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 statements (IDSs) submitted on 06/13/2024 (2), 08/12/2024, 01/17/2025 (3), 08/13/2025 (2), and 12/01/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the applicant’s use.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility application should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase “Not Applicable” should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM.
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR.
(g) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art including information disclosed under 37 CFR 1.97 and 1.98.
(h) BRIEF SUMMARY OF THE INVENTION.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(j) DETAILED DESCRIPTION OF THE INVENTION.
(k) CLAIM OR CLAIMS (commencing on a separate sheet).
(l) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(m) SEQUENCE LISTING. (See MPEP § 2422.03 and 37 CFR 1.821 - 1.825). A “Sequence Listing” is required on paper if the application discloses a nucleotide or amino acid sequence as defined in 37 CFR 1.821(a) and if the required “Sequence Listing” is not submitted as an electronic document either on read-only optical disc or as a text file via the patent electronic system.
Content of Specification
(a) TITLE OF THE INVENTION: See 37 CFR 1.72(a) and MPEP § 606. The title of the invention should be placed at the top of the first page of the specification unless the title is provided in an application data sheet. The title of the invention should be brief but technically accurate and descriptive, preferably from two to seven words. It may not contain more than 500 characters.
(b) CROSS-REFERENCES TO RELATED APPLICATIONS: See 37 CFR 1.78 and MPEP § 211 et seq.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT: See MPEP § 310.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT. See 37 CFR 1.71(g).
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM: The specification is required to include an incorporation-by-reference of electronic documents that are to become part of the permanent United States Patent and Trademark Office records in the file of a patent application. See 37 CFR 1.77(b)(5) and MPEP § 608.05. See also the Legal Framework for Patent Electronic System posted on the USPTO website (https://www.uspto.gov/sites/default/files/documents/2019LegalFrameworkPES.pdf) and MPEP § 502.05
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR. See 35 U.S.C. 102(b) and 37 CFR 1.77.
(g) BACKGROUND OF THE INVENTION: See MPEP § 608.01(c). The specification should set forth the Background of the Invention in two parts:
(1) Field of the Invention: A statement of the field of art to which the invention pertains. This statement may include a paraphrasing of the applicable U.S. patent classification definitions of the subject matter of the claimed invention. This item may also be titled “Technical Field.”
(2) Description of the Related Art including information disclosed under 37 CFR 1.97 and 37 CFR 1.98: A description of the related art known to the applicant and including, if applicable, references to specific related art and problems involved in the prior art which are solved by the applicant’s invention. This item may also be titled “Background Art.”
(h) BRIEF SUMMARY OF THE INVENTION: See MPEP § 608.01(d). A brief summary or general statement of the invention as set forth in 37 CFR 1.73. The summary is separate and distinct from the abstract and is directed toward the invention rather than the disclosure as a whole. The summary may point out the advantages of the invention or how it solves problems previously existent in the prior art (and preferably indicated in the Background of the Invention). In chemical cases it should point out in general terms the utility of the invention. If possible, the nature and gist of the invention or the inventive concept should be set forth. Objects of the invention should be treated briefly and only to the extent that they contribute to an understanding of the invention.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S): See MPEP § 608.01(f). A reference to and brief description of the drawing(s) as set forth in 37 CFR 1.74.
(j) DETAILED DESCRIPTION OF THE INVENTION: See MPEP § 608.01(g). A description of the preferred embodiment(s) of the invention as required in 37 CFR 1.71. The description should be as short and specific as is necessary to describe the invention adequately and accurately. Where elements or groups of elements, compounds, and processes, which are conventional and generally widely known in the field of the invention described, and their exact nature or type is not necessary for an understanding and use of the invention by a person skilled in the art, they should not be described in detail. However, where particularly complicated subject matter is involved or where the elements, compounds, or processes may not be commonly or widely known in the field, the specification should refer to another patent or readily available publication which adequately describes the subject matter.
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i) - (p).
(l) ABSTRACT OF THE DISCLOSURE: See 37 CFR 1.72 (b) and MPEP § 608.01(b). The abstract is a brief narrative of the disclosure as a whole, as concise as the disclosure permits, in a single paragraph preferably not exceeding 150 words, commencing on a separate sheet following the claims. In an international application which has entered the national stage (37 CFR 1.491(b)), the applicant need not submit an abstract commencing on a separate sheet if an abstract was published with the international application under PCT Article 21. The abstract that appears on the cover page of the pamphlet published by the International Bureau (IB) of the World Intellectual Property Organization (WIPO) is the abstract that will be used by the USPTO. See MPEP § 1893.03(e).
(m) SEQUENCE LISTING: See 37 CFR 1.821 - 1.825 and MPEP §§ 2421 - 2431. The requirement for a sequence listing applies to all sequences disclosed in a given application, whether the sequences are claimed or not. See MPEP § 2422.01.
The disclosure is objected to because of the following informalities:
The paragraph under the section, “Cross-Reference to Related Applications” should be updated to reflect the changes made in the Application Data Sheet (ADS) filed on 01/07/2025.
The specification is missing the section “BRIEF SUMMARY OF THE INVENTION” as Examiner has indicated above through the “Arrangement of the specification” and “Content of the specification”.
