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.
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 light emission unit in claims 1, 15, and 23
An image capturing means in claims 11 and 12
A light-emission-angle adjustment mechanism in claim 13
A position adjustment mechanism in claim 14
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.
A light emission unit in claims 1, 15, and 23 is interpreted as the lasers described in paragraphs 0132-0133 and their equivalents.
An image capturing means in claims 11 and 12 is interpreted as a charge coupled device (CCD) image sensor and its equivalents as per paragraph 0262 of the specification.
A light-emission-angle adjustment mechanism in claim 13 is described in paragraphs 0289-0291 and Fig. 15 of the specification as an internal motor for rotating a structural member and the structural member itself as depicted in Fig. 15. The light-emission-angle adjustment mechanism is interpreted as the structure depicted in Fig. 15 reference 93B and an internal motor for rotation and their equivalents.
A position adjustment mechanism in claim 14 is described in paragraphs 0292-0293 and Fig. 15 of the specification as linear motion mechanisms such as a lead screw or MEMS actuator and their equivalents.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “the position of the living body relative to the light emission unit is set so that the laser beam condensing region and a blood-vessel region inwards of the epidermis in the subject portion overlap” but it is unclear if this limitation is meant to convey that the positioning of the light emission unit is adjustable and thus being “set” to the particular position is an active process involving the selection of such a position or if the position being “set” to the particular position is simply an inherent result of how the device is constructed and thus any configuration where measurement is conducted is “set” in such a manner. For the purposes of this examination, the limitation is interpreted as the light emission unit being “set” in the particular position as an active process that involves a change and/or active selection of the position of the living body and/or the light emission unit relative to each other as such an interpretation appears to align with Applicant’s specification. Under this interpretation, it is further unclear what mechanism or element of the device performs the positioning of the light emission unit to actively “set” the position of the light emission unit relative to the living body to achieve the recited configuration and it is unclear what the process to achieve this positioning entails. Similarly, the recitation of “the position of the photodetector relative to the living body is set so that an image of the signal light from the blood-vessel region overlapping the laser-beam condensing region is transferred by the imaging lens to form a focused image on a light receiving surface of the photodetector” is interpreted as another active process that is separate and distinct from the setting of the light emission unit. As such, the above rejections and interpretations are similarly applied to the photodetector unit being “set”. This rejection is further applied to the similar limitations of claims 15 and 23.
Claims 2-14 are rejected by virtue of their dependance on claim 1.
Claims 16-22 are rejected by virtue of their dependance on claim 15.
Claim 3 recites “the position of the photodetector relative to the living body in a direction intersecting the optical path of the signal light is capable of being adjusted by changing the position of the photodetector in said direction” but it is unclear what element of the device performs this function. For the purposes of this examination, the limitation will be interpreted as any element performing the function. This rejection is further applied to the similar recitations of claim 5.
Claim 4 recites “the angle of the main surface” in line 4. There is insufficient antecedent basis for this limitation. This rejection is further applied to the similar limitations of claim 18.
Claim 5 recites “the image of the signal light” but it is unclear if this limitation is the same as, related to, or different from “signal light” of claim 1. In particular, it is unclear if the “image of” the signal light is different from the signal light itself. For the purposes of this examination, the limitations are considered to both refer to the signal light. This rejection is further applied to the similar recitations of claim 19.
Claim 5 recites “a focused image” in line 8 but it is unclear if this recitation is the same as, related to, or different from “a focused image” of claim 1 line 13. For the purposes of this examination, the limitations will be interpreted as referring to the same images. This rejection is similarly applied to claim 19.
Claims 6-8 are directed towards the measurement of a target substance and a reference substance with a first and second laser beam but it is unclear how these claims relate to the claimed device. In particular, it is unclear what relation, if any, the first substance and/or the reference substance of claims 6-8 has to the measured “a concentration of the substance in blood” of claim 1. It is unclear if the measurements of claims 6-8 are meant to further limit the measurement of claim 1 or are meant to be separate and distinct measurements. For the purposes of this examination, the limitations will be interpreted as measuring the concentration of any two different substances in blood.
Claim 8 recites “the measurement target portion” in line 8 but it is unclear how this limitation relates to “a specific region” of claim 1. It is unclear if this limitation is meant to be the same as the specific region or refer to a subset of the region. If the limitation is meant to refer to a subset of the specific region then the limitation lacks sufficient antecedent basis and it is unclear how this portion is differentiated from the specific region. This rejection is further applied to the similar limitations of claim 22.
