DETAILED ACTION
The following is a First Action, Non-Final Office Action on the merits.
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 .
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.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120, 365(c) & 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application Nos. 17/349299, 15/795062, 15/341512, PCT/US2015/029734 & 61/996390 provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Accordingly, the claims are given the priority date of 5/7/2014.
Specification
The disclosure is objected to because of the following informalities: update the first paragraph with appropriate patent information.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: amend “tissue by irreversible electroporation” to -the tissue by the irreversible electroporation- in ll. 12. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: amend “tissue by irreversible electroporation” to -the tissue by the irreversible electroporation- in ll. 13-14. Appropriate correction is required.
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.
(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.
Claim(s) 1, 3, 6 & 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sharkey et al. (2002/0049438).
Concerning claim 1, as illustrated in at least figs. 8A-10B, Sharkey et al. disclose a catheter for ablation of tissue by irreversible electroporation (electrosurgical instrument 810 is capable of being connected to an irreversible electroporation energy source; [0038], [0060]), the catheter comprising:
a tubular catheter shaft having a distal end portion terminating in a distal tip, an outer side and an inner side surrounding a lumen (shaft 827 has a distal end portion terminating in a distal tip, an outer side and an inner side surrounding a lumen 850; [0061]);
an outer electrode disposed on the outer side of the catheter shaft in the distal end portion, the outer electrode having an outer surface exposed on the outer side of the catheter shaft (electrode 822 is exposed on the shaft outer side at the distal portion and having an outer surface exposed on the outer side of shaft 827; [0061]); and
an inner electrode disposed on the inner side of the catheter shaft in the distal end portion, the inner electrode being recessed proximally from the distal tip of the catheter shaft and having an inner electrode surface exposed on the inner side of the catheter shaft (electrode 824 is disposed on the inners ide of shaft 827 in the distal portion, is located internally within aspiration lumen 850 and is electrically isolated from the active electrode 822 by insulator 828 and insulation material 830; [0061]),
wherein the outer electrode and the inner electrode are configured such that an electric field capable of ablating tissue by irreversible electroporation is generated when a voltage is applied between the outer electrode and the inner electrode (electrode 822 and electrode 824 are capable of being connected to an IRE source via conductors 816, 826 to generate an electric field that treats tissue by IRE when tissue is aspirated into the lumen; [0061]).
Concerning claim 3, Sharkey et al. disclose the inner electrode (824) is in the form of an annular cylinder (Fig. 8A-10B).
Concerning claim 6, Sharkey et al. disclose the lumen (85) of the catheter shaft (827) is configured to allow flow of an ionic fluid therethrough ([0062]).
Concerning claim 9, as illustrated in at least figs. 8A-10B, Sharkey et al. disclose a catheter for ablation of tissue by irreversible electroporation (electrosurgical instrument 810 is capable of being connected to an irreversible electroporation energy source; [0038], [0060]), the catheter comprising:
a tubular catheter shaft having a distal end portion terminating in a distal tip, an outer side and an inner side surrounding a lumen (shaft 827 has a distal end portion terminating in a distal tip, an outer side and an inner side surrounding a lumen 850; [0061]);
an outer electrode coupled to the outer side of the catheter shaft in the distal end (electrode 822/922/1022 is exposed on the shaft outer side; [0061]); and
an inner electrode coupled to the inner side of the catheter shaft in the distal end portion, the inner electrode being recessed proximally from the distal tip of the catheter shaft (electrode 824 is located internally within aspiration lumen 850 and is electrically isolated from the active electrode 822 by insulator 828 and insulation material 830; [0061]).
Claim(s) 1, 3, 6 & 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Woloszko et al. (7,879,034).
