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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/12/2026 has been entered.
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.
Claims 1, 3, 6 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Scheibe et al. (US 20070260223 A1) in view of Herlinger et al. (WO 2019108187 A1) in further view Snoke et al. (US 20140200402 A1).
Regarding claim 1, Scheibe discloses a steerable catheter or sheath (sheath assembly 100, Fig 1) for medical procedures ([0031]) comprising: a shaft (deflectable body 120, Fig 1) with a proximal end (portion 124, Fig 1) and a distal end (portion 126, Fig 1); one or more pull wires (pullwire 130, Fig 3) connected to said distal end (126) of said shaft (120) ([0017]); a handle (handle assembly 140, Fig 6) with a proximal end (1400, Annotated Fig 1) and a distal end (1300, Annotated Fig 1), connected at said distal end (1300, Annotated Fig 1) of said handle (140) to said proximal end (124) of said shaft (120) ([0019]) comprising: a hub (flush port assembly or luer fitting 196, Fig 1) at said proximal end (1400, Annotated Fig 1) of said handle (140) for connection to a hemostatic valve (hemostasis valve 193, Fig 1); said hemostatic valve (193); and a cap (Cap 147, Fig 1) at a proximal end (1400, Annotated Fig 1) of said handle (140); one or more skiving holes (1100, Annotated Fig 3) located at said proximal end (124) of said shaft (120) for permitting said one or more pull wires (130) to pass therethrough (Fig 2); a containment box (sliding member 146, Fig 2) located around said shaft (120) and encapsulating said one or more skiving holes (1100, Annotated Fig 3); and steering mechanism (rotating knob 142, Fig 1) located closer to said proximal end (1400, Annotated Fig 1) of said handle (140) than said distal end (1300, Annotated Fig 1) of said handle (140), said steering mechanism (142) connected to said one or more pull wires (130), and wherein manipulating said steering mechanism (142) causes tension to be applied to or diminished from one or more of said one or more pull wires (130) for steering said shaft (120) ([0035]).
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Scheibe is silent regarding the cap being transparent; wherein at least a portion of said handle located between said steering mechanism and said cap at said proximal end of said
Herlinger teaches a catheter (endovascular apparatus 10, Fig 1) comprising a handle (operator handle 12, Fig 1) a transparent cap (2000, Annotated Fig 2; [0028]: handle 12 housing, including proximal cap wall is transparent) at a proximal end (2001, Annotated Fig 2) of said handle (12); wherein at least a portion of said handle (12) located between a steering mechanism (Pivot mechanism 32; Fig 1) and said cap (2000, Annotated Fig 2) at said proximal end (2001, Annotated Fig 2) of said(12) is transparent for enabling viewing of air ingress into said steerable catheter or sheath ([0028]; housing 26 of handle 12 is transparent allowing the user to see inside of the handle).
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Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the handle assembly of device of Scheibe to be transparent and include a transparent portion between the cap and the steering mechanism as taught by Herlinger for the purpose of showing the interior of the handle which facilitates visual inspection ([0028]).
Scheibe/Herlinger are silent wherein the containment box is transparent and is configured to prevent air entry through said one or more skiving holes.
Snoke teaches a steerable catheter or sheath (medical introducer 20, Fig 2) comprising a transparent containment box (modular manifold 271, Fig 28-29; [0078]) configured to prevent air entry through said one or more skiving ([0150])
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Scheibe/Herlinger to make the containment box transparent and incorporate airtight sealing elements as taught by Snoke for the purpose of identifying gaseous material and preventing its entry into the shaft ([0078]; [0150])
Regarding Claim 3 Scheibe /Herlinger/Snoke disclose the catheter or sheath as defined in claim 1. Scheibe discloses wherein said handle (140) comprises a cavity (1000, Annotated Fig 3) for receiving a merging portion (1200, Annotated Fig 3) of said shaft (120) at said proximal end (124; portion of shaft 120 inside handle 140) of said shaft (120), and wherein one or more skiving holes (1100, Annotated Fig 3) are present in said merging portion (1200, Annotated Fig 3), said one or more pull wires (130) each transitioning from said shaft (120) to said handle (140) by passing through one of said one or more skiving holes respectively (1100, Annotated Fig 3), wherein said handle (140) further comprises a containment box (sliding member 146, Fig 2) for encapsulating a portion (1500, Annotated Fig 3) of each of said one or more pull wires (130) when exiting said shaft (120) and passing into said handle (140).
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Regarding Claim 6 Scheibe /Herlinger/Snoke disclose the catheter or sheath as defined in claim 3. Scheibe discloses wherein said containment box (146) comprises, for each of said one or more pull wires (130), a channel extension (1600, Channel through which the encapsulated portion of the pull wire 130 is located, Annotated Fig 3) for receiving within a channel of said channel extension (1600) said each of said one or more pull wires (130).
