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 .
Response to Amendment
The preliminary amendment filed on December 18th, 2024 has been entered. Claims 1-20 are canceled. Claims 21-29 are new. Claims 21-29 remain pending.
Specification
The disclosure is objected to because of the following informalities: the paragraph titled “CROSS REFERENCE TO RELATED APPLICATIONS”, needs to be updated to include the current status of the parent applications: U.S. application serial No. 18/335,449, filed on June 15, 2023, which is now abandoned, and U.S. application serial No. 16/464,738, filed on May 29, 2019, which is now U.S Patent No. 11,717,337.
Drawings
The drawings are objected to because Figure 2, box 208 the label “adjusting the system impedance to a target impedance to limit arcing form the catheter electrode” should be – adjusting the system impedance to a target impedance to limit arcing from the catheter electrode—. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 23 objected to because of the following informalities: “the catheter and the return electrode” should be – the catheter electrode and the return electrode—; as introduced in claim 21 Appropriate correction is required.
Claim 24 objected to because of the following informalities: “the catheter and the return electrode” should be – the catheter electrode and the return electrode—; as introduced in claim 21 Appropriate correction is required.
Claim 25 objected to because of the following informalities: “the catheter and the return electrode” should be – the catheter electrode and the return electrode—; as introduced in claim 21 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.
Claim 26 is 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 26 recites the limitation "the DC energy source" in line 5. There is insufficient antecedent basis for this limitation in the claim; for examination purposes the examiner is considering “the DC energy source” to be – a DC energy source—.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,717,337. Although the claims at issue are not identical, they are not patentably distinct from each other because, although U.S Patent No. 11,717,337 contains additional limitations relating to the structure of the device, U.S Patent No. 11,717,337 discloses all of the method limitations of claims 21-29, as shown below (in bold).
Instant Application 18/960,333
U.S Patent No. 11,717,337
21. (New) A method of controlling an electroporation system, the method comprising: positioning a return electrode; positioning a catheter electrode of a catheter within a body; determining a system impedance using the return electrode and the catheter electrode; calculating a target impedance based on a combination of a current density threshold and a characteristic of the catheter; and adjusting the system impedance to calculated target impedance.
1. A method of controlling an electroporation system including a direct current (DC) energy source, a return electrode connected to the DC energy source, and a catheter connected to the DC energy source, the catheter having at least one catheter electrode, the method comprising: positioning the return electrode near a target location within a body; positioning the catheter electrode within the body adjacent the target location within the body; determining a system impedance with the return electrode positioned near the target location and the catheter electrode positioned within the body; calculating a target impedance based on a combination of a current density threshold and a characteristic of the catheter; and adjusting the system impedance to calculated target impedance to limit arcing from the catheter electrode.
22. (New) The method of claim 21, wherein adjusting the system impedance to the calculated target impedance comprises adjusting a system resistance to a target resistance.
2. The method of claim 1, wherein adjusting the system impedance to the calculated target impedance comprises adjusting a system resistance to a target resistance.
23. (New) The method of claim 22, wherein adjusting the system resistance comprises connecting at least one resistor to one of the catheter and the return electrode.
3. The method of claim 2, wherein adjusting the system resistance comprises connecting at least one resistor to one of the catheter and the return electrode.
24. (New) The method of claim 22, wherein adjusting the system resistance comprises removing at least one resistor connected to one of the catheter and the return electrode.
4. The method of claim 2, wherein adjusting the system resistance comprises removing at least one resistor connected to one of the catheter and the return electrode.
25. (New) The method of claim 22, wherein the electroporation system includes an adjustable resistance connected to one of the catheter and the return electrode, and adjusting the system resistance comprises varying the adjustable resistance.
5. The method of claim 2, wherein the electroporation system includes an adjustable resistance connected to one of the catheter and the patch electrode, and adjusting the system resistance comprises varying the adjustable resistance.
26. (New) The method of claim 21, wherein calculating the target impedance comprises calculating the target impedance based at least in part on one or more of a surface area of the catheter electrode, a shape of the catheter, a shape of the catheter electrode, a size of the catheter, a distance between the catheter electrode and an additional catheter electrode on the catheter, a time interval between pulses of energy output by the DC energy source, and a target electrical current density for the catheter electrode.