Concerning claim 1, as illustrated in at least Fig. 1 & 7-11, Woloszko et al. disclose a catheter for ablation of tissue by irreversible electroporation (electrosurgical apparatus 50 is capable of being connected to an irreversible electroporation energy source; Col. 5-6, ll. 57-3), the catheter comprising:
a tubular catheter shaft having a distal end portion terminating in a distal tip, an outer side and an inner side surrounding a lumen (shaft 52 has a proximal end portion near the handle and a distal end portion terminating a distal tip and a lumen 70; Col. 5-6, ll. 57-13);
an outer electrode disposed on the outer side of the catheter shaft in the distal end portion, the outer electrode having an outer surface exposed on the outer side of the catheter shaft (active electrode 58 is disposed on outer side of catheter shaft 52 in the distal end portion and has an exposed outer surface on the outer side of shaft 52; Col. 5-6, ll. 57-3); and
an inner electrode disposed on the inner side of the catheter shaft in the distal end portion, the inner electrode being recessed proximally from the distal tip of the catheter shaft and having an inner electrode surface exposed on the inner side of the catheter shaft (return electrode 60 is disposed on the interior of shaft 52 in the distal end portion, and has a portion that is recessed proximally from the distal tip of shaft 57; Col. 5-6, ll. 57-3),
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wherein the outer electrode and the inner electrode are configured such that an electric field capable of ablating tissue by irreversible electroporation is generated when a voltage is applied between the outer electrode and the inner electrode (electrode 58 and electrode 62 are capable of being connected to an IRE source via conductors 64, 66 to generate an electric field that treats tissue by IRE when tissue is placed into the lumen; Col. 5-6, ll. 57-3).
Concerning claim 3, Woloszko et al. disclose the inner electrode (60) is in the form of an annular cylinder (Fig. 7-9).
Concerning claim 6, Woloszko et al. disclose the lumen (70) of the catheter shaft (52) is configured to allow flow of an ionic fluid therethrough (Col. 5-6, ll. 57-13; Fig. 7-11).
Concerning claim 9, as illustrated in at least Fig. 1 & 7-11, Woloszko et al. disclose a catheter for ablation of tissue by irreversible electroporation (electrosurgical apparatus 50 is capable of being connected to an irreversible electroporation energy source; Col. 5-6, ll. 57-3), the catheter comprising:
a tubular catheter shaft having a distal end portion terminating in a distal tip, an outer side and an inner side surrounding a lumen (shaft 52 has a proximal end portion near the handle and a distal end portion terminating a distal tip and a lumen 70; Col. 5-6, ll. 57-13);
an outer electrode coupled to the outer side of the catheter shaft in the distal end (active electrode 58 is disposed on outer side of catheter shaft 52; Col. 5-6, ll. 57-3); and
an inner electrode coupled to the inner side of the catheter shaft in the distal end portion, the inner electrode being recessed proximally from the distal tip of the catheter shaft (return electrode 60 is disposed on the interior of shaft 52 in the distal end portion, and has a portion that is recessed proximally from the distal tip of shaft 57; Col. 5-6, ll. 57-3).
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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.
Claim(s) 2, 7-8 & 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharkey et al. (2002/0049438), as applied to claims 1 & 9.
Concerning claims 2 & 10, Sharkey discloses the outer electrode (822/922/1022) has a proximal end and a distal end, and wherein the inner electrode (824) has a proximal end and a distal end, and wherein the distal end of the inner electrode (824) is recessed a distance from the distal tip of the catheter shaft (827) (Fig. 8A-10A). Sharkey fails to disclose the inner electrode is recessed between 0.5 mm and 10 mm from the distal tip of the catheter shaft. It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of Sharkey such that the inner electrode is recessed between 0.5 mm and 10 mm from the distal tip of the catheter shaft since Applicant places no criticality on this distance (the originally filed disclosure merely states: “the anode 141 is recessed from the distal tip, and could be placed with its distal portion between 0.5 mm and 10 mm away from the distal end of the catheter” and thus, there is no criticality placed on the specific distance range), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Concerning claims 7-8, Sharkey discloses the inner electrode length (L2) being longer than the outer electrode length (L1) (Fig. 8A-10B), but fails to specifically disclose the ratio to be between 1.3 and 10, and more specifically to be between 2 and 5. Sharkey fails to disclose the inner electrode is recessed between 0.5 mm and 10 mm from the distal tip of the catheter shaft. It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of Sharkey such that the inner electrode is recessed between 0.5 mm and 10 mm from the distal tip of the catheter shaft since Applicant places no criticality on this distance (the originally filed disclosure merely states: “The ratio L2/Li could have a value of at least 1.3, more preferably lie in the range 1.3 to 10, and still more preferably in the range 2 to 5” and thus, there is no criticality placed on the specific ratio range), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Woloszko et al. (7,879,034), as applied to claims 1 & 9.
