DETAILED ACTION
Non-Final Rejection
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of claims 1-12 in the reply filed on 9/2/2025 is acknowledged.
Claims Status
Claims 13-20 are withdrawn. Claims 1-12 remain pending.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 1
The excitation-signal generation unit in claim 1 was interpreted in view of Fig. 3, #31.
The transmission unit was interpreted in view of Fig. 3, #32.
The impedance-signal acquisition unit was interpreted in view of Fig. 5, # 33.
The processing unit was interpreted in view of Fig. 7, #35 and [0036] which states that the processing unit may be a single-chip microcomputer.
Claim 3
The data acquisition module and calculation modules which were interpreted as software to be executed by the processor (see [0094]).
Claim 7
The operational amplification unit was interpreted in view of Fig. 6, #34.
Claim 11
The anti-interference circuit was interpreted in view of Fig. 5, #333
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-12 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.
The term “high” in claim 1 (line 2) is a relative term which renders the claim indefinite. The term “high” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term “frequency” is rendered indefinite by the use of the term “high” in the claim. A review of the specification provides an exemplary frequency of 50 kHz but also notes that there is no limitation on the frequency.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Paul et al. (US 2008/02181319, cited in the IDS).
Regarding claim 1, Paul et al. disclose an impedance detection device for a living body (Abstract – “An electrode catheter and a method for assessing electrode-tissue contact and coupling are disclosed. An exemplary electrode catheter comprises an electrode adapted to apply electrical energy. A measurement circuit is adapted to measure impedance between the electrode and ground as the electrode approaches a target tissue. A processor determines a contact and coupling condition for the target tissue based at least in part on reactance of the impedance measured by the measurement circuit.”), comprising:
an excitation-signal generation unit (Fig. 3, #40, and [0078] reference to RF generator, [0079] states that 40 emits electrical energy/RF current) configured to generate and output a high-frequency excitation signal ([0090] notes that frequencies above 50 kHz were ideal in exemplary applications);
a transmission unit (electrode catheter 14, Fig. 1) comprising a first transmission port and a second transmission port, wherein the transmission unit is electrically connected with the excitation-signal generation unit via the first transmission port to receive the high-frequency excitation signal (Fig. 3 shows the generator output line leading to electrode catheter 14, [0083] states that 40 generates high frequency energy for ablation that is received by catheter, the location where the wire from 40 enters 14 is the first port); and is configured to transmit the high-frequency excitation signal to a detection site of the living body via the second transmission port (Fig. 2a shows the tip of catheter 14 which transmits the high frequency ablation energy to tissue, the tip of 14 is the second port), and wherein the second transmission port forms an impedance-signal detection point ([0008] notes that the electrode catheter 14 includes structures for measuring impedance at the tissue electrode interface);
an impedance-signal acquisition unit electrically connected with the impedance-signal detection point ([0008] reference to a measurement circuit adapted to measure impedance), and configured to acquire a sampling signal from the impedance-signal detection point in real time (impedance data is used to generate contact condition information in real time as noted in [0082]); and
a processing unit (Fig. 3, #50) electrically connected with the impedance-signal acquisition unit (50 is electrically connected to measurement circuit 42 as shown in Fig. 3), and configured to acquire the sampling signal and determine a real-time impedance value of the living body corresponding ([0084] states that processor 50 may determine a reactance and/or phase angle component of the impedance measurement) to a real-time sampling value of the sampling signal (processors work in the digital domain and it is inherent that the impedance data measured is from samples of data that has been digitized) according to an impedance calibration data table preset, wherein the impedance calibration data table pre-records a mapping relationship between a plurality of simulated impedance values of the living body and sampling values of a plurality of sampling signals ([0084] – “In an exemplary embodiment, contact or coupling conditions corresponding to various reactance and/or phase angles may be predetermined, e.g., during testing for any of a wide range of tissue types and at various frequencies. The contact or coupling conditions may be stored in memory 52, e.g., as tables or other suitable data structures. The processor 50 may then access the tables in memory 42 and determine a contact or coupling condition corresponding to impedance measurement based on the reactance component and/or phase angle”).
Regarding claim 2, Paul et al. disclose wherein the sampling signal is a voltage signal (see at least [0111] reference to voltage being sensed).
Regarding claim 3, Paul et al. disclose wherein the processing unit comprises a data acquisition module and a calculation module, wherein the data acquisition module is configured to acquire the sampling signal and determine the real-time sampling value of the sampling signal ([0084] quotation above in the claim 1 rejection, the processor would inherently include programming to perform the actions noted in [0084]); and the calculation module is configured to invoke the impedance calibration data table preset and query in the impedance calibration data table the real-time impedance value of the living body corresponding to the real-time sampling value of the sampling signal (again see [0084] where it references the processor accessing the tables to make a determination, these actions would necessarily require a program).
