DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 4, 2026 has been entered.
Currently, claims 1-20 are pending. No claims were amended in the May 4, 2026 After-Final response when compared the February 11, 2026 claim listing. Applicant’s filing of the Terminal Disclaimer on May 4, 2026 has obviated the previously-filed obviousness double patenting rejections set forth in the March 3, 2026 Final Office Action.
For the sake of completeness, the Examiner notes that the May 8, 2026 Advisory Action, incorrectly indicated that claims 5, 9, 15 and 19 stand only as objected to based on the acceptance of the Terminal Disclaimer and the removal of the prior obviousness-type double patenting rejections. This statement was improper as claims 5, 9, 15 and 19 remainder rejected under 35 U.S.C. 103 based on the combination of Mirza, Sisterolli and Ernster. The Examiner has reflected this corrected status of the claim rejections in the instant action.
The following is a complete response to the May 4, 2026 response and June 3, 2026 Request for Continued Examination.
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).
Response to Arguments
Applicant's arguments filed May 4, 2026 have been fully considered but they are not persuasive.
Applicant argues with respect to the rejection of independent claims 1 and 11 under 35 U.S.C. 103 as unpatentable over Mirza in view of Sisterolli on pages 5-9 of the Remarks filed May 4, 2026.
Applicant's provides, in Section A, for an overview of the subject matter of claims 1/11 on page 5 and generally alleges that the mapping set forth in the rejections "is geometrically unsupportable and directly contradicted by Sisterolli's own disclosure". Applicant specifically contends in section B on page 6 that each of claims 1 and 11 require an "arcuate-shaped distal cutting portion [that] circumscribes an arcuate portion of the aperture, and the insulated portion circumscribes the remaining portion of the aperture". Applicant continues that such results in an aperture that is not a complete oval or circle "but rather a distinctly arcuate opening (akin to a D-shape) formed by the structural interplay of the conductive and insulating elements at the distal tip." To highlight this, Applicant points to paragraphs [0053] and [0054] of the Specification discussing cutting portion 103a, aperture 107, non-cutting portion 105a and aperture 107, and concludes that the "aperture is thus defined by and shaped by the structural interaction of the arcuate cutting face and the insulated portion".
These arguments are not persuasive.
As a preliminary matter, the Examiner notes that claim 1 requires, most relevantly, that: “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.”
Similarly, claim 11 requires, most relevantly, that: “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.”
In review of the entirety of the language of each of claims 1 and 11, and particularly in view of the above-highlighted portions of each claim, the Examiner has failed to find any language in either claim that required the aperture itself to be arcuate-shaped or otherwise shaped in the manner argued for in section A on page 6 of the Remarks ("[t]he result is an aperture that is not a complete oval or circle, but rather a distinctly arcuate opening (akin to a D-shape)". At most, each claim defines "an aperture in communication with the lumen". It is, rather, the distal face of the distal cutting portion that "circumscribes an arcuate portion of an aperture" with the insulating portion circumscribing the remaining portion of the aperture. This position is supported by the cited-to paragraphs [0053] and [0054] of Applicant's own disclosure as well as the displayed in referenced figures 2A-C. Paragraph [0054] describes that it is the distal surface of electrode 103 that forms the cutting portion 103a that is "generally C-shaped or arcuate when viewing the distal face 104 from a distal-end-view. The cutting portion 103a is further described as being "non-circular" and arranged so as to "not completely encircle, circumscribe or enclose aperture 107". The balance of the Specification is consistent in describing the cutting portion, and not the aperture itself, as arcuate.
Turning to the rejection of claim 1, the Examiner notes that Mirza is relied upon to teach a distal cutting portion as shown in figure 1A with the distal portion at 106 being a cutting portion. Mirza is further relied upon to teach an insulated portion proximal to the distal cutting portion in the form of 104 being placed on 102 proximal to the defined distal cutting portion. Lastly, Mirza is relied on to teach that the distal cutting portion defines a distal face extending distally from the insulated portion and circumscribing a portion of an aperture view the exposed portion of 102 forming the distal cutting portion having a distal face that is around the aperture formed therethough.
Mirza is noted by the Examiner as being deficient in teaching that the distal cutting portion is arcuate-shaped such that it circumscribes an arcuate portion of the aperture, and wherein the insulated portion circumscribes the remaining portion of the aperture. The Examiner has relied upon the teaching of Sisterolli to cure these noted deficiencies in Mirza and has looked to the arrangement in figure 2A for such a teaching. Sisterolli provides, therein, for a distal cutting portion at 6' and an insulated proximal portion at 1'. Figure 2A then displays that the distal cutting portion defines a distal face that is arcuate, with such extending distally from the insulated portion. This arcuate distal face also circumscribes an arcuate portion of an aperture wherein the insulated portion circumscribes a remaining portion of the aperture. This arrangement is shown via the shape of 26 as in figures 1 and 2 of Sisterolli with 6' covering an arcuate portion around the aperture at 14, and with 1' covering the remaining portion.
Thus, the Examiner must maintain the position set forth in the rejection of claim 1 that the cutting portion defined by 6' in Sisterolli does indeed possess an arcuate shape that extending distally from the insulated portion at 1' with such only circumscribing an arcuate portion of the aperture defined at 14. This portion at 6' is substantially similar in shape to the Applicant's own portion at 103a as shown in figures 2A/B. Figure 2 of Sisterolli then further displays that the remainder portion of the aperture at 14 is circumscribed by the insulating portion at 1'.
Applicant further argues in section C on page 6 that "[t]he threshold question for the Examiner's mapping is whether Sisterolli's aperture is arcuate-shaped" and not oval-shaped. Applicant provides reasoning based on the general geometry of a hollow cylinder cut by an oblique plane to support that the aperture of Sisterolli must be oval shaped and not arcuate.
This is not persuasive.
As noted above, the Examiner is of the position that Applicant has erred when construing that the aperture in each of claims 1 and 11 must be arcuate in shape based on the language of each respective claim. The Examiner, rather, finds that each claim only requires that distal face of the distal cutting portion is to be "arcuate shaped" with that distal face circumscribing "an arcuate portion of an aperture", and with the remaining portion of the aperture being circumscribed by the insulated portion. To reinforce the position above, the Examiner finds that only the portion of the aperture circumscribed by the distal face of the distal cutting portion need be arcuate and not the entirety of the aperture. The Examiner finds that such is supported by an additional portion of the aperture needing to be circumscribed by the insulating portion.
Applicant further argues in Sections D-F on page 7-8 of the Remarks. These arguments, much like those in above-addressed sections B and C, are predicated on Applicant's interpretation that the aperture itself is required to be arcuate in shape. The Examiner has failed to find these arguments in each of sections D-F as persuasive in that, again, at no time do any of claims 1 or 11 (or any respective dependent claim) either implicitly or explicitly require that the aperture itself is arcuately shaped. Rather, it is the distal face of the distal cutting portion that is "arcuate-shaped" so as to circumscribe an arcuate portion of the aperture.
It is, therefore, for at least the reasoning set forth above that the Examiner maintains that the pending rejections under 35 U.S.C. 103 based on the combination of Mirza in view of Sisterolli are tenable.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD HUPCZEY, JR whose telephone number is (571)270-5534. The examiner can normally be reached Monday - Friday; 8 am - 4 pm.
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/Ronald Hupczey, Jr./ Primary Examiner, Art Unit 3794
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