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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/10/2023, 10/27/2023, and 07/09/2025 are being considered by the examiner.
Status of Claims
Claims 1-20 are currently pending and under examination.
Priority
The instant application (filed on 10/10/2023) is a continuation of PCT/JP2021/017201 (filed on 04/30/2021), filed under 35 USC 111(a). Acknowledgment is made of applicant's claim for domestic priority based on PCT/JP2021/017201. Instant claims 1-20 are sufficiently described in PCT/JP2021/017201 to receive an effective filing date of 04/30/2021. Therefore, all prior art will be evaluated with respect to this date.
Claim Objections
The following claims are objected to because of the following informalities:
• Claims 1, 9, and 17: The limitation “to which the a photo-responsive medical agent” contains both “the” and “a” as articles preceding “photo-responsive medical agent” (two instances in each claim)
• Claims 9 and 17: The term “photo-responsible” in the preamble may be intended to be “photo-responsive”
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 8-12, 14, and 16-20 are rejected under U.S.C 102(a)(1) and U.S.C 102(a)(2) as being anticipated by Svanberg (US PG Pub 2009/0099459, see “Notice of References Cited”)
Regarding Claim 1, Svanberg discloses a phototherapy assistance method for assisting phototherapy applied to an affected area ([0002]) using a photo-responsive medical agent ([0038] – sensitizers which respond to the treatment light), the phototherapy assistance method comprising:
• obtaining blood flow related information regarding blood flow of the affected area ([0019] – “device, when used, by analyzing a liquid flow in said tumour tissue”, [0002] – described as blood flow) based on reflected light of detection light that is irradiated onto the affected area when therapeutic light is being irradiated onto the affected area ([0019] – “The device comprises a first optical fibre for transmitting light between a light source, such as a laser, and said tumour tissue … and a second optical fibre that has a distal end interstitially inserted into a second position, different from said first position, of said tumour tissue for receiving light emitted from said first position at the distal end of said first optical fibre and transmitted therefrom through at least a part of said tissue from said first position and scattered in said tissue to said second position. Further, a proximal detector is arranged for receiving the light received from said tissue and transmitted there from via said second optical fibre for producing an output signal in dependence of the received light”), a wavelength of the detection light being different from that of the therapeutic light irradiated onto the affected area to which the a photo-responsive medical agent is applied ([0047] – instances where the wavelengths between the therapy and diagnostic light can be different: “The light radiation may be infrared light, near-infrared light (NIR) or visible light both in the therapy mode and the diagnostic mode”)
• generating progression degree related information regarding progression degree of the phototherapy in the affected area by associating the blood flow related information with the progression degree ([0017] – blood flow measurements are used to determine the effectiveness of therapy); and
• indicating the progression degree related information ([0068] – therapy progression displayed).
Therefore, Claim 1 is anticipated by Svanberg.
Regarding Claim 2, Svanberg anticipates the phototherapy assistance method according to Claim 1, as indicated hereinabove. Svanberg further discloses wherein
• the blood flow related information is one of a blood flow rate and a number of capillary vessels of the affected area which are used as a parameter for determination ([0017] – blood flow measurements are used to determine the effectiveness of therapy); and
• the progression degree related information can be obtained by determining whether or not the parameter for determination reaches a predetermined threshold ([0057] – “If the intensity A of any frequency component within said frequency range is above a predetermined threshold value, it is an indication of the presence of moving cells. If the intensity is below said threshold value, it is supposed that no moving cells are present, which is an indication of tissue necrosis or blood coagulation, i.e. how effective therapy is progressing”).
Therefore, Claim 2 is anticipated by Svanberg.
