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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 30 April 2026 has been entered.
The Examiner acknowledges the addition of new claim 26. Claims 1-26 are pending.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “RD” [Fig. 1].
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
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.
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.
Claim(s) 1-15, 18, and 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harris (US-20120190981-A1, previously presented) in view of Huang (US-20200100846-A1, effective filing date of 27 September 2019).
Regarding claim 1, Harries teaches
A cannula insertion system to insert a cannula into a human or animal body, comprising:
one or more sensors to determine a suitable location for insertion of the cannula [The system 8 includes primary sensors 91, including, but not limited to, a laser rangefinder 60, an NIR camera 61, and an ultrasound device 64 to collect sensor data 92 about the patient, which is sent to a master computer 90 and analyzed (Harris ¶0083, Fig. 20); the autonomous intravenous insertion system 8 of the present disclosure includes one or more primary sensors 91 for acquiring sensor data 92 in real-time relating to three-dimensional coordinates and an orientation of a patient's vein located beneath the skin surface of the patient's arm 7 (Harris ¶0084, Fig. 20)],
a cannula insertion device configured to hold the cannula and insert the cannula into the human or animal body [The needle tool 3 is designed to insert butterfly needles 41 into the patient's arm 7. The butterfly needle 41 may be gripped by a needle gripper assembly 200 comprising gripper fingers 42, a butterfly needle gripper body 46, a pneumatic piston 44, and butterfly needle gripper linkages 53. The needle gripper assembly 200 is similar to the catheter gripper 21 used in relation to the catheter tool 4 as described above. A stepper motor 43 moves the butterfly needle gripper body 46 along guide rails 45 to insert the butterfly needle 41. The needle tool 3 also includes stabilizer feet 40, which are shown in FIG. 11 in their retracted position (Harris ¶0067, Fig. 11)],
a cannula insertion device positioning system to support and position the cannula insertion device [FIG. 4A depicts the robot arm 1 and FIG. 4B and FIG. 4C depict two medical device holding tools 212, needle tool 3 and catheter tool 4. These tools can be attached to the robot arm 1 using the tool changer systems 9 and 10. Needle tool 3 is shown for manipulating butterfly needles 41 (Harris ¶0059, Figs. 4A, 4C); 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. After the procedure is performed, the robot arm 1 travels to an unloading position in order to discharge the used medical device (Harris ¶0040); the robot arm 1 is computer controlled and is designed to autonomously guide a medical device to a patient's vessel for the automatic insertion of the medical device into the patient's vessel (Harris ¶0041)], and
a control device arranged to control the positioning system to position, on the basis of the determined suitable location for insertion of the cannula, the cannula insertion device in a suitable position to insert the cannula into human or animal body [the robot arm 1 may include a high-precision mechanical positioning system and a control unit. In an embodiment, the control unit is a dedicated computer and motor driver that takes commands from the master computer 90 and controls the robot's position and motion (Harris ¶0041); see Harris ¶0040 regarding determined location for insertion],
wherein the cannula insertion system comprises a blood collection system to collect blood in one or more blood collection tubes supported by the blood collection system [the autonomous intravenous insertion system 8 has an automatic dispenser unit 74 that engages, disengages, and exchanges blood drawing tubes 78 with the inserted butterfly needle 41 (Harris ¶0072, Fig. 16)].
However, while Harris discloses wherein the blood collection system may be positioned relative in location to the cannula insertion device positioning system [new blood drawing tubes 78 are rotated around to the piercing needle 72, and pressed onto the piercing needle 72, allowing blood to flow from the butterfly needle 41 through a tube to the piercing needle 72, and into the blood drawing tube 78 (Harris ¶0072); In an embodiment, the autonomous intravenous insertion system 8 is provided with dispenser units 74 for needles 41, catheters 22, and blood drawing tubes 78. In an embodiment, the system 8 is capable of autonomous selection of correct medical devices to match the prescribed procedure in a timely manner, and to reliably and repeatably pick up the devices. The dispensers may also prevent contamination of the devices by keeping them separate from the hospital environment until ready for use. The dispensers are meant to be stationed near the robot arm 1, so that the robot arm 1 can pick up the appropriate tool upon command without having to be moved. Each piece of equipment may also be provided with its own storage unit that can be easily reloaded (Harris ¶0076); In an embodiment, the autonomous intravenous insertion system 8 of the present disclosure includes a tool docking and storage station 95 for the tools used by the system 8. In an embodiment, the tool docking and storage station 95 is an area out of reach to patients where the robot arm 1 can affix the correct tools for the job, and store unneeded tools until they are required. In an embodiment, the different devices and tools may be stored in a set of cubby-like units, where the system is pre-programmed to know what device is stored in each unit, as well as how to pick up, affix, and manipulate it. Alternatively, another possible configuration may be for each tool and complementary device to have its own dock and storage station (Harris ¶0081)], Harris fails to explicitly disclose wherein the blood collection system is movably arranged to at least partly follow movements of the cannula insertion device.
