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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because: “12” and “44” both appear to be directed towards one of either of the “tissue collection device” / “radially expanding frame or basket” in Fig. 2; “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.
Specification
The disclosure is objected to because of the following informalities:
¶0087 of the Specification [p. 23] appears to be empty [there is no text in ¶0087].
Appropriate correction is required.
Claim Objections
Claim 20 is/are objected to because of the following informalities:
Line 13 of claim 20 should be tabbed once to the right.
Appropriate correction is required.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 1, 13, and 15 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 9,855,066, hereinafter Tah.
Although the claims at issue are not identical, they are not patentably distinct from each other because conflicting claim 15 of Tah is considered to anticipate each and every limitation of instant claim 1 [see comparison below].
Conflicting claim 15 of Tah is further considered to anticipate instant claims 13 and 15.
Claim 1 of the Instant Application
Claim 15 of Conflicting Patent 9,855,066 [hereinafter Tah], which is considered to incorporate the subject matter of claims 10 and 14 therein
A tissue collection system, the system comprising:
A tissue retrieval system, the system comprising: [Tah Col 13:54]
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;
a sheath having a proximal end, a distal end, and a channel extending therebetween; [Tah Col 13:55-56]
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; and
a morcellating device configured to be disposed within the channel, the device comprising: a tube including a proximal end, a distal end, and a lumen extending therebetween along a longitudinal axis; [Tah Col 13:57-61]
a tissue collection device disposed adjacent to the distal end region of the inner tubular member, the tissue collection device comprising an expandable basket;
an expandable member attached to the distal end of the tube, the expandable member including a plurality of conducting elements extending distally from the distal end of the tube, at least two of the plurality of conductive elements being joined together by a material to define a basket [Tah Col 13:62-67]
wherein the tissue collection device is movable between a retracted delivery position and an extended sample collection position.
the morcellating device comprises an actuation mechanism configured to selectively move the conductive ring between an open configuration, in which the distal facing opening is radially expanded, and a closed configuration, in which the distal facing opening is radially closed [Tah Col 14:32-36]
wherein the basket is selectively closeable and expandable [Tah Col 14:37-38]
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 13-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Carson (US-20230404551-A1, PCT filed 18 November 2021).
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 [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 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)].
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 13, Carson teaches
The tissue collection system of claim 1, wherein the tissue collection device is coupled to the inner tubular member [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), wherein the cylindrical member 102 (tissue collection device) is considered to be coupled to the rod 118 (inner tubular member) via the cap 138].
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 [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 a radially expandable basket having a plurality of longitudinally extending struts extending between a proximal collar and a distal collar [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 are considered to extend between a proximal collar defined by the proximal end 106 of cylindrical member 102 and a distal collar defined by distal end 104 of cylindrical member 102];
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 [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)];
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 [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 are considered to extend between a proximal collar defined by the proximal end 106 of cylindrical member 102 and a distal collar defined by distal end 104 of cylindrical member 102, and 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)];
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, cited by Applicant).
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 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].
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carson, as applied to claim 1 above, in view of Rains (US-20120179161-A1).
Regarding claim 12, Carson teaches
The tissue collection system of claim 1.
However, Carson fails to explicitly disclose wherein the tissue collection device is a monolithic structure with the inner tubular member.
Rains discloses a tissue collection system comprising a monolithic structure of a tubular member and a tissue collection device adjacent to a distal end region of the tubular member, the tissue collection device comprising an expandable basket [The distal end 23 the shaft 21 may be coupled directly or indirectly to an expandable cutting device 25 which, as shown in FIGS. 1-3, includes four flexible cutting arms 26 (Rains ¶0035, Figs. 1-2); the cage structure of the expandable cutting device 25-25c and/or the drill tip 27 can be an integral with the shaft 21-21c (Rains ¶0052, Fig. 21)].
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 tissue collection device is a monolithic structure with the inner tubular member, as this modification merely amounts to a matter of obvious engineering choice. In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) [MPEP § 2144.04(V)(B)].
Conclusion
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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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791