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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/28/2026 has been entered.
Response to Arguments
Applicant's arguments filed 4/28/2026 with regards to the rejection of claim 1 over Kusleika (US 2008/0033482 A1) in view of Tran (US 2019/0365395 A1) have been fully considered but they are not persuasive.
Regarding claim 1, Applicant contends that none of either Kusleika or Tran expressly or adequately disclose or suggest the amended limitations of “the semi-spherical shape comprises a leading edge defining an open interior, the leading edge configured to be dragged along an interior surface of an anatomical structure to dislodge the UIM therefrom” on the grounds that the device of Kusleika is disclosed to be a passive capture system configured to capture dislodged material before it is allowed to drift too far downstream (Para. [0003]). Thus, Kusleika does not expressly disclose or suggest the amended limitations relating to a more active removal system as claimed.
While the Examiner agrees that Kusleika provides a disclosure of wherein the filter assembly is configured to capture loose debris, rather than actively scrape and remove debris from the vasculature, the Examiner respectfully disagrees with the contention that the device of Kusleika would not be reasonably capable of performing the recited function. Kusleika mentions in Para. [0034] wherein the filter expands to substantially fill the target vessel lumen. Kusleika additionally discusses in Para. [0041]-[0046], [0051] and [0054]-[0056] wherein the filter is configured to be translated (i.e., pushed/pulled) proximally and distally within the target vessel. From these disclosures, the Examiner respectfully contends that should a user have the filter in the expanded configuration (as shown in Fig. 7) and translate (i.e., push/pull) the filter axially within the vessel, the filter would reasonably contact and dislodge at least some UIM from the vessel walls upon contact therewith. Therefore, even if Kusleika does not provide an express disclosure of the claimed function, the device of Kusleika is understood to be reasonably capable of performing this function without impacting the functionality of the device.
In response to applicant's argument, pertaining to claim 4, that the references fail to address or discuss wherein the reinforcement elements are configured to prevent prolapse of the semi-spherical shape during dislodgement and capture of the UIM, it is noted that these features upon which applicant relies are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Should Applicant wish to provide this claimed function of the reinforcement elements as novel over the applied prior art, Examiner suggests the language recited in the submitted arguments be incorporated into the limitations of claim 4.
Applicant’s arguments with respect to claim(s) 8 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, Walters or Tran are relied upon to disclose or teach the amended limitations of “a catheter comprising a funnel positioned at the distal end of the catheter…the retriever is configured to be moved toward the funnel of the catheter to receive and hold the UIM therein, and upon contacting the inner surface of the funnel, a leading edge of the semi-spherical shape of the deployed configuration is caused to partially collapse to force the UIM into the funnel and/or lumen of the catheter”.
Applicant’s arguments with respect to claim(s) 15 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, Walters or Eaton are relied upon to disclose or teach the amended limitations of “advancing the retriever in the collapsed state, via the catheter, through and past the UIM without causing substantially fragmentation of the UIM.”
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) (previously of record).
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 (catheter C, 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 to define a mesh structure), 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 at which 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 (see Figs. 9-10 and Para. [0010]-[0011]; the filter transitions from the collapsed configuration to the expanded configuration when removed from the catheter due to radial constraints being removed therefrom);
in the expanded configuration, the outer diameter of the mesh structure is greater than the outer diameter in the collapsed configuration (see Para. [0012]);
wherein the mesh structure is configured to invert at the inversion point to cause the second section to collapse into the first section, thereby forming a semi-spherical shape defining the deployed configuration (see Figs. 7-8 and Para. [0020] and [0053]-[0054]);
the semi-spherical shape comprises a leading edge (“upper” circular edge located at the inversion point between the first and section sections, labeled as “152” in Fig. 7) defining an open interior (see Fig. 7 showing an open space defined within the radial confines of the collapsed second portion of the filter; see also Para. [0054]-[0056] mentioning wherein this space is configured to capture debris), the leading edge configured to be dragged along an interior surface of an anatomical structure to dislodge the UIM therefrom (see Para. [0034] mentioning wherein the filter expands to substantially fill the target vessel lumen; see also Para. [0041]-[0046], [0051] and [0054]-[0056] mentioning wherein the filter is configured to be translated (i.e., pushed/pulled) proximally and distally within the target vessel; from these disclosures, should a user have the filter in the expanded configuration (Fig. 7) and translate the filter axially, the filter would reasonably contact and dislodge at least some UIM from the vessel walls upon contact therewith during axial translation).