Huang discloses a robotic arm system for use in a medical setting that may operable with different medical instruments, wherein the robotic arm system comprises a robotic arm [robotic arm 3 as mounted on cart 11 (as depicted in Huang Fig. 2) is considered to be equivalent to the robot arm 1 (cannula insertion device positioning system) of Harris] and storage for relevant medical devices and tools wherein the storage is movably arranged to at least partly follow movements of the robotic arm [the cart body 11 has an instrument platform for loading equipment and placing the required surgical instruments, or carrying mobile scanners or X-ray machines (Huang ¶0025), wherein the storage being within cart 3 that facilitates movement of the robotic arm 3 itself is considered to read on the storage being movably arranged to at least partly follow movements of the robotic arm].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Harris to employ wherein the blood collection system is movably arranged to at least partly follow movements of the cannula insertion device, so as to facilitate coupling between the cannula insertion device and the blood collection system by maintaining proximity, and further amount to mere rearrangement of parts without modifying the operation of the device [repositioning the blood collection system relative to the cannula insertion device, while maintaining operability of the blood collection system to withdraw fluid based on coupling to the cannula] [MPEP 2144.04(VI)(C)].
Regarding claim 2, Harris in view of Huang teaches
The cannula insertion system of claim 1, wherein the blood collection system is mounted on the cannula insertion device positioning system to at least partly follow movements of the cannula insertion device [See § 103 modification of claim 1 above; Huang ¶0025].
Regarding claim 3, Harris in view of Huang teaches
The cannula insertion system of claim 1, wherein the cannula insertion device positioning system is arranged to move the cannula insertion device between an operating position from which a cannula may be inserted into the human or animal body, and a retracted position [Harris ¶¶0040-0041, wherein any position that is not the insertion position may be considered to read on the retracted position].
Regarding claim 4, Harris in view of Huang teaches
The cannula insertion system of claim 1, wherein the cannula insertion device positioning system comprises at least one movable stage, wherein the blood collection system is mounted on the at least one stage [See § 103 modification of claim 1 above; Huang ¶0025].
Regarding claim 5, Harris in view of Huang teaches
The cannula insertion system of claim 1, wherein the cannula insertion system comprises a blood collection tube exchange system to exchange blood collection tubes between a blood collection tube input device and the blood collection system [Harris ¶0072, Fig. 16].
Regarding claim 6, Harris in view of Huang teaches
The cannula insertion system of claim 5, wherein the blood collection system comprises an actuator to invert and/or rotate a blood collection tube during or after being filled with blood from the human or animal body [By way of a non-limiting example, FIG. 19 shows the manipulator 210 operating to place a filled blood drawing tube 78 into the tube storage unit 73. As shown in FIG. 19, the carriage 70 pulls the filled blood drawing tube 78 off of the piercing needle 72, and the collet chuck 71 rotates down to point into the tube storage unit 73 (Harris ¶0075, Fig. 19)].
Regarding claim 7, Harris in view of Huang teaches
The cannula insertion system of claim 1, wherein each cannula comprises a patient needle to be inserted into a patient [needle 41 (Harris Fig. 11)], a tube needle to be inserted in a blood collection tube [piercing needle 72 (Harris Figs. 16-19)] and a conduit connecting the patient needle and the tube needle [tube to needle (Figs. 16-19); In an embodiment, new blood drawing tubes 78 are rotated around to the piercing needle 72, and pressed onto the piercing needle 72, allowing blood to flow from the butterfly needle 41 through a tube to the piercing needle 72, and into the blood drawing tube 78 (Harris ¶0072)].
