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 .
DETAILED ACTION
Acknowledgement is made of applicant’s amendment which was received by the office on February 25, 2026. Claims 1-32 are currently pending. Claims 19-23 and 30-32 were withdrawn during an earlier restriction requirement. Claims 1-18 and 24-29 are currently under examination.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “means of measuring the pressure at the distal tip of the catheter” in claims 1-18 and 25-29, “anchoring device for anchoring the occlusion device” in claims 1-18 and 24-29, “anchoring device for anchoring the occlusion device” in claims 1-18 and 24-29, “first locking mechanism for steering and locking the distal tip in a desired configuration” in claim 2. “second locking mechanism for axially locking the anchor…” in claims 12 and 27. “fixation members for a fixed position of the handle during long-term operation of the device” in claim 13. “anchoring device for anchoring the occlusion device…” in claim 25.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Specifically, “means of measuring the pressure at the distal tip of the catheter” has been interpreted to include optical pressure sensors and equivalents thereof as disclosed within the specification, see para. [0029], [0045], [0161]-[0162] of US 2023/0293877 “anchoring device for anchoring the occlusion device” has been interpreted to include anchors similar to elements (30, 54, 65, 80, 90A, 122) including expandable members such as individual wires, basket-like or cage-like structures and equivalents thereof as disclosed within the specification, see abstract, para. [0050]-[0055] of US 2023/0293877, “first locking mechanism for steering and locking the distal tip in a desired configuration” has been interpreted to include a locking mechanism similar to 15 which includes a level 12 and equivalents thereof as disclosed within the specification, see para. [0140], [0145] of US 2023/0293877; “second locking mechanism for axially locking the anchor…” has been interpreted to include rotational locking members and equivalents thereof as disclosed within the specification, see para. [0152, [0219] of US 2023/0293877, “fixation members for a fixed position of the handle during long-term operation of the device” has been interpreted to include holes and equivalents thereof as disclosed within the specification, see para. [0140] of US 2023/0293877.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
In view of the amendment filed on 2/25/2026 clarifying the language of claim 27 the objections made against claim 27 in the office action of 7/15/2025 have been withdrawn.
Claim Rejections - 35 USC § 112
In view of the amendment filed on 2/25/2026 clarifying the language of claims 1,12 and 24-25 the objections made against claims 1-18 and 24-29 in the office action of 7/15/2025 have been withdrawn.
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.
Claims 16 and 28 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 16 recites “wherein the balloon has an axial length of 5 to 20 mm and/or a diameter of 5 to 20 mm.”, which is unclear regarding the structural limitations required of the occlusion device since claim 1 from which claim 16 indirectly depends recites “the occlusion device having a diameter of 5 - 20 mm”, therefore it appears that claim 16 is broadening the scope making it unclear exactly what structural limitations are required for the occlusion device, clarification is required. Claim 28 directly depends from claim 16 and is also rejected to for the reasons stated above regarding claim 16. As best understood, for the purpose of examination, claim 16 has been interpreted to include a diameter of 5 to 20 mm.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1,3, 5-8, 11, 14-17, 24 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2004/0215139 to Cohen (herein Cohen) in view of US 2003/0083617 to St. Germain et al. (herein Germain) and US 2015/0157326 to Schiemanck et al. (herein Schiemanck) (all previously cited).
In reference to at least claim 1
Cohen discloses a catheter assembly (e.g. catheter assembly 10) for the intermittent occlusion of the coronary sinus (e.g. placed in coronary sinus, Figs. 6-9) comprising a shaft (e.g. longitudinally extending member 12), the shaft having a plurality of lumens (e.g. multiple lumens present within the longitudinally extending member 12, Fig. 2), a distal end with a distal tip (e.g. longitudinally extending member 12 has a distal end with a distal tip near end 28), an occlusion device fixed to the distal tip (e.g. longitudinally extending member 12 has an occlusion device 26 or 130 fixed to the distal end, Figs. 1, 7-8), and operable through at least one of the plurality of lumens (e.g. occlusion device 26 or 130) and a proximal handle (e.g. handle 14 located on a proximal end), the catheter assembly further having at least the following: an anchoring device for anchoring the occlusion device in a predefined position in the coronary sinus (e.g. “anchor 138”, Fig. 9, para. [0119]), the distal end being deflectable/steerable (e.g. distal end including 28 is deflectable, Figs. 1,6-8) with deflection being controlled by an actuator arranged at the proximal handle (e.g. “The distal handle, hub, or knob may consist of additional movable knobs, levers, etc. for providing catheter tip deflection from straight to fully curved. Another embodiment may consist of some or all of the following additional controls for tightening and loosening said deflection, a control for changing the point of deflection and thereby altering the radius of curvature”, para. [0034]; “Optionally the catheter is steerable with inherent means to control the radius of curvature of the distal portion. In addition, other deflections and curvatures can be achieved by additional pull wires, levers, and mechanisms concealed within said catheter.”, para. [0035]).
