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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/07/2025 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
FIG. 1: Although this figure includes the labels 120 and 122, these labels do not appear in the specification.
FIG. 4: Although this figure includes the label 320, this label does not appear in the specification.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
[Page 1: Background, Lines 1-3]: As written it reads “Successful treatment of pulmonary diseases such as emphysema, asthma and COPD is important since these disease represent a significant global health issue with reduced quality of life”. However, this is the first indication of the term “COPD”, therefore, the term should be spelled out to provide clarity.
[Page 2, Lines 8-9]: As written it reads “It has been proposed to ablate nerve tissue by applying energy (RF, HIFU, Microwave, Radiation and Thermal Energy) directly to the nerves percutaneously”. However, this is the first indication of the terms “RF” and “HIFU”, therefore, the terms should be spelled out to provide clarity.
[Page 2, Lines 11-12]: As written it reads “This is an issue since nerves are too small to be visualized with standard ultrasound, CT, or MRI imaging methods”. However, this is the first indication of the terms “CT” and “MRI”, therefore, the terms should be spelled out to provide clarity.
[Page 15, Lines 11-12]: As written it reads “The outer diameter of the transducer 30 is approximately 1.5-3 mm in diameter, and preferably about 2 mm”. However, earlier in the same paragraph the transducer is denoted with the label “11”. Therefore, the examiner believes that “30” is a typo which should instead be “11”.
[Page 16, Lines 20-24]: As written it reads “Actuator or control unit 104 may be programmed or hard-wired, as discussed hereinafter, to activate transducer 11 in temporally spaced periods to generate pulsations to induce alveolar remodeling and optimize its effects based on diagnostic mode measurements and in some embodiments on AI analysis thereof”. However, this is the first instance of the term “AI” therefore, the term should be spelled out to provide clarity.
[Page 18, Lines 5-7]: As written it reads “Alternatively, or additionally, control unit 104 may include structures such as one or more controllable valves 114 connected in the fluid circuit for varying resistance of the circuit to fluid flow (not shown)”. However, the examiner notes that the label 114 was previously used to describe a digitizer (see FIG. 2). Therefore, the examiner would recommend removing the label 114. Alternatively, FIG. 2 includes the label 224 describing valves. If the label 224 represents the valves which are controlled by the control unit 104, the examiner would recommend updating the specification accordingly.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities:
Regarding claim 1, as written it reads “System for pulmonary treatment, comprising: an ultrasound transducer adapted for insertion into the bronchial tree of the mammalian subject and for transmitting circumferential ultrasound energy; and an actuator or control unit electrically connected to the transducer and adapted to control the ultrasound transducer to transmit ultrasound energy into an impact volume encompassing a bronchial branch so that the ultrasound energy is applied at a therapeutic level sufficient to a) inactivate conduction of bronchial nerves and to b) ablate smooth muscle, ablate goblet cells, and/or remodel emphysematous tissue throughout the impact volume”. However, the examiner believes that the word “A” should be included before the word “System” since this is not the only system that can be used for pulmonary treatment.
Additionally, this is the first indication of the terms “the bronchial tree” and “the mammalian subject”, therefore, the examiner would recommend amending the claim to recite “a bronchial tree” and “a mammalian subject” in order to avoid potential antecedent basis issues.
Appropriate correction is required.
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 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) 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):
(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). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) 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). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) 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) 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) 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) 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 actuator or control unit in claims 1-2, 4-8, 16-17, 21 and 24.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. That being said, the actuator or control unit is described in the specification when it states “The apparatus preferably also includes an actuator or control unit (e.g., programmed microprocessor or hard- wired logic circuit) electrically connected to the transducer” [Page 5, Lines 18-20]. Therefore, the examiner is interpreting the actuator or control unit to be a programmed microprocessor or hard-wired logic circuit used to perform specific functions. Thus, claims 1-2, 4-8, 16-17, 21 and 24 are not subject to further rejection under 35 U.S.C. 112(a)/112(b) with respect to the actuator or control unit.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) (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).
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.
Claim 12 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claim 12, as written it reads “wherein the lumen is connectable to a suction source to apply a vacuum to a distal emphysematous lung region to evacuate fluids and mucous”. However, by reciting the term “connectable”, it is unclear whether the system actually requires a suction source to be present, specifically, it appears that this is an optional feature. If the Applicant desires for the suction source to be included within the system (i.e. not just an optional feature), the examiner would recommend amending the claim language to remove the term “connectable” and replace it with a term such as “connects”, “connected” or “coupled”.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 4-11, 13, 16-17, and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Warnking US 2016/0287912 A1 “Warnking”.