Regarding Claim 17, Scheibe /Herlinger/Snoke discloses the catheter or sheath as defined in claim 1, wherein said at least a portion of said handle located between said steering mechanism and said cap that is transparent (modified portion of handle 140 of Scheibe; as modified in claim 1) encapsulates said hemostatic valve (Fig 2, [0020]: hemostasis valve 193 is encapsulated by handle assembly 140, specifically cap 147 and modified portion of handle, located between the steering mechanism 142 and the cap 147 as modified in claim 1).
Regarding Claim 18, Scheibe/Herlinger/Snoke the steerable catheter or sheath as defined in claim 1. Scheibe discloses the containment box has a clam-shell configuration for clamping onto the proximal end of the shaft.
Snoke teaches wherein the containment box (modular manifold 271, Fig 28) has a clam-shell configuration (Fig 29) for clamping onto the proximal end of the shaft (introducer tube 23, Fig 30).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Scheibe/Herlinger/Snoke with similar clamping configuration as taught by Snoke for the purpose of being modular and interchangeable ([0131; 0138]).
Claims 2 is rejected under 35 U.S.C. 103 as being unpatentable over Scheibe et al. (US 20070260223 A1) in view of Herlinger et al. (WO 2019108187 A1) in further view Snoke et al. (US 20140200402 A1) in view of Werneth et al. (US 20160346517 A1).
Regarding Claim 2, Scheibe /Herlinger/Snoke disclose the catheter or sheath as defined in claim 1. However, Scheibe is silent wherein said shaft is made from a transparent polymer.
Werneth teaches a sheath for medical procedures (patient access device 100, Fig 1A) comprising:a shaft (a hollow shaft 102, Fig 1A). Werneth further teaches wherein said shaft (102) is made from a transparent polymer ([0077]: “shaft 102 can include a rigid or semi-rigid transparent material. In other embodiments, one or more portions of shaft 102 can comprise a transparent compliant material”; ([0013]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the shaft material of device of Scheibe/Herlinger/Snoke with a similar transparent polymer material as taught by Werneth to visualize the air bubbles in the shaft ([0032])
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Scheibe et al. (US 20070260223 A1) in view of Herlinger et al. (WO 2019108187 A1) in further view of Snoke et al. (US 20140200402 A1) in view of Ramanathan (US 20180256848 A1).
Regarding claim 4, Scheibe/Herlinger/Snoke disclose the catheter or sheath as defined in claim 3. However, Scheibe is silent regarding wherein said containment box has a clam-shell configuration for clamping onto said merging portion of said shaft, wherein two halves of said clam-shell configuration of the containment box are sealed using one of a thermal process and a chemical process.
Ramanathan teaches a steerable catheter or sheath (embodiment of catheter system 101, Fig 4) for medical procedures ([0023]: “time saving medical device for use in medical procedures”) comprising: a shaft (inner tubular member 203; [0065]) a handle (control handle mechanism housing 406 and circular control ring 413 , Fig 4), wherein said handle comprises: a housing ( outer shell of 406 and 413); a containment box (control handle mechanism housing 406) has a clam-shell configuration (Fig 4) for clamping onto said merging portion of said shaft (flexible slider tube 405+ outer tubular member 103), wherein two halves ([0066]: “The control handle mechanism housing 406 is made in two halves, which when assembled are joined using adhesive or fasteners” ) of said clam-shell configuration of the containment box (406) are sealed using one of a thermal process and a chemical process. ([0066]: “The control handle mechanism housing 406 is made in two halves, which when assembled are joined using adhesive or fasteners”; adhesive bonding is a chemical process)
Therefore, it would have been obvious for one of ordinary skill in the art before the effective
filing date of the claim invention to modify the containment box of device of Scheibe/Herlinger/Snoke to have a clam-shell configuration sealed through adhesive bond as taught by Ramanathan to provide a leak free seal ([0065]: “An adhesive bond with an adhesive fillet 411 provides a leak-free seal between the flexible slider tube 405 and the proximal segment 410 of the outer tubular member 103 after assembly.”)
Regarding claim 5, Scheibe/Herlinger/Snoke disclose the catheter or sheath as defined in claim 3. Scheibe discloses the presence of skiving holes (1100, Annotated Fig 3). Scheibe is silent wherein said containment box further comprises o-rings for sealing around each of said one or more skiving holes to prevent air entry through said one or more skiving holes.
