DETAILED ACTION
The following is a Non-Final Office Action on the merits.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/4/2025 has been entered.
Response to Amendment
Acknowledgment is made to the amendment received 12/4/2025.
Applicant’s amendments are sufficient to overcome the claim objections set forth in the previous office action.
Applicant’s amendments are sufficient to overcome the 35 USC 112(b)/second paragraph objections set forth in the previous office action.
Claim Interpretation
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: “an electrode driver … configured to deploy the plurality of electrodes …” in claim 55, “circuitry configured to test an impedance between at least two of the plurality of electrodes …” in claim 58, “circuitry configured to test a temperature of the tissue…” in claim 61, “circuitry configured to keep the temperature to an increase of less than 8 degrees…” in claim 62, “a catheter means for insertion into the body…” in claim 63, “an electrode driver means for deploying the plurality of electrodes…” in claim 63, “a power source means for applying a direct current ablation…” in claim 63, “means for testing an impedance between at least two of the plurality of electrodes” in claim 66, “means for monitoring the impedance…” in claim 68, and “means for testing a temperature of the tissue…” in claim 69.
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 § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 55, 58-59, 61, 63, 66-67 & 69 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Edwards et al. (2005/0010203, previously cited) in view of Taylor et al. (Ablation of neoplasia by direct current, previously cited) as evidenced by Kroll et al. (2005/0222646, previously cited).
Concerning claim 55, as illustrated in Fig. at least Fig. 1 & 38, Edwards et al. disclose a single-session non-implantable minimally invasive treatment of tissue in a body (method for treating a target tissue such as the prostate with quick healing; [0030], [0088-0089], [0094]) comprising:
a catheter configured to be inserted into the body, wherein a portion of the catheter is configured to remain outside of the body when the catheter is in a treatment position proximate the tissue to be treated (catheter 14/430 is passed upwardly through the urethra 432 to a position adjacent the prostate such that the proximal end remains outside the body; [0077], [0119]);
a plurality of electrodes configured to be deployed through the catheter into the tissue proximate the treatment position (electrical conductors 442, 444 at the end of each stylet 434, 436 and separated by an angular spacing are extended through the urethral wall 432 and intermediate tissue until they are positioned in the transition zone 428, or lateral anterior lob, of the prostate tissue; [0080], [0119]);
an electrode driver mechanically coupled to the plurality of electrodes configured to deploy the plurality of electrodes into the tissue to be treated (electrode stylets 434, 436 are extended through intervening tissue to the target tissue by moving the manual tabs 356 and 358 toward the distal end of the handle; [0117 ]); and
a power source configured to apply ablation during the treatment to the plurality of electrodes based on input treatment parameters for a period of time that imparts a first necrotic zone of the tissue to be a treated and a second necrotic zone of the tissue to be treated via a voltage differential between a first electrode and a second electrode, wherein the first necrotic zone and the second necrotic zone necrotic coalesce to form a field of treatment (time and/or power levels are preset by the control unit along with a preset impedance value and a generator supplies current to electrodes 442 and 444 to create lesions having the approximate cross-sectional shape of overlapping zones 446 and 448 such that the lesions overlap to form a larger lesion, increasing the efficiency of the treatment, whereby more directed ablation can be obtained by using one or more of the stylets as the indifferent electrode and another of the styles as the active electrode, thereby using only stylets to complete the dipole; [0087], [0093], [0120], claim 66),
wherein during treatment, the system is configured to compare measured treatment parameters with the input treatment parameters to determine whether to pause or stop the treatment during the period of time (RF energy is delivered to the target tissue for a preselected time or until impedance exceeds the preset value at which time, the power supply can be reduced or terminated; [0093]).
