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 .
Response to Amendment
This action is in response to the remarks filed on 07/11/2025.
The amendments filed on 07/11/2025 have been entered. Applicant has added new claim 61. Accordingly claims 1-3, 5, 7, 9-11, 17, 19-21, 23-24, 26-32, 34-37, and 51-61 are pending. Claims 1 and 7 are presently amended.
The previous objection to claim 7 has been withdrawn in light of applicant’s amendments to claim 7.
Response to Arguments
Applicant's arguments filed 07/11/2025 have been fully considered but they are not persuasive.
Applicant argues that Rothman and Mayse do not teach the new limitation of claim 1 regarding said positioning allowing lateral movement of said ultrasound transceivers or the analogous limitation of new claim 61. Examiner respectfully disagrees because Rothman discloses in paragraph [0075]: “the therapeutic assembly 104 can be configured to form a continuous or discontinuous lesion that wraps around the circumference of the vessel (one or more times) along a particular length of the vessel (e.g., generally non-circumferential at longitudinal segments of the treatment location).” The longitudinal segments are created by lateral movement.
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.
Claim 61 is 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 61 recites the limitation “said catheter device moves in a lateral movement within said left pulmonary artery while emitting said unfocused ultrasound energy and while keeping said one or more ultrasound transceivers at a distance from an internal surface of said artery” which renders the claim indefinite. It is unclear whether this lateral movement of the catheter device is the same as or separate from the lateral movement of said ultrasound transceivers previously recited in amended claim 1. For the present purposes of examination, they have been treated as being the same, however further clarification is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 6, 9, 10, 17, 19-21, 23, 24, 26-32, 34, 36, 37, and 51-55, and 58-61 are rejected under 35 U.S.C. 103 as being unpatentable over Rothman et al. (US 2017/0354461, corresponding PCT filed November 14, 2015) in view of Mayse et al. (US 2016/0220851).
Regarding claim 1, Rothman discloses a method of treating pulmonary hypertension (“The present technology is directed to neuromodulation devices and associated systems and methods. Some embodiments of the present technology, for example, are directed to catheters and associated systems and methods for pulmonary neuromodulation ("PN") [...] PN is expected to efficaciously treat pulmonary hypertension.” [0048]) comprising:
introducing a catheter device (“intravascular catheter” [0053]) comprising ultrasound transceivers (“The catheter 110 can further include a therapeutic assembly 104 carried by or affixed to the distal portion 118 of the elongated shaft 116, and the therapeutic assembly 104 can have one or more energy delivery elements 106 configured to modulate nerves at or near the treatment location.” [0053]; also see “The energy generator 132 can be configured to generate a selected form and/or magnitude of energy for delivery to the treatment site via the energy delivery elements 106 of the therapeutic assembly 104. For example, the energy generator 132 can include an energy source (not shown) configured to generate RF energy (e.g., monopolar and/or bipolar, pulsed and/or non-pulsed, intravascular or extravascular, etc.), microwave energy, optical energy, ultrasound energy (e.g., intravascularly delivered ultrasound, extracorporeal ultrasound, high-intensity focused ultrasound (HIFU), etc.), direct heat energy, radiation (e.g., infrared, visible, gamma, etc.), or another suitable type of energy.” [0054]) into the pulmonary artery lumen (“The catheters, systems and methods of the present technology may effect PN in and/or near one or more pulmonary vessels. As used herein, "pulmonary vessel(s)" include any blood vessel that is adjacent to and/or provides intravascular access proximate to neural pathways that communicate with the pulmonary system. For example, pulmonary vessels can include pulmonary veins and pulmonary arteries, such as the main pulmonary artery ("MPA"), the bifurcated portion of the pulmonary artery, the right pulmonary artery ("RPA"), the left pulmonary artery ("LPA"), segmental pulmonary arteries, and sub-segmental pulmonary arteries.” [0049]);
positioning said ultrasound transceivers within the left pulmonary artery (“the main pulmonary artery ("MPA"), the bifurcated portion of the pulmonary artery, the right pulmonary artery ("RPA"), the left pulmonary artery ("LPA")” [0049]) at a region within the left pulmonary artery located between a first bifurcation of the left pulmonary artery towards a left lung and the main pulmonary artery (see Figs. 3D, Fig. 8B and corresponding descriptions), said ultrasound transceivers positioned at a predetermined minimal distance from a point of maximal curvature of an inferior wall of the left pulmonary artery ([0051], Figs. 3D, 8A, 9 and corresponding descriptions); wherein said positioning allows blood to flow between said ultrasound transceivers and an intimal aspect of a wall of said left pulmonary artery (“it may be advantageous to maintain the position of the therapeutic element at the center of the vessel lumen or in some cases, offset from the center of the vessel lumen by a particular distance. This can enhance control and/or monitoring of the treatment, reduce trauma to the body lumen, and/or have other advantages.” [0051]); wherein said positioning allows lateral movement of said ultrasound transceivers within the left pulmonary artery while said ultrasound transceivers emit unfocused ultrasound energy (“the therapeutic assembly 104 can be configured to form a continuous or discontinuous lesion that wraps around the circumference of the vessel (one or more times) along a particular length of the vessel (e.g., generally non-circumferential at longitudinal segments of the treatment location). In several of such embodiments, the lesion can have a helical/spiral configuration.” [0075]) and
thermally damaging target nerve tissue by emitting ultrasound energy from the ultrasound transceivers towards the left pulmonary artery wall (“the therapeutic assembly 104 can be configured to form a continuous or discontinuous lesion that wraps around the circumference of the vessel (one or more times) along a particular length of the vessel (e.g., generally non-circumferential at longitudinal segments of the treatment location). In several of such embodiments, the lesion can have a helical/spiral configuration.” [0075]), wherein said emitted ultrasound energy is with parameters selected to damage nerves beyond the wall of the left pulmonary artery when said ultrasound transceivers are positioned at said region (“The therapeutic assembly 2320 can then apply an energy field to the target site to cause electrically-induced and/or thermally-induced partial or full denervation of the nerves in communication with the pulmonary system (e.g., using electrodes or cryotherapeutic devices).” [0124]; also see [0054], [0059]).
