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 .
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 2-4 and 9-12 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.
In claim 2, it is unclear how “a detection result” relates to that in claim 1.
In claim 3, similarly to claim 2, it is unclear how “a detection result” relates to that in claim 1.
In claim 9, “the blood vessel” lacks antecedent basis.
In claim 12, it is unclear how “a detection result” relates to that in claim 9.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 10 is rejected under 35 U.S.C. 101 because Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 10 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 10 requires a specific blood vessel (which is part of a human organism).
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.
Claim(s) 1-5, 7-17, 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yarmush et al (US 2021/0378627) in view of Harris et al (US 9,364,171).
Regarding claim 1, Yarmush discloses a vascular puncture device configured to puncture a blood vessel, the vascular puncture device comprising: an imaging unit configured to come into contact with a skin surface and acquire a cross-sectional image of a human body (ultrasound probe; fig 10B; ¶s 13, 26 and 150); a needle 1080 including a needle tip (fig 10B); a drive unit configured to move the needle (¶149); a detection unit (¶17) configured to detect entry of a distal end of the outer tube into the blood vessel or contact or puncture of the needle tip with respect to a back wall of the blood vessel (successful cannulations and overshoot events); a control unit configured to receive information on the cross-sectional image, control an operation of the drive unit, and receive a detection result from the detection unit (¶12 and ¶17); and wherein the control unit is configured to: control the drive unit to move the needle to puncture the blood vessel with the needle (¶12 – configured to manipulate cannula according to determined trajectory); and control the drive unit to stop the puncture with the needle in a case where the detection unit is configured to detect the entry of the needle into the blood vessel or detect the contact or puncture of the needle tip with respect to the back wall of the blood vessel (¶s 29, 118 and 128).
While Yarmusch substantially discloses the invention as claimed, it does not disclose both an inner needle including a needle tip and an outer tube that is flexible and configured to cover the inner needle, the drive unit configured to move both the inner needle and the outer tube, nor wherein the control unit is configured to: control the drive unit to move the inner needle and the outer tube to puncture the blood vessel with the inner needle; and control the drive unit to stop the puncture with the inner needle in a case where the detection unit is configured to detect the entry of the distal end of the outer tube into the blood vessel or detect the contact or puncture of the needle tip with respect to the back wall of the blood vessel.
Harris discloses a vascular puncture device which comprises both an inner needle 22b (fig 10) including a needle tip (fig 7) and an outer tube (22/22a; fig 10) that is configured to cover the inner needle (figs 7 and 10), the drive unit configured to move both the inner needle and the outer tube (figs 8 and 9).
Harris doesn’t disclose the outer tube is flexible. The primary difference between the needle/catheter of Harris and needle of Yarmusch is that Harris uses a separate needle tip that can be withdrawn to aid with puncturing. Harris discloses the cannula/needle is withdrawn to allow the in-swelling cannula to remain in place (Col.4 ll 64-67). One of ordinary skill in the art would appreciate that an in-dwelling catheter that is non-rigid (and thus flexible) allows for easier conformation to blood vessels and reduces risk of damaging the patient if the patient moves with said in-dwelling catheter in place. While rigidity was needed for insertion, the rigidity was provided by the cannula/needle.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Yarmsuch such that it comprises both an inner needle including a needle tip and an outer tube that is flexible and configured to cover the inner needle, the drive unit configured to move both the inner needle and the outer tube as taught by Harris to allow for placement of an in-dwelling catheter (the outer tube) that has decreased chance of injuring a patient if said patient moves (or the needle is forcefully bumped).
Further, due to the configuration of Yarmusch’s sensors (force sensor, imaging unit/sensor) as they pertain to the single needle of Yarmusch, the sensors will also function similarly to the combined inner needle and outer tube of Harris (force sensor will detect forces on combined structure and imaging will be able to see combined structure); such that the control unit will be configured to: control the drive unit to move the inner needle and the outer tube to puncture the blood vessel with the inner needle; and control the drive unit to stop the puncture with the inner needle in a case where the detection unit is configured to detect the entry of the distal end of the outer tube into the blood vessel or detect the contact or puncture of the needle tip with respect to the back wall of the blood vessel.
Regarding claim 2, wherein the control unit is configured to: receive a detection result from a force sensor that is provided in the detection unit and detect a reaction force acting on the inner needle during puncture; and determine that the needle tip punctures the back wall and stop the puncture with the inner needle in a case where the reaction force detected by the force sensor increases and then increases again (¶25,¶115).