Concerning claims 7-8, Woloszko et al. disclose the inner electrode (60) length (L2) being longer than the outer electrode (58) length (L1) (Fig. 7-11), but fails to specifically disclose the ratio to be between 1.3 and 10, and more specifically to be between 2 and 5. Sharkey fails to disclose the inner electrode is recessed between 0.5 mm and 10 mm from the distal tip of the catheter shaft. It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of Woloszko such that the inner electrode is recessed between 0.5 mm and 10 mm from the distal tip of the catheter shaft since Applicant places no criticality on this distance (the originally filed disclosure merely states: “The ratio L2/Li could have a value of at least 1.3, more preferably lie in the range 1.3 to 10, and still more preferably in the range 2 to 5” and thus, there is no criticality placed on the specific ratio range), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
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 1, 6-10, 13 & 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,690,671. Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite an electroporation system/device comprising a catheter having a lumen, an outer electrode disposed on an outer surface of the catheter, an inner electrode disposed on an inner surface such that the inner electrode is recessed proximally from the catheter shaft distal tip, a system to generate an electric field to irreversibly electroporate tissue. The patent fails to disclose the inner electrode is recessed between 0.5 mm and 10 mm from the distal tip of the catheter shaft. It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of the patent such that the inner electrode is recessed between 0.5 mm and 10 mm from the distal tip of the catheter shaft since Applicant places no criticality on this distance (the originally filed disclosure merely states: “the anode 141 is recessed from the distal tip, and could be placed with its distal portion between 0.5 mm and 10 mm away from the distal end of the catheter” and thus, there is no criticality placed on the specific distance range), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. The patent fails to disclose fails to specifically disclose the ratio of the length of the inner electrode (L2) to the length of the outer electrode (L1) to be between 1.3 and 10, and more specifically to be between 2 and 5. Sharkey fails to disclose the inner electrode is recessed between 0.5 mm and 10 mm from the distal tip of the catheter shaft. It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of the patent such that the inner electrode is recessed between 0.5 mm and 10 mm from the distal tip of the catheter shaft since Applicant places no criticality on this distance (the originally filed disclosure merely states: “The ratio L2/Li could have a value of at least 1.3, more preferably lie in the range 1.3 to 10, and still more preferably in the range 2 to 5” and thus, there is no criticality placed on the specific ratio range), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claims 1-2, 6-10, 13-14 & 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,178,503. Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite an electroporation system/device comprising a catheter having a lumen, an outer electrode disposed on an outer surface of the catheter, an inner electrode disposed on an inner surface such that the inner electrode is recessed proximally from the catheter shaft distal tip, a system to generate an electric field to irreversibly electroporate tissue. The patent fails to disclose the inner electrode is recessed between 0.5 mm and 10 mm from the distal tip of the catheter shaft. It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of the patent such that the inner electrode is recessed between 0.5 mm and 10 mm from the distal tip of the catheter shaft since Applicant places no criticality on this distance (the originally filed disclosure merely states: “the anode 141 is recessed from the distal tip, and could be placed with its distal portion between 0.5 mm and 10 mm away from the distal end of the catheter” and thus, there is no criticality placed on the specific distance range), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. The patent fails to disclose fails to specifically disclose the ratio of the length of the inner electrode (L2) to the length of the outer electrode (L1) to be between 1.3 and 10, and more specifically to be between 2 and 5. Sharkey fails to disclose the inner electrode is recessed between 0.5 mm and 10 mm from the distal tip of the catheter shaft. It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of the patent such that the inner electrode is recessed between 0.5 mm and 10 mm from the distal tip of the catheter shaft since Applicant places no criticality on this distance (the originally filed disclosure merely states: “The ratio L2/Li could have a value of at least 1.3, more preferably lie in the range 1.3 to 10, and still