Claim 10 recites “within a section from the base to the photodetector in the optical path from the subject portion to the photodetector, the signal light propagates through a space except within a section in which the signal light passes through the imaging lens, and within a section from the light emission unit to the base in the optical path from the light emission unit to the subject portion, the laser beam propagates through a space except within a section in which the laser beam passes through the condenser lens” but it is unclear what “a space” is meant to entail and if the two references to “a space” are meant to refer to the same space or different spaces. For the purposes of this examination, the limitations will be interpreted as a first air gap and a second air gap such that the signal light travels through an air gap between the photodetector and the subject portion except for the imaging lens and the laser beam travels through an air gap from the light emission unit to the subject portion expect for the condenser lens. The first and second air gaps thus refer to different areas in space.
Claim 11 recites “a perpendicular direction” but it is unclear from what reference the direction is perpendicular to. For the purposes of this examination, the limitation will be interpreted as perpendicular to the main surface
Claim 18 recites “a reference measurement” but it is unclear if this measurement is the same as, related to, or different from “measuring a concentration of the substance in blood in the specific region” of claim 15. The relationship between the measurement in claim 15 and the reference measurement of claim 18 is unclear as both measurements appear to output “the concatenation of the substance in blood in the specific region”. For the purposes of this examination, the limitations will be interpreted as referring to the same measurement. This rejection is further applied to the similar recitation in claim 19.
Claim 20 recites “the target measurement” in line 4. This limitation lacks sufficient antecedent basis.
Claim 20 recites that the substance in blood, and the concentration of the substance in blood in the target measurement are referred to as first substance in blood and a concentration of a first substance in blood. The claim further recites that the reference measurement uses a second laser bean to determine a concentration of a second substance in blood. However claim 20 depends from claim 18 and claim 18 appears to set forth that “the concentration of the substance in blood in the specific region” as set forth by claim 15 is part of the reference measurement. This appears to contradict claim 20 which appears to set forth that “the concentration of the substance in blood” is part of the target measurement. The relationship between the measurement performed in claim 15, the reference measurement, and the target measurement is unclear. For the purposes of this examination, the limitations are being interpreted as referring to any two measurements of different substances. This rejection is similarly applied to claim 21 which appears to indicate that the concentration in the reference measurement is distinct from the concentration in the measurement of claim 15 but this again appears to contradict claim 18 from which claim 21 depends.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 15, and 23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “a measurement controller that measures a concentration of the substance in blood in the laser-beam condensing region based on the intensity of the signal light” which includes a scope of measuring the concentration of any and all substances in blood based on the received light intensity. The specification does not appear to describe how the light intensity signal is processed to determine substance in blood concentrations. In particular, paragraphs 0122-0124, 0130-0131, and 0305-0307 each describe variables which can be measured (glucose, hemoglobin, and lactic acid) and provide particular wavelengths to use for measuring these parameters but no description is provided as to how the received intensity signals are processed into the concentration of the substance in blood. The specification indicates that changing the wavelength allows the device to measure other target and reference substances in paragraphs 0305-0307 but no description is seemingly provided for how the intensity signals are transformed into concentration signals. While the determination of some substances in blood from optical signals may be well known, the claimed scope includes determinations that are not well-known and provides to method of how to determine these other parameters and thus lacks written description because the specification fails to provide the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function. This rejection is similarly applied to claims 15 and 23 which recites similar limitations.
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.