Paragraph [0023] should be amended to the following, “Intravascular lithotripsy systems, devices and methods have been described by Applicant. See PCT/US2022/074607, filed August 5, 2022 and entitled "INTRAVASCULAR LITHOTRIPSY BALLOON SYSTEMS, DEVICES AND METHODS", the entire contents of which are hereby incorporated by reference.”
Paragraph [0037] should be amended to the following, “In box 46, determination is made to maintain presently selected settings. In the illustrative embodiment, the presently selected settings include the discharge voltage of and applicable duration as applied immediately previously in box 42. For avoidance of doubt, if the initial settings have just immediately been applied in box 42, resulting in 20 amps of current, the initial settings would be applied in the next cycle of therapy. However, if the presently selected settings include updates to the settings, for example, updated duration and/or voltage settings from later portions of control 38, as discussed in additional detail herein, then maintaining presently selected settings would include the immediately applied updated settings. Maintaining presently selected settings proceeds openly to return to box 42, to again apply electrical energy to the electrodes to deliver IVL therapy.”
Paragraph [0059] should be amended to the following, “The applied energy storage may be adjusted on an ongoing basis, for example, for any given pulse. In practice, adjusting the energy storage capacity or magnitude may be conducted in conjunction with the level of voltage to be applied and/or in consideration of other aspects of power, efficiency, and/or technique. Moreover, under the lifetime of applied devices and systems, typical wear to components can alter the electrical and/or physical characteristics thereof, which may benefit from adjustment to the energy storage that is applied. For example, even small wear to electrodes can vary the spacing (gap) between a set of electrodes which can alter the conditions of the arc between electrodes. Accordingly, adjustable energy storage magnitude can accommodate variations in the electrodes and/or portions of the discharge system under repeated use, whether in individual therapy sessions or otherwise.”
Paragraph [0081] should be amended to the following, “In box 312, assessment of the energy storage system 112 is conducted. In the illustrative embodiment, the assessment includes determination of a voltage of the energy stored by the energy storage system 112. As mentioned above, the voltage monitoring system 180 can monitor voltage of the energy storage system 112, for example, via the voltage limiting system during charging. In some embodiments, the assessment may include determination of any other suitable parameters to support energy monitoring of the energy storage system 112.”
Paragraph [0084] should be amended to the following, “In box 318, assessment of the energy storage system 112 is conducted. Assessment of the energy storage systems 112 in box 318 is embodied as occurring immediately after attempted IVL therapy in box 316 to provide an indication of the energy state of the energy storage system 112 immediately after (attempted) discharge to the electrodes. In the illustrative embodiment, the assessment includes determination of a voltage of the energy stored by the energy storage system 112, embodied as conducted by the voltage monitoring as mentioned above, although in some embodiments, assessment of the energy storage system 112 in box 318 may differ from box 312 in methodology and/or practice.”
Paragraph [0085] should be amended to the following, “In box 320, the energy of the energy storage system 112 is determined. In the illustrative embodiment, the energy of the energy storage system 112 is again determined based on the measured voltage according to 1/2=C*V2 just as in box 314, yet after attempted delivery of IVL therapy. In some embodiments, determining energy of the energy storage system 112 in box 320 may differ in methodology and/or practice from that in box 314. Accordingly, the processor 24 can compute the current energy of the energy storage system 112, including immediately after (attempted) discharge of energy to the electrodes.”
Paragraph [0088] should be amended to the following, “In the illustrative embodiment, and with reference to FIG. 2 , the threshold energy discharge is a fixed predetermined value, for example, 600 millijoules (e.g., 3700 V, 90 nanofarad). However, in some embodiments, the threshold energy level for a given cycle may be determined based on the number of previous cycles in a therapy session, the number of cycles maintaining present settings (e.g., through box 46 of FIG. 2 ) in a therapy session, the number of particular successive cycles (e.g., number of successive cycles through box 46 or box 48 or box 52 or box 54 or box 58), the patient characteristics, environmental conditions (e.g., location within patient's body such as above the knee or below the knee), procedural approach, and/or product cycle lifetime (i.e., operable age), among other aspects.”
Paragraph [0093] should be amended to the following (closing quotation mark is missing where it recites “(“HV_WDO #)”), “Returning to FIGS. 3A and 3B, in the illustrative embodiment, the IVL control system 22 includes an umbrella monitoring system 190 configured to assist in safe operation. The umbrella monitoring system 190 illustratively includes a flip flop 192 and logic gate 194 for consideration of monitoring signals. The logic gate 194 is arranged to receive monitoring signals, embodied as energy storage system overvoltage (“VCAP1_OVER #”) from the voltage monitoring system 180, high voltage warning (“HV_WDO #”) from the watchdog system, and in some embodiments, may receive overcurrent from the current monitoring system (“ISNS_OVER #”).”
