DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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(s) is/are: “a measurement unit configured to irradiate a foot sole of an evaluation subject with near-infrared light” in claims 1 and 2; “the measurement unit is configured to perform a measurement of the regional oxygen saturation of the foot sole of the evaluation subject” in claim 3 .
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.
The measurement unit is defined, in para. [0019-0020, 0024] of the published specification (see US 20250195001 A1), as a main unit and a probe including irradiation units and detection units, a commercially available product, for example, provided by Hamamatsu Photonics K. K.
The evaluation unit is defined, in para. [0028, 0049] of the published specification (see US 20250195001 A1), as an operation unit, storage unit, and display unit, a computer, a tablet.
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.
Claim 3 is 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 “perform a measurement ... of the foot sole” and “perform a measurement ... of the arm or the head” in lines 2-4. It is unclear if the measurements performed are in addition to or the same measurements that are performed in claim 2. The limitations are suggested to recite “perform the measurement ... of the foot sole” and “perform the measurement ... of the arm or the head”.
Claim Rejections - 35 USC § 101
Claims 1-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claims 1, 2, 4, and 5 follows.
STEP 1
Regarding claims 1, 2, 4, and 5, the claims recite a series of structural elements and/or a series of steps or acts”, including an apparatus. Thus, the claims are directed to a machine and/or a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of:
an evaluation unit configured to evaluate lower extremity vascular disease of the evaluation subject based on the regional oxygen saturation of the foot sole;
an evaluation unit configured to evaluate lower extremity vascular disease of the evaluation subject based on a ratio or a difference between the regional oxygen saturation of the foot sole and the regional oxygen saturation of the arm or the head;
performing an evaluation of acquiring an index for evaluating lower extremity vascular disease of the evaluation subject by comparing the regional oxygen saturation of the foot sole with a threshold value;
performing an evaluation of acquiring an index for evaluating lower extremity vascular disease of the evaluation subject by comparing a ratio or a difference between the regional oxygen saturation of the foot sole and the regional oxygen saturation of the arm or the head with a threshold value.
set forth a judicial exception. These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claims 1, 2, 4, and 5 recite a measurement unit configured to perform a measurement of regional oxygen saturation, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The performed measurement of regional oxygen saturation does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the measurement of regional oxygen saturation, nor does the method use a particular machine to perform the Abstract Idea.
Regarding claims 1, 2, 4, and 5, the recited measurement unit is configured to perform pre-solutional data gathering activity, and the evaluation unit is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of:
a measurement unit configured to (performing a measurement/first measurement) irradiate a foot sole of an evaluation subject with near-infrared light, receive the near-infrared light scattered or absorbed by a tissue inside the foot sole, and measure a regional oxygen saturation of the foot sole based on a received light intensity
the measurement unit configured to (perform a second measurement) irradiate an arm or a head of the evaluation subject with the near-infrared light, receive the near-infrared light scattered or absorbed by a tissue inside the arm or the head, and measure a regional oxygen saturation of the arm or the head based on a received light intensity
The irradiating, receiving, and measuring steps are well-understood, routine and conventional activities for those in the field of medical diagnostics. Further, the irradiating, receiving, and measuring steps are each recited at a high level of generality such that it amounts to insignificant pre-solution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claims 1, 2, 4, and 5, the apparatus recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited measurement unit is a generic sensor configured to perform pre-solutional data gathering activity (as evidenced by the non-patent literature of record Siao et al. Pulse Oximetry as a Screening Test for Hemodynamically Significant Lower Extremity Peripheral Artery Disease in Adults with Type 2 Diabetes Mellitus. J ASEAN Fed Endocr Soc. 2018;33(2):130-136. doi: 10.15605/jafes.033.02.04. Epub 2018 Oct 31. PMID: 33442118; PMCID: PMC7784151), and the evaluation unit is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The dependent claims also fail to add something more to the abstract independent claims. Claims 3 and 6 are directed to insignificant pre-solution activity (i.e., mere data gathering steps) necessary to perform the abstract idea, which does not add anything significantly more. The steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
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 1 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Blazek (EP 2609854 A1 English Translation) in view of Siao (Siao et al. Pulse Oximetry as a Screening Test for Hemodynamically Significant Lower Extremity Peripheral Artery Disease in Adults with Type 2 Diabetes Mellitus. J ASEAN Fed Endocr Soc. 2018;33(2):130-136. doi: 10.15605/jafes.033.02.04. Epub 2018 Oct 31. PMID: 33442118; PMCID: PMC7784151.)
