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 .
Response to Amendment
The amendment filed Jul. 27, 2026 has been entered. Claims 1-22 remain pending in the application. Applicant’s amendments to the claims have overcome the 112(d) rejections previously set forth in the Final Office Action mailed May 1, 2026.
Response to Arguments
35 USC § 112(d):
Applicant amended claim 1 and successfully overcomes the previous rejection under 35 U.S.C. 112(d) and the rejection is withdrawn.
35 USC § 103:
Applicant’s arguments filed July 27, 2026 with respect to claims 1 has been considered but are moot because the new ground of rejection is being applied using Mueller and Mintz in light of the amendments to the claims. However below response addresses arguments still relevant to the new ground of rejection set forth below.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Mueller teaches that many modifications of structure, arrangement, proportions, the elements, materials, and components used in the practice of the invention, and otherwise, which are particularly adapted to specific environments and operative requirements without departing from those principles (Col. 2 ln. 55-60). Further, Mintz may teach the prongs being transverse to the central longitudinal axis, however there is nothing in the references that says the angle of emission cannot be varied. Mueller ‘917 proposes additional bends that allow the target to be better accessed and when viewed in combination with Mueller and Mintz, the lasers can be emitted in an axial direction. Additionally, Look is used in the dependent claim rejections and is used to modify the primary references mechanically. As shown in Fig. 71 of Look, the distal end is capable of bending 180 degrees and the written description confirms even exactly 180 degrees can be selected, which allows axial emission of the device in order to reach different portions of the thrombus.
In response to applicant's argument that Look is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, both Look and the primary references are concerned with treating a selected material in a vessel.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 22 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 22 recites the limitation “wherein the first bend and the second bend cause each of the plurality of fingers to exhibit an S-like shape”.
As-filed specification does not provide description of an “S-like” shape.
The specification as-filed does not provide a written description or set forth the metes and bounds of the amended limitations above. The specification does not provide blaze marks nor direction for the instant methods encompassing the above-mentioned "limitations" as they are currently recited. The instant claims now recite limitations which were not clearly disclosed in the specification as-filed, and now change the scope of the instant disclosure as-filed. Such limitations recited in the present claims, which did not appear in the specification, as-filed, introduce new concepts (See MPEP 2163.06). Applicant is required to cancel the new matter in the response to this Office action. Alternatively, applicant is invited to provide sufficient written support for the “limitations” indicated above.
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 22 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.
The term “S-like shape” in claim 22 is a relative term which renders the claim indefinite. The term “s-like” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The letter “S” can have many different shapes depending on the font and if it is script or not and therefore, it is unclear how “s-like” is defined in this case. For the purposes of examination, “S-like” will be interpreted as a shape with two bends where the distal tip and proximal end are in generally the same axial direction.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 8-10, & 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Mueller (US 5725521 A, published March 10, 1998) in view of Mintz (US 20220061870 A1, published March 3, 2022), and in even further view of Mueller (CA 2200917 A1, published Sept. 29, 1997, hereinafter referred to as “Mueller ‘917”).
Regarding claim 1, Mueller teaches a laser debulking device (Fig. 9 and Col. 8 ln. 41-43 “a multi-laser delivery means surgical or catheter device of the present invention”) for removing a selected material from vasculature of a subject (Col. 1 ln. 25-29 “These methods and apparatuses can be adapted for use in surgical applications throughout the human body or in animals for transmitting laser energy precisely, at predetermined positions and to predetermined depths” therefore, this device can also be used to transmit laser energy to selected material), the laser debulking device, comprising: a catheter (Col. 5 ln. 55-58 “In a preferred embodiment, the surgical device is adapted for use as a catheter device, the catheter device useful for use in vascular channels and organ chambers”) including: a proximal end region (Col. 5 ln. 45 “having a proximal end and a distal end”); and a distal end region opposite the proximal end region (Fig. 9 element 234 “distal end” and Col. 11 ln. 63); a plurality of fingers integrally formed with or attached to the distal end region (Fig. 9 and Col. 12 ln. 1 “a plurality of laser delivery means 238” attached to distal end region 234), and a plurality of laser emitters (Fig. 9 and Col. 12 ln. 3 “distal firing tips 240”), at least some of the plurality of fingers including at least one of the plurality of laser emitters (Fig. 9 and Col. 12 ln. 3-4 “distal firing tips 240 of the plurality of laser delivery means”).
