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 Amendment
This action is in response to the remarks filed on 6/15/2026.
The amendments filed on 6/15/2026 have been entered. Accordingly claims 1-19 remain pending. Claim 20 is cancelled. Claims 21-24 are newly added. Claims 7-10, 13-14, 18 and 20 were previously withdrawn from further consideration pursuant to 37 CFR 1.142(b),
The objections to the claims have been withdrawn in light of the amendments and the applicant’s remarks.
The claim rejections under35 USC 112 have been withdrawn in light of the amendments and the applicant’s remarks.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 6, 11-12, 15-17, 19, 21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Harris et all (US 20120190981 A1) in view of Hang et al (WO2022117849A1, the US equivalent of US 20240017039 A1 cited below).
Regarding claim 1, Harris teaches medical system for determining a position of a puncture point on a puncture zone beneath which a blood vessel is located (Fig. 20; paragraph [0031]; [0056]: "This technology may be considered helpful in many cases, such as in aiding a doctor or other medical personnel for (1) catheter guidance, (2) visual enhancement of surgical tool use underneath the skin, (3)), said system comprising;
a device arranged to be placed at a certain distance from the puncture zone (“the robot arm 1 is positioned directly above the desired insertion location. In an embodiment, the path for the robot arm 1 is continuously updated as the image insertion site is tracked by the vein tracker 110f,” [0108]), said device comprising:
a first illumination source, arranged to illuminate the puncture zone ([0039]: "a near-infrared light source 62'),
a stereoscopic optical sensor arranged to take first images of said blood vessel ("use multiple NIR cameras 61 "; [0206]: "Other three-dimensional localization systems include, but are not limited to, stereo cameras, a system of two or more cameras),
a computing module (Fig. 20: "Master computer) arranged to:
- calculate a 3D mapping of said blood vessel based on said first images ([0084]: "acquiring sensor data 92 in realtime relating to three-dimensional coordinates and an orientation of a patient's vein located beneath the skin surface of the patient's arm 7"; [0149]: "generating three-dimensional coordinates of the patient's vessel'),
- calculate a 3D mapping of the puncture zone ([0052]: "to obtain the relative topography of the insertion site”),
- determine the 3D position of a piercing point of a needle or catheter in the blood vessel ([0051]: "to identify an optimal insertion path for inserting a medical device into the vessel”),
- determine the 3D position of the puncture point, based on the 3D position of the piercing point and the 3D mapping of the puncture zone (0111]: "it can calculate where the final insertion position will be”),
the device comprising a projector for projecting onto the puncture zone said puncture point at the position determined by the computing module ([0092]: "the system highlighting potential insertion sites based on the same insertion site-finding algorithms used in automatic mode, and then returning these sites to the user in highly distinguishable bounding boxes."; [0115]: "showing on the skin surface target insertion sites where a predicted vessel of the patient is believed to exist”).
Although, it is believed that Harris teaches all the claimed limitations as can be clearly seen above; yet, in an interpretation, if one argues that the limitation of determine the 3D position of the puncture point (P), based on the 3D position of the piercing point (P') and the 3D mapping of the puncture zone is not taught, in an effort to provide compact prosecution, Hang reference is brought in to show the limitations.
However, in the same field of endeavor, Hang teaches vein detection device including a light source, a stereo camera. The processor configured to control the light source to illuminate a region of the skin, control the stereo camera to capture an image in the illuminated region, process the captured image to detect a vein of the patient illuminated by the light source, reconstruct a three-dimensional image of the detected vein (abst). processor can extract relevant features (e.g. various points along the vein). The processor can then perform a 3D reconstruction of the vein and determines the appropriate type of catheter to use, insertion site, and insertion angle based on the extracted points. The 3D reconstruction of the vein can be performed based on 3D coordinates and triangulation techniques of the extracted points in the stereo images [0037]. FIG. 9A. In this example, the mobile device display may include the 3D vein reconstruction 902 showing the vein 902A, the insertion sight 902B, catheter instructions 904 (e.g. catheter type selection, catheter gauge/length selection, depth of insertion, angle of insertion, etc.) [0101].
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FIG. 9B is a view of another software application interface 920 of the vein detection device. In this example, the mobile device display includes numerical data 924A, 924B and 924C representing vein feature data (e.g. insertion point), infusion treatment data (e.g. flowrate and catheter selection). The mobile device display may also include an optional comment window 924D for allowing the caregiver to record notes and feedback (e.g. insertion failure/success, etc.). In addition, the mobile device display may display the 3D vein reconstruction 922 [0102].