Regarding claim 1, Blazek discloses, a lower extremity vascular disease evaluation apparatus (Abstract, para. [0003]) comprising: a measurement unit (“PPG sensor”; “sensor proximal control and evaluation unit”; “light sources ... at least one light detector”, para. [0008, 0053, 0063-0064]) configured to irradiate a foot sole of an evaluation subject with near-infrared light ("PPG ... fixed in the area of the sole of the foot"; "measuring wavelengths is 940 nm"; "illuminates the measurement area", para. [0008, 0026, 0063-0064], fig. 6), receive the near-infrared light scattered or absorbed by a tissue inside the foot sole ("backscattered ... light detector which receives the reflected light", para. [0008, 0053, 0063-0064], fig. 6), measure a regional oxygen saturation of the foot sole based on a received light intensity ("determination of oxygen saturation is based on the ... backscattered radiation"; "venous oxygen saturation", para. [0023, 0040, 0063-0064]); and an evaluation unit (“computer-aided evaluation units”; “control and evaluation electronics”, para. [0053, 0063-0064]).
Blazek further discloses that the saturation value is an important diagnostic parameter for the combined assessment of respiratory function and peripheral dermal blood flow status in neonates, children and adults alike and that the unit calculates and displays the arteriovenous saturation difference (para. [0012, 0056]). Blazek does not expressly disclose that the evaluation unit is configured to evaluate lower extremity vascular disease of the evaluation subject based on the regional oxygen saturation of the foot sole.
However, Siao directed to determining if digital pulse oximetry is an acceptable screening tool to detect hemodynamically significant lower extremity peripheral artery disease (PAD) discloses evaluating lower extremity vascular disease of the evaluation subject based on the regional oxygen saturation of the foot (page 132, Methodology, “pulse oximeter ... toes” & page 133, Discussion, “result positive for PAD if the SpO2 of the big toe taken with the foot in resting position or on 12-inch leg elevation had a difference of at least 2% compared to the index finger SpO2.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Blazek such that the evaluation unit is configured to evaluate lower extremity vascular disease of the evaluation subject based on the regional oxygen saturation of the foot sole, in view of the teachings of Siao, as this would aid in detecting hemodynamically significant lower extremity peripheral artery disease (PAD) in patients.
Regarding claim 4, Blazek discloses a lower extremity vascular disease evaluation method (Abstract, para. [0003], figs. 1 & 6) comprising: performing a measurement of irradiating a foot sole of an evaluation subject with near-infrared light ("PPG ... fixed in the area of the sole of the foot"; "measuring wavelengths is 940 nm"; "illuminates the measurement area", para. [0008, 0026, 0063-0064], fig. 6), receiving the near-infrared light scattered or absorbed by a tissue inside the foot sole ("backscattered ... light detector which receives the reflected light", para. [0008, 0053, 0063-0064], fig. 6), and measuring a regional oxygen saturation of the foot sole based on a received light intensity ("determination of oxygen saturation is based on the ... backscattered radiation"; "venous oxygen saturation", para. [0023, 0040, 0063-0064]).
Blazek further discloses that the saturation value is an important diagnostic parameter for the combined assessment of respiratory function and peripheral dermal blood flow status in neonates, children and adults alike and that the unit calculates and displays the arteriovenous saturation difference (para. [0012, 0056]). Blazek does not expressly disclose performing an evaluation of acquiring an index for evaluating lower extremity vascular disease of the evaluation subject by comparing the regional oxygen saturation of the foot sole with a threshold value.
