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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-5, 9-10, & 13-14 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claims 6-7, & 9 objected to because of the following informalities:
Claim 6 recites “and/or”, should instead recite “and” or “or”.
Claim 7 recites “and/or”, should instead recite “and” or “or”.
Claim 9 recites “and/or”, should instead recite “and” or “or”.
. Appropriate correction is required.
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: “an irradiation unit configured to irradiate” interpreted as being a light in claim 1 ; “an imaging unit configured to capture an image” interpreted as being a camera in claims 1 & 13.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 9-10, & 13 are rejected under 35 U.S.C. 103 as being unpatentable over Yada et al (JP2006102360A; hereinafter referred to as Yada) in view of Wood et al (US20190239798A1; hereinafter referred to as Wood).
Regarding Claim 1, Yada discloses a blood vessel visualization device for visualizing a blood vessel of a living body (“A biological information presentation apparatus capable of accurately and quickly confirming biological feature information such as the position and direction of a blood vessel with a simple operation” [Abstract], the blood vessel visualization device comprising:
an first light source configured to irradiate a target site of the living body with light having a wavelength capable of passing through an inside of the living body, wherein a plurality of blood vessels exist inside the target site (“ The biological information presentation apparatus according to the present invention presents biological feature information as an image, and illuminates illumination light having a predetermined wavelength for photographing the feature information onto the biological body, and photographs the biological body” [Pg. 3];
an imaging unit configured to capture an image of the target site irradiated with the light (“Imaging means for acquiring biometric captured image information, image processing means for detecting the feature information based on the biometric captured image information, and converting the detected feature information into imaged projection image information, and the projection Projecting means for projecting a projected image based on image information onto the surface of the living body.” [Pg. 3];
a projector (“ The projection unit 404 generates projection light 423 to be projected on the surface of the living body based on the projection image information 414 from the image processing unit 403. The projected image information 414 is an image enhancement of a blood vessel image based on near-infrared image information.” [Pg. 5-6]);
and a processor (“The image processing means 403 detects biological feature information based on the biological captured image information 413, converts the detected feature information into blood vessel projection image information, and is realized mainly by a processor that executes a predetermined program.” [Pg. 6]) programmed to:
generate, using the image of the target site captured by the imaging unit, an entire blood vessel image obtained by visualizing the plurality of blood vessels that exist inside the target site (“ The feature extraction unit 801 generates feature information by extracting features of the biometric image information 413 input from the imaging unit. As will be described in detail later, as feature information, blood vessel pattern information related to a blood vessel route and a blood vessel branch point, optimal puncture region information that means a high linearity and thick region in the blood vessel pattern information, and affixed to the arm Special seal position information is included.” [Pg. 8]),
cause the projector to display the entire blood vessel image on the target site (“The feature extraction unit 801 extracts the features of the blood vessel image projected on the arm from the visible image information to generate blood vessel pattern information, and stores the blood vessel pattern information in the visible feature information storage unit 806… The corrected image information is updated and stored in the blood vessel emphasized image storage unit 803 as new blood vessel emphasized image information, and the stored blood vessel emphasized image information is selected by the selector unit 804 and projected as projection image information 414. 404 is projected to the arm 109 by the projection means 404.” [Pg. 9]),
select, using the image of the target site captured by the imaging unit, a puncturing blood vessel site optimal for puncturing (“in the biological information presentation device according to the present invention, the feature information generated by the feature extraction unit is a position shape of a blood vessel, a blood vessel branch point, a position of an image of a special sticker attached to a living body, or an optimum puncture region.” [Pg. 4], “ The optimal puncture region extracted in this manner may be superimposed on the blood vessel emphasized image information stored in the blood vessel emphasized image storage unit 803 and projected onto the arm 109, for example.” [Pg. 12]),
Yada does not specifically disclose that cause the projector to stop displaying the entire blood vessel image on the target site, and while the display of the entire blood vessel image is stopped, perform at least one of (i) causing the projector to highlight the selected puncturing blood vessel site, or (ii) causing a second light source to irradiate with a light beam a puncture position based on the puncturing blood vessel site.
