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 (IDS) submitted on 08/26/2025 were filed before the current cation on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Response to Amendment
The Amendments filed 08/25/2025 have been entered. Claims 1-6, 8-14, and 16-17 have been amended. Claims 21-22 have been added. Claims 1-18 and 21-22 are pending on the application.
Response to Arguments
Applicant's arguments filed 08/25/2025 have been fully considered but they are not persuasive.
Regarding the 101 Rejection, Applicant argues that the newly added limitation “the generator configured to operatively couple to a plurality of electrodes, wherein the plurality of electrodes are configured to ablate a target tissue” provides sufficient structure and specificity over any general generator in the art of electrosurgical intervention. However, that is not the case. No structure is recited to give function, and “a generator and electrodes that can ablate tissue” would be common to a wide variety of nonspecific generators and electrodes used to treat tissue, such as disclosed by Bahrami (US 20190117964 A1) in Fig 1 par [0141]. Similar arguments regarding the non-generality and supposed claimed specific structure of “control circuitry” and “a memory device” are also unpersuasive, due to the lack of claimed structure for these very broadly claimed devices which are, by applicant’s own admission, common in the art.
Applicant claims that the limitation in new claim 21 “the treatment program comprising indications of parameters associated with a series of electrical pulses to be applied through the electrodes to a target tissue to achieve the mechanism of action associated with the identified one of the plurality of predefined intensity levels” contributes to the invention to amount to a practical application of the judicial exception. However nothing is being positively recited. Only “indications of parameters associated with” applied electrical pulses are being claimed. Thus, applicant’s argument is not persuasive.
Regarding the 102 Rejection, Applicant has amended the independent claim 1 to include several new limitations. Applicant has amended to specify that “the generator and the plurality of electrodes are configured to ablate a target tissue”, which is disclosed by Bahrami par [0230]. Applicant has amended to specify that “the predefined intensity levels affect a microenvironment of the target tissue with different mechanisms of action”. However, Bahrami discloses in par [0230-0231] and [0250] different mechanisms of action such as thermal damage and irreversible and reversible electroporation which may be applied by the generator signals.
Applicant has amended to specify that the series of electrical pulses be applied “to achieve a specific therapeutic outcome”. This is quite vague and not directly supported by the Specification; see further discussion under the 112b Rejection below.
Applicant has amended to specify that the generator generates the series of electrical pulses “based on the generated treatment program”.
Claim Interpretation
Regarding claims 1-4, 6, 8-12, 14-15, and 21-22, the term “intensity level” is interpreted as a qualitative “treatment indicator” as based on Table 3 and par [0134] of the Specification. There is no direct mention that higher “intensity levels” mean higher voltage, longer pulses, or any other quantitative measurement which can be used for the mathematical expressions such as “greater than”. Thus the “intensity levels” are interpreted using the only associated numerical values, 0-3 in Table 3, and may comprise any sort of treatment indicator. Thus, the “greater than” of claim 14 line 2-3 is merely ranking the levels as “1, 2, 3” and so the third is greater than the second, and the second is greater than the first.
Regarding claims 15-16, the terms “altered tumor” and “immunosuppressive tumor” are considered to be equivalent. See Specification par [0068] “distinct solid tumor phenotypes (e.g., hot (or inflamed); altered, which can be excluded or immunosuppressed; and cold (or non- inflamed). These tumor phenotypes are characterized by high, intermediate and low immunoscores, respectively.” Reference is made to Galon (“Approaches to treat immune hot, altered and cold tumours with combination immunotherapies”; J Galon, D Bruni; Nature reviews Drug discovery, 2019) for describing immunoscore. Galon Fig 1b shows the relationship between immunoscore and tumor type. “four proposed types of tumour (hot, excluded, immunosuppressed and cold), based on Immunoscore” (Galon, page 2 col 2 line 13-16). Thus, the Immunoscores from 0-4 correlate with type of tumor from cold (low value) to altered/excluded/immunosuppressed (intermediate values) to hot (high value).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-18 and 21-22 rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Regarding claims 1 and 21, the claim(s) recite(s) instructions to “identify a one of a plurality of predefined intensity levels” (mental process), “generate a treatment program” (can be done mentally or with pencil and paper), and “send a control signal” (mere transmission of data). This judicial exception is not integrated into a practical application because the data being processed is not used in any practical application; only detection, manipulation, and transmission of data is positively recited. The thrust of the invention is to run a specific algorithm that tells a generator to generate a series of electrical pulses. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because a generator, electrodes, and control circuitry with memory are all common elements in the art, and are recited here at a very high level of generality, with no structure associated with functions performed.
