DETAILED ACTION
Applicant’s amendments and remarks, filed February 11, 2026. Currently, claims 1-20 are pending with claims 1, 2, 4, 8 and 10-20 amended. Applicant’s amendment to the Specification has obviated the previously-filed objection. Applicant’s amendments to the claims have overcome the previously-filed claim objections as well as the rejections under 35 U.S.C. 112(b). The following is a complete response to the February 11, 2026 communication.
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 .
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 6-8, 10-14, 16-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable Mirza et al. (US Pat. No. 8,192,425 B2) further in view of Sisterolli (WO 2010/135793 A1).
Regarding claim 1, Mirza provides for a radiofrequency (RF) puncture member for puncturing a septum of a patient’s heart (apparatus 100), the RF puncture member comprising: an elongate member defining a lumen extending from a proximal end to a distal portion (conductive member 102 with a lumen such as 208 in figure 2A therethrough; the distal portion is taken as the exposed end at 106 as shown in figure 1A), the distal portion including a distal cutting portion (see figure 1A with the distal portion at 106 being a cutting portion), and an insulating layer covering a portion of the distal portion of the elongate member (insulator 104), so as to define an insulated portion proximal to the distal cutting portion (via 104 being placed on 102 proximal to the distal cutting portion as defined above), wherein the distal cutting portion defines a distal face extending distally from the insulated portion and circumscribing a portion of an aperture (via the exposed portion of 102 forming the distal cutting portion having a distal facing face that is around the aperture formed therethrough).
Mirza, while providing for a plurality of shapes and arrangements of the distal portion of its device (see figures 4A-F, 6A-E), fails to specifically provide that the distal cutting portion is arcuate-shaped such that it circumscribes an arcuate portion of the aperture, and wherein the insulate portion circumscribes the remaining portion of the aperture.
Sisterolli provides an alternative manner of providing a cutting tip at the distal portion of an elongate member (27, see figure 2) including a distal cutting portion (6’) and an insulating layer covering a portion of the distal portion so as to define a insulated portion proximal to the distal cutting portion (1’). Sisterolli further provides that the distal cutting portion defines a distal face that is arcuate-shaped extending distally from the insulated portion and circumscribes an arcuate portion of an aperture in communication with a lumen of the device (in view of the shape of 26 as in figures 1 and 2 and with 6’ covering an arcuate portion around 14), and wherein the insulated portion circumscribes a remaining portion of the aperture (via 1’ covering the remaining portion).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to have utilized a distal portion arrangement as in Sisterolli to the distal portion of Mirza to provide for a known alternative manner of providing a distal portion that is capable of cutting tissue. The Examiner is of the position that one of ordinary skill in the art would readily recognize this alternative cutting tip would function equally as well as the various tip arrangements in Mirza to provide for the requisite passage of the tip through tissue. The Examiner is further of the position that both Mirza and Sisterolli contemplate similar and non-limiting changes in shape to the distal portion including completely conductive and partially conductive that each function to provide for the cutting as required.
Regarding claim 2, Mirza, in view of the combination with Sisterolli above, provides that the elongate member comprises an electrically conductive tube (102 is an electrically conductive tube).
Regarding claim 3, in view of the combination with distal portion arrangement in Sisterolli above, Sisterolli further provides that the combined distal portion includes that the outer diameter of the elongate member decreases towards the distal cutting portion (see figure 2 in Sisterolli with the tip at 26 tapering).
Regarding claim 4, in view of the combination with distal portion arrangement in Sisterolli above, Sisterolli further provides that the combined distal portion provides for the insulated portion of the elongate member to defines a sloped surface towards a distal end of the elongate member (see figure 2 of the Sisterolli providing for a sloped surface).
Regarding claim 6, in view of the combination in the rejection of claim 1 above, the Examiner is of the position that the combined distal cutting portion is configured to produce an elongated cut in the septum while mitigating the likelihood of coring.
