DETAILED ACTION
This office action is responsive to original claims filed on 05/21/2025. Presently, Claims 1 - 8 remain pending.
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 Objections
Claim 1 is objected to because of the following informalities:
Claim 1, Line 9 recites “the same size”, which should be changed to “a same size”.
Appropriate correction is required.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Glossop (US 20170020623 A1; hereafter Glossop), in view of Abraham (US 20080091109 A1; hereafter Abraham).
With regard to Claim 1, Glossop discloses an ultrasound-guided biopsy auxiliary device (Glossop, Para 0161; “… instrument 918 may comprise a biopsy needle …”; Para 0163; “TRUS probe 906 (or other ultrasound probe) may be affixed to a support mechanism 922”; Para 0164; “… support mechanism 922 may also hold template 900 (or a frame assembly that surrounds (or encompasses) all or a portion of template 900.” The disclosed “support mechanism 922” and “template 900” combine to be an auxiliary device that supports biopsy guided by TRUS 906) comprising:
a body (template 400) comprising:
a sampling conduit (guide elements 402) penetrating through the body (Glossop, Para 0129; “As shown in FIG. 4, template 400 may comprise one or more guide elements 402 that extend through the body of template 400.”);
an injection port located on a surface of the body (Glossop, Para 0130; “one or more of holes 402 may be used for different purposes. … Still other holes may be used to inject therapeutic agents, etc.”. Fig. 4 cited below shows that multiple holes are in the template); and
a plurality of positioning marks located in the body (Glossop, Para 0134; “Template 400 may further comprise one or more fiducial features (or registration features, or fiducial markers, or “fiducials”) 405 for use as a point of reference or a measure. Fiducial features 405 may comprise grids, holes, cuts, or markings (having any number of shapes) that may be designed to be visible under an imaging modality. Such features may be visible when viewed by the imaging equipment alone.”), wherein the positioning marks are provided along at least two directions perpendicular to each other (Glossop, Para 0128; “Although depicted as a square in FIG. 4, template 400 may have any shape”. The disclosed template 400 is in a square shape, so the 3 displayed fiducial markers in Fig. 4 should be along 2 directions that are perpendicular to each other), and in either direction, spacings between the positioning marks are in the same size (Glossop, Fig. 4 discloses 3 markers that are provided along two perpendicular directions, same as the disclosed “positioning marks 14” in Fig. 2 of Application, and because the template is square, the 2 spacings along the 2 directions are the same).
Glossop does not clearly and explicitly disclose the injection port being in fluid communication with the sampling conduit.
Abraham in the same field of endeavor discloses an injection port being in fluid communication with the sampling conduit (Abraham, Para 0055; “a side-arm (not shown) in fluid communication with one or more lumen 206 may also be located near the proximal end 202 of the elongate body 200. An aspiration device or syringe can be connected to the side arm …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Glossop, as suggested by Abraham, in order to have a side arm in fluid communication with the main guide element or hole. One of ordinary skill in the art would have been motivated to make the modification for the benefit of injecting fluid to a target site so as to precisely position the target site by imaging and reduce tissue injury (Abraham, Para 0055; “An aspiration device or syringe can be connected to the side arm, if desired, to aspirate blood clot and other materials through the lumen 206 or to inject water, saline, contrast agent or similar material may be injected through the device 100 to a target site.”; Para 0081; “The position of the fluid can then be confirmed using the device's ultrasound system, and the elongate body 200 can be pushed, under guidance, into the pericardial space. Additional material from the syringe can be injected, if necessary, to create a safe “pericardial pocket”.”).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Glossop and Abraham, in view of Miller et al (US 5758650 A; hereafter Miller).
With regard to Claim 2, Glossop and Abraham disclose the ultrasound-guided biopsy auxiliary device according to Claim 1, but do not explicitly and clearly disclose wherein the sampling conduit has a tapered structure.
Miller in the same field of endeavor discloses wherein the sampling conduit has a tapered structure (Miller, Column 6, Lines 56-57; “As FIG. 4 illustrates, a tapering, wedge-shaped recess is preferably cut into the top of the main body …”. In Fig. 4, the tapered structure is denoted as 404). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Glossop and Abraham, as suggested by Miller, in order to include a tapered structure. One of ordinary skill in the art would have been motivated to make the modification for the benefit of making insertion of a needle or other biopsy tool easier and reducing damaging the tip of the inserted tool (Miller, Column 6, Lines 59-62; “this recess helps form an opening wider than the groove itself so as to make it easier for the user to insert the tip of the needle into the guide when the needle cap is in place”).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Glossop and Abraham, in view of Grim et al (US 20200305927 A1; hereafter Grim).
With regard to Claim 3, Glossop and Abraham disclose the ultrasound-guided biopsy auxiliary device according to Claim 1, but do not explicitly and clearly disclose wherein the body is made of silicone, polyurethane or rubber.