Mueller does not disclose a sheath defining an interior passageway; the catheter being at least partially positioned within the interior passageway; the plurality of fingers configured to switch between a deployment state when the plurality of fingers are within the interior passageway and an expanded state when the plurality of fingers are at least partially outside of the interior passageway, wherein a maximum lateral dimension of the plurality of fingers is greater when in the expanded state than the deployment state; wherein, when in the expanded state, each of the plurality of fingers including at least one of the plurality of laser emitters includes one or more bends
Mintz’s invention relates to medical catheters, specifically catheters that include an expandable member configured to expand radially outward from a contracted configuration to an expanded configuration within a vessel of a patient, e.g., to engage a thrombus (¶[0003]). In Fig. 2B expandable member 18 may help improve aspiration of the clot into the catheter 10 by providing a relatively large diameter (or other cross-sectional dimension) (lateral dimension) and interior space for the clot to engage with the elongated body compared to examples in which an otherwise similar catheter does not include an expandable member (¶[0062]). Further, expandable member 18 may enable catheter 10 to maintain a lower profile during navigation to a target site within vasculature of a patient without compromising the size of the inner diameter (¶[0074]). Also, expandable member 18 may be configured to self-expand. For example, expandable member 18 may be formed from a shape memory material such as Nitinol. In some such examples, catheter 10 may include a retractable sheath over expandable member 18 (sheath defining an interior passageway) that helps retain expandable member 18 in a collapsed configuration, e.g., during navigation of elongated body 12 to a target treatment site within the vasculature of a patient (deployment state when the plurality of fingers are within the interior passageway). Once at the target treatment site, the retractable sheath may be withdrawn proximally over elongated body 12 to allow expandable member 18 to self-expand (¶[0102]) (expanded state when the plurality of fingers are at least partially outside of the interior passageway). An example of the expandable bending member includes a plurality of flexible prongs 34 that extend axially in a distal direction (¶[0104]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the laser fingers to switch between a deployment state and an expanded state with a larger lateral dimension and to have a sheath with an interior passageway for helping with the deployment in the device of Mueller as taught by Mintz in order to maintain a low profile while travelling to the target area, better engage the selected material once arriving at the target area, and remove the material more efficiently.
Mueller and Mintz do not disclose wherein, when in the expanded state, each of the plurality of fingers including at least one of the plurality of laser emitters includes one or more bends at or near the distal end region that at least initially bends away from a central longitudinal axis of the catheter, the one or more bends configured to cause the plurality of laser emitters to emit laser pulses axially at a location radially outwardly from the sheath.
Mueller ‘917’s invention relates to the surgical procedure known as laser-assisted transmyocardial revascularization (TMR), and more particularly, to improved methods and apparatuses for precisely positioning a fiber-optic or other waveguide adjacent the area or areas to be lased (pg. 1). FIG. 9 is a schematic view of a preferred embodiment of a suction cup-type fluoroscope locator and guide tether of the present invention. This device serves multiple uses, including use as a fluoroscopic marker or locator as well as a guide tether for a monorail-type mounted catheter device which can be positioned precisely thereby. This is important because spatial references are easily lost when working through long ports, 10 using cameras and tools with bends. FIG. 10 is a schematic view of a preferred embodiment of the device and method of performing TMR or other procedure. The system includes a suction cup-type fluoroscope locator and guide-tubing tether 282 anchored to tissue 282 adjacent the area being viewed or lased (pg. 20). See annotated Fig. 10 below depicting multiple bends that at least initially bend away from the central longitudinal axis and direct the laser axially at a location radially outwardly from the sheath. The methods and apparatuses can be adapted for use in surgical applications throughout the human body or in animals for transmitting laser energy precisely, at predetermined positions and to predetermined depths (pg. 1). The distal end of the elongated flexible laser delivery means comprises a known visualization system with an adjust visualization device (pg. 8). The fluoroscope locator and guide tether device for use as a fluoroscopic marker or locator as well as a guide tether for a monorail or other mounted-type fluoroscopic marking tools and materials, laser delivery means, visualization mean and other surgical equipment can be positioned precisely with the target tissue and conveying the laser delivery means along its length (pg. 10).
