DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or
under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 21, 2023 was considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: compression garment 60. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation is: respiratory therapy system in claims 2 and 12.
Prong 1: “system” is a generic placeholder. See MPEP 2181 §I, subsection A, ¶1.
Prong 2: no transition word is used, accompanied by functional language:
“respiratory therapy system”.
Prong 3: there is not sufficient structure to modify the generic placeholder “system”.
The examiner interprets the respiratory therapy device, such as the various PAP systems (see specification ¶[0047]-[0049]; Figs. 1-2) to cover the corresponding structure, materials, or acts described in the specification and equivalents thereof for the respiratory therapy system.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 3-4 and 13-14 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 3 recites “(i) a number of residual events exceeding a threshold, (ii) a severity of one or more residual events exceeding a threshold, (iii) a pattern of the one or more residual events matching a predetermined pattern” in lines 2-4. However, the relationship between the multiple recitations of “residual events” is not clear. The first two recitations both indicate first usage (i.e., indefinite article “a” and lack of definite article “the”, suggesting they are not related), and the third recitation indicates second use (i.e., definite article “the”, suggesting they are related). The similar phraseology suggests that they are the same and/or related. The relationship among these recitations should be made clear. Appropriate correction is required.
Claim 3 recites “(iv) a number of snore events exceeding a threshold, (v) a severity of one or more snore events exceeding a threshold, (vi) a pattern of the one or more snore events matching a predetermined pattern” in lines 4-6. However, the relationship between the multiple recitations of “snore events” is not clear. The first two recitations both indicate first usage (i.e., indefinite article “a” and lack of definite article “the”, suggesting they are not related), and the third recitation indicates second use (i.e., definite article “the”, suggesting they are related). The similar phraseology suggests that they are the same and/or related. The relationship among these recitations should be made clear. Appropriate correction is required.
Claim 4 recites “a predetermined relationship” in line 5; however, it is not clear what the predetermined relationship actually represents. The specification of the present application does not elaborate on what the relationship specifically represents. Is there a relationship if both thresholds have been met, or some other correlative metric? This renders the scope of the claim unclear. Appropriate clarification and correction is required.
Claim 13 recites “(i) a number of residual events exceeding a threshold, (ii) a severity of one or more residual events exceeding a threshold, (iii) a pattern of the one or more residual events matching a predetermined pattern” in lines 2-4. However, the relationship between the multiple recitations of “residual events” is not clear. The first two recitations both indicate first usage (i.e., indefinite article “a” and lack of definite article “the”, suggesting they are not related), and the third recitation indicates second use (i.e., definite article “the”, suggesting they are related). The similar phraseology suggests that they are the same and/or related. The relationship among these recitations should be made clear. Appropriate correction is required.
Claim 13 recites “(iv) a number of snore events exceeding a threshold, (v) a severity of one or more snore events exceeding a threshold, (vi) a pattern of the one or more snore events matching a predetermined pattern” in lines 4-6. However, the relationship between the multiple recitations of “snore events” is not clear. The first two recitations both indicate first usage (i.e., indefinite article “a” and lack of definite article “the”, suggesting they are not related), and the third recitation indicates second use (i.e., definite article “the”, suggesting they are related). The similar phraseology suggests that they are the same and/or related. The relationship among these recitations should be made clear. Appropriate correction is required.
Claim 14 recites “a predetermined relationship” in line 6; however, it is not clear what the predetermined relationship actually represents. The specification of the present application does not elaborate on what the relationship specifically represents. Is there a relationship if both thresholds have been met, or some other correlative metric? This renders the scope of the claim unclear. Appropriate clarification and correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-4, 10-14, and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed towards abstract ideas without significantly more.
Claim 1 interpretation: Under the broadest reasonable interpretation (BRI), the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See MPEP 2111. Based on the specification, the recitation “determining a shift in the bodily fluid within the user based, at least in part, on the sensor data” (see specification ¶[0098] and ¶[0142]; Fig. 1) is being interpreted as observations, evaluations, judgments, and opinions. The recitation is computer-implemented, as indicated in the specification (see specification ¶[0069]-[0072], ¶[0113]-[0114], and ¶[0176]-[0201]; Fig. 1).
