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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 29, 2025 has been entered.
Currently, claims 1-20 are pending with claims 1, 3, 10, 12 and 19 amended. The following is a complete response to the December 29, 2025 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 .
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claims 1-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Altmann et al. (US Pat. No. 9,314,208 B1).
Regarding claim 1, Altmann provides for a surgical system, comprising an elongate tubular body comprising a proximal end, a distal end and one or more working channels extending therebetween (see col. 11; 25-54 providing for the guiding sheath; such would have a working channel formed therethrough for the catheter to pass therethrough),
a working space expanding system positioned at a distal portion of the elongate tubular body (assembly 18 positioned at the distal end of the guide sheath as in col. 11; 25-54), the working space expanding system movable between a non-expanded insertion position and an expanded position to form an expanded region (See col. 3; 44-50), the working space expanding system including first and second flexible members (a first and a second spline 27) and an endcap (body 25), the endcap coupled to distal ends of the first and second flexible members (see at least figures 4A and 4B).
a surgical device disposed within a one of the one or more working channels of the elongate tubular body, the surgical device comprising an active electrode (a third spline 27), the surgical device comprising an active electrode (the third spline 27 having an electrode 240 therein),
at least one return electrode disposed on an outer surface of the endcap (any of 26R or 26D), and
a power source configured to deliver energy to the active electrode of the surgical device, and in electrical communication with the at least one return electrode (see col. 9; 15-31 providing for the connection to a mapping and ablation source of energy by leads 212/40),
wherein the surgical device can be advanced through the one of the one or more working channels to contact an inner wall of a body lumen at a plurality of positions while the working space expanding system is expanded (via the third spline 27 above capable of being advanced from the col. 11 guide sheath to contact tissue while the other splines are being expanded). The Examiner further notes that the limitations set forth in claim 1 of “can be advanced through the one of the one or more working channels to contact an inner wall of a body lumen at a plurality of positions while the working space expanding system is expanded” can further be interpreted as a functional recitation of the intended use of the claim surgical system. It is well established that 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 various splines forming the respective ones of the working space expanding system and the surgical device of Altmann are readily capable of performing the various claimed functional features set forth in the noted limitation..
Regarding claim 2, Altmann provides that the first and second flexible members are movable between the non-expanded position and the expanded position to form the expanded region (via each of the splines 27 moving as discussed in col. 3; 44-50).
Regarding claim 3, Altmann provides that the endcap is configured to contact the inner wall of a body lumen as the first and second flexible members move to the expanded position, to place the at least one return electrode in contact with the inner wall at a first location. The Examiner notes that the limitations set forth in claim 3 including the language of “configured to contact an inner wall of a body lumen as the first and second flexible members move …” is taken as a functional recitation of the intended use of the claim surgical system. It is well established that 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 disclosed end cap (body 25) of Altmann is readily capable of contacting tissue as the flexible members expand (splines 27) so as to place the at least one return electrode in contact with an inner wall of tissue.
Regarding claim 4, Altmann further provides that the at least one return electrode includes a first return electrode configured to contact the inner wall of the body lumen at the first location and a second return electrode configured to contact the inner wall of the body lumen at a second location different than the first location (via the inclusion of any two of 26P/D being located at differing positions on 25).
Regarding claim 5, Altmann provides that the surgical device comprises an active electrode and is configured to contact the inner wall of the body lumen at a third location to deliver energy from the power source (a respective one of the electrodes 240 on the third spline), through a portion of tissue of the body lumen, to the first and second return electrodes (the path of energy delivery from 240 through tissue and returning to each of the return electrodes formed by 26P/D would be dependent upon the connection of the leads 212/40).
Regarding claim 6, Altmann provides that the surgical device comprises an active electrode and is configured to contact the inner wall of the body lumen at a second location to deliver energy from the power source (a respective one of the electrodes 240 on the third spline), through a portion of tissue of the body lumen, to the at least one return electrode (the path of energy delivery from 240 through tissue and returning to each of the return electrodes formed by 26P/D would be dependent upon the connection of the leads 212/40).
Regarding claim 7, Altmann provides for a cover disposed around a portion of the working space expanding system (the protective sheath 222 forming an insulative cover over a portion of the system in the form of one or more of the splines).
Regarding claim 8, Altmann provides that the first and second flexible members are configured to bow, flex, or bend between the non-expanded insertion position and the expanded position (via each of the splines 27 being flexible and capable of bowing/flexing/bending to achieve the expanded shape).