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The catheter length and insertion angle shown in 924C of FIG. 9B and step 874 of FIG. 8C may be determined by geometrical angles and distances from the patient's skin 942 to the target vein 944 as shown in schematic 940 of FIG. 9C [0103].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with determine the 3D position of the puncture point (P), based on the 3D position of the piercing point (P') and the 3D mapping of the puncture zone as taught by Hang because it helps with the lack of a visible vein and/or palpable vein, dark skin and obesity. Furthermore, the choice of an appropriate catheter is not always governed by clear and universal guidelines ([0003] of Hang).
Regarding claim 2, Harris teaches the device comprising:
- a second illumination source, arranged to project a pattern onto said puncture zone, the stereoscopic optical sensor being arranged to take second images of the pattern, the computing module being arranged to calculate a 3D mapping of the puncture zone based on said second images ([0052] "the laser rangefinder 60 is also used to obtain the relative topography of the insertion site”).
Regarding claim 6, Harris teaches the stereoscopic optical sensor being a first optical sensor, the device and/or the system comprising a second optical sensor arranged to take third images of the puncture zone, the computing module being arranged to calculate a 3D mapping of the puncture zone based on said third images (“[0050], multiple NIR cameras 61 can provide a grayscale color image and a NIR image, which can be stitched together”).
Regarding claim 11, Harris teaches wherein the stereoscopic optical sensor is arranged to alternately take a first image to determine the 3D mapping of the blood vessel and/or of the needle and/or of the catheter and a second image to obtain the 3D mapping of the puncture zone (“the sensors used to localize a target vessel are a NIR only camera and a laser rangefinder. In an embodiment, other three-dimensional localization systems are used. Other three-dimensional localization systems include, but are not limited to, stereo cameras, a system of two or more cameras (not necessarily aligned as stereo cameras are), LADAR, LIDAR or other similar range finding unit, a system of one or more cameras combined with one or more laser rangefinders, and ultrasound” [0206]).
Further, Hang also teaches the stereo camera to capture an image in the illuminated region, process the captured image to detect a vein of the patient illuminated by the light source (abst). Vein detection device can capture images of the destination vein under illumination using a stereo vision camera system (e.g. two cameras side-by-side) in order to determine depth of the vein [0012].
Regarding claim 12, Harris teaches the alarm means are arranged to warn and/or confirm to the operator the entry of the needle and/or of the catheter into the blood vessel (“the insertion depth is preprogrammed but also monitored using feedback from the insertion procedure, such as visual information indicating the vessel has been punctured, or force feedback along the axis of the medical device tool 212” [0158]).
Regarding claim 15, Harris teaches the first illumination source and/or the second illumination source being arranged to emit a spectrum in the NIR and/or IR band, optionally to emit several different wavelengths in the NIR and/or IR band, for example to emit the wavelengths of 850 nm and 940 nm (“a near-infrared (NIR) camera 61 and a near-infrared (NIR) light source 62” [0046]).
Regarding claims 16 and 23, Harris teaches the first illumination source and/or the second illumination source being arranged to emit a spectrum in the visible or UV band, optionally to emit several different wavelengths in the visible and/or UV band, in order to enable the computing module to improve the 3D mapping of the blood vessel and/or to filter out visual artifacts such as hairs, pimples or tattoos (“the wavelength range used by the system to distinguish the patient's vessel from the environment surrounding the vessel comprises a range from about 720 nanometers to about 780 nanometers [note that visible wavelength is about 380-750nm which Harris covers 720-750]” [0048]).
Further, Hang also teaches FIG. 1B is a perspective view 120 of light propagation through a section of human skin at various wavelengths (e.g. 200 nm-750 nm) [0077].
Regarding claim 17, Harris teaches the computing module being arranged to determine and/or modify in real time the position of the puncture point so that the puncture point and the piercing point belong to a straight line corresponding to the main direction of the needle or of the catheter (“The laser rangefinder 60 can be mounted on the robot arm 1 in a fixed relation to the insertion needle. In an embodiment, the laser rangefinder 60 is designed to operate in conjunction with the NIR camera 61 to track the three-dimensional coordinates and orientation of a patient's vessel in real-time to identify an optimal insertion path for inserting a medical device into the vessel” [0051]).