Rothman fails to disclose wherein said ultrasound transceivers are arranged on a circumference of said catheter device such that each of said ultrasound transceivers faces a different and separate circumferential direction.
However, Mayse teaches, in the same field of endeavor, wherein said ultrasound transceivers are arranged on a circumference of said catheter device such that each of said ultrasound transceivers faces a different and separate circumferential direction (“a plurality of ultrasound transducers may be circumferentially spaced about the longitudinal axis A to generate a plurality of respective beams that circumferentially overlap to provide a continuous or generally continuous beam traveling outwardly from a portion or the entire circumference of the assembly. The assembly may be configured such that a beam or plurality of beams may be emitted simultaneously to cover up to 90°, 180°, 270°, or the entire 360° of the airway circumference.” [0126]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Rothman with wherein said ultrasound transceivers are arranged on a circumference of said catheter device such that each of said ultrasound transceivers faces a different and separate circumferential direction as taught by Mayse in order to provide ultrasound beam coverage of the entire 3600 circumference of the lumen ([0126] of Mayse).
Rothman also fails to disclose the ultrasound energy emitted being unfocused ultrasound.
However, Mayse further teaches, in the same field of endeavor, the ultrasound energy emitted being unfocused ultrasound (“the ultrasound energy emitter 350 may be configured to generate unfocused ultrasound energy” [0122]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Rothman with the ultrasound energy emitted being unfocused ultrasound as taught by Mayse. The rationale would have been the simple substitution of one known equivalent element, i.e., focused ultrasound, for another, i.e., unfocused ultrasound, to obtain the predictable result of a more widespread ultrasound beam. Further, Mayse also teaches that either focused or unfocused ultrasound could be used ([0137] of Mayse). See MPEP 2143.
Rothman fails to disclose that are located within a distance window of between 0.2 mm and 20 mm from said intimal aspect of the left pulmonary artery wall. However, it would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound with parameters to damage an area within a distance window between 0.2 mm and 20 mm, because Applicant has not disclosed that the claimed distance window provides an unexpected advantage, is used for a particular purpose, or solves a stated problem. Furthermore, it has been held before that "it is not inventive to discover the optimum or workable ranges by routine experimentation" (see MPEP 2144.05.II.A), one of ordinary skill in the art could have made the modification with known methods with no change in their respective functions. As such, the modification of the distance window would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Rothman. One of ordinary skill in the art would recognize that the distance window could be optimized according to a desired target region.
Regarding claim 2, Rothman modified by Mayse discloses the limitations of claim 1 as stated above. Mayse further teaches, in the same field of endeavor, wherein said energy parameters comprise an intensity selected to raise a temperature of said nerve tissue by between 10°C and 30 °C (“sufficient ultrasound energy to raise the temperature of the targeted nerve tissue beyond a threshold temperature for a selected duration which is effective in attenuating the transmission of nervous system signals. In some instances, the threshold temperature may exceed 40° C., and in some instances the threshold temperature may exceed 45° C. or 50° C” [0116], examiner notes that 47-50 is at least 10 degrees above normal body temperature, i.e. 37 degrees C.).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Rothman with wherein said energy parameters comprise an intensity selected to raise a temperature of said nerve tissue by between 10°C and 30 °C as taught by Mayse in order to effectively attenuate the transmission of nervous system signals ([0116] of Sverdlik).
Regarding claim 3, Rothman modified by Mayse discloses the limitations of claim 1 as stated above but fails to disclose wherein said energy parameters comprise an intensity selected to raise a blood temperature, from 37 °C, by between 5-9°C. However, it would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the energy parameters to comprise an intensity selected to raise a blood temperature, from 37 °C, by between 5-9°C, because Applicant has not disclosed that the claimed intensity provides an unexpected advantage, is used for a particular purpose, or solves a stated problem. Furthermore, it has been held before that "it is not inventive to discover the optimum or workable ranges by routine experimentation" (see MPEP 2144.05.II.A), one of ordinary skill in the art could have made the modification with known methods with no change in their respective functions. As such, the modification of the intensity would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Rothman. One of ordinary skill in the art would recognize that the intensity could be optimized to ensure blood temperature stays within a safe level.
Regarding claim 9, Rothman modified by Mayse discloses the limitations of claim 1 as stated above but fails to disclose wherein said thermally damaging comprises thermally damaging nerves only within a distance window of between 4-10 mm from the intimal aspect of the pulmonary artery wall.