Regarding Claim 3, Svanberg anticipates the phototherapy assistance method according to Claim 2, as indicated hereinabove. Svanberg further discloses wherein the obtaining of the blood flow related information comprises:
• irradiating detection light ([0040] – “The diagnostic source may be a laser emitting light at a specific wavelength. Diagnostic light is passed from diagnostic light source 9a via fibre 7a to fibre 6a and to the tissue 8”) for detecting the blood flow rate or the number of the capillary vessels onto the affected area ([0017] – blood flow measurements are used to determine the effectiveness of therapy);
• detecting the detection light reflected by the affected area ([0041] – “The diagnostic light is emitted through the distal end of fibre 6a into the tissue 8 and is scattered inside the tissue. The scattered diagnostic light is picked up by the distal ends of the other fibres 6b and passed to diagnostic sensors arranged in a diagnostic sensor unit 12”); and
• calculating the blood flow rate or the number of the capillary vessels based on the detected detection light ([0048-0049] – moving particles in blood are quantified as a flow measurement from the scattered light received by the detector).
Therefore, Claim 3 is anticipated by Svanberg.
Regarding Claim 4, Svanberg anticipates the phototherapy assistance method according to Claim 3, as indicated hereinabove. Svanberg further discloses wherein
• the detecting the detection light includes detecting an amount of the detection light reflected by the affected area ([0041] – “The diagnostic light is emitted through the distal end of fibre 6a into the tissue 8 and is scattered inside the tissue. The scattered diagnostic light is picked up by the distal ends of the other fibres 6b and passed to diagnostic sensors arranged in a diagnostic sensor unit 12”, [0064] – amplitude of signal detected); and
• the calculating the blood flow rate or the number of the capillary vessels is to calculate the blood flow rate based on the amount of the detection light ([0048-0049] – moving particles in blood are quantified as a flow measurement from the scattered light received by the detector, [0064] – amplitude of signal detected).
Therefore, Claim 4 is anticipated by Svanberg.
Regarding Claim 5, Svanberg anticipates the phototherapy assistance method according to Claim 3, as indicated hereinabove. Svanberg further discloses wherein
• the detecting the detection light includes obtaining image information based on the detection light reflected by the affected area ([0043] – “The combined reply of the diagnostic sensors in unit 12 (FIG. 2) is evaluated and a diagnostic image of the tissue 8 (FIG. 1) is obtained. Such a diagnostic image may include information about the light flux through the tumour, the autofluorescence of the tissue, or a fluorescence signal”), and
• the blood flow related information is extracted from the image information ([0048-0049 – blood flow measured from scattered light from the image information).
Therefore, Claim 5 is anticipated by Svanberg.
Regarding Claim 8, Svanberg anticipates the phototherapy assistance method according to Claim 3, as indicated hereinabove. Svanberg further discloses wherein
• the detection light is a pulsed ([0021] – oscillations of light interpreted as pulsing) laser beam ([0018] – laser) having a wavelength reflected by blood ([0048] – detecting scattered light from blood), and
• calculating the blood flow rate or the number of the capillary vessels is to calculate the blood flow rate based on a shifted amount of a frequency of the detected detection light ([0048] – “During such scattering, a Doppler shift results, in case moving particles provide such a scattering. In case no moving particles are present in the tissue, no Doppler shift results. That means that when moving particles are present, by interference with light scattered by non-moving tissue, such as the walls of a blood vessel, or non-moving tumour tissue, interference signals are produced which are the sum and the difference, respectively, between the Doppler shifted light and the non-shifted light”).
Therefore, Claim 8 is anticipated by Svanberg.
