DETAILED ACTION
This action is responsive to the “RESPONSE TO NON-FINAL OFFICE ACTION” filed 29 April 2026. The Examiner acknowledges the amendments to claims 1, 17, and 20, as well as the cancelation of claims 12-13. Claims 1-11 and 14-20 are 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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters “46b” and “46c” appear to refer to the same strut in Fig. 2; “46d” and “46e” appear to refer to the same strut in Fig. 2.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
Claim Rejections - 35 USC § 102
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) 1-5, 8-11, and 14-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Carson (US-20230404551-A1, PCT filed 18 November 2021, previously presented).
Regarding claim 1, Carson teaches
A tissue collection system, the system comprising:
an outer tubular member having a proximal end region and a distal end region and defining a lumen extending from the proximal end region to the distal end region [elongated hollow tube 112 (Carson ¶0050, Figs. 1-3), wherein as depicted in Carson Fig. 2, the elongated hollow tube comprises a distal end 114 and a proximal end 116];
an inner tubular member slidably disposed within the lumen of the outer tubular member, the inner tubular member defining a lumen extending from a proximal end region to a distal end region of the inner tubular member [rod 118 (Carson Fig. 8); a rod 118 having a distal end 120 and a proximal end 122. The rod 118 is positioned at least partially within the elongated hollow tube 112. An axial movement of the rod 118 with respect to the elongated hollow tube 112 (Carson ¶0046); the rod 118 includes a lumen 132 (Carson ¶0050)]; and
a tissue collection device disposed adjacent to the distal end region of the inner tubular member, the tissue collection device comprising an expandable basket having a proximal collar and a distal collar, wherein one of the proximal collar and the distal collar circumferentially surrounds an outer surface of the inner tubular member and is fixedly secured to the outer surface of the inner tubular member and the other one of the proximal collar and the distal collar circumferentially surrounds the outer surface of the inner tubular member and is movably disposed over the inner tubular member [cylindrical member 102 (Carson Figs. 1-4); The elongated hollow tube 112 is coupled to the proximal end 106 of the cylindrical member 102 (Carson ¶0046), wherein as depicted in at least Carson Figs. 3 and 4B, the cylindrical member 102 defines a “basket” based on the curvature of strips 110; See also Annotated Fig. 1 regarding the claimed “proximal collar” and “distal collar”];
wherein the tissue collection device is movable between a retracted delivery position and an extended sample collection position [An axial movement of the rod 118 with respect to the elongated hollow tube 112 causes the cylindrical member 102 to transition from a retracted position in which the plurality of strips 110 are aligned with the distal end 104 and the proximal end 106 of the cylindrical member 102 to an expanded position in which the plurality of strips 110 protrude radially outward from the distal end 104 and the proximal end 106 of the cylindrical member 102, such that a diameter of the cylindrical member 102 in the expanded position is greater than a diameter of the cylindrical member 102 in the retracted position. FIG. 2 illustrates the device 100 in the retracted position, while FIG. 3 illustrates the device 100 in the expanded position (Carson ¶0046, Figs. 1-4)].
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Annotated Fig. 1. The Examiner has annotated Figs. 4A-B of Carson to indicate the portions of cylindrical member 102 [taken to read on the tissue collection device] that are considered to read on the claimed proximal collar and distal collar, based on the broadest reasonable interpretation of “collars” as defined by the Applicant [For example, the struts 46 and collars 52, 54 may be cut from a single tube. It is further contemplated that the struts 46 and collars 52, 54 may be formed from or as a part of the inner tubular member 16. Said differently, the inner tubular member 16, struts 46, and collars 52, 54 may be formed as a single monolithic structure. For example, the cut tube may be the inner tubular member 16 or a separate tube, as desired (Applicant’s Specification ¶0055)] and the plain definition of a “collar” [something resembling a collar in shape or use (such as a ring or round flange to restrain motion or hold something in place) (https://www.merriam-webster.com/dictionary/collar)]; wherein the distal collar [identified portion of distal end 104 of cylindrical member 102] circumferentially surrounds an outer surface of the inner tubular member and is fixedly secured to the outer surface of the inner tubular member via cap 138 [the device 100 may include a cap 138 positioned at the distal end 104 of the cylindrical member 102, and the distal end 120 of the rod 118 is coupled to the cap 138 (Carson ¶0058, Figs. 2-3), wherein as depicted in Figs. 2-3, the distal collar moves based on movement of the cap 138] and the proximal collar circumferentially surrounds the outer surface of the inner tubular member and is movably disposed over the inner tubular member [Carson Figs. 2-3].