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Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have at least one bend and emit lasers axially at a location radially outwardly from the sheath as taught by Mueller ‘917 in the device of Mueller and Mintz because tubing is has multiple bends in order to improve locating and precisely position the lasers in the target area.
Regarding claim 2, Mueller teaches wherein at least a portion of the plurality of fingers extend in a generally distal direction when in the deployment state (see annotated Fig. 9 and Col. 12 ln. 1-3 “a plurality of laser delivery means 238 are shown extending a predetermined length E… laser energy can be simultaneously transmitted from the distal firing tips 240”), the distal direction extending along the central longitudinal axis of the catheter from the proximal end region to the distal end region (Col. 5 ln. 42-46 “the device comprising an outer lumen, the outer lumen having a proximal end and a distal end, the outer lumen defining the central axis of the surgical device”).
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Regarding claim 3, Mueller teaches wherein the plurality of laser emitters are configured to emit the laser pulses generally in a distal direction (see annotated Fig. 9 and Col. 12 ln. 1-3 “a plurality of laser delivery means 238 are shown extending a predetermined length E… laser energy can be simultaneously transmitted from the distal firing tips 240”), the distal direction extending along the central longitudinal axis of the catheter from the proximal end region to the distal end region (Col. 5 ln. 42-46 “the device comprising an outer lumen, the outer lumen having a proximal end and a distal end, the outer lumen defining the central axis of the surgical device”).
Regarding claim 8, Mueller does not teach wherein the distal end region of the catheter defines one or more aspiration channels configured to provide aspiration at or near the distal end region of the catheter.
Mintz discloses that to treat a patient with thrombosis, a clinician may position mouth 13 of catheter 10 in Fig. 2B in a blood vessel of the patient near the thrombus or other occlusion, and apply a suction force (also referred to herein as suction, vacuum force, or negative pressure) to the catheter 10 (e.g., to one or more lumens of the catheter (aspiration channels)) to engage the thrombus with suction force at mouth 13 of the catheter.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have one or more aspiration channels to provide aspiration at or near the distal region of the catheter in the device of Mueller as taught by Mintz in order to engage and remove the selected material in the vasculature.
Regarding claim 9, Mueller does not teach wherein the one or more aspiration channels includes a plurality of aspiration channels, each of the plurality of aspiration channels positioned between adjacent fingers of the plurality of fingers.
Mintz teaches a plurality of aspiration channels as taught in claim 8. The positioning of the aspiration channels is a design choice and therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to position the aspiration channels between adjacent fingers in the device of Mueller in view of Mintz in order to engage and remove the selected material in the vasculature.
Regarding claim 10, Mueller teaches the device wherein the plurality of laser emitters are connected to or are formed by a plurality of fiber optic cables (Col. 12 ln. 5-6 “any number of laser delivery means, such as optical fibers, can be used” and Col. 11 ln. 17-19 “laser delivery means 154” in Fig. 7).
Regarding claim 14, Mintz discloses the sheath is configured to slide along the catheter (.expandable member 18 may be configured to self-expand. For example, expandable member 18 may be formed from a shape memory material such as Nitinol. In some such examples, catheter 10 may include a retractable sheath over expandable member 18 that helps retain expandable member 18 in a collapsed configuration, e.g., during navigation of elongated body 12 to a target treatment site within the vasculature of a patient. Once at the target treatment site, the retractable sheath may be withdrawn proximally over elongated body 12 to allow expandable member 18 to self-expand” ¶[0102]).