However, in a similar field of endeavor, Wood teaches a miniature vein enhancer is operated in one of three modes to project an image of a patient's veins onto the imaged body region, aiding a practitioner in pinpointing veins for a venipuncture procedure [Abstract].
Wood also teaches to cause the projector to stop displaying the entire blood vessel image on the target site, and while the display of the entire blood vessel image is stopped, perform at least one of (i) causing the projector to highlight the selected puncturing blood vessel site, or (ii) causing a second light source to irradiate with a light beam a puncture position based on the puncturing blood vessel site (“The present invention is directed to technologies and processes associated with the use of one or more moving laser light sources to detect the presence of blood-filled structures, such as venous or arterial structures, below the surface of the skin and to project an image back on to the skin that shows the operator the pattern of detected structures.” [0011], “Since veins are linear structures, a novel technique can be used to accurately identify veins and to separately highlight one or more veins and ignore others without using image memory or signal processing techniques.” [0259], “A user interface can be implemented allowing the user to select a number of veins to detect simultaneously and to switch focus from vein to vein. Also, the user could control the width of the window to optimize the detection of the vein. Additionally, the user can turn this feature on and off so that they can either see all veins or just a specific vein or veins. Since there is inherent directionality to the procedure, the user can rotate the scanner to see only those veins at a particular orientation.” [0264])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Yada as outlined above with cause the projector to stop displaying the entire blood vessel image on the target site, and while the display of the entire blood vessel image is stopped, perform at least one of (i) causing the projector to highlight the selected puncturing blood vessel site, or (ii) causing a second light source to irradiate with a light beam a puncture position based on the puncturing blood vessel site as taught by Wood, because it is essential to stick a vein in exactly the right location [0004].
Regarding Claim 2, Yada discloses all limitations noted above except that the processor is programmed to, while the display of the entire blood vessel image is stopped, cause the projector to highlight the selected puncturing blood vessel site.
However, in a similar field of endeavor, Wood teaches the processor is programmed to, while the display of the entire blood vessel image is stopped, cause the projector to highlight the selected puncturing blood vessel site (“The present invention is directed to technologies and processes associated with the use of one or more moving laser light sources to detect the presence of blood-filled structures, such as venous or arterial structures, below the surface of the skin and to project an image back on to the skin that shows the operator the pattern of detected structures.” [0011], “Since veins are linear structures, a novel technique can be used to accurately identify veins and to separately highlight one or more veins and ignore others without using image memory or signal processing techniques.” [0259], “A user interface can be implemented allowing the user to select a number of veins to detect simultaneously and to switch focus from vein to vein. Also, the user could control the width of the window to optimize the detection of the vein. Additionally, the user can turn this feature on and off so that they can either see all veins or just a specific vein or veins. Since there is inherent directionality to the procedure, the user can rotate the scanner to see only those veins at a particular orientation.” [0264])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Yada as outlined above with the processor is programmed to, while the display of the entire blood vessel image is stopped, cause the projector to highlight the selected puncturing blood vessel site as taught by Wood, because it is essential to stick a vein in exactly the right location [0004].
