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 Amendment and Arguments
In view of the amendment filed December 18, 2025, claims 1, 8 and 13 have been amended and claims 6-7 and 11-12 have been canceled. Accordingly, claims 1-5, 8-10 and 13-14 are pending and under examination.
The amendment to independent claims 1, 8 and 13 overcome the rejection of claims 1-3, 6-7 and 13 under 35 U.S.C. 102(a)(1) as being anticipated by Sakamoto (US 2014/0094779, hereinafter “Sakamoto”). Examiner notes that Sakamoto discloses the first motion source is configured to generate multimodal vibrational motion (¶ [0021]: “The operating portion 2a has a switch (not illustrated) to turn on/off the vibration imparting device 1, a monitor to display a screen enabling the operator to select a preliminarily specified operation mode of the vibration imparting device 1, and buttons to specify the parameters of actual vibration such as the vibration frequency or the vibration wavelength.” and ¶ [0026]: “The control unit 6b controls the number of rotations of the motor 6c, and as a result, physical vibration of non-ultrasonic frequency can be generated on the converter 6d.”). Examiner acknowledges that Sakamoto fails to disclose a second motion source is configured to generate rotational motion to impart multimodal vibrational to an interventional device and wherein the first and the second motion sources impart the vibrational movement and rotational movement to the interventional device, both independent of one another and simultaneously.
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.
Claim(s) 1-3, is/are rejected under 35 U.S.C. 103 as being unpatentable over Sakamoto (US 2014/0094779, hereinafter “Sakamoto”) in view of Yang et al. (US 2017/0239447, hereinafter “Yang”) and Kuban et al. (US 2010/0174233, hereinafter “Kuban”).
Referring to claim 1, Sakamoto discloses a motion generating device (FIGS. 1-3, FIG. 2 is reproduced below) comprising: at least one motion source (motor 6c or combination of motor 6c and converter 6d as shown in FIG. 2); a mating surface (FIG. 2 shows vibrating portion 4 includes at least one lateral surface 4b1 that is mating with one surface of attachment mechanism 5. In alternative the concave portion 5a can be interpreted as a mating surface); and the first motion source is configured to generate multimodal vibrational motion to impart multimodal vibrational movement to an interventional device (guide catheter 10a or guidewire 10d as shown in Fig. 1. ¶ [0021]: “The operating portion 2a has a switch (not illustrated) to turn on/off the vibration imparting device 1, a monitor to display a screen enabling the operator to select a preliminarily specified operation mode of the vibration imparting device 1, and buttons to specify the parameters of actual vibration such as the vibration frequency or the vibration wavelength.” ¶ [0025]: “The converter 6d converts rotating motion of the motor 6c to reciprocating motion from the near side to the far side or from the far side to the near side in FIG. 2.” and ¶ [0026]: “The control unit 6b controls the number of rotations of the motor 6c, and as a result, physical vibration of non-ultrasonic frequency can be generated on the converter 6d.”).
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Referring again to claim 1, Sakamoto discloses the invention substantially as claimed except for disclosing a second motion source is configured to generate rotational motion to impart rotational movement to an interventional device, and wherein the first motion source and the second motion sources impart the vibrational movement and rotational movement to the interventional device, both independent of one another and simultaneously.
Referring still to claim 1, however, in the same field of endeavor, which is a system for treating a blockage in a blood vessel, Yang discloses apply vibration movement and rotational movement to catheter will breaks static friction between the inner diameter of the vessel and the outer diameter of the catheter, thereby improve catheter trackability through tortuous vasculatures (¶ [0136]). Yang further discloses reciprocation movement (which is also known as vibration movement) can perform independent or simultaneous with rotational movement (¶ [0092]). Furthermore, in the same field of endeavor, which is a system for treating blockage in a blood vessel, Kuban discloses control unit is configured to control first motor 132 and second motor 174 to impart multimodal rotational movement and reciprocal movement (which is also interpreted as vibrational movement) independent of one another and simultaneously to guidewire (Fig. 4, ¶¶ [0040], [0064], [0066]-[0071])
Still referring to claim 1, in view of Yang and Kuban’s teaching, it would have been obvious to one of ordinary skill in the art to have provided a second motion source to generate rotational motion to impart rotational movement to the interventional device of Sakamoto and configured the control unit of Sakamoto to allow the first motion source and the second motion sources impart multimodal vibrational movement and rotational movement to the interventional device, both independent of one another and simultaneously to improve trackability of the catheter through tortuous vasculatures.
