DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Species A, Claims 34-48, 50-56, 60-75 and 77 in the reply filed on 1/28/2026 is acknowledged.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 52 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 52 recites “wherein a first end of the wired catheter is located outside a body, and a second end of the wired catheter is located inside the body in proximity to the electrode array.” Claim 52 requires a human organism.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 47 and 70 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Claim 47, Claim 47 recites “wherein the plurality of electrodes comprises a massive number of electrodes.” The Present Specification does not elaborate on what number of electrodes constitutes a “massive” number of electrodes. For example, the Present Specification provides no guidance as to whether a “massive” number of electrodes is contemplated as a dozen electrodes or one thousand electrodes. Accordingly, one of ordinary skill in the art would be unable to deduce from the written description what the term “massive” means with respect to the number of electrodes.
Regarding Claim 70, Claim 70 recites “wherein the separately insulated conductive traces comprise a large number of braided conductive traces.” The Present Specification does not elaborate on what number of braided conductive traces constitutes a “large” number of braided conductive traces. For example, the Present Specification provides no guidance as to whether a “large” number of electrodes is contemplated as two braided conductive traces or one thousand braided conductive traces. Accordingly, one of ordinary skill in the art would be unable to deduce from the written description what the term “large” means with respect to the number of braided conductive traces.
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 44-46, 61, 62, 68, 69 and 77, and Claims 47, 48, 50, 51, 65 and 66 by dependency, 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.
Regarding Claim 44, Claim 44 recites “wherein the high-density connector system is configured to enable temporary electrical interfacing with a plurality of electrodes deployed in a body in minimally invasive fashion in proximity to electrophysiologically active tissue, while maintaining normal physiologic conditions in the tissue.” It is grammatically unclear whether the limitation “in minimally invasive fashion in proximity to electrophysiologically active tissue, while maintaining normal physiologic conditions in the tissue” modifies the recited “a plurality of electrodes deployed in a body” of the “high-density connector system.”
For purposes of this Office Action, the limitation “in minimally invasive fashion in proximity to electrophysiologically active tissue, while maintaining normal physiologic conditions in the tissue” is being interpreted to modify the recited “plurality of electrodes.”
Regarding Claim 45, Claim 45 recites “wherein the temporary electrical interfacing may last for one or more hours.” It is unclear in what sense the amount of time the interfacing lasts limits the structure of the claimed device. See MPEP 2173.05(p)(II).
Regarding Claim 46, Claim 46 recites “wherein the temporary electrical interfacing may last for one or more days.” It is unclear in what sense the amount of time the interfacing lasts limits the structure of the claimed device. See MPEP 2173.05(p)(II)
Regarding Claim 61, Claim 61 recites “wherein the catheter has a diameter of approximately 2 mm (6 French).” It is unclear in what sense the term “approximately” modifies the recited measurement.
Claims 62, 68 and 69 recite similar limitations, and are similarly indefinite based on term “approximately.”
Regarding Claim 69, Claim 69 recites “wherein the catheter has a bore ranging in size from approximately less than 0.1 mm to approximately greater than 10 mm.” It is grammatically unclear in what sense the term “ranging in size” modifies the limitation “from approximately less than 0.1 mm to approximately greater than 10 mm.” For example, the term “ranging in size” may suggest a taper, or may suggest a range of possible sizes.
For purposes of this Office Action, the above limitation is being interpreted to recite a range of potential sizes.
Regarding Claim 77, Claim 77 recites “wherein the rotating hemostatic valve is attached to an end of the catheter, with dual ports, allowing fluids to be flushed through the catheter during operation.” It is grammatically unclear in what sense the term “with dual ports” modifies the remainder of the claim. For example, it is unclear whether the rotating hemostatic valve has dual ports, whether the catheter has dual ports, or something else.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 34 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2012/0259238 A1 to Gunday et al. (“Gunday”).
Regarding Independent Claim 34, Gunday discloses:
A high-density connector system comprising: (Para. [0019], “These and other objectives are achieved, in one advantageous embodiment, by the provision of an electrically conductive mesh affixed to a balloon catheter. The balloon catheter may be inserted into the cavity to measure and provide a three-dimensional image of the interior of the cavity. As the balloon catheter is inflated and conforms to the inner surface area of the cavity, the electrically conductive mesh is stretched based on the inner surface area of the cavity;” Para. [0067]);
The preamble recitation “a high-density connector system” is being interpreted to recite a system that includes the components that the system is claimed to be comprised of. Gunday’s “electrically conductive mesh” and the “integrated circuits” associated therewith are such a “high-density connector system” as claimed, as it includes the structure required of such a system.
one or more multiplexing integrated circuits, (Para. [0067], “The integrated circuits 162 may include multiplexer(s) and de-multiplexer(s), which may be connected to a computer 112, 112′, 112″ via serial data in 170, serial data out 172, clock 174, power 176 and ground 178.”);
wherein the one or more multiplexing integrated circuits are configured for catheter deployment, (Para. [0068], “The integrated circuit(s) 162 are provided as a very small package suitable to be mounted in a catheter tubing (FIGS. 5 & 6).”);
wherein power and data lines of the one or more multiplexing integrated circuits are disposed within a wall of the catheter. (Para. [0021], “The mesh affixed to the surface of the balloon catheter may, for example, comprise a fiber mesh. It is contemplated that the mesh may be affixed to either the outer or inner surface of the balloon catheter;” Para. [0022], “The fiber mesh may comprise lycra, polyurethane, composite springs, or other appropriate material and will include electrical lines (or strings) therein that will vary in electrical characteristics depending upon the stretching or displacement of the mesh.”).
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.
Claims 34-37, 40, 52, 60, 63 and 67 are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0184799 A1 to Kipke et al. (“Kipke”) in view of US 5,562,722 A to Racz et al. (“Racz”) as evidenced by fiberwdm.com, "What are the advantages of multiplexing;" https://www.fiberwdm.com/blog/what-are-the-advantages-of-multiplex ing_b101, published 3/28/2023, accessed 2/11/2026.
