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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/18/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 8 pertaining to the amended limitations of “wherein the first section comprises a higher mesh wire density tan the second section, and the inversion point represents a transition between the higher mesh wire density of the first section and a lower mesh wire density of the second section” and “in the expanded configuration, the mesh structure is configured such that application of a longitudinal force thereto causes the first and second sections to compress until the higher mesh wire density first section resists further compression, causing the lower mesh wire density section section to invert at the inversion point and collapse into the first section, thereby forming a semi-spherical shape defining the deployed configuration”, pertaining to the additional amended limitations of the density differences between the first and second sections, have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, none of either Kusleika or Walters are relied upon to disclose these amended limitations.
Applicant's arguments filed 10/28/2025 pertaining to the rejection of claim 15 over Kusleika in view of Walters, further in view of Eaton, have been fully considered but they are not persuasive.
Regarding claim 15, Applicant contends that none of either Kuskeika, Walters or Eaton expressly disclose or adequately suggest the limitations of “advancing the retriever in the collapsed state, via the catheter past the UIM without causing substantial fragmentation of the UIM” (newly amended limitations). The examiner respectfully disagrees. In the combination of Kusleika and Eaton, Eaton provides a method of advancing an meshed filter (analogous to the structure and function of Kusleika) used in an occlusion treatment procedure (see Para. [0043]-[0044]) to capture debris and dislodged material from the occlusion-treatment procedure (see Eaton Para. [0043]-[0044] and Kusleika Para. [0004]-[0005], [0012], and [0026] mentioning wherein this is a common purpose of filter devices, such as the disclosed invention). Since Kusleika does not disclose an express method of introducing the filter relative to a target occlusion, merely that the filter is advanced within a target vessel/site, one of ordinary skill in the art would have looked to analogous prior art to incorporate a known method of introducing of meshed capture filter devices into a target site relative to an occlusion. Since Eaton clearly shows their respective filter to be inserted into a vessel and distally of the occlusion (see Fig. 3 and Para. [0043]-[0044]) in a collapsed form without contacting the sidewalls of the vessel or occlusion until after expansion (see Fig. 3 and Para. [0043]-[0044]), Eaton is understood to read on the limitation of “advancing the retriever, in the collapsed state, past the UIM without substantial fragmentation of the UIM” as incorporated into the device of Kusleika. Without an express recitation or drawing showing that the mesh filter causes fragmentation of an occlusion during insertion to a target site in a collapsed configuration, this limitation is understood to be met be Eaton, as incorporated into the device of Kusleika.
Applicant addition contends that it would not have been obvious to one of ordinary skill in the art to have modified the method of use of the filter of Kusleika with the teachings of Eaton on the grounds that that Eaton teaches an embolic protection device which is a protection filter to catch emboli released during stenosis treatment and is therefore different from the claimed invention which is designed to remove the stenosis itself. The examiner notes that, while the express function of the device of Eaton may differ from the specifics of the claimed invention, the device of Eaton merely needs to be analogous to the device of Kusleika, not the claimed invention. To that end, both the devices of Kusleika and Eaton are in the field of endeavor of mesh filter devices configured to trap debris from an occlusion treatment procedure within the vasculature (see Eaton Para. [0043]-[0044] and Kusleika Para. [0004]-[0005], [0012], and [0026] mentioning wherein this is a common purpose of filter devices, such as the disclosed invention). While Kusleika discloses the specifics of removing an occlusion, both Eaton and Kusleika are analogous since both devices, at their core concept, utilize filter devices in the capture of occlusion debris and thus Eaton is understood to be analogous to and combinable with Kusleika to provide a known method of introducing a filter assembly to a target site relative to an occlusion, which is expressly lacking from the disclose of Kusleika.
