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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/14/2026 has been entered.
Response to Arguments
The previous rejection of claim(s) 3 over 35 U.S.C. 112(a) as failing to comply with the written description requirement has been overcome in light of the amendments made canceling claim 3 on 8/03/2026.
The previous rejection of claim(s) 6-8 and 15-20 over 35 U.S.C. 112(b) as being indefinite has been overcome in light of the amendments made to claim(s) 6-8 and 15 on 8/03/2026.
Applicant’s arguments with respect to claim(s) 1-2 and 4-14 over Scott (US 2022/0273363) 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. Specifically, Benning et al. (US 2018/0140289 A1) is now being relied on for the limitations recited in claims 1 and 9.
Applicant’s arguments with respect to claim(s) 15-20 over Mueller (US 6,565,528) and/or Mueller in view of Weitzner (US 2018/0206864) 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. Specifically, Benning et al. (US 2018/0140289 A1) is now being relied on for the limitations recited in claim 15.
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.
Claim(s) 1, 4-5, 7-9, 13-15 and 19-24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Benning et al. (US 2018/0140289 A1).
Regarding claim 1, Benning discloses an apparatus (biopsy device 700; Figs. 7-8), comprising: an elongated medical sheath (outer elongate member 702) comprising a distal end (distal end of 702) configured to be movable and positionable proximate to a biological feature of a patient (area to be biopsied); and an expandable-and-collapsible support structure (one or more bands 724 and piercing tip 712) comprising a distal section (including at least distal portion of 724 and 712; Figs. 7-8) and a proximal section (including proximal portion of 724) and configured to be selectively movable (Figs. 7-8), at least in part, between a collapsed state (Fig. 7) within an interior of the elongated medical sheath (702) when the distal end of the elongated medical sheath is advanced through an initial puncture hole of the biological feature of the patient (because the stepped portion 714 of 712 has a diameter slightly larger than that of 702, the distal end of 702 may be advanced through an initial puncture hole created by 712; Fig. 7) and an expanded state (Fig. 8) at an exterior of the elongated medical sheath (702) when the distal end of the elongated medical sheath is past the initial puncture hole of the biological feature of the patient (see for example, Fig. 8); and a mechanical tissue-cutting assembly being supported by the expandable-and-collapsible support structure and comprising at least one distal mechanical tissue cutting device (piercing tip 112) positioned at the distal section of the expandable-and-collapsible support structure (Figs. 7-8) and being configured to form the initial puncture hole through the biological feature of the patient while the expandable-and-collapsible support structure is in the collapsed state (Fig. 7), and at least one proximal mechanical tissue cutting device (as bands 124 may comprise projections, barbs, or blades and the one or more bands 724 are substantially similar to the one or more bands 124; therefore, may also comprise projections, barbs, or blades; [0037]; [0042]) positioned at the proximal section of the expandable-and-collapsible support structure (as the projections, barbs, or blades are positioned on 724, which includes the proximal section) and being configured to dilate the initial puncture hole to form a larger puncture hole during rearward movement of the expandable-and-collapsible support structure toward the biological feature and before the expandable-and-collapsible support structure is fully retracted into the interior of the elongated medical sheath (any projections, barbs, or blades on the proximal portion of 724 would further cut or ablate tissue causing dilation when the device is moved proximally by a user, especially while being rotated and moved proximally by a user; [0045]).
Regarding claim 4, Benning discloses wherein the at least one distal mechanical tissue cutting device (712) comprises one or more sharp tips (piercing tip; [0042]).
Regarding claim 5, Benning discloses wherein the at least one proximal mechanical tissue cutting device (blades on 724) comprises one or more cutting blades (blades; [0037]; [0042]).
Regarding claim 7, Benning discloses wherein: the expandable-and-collapsible support structure (724, 712) once deployed from the interior of the elongated medical sheath (702), forms a tapered proximal section in the expanded state (Fig. 8).
Regarding claim 8, Benning discloses wherein: the expandable-and-collapsible support structure (724, 712), once deployed from the interior of the elongated medical sheath (702), is configured to expand radially at a at the distal section (at the distal section of 724).