Regarding claim 1, Warnking teaches “System for pulmonary treatment, comprising:” (“An ultrasound system, also referred to herein as an energization circuit 100 (FIG. 1), is releasably connected to catheter 10 and transducer 11 through a plug connector 102. A control unit 104 and an ultrasonic-signal generator 106 are arranged to control the amplitude and timing of the electrical signals so as to control the power level and duration of the ultrasound signals emitted by transducer 11. […] Ultrasonic signal generator 106 produces both therapeutic denervation signals and outgoing diagnostic imaging signals” [0044]. As shown in FIG. 1, the catheter 10 of the energization circuit 100 passed through the main bronchial trunk 2 (see [0017]). Therefore, the ultrasound system (i.e. energization circuit 100) in FIG. 1 represents a system for pulmonary treatment.);
“an ultrasound transducer adapted for insertion into the bronchial tree of the mammalian subject and for transmitting circumferential ultrasound energy” (See transducer 11 as discussed in [0044] above, and “The ultrasonic mechanical vibratory energy transmitted by the transducer 11 propagates generally radially outwardly and away from the transducer 11 encompassing a full circle, or 360° of arc about the proximal-to-distal axis of the transducer 11 and the axis of the bronchial section treated” [0052]. As shown in FIG. 1, the transducer 11 is located within the main bronchial trunk 2. Since the ultrasonic mechanical vibratory energy is propagated generally radially outward (i.e. full circle) and away from the transducer 11 such that it reaches the bronchial section (i.e. main bronchial trunk 2, see FIG. 1), the transducer 11 must be for transmitting circumferential ultrasound energy. Therefore, the system includes an ultrasound transducer (i.e. transducer 11) adapted for insertion into the bronchial tree (see FIG. 1) of the mammalian subject and for transmitting circumferential ultrasound energy (see [0052]).); and
“an actuator or control unit electrically connected to the transducer and adapted to control the ultrasound transducer to transmit ultrasound energy into an impact volume encompassing a bronchial branch so that the ultrasound energy is applied at a therapeutic level sufficient to a) inactivate conduction of bronchial nerves and to b) ablate smooth muscle, ablate goblet cells, and/or remodel emphysematous tissue throughout the impact volume” (See control unit 104 as discussed in [0044] above, and “One aspect of the invention provides an apparatus for inactivating bronchial nerves in a human or non-human mammalian subject” [0012]; “The physician then initiates the treatment through the user interface. In the treatment, the ultrasonic signal generating system or energization circuit, and particularly the control board and ultrasonic source, actuate transducer 11 to deliver therapeutically effective ultrasonic waves to [a] target or ultrasound treatment region 13 (FIG. 2)” [0052]; “The selected operating frequency, unfocused characteristic, placement, size, and the shape of the electromechanical transducer 11 allows the entire bronchial section and bronchial nerves to lie within the “near field” region of the transducer 11” [0053]; “The power level desirably is selected so that throughout the target region, solid tissues are heated to about 42° C. or more for several seconds or more, but desirably all of the solid tissues, including the wall of the bronchus remain well below 65° C. Thus, throughout the impact region, the solid tissues (including all of the bronchial nerves) are brought to a temperature sufficient to inactivate nerve conduction but below that which causes rapid necrosis of the tissues” [0056]; and “The target region 13 of the unfocused ultrasonic mechanical vibratory energy encompasses the entire bronchial section treated and closely surrounding tissues, and therefore ablates all of the bronchial nerves surrounding the bronchus” [0059].
The act of ablating all of the bronchial nerves surrounding the bronchus serves to remodel emphysematous tissue (i.e. of which bronchial tissue is a part). Therefore, since the control unit 104 is initiated by a physician to actuate the transducer 11 to deliver therapeutically effective ultrasonic waves to the ultrasound treatment region 13 (i.e. target region 13) in order to heat solid tissue to a temperature sufficient to inactivate nerve conduction or cause ablation, the control unit 104 represents an actuator or control unit electrically connected to the transducer and adapted to control the ultrasound transducer (i.e. 11) to transmit ultrasound energy into an impact volume (i.e. see target region 13 in FIG. 2) encompassing a bronchial branch (see FIG. 1) so that the ultrasound energy is applied at a therapeutic level (i.e. see [0052], [0056], for example) sufficient to a) inactivate conduction of bronchial nerves (see [0012], [0056]) and to b) ablate smooth muscle, ablate goblet cells, and/or remodel emphysematous tissue (i.e. through ablating bronchial nerves surrounding the bronchus, see [0059]) throughout the impact volume (i.e. target region 13).).
Regarding claim 2, Warnking discloses all features of the claimed invention as discussed with respect to claim 1 above, and Warnking further teaches “wherein the actuator or control unit is configured to energize the transducer, to process ultrasonic echo encoding electrical signals from the transducer, to generate volumetric A mode signal data from such signals and to make a volumetric A mode bronchial diameter measurement from the volumetric A mode signal data” (See [0044] and [0042] as discussed with respect to claim 1 above and “In another embodiment, the ultrasound system uses transducer 11 to measure the size of the bronchus. The control board and ultrasound source actuate the transducer 11 to emit short, low power signals which will be reflected by the bronchus. The ultrasonic waves in this pulse are reflected by the bronchial wall onto transducer 11 as echoes. Transducer 11 converts the echoes to echo signals. The ultrasound system then determines the size of bronchus 1 by analyzing the echo signals. […] The width of the return signal or echo represents the difference between dmax and dmin in case the bronchial section is not perfectly circular but oval shaped. The ultrasound system uses the measured bronchus size to set the acoustic power to be delivered by transducer 11 during application of therapeutic ultrasonic energy in later steps. For example, the control board may use a lookup table correlating a particular echo delay (and thus bronchial radius) with a particular power level. Generally, the larger the diameter, the more power should be used.” [0051].