Applicant further contends that Kusleika does not expressly disclose the limitations of “applying, via the outer sheath, a longitudinal force to the retriever, thereby causing the second section to invert at the inversion point and collapse into the first section and forming a semi-spherical shape defining the deployed configuration” on the grounds that Kusleika does not provide a teaching that a longitudinal force is applied to the retriever via the outer sheath. The examiner respectfully disagrees in light of the currently-recited limitations. As recited in Para. [0049]-[0051], Kusleika discloses wherein during deployment of the filter assembly from the outer catheter (see Figs. 9-10), the mandrel and filter assembly receive a longitudinal force via stop (40) which causes the filter to contact with and receive friction from the sidewalls of the catheter body while being advanced distally. This motion acts as a “longitudinal force” applied to the filter in the form of friction. As the filter exits the distal end of the catheter, the longitudinal force applied by the stop inverts the filter assembly as the filter exits the catheter. Therefore, since the catheter applies a constant longitudinal friction force during attempted inversion of the filter via the stop (40), the frictional force of the catheter plays an indirect role in causing inversion of the filter assembly in an indirect manner.
Lastly, Applicant contends that Kusleika, when modified by Eaton, does not disclose the limitations of “distally translating the retriever in the deployed configuration to cause the retriever to collect the UIM and draw the UIM towards a suction source of the aspiration system. The examiner respectfully disagrees. Eaton merely is provided to teach a method of introducing the filter assembly of Kusleika to a target vessel distally of an occlusion. Kusleika discloses the method of collecting any UIM in Para. [0049]-[0051] and [0069]-[0072] which mention wherein the filter is advanced distally out from the distal opening of the catheter “C” into the vessel (distally of an occlusion, as modified by Eaton) to collect any UIM or particulate (see Para. [0055]-[0056]) before the catheter “C” is advanced over the filter to aspirate any remaining particulate. Specifically, the filter exits the catheter to collect and debris from the UIM and is then withdrawn back into the catheter (with the collected debris) before aspiration of any remaining UIM debris through the catheter.
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.
Claim(s) 1 and 3-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kusleika (US 2008/0033482 A1)(previously of record) in view of Tran (US 2019/0365395 A1).
Regarding claim 1, Kusleika discloses:
A retriever (see Fig. 1) for use with an aspiration system for removal of undesirable intravascular material (UIM) (see Para. [0055]-[0056]), the aspiration system comprising:
a catheter (see Para. [0055]-[0056] and Fig. 9);
the retriever comprising:
a plurality of struts that are interconnected to define a mesh structure (see Fig. 1 showing wherein the filter (50) is formed from a plurality of interconnected struts), the mesh structure comprising a first section (see Examiner’s Diagram of Fig. 1 below illustrating a “first section” of the filter body) and a second section (see Examiner’s Diagram of Fig. 1 below illustrating a “second section” of the filter body) connected at an inversion point (see Examiner’s Diagrams of Figs. 1 and 7 below illustrating wherein the designated “first section” and “second section” are connected at an inversion point wherein the second section inverts and folds into the first section when transitioned from a collapsed to an expanded configuration, see Para. [0020] and [0053]-[0054]); wherein:
the mesh structure is configured to transition between a collapsed configuration (see Figs. 4-5 and Para. [0012] and [0017]), an expanded configuration (see Fig. 3 and Para. [0012], [0033] and [0040]), and a deployed configuration (see Fig. 7 and Para. [0012] and [0053]-[0054]), in the collapsed configuration, the mesh structure comprises an outer diameter less than or equal to an internal diameter of a lumen of the catheter such that the mesh structure is configured to be movable through the lumen (see Figs. 9-10 and Para. [0056]);
the mesh structure is configured to transition from the collapsed configuration to the expanded configuration in response to exiting the catheter (filter would transition from a collapsed configuration to an expanded configuration when removed from the catheter due to radial constraints being removed therefrom, see Figs. 9-10);
in the expanded configuration, the outer diameter of the mesh structure is greater than the outer diameter in the collapsed configuration (see Para. [0012]).