The Examiner is of the position that requirement in claim 6 of “configured to produce an elongated cut in the septum while mitigating the likelihood of coring” is a functional recitation of the intended use of the claimed device and the distal cutting portion. It is well established that such a functional recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the Examiner is of the position that the arcuate distal cutting portion per the combination of Mirza and Sisterolli is capable of being electrically energized to cut tissue including the formation of an elongated cut in tissue (such as the septum of the heart) that can minimize coring.
Regarding claim 7, in view of the combination with distal portion arrangement in Sisterolli above, the combined arrangement including the sloped surface provides that such is configured to dilate tissue as the elongate member is advanced through the elongated cut given that the tapered of the device along the sloped surface as defined in the rejection of claim 4 above would function to dilate tissue.
The Examiner, again, notes that the requirement of the distal cutting portion being configured to produce an elongated cut in the septum is a functional recitation of the intended use of the claimed device and the distal cutting portion. It is well established that such a functional recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the exposed distal cutting portion is capable of being electrically energized to cut tissue including the formation of an elongated cut in tissue (such as the septum of the heart).
Regarding claim 8, Mirza provides that the elongate member is comprised of electrically conductive material configured to conduct energy (102 is electrically conductive).
Regarding claim 10, in view of the combination with distal portion arrangement in Sisterolli above, combined elongate member and distal portion provides that the elongate member is a dilator (the Examiner is of the position that such would result in 102 of Mirza with the distal cutting portion per Sisterolli functioning as a dilator given that tapering of the device from the distal to the proximal end of the device).
Regarding claim 11, Mirza provides for a radiofrequency (RF) puncture system for puncturing a septum of a patient’s heart (see figure 7), the RF puncture system comprising an elongate member defining a lumen extending from a proximal end to a distal portion (conductive member 102 with a lumen such as 208 in figure 2A therethrough; the distal portion is taken as the exposed end at 106 as shown in figure 1A), the distal portion including a distal cutting portion (see figure 1A with the distal portion at 106 being a cutting portion), an insulating layer covering a portion of the distal portion of the elongate member (insulator 104), so as to define an insulated portion proximal to the distal cutting portion (via 104 being placed on 102 proximal to the distal cutting portion as defined above), a sheath including a sheath lumen configured to position the elongate member to the patient’s heart (see [0087] providing for the guiding sheath), and wherein the distal cutting portion defines a distal face extending distally from the insulated portion and circumscribing a portion of an aperture (via the exposed portion of 102 forming the distal cutting portion having a distal facing face that is around the aperture formed therethrough).
Mirza, while providing for a plurality of shapes and arrangements of the distal portion of its device (see figures 4A-F, 6A-E), fails to specifically provide that the distal cutting portion is arcuate-shaped such that it circumscribes an arcuate portion of the aperture, and wherein the insulate portion circumscribes the remaining portion of the aperture.
Sisterolli provides an alternative manner of providing a cutting tip at the distal portion of an elongate member (27, see figure 2) including a distal cutting portion (6’) and an insulating layer covering a portion of the distal portion so as to define a insulated portion proximal to the distal cutting portion (1’). Sisterolli further provides that the distal cutting portion defines a distal face that is arcuate-shaped extending distally from the insulated portion and circumscribes an arcuate portion of an aperture in communication with a lumen of the device (in view of the shape of 26 as in figures 1 and 2 and with 6’ covering an arcuate portion around 14), and wherein the insulated portion circumscribes a remaining portion of the aperture (via 1’ covering the remaining portion).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to have utilized a distal portion arrangement as in Sisterolli to the distal portion of Mirza to provide for a known alternative manner of providing a distal portion that is capable of cutting tissue. The Examiner is of the position that one of ordinary skill in the art would readily recognize this alternative cutting tip would function equally as well as the various tip arrangements in Mirza to provide for the requisite passage of the tip through tissue. The Examiner is further of the position that both Mirza and Sisterolli contemplate similar and non-limiting changes in shape to the distal portion including completely conductive and partially conductive that each function to provide for the cutting as required.
Regarding claim 12, Mirza, in view of the combination with Sisterolli above, provides that the elongate member comprises an electrically conductive tube (102 is an electrically conductive tube).