Regarding Independent Claim 34, Kipke teaches:
A high-density connector system comprising: (Abstract, “An improved deformable carrier or connector for an implantable neural interface device is described.”);
one or more multiplexing integrated circuits, (Para. [0043], “… the second electrical, subsystem may be a printed circuit board with or without on-board integrated circuits, comprise an on-chip circuitry for signal conditioning, filtering, or stimulus generation, be an Application Specific Integrated Circuit (ASIC), a multiplexer chip…”);
wherein the one or more multiplexing integrated circuits are configured for [carrier] deployment, (Para. [0020], “In that respect, the novel carrier 12 facilitates insertion or implantation of the electrode array 14 into body tissue and, once implanted, helps mitigate or eliminate drift (movement) of the implanted electrode array 14 within the tissue;” Para. [0022], “The neural interface device 10 has been implanted into the brain tissue with the electrode array 14 residing at a target tissue site 28.”);
Kipke’s “multiplexing integrated circuits” are configured for deployment via Kipke’s “carrier,” but Kipke uses a “carrier” rather than a catheter. Although Kipke’s “carrier” is of similar structure to a catheter, Kipke does not fairly teach “wherein the carrier is a catheter.” This deficiency is addressed below.
wherein power and data lines of the one or more multiplexing integrated circuits are disposed within a wall of the [carrier] (Para. [0021], “The conductor 20 preferably has coiled or otherwise stretchable or deformable sections 20A that coincide with the deformable segments 18 in the carrier 12 of the neural interface device 10. The conductor 20 is preferably a thin-film structure containing multiple individually conductive traces, but may be a wire or any suitable conductive material. The conductor 20 may be wound around the external surface of the carrier 12, wound within a wall of the carrier, or wound around an internal surface of the carrier.”).
Similarly to as explained above, the “power and data lines” (i.e., “conductor 20”) of Kipke’s “multiplexing integrated circuits” are disposed within a wall as claimed, but are disposed within a wall of Kikpe’s “carrier” rather than a catheter. Although Kipke’s “carrier” is of similar structure to a catheter, Kipke does not fairly teach “wherein the carrier is a catheter.” This deficiency is addressed below.
Kipke teaches a “carrier” rather than a catheter, and thus does not disclose:
configured for catheter deployment
within a wall of the catheter
Racz describes “An electrical stimulation catheter system particularly suited for treating the epidural space of a patient, which includes a multiple electrode stimulation catheter…” (Abstract). Racz is analogous art.
Racz remedies the deficiency of Kipke in that Racz explicitly teaches “wherein the carrier is a catheter.”
Racz teaches:
configured for catheter deployment (Abstract, “An electrical stimulation catheter system particularly suited for treating the epidural space of a patient, which includes a multiple electrode stimulation catheter, a stiffening element for the catheter and a device for securing an implanted catheter to the patient.”);
within a wall of the catheter (Col. 4, Ln. 6-9, “An electrical insulator 24 covers a portion of wire 22 and substantially the length of catheter 10…;” see also Col. 4, Ln. 62-64; Col. 6, Ln. 23-27)
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kipke with the teachings of Racz (i.e., to modify the device of Kipke such that its carrier is instead such a catheter as taught by Racz) in order to facilitate implantation into a patient for providing optimal positioning and treatment (Racz at Col. 2, Ln 35-38).
Regarding Claim 35, the combination of Kipke and Racz renders obvious the entirety of Claim 34 as explained above.
Racz additionally teaches:
wherein the catheter comprises a wired catheter, wherein the wall of the wired catheter contains individually insulated wires (Col. 4, Ln. 6-9, “An electrical insulator 24 covers a portion of wire 22 and substantially the length of catheter 10…;” see also Col. 4, Ln. 62-64; Col. 6, Ln. 23-27).
Racz’s “wire 22” (Col. 4, Ln. 6-9) and “electrically conducting ribbons 36, 38 and 80” (Col. 6, Ln. 23-27) are such “individually insulated wires” as claimed.
Regarding Claim 36, the combination of Kipke and Racz renders obvious the entirety of Claim 35 as explained above.
Racz additionally teaches:
wherein the individually insulated wires are exposed at a first end of the catheter and a second end of the wired catheter (Col. 6, Ln. 23-27, “The proximal ends of electrically conducting ribbons 36, 38 and 80 can extend out of the proximal end of the catheter, where they will be partially covered with a shrink wrap tubing to prevent short circuit as shown at 40 in FIG. 2;” Fig. 2, “wire 22” and “electrically conducting ribbons 36, 38 and 80”).
Racz’s wires (i.e., “wire 22” and “electrically conducting ribbons 36, 38 and 80”) are exposed at “the proximal end of the catheter” from which the extend (i.e., “a first end”) and the point where they connect to Racz’s “flexible electrodes 12, 14” (i.e., “a second end”).
Regarding Claim 37, the combination of Kipke and Racz renders obvious the entirety of Claim 35 as explained above.
Racz additionally teaches:
wherein the wired catheter is configured for use with an electrode array (Abstract, “An electrical stimulation catheter system particularly suited for treating the epidural space of a patient, which includes a multiple electrode stimulation catheter…. Preferably, leads for each electrode are secured to slideable rings around the proximal end of the catheter to prevent entanglement and confusion of the leads.”).
Regarding Claim 40, the combination of Kipke and Racz renders obvious the entirety of Claim 37 as explained above.
Racz additionally teaches:
wherein the individually insulated wires are connected to a subset of electrodes of the electrode array. (Col. 3, Ln. 1-4, “… first and second electrically conducting wires which interconnect the first and second flexible electrodes with the electrical stimulation power source.”).
Regarding Claim 52, the combination of Kipke and Racz renders obvious the entirety of Claim 37 as explained above.
Kipke additionally teaches:
wherein a first end of the wired catheter is located outside a body, and a second end of the wired catheter is located inside the body in proximity to the electrode array. (Fig. 2; Para. [0022]).
Regarding Claim 60, the combination of Kipke and Racz renders obvious the entirety of Claim 34 as explained above.