Regarding Claim 9, Yada discloses that the processor is programmed to: detect a motion vector of the living body based on the image, and to use the motion vector to cause the projector to perform the highlighting and/or cause the second light source to perform the irradiation following a motion of the living body (“When the living body moves or shakes, in the near-infrared image captured at the next time, the positions of the blood vessels 701 and 702 move to the blood vessels 711 and 712, respectively, and similarly, the blood vessel branch point 703 moves to the blood vessel branch point 713. The special seal image itself also moves from the special seal image 704 to the special seal image 714. Similarly, when the feature extraction unit 801 detects the pixel position of the special seal image 714 or the blood vessel branch point 713 in the captured image region 700, the feature extraction unit 801 stores the special seal image 714 stored in the near infrared feature information first storage unit 805. After the pixel position of the seal image 704 or the blood vessel branch point 703 is stored in the near infrared feature information second storage unit 810, the pixel position of the special seal image 714 or the blood vessel branch point 713 is stored in the near infrared feature information first memory. The data is stored in the means 805. Next, the misalignment detection unit 808 detects the special seal from the position of the special seal image 704 based on the information stored in the near infrared feature information first storage unit 805 and the near infrared feature information second storage unit 810. A vector to the position of the image 714 or a vector from the position of the blood vessel branch point 703 to the position of the blood vessel branch point 713 is calculated. For example, if the position of the blood vessel branch point 713 is shifted by 50 pixels in the horizontal left direction and 20 pixels in the vertical downward direction with respect to the position of the blood vessel branch point 703, the positional shift vector is (−50, +20). The position shift vector detected in this way is used for correcting the blood vessel emphasized image information stored in the blood vessel emphasized image storage unit 803. That is, the image correction unit 809 uses the blood vessel enhancement image information obtained by shifting the blood vessel enhancement image information stored in the blood vessel enhancement image storage unit 803 by the position shift vector as the blood vessel enhancement image information after motion correction. It is updated and stored in the image storage means 803 and transferred to the projection means 404 as projection image information 414.” [Pg. 11-12]).
Regarding Claim 10, Yada discloses the processor is programmed to acquire at least one or more parameters of straightness, length, thickness, depth, and extension direction of a plurality of blood vessel sites of the target site based on the image, and to select a blood vessel site of which the acquired parameter is equal to or greater than a threshold as the puncturing blood vessel site (“The feature extraction unit 801 generates feature information by extracting features of the biometric image information 413 input from the imaging unit. As will be described in detail later, as feature information, blood vessel pattern information related to a blood vessel route and a blood vessel branch point, optimal puncture region information that means a high linearity and thick region in the blood vessel pattern information, and affixed to the arm Special seal position information is included. “ [Pg. 8], “Next, in order to extract a region suitable for puncture, a plurality of points with high linearity of the dotted line connecting the center positions are extracted as sublists from each blood vessel list, and the average of the thickness of the blood vessels in each sublist N sub-lists (N is a natural number) are selected in order from the largest value. The area specified by the sublist selected in this way is set as an area suitable for puncture. In this example, two sublists are selected as the optimum puncture areas 611 and 612.” [Pg. 12]).
Regarding Claim 13, Yada discloses A blood vessel visualization method for visualizing a blood vessel of a living body(“A biological information presentation apparatus capable of accurately and quickly confirming biological feature information such as the position and direction of a blood vessel with a simple operation” [Abstract]), the blood vessel visualization method comprising:
irradiating, with a first light source, a target site of the living body with light having a wavelength capable of passing through an inside of the living body, wherein a plurality of blood vessels exist inside the target site (“ The biological information presentation apparatus according to the present invention presents biological feature information as an image, and illuminates illumination light having a predetermined wavelength for photographing the feature information onto the biological body, and photographs the biological body” [Pg. 3];
capturing, with an imaging unit, an image of the target site irradiated with the light (“Imaging means for acquiring biometric captured image information, image processing means for detecting the feature information based on the biometric captured image information, and converting the detected feature information into imaged projection image information, and the projection Projecting means for projecting a projected image based on image information onto the surface of the living body.” [Pg. 3];
using a processor (“The image processing means 403 detects biological feature information based on the biological captured image information 413, converts the detected feature information into blood vessel projection image information, and is realized mainly by a processor that executes a predetermined program.” [Pg. 6]):