However, while Kusleika discloses wherein in the expanded configuration, the mesh structure is configured such that application of a longitudinal force thereto causes the second section to invert at the inversion point and collapse into the first section (see Figs. 7-8 and Para. [0020] and [0053]-[0054]), thereby forming a semi-spherical shape defining the deployed configuration (see Fig. 7), and the semi-spherical shape is configured to receive and hold the UIM (see Para. [0003]-[0005] mentioning this as a commonly-utilized function of filters), Kusleika does not expressly disclose:
wherein the first section comprises a higher mesh wire density than the second section, and the inversion point represents a transition between the higher mesh wire density of the first section and a lower mesh wire density of the second section; and
wherein in the expanded section, upon application of a longitudinal force to the mesh structure, the first and second sections compress until the higher mesh density first section resists further compressing, causing the lower mesh wire density second section to invert at the inversion point and collapse into the first section.
In the same field of endeavor, namely inverting expansion mesh devices, Tran teaches:
A retriever (see Figs. 1A-1B) comprising:
A plurality of struts interconnected to define a mesh structure (expandable basket 102, see Fig. 1B and Para. [0052] and [0057] mentioning wherein the expandable basket is formed from a wire mesh network), the mesh structure defining a first section (distal portion 116, see Fig. 1I) and a second section (proximal portion 114, see Fig. 1I) connected at an inversion point (point between the proximal portion 114 and distal portion 116, see Figs. 1I-1K and Para. [0060]); wherein:
The mesh is configured to transition between a non-activation configuration (shown in Fig. 1I) and an activated, inverted configuration (shown in Figs. 1J-1K and Para. [0060]) via inversion of the second section at the inversion point to collapse and invert into the first section (see Figs. 1I-1K and Para. [0060]);
wherein the first section comprises a higher mesh wire density than the second section (see Para. [0052] and [0062]), and the inversion point represents a transition between the higher mesh wire density of the first section and a lower mesh wire density of the second section (see Para. [0052] and [0062] mentioning wherein the proximal portion 114 may comprise a smaller mesh fiber density than the distal portion 116 to allow for the distal portion 116 to remain stiffer while the proximal portion is more flexible to allow easier inversion at the inversion point between the two portions); and
wherein in the non-activated configuration, upon application of a longitudinal force to the mesh structure, the first and second sections compress (see Para. [0006], [0052], [0057] and [0062] mentioning wherein the proximal end of the expandable basket is axially moveable to apply a compressive force to the proximal portion 114 to cause inversion thereof) until the higher mesh density first section resists further compressing (see Para. [0006], [0052], [0057] and [0062]), causing the lower mesh wire density second section to invert at the inversion point and collapse into the first section (see Para. [0006], [0052], [0057] and [0062]).
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 mesh filter of Kusleika to have the first portion of the mesh filter structure comprise higher density mesh wires forming said first portion while having lower density mesh wires forming the second portion as taught and suggested by Tran to, in this case, allow for an easier, more controlled and predictable inversion of the less dense second portion into the stiffer, more dense first portion at the inversion point (see Tran Para. [0052] and [0062]). The resulting assembly would allow the higher density first portion to better resist the inverting longitudinal compressive force applied to the filter assembly while allowing the lower density second portion to more easily invert at the inversion point as shown and mentioned by Tran in see. [0006], [0052], [0057] and [0062] and Figs. 1I-1K.
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Examiner’s Diagram of Kusleika Fig. 1
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Examiner’s Diagram of Kusleika Fig. 7
Regarding claim 3, the combination of Kusleika and Tran discloses the invention of claim 1, Kusleika further discloses wherein the outer diameter corresponds to a diameter of an anatomical structure from which the UIM is being removed (see Para. [0034] and Fig. 3).
Regarding claim 4, the combination of Kusleika and Tran discloses the invention of claim 1, Kusleika further discloses one or more reinforcement struts disposed within the first section, the one or more reinforcement configured to radially support the first section (see Figs. 1-3 showing wherein the entirety of the filter is comprised of a plurality of reinforcement struts as part of the mesh structure which aid in radially supporting the filter structure).