However, Cohen does not explicitly teach the catheter assembly having the occlusion device having a diameter of 5 - 20 mm and adapted to occlude the coronary sinus ostium and means of measuring the pressure at the distal tip of the catheter assembly and distally to the occlusion device.
Germain discloses occlusion device for a vessel (e.g. para. [0010]) which includes a catheter (e.g. 102) and an occlusion device (e.g. occluder and/or constrictor 104 and 107) wherein the occlusion device is an inflatable balloon (e.g. “Distal balloon 104 and proximal balloon 107”, para. [0126]) wherein the balloon has an axial length of 5 to 20 mm and/or a diameter of 5 to 20 mm (e.g. “Both are preferably molded to have an initial inflated diameter of about 10 mm, with a capability of being inflated to 25 mm with increasing pressure”, para. [0126]-[0127], [0142]) allowing the balloons to accommodate variation in patient anatomy and allow the surgeon to vary constriction to adjust cerebral blood flow rate to the desired level (e.g. para. [0142]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the occlusion device of Cohen to include the balloon having a diameter of 5 to 20 mm, as taught by Germain, in order to accommodate variation in patient anatomy and allow the surgeon to vary constriction to adjust cerebral blood flow rate to the desired level (‘617, para. [0142]).
Schiemanck discloses a catheter system ( e.g. catheter system 120) that includes an occlusion device on a distal end (e.g. occlusion device 122) to occlude the coronary sinus (e.g. para. [0038]) in which the catheter system includes means of measuring the pressure at the distal tip of the catheter assembly and distally to the occlusion device using an optical pressure sensor (e.g. “Alternatively, a miniature pressure sensor can be positioned immediate adjacent to the distal ports 129 such that a sensor wire (e.g., electrical or optical) extends through the central lumen 125 for communication with the control system 140 (FIG. 2).”, para. [0044], [0049], [0050]). The sensor allows pressure and other parameters indicative of hemodynamic performance to be monitored (e.g. para. [0039]) protecting the coronary sinus from an overly pressurized balloon device (e.g. para. [0049]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the catheter system of Cohen to include means of measuring the pressure at the distal tip of the catheter assembly and distally to the occlusion device using an optical pressure sensor, as taught by Schiemanck, in order to allow pressure and other parameters indicative of hemodynamic performance to be monitored protecting the coronary sinus from an overly pressurized balloon device (e.g. ‘326, para. [0039], [0049]).
In reference to at least claim 3
Cohen modified by Germain and Schiemanck renders obvious a catheter assembly according to claim 1. Germain further discloses an occlusion device (e.g. occluder and/or constrictor 104) in which the occlusion device includes an anchoring device (e.g. ring 130 with anchoring mechanism, para. [0149]) that includes an expandable anchor (e.g. ring 130) Germain further discloses that the ring 130 with anchoring mechanism secures the occluder and prevents displacement in the vessel due to force exerted by blood flow (e.g. para. [0149]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the catheter assembly of Cohen modified by Germain and Schiemanck to include an expandable anchor, as taught by Germain, in order to secure the occlusion device preventing displacement in the vessel due to force exerted by blood flow (‘617, para. [0149]).
In reference to at least claim 5
Cohen modified by Germain and Schiemanck renders obvious a catheter assembly according to claim 3. Germain further discloses wherein the expandable anchor is adapted to be arranged proximally to the occlusion device (e.g. expandable struts 62 and 63 extending proximally to the occlusion devices 104 and 107, Fig. 10, para. [0143]).