Claims 1-8 and 15-23 are rejected under 35 U.S.C. 103 as being unpatentable over Zalevsky US Patent Application Publication Number US 2018/0110442 A1 hereinafter Zalevsky in view of Iikubo US Patent Application Publication Number US 2007/0060818 A1 hereinafter Iikubo, in view of Marchitto US Patent Application Publication Number US 2002/0016533 A1 hereinafter Marchitto, further in view of Monfre US Patent Application Publication Number US 2006/0200017 A1 hereinafter Monfre
Regarding claim 1, Zalevsky teaches a substance-in-blood concentration measurement device that measures a concentration of a substance in blood included in the blood in a subject portion of a living body, the substance-in-blood concentration measurement device (Abstract; Paragraph 0085) comprising:
a light emission unit that, condenses and emits a laser beam to a specific region in the subject portion, the specific region being present in skin located on the reverse side of the living body from a skin surface on a side of the living body facing the main surface (Paragraphs 0014 and 0076-0077: the light source which emits a light beam, or laser beam, into the body region of the subject which may be the skin of a user’s wrist; Fig. 2a: reference 202);
a photodetector that, receives signal light that is reflected light based on the laser beam, and detects an intensity of the signal light, the signal light having lower light intensity than the laser beam in some wavelengths (Paragraph 0072: the pixel detector array receives light from the object where the laser beam is focused; The received light is considered to inherent be of lower intensity in at least some wavelengths since it is reflected/scattered light);
an imaging lens that is disposed in a position between the subject portion and the photodetector where a focused image of the signal light from a laser-beam condensing region in the subject portion can be formed on the photodetector (Paragraph 0072: the pixel detector array and imaging optics; Fig. 1a and 2: references 112, 110, 108, 106, and points A and B; The pixel detector array is focused on plane 108 through lens 112. The light 106 on the focal plane is from the laser condensing region); and
a measurement controller that measures a concentration of the substance in blood in the laser-beam condensing region based on the intensity of the signal light (Paragraphs 0090-0091, 0119-0120; Blood parameters such as alcohol and glucose may be determined by the speckle pattern, or received light intensity), wherein
Zalevsky is further considered to at least suggest the limitation: a first angle formed by a normal to the surface of the skin of the subject portion and an optical path of the laser beam is different from a second angle formed by the normal and an optical path of the signal light from the laser-beam condensing region to the photodetector. This limitation is at least suggested by Figs. 1a-b and 2a. Fig. 2a illustrates the laser unit and beam (202 and 104) are at an angle to the surface of the skin (102). The photodetector (110) is further at an angle to the surface of the skin (102). Figs. 1a-b illustrate that the skin may change angles and such changes result in the shifting of the speckle pattern (106; Paragraph 0073-0074). Thus Fig. 1a and b illustrate that the angle between the skin and photodetector and thus also the skin and the laser emitter as illustrated in Fig. 2a, may change. Thus Zalevsky at least suggests configurations where a normal from the surface of the skin results in different angle between the normal and laser emitter and the photodetector.
Zalevsky fails to further teach or suggest the device comprising: a base having a main surface on which the living body can be placed and thus the light emitter and detector being on the main surface side of the base; the position of the living body relative to the light emission unit is set so that the laser-beam condensing region and a blood-vessel region inwards of the epidermis in the subject portion overlap, and the position of the photodetector relative to the living body is set so that an image of the signal light from the blood-vessel region overlapping the laser-beam condensing region is transferred by the imaging lens to form a focused image on a light receiving surface of the photodetector.
Iikubo teaches An apparatus for inspecting a function of an endothelium of a blood vessel of a living being the apparatus including an elbow-portion support member which supports an elbow portion of the living being; and a hand-dorsal-portion support member which supports a dorsal portion of a hand of the living being and which cooperates with the elbow-portion support member (Abstract). Thus, Iikubo is reasonably pertinent to the problem at hand.
Iikubo teaches a support member for supporting the elbow and hand during a procedure. The support member includes height adjusting mechanisms at both the elbow and the hand (Paragraphs 0061-0063; Fig. 11).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement a support stage as taught by Iikubo into the device of Zalevsky to support the bottom side of the particular portion of the body being imaging by Zalevsky because a support stage such as the one taught by Iikubo would allow the patient to rest their body onto the structure and remain still for imaging without interfering with the light path of Zalevsky while further providing the device with a means to adjust the positioning of the patient to best suit the particular measurements being performed.
Zalevsky in view of Iikubo fails to further teach the device wherein the position of the living body relative to the light emission unit is set so that the laser-beam condensing region and a blood-vessel region inwards of the epidermis in the subject portion overlap, and the position of the photodetector relative to the living body is set so that an image of the signal light from the blood-vessel region overlapping the laser-beam condensing region is transferred by the imaging lens to form a focused image on a light receiving surface of the photodetector.
Marchitto teaches various methods/systems of optical imaging of subsurface anatomical structures and biomolecules utilizing red and infrared radiant energy (Abstract). Thus, Marchitto falls within the same field of endeavor as Applicant’s invention.