However, Siao directed to determining if digital pulse oximetry is an acceptable screening tool to detect hemodynamically significant lower extremity peripheral artery disease (PAD) discloses performing an evaluation of acquiring an index for evaluating lower extremity vascular disease of the evaluation subject by comparing the regional oxygen saturation of the foot with a threshold value (page 132, Methodology, “pulse oximeter ... toes” & page 133, Discussion, “result positive for PAD if the SpO2 of the big toe taken with the foot in resting position or on 12-inch leg elevation had a difference of at least 2% compared to the index finger SpO2.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Blazek such that the method comprises performing an evaluation of acquiring an index for evaluating lower extremity vascular disease of the evaluation subject by comparing the regional oxygen saturation of the foot sole with a threshold value, in view of the teachings of Siao, as this would aid in detecting hemodynamically significant lower extremity peripheral artery disease (PAD) in patients.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Melker (US 20030236452 A1) in view of Blazek (EP 2609854 A1 English Translation).
Regarding claim 2, Melker discloses a lower extremity vascular disease evaluation apparatus (“non-invasive vascular perfusion/resistance monitor system”, para. [0018]) comprising: a measurement unit (“pulse oximeter probes”; “probe ... connect ... oximeter monitor”, para. [0018, 0047, 0080-0081]) configured to irradiate a foot of an evaluation subject with near-infrared light (fig. 7 , “toes”; “emits light around 880-940 nm”; “toe ... emit designated light at designated frequencies”; “right foot”, para. [0018, 0060, 0080, 0092]), receive the near-infrared light scattered or absorbed by a tissue inside the foot (fig. 7, “photodetector ... detects changes in the light ... differentially absorbed”, “measure reflectance of the tissue”; “signals from the CSS and from the PS are measured”, para. [0018, 0060, 0068, 0080]), and measuring measure a regional oxygen saturation of the foot based on a received light intensity (fig. 7, “calculates arterial blood oxygen saturation percentages based on the differential absorption of the different species of hemoglobin”, para. [0018, 0080]), and configured to irradiate an arm or a head of the evaluation subject with the near-infrared light (fig. 7 , “emits light around 880-940 nm”; “oximeter probe ... the head of the patient”; “emit designated light at designated frequencies”, para. [0018, 0060, 0080, 0092]), receiving receive the near-infrared light scattered or absorbed by a tissue inside the arm or the head (fig. 7, “photodetector ... detects changes in the light ... differentially absorbed”, “measure reflectance of the tissue”; “signals from the CSS and from the PS are measured”, para. [0018, 0060, 0068, 0080]), and measuring measure a regional oxygen saturation of the arm or the head based on a received light intensity (fig. 7, “calculates arterial blood oxygen saturation percentages based on the differential absorption of the different species of hemoglobin”, para. [0018, 0080]); and an evaluation unit (“computer”, para. [0018, 0020, 0080]) configured to evaluate lower extremity vascular disease of the evaluation subject based on a ratio or a difference between the regional oxygen saturation of the foot and the regional oxygen saturation of the arm or the head (“difference in saturation values ... used to assess ... peripheral vascular disease”; “percent oxygen saturation at the CSS and the PS are compared ... presence or absence of impaired peripheral perfusion ... output reading”, para. [0020, 0080, 0088]).
Melker further discloses that the non-invasive vascular perfusion/resistance monitor system has at least two pulse oximeter probes and that the second or third probe site is located at a "non-central" site (NCS), such as an extremity (i.e., fingers, toes, etc.) (para. [0020]). Melker does not expressly disclose a foot sole as a peripheral/non-central cite of interest on the patient.
