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 .
Response to Arguments
Applicant's arguments filed 01/27/2026 have been fully considered but they are not persuasive.
The rejections under 35 USC 112 have been withdrawn.
Regarding the amendments to claim 1, Examiner asserts that [0045] of Abbott teaches that the body can have slits to increase its flexibility. Previously-found reference of Hwang has been introduced into claim 1 to teach the drive mechanism. Thus, the 102 rejection has been withdrawn; however, all previously-found references have been maintained in the rejection.
Applicant argues, see Applicant’s arguments page 7, that the combination of Abbott and Hwang is improper. Examiner asserts that the exact actuation paradigm of Hwang’s magnetic navigation is irrelevant, as it is not being introduced to teach such. Hwang is introduced to teach a drive mechanism for a catheter, and Examiner further asserts that the compliant body of Abbott is configured to receive a catheter advanced via a drive mechanism. Examiner upholds the use of Hwang.
Applicant argues, see Applicant’s arguments page 7, that the combination of Abbott and Shachar is improper. Shachar is introduced to teach that an imaging system can track the position of a permanent magnet and display the position on a display. The body of Abbott comprises permanent magnets. Examiner asserts that the teachings of Shachar can be applied to the apparatus of Abbott and upholds the use of Shachar.
Applicant argues, see Applicant’s arguments pages 7-8, that the combination of Abbott and Kim is improper. Kim is introduced to teach that a magnet of a particular diameter exists in the art. Examiner asserts that the magnet of Kim can be used as the magnet in Abbott and upholds the use of Kim.
Applicant argues, see Applicant’s arguments page 8, that the combination of Abbott and Schwartz is improper. Schwartz teaches that a catheter body with a rectangular pattern of voids is known in the art. Examiner asserts that the teachings of Schwartz can be applied to Abbott, either to introduce the voids into the body of Abbott completely, or to modify the existing slits in the body of Abbott to be rectangular. Examiner upholds the use of Schwartz.
Claim Objections
Claim 15 is objected to because of the following informalities: “the pattern of voids comprise” should read –the pattern of voids comprises--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Rejections under 35 USC 112 have been withdrawn in response to Applicant’s amendments filed 01/27/2026.
Claim Rejections - 35 USC § 102
Rejections under 35 USC 102 have been withdrawn in response to Applicant’s amendments filed 01/27/2026.
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.
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 1-3, 5-9, & 20 are rejected under 35 U.S.C. 103 as being unpatentable over Abbott (US 2020/0100658) in view of Hwang (US 2022/0331534).
Regarding claims 1 & 5, Abbott teaches an apparatus comprising:
a permanent magnet (permanent magnet 408a, [0047]);
a segmented tubular member (compliant body 406, [0047]) comprising a first end (Figure 2c), a second end (Figure 2c), and a pattern of voids (series of exterior transverse slits, [0045]) on a distal portion of the segmented tubular member configured such that the pattern of voids provides variable flexibility along a length of the segmented tubular member ([0045]), wherein:
the permanent magnet is coupled to the first end of the segmented tubular member (Figure 2c);
the second end of the segmented tubular member is configured to receive a distal end of a catheter (Figure 2c); and
Per Figure 2c, compliant body 406 has a lumen; thus, it is configured to receive a catheter.
an electromagnet (electromagnetic actuator device 702, [0056]); and
a controller (servo drive, [0056]), wherein the controller is configured to:
control an electrical current to the electromagnet ([0056]); and
control a magnetic forced exerted by the electromagnet on the permanent magnet ([0056]).
Controlling the electrical current comprises controlling the magnetic force.
However, Abbott fails to disclose a drive mechanism configured to engage the catheter inserted into the first end of the segmented tubular member.
Hwang teaches a drive mechanism (driving unit 2, [0030]) configured to engage a catheter (medical device 3, [0030]) inserted into the first end of the segmented tubular member (medical tube 14, [0062]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus of Abbott to include a drive mechanism configured to engage a catheter inserted into the first end of the segmented tubular, as taught by Hwang. Automating the insertion process lessens the burden on the operator and allows for more precise positioning of the catheter. Additionally, using the segmented tubular member in conjunction with the catheter prevents any damage to the patient’s vasculature during the insertion.
Regarding claim 2, Abbott in view of Hwang teach the apparatus of claim 1, and Abbott further teaches that:
the permanent magnet is a first permanent magnet ([0047] & Figure 2c); and
the apparatus further comprises a second permanent magnet (permanent magnet 408b, [0047], Figure 2c) coupled to the segmented tubular member between the first end of the segmented tubular member and the second end of the segmented tubular member ([0047] & Figure 2c).
Regarding claim 3, Abbott in view of Hwang teach the apparatus of claim 2, and Abbott further teaches a third permanent magnet (permanent magnet 408c, [0047], Figure 2c) coupled to the segmented tubular member between the first end of the segmented tubular member and the second end of the segmented tubular member ([0047] & Figure 2c).