However, it would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distance window to 4-10 mm from the intimal aspect of the pulmonary artery wall, because Applicant has not disclosed that the claimed distance window provides an unexpected advantage, is used for a particular purpose, or solves a stated problem. Furthermore, it has been held before that "it is not inventive to discover the optimum or workable ranges by routine experimentation" (see MPEP 2144.05.II.A), one of ordinary skill in the art could have made the modification with known methods with no change in their respective functions. As such, the modification of the distance window would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Rothman. One of ordinary skill in the art would recognize that the distance window could be optimized according to a desired target region.
Regarding claim 10, Rothman modified Mayse discloses the limitations of claim 1 as stated above but fails to disclose wherein said thermally damaging comprises thermally damaging nerves only within a distance window of between 0.5-5 mm from the intimal aspect of the pulmonary artery wall.
However, it would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distance window to 0.5-5 mm from the intimal aspect of the pulmonary artery wall, because Applicant has not disclosed that the claimed distance window provides an unexpected advantage, is used for a particular purpose, or solves a stated problem. Furthermore, it has been held before that "it is not inventive to discover the optimum or workable ranges by routine experimentation" (see MPEP 2144.05.II.A), one of ordinary skill in the art could have made the modification with known methods with no change in their respective functions. As such, the modification of the distance window would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Rothman. One of ordinary skill in the art would recognize that the distance window could be optimized according to a desired target region.
Regarding claim 17, Rothman modified by Mayse discloses the limitations of claim 1 as stated above. Rothman further suggests positioning said ultrasound transceivers within said left pulmonary artery at a distance of less than 10 cm from a central longitudinal axis of the main pulmonary artery (e.g. see Fig. 3D, re-produced below and “the energy delivery elements 106 can be spaced apart along the support structure 210 every 1 mm to 50 mm, such as every 2 mm to every 15 mm (e.g., every 10 mm, etc.). In the deployed configuration, the support structure 210 and/or therapeutic assembly 104 can have an outer diameter between about 12 mm and about 20 mm (e.g., between about 15 mm and about 18 mm).” [0064]; also see Figs. 1, 3E, 8B and corresponding descriptions, [0086]).
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Regarding claim 19, Rothman modified by Mayse discloses the limitations of claim 19 as stated above. Rothman further discloses repeating said positioning and thermally damaging (“This process can be repeated until a sufficient nerve lesion is formed at the target site.” [0134]) at treatment locations along the long axis of the left pulmonary artery (“along a particular length of the vessel (e.g., generally non-circumferential at longitudinal segments of the treatment location).” [0075]).
Rothman fails to disclose between 6-16 treatment locations.
However, it would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the number of treatment locations to between 6-16, because Applicant has not disclosed that the claimed distance window provides an unexpected advantage, is used for a particular purpose, or solves a stated problem. Furthermore, it has been held before that "it is not inventive to discover the optimum or workable ranges by routine experimentation" (see MPEP 2144.05.II.A), one of ordinary skill in the art could have made the modification with known methods with no change in their respective functions. As such, the modification of the distance window would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Rothman. One of ordinary skill in the art would recognize that the number of treatment locations could be optimized according to a desired total target region.
Regarding claim 20, Rothman modified by Mayse discloses the limitations of claim 19 as stated above. Rothman further suggests wherein a number of said treatment locations is selected to: reduce at least one of: Right atrial pressure (RAP), Right ventricle pressures (RVP), Systolic pulmonary artery pressure (sPAP), Mean pulmonary artery pressures (mPAP), Pulmonary vascular resistance (PVR), NT-pro-BNP and/or increase at least one of: Cardiac output (CO), Cardiac Index (CI), Ejection Fraction (EF), Pulmonary distensability, Exercise tolerance--6 minutes walking distance (6MWD), Quality of life as assessed by questionnaire, cardiopulmonary exercise testing and VO2 max (“PN is expected to efficaciously treat pulmonary hypertension. Subjects with pulmonary hypertension generally have high blood pressure in the lung vasculature that may lead to heart failure and they may, for example, experience symptoms such as dyspnea (shortness of breath), syncope, fatigue, chest pain and/or edema, and/or other symptoms as well. PN using methods and/or devices described herein may provide a therapeutically beneficial reduction in one or more of these symptoms. Additionally, PN using the methods and/or devices of the present technology may modulate the release of circulating mediators of the nervous system (e.g., the sympathetic nervous system) and/or neuroendocrine system, thereby providing systemic modulation of such mediators and/or modulating the function of specific body organs other than the lungs. For example, the lungs produce significant quantities of catecholamines that affect heart rate, blood pressure, blood glucose levels, etc., and PN using the methods and/or devices of the present technology may increase or decrease the amount of catecholamines released from the lungs.” [0048]).
Regarding claim 21, Rothman modified by Mayse discloses the limitations of claim 19 as stated above but fails to disclose wherein a distance between adjacent treatment locations, as measured along the long axis of the artery ranges between 0.1 cm to 2 cm.
However, it would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distance between adjacent treatment locations to between 0.1 cm to 2 cm, because Applicant has not disclosed that the claimed distance window provides an unexpected advantage, is used for a particular purpose, or solves a stated problem. Furthermore, it has been held before that "it is not inventive to discover the optimum or workable ranges by routine experimentation" (see MPEP 2144.05.II.A), one of ordinary skill in the art could have made the modification with known methods with no change in their respective functions. As such, the modification of the distance between adjacent treatment locations would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Rothman. One of ordinary skill in the art would recognize that the distance window could be optimized according to a desired total target region.