Marchitto teaches a system that utilizes one or more imaging techniques to enhance imaging of ana anatomical structure or biomolecule (Paragraph 0024). The imaging technique may include pulsatile enhanced imaging which utilizes multiple wavelengths of light which correspond to different molecules having different characteristic absorbances (Paragraphs 0032-0033) Anatomic structures of interest may be illuminated with radiant energy such as is produced by a laser and the scattered photons may be used to detect biomolecules through means such as Raman spectroscopy (Paragraphs 0036-0037). Marchitto teaches that various types of imaging methods may be used to detect biomolecules (Paragraphs 0038-0051). Marchitto further teaches that the configuration of the emitters and detectors as well as their focal points may be optimized to suit the particular imaging method being utilized (Figs. 1A – 7F). The combination of different spectroscopic techniques and/or wavelengths of illumination may allow the system to locate an area of interest for a measurement such as a blood vessel from surrounding tissue and then interrogate the region of interest using the described spectral analysis techniques (Paragraph 0066)
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the combined usage of multiple spectroscopy types having various focal points for illumination and detection and use different wavelengths to detect different structures and molecules as taught by Marchitto into the device of Zalevsky in view of Iikubo because the use of one or more imaging techniques may improve the measurement accuracy of the body condition of interest of Zalevsky in view of Iikubo as Marchitto teaches that the use of one or more imaging techniques may enhance optical imaging of an anatomical structure or biomolecule (Marchitto: paragraph 0024).
Zalevsky in view of Iikubo further in view of Marchitto fails to further teach the device wherein the position of the living body relative to the light emission unit is set so that the laser-beam condensing region and a blood-vessel region inwards of the epidermis in the subject portion overlap, and the position of the photodetector relative to the living body is set so that an image of the signal light from the blood-vessel region overlapping the laser-beam condensing region is transferred by the imaging lens to form a focused image on a light receiving surface of the photodetector (As interpreted in light of the above presented 35 USC 112(b) rejections above, the “setting” of the probes requires active positioning)
Monfre teaches a targeting system used to direct a measuring system to a targeted sample site or volume. The targeting system increases analyte estimation performance by increasing precision and accuracy of sampling and/or by targeting an analyte rich tissue volume (Abstract). Thus, Monfre is reasonably pertinent to the problem at hand.
Monfre teaches a system having one or more probes which are associated with an actuator system and targeting system to optimize a multivariate response such as response due to chemical features or physical features to determine the optimal positioning of the probe(s) for measurement. The actuators may change the position of the probes in three dimensions as well as adjusting the rotation or tilt of the probe. The system may use closed loop feedback to determine the optimal position by moving the prove in various directions including towards and away from the measurement site to reach an optimal multivariate response (Paragraph 0096).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the actuators and feedback system of Monfre into the device of Zalevsky in view of Iikubo further in view of Marchitto because the actuators and feedback system of Monfre would allow the device of Zalevsky in view of Iikubo in view of Marchitto further in view of Monfre to change the position and angles of the emitter and detectors to find a configuration that optimizes the multivariate response for the parameter of interest (Monfre: Paragraph 0096) which may improve measurement accuracy.
Regarding claim 15 Zalevsky discloses a substance-in-blood concentration measurement method for measuring a concentration of a substance in blood included in the blood in a subject portion of a living body, the substance-in-blood concentration measurement method (Abstract; Paragraph 0085) comprising:
condensing and emitting a laser beam for a target measurement to a specific region in the subject portion by means of a light emission unit, the specific region being present in skin located on the reverse side of the living body from a skin surface on a side of the living body facing the main surface, (Paragraphs 0014 and 0076-0077: the light source which emits a light beam, or laser beam, into the body region of the subject which may be the skin of a user’s wrist; Fig. 2a: reference 202);
on the main surface-side of the base, using an imaging lens that is positioned between the subject portion and a photodetector to form a focused image of signal light on a photodetector (Paragraph 0072: the pixel detector array and imaging optics; Fig. 1a and 2: references 112, 110, 108, 106, and points A and B; The pixel detector array is focused on plane 108 through lens 112. The light 106 on the focal plane is from the laser condensing region), the signal light being reflected light of the laser beam, being emitted from a laser-beam condensing region in the subject portion, and having lower light intensity than the laser beam in some wavelengths (Paragraph 0072: the pixel detector array receives light from the object where the laser beam is focused; The received light is considered to inherent be of lower intensity in at least some wavelengths since it is reflected/scattered light); and
receiving the signal light by means of the photodetector and measuring a concentration of the substance in blood in the specific region based on the intensity of the received signal light (Paragraphs 0090-0091, 0119-0120; Blood parameters such as alcohol and glucose may be determined by the speckle pattern, or received light intensity).
Zalevsky is further considered to at least suggest the limitation a first angle formed by a normal to the surface of the skin of the subject portion and an optical path of the laser beam is different from a second angle formed by the normal and an optical path of the signal light from the specific region to the photodetector. This limitation is at least suggested by Figs. 1a-b and 2a. Fig. 2a illustrates the laser unit and beam (202 and 104) are at an angle to the surface of the skin (102). The photodetector (110) is further at an angle to the surface of the skin (102). Figs. 1a-b illustrate that the skin may change angles and such changes result in the shifting of the speckle pattern (106; Paragraph 0073-0074). Thus Fig. 1a and b illustrate that the angle between the skin and photodetector and thus also the skin and the laser emitter as illustrated in Fig. 2a, may change. Thus Zalevsky at least suggests configurations where a normal from the surface of the skin results in different angle between the normal and laser emitter and the photodetector.