In reference to at least claim 6
Cohen modified by Germain and Schiemanck renders obvious a catheter assembly according to claim 3. Germain further discloses wherein the expandable anchor is arranged circumferentially around the occlusion device (e.g. ring 130 with anchoring mechanism arranged around the occlusion device 104, Figs. 14-15, para. [0149]).
In reference to at least claim 7
Cohen modified by Germain and Schiemanck renders obvious an assembly according to claim 1. Cohen further discloses wherein the shaft comprises distal and/or proximal markers for angiographic identification of the position of the anchoring device in the coronary sinus (e.g. “or the electrodes can serve as opaque fluoroscopic markers”, para. [0050], “at least one radiopaque marker positioned on or near the distal end of the tubular body”, claims 47,108).
In reference to at least claim 8
Cohen modified by Germain and Schiemanck renders obvious an assembly according to claim 1. Cohen further discloses wherein the actuator of the handle is formed by a lever for controlling the movement of the distal tip (e.g. “The distal handle, hub, or knob may consist of additional movable knobs, levers, etc. for providing catheter tip deflection from straight to fully curved.”, para. [0034]).
In reference to at least claim 11
Cohen modified by Germain and Schiemanck renders obvious an assembly according to claim 1. Cohen further discloses wherein the distal end is deflectable up to at least + 90° to -90° (e.g. “It is within the scope of the invention that the catheter distal tip have a slight bend of greater than at least about 0.degree., up to at least about 180.degree., to at least about 270.degree., to the extent that the distal catheter configuration will be a spiral or pigtail.”, para. [0116]).
In reference to at least claim 14
Cohen modified by Germain and Schiemanck renders obvious an assembly according to claim 1. Cohen further discloses wherein the occlusion device and/or anchoring device is/are arranged circumferentially around the shaft (e.g. “annular inflatable balloon 26”, para. [0051]; “balloon 130”, para. [0118]).
In reference to at least claim 15
Cohen modified by Germain and Schiemanck renders obvious an assembly according to claim 1. Cohen further discloses wherein the occlusion device an inflatable balloon (e.g. “annular inflatable balloon 26”, para. [0051]; “balloon 130”, para. [0118]).
In reference to at least claim 16
Cohen modified by Germain and Schiemanck renders obvious an assembly according to claim 15. Cohen further discloses an occlusion device fixed to the distal tip (e.g. longitudinally extending member 12 has an occlusion device 26 or 130 fixed to the distal end, Figs. 1, 7-8) wherein the occlusion device an inflatable balloon (e.g. “annular inflatable balloon 26”, para. [0051]; “balloon 130”, para. [0118]). Germain further discloses wherein the occlusion device is an inflatable balloon (e.g. “Distal balloon 104 and proximal balloon 107”, para. [0126]) wherein the balloon has an axial length of 5 to 20 mm and/or a diameter of 5 to 20 mm (e.g. “Both are preferably molded to have an initial inflated diameter of about 10 mm, with a capability of being inflated to 25 mm with increasing pressure”, para. [0126]-[0127], [0142]) allowing the balloons to accommodate variation in patient anatomy and allow the surgeon to vary constriction to adjust cerebral blood flow rate to the desired level (e.g. para. [0142]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the occlusion device of Cohen modified by Germain and Schiemanck to include the balloon having a diameter of 5 to 20 mm, as taught by Germain, in order to accommodate variation in patient anatomy and allow the surgeon to vary constriction to adjust cerebral blood flow rate to the desired level (‘617, para. [0142]).