Regarding Claim 9, Svanberg discloses a phototherapy assistance system for assisting phototherapy applied to the affected area ([0002]) using the photo-responsive medical agent ([0038] – sensitizers which respond to the treatment light), the phototherapy assistance device comprising:
• a blood flow related information obtaining section which obtains blood flow related information regarding blood flow of the affected area ([0019] – “device, when used, by analyzing a liquid flow in said tumour tissue”, [0002] – described as blood flow) based on reflected light of detection light that is irradiated onto the affected area when therapeutic light is being irradiated onto the affected area ([0019] – “The device comprises a first optical fibre for transmitting light between a light source, such as a laser, and said tumour tissue … and a second optical fibre that has a distal end interstitially inserted into a second position, different from said first position, of said tumour tissue for receiving light emitted from said first position at the distal end of said first optical fibre and transmitted therefrom through at least a part of said tissue from said first position and scattered in said tissue to said second position. Further, a proximal detector is arranged for receiving the light received from said tissue and transmitted there from via said second optical fibre for producing an output signal in dependence of the received light”), a wavelength of the detection light being different from that of the therapeutic light irradiated onto the affected area to which the a photo-responsive medical agent is applied ([0047] – instances where the wavelengths between the therapy and diagnostic light can be different: “The light radiation may be infrared light, near-infrared light (NIR) or visible light both in the therapy mode and the diagnostic mode”);
• an information generating section which associates the blood flow related information with progression degree of the phototherapy in the affected area to generate progression degree related information regarding the progression degree ([0017] – blood flow measurements are used to determine the effectiveness of therapy); and
• an indication section which indicates the progression degree related information ([0068] – therapy progression displayed).
Therefore, Claim 9 is anticipated by Svanberg.
Regarding Claim 10, Svanberg anticipates the phototherapy assistance system according to Claim 9, as indicated hereinabove. Svanberg further discloses wherein,
• the blood flow related information is one of a blood flow rate and a number of capillary vessels of the affected area which are used as a parameter for determination ([0017] – blood flow measurements are used to determine the effectiveness of therapy); and
• the information generating section obtains the progression degree related information by determining whether or not the parameter for determination reaches a predetermined threshold ([0057] – “If the intensity A of any frequency component within said frequency range is above a predetermined threshold value, it is an indication of the presence of moving cells. If the intensity is below said threshold value, it is supposed that no moving cells are present, which is an indication of tissue necrosis or blood coagulation, i.e. how effective therapy is progressing”).
Therefore, Claim 10 is anticipated by Svanberg.
Regarding Claim 11, Svanberg anticipates the phototherapy assistance system according to Claim 10, as indicated hereinabove. Svanberg further discloses wherein the blood flow related information obtaining section comprises:
• a detection light irradiation section which irradiates detection light ([0040] – “The diagnostic source may be a laser emitting light at a specific wavelength. Diagnostic light is passed from diagnostic light source 9a via fibre 7a to fibre 6a and to the tissue 8”) for detecting the blood flow rate or the number of the capillary vessels onto the affected area ([0017] – blood flow measurements are used to determine the effectiveness of therapy);
• a light detection section which detects the detection light reflected by the affected area ([0041] – “The diagnostic light is emitted through the distal end of fibre 6a into the tissue 8 and is scattered inside the tissue. The scattered diagnostic light is picked up by the distal ends of the other fibres 6b and passed to diagnostic sensors arranged in a diagnostic sensor unit 12”); and
• a calculation section which calculates the blood flow rate or the number of the capillary vessels based on the detection light detected by the light detection section ([0048-0049] – moving particles in blood are quantified as a flow measurement from the scattered light received by the detector).
Therefore, Claim 11 is anticipated by Svanberg.
Regarding Claim 12, Svanberg anticipates the phototherapy assistance system according to Claim 11, as indicated hereinabove. Svanberg further discloses wherein
• the light detection section detects an amount of the detection light reflected by the affected area ([0041] – “The diagnostic light is emitted through the distal end of fibre 6a into the tissue 8 and is scattered inside the tissue. The scattered diagnostic light is picked up by the distal ends of the other fibres 6b and passed to diagnostic sensors arranged in a diagnostic sensor unit 12”, [0064] – amplitude of signal detected); and
• the calculation section calculates the blood flow rate based on the amount of the detection light detected by the light detection section ([0048-0049] – moving particles in blood are quantified as a flow measurement from the scattered light received by the detector, [0064] – amplitude of signal detected).
Therefore, Claim 12 is anticipated by Svanberg.
Regarding Claim 14, Svanberg anticipates the phototherapy assistance system according to claim 11, as indicated hereinabove. Svanberg further discloses wherein the detection light is a pulsed light ([0021] – oscillations of light interpreted as pulsing) or light having a wavelength which is different from a therapeutic light ([0047] – instances where the wavelengths between the therapy and diagnostic light can be different: “The light radiation may be infrared light, near-infrared light (NIR) or visible light both in the therapy mode and the diagnostic mode”).
