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 Group I, Species C and Species H (claims 1-5, 9-16 & 20) in the reply filed on August 4th, 2026 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted December 20th, 2024 has been considered by the Examiner.
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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: the “control unit” in claim 20.
In reference to the instant application’s Specification, [0092] describes “The control unit 42 is configured to control the energy source 12. Variable parameter combinations of the parameters voltage, current, pulse duration, pulse frequency, and number of pulses may be controlled to generate electric fields with different properties” such that the control unit is not clearly described as being hardware, software or a combination. Other mentions of a “control unit” throughout the Specification do not provide any further details about the control unit beyond the generic description given in [0092].
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.
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 Rejections - 35 USC § 112
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 9-10 & 20 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 9, the claim recites “wherein the conductive structure generates” in lines 1-2 and it is unclear if this is to be interpreted as an active method step or as a capability of the conductive structure since the claim is presumed to be an apparatus claim. For examination purposes, the limitation will be interpreted as “wherein the conductive structure is configured to generate”.
Regarding claim 10, the claim recites “wherein the conductive structure generates” in lines 1-2 and it is unclear if this is to be interpreted as an active method step or as a capability of the conductive structure since the claim is presumed to be an apparatus claim. For examination purposes, the limitation will be interpreted as “wherein the conductive structure is configured to generate”.
Regarding claim 20, the claim recites “a catheter” and it is unclear if this is the same catheter as that recited in claim 1, from which claim 20 depends, or a different catheter. For examination purposes, these are the same catheters and the limitation will be interpreted as “the catheter”
Regarding claim 20, the claim recites “a control unit” and based on the 112f interpretation above, it is unclear whether this feature is hardware or software or a combination. For examination purposes, any hardware, software, generic computer components or steps for controlling a generator will be interpreted as meeting this limitation.
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 1-5, 9-10, 16 & 20 are rejected under 35 U.S.C. 103 as being unpatentable over Maor et al. (U.S. Pub. No. 20090248012), herein referred to as “Maor” in view of Schorr et al. (U.S. Pub. No. 20190239941), herein referred to as “Schorr”.
Regarding claim 1, Maor discloses a catheter for locally treating a tissue in intravascular and intraluminal spaces (catheter 121; [0009]: A catheter device for insertion into a vessel; [0181]: While the present invention has been described with reference to the specific embodiments thereof, it should be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the true spirit and scope of the invention), the catheter comprising
a flexible, cylindrical body (catheter shaft 119; see flexibility in Fig. 10) having a first lumen (guidewire lumen 125) for receiving a guide wire for controlling the catheter ([0105]; Guidewire lumen 125 may be approximately 0.039'' in diameter and in communication with side arm extension opening 1 to accept a standard guidewire which is used for tracking device 121 to the target location within a vessel), a second lumen (either one of lumen 127 or 129, Fig. 11), and at least one third lumen for separately introducing chemical and/or biological therapeutic agents into the tissue ([0125]: If the electrical generator treatment parameters are set to deliver electrical pulses within the reversible range therapeutic agents may be injected through the catheter lumen to the target lesion site),
a conductive structure (spiral electrode assembly 123) for generating pulsed electric fields ([0014]: an electrical power source which provides electrical pulses; [0111]: When electrical current of opposite polarity is applied to electrodes 85 and 87, an electrical field is generated between the positive spiral electrode 85 and the negative spiral electrode), wherein the conductive structure comprises at least a first structural element (spiral electrode 85) and a second structural element (spiral electrode 87) and extends along a distal end segment of the cylindrical body ([0106]: Catheter shaft 119 extends into and through balloon 35, terminating at open distal tip 139. Helically surrounding the balloon surface is spiral electrode assembly 123, which is comprised of a first and second spiral electrode 85 and 87. In one embodiment, first spiral electrode element 85 is of a positive polarity and second electrode 87 is of a negative polarity), and
a first electrical supply line (electrode wire 133) for connecting the first structural element to an energy source ([0106]: Spiral electrode 85 is connected to first electrode wire 133 and spiral electrode 87 is connected to second electrode wire 135; [0104]: Extending from hub 3 are electrical cable wires 9 which terminate in connectors 11. Connectors 11 are connected to an electrical generator (not shown) to provide an electrical current to the spiral electrode assembly 123 which is coaxially arrangement over balloon 19) and
a second electrical supply line (electrode wire 135) for connecting the second structural element to the energy source ([0106]: Spiral electrode 85 is connected to first electrode wire 133 and spiral electrode 87 is connected to second electrode wire 135; [0104]: Extending from hub 3 are electrical cable wires 9 which terminate in connectors 11. Connectors 11 are connected to an electrical generator (not shown) to provide an electrical current to the spiral electrode assembly 123 which is coaxially arrangement over balloon 19), wherein the first and second supply lines are insulated from each other ([0105]: Wires 133 and 135 are electrically insulated from each other).