Therefore, the actuator or control unit (i.e. 104) is configured to energize the transducer (i.e. 11), to process ultrasonic echo encoding electrical signals from the transducer, to generate volumetric A mode signal data from such signals to make a volumetric A mode bronchial diameter (see [0051]) measurement from the volumetric A mode signal data (i.e. generated from echo signals received by the transducer 11).).
Regarding claim 4, Warnking discloses all features of the claimed invention as discussed with respect to claim 1 above, and Warnking further teaches “wherein the actuator or control unit is adapted to control activation or energization of the transducer based on the volumetric A mode measurement and optimized for each individual treatment site and the surrounding coupling fluid temperature as well as pre-cooling time so as to maintain the temperature of the bronchial wall below 40°C while achieving a temperature above 60°C throughout the impact volume surrounding the bronchial branch at the individual treatment site” (See [0044], [0042] and [0056] as discussed in claim 1 above, and [0051] as discussed in claim 2 above, and “The ultrasonic mechanical vibratory energy is applied with such an amplitude, frequency and duration that the energy inactivates all nerves in the target region. For example, the step of energizing the transducer may be so as to maintain the temperature of the bronchial wall below 65° C. while heating the solid tissues within the target region, including the nerves in the target region, to above 42° C” [0014]; “A circulation device is connected to lumens (not shown) within catheter 10 which in turn are connected to bladder 12. The circulation device is arranged to circulate a liquid, preferably a sterile aqueous liquid, through the catheter 10 to the transducer 11 in the bladder 12. The circulation device may include elements for holding the circulating coolant, pumps, a refrigerating coil (not shown), for providing a supply of liquid to the interior space of the bladder 12 at a controlled temperature, desirably at or below body temperature. The control board interfaces with the circulation device to control the flow of fluid into and out of the bladder 12” [0045] and “Since, necrosis of tissue typically occurs at temperatures of 65° C. or higher for approximately 10 sec or longer while inactivation of nerves typically occurs when the nerves are at temperatures of 42° C. or higher for several seconds or longer, the dosage of the ultrasonic mechanical vibratory energy is chosen to keep the temperature in the target region 13 between those temperatures for several seconds or longer. In addition, the circulation of cooled liquid through the bladder 12 containing the transducer 11 may also help reduce the heat being transferred from the transducer 11 to the inner layer of the bronchus. Hence, the transmitted therapeutic unfocused ultrasonic mechanical vibratory energy does not damage the inner layer of the bronchus, providing a safer treatment.” [0057].
Therefore, since the control unit 104 is configured to actuate the transducer 11 at a power level to heat the target region (i.e. solid tissues) are heated to about 42°C or more while the wall of the bronchus remains well below 65°C, the actuator or control unit is adapted to control activation or energization of the transducer (i.e. 11) based on the volumetric A mode measurement (i.e. [0042], [0051]) and optimized for each individual treatment site (i.e. solid tissue see [0014], uses the measured bronchus size to set acoustic power, see [0051]) and the surrounding coupling fluid temperature (i.e. cooled liquid in the bladder 12, see [0045]) as well as pre-cooling time so as to maintain the temperature of the bronchial wall below 40°C (i.e. below 65°C, see [0014], [0057]) while achieving a temperature above 60°C (i.e. above 42°C) throughout the impact volume (i.e. target region 13) surrounding the bronchial branch at the individual treatment site (i.e. corresponding to solid tissue/target tissue 13).).
Regarding claim 5, Warnking discloses all features of the claimed invention as discussed with respect to claim 1 above, and Warnking further teaches “wherein the actuator or control unit transmits ultrasound energy in the diagnostic mode to generate a signal and integrate ultrasound echoes to measure bronchial diameter” (See [0044] and [0042] as discussed in claim 1 above and [0051] as discussed in claim 2 above. Therefore, since the control unit 104 in conjunction with the ultrasonic signal generator 106 produces outgoing diagnostic imaging signals and the transducer 11 received echo signals used in measuring the size (i.e. maximum internal diameter, minimum internal diameter of the bronchial passageway, see [0042]) of the bronchus, the actuator or control unit transmits ultrasound energy in the diagnostic mode to generate a signal and integrate ultrasound echoes to measure bronchial diameter.).
