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 has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 101
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
The claims, specifically independent claims 1 and 11 recite an abstract idea, specifically a mental process, for monitoring peripheral blood flow of a patient and generating a dimensionless relative index of the monitored peripheral blood flow that, under the broadest reasonable interpretation, is capable of being performed mentally and/or by a human with the aid of pen and paper. This judicial exception is not integrated into a practical application because the limitation “generating a dimensionless relative index of the monitored peripheral blood flow of the patient: i) under the second physiologic condition based on the monitored peripheral blood flow under the first physiologic condition; or ii) under the first physiologic condition based on the monitored peripheral blood flow under the second physiologic condition” amount to an observation, evaluation, or judgement that a person would perform mentally or with pen and paper to relate the monitored peripheral blood flow under the first physiologic condition to the monitored peripheral blood flow under the second physiologic condition.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Regarding claim 1, the limitations “monitoring, by the wearable device, peripheral blood flow of the patient under a first physiologic condition” and “monitoring, by the wearable device, peripheral blood flow of the patient under a second physiologic condition different than the first physiologic condition” are merely insignificant extra-solution activity, such as mere data gathering, recited at a high level of generality and/or in a well-understood, routine, and conventional way, of the information needed to carry out the claimed algorithm. Similarly, the limitation “outputting an indication of the dimensionless relative index” is merely insignificant extra-solution activity, such as outputting the result of the claimed algorithm, recited at a high level of generality and/or in a well-understood, routine, and conventional way.
The claimed “wearable device” (claim 1), “housing configured for wearable attachment to the patient” (claim 11), and “physiologic sensor for monitoring peripheral blood flow of the patient” (claim 11) are well-understood, routine, and conventional in the art. They represent components and/or activities which would routinely be used in applying the abstract idea. As such, they do not meaningfully limit the claim, taken as a whole, to a particular application of the abstract idea; rather, the claim would tend to monopolize the abstract idea itself in practice. The claimed “processor” (claim 11) and “memory” (claim 11) are merely generic computer components performing generic computer functions which are well-understood, routine, and conventional in the art; as such, they do not meaningfully limit the claim to be more than just the abstract idea. With the exception of generic computer-implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper.
This judicial exception is not integrated into a practical application because the claim does not recite any limitations that amount to an improvement in the functioning of a computer, or an improvement to other technology or technical field, apply or use the judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, implement the judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
Regarding dependent claims 2-3, 5-10, 12-13, and 15-20, the limitations of these dependent claim(s) merely add details to the algorithm which forms the abstract idea, but does not contain any further “additional elements”. Thus, the dependent claim(s) are not significantly more than the extended abstract idea.
Dependent claims 4 and 14 recite an additional element of “a blood flow restriction device”. However, this additional element is not sufficient to make the claim as a whole amount to significantly more than the abstract idea because blood flow restriction devices are well-understood, routine, and conventional in the art, as evidenced by Schnall et al. (US 2004/0092832 A1 – see [0017]).
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6, 8, 11-16, 18, and 20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Jung (US Publication No. 2025/0288218 A1).