Referring to claim 2, the modified system of Sakamoto discloses the motion generating device of claim 1 further comprising a housing (base 2 as shown in FIG. 2 of Sakamoto reference. In alternative, base 2, vibration transmitting portion 3 and vibrating portion 4 are combined together to form a housing. Furthermore, base 2, vibration transmitting portion 3, vibrating portion 4 and attachment mechanism 5 are combined together to form a housing), wherein the mating surface is disposed on the housing.
Referring to claim 3, the modified system of Sakamoto discloses the motion generating device of claim 2 wherein the mating surface is a portion of an exterior of the housing (as indicated in the rejection of claim 2 above Sakamoto discloses the housing based on two interpretations. First interpretation is base 2, vibration transmitting portion 3 and vibrating portion 4 are combined together to form a housing. Based on this interpretation the mating surface 4b1 as shown in FIG. 2 is a portion of an exterior of the housing. Second interpretation is base 2, vibration transmitting portion 3, vibrating portion 4 and attachment mechanism 5 are combined together to form a housing. Based on the second interpretation the concave portion 5a is a portion of an exterior of the housing).
Referring to claim 13, the modified system of Sakamoto discloses a method for using a motion generating device to advance an interventional device (guiding catheter 10a (FIGS. 1-3) or guide wire 10d (FIG. 4)) the method comprising the steps of:
inserting an interventional device into a patient (¶¶ [0009], [0016] and [0039]);
attaching a motion generating device to the interventional device (FIG. 1 shows guiding catheter 10a is attached to motion generating device; ¶¶ [0017], [0032] and [0040]);
activating the motion generating device (¶ [0042]); and
advancing the motion generating device (in paragraph [0036] Sakamoto discloses the guiding catheter 10a is fixed on the attachment mechanism 5. In paragraph [0042] Sakamoto discloses the operator grasps the guiding catheter 10a to move the catheter in a forward direction after the motion generating device 5 is on. Based on the disclosure in paragraphs [0036] and [0042] one of ordinary skill in the art will understand that the motion generating device 5 is moving with the catheter).
Referring to claim 14, the modified system of Sakamoto discloses the method for using a motion generating device to advance an interventional device of claim 13 further comprising the steps of: adjusting characteristics of the motions generated by the motion generating device (Sakamoto discloses “An operating portion 2a is provided on a part of the base 2 so as to adjust parameters such as a vibration frequency or a vibration wavelength. The operator can specify the desired vibration frequency and the vibration wavelength by operating the operating portion 2a.” (¶ [0020]) and “variations of the physical vibration generated by the actuator 6 can be arbitrarily according to a position to be vibrated in the catheter system 10.” (¶ [0028])).
Referring again to claim 14, Sakamoto fails to specifically discloses the step of advancing the interventional device after adjusting the characteristics of the motions generated by the motion generating device. However, based on the disclosure in paragraphs [0020] and [0028] (a portion of each paragraph is reproduced above) examiner contends that one of ordinary skill in the art will understand that it would have been obvious to stop the motion generating device to adjusting the frequency and vibration wavelength when the friction force is increased during the advancement of the catheter then advancing the interventional device after the step of adjusting the characteristics of the motion generating device.
Claim(s) 4-5 and 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sakamoto, Yang et al. and Kuban et al. as applied to claim 1 above and further in view of Tejani (US 2014/0324024, hereinafter “Tejani”).
Referring to claim 4, the modified system of Sakamoto discloses the motion generating device of claim 1 wherein the mating surface comprises a mating surface bottom portion (concave surface 5a as shown in FIG. 2 of Sakamoto reference). Sakamoto fails to discloses a mating surface top portion.
Referring again to claim 4, however, in the same field of endeavor, which is a catheter system for insertion into a blood vessel, Tejani discloses the catheter system includes a catheter clip (FIGS. 1-4. FIGS. 3-4 are reproduced below) for securing the catheter to a convenient surface (¶ [0025]). Tejani further discloses that the catheter clip is designed to accommodate a range of catheter sizes (¶ [0026]). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the application, to have modified the concave portion 5a (FIG. 2) of Sakamoto to incorporate the catheter clip of Tejani to allow the surgeon to safely secure the catheter to the device of Sakamoto and allow the device of Sakamoto to be used with a wide range of catheter sizes.