Regarding claim 8, Harris in view of Huang teaches
The cannula insertion system of claim 3, further comprising a blood collection tube exchange system, wherein, in the retracted position, the blood collection tube exchange system may exchange one or more blood collection tubes supported by the blood collection system [Harris ¶¶0072, 0075, wherein based on the cited disclosure, it is understood that the exchange is operable to occur at any time, which would include in the retracted position].
Regarding claim 9, Harris in view of Huang teaches
The cannula insertion system of claim 1, wherein the cannula insertion system comprises a cannula exchange system to exchange a cannula held by the cannula insertion device [In an embodiment, the autonomous intravenous insertion system 8 is provided with dispenser units 74 for needles 41, catheters 22, and blood drawing tubes 78. In an embodiment, the system 8 is capable of autonomous selection of correct medical devices to match the prescribed procedure in a timely manner, and to reliably and repeatably pick up the devices (Harris ¶0076)], and wherein the cannula exchange system is arranged to dispose a used cannula in a cannula disposal container [In an embodiment, the autonomous intravenous insertion system 8 of the present disclosure includes a disposal unit 96 for containing used butterfly needles 41 and catheters 22 after use (Harris ¶0080)].
Regarding claim 10, Harris in view of Huang teaches
The cannula insertion system of claim 3, further comprising a cannula exchange system, wherein, in the retracted position, the cannula exchange system may exchange a second cannula with the cannula held by the cannula insertion device [Harris ¶0076, wherein based on the cited disclosure, it is understood that the exchange is operable to occur at any time, which would include in the retracted position].
Regarding claim 11, Harris in view of Huang teaches
The cannula insertion system of claim 9, wherein the cannula exchange system is arranged to select the cannula from a cannula supply comprising multiple cannulas [Harris ¶0076].
Regarding claim 12, Harris in view of Huang teaches
The cannula insertion system of claim 1, wherein the suitable location is located on or in an arm of the human, and wherein the one or more sensors are arranged to determine a shape of the arm and/or a location of an elbow pit of the human [The processed image is fed into the vein identification system 110d, which includes, but is not limited to, algorithms to find the patient's arm 7, find the patient's elbow, and analyze vein-like structures inside the arm and elbow area, among others (Harris ¶0098); Scoring of a potential target site is based on its size, shape, and closeness to the patient's elbow (without being directly on it), and is handled within the target site selection system 110e (Harris ¶0099)].
Regarding claim 13, Harris in view of Huang teaches
The cannula insertion system of claim 1, wherein the cannula insertion system comprises an end-effector supporting the one or more sensors and the cannula insertion device [Harris ¶0088, Fig. 21].
Regarding claim 14, Harris in view of Huang teaches
The cannula insertion system of claim 1, wherein the cannula insertion system is arranged to insert the cannula into a vein of the human or animal body [In an embodiment, the intravenous insertion procedure comprises intravenous insertion of a butterfly needle 41 into the vessel of a patient's arm 7. In an embodiment, the intravenous insertion procedure comprises intravenous insertion of a cannula into the vessel of the patient's arm 7. In an embodiment, the vessel comprises a vein. In an embodiment, the vessel comprises a subcutaneous vein. In an embodiment, the vessel comprises a superficial vein. In an embodiment, the vessel comprises a deep vein (Harris ¶0082)].
Regarding claim 15, Harris in view of Huang teaches
The cannula insertion system of claim 14, wherein the one or more sensors provide at least one sensor signal, and wherein the control device is arranged to create on the basis of the at least one sensor signal an image of the vein suitable for insertion of the cannula [In an embodiment, the frame grabber 110a is responsible for continuously grabbing images from the NIR camera 61… The frame processor 110b is responsible for processing the original input image from the frame grabber 110a in order to select veins from the surrounding skin. The processed image is fed into the vein identification system 110d, which includes, but is not limited to, algorithms to find the patient's arm 7, find the patient's elbow, and analyze vein-like structures inside the arm and elbow area, among others (Harris ¶0098); the system 8 uses one or more primary sensors 91, such as an NIR camera 61 or a laser rangefinder 60, to acquire real-time sensor data 92 relating to the patient's vessels (Harris ¶0139)].