In reference to at least claim 17
Cohen modified by Germain and Schiemanck renders obvious an assembly according to claim 1. Cohen further discloses the shaft having a plurality of lumens (e.g. multiple lumens present within the elongated sheath, Fig. 2) in which at least one lumen is adapted to control an expansion and contraction of the occlusion device (e.g. “One of ancillary lumens 36 is an inflation lumen for, and in fluid communication with, balloon 28,”, para. [0053]). Schiemanck further discloses the catheter system includes a shaft (e.g. 120) that includes a plurality of lumens (e.g. Fig. 5) in which at least two lumens of the plurality of lumen are adapted to control an expansion and contraction of the occlusion device (e.g. “123 serves to supply and discharge fluid (e.g. helium or carbon dioxide gas in this embodiment) for inflating and evacuating the balloon device 122. The ring segment-shaped lumen 124, which is smaller than the other lumen 123, likewise communicates with the interior of the balloon device 122 and serves to measure the fluid pressure within the balloon device 122.”, para. [0044]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the catheter system of Cohen modified by Germain and Schiemanck to include at least two lumens of the plurality of lumen being adapted to control an expansion and contraction of the occlusion device, as taught by Schiemanck, in order to allow measuring a fluid pressure within the occlusion device (‘326, para. [0044]).
In reference to at least claim 24
Cohen modified by Germain and Schiemanck renders obvious an assembly according to claim 1. Schiemanck discloses means of measuring the pressure at the distal tip of the catheter assembly and distally to the occlusion device using an optical pressure sensor (e.g. “Alternatively, a miniature pressure sensor can be positioned immediate adjacent to the distal ports 129 such that a sensor wire (e.g., electrical or optical) extends through the central lumen 125 for communication with the control system 140 (FIG. 2).”, para. [0044], [0049], [0050]). The sensor allows pressure and other parameters indicative of hemodynamic performance to be monitored (e.g. para. [0039]) protecting the coronary sinus from an overly pressurized balloon device (e.g. para. [0049]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter system of Cohen to include means of measuring the pressure at the distal tip of the catheter assembly and distally to the occlusion device using an optical pressure sensor, as taught by Schiemanck, in order to allow pressure and other parameters indicative of hemodynamic performance to be monitored protecting the coronary sinus from an overly pressurized balloon device (e.g. ‘326, para. [0039], [0049]).
In reference to at least claim 28
Cohen modified by Germain and Schiemanck renders obvious an assembly according to claim 16. Germain further discloses wherein the balloon has a toroidal shape (e.g. expandable member “occlusion device” 104 may include a toroidal shape around its periphery, Figs. 14-15, para. [0148]).
Claim(s) 2,9-10 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2004/0215139 to Cohen (herein Cohen) in view of US 2003/0083617 to St. Germain et al. (herein Germain) and US 2015/0157326 to Schiemanck et al. (herein Schiemanck) as applied to claim 1 further in view of US 2015/0057655 to Osypka (herein Osypka ’655 – previously cited).
In reference to at least claim 2
Cohen modified by Germain and Schiemanck renders obvious an assembly according to claim 1. Cohen further discloses wherein the handle (e.g. handle 14 located on a proximal end), comprises a defection actuator for steering (e.g. “The distal handle, hub, or knob may consist of additional movable knobs, levers, etc. for providing catheter tip deflection from straight to fully curved. Another embodiment may consist of some or all of the following additional controls for tightening and loosening said deflection, a control for changing the point of deflection and thereby altering the radius of curvature”, para. [0034]; “Optionally the catheter is steerable with inherent means to control the radius of curvature of the distal portion. In addition, other deflections and curvatures can be achieved by additional pull wires, levers, and mechanisms concealed within said catheter.”, para. [0035]). Cohen further discloses that “The distal handle, hub, or knob may consist of additional movable knobs, levers, etc. for providing catheter tip deflection from straight to fully curved. Another embodiment may consist of some or all of the following additional controls for tightening and loosening said deflection, a control for changing the point of deflection and thereby altering the radius of curvature” (e.g. para. [0034]).
However, Cohen modified by Germain and Schiemanck does not explicitly teach a first locking mechanism for steering and locking the distal tip in a desired configuration.
Osypka ‘655 discloses a catheter assembly (e.g. catheter assembly 110 Fig. 1A) that includes a handle (e.g. 116) that comprises a comprises a defection actuator (e.g. actuation mechanism 120; ) and first locking mechanism (e.g. lock surface 120b, para. [0087]) for steering (e.g. “for steering the deflectable distal end portion 114 of the catheter body 112 in one or more directions (e.g., bi-directionally as shown in this embodiment).”, para. [0086]) and locking the distal tip in a desired configuration (e.g. “includes lock surface 120b on the inside portion of the first half 116a defining an opening between the inside of the handle 116 and the outside thereof. The lock surface 120b includes one or more cam protrusions 120c extending from the lock surface 120b. The cam protrusions 120c include one or more lock protrusion 120d.”, pra. [0087], [0098]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the handle of Cohen modified by Germain and Schiemanck to include a first locking mechanism for steering and locking the distal tip in a desired configuration, as taught by Osypka ‘655, in order to provide an easy to use handle that allows the user to modify the sensitivity of the actuator (‘655, para. [0009], [0098]).