generating, using the image of the target site captured by the imaging unit, an entire blood vessel image obtained by visualizing the plurality of blood vessels that exist inside the target site (“ The feature extraction unit 801 generates feature information by extracting features of the biometric image information 413 input from the imaging unit. As will be described in detail later, as feature information, blood vessel pattern information related to a blood vessel route and a blood vessel branch point, optimal puncture region information that means a high linearity and thick region in the blood vessel pattern information, and affixed to the arm Special seal position information is included.” [Pg. 8]),
causing a projector to display the entire blood vessel image on the target site (“The projection unit 404 generates projection light 423 to be projected on the surface of the living body based on the projection image information 414 from the image processing unit 403. The projected image information 414 is an image enhancement of a blood vessel image based on near-infrared image information.” [Pg. 5-6], “The feature extraction unit 801 extracts the features of the blood vessel image projected on the arm from the visible image information to generate blood vessel pattern information, and stores the blood vessel pattern information in the visible feature information storage unit 806… The corrected image information is updated and stored in the blood vessel emphasized image storage unit 803 as new blood vessel emphasized image information, and the stored blood vessel emphasized image information is selected by the selector unit 804 and projected as projection image information 414. 404 is projected to the arm 109 by the projection means 404.” [Pg. 9]),
selecting, using the image of the target site captured by the imaging unit, a puncturing blood vessel site optimal for puncturing (“in the biological information presentation device according to the present invention, the feature information generated by the feature extraction unit is a position shape of a blood vessel, a blood vessel branch point, a position of an image of a special sticker attached to a living body, or an optimum puncture region.” [Pg. 4], “ The optimal puncture region extracted in this manner may be superimposed on the blood vessel emphasized image information stored in the blood vessel emphasized image storage unit 803 and projected onto the arm 109, for example.” [Pg. 12]),
Yada does not specifically disclose that causing the projector to stop displaying the entire blood vessel image on the target site, andwhile the display of the entire blood vessel image is stopped, performing at least one of (i) causing the projector to highlight the selected puncturing blood vessel site, or (ii) causing a second light source to irradiate with a light beam a puncture position based on the puncturing blood vessel site.
However, in a similar field of endeavor, Wood teaches a miniature vein enhancer is operated in one of three modes to project an image of a patient's veins onto the imaged body region, aiding a practitioner in pinpointing veins for a venipuncture procedure [Abstract].
Wood also teaches causing the projector to stop displaying the entire blood vessel image on the target site, andwhile the display of the entire blood vessel image is stopped, performing at least one of (i) causing the projector to highlight the selected puncturing blood vessel site, or (ii) causing a second light source to irradiate with a light beam a puncture position based on the puncturing blood vessel site (“The present invention is directed to technologies and processes associated with the use of one or more moving laser light sources to detect the presence of blood-filled structures, such as venous or arterial structures, below the surface of the skin and to project an image back on to the skin that shows the operator the pattern of detected structures.” [0011], “Since veins are linear structures, a novel technique can be used to accurately identify veins and to separately highlight one or more veins and ignore others without using image memory or signal processing techniques.” [0259], “A user interface can be implemented allowing the user to select a number of veins to detect simultaneously and to switch focus from vein to vein. Also, the user could control the width of the window to optimize the detection of the vein. Additionally, the user can turn this feature on and off so that they can either see all veins or just a specific vein or veins. Since there is inherent directionality to the procedure, the user can rotate the scanner to see only those veins at a particular orientation.” [0264])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Yada as outlined above with causing the projector to stop displaying the entire blood vessel image on the target site, andwhile the display of the entire blood vessel image is stopped, performing at least one of (i) causing the projector to highlight the selected puncturing blood vessel site, or (ii) causing a second light source to irradiate with a light beam a puncture position based on the puncturing blood vessel site as taught by Wood, because it is essential to stick a vein in exactly the right location [0004].
Claims 3 & 8 are rejected under 35 U.S.C. 103 as being unpatentable over Yada in view of Wood as applied to Claim 1 above, and further in view of Feeney (US20210393194A1)
Regarding Claim 3, Yada in view of Wood discloses all limitations noted above except that the processor is programmed to, while the display of the entire blood vessel image is stopped, cause the second light source to irradiate with the light beam the puncture position based on the puncturing blood vessel site.