Regarding claim 5, the combination of Kusleika and Tran discloses the invention of claim 1, Kusleika further discloses wherein the plurality of struts comprise a shape-memory material (see Para. [0032]-[0033] wherein the filter is formed from nitinol).
Regarding claim 6, the combination of Kusleika and Tran discloses the invention of claim 5, Kusleika further discloses wherein the shape-memory material comprises nitinol (see Para. [0032]-[0033]).
Regarding claim 7, the combination of Kusleika and Tran discloses the invention of claim 5, Kusleika further discloses wherein the shape of the deployed configuration has been heat set (see Para. [0033] mentioning wherein the shape of the filter is formed by heat setting the nitinol used to form the filter).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kusleika (US 2008/0033482 A1)(previously of record) in view of Tran (US 2019/0365395 A1), further in view of Bonnette (US 2016/0220346 A1)(previously of record).
Regarding claim 2, the combination of Kusleika and Tran discloses all of the limitations of the invention of claim 1.
However, Kusleika does not expressly disclose wherein the outer diameter is from about 8 mm to about 20 mm.
In the field of endeavor of vascular expandable filter devices, Bonnette discloses wherein it is known in the art for expandable filters to comprise a diameter of between 2mm – 48mm (see Para. [0029]).
Since Kusleika is silent regarding any express dimensions for the disclosed filter device, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the filters of Kusleika to comprise diameters of between 8mm and 20mm as applicant appears to have placed no criticality on the claimed range (see Spec. Pg. 33 reciting wherein the “outer diameter of the body section ‘can’ range from about 8mm to about 20mm” while providing an express recitation of alternative dimensions on Pg. 34 which may be substituted based on the type of procedure being performed) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim(s) 8 and 10-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kusleika (US 2008/0033482 A1)(previously of record) in view of Walters (US 2014/0277114 A1)(previously of record), further in view of Tran (US 2019/0365395 A1).
Regarding claim 8, Kusleika discloses:
A retriever assembly system (see Fig. 1) for use with an aspiration system for removal of undesirable intravascular material (UIM) (see Para. [0055]-[0056]), the retriever assembly comprising:
a delivery device (mandrel 20, see Fig. 1) comprising:
an elongate tubular body (mandrel 20, see Fig. 1) and an outer sheath (Catheter “C” in Figs. 9-10, see also Para. [0049]-[0051] and [0069]-[0072]) configured to be moved longitudinally with respect to the elongate tubular body (see Figs. 9-10 and Para. [0049]-[0051] and [0069]-[0072]); and
a retriever (filter 50, see Fig. 1) comprising:
a plurality of struts that are interconnected to define a mesh structure (see Fig. 1 showing wherein the filter (50) is formed from a plurality of interconnected struts), the mesh structure comprising a first section (see Examiner’s Diagram of Fig. 1 below illustrating a “first section” of the filter body) and a second section (e Examiner’s Diagram of Fig. 1 below illustrating a “second section” of the filter body) connected at an inversion point (see Examiner’s Diagrams of Figs. 1 and 7 below illustrating wherein the designated “first section” and “second section” are connected at an inversion point wherein the second section inverts and folds into the first section when transitioned from a collapsed to an expanded configuration, see Para. [0020] and [0053]-[0054]); wherein:
the mesh structure is configured to transition between a collapsed configuration (see Figs. 4-5 and Para. [0012] and [0017]), an expanded configuration (see Fig. 3 and Para. [0012], [0033] and [0040]), and a deployed configuration (see Fig. 7 and Para. [0012] and [0053]-[0054]), in the collapsed configuration, the mesh structure comprises an outer diameter less than or equal to an internal diameter of a lumen of the catheter such that the mesh structure is configured to be movable through the lumen (see Figs. 9-10 and Para. [0056]);
the mesh structure is configured to transition from the collapsed configuration to the expanded configuration in response to exiting the catheter (filter would transition from a collapsed configuration to an expanded configuration when removed from the catheter due to radial constraints being removed therefrom, see Figs. 9-10); and
the semi-spherical shape is configured to receive and hold the UIM (see Para. [0003]-[0005] mentioning this as a commonly-utilized function of filters).