Regarding claim 2, Carson teaches
The tissue collection system of claim 1, wherein the expandable basket comprises a plurality of longitudinally extending struts [The cylindrical member 102 includes a plurality of longitudinal slits 108 positioned between the distal end 104 and the proximal end 106 to thereby create a plurality of strips 110 positioned between the plurality of longitudinal slits 108 (Carson ¶0046, Figs. 1-4)].
Regarding claim 3, Carson teaches
The tissue collection system of claim 2, wherein one or more edges of at least one strut of the plurality of struts has a sharpened surface [The edges of the plurality of strips 110 may be rough (serrated) or sharpened to aid in the cutting (Carson ¶0047)].
Regarding claim 4, Carson teaches
The tissue collection system of claim 2, wherein a surface of at least one strut of the plurality of struts is textured [Carson ¶0047].
Regarding claim 5, Carson teaches
The tissue collection system of claim 2, further comprising one or more barbs coupled to at least one strut of the plurality of struts [Carson ¶0047; As shown in FIG. 10, the spikes 146 may be angled in a direction towards the proximal end 116 of the elongated hollow tube 112. As such, the spikes 146 may be used to tear the tissue from the target anatomy 101 when the device 100 is moved in the proximal direction along the longitudinal axis of the cylindrical member 102 (Carson ¶0053), wherein serrations/spikes are considered to read on the broadest reasonable interpretation of a “barb” defined as a sharp projection extending backward (as from the point of an arrow or fishhook) and preventing easy extraction (https://www.merriam-webster.com/dictionary/barb)].
Regarding claim 8, Carson teaches
The tissue collection system of claim 2, further comprising one or more teeth extending from at least one strut [Carson ¶¶0047, 0053, Fig. 10].
Regarding claim 9, Carson teaches
The tissue collection system of claim 8, wherein the one or more teeth are formed as a single monolithic structure with the at least one strut [Carson ¶¶0047, 0053, Fig. 10].
Regarding claim 10, Carson teaches
The tissue collection system of claim 2, wherein the plurality of struts comprises a plurality of individual filaments, the filaments coupled to one another at their respective proximal and distal ends [The geometry of the cylindrical member 102 of the device includes various patterns of slits, cutouts, or variations in thickness that determine the geometry of the cutting shapes and arrangement (Carson ¶0067), wherein as depicted in Figs. 4A-B, the strips 110 are coupled to one another at distal end 104 and proximal end 106m wherein the strips are considered to read on the broadest reasonable interpretation of a “filament”, defined as a single thread or a thin flexible threadlike object, process, or appendage (https://www.merriam-webster.com/dictionary/filament)].
Regarding claim 11, Carson teaches
The tissue collection system of claim 1, wherein the tissue collection device comprises a cut tube [Blades or cutting edges are created in the cylindrical member 102 by cutting out a plurality of longitudinal slits 108 in the cylindrical member 102 and sharpening edges along the edges of the cylindrical member 102 left next to those cut outs (Carson ¶0045)].
Regarding claim 14, Carson teaches
The tissue collection system of claim 1, wherein the tissue collection device is self-expanding [In one example, the device 100 includes a pre-loaded spring 148 configured to rotate the cylindrical member 102 once the cylindrical member 102 is in the expanded position. In one such example, the pre-loaded spring 148 is automatically triggered once the rod 118 exceeds a certain length of movement in a proximal direction (Carson ¶0055, Fig. 11)].