In reference to at least claims 9-10
Cohen modified by Germain and Schiemanck renders obvious an assembly according to claim 1. However, Cohen modified by Germain and Schiemanck does not explicitly teach a wherein the plurality of lumens is encompassed by an outer braided shaft.
Osypka ‘655 discloses a catheter assembly (e.g. catheter assembly 110 Fig. 1A) that includes a shaft (e.g. 112) that includes a plurality of lumens ( e.g. plurality of lumens, Figs. 1N1, 1N2) and an outer braided shaft (e.g. “The braided layer 112c can include any suitable braided structure made up of strands of any suitable material (e.g., biocompatible plastic, fabric, metal). In some embodiments, the braided layer 112 is formed into the one or more of the outer layer 112a and/or the secondary layer 112b such that the outer layer 112a and/or secondary layer 112b have braiding or mesh included therein (e.g., via over molding biocompatible plastic on a braded/mesh tubing).”, para. [0072]), a handle (e.g. 116) that has a defection actuator (e.g. actuation mechanism 120; ) and first locking mechanism (e.g. lock surface 120b, para. [0087]) for steering (e.g. “for steering the deflectable distal end portion 114 of the catheter body 112 in one or more directions (e.g., bi-directionally as shown in this embodiment).”, para. [0086]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the shaft of Cohen modified by Germain and Schiemanck to include the plurality of lumens being encompassed by an outer braided shaft, as taught by Osypka ‘655, providing reinforcement to the shaft in order to enhance control and resist kinking during use.
In reference to at least claim 13
Cohen modified by Germain and Schiemanck renders obvious an assembly according to claim 1. Cohen further discloses wherein the handle (e.g. handle 14 located on a proximal end), comprises a defection actuator for steering (e.g. “The distal handle, hub, or knob may consist of additional movable knobs, levers, etc. for providing catheter tip deflection from straight to fully curved. Another embodiment may consist of some or all of the following additional controls for tightening and loosening said deflection, a control for changing the point of deflection and thereby altering the radius of curvature”, para. [0034]; “Optionally the catheter is steerable with inherent means to control the radius of curvature of the distal portion. In addition, other deflections and curvatures can be achieved by additional pull wires, levers, and mechanisms concealed within said catheter.”, para. [0035]). Cohen further discloses that “The distal handle, hub, or knob may consist of additional movable knobs, levers, etc. for providing catheter tip deflection from straight to fully curved. Another embodiment may consist of some or all of the following additional controls for tightening and loosening said deflection, a control for changing the point of deflection and thereby altering the radius of curvature” (e.g. para. [0034]).
However, Cohen modified by Germain and Schiemanck does not explicitly teach fixation members for a fixed positioning of the handle during long-term operation of the device.
Osypka ‘655 discloses a catheter assembly (e.g. catheter assembly 110 Fig. 1A) that includes a handle (e.g. 116) that comprises a comprises a defection actuator (e.g. actuation mechanism 120; ) and fixation members (e.g. lock surface 120b, para. [0087]) for a fixed positioning of the handle during long-term operation of the device. (e.g. “includes lock surface 120b on the inside portion of the first half 116a defining an opening between the inside of the handle 116 and the outside thereof. The lock surface 120b includes one or more cam protrusions 120c extending from the lock surface 120b. The cam protrusions 120c include one or more lock protrusion 120d.”, pra. [0087], [0098]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the handle of Cohen modified by Germain and Schiemanck to include fixation members for a fixed positioning of the handle during long-term operation of the device, as taught by Osypka ‘655, in order to provide an easy to use handle that allows the user to modify the sensitivity of the actuator (‘655, para. [0009], [0098]).