Regarding claim 23, Rothman modified by Mayse discloses the limitations of claim 1 as stated above. Rothman further discloses wherein said positioning comprises positioning said ultrasound transceivers in the left pulmonary artery, between the first bifurcation of the left pulmonary artery and the main pulmonary artery, at a distance of between 0- and 2 cm from the bifurcation (see e.g. Fig. 8A and corresponding description and “the energy delivery elements 106 can be spaced apart along the support structure 210 every 1 mm to 50 mm, such as every 2 mm to every 15 mm (e.g., every 10 mm, etc.). In the deployed configuration, the support structure 210 and/or therapeutic assembly 104 can have an outer diameter between about 12 mm and about 20 mm (e.g., between about 15 mm and about 18 mm).” [0064]).
Regarding claim 24, Rothman further discloses wherein the locations are set per a specific patient anatomy according to pre-defined set boundaries determined using one or more of an angiogram, CT and MRI (“Image guidance, e.g., computed tomography (CT), fluoroscopy, intravascular ultrasound (IVUS), optical coherence tomography (OCT), intracardiac echocardiography (ICE), or another suitable guidance modality, or combinations thereof, may be used to aid the clinician's positioning and manipulation of the therapeutic assembly 104. For example, a fluoroscopy system (e.g., including a flat-panel detector, x-ray, or c-arm) can be rotated to accurately visualize and identify the treatment site. In other embodiments, the treatment site can be located using IVUS, OCT, and/or other suitable image mapping modalities that can correlate the treatment site with an identifiable anatomical structure (e.g., a spinal feature) and/or a radiopaque ruler (e.g., positioned under or on the patient) before delivering the catheter 110. Further, in some embodiments, image guidance components (e.g., IVUS, OCT) may be integrated with the catheter 110 and/or run in parallel with the catheter 110 to provide image guidance during positioning of the therapeutic assembly 104. For example, such image guidance components can be coupled to a distal portion of the catheter 110 to provide three-dimensional images of the vasculature proximate the site to facilitate positioning or deploying the therapeutic assembly 104 within the pulmonary blood vessel.” [0074]).
Regarding claim 26, Rothman modified by Mayse discloses the limitations of claim 1 as stated above. Mayse further teaches, in the same field of endeavor, wherein said thermally damaging comprises heating a nerve at two or more locations along an axon or a bundle of axons of said nerve (“FIGS. 9A and 10A provide detailed views of nerve axons of a nerve trunk associated with the distal airway before and after the treatment, respectively.” [0127]; also see Fig. 10A and corresponding description, [0129]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Rothman with wherein said thermally damaging comprises heating a nerve at two or more locations along an axon or a bundle of axons of said nerve as taught by Mayse in order to prevent damage to healthy tissue that surrounds target tissue ([0129 of Mayse).
Regarding claim 27, Rothman further discloses wherein said ultrasound transceivers comprise three ultrasound transceivers (“the support structure 210 can include, for example, between 1 and 12 energy delivery elements (e.g., 1 energy delivery element, 4 energy delivery elements, 10 energy delivery elements, 12 energy delivery elements, etc.).” [0064]) configured to be actuated simultaneously (“Energy delivery elements may be fired sequentially or simultaneously” [0054]) to treat 3 spaced apart locations arranged circumferentially with respect to the artery lumen (“In other embodiments, the therapeutic assembly 104 can be configured to form a continuous or discontinuous lesion that wraps around the circumference of the vessel (one or more times) along a particular length of the vessel (e.g., generally non-circumferential at longitudinal segments of the treatment location). In several of such embodiments, the lesion can have a helical/spiral configuration.” [0075]; also see e.g. Fig. 3D and corresponding description).
Regarding claim 28, Rothman further discloses actuating only one or two of said three ultrasound transceivers to prevent damage to non-targeted tissue (“As an example, a single energy delivery element may be selected at a time, or a combination of certain energy delivery elements or all of the energy delivery elements may be selected at a time. Energy delivery elements may be fired sequentially or simultaneously and/or may be fired according to a particular algorithm and/or operator input.” [0054]).
Regarding claim 29, Rothman further discloses automatically detecting (“The control algorithms 140 can be executed on a processor (not shown) of the system 100 to control energy delivery to the energy delivery elements 106. In some embodiments, selection of one or more parameters of an automated control algorithm 140 for a particular patient may be guided by diagnostic algorithms 133 that measure and evaluate one or more operating parameters prior to energy delivery.” [0059]) if one or more of said ultrasound transceivers are directed towards non-targeted tissue (“In some embodiments, the sensors can be used to monitor or detect the presence or location of target neural structures” [0058]), and deactivating those ultrasound transceivers (“As an example, a single energy delivery element may be selected at a time, or a combination of certain energy delivery elements or all of the energy delivery elements may be selected at a time.” [0054], examiner notes that unselected elements are deactived).
Regarding claim 30, Rothman further suggests targeting nerves which are sympathetic nerves (“PN using the methods and/or devices of the present technology may modulate the release of circulating mediators of the nervous system (e.g., the sympathetic nervous system)” [0048]). Rothman modified by Mayse discloses the limitations of the claim except that at least 60% in volume.
However, it would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sympathetic nerves to at least 60% in volume, because Applicant has not disclosed that the claimed distance window provides an unexpected advantage, is used for a particular purpose, or solves a stated problem. Furthermore, it has been held before that "it is not inventive to discover the optimum or workable ranges by routine experimentation" (see MPEP 2144.05.II.A), one of ordinary skill in the art could have made the modification with known methods with no change in their respective functions. As such, the modification of the distance between adjacent treatment locations would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Rothman. One of ordinary skill in the art would recognize that the distance window could be optimized according to a desired total target region.