Regarding claim 18, Harris in view of Huang teaches
The cannula insertion system of claim 1, further comprising a patient or treatment identification device [In an embodiment, a barcode reader 216 is added near the wrist stabilizing cuff 6 that would read a patient's bracelet barcode in order to collect patient data for the procedure. If not wearing a wristband, patients might enter their information into the touch screen user interface (Harris ¶0045)].
Regarding claim 25, Harris in view of Huang teaches
The cannula insertion system of claim 1, wherein the cannula insertion system comprises a blood presence sensor located near, on or in the cannula arranged to determine the presence of blood in the cannula [the secondary sensors 213 include a tactile sensor for sensing needle contact, a force sensor for `feeling` a successful vein penetration, or a color imager for detecting blood flow in the cannula (Harris ¶0085)].
Regarding claim 26, Harris in view of Huang teaches
The cannula insertion system of claim 1, wherein the blood collection system is movably arranged to follow fewer than six degrees of freedom of movements of the cannula insertion device [See § 103 modification of claim 1 above; Huang ¶0025].
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harris in view of Huang, as applied to claim 1 above, in further view of Song (US-20170028142-A1, previously presented).
Regarding claim 17 [written in longhand format, such that the entirety of the subject matter of claim 16 is incorporated therein], Harris in view of Huang teaches
The cannula insertion system of claim 1.
However, Harris in view of Huang fails to explicitly disclose wherein the cannula insertion system comprises a pressure applicator arranged to apply pressure on the insertion location after removal of the cannula from the insertion location, wherein the pressure applicator comprises a bandage support to support a bandage with which pressure is exerted on the insertion location.
Song discloses an automatic needle insertion system, wherein Song discloses a pressure applicator coupled to a needle insertion device, wherein the pressure applicator is arranged to apply pressure on the insertion location after removal of the cannula from the insertion location, wherein the pressure applicator comprises a bandage support to support a bandage with which pressure is exerted on the insertion location [Alternatively, as shown in FIGS. 1 and 2, the automatic needle insertion apparatus further includes an adhesive bandage application device 600 and a second control device 960. The adhesive bandage application device 600 is configured to apply an adhesive bandage at a position of the body part into which the needle is inserted by the needle insertion device 400 (Song ¶0043, Figs. 1-2); control the adhesive bandage application device 600 to execute the adhesive bandage application operation, so as to press the adhesive bandage onto the position of the body part where the needle has been inserted (Song ¶0044); After the intravenous drip has been completed, the adhesive bandage may be applied onto the wound by the adhesive bandage application device 600 (Song ¶0058), wherein it is understood that application of an adhesive bandage as disclosed requires the application of pressure].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Harris in view of Huang to employ a pressure applicator arranged to apply pressure on the insertion location after removal of the cannula from the insertion location, wherein the pressure applicator comprises a bandage support to support a bandage with which pressure is exerted on the insertion location, so as to cover and protect the puncture wound formed by the cannula after insertion [Song ¶0058].
Claim(s) 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harris in view of Huang, as applied to claim 1 above, in further view of Sarvazyan (US-20110066078-A1, previously presented).
Regarding claim 20 [written in longhand format, such that the entirety of the subject matter of claim 19 is incorporated therein], Harris in view of Huang teaches
The cannula insertion system of claim 1.
However, Harris in view of Huang fails to explicitly disclose wherein the cannula insertion system comprises a hand grip to be held by a hand of a patient, wherein the hand grip is configured to measure a holding force with which the hand grip is held by the patient and/or a holding position in which the hand grip is held by the patient, wherein the cannula insertion system is arranged to carry out a cannula insertion procedure if the holding force is within a predefined holding force range, and to abort the cannula insertion procedure if the holding force is outside the predefined holding force range.