Claim(s) 4,18, 25-26 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2004/0215139 to Cohen (Cohen) in view of US 2003/0083617 to St. Germain et al. (herein Germain) and US 2015/0157326 to Schiemanck et al. (herein Schiemanck) as applied to claims 1 and 3 further in view of US 2012/0316584 to Miles et al. (Miles).
In reference to at least claim 4
Cohen modified by Germain and Schiemanck renders obvious an assembly according to claim 3.
However, Cohen modified by Germain and Schiemanck does not explicitly teach the expandable anchor being arranged distally to the occlusion device.
Miles discloses a medical device for occluding an opening within tissue of a body (e.g. abstract) which includes a catheter (e.g. 16) and an occlusion device (e.g. occluder system 42) in which the occluder system includes an anchoring device (e.g. anchor system 44) that includes an expandable anchor (e.g. anchor system 44, “In one embodiment, the anchor system 44 may include a plurality of anchor components and an anchor hub system 70. The anchor hub system 70 may be configured to be positioned and disposed within or adjacent to the occluder hub system 46. The plurality of anchor components can include, for example, a first anchor component 72 and a second anchor component 74. Each of the first anchor component 72 and the second anchor component 74 may include a pedal or loop configuration (shown in FIGS. 2, 3, 3A, 6A and 6B in an expanded configuration”, para. [0141]-[0142]). Miles further discloses that the anchor system secures the occluder system in its desired position (e.g. para. [0164]). Miles further discloses the expandable anchoring being arranged distally to the occlusion device (e.g. “ While in the expanded configuration, each loop may extend distally of the occluder system 42 and radially outward to a larger configuration than the anchor hub system 70. In other words, at least a portion of the anchor components 72 and 74 extend distally beyond the distal-most portion of the occluder system 42 and radially beyond the radial-most portion of the occluder system as taken from a longitudinal axis 75 extending through the hub system 70.”, para. [0142]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the catheter assembly of Cohen modified by Germain and Schiemanck to include the expandable anchor being arranged distally to the occlusion device, as taught by Miles, in order to secure the occlusion device in its desired position reducing migration of the occlusion device (‘584, para. [0164]).
In reference to at least claim 18
Cohen modified by Germain and Schiemanck renders obvious an assembly according to claim 1.
However, Cohen modified by Germain and Schiemanck does not explicitly teach an anchoring device being made of a resilient material.
Miles discloses a medical device for occluding an opening within tissue of a body (e.g. abstract) which includes a catheter (e.g. 16) and an occlusion device (e.g. occluder system 42) in which the occluder system includes an anchoring device (e.g. anchor system 44) that includes an expandable anchor (e.g. anchor system 44, “In one embodiment, the anchor system 44 may include a plurality of anchor components and an anchor hub system 70. The anchor hub system 70 may be configured to be positioned and disposed within or adjacent to the occluder hub system 46. The plurality of anchor components can include, for example, a first anchor component 72 and a second anchor component 74. Each of the first anchor component 72 and the second anchor component 74 may include a pedal or loop configuration (shown in FIGS. 2, 3, 3A, 6A and 6B in an expanded configuration”, para. [0141]-[0142]). Miles further discloses wherein the anchoring device is made of a resilient material (e.g. “ the anchor segments 72 and 74 and the rings 110 may be laser cut from a sheet of Nitinol material in the shape of the intended fully expanded configuration”, para. [0157]) and that the anchor system secures the occluder system in its desired position (e.g. para. [0164]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the catheter assembly of Cohen modified by Germain and Schiemanck to include the anchoring device being made of a resilient material, as taught by Miles, in order to provide structural features of the occlusion device that facilitate delivery and release of the device through a catheter system or medical device system (‘584, para. [0186]).
In reference to at least claim 25
Cohen modified by Germain and Schiemanck renders obvious an assembly according to claim 1. Cohen further discloses the occlusion of the coronary sinus (e.g. placed in coronary sinus, Figs. 6-9) and an anchoring device (e.g. “anchor 138”, Fig. 9, para. [0119]).
However, Cohen does not explicitly teach the anchoring device for anchoring the occlusion device in the ostium.
