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 .
Election/Restrictions
Claims 16-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/27/2026.
Applicant’s election without traverse of claims 1-15 and 20 in the reply filed on 04/27/2026 is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the limitation "the aspiration port" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, “the aspiration port” should recite “an aspiration port”.
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) 1-6, 12, 14, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weitzner et al. (US 20180206864) [hereinafter Weitzner].
Regarding claim 1, Weitzner discloses a tissue debridement device (Figs. 7A-C, para. 0040-0041), comprising:
a sheath 215a (Fig. 7A, para. 0041);
a distal tip 213 (Fig. 7A, para. 0041: “the distal end 214a of the elongate member may include an atraumatic tip 213”); and
a plurality of rotating tines 146a coupled to the distal tip 213 and the sheath 215a (Fig. 7C, para. 0041: “a tissue disrupting element 140a with one or more cutting members 146a disposed around a support shaft 149, wherein the support shaft 149 is rotationally attached to the distal end 214a of the elongate member 215a); para. 0044: “In any of the embodiments of FIGS. 7A-9B, one or both sides of the cutting member(s) 140a-c may include a variety of cross-sectional forms defining a cutting surface…configured to engage and disrupt necrotic debris as the cutting member(s) rotate within the necrotic pocket”).
Regarding claim 2, Weitzner discloses comprising an aspiration port disposed on a distal end of the sheath 215a (para. 0048: “In addition, or alternatively, any of the embodiments of FIGS. 1-12B may further include a separate lumen configured to remove necrotic debris and fluid from within the necrotic pocket under suction. For example, the suction lumen may be integrally formed within the elongate member and extend between the distal and proximal ends”).
Regarding claim 3, Weitzner discloses the rotating tines 146a configured to morcellate tissue (para. 0040 discloses that the tissue disrupting element is used to physically disrupt necrotic debris by way of pulverization, blending, maceration).
Regarding claim 4, Weitzner discloses the rotating tines 146a configured to create, via rotation, a flow of the morcellated tissue towards the aspiration port (interpreted as “an aspiration port”, see 112(b) rejection above) (para. 0048 of Weitzner discloses that the rotation of the tissue disrupting element i.e. the rotating tines 146a of Fig. 7A creates a flow of necrotric debris around the elongate member and that the elongate member may comprising a suction lumen that extends between a distal end proximal end of the elongate member. Therefore, the elongate member includes an aspiration port by way of the suction lumen and the rotating tines are capable of creating a flow of debris towards the aspiration port of the elongate member; para. 0048: “In any of the embodiments of FIGS. 1-12B, necrotic debris disrupted by…a tissue disrupting element (FIGS. 7A-12B) may circulate within the necrotic pocket and flow/exit around the elongate member… any of the embodiments of FIGS. 1-12B may further include a separate lumen configured to remove necrotic debris and fluid from within the necrotic pocket under suction…the suction lumen may be integrally formed within the elongate member and extend between the distal and proximal ends”).
Regarding claim 5, Weitzner discloses comprising an infusion port (para. 0048 of Weitzner discloses that a suction lumen may also be used to introduce a wash solution. Therefore, the Weitzner discloses an infusion port by way of the suction lumen used to introduce the wash solution to a target site. Para. 0048: “any of the embodiments of FIGS. 1-12B may further include a separate lumen configured to remove necrotic debris and fluid from within the necrotic pocket under suction… The suction lumen may also be used as an aspiration lumen through which a bolus of wash solution may be gently introduced into the necrotic pocket”).
Regarding claim 6, Weitzner discloses wherein the distal tip 213 is atraumatic (Fig. 7A, para. 0041: “the distal end 214a of the elongate member may include an atraumatic tip 213”).
Regarding claim 12, Weitzner discloses wherein the distance between the distal tip 213 and the sheath 215a can be adjusted to adjust a diameter of the rotating tines (Figs. 7A-C, para. 0041: “the cutting member(s) 146a may be slidably disposed within a groove or lumen (not shown) formed within the distal portion 215a of the elongate member 215a. When constrained within the groove or lumen, the cutting member(s) may be held substantially parallel to the support shaft 149. The support shaft 149 may be advanced distally beyond the distal end 214a of the elongate member 215a such that the cutting member(s) are released from constraint within the groove or lumen (FIG. 7B), thereby allowing the cutting member(s) to bow radially outward (FIG. 7C)”).
Regarding claim 14, Weitzner discloses wherein the sheath 215a is configured to be inserted into a working channel of an endoscope (Fig. 13, para. 0049: “any of the necrosectomy tools of the present disclosure may be introduced into a necrotic pocket 2 through a first working channel 86 of an endoscope 80”).