However, while Kusleika discloses an elongate tubular delivery device (mandrel 20, see Fig. 1), Kusleika does not expressly disclose wherein the delivery device is a catheter comprising a lumen. Additionally, while Kusleika discloses wherein in the expanded configuration, the mesh structure is configured such that application of a longitudinal force thereto causes the second section to invert at the inversion point and collapse into the first section (see Figs. 7-8 and Para. [0020] and [0053]-[0054]), thereby forming a semi-spherical shape defining the deployed configuration (see Fig. 7), and the semi-spherical shape is configured to receive and hold the UIM (see Para. [0003]-[0005] mentioning this as a commonly-utilized function of filters), Kusleika does not expressly disclose:
wherein the first section comprises a higher mesh wire density than the second section, and the inversion point represents a transition between the higher mesh wire density of the first section and a lower mesh wire density of the second section; and
wherein in the expanded section, upon application of a longitudinal force to the mesh structure, the first and second sections compress until the higher mesh density first section resists further compressing, causing the lower mesh wire density second section to invert at the inversion point and collapse into the first section.
In the same field of endeavor, namely expandable occlusion assemblies for treating blockages within the vasculature, Walters teaches wherein an elongate delivery guidewire (guidewire 72, see Figs. 3C-3D) to which an expandable balloon assembly is attached (see Figs. 3C-3D) may include a hollow tube with the expandable balloon coupled thereto (see Abstract, Para. [0020] and [0024] and Figs 3C-3D).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)) to have obtained the predictable result of having the elongate tubular guidewire to which the filter of Kusleika is mounted comprise a hollow internal lumen as disclosed by Walters, since the overall construction would remained unchanged since the hollow guidewire of Walters also comprises an external expandable member attached thereto. Further, Walters discloses wherein the guidewire ’can’ comprise a hollow body, indicating this is an optional feature and does not comprise inherent criticality necessitating the guidewire be hollow to ensure the function of the resulting device. Therefore, one of ordinary skill in the art would have expected the elongate guidewire body of Kusleika to function equally well having either a solid or hollow body given the optional interchangeable nature of guidewires being either hollow or solid as disclosed by Walters. The resulting combination would function with a reasonable expectation of success for one of ordinary skill in the art.
In the same field of endeavor, namely inverting expansion mesh devices, Tran teaches:
A retriever (see Figs. 1A-1B) comprising:
A plurality of struts interconnected to define a mesh structure (expandable basket 102, see Fig. 1B and Para. [0052] and [0057] mentioning wherein the expandable basket is formed from a wire mesh network), the mesh structure defining a first section (distal portion 116, see Fig. 1I) and a second section (proximal portion 114, see Fig. 1I) connected at an inversion point (point between the proximal portion 114 and distal portion 116, see Figs. 1I-1K and Para. [0060]); wherein:
The mesh is configured to transition between a non-activation configuration (shown in Fig. 1I) and an activated, inverted configuration (shown in Figs. 1J-1K and Para. [0060]) via inversion of the second section at the inversion point to collapse and invert into the first section (see Figs. 1I-1K and Para. [0060]);
wherein the first section comprises a higher mesh wire density than the second section (see Para. [0052] and [0062]), and the inversion point represents a transition between the higher mesh wire density of the first section and a lower mesh wire density of the second section (see Para. [0052] and [0062] mentioning wherein the proximal portion 114 may comprise a smaller mesh fiber density than the distal portion 116 to allow for the distal portion 116 to remain stiffer while the proximal portion is more flexible to allow easier inversion at the inversion point between the two portions); and
wherein in the non-activated configuration, upon application of a longitudinal force to the mesh structure, the first and second sections compress (see Para. [0006], [0052], [0057] and [0062] mentioning wherein the proximal end of the expandable basket is axially moveable to apply a compressive force to the proximal portion 114 to cause inversion thereof) until the higher mesh density first section resists further compressing (see Para. [0006], [0052], [0057] and [0062]), causing the lower mesh wire density second section to invert at the inversion point and collapse into the first section (see Para. [0006], [0052], [0057] and [0062]).