Further, Hang also teaches device display may include the 3D vein reconstruction 902 showing the vein 902A, the insertion sight 902B, catheter instructions 904 (e.g. catheter type selection, catheter gauge/length selection, depth of insertion, angle of insertion, etc.) as well as arrows 902C instructing the caregiver on how the vein detection device should be moved in a specific direction with respect to the target location (e.g. adjusted on the patient's arm to better located the vein) [0101].
Regarding claim 19, Harris teaches the projector (4) or a second projector of the device (10) is/are arranged to project onto the puncture zone (40) or onto another area of the patient an image or video in order to distract him during the puncture (“the master computer 90 is configured to transform the preprocessed image of the patient's arm 7 into the patient arm having a plurality of boxes projected onto it. The plurality of boxes projected onto the patient's arm 7 on the display function as bounding boxes to establish a perimeter within which a vessel is believed to exist in the patient's arm 7 underneath the subject's skin” [0115]).
Further, Hang also teaches processor 502 performs rectification (e.g. projecting the image onto a common image plane) by establishing an epipolar geometrical constraint based on triangulation [0098].
Regarding claim 21, Harris teaches wherein the first illumination source or the second illumination source are arranged to emit to emit several different wavelengths in the NIR or IR band (“similar camera coupled with a bandpass filter used to isolate a near-infrared (NIR) frequency range. This imaging device is referred to throughout this document as an NIR camera 61. In an embodiment, the NIR frequency range is a narrow frequency range. In an embodiment, the wavelength range used by the system to distinguish the patient's vessel from the environment surrounding the vessel comprises a range from about 720 nanometers to about 780 nanometers. It should be noted that other NIR wavelength ranges” [0048]).
Hang also teaches operating wavelength of the light source and the stereo camera can be in the near infrared (NIR) spectrum [0009]. Vein detection device 400 houses near infrared (NIR) light source(s) (e.g. NIR LEDs) [0084].
Claims 3-5, 22 are rejected under 35 U.S.C. 103 as being unpatentable over Harris et all (US 20120190981 A1) in view of Hang et al and further in view of Goldman et al (US 20140303506 A1).
Regarding claim 3, the above combination teaches all the limitations of the claims except for pattern is formed of dots.
However, in the same field of endeavor, Goldman teaches creating a three-dimensional imaging system is disclosed. There is a first source of laser light and a second source of laser light having a wavelength different from the wavelength of the laser light of the first source (abst). In FIG. 6, diagonal striped patterns, checked pattern, and a light grey pattern were utilized for differentiating between the various different veins/arteries, however, the invention is not limited thereto. Varying patterns, such as dotted lines having different dot-space characteristics could have been utilized to represent veins at different depths [0031].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with pattern is formed of dots as taught by Goldman because it helps to provide a method and the technology to display blood flowing at a given depth in the patient ([0004] of Goldman).
Regarding claim 4, the above combination teaches all the limitations of the claims except for the pattern include a reference dot, for example a dot that has a different brightness and/or size and/or shape and/or color from the other dot.
However, in the same field of endeavor, Goldman teaches creating a three-dimensional imaging system is disclosed. There is a first source of laser light and a second source of laser light having a wavelength different from the wavelength of the laser light of the first source (abst). In FIG. 6, diagonal striped patterns, checked pattern, and a light grey pattern were utilized for differentiating between the various different veins/arteries, however, the invention is not limited thereto. Varying patterns, such as dotted lines having different dot-space characteristics could have been utilized to represent veins at different depths [0031].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with pattern include a reference dot, for example a dot that has a different brightness and/or size and/or shape and/or color from the other dot as taught by Goldman because it helps to provide a method and the technology to display blood flowing at a given depth in the patient ([0004] of Goldman).
Regarding claim 5, the above combination teaches all the limitations of the claims except for the projecting a dot onto the puncture zone, the set of such dots forming the pattern.
However, in the same field of endeavor, Goldman teaches creating a three-dimensional imaging system is disclosed. There is a first source of laser light and a second source of laser light having a wavelength different from the wavelength of the laser light of the first source (abst). In FIG. 6, diagonal striped patterns, checked pattern, and a light grey pattern were utilized for differentiating between the various different veins/arteries, however, the invention is not limited thereto. Varying patterns, such as dotted lines having different dot-space characteristics could have been utilized to represent veins at different depths [0031].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with projecting a dot onto the puncture zone, the set of such dots forming the pattern as taught by Goldman because it helps to provide a method and the technology to display blood flowing at a given depth in the patient ([0004] of Goldman).
