DETAILED ACTION
Status of Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1, 3, 5-14, and 21-24 are pending.
Claims 2, 4, and 15-20 are cancelled.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/05/2026 has been entered.
Response to Arguments
Applicant argues the prior art does not teach the limitations recited in the claims as amended. See Remarks at 8-12.
Applicant’s argument has been fully considered but it is not persuasive. See discussion below.
Note that all claims are drawn to the same invention claimed in the application prior to the entry of the submission under 37 CFR 1.114 and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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.
Claims 1, 3, 5-7, 9, 11-13, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Herlihy et al. (US 20100010505 A1, 2010-01-14) (hereinafter “Herlihy”).
Regarding claims 1, 3, 5-7, 9, 11-13, and 21, Herlihy teaches an apparatus for accessing a target vessel, the apparatus comprising: a moveable base (e.g., 130) configured for planar and rotational positioning relative to the patient (e.g., along track 132, along with support arm 17), wherein the moveable base is configured with a locking mechanism (e.g., 145, 158) to lock a location of the moveable base relative to the patient; a guidewire (70); a needle (60), the needle defining a first lumen configured to receive the guidewire such that the guidewire can be advanced via the needle into the target vessel; and a catheter (55) defining a second lumen, the catheter disposable about the guidewire such that the catheter can be advanced along the guidewire and into the target vessel; a robotic system (17, 20) configured to selectively advance the needle, the guidewire, and the catheter into the target vessel (e.g., [0015], [0036]); the robotic system having a first portion and a second portion, wherein the first portion is coupled to a surface of the movable base (e.g., comprising 10, 130, 150) such that the moveable base supports the robotic system and a second portion is movable relative to the surface to position the guidewire, the needle, and the catheter for insertion into the target vessel of the patient (e.g., Fig. 1, 4A), where the moveable base is configured with a locking mechanism (e.g., 158) to lock a location of the moveable (e.g., [0058], [0060]); and a control unit operatively coupled to the robotic system, the control unit configured to control the robotic system to: advance the needle until the sharpened tip of the needle is disposed in the target vessel; advance the guidewire through the first lumen of the needle until a distal end of the guidewire extends a predetermined distance from the sharpened tip of the needle; and advance the catheter over at least the guidewire such that a distal end of the catheter is disposed in the target vessel; and an imaging system (e.g., 11; [0047]; Fig. 1) coupled to the second portion of the robotic system and configured to capture1 a transverse view and a longitudinal view of the target vessel while the needle, the guidewire, and the catheter are being advanced (e.g., [0036]-[0037]); and a display (e.g., monitors 12; [0037]) coupled to the moveable base and configured to display the transverse view, the longitudinal view, and a status information on a task being performed by the robotic system (e.g., [0035]-[0038]). See, e.g., [0015], [0040]-[0044]; esp. [0037](“ The imaging function may be used to delineate [construed as 3-dimensional transverse and longitudinal] the geometry and position of the target vessel. In one embodiment, the ultrasound machine 11 has Doppler signaling for locating and targeting of the central vein below the skin”); [0047] (“Using ultrasound imaging, the device 5 identifies the target lumen, which, in this example, is the central vein 7. The device 5 is moved by the operator until a precise [3-dimensoinal] location in the target lumen is aligned with the crosshair [i.e., status information] on the [display] monitor 12. Additionally, the imaging function allows the operator to select a [3-dimensional] path for the needle 60 to avoid accidentally puncturing any adjacent structures”)) (as recited in claim 1); wherein the imaging system is an ultrasound imaging system (e.g., [0035]-[0038]) (as recited in claim 3); wherein the imaging system is attached to the robotic system near the guidewire, the needle, and the catheter (e.g., [0035]-[0038]) (as recited in claim 5); wherein the target vessel is an artery (e.g., [0074]) (as recited in claim 6); further comprising a coupler configured to releasably couple the catheter to the robotic system, the coupler configured to decouple the catheter from the robotic system after the catheter has been advanced into the target vessel (e.g., [0013], [0042]-[0043]) (as recited in claim 7); wherein the second portion of the robotic system is movable to position the guidewire, the needle, and the catheter at a predetermined acute angle relative to a longitudinal axis of the target vessel (as recited in claim 9); wherein the second lumen defined by the catheter is sized to receive the guidewire and the needle, and the robotic system is configured to advance the catheter over the guidewire and the needle (as recited in claim 11); wherein the control unit is configured to control the robotic system to retract the needle or the guidewire (as recited in claim 12); wherein the target vessel is at least one of a femoral artery, a jugular vein, or a peripheral artery (as recited in claim 13), as noted above; a cartridge including a plurality of guides coupled to the guidewire, the needle, and the catheter (e.g., [0013]) (as recited in claim 21).