Zalevsky fails to further teach or suggest the method comprising: placing the living body on a main surface of a base, and, emitting and receiving the light from the main surface-side of the base; the laser beam for the target measurement being absorbed by a substance in blood that is a measurement-target substance; the position of the living body relative to the light emission unit is set so that the laser-beam condensing region and a blood-vessel region inwards of the epidermis in the subject portion overlap, and; the position of the photodetector relative to the living body is set so that an image of the signal light from the blood-vessel region overlapping the laser-beam condensing region is transferred by the imaging lens to form a focused image on a light receiving surface of the photodetector.
Iikubo teaches a support member for supporting the elbow and hand during a procedure. The support member includes height adjusting mechanisms at both the elbow and the hand (Paragraphs 0061-0063; Fig. 11).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement a support stage as taught by Iikubo into the method of Zalevsky to support the bottom side of the particular portion of the body being imaging by Zalevsky because a support stage such as the one taught by Iikubo would allow the patient to rest their body onto the structure and remain still for imaging without interfering with the light path of Zalevsky while further providing the device with a means to adjust the positioning of the patient to best suit the particular measurements being performed.
Zalevsky in view of Iikubo fails to further teach the method wherein the laser beam for the target measurement being absorbed by a substance in blood that is a measurement-target substance; the position of the living body relative to the light emission unit is set so that the laser-beam condensing region and a blood-vessel region inwards of the epidermis in the subject portion overlap, and; the position of the photodetector relative to the living body is set so that an image of the signal light from the blood-vessel region overlapping the laser-beam condensing region is transferred by the imaging lens to form a focused image on a light receiving surface of the photodetector.
Marchitto teaches a system that utilizes one or more imaging techniques to enhance imaging of ana anatomical structure or biomolecule (Paragraph 0024). The imaging technique may include pulsatile enhanced imaging which utilizes multiple wavelengths of light which correspond to different molecules having different characteristic absorbances (Paragraphs 0032-0033) Anatomic structures of interest may be illuminated with radiant energy such as is produced by a laser and the scattered photons may be used to detect biomolecules through means such as Raman spectroscopy (Paragraphs 0036-0037). Marchitto teaches that various types of imaging methods may be used to detect biomolecules (Paragraphs 0038-0051). Marchitto further teaches that the configuration of the emitters and detectors as well as their focal points may be optimized to suit the particular imaging method being utilized (Figs. 1A – 7F). The combination of different spectroscopic techniques and/or wavelengths of illumination may allow the system to locate an area of interest for a measurement such as a blood vessel from surrounding tissue and then interrogate the region of interest using the described spectral analysis techniques (Paragraph 0066)
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the combined usage of multiple spectroscopy types having various focal points for illumination and detection and use different wavelengths to detect different structures and molecules as taught by Marchitto into the method of Zalevsky in view of Iikubo because the use of one or more imaging techniques may improve the measurement accuracy of the body condition of interest of Zalevsky in view of Iikubo as Marchitto teaches that the use of one or more imaging techniques may enhance optical imaging of an anatomical structure or biomolecule (Marchitto: paragraph 0024).
Zalevsky in view of Iikubo further in view of Marchitto fails to further teach the device wherein the position of the living body relative to the light emission unit is set so that the laser-beam condensing region and a blood-vessel region inwards of the epidermis in the subject portion overlap, and; the position of the photodetector relative to the living body is set so that an image of the signal light from the blood-vessel region overlapping the laser-beam condensing region is transferred by the imaging lens to form a focused image on a light receiving surface of the photodetector (As interpreted in light of the above presented 35 USC 112(b) rejections above, the “setting” of the probes requires active positioning).
Monfre teaches a system having one or more probes which are associated with an actuator system and targeting system to optimize a multivariate response such as response due to chemical features or physical features to determine the optimal positioning of the probe(s) for measurement. The actuators may change the position of the probes in three dimensions as well as adjusting the rotation or tilt of the probe. The system may use closed loop feedback to determine the optimal position by moving the prove in various directions including towards and away from the measurement site to reach an optimal multivariate response (Paragraph 0096).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the actuators and feedback system of Monfre into the method of Zalevsky in view of Iikubo further in view of Marchitto because the actuators and feedback system of Monfre would allow the method of Zalevsky in view of Iikubo in view of Marchitto further in view of Monfre to change the position and angles of the emitter and detectors to find a configuration that optimizes the multivariate response for the parameter of interest (Monfre: Paragraph 0096) which may improve measurement accuracy.
