DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election of group I, including claims 1-12, in the reply filed on 01/20/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-2, 4-6, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fujie et al. (US 2018/0000511 A1).
With respect to claim 1, Fujie discloses a vascular puncture device configured to puncture a blood vessel, the vascular puncture device comprising (as seen on Figure 2 attached herein): an imaging unit configured to come into contact with a skin surface and acquire a cross-sectional image of a human body (see ultrasonic probe #15 as the claimed imaging unit in contact with patient’s skin S as also described in paragraph 0014); a puncture unit including a needle tip; a
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drive unit configured to move the puncture unit (see puncture assistance robot #33 including a needle actuator as the claimed drive unit and a needle N); a control unit configured to receive information on the cross-sectional image (device #11 having detecting means #18 connected to image generation means #17) and control an operation of the drive unit (see controller #40 to control the needle actuator); and wherein the control unit is configured to: identify at least one blood vessel from information on the cross-sectional image; determine whether the identified at least one blood vessel is an artery or a vein from information on the cross-sectional image of the identified at least one blood vessel (see paragraph 0018 disclosing the possibility of identifying the vessel type including vein); set a blood vessel to be punctured from among the identified at least one blood vessel; and control the drive unit to move the puncture unit to puncture the blood vessel set to be punctured with the puncture unit (see paragraphs 0013, 0018 and 0022).
With respect to claim 2, Fujie discloses the control unit is configured to determine that the identified at least one blood vessel is the artery in a case where pulsation of the identified at least one blood vessel is detectable from the cross-sectional image, or in a case where the detected pulsation is equal to or larger than a threshold or exceeds the threshold (see paragraph 0023-0025).
With respect to claim 4, Fujie discloses the control unit is configured to detect a thickness of a media of the identified at least one blood vessel from the cross-sectional image, and determine whether the identified at least one blood vessel is the artery or the vein based on the thickness of the detect media of the identified at least one blood vessel (see paragraph 0005 implicitly teaching thickness by stating the identification of size of the blood vessel).
With respect to claim 5, Fujie discloses the control unit is configured to detect an elasticity of the identified blood vessel from the cross- sectional image, and determine whether the identified at least one blood vessel is the artery or the vein based on the detected elasticity of the identified at least one least one blood vessel (see paragraph 0017 disclosing the vessel deformation and detection of vascular diameter in paragraphs 0007 and 0014 that are elasticity characteristics).
With respect to claim 6, Fujie discloses the control unit is configured to determine whether the identified at least one blood vessel is the artery or the vein based on whether or not at least one of presence or absence or a magnitude of pulsation, a blood flow direction, a thickness of a media, or a magnitude of elasticity satisfies a condition indicating that the identified at least one blood vessel is the artery from the cross-sectional image of the identified at least one blood vessel (see paragraph 0005 implicitly teaching thickness by stating the identification of size of the blood vessel; see paragraph 0017 disclosing the vessel deformation and detection of vascular diameter in paragraphs 0007 and 0014 that are elasticity characteristics).
With respect to claim 12, Fujie discloses a vascular puncture system comprising (as seen on Figure 2 attached herein): an imaging unit configured to come into contact with a skin surface and acquire a cross-sectional image of a human body (see ultrasonic probe #15 as the claimed imaging unit in contact with patient’s skin S as also described in paragraph 0014); a puncture unit including a needle tip; a drive unit configured to move the puncture unit (see puncture assistance robot #33 including a needle actuator as the claimed drive unit and a needle N); a control unit configured to receive information on the cross-sectional image (device #11 having detecting means #18 connected to image generation means #17) and control an operation of the drive unit (see controller #40 to control the needle actuator); and wherein the control unit is configured to: identify at least one blood vessel from information on the cross- sectional image; determine whether the identified at least one blood vessel is an artery or a vein from information on the cross-sectional image of the identified at least one blood vessel (see paragraph 0018 disclosing the possibility of identifying the vessel type including vein); set a blood vessel to be punctured from among of the identified at least one blood vessels; and control the drive unit to move the puncture unit to puncture the blood vessel set to be punctured with the puncture unit (see paragraphs 0013, 0018 and 0022).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Fujie et al. (US 2018/0000511 A1) in view of Neerken et al. (US 2008/0275396 A1).
With respect to claim 3, Fujie discloses the claimed invention as stated above except for specifying that the control unit is configured to detect a blood flow direction of the identified at least one blood vessel from the cross-sectional image, and determine whether the identified at least one blood vessel is the artery or the vein based on the blood flow direction (see paragraphs 0062-0063). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have a the control unit configured to detect a blood flow direction of the identified at least one blood vessel from the cross-sectional image, and determine whether the identified at least one blood vessel is the artery or the vein based on the blood flow direction as taught by Neerken in combination with Fujie’s control unit for the purpose of more accurately distinguish between an artery from a vein since if the blood is flowing away from the heart, the blood flow is in direction to an artery as opposed blood flowing towards the heart, hence blood flowing in direction of a vein (as taught by Neerken in paragraph 0062).
