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 .
Claim Objections
Claim 21 is objected to because of the following informalities: the claim should be dependent on claim 20. Claims 22-25 are also objected because they are dependent on claim 21. Appropriate correction is required.
Claim 24 is objected to because of the following informalities: extra “and”. Appropriate correction is required.
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 1-26 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 1 recites the limitation "its distal end" in line 5. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether this distal end is different from the distal end of the end effector as previously cited in claim 1, or if they are the same structure. For examination purposes, Examiner will treat the “its distal end” as the distal end of the first tensile member. Claims 2-26 are also rejectedbecause they are dependent on claim 1.
Claim 17 recites the limitation "the rotation" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "the rotation" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites the following limitations: "one of the female and male members" in line 1, “one of the inner surface of the outer shaft and the outer surface of the inner shaft” in lines 2-3, "the other of female and male members" in line 3, and “the other of the inner surface of the outer shaft and the outer surface of the inner shaft” in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. Claims 22-25 are also rejected because they are dependent on claim 21.
Claim Rejections - 35 USC § 102
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5, 7, 9-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rao (U.S. Application No. 20210085386 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, with its distal end affixed to a distal portion of the inner shaft (pa. 0048, 0054 & Figs. 5A-6C); and
a control handle (110) proximal of the catheter body and including a first control member (200) (pa. 0030) that is 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).
Regarding claim 2, Rao 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 (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 (pa. 0049, 0056-0057 & Figs. 5B-6B).
Regarding claim 3, Rao discloses wherein deflection of the distal portion of the inner shaft urges deflection of a distal portion of the outer shaft (See Figs. 6B-6C).
Regarding claim 5, Rao discloses wherein the outer shaft is configured for translation along the longitudinal axis relative to the inner shaft (via manipulation of actuator 250) (pa. 0039).
Regarding claim 7, Rao discloses further comprising an additional control member (250) affixed to the outer shaft and configured to control translation along the longitudinal axis relative to the inner shaft (pa. 0039).
Regarding claim 9, Rao discloses further comprising an indicator (i.e., an exposed/external rectangular portion of actuator 250) of a rotational or translational position of the outer shaft (pa. 0039).
Regarding claim 10, Rao discloses wherein the indicator includes a tactile indicator (pa. 0039).
Regarding claim 11, Rao discloses wherein the indicator includes a visual indicator (pa. 0039 & Figs. 2A-2B)
Regarding claim 12, Rao discloses wherein the additional control member is distal of the first control member (see Fig. 2A).
Regarding claim 13, Rao discloses wherein the inner shaft comprises an off-axis lumen (164) and the first tensile member extends through the off-axis lumen (pa. 0067 & Fig. 9).
Regarding claim 14, Rao 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 (pa- 0067 & Fig. 9).
Regarding claim 15, Rao discloses at least one of the first and second tensile members extends between at least a portion of the inner and outer shafts (pa- 0067 & Fig. 9).
Regarding claim 16, Rao 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) (pa. 0040-0041).
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 4, 6, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Rao as applied to claim 1 above, and further in view of Paskar (U.S. Application No. 20140088684 A1).
Regarding claim 4, Rao discloses movement of the outer shaft relative to the inner shaft via control member (250) (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 translationally and/or rotationally relative to the inner shaft in order to ablate or map a portion of the heart based upon the position of said catheter system in the heart (pa. 0125, 0131, 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 modified the additional control member of Rao to allow the outer shaft to rotate relative to the inner shaft, as taught by Paskar, in order to more efficiently ablate or map a portion of the heart based upon the position of said catheter system (Paskar, pa. 0125).
Regarding claim 6, Rao discloses movement of the outer shaft relative to the inner shaft (pa. 0039).
However, Rao does not disclose further comprising an additional control member affixed to the outer shaft and configured to control rotation about the longitudinal axis of the outer shaft relative to the inner shaft.
Paskar, in the same field of endeavor, teaches an additional control member (145C) (analogous to the additional control member of Rao) affixed to the outer shaft and configured to control rotation about the longitudinal axis of the outer shaft relative to the inner shaft (0131, 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 modified the additional control member of Rao to allow the outer shaft to rotate relative to the inner shaft, as taught by Paskar, in order to more efficiently ablate or map a portion of the heart based upon the position of said catheter system (Paskar, pa. 0125).
Regarding claim 8, Rao discloses an additional control member (250) affixed to the outer shaft and configured to control translation of the outer shaft relative to the inner shaft (pa. 0039).
However, Rao does not disclose the control member being able to control the rotation about the longitudinal axis of the outer shaft.
Paskar, in the same field of endeavor, teaches an additional control member (145C) (analogous to the additional control member of Rao) affixed to the outer shaft and configured to control rotation about the longitudinal axis of the outer shaft relative to the inner shaft (0131, 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 modified the additional control member of Rao to allow the outer shaft to rotate relative to the inner shaft, as taught by Paskar, in order to more efficiently ablate or map a portion of the heart based upon the position of said catheter system (Paskar, pa. 0125).