6. The method of claim 1, wherein calculating the target impedance comprises calculating the target impedance based at least in part on one or more of a surface area of the catheter electrode, a shape of the catheter, a shape of the catheter electrode, a size of the catheter, a distance between the catheter electrode and an additional catheter electrode on the catheter, a time interval between pulses of energy output by the DC energy source, and a target electrical current density for the catheter electrode.
27. (New) The method of claim 21, wherein determining the system impedance comprises: shorting the catheter electrode and an additional catheter electrode together; and outputting a known non-electroporation signal using the shorted catheter electrode and the additional catheter electrode.
7. The method of claim 1, wherein determining the system impedance comprises: shorting the catheter electrode and an additional catheter electrode together; and outputting a known non-electroporation signal using the shorted catheter electrode and the additional catheter electrode.
28. (New) A method of detecting arcing in an electroporation system, the method comprising: positioning a return electrode; positioning a catheter electrode of a catheter within a body; monitoring a system impedance using the return electrode and the catheter electrode; detecting a positive deflection in the system impedance, the positive deflection indicative of arcing, wherein the positive deflection is detected by monitoring the second derivative of the system impedance; and generating an alert, based on the detection.
8. A method of detecting arcing in an electroporation system including a direct current (DC) energy source, a return electrode connected to the DC energy source, and a catheter connected to the DC energy source, the catheter having at least one catheter electrode, the method comprising: positioning the return electrode near a target location within a body; positioning the catheter electrode within the body adjacent the target location within the body; monitoring a system impedance with the return electrode positioned near the target location and the catheter electrode positioned within the body; detecting a positive deflection in the system impedance, the positive deflection indicative of arcing, wherein the positive deflection is detected by monitoring one of i) the integral of the system impedance and ii) the second derivative of the system impedance; and generating an alert, based on the detection, the alert indicating that arcing has occurred.
29. (New) A method of detecting arcing in an electroporation system, the method comprising: positioning a return electrode; positioning a catheter electrode of a catheter within a body; monitoring a system impedance using the return electrode; detecting a positive deflection in the system impedance, the positive deflection indicative of arcing, wherein the positive deflection is detected by monitoring the integral of the system impedance; and generating an alert, based on the detection.
8. A method of detecting arcing in an electroporation system including a direct current (DC) energy source, a return electrode connected to the DC energy source, and a catheter connected to the DC energy source, the catheter having at least one catheter electrode, the method comprising: positioning the return electrode near a target location within a body; positioning the catheter electrode within the body adjacent the target location within the body; monitoring a system impedance with the return electrode positioned near the target location and the catheter electrode positioned within the body; detecting a positive deflection in the system impedance, the positive deflection indicative of arcing, wherein the positive deflection is detected by monitoring one of i) the integral of the system impedance and ii) the second derivative of the system impedance; and generating an alert, based on the detection, the alert indicating that arcing has occurred.
Allowable Subject Matter
Claims 21-29 would be allowable once the nonstatutory double patenting rejection, set forth in this office action, is addressed via an approved terminal disclaimer, and upon addressing the 112(b) rejections set forth in this office action(claim 26).