Claims 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Fujie et al. (US 2018/0000511 A1) in view of Szczech et al. (US 2004/0133111 A1)
With respect to claim 7, Fujie discloses the claimed invention except for specifying a control unit is configured to adjust a position and an angle of the puncture unit by the drive unit to enable the puncture unit to puncture the identified at least one blood vessel determined to be the artery in the cross-sectional image. However, Szczech discloses adjusting a position and an angle of the puncture unit by the drive unit to enable the puncture unit to puncture the identified at least one blood vessel determined to be the artery in the cross-sectional image (see paragraph 0047-0049). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have the capacity of adjusting a position and an angle of the puncture unit by the drive unit to enable the puncture unit to puncture the identified at least one blood vessel determined to be the artery in the cross-sectional image as taught by Szczech in combination with Fujie’s control unit for the purpose of providing a control unit capable of providing a variety of paths to guide the needle in accordance to the locations selected from the data obtained from the imaging device to enhance the ease of use and the accuracy of needle placement (see paragraphs 0042-0043).
With respect to claim 8, Fujie discloses except for specifying the control unit is configured to detect a pulsation of the identified at least one blood vessel determined to be the artery from the cross-sectional image, and adjust at least one of a position or an angle of the puncture unit before puncture or a puncture speed during the puncture according to a pulsation rate. However, Szczech discloses a control unit configured to detect a pulsation of the identified at least one blood vessel determined to be the artery from the cross-sectional image, and adjust at least one of a position or an angle of the puncture unit before puncture or a puncture speed during the puncture according to a pulsation rate (see paragraph 0047-0049). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have a control unit configured to detect a pulsation of the identified at least one blood vessel determined to be the artery from the cross-sectional image, and adjust at least one of a position or an angle of the puncture unit before puncture or a puncture speed during the puncture according to a pulsation rate as taught by Szczech in combination with Fujie’s control unit for the purpose of providing a variety of paths to guide the needle in accordance to the locations selected from the data obtained with the imaging device to enhance the ease of use and the accuracy of needle placement (see paragraphs 0042-0043).
With respect to claim 9, Fujie discloses the control unit configured to detect a thickness of a media of the identified at least one blood vessel determined to be the artery or the vein from the cross-sectional image (see paragraph 0005 implicitly teaching thickness by stating the identification of size of the blood vessel) Furthermore, Fujie discloses the claimed invention as stated above except for adjusting at least one of a position or an angle of the puncture unit before puncture or a puncture speed during the puncture according to the detected thickness of the media of the identified at least one blood vessel. However, Szczech discloses adjusting at least one of a position or an angle of the puncture unit before puncture or a puncture speed during the puncture according to the detected thickness of the media of the identified at least one blood vessel (see paragraph 0047-0049). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to adjust at least one of a position or an angle of the puncture unit before puncture or a puncture speed during the puncture according to the detected thickness of the media of the identified at least one blood vessel as taught by Szczech in combination with Fujie’s control unit for the purpose of providing a variety of paths to guide the needle in accordance to the locations selected from the data obtained with the imaging device to enhance the ease of use and the accuracy of needle placement (see paragraphs 0042-0043).
With respect to claim 10, Fujie discloses the control unit is configured to detect a thickness and/or a position of a calcified portion present in the identified at least one blood vessel determined to be the artery or the vein from the cross-sectional image (see paragraph 0005 implicitly teaching thickness by stating the identification of size of the blood vessel), Furthermore, Fujie discloses the claimed invention as stated above except for adjusting at least one of a position or an angle of the puncture unit before puncture or a puncture speed during the puncture according to the thickness and/or the position of the detected calcified portion of the identified at least one blood vessel. However, Szczech discloses adjusting at least one of a position or an angle of the puncture unit before puncture or a puncture speed during the puncture according to the thickness and/or the position of the detected calcified portion of the identified at least one blood vessel (see paragraph 0047-0049). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to adjust at least one of a position or an angle of the puncture unit before puncture or a puncture speed during the puncture according to the thickness and/or the position of the detected calcified portion of the identified at least one blood vessel as taught by Szczech in combination with Fujie’s control unit for the purpose of providing a variety of paths to guide the needle in accordance to the locations selected from the data obtained with the imaging device to enhance the ease of use and the accuracy of needle placement (see paragraphs 0042-0043).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Fujie et al. (US 2018/0000511 A1) in view of Brattain et al. (US 2021/0045711 A1)
With respect to claim 11, Fujie discloses the claimed invention as stated above except for when determining whether the identified at least one blood vessel is the artery or the vein, the control unit is configured to determine whether the identified at least one blood vessel is the artery or the vein by a machine-learned model from the information on the cross-sectional image of the identified at least one blood vessel. However, Brattain discloses determining whether the identified at least one blood vessel is the artery or the vein by a machine-learned model from the information on the cross-sectional image of the identified at least one blood vessel (see paragraphs and 0017 and 0048-0050). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to determine whether the identified at least one blood vessel is the artery or the vein, the control unit is configured to determine whether the identified at least one blood vessel is the artery or the vein by a machine-learned model from the information on the cross-sectional image of the identified at least one blood vessel as taught by Brattain in combination with Fujie’s control unit for the purpose of performing vessel segmentation in a robust manner over time for a subject without misclassification and without a need to find a specific time frame or a specific probe position to identify vessels of interest in order to further identify the insertion point of the needle after classifying the blood vessel (see paragraphs 0051-0052).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The additional prior art cited in the PTO 892 not relied upon discloses ultrasound devices used in conjunction puncture devices to insert a needle.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIXOMARA VARGAS whose telephone number is (571)272-2252. The examiner can normally be reached Monday-Friday 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Raymond Keith can be reached at 571-270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DIXOMARA VARGAS/Primary Examiner, Art Unit 3798
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