Regarding claim 15, Mueller, Mintz, and Mueller ‘917 teach the laser thrombus-debulking device of claim 1. Mueller also teaches a laser source (“any suitable laser source, pulsed or otherwise, could provide laser energy to the laser delivery means” Col. 12 ln. 45-47); and a plurality of optical fiber cables configured to receive laser pulses generated by the laser source (Col. 12 ln. 5-6 “any number of laser delivery means, such as optical fibers, can be used” and Col. 11 ln. 17-19 “laser delivery means 154” in Fig. 7), the plurality of optical fiber cables coupled to the plurality of laser emitters (Fig. 9 “laser energy can be simultaneously transmitted from the distal firing tips 240 of the plurality of laser delivery means” Col. 12 ln. 2-4).
Regarding claim 21, Mueller in view of Mintz does not disclose wherein, when in the expanded state, the plurality of fingers includes a first bend and a second bend.
Mueller ‘917’s invention relates to the surgical procedure known as laser-assisted transmyocardial revascularization (TMR), and more particularly, to improved methods and apparatuses for precisely positioning a fiber-optic or other waveguide adjacent the area or areas to be lased (pg. 1). FIG. 9 is a schematic view of a preferred embodiment of a suction cup-type fluoroscope locator and guide tether of the present invention. This device serves multiple uses, including use as a fluoroscopic marker or locator as well as a guide tether for a monorail-type mounted catheter device which can be positioned precisely thereby. This is important because spatial references are easily lost when working through long ports, 10 using cameras and tools with bends. FIG. 10 annotated above is a schematic view of a preferred embodiment of the device and method of performing TMR or other procedure. The system includes a suction cup-type fluoroscope locator and guide-tubing tether 282 anchored to tissue 282 adjacent the area being viewed or lased (pg. 20). See annotated Fig. 10 below depicting the first and second bend.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the device of Mueller and Mintz with a first bend and a second bend as taught by Mueller ‘917 in order to improve locating and precisely position the lasers in the target area.
Regarding claim 22, Mueller ‘917 teaches wherein the first bend and the second bend cause each of the plurality of fingers to exhibit an S-like shape (as shown in the annotated figure 10 above, the two bends form the shape of an “S”).
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make each of the fingers exhibit this S-like shape, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. Each of the fingers would benefit from the teachings of Mueller ‘917 of being able to improve locating and positioning of the lasers in the target area.
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Mueller in view of Mintz, and in even further view of Mueller ‘917 (hereinafter referred to as “modified Mueller”), as applied to claim 1 above, and in even further view of Look et al. (US 20170100142 A1, published April 13, 2017, hereinafter referred to as “Look”).
Regarding claims 4, 5 and 6, modified Mueller teaches the laser debulking device of claim 1. Mueller also teaches the proximal direction extending along the central longitudinal axis of the catheter from the distal end region to the proximal end region (See annotated Fig. 9 above and Col. 5 ln. 42-46 “the device comprising an outer lumen, the outer lumen having a proximal end and a distal end, the outer lumen defining the central axis of the surgical device”).
Modified Mueller does not teach wherein at least a portion of the plurality of fingers extend generally in a proximal direction when in the deployment state, wherein the plurality of laser emitters are configured to emit laser pulses generally in a proximal direction, and wherein the first bend is a generally 180° bend.
Look’s aspiration catheter has a proximal end adjacent the proximal end of the aspiration catheter and a distal end adjacent the distal end of the tubular aspiration member, the distal end of the high pressure injection lumen including a curved portion configured to change a direction of fluid flow through the high pressure injection lumen by at least about 90° (¶[0005]). In Fig. 73, the saline ejected from the orifice 390B may macerate the thrombus against the inner wall 391 of the distal tube 314, thus maintaining continued aspiration. Fig. 71 shows that the full distal curve may be approximately 180° and an angle anywhere between 90° and 180°, even including 90° or 180°, may be chosen (¶[0141]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to extend the fingers in the proximal direction with a 180° bend and emit laser pulses in this direction when deployed in the device of modified Mueller in order to alter the direction of the treatment of the selected material within the vessel.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over modified Mueller as applied to claim 1 above, and further in view of Fox et al. (US 4784132 A, published November 15, 1988, hereinafter referred to as “Fox”).
