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 17 is objected to because of the following informalities:
Claim 17, Line 2 recites “a biostimulator transport sytem” however this limitation should read “a biostimulator transport system” in order to correct a typographical error.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 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(s) 1-5, 7, 9-13, 15, and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Khairkhahan (US PGPub 2012/0165827) in view of Schmidt (US PGPub 2015/0051615) and Osypka (US PGPub 2015/0057655).
Regarding Claim 1 and 9, Khairkhahan teaches a biostimulator delivery system (Figures 1-2), comprising:
a docking cap (204; Figure 2A);
a catheter shaft (206) coupled to the docking cap (204) and having a deflectable catheter section (Paragraph 0053 discloses steering and deflecting a distal portion of the catheter with the docking cap);
a tether/snare (203; Figure 2A-2B) extending through the catheter shaft (206; Paragraph 0045-0047); and
a handle (108; Figure 1)(408; Figure 4; Paragraph 0053) including a housing coupled to the catheter shaft (206; Figure 1-2A)(Figure 4), a hub (412) disposed in the housing (408)
Khairkhahan is silent on the limitation:
a pull wire coupled to the deflectable catheter section
a hub disposed in the housing and coupled to the pull wire
Schmidt teaches a biostimulator delivery system (Figure 1) comprising a docking cap (146; Figure 3), a catheter shaft (24a; Figure 3) coupled to the docking cap (146) and having a deflectable section (245; Figure 3; Paragraph 0053), a handle (200) comprising a housing (254) and a hub (258 but also see 256 in Figures 4-5) disposed in the housing, wherein Schmidt teaches
A pull wire coupled to the deflectable catheter section (Paragraph 0056)
A hub (258; Figures 3-4) disposed in the housing and coupled to the pull wire (Paragraph 0056-0058).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention modify system of Khairkhahan to include a pull wire and hub, as presently claimed, for the advantage of controlling the amount of deflection in the catheter to appropriately place the biostimulator.
Therefore, it is the Examiner' s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute the deflection mechanism taught by Khairkhahan with the deflection mechanism as taught by Schmidt since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; In this case, the deflection mechanism of Schmidt would be sufficient to deflect the distal end of the catheter of Khairkhahan.
The combination further fails to disclose:
a brake assembly rotatable between a first brake position and a second brake position to resist rotation of the hub relative to the housing, wherein the brake assembly applies a greater resistance to rotation of the hub in the second brake position than in the first brake position.
Osypka teaches a steerable catheter, with a similar deflection mechanism as taught by Schmidt, comprising a catheter shaft (112; Figure 1A) with a deflectable distal end portion (114; Figure 1A), a pull wire (steering cables 134,136; Figure 1M, 1N1, and Paragraph 0068), a handle (116), a hub (120) disposed in the housing of the handle (Figure 2B), the hub coupled to the pull wire (134; see Figure 2F), wherein Osypka further teaches:
a brake assembly (121; Figure 2A, 2G and 2H) rotatable between a first brake position and a second brake position to resist rotation of the hub (120) relative to the housing (Paragraph 0093-0095), wherein the brake assembly (121) applies a greater resistance to rotation of the hub in the second brake position than in the first brake position (Paragraph 0095-0096 and Paragraph 0098).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination of references above, to include the brake assembly teachings of Osypka, for the advantage of being able to lock the catheter in different deflection configurations but also to allow for modifying the sensitivity of the actuating mechanism using the locking mechanism (Paragraph 0098; Osypka).
Regarding Claim 2 and 10, the combination of references disclosed above teaches the biostimulator delivery system of claim 1, and 9 wherein Osypka teaches the hub (120) includes an arced wall over which the pull wire (134, 136) is wrapped (Paragraph 0090; Figures 2B-2F).
Regarding Claim 3 and 11, the combination of references disclosed above teaches the biostimulator delivery system of claim 1 and 9, wherein Osypka teaches the brake assembly includes a hub washer (123; Figure 2B-2C) disposed within the housing (Figure 2B-2C) and rotationally fixed relative to the hub (120) (Paragraph 0091-0092).
Regarding Claim 4 and 12, the combination of references disclosed above teaches the biostimulator delivery system of claim 3 and 11, wherein Osypka the brake assembly includes a threaded shaft (attachment member, screw; Paragraph 0094) coupled to a knob (121) and extending through the hub washer (123) such that rotation of the knob (121) causes translation of the knob (121) along the threaded shaft (screw) to compress the housing (Paragraph 0094) between the knob (121) and the hub washer (123; Paragraph 0094).
Regarding Claim 5 and 13, the combination of references disclosed above teaches the biostimulator delivery system of claim 4 and 12, wherein Osypka teaches the knob (121) is coupled to the threaded shaft by a threaded insert disposed within the knob (121; Paragraph 0093; Figures 2G and 2G, element 121d is for receiving a screw to attach the friction lock member 123 to locking tab 121).
Regarding Claim 7 and 15, the combination of references disclosed above teaches the biostimulator delivery system of claim 1 and 9, wherein Osypka teaches the handle (116) includes a deflection lever (124/146; Figure 1B) coupled to the hub (120) to rotate the hub (120) and deflect the deflectable catheter section (114; Paragraph 0089 and Paragraph 0099), and wherein the brake assembly includes a brake lever (121) extending from the housing (116) opposite the deflection lever (124; Figure 1B and Figure 2A).