Paragraph [0096] should be amended to the following (closing quotation mark is missing where it recites “(“HV_WDO #)”, and there is an unnecessary quotation mark where it recites, “via transistors [Q12, Q13].””), “Accordingly, the logic gate 194 receives monitoring signals discussed above comprising: (1) energy storage system overvoltage (“VCAP1_OVER #”) from the voltage monitoring system 180, (2) high voltage warning (“HV_WDO #”) from the watchdog system, and in some embodiments, (3) may receive overcurrent from the current monitoring system (“ISNS_OVER #”). These monitoring signals ae also connected to a three-input AND logic gate [U12], which is upstream of a D flip-flop with asynchronous set and reset functionality [U15], so that any signal that asserts for longer than the minimum pulse width of the flip-flop [U15] will cause its outputs [HV_DISABLED, HV_DISABLED #] to assert. These signals travel downstream and inhibits the operation of the gate driver [U11], variable low-voltage supply [U6], high-voltage module [U7], and slightly changes the turn-on and turn-off operation of the switching devices [Q10, Q11] via transistors [Q12, Q13]. This system allows any one of monitoring signals to disable the output of the system if asserted longer than an established duration.”
Paragraph [0098] should be amended to the following, “Examples of suitable processors may include one or more microprocessors, integrated circuits, system-on-a-chips (SoC), among others. Examples of suitable memory, may include one or more primary storage and/or non-primary storage (e.g., secondary, tertiary, etc. storage); permanent, semi-permanent, and/or temporary storage; and/or memory storage devices including but not limited to hard drives (e.g., magnetic, solid state), optical discs (e.g., CD-ROM, DVD-ROM), RAM (e.g., DRAM, SRAM, DRDRAM), ROM (e.g., PROM, EPROM, EEPROM, Flash EEPROM), volatile, and/or non-volatile memory; among others. Communication circuitry 28 includes components for facilitating processor operations, for example, suitable components may include transmitters, receivers, modulators, demodulators, filters, modems, analog/digital (AD or DA) converters, diodes, switches, operational amplifiers, and/or integrated circuits. In some embodiments, memory 26 may represent one or more memory devices operable for IVL therapy operation. For example, each memory (e.g., 154, 178) may be included as part of memory 26, shared, or isolated therefrom.”
Paragraph [00105] should be amended to the following (one of the amendments in this paragraph is removing an unnecessary parenthesis), “With continued reference to FIG. 1 , and in some embodiments FIG. 2 , FIG. 6 illustrates initiation of a voltage pulse generation and control system 200 that begins with box 202 which requires determination of a particular balloon characteristic of interest, for example the outer diameter (“OD”) of the IVL system's balloon. In a first embodiment, if the balloon's outer diameter is, e.g., 2.5 mm or 3.5 mm, then in box 204 the starting voltage is set to 3000V, also referred to as the predetermined lower voltage threshold of the acceptable voltage magnitude window. The IVL therapy is initiated in box 206 by application of a series of voltage pulses (or shocks) from the electric pulse generation system 20 wherein each voltage pulse travels to the electrodes 18 within the balloon 16. If, in box 208, the target voltage magnitude is not at the predetermined upper voltage threshold, e.g., 3500V, then as in box 209, the target voltage is increased by an exemplary 25V (from 3000V to 3025V) and another series of voltage pulses (in this case 10 pulses) is executed, as in box 210 at 3025V. This process continues with cycling between boxes 208, 209 and 210 until the target voltage is at 3500V. When the target threshold voltage, or predetermined upper voltage threshold, is reached, and/or in some embodiments a predetermined maximum or desired number of voltage pulses, e.g, 300 pulses (or shocks) have been generated, then as in box 212, control system 22 determines if the number of generated voltage pulses (or shocks) in the plurality of series of voltage pulses has reached a maximum, or desired, number of pulses, e.g., 300 voltage pulses. If the maximum or desired, e.g., 300, voltage pulse threshold has not been reached, then as in box 214 another series of, e.g., 10, voltage pulses (or shocks) are applied. When the maximum or desired, e.g., 300 voltage pulse threshold has been reached, then as in box 216, additional voltage pulses (or shocks) are not allowed.”
Paragraph [00107] should be amended to the following, “In a second embodiment, with continued reference to FIG. 1 , and in some embodiments, FIG. 2 , if the balloon's outer diameter is determined in box 202 to be, e.g., 3.5 mm or 4.0 mm, then the electric pulse generation system 20 initiates therapy at box 218 the starting voltage is set to 3250V, also referred to as the predetermined lower voltage threshold of the acceptable voltage magnitude window). The IVL therapy is initiated in box 220 by application of a series of voltage pulses from the electric pulse generation system 20 wherein each voltage pulse travels to the electrodes 18 within the balloon 16. If, in box 222, the target voltage magnitude is not at the predetermined upper voltage threshold, e.g., 3500V, then as in box 223, the target voltage is increased by an exemplary 25V (from 3250V to 3275V) and another series of voltage pulses (in this case 10 pulses) is executed, as in box 224, at 3275V. This process continues with cycling between boxes 222, 223 and 224 until the target voltage is at 3700V. When the target threshold voltage, or predetermined upper voltage threshold, is reached, and/or in some embodiments a maximum or desired number of pulses, e.g, 300 pulses (or shocks when applied to the one or more pairs of spaced-apart electrodes) have been generated, then as in box 212, control system 22 determines if the number of generated voltage pulses (or shocks) in the plurality of series of voltage pulses has reached a maximum, or desired, number of pulses, e.g., 300 voltage pulses. If the maximum or desired, e.g., 300, voltage pulse threshold has not been reached, then as in box 214 another series of, e.g., 10, voltage pulses (or shocks) are applied. When the maximum or desired, e.g., 300 voltage pulse threshold has been reached, then as in box 216, additional voltage pulses (or shocks) are not allowed.”