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Rao as applied to claim 1 above, and further in view of Wang (E.P. Application No. 2887900 B1).
Regarding claim 17, Rao discloses the invention substantially as claimed in claim 1 discussed above.
However, Rao does not disclose wherein the rotation about the longitudinal axis of the outer shaft ranges between about 0 and 360 degrees.
Wang, in the same field of endeavor, teaches a catheter device system for mapping and ablating tissue, comprising a handle with a control knob (18), an outer shaft (11), and an inner shaft (12), wherein the outer shaft is manipulated to rotate by a given angle up to 360° to ensure there is no blind spot when electrical stimulation is delivered (pa. 0027 & Fig. 1-4).
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 modified the additional control member of Rao to allow rotation of any given angle up to 360°, as taught by Wang, to ensure there is no blind spot when electrical stimulation is delivered to the tissue (Wang, pa. 0027 & Fig. 1-4).
Regarding claim 18, Rao discloses the invention substantially as claimed in claim 1 discussed above.
However, Rao does not disclose wherein the rotation about the longitudinal axis of the outer shaft relative to the inner shaft ranges between about 0 and 90 degrees.
Wang, in the same field of endeavor, teaches a catheter device system for mapping and ablating tissue, comprising a handle with a control knob (18), an outer shaft (11), and an inner shaft (12), wherein the outer shaft is manipulated to rotate by a given angle up to 360° to ensure there is no blind spot when electrical stimulation is delivered (pa. 0027 & Fig. 1-4).
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 modified the additional control member of Rao to allow rotation of any given angle from 0-90°, as taught by Wang, to ensure there is no blind spot when electrical stimulation is delivered to the tissue (Wang, pa. 0027 & Fig. 1-4).
Claims 19-25 are rejected under 35 U.S.C. 103 as being unpatentable over Rao as applied to claim 1 above, and further in view of Gianotti (U.S. Application No. 20180154110 A1).
Regarding claim 19, Rao discloses translation along the longitudinal axis of the outer shaft relative to the inner shaft (pa. 0039).
However, Rao does 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.
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 and their complementary circular, rounded well-like features) configured to limit translation along the longitudinal axis of the outer shaft and the inner shaft to a predetermined distance (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 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 20, Rao discloses translation along the longitudinal axis of the outer shaft relative to the inner shaft (pa. 0039).
However, Rao does 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 stop members that include a female member (i.e., complementary circular, rounded well-like features) and a male member (802-806), 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 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 21, as best understood, Rao discloses the invention substantially as claimed in claims 1 and 19 and discussed above.
However, Rao does not disclose wherein one of the female and male members is disposed on one of the inner surface of the outer shaft and the outer surface of the inner shaft, and the other of female and male members is disposed on the other of the inner surface of the outer shaft and the outer surface of the inner shaft.
Gianotti, in the same field of endeavor, teaches wherein one of the female and male members (i.e., the top 802-806 members and their complementary circular, rounded well-like features) is disposed on one of the inner surface of the outer shaft and the outer surface of the inner shaft (see Fig. 8), and the other of female and male members (i.e., the bottom 802-806 members and their complementary circular, rounded well-like features) is disposed on the other of the inner surface of the outer shaft and 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 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 22, Rao discloses the invention substantially as claimed in claims 1 and 22 and discussed above.
However, Rao does not disclose wherein at least one of the female and male members extends circumferentially on one of the inner surface of the outer shaft and the outer surface of the inner shaft.
Gianotti, in the same field of endeavor, teaches wherein at least one of the female and male members extends circumferentially on one of the inner surface of the outer shaft and the outer surface of the inner shaft (see Fig. 8).
Regarding claim 23, Rao discloses the invention substantially as claimed in claims 1 and 22 and discussed above.
However, Rao does not disclose wherein the other of the female and male members extends from the other of the inner surface of the outer shaft and the outer surface of the inner shaft.
Gianotti, in the same field of endeavor, teaches wherein the other of the female and male members extends from the other of the inner surface of the outer shaft and the outer surface of the inner shaft (see Fig. 8).
Regarding claim 24, Rao discloses the invention substantially as claimed in claims 1 and 22 and discussed above.
However, Rao does not disclose wherein the other of the female and male members extends circumferentially on the other of the inner surface of the other shaft and the other surface of the inner shaft.
Gianotti, in the same field of endeavor, teaches wherein the other of the female and male members extends circumferentially on the other of the inner surface of the other shaft and the other surface of the inner shaft (see Fig. 8).
Regarding claim 25, Rao discloses the invention substantially as claimed in claims 1 and 22 and discussed above.
However, Rao does not disclose wherein the other of the female and male members is configured as a body with a radial dimension.
Gianotti, in the same field of endeavor, teaches wherein the other of the female and male members is configured as a body with a radial dimension (see Fig. 8).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Rao and Gianotti as applied to claims and 19 above, and further in view of Westlund (U.S. Application No. 20030105451 A1).
Regarding claim 26, Rao/Gianotti 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.
Conclusion
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/A.V.G./Examiner, Art Unit 3794 /Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794