Grim in the same field of endeavor discloses wherein the body is made of silicone, polyurethane or rubber (Grim, Para 0047; “The coupling wedge 142 is fabricated from an acoustically-transparent material, such as, for example, PEEK, silicone, polyurethane, etc.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Glossop and Abraham, as suggested by Grim, in order to use silicone or polyurethane as material. One of ordinary skill in the art would have been motivated to make the modification for the benefit of increased stability by conforming the device to different body surfaces and facilitating ultrasound transmission into tissue (Grim, Para 0047; “… an acoustically-transparent material … The coupling wedge 142 closes a gap between the bottom surface 134, 136 of the transducers 108, 110 and a skin surface during use, thereby facilitating the transmission of ultrasound waves from the transducers 108, 110 into tissue.”).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Glossop and Abraham, in view of Martens et al (US 20110208225 A1; hereafter Martens).
With regard to Claim 4, Glossop and Abraham disclose the ultrasound-guided biopsy auxiliary device according to Claim 1, but do not explicitly and clearly disclose wherein the body has a thickness between 5 mm and 50 mm.
Martens in the same field of endeavor discloses wherein the body has a thickness between 5 mm and 50 mm (Martens, Para 0046; “The thickness or height of the guiding tool may be between 5 and 10 mm thick, preferably 10 mm.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Glossop and Abraham, as suggested by Martens, in order to use a guiding tool of thickness of more than 5 mm. One of ordinary skill in the art would have been motivated to make the modification for the benefit of providing enough support for better guiding behavior (Martens, Para 0046; “A thicker the guiding tool may provide better guiding behaviour.”).
Claims 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Glossop and Abraham, in view of Cermak et al (US 20090143684 A1; hereafter Cermak).
With regard to Claim 5, Glossop and Abraham disclose the ultrasound-guided biopsy auxiliary device according to Claim 1, but do not explicitly and clearly disclose an ultrasound probe comprising the device at a front end.
Cermak in the same field of endeavor discloses an ultrasound probe comprising an ultrasound-guided biopsy auxiliary device at a front end (Cermak, Para 0031; “The puncture device guidance system 20 basically comprises a bracket or adaptor 22 and a needle guide 24. The adaptor 22 is an integral unit which is best seen in FIGS. 1, 3, 4 and 5 and basically comprises a ring-like member having a hollow interior space shaped to accommodate the distal end portion of the transducer 10.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Glossop and Abraham, as suggested by Cermak, in order to couple the device at a front end of an ultrasound probe. One of ordinary skill in the art would have been motivated to make the modification for the benefit of aligning ultrasound beam and interventional tool along approximately a same direction so that the entire trajectory of the insertion is covered and monitored reducing potential tissue injury.
With regard to Claim 7, Glossop, Abraham and Cermak disclose the ultrasound probe according to Claim 5, but do not disclose wherein the ultrasound-guided biopsy auxiliary device is detachably provided at the front end of the ultrasound probe.
Cermak further discloses wherein the ultrasound-guided biopsy auxiliary device is detachably provided at the front end of the ultrasound probe (Cermak, Para 0031; “The adaptor is arranged to be releasably secured to the transducer via either frictional engagement or mechanical means, e.g., mating components of the transducer and adaptor. In either case the adaptor 22 is a reusable member that is mounted on the transducer 10.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Glossop, Abraham and Cermak, as further suggested by Cermak, in order to provide the device to ultrasound probe in a detachable way. One of ordinary skill in the art would have been motivated to make the modification for the benefit of easily replacing the device for different patients.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Glossop, Abraham and Cermak, in view of Grim.
With regard to Claim 6, Glossop, Abraham and Cermak disclose the ultrasound probe according to Claim 5, but do not disclose wherein the ultrasound-guided biopsy auxiliary device is integrally mounted to the front end of the ultrasound probe.
Grim in the same field of endeavor discloses wherein the ultrasound-guided biopsy auxiliary device is integrally mounted to the front end of the ultrasound probe (Grim, Para 0049; “The coupling wedge 142 may be fabricated and subsequently affixed to the transducers 108, 110 or may be molded around the transducers 108, 110.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Glossop, Abraham and Cermak, as suggested by Grim, in order to integrate the device to the front end of ultrasound probe. One of ordinary skill in the art would have been motivated to make the modification for the benefit of avoiding relative movement between ultrasound probe and the device so as to increase localization precision of the biopsy needle.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Glossop, Abraham and Cermak, in view of Tian et al (US 20200187981 A1; hereafter Tian).
With regard to Claim 8, Glossop, Abraham and Cermak disclose the ultrasound probe according to Claim 5, but do not disclose wherein the ultrasound probe comprises a capacitive micromachined ultrasonic transducer (CMUT) or a piezoelectric micromachined ultrasonic transducer (PMUT).
Tian in the same field of endeavor discloses wherein the ultrasound probe comprises a capacitive micromachined ultrasonic transducer (CMUT) or a piezoelectric micromachined ultrasonic transducer (PMUT) (Tian, Para 0038; “… an ultrasound transducer element may comprise a piezoelectric device”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Glossop, Abraham and Cermak, as suggested by Tian, in order to use a piezoelectric-based ultrasound transducer. One of ordinary skill in the art would have been motivated to make the modification for the benefit of the piezoelectric-based ultrasound transducer being one of the most widely used ultrasound transducer.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEI ZHANG whose telephone number is (571)272-7172. The examiner can normally be reached Monday-Friday 8am-5pm E.T..
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/L.Z./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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