Kipke additionally teaches:
wherein the multiplexing integrated circuits comprise a multiplexer custom application specific integrated circuit (ASIC) (Para. [0043], “For example, the second electrical, subsystem may be a printed circuit board with or without on-board integrated circuits, comprise an on-chip circuitry for signal conditioning, filtering, or stimulus generation, be an Application Specific Integrated Circuit (ASIC),…”)
Regarding Claim 63, the combination of Kipke and Racz renders obvious the entirety of Claim 60 as explained above.
Kipke additionally teaches:
wherein the catheter is a wired catheter and the multiplexer ASIC is configured to increase a bandwidth of the wired catheter. (Para. [0043], “For example, the second electrical, subsystem may be a printed circuit board with or without on-board integrated circuits, comprise an on-chip circuitry for signal conditioning, filtering, or stimulus generation, be an Application Specific Integrated Circuit (ASIC),…”)
Multiplexing inherently increases bandwidth. See, e.g., fiberwdm.com, "What are the advantages of multiplexing;" https://www.fiberwdm.com/blog/what-are-the-advantages-of-multiplex ing_b101, published 3/28/2023, accessed 2/11/2026. The limitation “is configured to increase bandwidth…” is thus being interpreted as an intended use of the recited multiplexing. Kipke’s ASIC accomplishes this.
Regarding Claim 67, the combination of Kipke and Racz renders obvious the entirety of Claim 34 as explained above.
Racz additionally discloses:
wherein the power and data lines are separately insulated conductive traces (Col. 4, Ln. 6-9, “An electrical insulator 24 covers a portion of wire 22 and substantially the length of catheter 10…;” see also Col. 4, Ln. 62-64; Col. 6, Ln. 23-27).
Claims 38 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0184799 A1 to Kipke et al. (“Kipke”) in view of US 5,562,722 A to Racz et al. (“Racz”) as applied to Claim 37 above, and further in view of US 2010/0292602 A1 to Worrell et al. (“Worrell”).
Regarding Claim 38, the combination of Kipke and Racz renders obvious the entirety of Claim 37 as explained above.
The combination of Kipke and Racz does not disclose:
wherein the electrode array comprises an endovascular electrode array
Worrell describes “microelectrode arrays” useful for detecting epileptic events (Worrell at Para. [0045]). Worrell is analogous art.
Worrell teaches:
wherein the electrode array comprises an endovascular electrode array (Para. [0065], “The device operates on data from one or more scalp, subgaleal, epidural, subdural, intraparenchymal, endovascular electrodes, or a combination thereof. “).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Kipke and Racz with the teachings of Worrell (i.e., to modify the device of combined Kipke and Racz so that it is used in conjunction with such an endovascular electrode array as taught by Worrell) in order to facilitate detection of epileptic events by allow for detection of “microseizures” Worrell at Para. [0045]).
Regarding Claim 41, the combination of Kipke, Racz and Worrell renders obvious the entirety of Claim 38 as explained above.
Worrell additionally teaches:
wherein the individually insulated wires run from an interface in a brain to amplification or recording electronics external to the brain (Fig. 19, Para. [0066], “A sensing subsystem detects the response to the electrical stimulation and is coupled to a CPU and analysis module to calculate the frequency or other response signals. An output module initiates interventions or patient reporting. The device components can be enclosed in a biocompatible housing.”)
Worrell’s “electrodes” shown in Fig. 19 are such an interface, and Worrell’s “CPU and analysis module” is such “recording electronics” as claimed.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of combined Kipke, Racz and Worrell (i.e., to modify the device of combined Kipke, Racz and Worrell such that Kipke’s insulated wires extend from Worrell’s electrodes to Worrell’s “CPU and analysis module”) in order to “measure the response of a region of a patient's brain using wide-band stimulation” (Worrell at Para. [0066]).
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0184799 A1 to Kipke et al. (“Kipke”) in view of US 5,562,722 A to Racz et al. (“Racz”) as applied to Claim 37 above, and further in view of US 20050251219 A1 to Evans (“Evans”).
Regarding Claim 39, the combination of Kipke and Racz renders obvious the entirety of Claim 37 as explained above.
The combination of Kipke and Racz does not disclose:
wherein the electrode array comprises an endoscopic electrode array
Evans describes “placement of an instrument, specifically electrodes, in the GI tract allows for placement of electrodes for gastric electrical stimulation into the gastric wall using endoscopic techniques” (Abstract). Evans is analogous art.
Evans teaches:
wherein the electrode array comprises an endoscopic electrode array (Para. [0013], “The device and method for placement of electrodes or other instruments in the GI tract allows for placement of electrodes for GES into the gastric wall using endoscopic techniques.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Kipke and Racz with the teachings of Evans (i.e., to modify the device of combined Kipke and Racz such that its electrode array is such an endoscopic electrode array as taught by Evans) in order to “stimulate contractions in the gastrointestinal (GI) tract” (Evans at Para. [0005]) while minimizing “the surgically invasive nature of procedures used to implant electrodes, and … risks associated with general anesthesia and surgical techniques including bleeding, infection, pain, and others” (Evans at Para. [0011]).
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0184799 A1 to Kipke et al. (“Kipke”) in view of US 5,562,722 A to Racz et al. (“Racz”) as applied to Claim 37 above, and further in view of US 20050256541 A1 to Stypulkowski (“Stypulkowski”).
Regarding Claim 42, the combination of Kipke and Racz renders obvious the entirety of Claim 37 as explained above.
The combination of Kipke and Racz does not disclose:
wherein the wired catheter is configured to test the electrode array
Stypulkowski describes a “Catheter With Temporary Stimulation Electrode” (Title). Stypulkowski is analogous art.
Stypulkowski teaches:
wherein the wired catheter is configured to test the electrode array (Abstract, “A stylet having at least one temporary stimulation electrode disposed at its distal end is removably positioned within a lumen of the catheter. A test stimulation is delivered via the temporary stimulation electrode to produce a patient response.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Kipke and Racz with the teachings of Stypulkowski (i.e., to configure the wired catheter of combined Kipke and Racz to test the electrode array in the manner of Stypulkowski) in order to ensure proper positioning (Stypulkowski at Abstract).