However, in a similar field of endeavor, Feeney teaches
Feeney also teaches the processor is programmed to, while the display of the entire blood vessel image is stopped, cause the second light source to irradiate with the light beam the puncture position based on the puncturing blood vessel site (“FIG. 7 shows an example co-registration illumination system 700 to include subsystem 12, imaging subsystem 14, and image processing 15 means of captured imaged areas 20 (i e., of an arm's 16 desired vein structure 18). The operator can visualize the vein 18 structure via some monitor 24 screen, as known to those skilled in the art, either attached or detached from the imaging subsystem 14. The co-registration itself is enabled via a projection subsystem 13 for marker location of an area. In particular, to enhance the ability of the operator to correlate the image to the visual perception, specific markers (i e., crosshairs 23, as shown in FIG. 7) on the arm 16, veins 18, can be used that are projected on the imaged area 20, as shown in the left lower depiction 26 of FIG. 7 and displayed on the monitor 24 (or correlated to a specific location within the image presented in the monitor, such as the center of the image), as shown in the right lower depiction 28 of FIG. 7. This can include but is not limited to, low power laser sources such as one or more red laser pointer(s) that help establish this correlation.” [0056]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Yada in view of Wood as outlined above with the processor is programmed to, while the display of the entire blood vessel image is stopped, cause the second light source to irradiate with the light beam the puncture position based on the puncturing blood vessel site as taught by Feeney, because it can be used to allow the user to associate the visual perception with the images obtained by the system [0057].
Regarding Claim 8, Yada discloses all limitations noted above except that the processor is configured to cause the projector to initially highlight at least the puncturing blood vessel site, and subsequently cause the projector end the highlighting of the puncturing blood vessel site and cause the second light source to begin or continue the irradiation of the puncture position.
However, in a similar field of endeavor, Wood teaches that the processor is configured to cause the projector to initially highlight at least the puncturing blood vessel site, and subsequently cause the projector end the highlighting of the puncturing blood vessel site (“The present invention is directed to technologies and processes associated with the use of one or more moving laser light sources to detect the presence of blood-filled structures, such as venous or arterial structures, below the surface of the skin and to project an image back on to the skin that shows the operator the pattern of detected structures.” [0011], “Since veins are linear structures, a novel technique can be used to accurately identify veins and to separately highlight one or more veins and ignore others without using image memory or signal processing techniques.” [0259], “A user interface can be implemented allowing the user to select a number of veins to detect simultaneously and to switch focus from vein to vein. Also, the user could control the width of the window to optimize the detection of the vein. Additionally, the user can turn this feature on and off so that they can either see all veins or just a specific vein or veins. Since there is inherent directionality to the procedure, the user can rotate the scanner to see only those veins at a particular orientation.” [0264])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Yada as outlined above with the processor is configured to cause the projector to initially highlight at least the puncturing blood vessel site, and subsequently cause the projector end the highlighting of the puncturing blood vessel site as taught by Wood, because it is essential to stick a vein in exactly the right location [0004].
Yada in view of Wood does not specifically teach cause the second light source to begin or continue the irradiation of the puncture position.