Regarding claim 3, wherein the control unit is configured to: receive a detection result from at least one force sensor that is provided in the detection unit and detect a reaction force acting on the inner needle and a reaction force acting on the outer tube during puncture; and determine that the outer tube hits the back wall after the back wall is punctured by the needle tip and stop the puncture with the inner needle in a case where the reaction force acting on the outer tube detected by the force sensor increases after the reaction force acting on the inner needle detected by the force sensor increases (¶25, ¶115; force sensor will detect forces on composite device of both inner needle and outer tube, while it doesn’t differentiate between them, it detects the forces).
Regarding claim 4, wherein the control unit is configured to stop the puncture with the inner needle in a case where the reaction force on the inner needle detected by the force sensor is equal to or larger than a threshold (¶115; a second sharp sudden increase in force has to be higher than the threshold of the sudden decrease in force, the decrease in force setting a threshold which the second increase must be higher than).
Regarding claim 5, while Yarmush substantially discloses the invention as claimed, it does not disclose wherein the control unit is configured to: receive a detection result from an optical sensor that is provided in the detection unit and detect backflow of blood from the inner needle during puncture; and stop the puncture with the inner needle in a case where the optical sensor detects occurrence of the backflow of the blood and stop of the backflow after the occurrence.
Yarmush discloses using blood flash data and manipulating the cannula appropriately based on the blood flash data (¶18).
One of ordinary skill in the art recognizes that flashback chambers are often visual and using a camera (optical sensor) is merely automating the visual confirmation of blood flashback.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Yarmush such that the control unit is configured to: receive a detection result from an optical sensor that is provided in the detection unit and detect backflow of blood from the inner needle during puncture; and stop the puncture with the inner needle in a case where the optical sensor detects occurrence of the backflow of the blood and stop of the backflow after the occurrence as suggested by Yarmush itself to provide a specific means of observing the blood flashback which confirms or disproves proper placement of the device.
Regarding claim 7, while Yarmush and Harris substantially disclose the invention as claimed, they do not disclose wherein the control unit is configured to receive a detection result from an ultrasound marker that is provided in the detection unit and disposed in a distal end portion of the outer tube.
Yarmush discloses use of ultrasonic imaging (¶53).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to provide an ultrasound marker on the distal end portion of the outer tube (the control unit is configured to perform ultrasound on affected areas and thus will receive a detection result of such a marker) as suggested by Yarmush itself to confirm proper placement of the outer tube.
Regarding claim 8, while Yarmsush substantially discloses the invention as claimed, it does not disclose wherein the control unit is configured to use a machine-learned model obtained from detection results from the detection unit to detect the entry of the distal end of the outer tube into the blood vessel or detect the contact or puncture of the needle tip with respect to the back wall of the blood vessel by the detection unit.
Yarmush discloses different events have different profiles (¶114-117).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Yarmush such that the control unit is configured to use a machine-learned model obtained from detection results from the detection unit to detect the entry of the distal end of the outer tube into the blood vessel or detect the contact or puncture of the needle tip with respect to the back wall of the blood vessel by the detection unit as suggested by Yarmush itself to allow the control unit to more efficiently/confidently detect the proper profile and the event associated with said profile.
Regarding claim 9, Yarmush discloses a vascular puncture device configured to puncture a blood vessel, the vascular puncture device comprising: an imaging unit configured to come into contact with a skin surface and acquire a cross-sectional image of a human body (ultrasound probe; fig 10B; ¶s 13, 26 and 150); a needle 1080 including a needle tip (fig 10B); a drive unit configured to move the needle (¶149); a detection unit (¶17) configured to detect entry of a distal end of the outer tube into the blood vessel or contact or puncture of the needle tip with respect to a back wall of the blood vessel (successful cannulations and overshoot events); a control unit configured to receive information on the cross-sectional image, control an operation of the drive unit, and receive a detection result from the detection unit (¶12 and ¶17); and wherein the control unit is configured to: control the drive unit to move the needle to puncture the blood vessel with the needle (¶12 – configured to manipulate cannula according to determined trajectory); and control the drive unit to stop the puncture with the needle in a case where the detection unit detects the entry of the distal end of the outer tube into the blood vessel or detects the contact or puncture of the needle tip with respect to the back wall of the blood vessel (¶s 29, 118 and 128).
While Yarmusch substantially discloses the invention as claimed, it does not disclose both an inner needle including a needle tip and an outer tube that is flexible and configured to cover the inner needle, the drive unit configured to move both the inner needle and the outer tube, nor wherein the control unit is configured to: control the drive unit to move the inner needle and the outer tube to puncture the blood vessel with the inner needle; and control the drive unit to stop the puncture with the inner needle in a case where the detection unit detects the entry of the distal end of the outer tube into the blood vessel or detects the contact or puncture of the needle tip with respect to the back wall of the blood vessel.
Harris discloses a vascular puncture device which comprises both an inner needle 22b (fig 10) including a needle tip (fig 7) and an outer tube (22/22a; fig 10) that is configured to cover the inner needle (figs 7 and 10), the drive unit configured to move both the inner needle and the outer tube (figs 8 and 9).