Edwards et al. fail to disclose the power source configured to apply a direct current ablation during the treatment to the plurality of electrodes for a period of time of less than 60 minutes at a controlled current level that imparts a voltage differential between a first electrode and a second electrode that is substantially non-thermal for the period of time. However, Taylor discloses a system for treating tissue via direct current ablation using electrodes to supply low-voltage direct electrical current at 20 mA per electrode and stopping the treatment when the treatment duration reaches a treatment parameter duration of approximately 45 min having performed a non-thermal treatment by avoiding generating heat. At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of Edwards et al. such that the power source is configured to apply a direct current ablation during the treatment to the plurality of electrodes for a period of time of less than 60 minutes at a controlled current level that imparts a voltage differential between at least two of the plurality of electrodes that is non-thermal for the period of time in order to provide the benefit of tumor debulking and striking necrosis in tumor tissue for a low-cost treatment alternative as taught by Taylor. (Summary; Pg. 342, Col. 2-3; Pg. 344, Col. 2; Pg. 345, Col. 2)
Kroll teaches that upon application direct current, pH changes occur in the tissue, and specifically the concentration of chlorine ions is high around the anode while the concentration of sodium and potassium ions is found to be higher around the cathode and pH changes due to electrical therapy cause the tissue around the anode to become strongly acidic, down to 2.1, while the tissue around the cathode becomes strongly basic, up to 12.9 ([0078]). Thus, as evidenced by Kroll, the modified invention of Edwards et al. in view of Taylor et al. disclose the controlled current level to impart a high pH from a first electrode of the plurality of electrodes to the first necrotic zone of the tissue to be treated and a low pH from a second electrode of the plurality of electrodes to the second necrotic zone of the tissue to be treated.
Edwards et al. in view of Taylor et al., as evidenced by Kroll, fails to specifically teach the plurality of electrodes create necrotic zones that coalesce to form a field of treatment with the direct current ablation. However, Edwards et al. further teach the use of overlapping necrotic zones such that the lesions overlap to form a larger lesion, increasing the efficiency of the treatment. At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of Edwards et al. in view of Taylor, as evidenced by Kroll, such that the plurality of electrodes create necrotic zones that coalesce to form a field of treatment with the direct current ablation in order to provide the benefit of forming a larger lesion and thereby increasing the efficiency of the treatment as taught by Edwards et al. ([0120]).
Concerning claim 58, Edwards et al. disclose circuitry configured to test an impedance between at least two of the plurality of electrodes once deployed in the tissue to be treated ([0093]).
Concerning claim 59, as discussed in the rejection of claim 55 above, Taylor discloses the current source to emit 20 mA of current to the electrode. One of ordinary skill in the art would recognize that the tissue load/impedance would change upon application of the 20mA of current and to keep the current constant, voltage must be adjusted within a reasonable range (e.g., voltage compliance) allowed by the power source.
Concerning claim 61, Edwards et al. further disclose circuitry configured to test a temperature of the tissue to be treated ([0079]; Fig. 2).
Concerning claim 63, as illustrated in Fig. at least Fig. 1 & 38, Edwards et al. disclose a single-session non-implantable minimally invasive treatment of tissue in a body (method for treating a target tissue such as the prostate with quick healing; [0030], [0088-0089], [0094]) comprising:
a catheter means for insertion into the body, wherein a portion of the catheter means remain outside of the body when the catheter is in a treatment position proximate the tissue to be treated (catheter 14/430 is passed upwardly through the urethra 432 to a position adjacent the prostate such that the proximal end remains outside the body; [0077], [0119]);
a plurality of electrodes configured to be deployed through the catheter into the tissue proximate the treatment position (electrical conductors 442, 444 at the end of each stylet 434, 436 and separated by an angular spacing are extended through the urethral wall 432 and intermediate tissue until they are positioned in the transition zone 428, or lateral anterior lob, of the prostate tissue; [0080], [0119]);
an electrode driver means for deploying the plurality of electrodes into the tissue to be treated (electrode stylets 434, 436 are extended through intervening tissue to the target tissue by moving the manual tabs 356 and 358 toward the distal end of the handle; [0117 ]); and
a power source configured to apply ablation during the treatment to the plurality of electrodes based on input treatment parameters for a period of time that imparts a first necrotic zone of the tissue to be a treated and a second necrotic zone of the tissue to be treated via a voltage differential between a first electrode and a second electrode, wherein the first necrotic zone and the second necrotic zone necrotic coalesce to form a field of treatment (time and/or power levels are preset by the control unit along with a preset impedance value and a generator supplies current to electrodes 442 and 444 to create lesions having the approximate cross-sectional shape of overlapping zones 446 and 448 such that the lesions overlap to form a larger lesion, increasing the efficiency of the treatment, whereby more directed ablation can be obtained by using one or more of the stylets as the indifferent electrode and another of the styles as the active electrode, thereby using only stylets to complete the dipole; [0087], [0093], [0120], claim 66),
wherein during treatment, the system is configured to compare measured treatment parameters with the input treatment parameters to determine whether to pause or stop the treatment during the period of time (RF energy is delivered to the target tissue for a preselected time or until impedance exceeds the preset value at which time, the power supply can be reduced or terminated; [0093]).