Regarding claim 13, in view of the combination with distal portion arrangement in Sisterolli above, Sisterolli further provides that the combined distal portion includes that the outer diameter of the elongate member decreases towards the distal cutting portion (see figure 2 in Sisterolli with the tip at 26 tapering).
Regarding claim 14, in view of the combination with distal portion arrangement in Sisterolli above, Sisterolli further provides that the combined distal portion provides for the insulated portion of the elongate member to defines a sloped surface towards a distal end of the elongate member (see figure 2 of the Sisterolli providing for a sloped surface).
Regarding claim 16, in view of the combination in the rejection of claim 1 above, the Examiner is of the position that the combined distal cutting portion is configured to produce an elongated cut in the septum while mitigating the likelihood of coring.
The Examiner is of the position that requirement in claim 6 of “configured to produce an elongated cut in the septum while mitigating the likelihood of coring” is a functional recitation of the intended use of the claimed device and the distal cutting portion. It is well established that such a functional recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the Examiner is of the position that the arcuate distal cutting portion per the combination of Mirza and Sisterolli is capable of being electrically energized to cut tissue including the formation of an elongated cut in tissue (such as the septum of the heart) that can minimize coring.
Regarding claim 17, in view of the combination with distal portion arrangement in Sisterolli above, the combined arrangement including the sloped surface provides that such is configured to dilate tissue as the elongate member is advanced through the elongated cut given that the tapered of the device along the sloped surface as defined in the rejection of claim 4 above would function to dilate tissue.
The Examiner, again, notes that the requirement of the distal cutting portion being configured to produce an elongated cut in the septum is a functional recitation of the intended use of the claimed device and the distal cutting portion. It is well established that such a functional recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the exposed distal cutting portion is capable of being electrically energized to cut tissue including the formation of an elongated cut in tissue (such as the septum of the heart).
Regarding claim 18, Mirza provides that the elongate member is comprised of electrically conductive material configured to conduct energy (102 is electrically conductive).
Regarding claim 20, in view of the combination with distal portion arrangement in Sisterolli above, combined elongate member and distal portion provides that the elongate member is a dilator (the Examiner is of the position that such would result in 102 of Mirza with the distal cutting portion per Sisterolli functioning as a dilator given that tapering of the device from the distal to the proximal end of the device).
Claims 5, 9, 15 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Mirza et al. (US Pat. No. 8,192,425 B2) in view of Sisterolli (WO 2010/135793 A1) as applied to claims 3 and 13 respectively above, and further in view of Ernster (US Pat. No. 5,968,042).
Regarding claims 5, 9, 15 and 19, Mirza fails to provide that the distal cutting portion defines a notch extending axially to a distal end of the elongate member (claims 5 and 15) and that the distal cutting portion further comprises at least one beveled corner (claims 9 and 19). Sisterolli, while providing for a tapered distal portion including the distal cutting portion, fails to contemplate the notch or beveled corner.
Ernster discloses an exemplary manner of forming an electrically conductive distal portion of a surgical device wherein the device has a blunt shape as in Mirza (see figure 3) or for such to include a distal cutting portion defining a notch extending axially to a distal end of the elongate member and for the inclusion of at least one beveled corner (see figure 2 with the notch at 25 extending to a distal end of tube within 30, and beveled via the overall angled shape of the end at 22) similar to the tapered arrangement in figure 2 of Sisterolli. Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a notch in the beveled distal cutting portion of the combination in Mirza and Sisterolli in view of the teaching in Ernster. Such would provide for an alternative known conductive portion at the distal end of the device with Ernster readily disclosing that the inclusion of such a tip allows for focused treatment of energy while also preventing clogging of the tip via the inclusion of the notch 25 (see col. 3; 56-67).
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 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2-10 of U.S. Patent No. U.S. Patent No. 12,011,210 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding instant independent claim 1, each of the limitations set forth in the claim can be found in the combination of limitations provided by patented claims 1 and 2. The difference between the patented claim 2 and instant claim 1 is that the patented claim includes additional elements and is, thus, more specific than instant claim 1. As a result, the invention of patented claim 2 is in effect a “species” of the “generic” invention of instant claim 1. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since instant claim 1 is anticipated by patented claim 2, it is not patentably distinct from patented claim 2.