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.
Claims 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Herlihy.
Regarding claims 22-24, Herlihy teaches a robotic system, comprising a linear actuator to advance and retract various instruments (e.g., [0038], [0065], [0041], [0047]), as discussed above. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Herlihy such that the invention further comprises a plurality of actuators each configured to couple to a different guide member of the plurality of guides, the plurality of actuators configured to advance and retract the plurality of guides to move the needle, the guidewire, and the catheter (as recited in claim 22); wherein the control unit advances each of the needle, the guidewire, and the catheter by actuating at least one actuator of the plurality of actuators (as recited in claim 23); wherein the plurality of actuators is configured to linearly advance and retract the plurality of guides (as recited in claim 24) in order to provide a more versatile system for treatment.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Herlihy in view of Rosenberg et al. (US 20060276775 A1, 2006-12-07) (hereinafter “Rosenberg”).
Regarding claim 8, Herlihy teaches a robotic system, as discussed above. However, Herlihy does not expressly teach use of a dilator. Rosenberg teaches a use of a dilator. See, e.g., [0390]-[0392]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Sharon with the invention taught by Herlihy such that the apparatus further comprises a dilator, the robotic system further being configured to selectively advance the dilator, the control unit further being configured to control the robotic system to advance the dilator over at least the guidewire before advancing the catheter in order to improve the efficacy of the treatment by using appropriate instruments.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Herlihy in view of Sharon et al. (US 20210236217 A1, 2021-08-05) (hereinafter “Sharon”).
Regarding claim 14, Herlihy teaches a robotic system, as discussed above. However, Herlihy does not expressly teach a surgical bed. Sharon teaches a surgical robot attached onto a surgical bed. See, e.g., [0210], [0318]-[0319]. Sharon teaches the advantages of securing instruments to the surgical bed. See e.g., [0318]-[0320]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Sharon with the invention taught by Herlihy such that the apparatus further comprises: moveable base (construed as the surgical bed of Sharon in conjunction with the movable base taught by Herlihy) includes at least one flat portion configured to support the patient during a medical procedure in order to improve the efficacy and accuracy of the treatment.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Herlihy. Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Herlihy in view of Sharon.
Regarding claims 10 and 20, Herlihy teaches a robotic system, as discussed above. However, Herlihy does not expressly teach wherein the predetermined acute angle is between about 20 and about 60 degree.
It would have been an obvious matter of design choice, before the effective filing date of the claimed invention, for a person of ordinary skill in the art to arrive at the recited predetermined acute angles because Applicant has not disclosed that the recited angles provides an advantage, is used for a particular purpose, or solves a stated problem.
Therefore, it would have been prima facie obvious to modify invention taught by Herlihy (in view of Sharon) to obtain the invention as specified in claims 10 and 20 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Herlihy (in view of Sharon).
Conclusion
All claims are drawn to the same invention claimed in the application prior to the entry of the submission under 37 CFR 1.114 and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 extension fee 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 SCOTT T LUAN whose telephone number is (571)270-1860. The examiner can normally be reached on 9am-5pm, M-F (generally).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, William Thomson, can be reached on 571-272-3718. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Scott Luan, Ph.D.
/SCOTT LUAN/Primary Examiner, Art Unit 3792
1 Concerning the imaging system, the operation at issue is “capture” rather than “display” or “show,” as argued by Applicant. See Remarks at 8 (“These paragraphs do not discuss displaying a transverse view and a longitudinal view of the target vessel while the needle, the guidewire, and the catheter are being advanced. . . . This paragraph does not make reference to showing a longitudinal and transverse view.”) (emphasis added).