DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The Amendments filed May 11, 2026 have been entered. Applicant’s amendments have overcome the claim objections and the 112(b) rejections previously set-forth in the Non-Final Office Action mailed on 12/10/2025. Currently claims 1 and 17 have been amended, claims 6-8, 12, 21-25 have been cancelled, claims 27-32 have been newly added, and claims 1-5, 9-11, 13-20, and 26-32 are pending in the application.
Claim Objections
Claim 1 is objected to because of the following informalities: the claim contains the following language “the second control member fixedly secured [0098 and 00101]”. Examiner suggests amending the claim to delete these paragraph numbers. For examination purposes, Examiner will not give these numbers any weight/meaning.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 31-32 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 31 recites the limitation "wherein the female member extends circumferentially on the outer surface of the inner shaft". The recitation renders the scope of the claim as indefinite because of its dependency to claim 29. Currently, claim 29 requires the female member to extends circumferentially on the inner surface of the outer shaft. Claim 31 recites that the female member to extends circumferentially on the outer surface of the inner shaft. The claim limitation of claim 31 contradicts what is previously required on claim 29, thereby rendering the claim as indefinite since it is unclear if the female member extends circumferentially on the inner surface of the outer shaft or if it extends circumferentially on the outer surface of the inner shaft. For examination purposes, Examiner will treat claim 31 as being dependent on claim 28 which states wherein the male member is disposed on an inner surface of the outer shaft, and the female member is disposed on an outer surface of the inner shaft.
Claim 32 recites the limitation "wherein the male member extends radially on the inner surface of the outer shaft". The recitation renders the scope of the claim as indefinite because of its dependency to claim 29. Currently, claim 29 requires the female member to extends circumferentially on the inner surface of the outer shaft. Claim 32 recites that the male member to extend radially on the inner surface of the outer shaft. The claim limitation of claim 32 contradicts what is previously required on claim 29, thereby rendering the claim as indefinite since it is unclear how both the female member and the male members can coexist on the inner surface of the outer shaft. For examination purposes, Examiner will treat claim 32 as being dependent on claim 28 which states wherein the male member is disposed on an inner surface of the outer shaft, and the female member is disposed on an outer surface of the inner shaft.
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.
Claims 1-5, 9-11, 13-19 are rejected under 35 U.S.C. 103 as being unpatentable over Rao (U.S. Application No. 20210085386 A1), in view of Paskar (U.S. Application No. 20140088684 A1), and further in view of MacAdam (U.S. Application No. 20090306549 A1).
Regarding independent claim 1, Rao discloses a catheter (100) comprises:
an elongated flexible catheter body (120) (pa. 0030 & Figs. 1-2B) defining a longitudinal axis (LA) and including an inner shaft (i.e., tubular member (126) of end effector 300) and an outer shaft (122) (pa. 0031-0032 & Fig. 4);
an end effector (300) affixed to a distal end (125) of the outer shaft (pa. 0032);
a first tensile member (162) extending along the longitudinal axis, the first tensile member including a distal end affixed to a distal portion of the inner shaft (pa. 0048, 0054 & Figs. 5A-6C);
a control handle (110) proximal of the catheter body and including a first control member (200) (pa. 0030) and a second control member (250) distal of the first control member (pa. 0039 & Fig. 3), the first control member configured to pivot at a joint (see central pivot point in Fig. 7A) about an axis generally perpendicular to the longitudinal axis (see Fig. 2A) (pa. 0049), a proximal end of the first tensile member affixed to the first control member at a first location (i.e., at lower cable recess 222 and lower plug opening 224) laterally offset from the joint such that the first tensile member deflects a distal portion of the inner shaft toward a first side of the control handle when the first control member pivots about the joint in a first direction (pa. 0049, 0058-0059 & Figs. 5C-6C), the second control member fixedly secured to a proximal end of the outer shaft (see Fig. 2A) and configured to translate on the inner shaft (the second control member being in close proximity to the inner shaft, thereby being able to translate on/along the inner shaft), relative thereto, in controlling translation of the outer shaft relative to the inner shaft (pa. 0039).