Claim 11 interpretation: Under the broadest reasonable interpretation (BRI), the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See MPEP 2111. Based on the specification, the recitation “determine a shift in the bodily fluid within the user based, at least in part, on the sensor data” (see specification ¶[0098] and ¶[0142]; Fig. 1) is being interpreted as observations, evaluations, judgments, and opinions. The recitation is computer-implemented, as indicated in the specification (see specification ¶[0069]-[0072], ¶[0113]-[0114], and ¶[0176]-[0201]; Fig. 1), and in the claim, lines 1-4.
Step 1: This part of eligibility analysis evaluates whether the claim falls within any statutory category. MPEP 2106.03. Claim 1 recites a method, which is directed towards a process (a statutory category of invention). Claim 11 recites a device (i.e., the system), which is directed towards a machine/manufacture (a statutory category of invention). Step 1: YES.
Step 2A Prong One: This part of the eligibility analysis evaluates whether the claim recites a judicial exception. As explained in MPEP 2106.04(a)(2)(III). The courts consider a mental process (thinking) that “can be performed in the human mind, or by a human using a pen and paper” to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). The “mental processes” abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgements, and opinions. As discussed in the claim interpretation section, the limitations include, under the BRI, observations, evaluations, judgments, and opinions for the determination of a shift in the bodily fluid within the user. Accordingly, the limitations as seen in claims 1 and 11 recite judicial exceptions (abstract ideas that fall within the mental process grouping).
In particular, claim 1 recites the following elements, which are part of the abstract idea (i.e., the algorithm):
a method comprising:
receiving sensor data from one or more sensors associated with a user,
the sensor data indicating an amount of bodily fluid within one or more extremities of the user;
determining a shift in the bodily fluid within the user based, at least in part, on the sensor data; and
responsive to the shift in the bodily fluid satisfying a fluid threshold, causing, at least in part, a correction for the shift in the bodily fluid to be applied to the user.
Furthermore, claim 11 recites the following elements, which are part of the abstract idea (i.e., the algorithm):
receive sensor data from one or more sensors associated with a user,
the sensor data indicating an amount of bodily fluid within one or more extremities of the user;
determine a shift in the bodily fluid within the user based, at least in part, on the sensor data; and
responsive to the shift in the bodily fluid satisfying a fluid threshold, cause, at least in part, a correction for the shift in the bodily fluid to be applied to the user.
Step 2A Prong One: YES.
Step 2A Prong Two: This part of the eligibility analysis evaluates whether the claim as a
whole integrates the judicial exceptions into a practical application of the exception. This
evaluation is performed by (a) identifying whether there are any additional elements recited in
the claim beyond the judicial exceptions, and (b) evaluating those additional elements
individually and in combination to determine whether the claim as a whole integrates the exceptions into a practical application. Claim 1 recites no other element, such that claim 1 recites no element that integrates the judicial exceptions into a practical application. Claim 11 recites additional elements related to a generic computer (i.e., the memory and the control system including one or more processors). Therefore, the device and method are merely instructions to implement an abstract idea on a generic computer or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f).
The claims 1 and 11 also recite elements related to the input of data, which are mere insignificant extra-solution activity (i.e., pre-solution activity), and thus do not integrate the exceptions into a practical application. See MPEP 2106.05(g).
The claims 1 and 11 also recite that the sensor data is received from sensors. However, the sensors are not positively recited in the claim (i.e., the data is merely received from sensors, the sensors are not claimed themselves), and thus do not integrate the exceptions into a practical application.