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0184799 A1 to Kipke et al. (“Kipke”) in view of US 5,562,722 A to Racz et al. (“Racz”) and US 2010/0292602 A1 to Worrell et al. (“Worrell”) as applied to Claim 41 above, and further in view of US 2009/0240314 A1 to Kong et al. (“Kong”).
Regarding Claim 43, the combination of Kipke, Racz and Worell renders obvious the entirety of Claim 41 as explained above.
The combination of Kipke, Racz and Worrell does not disclose:
wherein the electrode array is an electrode array with one or more on-board multiplexers
Kong describes “an implantable electrode lead system that includes a series of shims stacked upon each other, a series of first components, and a series of second components connected to the series of first components through a series of connectors” (Abstract). Kong is analogous art.
Kong teaches:
wherein the electrode array is an electrode array with one or more on-board multiplexers (Para. [0042], “…the total number of active channels required for the mutually coupling interconnection feature can be reduced by utilizing the on-board multiplexing circuitries such that the ratio of active interconnection channels to the total number of the electrode sites from the electrode lead assembly 100 is 1:2 or greater.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Kipke, Racz and Worrell with the teachings of Kong (i.e., to modify the electrode array of combined Kipke, Racz and Worrell such that it is an electrode array with one or more on-board multiplexers as taught by Kong) in order to reduce the total number of active channels required by the device (Kong at Para. [0042]).
Claims 44-46 are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0184799 A1 to Kipke et al. (“Kipke”) in view of US 5,562,722 A to Racz et al. (“Racz”) as applied to Claim 34 above, and further in view of US 8,147,275 B1 to Drake et al. (“Drake”).
Regarding Claim 44, the combination of Kipke and Racz renders obvious the entirety of Claim 34 as explained above.
The combination of Kipke and Racz does not disclose:
wherein the high-density connector system is configured to enable temporary electrical interfacing with a plurality of electrodes deployed in a body in minimally invasive fashion in proximity to electrophysiologically active tissue, while maintaining normal physiologic conditions in the tissue
Drake describes “adapters for implantable medical electrical leads and more particularly to adapters that provide an interface facilitating temporary electrical connection with a medical device” (Col. 1, Ln. 7-11). Drake is analogous art.
Drake teaches:
wherein the high-density connector system is configured to enable temporary electrical interfacing (Abstract, “An interface adapter for an implantable medical electrical lead facilitates temporary electrical connection between an external medical device and a connector terminal of the lead.”);
with a plurality of electrodes deployed in a body in minimally invasive fashion in proximity to electrophysiologically active tissue, while maintaining normal physiologic conditions in the tissue (Col. 3, Ln. 21-29, “FIG. 1 is a schematic showing a portion of a body 30 of a patient in which a medical electrical lead 32, for example, a cardiac lead, has been implanted, such that a proximal portion thereof extends outside body 30. With reference to FIG. 1, those skilled in the art understand that a distal portion (not shown) of lead 32, to which stimulation and/or sensing electrodes are mounted, has been implanted either endocardially or epicardially, with the assistance of a stylet 46, inserted within a lumen of lead 32….”);
As explained above, the limitation “in minimally invasive fashion in proximity to electrophysiologically active tissue, while maintaining normal physiologic conditions in the tissue” is being interpreted to modify the recited “plurality of electrodes.”
Drake’s electrodes are so-deployed.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Kipke and Racz with the teachings of Drake (i.e., to configure the system of combined Kipke and Racz to enable temporary electrical interfacing in the manner of Drake) in order to “provide an enhanced interface that facilitates temporary electrical connection with external medical devices for lead implant evaluation” (Drake at Col. 1, Ln. 49-50).
Regarding Claim 45, the combination of Kipke, Racz and Drake renders obvious the entirety of Claim 44 as explained above.
Drake additionally teaches:
wherein the temporary electrical interfacing may last for one or more hours (Col. 3, Ln. 37-51).
Drake describes Drake’s temporary electrical interfacing being employed in “temporary pacemakers” and in the context of evaluating implants. In either instance, the electrical interfacing “may” last for the duration claimed.
Regarding Claim 46, the combination of Kipke, Racz and Drake renders obvious the entirety of Claim 44 as explained above.
Drake additionally teaches:
wherein the temporary electrical interfacing may last for one or more days (Col. 3, Ln. 37-51).
Drake describes Drake’s temporary electrical interfacing being employed in “temporary pacemakers” and in the context of evaluating implants. In either instance, the electrical interfacing “may” last for the duration claimed.
Claims 47 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0184799 A1 to Kipke et al. (“Kipke”) in view of US 5,562,722 A to Racz et al. (“Racz”) and US 8,147,275 B1 to Drake et al. (“Drake”) as applied to Claim 44 above, and further in view of US 20130134546 A to Cheng et al. (“Cheng”).
Regarding Claim 47, the combination of Kipke, Racz and Drake renders obvious the entirety of Claim 44 as explained above.
The combination of Kipke, Racz and Drake does not disclose:
wherein the plurality of electrodes comprises a massive number of electrodes
Cheng describes “high density multi-electrode arrays” (Para. [0001]). Cheng is analogous art.
Cheng teaches:
wherein the plurality of electrodes comprises a massive number of electrodes (Para. [0035], “In exemplary embodiments a high density micro-electrode array in accordance with the present disclosure may have an electrode density of greater than approximately one hundred thousand electrodes per square millimeter.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Kipke, Racz and Drake with the teachings of Cheng (i.e., to use as the electrodes of Kipke, Racz and Drake such a “high density multi-electrode array” as taught by Cheng, which comprises a massive number of electrodes) in order to facilitate electrical interfacing with neurons (Cheng at Para. [0002]).
Regarding Claim 48, the combination of Kipke, Racz and Drake renders obvious the entirety of Claim 44 as explained above.
The combination of Kipke, Racz and Drake does not disclose:
wherein the electrophysiologically active tissue comprises neural tissue
Cheng describes “high density multi-electrode arrays” (Para. [0001]). Cheng is analogous art.
