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
Claims 1, 11, and 42 are objected to because of the following informalities:
-Claim 1, line 1: please correct “Apparatus” to “An apparatus”
-Claim 11, line 2: please correct “the channel” to “the working channel”
-Claim 42, line 4: please correct “to” to “than”
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 30-31 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 30 recites the limitation "the anchoring location" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether Applicant intends to introduce an anchoring location in claim 30 or whether claim 24 (from which claim 30 depends) should depend from claim 19 which introduces an anchoring location. For examination purposes, the Examiner interprets “the anchoring location” in claim 30 as “an anchoring location of the wire”.
Claim 31 recites the limitation "the anchoring location" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether Applicant intends to introduce an anchoring location in claim 31 or whether claim 24 (from which claim 31 depends) should depend from claim 19 which introduces an anchoring location. For examination purposes, the Examiner interprets “the anchoring location” in claim 31 as “an anchoring location of the wire”.
Claim Rejections - 35 USC § 102
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.
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 1-4, 8, 11, 19, 24, 30-31, 38-44, and 55 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Snoke et al. (US 5,399,164 A).
Regarding claim 1, Snoke discloses an apparatus (see Figs. 1-4, 6, and 11) for facilitating a procedure on a subject (see col. 2 lines 25-32, col. 3 lines 36-52), the apparatus comprising:
an extracorporeal interface (housing 30) (see Fig. 1, col. 3 lines 36-52); and
a catheter (elongate tube 40 and control wires 51-52) that comprises:
a tube (elongate tube 40) comprising:
a proximal region (proximal portion 41), coupled to the extracorporeal interface (housing 30) (see Figs. 3-4, col. 3 lines 36-52, col. 4 lines 1-14);
an intermediate region (medial portion 42), distal from the proximal region (proximal portion 41), and dimensioned for advancement into the subject (see Figs. 3-4, col. 2 lines 25-32, col. 4 lines 1-14);
a steering region (distal portion 43), distal from the intermediate region (medial portion 42), and dimensioned for advancement into the subject (see Figs. 3-4, col. 2 lines 25-32, col. 3 lines 52-68, col. 4 lines 1-14, col. 5 lines 30-57); and
a bearing surface (surface of distal portion 43 around which control wire 51 loops) at the steering region (distal portion 43) (see Figs. 3-4 and 11, col. 4 lines 1-14, col. 5 lines 30-57); and
a wire (control wire 51) that:
extends, from the extracorporeal interface (housing 30), distally through the proximal region (proximal portion 41) and the intermediate region (medial portion 42) to the steering region (distal portion 43), the extracorporeal interface (housing 30) being configured to apply a force that tensions the wire (control wire 51) (see Figs. 1-4 and 11, col. 3 lines 52-68, col. 4 lines 1-14, col. 5 lines 30-57), and
within the steering region (distal portion 43), is arranged in a pulley arrangement (arrangement between control wheel 35, control wire 51, and distal portion 43) in which the wire (control wire 51) curves around the bearing surface (surface of distal portion 43 around which control wire 51 loops), the pulley arrangement (arrangement between control wheel 35, control wire 51, and distal portion 43) multiplying the force within the steering region (distal portion 43), compared to within the intermediate region (medial portion 42) (see Figs. 1-4 and 11, col. 3 lines 52-68, col. 4 lines 1-14, col. 5 lines 30-57; control wire 51 loops around a surface within distal portion 43 and an end of control wire 51 is fixed to distal portion 43 such that as control wheel 35 is engaged to apply tension to control wire 51, the force within the distal portion 43 would be multiplied to bend distal portion 43 more than medial portion 42).
Regarding claim 2, Stoke discloses the apparatus according to claim 1, wherein the wire (control wire 51):
has a terminus (end of control wire 51 which is fixed to distal portion 43) that is anchored to the tube (elongate tube 40) (see Fig. 11, col. 5 lines 30-57, an end of control wire 51 is looped through and then fixed to distal portion 43 such that the fixed end of control wire 51 is a terminus),
defines a first longitudinal segment (segment of control wire 51 extending from the housing 30 to the loop in Fig. 11) between the extracorporeal interface (housing 30) and the bearing surface (surface of distal portion 43 around which control wire 51 loops) (see Figs. 1 and 11, col. 3 lines 52-68, col. 5 lines 30-57), and
defines a second longitudinal segment (segment of control wire 51 extending from the loop in Fig. 11 to the end of control wire 51 which is fixed to distal portion 43) between the bearing surface (surface of distal portion 43 around which control wire 51 loops) and the terminus (end of control wire 51 which is fixed to distal portion 43) (see Fig. 11, col. 5 lines 30-57), and
wherein, within the steering region (distal portion 43), the first longitudinal segment (segment of control wire 51 extending from the housing 30 to the loop in Fig. 11) is substantially parallel with the second longitudinal segment (segment of control wire 51 extending from the loop in Fig. 11 to the end of control wire 51 which is fixed to distal portion 43) (see Fig. 11, the longitudinal segments of control wire 51 are shown to be parallel).