Regarding claim 20, Weitzner discloses a system (Figs. 7A-C, para. 0040-0041) comprising:
a tissue debridement device (a necrosectomy tool shown in Figs. 7A-C, para. 0040: “a necrosectomy tool which utilizes a tissue disrupting element carried on or about the distal end of a delivery device to facilitate disruption and removal of necrotic debris without disrupting or damaging the tissue wall of the necrotic pocket”; para. 0041: “Referring to FIGS. 7A-7C, a necrosectomy tool of the present disclosure may include an elongate member 710 comprising a tissue disrupting element 140a”), the tissue debridement device comprising:
a sheath 215a (Fig. 7A, para. 0041);
a distal tip 213 (Fig. 7A, para. 0041: “the distal end 214a of the elongate member may include an atraumatic tip 213”); and
a plurality of rotating tines 146a coupled to the distal tip 213 and the sheath 215a (Fig. 7C, para. 0041: “a tissue disrupting element 140a with one or more cutting members 146a disposed around a support shaft 149, wherein the support shaft 149 is rotationally attached to the distal end 214a of the elongate member 215a); para. 0044: “In any of the embodiments of FIGS. 7A-9B, one or both sides of the cutting member(s) 140a-c may include a variety of cross-sectional forms defining a cutting surface…configured to engage and disrupt necrotic debris as the cutting member(s) rotate within the necrotic pocket”) and
an endoscope configured to receive the tissue debridement device (Fig. 13, para. 0049: “any of the necrosectomy tools of the present disclosure may be introduced into a necrotic pocket 2 through a first working channel 86 of an endoscope 80”).
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.
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) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Weitzner et al. (US 20180206864) [hereinafter Weitzner] as applied to claim 1 above, and further in view of Maitland et al. (US 20020095169) [hereinafter Maitland].
Regarding claim 7, Weitzner discloses all of the limitations set forth above in claim 1. However, Weitzner fails to disclose wherein the distal tip comprises a probe configured to indicate healthy tissue.
Maitland in the same field of endeavor of occlusion removal devices (Figs. 1-3, para. 0056) teaches that it is known in the art for a distal tip of the device that is positioned around a blockage within a body lumen to comprise a diagnostic sensor 47 configured to indicate healthy tissue (para. 0081: “a sensor 47 on the distal tip allows for the interrogation of the environment distal to the blockage. In medical applications, for example, this could include a diagnostic that would measure the viability of the distal vessel relative to reinstated blood flow”).
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 distal tip in Weitzner to include the diagnostic sensor of Maitland in order to allow the device of Weitzner to detect the health of the tissue wall during the procedure (para. 0081: “Since reintroducing blood to necrotic tissue will result in a potentially worse medical condition, a sensor that would help determine the health of the vessel wall would be extremely useful”), thereby providing a measurable indication of debris removal from the tissue wall.
Claim(s) 8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Weitzner et al. (US 20180206864) [hereinafter Weitzner] as applied to claim 1 above, and further in view of Weber (US 20040122457).
Regarding claim 8, Weitzner discloses all of the limitations set forth above in claim 1. Weitzner further discloses that the plurality of rotating tines 146a comprise a sharp surface along the entire length of the rotating tines (para. 0044: “In any of the embodiments of FIGS. 7A-9B, one or both sides of the cutting member(s) 140a-c may include a variety of cross-sectional forms defining a cutting surface (e.g., sharpened edge, abrasive surface, serrations, teeth, etc.) configured to engage and disrupt necrotic debris as the cutting member(s) rotate within the necrotic pocket”).
However, Weizner fails to disclose wherein each of the rotating tines comprise a sharp section disposed between blunt sections.
Weber in the same field of endeavor of expandable cutting devices 10 used for excising occlusive material in body lumens such as a gastrointestinal tract (para. 0062: “The intravascular cutting device 10 can be rotated to excise the lesion” and para. 0064: “devices and methods in accordance with the invention can be adapted for use in the digestive or gastrointestinal tract”) teaches that it is known in the art for rotating tines 18 to comprise a sharp section 20 (para. 0028: “] A cutting wire 18 includes a cutting blade 20 that is attached to the cutting wire 18) disposed between blunt sections (interpreted as wire sections of the rotating tines 18 that are proximal and distal to cutting blades 20).
Weber further teaches that rotating tines having a single sharp section is a known alternative to having a sharp surface extending along the entire length of the rotating tines (para. 0029: “While not illustrated, each cutting wire 18 can have a plurality of blades 20 spaced out along the length of the cutting wire 18”).
Since Weber explicitly teaches that having a sharp section in between blunt sections is a known alternative to having the continuous sharp surface as discussed in Weitzner in the art of cutting devices, it would have been obvious to one of ordinary skill in the art to modify the rotating tines comprising only the sharp surface as discussed in Weitzner to include the blunt wire sections adjacent to the sharp section, as taught by Weber in order to localize the cutting to a specific treatment area, thereby preventing surround tissues from being damaged which is desired by Weitzner (para. 0040: “the present disclosure relates to a necrosectomy tool which utilizes a tissue disrupting element carried on or about the distal end of a delivery device to facilitate disruption and removal of necrotic debris without disrupting or damaging the tissue wall of the necrotic pocket”).