Claim 23 recites similar limitations to claim 15 and is rejected on the same basis as claim 15.
Regarding claims 2, 4, and 16, Zalevsky in view of Iikubo in view of Marchitto further in view of Monfre teaches the substance-in-blood concentration measurement device and method according to claims 1 and 15 respectively. Modified Zalevsky fails to further teach the device wherein the base is capable of adjusting the position of the living body relative to the light emission unit by changing the height of the main surface in a direction perpendicular to the main surface, or the device wherein the base is capable of adjusting the first angle and the second angle simultaneously by changing the angle of the main surface relative to the optical path of the laser beam within a plane that is defined by the optical path of the laser beam and the optical path from the subject portion to the photodetector.
Iikubo teaches a support mechanism which may adjust the height of the living body portion relative to the probe. The system of Iikubo may include two height adjustment mechanisms and thus may adjust the angle of the body portion by adjusting one of the heights relative to the other when the body portion if the portion of the body disposed between the supports (i.e. the forearm angle changes when the hand support is raised or lowered relative to the elbow support) (Paragraphs 0012-0014 and 0061-0062; Fig. 11 references 86 and 88).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement a support stage as taught by Iikubo into the device of modified Zalevsky to support the particular portion of the body being imaging by Zalevsky because a support stage such as the one taught by Iikubo would allow the patient to rest their body onto the structure and remain still for imaging while further providing the device with a means to adjust the positioning of the patient to best suit the particular measurements being performed at the specific location.
Regarding claim 18, Zalevsky in view of Iikubo in view of Marchitto further in view of Monfre teaches the substance-in-blood concentration measurement method claim 15. Modified Zalevsky fails to further teach the method further comprising prior to the target measurement, adjusting the first angle and the second angle simultaneously based on the concentration of the substance in blood by performing a reference measurement in which the concentration of the substance in blood in the specific region is measured while changing the angle of the main surface within a plane that is defined by the optical path of the laser beam and the optical path from the subject portion to the photodetector.
Iikubo teaches a support mechanism which may adjust the height of the living body portion relative to the probe. The system of Iikubo may include two height adjustment mechanisms and thus may adjust the angle of the body portion by adjusting one of the heights relative to the other when the body portion if the portion of the body disposed between the supports (i.e. the forearm angle changes when the hand support is raised or lowered relative to the elbow support) (Paragraphs 0012-0014 and 0061-0062; Fig. 11 references 86 and 88).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement a support stage as taught by Iikubo into the device of modified Zalevsky to support the particular portion of the body being imaging by Zalevsky because a support stage such as the one taught by Iikubo would allow the patient to rest their body onto the structure and remain still for imaging while further providing the device with a means to adjust the positioning of the patient to best suit the particular measurements being performed at the specific location.
Modified Zalevsky further in view of Iikubo thus teaches a support mechanism which may change the first and second angle simultaneously by changing the angle of the object, but fails to teach this adjustment being based on the concentration of the substance in blood by performing a reference measurement in which the concentration of the substance in blood in the specific region is measured
Monfre teaches a system having one or more probes which are associated with an actuator system and targeting system to optimize a multivariate response for responses due to chemical features or physical features to determine the optimal positioning of the probe(s) for measurement, or provide a focused image on the detectors which produces the maximal intensity measure of the analyte of interest. The actuators may change the position of the probes in three dimensions as well as adjusting the rotation or tilt of the probe. The system may use closed loop feedback to determine the optimal position by moving the prove in various directions including towards and away from the measurement site to reach an optimal multivariate response (Paragraph 0096).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the actuators and feedback system of Monfre into the device of modified Zalevsky in view of Iikubo such that the feedback system may be used to determine an optimal angle and position of the object in relation to the probe because adjustment of the angle and position of the object achieves the same effect as adjusting the angle and position of the probe. Thus the feedback system to determine an optimal measurement position of Monfre is readily applied to adjustment of the object position and angle relative to the probe to achieve the same affect. Such a feedback system provides the benefit of determining a configuration that optimizes the multivariate response for the parameter of interest (Monfre: Paragraph 0096) which may improve measurement accuracy.