more preferably in the range 2 to 5” and thus, there is no criticality placed on the specific ratio range), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. The patent fails to disclose fails to specifically disclose the ratio of the length of the inner electrode (L2) to the length of the outer electrode (L1) to be between 1.3 and 10, and more specifically to be between 2 and 5. Sharkey fails to disclose the inner electrode is recessed between 0.5 mm and 10 mm from the distal tip of the catheter shaft. It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of the patent such that the inner electrode is recessed between 0.5 mm and 10 mm from the distal tip of the catheter shaft since Applicant places no criticality on this distance (the originally filed disclosure merely states: “The ratio L2/Li could have a value of at least 1.3, more preferably lie in the range 1.3 to 10, and still more preferably in the range 2 to 5” and thus, there is no criticality placed on the specific ratio range), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claims 1-2, 6-10, 13-14 & 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,329,447. Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite an electroporation system/device comprising a catheter having a lumen, an outer electrode disposed on an outer surface of the catheter, an inner electrode disposed on an inner surface such that the inner electrode is recessed proximally from the catheter shaft distal tip, a system to generate an electric field to irreversibly electroporate tissue. The patent fails to disclose the inner electrode is recessed between 0.5 mm and 10 mm from the distal tip of the catheter shaft. It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of the patent such that the inner electrode is recessed between 0.5 mm and 10 mm from the distal tip of the catheter shaft since Applicant places no criticality on this distance (the originally filed disclosure merely states: “the anode 141 is recessed from the distal tip, and could be placed with its distal portion between 0.5 mm and 10 mm away from the distal end of the catheter” and thus, there is no criticality placed on the specific distance range), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. The patent fails to disclose fails to specifically disclose the ratio of the length of the inner electrode (L2) to the length of the outer electrode (L1) to be between 1.3 and 10, and more specifically to be between 2 and 5. Sharkey fails to disclose the inner electrode is recessed between 0.5 mm and 10 mm from the distal tip of the catheter shaft. It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of the patent such that the inner electrode is recessed between 0.5 mm and 10 mm from the distal tip of the catheter shaft since Applicant places no criticality on this distance (the originally filed disclosure merely states: “The ratio L2/Li could have a value of at least 1.3, more preferably lie in the range 1.3 to 10, and still more preferably in the range 2 to 5” and thus, there is no criticality placed on the specific ratio range), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claims 1-2, 6-10, 13-14 & 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 18/346575 (reference application, now allowed). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite an electroporation system/device comprising a catheter having a lumen, an outer electrode disposed on an outer surface of the catheter, an inner electrode disposed on an inner surface such that the inner electrode is recessed proximally from the catheter shaft distal tip, a system to generate an electric field to irreversibly electroporate tissue. The application fails to disclose the inner electrode is recessed between 0.5 mm and 10 mm from the distal tip of the catheter shaft. It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of the patent such that the inner electrode is recessed between 0.5 mm and 10 mm from the distal tip of the catheter shaft since Applicant places no criticality on this distance (the originally filed disclosure merely states: “the anode 141 is recessed from the distal tip, and could be placed with its distal portion between 0.5 mm and 10 mm away from the distal end of the catheter” and thus, there is no criticality placed on the specific distance range), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. The application fails to disclose fails to specifically disclose the ratio of the length of the inner electrode (L2) to the length of the outer electrode (L1) to be between 1.3 and 10, and more specifically to be between 2 and 5. Sharkey fails to disclose the inner electrode is recessed between 0.5 mm and 10 mm from the distal tip of the catheter shaft. It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of the patent such that the inner electrode is recessed between 0.5 mm and 10 mm from the distal tip of the catheter shaft since Applicant places no criticality on this distance (the originally filed