human-perceptible notifications regarding the time spent in the prone position (the display of the patient monitor; paragraphs 0016, 0020, 0029, 0090, 0149-0150, 0152, and 0176 of Lee); and output human-perceptible notifications regarding the termination of the proning protocol or indicating the removal of the particular orientation from the proning protocol (notifying the caregiver to turn the patient with CHF away from the supine position).
With respect to claim 21, the combination teaches or suggests that the proning protocol defines at least one of (a) a minimum duration spent in the prone position or (b) a maximum duration spent out of the prone position (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).
Claims 1-2, 4, 6-7, 9, 13, 19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Lee, in view of Larson, and further in view of U.S. Patent Application Publication No. 2002/0104535 (Biondo)(previously cited) and U.S. Patent Application Publication No. 2009/0234240 (Kuenzler)(previously cited).
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). Biondo 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). Kuenzler 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);
monitoring an orientation of the person over time based on the orientation-related sensor data (the monitoring or orientation over time; paragraphs 0011-0012, 0014, 0020, 0022, 0025, 0029, 0082, 0090, and 0149-0153 of Lee);
comparing the monitored orientation of the person to a defined proning protocol for the person, the proning protocol defining orientation-based rules or parameters to encourage time spent in a prone 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; paragraph 0020, 0029, 0090, 0149-0150, 0152, and 0176 of Lee); and
based on the comparison, outputting at least one visual or audible notification regarding the time spent in the prone position (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 orientation of 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), the physiological sensor data indicating at least one of (a) respiratory data (the respiratory rate), (b) heart rate data, or (c) oxygen saturation data of the person;
analyzing the physiological sensor data, including at least one of:
(a) comparing the respiratory data with (i) a respiratory rate protocol termination threshold value or (ii) a respiratory rate position removal threshold value different than the respiratory rate protocol termination threshold value (comparing the respiratory rate to the threshold as suggested by Kuenzler); or
(b) comparing the oxygen saturation data with (i) an oxygen saturation protocol termination threshold value or (ii) an oxygen saturation position removal threshold value different than the oxygen saturation protocol termination threshold value; and
based at least on the analysis of the physiological sensor data, either:
(a) automatically terminating the proning protocol for the person if the respiratory data exceeds the respiratory rate protocol termination threshold value or the oxygen saturation data exceeds the oxygen saturation protocol termination threshold value, and outputting a message indicating the termination of the proning protocol; or
(b) automatically removing the particular orientation from the proning protocol for the person if the respiratory data exceeds the respiratory rate position removal threshold value (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) or the oxygen saturation data exceeds the oxygen saturation position removal threshold value, and outputting a message indicating the removal of the particular orientation from the proning protocol (notifying the caregiver to turn the patient with ARDS away from the supine position).
With respect to claim 2, the combination teaches or suggests that the at least one orientation-related sensor provided in the wearable sensor device comprises at least one accelerometer (the wearable accelerometer in the wireless sensor 102; paragraphs 0011, 0013, 0016, 0018, 0027, and 0071-0072 of Lee; paragraphs 0106-0107 of Larson) and the orientation-related sensor data comprises acceleration data indicative of the orientation of the person (the data from the accelerometer).
With respect to claim 4, the combination teaches or suggests that receiving the orientation-related sensor data generated by at least one orientation-related sensor comprises receiving the orientation-related sensor data at a processor provided in a device separate from the wearable sensor device (the processor in the patient monitor 106 that performs the receiving is separate from the wearable sensor 102; paragraphs 0011-0012, 0071, 0079, 0090, 0195 of Lee).
With respect to claim 6, the combination teaches or suggests that the steps of (a) monitoring the orientation of the person over time based on the orientation-related sensor data, (b) comparing the monitored orientation of the person to the defined proning protocol, and (c) outputting the at least one visual or audible notification regarding the time spent in the prone position are performed by an application provided at the device separate from the wearable sensor device (the processor in the patient monitor 106 that performs the monitoring, comparing, and outputting is separate from the wearable sensor 102 (paragraphs 0011-0012, 0071, 0079, 0090, and 0195 of Lee); computer programs are used to implement these functions (paragraph 0223 of Lee)).
With respect to claim 7, the combination teaches or suggests communicating the orientation-related sensor data from the wearable sensor device to a mobile device; and monitoring, by an application hosted on the mobile device, the orientation of the person over time based on the orientation-related sensor data communicated by the wearable sensor device (the processor in the patient monitor 106 that performs the monitoring is separate from the wearable sensor 102 (paragraphs 0011-0012, 0071, 0079, 0090, 0195 of Lee); the patient monitor 106 is a portable device, thus making it a mobile device (paragraph 0079 of Lee); computer programs are used to implement these functions (paragraph 0223 of Lee)).
With respect to claim 9, the combination teaches or suggests that the proning protocol defines at least one of (a) a minimum duration spent in the prone position or (b) a maximum duration spent out of the prone position (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).
With respect to claim 13, the combination teaches or suggests that the physiological sensor data is generated by at least one physiological data sensor provided in the wearable sensor device (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).