Examiner is interpreting the phrase “fixedly secured” as being directly or indirectly connected to. In this case, the second control member of Rao is located on the outer surface of the handle assembly/control handle (110), wherein at least a portion of the control handle is attached/connected to the proximal end of the outer shaft (see Fig. 2A). Therefore, the second control member fixedly secured, or at least indirectly connected to, a proximal end of the outer shaft.
However, Rao does not disclose controlling rotation about the longitudinal axis of the outer shaft relative to the inner shaft.
Paskar, in the same field of endeavor, teaches an ablation catheter system comprising an outer catheter shaft (19C) and an inner catheter shaft (13C), wherein the outer shaft can be manipulated rotationally relative to the inner shaft, via a thumb actuable lever (145C) (analogous to the second control member of Rao), in order to ablate or map a portion of the heart based upon the position of said catheter system in the heart (pa. 0125, 0133 & Fig. 8-C).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the rotational functionalities of the outer shaft taught by Paskar to the outer shaft of Rao in order to allow the outer shaft of Rao to additionally be configured to rotate relative to the inner shaft for the purpose of more efficiently ablating/mapping different portions of the heart (Paskar, pa. 0125).
However, the Rao/Paskar combination does not provide for the second control member to be configured for both rotation as well as translation on the inner shaft. Rao only discloses a second control member in the form of a slider that is operable to translate longitudinally, while Paskar only teaches a similar control member in form of a rotatable level. Neither control member is structurally capable of performing the dual motion functionally required in the claim language.
MacAdam, in the same field of endeavor, teaches a catheter (1) comprising a handle (3) further comprising an actuator (9) that controls the longitudinal and rotational movement of an ultrasound assembly (7). The actuator comprises a wheel (31) disposed on a cylindrical sleeve (33), wherein the wheel is configured to be slidable over and rotatable about members of the handle (pa. 0029 & Fig. 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the second control member of Rao with the wheel taught by MacAdam for the purpose of allowing the user to have both the rotational and axial control of the movement of the outer shaft relative to the inner shaft in order to more effectively provide treatment to the targeted area of the patient.
Regarding claim 2, Rao/Paskar/MacAdam combination discloses comprising a second tensile member (172) that extends along the longitudinal axis, with a distal end affixed to the distal portion of the inner shaft (Rao, pa. 0048, 0054 & Figs. 5A-6C), a proximal end of the second tensile member affixed to the first control member at a second location (i.e., at an upper cable recess 222 and upper plug opening 224) laterally offset from the joint and opposite to the first location such that the second tensile member deflects the distal portion of the inner shaft toward a second side of the control handle opposite to the first side when the first control member pivots about the joint in a second direction opposite to the first direction (Rao, pa. 0049, 0056-0057 & Figs. 5B-6B).
Regarding claim 3, Rao/Paskar/MacAdam combination discloses wherein deflection of the distal portion of the inner shaft urges deflection of a distal portion of the outer shaft (Rao, see Figs. 6B-6C).
Regarding claim 4, Rao discloses translational movement of the outer shaft relative to the inner shaft via the second control member (pa. 0039).
However, Rao does not disclose wherein the outer shaft is configured for rotation about the longitudinal axis relative to the inner shaft.
Paskar, in the same field of endeavor, teaches an ablation catheter system comprising an outer catheter shaft (19C) and an inner catheter shaft (13C), wherein the outer shaft can be manipulated rotationally relative to the inner shaft, via a thumb actuable lever (145C) (analogous to the second control member of Rao), in order to ablate or map a portion of the heart based upon the position of said catheter system in the heart (pa. 0125, 0133 & Fig. 8-C).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the rotational functionalities of the outer shaft taught by Paskar to the outer shaft of Rao in order to allow the outer shaft of Rao to additionally be configured to rotate relative to the inner shaft for the purpose of more efficiently ablating/mapping different portions of the heart (Paskar, pa. 0125).