Regarding claims 2-18 and 22, none of the dependent claims integrate the judicial exception into a practical application, and only further manipulate and transmit data. The additional element recited in claim 8 (a sensor) is also a well-known element of the art and recited at a very high level of generality, and thus is not sufficient to amount to significantly more than the judicial exception. The additional element recited in claim 10 (a display unit) is also a well-known element of the art and recited at a very high level of generality, and thus is not sufficient to amount to significantly more than the judicial exception.
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.
Claims 1-18 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 (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the claim recites “a specific therapeutic outcome” in line 14 of the claim. It is unclear what is meant by this, as no “therapeutic outcomes” are recited in the Specification, and the term by itself is vague enough to be almost meaningless. Thus, the claim is considered indefinite. Claims 2-18 are similarly rejected for inheriting the deficiencies of claim 1 without ameliorating them.
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.
Claims 1-2, 8-9, 13-14, and 21 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Bahrami (US 20190117964 A1).
Regarding claim 1, Bahrami discloses
An ablation therapy device, comprising:
a generator, the generator to operatively couple to a plurality of electrodes, wherein the generator and the plurality of electrodes are configured to ablate a target tissue (Bahrami Fig 1 par [0141]; par [0230] configured to ablate tissue);
control circuitry coupled to the generator (Bahrami Fig 15 par [0221]); and
a memory device storing instructions that when executed by the control circuitry cause the control circuitry to:
identify a one of a plurality of predefined intensity levels (Bahrami par [0199]), wherein the predefined intensity levels affect a microenvironment of the target tissue with different mechanisms of action (Bahrami par [0230-0231],[0250] intensity levels affect a microenvironment with different mechanisms of action such as thermal damage and irreversible and reversible electroporation);
generate a treatment program based on the one of the plurality of predefined intensity levels (Bahrami par [0199]), the treatment program comprising indications of a series of electrical pulses to be applied through the electrodes to a target tissue to achieve a specific therapeutic outcome (Bahrami par [0195]); and
send a control signal to the generator to cause the generator to generate the series of electrical pulses based on the generated treatment program (Bahrami par [0195]).
Regarding claim 2, Bahrami discloses the ablation therapy device of claim 1.
Bahrami further discloses wherein the memory device further stores instructions, which when executed cause the control circuitry to receive an indication of the one of the plurality of predefined intensity levels (Bahrami par [0195] [0392]).
Regarding claim 8, Bahrami discloses the ablation therapy device of claim 1.
Bahrami further discloses a sensor (Bahrami Fig 15 (1510) par [0224] [0371]), the sensor arranged to measure a characteristic produced responsive to application of the electrical pulses of the series of electrical pulses to be applied to through the electrodes to the target tissue (Bahrami par [0194] [0371]), and wherein the memory device further stores instructions, which when executed cause the control circuitry to:
receive from the sensor, an indication of the characteristic (Bahrami par [0372]); and
determine whether the one of the plurality of predefined intensity levels is met or exceeded based on the indication of the characteristic (Bahrami par [0382]).
Regarding claim 9, Bahrami discloses the ablation therapy device of claim 8.
Bahrami further discloses wherein the memory device further stores instructions, which when executed cause the control circuitry to send a control signal to the generator to cause the generator to pause generation of the series of electrical pulses based on a determination that the one of the plurality of predefined intensity levels is met or exceeded (Bahrami par [0217] stop treatment when target reached).
Regarding claim 13, Bahrami discloses the ablation therapy device of claim 1.
Bahrami further discloses wherein the series of electrical pulses are sufficient to reversibly electroporate cells within the target tissue, irreversibly electroporate cells within the target tissue, thermally ablate cells within the target tissue, non-thermally ablate cells within the target tissue, and/or result in electrolysis of cells within the target tissue (Bahrami par [0187] electroporation).
Regarding claim 14, Bahrami discloses the ablation therapy device of claim 1.
Bahrami further discloses wherein the plurality of predefined intensity levels comprise at least a first intensity level, a second intensity level greater than the first intensity level, and a third intensity level greater than the second intensity level (see claim interpretation above; any set of three “intensity levels” will always be ranked as such).