Regarding claim 1, Jung discloses a method for monitoring peripheral blood flow of a patient using a wearable device (see Figures 2A-B), the method comprising:
monitoring, by the wearable device, peripheral blood flow of the patient under a first physiologic condition (see Figures 6-7 and [0107] – “A third line 613 may indicate a blood flow rate information value that changes over time. An interval 615 may be time before a compression timing. An interval 617 may be time after the compression timing and before a relaxation timing. An interval 619 may be time after the relaxation timing” and [0111] – “A first line 703 may be blood flow rate information that changes according to an operation of a cuff over time. An interval 705 may be time at which a value of blood flow rate information does not vibrate and increases. The interval 705 may correspond to the interval 617 of FIG. 6. The interval 705 may be time between a compression timing of the cuff and relaxation timing of the cuff”);
monitoring, by the wearable device, peripheral blood flow of the patient under a second physiologic condition different than the first physiologic condition (see Figures 6-7 and [0107] – “A third line 613 may indicate a blood flow rate information value that changes over time. An interval 615 may be time before a compression timing. An interval 617 may be time after the compression timing and before a relaxation timing. An interval 619 may be time after the relaxation timing” and [0111] – “A first line 703 may be blood flow rate information that changes according to an operation of a cuff over time. An interval 705 may be time at which a value of blood flow rate information does not vibrate and increases. The interval 705 may correspond to the interval 617 of FIG. 6. The interval 705 may be time between a compression timing of the cuff and relaxation timing of the cuff”);
generating a dimensionless relative index of the monitored peripheral blood flow of the patient:
under the second physiologic condition based on the monitored peripheral blood flow under the first physiologic condition (see [0115] – “According to an embodiment, the first perfusion index information in the interval 715 may be lower than the second perfusion index information in the interval 719. This is because blood flow is blocked for a short time period in the interval 717, and a reactive hyperemia phenomenon occurs in the interval 719. When the reactive hyperemia occurs, a blood flow rate may increase. Therefore, when the reactive hyperemia occurs in the interval 719, a perfusion index information value may also increase. The at least one processor 420 may identify vascular health information based on a ratio of the second perfusion index information to the first perfusion index information”); or
ii) under the first physiologic condition based on the monitored peripheral blood flow under the second physiologic condition (see [0115] – “According to an embodiment, the first perfusion index information in the interval 715 may be lower than the second perfusion index information in the interval 719. This is because blood flow is blocked for a short time period in the interval 717, and a reactive hyperemia phenomenon occurs in the interval 719. When the reactive hyperemia occurs, a blood flow rate may increase. Therefore, when the reactive hyperemia occurs in the interval 719, a perfusion index information value may also increase. The at least one processor 420 may identify vascular health information based on a ratio of the second perfusion index information to the first perfusion index information”); and
outputting an indication of the dimensionless relative index (see Figure 8 and [0118] – “Referring to FIG. 8, an electronic device 200 may display a notification indicating a vascular health state based on vascular health information. The vascular health information may include the vascular dilation index of FIG. 7. A notification 801 may indicate a high degree of vascular health. A notification 803 may indicate a low degree of vascular health”).
Regarding claim 2, Jung discloses generating the dimensionless relative index of the monitored peripheral blood flow of the patient comprises generating the dimensionless relative index of the monitored peripheral blood flow of the patient under the second physiologic condition based on the monitored peripheral blood flow under the first physiologic condition (see [0115] – “According to an embodiment, the first perfusion index information in the interval 715 may be lower than the second perfusion index information in the interval 719. This is because blood flow is blocked for a short time period in the interval 717, and a reactive hyperemia phenomenon occurs in the interval 719. When the reactive hyperemia occurs, a blood flow rate may increase. Therefore, when the reactive hyperemia occurs in the interval 719, a perfusion index information value may also increase. The at least one processor 420 may identify vascular health information based on a ratio of the second perfusion index information to the first perfusion index information”);
the first physiologic condition comprises an artificially restricted peripheral blood flow (see Figure 7 and [0111] – “An interval 717 may be time after the compression timing and before the relaxation timing”); and
the second physiologic condition comprises peripheral blood flow of the patient without an artificial restriction (see Figure 7 and [0111] – “An interval 715 may be time before the compression timing. An interval 717 may be time after the compression timing and before the relaxation timing. An interval 719 may be time after the relaxation timing”).
Regarding claim 3, Jung discloses occluding peripheral blood flow of the patient proximal to the wearable device to create the first physiologic condition; and
ceasing occlusion of the peripheral blood flow of the patient to create the second physiologic condition (see Figures 6-7 and [0111] – “An interval 715 may be time before the compression timing. An interval 717 may be time after the compression timing and before the relaxation timing. An interval 719 may be time after the relaxation timing”).
Regarding claim 4, Jung discloses the wearable device includes a blood flow restriction device (410) configured to occlude peripheral blood flow of the patient (see Figure 4 and [0077] – “According to an embodiment, the cuff 410 may be included in the electronic device 400 or may be included in an external electronic device (e.g., a blood pressure monitor). When the cuff 410 is included in the external electronic device, the cuff 410 may not be included in the electronic device 400. The cuff 410 may include a device that inflates by introduction of fluid. The cuff 410 may apply pressure to an object by inflating by the introduced fluid. According to an embodiment, the object may be an arm on which the user wears the electronic device 400. A position of the cuff included in the external electronic device (e.g., the blood pressure monitor) may be closer to a heart than a position of the electronic device 400. A position of the cuff included in the electronic device 400 may be closer to the heart than a position of the PPG sensor 440. The cuff 410 may apply pressure to the arm on which the user wears the electronic device 400 to induce reactive hyperemia in blood vessels of the user”).