Sarvazyan discloses systems for monitoring pain of a patient undergoing a medical procedure, wherein Sarvazyan discloses a hand grip to be held by a hand of a patient, wherein the hand grip is configured to measure a holding force with which the hand grip is held by the patient and/or a holding position in which the hand grip is held by the patient [FIG. 1 displays a general view of the patient pain monitor 20 placed on a patient's hand and retained with a strap 57 including a Velcro.RTM. or a buckle closure means. Pain monitor 20 is therefore adapted for patient's fingers to continuously grip the device. When experiencing pain, the patient is instructed to squeeze the pain monitor 20 proportionally to the level of pain (Sarvazyan ¶0030, Fig. 1)], wherein the hand grip further determines whether the holding force is within or outside of a predefined holding force range [The load cell 74 monitors the squeeze through measuring the force exerted by the spring 71. Reduction in gap when the halves are squeezed by a patient serves as a biofeedback to the patient as to the degree of squeeze of the device (Sarvazyan ¶0035, Fig. 6), wherein no squeeze may be considered to be “within range” and wherein any squeeze may be considered “outside the range”]; and wherein Sarvazyan further discloses that knowledge of the pain experienced by the patient is useful in adjusting a course of the medical procedure undergone by the patient [The invention is particularly useful for medical procedures when the patient is not sedated or sedated locally or partially. Frequently, the medical practitioner needs to have patient's feedback as to his or her pain in response to certain steps during the procedure (Sarvazyan ¶0003)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Harris in view of Huang to employ a hand grip to be held by a hand of a patient, wherein the hand grip is configured to measure a holding force with which the hand grip is held by the patient and/or a holding position in which the hand grip is held by the patient, wherein the cannula insertion system is arranged to carry out a cannula insertion procedure if the holding force is within a predefined holding force range, and to abort the cannula insertion procedure if the holding force is outside the predefined holding force range, so as to allow for monitoring of pain experienced by the patient during the cannula insertion procedure and allow for intervention if the patient is experiencing pain [Language barriers and difficulties that some patients have deciding on a proper expression of pain assessment (such as with speech-deficient patients) can cause delayed or incorrect perception of the level of patient's discomfort by the medical practitioner. Accurate knowledge of the level of pain would allow the medical practitioner to adjust the course of procedure (Sarvazyan ¶0004)].
Regarding claim 21 [written in longhand format, such that the entirety of the subject matter of claim 19 is incorporated therein], Harris teaches
The cannula insertion system of claim 1.
However, Harris in view of Huang fails to explicitly disclose wherein the cannula insertion system comprises a hand grip to be held by a hand of a patient, wherein the hand grip is configured to measure a holding force with which the hand grip is held by the patient and/or a holding position in which the hand grip is held by the patient, wherein the hand grip, or at least a part thereof, is movable between a stand-by position and an activated position, wherein the cannula insertion system is arranged to carry out a cannula insertion procedure if the hand grip or the movable part thereof is arranged in the activated position, and to abort the cannula insertion procedure if the hand grip or the movable part thereof is arranged in the stand-by position.
Sarvazyan discloses systems for monitoring pain of a patient undergoing a medical procedure, wherein Sarvazyan discloses a hand grip to be held by a hand of a patient, wherein the hand grip is configured to measure a holding force with which the hand grip is held by the patient and/or a holding position in which the hand grip is held by the patient [Sarvazyan ¶0030, Fig. 1], wherein the hand grip, or at least a part thereof, is movable between a stand-by position and an activated position [Sarvazyan ¶0035, Fig. 6, wherein no squeeze may be considered to be “stand-by” and wherein any squeeze may be considered “activated”]; and wherein Sarvazyan further discloses that knowledge of the pain experienced by the patient is useful in adjusting a course of the medical procedure undergone by the patient [Sarvazyan ¶0003].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Harris in view of Huang to employ a hand grip to be held by a hand of a patient, wherein the hand grip is configured to measure a holding force with which the hand grip is held by the patient and/or a holding position in which the hand grip is held by the patient, wherein the hand grip, or at least a part thereof, is movable between a stand-by position and an activated position, wherein the cannula insertion system is arranged to carry out a cannula insertion procedure if the hand grip or the movable part thereof is arranged in the activated position, and to abort the cannula insertion procedure if the hand grip or the movable part thereof is arranged in the stand-by position, so as to allow for monitoring of pain experienced by the patient during the cannula insertion procedure and allow for intervention if the patient is experiencing pain [Sarvazyan ¶0004].
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harris in view of Huang, as applied to claim 1 above, in further view of Guzman (US-6506206-B1, previously presented).