Regarding claim 5, Rao/Paskar/MacAdam combination discloses wherein the outer shaft is configured for translation along the longitudinal axis relative to the inner shaft (Rao, pa. 0039).
Regarding claims 9-11, Rao/Paskar combination discloses the invention substantially as claimed in claim 1 discussed above.
However, they do not disclose the second control member comprising an indicator of a rotational or translational position of the outer shaft, wherein the indicator includes a tactile indicator or a visual indicator.
MacAdam, in the same field of endeavor, teaches the handle is configured to provide visual or sensory information to the user. For example, an indication of the degree of rotation of the actuator (9) is provided, which corresponds to the radial location of the ultrasound assembly. This indication may be visual (e.g., using numbers or other markers) or tactile (e.g., a varying degree of friction). Similarly, an indication of the degree of longitudinal extension of the actuator is provided, which corresponds to a longitudinal location of the ultrasound assembly (pa. 0030).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the second control member of Rao with the wheel taught by MacAdam, which includes the visual/sensory indicators of a rotational and translational position of a shaft assembly, for the purpose of allowing the user to have precise rotational and axial control of the movement of the outer shaft relative to the inner shaft in order to more effectively provide treatment to the targeted area of the patient.
Regarding claim 13, Rao/Paskar/MacAdam combination discloses wherein the inner shaft comprises an off-axis lumen (164) and the first tensile member extends through the off-axis lumen (Rao, pa. 0067 & Fig. 9).
Regarding claim 14, Rao/Paskar/MacAdam combination discloses wherein the inner shaft comprises at least first and second diametrically-opposing lumens (164, 174, respectively), and the first tensile member extends through the first diametrically-opposed lumen and the second tensile member extends through the second diametrically-opposed lumen (Rao, pa. 0067 & Fig. 9).
Regarding claim 15, Rao/Paskar/MacAdam combination discloses at least one of the first and second tensile members extends between at least a portion of the inner and outer shafts (Rao, pa. 0067 & Fig. 9).
Regarding claim 16, Rao/Paskar/MacAdam combination discloses the end effector includes a planar structure (i.e., in the non-expanded state, see Fig. 8A) configured to support an array of electrodes (310) (Rao, pa. 0040-0041).
Regarding claim 17, Rao/Paskar combination discloses the invention substantially as claimed in claim 1 discussed above.
However, they do not disclose wherein rotation of the second control member about the longitudinal axis of the outer shaft ranges between about 0 and 360 degrees.
MacAdam, in the same field of endeavor, teaches the catheter is able to be reconfigured between the arrangement seen in Figs. 4-5 by rotating the wheel counterclockwise/clockwise by an angle of greater than 360° (pa. 0032).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the second control member of Rao with the wheel taught by MacAdam, which includes the rotation about the longitudinal axis to be in range between about 0 and 360 degrees, for the purpose of allowing the user to have precise rotational and axial control of the movement of the outer shaft relative to the inner shaft in order to more effectively provide treatment to the targeted area of the patient.
Regarding claim 18, Rao/Paskar combination discloses the invention substantially as claimed in claim 1 discussed above.
However, they do not disclose wherein rotation about the longitudinal axis of the outer shaft relative to the inner shaft ranges between about 0 and 90 degrees.
MacAdam, in the same field of endeavor, teaches the catheter is able to be reconfigured between the arrangement seen in Figs. 4-5 by rotating the wheel counterclockwise/clockwise by an angle of greater than 360°, which rotates the ultrasound assembly by the same angle (pa. 0032).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the second control member of Rao with the wheel taught by MacAdam, which includes the rotation about the longitudinal axis to be in range between about 0 and 360 degrees which in turn allow for the rotation of the shaft to be at the same angle, for the purpose of allowing the user to have precise rotational and axial control of the movement of the outer shaft relative to the inner shaft in order to more effectively provide treatment to the targeted area of the patient.
Regarding claim 19, Rao/Paskar combination discloses translation along the longitudinal axis of the outer shaft relative to the inner shaft (pa. 0039).