disclosure merely states: “The ratio L2/Li could have a value of at least 1.3, more preferably lie in the range 1.3 to 10, and still more preferably in the range 2 to 5” and thus, there is no criticality placed on the specific ratio range), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 6, 9, 13-14 & 19-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/664163 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite an electroporation system/device comprising a catheter having a lumen, an outer electrode disposed on an outer surface of the catheter, an inner electrode disposed on an inner surface such that the inner electrode is recessed proximally from the catheter shaft distal tip, a system to generate an electric field to irreversibly electroporate tissue. The application fails to disclose the inner electrode is recessed between 0.5 mm and 10 mm from the distal tip of the catheter shaft. It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of the patent such that the inner electrode is recessed between 0.5 mm and 10 mm from the distal tip of the catheter shaft since Applicant places no criticality on this distance (the originally filed disclosure merely states: “the anode 141 is recessed from the distal tip, and could be placed with its distal portion between 0.5 mm and 10 mm away from the distal end of the catheter” and thus, there is no criticality placed on the specific distance range), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. The application fails to disclose fails to specifically disclose the ratio of the length of the inner electrode (L2) to the length of the outer electrode (L1) to be between 1.3 and 10, and more specifically to be between 2 and 5. Sharkey fails to disclose the inner electrode is recessed between 0.5 mm and 10 mm from the distal tip of the catheter shaft. It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of the patent such that the inner electrode is recessed between 0.5 mm and 10 mm from the distal tip of the catheter shaft since Applicant places no criticality on this distance (the originally filed disclosure merely states: “The ratio L2/Li could have a value of at least 1.3, more preferably lie in the range 1.3 to 10, and still more preferably in the range 2 to 5” and thus, there is no criticality placed on the specific ratio range), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. The application fails to disclose the inner electrode is in the form of an annular cylinder. It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively field to modify the invention of the application such that the inner electrode is in the form of an annular cylinder is of whatever desired or expedient form or shape, since a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 4-5 & 11-12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 13-14 & 19-20 would be allowable if appropriate terminal disclaimer(s) are submitted.
Claims 15-18 would be allowable if appropriate terminal disclaimer(s) are submitted and are rewritten in independent form including all of the limitations of the base claim and any intervening claims
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
The following is a statement of reasons for the indication of allowable subject matter: the prior art, neither alone nor in combination teaches a catheter comprising an interiorly recessed electrode and an outer electrode, the proximal end of the outer electrode being located proximally relative to the proximal end of the inner electrode (claims 4 & 11) nor a catheter comprising an interiorly recessed electrode and an outer electrode and a waveform generator configured to apply a pulsed voltage waveform between the electrodes such that an electric field capable of ablating tissue by IRE is generated (claim 13).
The closest prior art is regarded as: Woloskzo et al. (7,879,034), Sharkey et al. (2002/0049438) and Stewart et al. (2013/0030430). Woloszko et al. and Sharkey et al. both disclose an external electrode on an outer surface of a shaft and an internal electrode internal to the shaft. Stewart et al. teaches irreversible electroporation of myocardial tissue to treat ventricular tachycardia to be preferable over cryogenic and RF applications in view of improvement of safety, treatment duration and efficacy ([0008]). However, it would not have been obvious to one of ordinary skill in the art to modify the invention of Woloszko or Sharkey et al. with the electroporation generator of Stewart et al. to generate an electric field since the target tissue is located external to the catheter and thus would not be located within the electric field generated between the electrodes to ablate the tissue by IRE.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure Woloszko et al. (6,832,996) teaches an outer electrode (1810) and an inner electrode (1820) proximally recessed from a catheter shaft distal end.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
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