The claims 1 and 11 also recite an element relating to applying a treatment or prophylaxis (i.e., the correction applied to the user). A claim that recites a particular treatment or prophylaxis “meaningfully limits the claim by going beyond generally linking the use of the judicial exception to a particular technological environment, and thus transforms a claim into patent-eligible subject matter. See MPEP § 2106.04(d)(2). In order to qualify as a “treatment” or “prophylaxis", the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration. For example, a step of "prescribing a topical steroid to a patient with eczema" is not a positive limitation because it does not require that the steroid actually be used by or on the patient, and a recitation that a claimed product is a "pharmaceutical composition" or that a "feed dispenser is operable to dispense a mineral supplement" are not affirmative limitations because they are merely indicating how the claimed invention might be used. Furthermore, the treatment or prophylaxis limitation must be "particular," i.e., specifically identified so that it does not encompass all applications of the judicial exception(s).In this case, the treatment or prophylaxis is recited generically as “a correction for the shift”, and thus cannot be seen as a particular treatment or prophylaxis. Therefore, this claimed element cannot be seen as integration into a practical application.
Step 2A Prong Two: NO.
Step 2B: This part of the eligibility analysis evaluates whether the claim as a whole, amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05. As explained with Step 2A Prong Two, claim 1 recites no other element, such that claim 1 recites no element that adds an inventive concept to the claim and/or amounts to significantly more than the recited exception. Claim 11 recites additional elements related to a generic computer (i.e., the memory and the control system including one or more processors). The device and method (claims 1 and 11) utilizing a generic computer do not qualify as significantly more because these limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
The claims 1 and 11 also recite elements related to the input of data, which are mere insignificant extra-solution activity (i.e., pre-solution activity), and thus do not add an inventive concept to the claim and/or amounts to significantly more than the recited exceptions. See MPEP 2106.05(g).
The claims 1 and 11 also recite that the sensor data is received from sensors. However, the sensors are not positively recited in the claim (i.e., the data is merely received from sensors, the sensors are not claimed themselves), and thus do not add an inventive concept to the claim and/or amounts to significantly more than the recited exceptions.
Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no
indication that the combination of elements improves the functioning of a computer, for
example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is
no indication that the combination of elements includes a particular solution to a computer-based
problem or a particular way to achieve a desired computer-based outcome. Rather, the collective
functions of the claimed invention merely provide conventional computer implementation, i.e.,
the computer is simply a tool to perform the process. Step 2B: NO.
Claims 1 and 11 are not eligible.
Claims 2-4 and 10; and 12-14 and 20 depend from claims 1 and 1, respectively, merely further define the abstract ideas of claims 1 and 28. Claims 2-4 and 10; and 12-14 and 20 recite additional elements directed towards the input and output of data, which are mere insignificant extra-solution activity (i.e., pre-solution and post-solution activity), and thus do not integrate the exceptions into a practical application, add an inventive concept to the claim, and/or amounts to significantly more than the recited exceptions. See MPEP 2106.05(g). The claims recite no element that integrates the judicial exceptions into a practical application. The method/devices are merely instructions to implement an abstract idea on a generic computer or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f). The claims recite no element that adds an inventive concept to the claim and/or amounts to significantly more than the recited exception. The method/devices utilizing a generic computer do not qualify as significantly more because these limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome.
The claims 2 and 12 also recite that the respiratory therapy data is received from a respiratory therapy system. However, the respiratory therapy system is not positively recited in the claims (i.e., the data is merely received from the respiratory therapy system, the respiratory therapy system is not claimed itself), and thus do not integrate the exceptions into a practical application, add an inventive concept to the claims, and/or amounts to significantly more than the recited exceptions.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 6, 9-14, 16, and 19-20 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Narayan et al. (US Patent Application Publication 2019/0000350), hereinafter Narayan.