Regarding claim 3, Snoke discloses the apparatus according to claim 1, wherein the wire (control wire 51) extends proximally away from the bearing surface (surface of distal portion 43 around which control wire 51 loops) to a terminus (end of control wire 51 which is fixed to distal portion 43) of the wire (control wire 51) (see Fig. 11, col. 5 lines 30-57, an end of control wire 51 is looped through and then fixed to distal portion 43 such that the fixed end of control wire 51 is a terminus).
Regarding claim 4, Snoke discloses the apparatus according to claim 1, wherein the steering region (distal portion 43) is a distal region of the tube (elongate tube 40) (see Figs. 3-4, col. 4 lines 1-14).
Regarding claim 8, Snoke discloses the apparatus according to claim 1, wherein the tube (elongate tube 40) extends from the proximal region (proximal portion 41), along the intermediate region (medial portion 42), to the steering region (distal portion 43), to define a longitudinal axis (longitudinal axis of elongate tube 40) of the tube (elongate tube 40), and in response to application of the force to the wire (control wire 51), at the bearing surface (surface of distal portion 43 around which control wire 51 loops), the wire (control wire 51) slides around a transverse axis (transverse/perpendicular axis of loop of control wire 51, see Fig. 11) that is transverse to the longitudinal axis (longitudinal axis of elongate tube 40) (see Figs. 3-4 and 11, col. 3 lines 52-68, col. 4 lines 1-14, col. 5 lines 30-57).
Regarding claim 11, Snoke discloses the apparatus according to claim 1, wherein the tube (elongate tube 40) defines a working channel (either of working lumens 46-47) therethrough, and the wire (control wire 51) at least partially circumscribes the working channel (either of working lumens 46-47) at the bearing surface (surface of distal portion 43 around which control wire 51 loops) (see Figs. 6 and 11, col. 3 lines 46-52, col. 4 line 67-col. 5 line 10, control wire 51 at least partially surrounds the working lumens 46-47).
Regarding claim 19, Snoke discloses the apparatus according to claim 1, wherein the wire (control wire 51) has a terminus (end of control wire 51 which is fixed to distal portion 43) that is anchored to the tube (elongate tube 40) at an anchoring location within the steering region (distal portion 43) (see Fig. 11, col. 5 lines 30-57, an end of control wire 51 is looped through and then fixed to distal portion 43 such that the fixed end of control wire 51 is a terminus).
Regarding claim 24, Snoke discloses the apparatus according to claim 1, wherein:
the bearing surface (surface of distal portion 43 around which control wire 51 loops) is a first bearing surface (see Fig. 11),
the tube (elongate tube 40) comprises a second bearing surface (surface of distal portion 43 where end of control wire 51 is fixed) (see Fig. 11, col. 5 lines 30-57, an end of control wire 51 is looped through and then fixed to distal portion 43), and
the wire (control wire 51):
extends, from the first bearing surface (surface of distal portion 43 around which control wire 51 loops), proximally to the second bearing surface (surface of distal portion 43 where end of control wire 51 is fixed) (see Fig. 11, col. 5 lines 30-57),
is slidable over the second bearing surface (surface of distal portion 43 where end of control wire 51 is fixed) (see Fig. 11, col. 5 lines 30-57), and
curves around the second bearing surface (surface of distal portion 43 where end of control wire 51 is fixed) and distally away from the second bearing surface (surface of distal portion 43 where end of control wire 51 is fixed) (see Fig. 11, col. 5 lines 30-57).
Regarding claim 30, Snoke discloses the apparatus according to claim 24, wherein an anchoring location of the wire (control wire 51) is located closer to the first bearing surface (surface of distal portion 43 around which control wire 51 loops) than to the second bearing surface (surface of distal portion 43 where end of control wire 51 is fixed) (see Fig. 11, col. 5 lines 30-57, control wire 51 is anchored to the elongate tube 40 via the loop shown in Fig. 11 which can be considered an anchoring location).