Regarding claim 31, Rothman modified by Mayse discloses the limitations of claim 1 as stated above, in particular Mayse was relied on to teach unfocused ultrasound energy. Mayse further teaches, in the same field of endeavor, adjusting the parameters of the unfocused ultrasound energy to adjust the size of a treatment zone ([0116], [0120], [0122]) but fails to disclose to particularly disclose wherein said energy comprises unfocused ultrasound energy having the following parameters: an intensity between 40[W/cm^2]-60[W/cm^2], a frequency between 10[MHz]-12[MHz] and an excitation duration between 30 [sec] to 50 [sec].
However, it would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the parameters to an intensity between 40[W/cm^2]-60[W/cm^2], a frequency between 10[MHz]-12[MHz] and an excitation duration between 30 [sec] to 50 [sec], because Applicant has not disclosed that the claimed parameters provides an unexpected advantage, is used for a particular purpose, or solves a stated problem. Furthermore, it has been held before that "it is not inventive to discover the optimum or workable ranges by routine experimentation" (see MPEP 2144.05.II.A), one of ordinary skill in the art could have made the modification with known methods with no change in their respective functions. As such, the modification of the parameters would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Rothman. One of ordinary skill in the art would recognize that the parameters could be optimized according to a desired treatment zone size as taught by Mayse.
Regarding claim 32, Rothman further discloses wherein said positioning comprises expanding a distancing device and avoiding movement of the catheter once the distancing device has been expanded (“one or more anchoring devices [distancing device] for stabilizing [avoiding movement] the distal portion and/or therapeutic assembly relative to the vessel wall and/or selectively positioning the distal portion and/or therapeutic assembly relative to the vessel wall (e.g., at a central location within the vessel lumen, selectively offset from the center of the vessel lumen).” [0086]).
Regarding claim 36, Rothman further discloses wherein during said thermally damaging, said catheter device moves in a lateral movement within said left pulmonary artery (e.g. see helical/spiral configuration of distal end of catheter in Fig. 10, re-produced below, and corresponding description) while keeping said one or more ultrasound transceivers at a distance from an internal surface of said artery (“anchoring devices for stabilizing the distal portion and/or therapeutic assembly relative to the vessel wall and/or selectively positioning the distal portion and/or therapeutic assembly relative to the vessel wall (e.g., at a central location within the vessel lumen, selectively offset from the center of the vessel lumen).” [0086]).
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Regarding claim 37, Rothman modified by Mayse discloses the limitations of claim 36 as stated above but is silent on wherein said lateral movement is up to a distance of 5 cm.
However, it would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the lateral movement to up to a distance of 5 cm, because Applicant has not disclosed that the claimed lateral movement provides an unexpected advantage, is used for a particular purpose, or solves a stated problem. Furthermore, it has been held before that "it is not inventive to discover the optimum or workable ranges by routine experimentation" (see MPEP 2144.05.II.A), one of ordinary skill in the art could have made the modification with known methods with no change in their respective functions. As such, the modification of the parameters would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Rothman. One of ordinary skill in the art would recognize that the lateral movement could be optimized according to a desired target zone.
Regarding claim 51, Rothman modified by Mayse discloses the limitations of claim 1 as stated above but is silent on wherein said positioning is at a distance of less than 7 mm from said point of maximal curvature.
However, it would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the positioning at a distance of less than 7 mm from said point of maximal curvature, because Applicant has not disclosed that the claimed distance provides an unexpected advantage, is used for a particular purpose, or solves a stated problem. Furthermore, it has been held before that "it is not inventive to discover the optimum or workable ranges by routine experimentation" (see MPEP 2144.05.II.A), one of ordinary skill in the art could have made the modification with known methods with no change in their respective functions. As such, the modification of the distance would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Rothman. One of ordinary skill in the art would recognize that the positioning distance could be optimized according to a desired target zone.
Regarding claim 52, Rothman modified by Mayse discloses the limitations of claim 1 as stated above but is silent on wherein said nerve tissue is located within a distance range of 0.2mm-30mm from said point of maximal curvature.
However, it would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distance range to 0.2mm-30mm from said point of maximal curvature, because Applicant has not disclosed that the claimed distance provides an unexpected advantage, is used for a particular purpose, or solves a stated problem. Furthermore, it has been held before that "it is not inventive to discover the optimum or workable ranges by routine experimentation" (see MPEP 2144.05.II.A), one of ordinary skill in the art could have made the modification with known methods with no change in their respective functions. As such, the modification of the distance would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Rothman. One of ordinary skill in the art would recognize that the positioning distance could be optimized according to a desired target zone.
Regarding claim 53, Rothman further discloses wherein said location is selected to target high density nerve tissue substantially without damaging non-target tissue (“it may be advantageous to maintain the position of the therapeutic element at the center of the vessel lumen or in some cases, offset from the center of the vessel lumen by a particular distance. This can enhance control and/or monitoring of the treatment, reduce trauma to the body lumen, and/or have other advantages.” [0051]).
Regarding claim 54, Rothman further discloses wherein said location is selected to target posterior and/or anterior nerve plexuses extending along the length of the left pulmonary artery towards the left lung (“For example, the vagal and phrenic nerves may lie outside the lungs (e.g., in the neck region and/or in the inlet to the thoracic cavity) at various locations that may render them amenable to access via cutaneous puncture or to transcutaneous denervation. As such, devices and/or methods described herein may be used to effect modulation of vagal and/or phrenic nerves from within a carotid vein and/or a jugular vein.” [0265]).