Regarding claim 6, Warnking discloses all features of the claimed invention as discussed with respect to claim 1 above, and Warnking further teaches “wherein the actuator or control unit is configured to transmit ultrasound energy at a subtherapeutic level in a diagnostic mode to provide centering of the transducer in the bronchial branch” (See [0044] as discussed with respect to claim 1 above and [0051] as discussed in claim 2 above. Therefore, since the control unit 104 in combination with the ultrasonic signal generator 106 produces an outgoing diagnostic imaging signal (i.e. a low power signal, see [0051]), the actuator or control unit is configured to transmit ultrasound energy at a subtherapeutic level in a diagnostic mode to provide centering of the transducer in the bronchial branch (i.e. main branch 2, see FIG. 1 and [0017]).).
Regarding claim 7, Warnking discloses all features of the claimed invention as discussed with respect to claim 1 above, and Warnking further teaches “wherein the actuator or control unit is adapted to control the ultrasound transducer to transmit the ultrasound energy in a pulsed function interleaved with volumetric A mode diagnostic acquisitions, thereby operating in a quasi-simultaneous therapeutic/diagnostic mode” (See [0044] as discussed in claim 1 above and “For example, the ultrasound system may control the transducer 11 to transmit ultrasonic mechanical vibratory energy in a pulsed function during application of therapeutic ultrasonic energy. […] The pulsed therapeutic function can also be interleaved with a diagnostic imaging mode when an ultrasound array is used instead of a cylindrical solid transducer. This way diagnostic ultrasound imaging can be obtained (quasi)simultaneously to the therapeutic treatment” [0061]. Therefore, the actuator or control unit is adapted to control the ultrasound transducer to transmit the ultrasound energy in a pulsed function interleaved with volumetric A mode diagnostic acquisitions, thereby operating in a quasi-simultaneous therapeutic/diagnostic mode.).
Regarding claim 8, Warnking discloses all features of the claimed invention as discussed with respect to claim 1 above, and Warnking further teaches “wherein the actuator or control unit is adapted to control the ultrasound transducer to transmit the ultrasound energy in pulses to mechanically remodel emphysematous tissue by inducing mechanical stress in the affected lung segments to cause fibrosis” (See [0044], [0053] and [0059] as discussed with respect to claim 1 above and [0061] as discussed with respect to claim 7 above. Bronchial passageways are present within lung segments. The act of ablating all of the bronchial nerves surrounding the bronchus serves (see [0059]) to remodel emphysematous tissue (i.e. of which bronchial tissue is a part). Therefore, since the control unit 104 in combination with the ultrasonic signal generator 106 produces therapeutic denervation signals, the actuator or control unit is adapted to control the ultrasound transducer to transmit the ultrasound energy in pulses to mechanically remodel emphysematous tissue (i.e. ablate bronchial nerves) by inducing mechanical stress in the affected lung segments to cause fibrosis.).
Regarding claim 9, Warnking discloses all features of the claimed invention as discussed with respect to claim 1 above, and Warnking further teaches “further comprising an occluding balloon expandable to prevent backflow of liquid injected into a distal section of the bronchial tree” (“Catheter 10 has a compliant balloon or inflatable bladder 12 mounted at the distal end. In its inflated condition (FIGS. 2 and 3), bladder 12 will engage the bronchial wall and therewith allow for ultrasound to be conducted from transducer into the bronchial wall and surrounding tissues” [0039]. Therefore, the system further comprises an occluding balloon (i.e. compliant balloon/inflatable bladder 12) expandable to prevent backflow of liquid injected into a distal section of the bronchial tree.).
Regarding claim 10, Warnking discloses all features of the claimed invention as discussed with respect to claim 9 above, and Warnking further teaches “further comprising an elongated member supporting the transducer, wherein the elongated member is introduced through an introducer, and the introducer supports the occluding balloon” (“Yet another embodiment provides for a guide wire 14 (in FIG. 2) to be delivered through the working channel of the bronchoscope to the treatment site and the ultrasound treatment catheter to be advanced over the wire after the bronchoscope has been withdrawn” [0048]. As shown in FIG. 2, the catheter 10 containing the transducer 11 and the compliant balloon/inflatable bladder 12 is moved along the guide wire 14. In this case, the catheter 10 represents an elongated member supporting the transducer, wherein the elongated member is introduced through an introducer (i.e. guide wire 14) and the introducer supports the occluding balloon (i.e. compliant balloon/inflatable bladder 12). Thus, the system further comprises an elongated member supporting the transducer, wherein the elongated member is introduced through an introducer, and the introducer supports the occluding balloon (i.e. compliant balloon/inflatable bladder 12).).