Regarding claim 11, modified Weitzner discloses wherein the rotating tines comprise a wire (Fig. 1, para. 0025 of Weber: “the cutting unit 12 can include one, two, three, four or more cutting wires 18”) and wherein the sharp section has a flat shaped profile (see Fig. 7C of Weitzner which illustrates the sharp, cutting, surface of the rotating tines having a flat shaped profile).
Claim(s) 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Weitzner et al. (US 20180206864) [hereinafter Weitzner] in view of Weber (US 20040122457) as applied to claim 8 above, and further in view of Sutton (US 20170020556) [hereinafter Sutton].
Regarding claims 9 and 10, modified Weitzner discloses all of the limitations set forth above in claim 8. Modified Weitzner further discloses wherein the rotating tines comprise a wire (Fig. 1, para. 0025 of Weber: “the cutting unit 12 can include one, two, three, four or more cutting wires 18”).
However, modified Weitzner fails to disclose wherein the sharp section comprises a smaller diameter than the blunt sections (claim 9)/wherein the blunt sections comprise a coating (claim 10).
Sutton in the same field of endeavor of expandable cutting devices 1722 (Fig. 17) teaches that it is known in the art for sharp sections 1740 (Fig. 17, para. 0083: “The macerating element 1722 can be configured such that the first uncoated portion 1740 cuts, destroys or macerates a clot that it comes into contact with.”) to comprise a smaller diameter than blunt sections 1738 (para. 0083: “The coated portion 1738 can be configured to not cut, damage, or harm the portions of the patient's circulatory system that it contacts”) due to a therapeutic coating provided on the blunt sections for the purpose of delivering drugs to a treatment site during the cutting procedure (Fig. 17, para. 0082).
In light of this teaching, 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 blunt sections in modified Weitzner to include the therapeutic coating of Sutton in order to allow the device to treat the tissue wall with drugs that would prevent formation of occlusive material at the treatment site (para. 0082-0083 of Sutton), thereby increasing the utility of the device.
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Weitzner et al. (US 20180206864) [hereinafter Weitzner] as applied to claim 12 above, and further in view of Cox (US 20070005093).
Regarding claim 13, Weitzner discloses all of the limitations set forth above in claim 12. Weitzner further discloses comprising a central guide 149 coupling the distal tip 213 with the sheath 215a (Fig. 7B, para. 0041: “wherein the support shaft 149 is rotationally attached to the distal end 214a of the elongate member 710”). However, Weitzner fails to disclose a handle such that that the central guide is coupled to the handle at a proximal end of the sheath and the distance between the distal tip and the sheath adjustable by the handle.
Cox in the same field of endeavor of expandable strut devices 10 teaches that it is known in the art for a central guide 18 to be coupled to a handle 16 at a proximal end of a sheath 12 for the purpose of axially translating the central guide (Figs. 1A-B, para. 0048).
The combination of Weitzner and Cox would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention (i.e., one skilled in the art would have recognized that the handle coupled proximally to the central guide, as taught by Cox, would allow the central guide 149 of Weitzner to be slidingly translated relative to the sheath 215a of Weitzner and adjust the distance between the distal tip 213 and the sheath 215a of Weitzner as intended (see Figs. 7A-C of Weitzner); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Weitzner et al. (US 20180206864) [hereinafter Weitzner].
Regarding claim 15, Weitzner discloses all of the limitations set forth above in claim 12. Weitzner further discloses that the tissue debridement device may comprise a camera when introduced without a deliver device to allow the medical profession to visualize the device, the debris and tissue wall of the target site (para. 0049: “In one embodiment, a necrosectomy tool of the present disclosure may be introduced into the necrotic pocket in the absence of a delivery device (e.g., endoscope, etc.). In such an embodiment, the necrosectomy tool may include steering capability and a camera and light source (not depicted) to allow the medical professional to visualize the steerable necrosectomy tool, necrotic debris and tissue wall of the necrotic pocket”).
However, Weitzner fails to disclose wherein the distal tip comprises the camera.
There are only a finite number of areas to position the camera so that the camera may visualize the device, debris and tissue wall as described in Weitzner such as on the distal tip or on a distal end of the sheath. Each possibility yields the predictable result of the device being able to capture the procedure in real time. Therefore, it would be obvious to one of ordinary skill to modify the distal tip of Weitzner to include the camera, in order to achieve the predictable result of visualize the device, debris and tissue wall during the procedure; KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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