Regarding independent claim 1, please see the following table:
Instant Application
Patented Claim
Claim 1:
an elongate member defining a lumen extending from a proximal end to a distal portion, the distal portion including a distal cutting portion;
an insulating layer covering a portion of the distal portion of the elongate member, so as to define an insulated portion proximal to the distal cutting portion;
wherein the distal cutting portion defines a distal face that is arcuate-shaped extending distally from the insulated portion and circumscribes an arcuate portion of an aperture in communication with the lumen and wherein the insulated portion circumscribes a remaining portion of the aperture
Claim 1:
an elongate member having a longitudinal axis and defining a lumen for fluid; a distal portion which includes an electrode and a distal face; the distal face defining at least one aperture
Claim 2:
elongate member is comprised of … an electrically insulating material and wherein an electrically exposed portion of the distal face of the elongate member forms the at least one cutting portion;
Claim 1:
a portion of the at least one cutting portion defining a leading portion partially surrounding a circumference of the at least one aperture + Claim 2 subject matter above
Regarding instant claim 2, see patented claim 2;
Regarding instant claim 3, see patented claim 1;
Regarding instant claim 4, see patented claims 4 and 5;
Regarding instant claim 5, see patented claim 10;
Regarding instant claim 6, see patented claim 6;
Regarding instant claim 7, see patented claim 7;
Regarding instant claim 8, see patented claims 1 and 2;
Regarding instant claim 9 see patented claim 9;
Regarding instant claim 10, see patented claim 7.
Claims 11-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-10 of U.S. Patent No. 12,011,210 B2 in view of Mirza et al. (US Pat. No. 8,192,425 B2).
Regarding claim 11, a plurality of the limitations set forth in the claim can be found in the combination of limitations provided by patented claims 1 and 2. The primary difference between the patented claim 2 and instant claim 11 is that the patented claim includes additional elements and is, thus, narrower in some aspects than instant claim 11. As a result, the invention of patented claim 2 is in effect a “species” of the “generic” invention of instant claim 11. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Regarding independent claim 11, please see the following table:
Instant Application
Patented Claim
Claim 11:
an elongate member defining a lumen extending from a proximal end to a distal portion, the distal portion including a distal cutting portion;
an insulating layer covering a portion of the distal portion of the elongate member, so as to define an insulated portion proximal to the distal cutting portion;
wherein the distal cutting portion defines a distal face extending distally from the insulated portion and circumscribes an arcuate portion of an aperture in communication with the lumen and wherein the insulated portion circumscribes a remaining portion of the aperture.
Claim 1:
an elongate member having a longitudinal axis and defining a lumen for fluid; a distal portion which includes an electrode and a distal face; the distal face defining at least one aperture
Claim 2:
elongate member is comprised of … an electrically insulating material and wherein an electrically exposed portion of the distal face of the elongate member forms the at least one cutting portion;
Claim 1:
a portion of the at least one cutting portion defining a leading portion partially surrounding a circumference of the at least one aperture + Claim 2 subject matter above
Instant claim 11 is narrower in other aspects, including the requirement of a sheath including a sheath lumen configured to position the elongate member to the patient’s heart. Mirza, however, provides for a sheath including a sheath lumen configured to position the elongate member to the patient’s heart (see [0087] providing for the guiding sheath). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a sheath as in Mirza with the device per patented claim 2 to provide for a known manner in the art of directing an electrosurgical instrument within the body to a target site.
Regarding instant claim 12, see patented claim 2;
Regarding instant claim 13, see patented claim 1;
Regarding instant claim 14, see patented claims 4 and 5;
Regarding instant claim 15, see patented claim 10;
Regarding instant claim 16, see patented claim 6;
Regarding instant claim 17, see patented claim 7;
Regarding instant claim 18, see patented claims 1 and 2;
Regarding instant claim 19, see patented claim 9;
Regarding instant claim 20, see patented claim 7.
Claims 1-3, 6-8, 10-13, 16-18 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. 11,020,173 B2 in view of Mirza et al. (US Pat. No. 8,192,425 B2).