Regarding Claims 1 and 11, Narayan teaches computerized devices capable of diagnosis tailoring for an individual, and capable of controlling effectors to deliver therapy to the individual, also tailored to the individual (see abstract and Figs. 1 and 9). Narayan teaches a method/system (see abstract and Figs. 1 and 9) comprising:
a memory storing machine-readable instructions (¶[0106] the system including the memory and the processor, ¶[0311]-[0312] the computer system 2000 including the processor 2002 and the memory 2004/2006; Figs. 1 and 21); and
a control system including one or more processors configured to execute the machine- readable instructions (¶[0106]-[0109] the systems including the memory and the processor, ¶[0193] the computing device 116, the signal processing device 114, and/or the control device 120, ¶[0311]-[0312] the computer system 2000 including the processor 2002 and the memory 2004/2006; Figs. 1 and 21), and the method to:
receive sensor data from one or more sensors associated with a user (¶[0194]-[0198] the system detects signals from sensors at 155, which form the sensed signatures at 160, which are directed towards the analytical engine 165, for directed treatments via the effectors 175, ¶[0227] the body sensor 600, including various sensors therewithin, including the galvanometer 650 for detecting skin impedance or conductance; Figs. 2-4, 7, and 9),
the sensor data indicating an amount of bodily fluid within one or more extremities of the user (¶[0227] the body sensor 600, including various sensors therewithin, including the galvanometer 650 for detecting skin impedance or conductance, ¶[0114], ¶[0117], ¶[0256] the rostral-to-peripheral (i.e., higher body impedance, such as neck and chest, to lower body impedance, such as leg and lower back) ratio of skin impedance utilized to indicate rostral fluid accumulation, the rostral fluid accumulation is a sensed signature; Figs. 7 and 9);
determine a shift in the bodily fluid within the user based, at least in part, on the sensor data (¶[0112], ¶[0132], ¶[0207] baseline signatures are analyzed and learned by the system, the analysis engine determines when sensed signals (i.e., the signatures) deviate from the baseline, the baseline is a threshold, ¶[0114], ¶[0117], ¶[0256] the rostral-to-peripheral ratio of skin impedance monitored for increase, would be relative to the baseline as the rostral-to-peripheral ratio of skin impedance is a sensed signature; Figs. 7 and 9); and
responsive to the shift in the bodily fluid satisfying a fluid threshold (¶[0112], ¶[0132], ¶[0207] baseline signatures are analyzed and learned by the system, the analysis engine determines when sensed signals (i.e., the signatures) deviate from the baseline, the baseline is a threshold, ¶[0114], ¶[0117], ¶[0256] the rostral-to-peripheral ratio of skin impedance monitored for increase, would be relative to the baseline as the rostral-to-peripheral ratio of skin impedance is a sensed signature; Figs. 7 and 9), cause, at least in part, a correction for the shift in the bodily fluid to be applied to the user (¶[0194]-[0198] the system detects signals from sensors at 155, which form the sensed signatures at 160, which are directed towards the analytical engine 165, for directed treatments via the effectors 175, ¶[0114], ¶[0117], ¶[0256] in response to the rostral-to-peripheral ratio of skin impedance increasing, the effector is applied, including applying negative pressure in the lower extremities 840; Figs. 2, 7, and 9; see also ¶[0260]-[0270] the system that monitors the sensor values for sleep disordered breathing, and applies effectors as a result; Fig. 13).