Paragraph [00112] should be amended to the following, “In contrast, each of the 2.5 mm and 4.0 mm TEST devices begin at a higher voltage magnitude than the KNOWN devices. The 2.5 mm TEST device begins at a lower voltage than does the 4.0 mm device. As illustrated, both the 2.5 mm and the 4.0 mm TEST device voltage (lower data cluster) rise slowly over the generated voltage pulses, plateauing at approximately 180 pulses, thereafter remaining substantially flat or constant. Referring back to FIG. 3 , this pattern of increasing voltage, followed by a flattened or constant voltage region conforms with boxes 204-210 (2.5 mm) and boxes 218-224 (4.0 mm). In each case, the average voltage of the 4.0 mm TEST device is greater than that of the 2.5 mm TEST device.”
Paragraph [00117] should be amended to the following, “In summary, the IVL devices operated and controlled according to the present disclosure provide an increasing voltage to the voltage pulses until the upper voltage magnitude threshold is reached. Then, the voltage progress at the upper voltage magnitude threshold until 300 pulses have been executed, or the physician determines therapy is complete. This, as shown above, leads to constant and/or slightly increasing pressure output from each voltage pulse. The pressure output magnitudes, and associated slopes, may be manipulated by modifying the magnitude of each incremental increase in voltage. In some embodiments, the voltage magnitude may be incrementally increased as in FIG. 2 . In others, the voltage magnitude may be increased incrementally for at least two series of voltage pulses, then held constant for one or more voltage pulses, then subsequent voltage pulse series may resume the incremental increase in magnitude. In other embodiments, the voltage magnitude may be decreased for one or more series of voltage pulses. All combinations of voltage increase, voltage decrease, and/or no change in voltage over a plurality of a series of voltage pulses in order to manipulate the resulting pressure output are within the scope of the present invention.”
Paragraph [00121] should be amended to the following, “Examples of suitable processors may include one or more microprocessors, integrated circuits, system-on-a-chips (SoC), among others. Examples of suitable memory, may include one or more primary storage and/or non-primary storage (e.g., secondary, tertiary, etc. storage); permanent, semi-permanent, and/or temporary storage; and/or memory storage devices including but not limited to hard drives (e.g., magnetic, solid state), optical discs (e.g., CD-ROM, DVD-ROM), RAM (e.g., DRAM, SRAM, DRDRAM), ROM (e.g., PROM, EPROM, EEPROM, Flash EEPROM), volatile, and/or non-volatile memory; among others. Communication circuitry 28 includes components for facilitating processor operations, for example, suitable components may include transmitters, receivers, modulators, demodulators, filters, modems, analog/digital (AD or DA) converters, diodes, switches, operational amplifiers, and/or integrated circuits. In some embodiments, memory 26 may represent one or more memory devices operable for IVL therapy operation. For example, each memory (e.g., 154, 178) may be included as part of memory 26, shared, or isolated therefrom.”
Appropriate correction is required.
Claim Objections
Claims 1 and 10-12 are objected to because of the following informalities:
Claim 1 should be amended to the following, “An intravascular lithotripsy (“IVL”) system comprising:
at least one set of spaced-apart electrodes for arrangement within a body lumen and in association with a fluid-fillable member configured to contain fluid therein;
an electric pulse generation system configured to provide electrical energy to the at least one set of spaced-apart electrodes to generate spark for intravascular lithotripsy (IVL) therapy, the electric pulse generation system including an IVL control system comprising a processor configured to execute instructions stored on memory and communications circuitry configured to communicate signals based on commands from the processor,
wherein the electric pulse generation system comprises an electrical power system, wherein the electrical power system includes an AC power source and a DC power storage system and an energy storage system,
wherein the AC power source is configured for connection with an AC power receptacle to receive AC power, and
wherein the electric pulse generation system is configured to selectively provide power from the AC power source or the DC power storage system for IVL operations.” This helps maintain consistency, clarity, and avoid ambiguity. In terms of the change from “an energy charge system” to “an energy storage system,” Examiner notes that the disclosure of the current application contained nothing with regards to an “energy charge system” but did indeed support an “energy storage system” (Figure 3B, paragraphs [0050]-[0053], as energy storage system (112)). Further, dependent claims 5-9 which depend upon claim 1 all refer to it as the “energy storage system” and not as the “energy charge system”.
Similar to claim 1, claim 10 should be amended to the following, “An intravascular lithotripsy (“IVL”) system comprising:
at least one set of spaced-apart electrodes for arrangement within a body lumen and in association with a fluid-fillable member configured to contain fluid therein;
an electric pulse generation system configured to provide electrical energy to the at least one set of spaced-apart electrodes to generate an electrical arc for intravascular lithotripsy (IVL) therapy, the electric pulse generation system including an IVL control system comprising a processor configured to execute instructions stored on memory and communications circuitry configured to communicate signals based on commands from the processor,
wherein the electric pulse generation system comprises an electrical power system, wherein the electrical power system includes an AC power source and a DC power storage system and an energy storage system,
wherein the AC power source is configured for connection with an AC power receptacle to receive AC power, and
wherein the AC power source is electrically operatively connectable with the electric pulse generation system and with the DC power storage system.”
