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 .
Election/Restrictions
Claims 7-10, 13-14, 18 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group of inventions and the species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2/17/2026 and the telephone conversation on 3/3/2026 as outlined in the attached Interview Summary.
Applicant's election with traverse in the reply filed on 2/17/2026 is acknowledged. The traversal is on the ground(s) that the applicant argues the following;
Based on these features, it is possible to calculate the 3D position of puncture point more accurately and thus the number of failures by the operator using the system according to the invention is reduced compared to existing technology, such as Harris. There is nothing in Harris that suggests one of ordinary skill would have been motivated to modify Harris to address the aforementioned deficiencies or to provide the benefits of the missing features. This is, for example, because Harris is instead directed to a standalone device which does not suffer from operator error resulting from manual insertion. At least for these reasons, the subject matter of claim 1 is inventive in relation to Harris.
This is not found persuasive because;
As also clearly and factually outlined below, Harris teaches all the claimed limitations that the group I and II of the inventions lack unity and do not relate to a single inventive concept because they do not share a special technical feature in view of Harris (US 2012/0190981).
Where Harris specifically teaches
- 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”),
As for the species, claims that are withdrawn would have to be rejoined at the time of allowance (if/when found allowable).
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claims 4-6, 11-12 and 15-17 are objected to because of the following informalities:
Claim recites the limitation of “and/or” which should rather be either “and” or “or” to prevent any possible ambiguity due to the interpretation.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4, 15 and 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 4 and 15, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 16, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Similarly claims 15-16 also recite the limitation of “optionally” which renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 and 19 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 claim 16, 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” [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].
Claims 3-5 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).
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at 571-272 7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SERKAN AKAR/ Primary Examiner, Art Unit 3797