Regarding claim 7, modified Mueller teaches the device of claim 1. Mueller also teaches wherein the plurality of laser emitters are configured to emit laser pulses therefrom in an emittance direction when the plurality of fingers is in the expanded state (Fig. 9 “laser energy can be simultaneously transmitted from the distal firing tips 240 of the plurality of laser delivery means” Col. 12 ln. 2-4 and therefore the direction of the laser is in the direction of the distal tips).
Modified Mueller does not disclose the emittance direction extending at an angle of less than 0° to about -5° relative to the central longitudinal axis of the catheter.
Fox’s invention relates to a method of and apparatus for the laser treatment of occluded body lumens of mammals, especially humans, and more particularly to the intraluminal use of laser energy to perforate and/or remove luminal occlusions, such as thrombi and/or atherosclerotic placques in the cardiovascular system (Col. 1 ln. 18-24). Fig. 4 shows the distal end of the catheter 10 in a lumen L adjacent a partial occlusion X. Beam B has a total divergence angle 50 of 5° (emittance direction of -5° relative to a central longitudinal axis of the catheter) however, because the beam has been prismatically canted by the lens system 46, 48 shown in FIG. 2, the diverging beam does not impinge on the wall of the lumen L, but rather is directed toward the central portion of the lumen L. Likewise, the lowermost pair of diverging dotted lines in FIG. 4 represents a laser energy beam B' from laser fiber 18a when said fiber is positioned exactly 180° from the position at which beam B was generated. Beam B' also has a total divergence angle 52 of 5° as shown in FIG. 4 (Col. 8 ln. 43-59).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to emit laser pulses at a -5° angle relative to the centerline axis as taught by Fox in the device of modified Mueller in order to avoid impinging on the lumen wall of the target area.
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over modified Mueller, as applied to claim 1 above, and further in view of Fornell (Fornell, D. “An Introduction to Embolic Protection Devices”. September 3, 2008. DAIC. https://www.dicardiology.com/article/introduction-embolic-protection-devices).
Regarding claims 11-13, modified Mueller teaches the device of claim 1.
Modified Mueller fails to disclose the device further comprising a capture bag configured to receive and hold removed material.
Fornell teaches that the use of embolic protection devices (EPD) during percutaneous cardiac procedures has helped reduce the number of complications due to debris being released into the bloodstream and causing blockages in smaller vessels. The devices are designed to capture and remove debris that may be dislodged during procedures. One device is a “distal filter” (capture bag) which the physician guides into position past the area of blockage to be treated (the capture bag is positioned distally relative to the plurality of fingers). Once in place, the constraint is released and the filter pops open into position. If plaque or blood clots are dislodged during the procedure, the filter will catch them to prevent the emboli from traveling downstream, reducing the chance of an event such as a heart attack. At the end of the procedure the filter containing debris is captured in a retrieval sheath and removed from the patient’s body.
Therefore, it would have been obvious to a person having ordinary skill in the art (PHOSITA) before the effective filing date of the claimed invention to add a capture bag positioned distally relative to the plurality of fingers as taught by Fornell in the device of modified Mueller in order to prevent the selected material from travelling downstream and to reduce the chance of a heart attack.
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Mintz in view of Mueller and Mueller ‘917.