Regarding claim 22, the above combination teaches all the limitations of the claims except for wavelengths of 850 nm and 940 nm.
However, in the same field of endeavor, Goldman teaches creating a three-dimensional imaging system is disclosed. There is a first source of laser light and a second source of laser light having a wavelength different from the wavelength of the laser light of the first source (abst). In FIG. 6, diagonal striped patterns, checked pattern, and a light grey pattern were utilized for differentiating between the various different veins/arteries, however, the invention is not limited thereto. Varying patterns, such as dotted lines having different dot-space characteristics could have been utilized to represent veins at different depths [0031]. A broader range of wavelengths (700 nm to 1000 nm) could be utilized. Similarly, in the event a broader range of wavelengths are emitted by laser 183, the 740 nm photo detector 182 could be changed to a different wavelength to receive the associated wavelength (700 nm-1000 nm).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with wavelengths of 850 nm and 940 nm as taught by Goldman because it helps to provide a method and the technology to display blood flowing at a given depth in the patient ([0004] of Goldman).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Harris et all (US 20120190981 A1) in view of Hang et al and further in view of Breteau et al (WO2022090201A1, the citations are from the US equivalent of US20230293827A1).
Regarding claim 24, the above combination teaches all the limitations of the claims except for the visual artifacts comprise hairs, pimples or tattoos.
However, in the same field of endeavor, Breteau teaches method for determining at least one optimal insertion segment (810 a, 810 b, 810 c, 810 d) in a limb of a patient for inserting a needle into a vein of the patient, said segment (810 a, 810 b, 810 c, 810 d) being representative of an insertion point (820 a, 820 b, 820 c, 820 d), an insertion direction and a maximum insertion length, comprising a step of near-infrared illumination of the limb of the patient, a step of acquiring near-infrared images of the limb of the patient. Step of pre-processing the acquired images to obtain an image of the veins, a step of applying a linear structure detection filter to said image of the veins to obtain a vascular profile map, a step of binarizing the vascular profile map (abst).
The pre-processing step allows an image of the blood vessels on the part of the body of the patient to be obtained in order to prepare for the filtering in the following step. In particular, the pre-processing step can comprise the isolation and/or removal, on the image, of irregularities on the skin such as hairs, moles, tattoos, etc., as well as optionally blood capillaries if the desire is to view veins or arteries only [0028].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with visual artifacts comprise hairs, pimples or tattoos as taught by Breteau because improve the procedure for determining an optimal insertion segment for allowing in particular automatic and autonomous operation of the choice of the optimal insertion segment in a large number of patients of various profiles, i.e. regardless of their morphology, skin pigmentation, marks, moles, hair, etc. (Breteau).
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive at least for the following reasons;
Regarding the rejection of claim, the applicant argues the following;
Regarding independent claim 1, the cited prior art does not teach or render obvious "a computing module arranged to...determine the 3D position of the puncture point, based on the 3DPage position of the piercing point and the 3D mapping of the puncture zone," as recited by the claim. The Office action acknowledges that Harris may not teach this limitation and therefore cites Hang. Indeed, Harris is silent about the specific mathematical or geometric relationship by which the 3D position of puncture point P is calculated as a function of both the piercing point position P' and the 3D puncture zone mapping simultaneously. In particular, paragraph [0111] of Harris cited by the Office indicates that a vein depth underneath the skin is computed and that this depth can be sent to the robot so it can calculate where the final insertion position will be. While paragraph [0111] does indicate that a position of puncture point P is calculated, it is computed based on the vein depth underneath the skin, and not based on both the piercing point position P' and the 3D puncture zone mapping, as required by claim 1.
Initially, it is noted that the office action clearly states “it is believed that Harris teaches all the claimed limitations as can be clearly seen above”.
Contrary to the applicant’s assertion, the cited prior art specifically teaches the following;
needle 41 is appended to the needle tool 3, the three-dimensional spatial coordinates along with the orientation of the selected vein are determined, and the robot arm 1 moves the butterfly needle 41 to that position for insertion. [0040].
In an embodiment, the one or more primary sensors 91 comprise an NIR camera 61 for determining the three-dimensional coordinates of the vessel of the patient receiving the medical procedure. In an embodiment, the NIR camera 61 can be used to determine an optimal orientation for insertion of a medical device into the vessel of the patient [0049].