Therefore, Claim 14 is anticipated by Svanberg.
Regarding Claim 16, Svanberg anticipates the phototherapy assistance system according to claim 10, as indicated hereinabove. Svanberg further discloses comprising:
• a light amount adjustment section which adjusts an amount of therapeutic light irradiated onto the affected area ([0066] – “In this manner, a system is provided, where the therapy is locally adapted to the present flow distribution. On the other hand, regions of the tissue may in this manner be identified, where therapeutic radiation may be stopped, preventing disadvantageous patient damage due to over-radiation”),
• wherein the light amount adjustment section reduces the amount of the therapeutic light when the information generating section determines that the parameter for determination reaches a predetermined threshold ([0064] – the treatment light may be interrupted if a particular threshold is reached).
Therefore, Claim 14 is anticipated by Svanberg.
Regarding Claim 17, Svanberg discloses a processor ([0021] – computational elements used to control light and detector settings to analyze reflected light signals) for assisting phototherapy applied to the affected area ([0002]) using the photo-responsible medical agent ([0038] – sensitizers which respond to the treatment light), the phototherapy assistance device comprising:
• a blood flow related information obtaining section which obtains blood flow related information regarding blood flow of the affected area ([0019] – “device, when used, by analyzing a liquid flow in said tumour tissue”; [0002] – described as blood flow)) based on reflected light of detection light that is irradiated onto the affected area when therapeutic light is being irradiated onto the affected area ([0019] – “The device comprises a first optical fibre for transmitting light between a light source, such as a laser, and said tumour tissue … and a second optical fibre that has a distal end interstitially inserted into a second position, different from said first position, of said tumour tissue for receiving light emitted from said first position at the distal end of said first optical fibre and transmitted therefrom through at least a part of said tissue from said first position and scattered in said tissue to said second position. Further, a proximal detector is arranged for receiving the light received from said tissue and transmitted there from via said second optical fibre for producing an output signal in dependence of the received light”), a wavelength of the detection light being different from that of the therapeutic light irradiated onto the affected area to which the a photo-responsive medical agent is applied ([0047] – instances where the wavelengths between the therapy and diagnostic light can be different: “The light radiation may be infrared light, near-infrared light (NIR) or visible light both in the therapy mode and the diagnostic mode”);
• an information generating section which associates the blood flow related information with progression degree of the phototherapy in the affected area to generate progression degree related information regarding the progression degree ([0017] – blood flow measurements are used to determine the effectiveness of therapy); and
• an indication section which indicates the progression degree related information generated by the information generating section ([0068] – therapy progression displayed).
Therefore, Claim 17 is anticipated by Svanberg.
Regarding Claim 18, Svanberg anticipates the processor for assisting phototherapy according to Claim 17, as indicated hereinabove. Svanberg further discloses
• the blood flow related information is one of a blood flow rate and a number of capillary vessels of the affected area which are used as a parameter for determination ([0017] – blood flow measurements are used to determine the effectiveness of therapy); and
• the information generating section obtains the progression degree related information by determining whether or not the parameter for determination reaches a predetermined threshold ([0057] – “If the intensity A of any frequency component within said frequency range is above a predetermined threshold value, it is an indication of the presence of moving cells. If the intensity is below said threshold value, it is supposed that no moving cells are present, which is an indication of tissue necrosis or blood coagulation, i.e. how effective therapy is progressing”).
Therefore, Claim 18 is anticipated by Svanberg.
