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 § 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) 1-2 and 6-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sasaki et al. (US 2022/0151707; hereinafter Sasaki) in view of Stringer (US 2007/0016030).
Sasaki shows an ultrasound probe inserted into a body cavity ([0014]; Fig. 2), the ultrasound probe comprising: an ultrasound transducer that radiates an ultrasound wave ([0018]); and a case that accommodates the ultrasound transducer, wherein the case includes a puncture guide that is a hole or a notch into which a puncture needle is inserted and that guides a puncture direction of the puncture needle ([0020]), and a position sensor/marker indicating the position of the puncture guide ([0022]), wherein the case has a cylindrical shape with an upper surface and a lower surface, and wherein the puncture guide has an entry point on the upper surface of the case and an exit point on the lower surface of the case, thereby forming a guide hole through the upper surface and the lower surface of the case ([0026]; Figs. 2-3).
Sasaki also shows wherein the ultrasound transducer is disposed in a fixed manner at a predetermined location within the case ([0018]; Figs. 2-3); wherein the puncture guide is adjacent to the ultrasound transducer in an axial direction of the case ([0018]; Figs. 2-3); wherein the puncture guide is disposed on each side of the ultrasound transducer in an axial direction of the case ([0018]; Fig. 3).
Sasaki fails to show a guide marker that is provided on an outer surface of the case and that indicates a guide direction of the puncture guide. Sasaki also fails to show wherein the guide marker is a figure that indicates an inclination of a wall in an end portion of the puncture guide in an axial direction; wherein the guide marker is disposed on the outer surface of the case in a manner such that the guide marker is directly visible to an operator; wherein the guide marker is a pattern including a line that is parallel to an inclination of a wall in an end portion of the puncture guide.
Stringer discloses an ultrasonic vascular sensor assembly. Stringer teaches a guide marker that is provided on an outer surface of the case and that indicates a guide direction of the puncture guide ([0055]; Fig. 8A). Stringer also teaches wherein the guide marker is a figure that indicates an inclination of a wall in an end portion of the puncture guide in an axial direction ([0055]; Fig. 8A); wherein the guide marker is disposed on the outer surface of the case in a manner such that the guide marker is directly visible to an operator ([0055]; Fig. 8A); wherein the guide marker is a pattern including a line that is parallel to an inclination of a wall in an end portion of the puncture guide ([0055]; Fig. 8A).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Sasaki, as a substitute or in addition to the position sensor marking, to utilize a guide marker that is provided on an outer surface of the case and that indicates a guide direction of the puncture guide as taught by Stringer, in order to provide the user with a visual reference point highlighting the puncture guide by which to more accurately guide the puncture needle.
Claim(s) 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sasaki et al. (US 2022/0151707; hereinafter Sasaki) in view of Stringer (US 2007/0016030) as applied to claim 2 above, and further in view of Hirayama (US 2017/0281127).
Sasaki fails to show wherein the puncture guide has a tapered portion whose dimension in a front-rear direction decreases as the tapered portion advances from an entrance into the case, and the guide marker has a substantially triangular shape that is surrounded by a first line indicating an inclination of a wall at one end of the puncture guide in the axial direction, a second line indicating an inclination of a wall at the other end of the puncture guide in the axial direction, and a third line connecting the first line and the second line; wherein the guide marker includes a line that indicates a trajectory of a central axis of the puncture needle advancing along the wall in the end portion of the puncture guide in the axial direction; wherein a color of the guide marker is opposite to a color of the case.
Hirayama discloses an ultrasound probe. Hirayama teaches wherein the puncture guide has a tapered portion whose dimension in a front-rear direction decreases as the tapered portion advances from an entrance into the case, and the guide marker has a substantially triangular shape that is surrounded by a first line indicating an inclination of a wall at one end of the puncture guide in the axial direction, a second line indicating an inclination of a wall at the other end of the puncture guide in the axial direction, and a third line connecting the first line and the second line ([0041], [0053]); wherein the guide marker includes a line that indicates a trajectory of a central axis of the puncture needle advancing along the wall in the end portion of the puncture guide in the axial direction ([0041]); wherein a color of the guide marker is opposite to a color of the case ([0060]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Sasaki and Stringer to utilize markings having different shapes/colors, such as a triangular shape as taught by Hirayama, in order to aid the user by providing a visual indication of the puncture direction. Furthermore, it would be within the level of one of ordinary skill in the art, to utilize a variety of known shapes/colors to provide the user with a readily visible marking to aid in the puncture procedure.
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sasaki et al. (US 2022/0151707; hereinafter Sasaki) in view of Stringer (US 2007/0016030) as applied to claim 1 above, and further in view of Corr et al. (US 2022/0409233; hereinafter Corr).
Sasaki fails to show wherein the puncture guide includes a lateral hole that connects a side face of the case and the guide hole; wherein the guide hole has an hourglass shape having a decreasing dimension toward a center portion in a penetrating direction.
Corr discloses an image-guided tissue access device. Corr teaches wherein the puncture guide includes a lateral hole that connects a side face of the case and the guide hole (Fig. 11); wherein the guide hole has an hourglass shape having a decreasing dimension toward a center portion in a penetrating direction (as illustrated in Fig. 11, the guide holes are embodied in a circular tapered form with a decreasing dimension toward a center portion in a penetrating direction, corresponding with an hourglass type shape; needle guide may be embodied in a variety of shapes, [0056]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Sasaki and Stringer to utilize a lateral hole as taught by Corr, in order to provide additional holes for needles of differing sizes. Furthermore, it would have been obvious to one of ordinary skill in the art, to utilize a guide hole which has an hourglass shape having a decreasing dimension toward a center portion in a penetrating direction as taught by Sasaki, as Sasaki teaches that the needle guide may be embodied in different shapes ([0057]), and wherein different shapes may be more suitably adapted to different types/shapes of needles/puncturing devices. Furthermore, it is noted that it has been held that changes in size/shape are within the level of one of ordinary skill in the art (In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955); In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966)).
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 JONATHAN CWERN whose telephone number is (571)270-1560. The examiner can normally be reached Monday - Friday, 8:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN CWERN/Primary Examiner, Art Unit 3797
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