Regarding claim 16 and 17, a method (“Fig. 15 is a flow diagram of an example method of aspiration using catheter 10 [Fig. 2A/2B]” ¶[0199]) of using a debulking device (Fig.’s 2A and 2B conceptual side view and cross-sectional view of the aspiration catheter in ¶[0009]- ¶[0010]), the method comprising: positioning a distal end region of a catheter adjacent to or through a selected material in a vasculature of a subject to be debulked (“a clinician introduces catheter 10 [Fig.’s 2A-2B] into vasculature of a patient (Fig. 15 element 150) and navigates catheter 10 to a target treatment site within a patient” ¶[0199]), the selected material to be debulked located within a vascular structure (“within the vasculature” ¶[0200]) wherein the laser debulking device includes a sheath defining an interior passageway and the catheter is at least partially positioned within the interior passageway (“catheter 10 may include a retractable sheath over expandable member 18 ” ¶[0102]); and switching a plurality of fingers from a deployment state where the plurality of fingers are within the interior passageway to an expanded state where the plurality of fingers are at least partially outside the interior passageway (Fig. 15 element 152 and “Once adjacent a target treatment site, expandable member 18 may be deployed from a collapsed configuration to an expanded configuration” ¶[0200]; “catheter 10 may include a retractable sheath over expandable member 18 that helps retain expandable member 18 in a collapsed configuration, e.g., during navigation of elongated body 12 to a target treatment site within the vasculature of a patient. Once at the target treatment site, the retractable sheath may be withdrawn proximally over elongated body 12 to allow expandable member 18 to self-expand” ¶[0102]), the plurality of fingers attached to or forming the distal end region (“In Fig.’s 2A-6B, one example of expandable member 18 includes a tubular body 33 and a plurality of flexible prongs 34 extending axially from tubular body 33 in a distal direction” ¶[0104]) and rotating the plurality of fingers (Fig. 2A “In some cases, a clinician may steer catheter 10 through the vasculature of a patient by pushing or rotating handle 14 and/or proximal portion 16A of catheter 10 to navigate distal portion 16B of elongated body 12 through the vasculature of a patient. The clinician may apply torque to handle 14 and/or proximal portion 16A of the catheter 10 (or at least a portion of elongated body 12 that is more proximal than distal portion 16B implanted in the patient) in order to rotate distal portion 16B of catheter 10.” ¶[0070])
Mintz does not disclose a laser debulking device, the plurality of fingers in the expanded state, emitting a plurality of laser pulses from a plurality of laser emitters towards the selected material to be debulked, at least some of the plurality of fingers including at least one of the plurality of laser emitters; wherein, when in the expanded state, each of the plurality of fingers including at least one of the plurality of laser emitters includes one or more bends at or near the distal end region that at least initially bends away from a central longitudinal axis of the catheter, the one or more bends configured to cause the plurality of laser emitters to emit laser pulses axially at a location radially outwardly from the sheath.
Mueller’s invention relates to improved methods and apparatuses for precisely positioning a fiber-optic or other waveguide adjacent the area or areas to be lased and can be adapted for use in surgical applications throughout the human body or in animals for transmitting laser energy precisely, at predetermined positions and to predetermined depths (Col. 1 ln. 18-19 and 26-29). Fig. 9 shows the multi-laser delivery means surgical or catheter device with a plurality of laser delivery means 238. With this device, laser energy can be simultaneously transmitted from the distal firing tips 240 of the plurality of laser delivery means (Col. 8 ln. 41-43 and Col. 12 ln. 1-3). The device includes method steps of maintaining the spatial relationship between the surgical or catheter device and the tissue to be lased and delivering laser energy to the subject tissue such that TMR channels are created in the tissue to be lased (Col. 6 ln. 56-59).
Therefore, it would have been obvious to a person having ordinary skill in the art (PHOSITA) before the effective filing date of the claimed invention to add lasers emitters and emit lasers after expansion from the fingers of the device of Mintz in view of Mueller in order to treat a selected material with transmitting laser energy that allows precise positioning of laser emission at desired treatment location.
Mintz and Mueller do not disclose wherein, when in the expanded state, each of the plurality of fingers including at least one of the plurality of laser emitters includes one or more bends at or near the distal end region that at least initially bends away from a central longitudinal axis of the catheter, the one or more bends configured to cause the plurality of laser emitters to emit laser pulses axially at a location radially outwardly from the sheath.