However, in a similar field of endeavor, Feeney teaches that cause the second light source to begin or continue the irradiation of the puncture position (“FIG. 7 shows an example co-registration illumination system 700 to include subsystem 12, imaging subsystem 14, and image processing 15 means of captured imaged areas 20 (i e., of an arm's 16 desired vein structure 18). The operator can visualize the vein 18 structure via some monitor 24 screen, as known to those skilled in the art, either attached or detached from the imaging subsystem 14. The co-registration itself is enabled via a projection subsystem 13 for marker location of an area. In particular, to enhance the ability of the operator to correlate the image to the visual perception, specific markers (i e., crosshairs 23, as shown in FIG. 7) on the arm 16, veins 18, can be used that are projected on the imaged area 20, as shown in the left lower depiction 26 of FIG. 7 and displayed on the monitor 24 (or correlated to a specific location within the image presented in the monitor, such as the center of the image), as shown in the right lower depiction 28 of FIG. 7. This can include but is not limited to, low power laser sources such as one or more red laser pointer(s) that help establish this correlation.” [0056]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Yada in view of Wood as outlined above with the cause the second light source to begin or continue the irradiation of the puncture position as taught by Feeney, because it can be used to allow the user to associate the visual perception with the images obtained by the system [0057].
Claim 6 are rejected under 35 U.S.C. 103 as being unpatentable over Yada in view of Wood as applied to Claim 1 above, and further in view of Luciano et al (US20110125028A1; hereinafter referred to as Luciano).
Regarding Claim 6, Yada in view of Wood discloses all limitations noted above except that the processor is programmed to cause the projector to stop the highlighting and/or cause the second light source to stop the irradiation when a predetermined period of time elapses after the highlighting is performed.
However, in a similar field of endeavor, Luciano teaches A portable vein viewer apparatus may be battery powered and hand-held to reveal patient vasculature information to aid in venipuncture processes [Abstract].
Luciano also teaches that the processor is programmed to cause the projector to stop the highlighting and/or cause the second light source to stop the irradiation when a predetermined period of time elapses after the highlighting is performed (“FIG. 17 is a series of screen shots of the LCD display illustrating changing of the Display Time-out interval.” [0021]).
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It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Yada in view of Wood as outlined above with the processor is programmed to cause the projector to stop the highlighting and/or cause the second light source to stop the irradiation when a predetermined period of time elapses after the highlighting is performed as taught by Luciano, because it preserves battery power [Fig. 17].
Claim 7 are rejected under 35 U.S.C. 103 as being unpatentable over Yada in view of Wood as applied to Claim 1 above, and further in view of Aharoni et al (US20160256101A1; hereinafter referred to as Aharoni).
Regarding Claim 7, Yada in view of Wood discloses all limitations noted above except that the processor is programmed to recognize a position of a puncture needle based on the image, wherein the processor is programmed to cause the projector to stop the highlighting and/or cause the second light source to stop the irradiation when the recognized puncture needle comes into contact with the puncturing blood vessel site or the puncture position.
However, in a similar field of endeavor, Aharoni teaches vein visualization systems and in particular to a vein visualization system for the assistance in the insertion of hypodermic needles and catheters in venipuncture [0001].
Aharoni also teaches that the processor is programmed to recognize a position of a puncture needle based on the image, wherein the processor is programmed to cause the projector to stop the highlighting and/or cause the second light source to stop the irradiation when the recognized puncture needle comes into contact with the puncturing blood vessel site or the puncture position (“ the light emanating point clearly marks the position of the tip of the needle, so that the position of the tip relative to the vein can be visualized… as the light emanating point draws near to the target vein the traverse dimension of the illuminating halo decreases monotonically as a larger portion of illumination cone 19 is blocked directly by the absorbing blood in the vein. Indeed, when the tip of the needle is just at the front wall of the vein, a large portion of the illumination 19 is absorbed by the blood inside the vein, with essentially all the illumination being blocked once the needle's tip pierces the front wall of the vein and the point from which the illumination cone 19 emanates is immersed in blood.” [0036]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Yada in view of Wood as outlined above with the processor is programmed to recognize a position of a puncture needle based on the image, wherein the processor is programmed to cause the projector to stop the highlighting and/or cause the second light source to stop the irradiation when the recognized puncture needle comes into contact with the puncturing blood vessel site or the puncture position as taught by Aharoni, because it facilitates the accurate guidance of the needle tip towards the selected vein [0036].