Claim 11 should be amended to the following given the objection to claim 10 above, “The IVL system of claim 10, wherein, when the AC power source is not connected with the electric pulse generation system and the DC power storage system, DC power from the DC power storage system is delivered directly to the energy storage system.”
Claim 12 should be amended to the following to give clarity and avoid ambiguity, “The IVL system of claim 10, wherein the IVL control system is further configured to selectively charge the energy storage system from at least one of the group consisting of:
the DC power storage system only;
the AC power source; and
directly from DC power that is converted from the AC power source.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 19-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 19 recites the limitation "the DC power storage device" in the 4th line of text of the claim. There is insufficient antecedent basis for this limitation in the claim. The limitation was first introduced in claim 15, however, claim 19 depends upon claim 10, which did not disclose the limitation. The limitation will be interpreted as “a DC power storage device of the DC power storage system” alternatively the dependency of the claim can be changed to claim 15 instead of claim 10.
Claim 20 is rejected by virtue of its dependency on claim 19.
Claim Rejections - 35 USC § 103
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 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.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hakala (US 2014/0074111 A1), in view of Millis (US 2017/0020598 A1), and further in view of Tsukamoto (US 9192772 B1).
Regarding claim 1, Hakala discloses, a treatment system for percutaneous coronary angioplasty or peripheral angioplasty in which a dilation catheter is used to cross a lesion in order to dilate the lesion and restore normal blood flow in the artery. Hakala teaches, an intravascular lithotripsy ("IVL") system (Figure 1, angioplasty balloon catheter (20); Paragraphs [0055]-[0056] & [0058], where it is disclosed that angioplasty balloon catheter (20) is provided with electrodes for generating shock waves in fluid-filled balloon to treat calcified lesions, which is a form of IVL) comprising:
at least one set of spaced-apart electrodes (Figures 2-3, electrodes (22 & 24); Paragraphs [0056]-[0058], where it is disclosed that electrodes (22 & 24) spaced apart in balloon (26) for arcs) for arrangement within a body lumen (Paragraph [0055]: in artery or vein) and in association with a fluid-fillable member (Figure 1, balloon (26); Paragraph [0055]) configured to contain fluid therein (Paragraph [0056]: balloon filled with saline or water);
an electric pulse generation system (Figures 2 and 4-6, source (40) and switch circuit (86); Paragraphs [0057]-[0060] and [0062], where source (40) and switch circuit (86) providing high voltage pulses to electrodes) configured to provide electrical energy to the at least one set of spaced-apart electrodes to generate spark for intravascular lithotripsy (IVL) therapy (Paragraphs [0058]-[0060] disclose, high voltage pulses form arcs generating shock waves in fluid for therapy), the electric pulse generation system including an IVL control system comprising a processor (Figure 6, microprocessor (90); Paragraph [0062]) configured to execute instructions stored on memory (Paragraph [0062]: microprocessor inherently indicates stored instructions) and communications circuitry (Figure 6, optical driver (92) and isolator (98); Paragraph [0062], optical driver (92) and isolator (98) for signals) configured to communicate signals based on commands from the processor (Paragraph [0062], controls switch (86) via optical driver), and
wherein the electric pulse generation system comprises an electrical power system (Figure 4 and paragraphs [0057]-[0060], capacitance stores high voltage from source (40); Figure 6 and paragraph [0062], power source (80) with high voltage on line (88)), wherein the electric pulse generation system includes ... an energy storage system (Figure 4, capacitance as energy storage for high voltage; Paragraph [0059]).
Hakala does not explicitly disclose that the electrical power system includes an AC power source and a DC power storage system, wherein the AC power source is configured for connection with an AC power receptacle to receive AC power, and wherein the electric pulse generation system is configured to selectively provide power from the AC power source or the DC power storage system for IVL operations (although Hakala inherently indicates a power source at paragraphs [0058] and [0062] for providing high voltage, it does not detail selective AC/DC integration for portability).
Millis discloses, portable electrosurgical systems for tissue treatment (Paragraphs [0028]-[0030], electrosurgical system (100) with RF wave generator (102) for cutting/cauterizing). Millis teaches, an electrical power system that includes an AC power source (Figures 2-3, connector (132) for AC wall socket; Paragraph [0044]), and wherein the electric pulse generation system is configured to selectively provide power from the AC power source or the DC power storage system for electrosurgical operations (Paragraphs [0042]-[0045], disclose, battery powers generator when no external AC available; recharges via AC; system selects battery for portability or AC when plugged in, enabling use in non-traditional settings like outdoors or war zones). Millis further teaches, the system can be battery-powered for portability without continuous AC connection (Paragraph [0043] discloses, battery allows use where external power unavailable), and includes recharging from AC (Paragraph [0044]).