Regarding claim 11, Warnking discloses all features of the claimed invention as discussed with respect to claim 1 above, and Warnking further teaches “further comprising a catheter with a lumen operatively connectable to a source of pressurized or pressurizable saline liquid to flood a distal emphysematous section of the bronchial tree with saline liquid in order to ensure ultrasound conduction and thermal and mechanical interaction throughout a treatment volume within or proximate the bronchial branch” (See catheter 10 in FIG. 2, [0044] as discussed with respect to claim 1 above and “Alternatively or additionally, the control circuit may include structures such as controllable valves connected in the fluid circuit for varying resistance of the circuit to fluid flow (not shown). The ultrasound system may further include pressure sensors, to monitor the liquid flow through the catheter 10. At least one pressure sensor monitors the flow of the liquid to the distal end of catheter 10 to determine if there is a blockage while the other monitors leaks in the catheter 10” [0045]; “Ultrasound transmissibility between the bladder and the bronchial wall may be enhanced by providing the outer surface of the bladder with a layer of liquid, for instance, saline solution or biocompatible gel” [0063]. Therefore, the system further comprises a catheter (i.e. 10) with a lumen operatively connectable to a source of pressurized or pressurizable saline liquid to flood a distal emphysematous section of the bronchial tree (i.e. main branch 2, see [0017]) with saline liquid in order to ensure ultrasound conduction (i.e. ultrasound transmissibility) and thermal and mechanical interaction throughout a treatment volume within or proximate the bronchial branch.).
Regarding claim 13, Warnking discloses all features of the claimed invention as discussed with respect to claim 1 above, and Warnking further teaches “further comprising an elongated member with a distal end and a proximal end, the transducer being mounted to the elongated member adjacent the distal end inside a balloon” (See [0044] as discussed with respect to claim 1 and catheter 10 in FIG. 2. Therefore, the system further comprises an elongate member (i.e. catheter 10) with a distal end and a proximal end, the transducer (i.e. 11) being mounted to the elongated member adjacent the distal end inside a balloon (i.e. compliant balloon or inflatable bladder 12, see [0039]).).
Regarding claim 16, Warnking discloses all features of the claimed invention as discussed with respect to claim 1 above, and Warnking further teaches “wherein the actuator or control unit is further adapted to process volumetric A mode signals to determine depth of emphysematous tissue and to optimize the ultrasound ablation energy and cooling temperature for the determined depth” (See [0051] as discussed in claim 2 above; [0061] as discussed in claim 7 above; [0014], [0045] and [0057] as discussed in claim 4 above; and “As discussed hereinafter in detail with reference to FIG. 18, the control system 456 translates these ablation markers into focusing, power and time parameters to control the ablation beam in the desired location and to ablate a lesion of the appropriate depth. During the ablation process the ablation site is monitored via ultrasound in an interlaced mode to allow the user to control the ablation process under essentially real time visualization” [0087].
Therefore, since the ultrasound system measures the size of the bronchus and uses it to set the acoustic power used to deliver therapeutic ultrasonic energy to the desired location (i.e. corresponding to the bronchus) and the ablation site (i.e. located at a specific depth) is monitored during the ablation process (i.e. interleaving therapeutic function with diagnostic imaging, see [0061]), the actuator or control unit is further adapted to process volumetric A mode signals (i.e. diagnostic imaging signals, see [0044]) to determine depth of emphysematous tissue (i.e. bronchus, see FIG. 2) and to optimize the ultrasound ablation energy and cooling temperature (i.e. see [0014], [0045], [0057]) for the determined depth (i.e. corresponding to the bronchus).).
Regarding claim 17, Warnking discloses all features of the claimed invention as discussed with respect to claim 1 above, and Warnking further teaches “further comprising an elongated member with a distal end and a proximal end, the transducer being disposed inside a compliant balloon mounted to the distal end of the elongated member and filled with circulating transducer-cooling and ultrasound-coupling fluid” (See [0044] as discussed in claim 1 above, [0039] as discussed in claim 9 above, catheter 10 in FIG. 2; and “This bladder is filled with a circulating cooling fluid which serves in part to conduct ultrasonic mechanical vibratory energy from the transducer to the bronchial walls and surrounding tissue and nerves. This cooling fluid also transports excessive heat away from the transducer” [0013]; “Once the distal end of the catheter is in position within a bronchial branch, pumps bring bladder 12 to an inflated condition (steps 210 and 212 in FIG. 7) as depicted in FIGS. 2 and 3. In this condition, the compliant bladder 12 engages the bronchial wall, and thus centers transducer 11 within the bronchial branch, with the axis of the transducer approximately coaxial with the axis of the bronchial branch. This not only provides for a relatively homogeneous energy distribution circumferentially, but also keeps the very high energy levels close to the transducer located inside the cooling fluid where they are harmless, since ultrasound does not interact with fluid (see FIG. 4)” [0049].