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 mesh filter of Kusleika to have the first portion of the mesh filter structure comprise higher density mesh wires forming said first portion while having lower density mesh wires forming the second portion as taught and suggested by Tran to, in this case, allow for an easier, more controlled and predictable inversion of the less dense second portion into the stiffer, more dense first portion at the inversion point (see Tran Para. [0052] and [0062]). The resulting assembly would allow the higher density first portion to better resist the inverting longitudinal compressive force applied to the filter assembly while allowing the lower density second portion to more easily invert at the inversion point as shown and mentioned by Tran in see. [0006], [0052], [0057] and [0062] and Figs. 1I-1K.
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Examiner’s Diagram of Kusleika Fig. 1
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Examiner’s Diagram of Kusleika Fig. 7
Regarding claim 10, the combination of Kusleika, Tran and Walters discloses the invention of claim 8, Kusleika further discloses wherein the outer diameter corresponds to a diameter of an anatomical structure from which the UIM is being removed (see Para. [0034] and Fig. 3).
Regarding claim 11, the combination of Kusleika, Tran and Walters discloses the invention of claim 8, Kusleika further discloses wherein the retriever further comprises one or more reinforcement struts disposed within the first section, the one or more reinforcement configured to radially support the first section (see Figs. 1-3 showing wherein the entirety of the filter is comprised of a plurality of reinforcement struts as part of the mesh structure which aid in radially supporting the filter structure).
Regarding claim 12, the combination of Kusleika, Tran and Walters discloses the invention of claim 8, Kusleika further discloses wherein the plurality of struts comprise a shape-memory material (see Para. [0032]-[0033] wherein the filter is formed from nitinol).
Regarding claim 13, the combination of Kusleika, Tran and Walters discloses the invention of claim 12, Kusleika further discloses wherein the shape-memory material comprises nitinol (see Para. [0032]-[0033]).
Regarding claim 14, the combination of Kusleika, Tran and Walters discloses the invention of claim 12, Kusleika further discloses wherein the shape of the deployed configuration has been heat set (see Para. [0033] mentioning wherein the shape of the filter is formed by heat setting the nitinol used to form the filter).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kusleika (US 2008/0033482 A1)(previously of record) in view of Walters (US 2014/0277114 A1)(previously of record), further in view of Tran (US 2019/0365395 A1), further in view of Bonnette (US 2016/0220346 A1)(previously of record).
Regarding claim 9, the combination of Kusleika, Tran and Walters discloses all of the limitations of the invention of claim 8.
However, Kusleika does not expressly disclose wherein the outer diameter is from about 8 mm to about 20 mm.
However, in the field of endeavor of vascular expandable filter devices, Bonnette discloses wherein it is known in the art for expandable filters to comprise a diameter of between 2mm – 48mm (see Para. [0029]).
Since Kusleika is silent regarding any express dimensions for the disclosed filter device, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the filters of Kusleika to comprise diameters of between 8mm and 20mm as applicant appears to have placed no criticality on the claimed range (see Spec. Pg. 33 reciting wherein the “outer diameter of the body section ‘can’ range from about 8mm to about 20mm” while providing an express recitation of alternative dimensions on Pg. 34 which may be substituted based on the type of procedure being performed) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim(s) 15 and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kusleika (US 2008/0033482 A1) in view of Walters (US 2014/0277114 A1), further in view of Eaton (US 2010/0274277 A1).