Regarding claim 15, Carson teaches
The tissue collection system of claim 1, further comprising an actuation mechanism coupled to a proximal or distal end of the tissue collection device [In use, by pulling on the rod 118 relative to the elongated hollow tube 112, the cylindrical member 102 is compressed, also causing the cylindrical member 102 to expand radially. The expanded cylindrical member 102 bows outward and exposes itself as a plurality of strips 110 surrounding the longitudinal axis of the cylindrical member 102, as shown in FIG. 3 (Carson ¶0047, Fig. 3)].
Regarding claim 16, Carson teaches
The tissue collection system of claim 1, wherein the inner tubular member further comprises one or more cut-out regions, the one or more cut-out regions adjacent to the tissue collection device [a plurality of through-holes 134 to enable suction of samples extracted via the plurality of strips 110 out of the lumen 132 of the rod 118 (Carson ¶0050, Fig. 8), wherein as depicted in Carson Fig. 8, the rod 118 comprises the through-holes 134, which are considered to be adjacent to the cylindrical member 102 (tissue collection device)].
Regarding claim 17, Carson teaches
A tissue collection system, the system comprising:
an outer tubular member having a proximal end region and a distal end region and defining a lumen extending from the proximal end region to the distal end region [elongated hollow tube 112 (Carson ¶0050, Figs. 1-3), wherein as depicted in Carson Fig. 2, the elongated hollow tube comprises a distal end 114 and a proximal end 116;
an inner tubular member slidably disposed within the lumen of the outer tubular member, the inner tubular member defining a lumen extending from a proximal end region to a distal end region of the inner tubular member, the lumen extending to an opening at a distal end of the inner tubular member [rod 118 (Carson Fig. 8); a rod 118 having a distal end 120 and a proximal end 122. The rod 118 is positioned at least partially within the elongated hollow tube 112. An axial movement of the rod 118 with respect to the elongated hollow tube 112 (Carson ¶0046); In another example, the rod 118 includes a lumen 132. In one such example, as shown in FIG. 8, the distal end 114 of the elongated hollow tube 112 includes a plurality of through-holes 134 to enable suction of samples extracted via the plurality of strips 110 out of the lumen 132 of the rod 118 (Carson ¶0050), wherein the plurality of through-holes 134 are considered to define an opening at the distal end of the rod 118]; and
a tissue collection device disposed adjacent to the distal end region of the inner tubular member, the tissue collection device comprising a radially expandable basket having a plurality of longitudinally extending struts extending between a proximal collar and a distal collar, wherein one of the proximal collar and the distal collar circumferentially surrounds and is fixedly secured to an outer surface of the inner tubular member and the other one of the proximal collar and the distal collar circumferentially surrounds and is movably disposed over the inner tubular member [cylindrical member 102 (Carson Figs. 1-4); The elongated hollow tube 112 is coupled to the proximal end 106 of the cylindrical member 102 (Carson ¶0046), wherein as depicted in at least Carson Figs. 3 and 4B, the cylindrical member 102 defines a “basket” based on the curvature of strips 110; See also Annotated Fig. 1 regarding the claimed “proximal collar” and “distal collar”];
wherein the tissue collection device is movable between a retracted collapsed delivery position and an extended expanded sample collection position [An axial movement of the rod 118 with respect to the elongated hollow tube 112 causes the cylindrical member 102 to transition from a retracted position in which the plurality of strips 110 are aligned with the distal end 104 and the proximal end 106 of the cylindrical member 102 to an expanded position in which the plurality of strips 110 protrude radially outward from the distal end 104 and the proximal end 106 of the cylindrical member 102, such that a diameter of the cylindrical member 102 in the expanded position is greater than a diameter of the cylindrical member 102 in the retracted position. FIG. 2 illustrates the device 100 in the retracted position, while FIG. 3 illustrates the device 100 in the expanded position (Carson ¶0046, Figs. 1-4)].
Regarding claim 18, Carson teaches
The tissue collection system of claim 17, wherein the tissue collection device is a cut tube [Carson ¶0045].
Regarding claim 19, Carson teaches
The tissue collection system of claim 17, wherein at least one strut of the plurality of struts includes a radially extending tissue disruption feature [Carson ¶¶0047, 0053, Fig. 10].