Tsukamoto discloses, portable medical power systems for medical devices requiring reliable, redundant power. Tsukamoto teaches, an electrical power system that includes an AC power source (Figure 1, nonportable power source (40); Col. 7, line 5-9, discloses, “The nonportable power source (40) can be used to recharge all of the smaller portable systems. It is the primary recharging station, comprising a permanent power supply, such as a wall socket (44), which preferably includes an uninterruptible power supply (UPS) (45).”) and a DC power storage system (Figure 1, wearable power source (20) and cart (30) with batteries; Col. 5, line 5-17, Col. 6, line 16-17, and Col. 6, line 46-Col. 7, line 4), wherein the AC power source is configured for connection with an AC power receptacle to receive AC power (Figure 1, wall socket (44); Col. 7, line 5-9), and wherein the system is configured to selectively provide power from the AC power source or the DC power storage system for medical operations (Figure 3; Col. 3, line 66-Col. 4, line 2, Col. 7, line 21-Col. 9, line 22, and, Col. 10, line 16-54, disclose, energy management systems … selectively provide power from AC (nonportable (40)) or DC batteries (vest/cart) based on availability; prioritizes AC when available, switches to DC for portability; redundancy ensures uninterrupted power). Tsukamoto further teaches, selective switching between AC and DC for reliability and mobility in medical contexts (Col. 10, line 24-38 and line 41-47: “transitions without interruption”; “optimizes by choosing largest/available source”).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Hakala’s IVL system (with its electric pulse generation and energy storage for shock wave therapy) to incorporate an electrical power system including an AC power source and a DC power storage system, wherein the AC power source is configured for connection with an AC power receptacle to receive AC power, and wherein the electric pulse generation system is configured to selectively provide power from the AC power source or the DC power storage system for IVL operations, as taught by the combination of Millis and Tsukamoto, as both references and the claimed invention are directed to medical devices requiring reliable, redundant power. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hakala’s IVL system (with its electric pulse generation and energy storage for shock wave therapy) to incorporate an electrical power system including an AC power source and a DC power storage system, wherein the AC power source is configured for connection with an AC power receptacle to receive AC power, and wherein the electric pulse generation system is configured to selectively provide power from the AC power source or the DC power storage system for IVL operations, as taught by the combination of Millis and Tsukamoto, as such a modification would have been predictable, namely, to enable portable, battery-powered operation of the IVL system in non-traditional setting (e.g., outdoors or emergencies) without continuous AC reliance, while allowing AC charging for reliability (Paragraphs [0042]-[0045] of Millis: battery for portability, AC for recharging yields predictable mobility benefits). Further, Tsukamoto provides motivation by teaching selective AC/DC management ensures redundant, uninterrupted power for medical devices, improving patient mobility and quality of life (predictable results from prioritizing AC when available, switching to batteries otherwise). This combination applies known techniques (Millis’s portable battery/AC integration; Tsukamoto’s selective energy management system (EMS)) to improve Hakala’s pulse generator in a similar way (portable, reliable power for tissue treatment), yielding predictable results of a mobile IVL system without sacrificing therapy efficacy (per KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007): applying known techniques to improve similar devices).
Regarding claim 2, Hakala in view of Millis and Tsukamoto teaches the IVL system of claim 1, wherein the AC power source is electrically operatively connectable with the electric pulse generation system and with the DC power storage system (Paragraphs [0043]-[0045] of Millis disclose, AC connector (132) connects to recharging unit for battery (DC storage) and powers system; Col. 3, line 48-53, Col. 3, line 66-Col. 4, line 2, and Col. 7, line 5-9 of Tsukamoto disclose, AC nonportable (40) connects to DC systems like vest/cart for recharging/operation).
Regarding claim 3, Hakala in view of Millis and Tsukamoto teaches the IVL system of claim 1, wherein the DC power storage system is configured to receive AC power from the AC power source (Paragraph [0044] of Millis discloses, battery (DC) receives AC via connector (132) for recharging; Col. 7, line 5-9 of Tsukamoto disclose, wall socket recharges DC batteries in vest/cart).
Regarding claim 4, Hakala in view of Millis and Tsukamoto teaches the IVL system of claim 3, wherein the DC power storage system is configured to convert AC power to DC power for charging a DC power storage device of the DC power storage system (Paragraph [0044] of Millis discloses, recharging unit converts AC to DC for battery; Col. 7, line 5-10 of Tsukamoto disclose, AC recharges secondary DC batteries via energy management system (EMS)).
Regarding claim 5, Hakala in view of Millis and Tsukamoto teaches the IVL system of claim 1, wherein the IVL control system is configured to selectively charge the energy storage system from the DC power storage system only (Paragraphs [0042]-[0043] of Millis disclose, battery (DC) powers system/selectively charges when AC unavailable; Col. 8, line 57-22 of Tsukamoto, disclose, EMS selectively uses DC batteries alone for portability).
Regarding claim 6, Hakala in view of Millis and Tsukamoto teaches the IVL system of claim 1, wherein the IVL control system is further configured to selectively charge the energy storage system from the AC power source (Paragraph [0044] of Millis, where AC directly powers/recharges; ; Col. 7, line 21-Col. 8, line 56 of Tsukamoto, disclose, AC nonportable selectively charges/recharges systems).
Regarding claim 7, Hakala in view of Millis and Tsukamoto teaches the IVL system of claim 1, wherein the IVL control system is further configured to selectively charge the energy storage system directly from DC power that is converted from the AC power source (Paragraph [0044] of Millis discloses, AC converted to DC for recharging; Col. 7, line 5-9 of Tsukamoto, disclose, AC converted/recharges DC systems).
Regarding claim 8, Hakala in view of Millis and Tsukamoto teaches the IVL system of claim 2, wherein, when the AC power source is not connected with the electric pulse generation system and the DC power storage system, DC power from the DC power storage system is delivered directly to the energy storage system (Paragraph [0043] of Millis discloses, battery (DC) delivers power when AC unavailable; Col. 8, line 57-Col. 9, line 22 of Tsukamoto, disclose, DC batteries power when AC disconnected).