Regarding claim 15, Kusleika discloses:
A method for removing undesirable intravascular material (UIM) from an anatomical structure of a subject via an aspiration system, the method comprising:
accessing the anatomical structure with a retriever assembly (see Fig. 1 and 9-10), the retriever assembly comprising:
a delivery device (mandrel 20, see Fig. 1) comprising:
an elongate tubular body (mandrel 20, see Fig. 1), and an outer sheath (Catheter “C” in Figs. 9-10, see also Para. [0049]-[0051] and [0069]-[0072]) configured to be moved longitudinally with respect to the elongate tubular body (see Figs. 9-10 and Para. [0049]-[0051] and [0069]-[0072]); and
a retriever (filter 50, see Fig. 1) comprising a plurality of struts that are interconnected to define a mesh structure (see Fig. 1 showing wherein the filter (50) is formed from a plurality of interconnected struts);
the mesh structure comprising a first section (see Examiner’s Diagram of Fig. 1 below illustrating a “first section” of the filter body) and a second section (see Examiner’s Diagram of Fig. 1 below illustrating a “second section” of the filter body) connected at an inversion point (see Examiner’s Diagrams of Figs. 1 and 7 below illustrating wherein the designated “first section” and “second section” are connected at an inversion point wherein the second section inverts and folds into the first section when transitioned from a collapsed to an expanded configuration, see Para. [0020] and [0053]-[0054]), wherein:
the mesh structure is configured to transition between a collapsed configuration (see Figs. 4-5 and Para. [0012] and [0017]), an expanded configuration (see Fig. 3 and Para. [0012], [0033] and [0040]), and a deployed configuration (see Fig. 7 and Para. [0012] and [0053]-[0054]);
advancing the retriever in the collapsed state (see Para. [0056] mentioning wherein the filter is collapsed when inserted into a catheter device as shown in Fig. 10), via the catheter (see Para. [0027]);
wherein in the expanded configuration, the outer diameter of the mesh structure is greater than the outer diameter in the collapsed configuration (see Para. [0012]);
applying, via the outer sheath, a longitudinal force to the retriever, thereby causing the second section to invert at the inversion point and collapse into the first section and forming a semi-spherical shape defining the deployed configuration (see Para. [0049]-[0051] wherein during deployment of the filter, said filter contacts and slides along the interior wall of the catheter, generating a longitudinal force as the filter slides along the interior wall and permitting and leading to the filter assuming the deployed configuration as shown in Fig. 7); and
distally translating the retriever in the deployed configuration to cause the retriever to collect the UIM and draw the UIM towards a suction source of the aspiration system (see Para. [0049]-[0051] and [0069]-[0072] wherein the filter is advanced distally out from the distal opening of the catheter “C” into the vessel to collect any UIM or particulate, see Para. [0055]-[0056] before the catheter “C” is advanced over the filter to aspirate any remaining particulate).
However, while Kusleika discloses an elongate tubular delivery device (mandrel 20, see Fig. 1), Kusleika does not expressly disclose wherein the delivery device is a catheter comprising a lumen;
advancing the retriever past the UIM without causing substantial fragmentation of the UIM, thereby causing the retriever to exit the catheter upstream of the UIM and transition to the expanded configuration.
In the same field of endeavor, namely expandable occlusion assemblies for treating blockages within the vasculature, Walters teaches wherein an elongate delivery guidewire (guidewire 72, see Figs. 3C-3D) to which an expandable balloon assembly is attached (see Figs. 3C-3D) may include a hollow tube with the expandable balloon coupled thereto (see Abstract, Para. [0020] and [0024] and Figs 3C-3D).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)) to have obtained the predictable result of having the elongate tubular guidewire to which the filter of Kusleika is mounted comprise a hollow internal lumen as disclosed by Walters, since the overall construction would remained unchanged since the hollow guidewire of Walters also comprises an external expandable member attached thereto. Further, Walters discloses wherein the guidewire ‘can’ comprise a hollow body, indicating this is an optional feature and does not comprise inherent criticality necessitating the guidewire be hollow to ensure the function of the resulting device. Therefore, one of ordinary skill in the art would have expected the elongate guidewire body of Kusleika to function equally well having either a solid or hollow body given the optional interchangeable nature of guidewires being either hollow or solid as disclosed by Walters. The resulting combination would function with a reasonable expectation of success for one of ordinary skill in the art.