Regarding claim 20, Carson teaches
A tissue collection system, the system comprising:
an outer tubular member having a proximal end region and a distal end region and defining a lumen extending from the proximal end region to the distal end region;
an inner tubular member slidably disposed within the lumen of the outer tubular member, the inner tubular member defining a lumen extending from a proximal end region to a distal end region of the inner tubular member, the lumen extending to an opening at a distal end of the inner tubular member [rod 118 (Carson Fig. 8); a rod 118 having a distal end 120 and a proximal end 122. The rod 118 is positioned at least partially within the elongated hollow tube 112. An axial movement of the rod 118 with respect to the elongated hollow tube 112 (Carson ¶0046); In another example, the rod 118 includes a lumen 132. In one such example, as shown in FIG. 8, the distal end 114 of the elongated hollow tube 112 includes a plurality of through-holes 134 to enable suction of samples extracted via the plurality of strips 110 out of the lumen 132 of the rod 118 (Carson ¶0050), wherein the plurality of through-holes 134 are considered to define an opening at the distal end of the rod 118];
a tissue collection device disposed adjacent to the distal end region of the inner tubular member, the tissue collection device comprising a radially expandable basket having a plurality of longitudinally extending wires extending between a proximal collar and a distal collar, wherein one of the proximal collar and the distal collar circumferentially surrounds and is fixedly secured to an outer surface of the inner tubular member and the other one of the proximal collar and the distal collar circumferentially surrounds and is movably disposed over the inner tubular member [cylindrical member 102 (Carson Figs. 1-4); The elongated hollow tube 112 is coupled to the proximal end 106 of the cylindrical member 102 (Carson ¶0046), wherein as depicted in at least Carson Figs. 3 and 4B, the cylindrical member 102 defines a “basket” based on the curvature of strips 110, wherein the strips 110 comprising nitinol is considered to read on the broadest reasonable interpretation of “wires”, defined as metal in the form of a usually very flexible thread (https://www.merriam-webster.com/dictionary/wire); See also Annotated Fig. 1 regarding the claimed “proximal collar” and “distal collar”]; and
at least one barb coupled to at least one wire of the plurality of longitudinally extending wires, the at least one barb including a radially extending free end [The edges of the plurality of strips 110 may be rough (serrated) or sharpened to aid in the cutting (Carson ¶0047); As shown in FIG. 10, the spikes 146 may be angled in a direction towards the proximal end 116 of the elongated hollow tube 112. As such, the spikes 146 may be used to tear the tissue from the target anatomy 101 when the device 100 is moved in the proximal direction along the longitudinal axis of the cylindrical member 102 (Carson ¶0053)];
wherein the tissue collection device is movable between a retracted collapsed delivery position and an extended expanded sample collection position [An axial movement of the rod 118 with respect to the elongated hollow tube 112 causes the cylindrical member 102 to transition from a retracted position in which the plurality of strips 110 are aligned with the distal end 104 and the proximal end 106 of the cylindrical member 102 to an expanded position in which the plurality of strips 110 protrude radially outward from the distal end 104 and the proximal end 106 of the cylindrical member 102, such that a diameter of the cylindrical member 102 in the expanded position is greater than a diameter of the cylindrical member 102 in the retracted position. FIG. 2 illustrates the device 100 in the retracted position, while FIG. 3 illustrates the device 100 in the expanded position (Carson ¶0046, Figs. 1-4)].
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carson, as applied to claim 5 above, in view of Cook (US-20080033534-A1, previously presented).
Regarding claim 6, Carson teaches
The tissue collection system of claim 5.
However, Carson fails to explicitly disclose wherein the one or more barbs comprises a wire wound around the at least one strut.
Cook discloses systems and methods employing one or more barbs comprising a wire wound around a strut [To form the helical coil 38 of the illustrative barb 11 of FIGS. 2-3, a length of 0.008-0.012'' diameter wire (such as 0.01'' spring stainless steel wire) is either machine wound or hand wound around the strut 15 so that the strut 15 traverses the lumen 21 formed by the helical coil 38, thus forming a mechanical attachment 17 between the barb 11 and strut 15. This is best shown in FIG. 3 (Cook ¶0051); The distal end 30 of the barb includes a bevel 35 to facilitate penetration of the vessel wall (Cook ¶0055)].