Regarding claim 5, Jung discloses receiving a first indication of a start of the first physiologic condition (see [0109] – “The at least one processor 420 may identify start timing information of an interval at which a value of the blood flow rate information does not vibrate and increases as the compression timing information. This is because when the cuff operates and the blood flow is blocked for a short time period, the blood flow rate decreases and the value of blood flow rate information increases. In addition, in the interval 617, since the pressure applied by the cuff of the external electronic device (e.g., the external electronic device 505 of FIG. 5) is greater than blood pressure of the blood vessels in a systolic phase, the pulse wave generated by the heartbeat may not be formed. In the interval 619, the blood flow rate information of the third line 613 may vibrate and decrease. The at least one processor 420 may identify start timing information of the interval 619 as the relaxation timing information. The start timing information of the interval 619 may correspond to end timing information of the interval 617”); and
receiving a second indication of an end of the first physiologic condition and a start of the second physiologic condition, wherein monitoring peripheral blood flow of the patient under the first physiologic condition is performed in response to receiving the first indication and monitoring peripheral blood flow of the patient under the second physiologic condition is performed in response to receiving the second indication (see [0109] – “The at least one processor 420 may identify start timing information of an interval at which a value of the blood flow rate information does not vibrate and increases as the compression timing information. This is because when the cuff operates and the blood flow is blocked for a short time period, the blood flow rate decreases and the value of blood flow rate information increases. In addition, in the interval 617, since the pressure applied by the cuff of the external electronic device (e.g., the external electronic device 505 of FIG. 5) is greater than blood pressure of the blood vessels in a systolic phase, the pulse wave generated by the heartbeat may not be formed. In the interval 619, the blood flow rate information of the third line 613 may vibrate and decrease. The at least one processor 420 may identify start timing information of the interval 619 as the relaxation timing information. The start timing information of the interval 619 may correspond to end timing information of the interval 617”).
Regarding claim 6, Jung discloses monitoring peripheral blood flow of the patient under the first physiologic condition comprises determining a first numerical value representing the peripheral blood flow of the patient under the first physiologic condition (see [0115] – “According to an embodiment, the first perfusion index information in the interval 715 may be lower than the second perfusion index information in the interval 719. This is because blood flow is blocked for a short time period in the interval 717, and a reactive hyperemia phenomenon occurs in the interval 719. When the reactive hyperemia occurs, a blood flow rate may increase. Therefore, when the reactive hyperemia occurs in the interval 719, a perfusion index information value may also increase. The at least one processor 420 may identify vascular health information based on a ratio of the second perfusion index information to the first perfusion index information”);
monitoring peripheral blood flow of the patient under the second physiologic condition comprises determining a second numerical value representing the peripheral blood flow of the patient under the second physiologic condition (see [0115] – “According to an embodiment, the first perfusion index information in the interval 715 may be lower than the second perfusion index information in the interval 719. This is because blood flow is blocked for a short time period in the interval 717, and a reactive hyperemia phenomenon occurs in the interval 719. When the reactive hyperemia occurs, a blood flow rate may increase. Therefore, when the reactive hyperemia occurs in the interval 719, a perfusion index information value may also increase. The at least one processor 420 may identify vascular health information based on a ratio of the second perfusion index information to the first perfusion index information”); and
generating the dimensionless relative index of the monitored peripheral blood flow of the patient comprises generating the dimensionless relative index of the monitored peripheral blood flow of the patient under the second physiologic condition based on the first numerical value and the second numerical value (see [0115] – “According to an embodiment, the first perfusion index information in the interval 715 may be lower than the second perfusion index information in the interval 719. This is because blood flow is blocked for a short time period in the interval 717, and a reactive hyperemia phenomenon occurs in the interval 719. When the reactive hyperemia occurs, a blood flow rate may increase. Therefore, when the reactive hyperemia occurs in the interval 719, a perfusion index information value may also increase. The at least one processor 420 may identify vascular health information based on a ratio of the second perfusion index information to the first perfusion index information”).