However, Blazek directed to a device for the non-invasive determination of venous oxygen saturation (para. [0014]) discloses a foot sole as a peripheral/non-central cite of interest on the patient (fig. 6, "PPG ... fixed in the area of the sole of the foot", para. [0008]). Blazek further discloses the PPG sensor can be fixed in the area of the sole of the foot, the illuminating the measurement area with a measuring wavelength of 940 nm, receiving reflected and/or backscattered and/or transmitted and determining the venous oxygen saturation and that PPG can be used not only for the early detection of leg vein diseases but also to assess the hemodynamic impact of special stress situations (para. [0003, 0008, 0014, 0026, 0063-0064]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Melker, such that the peripheral/non-central cite of interest on the patient is a foot sole, in view of the teachings of Blazek, as this would aid in the detection of leg vein diseases by incorporating the flexible PPG sensor of Blazek that can be fixed in the area of the sole of the foot as one of the at least two pulse oximeter probes.
Regarding claim 3, Melker, as modified by Blazek hereinabove, discloses the lower extremity vascular disease evaluation apparatus according to Claim 2, wherein the measurement unit (“pulse oximeter probes”, para. [0018, 0079, 0080]) is configured to perform a measurement of the regional oxygen saturation of the foot sole of the evaluation subject and a measurement of the regional oxygen saturation of the arm or the head of the evaluation subject in a common period (“two or more probes are used together ... continuous and simultaneous cross-site comparisons ... simultaneously”; “same time span”, para. [0079-0080], fig. 7).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Melker (US 20030236452 A1) in view of Blazek (EP 2609854 A1English Translation), and further in view of Kobayashi (US 20160128634 A1).
Regarding claim 5, Melker discloses a lower extremity vascular disease evaluation method (fig. 7, “non-invasive vascular perfusion/resistance”; “method”, para. [0018, 0080]) comprising: performing a first measurement of irradiating afoot of an evaluation subject with near-infrared light (fig. 7 , “toes”; “emits light around 880-940 nm”; “pulse oximeter probe ... toe ... emit designated light at designated frequencies”; “right foot”, para. [0018, 0060, 0080, 0092]), receiving the near-infrared light scattered or absorbed by a tissue inside the foot (fig. 7, “photodetector ... detects changes in the light ... differentially absorbed”, “measure reflectance of the tissue”; “signals from the CSS and from the PS are measured”, para. [0018, 0060, 0068, 0080]), and measuring a regional oxygen saturation of the foot based on a received light intensity (fig. 7, “calculates arterial blood oxygen saturation percentages based on the differential absorption of the different species of hemoglobin”, para. [0018, 0080]); performing a second measurement of irradiating an arm or a head of the evaluation subject with the near-infrared light (fig. 7 , “emits light around 880-940 nm”; “oximeter probe ... the head of the patient”; “emit designated light at designated frequencies”, para. [0018, 0060, 0080, 0092]), receiving the near-infrared light scattered or absorbed by a tissue inside the arm or the head (fig. 7, “photodetector ... detects changes in the light ... differentially absorbed”, “measure reflectance of the tissue”; “signals from the CSS and from the PS are measured”, para. [0018, 0060, 0068, 0080]), and measuring a regional oxygen saturation of the arm or the head based on a received light intensity (fig. 7, “calculates arterial blood oxygen saturation percentages based on the differential absorption of the different species of hemoglobin”, para. [0018, 0080]); and performing an evaluation of acquiring an index for evaluating lower extremity vascular disease of the evaluation subject by comparing a ratio or a difference between the regional oxygen saturation of the foot sole and the regional oxygen saturation of the arm or the head (“difference in saturation values ... used to assess ... peripheral vascular disease”; “percent oxygen saturation at the CSS and the PS are compared ... presence or absence of impaired peripheral perfusion ... output reading”, para. [0020, 0080, 0088])
Melker further discloses that the non-invasive vascular perfusion/resistance monitor system has at least two pulse oximeter probes and that the second or third probe site is located at a "non-central" site (NCS), such as an extremity (i.e., fingers, toes, etc.) (para. [0020]). Melker does not expressly disclose a foot sole as a peripheral/non-central cite of interest on the patient.