Regarding claim 9, Altmann provides that the at least one return electrode comprises a plurality of return electrodes disposed uniformly around a circumference of the endcap (within the broadest reasonable interpretation, the plurality of electrodes taken as either two diametrically opposed ones of 26D/R would be uniformly disposed about the circumference of 25).
Regarding claim 10, Altmann provides for a surgical system comprising an elongate tubular body comprising a proximal end, a distal end and one or more working channels extending therebetween (see col. 11; 25-54 providing for the guiding sheath; such would have a working channel formed therethrough for the catheter to pass therethrough),
a working space expanding system positioned at a distal portion of the elongate tubular body (assembly 18 positioned at the distal end of the guide sheath as in col. 11; 25-54), the working space expanding system movable between a non-expanded insertion position and an expanded position to form an expanded region (See col. 3; 44-50), the working space expanding system including first and second flexible members (a first and a second spline 27) and an endcap (body 25), the endcap coupled to distal ends of the first and second flexible members (see at least figures 4A and 4B),
a plurality of return electrodes disposed on an outer surface of the endcap (any two of 26R or 26D),
a surgical device disposed within a first working channel of the elongate tubular body (a third spline 27), the surgical device comprising an active electrode (the third spline 27 having an electrode 240 therein), and a power source in electrical communication with the plurality of return electrodes and the active electrode, the power source configured to deliver energy to the active electrode (see col. 9; 15-31 providing for the connection to a mapping and ablation source of energy by leads 212/40),
wherein the surgical device can be advanced through the one of the one or more working channels to contact an inner wall of a body lumen at a plurality of positions while the working space expanding system is expanded (via the third spline 27 above capable of being advanced from the col. 11 guide sheath to contact tissue while the other splines are being expanded). The Examiner further notes that the limitations set forth in claim 1 of “can be advanced through the one of the one or more working channels to contact an inner wall of a body lumen at a plurality of positions while the working space expanding system is expanded” can further be interpreted as a functional recitation of the intended use of the claim surgical system. It is well established that 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 various splines forming the respective ones of the working space expanding system and the surgical device of Altmann are readily capable of performing the various claimed functional features set forth in the noted limitation..
Regarding claim 11, Altmann provides that the first and second flexible members are movable between the non-expanded position and the expanded position to form the expanded region (via each of the splines 27 moving as discussed in col. 3; 44-50).
Regarding claim 12, Altmann provides that the endcap is configured to contact the inner wall of the body lumen as the first and second flexible members move to the expanded position, to place the at least one return electrode in contact with the inner wall at a first location. The Examiner notes that the limitations set forth in claim 3 including the language of “configured to contact an inner wall of a body lumen as the first and second flexible members move …” is taken as a functional recitation of the intended use of the claim surgical system. It is well established that 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 disclosed end cap (body 25) of Altmann is readily capable of contacting tissue as the flexible members expand (splines 27) so as to place the at least one return electrode in contact with an inner wall of tissue.
Regarding claim 13, Altmann further provides that the at least one return electrode includes a first return electrode configured to contact the inner wall of the body lumen at the first location and a second return electrode configured to contact the inner wall of the body lumen at a second location different than the first location (via the inclusion of any two of 26P/D being located at differing positions on 25).
Regarding claim 14, Altmann provides that the surgical device comprises an active electrode and is configured to contact the inner wall of the body lumen at a second location to deliver energy from the power source (a respective one of the electrodes 240 on the third spline), through a portion of tissue of the body lumen, to the at least one return electrode (the path of energy delivery from 240 through tissue and returning to each of the return electrodes formed by 26P/D would be dependent upon the connection of the leads 212/40).
Regarding claim 15, Altmann provides that the delivered energy is capable of affecting the portion of tissue of the body lumen (via the ablating of tissue via the application of the energy thereto).
Regarding claim 16, Altmann provides for a sleeve disposed around a distal portion of the elongate tubular body (34).
Regarding claim 17, Altmann provides that the first and second flexible members are configured to bow, flex, or bend between the non-expanded insertion position and the expanded position (via each of the splines 27 being flexible and capable of bowing/flexing/bending to achieve the expanded shape).
Claim 19 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kordis et al. (US Pat. No. 5,636,634).