Harris doesn’t disclose the outer tube is flexible. The primary difference between the needle/catheter of Harris and needle of Yarmusch is that Harris uses a separate needle tip that can be withdrawn to aid with puncturing. Harris discloses the cannula/needle is withdrawn to allow the in-swelling cannula to remain in place (Col.4 ll 64-67). One of ordinary skill in the art would appreciate that an in-dwelling catheter that is non-rigid (and thus flexible) allows for easier conformation to blood vessels and reduces risk of damaging the patient if the patient moves with said in-dwelling catheter in place. While rigidity was needed for insertion, the rigidity was provided by the cannula/needle.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Yarmsuch such that it comprises both an inner needle including a needle tip and an outer tube that is flexible and configured to cover the inner needle, the drive unit configured to move both the inner needle and the outer tube as taught by Harris to allow for placement of an in-dwelling catheter (the outer tube) that has decreased chance of injuring a patient if said patient moves (or the needle is forcefully bumped).
Further, due to the configuration of Yarmusch’s sensors (force sensor, imaging unit/sensor) as they pertain to the single needle of Yarmusch, the sensors will also function similarly to the combined inner needle and outer tube of Harris (force sensor will detect forces on combined structure and imaging will be able to see combined structure); such that the control unit will be configured to: control the drive unit to move the inner needle and the outer tube to puncture the blood vessel with the inner needle; and control the drive unit to stop the puncture with the inner needle in a case where the detection unit detects the entry of the distal end of the outer tube into the blood vessel or detects the contact or puncture of the needle tip with respect to the back wall of the blood vessel.
Regarding claim 10, wherein the needle tip of the inner needle is longer than an outer diameter in a puncture direction of a target blood vessel to be punctured (capable of an overshoot event - ¶115).
Regarding claim 11, wherein the inner needle is solid (as opposed to another state of matter, like liquid).
While the above is the broadest reasonable interpretation, the examiner notes another interpretation could be a needle without a lumen (and probably what was intended). The needle was modified by Harris in the combination in claim 9. Harris discloses the needle is solely used to stiffen the catheter (Col.10 ll 16-18). Such that a needle without a lumen is obvious to provides the most reinforcement while allowing for a narrower size (to fit within the catheter).
Regarding claim 12, wherein the control unit is configured to: receive a detection result from a force sensor that is provided in the detection unit and detect a reaction force acting on the inner needle during puncture; and determine that the needle tip punctures the back wall and stop the puncture with the inner needle in a case where the reaction force detected by the force sensor increases and then increases again (¶25, ¶115).
Regarding claim 13, Yarmusch discloses a method for puncturing a blood vessel, the method comprising: acquiring a cross-sectional image of a human body (via ultrasound probe; fig 10B; ¶s 13, 26 and 150); detecting entry of a distal end of a needle into the blood vessel or contact or puncture of a needle tip of a needle with respect to a back wall of the blood vessel (¶17 - successful cannulations and overshoot events); moving the needle to puncture the blood vessel with the needle (¶149); and stopping the puncture with the needle when in a case where the detection of the entry of the distal end of the needle into the blood vessel or the detection of contact or puncture of the needle tip with respect to the back wall of the blood vessel (¶s 29, 118, 128).
While Yarmusch substantially discloses the invention as claimed, it does not disclose an outer tube on the inner needle, such that it does not discloses detecting entry of a distal end of an outer tube into the blood vessel or contact or puncture of a needle tip of an inner needle with respect to a back wall of the blood vessel, the outer tube configured to cover the inner needle; moving the inner needle and the outer tube to puncture the blood vessel with the inner needle; and stopping the puncture with the inner needle when in a case where the detection of the entry of the distal end of the outer tube into the blood vessel or the detection of contact or puncture of the needle tip with respect to the back wall of the blood vessel.
Harris discloses a vascular puncture device which comprises both an inner needle 22b (fig 10) including a needle tip (fig 7) and an outer tube (22/22a; fig 10) that is configured to cover the inner needle (figs 7 and 10), the drive unit configured to move both the inner needle and the outer tube (figs 8 and 9).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Yarmush such that the single needle instead comprises an outer tube and an inner needle as taught by Harris to allow for placement of an in-dwelling catheter (the outer tube) that has decreased chance of injuring a patient if said patient moves (or the needle is forcefully bumped).
Further, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify the method of Yarmush to accommodate the outer tube and inner needle combination while maintaining the disclosed functionality and thus includes the steps of detecting entry of a distal end of an outer tube into the blood vessel or contact or puncture of a needle tip of an inner needle with respect to a back wall of the blood vessel, the outer tube configured to cover the inner needle; moving the inner needle and the outer tube to puncture the blood vessel with the inner needle; and stopping the puncture with the inner needle when in a case where the detection of the entry of the distal end of the outer tube into the blood vessel or the detection of contact or puncture of the needle tip with respect to the back wall of the blood vessel as taught by Yarmush itself to assist in ensuring proper placement of the device.