Regarding claim 21, Bahrami discloses
An ablation therapy device, comprising:
a generator, the generator to operatively couple to a plurality of electrodes, wherein the generator and the plurality of electrodes are configured to ablate a target tissue (Bahrami Fig 1 par [0141]; par [0230] configured to ablate tissue);
control circuitry coupled to the generator (Bahrami Fig 15 par [0221]); and
a memory device storing instructions that when executed by the control circuitry cause the control circuitry to:
identify a one of a plurality of predefined intensity levels (Bahrami par [0199]), wherein the predefined intensity levels affect a microenvironment of the target tissue with different mechanisms of action (Bahrami par [0230-0231],[0250] intensity levels affect a microenvironment with different mechanisms of action such as thermal damage and irreversible and reversible electroporation);
generate a treatment program based on the one of the plurality of predefined intensity levels (Bahrami par [0199]), the treatment program comprising indications of parameters associated with a series of electrical pulses to be applied through the electrodes to a target tissue to achieve the mechanism of action associated with the identified one of the plurality of predefined intensity levels (Bahrami par [0195]; [0199]); and
send a control signal to the generator to cause the generator to generate the series of electrical pulses based on the generated treatment program (Bahrami par [0195]).
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.
Claims 3 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Bahrami (US 20190117964 A1) in view of Galon (“Approaches to treat immune hot, altered and cold tumours with combination immunotherapies”; J Galon, D Bruni; Nature reviews Drug discovery, 2019).
Regarding claim 3, Bahrami discloses the ablation therapy device of claim 1.
Bahrami further discloses wherein the target tissue comprises a tumor (Bahrami par [0189]); and wherein the memory device further stores instructions, which when executed cause the control circuitry to: receive an indication of a measurement of the tumor; and determine the one of the plurality of predefined intensity levels based on the measurement (Bahrami par [0180] tumor-specific measurements acquired beforehand used to determine EP level).
Bahrami fails to explicitly disclose the measurement of the tumor being the immunoscore.
However, Galon discloses the immunoscore as a way of measuring complex immunological factors with a single number (Galon Fig 1b, page 2 col 2 line 13-16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have used immunoscore as a metric of measurement for tumors, as such a metric allows for measuring complex immunological factors with a single number (Galon Fig 1b, page 2 col 2 line 13-16).
Regarding claim 15, Bahrami discloses the ablation therapy device of claim 14.
Bahrami further discloses wherein the first intensity level is associated with a first tumor type, the second intensity level is associated with a second tumor type different than the first tumor type, and the third intensity level is associated with a third tumor type different than the first tumor type and the second tumor type (any different intensity levels would be associated with different tumor types)
Bahrami fails to explicitly disclose wherein the first tumor type is a hot tumor, the second tumor type is an altered tumor, and the third tumor type is a cold tumor.
However, Galon discloses different types of tumors including hot, cold, and altered, as well as a useful metric in the immunoscore (Galon Fig 1b, page 2 col 2 line 13-16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have set the different types of tumors to be those types associated with immunological response, as immunological response and type of tumor is important for treatment (Galon page 2 col 2 line 13-16).
Claims 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Bahrami (US 20190117964 A1) in view of Davalos (US 20190282294 A1) and Galon (“Approaches to treat immune hot, altered and cold tumours with combination immunotherapies”; J Galon, D Bruni; Nature reviews Drug discovery, 2019).
Regarding claim 4, Bahrami in view of Galon discloses the ablation therapy device of claim 3.
Bahrami further discloses wherein a plurality of ablation modalities (Bahrami par [0230]) the memory device further stores instructions, which when executed cause the control circuitry to: determine a setting based on the measurement (Bahrami par [0196]); and generate the treatment program based on the setting and the one of the plurality of predefined intensity levels (Bahrami par [0199]).
Bahrami fails to explicitly disclose determining an ablation modality of a plurality of ablation modalities; the measurement of the tumor being the immunoscore.
However, Davalos discloses a method of treating tumors including determining an ablation modality of a plurality of ablation modalities based on the measurement of the tumor, and generating the treatment program based on the ablation modality of the plurality of ablation modalities (Davalos par [0084] forming treatment plan based on measurement parameter…par [0089] treatment may be various ablation techniques).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to determine one of several ablation modalities for use in treatment, as different ablation modalities are suited to different therapeutic outcomes (Davalos par [0084])
Furthermore, Galon discloses the immunoscore as a way of measuring complex immunological factors with a single number (Galon Fig 1b, page 2 col 2 line 13-16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have used immunoscore as a metric of measurement for tumors, as such a metric allows for measuring complex immunological factors with a single number (Galon Fig 1b, page 2 col 2 line 13-16).