Regarding claim 31, Snoke discloses the apparatus according to claim 24, wherein an anchoring location of the wire (control wire 51) is located closer to the second bearing surface (surface of distal portion 43 where end of control wire 51 is fixed) than to the first bearing surface (surface of distal portion 43 around which control wire 51 loops) (see Fig. 11, col. 5 lines 30-57, control wire 51 is anchored to the elongate tube 40 by fixing the end of control wire 51 to the distal portion 43 which can be considered an anchoring location).
Regarding claim 38, Snoke discloses the apparatus according to claim 1, wherein the wire (control wire 51) is a first wire, and the catheter (elongate tube 40 and control wires 51-52) further comprises a second wire (control wire 52) that extends from the extracorporeal interface (housing 30), distally through the proximal region (proximal portion 41) and the intermediate region (medial portion 42) to the steering region (distal portion 43) (see Figs. 2-4, 6, and 11, col. 3 lines 53-68, col. 4 lines 1-14, col. 4 line 67-col. 5 line 10, col. 5 lines 30-57).
Regarding claim 39, Snoke discloses the apparatus according to claim 38, wherein:
the first wire (control wire 51) is engaged with the tube (elongate tube 40) in a manner in which tensioning of the first wire (control wire 51) bends the steering region (distal portion 43) (see Figs. 3-4 and 11, col. 3 lines 53-58, col. 5 lines 30-57); and
the second wire (control wire 52) is engaged with the tube (elongate tube 40) in a manner in which tensioning of the second wire (control wire 52) straightens the steering region (distal portion 43) (see Figs. 3-4 and 11, col. 3 lines 53-58, col. 5 lines 30-57).
Regarding claim 40, Snoke discloses the apparatus according to claim 38, wherein, within the steering region (distal portion 43):
the catheter (elongate tube 40 and control wires 51-52) comprises a shaft (elongate tube 40 and control wires 51-52 form a shaft, see Figs. 1 and 3-4) within a circumferential wall (outer circumferential wall of elongate tube 40) defined by the tube (elongate tube 40) (see Figs. 1, 3-4, 6, and 11),
the first wire (control wire 51) is mounted medially with respect to the shaft (elongate tube 40 and control wires 51-52 form a shaft, see Figs. 1 and 3-4) (see Fig. 6, control wire 51 is mounted within the outer circumferential wall of the elongate tube 40 toward the longitudinal axis of the elongate tube which can be considered a medial mounting), and
the second wire (control wire 52) is mounted laterally with respect to the shaft (elongate tube 40 and control wires 51-52 form a shaft, see Figs. 1 and 3-4) (see Fig. 6, control wire 52 is mounted toward the side of the outer circumferential wall of the elongate tube 40 which can be considered a lateral mounting).
Regarding claim 41, Snoke discloses the apparatus according to claim 38, wherein:
the force that tensions the first wire (control wire 51) is a first force (see Figs. 3-4 and 11, col. 3 lines 53-68, col. 4 line 67-col. 5 line 10, col. 5 lines 30-57),
the pulley arrangement (arrangement between control wheel 35, control wire 51, and distal portion 43) is a first pulley arrangement (see Figs. 3-4 and 11, col. 3 lines 53-68, col. 4 line 67-col. 5 line 10, col. 5 lines 30-57),
the extracorporeal interface (housing 30) is configured to apply a second force that tensions the second wire (control wire 52) (see Figs. 3-4 and 11, col. 3 lines 53-68, col. 4 line 67-col. 5 line 10, col. 5 lines 30-57), and
the second wire (control wire 52) is arranged in a second pulley arrangement (arrangement between control wheel 35, control wire 52, and distal portion 43) within the steering region (distal portion 43), the second pulley arrangement (arrangement between control wheel 35, control wire 52, and distal portion 43) multiplying the second force within the steering region (distal portion 43), compared to within the intermediate region (medial portion 42) (see Figs. 3-4 and 11, col. 3 lines 53-68, col. 4 line 67-col. 5 line 10, col. 5 lines 30-57, control wire 52 loops around a surface within distal portion 43 and an end of control wire 52 is fixed to distal portion 43 such that as control wheel 35 is engaged to apply tension to control wire 52, the force within the distal portion 43 would be multiplied to bend distal portion 43 more than medial portion 42).