Therefore, the system further comprises an elongated member (i.e. catheter 10) with a distal end and a proximal end, the transducer (i.e. 11) being disposed inside a compliant balloon (i.e. 12) mounted to the distal end of the elongated member (i.e. catheter 10) and filled with a circulating transducer-cooling and ultrasound-coupling fluid (See [0013], [0049]).);
“wherein the actuator or control unit is configured to control the ultrasound transducer to vary acoustic power and transducer-activation duration and to vary temperature of the circulating transducer-cooling and ultrasound-coupling fluid to optimize, in accordance with volumetric A mode determined size of the bronchial branch, therapeutic effectiveness of the ultrasound energy generated in the impact volume and target nerves, smooth muscle, goblet cells and/or or emphysematous tissue to be treated” (See [0051] as discussed in claim 2 above, and [0045] as discussed in claim 4 above. Therefore, the actuator or control unit (i.e. 104) is configured to control the ultrasound transducer (i.e. 11) to vary acoustic power and transducer-activation duration (i.e. see [0051]) and to vary temperature of the circulating transducer-cooling and ultrasound-coupling fluid (i.e. see [0045]) to optimize, in accordance with volumetric A mode determined size of the bronchial branch (see [0051]), therapeutic effectiveness of the ultrasound energy generated in the impact volume (i.e. target region 13, see FIG. 2) and target nerves (i.e. bronchial nerves, see [0059]), smooth muscle, goblet cells and/or or emphysematous tissue to be treated.).
Regarding claim 21, Warnking discloses all features of the claimed invention as discussed with respect to claim 13 above, and Warnking further teaches “wherein the balloon is filled with a cooling fluid and the actuator or control unit maintains a temperature of the cooling fluid at or below body temperature” (See [0045] as discussed in claim 4 above. Therefore, the balloon (i.e. compliant balloon or inflatable bladder 12) is filled with a cooling fluid (i.e. sterile aqueous liquid, see [0045]) and the actuator or control unit maintains a temperature of the cooling fluid at or below body temperature (i.e. through the circulation device, [0045]).).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Warnking US 2016/0287912 A1 “Warnking” as applied to claim 13 above, and further in view of Warnking et al. WO 2021/201963 A1 “Warnking-2”.
Regarding claim 14, Warnking discloses all features of the claimed invention as discussed with respect to claim 13 above, and Warnking further teaches “wherein the balloon is filled with circulating fluid, in order to cool, center, align and acoustically couple the transducer with a wall of the bronchial branch” (See [0013] and [0049] ad discussed in claim 17 above. Therefore, the balloon (i.e. compliant balloon or inflatable bladder 12, see [0039]) is filled with circulating fluid (i.e. cooling fluid) in order to cool (see [0013]), center, (see [0049]), align (see [0049]) and acoustically couple (i.e. such that the balloon conducts ultrasonic mechanical vibratory energy from the transducer, see [0013]) the transducer with a wall of the bronchial branch (i.e. main branch 2, see FIG. 1).).
However, Warnking does not teach “the balloon includes a porous membrane to engage the wall of the bronchial branch with fluid for improved acoustic coupling while enabling moving the balloon axially to achieve optimal positioning based on volumetric A mode signal analysis of emphysematous tissue”.
Warnking-2 is within the same field of endeavor as the claimed invention because it involves apparatuses and methods for deactivating bronchial nerves (see [Abstract]).
Warnking-2 teaches “the balloon includes a porous membrane to engage the wall of the bronchial branch with fluid for improved acoustic coupling while enabling moving the balloon axially to achieve optimal positioning based on volumetric A mode signal analysis of emphysematous tissue” (“In a further variant, the balloon 12 may be formed from a porous membrane or include holes, such that cooled liquid circulated within the balloon may escape or flow from the balloon 12 against the bronchial walls to improve acoustic contact” [0068]; “wherein the compliant balloon includes a porous membrane engageable with the wall of the bronchial section with fluid for improved acoustic coupling while preserving longitudinal movability of the compliant balloon” [Claim 28].
Therefore, the balloon includes a porous membrane to engage the wall of the bronchial branch (i.e. bronchial section) with fluid for improved acoustic coupling while enabling moving the balloon axially (i.e. longitudinal movability) to achieve optimal positioning based on volumetric A mode signal analysis of emphysematous tissue (i.e. bronchial tissue).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Warnking such that the balloon includes a porous membrane to engage the wall of the bronchial branch with fluid for improved acoustic coupling while enabling moving the balloon axially to achieve optimal positioning based on volumetric A mode signal analysis of emphysematous tissue as disclosed in Warnking-2 in order to enable the balloon to continue moving while also providing improved acoustic coupling such that a transducer can obtain images of a bronchial passageway. A porous membrane is one of a finite number of configurations which can be included within a balloon to allow fluids to pass therethrough with a reasonable expectation of success. Thus, modifying the system of Warnking such that the balloon includes a porous membrane to engage the wall of the bronchial branch with fluid for improved acoustic coupling while enabling moving the balloon axially to achieve optimal positioning based on volumetric A mode signal analysis of emphysematous tissue as disclosed in Warnking-2 would yield the predictable result of enabling the balloon to continue moving while also providing improved acoustic coupling such that a transducer can obtain images of a bronchial passageway.
Claim(s) 12, 18-19, and 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Warnking US 2016/0287912 A1 “Warnking” as applied to claim 1 above, and further in view of Krimsky US 2018/0214203 A1 “Krimsky”.
Regarding claim 12, Warnking discloses all features of the claimed invention as discussed with respect to claim 11 above. However, Warnking does not teach “wherein the lumen is connectable to a suction source to apply a vacuum to a distal emphysematous lung region to evacuate fluids and mucous”.