Regarding claim 11, Paul et al. teach wherein the impedance-signal acquisition unit further comprises an anti-interference circuit, wherein the anti-interference circuit is configured to process the sampling signal to filter out an interference signal in the sampling signal ([0039] states that in regards to the impedance measurement, “Filters may be used to allow each of the various frequencies from this common electrical signal to be separately analyzed to determine if any of these frequencies generates an electrical parameter of a requisite value.”)
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.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Paul et al. (US 2008/02181319, cited in the IDS) in view of Pellar (US 2006/0041609).
Regarding claim 4, Paul et al. do not disclose wherein the calculation module is further configure to query, in the impedance calibration data table, two sampling values proximate to the real-time sampling value of the sampling signal and simulated impedance values of the living body respectively corresponding to the two sampling values on condition that the real-time impedance value of the living body corresponding to the real-time sampling value of the sampling signal is not found in the impedance calibration data table, and to calculate the real-time impedance value of the living body corresponding to the real-time sampling value of the sampling signal according to the simulated impedance values of the living body respectively corresponding to the two sampling values and a preset linear formula (Paul just notes that tables that associate conditions with impedance measurements may be predetermined). However, the above limitations were interpreted as the use of linear interpolation between known points on a lookup table to estimate a result which is generally known in the arts. For example, Pellar teaches a system and method of lookup table interpolation. Pellar specifically teaches that a standard linear interpolation may be used between input values on the lookup table to generate output values (see [0020]). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to modify Paul et al.’s analysis programs to estimate output values (conditions) by interpolating between input values of the lookup table as taught by Pellar because it amounts to combining prior art elements according to known methods to yield predictable results. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. There would have been a reasonable expectation of success given that this involves adding some additional programming for applying a linear interpolation to data in a table.
Regarding claim 5, Paul et al. do not disclose wherein the preset linear formula is
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However, Paul was modified in view of Pellar in the claim 4 rejection to use a standard linear interpolation to interpolate between values on a lookup table. The above formula appears to be the application of a standard linear interpolation formula to the data acquired. The rationale for modifying remains the same.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Paul et al. (US 2008/02181319, cited in the IDS) in view of Bloom et al. (US 2018/0256240, cited in the IDS).
Regarding claim 6, Paul et al. do not disclose wherein the transmission unit further comprises a voltage-dividing resistor electrically connected between the first transmission port and the second transmission port, and is configured to transmit the high-frequency excitation signal to the detection site of the living body via the voltage-dividing resistor and the second transmission port. However, the use of voltage dividing circuits (which include resistors) in ablation devices was generally known in the arts. Bloom et al. teach an electrosurgical system that applies a voltage divider to reduce the delivered RF voltage (see [0049]). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to modify Paul et al. to use the claim voltage dividing circuit as taught by Bloom et al. for use in a RF electrosurgical device for reducing delivered voltage because amounts to combining prior art elements according to known methods to yield predictable results. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Paul et al. (US 2008/02181319, cited in the IDS).
Regarding claim 7, Paul et al. do not disclose the impedance detection device for the living body further comprising an operational amplification unit electrically connected between the impedance-signal acquisition unit and the processing unit, wherein the operational amplification unit is configured to receive the sampling signal output by the impedance-signal acquisition unit and amplify the sampling signal by a preset multiple. Paul does state in [0112] that:
“A signal scaling circuit 92 may also be provided to amplify the output (e.g., from milli-volts to volts) for use by various devices (e.g., the processor 50 and display device 54 in FIG. 3).”
Thus, while Paul does state the use of signal scaling circuit to perform the claimed function of amplification, a specific device is not disclosed. The Office takes Official Notice that op-amps are widely known for amplifying signals. Paul also does not state that the operation amplification unit is between the impedance acquisition unit and processing unit. However, the choice of locating the amplification structure after the impedance sensor and the processor that processes the signal would have been an obvious design choice as there are but three options (before the impedance acquisition structure, the claimed location, and after the processor). The latter does not make sense, leaving only two realistic choices. A person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense.
Regarding claim 8, Paul et al. disclose wherein the operational amplification unit comprises a filter circuit and an operational amplification circuit, wherein the filter circuit is configured to filter the sampling signal received by the operational amplification unit to filter out an interference signal in the sampling signal, and the operational amplification circuit is configured to amplify the sampling signal by the preset multiple as follows:
As noted in the claim 7 rejection, Paul discloses an scaling/amplification circuit (Paul states that the scaling is done to increase the signal from mV to V which indicates a preset scaling value). Paul also discloses at [0039] that in regards to the impedance measurement, “Filters may be used to allow each of the various frequencies from this common electrical signal to be separately analyzed to determine if any of these frequencies generates an electrical parameter of a requisite value.”