Regarding claim 5, Bahrami in view of Davalos and Galon discloses the ablation therapy device of claim 4.
Bahrami further discloses wherein the plurality of ablation modalities comprise irreversible electroporation (IRE), high-frequency (IRE) (HFIRE), non-thermal ablation, reversible electroporation, or pulsed field ablation (Bahrami par [0187] electroporation).
Regarding claim 6, Bahrami in view of Davalos and Galon discloses the ablation therapy device of claim 4.
Bahrami further discloses wherein the memory device further stores instructions, which when executed cause the control circuitry to: determine a therapy to be applied based on the measurement; and generate the treatment program.
Bahrami fails to explicitly disclose determining a recommended complementary therapy; or the measurement of the tumor being the immunoscore.
However, Davalos discloses a method of treating tumors including determining a recommended complementary therapy (Davalos par [0084]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to determine a recommended complementary therapy for use in treatment, as different complementary therapy are suited to different therapeutic outcomes (Davalos par [0084]).
Furthermore, Galon discloses the immunoscore as a way of measuring complex immunological factors with a single number (Galon Fig 1b, page 2 col 2 line 13-16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have used immunoscore as a metric of measurement for tumors, as such a metric allows for measuring complex immunological factors with a single number (Galon Fig 1b, page 2 col 2 line 13-16).
Regarding claim 7, Bahrami in view of Davalos and Galon discloses the ablation therapy device of claim 6.
Davalos further discloses wherein the recommended complementary therapy includes at least one of: immunotherapy, chemotherapy, radiation, vaccination, and surgical intervention (Davalos par [0089]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to determine a recommended complementary therapy for use in treatment, as different complementary therapy are suited to different therapeutic outcomes (Davalos par [0084]).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Bahrami (US 20190117964 A1) in view of Neal (US 20160058493 A1).
Regarding claim 10, Bahrami discloses the ablation therapy device of claim 8.
Bahrami further discloses a display unit coupled to the control circuitry (Bahrami Fig 16 (B) par [0221])
Bahrami fails to explicitly disclose wherein the memory device further stores instructions, which when executed cause the control circuitry to: generate a graphical information element comprising an indication that the one of the plurality of predefined intensity levels is met or exceeded based on a determination that the one of the plurality of predefined intensity levels is met or exceeded; and send the graphical information element to the display unit to cause the display unit to display the indication that the one of the plurality of predefined intensity levels is met or exceeded.
However, Neal discloses an ablation therapy device with a memory device storing instructions (Neal Fig 1-3 memory (44) par [0029]), which when executed cause the control circuitry to: generate a graphical information element comprising an indication that the one of the plurality of predefined intensity levels is met or exceeded based on a determination that the one of the plurality of predefined intensity levels is met or exceeded (Neal par [0028] graphical information associated with procedure); and
send the graphical information element to the display unit to cause the display unit to display the indication that the one of the plurality of predefined intensity levels is met or exceeded (Neal par [0029] display successful treatment).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the invention of Bahrami to display relevant procedure information such as disclosed by Neal, as such data and input allows a physician to plan for, execute, and review the results of a medical treatment procedure (Neal par [0029]).
Regarding claim 11, Bahrami in view of Neal discloses the ablation therapy device of claim 10.
Neal further discloses wherein the memory device further stores instructions, which when executed cause the control circuitry to: receive, responsive to displaying the graphical information element, an indication to continue application of electrical pulses to the target tissue (Neal Fig 5A (58) par [0049]); identify another one of the plurality of predefined intensity levels (Neal Fig par [0047] recommended parameter changes); generate a secondary treatment program based on the other one of the plurality of predefined intensity levels (Neal Fig par [0047] recommended parameter changes), the secondary treatment program comprising indications of a secondary series of electrical pulses to be applied through the electrodes to the target tissue (Neal Fig 5A (46) par [0049]); and send a second control signal to the generator to cause the generator to generate the secondary series of electrical pulses (Neal Fig 5A (46) par [0049]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the invention of Bahrami such as disclosed by Neal, as changing the treatment program can improve safety (Neal par [0047]).
Claims 12 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Bahrami (US 20190117964 A1) in view of Podhajsky (US 20120265194 A1).
Regarding claim 12, Bahrami discloses The ablation therapy device of claim 8.
Bahrami further discloses processing the current data for analysis (Bahrami par [0194] further data processing [0226] various computational routines for data processing); determine that the one of the plurality of predefined intensity levels is met or exceeded based on processed data (Bahrami par [0382]).