Regarding claim 55, Rothman further discloses wherein said ultrasound transceivers are flat and elongated (deformable members 1804 in Figs. 18A-B are flat and elongated and can include one or more ultrasound transceivers as described in e.g. [0102]; also see Fig. 18A-B and corresponding descriptions).
Regarding claim 58, Rothman modified by Mayse discloses the limitations of claim 1 as stated above and Mayse further teaches wherein said thermally damaging comprises thermally damaging said target nerve tissue while sparing said intimal aspect and without causing substantial thermal damage to said non-targeted tissue (“sufficient ultrasound energy to raise the temperature of the targeted nerve tissue beyond a threshold temperature for a selected duration which is effective in attenuating the transmission of nervous system signals. In some instances, the threshold temperature may exceed 40° C., and in some instances the threshold temperature may exceed 45° C. or 50° C. for the treatment duration. Conversely, temperatures at the surface tissue of the airway wall may be preferentially maintained below the threshold temperature” [0116]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Rothman with wherein said thermally damaging comprises thermally damaging said target nerve tissue while sparing said intimal aspect and without causing substantial thermal damage to said non-targeted tissue as taught by Mayse in order to treat selectively targeted tissue and prevent damage to untreated tissue ([0116] of Mayse).
Regarding claim 59, Rothman modified by Mayse discloses the limitations of claim 1 as stated above and Rothman further discloses wherein the applied energy parameters are selected to produce a temperature profile in the target nerve tissue which thermally damages nerve tissue, but does not have a substantial effect of necrosis or denaturation on non-targeted nerve tissue (“sufficient ultrasound energy to raise the temperature of the targeted nerve tissue beyond a threshold temperature for a selected duration which is effective in attenuating the transmission of nervous system signals. In some instances, the threshold temperature may exceed 40° C., and in some instances the threshold temperature may exceed 45° C. or 50° C. for the treatment duration. Conversely, temperatures at the surface tissue of the airway wall may be preferentially maintained below the threshold temperature” [0116]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Rothman with wherein the applied energy parameters are selected to produce a temperature profile in the target nerve tissue which thermally damages nerve tissue, but does not have a substantial effect of necrosis or denaturation on non-targeted nerve tissue as taught by Mayse in order to treat selectively targeted tissue and prevent damage to untreated tissue ([0116] of Mayse).
Regarding claim 60, Rothman modified by Mayse discloses the limitations of claim 1 as stated above and Rothman further discloses wherein said ultrasound transceivers are configured to apply a selective treatment in which only a part of the tissue and/or a certain type of the tissue within a target volume is affected by energy emitted by said transceivers (“sufficient ultrasound energy to raise the temperature of the targeted nerve tissue beyond a threshold temperature for a selected duration which is effective in attenuating the transmission of nervous system signals. In some instances, the threshold temperature may exceed 40° C., and in some instances the threshold temperature may exceed 45° C. or 50° C. for the treatment duration. Conversely, temperatures at the surface tissue of the airway wall may be preferentially maintained below the threshold temperature” [0116]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Rothman with wherein said ultrasound transceivers are configured to apply a selective treatment in which only a part of the tissue and/or a certain type of the tissue within a target volume is affected by energy emitted by said transceivers as taught by Mayse in order to treat selectively targeted tissue and prevent damage to untreated tissue ([0116] of Mayse).
Regarding claim 61, Rothman modified by Mayse discloses the limitations of claim 1 as stated above and Rothman further discloses, as best understood in light of the 35 U.S.C. 112(b) rejection stated above, wherein during said thermally damaging, said catheter device moves in a lateral movement within said left pulmonary artery while emitting said unfocused ultrasound energy (“the therapeutic assembly 104 can be configured to form a continuous or discontinuous lesion that wraps around the circumference of the vessel (one or more times) along a particular length of the vessel (e.g., generally non-circumferential at longitudinal segments of the treatment location).” [0075]) and while keeping said one or more ultrasound transceivers at a distance from an internal surface of said artery (“the therapeutic assembly 104 can be configured to cause therapeutically-effective neuromodulation (e.g., using ultrasound energy) without contacting a vessel wall.” [0075]; also see [0086]).
Claim 5, 7, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Rothman in view of Mayse as applied to claim 1 above and further in view of Sverdlik et al. (US 2012/0265227).
Regarding claim 5, Rothman modified by Mayse discloses the limitations of claim 1 as stated above but fails to disclose wherein said energy parameters are selected taking into account one or both of self-heat generation in a tissue volume being treated and heat absorption in said tissue volume.
However, Sverdlik teaches, in the same field of endeavor, wherein said energy parameters are selected taking into account one or both of self-heat generation in a tissue volume being treated and heat absorption in said tissue volume (“Curve 714 is an exemplary illustration of a simplified estimate of the effect of heating of wall 710 due to ultrasonic energy 708 absorption (e.g., attenuation) as a function of distance away from lumen 730. As energy 708 travels through wall 710, it is absorbed, resulting in tissue of wall 710 heating up. Without blood flow 702, the tissues closest to lumen 730 heat up the most and the tissues furthest away heat up the least.” [0308]; also see e.g. [0133], [0142], [0208], [0423]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Rothman with wherein said energy parameters are selected taking into account one or both of self-heat generation in a tissue volume being treated and heat absorption in said tissue volume as taught by Sverdlik in order to provide the desired thermal effect within safety considerations ([0208] of Sverdlik).