Edwards et al. fail to disclose the power source configured to apply a direct current ablation during the treatment to the plurality of electrodes for a period of time of less than 60 minutes at a controlled current level that imparts a voltage differential between a first electrode and a second electrode that is substantially non-thermal for the period of time. However, Taylor discloses a system for treating tissue via direct current ablation using electrodes to supply low-voltage direct electrical current at 20 mA per electrode and stopping the treatment when the treatment duration reaches a treatment parameter duration of approximately 45 min having performed a non-thermal treatment by avoiding generating heat. At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of Edwards et al. such that the power source is configured to apply a direct current ablation during the treatment to the plurality of electrodes for a period of time of less than 60 minutes at a controlled current level that imparts a voltage differential between at least two of the plurality of electrodes that is non-thermal for the period of time in order to provide the benefit of tumor debulking and striking necrosis in tumor tissue for a low-cost treatment alternative as taught by Taylor. (Summary; Pg. 342, Col. 2-3; Pg. 344, Col. 2; Pg. 345, Col. 2)
Kroll teaches that upon application of direct current, pH changes occur in the tissue, and specifically the concentration of chlorine ions is high around the anode while the concentration of sodium and potassium ions is found to be higher around the cathode and pH changes due to electrical therapy cause the tissue around the anode to become strongly acidic, down to 2.1, while the tissue around the cathode becomes strongly basic, up to 12.9 ([0078]). Thus, as evidenced by Kroll, the modified invention of Edwards et al. in view of Taylor et al. disclose the controlled current level to impart a high pH from a first electrode of the plurality of electrodes to the first necrotic zone of the tissue to be treated and a low pH from a second electrode of the plurality of electrodes to the second necrotic zone of the tissue to be treated.
Edwards et al. in view of Taylor, as evidenced by Kroll, fail to specifically teach the plurality of electrodes create necrotic zones that coalesce to form a field of treatment with the direct current ablation. However, Edwards et al. further teach the use of overlapping necrotic zones such that the lesions overlap to form a larger lesion, increasing the efficiency of the treatment. At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of Edwards et al. in view of Taylor, as evidenced by Kroll, such that the plurality of electrodes create necrotic zones that coalesce to form a field of treatment with the direct current ablation in order to provide the benefit of forming a larger lesion and thereby increasing the efficiency of the treatment as taught by Edwards et al. ([0120]).
Claim 66 is rejected upon the same rationale as applied to claim 58.
Claim 67 is rejected upon the same rationale as applied to claim 59.
Claim 69 is rejected upon the same rationale as applied to claim 61.
Claims 62 & 70-72 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Edwards et al. (2005/0010203, previously cited) in view of Taylor et al. (Ablation of neoplasia by direct current, previously cited) as evidenced by Kroll et al. (2005/0222646, previously cited), as applied to claims 55 & 63, in further view of Kroll et al. (2005/0222646, previously cited).
Concerning claim 62¸ Edwards et al. in view of Taylor et al., as evidenced by Kroll et al., fail to specifically disclose the circuitry configured to keep the temperature to an increase of less than 8 degrees F during the treatment. However, Kroll further discloses circuitry configured to keep a temperature increase undetectable by thermocouples, and thus, less than 8 degrees and less than that required to cause thermal damage to the tissue. At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of Edwards et al. in view of Taylor et al., as evidenced by Kroll et al. to further comprise circuitry configured to keep the temperature to an increase of less than 8 degrees F during the treatment in order to provide the benefit of keeping the temperature increase less than that required to cause thermal damage to tissue as taught by Kroll (Pg. 344, Col. 2).
Claim 70 is rejected upon the same rationale as applied to claim 62.