Cheng teaches:
wherein the electrophysiologically active tissue comprises neural tissue (Para. [0026], “The periphery circuit may contain one or more of the following units: electrode addressing control, signal amplification and detection, neuron stimulation generation, timing, interface to outside chips/instrumentations, etc.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Kipke, Racz and Drake with the teachings of Cheng (i.e., to modify the device of Kipke, Racz and Drake for use in conjunction with neural tissue in the manner of Cheng’s use) in order to “stimulate or probe brain activity, to stimulate neurons and study the resulting neuron plasticity or to train live neural networks and use them for computation” (Cheng at Para. [0002]).
Claims 50 and 51 are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0184799 A1 to Kipke et al. (“Kipke”) in view of US 5,562,722 A to Racz et al. (“Racz”) and US 8,147,275 B1 to Drake et al. (“Drake”) as applied to Claim 44 above, and further in view of US 2014/0288667 A1 to Oxley (“Oxley”).
Regarding Claim 50, the combination of Kipke, Racz and Drake renders obvious the entirety of Claim 44 as explained above.
The combination of Kipke, Racz and Drake does not disclose:
wherein the catheter is configured to deploy electrode interfaces into fluid-containing compartments where normal fluid flow will be constantly maintained
Oxley describes “An intravascular device for placement within an animal vessel, the intravascular device being adapted to at least one of sense and stimulate activity of neural tissue…” (Abstract). Oxley is analogous art.
Oxley teaches:
wherein the catheter is configured to deploy electrode interfaces into fluid-containing compartments where normal fluid flow will be constantly maintained (Para. [0227], “A hole is drilled through the skin layer, skull and dura, and stimulating electrodes 134 are inserted into the subarachnoid space 136 and subdural space 138 beneath the skull 140…”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Kipke, Racz and Drake with the teachings of Oxley (i.e., to configure the device of Kipke, Racz and Drake for use in the subarachnoid space in the manner described by Oxley) in order to facilitate sensing or stimulating the subject area (Oxley at Para. [0227]).
Regarding Claim 51, the combination of Kipke, Racz, Drake and Oxley renders obvious the entirety of Claim 50 as explained above.
Oxley additionally discloses:
wherein the fluid-containing compartments comprise a ventricular system of a brain, a spinal subarachnoid space, or a venous or arterial system of the brain, or some combination thereof (Para. [0227], “A hole is drilled through the skin layer, skull and dura, and stimulating electrodes 134 are inserted into the subarachnoid space 136 and subdural space 138 beneath the skull 140…”).
Claims 53 and 54 are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0184799 A1 to Kipke et al. (“Kipke”) in view of US 5,562,722 A to Racz et al. (“Racz”) as applied to Claim 37 above, and further in view of US 20130267928 A1 to Imran et al. (“Imran”).
Regarding Claim 53, the combination of Kipke and Racz renders obvious the entirety of Claim 37 as explained above.
The combination of Kipke and Racz does not disclose:
wherein the wired catheter is configured to conform anatomically to a trajectory or a compartment within a body
Imran describes “APPARATUS, SYSTEMS AND METHODS FOR DELIVERY OF MEDICATION TO THE BRAIN TO TREAT NEUROLOGICAL CONDITIONS” (Title). Imran is analogous art.
Imran teaches:
wherein the wired catheter is configured to conform anatomically to a trajectory or a compartment within a body (Para. [0008], “The catheter may comprise any number of biocompatible polymers known in the art including for example silicone, polyurethane, PTFF, etc. In some embodiments, the catheter lumen may also include an inner lining of coiled wire to maintain the patency of the lumen when the catheter is put into a bent or deformed position, such as when it conforms to the shape of a ventricle.”)
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Kipke and Racz with the teachings of Imran (i.e., to modify the device of combined Kipke and Racz such that its wired catheter is made from such materials as described in Imran, thereby enabling it to conform in the manner claimed) in order to prevent deformation of the anatomy into which the device is inserted (Imran at Abstract).
Regarding Claim 54, the combination of Kipke, Racz and Imran renders obvious the entirety of Claim 53 as explained above.
Imran additionally teaches:
wherein the trajectory comprises vascular access from a femoral artery or a femoral vein to a deep venous system of a brain, transcortical insertion into a ventricular system of the brain, venous or arterial access to the brain, or stereotactic access to the ventricular system. (Para. [0008])
Imran’s device is made of a material that conforms to any trajectory, including those above.
Claims 55 and 56 are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0184799 A1 to Kipke et al. (“Kipke”) in view of US 5,562,722 A to Racz et al. (“Racz”) as applied to Claim 35 above, and further in view of US 7937152 B1 to Lozano et al. (“Lozano”).
Regarding Claim 55, the combination of Kipke and Racz renders obvious the entirety of Claim 35 as explained above.
The combination of Kipke and Racz does not disclose:
wherein the wired catheter establishes access to an anatomical target, and conformable, foldable, rollable, or otherwise collapsible electrode arrays may be deployed through the wired catheter to a location inside the anatomical target.
Lozano describes “Systems and methods for treating pain using brain stimulation” (Title). Lozano is analogous art.
Lozano teaches:
wherein the wired catheter establishes access to an anatomical target, and conformable, foldable, rollable, or otherwise collapsible electrode arrays may be deployed through the wired catheter to a location inside the anatomical target. (Col. 6, Ln. 21-44)
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Kipke and Racz with the teachings of Lozano (i.e., to use such a collapsible electrode as taught by Lozano in the device of Kipke and Racz) in order to regulate forces applied during implantation (Lozano at Col. 3, Ln. 37-43).
Regarding Claim 56, the combination of Kipke, Racz and Lozano renders obvious the entirety of Claim 55 as explained above.
Lozano additionally teaches:
wherein the anatomical target comprises a brain (Col. 6, Ln. 40-44)
Claims 61 and 62 are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0184799 A1 to Kipke et al. (“Kipke”) in view of US 5,562,722 A to Racz et al. (“Racz”) as applied to Claim 60 above, and further in view of US 2016/0095535 A1 to Hettrick et al. (“Hettrick”) as evidenced by Wikipedia, "French catheter scale," https://en.wikipedia.org/wiki/French_catheter_scale, accessed 2/11/2026.