Regarding claim 9, Hakala in view of Millis and Tsukamoto teaches the IVL system of claim 1, wherein the DC power storage system comprises one or more batteries (Paragraphs [0042]-[0044] of Millis, disclose, rechargeable batteries; Col. 5, line 31-34, Col. 7, line 21-36, and Col. 7, line 53-Col. 8, line 31 of Tsukamoto, disclose, DC batteries (22/32)).
Regarding claim 10, Hakala teaches, an intravascular lithotripsy ("IVL") system (Figure 1, angioplasty balloon catheter (20); Paragraphs [0055]-[0056] & [0058], where it is disclosed that angioplasty balloon catheter (20) is provided with electrodes for generating shock waves in fluid-filled balloon to treat calcified lesions, which is a form of IVL) comprising:
at least one set of spaced-apart electrodes (Figures 2-3, electrodes (22 & 24); Paragraphs [0056]-[0058], where it is disclosed that electrodes (22 & 24) spaced apart in balloon (26) for arcs) for arrangement within a body lumen (Paragraph [0055]: in artery or vein) and in association with a fluid-fillable member (Figure 1, balloon (26); Paragraph [0055]) configured to contain fluid therein (Paragraph [0056]: balloon filled with saline or water);
an electric pulse generation system (Figures 2 and 4-6, source (40) and switch circuit (86); Paragraphs [0057]-[0060] and [0062], where source (40) and switch circuit (86) providing high voltage pulses to electrodes) configured to provide electrical energy to the at least one set of spaced-apart electrodes to generate an electrical arc for intravascular lithotripsy (IVL) therapy (Paragraphs [0058]-[0060] disclose, high voltage pulses form arcs generating shock waves in fluid for therapy), the electric pulse generation system including an IVL control system comprising a processor (Figure 6, microprocessor (90); Paragraph [0062]) configured to execute instructions stored on memory (Paragraph [0062]: microprocessor inherently indicates stored instructions) and communications circuitry (Figure 6, optical driver (92) and isolator (98); Paragraph [0062], optical driver (92) and isolator (98) for signals) configured to communicate signals based on commands from the processor (Paragraph [0062], controls switch (86) via optical driver), and
wherein the electric pulse generation system comprises an electrical power system (Figure 4 and paragraphs [0057]-[0060], capacitance stores high voltage from source (40); Figure 6 and paragraph [0062], power source (80) with high voltage on line (88)), wherein the electric pulse generation system includes .. an energy storage system (Figure 4, capacitance as energy storage for high voltage; Paragraph [0059]).
Hakala does not explicitly disclose that the electrical power system includes an AC power source and a DC power storage system, wherein the AC power source is configured for connection with an AC power receptacle to receive AC power, and wherein the AC power source is electrically operatively connectable with the electric pulse generation system and with the DC power storage system (although Hakala inherently indicates a power source at paragraphs [0058] and [0062] for providing high voltage, it does not detail selective AC/DC integration for portability).
Millis teaches, an electrical power system that includes an AC power source configured for connection with an AC power receptacle to receive AC power (Figures 2-3, connector (132) for AC wall socket – recharging; Paragraph [0044]) and a DC power storage system (Paragraphs [0042]-[0045], where rechargeable battery is incorporated for portability), and wherein the AC power source is electrically operatively connectable with the electric pulse generation system and with the DC power storage system (Paragraph [0044] discloses, AC connects to recharging unit for battery (DC storage) and powers system).
Tsukamoto teaches, an electrical power system that includes an AC power source (Figure 1, nonportable power source (40); Col. 7, line 5-9, discloses, “The nonportable power source (40) can be used to recharge all of the smaller portable systems. It is the primary recharging station, comprising a permanent power supply, such as a wall socket (44), which preferably includes an uninterruptible power supply (UPS) (45).”) and a DC power storage system (Figure 1, wearable power source (20) and cart (30) with batteries; Col. 5, line 5-17, Col. 6, line 16-17, and Col. 6, line 46-Col. 7, line 4), wherein the AC power source is configured for connection with an AC power receptacle to receive AC power (Figure 1, wall socket (44); Col. 7, line 5-9), and wherein the AC power source is electrically operatively connectable with the electric pulse generation system and with the DC power storage system (Col. 7, line 6-9, disclose, “nonportable power source (40) can be used to recharge all of the smaller portable system”).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Hakala’s IVL system (with its electric pulse generation and energy storage for shock wave therapy) to incorporate an electrical power system including an AC power source and a DC power storage system, wherein the AC power source is configured for connection with an AC power receptacle to receive AC power, and wherein the AC power source is electrically operatively connectable with the electric pulse generation system and with the DC power storage system, as taught by the combination of Millis and Tsukamoto, as both references and the claimed invention are directed to medical devices requiring reliable, redundant power. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hakala’s IVL system (with its electric pulse generation and energy storage for shock wave therapy) to incorporate an electrical power system including an AC power source and a DC power storage system, wherein the AC power source is configured for connection with an AC power receptacle to receive AC power, and wherein the AC power source is electrically operatively connectable with the electric pulse generation system and with the DC power storage system, as taught by the combination of Millis and Tsukamoto, as such a modification would have been predictable, namely, to enable portable, battery-powered operation of the IVL system in non-traditional setting (e.g., outdoors or emergencies) without continuous AC reliance, while allowing AC charging for reliability (Paragraphs [0042]-[0045] of Millis: battery for portability, AC for recharging yields predictable mobility benefits). Further, Tsukamoto provides motivation by teaching such AC/DC connectivity ensures redundant, uninterrupted power for medical devices, improving patient mobility and quality of life (predictable results from recharging portable systems via AC). This combination applies known techniques (Millis’s portable battery/AC integration; Tsukamoto’s AC connectivity to DC systems) to improve Hakala’s pulse generator in a similar way (portable, reliable power for tissue treatment), yielding predictable results of a mobile IVL system without sacrificing therapy efficacy (per KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007): applying known techniques to improve similar devices).