Regarding Claim 17, Khairkhahan teaches a biostimulator delivery system (Figures 1-2), comprising:
a biostimulator transport system (100; Figure 1)(2; Figure 2A) including
a docking cap (204; Figure 2A);
a catheter shaft (206) coupled to the docking cap (204) and having a deflectable catheter section (Paragraph 0053 discloses steering and deflecting a distal portion of the catheter with the docking cap);
a handle (108; Figure 1)(408; Figure 4; Paragraph 0053) including a housing coupled to the catheter shaft (206; Figure 1-2A)(Figure 4), a hub (412) disposed in the housing (408)
a biostimulator (102; Figure 1)(202; Figure 2A) having an attachment feature (220; Figure 2B) to be received by the docking cap (204; Figure 2A)
Khairkhahan is silent on the limitation regarding the transport system comprising:
a pull wire coupled to the deflectable catheter section
a hub disposed in the housing and coupled to the pull wire
Schmidt teaches a biostimulator delivery system (Figure 1) comprising a docking cap (146; Figure 3), a catheter shaft (24a; Figure 3) coupled to the docking cap (146) and having a deflectable section (245; Figure 3; Paragraph 0053), a handle (200) comprising a housing (254) and a hub (258 but also see 256 in Figures 4-5) disposed in the housing, wherein Schmidt teaches
A pull wire coupled to the deflectable catheter section (Paragraph 0056)
A hub (258; Figures 3-4) disposed in the housing and coupled to the pull wire (Paragraph 0056-0058).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention modify system of Khairkhahan to include a pull wire and hub, as presently claimed, for the advantage of controlling the amount of deflection in the catheter to appropriately place the biostimulator.
Therefore, it is the Examiner' s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute the deflection mechanism taught by Khairkhahan with the deflection mechanism as taught by Schmidt since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; In this case, the deflection mechanism of Schmidt would be sufficient to deflect the distal end of the catheter of Khairkhahan.
The combination further fails to disclose:
a brake assembly rotatable between a first brake position and a second brake position to resist rotation of the hub relative to the housing, wherein the brake assembly applies a greater resistance to rotation of the hub in the second brake position than in the first brake position.
Osypka teaches a steerable catheter, with a similar deflection mechanism as taught by Schmidt, comprising a catheter shaft (112; Figure 1A) with a deflectable distal end portion (114; Figure 1A), a pull wire (steering cables 134,136; Figure 1M, 1N1, and Paragraph 0068), a handle (116), a hub (120) disposed in the housing of the handle (Figure 2B), the hub coupled to the pull wire (134; see Figure 2F), wherein Osypka further teaches:
a brake assembly (121; Figure 2A, 2G and 2H) rotatable between a first brake position and a second brake position to resist rotation of the hub (120) relative to the housing (Paragraph 0093-0095), wherein the brake assembly (121) applies a greater resistance to rotation of the hub in the second brake position than in the first brake position (Paragraph 0095-0096 and Paragraph 0098).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination of references above, to include the brake assembly teachings of Osypka, for the advantage of being able to lock the catheter in different deflection configurations but also to allow for modifying the sensitivity of the actuating mechanism using the locking mechanism (Paragraph 0098; Osypka).
Regarding Claim 18, the combination of references disclosed above teaches the biostimulator delivery system of claim 17, wherein Osypka teaches the hub (120) includes an arced wall over which the pull wire (134, 136) is wrapped (Paragraph 0090; Figures 2B-2F).
Regarding Claim 19, the combination of references disclosed above teaches the biostimulator delivery system of claim 17, wherein Osypka teaches the handle (116) includes a deflection lever (124/146; Figure 1B) coupled to the hub (120) to rotate the hub (120) and deflect the deflectable catheter section (114; Paragraph 0089 and Paragraph 0099), and wherein the brake assembly includes a brake lever (121) extending from the housing (116) opposite the deflection lever (124; Figure 1B and Figure 2A).
Allowable Subject Matter
Claim 6, 8, 14, 16 and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The prior art of record fails to disclose:
Claim 6, the biostimulator delivery system of claim 4, wherein the brake assembly includes a brake washer disposed between the knob and the housing.
Claim 8, the biostimulator delivery system of claim 1, wherein the handle further includes a first handle portion including a first counter-rotation feature having a protrusion, and a second handle portion including a second counter-rotation feature including a plurality of offset lobes, wherein the second handle portion is movable from a first position in which the plurality of offset lobes are not aligned with the protrusion to a second position in which the plurality of offset lobes are aligned with the protrusion.
Claim 14, the biostimulator retrieval system of claim 12, wherein the brake assembly includes a brake washer disposed between the knob and the housing.
Claim 16, the biostimulator retrieval system of claim 9, wherein the handle further includes a first handle portion including a first counter-rotation feature having a protrusion, and a second handle portion including a second counter-rotation feature including a plurality of offset lobes, wherein the second handle portion is movable from a first position in which the plurality of offset lobes are not aligned with the protrusion to a second position in which the plurality of offset lobes are aligned with the protrusion.
Claim 20, the biostimulator system of claim 17, wherein the handle further includes a first handle portion including a first counter-rotation feature having a protrusion, and a second handle portion including a second counter-rotation feature including a plurality of offset lobes, wherein the second handle portion is movable from a first position in which the plurality of offset lobes are not aligned with the protrusion to a second position in which the plurality of offset lobes are aligned with the protrusion.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMED G GABR/Primary Examiner, Art Unit 3771
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