Regarding Claims 2 and 12, Narayan teaches the method/system of claims 1 and 11 as stated above. Narayan further teaches receiving respiratory therapy data from a respiratory therapy system associated with the user (¶[0194]-[0198] the system detects signals from sensors at 155, which form the sensed signatures at 160, which are directed towards the analytical engine 165, for directed treatments via the effectors 175, ¶[0106]-[0109], ¶[0114]-[0115], ¶[0222], ¶[0233]-[0250] the sensed signatures for sleep apnea, via various sensors, including the consumer sensors such as microphones; Figs. 2-4, 6-7F, and 9),
the respiratory therapy data indicating a severity of obstructive sleep apnea for the user (¶[0247]-[0250] the detecting of apnea via sounds recorded via microphone, such as with no spectral peak prominence identified above a baseline threshold for a duration of more than 10 seconds, ¶[0251] the disturbance events, then identified as loud snores or arousal events, identified based on an analysis of the tallest peak forward and backward to baseline, when the area is above a threshold; Figs. 7D-7G) and being associated with a same collection period as the sensor data (¶[0106]-[0109] and ¶[0112] the signatures are sensed on a near-continuous basis, subsequent signatures that deviate from the baseline used as determination for applying effectors, ¶[0256] the various sensors/effectors for sleep-disordered breathing are working congruently; Fig. 9); and
causing, at least in part, the correction for the shift in the bodily fluid to be applied to the user based, at least in part, on the severity of the obstructive sleep apnea satisfying a severity threshold (¶[0247]-[0250] the detecting of apnea via sounds recorded via microphone, such as with no spectral peak prominence identified above a baseline threshold for a duration of more than 10 seconds, ¶[0251] the disturbance events, then identified as loud snores or arousal events, identified based on an analysis of the tallest peak forward and backward to baseline, when the area is above a threshold, ¶[0106]-[0109] and ¶[0112] the signatures are sensed on a near-continuous basis, subsequent signatures that deviate from the baseline used as determination for applying effectors, ¶[0256] the various sensors/effectors for sleep-disordered breathing, the sensed signatures used to start application of the effectors; Figs. 7D-7G and 9; see also ¶[0260]-[0270] the system that monitors the sensor values for sleep disordered breathing, and applies effectors as a result; Fig. 13).
Regarding Claims 3 and 13, Narayan teaches the method/system of claims 2 and 12 as stated above. Narayan further teaches the severity of the obstructive sleep apnea satisfying the severity threshold corresponds to (i) a number of residual events exceeding a threshold, (ii) a severity of one or more residual events exceeding a threshold, (iii) a pattern of the one or more residual events matching a predetermined pattern, (iv) a number of snore events exceeding a threshold, (v) a severity of one or more snore events exceeding a threshold, (vi) a pattern of the one or more snore events matching a predetermined pattern, (vii) an auto-setting on the respiratory therapy system exceeding a threshold, or (viii) a combination thereof (¶[0247]-[0250] the detecting of apnea via sounds recorded via microphone, such as with no spectral peak prominence identified above a baseline threshold for a duration of more than 10 seconds, ¶[0251] the disturbance events, then identified as loud snores or arousal events, identified based on an analysis of the tallest peak forward and backward to baseline, when the area is above a threshold; Figs. 7D-7G).
Regarding Claims 4 and 14, Narayan teaches the method/system of claims 2 and 12 as stated above. Narayan further teaches alerting the user, a healthcare provider associated with the user, or a combination thereof of the shift in the bodily fluid as being a possible contributor to the obstructive sleep apnea based, at least in part, on a relationship between the shift in the bodily fluid and the severity of obstructive sleep apnea matching a predetermined relationship (¶[0196] and ¶[0233] the alarm to awake an individual if sleep apnea detected, ¶[0194]-[0198], ¶[0256], and ¶[0260]-[0270] the system detects signals from sensors at 155, which form the sensed signatures at 160, which are directed towards the analytical engine 165, for directed treatments via the effectors 175, the analysis engine takes in all monitored signatures over time, to determine the health and apply effectors, so the effector of alerting the user (i.e., the alarm), would be based off of the shift in the bodily fluid and the severity of obstructive sleep apnea; Figs. 2-5, 9, and 13).
Regarding Claims 6 and 16, Narayan teaches the method/system of claims 1 and 11 as stated above. Narayan further teaches the correction comprises applying a pressure differential across the user to cause the bodily fluid to flow towards the one or more extremities of the user (¶[0114], ¶[0117], ¶[0256] in response to the rostral-to-peripheral ratio of skin impedance increasing, the effector is applied, including applying negative pressure in the lower extremities 840; Fig. 7).
Regarding Claims 9 and 19, Narayan teaches the method/system of claims 6 and 16 as stated above. Narayan further teaches the pressure differential comprises applying negative pressure applied to the one or more extremities of the user (¶[0114], ¶[0117], ¶[0256] in response to the rostral-to-peripheral ratio of skin impedance increasing, the effector is applied, including applying negative pressure in the lower extremities 840; Fig. 7).