Regarding claim 19, Kordis provides for a surgical system comprising an elongate tubular body comprising a proximal end, a distal end and one or more working channels extending therebetween (see figure 24 with the body at 16 with the lumen formed therein),
an elongate insulated sheath configured to extend over at least a portion of an outer surface of the elongate tubular body (introducer 14 as in figure 24),
a working space expanding system positioned at a distal portion of the elongate tubular body (basket 24, see figures 24-26), the working space expanding system movable between a non-expanded insertion position and an expanded position to form an expanded region (see at least col. 7; 8-17 and figures 1-4), the working space expanding system including first and second flexible members (splines 36) and an endcap (end cap 34), the endcap coupled to distal ends of the first and second flexible members (as in the figures),
a plurality of return electrodes disposed on an outer surface of the endcap (see col. 7; 45-47 providing for “one or more electrodes 26 can be located on the end cap 34”),
a surgical device disposed within a first working channel of the elongate tubular body (ablation catheter 90 with ablating element 88 as in figures 24-2615), the surgical device comprising an active electrode (88 being providing ablation energy through the plug 102), wherein the surgical device can be advanced through the one of the one or more working channels to contact an inner wall of a body lumen at a plurality of positions while the working space expanding system is expanded (see col. 13; 37 – col. 15; 17 describing the movement of 88 while the basket 24 is expanded such that 88 can be moved to contact tissue).
and a power source in electrical communication with the plurality of return electrodes and the active electrode, the power source configured to deliver energy to the active electrode (power source required as in col. 15; 15-19 to provide for ablation energy to be provided to both 88 and the various 26; the Examiner notes that inasmuch that the electrodes of the endcap are described as “return electrodes”, such are only required to be in communication with the power source and the instant claim makes no mention as the type of energy delivered thereto nor specifically requires an energy path, for example, from the active electrode on the surgical device through tissue and through the plurality of return electrodes on the end cap).
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 18 is rejected under 35 U.S.C. 103 as being unpatentable over Altmann et al. (US Pat. No. 9,314,208 B1) as applied to claim 10 above, and further in view of Sommer et al. (US Pat. No. 6,978,178 B2).
Regarding claim 18, Altmann fails to specifically provide for a plurality of return electrodes are nonuniformly disposed around a circumference of the endcap. Sommer discloses a similar arrangement for the orientation of electrodes at the distal tip of a device. Sommer specifically contemplates for an even circumferential distribution of the electrodes, or for the plurality of electrodes to be non-uniformly distributed (See col. 6; 60 – col. 7; 13.) Therefore, it is the Examiner’s position that it would have been an obvious consideration to one of ordinary skill in the art at the time of filing to utilize a non-uniform circumferential distribution of the electrodes of 26D/R of Altmann in view of the teaching in Sommer. Sommer, like the instant disclosure, readily recognizes that either arrangement functions equally as well as one another to provide a conductive portion at the distal tip of the device, with the instant disclosure failing to provide for any criticality or unexpected results with switching between either arrangement.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Kordis et al. (US Pat. No. 5,636,634) as applied to claim 19, respectively, above, and further in view of Sommer et al. (US Pat. No. 6,978,178 B2).
Regarding claim 20, Kordis fails to specifically provide for a plurality of return electrodes are nonuniformly disposed around a circumference of the endcap. Sommer discloses a similar arrangement for the orientation of electrodes at the distal tip of a device. Sommer specifically contemplates for an even circumferential distribution of the electrodes, or for the plurality of electrodes to be non-uniformly distributed (See col. 6; 60 – col. 7; 13.) Therefore, it is the Examiner’s position that it would have been an obvious consideration to one of ordinary skill in the art at the time of filing to utilize a non-uniform circumferential distribution of the electrodes on the end cap 34 of Kordis in view of the teaching in Sommer. Sommer, like the instant disclosure, readily recognizes that either arrangement functions equally as well as one another to provide a conductive portion at the distal tip of the device, with the instant disclosure failing to provide for any criticality or unexpected results with switching between either arrangement.
Response to Arguments
Applicant's arguments filed December 29, 2025 have been fully considered but they are not persuasive.
Applicant argues on pages 7-8 of the Remarks with respect to the prior rejection of independent claims 1 and 9 under 35 U.S.C. 102(a)(1) as anticipated by Altmann.
Therein, Applicant contends that Altmann fails to provide for each and every limitation set forth in independent claim 1 including the added requirements with respect to the surgical device being disposed in one of the one or more working channels of the elongate tubular member such that “the surgical device can be advanced through the one of the one or more working channels to contact an inner wall of a body lumen at a plurality of positions while the working space expanding system is expanded”.