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 system of Carson to employ wherein the one or more barbs comprises a wire wound around the at least one strut, as this modification would amount to simple substitution of one known element [“barbs” of Carson ¶¶0047, 0053, Fig. 10] for another [barb of cook ¶¶0051, 0055, Figs. 2-3] with similar expected results [hook into tissue] [MPEP § 2143(I))(B)].
Regarding claim 7, Carson in view of Cook teaches
The tissue collection system of claim 6, wherein at least one free end of the wire extends radially from the at least one strut [see § 103 modification above; Cook Figs. 2-3].
Response to Arguments
Applicant's arguments, see Applicant’s Remarks p. 7-8, filed 29 April 2026, have been fully considered but they are not considered entirely persuasive.
The previously presented drawing objection for reference characters “12” and “44” both appearing to be directed towards one of either of the “tissue collection device” and “radially expanding frame or basket” in Fig. 2 has been overcome.
The Applicant asserts that the struts 46b / 46c and struts 46d / 46e each reference separate and distinct struts, wherein strut 46b merely obscures a portion of strut 46c and strut 46e merely obstructs a portion of 46d. However, the Examiner disagrees with the Applicant’s argument, as the obscuring of struts 46c and 46d by struts 46b and 46e is what makes Fig. 2 appear to depict the reference characters 46b / 46c and 46d / 46e as respectively being directed towards the same struts.
Applicant’s arguments, see Applicant’s Remarks p. 8, with respect to the previously presented Specification objection have been fully considered and are persuasive. The Specification objection has been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 8, with respect to the previously presented claim objection(s) have been fully considered and are persuasive. The objection to claim 20 has been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 8-9, with respect to the previously applied Non-Statutory Double Patenting Rejection(s) have been fully considered and are persuasive. The Non-Statutory Double Patenting Rejection(s) have been withdrawn.
Applicant's arguments, see Applicant’s Remarks p. 9-10, with respect to the previously applied rejections of claims 1, 17, and 20 under § 103 have been fully considered but they are not persuasive.
The Applicant asserts that Carson fails to teach the amended subject matter to require that the tissue collection device comprises an expandable basket having a proximal collar and a distal collar, wherein one of the proximal collar and the distal collar circumferentially surrounds and is fixedly secured to an outer surface of the inner tubular member and the other one of the proximal collar and the distal collar circumferentially surrounds and is movably disposed over the inner tubular member; wherein the Applicant notes that the distal end 104 [previously applied to read on the claimed distal collar] is not fixedly secured to the outer surface of the rod 118 but rather to the cap 138, and wherein the Applicant further notes that the rod 118 of Carson is not a tubular member with a lumen therein and the cap 138 at the distal end thereof negates the possibility of the rod 118 having a lumen. However, the Examiner disagrees with the Applicant’s argument that the distal end 104 is not fixedly secured to the outer surface of the rod 118, but rather to the cap 138, as the Examiner notes that the cap 138 itself is considered to fixedly secure the distal end 104 [distal collar] to the outer surface of the rod 118 [the device 100 may include a cap 138 positioned at the distal end 104 of the cylindrical member 102, and the distal end 120 of the rod 118 is coupled to the cap 138 (Carson ¶0058, Figs. 2-3), wherein as depicted in Figs. 2-3, the distal collar moves based on movement of the cap 138]. The Examiner further disagrees with the Applicant’s argument that the cap 138 at the distal end of the rod 118 negates the possibility of the rod 118 having a lumen, as Carson explicitly discloses that the rod 118 may have a lumen and explicitly depicts both the lumen of rod 118 and cap 138 in the same embodiment [the rod 118 includes a lumen 132 (Carson ¶0050, Fig. 8)].
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 SEVERO ANTONIO P LOPEZ whose telephone number is (571)272-7378. The examiner can normally be reached M-F 9-6 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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