However, they do not disclose further comprising stop members configured to limit translation along the longitudinal axis of the outer shaft and the inner shaft to a predetermined distance.
MacAdam, in the same field of endeavor, teaches the handle may further comprise interface features such as a locking mechanism in order to temporarily stop or lock the rotational and/or sliding movement of the actuator (pa. 0030).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the stop members taught by MacAdam to the control handle of Rao for the purpose of providing the user with more limited/controlled advancement of the outer shaft.
Claims 20, 27-32 are rejected under 35 U.S.C. 103 as being unpatentable over Rao, Paskar, and MacAdam as applied to claim 1 above, and further in view of Gianotti (U.S. Application No. 20180154110 A1).
Regarding claim 20, Rao/Paskar/MacAdam combination discloses the invention substantially as claimed in claims 1 and 19 discussed above.
However, they do not disclose wherein the stop members include a female member and a male member, the female member configured with proximal and distal stops defining a translating region therebetween with a predetermined length parallel with the longitudinal axis, the male member configured to move in the translating region between the proximal and distal stops relative to the female member.
Gianotti, in the same field of endeavor, teaches a catheter comprising an outer shaft (810), an inner shaft (808), and a plurality of locking mechanisms/stop members (802-806) configured to limit translation along the longitudinal axis of the outer shaft and the inner shaft to a predetermined distance (pa. 0031 & Fig. 8). The stop members include a female member (i.e., complementary circular, rounded well-like features found on the outer shaft, as well as the valleys/elongated low portions, between the circular, rib-like features found on the inner shaft) and a male member (i.e., circular, rib-like features found on the inner shaft, as well as the rectangular hills between the complementary circular, rounded well-like features found on the outer shaft), the female member configured with proximal (i.e., complementary round feature where member 806 fits into) and distal stops (i.e., complementary round feature where member 802 fits into) defining a translating region therebetween with a predetermined length parallel with the longitudinal axis, the male member configured to move in the translating region between the proximal and distal stops relative to the female member (pa. 0031 & Fig. 8).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the female and male stop members to the inner and outer shafts of Rao for the purpose of providing the user with more limited/controlled advancement of the outer shaft.
Regarding claim 27, Rao/Paskar/MacAdam combination discloses the invention substantially as claimed in claims 1 and 20 and discussed above.
However, they do not disclose wherein the female member is disposed on an inner surface of the outer shaft, and the male member is disposed on an outer surface of the inner shaft.
Gianotti, in the same field of endeavor, teaches wherein the female member (i.e., complementary circular, rounded well-like features found on the outer shaft) is disposed on an inner surface of the outer shaft, and the male member (i.e., circular, rib-like features found on the inner shaft) is disposed on an outer surface of the inner shaft (see Fig. 8).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the female and male stop members to the inner and outer shafts of Rao for the purpose of providing the user with more limited/controlled advancement of the outer shaft.
Regarding claim 28, Rao/Paskar/MacAdam combination discloses the invention substantially as claimed in claims 1 and 20 and discussed above.
However, they do not disclose wherein the male member is disposed on an inner surface of the outer shaft, and the female member is disposed on an outer surface of the inner shaft.
Gianotti, in the same field of endeavor, teaches wherein the male member (i.e. the rectangular hills between the complementary circular, rounded well-like features found on the outer shaft) is disposed on an inner surface of the outer shaft, and the female member (i.e., the valleys/elongated low portions, between the circular, rib-like features found on the inner shaft) is disposed on an outer surface of the inner shaft.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the female and male stop members to the inner and outer shafts of Rao for the purpose of providing the user with more limited/controlled advancement of the outer shaft.
Regarding claims 29-30, Rao/Paskar/MacAdam combination discloses the invention substantially as claimed in claims 1 and 27 and discussed above.
However, they do not disclose wherein the female member extends circumferentially on the inner surface of the outer shaft, and the male extends radially on the outer surface of the inner shaft.