Ramanathan teaches a steerable catheter or sheath (embodiment of catheter system 101, Fig 4) for medical procedures ([0023]: “time saving medical device for use in medical procedures”) comprising: a shaft (inner tubular member 203; [0065]) a handle (control handle mechanism housing 406 and circular control ring 413, Fig 4), wherein said handle comprises: a housing (outer shell of 406 and 413); a containment box (406) further comprises o-rings ([0090]: “A sealing means, such as O-rings, is used to ensure the telescoping handle mechanism is also sealed.”) to prevent air entry ([0090]; “The distal most tip of the telescoping handle is attached to the proximal end of the catheter inner tubular member 203. The attachment provides for a sealed lumen preventing a leak path for air to enter into the body. A sealing means, such as O-rings, is used to ensure the telescoping handle mechanism is also sealed.”
Therefore, it would have been obvious for one of ordinary skill in the art before the effective
filing date of the claim invention to modify skiving holes of device of Scheibe/Herlinger/Snoke with similar o-rings as taught by Ramanathan to seal the containment box of Scheibe and prevent a leak path of air through openings like skiving holes. O-rings, and their sealing function is well known in the art ([0090]; “The distal most tip of the telescoping handle is attached to the proximal end of the catheter inner tubular member 203. The attachment provides for a sealed lumen preventing a leak path for air to enter into the body. A sealing means, such as O-rings, is used to ensure the telescoping handle mechanism is also sealed.”).
Claims 7 is rejected under 35 U.S.C. 103 as being unpatentable over Scheibe et al. (US 20070260223 A1) in view of Herlinger et al. (WO 2019108187 A1) in further view of Snoke et al. (US 20140200402 A1) in view of Knudson et al. (US 20060084964 A1)
Regarding Claim 7, Scheibe/Herlinger/Snoke disclose the catheter or sheath as defined in claim 6. Scheibe is silent wherein each channel extension comprises a groove for receiving an O-ring for further sealing a pull wire located within said channel of said channel extension.
Knudson teaches a steerable catheter or sheath ([0044], Fig 1) comprising a containment box (bottom actuator panel 56, top actuator panel 58 and pivot actuator 18, Fig 1-2) for each of one or more pull wires (first steering cable 38, a second steering cable 40, Fig 2), a channel extension (first slave cylinder 24 and slave cylinder 26, Fig 2) for receiving within a channel (channel inside first slave cylinder 24 and slave cylinder 26, Fig 2) of said channel extension (24, 26) said each of said one or more pull wires (38, 40); wherein each channel extension (24, 26) comprises a groove for receiving an O-ring for further sealing a pull wire located within said channel of said channel extension ([0048]: “Each of the apertures in the distal ends of each of the first and second slave cylinders 24, 26 is provided with a sealing member, for example, an O-ring, that seals around each of the first steering cable 38 and second steering cable 40, respectively, to insure that none of the fluid within the first and second slave cylinders 24, 26 leaks through the apertures.”; the presence of a groove or cavity in the apertures of the slave cylinders 24 and 26 is an inherent feature needed to position and constrain the O-ring in place.)
Therefore, it would have been obvious for one of ordinary skill in the art before the effective
filing date of the claim invention to modify the containment box of device of Scheibe/Herlinger/Snoke with similar O-rings and their respective grooves as taught by Knudson to seal around the pull wires inside the containment box ([0048]: “Each of the apertures in the distal ends of each of the first and second slave cylinders 24, 26 is provided with a sealing member, for example, an O-ring, that seals around each of the first steering cable 38 and second steering cable 40, respectively, to insure that none of the fluid within the first and second slave cylinders 24, 26 leaks through the apertures.”
Claims 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Scheibe et al. (US 20070260223 A1) in view of Herlinger et al. (WO 2019108187 A1) in further view of Snoke et al. (US 20140200402 A1) in view of Rothe et al. (US 20100004633 A1).
Regarding Claim 8, Scheibe/Herlinger/Snoke disclose the catheter or sheath as defined in claim 1. Scheibe is silent regarding a transparent portion of said catheter or sheath.
Herlinger teaches a catheter (endovascular apparatus 10, Fig 1) comprising a handle (operator handle 12, Fig 1) a transparent cap (2000, Annotated Fig 2; [0028]: handle 12 housing, including proximal cap wall is transparent) at a proximal end (2001, Annotated Fig 2) of said handle (12); wherein at least a portion of said handle (12) located between a steering mechanism (Pivot mechanism 32; Fig 1) and said cap (2000, Annotated Fig 2) at said proximal end (2001, Annotated Fig 2) of said(12) is transparent for enabling viewing of air ingress into said steerable catheter or sheath ([0028]; housing 26 of handle 12 is transparent allowing the user to see inside of the handle).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the handle assembly of device of Scheibe to be transparent and include a transparent portion between the cap and the steering mechanism as taught by Herlinger for the purpose of showing the interior of the handle which facilitates visual inspection ([0028]).