But Maor fails to disclose wherein the cylindrical body has radiopaque features.
However, Schorr discloses wherein the cylindrical body has radiopaque features ([0085]: In some embodiments, probe 100 can include means for enhancing the visualization thereof … Such means may be a visible marker, a radiopaque marker or markers). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the cylindrical body of Maor to have radiopaque markers, as taught by Schorr, for the purpose of enhancing visualization of the probe for use with magnetic resonance imaging or ultrasound (Schorr: [0085]).
Regarding claim 2, Maor discloses wherein the conductive structure is disposed on an outer surface of the cylindrical body ([0102]: In a constrained state, as shown in FIG. 8B, electrode assembly 26 is in a collapsed position around shaft 15 and balloon 19).
Regarding claim 3, Maor discloses wherein the conductive structure is disposed on an inner side of the cylindrical body ([0115]: shown in FIG. 18B, balloon electrode assembly 421 may include two or more electrode rings 423 and 425 of opposite polarity. Rings 423 and 425 may be attached to the outer or inner surface of balloon 427, or may be embedded within the balloon wall; wherein the balloon is seen as being part of the catheter shaft/cylindrical body).
Regarding claim 4, Maor discloses wherein the conductive structure is disposed both on an outer side and on the inner side of the cylindrical body ([0115]: shown in FIG. 18B, balloon electrode assembly 421 may include two or more electrode rings 423 and 425 of opposite polarity. Rings 423 and 425 may be attached to the outer or inner surface of balloon 427, or may be embedded within the balloon wall; wherein the balloon is seen as being part of the catheter shaft/cylindrical body and “embedded” is seen as being both inside and outside a surface).
Regarding claim 5, Maor discloses wherein at least the first structural element and the second structural element of the conductive structure are disposed parallel to a longitudinal axis of the cylindrical body ([0117]: FIG. 18D illustrates an embodiment of an electroporation balloon catheter 441 in which a series of opposite polarity prongs 447 and 449 are present in an alternating pattern across the balloon body 451. Electrode 443 is comprised of a plurality of distally extending prongs 447 which may be of a positive polarity. Interspaced between each positive polarity prong 447 are negatively charged proximally extending prongs 449 of electrode 445. The alternating positive and negative polarity electrode prongs create a ablation zone extending radially outward from the balloon body; see Fig. 18D where the electrodes are parallel to the longitudinal axis).
Regarding claim 9, Maor discloses wherein the conductive structure generates pulsed electric fields when a voltage is applied, causing reversible pore formation in cell membranes of the tissue ([0077]: the electrical parameters may be set to create an electrical field that temporarily or reversibly electroporate cellular structures. The smooth muscle cells comprising the target lesion will temporarily permeabilize, allowing the transport of a drug into the intracellular structure; [0120]: Treatment protocol parameters such as pulse width, number of pulses and voltage are set using the generator interface (207); [0125]: If the electrical generator treatment parameters are set to deliver electrical pulses within the reversible range therapeutic agents may be injected through the catheter lumen to the target lesion site).
Regarding claim 10, Maor discloses wherein the conductive structure generates pulsed electric fields when a voltage is applied, causing irreversible pore formation in cell membranes of the tissue ([0078]: The present invention is not specific to any of these embodiments and other embodiments can be used to provide various catheter configurations which include first and second electrodes connected to a power source which provides to the electrodes a sufficient amount of electrical energy to carry out irreversible electroporation on substantially all of the cells in the vessel target area without subjecting the target area or surrounding area to thermal damage; [0120]: Treatment protocol parameters such as pulse width, number of pulses and voltage are set using the generator interface (207); [0124]: When electrical pulses are administered within the irreversible parameter ranges, permanent pore formation occurs in the cellular membrane, resulting ablation of the smooth muscle cells 509 of the vessel wall).
Regarding claim 16, Maor discloses an expandable balloon (balloon 19), wherein the conductive structure extends at least in sections along the balloon ([0106]: Helically surrounding the balloon surface is spiral electrode assembly 123, which is comprised of a first and second spiral electrode 85 and 87).