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Yada in view of Wood as applied to Claim 10 above, and further in view of Breteau et al (US20230293827A1; hereinafter referred to as Breteau).
Regarding Claim 11, Yada discloses all limitations noted above except that the selection unit is programmed to: change and re-select the threshold in a case where there are multiple selected puncturing blood vessel sites of which the acquired parameter is equal to or greater than a threshold, and change and re-select the threshold in a case where there is no selected puncturing blood vessel site of which the acquired parameter is equal to or greater than the threshold.
However, in a similar field of endeavor, Breteau teaches a method for determining at least one optimal insertion segment in a limb of a patient for inserting a needle into a vein of the patient,
Breteau also teaches that the selection unit is programmed to: change and re-select the threshold in a case where there are multiple selected puncturing blood vessel sites of which the acquired parameter is equal to or greater than a threshold, and change and re-select the threshold in a case where there is no selected puncturing blood vessel site of which the acquired parameter is equal to or greater than the threshold (“the predetermined classification parameters for classifying the insertion segments are selected from one or more parameters from the following list: the location of the segment with respect to a known pattern of positions of blood vessels on the part of the body of the patient; the average density of all of the points of the blood vessel included within contours of the blood vessel corresponding to the segment, calculated on the vascular profile map; the length of the segment; the depth of the blood vessel in the segment; the diameter of the blood vessel in the segment; the orientation of the segment; the presence or absence of irregularities on the skin on the insertion segment; a preference of the patient; a previous insertion history for the same patient. the classification of the insertion segments depends on one or more parameters, optionally weighted, so as to provide optimised determination of the optimal insertion segment, in particular for maximising the chances of success of insertion of the needle and for limiting as well as possible the safety risks.” [0037-0047])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Yada as outlined above with that the selection unit is programmed to: change and re-select the threshold in a case where there are multiple selected puncturing blood vessel sites of which the acquired parameter is equal to or greater than a threshold, and change and re-select the threshold in a case where there is no selected puncturing blood vessel site of which the acquired parameter is equal to or greater than the threshold as taught by Breteau, because it would maximise the chances of success of insertion of the needle and for limiting as well as possible the safety risks [0047].
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Yada in view of Wood as applied to Claim 1 above, and further in view of Peng et al (CN 112022346 A; hereinafter referred to as Peng).
Regarding Claim 12, Yada in view of Wood discloses all limitations noted above except a machine learning model programmed to use the image as input data and to output, as output data, puncture success rates of a plurality of blood vessel sites of the target site shown in the image, wherein: the selection unit is programmed to select a blood vessel site having a puncture success rate higher than a threshold as the puncturing blood vessel site.
However, in a similar field of endeavor, Peng teaches a control method of a fully automatic venipuncture identification [Technical Field]
Peng also teaches a machine learning model programmed to use the image as input data and to output, as output data, puncture success rates of a plurality of blood vessel sites of the target site shown in the image, wherein: the selection unit is programmed to select a blood vessel site having a puncture success rate higher than a threshold as the puncturing blood vessel site (“The monocular near-infrared camera continuously obtains the two-dimensional near-infrared image of the target, and scores the blood vessels identified in the two-dimensional infrared image through the image neural network, and takes the vein with the highest score as the target blood vessel… Score the blood vessel segmentation map based on Bayes' theorem, which regards the probability of simultaneous occurrence of independent events as the product of the respective occurrence probabilities of the two events” [Summary of the Invention])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Yada in view of Wood as outlined above with a machine learning model programmed to use the image as input data and to output, as output data, puncture success rates of a plurality of blood vessel sites of the target site shown in the image, wherein: the selection unit is programmed to select a blood vessel site having a puncture success rate higher than a threshold as the puncturing blood vessel site as taught by Peng, because it would significantly improving the safety of the puncture process [Summary of the Invention].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/Steven Maldonado/
Patent Examiner, Art Unit 3797
/MICHAEL T ROZANSKI/Primary Examiner, Art Unit 3797
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