In the same field of endeavor, namely expandable filter devices, Eaton teaches wherein, during a filtration procedure, an expandable filter mesh (20, see Fig. 3A) is advanced, in a compressed state (see Para. [0043]-[0044] and Fig. 3A) distally beyond an occlusion (50,see Fig. 3A) without causing substantial fragmentation of the UIM (see Fig. 3A and Para. [0043]-[0044]; as Fig. 3A clearly shows the filter of Eaton not in-contact with the occlusion, in combination with the disclosure that the filter is advanced past said occlusion in a compressed form, this is taken to mean that the advancement of the filter past the occlusion does not cause substantial fragmentation of said occlusion unless otherwise specified) before being expanded (see Figs. 3A-3B and Para. [0043]-[0044]) to then capture and trap and particulates within the mesh structure (see Para. [0044] and Fig, 3C).
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 filter device of Kusleika to be provided a known capture method as disclosed by Eaton, wherein the filter assembly of Kusleika is advanced, in a compressed state within its delivery catheter, distally beyond an occlusion (without causing substantial contact or fragmentation of said occlusion until such time as the filter is later expanded) before being expanded, capturing any particulates before being again a collapsed, trapping any captured particulates therein (see Eaton Para. [0043]-[0044] and Figs. 3A-3C). Since Kusleika does not provide any known method of using the disclosed filter assembly, one of ordinary skill in the art would look to device of a similar shape and construction to provide a known method of using the device of Kusleika to capture particulates within a desired occluded vessel.
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Examiner’s Diagram of Kusleika Fig. 1
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Examiner’s Diagram of Kusleika Fig. 7
Regarding claim 17, the combination of Kusleika, Walters and Eaton discloses the method of claim 15, Kusleika further discloses wherein the outer diameter corresponds to a diameter of an anatomical structure from which the UIM is being removed (see Para. [0034] and Fig. 3).
Regarding claim 18, the combination of Kusleika, Walters and Eaton discloses the method of claim 15, Kusleika further discloses wherein the retriever further comprises one or more reinforcement struts disposed within the first section, the one or more reinforcement configured to radially support the first section (see Figs. 1-3 showing wherein the entirety of the filter is comprised of a plurality of reinforcement struts as part of the mesh structure which aid in radially supporting the filter structure).
Regarding claim 19, the combination of Kusleika, Walters and Eaton discloses the method of claim 15, Kusleika further discloses wherein the plurality of struts comprise a shape-memory material (see Para. [0032]-[0033] wherein the filter is formed from nitinol).
Regarding claim 20, the combination of Kusleika, Walters and Eaton discloses the invention of claim 19, Kusleika further discloses wherein the shape-memory material comprises nitinol (see Para. [0032]-[0033]).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kusleika (US 2008/0033482 A1)(previously of record) in view of Walters (US 2014/0277114 A1)(previously of record), further in view of Eaton (US 2010/0274277 A1)(previously of record), further in view of Bonnette (US 2016/0220346 A1)(previously of record).
Regarding claim 16, the combination of Kusleika, Walters and Eaton discloses all of the limitations of the method of claim 15.
However, none of either Kusleika, Walters of Eaton expressly disclose wherein the outer diameter is from about 8 mm to about 20 mm.
However, in the field of endeavor of vascular expandable filter devices, Bonnette discloses wherein it is known in the art for expandable filters to comprise a diameter of between 2mm – 48mm (see Para. [0029]).
Since Kusleika is silent regarding any express dimensions for the disclosed filter device, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the filters of Kusleika to comprise diameters of between 8mm and 20mm as applicant appears to have placed no criticality on the claimed range (see Spec. Pg. 33 reciting wherein the “outer diameter of the body section ‘can’ range from about 8mm to about 20mm” while providing an express recitation of alternative dimensions on Pg. 34 which may be substituted based on the type of procedure being performed) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 10300256 B2 to Aboytes, US 20030144687 At to Brady, US 20020138094 A1 to Borillo and US 20220387759 A1 to Turovskiy all disclose inverting filter capture systems comprising a delivery catheter.
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 MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771