DETAILED ACTION
This action is responsive to the “Amendment Under 37 C.F.R. § 1.111” filed 18 November 2025. The Examiner acknowledges the amendments to claims 1, 8, 10, 12, 14, 18, and 23. Claims 1-25 are pending.
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 .
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-15, 18, and 25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Harris (US-20120190981-A1, previously presented).
Regarding claim 1, Harris 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)],
wherein the blood collection system is movably arranged to at least partly follow movements of the cannula insertion device [enabling the system 8 to autonomously affix tools to manipulate end-effectors for a desired medical procedure. These tools pick up and manipulate the medical devices 22 and 41 mentioned above during insertion procedures (Harris ¶0060); In an embodiment, the primary sensors 91 and the medical device holding tools 210 are mounted onto the sixth axis of the robot arm 1, together making the robot arm's end effector (Harris ¶0088, Fig. 21); FIG. 16 shows an embodiment of a manipulator 210 for blood drawing tubes 78. In an embodiment, the manipulator 210 is used for connecting the butterfly needles 41 to blood drawing tubes 78 to collect the blood samples from the patient (Harris ¶0072, Fig. 16); In an embodiment, one or more of the primary sensors 91 may be rigidly mounted on the robot arm 1 in a fixed relation to the butterfly needle 41. In other words, if the butterfly needle 41 pivots, the one or more primary sensors 91 pivot with the butterfly needle 41 (Harris ¶0047), wherein as disclosed in ¶¶0047, 0088 and as depicted in Fig. 22, the sensors 91 and medical device holding tools 212, which is considered to include the automatic dispenser unit 74 (based on ¶0094 defining tools for handling VACUTAINER.RTM. phlebotomy equipment as included in the medical device holding tools 212), are positioned on the end effector of the robot arm, which is considered to encompass the cannula insertion device positioning system, such that the blood collection system at least partly follows movements of the cannula insertion device].
Regarding claim 2, Harris 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 [Harris ¶¶0047, 0088, Fig. 22].
Regarding claim 3, Harris 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 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 [Harris ¶0088, Fig. 22].
Regarding claim 5, Harris 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 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 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 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 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 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 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 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 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 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 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 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 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)].
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) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harris, as applied to claim 1 above, in 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 teaches
The cannula insertion system of claim 1.
However, Harris 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 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, as applied to claim 1 above, in 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 teaches
The cannula insertion system of claim 1.
However, Harris 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 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, Harris teaches
The cannula insertion system of claim 1.
However, Harris 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 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, as applied to claim 1 above, in view of Guzman (US-6506206-B1, previously presented).
Regarding claim 22, Harris 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 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 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, as applied to claim 1 above, in view of Keith (US-6126609-A, previously presented).
Regarding claim 23, Harris 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 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 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, as applied to claim 1 above, in view of Grunwald (US-20160278869-A1, previously presented).
Regarding claim 24, Harris 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 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 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. 8, filed 18 November 2025, with respect to the previously presented Specification objections have been fully considered and are persuasive. The Specification objection regarding new matter has been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 8, with respect to the previously presented claim objections have been fully considered and are persuasive. The claim objections of claims 1, 8, 12, and 14 have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 8-9, with respect to the previously applied claim rejections under § 112(b) have been fully considered and are persuasive. The rejections of claims 8, 10, 18, and 23 under § 112(b) been withdrawn.
Applicant's arguments, see Applicant’s Remarks p. 9-14, with respect to the previously applied claim rejections under § 102 and § 103 have been fully considered but they are not persuasive.
The Applicant asserts that claim 1 is patentable over the previously presented Harris reference, as the Applicant argues that Harris fails to disclose or suggest the limitation “wherein the blood collection system is movably arranged to at least partly follow movements of the cannula insertion device”, wherein the Applicant further argues that Harris fails to disclose or suggest that the automatic dispenser unit 74 [as part of manipulator 210 which functions in relation to the piercing needle 72] at least partly follows movements of the needle tool 3 or any medical device holding tool 212 [which the Applicant notes holds butterfly needle 41] and that the cited portion of ¶0088 of Harris regarding “the medical device holding tools 210 are mounted onto the sixth axis of the robot arm” is a typographical error and should read “the medical device holding tools [[210]] 212…”, such that the manipulator 210 and automatic dispenser unit 74 is not mounted onto the sixth axis of the robot arm. However, the Examiner disagrees with the Applicant’s argument, as the Examiner notes that even in spite of the alleged typographical error, Harris defines the medical device holding tools as “any relevant medical device holding tools 212 for handling standard medical devices such as cannulas, Y-type catheters, VACUTAINER.RTM. phlebotomy equipment, and syringes” [Harris ¶0094, emphasis applied], such that the automatic dispenser unit 74 of manipulator 210 being configured to handle [engage, disengage, and exchange] VACUTAINER.RTM. tubes [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. In an embodiment, the blood drawing tubes 78 are VACUTAINER.RTM. tubes. FIG. 16 shows an embodiment of a manipulator 210 for blood drawing tubes 78. In an embodiment, the manipulator 210 is used for connecting the butterfly needles 41 to blood drawing tubes 78 to collect the blood samples from the patient (Harris ¶0072)] is considered to be included as a medical device holding tool 212 that may be mounted onto the sixth axis of the robot arm to at least partly follow movements of the cannula insertion device [Harris ¶0088].
Regarding the previously applied rejections under § 103, the Applicant notes that based on the above presented arguments of Harris, the additionally presented references fail to cure the argued deficiencies of Harris. However, for the above stated reasons, Harris is not considered to have any deficiencies regarding the anticipation of claim 1, such that none of the previously presented additional references are required to cure the alleged deficiencies of Harris.
Conclusion
THIS ACTION IS MADE FINAL. 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 SEVERO ANTONIO P LOPEZ whose telephone number is (571)272-7378. The examiner can normally be reached M-F 9-6 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/S.P.L./Examiner, Art Unit 3791