In an embodiment, the laser rangefinder 60 is designed to operate in conjunction with the NIR camera 61 to track the three-dimensional coordinates and orientation of a patient's vessel in real-time to identify an optimal insertion path for inserting a medical device into the vessel. In an embodiment, the laser rangefinder 60 is designed to operate in conjunction with the NIR camera 61 to enable the robot arm 1 of the system 8 to guide a medical device attached to the robot arm 1 along the optimal insertion path to autonomously insert the medical device into the vessel. In an embodiment, the laser rangefinder 60 and the NIR camera 61 work together to determine the three-dimensional coordinates and orientation of the patient's vessel so that the primary actuators 93 can guide the medical device to be inserted into the patient's vessel to the three-dimensional coordinates of the vessel for insertion of the medical device into the vessel [0051].
The path taken leads the laser rangefinder 60 directly over the insertion site, at which point the target location in three-dimensional space can be determined. The topography of the around the targeted site is also mapped using the laser rangefinder 60 so the robot arm 1 can be adjusted accordingly [0144].
Further, it is also not clear what “specific mathematical or geometric relationship by which the 3D position of puncture point P is calculated” is the applicant is referring to as the claims do not recite specific mathematical or geometric relationship by which the 3D position of puncture point P is calculated with or by.
In addition, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the specific mathematical or geometric relationship by which the 3D position of puncture point P is calculated as a function of both the piercing point position P' and the 3D puncture zone mapping simultaneously) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The applicant further argues the following;
Further, Hang fails to make up for the deficiencies of Harris. Hang is directed to a vein detection device comprising a light source, stereo camera system, processor, and mobile device interface, designed to assist a caregiver in the handheld, manual insertion of a catheter. Hang's teaching regarding the determination of catheter length and insertion angle, as illustrated in Figure 9C and discussed in paragraph [0103], addresses the geometric relationship between skin surface and target vein to compute catheter dimensions. While Hang discusses the insertion point (piercing point) of the vein, nowhere does it discuss calculating a puncture point on the skin as required by claim 1. Thus, Hang's teachings are fundamentally distinct from the claimed invention's requirement to compute the 3D position of a puncture point based on the position of a piercing point and a 3D mapping of the puncture zone itself.
However, as clearly and factually outlined in the previous office and also reiterated here, Hang in fact teaches calculating a puncture point on the skin. Hang specifically teaches the following;
The processor can then perform a 3D reconstruction of the vein and determines the appropriate type of catheter to use, insertion site, and insertion angle based on the extracted points. The 3D reconstruction of the vein can be performed based on 3D coordinates and triangulation techniques of the extracted points in the stereo images [0037].
images are then processed (hence, calculated) using stereoscopy techniques to determine three dimensional (3D) coordinates of the destination vein (insertion [puncture] point) and a resultant 3D reconstructed vein image. From this information, system 200 can determine a depth 212 at which the destination vein lies beneath the skin surface [0079].
processor 502 can determine a region of interest (ROI) in step 808 (e.g. a segment of the image containing the destination vein [insertion point]) … processor 502 extracts (calculates) relevant features (e.g. various points along the vein). In step 812, processor 502 performs a 3D reconstruction of the vein and determines the appropriate type of catheter to use, insertion site, and insertion angle based on the extracted points. As described above, the 3D reconstruction of the vein in step 812 is performed based on 3D coordinates and triangulation techniques of the extracted points in the stereo images [0097].
FIG. 9A. In this example, the mobile device display may include the 3D vein reconstruction 902 showing the vein 902A, the insertion sight 902B, catheter instructions 904 (e.g. catheter type selection, catheter gauge/length selection, depth of insertion, angle of insertion, etc.) [0101].
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FIG. 9B is a view of another software application interface 920 of the vein detection device. In this example, the mobile device display includes numerical data 924A, 924B and 924C representing vein feature data (e.g. insertion point), infusion treatment data (e.g. flowrate and catheter selection). The mobile device display may also include an optional comment window 924D for allowing the caregiver to record notes and feedback (e.g. insertion failure/success, etc.). In addition, the mobile device display may display the 3D vein reconstruction 922 [0102].
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The catheter length and insertion angle shown in 924C of FIG. 9B and step 874 of FIG. 8C may be determined by geometrical angles and distances from the patient's skin 942 to the target vein 944 as shown in schematic 940 of FIG. 9C [0103].