Regarding claim 11, Hakala in view of Millis and Tsukamoto teaches the IVL system of claim 10, wherein, when the AC power source is not connected with the electric pulse generation system and the DC power storage system, DC power from the DC power storage system is delivered directly to the energy storage system (Paragraph [0043] of Millis discloses, battery (DC) delivers power when AC unavailable; Figure 3 along with Col. 3, line 66-Col. 4, line 2, Col. 7, line 21-Col. 9, line 22, and, Col. 10, line 16-54 of Tsukamoto, disclose/illustrate, energy management systems (EMS) … selectively provide power from AC (nonportable (40)) or DC batteries (vest/cart) based on availability; prioritizes AC when available, switches to DC for portability; redundancy ensures uninterrupted power).
Regarding claim 12, Hakala in view of Millis and Tsukamoto teaches the IVL system of claim 10, wherein the IVL control system is further configured to selectively charge the energy storage system from at least one of the group consisting of: the DC power storage system only; the AC power source; and directly from DC power that is converted from the AC power source ((Paragraphs [0042]-[0045] of Millis disclose, selective from battery only, AC, or converted DC; Col. 10, line 30-38, disclose, “The optimum source is the tethered source when present”; selective DC/AC charging).
Regarding claim 13, Hakala in view of Millis and Tsukamoto teaches the IVL system of claim 10, wherein the DC power storage system comprises one or more batteries (Paragraphs [0042]-[0044] of Millis, disclose, rechargeable batteries; Col. 5, line 31-34, Col. 7, line 21-36, and Col. 7, line 53-Col. 8, line 31 of Tsukamoto, disclose, DC batteries (22/32)).
Regarding claim 14, Hakala in view of Millis and Tsukamoto teaches the IVL system of claim 10, wherein the DC power storage system is configured to receive energy from the AC power source (Paragraph [0044] of Millis discloses, battery (DC) receives AC via connector (132) for recharging; Col. 7, line 5-9 of Tsukamoto disclose, wall socket recharges DC batteries in vest/cart).
Regarding claim 15, Hakala in view of Millis and Tsukamoto teaches the IVL system of claim 14, wherein the DC power storage system is configured to convert AC power to DC power for charging a DC power storage device of the DC power storage system (Paragraph [0044] of Millis discloses, recharging unit converts AC to DC for battery; Col. 7, line 5-10 of Tsukamoto disclose, AC recharges secondary DC batteries via energy management system (EMS)).
Regarding claims 16-18, Hakala in view of Millis and Tsukamoto teaches , a method of powering an IVL system as in claim 10 (see above rejection of claim 1), comprising: connecting the AC power source to the electric pulse generation system; connecting the AC power source to the DC power storage system; selectively charging the energy storage system with energy from the AC power source to the IVL system; and discharging energy from the charged energy storage system; and initiating voltage pulses with the IVL system with the discharged energy (Paragraphs [0058]-[0062] of Hakala, where charging capacitance (energy storage) and discharging of pulses; Millis/Tsukamoto, disclose AC connection/charging as stated previously). Claim 17 further comprising selectively charging the energy storage system directly with DC power that is converted from the AC power source (Disclosure of Paragraph [0044] of Millis; Tsukamoto previously stated AC conversion). Claim 18 further comprising charging the DC power storage system with energy from the AC power source (Millis’s/Tsukamoto’s previously stated recharging). The method steps are obvious as the natural use of the modified apparatus.
Regarding claims 19-20, Hakala in view of Millis and Tsukamoto teaches , a method of powering an IVL system as in claim 10 (see above rejection of claim 1), comprising: connecting the AC power source to the electric pulse generation system; connecting the AC power source to a DC power storage device; selectively charging the energy storage system with energy from the DC power storage system to the IVL system; and discharging energy from the charged energy storage system; and initiating voltage pulses with the IVL system with the discharged energy Paragraphs [0058]-[0062] of Hakala, where charging capacitance (energy storage) and discharging of pulses; The disclosure of Millis paragraphs [0042]-[0045], where battery (DC) charges/powers when AC connected but selective; Tsukamoto’s disclosure as previously stated discloses selective DC use). Claim 20 further comprising charging the DC power storage system with the AC power source (Millis’s/Tsukamoto’s previously stated recharging). The method steps are obvious as the natural use of the modified apparatus.
Conclusion
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/O.N./Examiner, Art Unit 3771
/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771