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 receiving 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:
monitor an orientation of the person over time based on the received orientation data (the monitoring or orientation over time; paragraphs 0011-0012, 0014, 0020, 0022, 0025, 0029, 0082, 0090, and 0149-0153 of Lee);
analyze the monitored orientation of the person with respect to a defined proning protocol for the person, the proning protocol defining orientation-based rules or parameters to encourage time spent in a prone 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; paragraph 0020, 0029, 0090, 0149-0150, 0152, and 0176 of Lee); and
generate notifications based on the analysis of the monitored orientation of the person with respect to the defined proning 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);
analyze the physiological sensor data, including at least one of:
(a) comparing the respiratory data with (i) a respiratory rate protocol termination threshold value or (ii) a respiratory rate position removal threshold value different than the respiratory rate protocol termination threshold value (comparing the respiratory rate to the threshold as suggested by Kuenzler); or
(b) comparing the oxygen saturation data with (i) an oxygen saturation protocol termination threshold value or (ii) an oxygen saturation position removal threshold value different than the oxygen saturation protocol termination threshold value; and
based at least on the analysis of the physiological sensor data, either:
(a) automatically terminate the proning protocol for the person if the respiratory data exceeds the respiratory rate protocol termination threshold value or the oxygen saturation data exceeds the oxygen saturation protocol termination threshold value; or
(b) automatically remove the particular orientation from the proning protocol for the person if the respiratory data exceeds the respiratory rate position removal threshold value (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) or the oxygen saturation data exceeds the oxygen saturation position removal threshold value;
an output device configured to (a) output human-perceptible notifications regarding the time spent in the prone position (the display of the patient monitor; paragraphs 0016, 0020, 0029, 0090, 0149-0150, 0152, and 0176 of Lee); and output human-perceptible notifications regarding the termination of the proning protocol or indicating the removal of the particular orientation from the proning protocol (notifying the caregiver to turn the patient with ARDS away from the supine position).
With respect to claim 21, the combination teaches or suggests that the proning protocol defines at least one of (a) a minimum duration spent in the prone position or (b) a maximum duration spent out of the prone position (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).
Response to Arguments
The Applicant’s arguments filed on 3/11/2026 have been fully considered.
Claim objection
In view of the claim amendments filed on 3/11/2026, the previous claim objections have been withdrawn. There are new grounds of claim objections that were necessitated by the claim amendments filed on 3/11/2026.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
In view of the claim amendments filed on 3/11/2026, 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 wearable sensor” in lines 13-14. The Examiner cannot find a reason to withdraw the rejection.
There are new grounds of claim rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, that were necessitated by the claim amendments filed on 3/11/2026.
35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourth paragraph
There are new grounds of claim rejection under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourth paragraph, that were necessitated by the claim amendments filed on 3/11/2026.
35 U.S.C. 101
In view of the claim amendments filed on 3/11/2026, the previous claim rejections under 35 U.S.C. 101 have been withdrawn.
Prior art rejections
The Applicant asserts:
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The argument is not persuasive. The prior art teaches these features as outlined above. For example, the combination of Lee and Larson teaches or suggests the steps of:
receiving physiological sensor data associated with a particular orientation of 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), the physiological sensor data indicating at least one of (a) respiratory data (the respiratory rate), (b) heart rate data, or (c) oxygen saturation data of the person;
comparing the respiratory data with (i) a respiratory rate protocol termination threshold value or (ii) a respiratory rate position removal threshold value different than the respiratory rate protocol termination threshold value (comparing the respiratory rate to the threshold of the normal range as suggested by Larson); and
based at least on the analysis of the physiological sensor data, automatically removing the particular orientation from the proning protocol for the person if the respiratory data exceeds the respiratory rate position removal threshold value (the determination to turn the patient with CHF away from the supine position (i.e., removing the supine position from the proning protocol) when the respiratory rate exceeds the threshold of the normal range) and outputting a message indicating the removal of the particular orientation from the proning protocol (notifying the caregiver to turn the patient with CHF away from the supine position).
Similarly, the combination of Lee, Larson, Biondo, and Kuenzler teaches or suggests the steps of:
receiving physiological sensor data associated with a particular orientation of 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), the physiological sensor data indicating at least one of (a) respiratory data (the respiratory rate), (b) heart rate data, or (c) oxygen saturation data of the person;
comparing the respiratory data with (i) a respiratory rate protocol termination threshold value or (ii) a respiratory rate position removal threshold value different than the respiratory rate protocol termination threshold value (comparing the respiratory rate to the threshold as suggested by Kuenzler); and
based at least on the analysis of the physiological sensor data, automatically removing the particular orientation from the proning protocol for the person if the respiratory data exceeds the respiratory rate position removal threshold value (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) and outputting a message indicating the removal of the particular orientation from the proning protocol (notifying the caregiver to turn the patient with ARDS away from the supine position).
For at least the above reasons, the prior art rejections are proper.
Conclusion
Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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