Krimsky is within the same field of endeavor as the claimed invention because it involves a medical instrument for enhancing diagnosis and treatment (see [Abstract]).
Krimsky teaches “wherein the lumen is connectable to a suction source to apply a vacuum to a distal emphysematous lung region to evacuate fluids and mucous” (“Catheter 701, via port 705a and tube 705, is in fluid communication with a vacuum source (not shown) or a liquid source (not shown). Port 705a is in fluid communication with lumen 701a of the catheter 701. Tube 705 is configured and coupled with catheter 701, via port 705a, such that one end of tube 705 is attached to an end of lumen 701a of catheter 701 that is proximal to the clinician, via port 705a, and the other end of tube 705 is coupled with the vacuum or liquid source. As described above, the vacuum source described herein includes, but is not limited to, a pump or a syringe. The vacuum source generates a vacuum by suctioning air, through tube 705, via lumen 701a, around ablation probe 702.” [0078]; “In some embodiments, the tissue-to-tool interface between the medical instrument and the tissue may be created by suctioning air around the medical instrument such that the tissue is drawn closer to the medical instrument. The vacuum used in suctioning the air around medical instrument may be sufficient to draw the tissue closer to the medical instrument, however, may not be sufficient to induce atelectasis (i.e., the complete collapse of the tissue as a result of the withdrawal of the air in a given portion of the organ). In some embodiments, the tissue-to-tool interface between the medical instrument and the tissue may be created by injecting fluid that provides a more consistent environment or zone around medical instrument for delivering energy” [0045].
Therefore, the lumen (i.e. tube 705) of the catheter 701 is attached to a vacuum source (i.e. pump or syringe) which suctions air therethrough to create a tissue-to-tool interface. The act of suctioning air through the tube 705 would necessarily cause the evacuation of fluids and mucous surrounding the tissue to which the tool (i.e. catheter) is attached. Thus, the lumen is connectable to a suction source to apply a vacuum to a distal emphysematous lung region (i.e. alveoli, see FIG. 6) to evacuate fluids and mucous.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Warnking such that the lumen of the catheter is connectable to a suction source to apply a vacuum to a distal emphysematous lung region (i.e. alveoli, see FIG. 6) to evacuate fluids and mucous as disclosed in Krimsky in order to allow for a firm connection to be made between the catheter and the tissue being examined/treated. Connecting a vacuum source with a catheter is one of a finite number of techniques which can be used to create a firm connection between the catheter and tissue with a reasonable expectation of success. Thus, modifying the system of Warnking such that the lumen of the catheter is connectable to a suction source to apply a vacuum to a distal emphysematous lung region (i.e. alveoli, see FIG. 6) to evacuate fluids and mucous as disclosed in Krimsky would yield the predictable result of allowing for a firm connection to be made between the catheter and the tissue being examined/treated
Regarding claim 18, Warnking discloses all features of the claimed invention as discussed with respect to claim 1 above, and Warnking further teaches “wherein the system further comprises a catheter for supporting the transducer and an introducer having a lumen for passage of the catheter, the catheter having a first balloon containing the transducer […]” (“FIG. 2 is showing a treatment catheter 10 advanced through a bronchoscope 5 into the right bronchial branch and the diagrammatic sectional view depicting the unfocused ultrasound treatment volume 13.” [0018].
As shown in FIG. 2, the transducer 11 is located within a compliant balloon or inflatable bladder 12 (see [0039]) of the catheter 10 and the bronchoscope 5 has a lumen through which the catheter 10 passes. Therefore, the system further comprises a catheter 10 for supporting the transducer (i.e. 11) and an introducer (i.e. bronchoscope 5) having a lumen for passage of the catheter, the catheter having a first balloon containing the transducer.
However, Warnking does not teach “the introducer having a second balloon proximal the first balloon to prevent flow of fluid proximal the second balloon”.