Miles discloses a medical device for occluding an opening within tissue of a body (e.g. abstract) which includes a catheter (e.g. 16) and an occlusion device (e.g. occluder system 42) in which the occluder system includes an anchoring device (e.g. anchor system 44) that includes an expandable anchor (e.g. anchor system 44, “In one embodiment, the anchor system 44 may include a plurality of anchor components and an anchor hub system 70. The anchor hub system 70 may be configured to be positioned and disposed within or adjacent to the occluder hub system 46. The plurality of anchor components can include, for example, a first anchor component 72 and a second anchor component 74. Each of the first anchor component 72 and the second anchor component 74 may include a pedal or loop configuration (shown in FIGS. 2, 3, 3A, 6A and 6B in an expanded configuration”, para. [0141]-[0142]). Miles further discloses the occluder system being anchored in an ostium (e.g. “Before deploying the occluder system 42, the physician may initially manipulate the distal portion 20 of the delivery system 10 distal of the ostium 9 of the LAA 5.”, para. [0150]) and that the anchor system secures the occluder system in its desired position (e.g. para. [0164]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the catheter assembly of Cohen modified by Germain and Schiemanck to include an anchoring device for anchoring the occlusion device in the ostium, as taught by Miles, in order to secure the occlusion device in its desired position reducing migration of the occlusion device (‘584, para. [0164]).
In reference to at least claim 26
Cohen modified by Germain and Schiemanck renders obvious an assembly according to claim 3.
Miles discloses a medical device for occluding an opening within tissue of a body (e.g. abstract) which includes a catheter (e.g. 16) and an occlusion device (e.g. occluder system 42) in which the occluder system includes an anchoring device (e.g. anchor system 44) that includes an expandable anchor (e.g. anchor system 44, “In one embodiment, the anchor system 44 may include a plurality of anchor components and an anchor hub system 70. The anchor hub system 70 may be configured to be positioned and disposed within or adjacent to the occluder hub system 46. The plurality of anchor components can include, for example, a first anchor component 72 and a second anchor component 74. Each of the first anchor component 72 and the second anchor component 74 may include a pedal or loop configuration (shown in FIGS. 2, 3, 3A, 6A and 6B in an expanded configuration”, para. [0141]-[0142]). Miles further discloses wherein the expandable anchor consists of individual expandable members (e.g. anchor system 44, “In one embodiment, the anchor system 44 may include a plurality of anchor components and an anchor hub system 70. The anchor hub system 70 may be configured to be positioned and disposed within or adjacent to the occluder hub system 46. The plurality of anchor components can include, for example, a first anchor component 72 and a second anchor component 74. Each of the first anchor component 72 and the second anchor component 74 may include a pedal or loop configuration (shown in FIGS. 2, 3, 3A, 6A and 6B in an expanded configuration”, para. [0141]-[0142]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the catheter assembly of Cohen modified by Germain and Schiemanck to include the expandable anchor consisting of individual expandable members, as taught by Miles, in order to secure the occlusion device in its desired position reducing migration of the occlusion device (‘584, para. [0164]).
In reference to at least claim 29
Cohen modified by Germain, Schiemanck and Miles renders obvious a catheter assembly according to claim 18. Miles further discloses wherein the resilient material is a shape memory material (e.g. “ the anchor segments 72 and 74 and the rings 110 may be laser cut from a sheet of Nitinol material in the shape of the intended fully expanded configuration”, para. [0157]) and that the anchor system secures the occluder system in its desired position (e.g. para. [0164]).
Claim(s) 12 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2004/0215139 to Cohen (herein Cohen) in view of US 2003/0083617 to St. Germain et al. (herein Germain), US 2015/0157326 to Schiemanck et al. (herein Schiemanck) and US 2015/0057655 to Osypka ( herein Osypka ’655) as applied to claim 2 further in view of US 2012/0316584 to Miles et al. (Miles).
In reference to at least claim 12
Cohen modified by Germain and Schiemanck and Osypka ‘655 renders obvious an assembly according to claim 2.