Regarding claim 42, Snoke discloses the apparatus according to claim 41, wherein:
the first pulley arrangement (arrangement between control wheel 35, control wire 51, and distal portion 43) multiplies the first force by a first factor (see Figs. 1-4 and 11, col. 3 lines 52-68, col. 4 lines 1-14, col. 5 lines 30-57; control wire 51 loops around a surface within distal portion 43 and an end of control wire 51 is fixed to distal portion 43 such that as control wheel 35 is engaged to apply tension to control wire 51, the force within the distal portion 43 would be multiplied to bend distal portion 43 more than medial portion 42), and
the second pulley arrangement (arrangement between control wheel 35, control wire 52, and distal portion 43) multiplies the second force by a second factor (see Figs. 3-4 and 11, col. 3 lines 53-68, col. 4 line 67-col. 5 line 10, col. 5 lines 30-57, control wire 52 loops around a surface within distal portion 43 and an end of control wire 52 is fixed to distal portion 43 such that as control wheel 35 is engaged to apply tension to control wire 52, the force within the distal portion 43 would be multiplied to bend distal portion 43 more than medial portion 42), the second factor being different to the first factor (see col. 3 lines 53-68, col. 5 lines 30-57, control wires 51-52 individually experience different tension forces).
Regarding claim 43, Snoke discloses the apparatus according to claim 1, wherein, within the steering region (distal portion 43), the catheter (elongate tube 40 and control wires 51-52) comprises a shaft (elongate tube 40 and control wires 51-52 form a shaft, see Figs. 1 and 3-4) within a circumferential wall (outer circumferential wall of elongate tube 40) defined by the tube (elongate tube 40) (see Figs. 1, 3-4, 6, and 11), the shaft (elongate tube 40 and control wires 51-52 form a shaft, see Figs. 1 and 3-4) being configured to facilitate steering of the steering region (distal portion 43) (see Figs. 1, 3-4, 6, and 11, col. 3 lines 53-68, col. 5 lines 30-57).
Regarding claim 44, Snoke discloses the apparatus according to claim 43, wherein the shaft (elongate tube 40 and control wires 51-52 form a shaft, see Figs. 1 and 3-4) is substantially tubular (see Figs. 1, 3-4, 6, and 11).
Regarding claim 55, Snoke discloses the apparatus according to claim 1, wherein the extracorporeal interface (housing 30) is configured to receive the proximal region (proximal portion 41) of the catheter (elongate tube 40 and control wires 51-52) in a manner that operatively couples the extracorporeal interface (housing 30) to the steering region (distal portion 43) via the wire (control wire 51) (see Figs. 1-4, 6, and 11, col. 3 line 36-col. 4 line 14).
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.
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Snoke et al. (US 5,399,164 A), as applied to claim 43 above, in view of Hallauer et al. (US 2023/0069698 A1).
Regarding claim 45, Snoke discloses the apparatus according to claim 43. However, Snoke fails to state wherein the shaft comprises a chain of vertebrae mutually coupled at one side of the shaft and disjoined at another side of the shaft.
Hallauer teaches an apparatus (see Figs. 1-3) wherein the shaft (tip deflection portion 6) comprises a chain of vertebrae (vertebrae 16) mutually coupled at one side (side shown in Fig. 3) of the shaft (tip deflection portion 6) and disjoined at another side (side shown in Fig. 2) of the shaft (tip deflection portion 6) (see Figs. 1-3, par. [0047]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Snoke to include wherein the shaft comprises a chain of vertebrae mutually coupled at one side of the shaft and disjoined at another side of the shaft, as taught by Hallauer, in order to function as an alternative mechanism to induce flexibility of the shaft which allows individual portions of the shaft to directly pivot relative to each other (see Hallauer par. [0047]).
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over Snoke et al. (US 5,399,164 A), as applied to claim 1 above, in view of Byrd (US 8,052,607 B2).
Regarding claim 50, Snoke discloses the apparatus according to claim 1. However, Snoke fails to state wherein the catheter comprises a rotatable bearing that provides the bearing surface.
Byrd teaches an apparatus (see Figs. 9-13) wherein the catheter (catheter assembly 10) comprises a rotatable bearing (pivot head assembly 50) that provides the bearing surface (surface which pivot cables 62+64 loop around) (see Figs. 9-13, col. 11 line 11-col. 12 line 14).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Snoke to include wherein the catheter comprises a rotatable bearing that provides the bearing surface, as taught by Byrd, in order to function as an alternative mechanism to induce steering of the shaft which allows the wire to control a pivotable distal head of the apparatus (see Byrd col. 11 line 11-col. 12 line 14).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
Prosecution Insights