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 .
DETAILED ACTION
Claim Rejections - 35 USC § 102
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 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 1-7, 10, 11, 13, 16-21 and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jang et al (US 2022/0071654).
Regarding claim 1, Jang discloses a system for facilitating performing a therapeutic activity at a predetermined treatment site in a patient, the system comprising:
an elongated miniature device 10 extending along a longitudinal axis spanning between a distal cutting end formed with a sharp cutting portion 40, and a blunt proximal abutting end, the elongated body comprising a substantially non-convex bottom surface 50 extending substantially between the cutting end and the abutting end; and
a driving device configured to generate a varying magnetic field to remotely control motion of the miniature device, see paragraphs [0054] to [0058].
Regarding claim 2, Jang discloses the miniature device 10 defining first and second lateral planes being perpendicular to each other and mutually perpendicular to the longitudinal axis, wherein the widest width 40 of the miniature device along the direction of the first lateral plane is at least twice the largest height of the miniature device along the direction of the second lateral plane, see paragraphs [0043], [0044] and [0087].
Regarding claim 3, Jang discloses for each point along a majority of the longitudinal axis, the width of the miniature device along the direction of the first lateral plane is at least twice the height of the miniature device along the direction of the second lateral plane, see paragraph [0044].
Regarding claim 4, Jang discloses the bottom surface of the miniature device is concave, the support groove in paragraph [0043] is being considered concave.
Regarding claim 5, Jang discloses the bottom surface of the miniature device is substantially planar, see paragraph [0043] and Fig. 1 and Fig. 2.
Regarding claim 6, Jang discloses, in a direction perpendicular to the longitudinal axis, the width of the bottom surface 40 spans a majority of the width of the miniature device, along a majority of the length of the miniature device, see paragraph [0044] and Fig. 1.
Regarding claim 7, Jang discloses the width of the bottom surface 40 is the width of the miniature device, along a majority of the length of the miniature device, see paragraph [0044] and Fig. 1.
Regarding claim 10, Jang discloses the miniature device comprising a shoulder 20 formed proximally to and facing the cutting portion.
Regarding claim 11, Jang discloses the miniature device comprising a distal cutting element comprising the cutting end 40, a proximal abutting element comprising the abutting end, and a linking element 30 connecting the cutting and abutting elements, the linking element being configured to selectively disconnect the cutting and abutting elements, see paragraph [0044].
Regarding claim 13, Jang discloses the miniature device comprising an external thread 41 formed at least on a distal end thereof.
Regarding claim 16, Jang discloses the miniature device comprises a magnetic material 35.
Regarding claim 17, Jang discloses the magnetic material being magnetized along the longitudinal axis, see paragraph [0054].
Regarding claim 18, Jang discloses the driving device is designed to generate the varying magnetic to move the miniature device to a predefined location in the patient, and to rotate it at the location, see paragraph [0082].
Regarding claim 19, Jang discloses the driving device is designed to generate the varying magnetic to rotate the miniature device such that the cutting portion thereof contacts a treatment site of a tissue in the patient, and the abutting end bears upon a contra location of a tissue opposite the treatment site, thereby facilitating piercing at the treatment site by the cutting portion, see paragraph [0082].
Regarding claim 20, Jang discloses the tissue opposite the treatment site is a hard tissue, see paragraph [0084], where the body bend corresponds to the tissue opposite the treatment site being hard tissue.
Regarding claim 21, Jang discloses the driving device is designed to generate the varying magnetic to move the miniature device within the patient such that it is oriented substantially along its longitudinal axis, wherein the abutting end of the miniature device constitutes a leading edge thereof, at least while moving toward the treatment site, see paragraph [0087].
Regarding claim 23, Jang discloses the therapeutic activity comprises performing one or more cutting operations, see paragraphs [0053] and [0054].
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.
Claims 8, 9, 12, 15, 22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Jang et al (US 2022/0071654) in view of Creighton (US 2012/0226093).
Regarding claim 8, Jang meets all of the limitations except for the cutting portion of the miniature device is covered by a coating configured to dissolve within the patient after a predetermined amount of time has passed, thereby exposing the cutting portion.
Creighton teaches coating magnetic particles with biodegradable substances, see paragraph [0255]. Also, Creighton teaches coating an abrasive cap or surface ensures minimal damage to healthy tissue and maximal damage to a vessel obstruction, see paragraph [0171].
One of ordinary skill in the art would have found it obvious to coat the cutting portion 41 in the Jang device with a biodegradable substance as suggested by Creighton to prevent cutting prior to reaching a targeted treatment location. Motivation for the addition of the coating is provided by the added feature of increasing dispersion of therapeutic agents within the coating.
Regarding claim 9, Jang meets all of the limitations except for the cutting portion of the miniature device comprising one or more barbs configured to inhibit removal of cutting portion from a tissue pierced thereby.
Creighton teaches coating an abrasive cap or surface to ensure minimal damage to healthy tissue, see paragraph [0171].
One of ordinary skill in the art would have found it obvious, based on the teaching of Creighton to protect vascular tissue from damage, to configure the surface of cutting portion 41 in Jang with one or more barbs configured to inhibit removal of cutting portion from a tissue pierced thereby.
Regarding claim 12, Jang meets all of the limitations except for the linking element comprises a material configured to dissolve within the patient after a predetermined amount of time has passed, thereby disconnecting the cutting and abutting elements.
Creighton teaches dissolving occlusions or mechanically removing occlusions to open block blood vessels, see paragraph [0118].
Based on this teaching in Creighton, one of ordinary skill in the art would have been motivated to disconnect the cutting and abutting elements in the Jang device with a material configured to dissolve within the patient after a predetermined amount of time has passed where a block vessel has been made patent. Disconnecting the cutting and abutting elements would be desirable to prevent further unintended cutting.
Regarding claim 15, Jang meets all of the limitations except for the miniature device is covered with a lubricious coating.
Creighton teaches providing a coating to ensure minimal damage to healthy tissue, see paragraph [0171].
One of ordinary skill in the art would have found it obvious to coat the miniature device with a lubricious coating to ensure the device travels smoothly through a blood vessel so as to minimize the damage to health vessel tissue as suggested by Creighton.
Regarding claim 22, Jang meets all of the limitations except for the therapeutic activity comprises delivery of one or more therapeutic components.
Creighton teaches the therapeutic activity comprises delivery of one or more therapeutic components, see paragraph [0020].
One of ordinary skill in the art would have found it obvious to deliver one or more therapeutic components as suggested by Creighton using the device of Jang because the skilled artisan would have readily understood treating with several modalities improves the success of the therapeutic outcome.
Regarding claim 24, Jang meets all of the limitations except for the therapeutic activity comprises treatment of a glioblastoma multiform.
Creighton teaches the therapeutic activity comprises treatment of cancer, see paragraph [0020].
One of ordinary skill in the art would have found it obvious to deliver a therapeutic agent to treat a glioblastoma multiform because this is a type of cancer treatable as suggested by Creighton.
Allowable Subject Matter
Claim 14 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to George Manuel whose telephone number is (571) 272-4952.
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/George Manuel/
Primary Examiner
Art Unit: 3792
10/27/2025