Miles discloses a medical device for occluding an opening within tissue of a body (e.g. abstract) which includes a catheter (e.g. 16) and an occlusion device (e.g. occluder system 42) in which the occluder system includes an anchoring device (e.g. anchor system 44) that includes an expandable anchor (e.g. anchor system 44, “In one embodiment, the anchor system 44 may include a plurality of anchor components and an anchor hub system 70. The anchor hub system 70 may be configured to be positioned and disposed within or adjacent to the occluder hub system 46. The plurality of anchor components can include, for example, a first anchor component 72 and a second anchor component 74. Each of the first anchor component 72 and the second anchor component 74 may include a pedal or loop configuration (shown in FIGS. 2, 3, 3A, 6A and 6B in an expanded configuration”, para. [0141]-[0142]). Miles further discloses a second locking mechanism for axially locking the anchor with respect to the occlusion device (e.g.” Movement of the actuation knob 1016 from the second position 1022 to the third position 1024 in the channel 1018 may lock the anchor portion 1014 to the anchors deployed position”, para. [0263]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the catheter assembly of Cohen to include a second locking mechanism for axially locking the anchor with respect to the occlusion device, as taught by Miles, in order to reduce the likelihood of inadvertently releasing the occlusion device (‘584, para. [0271]).
In reference to at least claim 27
Cohen modified by Germain, Schiemanck, Osypka ‘655 and Miles renders obvious a catheter assembly according to claim 12. Miles further discloses wherein the second locking mechanism is a rotational knob located around the center of the proximal handle (e.g.” Movement of the actuation knob 1016 from the second position 1022 to the third position 1024 in the channel 1018 may lock the anchor portion 1014 to the anchors deployed position”, para. [0263]).
Response to Arguments
35 USC 102 – Anticipation
Applicant’s arguments, see 8-9, filed 2/25/2026, with respect to the rejection(s) of claim(s) 1,11 and 14-15 using Osypka under 35 USC 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn in view of the claim amendments requiring the catheter assembly to include a diameter of 5-20 mm, measuring the pressure at the distal tip, an anchoring device and the distal end being deflectable and/or steerable. However, upon further consideration, a new ground(s) of rejection is made in view of Cohen, Germain and Schiemanck, see rejection above.
Applicant’s arguments, see 8-9, filed 2/25/2026, with respect to the rejection(s) of claim(s) 1,7-8,11 and 14-15 using Cohen under 35 USC 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn in view of the claim amendments requiring the catheter assembly to include a diameter of 5-20 mm, measuring the pressure at the distal tip, an anchoring device and the distal end being deflectable and/or steerable. However, upon further consideration, a new ground(s) of rejection is made in view of Germain and Schiemanck, see rejection above.
35 USC 103 – Obviousness
Applicant's arguments regarding the 103 rejections, see pg. 10 filed 2/25/2026 have been fully considered but they are not persuasive. Applicant argues “None of the cited documents describes more than two features of the list of the newly amended claim 1. Starting from Cohen `139 as closest prior art, the skilled person has no incentive to combine the cited document to arrive at the claimed subject-matter. However, if the skilled person would still try to combine all documents, only a fundamental reconstruction of the Cohen `139 catheter can lead to the claimed subject-matter which cannot support obviousness.”, see pg. 10 of response filed 2/25/2026. This is not persuasive. The combination of Cohen, Germain and Schiemanck renders obvious the claimed invention, see 103 rejection above. 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, there is some teaching, suggestion, or motivation to do so found in the references themselves. Regarding the diameter of 5-20 mm, as stated in the rejection above, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the occlusion device of Cohen to include the balloon having a diameter of 5 to 20 mm, as taught by Germain, in order to accommodate variation in patient anatomy and allow the surgeon to vary constriction to adjust cerebral blood flow rate to the desired level (‘617, para. [0142]). Regarding the means for measuring pressure, as stated in the rejection above, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the catheter system of Cohen to include means of measuring the pressure at the distal tip of the catheter assembly and distally to the occlusion device using an optical pressure sensor, as taught by Schiemanck, in order to allow pressure and other parameters indicative of hemodynamic performance to be monitored protecting the coronary sinus from an overly pressurized balloon device (e.g. ‘326, para. [0039], [0049]).
Conclusion
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 JENNIFER L GHAND whose telephone number is (571)270-5844. The examiner can normally be reached Mon-Fri 7:30AM - 3:30PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JENNIFER MCDONALD can be reached at (571)270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JG/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
Prosecution Insights