Regarding claim 8, Jung discloses generating the dimensionless relative index comprises dividing the second numerical value by the first numerical value (see [0115] – “According to an embodiment, the first perfusion index information in the interval 715 may be lower than the second perfusion index information in the interval 719. This is because blood flow is blocked for a short time period in the interval 717, and a reactive hyperemia phenomenon occurs in the interval 719. When the reactive hyperemia occurs, a blood flow rate may increase. Therefore, when the reactive hyperemia occurs in the interval 719, a perfusion index information value may also increase. The at least one processor 420 may identify vascular health information based on a ratio of the second perfusion index information to the first perfusion index information”).
Regarding claim 11, Jung discloses a system for monitoring peripheral blood flow of a patient, the system comprising:
a housing configured for wearable attachment to the patient (see Figures 2A-B);
a physiologic sensor (440) for monitoring peripheral blood flow of the patient disposed within the housing;
a processor (120, 420) communicably couplable to the physiologic sensor (see Figures 1 and 4); and
a memory (130) communicably coupled to the processor, the memory storing instructions that, when executed by the processor (see [0033] – “The memory 130 may store various data used by at least one component (e.g., the processor 120 or the sensor module 176) of the electronic device 101. The various data may include, for example, software (e.g., the program 140) and input data or output data for a command related thereto”), program the processor to:
monitor peripheral blood flow of the patient under a first physiologic condition using the physiologic sensor (see Figures 6-7 and [0107] – “A third line 613 may indicate a blood flow rate information value that changes over time. An interval 615 may be time before a compression timing. An interval 617 may be time after the compression timing and before a relaxation timing. An interval 619 may be time after the relaxation timing” and [0111] – “A first line 703 may be blood flow rate information that changes according to an operation of a cuff over time. An interval 705 may be time at which a value of blood flow rate information does not vibrate and increases. The interval 705 may correspond to the interval 617 of FIG. 6. The interval 705 may be time between a compression timing of the cuff and relaxation timing of the cuff”);
monitor peripheral blood flow of the patient under a second physiologic condition different than the first physiologic condition using the physiologic sensor (see Figures 6-7 and [0107] – “A third line 613 may indicate a blood flow rate information value that changes over time. An interval 615 may be time before a compression timing. An interval 617 may be time after the compression timing and before a relaxation timing. An interval 619 may be time after the relaxation timing” and [0111] – “A first line 703 may be blood flow rate information that changes according to an operation of a cuff over time. An interval 705 may be time at which a value of blood flow rate information does not vibrate and increases. The interval 705 may correspond to the interval 617 of FIG. 6. The interval 705 may be time between a compression timing of the cuff and relaxation timing of the cuff”);
generate a dimensionless relative index of the monitored peripheral blood flow of the patient:
under the second physiologic condition based on the monitored peripheral blood flow under the first physiologic condition (see [0115] – “According to an embodiment, the first perfusion index information in the interval 715 may be lower than the second perfusion index information in the interval 719. This is because blood flow is blocked for a short time period in the interval 717, and a reactive hyperemia phenomenon occurs in the interval 719. When the reactive hyperemia occurs, a blood flow rate may increase. Therefore, when the reactive hyperemia occurs in the interval 719, a perfusion index information value may also increase. The at least one processor 420 may identify vascular health information based on a ratio of the second perfusion index information to the first perfusion index information”); or
under the first physiologic condition based on the monitored peripheral blood flow under the second physiologic condition (see [0115] – “According to an embodiment, the first perfusion index information in the interval 715 may be lower than the second perfusion index information in the interval 719. This is because blood flow is blocked for a short time period in the interval 717, and a reactive hyperemia phenomenon occurs in the interval 719. When the reactive hyperemia occurs, a blood flow rate may increase. Therefore, when the reactive hyperemia occurs in the interval 719, a perfusion index information value may also increase. The at least one processor 420 may identify vascular health information based on a ratio of the second perfusion index information to the first perfusion index information”); and
output an indication of the dimensionless relative index (see Figure 8 and [0118] – “Referring to FIG. 8, an electronic device 200 may display a notification indicating a vascular health state based on vascular health information. The vascular health information may include the vascular dilation index of FIG. 7. A notification 801 may indicate a high degree of vascular health. A notification 803 may indicate a low degree of vascular health”).