Mueller ‘917’s invention relates to the surgical procedure known as laser-assisted transmyocardial revascularization (TMR), and more particularly, to improved methods and apparatuses for precisely positioning a fiber-optic or other waveguide adjacent the area or areas to be lased (pg. 1). FIG. 9 is a schematic view of a preferred embodiment of a suction cup-type fluoroscope locator and guide tether of the present invention. This device serves multiple uses, including use as a fluoroscopic marker or locator as well as a guide tether for a monorail-type mounted catheter device which can be positioned precisely thereby. This is important because spatial references are easily lost when working through long ports, 10 using cameras and tools with bends. FIG. 10 is a schematic view of a preferred embodiment of the device and method of performing TMR or other procedure. The system includes a suction cup-type fluoroscope locator and guide-tubing tether 282 anchored to tissue 282 adjacent the area being viewed or lased (pg. 20). See annotated Fig. 10 below depicting multiple bends that at least initially bend away from the central longitudinal axis and direct the laser axially at a location radially outwardly from the sheath. The methods and apparatuses can be adapted for use in surgical applications throughout the human body or in animals for transmitting laser energy precisely, at predetermined positions and to predetermined depths (pg. 1). The distal end of the elongated flexible laser delivery means comprises a known visualization system with an adjust visualization device (pg. 8). The fluoroscope locator and guide tether device for use as a fluoroscopic marker or locator as well as a guide tether for a monorail or other mounted-type fluoroscopic marking tools and materials, laser delivery means, visualization mean and other surgical equipment can be positioned precisely with the target tissue and conveying the laser delivery means along its length (pg. 10).
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Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have at least one bend and emit lasers axially at a location radially outwardly from the sheath as taught by Mueller ‘917 in the device of Mintz and Mueller because the tubing has multiple bends in order to improve locating and precisely position the lasers in the target area.
Regarding claim 18, Mintz teaches wherein the material to be debulked includes a thrombus (“to aspirate the thrombus from the vasculature via the lumens 22,25 (Fig. 2A) (Fig. 15 element 154)” ¶[0202]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Mintz in view of Mueller and Mueller ‘917, as applied to claim 16 above, and further in view of Look.
Regarding claim 20, Mintz and Mueller and Mueller ‘917 do not disclose wherein the material to be debulked includes tissue within or adjacent to an inferior vena cava filter.
Mueller ‘917 teaches that the device can be used in any location of interest (“The methods and apparatuses can be adapted for use in surgical applications throughout the human body or in animals for transmitting laser energy precisely, at predetermined positions and to predetermined depths” (pg. 1)). Look’s invention relates to the common goal of removing undesired matter such as a thrombus from a fluid carrying cavity, duct, or lumen of the body, such as a blood vessel (¶[0002]). Fig.’s 1 & 2 depict the device in use within a blood vessel. This blood vessel (element 102) may also comprise the inferior vena cava (¶[0094]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use the device of Mintz in view of Mueller and Mueller ‘917 in order to treat tissue within an inferior vena cava as taught by Look in order to remove undesired material from the target region.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Mintz in view of Mueller and Mueller ‘917, as applied to claim 16 above, in further view of Black (Sullivan, G. et al. “Venous Stent Maintenance: Improving Patency in Postthrombotic Patients”. Endovascular Today. Vol. 23, No. 7. p.55-62. July 2024).
Regarding claim 19, Mintz in view of Mueller and Mueller ‘917 teaches the method of claim 16.
Mintz further teaches wherein the material to be debulked includes an occlusion (the catheter can be used in various medical procedures including occlusion of a blood vessel (arterial or venous) in ¶[0065]). The device of Mintz is configured to be expanded and contracted in a controlled manner, e.g., in response to user actuation or automatically under the control of control circuitry of a device, rather than self-expanding with little to no user intervention (¶[0004]).
Mintz and Mueller and Mueller ‘917 do not teach the occlusion being in an occluded venous stent.
Black teaches what to do when coming across an occluded venous stent: “once across, you need to debulk.” Black teaches that this is where things fall short as there are no venous debulking tools on the market (page 60).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use the device of Mintz in view of Mueller and Mueller ‘917 to treat an occlusion in an occluded venous stent as taught by Black in order to treat venous occlusions using a catheter device that allows self-expansion with little or no user intervention.
Conclusion
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/E.N.C./Patent Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