Regarding claim 7, Rothman modified Mayse and Sverdlik discloses the limitations of claim 5 as stated above. Mayse further teaches, in the same field of endeavor, wherein said energy parameters of said unfocused ultrasound energy are selected so that only nerve tissue found within coverage of the emitted energy beam is affected (“a treatment zone radially offset from surface tissue of the airway wall may be subjected to sufficient ultrasound energy to raise the temperature of the targeted nerve tissue beyond a threshold temperature for a selected duration which is effective in attenuating the transmission of nervous system signals. In some instances, the threshold temperature may exceed 40° C., and in some instances the threshold temperature may exceed 45° C. or 50° C. for the treatment duration. Conversely, temperatures at the surface tissue of the airway wall may be preferentially maintained below the threshold temperature by utilizing cooling techniques or other techniques described herein.” [0116]), while non-target tissue within the beam coverage is substantially unaffected (“Tissue surrounding or adjacent to the targeted nerve tissue may be affected but not permanently damaged [...]a therapeutically effective amount of energy does not reach a significant portion of the non-targeted smooth muscle tissue” [0131]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Rothman with wherein said energy parameters of said unfocused ultrasound energy are selected so that only nerve tissue found within coverage of the emitted energy beam is affected, while non-target tissue within the beam coverage is substantially unaffected as taught by Mayse in order to protect non-targeted tissue ([0131] of Mayse).
Regarding claim 34, Rothman modified by Mayse discloses the limitations of claim 1 as stated above but fails to disclose administering a systemic anticoagulant to a patient prior to said introducing of said catheter device
However, Sverdlik teaches, in the same field of endeavor, administering a systemic anticoagulant to a patient prior to said introducing of said catheter device (“add extra lumen anti-coagulation treatment” see Table following [0434]; also see “Intravenous heparin was administered to achieve an intraprocedural activated clotting time (ACT)>250 seconds” [0563]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Rothman with administering a systemic anticoagulant to a patient prior to said introducing of said catheter device as taught by Sverdlik in order to prevent significant coagulation of blood ([0052] of Sverdlik).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Rothman in view of Mayse as applied to claim 1 above and further in view of Pilcher et al. (US 2017/0312021, filed June 27, 2016, hereinafter “Pilcher”).
Regarding claim 11, Rothman modified by Mayse discloses the limitations of claim 1 as stated above. Rothman further discloses wherein thermally damaging nerve tissue comprises thermally damaging one or more nerves extending along at least a longitudinal segment of the left artery (“For example, the therapeutic assembly 104 can be used to modulate nerves proximate the wall of the main pulmonary artery, the left pulmonary artery, and/or the right pulmonary artery and/or any branch or extension, and/or other pulmonary vessels or sites proximate to neural pathways in communication with the pulmonary system” [0077]; also see [0075]).
Rothman fails to specifically disclose one or more nerve plexuses.
However, Pilcher teaches, in the same field of endeavor, thermally damaging nerve tissue comprises thermally damaging one or more nerve plexuses extending along at least a longitudinal segment of the left, right and/or main pulmonary artery (“neuromodulation (e.g., decreasing activity) of at least one sympathetic nerve innervating one or more of the pulmonary trunk 18, the left or right pulmonary arteries 20, 21, or branches thereof within a patient is anticipated to be therapeutically beneficial for treating lung cancer. In some instances, neuromodulation of the pulmonary plexus 24, 25 or one or more nerve fibers thereof can be achieved via application of a suitable treatment modality, e.g., cryotherapeutic, direct heat, electrode-based, transducer-based, chemical-based, or another suitable treatment modality within a target vessel as described above” [0061], Fig. 4 and corresponding description; also see [0095]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Rothman with thermally damaging nerve tissue comprises thermally damaging one or more nerve plexuses extending along at least a longitudinal segment of the left, right and/or main pulmonary artery as taught by Pilcher in order to provide therapeutic benefit such as for treating lung cancer ([0061] of Pilcher).
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Rothman in view of Mayse as applied to claim 1 above and further in view of Sverdlik, Brun (US 2018/0055988, corresponding PCT filed February 12, 2016) and Kanner et al. (US 2010/0185156, July 22, 2010, hereinafter “Kanner”).
Regarding claim 35, Rothman modified by Mayse discloses the limitations of claim 1 as stated above but fails to disclose monitoring activated clotting time during treatment.
However, Sverdlik teaches, in the same field of endeavor, monitoring activated clotting time during treatment (“Intravenous heparin was administered to achieve an intraprocedural activated clotting time (ACT)>250 seconds” [0563]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Rothman with monitoring activated clotting time during treatment as taught by Sverdlik in order to prevent significant coagulation of blood ([0052] of Sverdlik).
Rothman modified by Sverdlik is silent on stopping treatment if the activated clotting time is shorter than 275 seconds.
However, Brun teaches, in an analogous field of endeavor, (e.g. see blood monitoring in title), stopping treatment if the activated clotting time is shorter than a target (“periodically sampling blood every 30 to 60 minutes and measuring the activated clotting time. As a result of the monitoring, for example, in a case where thrombus formation is observed, the extracorporeal circulation device needs to be entirely replaced before the circulation is resumed [stopping treatment].” [0005]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Rothman with stopping treatment if the activated clotting time is shorter than a target as taught by Brun in order to minimize repercussions of thrombus formation ([0005] of Brun).