Regarding claim 12, Jung discloses the instructions program the processor to generate the dimensionless relative index of the monitored peripheral blood flow of the patient under the second physiologic condition based on the monitored peripheral blood flow under the first physiologic condition (see [0115] – “According to an embodiment, the first perfusion index information in the interval 715 may be lower than the second perfusion index information in the interval 719. This is because blood flow is blocked for a short time period in the interval 717, and a reactive hyperemia phenomenon occurs in the interval 719. When the reactive hyperemia occurs, a blood flow rate may increase. Therefore, when the reactive hyperemia occurs in the interval 719, a perfusion index information value may also increase. The at least one processor 420 may identify vascular health information based on a ratio of the second perfusion index information to the first perfusion index information”);
the first physiologic condition comprises an artificially restricted peripheral blood flow (see Figure 7 and [0111] – “An interval 717 may be time after the compression timing and before the relaxation timing”); and
the second physiologic condition comprises peripheral blood flow of the patient without an artificial restriction (see Figure 7 and [0111] – “An interval 715 may be time before the compression timing. An interval 717 may be time after the compression timing and before the relaxation timing. An interval 719 may be time after the relaxation timing”).
Regarding claim 13, Jung discloses the instructions program the processor to:
occlude peripheral blood flow of the patient proximal the housing to create the first physiologic condition; and
cease occlusion of the peripheral blood flow of the patient to create the second physiologic condition (see Figures 6-7 and [0111] – “An interval 715 may be time before the compression timing. An interval 717 may be time after the compression timing and before the relaxation timing. An interval 719 may be time after the relaxation timing”).
Regarding claim 14, Jung discloses a blood flow restriction device (410) controllable by the processor and configured to occlude peripheral blood flow of the patient (see Figure 4 and [0077] – “According to an embodiment, the cuff 410 may be included in the electronic device 400 or may be included in an external electronic device (e.g., a blood pressure monitor). When the cuff 410 is included in the external electronic device, the cuff 410 may not be included in the electronic device 400. The cuff 410 may include a device that inflates by introduction of fluid. The cuff 410 may apply pressure to an object by inflating by the introduced fluid. According to an embodiment, the object may be an arm on which the user wears the electronic device 400. A position of the cuff included in the external electronic device (e.g., the blood pressure monitor) may be closer to a heart than a position of the electronic device 400. A position of the cuff included in the electronic device 400 may be closer to the heart than a position of the PPG sensor 440. The cuff 410 may apply pressure to the arm on which the user wears the electronic device 400 to induce reactive hyperemia in blood vessels of the user”).
Regarding claim 15, Jung discloses the instructions program the processor to:
receive a first indication of a start of the first physiologic condition (see [0109] – “The at least one processor 420 may identify start timing information of an interval at which a value of the blood flow rate information does not vibrate and increases as the compression timing information. This is because when the cuff operates and the blood flow is blocked for a short time period, the blood flow rate decreases and the value of blood flow rate information increases. In addition, in the interval 617, since the pressure applied by the cuff of the external electronic device (e.g., the external electronic device 505 of FIG. 5) is greater than blood pressure of the blood vessels in a systolic phase, the pulse wave generated by the heartbeat may not be formed. In the interval 619, the blood flow rate information of the third line 613 may vibrate and decrease. The at least one processor 420 may identify start timing information of the interval 619 as the relaxation timing information. The start timing information of the interval 619 may correspond to end timing information of the interval 617”); and
receive a second indication of an end of the first physiologic condition and a start of the second physiologic condition, wherein the instructions program the processor to monitor peripheral blood flow of the patient under the first physiologic condition in response to receiving the first indication and to monitor peripheral blood flow of the patient under the second physiologic condition in response to receiving the second indication (see [0109] – “The at least one processor 420 may identify start timing information of an interval at which a value of the blood flow rate information does not vibrate and increases as the compression timing information. This is because when the cuff operates and the blood flow is blocked for a short time period, the blood flow rate decreases and the value of blood flow rate information increases. In addition, in the interval 617, since the pressure applied by the cuff of the external electronic device (e.g., the external electronic device 505 of FIG. 5) is greater than blood pressure of the blood vessels in a systolic phase, the pulse wave generated by the heartbeat may not be formed. In the interval 619, the blood flow rate information of the third line 613 may vibrate and decrease. The at least one processor 420 may identify start timing information of the interval 619 as the relaxation timing information. The start timing information of the interval 619 may correspond to end timing information of the interval 617”).