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Referring to claim 5, the modified system of Sakamoto discloses the motion generating device of claim 4, wherein the motion generating device has an open position (see FIGS. 3-4 above), and a closed position (see FIGS. 3-4 above); and wherein the mating surface top portion and the mating surface bottom portion are separate from each other along their lengths in the open position (see FIG. 4 above); and wherein the mating surface top portion and the mating surface bottom portion are in contact with each other along at least a portion of their lengths in the closed position (see FIG. 3 above).
Referring to claim 8, Sakamoto discloses a motion generating device (FIGS. 1-3, FIG. 2 is reproduced above) comprising:
a housing comprising (see Fig. 2 of Sakamoto reference, which is reproduced above. The figure shows base 2, vibration transmitting portion 3, vibrating portion 4 and attachment mechanism 5 are combined together to form a housing) a housing top portion and a housing bottom portion (in paragraph [0036] Sakamoto discloses the guiding catheter 10a is fixed on the attachment mechanism 5. In paragraph [0042] Sakamoto discloses the operator grasps the guiding catheter 10a to move the catheter in a forward direction after the motion generating device 5 is on. Based on the disclosure in paragraphs [0036] and [0042] one of ordinary skill in the art will understand that the motion generating device 5 is portable and moving with the catheter. Since the motion generating device of Sakamoto is portable and it can be rotated in any direction, thus, the bottom portion, which indicated as base 2 can become the top portion and the concave portion 5a can become the bottom portion), a mating surface on the housing (the concave portion 5a as shown in FIG. 2 has been interpreted as a mating surface), and a first motion source is configured to generate multimodal vibrational motion to impart multimodal vibrational movement to an interventional device (see rejection of claim 1 above).
Sakamoto discloses the invention substantially as claimed except for disclosing (1) a second motion source is configured to generate rotational motion to impart rotational movement to an interventional device, and wherein the first motion source and the second motion sources impart the vibrational movement and rotational movement to the interventional device, both independent of one another and simultaneously (2) the mating surface comprises a mating surface top portion and a mating surface bottom portion wherein the mating surface top portion is disposed on the housing top portion and the mating surface bottom portion is disposed on the housing bottom portion; the motion generating device comprises an open position and a closed position; wherein the mating surface top portion and the mating surface bottom portion are separated at an edge in the open position; and wherein the mating surface top portion and the mating surface bottom portion are in contact along at least a portion of their lengths in the closed position.
As to (1), see the rejection of claim 1 above.
As to (2), however, in the same field of endeavor, which is a catheter system for insertion into a blood vessel, Tejani discloses the catheter system includes a catheter clip (FIGS. 1-4. FIGS. 3-4 are reproduced above) for securing the catheter to a convenient surface (¶ [0025]). Tejani further discloses that the catheter clip is designed to accommodate a range of catheter sizes (¶ [0026]). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the application, to have modified the concave portion 5a (FIG. 2) of Sakamoto to incorporate the catheter clip of Tejani to allow the surgeon to safely secure the catheter to the device of Sakamoto and allow the device of Sakamoto to be used with a range of catheter sizes.
Examiner notes that the portions 108a and 108b (see FIGS. 3-4 of Tejani reference) can be interpreted as top portion 108a and bottom portion 108b or bottom portion 108a and top portion 108b dependent on the orientation of the Sakamoto device.
Referring to claim 9, the modified system of Sakamoto discloses the motion generating device of claim 8 further comprising: a hinge 104 (FIGS. 3-4 of Tejani reference, which are reproduced above) wherein the housing top portion 108a/108b and the housing bottom portion 108b/108a are connected by the hinge.
Referring to claim 10, the modified system of Sakamoto discloses the motion generating device of claim 8 further comprising a securing mechanism 110a, 110b (FIGS. 3-4 of Tejani reference, which are reproduced above) configured to hold the housing top portion and the housing bottom portion together.
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 TUAN V NGUYEN whose telephone number is (571)272-5962. The examiner can normally be reached Monday - Friday 8:30 AM - 5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TUAN V NGUYEN/Primary Examiner, Art Unit 3771