Regarding Claim 61, the combination of Kipke and Racz renders obvious the entirety of Claim 60 as explained above.
The combination of Kipke and Racz does not disclose:
wherein the catheter has a diameter of approximately 2 mm (6 French)
Hettrick describes “Systems and methods for evaluating neuromodulation via hemodynamic responses…” which “…include, for example, a neuromodulation catheter comprising an elongated shaft having a distal portion, and a plurality of electrodes spaced along a distal portion” (Abstract). Hettrick is analogous art.
Hettrick teaches:
wherein the catheter has a diameter of approximately 2 mm (6 French) (Para. [0058], “The neuromodulation catheter 602 can include an elongated shaft 608 having a proximal portion 608b, a distal portion 608a, a handle 610 operably connected to the shaft 608 at the proximal portion 608b, and a neuromodulation assembly 620 operably connected to the shaft 608 at the distal portion 608a, The shaft 608 and the neuromodulation assembly 620 can be 2, 3, 4, 5, 6, or 7 French or another suitable size.”)
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Kipke and Racz with the teachings of Hettrick because such a modification entails only a change in size/proportion, which is a common practice that courts have held require only ordinary skill in the art. MPEP2144.04(IV).
Regarding Claim 62, the combination of Kipke, Racz and Hettrik renders obvious the entirety of Claim 60 as explained above.
The combination of Kipke and Racz does not disclose:
wherein the catheter has a diameter of approximately less than 0.5 mm to approximately 4 mm
Hettrick describes “Systems and methods for evaluating neuromodulation via hemodynamic responses…” which “…include, for example, a neuromodulation catheter comprising an elongated shaft having a distal portion, and a plurality of electrodes spaced along a distal portion” (Abstract). Hettrick is analogous art.
Hettrick teaches:
wherein the catheter has a diameter of approximately less than 0.5 mm to approximately 4 mm (Para. [0058], “The neuromodulation catheter 602 can include an elongated shaft 608 having a proximal portion 608b, a distal portion 608a, a handle 610 operably connected to the shaft 608 at the proximal portion 608b, and a neuromodulation assembly 620 operably connected to the shaft 608 at the distal portion 608a, The shaft 608 and the neuromodulation assembly 620 can be 2, 3, 4, 5, 6, or 7 French or another suitable size.”)
Hettrik’s range of any suitable size overlaps the claimed range of 0.5 mm to approximately 4 mm. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Although Hettrik does not disclose the precise range of 0.5 mm to approximately 4 mm as claimed, it would have been obvious for a person of ordinary skill in the art to select any size from Hettrik’s disclosure as doing so would be likely to result in success.
Hettrik’s 2 French corresponds to .67 mm, and Hettrik’s 7 French corresponds to 2.33 mm. Hettrik additionally discloses “another suitable size,” of which 12 French is one. 12 French corresponds to 4 mm. See Wikipedia, "French catheter scale," https://en.wikipedia.org/wiki/ French_catheter_scale, accessed 2/11/2026 at Pg. 2.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Kipke and Racz with the teachings of Hettrick because such a modification entails only a change in size/proportion, which is a common practice that courts have held require only ordinary skill in the art. MPEP2144.04(IV)
Claim 64 is rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0184799 A1 to Kipke et al. (“Kipke”) in view of US 5,562,722 A to Racz et al. (“Racz”) as applied to Claim 63 above, and further in view of US 2014/0303452 A1 to Ghaffari (“Ghaffari”).
Regarding Claim 64, the combination of Kipke and Racz renders obvious the entirety of Claim 63 as explained above.
The combination of Kipke and Racz does not disclose:
wherein the multiplexer ASIC has one or more features of catheter compatibility, the features of catheter compatibility comprising narrow aspect ratio, thinness, or flexibility.
Ghaffari describes “Systems, Methods, and Devices Having Stretchable Integrated Circuitry for Sensing and Delivering Therapy” (Title). Ghaffari is analogous art.
Ghaffari teaches:
wherein the multiplexer ASIC has one or more features of catheter compatibility, the features of catheter compatibility comprising narrow aspect ratio, thinness, or flexibility. (Para. [0111], “The devices can be, or their functionality can include, integrated circuits, processors, controllers, microprocessors, diodes, capacitors, power storage elements, antennae, ASICs, sensors, image elements (e.g. CMOS, CCD imaging elements), amplifiers, A/D and D/A converters, associated differential amplifiers, buffers, microprocessors, optical collectors, transducer including electro-mechanical transducers, piezo-electric actuators, light emitting electronics which include LEDs, logic, memory, clock, and transistors including active matrix switching transistors, and combinations thereof;” Para. [0117], “In some embodiments of the invention, semiconductors are printed onto flexible plastic substrates, creating bendable macro-electronic, micro-electronic, and/or nano-electronic devices.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Kipke and Racz with the teachings of Ghaffari (i.e., to modify the ASIC of combined Kipke and Racz such that it is flexible as taught by Ghaffari) in order to facilitate device conformity to the pertinent anatomic structure, thereby increases measurement accuracy and/or treatment effectiveness (Ghaffari at Paras. [0008] through [0009]).
Claims 65-66 are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0184799 A1 to Kipke et al. (“Kipke”) in view of US 5,562,722 A to Racz et al. (“Racz”) and US 8,147,275 B1 to Drake et al. (“Drake”) as applied to Claim 44 above, and further in view of US 2011/0282179 A1 to Zdeblik (“Zdeblik”).
Regarding Claim 65, the combination of Kipke, Racz and Drake renders obvious the entirety of Claim 44 as explained above.
The combination of Kipke, Racz and Drake does not disclose:
wherein the wired catheter incorporates multiple multiplexing elements
Zdeblik describes a “Shielded stimulation and sensing system and method” in the context of “stimulation or sensing of electrical activity” (Abstract). Zdeblik is analogous art.