Rothman modified by Brun is silent on the target activated clotting time being shorter than 275 seconds. Although Sverdlik does teach a target of greater than 250 seconds as shown above.
However, Kanner teaches, in an analogous field of endeavor (e.g. see [0057], [0073]), a target activated clotting time of 275 seconds (“to prolong activated clotting time to a target range of approximately 275 seconds during device deployment.”). However, it would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust the activated clotting time to 275 seconds, because Applicant has not disclosed that the claimed time provides an unexpected advantage, is used for a particular purpose, or solves a stated problem. Furthermore, it has been held before that "it is not inventive to discover the optimum or workable ranges by routine experimentation" (see MPEP 2144.05.II.A), one of ordinary skill in the art could have made the modification with known methods with no change in their respective functions. As such, the modification of the timing would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Rothman.
Claims 56 and 57 are rejected under 35 U.S.C. 103 as being unpatentable over Rothman in view of Mayse as applied to claim 1 above and further in view of Alleman et al. (US 2012/0083717, April 5, 2012, hereinafter “Alleman”) and Hananel et al. (US 2017/0246482, filed February 27, 2017, hereinafter “Hananel”).
Regarding claim 56, Rothman modified by Mayse discloses the limitations of claim 1 as stated above but fails to disclose wherein said positioning allows said thermally damaging of said target nerve tissue by emitting beams of unfocused ultrasound energy having a divergence angle smaller than 60 degrees while forming a separation angle of at least 20 degrees between said emitted beams and non-targeted tissue.
However, Alleman teaches, in the same field of endeavor, emitting beams of unfocused ultrasound energy having a divergence angle (“Non-focused transducer--refers to a transducer producing a divergent beam exiting the near field, where beam diameter progressively increases with depth in the far field. The near field length and hence the natural divergence of an ultrasonic beam are determined by aperture (equal to element diameter in the case of conventional monolithic transducers) and wavelength (wave velocity divided by frequency). For an unfocused transducer, the near field length, beam spread angle, and beam diameter can be calculated as follows: L=D.sup.2f.sub.c/4c where, L is near field length, D is element diameter or aperture, f.sub.c is the frequency, and c is the sound velocity in the medium.” [0086]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Rothman with emitting beams of unfocused ultrasound energy having a divergence angle as taught by Alleman in order to target a larger area ([0086] of Alleman).
Rothman modified by Alleman fails to disclose the divergence angle being smaller than 60 degrees. However it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the angle smaller than 60 degrees, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Rothman modified by Alleman fails to disclose while forming a separation angle of at least 20 degrees between said emitted beams and non-targeted tissue.
However, Hananel teaches, in the same field of endeavor, while forming a separation angle of at least 20 degrees between said emitted beams and non-targeted tissue (“Coupling member 130 may be used to modify the position of the treatment location, specifically with respect to ultrasound reflections off surrounding bones (e.g., vertebra and vertebra processes). Angle α may be selected to increase the energy beam absorption by the bone tissue adjacent to the target nerve as well as to reduce the possibility of damage to sensitive non-targeted tissue such as the nerve root and/or spinal cord. For example, angle α may be selected to provide protection of the nerve roots and spinal cord from accidental damage by the energy beam, by shielding them by vertebral bone (e.g., by specific vertebra processes and vertebra lamina). In a non-limiting illustrational example, the vertebra processes may allow a 40° access angle to the treatment location from the vertical to the skin and the depth to the treatment location may be 5 cm. Coupling member 130 may be selected or adjusted to position device 100 at a corresponding energy delivery location, from which ultrasound energy may be focused at the defined treatment location.” [0035]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Rothman with while forming a separation angle of at least 20 degrees between said emitted beams and non-targeted tissue as taught by Hananel in order to reduce damage to sensitive non-target tissue ([0035] of Hananel).
Regarding claim 57, Rothman modified by Mayse, Alleman, and Hananel discloses the limitations of claim 56 as stated above and Hananel further teaches wherein said positioning allows said thermally damaging of said target tissue by emitting said beams of unfocused ultrasound energy, while forming a separation angle of at least 20 degrees between said emitted beams and non-targeted organs (“Coupling member 130 may be used to modify the position of the treatment location, specifically with respect to ultrasound reflections off surrounding bones (e.g., vertebra and vertebra processes). Angle α may be selected to increase the energy beam absorption by the bone tissue adjacent to the target nerve as well as to reduce the possibility of damage to sensitive non-targeted tissue such as the nerve root and/or spinal cord. For example, angle α may be selected to provide protection of the nerve roots and spinal cord from accidental damage by the energy beam, by shielding them by vertebral bone (e.g., by specific vertebra processes and vertebra lamina). In a non-limiting illustrational example, the vertebra processes may allow a 40° access angle to the treatment location from the vertical to the skin and the depth to the treatment location may be 5 cm. Coupling member 130 may be selected or adjusted to position device 100 at a corresponding energy delivery location, from which ultrasound energy may be focused at the defined treatment location.” [0035]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Rothman with wherein said positioning allows said thermally damaging of said target tissue by emitting said beams of unfocused ultrasound energy, while forming a separation angle of at least 20 degrees between said emitted beams and non-targeted organs as taught by Hananel in order to avoid damage to vulnerable structures.
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.
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/A.A./Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797