Regarding claim 16, Jung discloses the instructions program the processor to:
determine a first numerical value representing the peripheral blood flow of the patient under the first physiologic condition (see [0115] – “According to an embodiment, the first perfusion index information in the interval 715 may be lower than the second perfusion index information in the interval 719. This is because blood flow is blocked for a short time period in the interval 717, and a reactive hyperemia phenomenon occurs in the interval 719. When the reactive hyperemia occurs, a blood flow rate may increase. Therefore, when the reactive hyperemia occurs in the interval 719, a perfusion index information value may also increase. The at least one processor 420 may identify vascular health information based on a ratio of the second perfusion index information to the first perfusion index information”);
determine a second numerical value representing the peripheral blood flow of the patient under the second physiologic condition (see [0115] – “According to an embodiment, the first perfusion index information in the interval 715 may be lower than the second perfusion index information in the interval 719. This is because blood flow is blocked for a short time period in the interval 717, and a reactive hyperemia phenomenon occurs in the interval 719. When the reactive hyperemia occurs, a blood flow rate may increase. Therefore, when the reactive hyperemia occurs in the interval 719, a perfusion index information value may also increase. The at least one processor 420 may identify vascular health information based on a ratio of the second perfusion index information to the first perfusion index information”); and
generate the dimensionless relative index of the monitored peripheral blood flow of the patient comprises generating the dimensionless relative index of the monitored peripheral blood flow of the patient under the second physiologic condition based on the first numerical value and the second numerical value (see [0115] – “According to an embodiment, the first perfusion index information in the interval 715 may be lower than the second perfusion index information in the interval 719. This is because blood flow is blocked for a short time period in the interval 717, and a reactive hyperemia phenomenon occurs in the interval 719. When the reactive hyperemia occurs, a blood flow rate may increase. Therefore, when the reactive hyperemia occurs in the interval 719, a perfusion index information value may also increase. The at least one processor 420 may identify vascular health information based on a ratio of the second perfusion index information to the first perfusion index information”).
Regarding claim 18, Jung discloses the instructions program the processor to generate the dimensionless relative index by dividing the second numerical value by the first numerical value (see [0115] – “According to an embodiment, the first perfusion index information in the interval 715 may be lower than the second perfusion index information in the interval 719. This is because blood flow is blocked for a short time period in the interval 717, and a reactive hyperemia phenomenon occurs in the interval 719. When the reactive hyperemia occurs, a blood flow rate may increase. Therefore, when the reactive hyperemia occurs in the interval 719, a perfusion index information value may also increase. The at least one processor 420 may identify vascular health information based on a ratio of the second perfusion index information to the first perfusion index information”).
Regarding claim 20, Jung discloses the processor and the memory are disposed within the housing (see Figures 1-3).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 7 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jung, further in view of Naghavi et al. (US Publication No. 2007/0225614 A1).
Regarding claims 7 and 17, it is noted Jung does not specifically teach determining the first numerical value representing the peripheral blood flow of the patient under the first physiologic condition comprises determining a plurality of numerical values and determining the first numerical value as an average of the plurality of numerical values, where each numerical value of the plurality of numerical values represents the peripheral blood flow of the patient at a different time while the first physiologic condition persists. However, Naghavi et al. teaches determining the first numerical value representing the peripheral blood flow of the patient under the first physiologic condition comprises determining a plurality of numerical values and determining the first numerical value as an average of the plurality of numerical values, where each numerical value of the plurality of numerical values represents the peripheral blood flow of the patient at a different time while the first physiologic condition persists (see Figures 21-22 and [0235] – “In an exemplary embodiment, several graphs similar to graph 1800 may be taken from a subject and then averaged to get an average graph for the subject which may indicate the average response for the subject over a period of time” and [0488] – “Similar to blood pressure measurements, endothelial function and vascular reactivity are highly variable physiologic parameters. Multiple measurements and averaging of such variables are expected to provide a more accurate assessment”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method and system of Jung to include determining the first numerical value representing the peripheral blood flow of the patient under the first physiologic condition comprises determining a plurality of numerical values and determining the first numerical value as an average of the plurality of numerical values, where each numerical value of the plurality of numerical values represents the peripheral blood flow of the patient at a different time while the first physiologic condition persists, as disclosed in Naghavi et al. so as to provide a more accurate assessment of the peripheral blood flow under the first physiologic condition (see Naghavi et al.: [0488]).
Claim(s) 9-10 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jung, further in view of Franck (US Publication No. 2024/0206747 A1).