Regarding instant independent claims 1 and 11, a plurality of the limitations set forth in each instant claim can be found in the limitations provided by patented claim 1. The primary difference between the patented claim 1 and each of instant claims 1 and 11 is that the patented claim includes additional elements and is, thus, narrower in some aspects than each of instant claims 1 and 11. As a result, the invention of patented claim 1 is in effect a “species” of the “generic” invention of each of instant claims 1 and 11. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Regarding each of instant claims 1 and 11, please see the following table:
Instant Application
Patented Claim
Claim 1 or 11:
an elongate member defining a lumen extending from a proximal end to a distal portion, the distal portion including a distal cutting portion;
wherein the distal cutting portion defines a distal face extending distally from the insulated portion and circumscribes an arcuate portion of an aperture in communication with the lumen and wherein the insulated portion circumscribes a remaining portion of the aperture
Claim 1:
an elongate tubular member defining a lumen for receiving a fluid; a distal face defining at least one aperture; the distal face consisting of a single cutting portion which is comprised of an electrically conductive material
wherein a distal surface of a single electrode defines the single cutting portion, the single cutting portion is substantially arcuate, only partially surrounds the at least one aperture
Each of instant claims 1 and 11 are narrower in other aspects, including the requirement of a) an insulating layer covering a portion of the distal portion of the elongate member, so as to define an insulated portion proximal to the distal cutting portion (claims 1 and 11), and b) a sheath including a sheath lumen configured to position the elongate member to the patient’s heart (claim 11). Mirza, however, provides for an insulating layer covering a portion of the distal portion of the elongate member (insulator 104), so as to define an insulated portion proximal to the distal cutting portion (via 104 being placed on 102 proximal to the distal cutting portion as defined above) as well as a sheath including a sheath lumen configured to position the elongate member to the patient’s heart (see [0087] providing for the guiding sheath). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized the construction of the elongate member in Mirza (for claims 1 and 11) as well as a sheath as in Mirza (for claim 11) with the device per patented claim 1 to provide for a known manner constructing an exemplary surgical perforation device in the art as well to provide for the directing an electrosurgical instrument within the body to a target site.
Regarding instant claims 2, 8, 12 and 18, Mirza would further provide for such as feature as in the rejections under 35 U.S.C. 102 above. Such would be further obvious in light of the rationale proffered above;
Regarding instant claims 3 and 13, see patented claim 7;
Regarding instant claims 6 and 16, see patented claim 1;
Regarding instant claims 7 and 17, see patented claim 7;
Regarding instant claims 10 and 20, see patented claim 7.
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. U.S. Patent No. 10,751,115 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding instant independent claim 1, each of the limitations set forth in the claim can be found in the limitations provided by patented claim 1. The difference between the patented claim 1 and instant claim 1 is that the patented claim includes additional elements and is, thus, more specific than instant claim 1. As a result, the invention of patented claim 1 is in effect a “species” of the “generic” invention of instant claim 1. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since instant claim 1 is anticipated by patented claim 1, it is not patentably distinct from patented claim 1.
Regarding independent claim 1, please see the following table:
Instant Application
Patented Claim
Claim 1:
an elongate member defining a lumen extending from a proximal end to a distal portion, the distal portion including a distal cutting portion;
an insulating layer covering a portion of the distal portion of the elongate member, so as to define an insulated portion proximal to the distal cutting portion;
wherein the distal cutting portion defines a distal face extending distally from the insulated portion and circumscribes an arcuate portion of an aperture in communication with the lumen and wherein the insulated portion circumscribes a remaining portion of the aperture
Claim 1:
an elongate member defining a lumen for receiving a fluid, wherein the elongate member comprises an electrically conductive tubular member having a distal open end; a distal face of the energy delivery device defining an aperture in communication with the lumen
at least one electrically insulated portion formed using electrically insulating material, wherein the electrically insulating material covers at least a portion of an outside surface of a sidewall of the elongate member
the distal face including at least one electrically exposed conductive portion which partially surrounds the aperture
Regarding instant claim 2, see patented claim 1;
Regarding instant claim 3, see patented claim 1 with the disclosed bevel;
Regarding instant claim 4, see patented claim 1 with the disclosed bevel;
Regarding instant claim 5, see patented claim 1 with the disclosed bevel;
Regarding instant claim 6, see patented claim 1;
Regarding instant claim 7, see patented claim 1;
Regarding instant claim 8, see patented claim 1;
Regarding instant claim 9, see patented claim 1;
Regarding instant claim 10, see patented claim 1.