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Examiner’s Diagram of Kusleika Fig. 1
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Examiner’s Diagram of Kusleika Fig. 7
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.
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).
20120053596
Regarding claim 4, the combination of Kusleika and Tran discloses the invention of claim 1, Kusleika further discloses a reinforcement element associated with at least the first section of the mesh structure (see Fig. 7; when the second section of the filter collapses into the first section, the second section acts as a “reinforcement element” which strengthens the resulting semi-spherical shape shown in Fig. 7).
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) (previously of record), 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) 8-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kusleika (US 2008/0033482 A1)(previously of record) in view of Bonnette (US 2016/0220346 A1) (previously of record), further in view of Tran (US 2019/0365395 A1) (previously of record).
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 catheter delivery device comprising:
a catheter (catheter “C”, see Figs. 9-10, see also Para. [0049]-[0051] and [0069]-[0072]) comprising a lumen (see Figs. 9-10); 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 forming a mesh structure), 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 (see Para. [0010]; the filter transitions from the collapsed configuration to the 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); and
in the deployed configuration, the retriever is configured to be moved toward the distal end of the catheter (see Figs. 9-10 and Para. [0049]-[0051] and [0069]-[0072]) to receive and hold the UIM therein (see Para. [0003]-[0005] and [0053]-[0056]), and upon contacting the inner surface of the catheter, a leading edge of the semi-spherical shape of the deployed configuration is cause to partially collapse to force the UIM into the catheter and/or lumen thereof (see Para. [0051] and [0055]-[0056] mentioning wherein, when withdrawing the filter assembly, the filter assembly is pulled proximally toward the distal end of the catheter until the components contact one-another; during this phase, the catheter may be utilized to apply a suction force to vacuum debris, captured by the filter, into the lumen thereof before the filter is then pulled further proximally to radially collapse the filter against the distal end of the catheter body, allowing a user to fully withdraw the filter assembly into the catheter; adjusting sliders 160/165 allows a user to change the shape of the filter, as desired, during withdrawal of the filter within the lumen of the catheter).
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Examiner’s Diagram of Kusleika Fig. 1
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Examiner’s Diagram of Kusleika Fig. 7
However, while Kusleika discloses wherein, during withdrawal of the filter, the filter is pulled proximally until the entirety of the filter is pulled into the catheter, radially collapsing the filter (see Para. [0055]-[0056]), Kusleika does not expressly disclose:
an outer sheath configured to be moved longitudinally with respect to the catheter;
wherein the catheter comprises a funnel positioned at the distal end of the catheter; and
in the deployed configuration, the retriever is configured to be moved toward the funnel of the catheter to receive and hold the UIM therein, and upon contracting the inner surface of the funnel, a leading edge of the semi-spherical shape of the deployed configured is caused to partially collapse to force the UIM into the funnel and/or lumen of the catheter.
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, Bonnette teaches a retriever assembly (see Fig. 2) comprising a catheter delivery device comprising: an outer sheath (delivery sheath 12, see Fig. 2), a catheter comprising a lumen (capture sleeve 14, see Fig. 2) and a retriever (guidewire 22, see Fig. 2); wherein the outer sheath and catheter are slidable relative to one-another (see Para. [0093]-[0095] and [0097]); wherein the distal end of the catheter is in the shape of a radially expandable and collapsible tapered funnel (see Fig. 2 and Para. [0089] and [0101]-[0103]) configured to allow the filters and captured debris to more easily enter the catheter to be captured therein (see Para. [0101]-[0103]); wherein the outer sheath serves as a guide element and compressive sheath utilized to compress the subcomponents of the capture system (i.e., capture sleeve 14 and filters 22/24) and any debris captured therein (see Para. [0101]-[0103]).