Regarding Claim 19, Svanberg anticipates the processor for assisting phototherapy according to Claim 18, as indicated hereinabove. Svanberg further discloses wherein the blood flow related information obtaining section comprises:
• a detection light irradiation section ([0040] – “The diagnostic source may be a laser emitting light at a specific wavelength. Diagnostic light is passed from diagnostic light source 9a via fibre 7a to fibre 6a and to the tissue 8”) which irradiates detection light for detecting the blood flow rate or the number of the capillary vessels onto the affected area ([0017] – blood flow measurements are used to determine the effectiveness of therapy);
• a light detection section which detects the detection light reflected by the affected area ([0041] – “The diagnostic light is emitted through the distal end of fibre 6a into the tissue 8 and is scattered inside the tissue. The scattered diagnostic light is picked up by the distal ends of the other fibres 6b and passed to diagnostic sensors arranged in a diagnostic sensor unit 12”); and
• a calculation section which calculates the blood flow rate or the number of the capillary vessels based on the detection light detected by the light detection section ([0048-0049] – moving particles in blood are quantified as a flow measurement from the scattered light received by the detector).
Therefore, Claim 19 is anticipated by Svanberg.
Regarding Claim 20, Svanberg anticipates the processor for assisting phototherapy according to Claim 19, as indicated hereinabove. Svanberg further discloses wherein
• the light detection section detects an amount of the detection light reflected by the affected area ([0041] – “The diagnostic light is emitted through the distal end of fibre 6a into the tissue 8 and is scattered inside the tissue. The scattered diagnostic light is picked up by the distal ends of the other fibres 6b and passed to diagnostic sensors arranged in a diagnostic sensor unit 12”, [0064] – amplitude of signal detected), and
• the calculation section calculates the blood flow rate based on the amount of the detection light detected by the light detection section ([0048-0049] – moving particles in blood are quantified as a flow measurement from the scattered light received by the detector, [0064] – amplitude of signal detected).
Therefore, Claim 20 is anticipated by Svanberg.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C.
103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 6-7 are rejected under U.S.C 103 as being unpatentable over Svanberg (US PG Pub 2009/0099459, see “Notice of References Cited”) in view of Phillips (US PG Pub 2020/0214579 A1, see “Notice of References Cited”).
Regarding Claim 6, Svanberg anticipates the phototherapy assistance method according to Claim 3, as indicated hereinabove. Svanberg discloses the use of visible light ([0047] – “The light radiation may be infrared light, near-infrared light (NIR) or visible light both in the therapy mode and the diagnostic mode”). However, Svanberg does not disclose the detection light includes blue light.
Phillips, in the same field of endeavor of measuring blood flow information ([0050]), teaches a variety of visible light wavelengths (including blue) use to measure blood flow characteristics ([0043] – “the at least one light source 106 includes a plurality of LEDs l07a-h each corresponding to a single color of a light spectrum (e.g., violet, blue, green, yellow, orange, red and infrared) such that the plurality of LEDs each corresponds to a different wavelength of light. In these embodiments, the different wavelength of light for each of the plurality of LEDs ranges from 425 nm to 1100 nm on the light spectrum”). Blue light is better able to revolve microcirculation in the capillaries ([0065] – “Also, the measurement of temporal variation in volume, quantity, flux, intensity, or magnitude of the pulse wave at different wavelengths using the same principal allows the measurement of the relative resistance of smaller capillaries at shallower depth as registered in the blue or green spectrum versus larger arterioles and arteries as registered in the red and infrared spectrum”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Svanberg’s method of using a flow detector during photodynamic therapy by incorporating the use of blue light for detection of blood flow properties in Phillips. This would have been obvious because both Svanberg and Phillips discuss measuring blood flow properties via visible light reflected from blood and Phillips provides a solution/improvement by using blue light’s shorter wavelength to measure microcirculation in the capillaries (which could be used to measure microcirculation in the tumor in Svanberg). Therefore, a person of ordinary skill in the art would be motivated to improve the method of Svanberg by incorporating the use of blue light for detection of blood flow propeties in Phillips
Therefore, Claim 6 is obvious over Svanberg in view of Phillips.
Regarding Claim 7, the phototherapy assistance method according to Claim 6 is obvious over Svanberg in view of Phillips, as indicated hereinabove. Svanberg discloses the use of visible light ([0047] – “The light radiation may be infrared light, near-infrared light (NIR) or visible light both in the therapy mode and the diagnostic mode”). However, Svanberg does not disclose the detection light further includes light having a longer wavelength than the blue light.