Regarding claim 22, Harris in view of Huang teaches
The cannula insertion system of claim 1, wherein the cannula insertion system comprises a tourniquet device [FIG. 2B illustrates a patient's arm 7 cuffed inside an automatic tourniquet cuff 5 and wrist stabilizing cuff 6, which can be used to increase the visibility of veins and stabilize the patient's arm 7 during the procedure (Harris ¶0045, Fig. 2B)].
However, while Harris discloses that the tourniquet may comprise an ordinary tourniquet [In an embodiment, the automatic tourniquet cuff 5 serves as an ordinary tourniquet, that is, it increases vessel size and visibility which ultimately aids with the vein identification procedure (Harris ¶0045)], Harris in view of Huang fails to explicitly disclose wherein the tourniquet comprises a safety release device to release the tourniquet from a patient's arm or to release the tourniquet from the cannula insertion system if a pulling force exceeds a pulling force threshold.
Guzman discloses a tourniquet to reduce blood flow to an area, wherein the tourniquet comprises a safety release device to release the tourniquet from a patient's arm or to release the tourniquet from the cannula insertion system if a pulling force exceeds a pulling force threshold [During use, tourniquet cuff 10 is wrapped around a patient's limb, with polyester nap layer 20 adjacent the patient's limb, so that VELCRO loop-portion 90 engages VELCRO hook-portion 80 securing tourniquet cuff 10 to the patient's limb (Guzman Col 5:57-61, Fig. 1), wherein the Examiner notes that the VELCRO hook and loop portions of the tourniquet of Guzman are considered to define the safety release device, as hook and loop fasteners are considered to be defined by their function of the hooks to release from the loops (or vice versa) upon application of a pulling force exceeding a pulling force required to release the hooks from the loops (or vice versa)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tourniquet of the system of Harris in view of Huang to employ a safety release device to release the tourniquet from a patient's arm or to release the tourniquet from the cannula insertion system if a pulling force exceeds a pulling force threshold, so as to facilitate ease of release of the tourniquet from the patient’s arm and allow for reusability of the tourniquet; and wherein the modification is further considered to amount to mere simple substitution of one known element for another to obtain predictable results [tourniquet of Harris for the tourniquet of Guzman, wherein both are configured to apply pressure to a limb to reduce the flow of blood] [MPEP § 2143(I)(B)].
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harris in view of Huang, as applied to claim 5 above, in view of Keith (US-6126609-A, previously presented).
Regarding claim 23, Harris in view of Huang teaches
The cannula insertion system of claim 5.
However, while Harris broadly discloses monitoring how full a blood collection tube is or when it is necessary to exchange a blood collection tube for a new tube [In an embodiment, the parameter for needle insertion for phlebotomy comprises instructions to monitor how full the loaded tubes are. In an embodiment, the parameter for needle insertion for phlebotomy comprises instructions to change the tubes when necessary or desirable (Harris ¶0122)], Harris in view of Huang fails to explicitly disclose wherein the blood collection tube exchange system comprises a blood quantity sensor arranged to provide a blood quantity signal representative for a quantity of blood present in a blood collection tube of the one or more blood collection tubes supported by the blood collection system.
Keith discloses systems for collecting blood from a patient, wherein Keith discloses a blood quantity sensor arranged to provide a blood quantity signal representative for a quantity of blood present in a blood collection tube [a sensor 78 may be incorporated in blood sampling device 110. As shown in FIG. 7, one example of a suitable sensor 78 is an optical sensor which optically detects a blood fill level 89 in tube C. However, an optical sensor is only one type of sensor which may be suitable for use with the present invention. One of skill in the art would recognize that other types of sensors may be suitable for sensing desired blood fill level and thus can be employed in the present invention (Keith Col 6:52-60, Fig. 7)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the blood collection tube exchange system of the system of Harris in view of Huang to employ a blood quantity sensor arranged to provide a blood quantity signal representative for a quantity of blood present in a blood collection tube of the one or more blood collection tubes supported by the blood collection system, so as to facilitate exchanging of filled blood collection tubes [Harris ¶¶0072-0075, Figs. 16-19; Once the desired blood fill level is detected by sensor 78, blood flow through flexible tubing H is interrupted by clamp 82, and sensor 78 reactivates roller assembly 68, moving blood sampling tube C back into first position 90 and thus disengaging tube C from second needle J. Once blood sampling tube C is moved into first position 90, carriage assembly 80 is advanced in direction 89 so that another tube opening 88 is aligned with holder 14 by servo motor 81. A blood sampling tube C from the other opening 88 is subsequently moved into second position 92, engaging blood sampling tube C with second needle J (Keith Col 7:29-39)].