However, Blazek directed to a device for the non-invasive determination of venous oxygen saturation (para. [0014]) discloses a foot sole as a peripheral/non-central cite of interest on the patient (fig. 6, "PPG ... fixed in the area of the sole of the foot", para. [0008]). Blazek further discloses the PPG sensor can be fixed in the area of the sole of the foot, the illuminating the measurement area with a measuring wavelength of 940 nm, receiving reflected and/or backscattered and/or transmitted and determining the venous oxygen saturation and that PPG can be used not only for the early detection of leg vein diseases but also to assess the hemodynamic impact of special stress situations (para. [0003, 0008, 0014, 0026, 0063-0064]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Melker, such that the peripheral/non-central cite of interest on the patient is a foot sole, in view of the teachings of Blazek, as this would aid in the detection of leg vein diseases by incorporating the flexible PPG sensor of Blazek that can be fixed in the area of the sole of the foot as one of the at least two pulse oximeter probes.
Melker further discloses that the data suggests that in a healthy subject the CSS and PS readings taken at or near the same time will be relatively close, within about 5 percentage points or less, and all of the readings will be high (para. [0086-0089])
Melker, as modified by Blazek hereinabove, does not expressly disclose performing an evaluation of acquiring an index for evaluating lower extremity vascular disease of the evaluation subject by comparing a ratio or a difference between the regional oxygen saturation of the foot sole and the regional oxygen saturation of the arm or the head with a threshold value.
However, Kobayashi directed to a method for evaluating the condition of a patient using a measuring system including first and second sensors for measuring the blood refill time or index related to the blood oxygen saturation of the subject (para. [0027-0028]) discloses performing an evaluation of peripheral circulation of the evaluation subject by comparing a ratio or a difference between the regional oxygen saturation of the first portion (first measurement value, para. [0071]) and the regional oxygen saturation of the arm or the head (second measurement value, para. [0071]) with a threshold value (“index related to the blood oxygen saturation ... measurement value”; “evaluation method ... difference value ... subtracting ... threshold ... indicated ... peripheral circulation”, para. [0042, 0070-0072, 0081]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Melker, as modified by Blazek hereinabove, such that the method comprises performing an evaluation of acquiring an index for evaluating lower extremity vascular disease of the evaluation subject by comparing a ratio or a difference between the regional oxygen saturation of the foot sole and the regional oxygen saturation of the arm or the head with a threshold value, in view of the teachings of Kobayashi, as this would aid in performing an evaluation method to provide indications of peripheral circulation by incorporating the predetermined thresholds of Kobayashi into the assessment of peripheral vascular disease based on the difference in saturation values of Melker.
Regarding claim 6, Melker, as modified by Blazek and Kobayashi hereinabove, discloses the lower extremity vascular disease evaluation apparatus according to Claim 2, wherein the measurement unit (“pulse oximeter probes”, para. [0018, 0079, 0080]) is configured to perform a measurement of the regional oxygen saturation of the foot sole of the evaluation subject and a measurement of the regional oxygen saturation of the arm or the head of the evaluation subject in a common period (“two or more probes are used together ... continuous and simultaneous cross-site comparisons ... simultaneously”; “same time span”, para. [0079-0080], fig. 7).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Mao (US 20080269620 A1) directed to methods of diagnosing peripheral vascular disease (PVD) using measured changes in oxygen saturation in tissue; Melker (US 9198586 B2) directed to methods of monitoring oxygenation by positive end expiratory pressure using photoplethysmography; Linders (US 20230172471 A1) directed to an apparatus for measuring foot blood flow comprising a plurality of PPG sensors (figs. 1A-1B); Lee (KR-20100119338-A English Translation) directed to an evaluation apparatus and method of peripheral blood vessel and blood flow state.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW ELI HOFFPAUIR whose telephone number is (571)272-4522. The examiner can normally be reached Monday-Friday 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791
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