Zdeblik teaches:
wherein the wired catheter incorporates multiple multiplexing elements (Para. [0079], “Referring to FIG. 9B, in this embodiment, multiple amplifiers are used to multiplex analog signals down a two-wire bus.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Kipke, Racz and Drake with the teachings od Zdeblik (i.e., to include multiple multiplexing elements in the manner of Zdeblik) in order to facilitate sensing at multiple locations (Zdeblik at Para. [0079]).
Regarding Claim 66, the combination of Kipke, Racz, Drake and Zdeblik renders obvious the entirety of Claim 65 as explained above.
Kipke additionally teaches:
wherein the multiplexer ASIC conditions or controls a signal output from an implanted electrode array, (Para. [0043], “For example, the second electrical, subsystem may be a printed circuit board with or without on-board integrated circuits, comprise an on-chip circuitry for signal conditioning, filtering, or stimulus generation, be an Application Specific Integrated Circuit (ASIC), a multiplexer chip, a buffer amplifier, an electronics interface, an implantable pulse generator, an implantable rechargeable battery, integrated electronics for real-time signal processing of the commands sent to the stimulation electrodes 52 or received from the recording electrodes 54, integrated electronics for control of any fluidic components, and any other suitable electrical subsystem.”);
and the multiplexing elements are connected to power and data leads located in a wall of the wired catheter (Para. [0021], “The conductor 20 preferably has coiled or otherwise stretchable or deformable sections 20A that coincide with the deformable segments 18 in the carrier 12 of the neural interface device 10. The conductor 20 is preferably a thin-film structure containing multiple individually conductive traces, but may be a wire or any suitable conductive material. The conductor 20 may be wound around the external surface of the carrier 12, wound within a wall of the carrier, or wound around an internal surface of the carrier;” Para. [0043]).
Claims 68-69 are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0184799 A1 to Kipke et al. (“Kipke”) in view of US 5,562,722 A to Racz et al. (“Racz”) as applied to Claim 67 above, and further in view of GB 2510452 A to Stovicek (“Stovicek”).
Regarding Claim 68, the combination of Kipke and Racz renders obvious the entirety of Claim 67 as explained above.
The combination of Kipke and Racz does not disclose:
wherein the catheter has a bore of approximately 2 mm (6 French)
Stovicek describes “Method of mapping the heart with a trackable electrode catheter” (Title). Sotivecek is reasonably pertinent to the problem faced by the inventor, and is thus analogous art.
Stovicek teaches:
wherein the catheter has a bore of approximately 2 mm (6 French). (Pg. 26, Ln. 7-12, “This is achieved through a system of preferably a pair (or even a single catheter) or larger set of multi-polar electrode catheters that are non-expandable, at least one of them steerable and capable of delivering cardiac ablation, including cooled type ablation and force-feedback sensing [27], and all of them having usual bore access requirement to the patient's vessels (measured in French units, usually 3-8 Fr (1-2.7mm), see FIG. 4-7).”).
Stovicek’s “1-2.7mm” is “approximately 2 mm.”
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Kipke and Racz with the teachings of Stovicek (i.e., to size the bore of Racz’s catheter between 1-2.7 mm in the manner of Stovicek) in order to comply with standard access requirements to a patient’s vessels (Stovicek at Pg. 26, Ln. 7-12).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Kipke and Racz with the teachings of Stovicek (i.e., to size the bore of Racz’s catheter between 1-2.7 mm in the manner of Stovicek) because such a modification entails only a change in size/proportion, which is a common practice that courts have held require only ordinary skill in the art. MPEP2144.04(IV).
Regarding Claim 69, the combination of Kipke and Racz renders obvious the entirety of Claim 67 as explained above.
The combination of Kipke and Racz does not disclose:
wherein the catheter has a bore ranging in size from approximately less than 0.1 mm to approximately greater than 10 mm
Stovicek describes “Method of mapping the heart with a trackable electrode catheter” (Title). Sotivecek is reasonably pertinent to the problem faced by the inventor, and is thus analogous art.
Stovicek teaches:
wherein the catheter has a bore ranging in size from approximately less than 0.1 mm to approximately greater than 10 mm (Pg. 26, Ln. 7-12, “This is achieved through a system of preferably a pair (or even a single catheter) or larger set of multi-polar electrode catheters that are non-expandable, at least one of them steerable and capable of delivering cardiac ablation, including cooled type ablation and force-feedback sensing [27], and all of them having usual bore access requirement to the patient's vessels (measured in French units, usually 3-8 Fr (1-2.7mm), see FIG. 4-7).”).
Stovicek’s “1-2.7mm” overlaps the claimed range of “less than 0.1 mm to approximately greater than 10 mm.” In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Although Stovicek does not disclose the precise range of less than 0.1 mm to approximately greater than 10 mm as claimed, it would have been obvious for a person of ordinary skill in the art to select any size from Stovicek’s disclosure as doing so would be likely to result in success.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Kipke and Racz with the teachings of Stovicek (i.e., to size the bore of Racz’s catheter between 1-2.7 mm in the manner of Stovicek) in order to comply with standard access requirements to a patient’s vessels (Stovicek at Pg. 26, Ln. 7-12).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Kipke and Racz with the teachings of Stovicek (i.e., to size the bore of Racz’s catheter between 1-2.7 mm in the manner of Stovicek) because such a modification entails only a change in size/proportion, which is a common practice that courts have held require only ordinary skill in the art. MPEP2144.04(IV).
Claims 70-72 are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0184799 A1 to Kipke et al. (“Kipke”) in view of US 5,562,722 A to Racz et al. (“Racz”) as applied to Claims 34 and 67 above, and further in view of US 2005/0060885 A1 to Johnson et al. (“Johnson”).
Regarding Claim 70, the combination of Kipke and Racz renders obvious the entirety of Claim 67 as explained above.
The combination of Kipke and Racz does not disclose:
wherein the separately insulated conductive traces comprise a large number of braided conductive traces.
Johnson describes “Method For Manufacturing Medical Device Having Embedded Traces And Formed Electrodes” (Title). Johnson is analogous art.
wherein the separately insulated conductive traces comprise a large number of braided conductive traces. (Para. [0009], “The conductive wires may be braided, channeled, run through, or formed within the catheter's wall structure.”)