Regarding claims 3, 5, 17, and 19, Zalevsky in view of Iikubo in view of Marchitto further in view of Monfre teaches the substance-in-blood concentration measurement device and method according to claims 1 and 15 respectively. Modified Zalevsky fails to further teach the device wherein the position of the photodetector relative to the living body in a direction intersecting the optical path of the signal light is capable of being adjusted by changing the position of the photodetector in said direction, or the device wherein the position of the photodetector relative to the living body in a direction along the optical path of the signal light is capable of being adjusted by changing the position of the photodetector in said direction, and the position of the photodetector is adjusted based on the concentration of the substance in blood so that the image of the signal light from the blood-vessel region is transferred by the imaging lens to form a focused image on the light receiving surface of the photodetector.
Monfre teaches a system having one or more probes which are associated with an actuator system and targeting system to optimize a multivariate response for responses due to chemical features or physical features to determine the optimal positioning of the probe(s) for measurement, or provide a focused image on the detectors which produces the maximal intensity measure of the analyte of interest. The actuators may change the position of the probes in three dimensions as well as adjusting the rotation or tilt of the probe. The system may use closed loop feedback to determine the optimal position by moving the prove in various directions including towards and away from the measurement site to reach an optimal multivariate response (Paragraph 0096).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the actuators and feedback system of Monfre into the device of modified Zalevsky because the actuators and feedback system of Monfre would allow the device of modified Zalevsky to adjust the position and angles of the emitter and detectors to find a configuration that optimizes the multivariate response for the parameter of interest (Monfre: Paragraph 0096) which may improve measurement accuracy.
Regarding claims 6-8 and 20-22, Zalevsky in view of Iikubo in view of Marchitto further in view of Monfre teaches the substance-in-blood concentration measurement device and method according to claims 1 and 18 respectively. Modified Zalevsky fails to further teach the device wherein the light emission unit is capable of selectively emitting: a first laser beam for a target measurement that is absorbed by a first substance in blood that is a measurement-target substance; and a second laser beam for a reference measurement that is absorbed by a second substance in blood that is a reference substance, and an absorption rate at which the second laser beam is absorbed by the second substance in blood in the reference measurement is higher than an absorption rate at which the first laser beam is absorbed by the first substance in blood in the target measurement. The device wherein a concentration of the reference substance in blood is more stable than a concentration of the measurement-target substance in blood, and the device wherein the measurement controller is capable of measuring, based on emission of the second laser beam, a concentration of the second substance in blood in a state in which the specific region is included in the blood-vessel region in the subject portion, and is capable of measuring, based on emission of the first laser beam, a concentration of the first substance in blood in the specific region as a concentration of the first substance in blood in the measurement-target portion.
Marchitto teaches a system that utilizes one or more imaging techniques to enhance imaging of ana anatomical structure or biomolecule (Paragraph 0024). The imaging technique may include pulsatile enhanced imaging which utilizes multiple wavelengths of light which correspond to different molecules having different characteristic absorbances (Paragraphs 0032-0033). Additionally, anatomic structures of interest may be illuminated with radiant energy in certain wavelengths such as is produced by a laser and the scattered photons may be used to detect biomolecules through means such as Raman spectroscopy (Paragraphs 0036-0037). Marchitto teaches that various types of imaging methods may be used to detect biomolecules (Paragraphs 0038-0051). Marchitto further teaches that the configuration of the emitters and detectors as well as their focal points may be optimized to suit the particular imaging method being utilized (Figs. 1A – 7F). The combination of different spectroscopic techniques and/or wavelengths of illumination may allow the system to locate an area of interest for a measurement such as a blood vessel from surrounding tissue by detecting hemoglobin (Paragraph 0033) and then interrogate the region of interest using the described spectral analysis techniques (Paragraph 0066). Thus Marchitto teaches the use of various wavelengths of illumination to detect different analytes such as oxy and deoxyhemoglobin, myoglobin, pharmaceuticals, liver enzymes, and glucose and can further be used to detect blood vessels and focus the system on said vessels rather than surrounding tissue. These different analytes have varying degrees of stability in the blood.