The following is a statement of reasons for the indication of allowable subject matter:
Independent claim 21 recites “a method of controlling an electroporation system, the method comprising: positioning a return electrode; positioning a catheter electrode of a catheter within a body; determining a system impedance using the return electrode and the catheter electrode; calculating a target impedance based on a combination of a current density threshold and a characteristic of the catheter; and adjusting the system impedance to calculated target impedance”. The Wham reference (US 20070250052 A1) provides a teaching for a method of controlling an electroporation system, the method comprising positioning a return electrode ([0005] & [0016]); positioning a catheter electrode of a catheter within a body ([0005], [0007], & [0025]); determining a system impedance using the return electrode and the catheter electrode ([0022], [0023], & [0025]), calculating a target impedance ([0022] & [0026]), and adjusting the system impedance to calculated target impedance ([0026]); however, the Wham reference does not provide a teaching for the method of “calculating a target impedance based on a combination of a current density threshold and a characteristic of the catheter”. The Guziak reference (US 6162216 A) provides a teaching for a method for maintaining a constant current density to prevent localized hot spots ([Col. 1, line 50-58]), the method comprising sensing an electrical impedance, calculating a surface area of the cannula in contact with tissue based on the impedance, and adjusting the electrical current to maintain a constant current density over the surface area of the cannula in contact with tissue; Guziak further provides a teaching for the surface area of the probe in contact with tissue being inversely and approximately linearly related to the electrical impedance of the probe ([Col. 2, line 47 – Col. 3, line 9] & [Col. 5, lines 8-30]); however the Guziak reference does not provide a teaching for the method of “calculating a target impedance based on a combination of a current density threshold and a characteristic of the catheter”. The Woloszko reference (US 20160022349 A1) provides a teaching for a method wherein the impedance of the electrode circuit is dependent on many factors such as the distance between the electrodes, the quality of the electrode surface the electrode surface area in contact with the medium, the style of the probe ([0062] & [0062]); however the Woloszko reference does not provide a teaching for the method of “calculating a target impedance based on a combination of a current density threshold and a characteristic of the catheter”. The examiner further notes that no other reference or combination of references have been found to disclose fairly suggest, or make obvious each and every limitation and combination of limitations set forth in independent claim 21. Claims 22-27 are also indicated as comprising allowable subject matter as they depend from claim 21.
Claim 28 recites the limitation “a method of detecting arcing in an electroporation system, the method comprising: positioning a return electrode; positioning a catheter electrode of a catheter within a body; monitoring a system impedance using the return electrode and the catheter electrode; detecting a positive deflection in the system impedance, the positive deflection indicative of arcing, wherein the positive deflection is detected by monitoring the second derivative of the system impedance; and generating an alert, based on the detection”. Claim 29 recites “a method of detecting arcing in an electroporation system, the method comprising: positioning a return electrode; positioning a catheter electrode of a catheter within a body; monitoring a system impedance using the return electrode; detecting a positive deflection in the system impedance, the positive deflection indicative of arcing, wherein the positive deflection is detected by monitoring the integral of the system impedance; and generating an alert, based on the detection” The Wham reference (US 20070250052 A1) provides a teaching for a method of detecting arcing in an electroporation system ([0019]), the method comprising: positioning a return electrode ([0005] & [0016]); positioning a catheter electrode of a catheter within a body ([0005], [0007], & [0025]); monitoring a system impedance using the return electrode and the catheter electrode ([0022], [0023], & [0025]); detecting a positive deflection in the system impedance, the positive deflection indicative of arcing ([0024 & [0027]); however the Wham reference does not provide a teaching of the method of “wherein the positive deflection is detected by monitoring the second derivative of the system impedance; and generating an alert, based on the detection” (claim 28) or “wherein the positive deflection is detected by monitoring the integral of the system impedance; and generating an alert, based on the detection” (claim 29). The Woloszko reference (US 20160022349 A1) provides a teaching for generating an alert, based on the detection that arcing has occurred ([0066]), however the Woloszko reference does not provide a teaching for the method of “wherein the positive deflection is detected by monitoring the second derivative of the system impedance” (claim 28) or “wherein the positive deflection is detected by monitoring the integral of the system impedance” (claim 29). The Christopherson reference (US 20020058933 A1) provides a teaching for wherein the positive deflection in the system impedance is detected by monitoring the derivative of the system impedance ([0116]); however the Christopherson reference does not provide a teaching for the method of “wherein the positive deflection is detected by monitoring the second derivative of the system impedance” (claim 28) or “wherein the positive deflection is detected by monitoring the integral of the system impedance” (claim 29). The examiner further notes that no other reference or combination of references have been found to disclose fairly suggest, or make obvious each and every limitation and combination of limitations set forth in independent claim 28 or Independent claim 29.
Conclusion
Accordingly, claim 21-29 are rejected; however, claims 21-29 would be allowable once the no statutory double patenting rejection, set forth in this office action, is addressed via an approved terminal disclaimer, and upon addressing the 112(b) rejections set forth in this office action (claim 26).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARINA D TEMPLETON whose telephone number is (571)272-7683. The examiner can normally be reached M-F 8:00am to 5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.D.T./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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