Claims 11-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,751,115 B2 in view of Mirza et al. (US Pat. No. 8,192,425 B2).
Regarding claim 11, a plurality of the limitations set forth in the claim can be found in the limitations provided by patented claim 1. The primary difference between the patented claim 1 and instant claim 11 is that the patented claim includes additional elements and is, thus, narrower in some aspects than instant claim 11. As a result, the invention of patented claim 1 is in effect a “species” of the “generic” invention of instant claim 11. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Regarding independent claim 11, please see the following table:
Instant Application
Patented Claim
Claim 11:
an elongate member defining a lumen extending from a proximal end to a distal portion, the distal portion including a distal cutting portion;
an insulating layer covering a portion of the distal portion of the elongate member, so as to define an insulated portion proximal to the distal cutting portion;
wherein the distal cutting portion defines a distal face extending distally from the insulated portion and circumscribes an arcuate portion of an aperture in communication with the lumen and wherein the insulated portion circumscribes a remaining portion of the aperture
Claim 1:
an elongate member defining a lumen for receiving a fluid, wherein the elongate member comprises an electrically conductive tubular member having a distal open end; a distal face of the energy delivery device defining an aperture in communication with the lumen
at least one electrically insulated portion formed using electrically insulating material, wherein the electrically insulating material covers at least a portion of an outside surface of a sidewall of the elongate member
the distal face including at least one electrically exposed conductive portion which partially surrounds the aperture
Instant claim 11 is narrower in other aspects, including the requirement of a sheath including a sheath lumen configured to position the elongate member to the patient’s heart. Mirza, however, provides for a sheath including a sheath lumen configured to position the elongate member to the patient’s heart (see [0087] providing for the guiding sheath). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a sheath as in Mirza with the device per patented claim 1 to provide for a known manner in the art of directing an electrosurgical instrument within the body to a target site.
Regarding instant claim 12, see patented claim 1;
Regarding instant claim 13, see patented claim 1;
Regarding instant claim 14, see patented claims 1;
Regarding instant claim 15, see patented claim 1;
Regarding instant claim 16, see patented claim 1;
Regarding instant claim 17, see patented claim 1;
Regarding instant claim 18, see patented claim 1;
Regarding instant claim 19, see patented claim 1;
Regarding instant claim 20, see patented claim 1.
Response to Arguments
Applicant’s arguments, see pages 7-10 of the Remarks filed February 11, 2026, with respect to the rejection of each of independent claims 1 and 11 under 35 U.S.C. 102(a)(1) as anticipated by Mirza have been fully considered and are persuasive. Specifically, the Examiner finds Applicant’s highlighting of the required arcuate shape of the distal face of the distal cutting portion that circumscribes an arcuate portion of the aperture as persuasive in overcoming the application of Mirza under 35 U.S. C. 102. Therefore, the prior rejections based on Mirza have been withdrawn. However, upon further consideration, the following new grounds of rejection have been set forth in the action above:
Claims 1-4, 6-8, 10-14, 16-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable Mirza et al. (US Pat. No. 8,192,425 B2) further in view of Sisterolli (WO 2010/135793 A1).
Claims 5, 9, 15 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Mirza et al. (US Pat. No. 8,192,425 B2) in view of Sisterolli (WO 2010/135793 A1) as applied to claims 3 and 13 respectively above, and further in view of Ernster (US Pat. No. 5,968,042).
It is the Examiner’s position that the newly cited Sisterolli reference readily cures the deficiencies in the Mirza reference with respect to the amended subject matter in each of independent claims 1 and 11 for at least the reasoning articulated in the rejections above.
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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/Ronald Hupczey, Jr./ Primary Examiner, Art Unit 3794