Regarding claim 20, Maor discloses a catheter system ([0120]: Once correctly positioned within the anatomical lumen, electrical connectors 11 of the catheter 10 are connected to an electrical generator (205)) comprising a catheter according to claim 1 (catheter 10/catheter 121), wherein the catheter system further comprises a control unit for controlling the energy source ([0120]: Treatment protocol parameters such as pulse width, number of pulses and voltage are set using the generator interface (207); wherein the generator having a user interface for setting protocol parameters is seen as having a control unit since the generator converts a user input into known energy outputs).
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Maor in view of Schorr as applied to claim 1 above, and further in view of Cao et al. (U.S. Pub. No. 20170105793), herein referred to as “Cao”.
Regarding claim 11, Maor discloses that the electrode may be made of a conductive ink ([0108]: electrodes 85 and 87 may be comprised of a conductive ink which is applied in the desired pattern to the exterior balloon surface. As an example, the conductive ink may be comprised of an adhesive binder material loaded with silver particles; Maor is silent to what the adhesive binder may be comprised of) but Maor in view of Schorr fails to disclose wherein the conductive structure is partially or completely formed from an electrically conductive plastic.
However, Cao discloses wherein the conductive structure is partially or completely formed from an electrically conductive plastic ([0031]: electrodes 142 and 144 may include a conductive ink. A suitable conductive ink can be composed of a binder or base, and a conductive filler dispersed in the binder. The binder can be composed of a flexible, compliant polymer (e.g., urethane), silicone). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the conductive structure of Maor in view of Schorr to be formed from an electrically conductive plastic, as taught by Cao, for the purpose of enabling biocompatibility and the ability to stretch during device operation (Cao: [0031]).
Regarding claim 12, Maor in view of Schorr fails to disclose wherein the conductive structure is partially or completely formed from a doped plastic.
However, Cao discloses wherein the conductive structure is partially or completely formed from a doped plastic ([0031]: electrodes 142 and 144 may include a conductive ink. A suitable conductive ink can be composed of a binder or base, and a conductive filler dispersed in the binder. The binder can be composed of a flexible, compliant polymer (e.g., urethane), silicone). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the conductive structure of Maor in view of Schorr to be formed from a doped plastic, as taught by Cao, for the purpose of enabling biocompatibility and the ability to stretch during device operation (Cao: [0031]).
Regarding claim 13, Maor in view of Schorr and Cao discloses wherein the conductive structure is partially or completely formed from a plastic material mixed with electrically conductive additives (Cao: [0031]: electrodes 142 and 144 may include a conductive ink. A suitable conductive ink can be composed of a binder or base, and a conductive filler dispersed in the binder. The binder can be composed of a flexible, compliant polymer (e.g., urethane), silicone).
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Maor in view of Schorr as applied to claim 1 above, and further in view of Salahieh et al. (U.S. Pub. No. 20230270492, earliest effective filing date), herein referred to as “Salahieh”.
Regarding claim 14, Maor in view of Schorr fails to disclose wherein the conductive structure is partially or completely formed from a fibre-plastic composite.
However, Salahieh discloses wherein the conductive structure is partially or completely formed from a fibre-plastic composite ([0099]: The materials used to create the electrodes 14 can vary. The electrodes 14 can be a thin film of an electro-conductive or optical ink. The ink can be polymer-based for better adhesion to the membrane. The electrode material can be a biocompatible, low resistance metal such as silver, silver flake, gold, and platinum which are additionally radiopaque. Inks may additionally comprise materials such as carbon and/or graphite in combination with the more conductive materials already described. The addition of carbon and/or graphite can increase the conductivity of the polymer matrix. When incorporated as fibers the carbon and/or graphite add additional structural integrity to the ink electrode). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the conductive structure of Maor in view of Schorr to be formed from a fibre-plastic composite, as taught by Salahieh, for the purpose of the fibers adding additional structural integrity to the electrode (Salahieh: [0099]).
Regarding claim 15, Maor in view of Schorr and Salahieh disclose wherein the conductive structure is partially or completely formed from a carbon fibre-reinforced plastic (Salahieh: [0099]: The materials used to create the electrodes 14 can vary. The electrodes 14 can be a thin film of an electro-conductive or optical ink. The ink can be polymer-based for better adhesion to the membrane. The electrode material can be a biocompatible, low resistance metal such as silver, silver flake, gold, and platinum which are additionally radiopaque. Inks may additionally comprise materials such as carbon and/or graphite in combination with the more conductive materials already described. The addition of carbon and/or graphite can increase the conductivity of the polymer matrix. When incorporated as fibers the carbon and/or graphite add additional structural integrity to the ink electrode).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Ziegler whose telephone number is (571)272-1991. The examiner can normally be reached M-F 8:30 a.m. - 5 p.m. EST.
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
Prosecution Insights