Regarding claim 14, further comprising: receiving a detection result from a force sensor and detecting a reaction force acting on the inner needle during puncture; and determining that the needle tip punctures the back wall and stopping the puncture with the inner needle in a case where the reaction force detected by the force sensor increases and then increases again (¶25, ¶115).
Regarding claim 15, further comprising: receiving a detection result from at least one force sensor and detecting a reaction force acting on the inner needle and a reaction force acting on the outer tube during puncture; and determining that the outer tube hits the back wall after the back wall is punctured by the needle tip and stopping the puncture with the inner needle in a case where the reaction force acting on the outer tube detected by the force sensor increases after the reaction force acting on the inner needle detected by the force sensor increases (¶25, ¶115; force sensor will detect forces on composite device of both inner needle and outer tube, while it doesn’t differentiate between them, it detects the forces).
Regarding claim 16, further comprising: stopping the puncture with the inner needle in a case where the reaction force on the inner needle detected by the force sensor is equal to or larger than a threshold (¶115; a second sharp sudden increase in force has to be higher than the threshold of the sudden decrease in force, the decrease in force setting a threshold which the second increase must be higher than).
Regarding claim 17, while Yarmush substantially discloses the invention as claimed, it does not disclose further comprising: receiving a detection result from an optical sensor and detecting backflow of blood from the inner needle during puncture; and stopping the puncture with the inner needle in a case where the optical sensor detects occurrence of the backflow of the blood and stop of the backflow after the occurrence.
Yarmush discloses using blood flash data and manipulating the cannula appropriately based on the blood flash data (¶18).
One of ordinary skill in the art recognizes that flashback chambers are often visual and using a camera (optical sensor) is merely automating the visual confirmation of blood flashback.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Yarmush such that it further comprises: receiving a detection result from an optical sensor and detecting backflow of blood from the inner needle during puncture; and stopping the puncture with the inner needle in a case where the optical sensor detects occurrence of the backflow of the blood and stop of the backflow after the occurrence as suggested by Yarmush itself to provide a specific means of observing the blood flashback which confirms or disproves proper placement of the device.
Regarding claim 19, while Yarmush substantially discloses the invention as claimed, it does not disclose further comprising: receiving a detection result from an ultrasound marker that is provided in the detection unit and disposed in a distal end portion of the outer tube.
Yarmush discloses use of ultrasonic imaging (¶53).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Yarmush such that it further comprises receiving a detection result from an ultrasound marker that is provided in the detection unit and disposed in a distal end portion of the outer tube as suggested by Yarmush itself to confirm proper placement of the outer tube.
Regarding claim 20, while Yarmush substantially discloses the invention as claimed, it does not disclose further comprising: detecting the entry of the distal end of the outer tube into the blood vessel using a machine learning model; or detecting the contact or puncture of the needle tip with respect to the back wall of the blood vessel using the machine learning model.
Yarmush discloses different events have different profiles (¶114-117).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Yarmush such that it further comprises detecting the entry of the distal end of the outer tube into the blood vessel using a machine learning model; or detecting the contact or puncture of the needle tip with respect to the back wall of the blood vessel using the machine learning model as suggested by Yarmush itself to allow the control unit to more efficiently/confidently detect the proper profile and the event associated with said profile.
Claim(s) 6 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yarmush et al (US 2021/0378627) in view of Harris et al (US 9,364,171) and Schultz et al (US 2021/0100987).
Regarding claims 6 and 18, while Yarmush substantially discloses the invention as claimed, it does not disclose wherein the control unit is configured to: receive a detection result from a flow rate sensor that is provided in the detection unit and detect backflow of blood from the inner needle during puncture; and stop the puncture with the inner needle in a case where the flow rate sensor detects occurrence of the backflow of the blood and stop of the backflow after the occurrence.
Yarmush discloses using blood flash data and manipulating the cannula appropriately based on the blood flash data (¶18).
Schultz discloses a needle placement device which includes a flow rate sensor (or pressure change or temperature change) when puncturing a blood vessel to determine if the device is placed correctly and needs to be moved (or not if placed correctly) - ¶365.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Yarmush such that the control unit is configured to: receive a detection result from a flow rate sensor that is provided in the detection unit and detect backflow of blood from the inner needle during puncture; and stop the puncture with the inner needle in a case where the flow rate sensor detects occurrence of the backflow of the blood and stop of the backflow after the occurrence as taught by Schultz as part of Yarmush’s desire to utilize blood flash data to instruct the cannula positioning.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783
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