Phillips, in the same field of endeavor of measuring blood flow information ([0050]), teaches a variety of visible light wavelengths use to measure blood flow characteristics ([0043] – “the at least one light source 106 includes a plurality of LEDs l07a-h each corresponding to a single color of a light spectrum (e.g., violet, blue, green, yellow, orange, red and infrared) such that the plurality of LEDs each corresponds to a different wavelength of light. In these embodiments, the different wavelength of light for each of the plurality of LEDs ranges from 425 nm to 1100 nm on the light spectrum”). Light with higher wavelengths than blue light are able to travel deeper into the tissue to resolve bigger vessels ([0065] – “Also, the measurement of temporal variation in volume, quantity, flux, intensity, or magnitude of the pulse wave at different wavelengths using the same principal allows the measurement of the relative resistance of smaller capillaries at shallower depth as registered in the blue or green spectrum versus larger arterioles and arteries as registered in the red and infrared spectrum”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Svanberg’s method of using a flow detector during photodynamic therapy by incorporating the use of light with longer wavelengths than blue light for detection of blood flow properties in Phillips. This would have been obvious because both Svanberg and Phillips discuss measuring blood flow properties via light reflected from blood and Phillips provides a solution/improvement by using longer wavelength light to measure deeper vessels (which could be used to measure larger vessels in the tumor in Svanberg). Therefore, a person of ordinary skill in the art would be motivated to improve the method of Svanberg by incorporating the use of light with longer wavelengths than blue light for detection of blood flow properties in Phillips.
Therefore, Claim 7 is obvious over Svanberg in view of Phillips.
Claim 13 is rejected under U.S.C 103 as being unpatentable over Svanberg (US PG Pub 2009/0099459, see “Notice of References Cited”) in view of Ong (NPL, “Blood Flow Measurements Enable Optimization of Light Delivery for Personalized Photodynamic Therapy,” see “Notice of References Cited”).
Regarding Claim 13, Svanberg anticipates the phototherapy assistance system according to Claim 10, as indicated hereinabove. Svanberg discloses wherein the blood flow related information obtaining section sets the predetermined threshold ([0057]). However, Svanberg does not disclose a predetermined threshold based on the blood flow related information at a start of the phototherapy.
Ong, in the same field of endeavor of measuring tissue perfusion during photodynamic therapy (Abstract), teaches the measuring of reflected light from a tissue to characterize blood flow (Introduction, Pages 2-3 – “Noninvasive measurement of relative blood flow (rBF) in tumor is measured by diffuse correlation spectroscopy (DCS). This technology has been validated and employed for monitoring of blood flow in brain, skeletal muscle, and tumors, as well as for determination of vascular response during PDT. DCS is sensitive to flow in tumor microvasculature, i.e., tumor arterioles, capillaries, and venules, and it can be used in a noncontact configuration that permits continuous monitoring during PDT without interfering with treatment light delivery”). Baseline blood flow readings are used to normalize changes in blood flow during photodynamic therapy (Materials and Methods, Page 4 – “Relative blood flow (rBF) was calculated by normalizing the blood flow index (denoted BFi) measured at time t (i.e., BFi(t)) to the baseline flow measurements (BFi(0)); rBF(t) = BFi(t)/BFi(0) 100%. The percent change in rBF per minute (i.e., %rBFmin-1) or the slope of rBF was computed in real time by fitting a linear regression model to 72 rBF readings (~3.5 min of data). These parameters provided the source data for defining BFI-PDT light delivery and for in situ decisions about how light irradiances should be varied”). These blood measurements are controlled via irradiance settings and flow thresholds (Discussion, Page 14 – “However, continued refinement of treatment parameters, such as the choice of treatment irradiances and the threshold rBF slopes that trigger change in irradiances employed for BFI-PDT, are very likely to provide further improvements in response”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Svanberg’s system with a flow detector during photodynamic therapy by incorporating the use of baseline flows when determining flow thresholds for modifying photodynamic therapy in Ong. This would have been obvious because both Svanberg and Ong discuss measuring blood flow to control photodynamic therapy and Ong provides a solution/improvement by defining flow relative to baseline levels to better normalize flow changes during treatment. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Svanberg by incorporating the use of baseline flows when determining flow thresholds for modifying photodynamic therapy in Ong.