Further, as also acknowledged by the application Hang is in the very same field of BRAODLY CLAIMED invention teaching the same limitations as required by those claims. The applicant also notes this by stating “Hang is directed to a vein detection device comprising a light source, stereo camera system, processor, and mobile device interface, designed to assist a caregiver in the handheld, manual insertion of a catheter. Hang's teaching regarding the determination of catheter length and insertion angle, as illustrated in Figure 9C and discussed in paragraph [0103], addresses the geometric relationship between skin surface and target vein to compute catheter dimensions. While Hang discusses the insertion point (piercing point) of the vein,”
The applicant further argues the following;
Further, regarding claim 17, the cited references fail to teach or render obvious a "computing module arranged to determine or modify in real time the position of the puncture point so that the puncture point and the piercing point belong to a straight line corresponding to the main direction of the needle or of the catheter." For allegedly disclosing this limitation, the Office action cites the teachings in paragraph [00051] of Harris relating to using a laser rangefinder 60 and NIR camera 61 to track the three-dimensional coordinates and orientation of the patient's vessel in real- time to identify an optimal insertion path. The Office also cites paragraph [0101] of Hang relating to displaying arrows to instruct the caregiver on how more the vein detection device. However, neither reference teaches keeping the puncture point and the piercing point in a straight line corresponding to the main direction of the needle as required by claim 1. The inclusion of this specific geometric constraint, i.e. that P and P' must remain collinear with the main direction of the needle or catheter, represents a precise geometric relationship that neither Harris nor Hang teaches, and the combination of which would not have been obvious to one of ordinary skill in the art at the time of invention.
Further, Harris, when carefully examined, does not teach this geometric constraint. Harris teaches that a robot arm 1 is positioned directly above a desired insertion location with the laser rangefinder 60 and NIR camera 61 operating in conjunction to track three-dimensional coordinates and orientation of the patient's vessel in real time to identify an optimal insertion path. This teaching concerns the adaptation of robot positioning to the detected movement of the blood vessel itself, not the maintenance of a specific collinear geometric relationship between two distinct puncture points as a function of a dynamically changing needle direction. Harris explicitly describes a scenario in which "the robot arm 1 is positioned directly above the desired insertion location" with "the path for the robot arm 1 continuously updated as the image insertion site is tracked", but this describes adjustment of the robotic end-effector to track a moving target, not the geometric constraint described by claim 17.
Furthermore, Harris contemplates an autonomous robotic system in which, once the insertion site is identified and the optimal insertion path determined, the robot executes the insertion autonomously. The system is not designed to accommodate real-time changes in needle direction initiated by an operator during the insertion procedure. Harris does not contemplate, and indeed does not suggest, that the direction of insertion would change dynamically in time, nor does Harris teach an algorithm that would recalculate the puncture point position to maintain collinearity with such a changing direction. The scenario presented in Harris is one of autonomous, predetermined insertion following initial site identification, not continuous geometric recalculation in response to operator-induced directional changes.
However, Harris specifically teaches the following;
computer 90 may be configured to evaluate the target insertion site in real-time so that when a movement of the patient's arm 7 displaces the identified target insertion site with respect to the position of the medical device tool 212 to be inserted, the control program sends in real-time updated three-dimensional coordinates of the target insertion site to a robot controller 1a so that the at least one actuator 93 can be repositioned for the medical device tool 212 to be inserted through the target insertion site. That is, the robot arm 1 repositions itself in the optimal orientation so the tool 212 is in line with the targeted vessel [0152].
“the medical device tool 212 is inserted in a straight line path into the vessel. In an embodiment, the medical device tool 212 is inserted in a straight line path into the vessel through the target insertion site to a depth equivalent to the depth determined during step 147” [0162].
Further, Hang also teaches device display may include the 3D vein reconstruction 902 showing the vein 902A, the insertion sight 902B, catheter instructions 904 (e.g. catheter type selection, catheter gauge/length selection, depth of insertion, angle of insertion, etc.) as well as arrows 902C instructing the caregiver on how the vein detection device should be moved in a specific direction with respect to the target location (e.g. adjusted on the patient's arm to better located the vein) [0101].
In addition, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., automated, real-time algorithmic recalculation that maintains a precise geometric constraint, and it is directed to a closed-loop geometric feedback algorithm that ensures collinearity between P and P' with respect to the needle's instantaneous direction vector) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
As can be clearly and factually seen above, the cited prior art teaches the argued points.
Therefore, the rejections are maintained.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERKAN AKAR whose telephone number is (571)270-5338. The examiner can normally be reached 9am-5pm M-F.
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/SERKAN AKAR/ Primary Examiner, Art Unit 3797
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