Regarding claims 9 and 19, it is noted Jung does not specifically teach generating the dimensionless relative index comprises setting a numerical value representing a highest peripheral blood flow of the patient monitored by the wearable device as a maximum bound, setting the first numerical value as a minimum bound, and rescaling the second numerical value to a value between the minimum bound and the maximum bound. However, Franck teaches generating the dimensionless relative index comprises setting a numerical value representing a highest peripheral blood flow of the patient monitored by the wearable device as a maximum bound, setting the first numerical value as a minimum bound, and rescaling the second numerical value to a value between the minimum bound and the maximum bound (see [0081] – “In some embodiments, step 103 comprises scaling the envelope data set or the set of PDFs based on the envelope data set. This scaling is performed using a scaling factor referred to as a “blood flow scaling factor”. The blood flow scaling factor can be used to align the blood flow values in the set of PDFs and the measurements of blood flow in the envelope data set. Thus, the blood flow scaling factor can be used to normalise the blood flow values of each PDF to the envelope data set, or to normalise the blood flow measurements in the envelope data set… In some embodiments, the blood flow scaling factor is determined based on the measurement of the blood flow in the envelope data set with the highest magnitude. For example, the measurement of blood flow with the maximum amplitude can be scaled to 1, and all other amplitudes can be scaled accordingly. However, it is possible that the highest magnitude blood flow measurement is an artefact, leading to a significant error, so preferably the blood flow scaling factor is determined from a plurality of the highest magnitude measurements of blood flow to make the scaling less sensitive to outlier measurements and other errors. The blood flow scaling factor can be determined from a function of the plurality of highest magnitude measurements, and the function can be an average, such as mean, mode or median (with median being a more preferable option to mean and mode). The number of measurements to use to determine the blood flow scaling factor can be between 2 and 10, for example 3, 5 or 7. When taking the median and using the 3 highest magnitude measurements, the blood flow scaling factor is robust to one of the maxima being an artefact, when taking the median and using the 5 highest magnitude measurements, the blood flow scaling factor is robust to two of the maxima being an artefact, etc. Determining the blood flow scaling factor from a plurality of the highest magnitude blood flow measurements also contributes to the blood pressure measurement technique being less reliant on a single measurement point in the envelope data set”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method and system of Jung to include generating the dimensionless relative index comprises setting a numerical value representing a highest peripheral blood flow of the patient monitored by the wearable device as a maximum bound, setting the first numerical value as a minimum bound, and rescaling the second numerical value to a value between the minimum bound and the maximum bound, as disclosed in Franck so as to account for a number of factors that can affect the magnitude of the blood flow measurements, such as physical characteristics of the subject, the cuff size, cuff type, how firmly the cuff is attached to the body part, etc. and to make the measurements less sensitive to outlier measurements and other errors (see Franck: [0081]).
Regarding claim 10, Franck teaches generating the dimensionless relative index comprises, when a new numerical value representing peripheral blood flow of the patient higher than the numerical value representing the highest peripheral blood flow is determined, setting the new numerical value as a new maximum bound, and rescaling the second numerical value to between the minimum bound and the new maximum bound (see [0082] – “In a similar manner, certain values of systolic blood pressure and diastolic blood pressure are more likely. e.g. values within the typical physiological ranges, and can have probabilities in the PDFs that make these more likely. Likewise, certain values of pulse pressure are also more likely, and the PDFs should be constructed accordingly. With this prior information being taken into account in the PDFs, there is a relatively low likelihood of the subject being considered to have a systolic and diastolic blood pressure outside the usual physiological range unless it is strongly supported by the measured envelope data set” and [0083] – “In some embodiments, the prior information may also or alternatively comprise dynamic information, i.e. information that does change, or does change quickly. Dynamic information can include one or more previous values of systolic blood pressure and diastolic blood pressure for the subject. This dynamic information can be used to generate the PDFs such that it is more likely that the new values for systolic and diastolic blood pressure found using the envelope data set are close to the previous values of systolic and diastolic blood pressure for the subject. The exact effect of the previous values for the subject on the PDFs can depend on how recent the previous values are, since blood pressure changes relatively slowly, and so more recent previous values are more likely to be indicative of the current values for systolic and diastolic blood pressure than older previous values”).
Conclusion
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/DEVIN B HENSON/Primary Examiner, Art Unit 3791
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