Regarding claim 9, Benning discloses an apparatus (biopsy device 700; Figs. 7-8), comprising: an elongated medical sheath (outer elongate member 702) comprising a distal end (distal end of 702) configured to be movable and positionable proximate to a biological feature of a patient (area to be biopsied); and an expandable-and-collapsible support structure (one or more bands 724 and piercing tip 712) configured to be selectively movable (Figs. 7-8), at least in part, between a collapsed state (Fig. 7) within an interior of the elongated medical sheath (702) when the distal end of the elongated medical sheath is advanced through an initial puncture hole of the biological feature of the patient (because the stepped portion 714 of 712 has a diameter slightly larger than that of 702, the distal end of 702 may be advanced through an initial puncture hole created by 712; Fig. 7) and an expanded state (Fig. 8) at an exterior of the elongated medical sheath (702) when the distal end of the elongated medical sheath is past the initial puncture hole of the biological feature of the patient (Fig. 8), the expandable-and-collapsible support structure including an expandable-and-collapsible cage structure (one or more bands 724) having a distal section (including at least distal portion of 724 and 712; Figs. 7-8) and a proximal section (including proximal portion of 724); and a mechanical tissue-cutting assembly being supported by the expandable-and-collapsible support structure, the mechanical tissue-cutting assembly includes: at least one sharp tip (piercing tip 712) being positioned at the distal section of the expandable-and-collapsible cage structure (Figs. 7-8) and being configured to form the initial puncture hole through the biological feature of the patient while the expandable-and-collapsible cage structure is in the collapsed state (because the stepped portion 714 of 712 has a diameter slightly larger than that of 702, the distal end of 702 may be advanced through an initial puncture hole created by 712; Fig. 7); and at least one cutting blade (as bands 124 may comprise projections, barbs, or blades and the one or more bands 724 are substantially similar to the one or more bands 124; therefore, may also comprise projections, barbs, or blades; [0037]; [0042]) being positioned at the proximal section of the expandable-and-collapsible cage structure (as the projections, barbs, or blades are positioned on 724, which includes the proximal section) and being configured to dilate the initial puncture hole to form a larger puncture hole during rearward movement of the expandable-and-collapsible cage structure toward the biological feature and before the expandable-and-collapsible cage structure is fully retracted into the interior of the elongated medical sheath (any projections, barbs, or blades on the proximal portion of 724 would further cut or ablate tissue causing dilation when the device is moved proximally by a user prior to being collapsed, especially while being rotated and moved proximally by a user; [0045]).
Regarding claim 13, Benning discloses wherein: the expandable-and-collapsible cage structure (724, 712), once deployed, forms a tapered proximal section in the expanded state (Fig. 8).
Regarding claim 14, Benning discloses wherein: the expandable-and-collapsible cage structure (724, 712), once deployed, is configured to expand radially at the distal section of the expandable-and-collapsible cage structure (at the distal section of 724).
Regarding claim 15, Benning discloses an apparatus (biopsy device 700), comprising: an elongated medical sheath (outer elongate member 702) configured to be movable and positionable proximate to a biological feature of a patient (area to be biopsied); and an expandable-and-collapsible support structure (one or more bands 724 and piercing tip 712) configured to be selectively movable, at least in part, between a collapsed state (Fig. 7) within an interior of the elongated medical sheath (702) and an expanded state (Fig. 8) at an exterior of the elongated medical sheath (702), the expandable-and-collapsible support structure including an expandable-and-collapsible cage structure (724) having a distal section (including at least distal portion of 724 and 712; Figs. 7-8) and a proximal section (including proximal portion of 724); and a mechanical tissue-cutting assembly being supported by the expandable-and-collapsible support structure, the mechanical tissue-cutting assembly includes: a first cutting blade (712) at the distal section of the expandable-and-collapsible cage structure (Figs. 7-8) and being configured to form an initial puncture hole through the biological feature of the patient while the expandable-and-collapsible cage structure is in the collapsed state (because the stepped portion 714 of 712 has a diameter slightly larger than that of 702, the distal end of 702 may be advanced through an initial puncture hole created by 712; Fig. 7); and at least one second cutting blade (as bands 124 may comprise projections, barbs, or blades and the one or more bands 724 are substantially similar to the one or more bands 124; therefore, may also comprise projections, barbs, or blades; [0037]; [0042]) positioned at the proximal section of the expandable-and-collapsible cage structure (as the projections, barbs, or blades are positioned on 724, which includes the proximal section) and being configured to dilate the initial puncture hole to form a larger puncture hole during rearward movement of the expandable-and-collapsible cage structure toward the biological feature and before the expandable-and-collapsible cage structure is fully retracted into the interior of the elongated medical sheath (any projections, barbs, or blades on the proximal portion of 724 would further cut or ablate tissue causing dilation when the device is moved proximally by a user prior to being collapsed, especially while being rotated and moved proximally by a user; [0045]).
Regarding claim 19, Benning discloses wherein: the expandable-and-collapsible cage structure (724, 712), once deployed, forms a tapered proximal section in the expanded state (Fig. 8).
Regarding claim 20, Benning discloses wherein: the expandable-and-collapsible cage structure (724, 712), once deployed, is configured to expand radially at the distal section of the expandable-and-collapsible cage structure (at the distal section of 724).
Regarding claim 21, Benning discloses wherein the at least one proximal mechanical tissue cutting device (blades) is configured to dilate the initial puncture hole while the expandable-and-collapsible support structure is being returned at least partially through the initial puncture hole (any projections, barbs, or blades on the proximal portion of 724 would further cut or ablate tissue causing dilation when the device is moved proximally by a user prior to being collapsed).
Regarding claim 22, Benning discloses wherein the at least one proximal mechanical tissue cutting device (blades) is configured to dilate the initial puncture hole while the expandable-and-collapsible support structure is being retracted toward the elongated medical sheath (any projections, barbs, or blades on the proximal portion of 724 would further cut or ablate tissue causing dilation when the device is moved proximally by a user prior to being collapsed).