Therefore, Claim 13 is obvious over Svanberg in view of Ong.
Claim 15 is rejected under U.S.C 103 as being unpatentable over Svanberg (US PG Pub 2009/0099459, see “Notice of References Cited”) in view of Kumar (NPL, “PulseCam: a camera-based, motion-robust and highly sensitive blood perfusion imaging modality,” see “Notice of References Cited”).
Regarding Claim 15, Svanberg anticipates the phototherapy assistance system according to Claim 9, as indicated hereinabove. Svanberg discloses blood flow is quantified via the measurement of reflected light received by a detector ([0048-0049] – moving particles in blood are quantified as a flow measurement from the scattered light received by the detector). However, Svanberg does not disclose wherein the blood flow related information is a color of the affected area, wherein the blood flow related information obtaining section comprises:
• an image obtaining section which obtains a white light image of the affected area; and
• a color detection section which detects the color of the affected area from the white light image obtained by the image obtaining section.
Kumar, in the same field of endeavor of measuring blood flow information (Abstract, Page 1), teaches a white light video recording of tissue is used to detect flow based on tissue color (Page 1 – “we develop a novel camera-based, multi-sensor, motion-robust blood perfusion imaging modality, named PulseCam, that can reliably measure spatial maps and temporal trends of peripheral blood perfusion over the skin surface or internal tissue”; Results, Page 4 – “Figure 2(a) shows a schematic diagram of our experimental setup consisting of a CMOS color camera, a pulse oximeter, and two white LED light sources”). Reference flow readings (Figure 1, Page 2 – “PulseCam combines the video recording of the skin surface (or internal tissue) and a reference blood volume waveform to reliably obtain blood perfusion map over the entire imaged skin surface or tissue region”) and skin tone compensation (Results, Page 4 – “These variations are primarily due to varying level of melanin in the epidermal layer of the skin in participants of varying skin tones. To compensate for this variability, we performed a per-participant temporal normalization of the perfusion estimate by dividing the perfusion estimate with the mean perfusion in the first 20 second of the experiment”) are used to normalize data.
Regarding the deficiencies of existing technology, Kumar additionally teaches:
Specifically, Near-infrared Spectroscopy (NIRS) has been used to measure tissue oxygenation and hemoglobin concentration, and a pulse oximeter (PulseOx) is routinely used to measure arterial oxygen saturation (SpO2). Advanced PulseOx can also measure peripheral perfusion index (PPI) that is used in both research and clinical settings as a non-invasive marker of peripheral perfusion. Laser Doppler Flowmetry (LDF) is another popular modality used to measure micro-circulatory blood flow in tissue, especially to assess wound healing and for skin disease research. However, all of these contact-based optical modalities can only measure blood perfusion at a specific location on the skin surface, i.e., the point-of-contact, and their measurements are sensitive to the exact placement of the probe. The high spatial variability in blood perfusion across tissue such as the skin limits the clinical utility of such single point contact-based modalities. (Page 1)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Svanberg’s system with a flow detector during photodynamic therapy by incorporating the determination of tissue blood flow by surface analysis of video in Kumar. This would have been obvious because both Svanberg and Kumar discuss measuring blood flow properties via light reflections and Kumar provides a solution/improvement with blood flow determinations over a wider area to account for region-specific changes in blood flow surrounding the treatment area in Svanberg. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Svanberg by incorporating the determination of tissue flow by surface analysis of video in Kumar.
Therefore, Claim 15 is obvious over Svanberg in view of Kumar.
Contact Information
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/Benjamin A. Schmitt/
Examiner
Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796