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harris in view of Huang, as applied to claim 1 above, in view of Grunwald (US-20160278869-A1, previously presented).
Regarding claim 24, Harris in view of Huang teaches
The cannula insertion system of claim 1.
However, while Harris does disclose the use of an ultrasound device for acquiring an ultrasound image of the vessel for cannula insertion [In an embodiment, the primary sensors 91 further include an ultrasound device 64 (having one or more ultrasound transducers) for acquiring an ultrasound image of the vessel of the patient receiving the medical procedure (Harris ¶0053)], Harris in view of Huang fails to explicitly disclose wherein the one or more sensors are arranged to determine one or more locations of nerves, and wherein the control device is arranged to prevent the insertion of the cannula into the nerves.
Grunwald discloses systems and method for ultrasound-assisted vascular access, wherein Grunwald discloses the use of an ultrasound device for to determine one or more locations of nerves, in order to avoid said one or more nerves during a vascular access procedure [The hand held ultrasound imaging device 170 is used during the vascular access procedure in order to: a) Assess blood vessel size and select the appropriate catheter size of approximately ⅓ of the blood vessel size. b) Verify blood vessel patency to see if there are potential obstacles along the catheter path c) Guide the insertion of the needle into the right blood vessel and avoid injuring nerves or other relevant tissue. d) Verify if the catheter is on the desired path or has reached an undesired location wherever such path and/or location can be visualized by ultrasound imaging (Grunwald ¶¶0032-0036)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Harris in view of Huang to arrange the one or more sensors to determine one or more locations of nerves, and arrange the control device to prevent the insertion of the cannula into the nerves, in order to properly guide the cannula into a vessel and prevent injury to the one or more nerves [Grunwald ¶¶0032-0036].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 7-13, filed 30 April 2026, with respect to the rejection(s) of claim(s) 1 and those dependent therefrom under § 102 and § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection of claim 1 is made in view of Harris (US-20120190981-A1, previously presented) in view of Huang (US-20200100846-A1, effective filing date of 27 September 2019).
The Applicant asserts that Harris fails to disclose or suggest each and every feature of claim 1 including, for example, “wherein the blood collection system is movably arranged to at least partly follow movements of the cannula insertion device”, as the Applicant notes that the automatic dispenser unit/tube changer and storage 74 as a separate hardware unit from the medical device holding tools 212 on the end effector [Applicant cites Harris Fig. 21], wherein medical device tools 212 including needle tool/needle manipulator 3 can be mounted on the robot arm and “support or secondary systems (drawn on the left side of the diagram” that include the automatic dispenser unit/tube changer and storage 74, which the Applicant notes that Harris does not disclose or suggest are mounted on an end effector as the Office Action alleges. Furthermore, the Applicant asserts that even if one were to consider the needle tool 3 and the automatic dispenser unit 74 as “medical device holding tools 212” (which Applicant does not concede), the automatic dispenser unit 74 would not be arranged to at least partly follow movements of the needle tool 3 in the manner suggested by the Office Action, because in Harris’s system, no two medical device holding tools 212 are ever simultaneously attached to the robot arm [Applicant cites ¶¶0058-0060, Figs. 4A-C of Harris as disclosing and depicting separate instances of a single medical device holding tool being attached to the robot arm in the alternative]. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 1 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. Harris (US-20120190981-A1, previously presented) in view of Huang (US-20200100846-A1, effective filing date of 27 September 2019) is presently applied to teach the argued limitation, as Huang discloses a robotic arm system comprising storage that is movably arranged to at least partly follow movements of a robotic arm [Huang ¶0025, wherein storage being within cart 3 that facilitates movement of the robotic arm 3 itself is considered to read on the storage being movably arranged to at least partly follow movements of the robotic arm].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Bodduluri (US-20080167674-A1) discloses automated systems for manipulating a cannula insertion device configured to hold a cannula and insert the cannula into a human and a fluid reservoir fluidically coupled to the cannula and movably arranged to at least partly follow movements of the cannula insertion device [Bodduluri ¶¶0079-0080, Fig. 2A]
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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