Regarding Claims 10 and 20, Narayan teaches the method/system of claims 1 and 11 as stated above. Narayan further teaches the one or more extremities comprise one or both legs, one or both ankles, one or both feet, one or both toes, one or both wrists, one or both hands, or a combination thereof (¶[0114], ¶[0117], ¶[0256] the rostral-to-peripheral (i.e., higher body impedance, such as neck and chest, to lower body impedance, such as leg and lower back) ratio of skin impedance utilized to indicate rostral fluid accumulation, the rostral fluid accumulation is a sensed signature; Figs. 7 and 9).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Narayan as applied to claims 1 and 11 above, and in view of Emmons et al. (US Patent Application Publication 2015/0335507), hereinafter Emmons, and as evidenced by Schindhelm et al. (US Patent Application Publication 2020/0113484), hereinafter Schindhelm.
Regarding Claims 5 and 15, Narayan teaches the method/system of claims 1 and 11 as stated above. Narayan does not specifically teach that the correction comprises adjusting an orientation of the user to cause the bodily fluid to flow towards the one or more extremities of the user.
Emmons teaches a sleep apparatus such as a mattress (see abstract and Figs. 1-3), in which the sleep position of the user may be analyzed and adjusted to support optimum sleep position based on physiological measurements (see ¶[0031] and ¶[0222]), and may adjust sleep position based on sleep apnea (see ¶[0020]-[0021], ¶[0035], ¶[0037], and ¶[0039], and ¶[0224]), in which the head and torso section of the user may be inclined, such as the reverse Trendelenburg position (see ¶[0214]-[0215] and ¶[0218]; Fig. 3).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the position/orientation modality of Emmons as an effector in Narayan to change the user into a better position (i.e., inclined) because (1) it is the application of a known technique to a known device/method ready for improvement to yield predictable results and/or (2) this effector would help to combat adverse events (i.e., such as sleep apnea) and to reverse rostral fluid accumulation to enhance ease of breathing, see for example Schindhelm ¶[0083], in which an inclined position (i.e., the patients propping themselves up with pillows) reduces fluid build-up and enhances ease of breathing.
Claims 7-8 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Narayan as applied to claims 6 and 16 above, and in view of Pamplin et al. (US Patent Application Publication 2022/0409437), hereinafter Pamplin.
Regarding Claims 7 and 17, Narayan teaches the method/system of claims 6 and 16 as stated above. Narayan does not specifically teach that the pressure differential comprises positive pressure applied to the user at a chest, a neck, or a combination thereof.
Pamplin teaches compressive garments, such as to promote lymphatic circulation, via one or more angled teeth, struts, and/or lattices (see abstract and Figs. 2A-4), in which the compressive garment may be a shirt (see ¶[0073]), and may include directing fluid flow away from the trunk of the user, opposite of the arrow 206 as shown in Fig. 1A (see ¶[0074]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the compressive garment shirt modality to direct fluid flow away from the trunk of the user of Pamplin as an effector to help reverse rostral fluid accumulation of Narayan because (1) it is the application of a known technique to a known device/method ready for improvement to yield predictable results and/or (2) the compressive garment shirt would help to direct fluid flow away from the trunk of the user (see Pamplin ¶[0074]), which would help to reverse rostral fluid accumulation.
Regarding Claims 8 and 18, Narayan teaches the method/system of claims 7 and 17 as stated above. The modified Narayan further teaches the positive pressure is applied using a compression garment worn on the chest of the user (see Pamplin ¶[0073]-[0074] the compressive garment shirt modality to direct fluid flow away from the trunk of the user, opposite of the arrow 206 as shown in Fig. 1A).
Conclusion
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/J.D.M./ Examiner, Art Unit 3791
/JENNIFER ROBERTSON/ Supervisory Patent Examiner, Art Unit 3791