Regarding claim 6, Abbott in view of Hwang teach the apparatus of claim 1, and Abbott further teaches that the permanent magnet comprises a central channel (Figure 2c).
Regarding claim 7, Abbott in view of Hwang teach the apparatus of claim 1, and Abbott further teaches that the electromagnet comprises a pair of Helmholtz coils ([0056]).
Regarding claim 8, Abbott in view of Hwang teach the apparatus of claim 7, and Abbott further teaches that:
the pair of Helmholtz coils is a first pair of Helmholtz coils ([0056] & Figure 4b);
the electromagnet comprises a second pair of Helmholtz coils ([0056] & Figure 4b); and
the controller is configured to control a magnetic force exerted by the electromagnet on the permanent magnet in three-dimensional space ([0056]).
Regarding claim 9, Abbott in view of Hwang teach the apparatus of claim 8, and Abbott further teaches that the electromagnet comprises a third pair of Helmholtz coils ([0056] & Figure 4b).
Claim 20 is rejected for similar reasons to claim 1.
Claims 10-11 & 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Abbott in view of Hwang, as applied to claim 1, above, in further view of Shachar (US 2004/0019447).
Regarding claims 10-11 & 19, Abbott in view of Hwang teach the apparatus of claim 1.
However, Abbott in view of Hwang fail to disclose: an imaging device; wherein the imaging device is configured to provide imaging data of the permanent magnet; and a visual display configured to display a position of the permanent magnet.
Shachar teaches:
an imaging device (guidance, control, and imaging (GCI) apparatus 501, [0071]);
wherein the imaging device is configured to provide imaging data of the permanent magnet (permanent magnets, [0142]) ([0088] & [0142]); and
a visual display (monitor 325, [0088]) configured to display a position of the permanent magnet ([0088] & [0142]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus of Abbott and Hwang to include: an imaging device; wherein the imaging device is configured to provide imaging data of the permanent magnet; and a visual display configured to display a position of the permanent magnet, as taught by Shachar. This provides tracking capabilities to allow the user to navigate the catheter to the proper position.
Regarding claims 16-18, Abbott in view of Hwang teach the apparatus of claim 1.
However, Abbott in view of Hwang fail to disclose: a magnetic sensor configured to detect a position of the permanent magnet; wherein the magnetic sensor is configured as an array of sensors circumscribing the permanent magnet; and wherein the sensor is coupled to the controller.
Shachar teaches:
a magnetic sensor (magnetic field sensors, [0129]) configured to detect a position of the permanent magnet (permanent magnets, [0142]) ([0137] & [0142]);
wherein the magnetic sensor is configured as an array of sensors ([0129]) circumscribing the permanent magnet (Figure 13); and
wherein the sensor is coupled to the controller (microcontrollers 102x, 102y, and 102z, [0137]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus of Abbott and Hwang to include: a magnetic sensor configured to detect a position of the permanent magnet; wherein the magnetic sensor is configured as an array of sensors circumscribing the permanent magnet; and wherein the sensor is coupled to the controller, as taught by Shachar. This allows the position of the catheter in the body to be ascertained, resulting in a more effective procedure.
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Abbott in view of Hwang, as applied to claim 1, above, in further view of Kim (US 2023/0320695).
Regarding claims 12-14, Abbott in view of Hwang teach the apparatus of claim 1.
However, Abbott in view of Hwang fail to disclose that the permanent magnet and the segmented tubular member each have an outer diameter between 0.1 millimeters and 4.0 millimeters.
Kim teaches that the permanent magnets (permanent magnets (142), [0050], Figure 4) and the segmented tubular member (catheter-type ultrasound endoscope (100), [0050], Figure 4) each have an outer diameter between 0.1 millimeters and 4.0 millimeters ([0060] & Figure 4).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus of Abbott and Hwang such that the permanent magnets and the segmented tubular member each have an outer diameter between 0.1 millimeters and 4.0 millimeters, as taught by Kim. A smaller diameter allows more vessels and ducts to be accessed.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Abbott in view of Hwang, as applied to claim 1, above, in further view of Schwartz (US 5,573,520).
Regarding claim 15, Abbott in view of Hwang teach the apparatus of claim 1.
However, Abbott in view of Hwang fail to disclose that the pattern of voids comprises a rectangular pattern of voids.
Schwartz teaches that the pattern of voids (tube 50, Column 9, Line 37) comprises a rectangular pattern of voids (Figure 9).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus of Abbott and Hwang such that the pattern of voids comprises a rectangular pattern of voids, as taught by Schwartz. Placing voids in the catheter increases its flexibility, giving it a greater range of motion when navigating it.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ADAM KOLKIN whose telephone number is (571)272-5480. The examiner can normally be reached Monday-Friday 1:00PM-10:00PM EDT.
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, Keith Raymond can be reached at (572)-270-1790. 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.
/ADAM D. KOLKIN/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798