Regarding claim 23, Benning discloses wherein the larger puncture hole has a size configured to allow transcatheter delivery of a medical device through the biological feature (because elongate member 703 has a diameter less than that of the one or more bands 724 that are capable of creating the larger puncture hole, a transcatheter is also capable of fitting within the larger hole created by the blades of 724).
Regarding claim 24, Benning discloses wherein the expandable-and-collapsible support structure (724, 712) comprises a shape-memory material configured to form a biased shape after exiting the distal end of the elongated medical sheath (as the one or more bands 124, substantially similar to bands 724 may include shape memory material; [0035]; [0042]).
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) 6, 12 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Benning et al. (US 2018/0140289 A1) in view of Scott et al. (US 2022/0273363).
Regarding claims 6, 12 and 18, Benning fails to disclose wherein: the expandable-and-collapsible support structure/cage structure, once deployed from the interior of the elongated medical sheath, forms a tear drop shape in the expanded state.
However, Scott teaches an apparatus (medical system 10; Fig. 1), comprising: an elongated medical sheath (shaft 20) comprising a distal end (distal end of 20) configured to be movable and positionable proximate to a biological feature (target tissue 70) of a patient (Figs. 2A-2C); and an expandable-and-collapsible support structure (end effector 30; Fig. 1) comprising a distal section (at probe tip 30a) and a proximal section (at expandable elements 38a, 38b) and configured to be selectively movable, at least in part, between a collapsed state (Fig. 2A) within an interior of the elongated medical sheath (20) when the distal end of the elongated medical sheath is advanced through a puncture of the biological feature of the patient (Fig. 2A) and an expanded state (Figs. 1, 2C) at an exterior of the elongated medical sheath (20) when the distal end of the elongated medical sheath is past the puncture of the biological feature of the patient (Fig. 2C); and a mechanical tissue-cutting assembly (probe tip 30a) being supported by the expandable-and-collapsible support structure (30; Fig. 1) and comprising at least one mechanical tissue cutting device (sharp distalmost surface of 30a; [0056]) positioned at the distal section of the expandable-and-collapsible support structure (30; Fig. 1) and being configured to create the puncture of the biological feature of the patient while the expandable-and-collapsible support structure is in the collapsed state (Fig. 2A). Scott teaches wherein: the expandable-and-collapsible support structure (30), once deployed from the interior of the elongated medical sheath (20), forms a tear drop shape in the expanded state (Fig. 1), or alternatively forms an ovoid shape (Figs. 2A-2C), similar to that of Benning.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the expandable-and-collapsible support structure/cage structure of Benning to be tear drop shaped as taught by Scott. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded the predictable result of ablating/cutting tissue. Further, a change in shape of the expandable-and-collapsible support structure/cage structure is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed expandable-and-collapsible support structure/cage structure is significant and Scott teaches both choices are known to those of ordinary skill in the art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claim(s) 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Benning et al. (US 2018/0140289 A1) in view of Hatta et al. (US 2017/0354435 A1).
Regarding claims 25-26, Benning discloses the expandable-and-collapsible support structure (724) is made from a metal (as the one or more bands 124, substantially similar to bands 724 may include shape memory material such as nitinol; [0035]; [0042]), but fails to disclose wherein the expandable-and-collapsible support structure includes a flexible wire cage having wires arranged in a cross-hatch pattern, wherein the expandable-and-collapsible support structure includes bends formed of a metal softer than a metal of other portions of the expandable-and-collapsible support structure.
However, Hatta teaches an apparatus (Figs. 3A-3C), comprising: an elongated medical sheath (outer sheath 80) comprising a distal end configured to be movable and postionable proximate to a biological feature of a patient (Figs. 3A-3C); and an expandable-and-collapsible support structure (cutting unit 40) comprising at least one proximal mechanical tissue cutting device (struts 41 including blades 47; [0072]), and wherein the expandable-and-collapsible support structure (40) includes a flexible wire cage (support portion 50 configured of multiple wires 51 that are radially expandable; Figs. 3B-3C; [0076]) having wires (51) arranged in a cross-hatch pattern (Fig. 3C) within the at least one proximal mechanical tissue cutting device (41, 47) for the purpose of supporting the cutting unit radially inward ([0076]). In order not to cause damage to the biological tissues in contact, it is preferable to form the wires (51) so that rigidity of the wires (51) is lower than that of the at least one proximal mechanical tissue cutting device (41) and a corner portion in a cross section has the curvature, and is more preferable to form the wires (51) so that the cross section has a circular shape ([0080]). Thus, the wires (51) and the bends thereof are softer than other portions (41) of the expandable-and-collapsible support structure (40). The wires (51) may be made from a shape memory metal ([0082]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the expandable-and-collapsible support structure of Benning to include the reduced rigidity flexible wire cage having wires arranged in a cross-hatch pattern as taught by Hatta in order to provide additional support to the support structure as well as provide an additional cage to capture tissue. The modification would cause the bends of the flexible wire cage to be formed of a metal softer than that of the one or more bands 724 of the expandable-and-collapsible support structure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Wilson et al. (US 10,303,018 B2) and Weber (US 2013/0116715 A1) are noted for teaching proximally facing blades.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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/SARAH A LONG/Primary Examiner, Art Unit 3771
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