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 device of Kusleika to include an expandable and collapsible flared tip onto the distal end of the catheter as taught and suggested by Bonnette to, in this case, allow the filters and captured debris to more easily enter the catheter to be captured therein (see Para. [0101]-[0103]). To facilitate this easier capture system, it would have further been obvious to one of ordinary skill in the art to have incorporated an outer capture sheath surrounding the catheter and filter assemblies of Kusleika as disclosed by Bonnette to, in this case, serve as a compressive system to be slid over the flared catheter and filter assemblies to compress the nested assemblies, and any captured debris, within the confines of the outer capture sleeve (see Bonnette Para. [0101]-[0103]).
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.
Regarding claim 9, the combination of Kusleika, Tran and Bonnette 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).
Regarding claim 10, the combination of Kusleika, Tran and Bonnette 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 Bonnette 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 Bonnette 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 Bonnette 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 Bonnette 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) 15 and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kusleika (US 2008/0033482 A1)(previously of record) in view of Marchand (US 2017/0112514 A1), further in view of Brady (US 2013/0144326 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 catheter delivery device comprising:
a catheter comprising a lumen (catheter C, see Figs. 9-10; see also Para. [0049]-[0051] and [0069]-[0072]);
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).
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Examiner’s Diagram of Kusleika Fig. 1
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Examiner’s Diagram of Kusleika Fig. 7
However, Kusleika does not expressly disclose:
an outer sheath configured to be moved longitudinally with respect to the elongate tubular body;
advancing the retriever through and 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, Marchand teaches a retriever assembly (see Figs. 1-2) comprising a catheter delivery device comprising: an outer sheath (outer shaft 138, see Fig. 2), a catheter comprising a lumen (intermediate shaft 140, see Fig. 2) and a retriever (inner shaft 200, see Fig. 2); wherein the outer sheath and catheter are slidable relative to one-another (see Para. [0030], [0088] and [0162]); wherein the outer sheath is configured to be locked at a relative axial location to the catheter body (see Para. [0030], [0088] and [0162]) to provide a more versatile positioning system for navigation the filter assembly through the vasculature.
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 device of Kusleika to include an outer sheath surrounding the catheter and filter assemblies of Kusleika as disclosed by Marchand to, in this case, serve as a selectively lockable guide tube to which the catheter was fixedly be secured at a desired location within the body (see Marchand Para. [0030], [0088] and [0162)
In the same field of endeavor, namely expandable filter devices, Brady teaches wherein, during a filtration procedure, an expandable filter mesh (retrieval element 41, see Fig. 7A) is advanced, in a compressed state through and distally beyond an occlusion (see Figs. 35A-35C and Para. [0851]) without causing substantial fragmentation of the UIM (see Figs. 35A-35C and Para. [0815]; as Figs. 35A-35G clearly shows the filter of Brady passing through and beyond the occlusion 211 while leaving the occlusion as a substantially singular piece, this is taken to mean that the advancement of the filter through and past the occlusion does not cause substantial fragmentation of said occlusion unless otherwise specified) before being expanded (see Figs. 35A-35G and Para. [0851]) to then capture and trap and particulates within the mesh structure (see Figs. 35A-35G and Para. [0851]).
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 Brady, wherein the filter assembly of Kusleika is advanced, in a compressed state within its delivery catheter, through and 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 Brady Figs, 35A-35G and Para. [0851]). 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.
Regarding claim 17, the combination of Kusleika, Marchand and Brady 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, Marchand and Brady 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, Marchand and Brady 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, Marchand and Brady 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 Marchand (US 2017/0112514 A1), further in view of Brady (US 2013/0144326 A1), further in view of Bonnette (US 2016/0220346 A1) (previously of record).
Regarding claim 16, the combination of Kusleika, Marchand and Brady discloses all of the limitations of the method of claim 15.
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).
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 2014/0005712 A1 to Martin, US 2023/0132996 A1 to Stefanov, US 2022/0395667 A1 to Keating and US 2012/0053596 A1 to Gordon all disclose inverting filter capture systems comprising a delivery catheter and/or a reinforcement system for expandable filter assemblies.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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