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Paul et al. (US 2008/02181319, cited in the IDS) in view of Bowers (US 2003/0181898).
Regarding claim 9, Paul et al. do not disclose wherein the excitation-signal generation unit comprises a first input port, a first output port, and a waveform conversion circuit electrically connected between the first input port and the first output port, wherein the first input port is configured to receive a high-frequency pulse width modulation (PWM) square-wave signal; the waveform conversion circuit is configured to convert the high-frequency PWM square-wave signal into a high-frequency sine-wave signal, wherein the high-frequency sine-wave signal is the high-frequency excitation signal; and the first output port is configured to output the high-frequency excitation signal. However, ablation/electrosurgical hardware using high frequency square waves as an input while outputting a high frequency sine wave was known in the arts. Bowers teaches an electrosurgical generator (see Abstract). Bowers teaches that the RF output circuitry receives a square wave input and converts it to a sine wave (see [0086]). Bowers also notes that the input frequency is around 500kHz (see at least [0089]). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to modify Paul et al. to use the claimed input and output signals for the ablation catheter as taught by Bowers because Bowers teaches that this produces the appropriate output waveform to create good clinical effect while lowering the RF energy in the high frequencies above the fundamental thus reducing the effect of high RF leakage.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Paul et al. in view of Bowers as applied to claim 9 and further in view of Stevens-Wright (US 2007/0167940).
Regarding claim 10, Paul et al. disclose wherein the processing unit is further electrically connected with the excitation-signal generation unit (see Fig. 3 where the processor is connected to generator 40), but do not disclose that the processing unit is configured to provide the high-frequency PWM square-wave signal for the excitation-signal generation unit. However, Stevens-Wright teaches an apparatus for use in tissue ablation procedures. Stevens-Wright teaches an ablation catheter (Fig 1) where a control module comprising, “a processor operatively connected to the input interface and programmed to select an operating parameter value for supplying energy to the ablation electrode with the energy supply, the selection being a function of the three signals received by the input interface, and an output interface operatively connected to the processor and configured to provide the selected operating parameter value” ([0015]). In this case, the processor controls the flow of the correct ablation signal from the ablation energy supply (Fig. 1, #4) through the control module (which includes the processor) to the electrosurgical device (see also Fig. 6). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to further modify Paul et al. to use a processor for providing the claimed signals as taught by Stevens-Wright for electrosurgery because Stevens-Wright teaches that the processor can help provide a level of control that improves the delivery of energy without exceeding temperatures that result in harm to tissue.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Paul et al. in view of Hull et al. (US 2016/0184004).
Regarding Claim 12, Paul et al. do not disclose wherein the anti-interference circuit comprises a capacitor, an RC low-pass filter circuit, and an LC parallel frequency-selection circuit electrically connected in sequence, wherein the capacitor is configured to isolate a direct current (DC) component in the sampling signal; the RL low-pass filter circuit is configured to allow an alternating current (AC) component in the sampling signal to pass through; and the LC parallel frequency-selection circuit is configured to filter out interference of a power frequency in the sampling signal and a radiofrequency current signal for radiofrequency ablation aliased in the sampling signal. Hull et al. however teaches an electrophysiology system that includes an ablation generator that has an input port for receiving a monitoring signal/impedance (see Abstract and [0023]). Hull et al. teach that the filtering circuit may include a LC parallel traps that are tuned to preset frequencies ([0008]) as well as an RC filter for filtering an ablation signal, the RC filter and LC trap both including capacitors (see [0064]). Hull teach that the LC traps of the filtering circuit is disposed in the signal pathway in series ([0009]) and note that the RC filter also is included with the filtering hardware ([0064]) and therefore would be connected in sequence. A RC low pass filter would inherently allow an AC current to pass through (filters pass or block AC signals) while capacitors inherently block DC currents. Hull note the LC traps are used both in the mapping/navigation impedance system as well as the in the ablation signal part of the system (see [0059]). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to modify Paul et al. to include the claimed structures of the anti-interference circuit as taught by Hull et al. because it is the use of known technique to improve similar devices (methods or products) in the same way. The claim would have been obvious because the technique for improving a particular class of devices was part of the ordinary capabilities of a person of ordinary skill in the art, in view of the teaching of the technique for improvement in other situations.
Conclusion
Claims 1-12 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tho Q. Tran whose telephone number is (571)270-1892. The examiner can normally be reached 7-5.
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/THO Q TRAN/ Examiner, Art Unit 3791
/JACQUELINE CHENG/ Supervisory Patent Examiner, Art Unit 3791