However, Scheibe/Herlinger/Snoke are silent regarding a system for preventing air ingress when performing a medical procedure comprising: an air detection sub-system positionable in proximity of said transparent portion of said catheter or sheath for detecting air ingress in said catheter or sheath, wherein said detection is performed using video picture analysis or optical coherence tomography.
Rothe teaches a system for preventing air ingress when performing a medical procedure ([0107]) comprising: an air detection sub-system (processing unit 418, Fig 31; in proximity to proximal end of catheter 52) for detecting air ingress in a catheter or sheath (Fig 31)([0107]; [0108]: “Processing unit 418 may also be electrically coupled to handle 52 and may also be able to process, display and store several data, including total amount of saline used for the entire procedure, power and duration of ablation, impedance of tissue in contact with hood, rate of flow of saline, temperature of saline, and time of detection of air bubbles during the procedure.”), wherein said detection is performed using video picture analysis or optical coherence tomography. ([0109]: “an imaging sensor 430 which may also incorporate a light source, e.g., LEDs, and power supply, may additionally be integrated directly into handle 52. A video cable may be connected to the proximal end of the handle 52 and can be directly plugged into any standard video display monitors (such as ones accepting S-Video, DVI, VGA, RCA inputs), rather than utilizing a separate video processing unit.”)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the proximal end of device of Scheibe/Herlinger/Snoke with a similar video picture air detection sub-system as the one taught by Rothe to detect air bubble and alert the operator ([0110]).
Regarding Claim 10, Scheibe/Herlinger/Snoke/Rothe discloses the system as defined in claim 8. Scheibe is silent wherein said air detection sub-system further comprises an alert system for alerting the user when air ingress is detected.
Rothe teaches an air detection sub-system (processing unit 418, Fig 31) further comprising an alert system for alerting the user when air ingress is detected ([0110]: “As processing unit 418 may incorporate processors for detecting various physiological parameters, one or more detection indicators 432, e.g., for bubble detection, (…). If air bubbles are detected in the irrigation channel, the detection indicator 432 may be activated to alert the operator of air bubbles. A soft alarm may also be triggered to further alert the operator.)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Scheibe/Herlinger/Snoke/Rothe with a similar an alarm as taught by Rothe for the purpose of alerting the user if there is presence of air bubbles ([0110]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Scheibe et al. (US 20070260223 A1) in view of Herlinger et al. (WO 2019108187 A1) in further view of Snoke et al. (US 20140200402 A1) in view of Rothe et al. (US 20100004633 A1) in further view of Von (WO 2018044450 A1).
Regarding Claim 9 Scheibe/Herlinger/Snoke/Rothe disclose the system as defined in claim 8. Scheibe is silent regarding further comprising: a carbon dioxide blanketing apparatus for flooding said handle of said catheter or sheath with carbon dioxide upon said air detection sub-system detecting air ingress in said handle of said catheter or sheath
Rothe discloses an air detection sub-system (processing unit 418, Fig 31) further comprises an alert system for alerting the user when air ingress is detected in a handle (handle 52, Fig 31) of a catheter (Fig 31) ([0110]: “As processing unit 418 may incorporate processors for detecting various physiological parameters, one or more detection indicators 432, e.g., for bubble detection, (…). If air bubbles are detected in the irrigation channel, the detection indicator 432 may be activated to alert the operator of air bubbles. A soft alarm may also be triggered to further alert the operator.)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Scheibe/Herlinger/Snoke/Rothe with a similar an alarm as taught by Rothe for the purpose of alerting the user if there is presence of air bubbles ([0110]).
However, Scheibe/Herlinger/Snoke/Rothe are silent regarding further comprising: a carbon dioxide blanketing apparatus for flooding said handle of said catheter or sheath with carbon dioxide upon said air detection sub-system detecting air ingress in said handle of said catheter or sheath.
Von teaches a system for preventing air ingress (delivery system 100, Fig 1; [0009]) comprising a handle (handle assembly 102, Fig 1) and a shaft (delivery member 104) ; a carbon dioxide blanketing apparatus (flushing fluid or gas delivery device 180, Fig 1; [0033]: “a flushing fluid or gas delivery device 180, such as a C02MMA DER or other device or system that provides a source of a flushing fluid or gas (e.g., C0.sub.2)”) for flooding said handle (102) of said catheter or sheath (steering catheter, Fig 1 [0012]) with carbon dioxide ([0032]–[0033]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective
filing date of the claim invention to incorporate a similar carbon dioxide blanketing apparatus as the one taught by Von to collaborate with the detection system disclosed by Scheibe/Herlinger/Snoke/Rothe in order to flush the system with CO2 to guarantee that the system will be filled with the inert gas and any air emboli can be eliminated ([0023]).
Response to Arguments
Applicant’s arguments with respect to claims 1-13, 15-18 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00.
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/Primary Examiner, Art Unit 3783
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