Applicant contends that on page 8 that “the electrodes of Altmann are not active and return as alleged by the Office but are instead different arrays for different mapping purposes.” Applicant further argues that “[n]othing within Altmann suggests or implies that the electrodes 26R and/or 26D are return electrode while the electrodes 240 are active electrodes.” Applicant also alleges that the cited section of Altmann (col. 9, lines 15-31) fails to suggest that “energy can be applied in concert” and that, rather, the energy in Altmann is required to be used independently of one another.
The Examiner must disagree.
As a preliminary matter, the Examiner notes that instant claim 1 presently recites the following relevant limitations:
a surgical device disposed within a one of the one or more first working channels of the elongate tubular body, the surgical device comprising an active electrode;
at least one return electrode disposed on an outer surface of the endcap;
a power source configured to deliver energy to the active electrode of the surgical device, and in electrical communication with the at least one return electrode.
While Applicant contends in the Remarks as noted above that the Altman fails to suggest “that energy can be applied in concern”, the Examiner notes that nothing in the language of claim 1 requires for the energy from the power source to be applied in concert as alleged. Claim 1, as drafted, requires the power source to be “configured to delivery energy to the active electrode of the surgical device”, and for the power source to be “in electrical communication with the at least one electrode”. The Examiner is of the position that claim 1 fails to set forth any structural or functional requirements that necessitates an interpretation of the energy to be applied to the active electrode and at least one return electrode in concert as alleged by Applicant. At most, the power source needs to be functionally capable of delivering energy to the active electrode. There is nothing in the claim that requires, for example, the power source to be configured to deliver energy through the active electrode and to the at least one return electrode. There is nothing that requires the energy to be delivered and/or received via the at least one return electrode. The at least one return electrode only needs to be in electrical communication with the power source.
Thus, the Examiner is of the position that the disclosure in col. 9, line 15-31 of “each of the ring electrodes 240 on the spines 27 and each of the microelectrodes 26 is electrically connected via the lead wires 212 and 40, respectively, to an appropriate mapping system and/or source of ablation energy”, does indeed support the power source to be functionally capable of delivering energy to the active electrode, as well as being in electrical communication with each of the at least one return electrodes. Further, the Examiner takes this cited portion of Altmann to support connection to an ablation source and not just a mapping source as alleged by Applicant.
The Examiner is further of the position that the specific naming conventions of “active electrode” and “return electrode” do not requires as narrow of an interpretation as appears to be desired by Applicant in the Remarks. There is nothing in independent claim 1 that requires an application of energy or an energy path that for the claimed energy through the at least one return electrode back to the power source, let alone for the application of energy to be in concert as argued. The Examiner does not find that the claim term of “return electrode” carries an inherent definition or interpretation in the claim that the energy from the power source is configured to be delivered, for example, to the active electrode through tissue and then be returned back to the power source through the at least one return electrode. It is well established that while the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). If Applicant desires such a narrower interpretation as argued for in the Remarks, language to such an effect should be added to the claim to affirmatively capture such subject matter.
The Examiner further notes that substantially the same rationale is equally applicable to the similar limitations in independent claim 10 including the power source being in electrical communication with the plurality of return electrode and the active electrode and the power source being configured to deliver energy to the active electrode.
Thus, it is for at least the reasoning set forth above that the Examiner maintains that the rejection of claims 1-17 under 35 U.S.C. 102(a)(1) as being anticipated by Altmann et al. (US Pat. No. 9,314,208 B1) remains tenable.
Applicant’s arguments with respect to claim 19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, Applicant’s amendments to claim 19 in the December 29, 2025 response has necessitated the newly proffered grounds of rejection set forth in the action above of claim 19 under 35 U.S.C. 102(a)(1) as anticipated by Kordis.
The Examiner notes, for the sake of completeness, that the Kordis reference is also considered to be particularly pertinent to the remaining pending claims 1-18. The difference between independent claims 1 and 10 and independent claim 19 being that necessitated the new grounds of rejection being that claim 19 requires additional features of the elongate tubular body that includes “an elongated insulated sheath configured to extend over at least a portion of an outer surface of the elongate tubular body” wherein the surgical device “can be advanced through the one of the one or more working channels to contact an inner wall of a body lumen at a plurality of positions while the working space expanding system is expanded”.
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