Bahrami fails to explicitly disclose wherein the memory device further stores instructions, which when executed cause the control circuitry to: normalize the current for a first electrical pulse of the series of electrical pulses; normalize the current for a second electrical pulse of the series of electrical pulses; determine whether a difference between the normalized current for the first electrical pulse and the normalized current for the second electrical pulse is greater than or equal to a threshold value; and determine that the difference between the normalized current for the first electrical pulse and the normalized current for the second electrical pulse is greater than or equal to the threshold value.
However, Podhajsky discloses a similar ablation therapy device (Podhajsky Fig 1&2 generator (20) memory (26) par [0029,0032]) the memory device storing instructions, which when executed cause the control circuitry to:
normalize the current for a first electrical pulse of a series of electrical pulses (Podhajsky Fig 9 (202) par [0044] normalize parameter [0033] parameter may be current);
normalize the current for a second electrical pulse of a series of electrical pulses (Podhajsky Fig 9 (206) par [0052]);
determine whether a difference between the normalized current for the first electrical pulse and the normalized current for the second electrical pulse is greater than or equal to a threshold value (Podhajsky Fig 9 (206) par [0052]); and
determine that the difference between the normalized current for the first electrical pulse and the normalized current for the second electrical pulse is greater than or equal to the threshold value (Podhajsky Fig 9 (214) par [0053]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have used data processing such as normalization and slope analysis such as disclosed by Podhajsky with the invention of Bahrami, as such analysis is very useful for tracking energy application during therapy (Podhajsky par [0048]).
Regarding claim 22, Bahrami discloses The ablation therapy device of claim 21.
Bahrami fails to explicitly disclose wherein the predefined intensity levels are characterized by a rate of change of normalized current.
However, Podhajsky discloses a similar ablation therapy device (Podhajsky Fig 1&2 generator (20) par [0029,0032]) wherein generator intensity levels are characterized by a rate of change of normalized current (Podhajsky Fig 9 (202) par [0044] normalize parameter [0033] parameter may be current; par [0011] regulating output based on normalized parameter).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have used data processing such as normalization such as disclosed by Podhajsky with the invention of Bahrami, as such analysis is very useful for managing energy application during therapy (Podhajsky par [0048]).
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Bahrami (US 20190117964 A1) in view of Davalos (US 20190282294 A1) and Galon (“Approaches to treat immune hot, altered and cold tumours with combination immunotherapies”; J Galon, D Bruni; Nature reviews Drug discovery, 2019) and Rodriguez (US 20190336757 A1)
Regarding claim 16, Bahrami in view of Galon discloses the ablation therapy device of claim 15.
Bahrami fails to explicitly disclose wherein the series of electrical pulses are sufficient to change the tumor type from a cold tumor to either an altered tumor or a hot tumor, or from an altered tumor to a hot tumor.
However, Davalos discloses an ablation therapy device wherein the series of electrical pulses are sufficient to change the tumor type based on immunological response (Davalos par [0024,0118]).
Furthermore, Rodriguez discloses electroporation being able to change the immunological response and type of tumor from cold to hot (Rodriguez par [0519]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to apply electrical pulses sufficient to increase the immunological response such as disclosed by Davalos and Rodriguez with the invention of Bahrami, as an increased immune response is associated with better treatment outcomes (Davalos par [0082]).
Regarding claim 17, Bahrami discloses the ablation therapy device of claim 16.
Bahrami fails to explicitly disclose wherein the memory device further stores instructions, which when executed cause the control circuitry to: determine a complementary therapy to be applied to the changed tumor; and generate the treatment program based on the complementary therapy and the series of electrical pulses.
However, Davalos discloses a method of treating tumors including determining a complementary therapy to be applied to the changed tumor, and generating generate the treatment program based on the complementary therapy and the series of electrical pulses (Davalos par [0084] forming treatment plan based on measurement parameter).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to determine a recommended complementary therapy for use in treatment, as different complementary therapy are suited to different therapeutic outcomes (Davalos par [0084]).
Regarding claim 18, Bahrami in view of Davalos discloses the ablation therapy device of claim 17.
Davalos further discloses wherein the recommended complementary therapy includes at least one of: immunotherapy, chemotherapy, radiation, vaccination, and surgical intervention (Davalos par [0089]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to determine a recommended complementary therapy for use in treatment, as different complementary therapy are suited to different therapeutic outcomes (Davalos par [0084]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/MATTHEW DAVID BECTON/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794