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Kipke and Racz with the teachings of Johnson (i.e., to use such braided traces as taught by Johnson in the device of combined Kipke and Racz) in order to “permit bending and movement of the catheter as necessary” (Johnson at Para. [0009]).
Regarding Claim 71, the combination of Kipke and Racz renders obvious the entirety of Claim 67 as explained above.
The combination of Kipke and Racz does not disclose
wherein a conductive surface of the conductive traces is exposed at a first end of the catheter and a second end of the catheter, so as to support one or more sensors containing a plurality of multiplexers (Para. [0012], “Generally, one method for manufacturing a device with arbitrarily-shaped electrodes may be forming a device body from a nonconductive material, determining a shape for the electrode, forming the electrode from a conductive, biocompatible material in the determined shape, attaching an electrically conductive element (such as a trace or wire) to the electrode, affixing the electrically conductive element and the electrode to a section of the device, overmolding the electrode with an overmold material, and removing a portion of the overmold material above the electrode sufficient to expose the electrode. “).
The recitation “so as to support one or more sensors containing a plurality of multiplexers” is being interpreted as an intended use/purpose of the recited manner of exposing.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Kipke and Racz with the teachings of Johnson (i.e., to use such exposed traces as taught by Johnson in the device of combined Kipke and Racz) in order to facilitate electrical connection (Johnson at Para. [0012]).
Regarding Claim 72, the combination of Kipke and Racz renders obvious the entirety of Claim 34 as explained above.
The combination of Kipke and Racz does not disclose:
wherein the catheter is created using wire braiding or polymer extrusion techniques (Para. [0052], “ Continuing the discussion of FIG. 1, wire or nonconductive fiber of any suitable material (generally, "braided material" or "braided wire" 118) may be braided into a tube 112 section or portion of the jacket 114 to stabilize and stiffen the catheter. Alternatively, such braided material 118 may be co-extruded with a layer or placed between layers.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Kipke and Racz with the teachings of Johnson (i.e., to use such wire braiding or extrusion techniques as taught by Johnson to form the device of combined Kipke and Racz) in order to stabilize and/or stiffen the catheter (Johnson at Para. [0052]).
Claims 73-75 and 77 are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0184799 A1 to Kipke et al. (“Kipke”) in view of US 5,562,722 A to Racz et al. (“Racz”) as applied to Claim 34 above, and further in view of WO 2009/073754 A2 to Ransbury et al. (“Ransbury”) as evidenced by Namba K, Song JK, Niimi Y, Heran NS, Berenstein A. A new hemostasis valve for neuroendovascular procedures. Interv Neuroradiol. 2007 Mar;13(1):51-3.
Regarding Claim 73, the combination of Kipke and Racz renders obvious the entirety of Claim 34 as explained above.
The combination of Kipke and Racz does not disclose:
wherein the catheter is integrated with a rotating hemostatic valve, so as to support deployment of electrode interfaces into fluid-containing compartments.
Ransbury describes “Implantation methods, systems and tools for intravascular implantable devices” (Title). Ransbury is reasonably pertinent to the problem faced by the inventor, and is thus analogous art.
Ransbury teaches:
wherein the catheter is integrated with a rotating hemostatic valve, so as to support deployment of electrode interfaces into fluid-containing compartments (Pg. 16, Ln. 31-35, “In one embodiment, the sheath introducer 250 includes at a proximal end 252 a removable cap assembly 254 with an iris or box fold valve 256 followed upstream by a rotating hemostasis valve 258 that extends into the introducer shaft 260.”).
The limitation “so as to support deployment of electrode interfaces into fluid-containing compartments” is being interpreted as an intended use of the claimed rotating hemostatic valve.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Kipke and Racz with the teachings of Ransbury (i.e., to integrate such a rotating hemostatic valve as is integrated into Ransbury’s introducer into the catheter of combined Kipke and Racz) in order to facilitate introduction of the devices into a patient’s vascular system (Ransbury at Pg 16, Ln. 30-31).
Regarding Claim 74, the combination of Kipke, Racz and Ransbury renders obvious the entirety of Claim 73 as explained above.
Ransbury additionally teaches:
wherein the fluid- containing compartments comprise a brain or a nervous system. (Pg. 16, Ln. 31-35)
Ransbury’s is rotating hemostatic valve capable of such a use. See Namba K, Song JK, Niimi Y, Heran NS, Berenstein A. A new hemostasis valve for neuroendovascular procedures. Interv Neuroradiol. 2007 Mar;13(1):51-3 at Summary (“In neuroendovascular procedures, a hemostasis valve is commonly used for continuous irrigation of guide and microcatheters to decrease the risk of thromboembolism.”).
Regarding Claim 75, the combination of Kipke, Racz and Ransbury renders obvious the entirety of Claim 74 as explained above.
Ransbury additionally teaches:
wherein the fluid- containing compartments comprise a brain or a nervous system. (Pg. 16, Ln. 31-35)
Ransbury’s is rotating hemostatic valve capable of such a use. See Namba K, Song JK, Niimi Y, Heran NS, Berenstein A. A new hemostasis valve for neuroendovascular procedures. Interv Neuroradiol. 2007 Mar;13(1):51-3 at Summary.
Regarding Claim 77, the combination of Kipke, Racz and Ransbury renders obvious the entirety of Claim 73 as explained above.
Ransbury additionally teaches:
wherein the rotating hemostatic valve is attached to an end of the catheter, with dual ports, allowing fluids to be flushed through the catheter during operation (Pg. 16, Ln. 31-35; Pg. 17, Ln. 15-25).
Ransbury’s rotating hemostatic valve accomplishes the use of allowing fluids to be flushed through the catheter during operation by virtue of it being a rotating hemostatic valve. See Namba K, Song JK, Niimi Y, Heran NS, Berenstein A. A new hemostasis valve for neuroendovascular procedures. Interv Neuroradiol. 2007 Mar;13(1):51-3 at Summary.
Conclusion
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/C.J.M./Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796