Krimsky teaches “the introducer having a second balloon proximal the first balloon to prevent flow of fluid proximal the second balloon” (“Turning now to FIG. 6, there is shown an enlarged view of a portion of an extended working channel 96 comprising a port or opening 18 and balloons 14, 21 within an airway of a patient. FIG. 6 depicts an airway 10, an alveolus 11 that branches off airway 10, and a lesion 28 that is formed within alveolus 11. EWC 96 is inserted into airway 10 and a proximal balloon 14 extends from EWC 96. Balloon 14 may extend laterally from EWC 96, as depicted in FIG. 6, and seal the portion of the airway 10 proximal of the distal end of EWC 96. Medical instrument 19 extends from the distal end of EWC 96. Medical instrument 19, as described above, may be a microwave ablation catheter. In some embodiments, medical instrument 19 may be a catheter configured to deliver therapeutic substance, such as a chemotherapy substance, to the target tissue” [0071]; “In embodiments where medical instrument 19 delivers a therapeutic substance the tissue-to-tool interface created between medical instrument 19 and lesion 28 improves delivery of the therapeutic substance to lesion 28 by eliminating leakage of the therapeutic substance beyond the portion of the airway 10 isolated by balloons 14 and 21, thus limiting the therapeutic substance to those areas where they will be most effective, namely alveolus 11 and a small section of airway 10” [0074]. As shown in FIG. 6, the balloon 14 is located on the extended working channel 96 (i.e. the introducer) and is located proximally of the balloon 21. Additionally, the balloons 14 and 21 prevent the leakage of the therapeutic substance (i.e. proximal the balloon 14 and distal the balloon 21). Therefore, the introducer has a second balloon (i.e. 14) proximal the first balloon to prevent flow of fluid (i.e. therapeutic substance, for example) proximal the second balloon.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Warnking such that the introducer has a second balloon proximal the first balloon to prevent flow of fluid proximal the second balloon as disclosed in Krimsky in order to limit the location to which fluid can flow within the bronchial branch (i.e. to which the alveoli connects). Providing multiple balloons is one of a finite number of techniques which can be used to limit fluid flow when a device is placed within the bronchial branch with a reasonable expectation of success. Thus, modify the system of Warnking such that the introducer has a second balloon proximal the first balloon to prevent flow of fluid proximal the second balloon as disclosed in Krimsky would yield the predictable result of limiting the location to which fluid can flow within the bronchial branch (i.e. to which the alveoli connects).
Regarding claim 19, Warnking in view of Krimsky discloses all features of the claimed invention as discussed with respect to claim 18 above, and Warnking further teaches “wherein the introducer or catheter has a lumen for passage of the fluid into a distal section of the bronchial tree for ultrasound conduction” (See [0013] as discussed in claim 17 above. As shown in FIG. 2, the compliant balloon/inflatable bladder 12 is within a distal section of the bronchial tree. In order for the bladder 12 to be filled with a circulating cooling fluid to allow for conduct of ultrasonic mechanical vibratory energy from the transducer to the bronchial walls, either the introducer (i.e. bronchoscope 5) or the catheter (i.e. 10) must have a lumen for passage of the fluid into a distal section of the bronchial tree for ultrasound conduction. Thus, the introducer or catheter inherently has a lumen for passage of the fluid into a distal section of the bronchial tree for ultrasound conduction.).
Regarding claim 23, Warnking in view of Krimsky discloses all features of the claimed invention as discussed with respect to claim 18 above, and Warnking further teaches “further comprising a pressure sensor to monitor pressure to enable the […] balloon to be maintained in an expanded occluding condition” (“The ultrasound system may further include pressure sensors, to monitor the liquid flow through the catheter 10. At least one pressure sensor monitors the flow of the liquid to the distal end of catheter 10 to determine if there is a blockage while the other monitors leaks in the catheter 10. While the balloon is in an inflated state, the pressure sensors maintain a desired pressure in the balloon preferably so that the compliant balloon occludes the bronchus” [0045]. Therefore, the system further comprises a pressure sensor to monitor pressure to enable the balloon to be maintained in an expanded occluding condition (i.e. occluding the bronchus).).
Krimsky further teaches the “second” balloon (See Krimsky: [0071] and [0074] as discussed in claim 18 above. Therefore, the device includes a second balloon.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Warnking such that the introducer has a second balloon proximal the first balloon to prevent flow of fluid proximal the second balloon as disclosed in Krimsky in order to limit the location to which fluid can flow within the bronchial branch (i.e. to which the alveoli connects). Providing multiple balloons is one of a finite number of techniques which can be used to limit fluid flow when a device is placed within the bronchial branch with a reasonable expectation of success. Thus, modify the system of Warnking such that the introducer has a second balloon proximal the first balloon to prevent flow of fluid proximal the second balloon as disclosed in Krimsky would yield the predictable result of limiting the location to which fluid can flow within the bronchial branch (i.e. to which the alveoli connects).
Regarding claim 24, Warnking in view of Krimsky discloses all features of the claimed invention as discussed with respect to claim 18 above, and Warnking further teaches “wherein the fluid floods the distal section, and the actuator or control unit is configured to test the flooded section” (See [0045] as discussed in claim 4 above and [0044] as discussed in claim 1 above. Therefore, the fluid floods the distal section and the actuator or control unit is configured to test the flooded section (i.e. through diagnostic imaging signals and/or therapeutic denervation signals, see [0044]).).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Van der Weide et al. US 2020/0197090 A1 “Van der Weide” is pertinent to the applicant’s disclosure because it discloses “In some embodiments, the anchoring element is an inflatable balloon (e.g., wherein inflation of the balloon secures the antenna at a particular tissue region). An additional advantage of utilizing an inflatable balloon as an anchoring element is the inhibition of blood flow or air flow to a particular region upon inflation of the balloon. Such air or blood flow inhibition is particularly useful in, for example, cardiac ablation procedures and ablation procedures involving lung tissue, vascular tissue, and gastrointestinal tissue” [0122].
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne M Kozak can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAITLYN E SEBASTIAN/Examiner, Art Unit 3797