Concerning claims 71-72, Edwards et al. fail to disclose the input treatment parameters to include a dose of the treatment in coulombs, a current level of the treatment, a duration of the treatment at a predetermined current level, or combinations thereof. However, Kroll et al. further disclose a power source configured to apply treatment based on input treatment parameters that include current and time durations to optimize therapy. At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of Edwards et al. in view of Taylor et al., as evidenced by Kroll et al. such that the input treatment parameters include a dose of the treatment in coulombs, a current level of the treatment, a duration of the treatment at a predetermined current level, or combinations thereof in order to provide the benefit of optimizing therapy as taught by Kroll et al. ([0167], [0307]; Fig. 49)
Claims 56-57 & 64-55 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Edwards et al. (2005/0010203, previously cited) in view of Taylor et al. (Ablation of neoplasia by direct current, previously cited) as evidenced by Kroll et al. (2005/0222646, previously cited), as applied to claims 55 & 63, in further view of Fabian et al. (5,431,625, previously cited).
Concerning claims 56-57 & 64-65, while Taylor et al. disclose the current is increased and decreased gradually at the beginning and end of a treatment period to avoid the risk of cardiac arrhythmias (Materials and methods: Human studies, Par. 2) Edwards et al. in view of Taylor et al., as evidenced by Kroll et al., fail to disclose the power source configured to increase or decrease the controlled current level at a controlled ramp rate of between approximately 0.1 mA/sec and 10 mA/sec. However, Fabian et al. discloses a direct-current delivery method which uses a ramp rate increase at the beginning of treatment between approximately 0.1 mA/sec and 10 mA/sec and a ramp rate decrease at the end of treatment. At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of Edwards et al. in view of Taylor et al., as evidenced by Kroll et al., such that the power source is configured to increase or decrease the controlled current level at a controlled ramp rate of between approximately 0.1 mA/sec and 10 mA/sec in order to provide the benefit of reducing some of the discomfort experienced by the patient as taught by Fabian et al. (Col. 1, Il. 18-31, Col. 2, Il. 23-31, Col. 3, Il. 56-63, Col. 4, ll. 15-25, Col. 5, Il. 13-29)
Claims 60 & 68 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Edwards et al. (2005/0010203, previously cited) in view of Taylor et al. (Ablation of neoplasia by direct current, previously cited) as evidenced by Kroll et al. (2005/0222646, previously cited), as applied to claims 55 & 63, in further view of Stone et al. (2006/0235286, previously cited).
Concerning claims 60 & 68, while Edwards et al. disclose testing/monitoring impedance ([0093]), Edwards et al. in view of Taylor et al., as evidenced by Kroll et al., fail to disclose circuitry configured to monitor the impedance to verify adequate contact between the electrodes and the tissue to be treated. However, Stone et al. disclose circuitry configured to test an impedance between at least two of the plurality of electrodes once deployed in the tissue to be treated. At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of Edwards et al. in view of Taylor et al., as evidenced by Kroll, to further comprise circuitry configured to test an impedance between at least two of the plurality of electrodes once deployed in the tissue to be treated and monitor the impedance to verify adequate contact between the electrodes and the tissue to be treated in order to provide the benefit of determining if the electrodes are in the proper location for therapy and achieving optimum treatment as taught by Stone et al. ([0076], [0136]).
Response to Arguments
Applicant's arguments filed 12/4/2025 have been fully considered but they are not persuasive.
In response to Applicant’s arguments that Edwards feedback for thermal management and safety in an RF system is irrelevant in a non-thermal DC system, the Examiner respectfully disagrees. Edwards clearly teaches using measured treatment parameters in a feedback look, which is applicable to other energy treatment modalities, including non-thermal DC. The Examiner notes that the independent claims fail to recite the specific treatment parameters and that Edwards is not relied upon to teach the specific input treatment parameters in dependent claims 71-72.
In response to Applicant’s arguments that “it would not be obvious to integrate Kroll’s feedback concept into the Edwards/Taylor combination because Kroll primarily teaches a fully implantable system intended for long-term therapy”, the Examiner respectfully disagrees. First, the Examiner notes that Kroll is not cited for teaching any type of feedback system in the independent claims, but rather, is an evidentiary reference that states how pH of tissue chances when DC is applied. Second, with respect to dependent claims 71-72 that recites the feedback input treatment parameters, the Examiner maintains that one of ordinary skill in the art would look to a DC treatment to teach parameters used in a feedback system that optimizes the therapy, no matter the time frame involved.
In response to Applicant's argument that “Kroll often uses the generator housing itself as an electrode”, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In response to Applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Conclusion
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
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