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the combined usage of multiple spectroscopy types and using different wavelengths to detect different structures and molecules as taught by Marchitto because the use of one or more imaging techniques may improve the measurement accuracy of the body condition of interest of modified Zalevsky as Marchitto teaches that the use of one or more imaging techniques may enhance optical imaging of an anatomical structure or biomolecule (Marchitto: paragraph 0024).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Zalevsky US Patent Application Publication Number US 2018/0110442 A1 hereinafter Zalevsky in view of Iikubo US Patent Application Publication Number US 2007/0060818 A1 hereinafter Iikubo, in view of Marchitto US Patent Application Publication Number US 2002/0016533 A1 hereinafter Marchitto, in view of Monfre US Patent Application Publication Number US 2006/0200017 A1 hereinafter Monfre as applied to claim 1 above and further in view of Yamakawa US Patent Application Publication Number US 2018/0000386 A1 hereinafter Yamakawa
Regarding claims 9-10 , Zalevsky in view of Iikubo in view of Marchitto further in view of Monfre teaches the substance-in-blood concentration measurement device according to claim 1. Modified Zalevsky further teaches the device wherein within a section from the base to the photodetector in the optical path from the subject portion to the photodetector, the signal light propagates through a space except within a section in which the signal light passes through the imaging lens, and within a section from the light emission unit to the base in the optical path from the light emission unit to the subject portion, the laser beam propagates through a space (Fig. 2a: the light passes through air to and from the subject portion except for the imaging lens).
Modified Zalevsky fails to further teach the device further comprising a condenser lens that is positioned between the light emission unit and the subject portion in the optical path of the laser beam, and that condenses the laser beam to the laser- beam condensing region and the device wherein the light from the light emission unit passes through space except within a section in which the laser beam passes through the condenser lens
Yamakawa teaches a non-invasive substance in blood concentration measurement device (Abstract). Thus Yamakawa falls within the same field of endeavor as Applicant’s invention.
Yamakawa teaches the use of a condenser lens to concentrate the laser light into a desired area (Paragraph 0059).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the condenser lens of Yamakawa into the device of modified Zalevsky because it allows the system to focus the light of the laser emitter into the desired region and is a simple substitution of one known element (the focusing mechanism of modified Zalevsky) for another known element (a condenser lens to focus the light) with no surprising technical effect.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Zalevsky US Patent Application Publication Number US 2018/0110442 A1 hereinafter Zalevsky in view of Iikubo US Patent Application Publication Number US 2007/0060818 A1 hereinafter Iikubo, in view of Marchitto US Patent Application Publication Number US 2002/0016533 A1 hereinafter Marchitto, in view of Monfre US Patent Application Publication Number US 2006/0200017 A1 hereinafter Monfre as applied to claim 1 above and further in view of Vaidya US Patent Application Publication Number US 2014/0155736 A1 hereinafter Vaidya.
Regarding claims 11-12 , Zalevsky in view of Iikubo in view of Marchitto further in view of Monfre teaches the substance-in-blood concentration measurement device according to claim 1. Modified Zalevsky fails to further disclose the device further comprising an image-capturing means that captures an image including the living body, wherein the measurement controller detects an image portion corresponding to the living body from the acquired image and calculates a positional deviation amount from a reference position where the image portion should be located, and the base is capable of changing the height of the main surface in a perpendicular direction so as to compensate for the positional deviation amount, and further comprising an image-capturing means that captures an image including the living body, wherein the measurement controller detects an image portion corresponding to the living body from the acquired image and calculates an angular deviation amount from a reference angle in which the image portion should be oriented, and the base is capable of changing the angle of the main surface with respect to the optical path of the laser beam so as to compensate for the angular deviation amount.
Vaidya teaches a method for automated landmarking comprising obtaining one or more localizer images of a patient, comparing the one or more localizer images with a reference image, computing a difference between the one or more localizer images and the reference image, determining a desired position of the patient based on the computed difference, and maneuvering the patient, a support platform, or both the patient and the support platform to the desired position for imaging an anatomical region of interest in the patient (Abstract). Thus, Vaidya is reasonably pertinent to the problem at hand.
Vaidya teaches a system for capturing an image of the subject, comparing the image to a reference image, and driving a support system to adjust the position of the patient to match the position in the reference image (Paragraphs 0022-0023).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the imaging comparison and use of the difference in position from a reference image to drive a support system as taught by Vaidya into the device of modified Zalevsky such that the support system of Iikubo incorporated into modified Zalevsky includes a camera and closed loop adjustment of patient position to match a reference as taught by Vaidya because incorporating this functionality may reduce the amount of time it takes for a physician to adjust the positioning of the patient to a desired state in order to obtain optimal measurements from the region of interest.
Claims 13-14 are not rejected over the prior art. Claims 13 and 14 are being interpreting to cover the corresponding structure described in the specification as described in the above presented claim interpretation section. The prior art of record does not teach or reasonably suggest a light-emission-angle adjustment mechanism as required by the claim.
Conclusion
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/MATTHEW ERIC OGLES/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791