Gianotti, in the same field of endeavor, teaches wherein the female member extends circumferentially on the inner surface of the outer shaft, and the male extends radially on the outer surface of the inner shaft (see Fig. 8).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the female and male stop members to the inner and outer shafts of Rao for the purpose of providing the user with more limited/controlled advancement of the outer shaft.
Regarding claims 31-32, Rao/Paskar/MacAdam combination discloses the invention substantially as claimed in claims 1 and 29 and discussed above.
However, they do not disclose wherein the female member extends circumferentially on the outer surface of the inner shaft, and the male member extends radially on the inner surface of the outer shaft.
Gianotti, in the same field of endeavor, teaches wherein the female member extends circumferentially on the outer surface of the inner shaft, and the male member extends radially on the inner surface of the outer shaft (see Fig. 8).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the female and male stop members to the inner and outer shafts of Rao for the purpose of providing the user with more limited/controlled advancement of the outer shaft.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Rao, Paskar, and MacAdam as applied to claims 1 and 19 above, and further in view of Westlund (U.S. Application No. 20030105451 A1).
Regarding claim 26, Rao/Paskar/MacAdam combination discloses translation along the longitudinal axis of the outer shaft relative to the inner shaft (Rao, pa. 0039).
However, they do not disclose wherein the predetermined distance ranges between about 0 and 1.0”.
Westlund, in the same field of endeavor, teaches catheter comprising an inner shaft (101) and an outer shaft (102) able to travel in the longitudinal direction relative to each other, wherein the predetermined travel distance is about 5” (pa. 0037).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the travel distance of the longitudinal translation of the outer shaft of Roe to be between about 0 and 1.0”, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Response to Arguments
Applicant's arguments filed 05/11/2026 have been fully considered but they are not persuasive.
With regards to newly amended independent claim 1, Applicant argues that the Rao reference does not disclose the claim limitation of the second control member fixedly secured to a proximal end of the outer shaft. However, Examiner, respectfully, disagrees.
As stated in the rejection above, Examiner is interpreting the phrase “fixedly secured”, within its broadest reasonable interpretation, to mean being directly or indirectly connected to. In this case, the second control member of Rao is located on the outer surface of the handle assembly/control handle (110), wherein at least a portion of the control handle is attached/connected to the proximal end of the outer shaft (see Fig. 2A). The Examiner has failed to find any special definition or other requirement in the disclosure that would require a narrower interpretation of the term “fixedly secured” than that proffered by the Examiner above. As such, the Examiner readily maintains that the actuator (250) of Rao is indeed “fixedly secured” to the proximal end of the outer shaft as required in claim 1 in view of above-noted broadest reasonable of the “fixedly secured” limitation. If Applicant desires a narrower interpretation of this terminology, Applicant is respectfully invited to submit further limitations that further define the manner in which the second control member and the proximal end of the outer shaft are fixedly secured to one another to define on the combined arrangement of Rao, Paskar and MacAdams. Hence, for the reasonings set-forth above the rejection is maintained.
With regards to newly amended independent claim 1, Applicant argues that neither the Rao nor the Paskar reference teach a control member that is able to both rotate and translate on the shaft. Examiner finds this to be persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, the following new grounds of rejection have been set forth in the action above:
Claims 1-5, 9-11, 13-19 are rejected under 35 U.S.C. 103 as being unpatentable over Rao (U.S. Application No. 20210085386 A1), in view of Paskar (U.S. Application No. 20140088684 A1), and further in view of MacAdam (U.S. Application No. 20090306549 A1).
Claims 20, 27-32 are rejected under 35 U.S.C. 103 as being unpatentable over Rao, Paskar, and MacAdam as applied to claim 1 above, and further in view of Gianotti (U.S. Application No. 20180154110 A1).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Rao, Paskar, and MacAdam as applied to claims 1 and 19 above, and further in view of Westlund (U.S. Application No. 20030105451 A1).
It is the Examiner’s position that the newly filed rejections based on the combination of references are tenable for at least the reasoning set forth in the action 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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/A.V.G./Examiner, Art Unit 3794 /Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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