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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/27/2026 has been entered.
Response to Amendment
Claims 1, 4, 5, 36, 39, and 40 have been amended. Claims 1-10, 36-45, and 47-48 remain pending.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-10, 36-45, and 47-48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Falb et al. (US 20160271368, henceforth Falb, previously made of record) in view of Agrawal et al. (US 20180126143, henceforth Agrawal, previously made of record) and Dodson et al. (US 20160166822, henceforth Dodson).
Regarding claim 1, Falb discloses a robotic catheter system (assembly of fig. 10) which includes hemostasis valves (Y-connector 233, fig. 2 and [0054]) used for prevention of blood bleedback in interventional procedures ([0085]-[0087]) which are configured to be used during operation of the robotic catheter system ([0054] and [0055]) and comprising a coupler (terminal end 254, fig. 10) at a distal end of an elongated medical device support track ([0065], end 254 distally terminates flexible track 216) where the coupler is configured to directly couple to other elements (see fig. 10, end 254 couples to sheath clip 256). Falb additionally discloses that a guide catheter is configured to proceed distally from the medical device support track ([0076]).
Falb does not disclose a hemostasis valve with an outer member, the outer member being rotatable during operation of the robotic catheter system, and a non-rotating portion. Agrawal teaches a hemostasis valve (hemostasis valve 10, fig. 2) with an outer member (plunger 16, fig. 2) which is rotatable (see [0063]) and a non-rotating portion (side port 18, main body portion 14, and adaptor 12, fig. 2, are non-rotating relative to the longitudinal device of valve 10 when plunger 16 is rotated), where the outer member is rotatable when the non-rotating portion is engaged (see [0063], “The user may then apply a radially applied gripping force to rotate the plunger 16 and the lock nut 38 to further distally advance the plunger 16 and the lock nut 38. When the plunger 16 and the lock nut 38 are in the desired longitudinal position, the threaded engagement of the lock nut 38 and the proximal portion 20 of the main body portion 14 may be sufficient to lock the main body portion 14 in a distally advanced configuration”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the hemostasis valve of Agrawal to the distal end of the medical device support track of Falb distal to the sheath clip for allowing the guide catheter of Falb to pass through a valve to allow for additional interventional devices to be inserted (see Agrawal [0059]-[0061]) and to have provided an ability to flush or infuse contrast through a point distal to the medical device support track such as by using a powered high pressure contrast injector which might not be compatible with the guide catheter holding assembly of Falb (see Agrawal [0059] and [0061] and see Falb fig. 4).
Falb as modified does not disclose an adaptor system for the robotic catheter system as claimed. Dodson teaches an adaptor system (system of fig. 21), the adaptor system comprising: an adaptor (device 70 shown in fig. 21) including a body (body portions 90 and 92, fig. 21, make up the claimed body) defining an opening (space extending between flanges 30 and 82, fig. 21) configured to encompass an outer member (see fig. 21, the opening encompasses an outer member of Y-port feeding adapter 2 where the outer member is the connection of tubes), a distal end connector (the distal most end surface of flange 30, fig. 21) configured to engage a non-rotating portion (see fig. 21, flange 30 engages with outlet conduit 6 and outlet tube 16 which are not rotating portions of adapter 2), and a proximal end connector (the proximal most end surface flange 82’, fig. 21) configured to directly couple with a coupler (see figs. 19 and 21, flange 82’ of fig. 21 is configured to directly couple and come into contact with inlet port 9, which is a coupler, of inlet conduit 8) at a distal end of a medical tube (see figs. 18 and 21, inlet port 9 is at the distal end of conduit 8), wherein the body extends between the distal end connector and the proximal end connector (see fig. 21, the body extends longitudinally between the flanges) and the outer member is not prevented from rotation within the opening when the distal end connector is engaged with the non-rotating portion of the hemostasis valve and the proximal end connector is coupled with the coupler (see fig. 21 and see not relied on exemplary fig. 10; the inserted Y-port feeding adapter 2 is partially rotatable when inserted into the device 70 up until the point at which the Y-branch portions of adapter 2 interfere with the body of the device 70; since no structures are present to prevent rotation, the Y-port adapter is rotatable as claimed). Dodson additionally discloses that its adapter is provided with adjustable lengths to provide a variety of different kinds of medical tubes with separation prevention (see [0103] and [0105]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the adaptor system of Dodson to the robotic catheter system of Falb as modified to have provided the robotic catheter system of Falb with the added hemostasis valve of Agrawal with the prevention of disconnection between components which are locked together (see Dodson [0007] and [0008]) and to have done so with an adjustable length assembly such as to allow for various devices to be inserted or not (Dodson [0103]).
Thus, in the modified system, the adaptor system of Dodson would be used with the robotic system of Falb and the hemostasis valve of Agrawal such that the hemostasis valve of Agrawal is added to the distal end of the coupler of Falb and the adaptor of Dodson extends longitudinally such that it is attached onto the distal most end of the hemostasis valve and the support track of Falb to prevent unintentional disconnection of elements relative to each other. In this modified system, the adaptor of Falb would be configured to allow rotation of the hemostasis valve rotatable portion (plunger 16) such as to allow for closing and opening of the hemostasis valve around the guide catheter of Falb extending through the hemostasis valve and adaptor. Thus, the hemostasis valve of Agrawal would be arranged within the adaptor of Dodson similarly to the Y-port shown in Dodson fig. 21.
{Subsequent references are to Dodson unless otherwise stated.}
Regarding claim 2, Falb as modified discloses the adaptor system of claim 1 wherein the adaptor has a longitudinal axis that is co-axial with a longitudinal axis of the hemostasis valve (see annotated fig. 21; the provided dashed axis is the longitudinal axis of the hemostasis valve in the modified system, and the solid line with bracket ends is the longitudinal axis of the device, with the axes being coaxial).
PNG
media_image1.png
467
799
media_image1.png
Greyscale
Annotated fig. 21 from Dodson relied upon for the rejection of claims
Regarding claim 3, Falb as modified discloses the adaptor system of claim 1 wherein the opening in the body is defined by a first leg and a second leg (see exemplary fig. 18 which is not relied upon; flanges 82 and 30 are each composed of a pair of legs which extend along a curve about the longitudinal axis and extend along the longitudinal axis) extending intermediate the distal end connector and the proximal end connector (see fig. 18; since the connectors are considered to be the end most surfaces of the respective flanges, the legs of flange 82 are considered to extend intermediate to the connectors).
Regarding claim 4, Falb as modified discloses the adaptor system of claim 1 wherein the hemostasis valve is a y-connector hemostasis valve (see Agrawal fig. 2, valve 10 is a Y-connector hemostasis valve) and the distal end connector is configured to be removably connected to the non-rotating portion of the y-connector hemostasis valve (see Dodson fig. 21, the elements are removably connected as the flanges can be connected about the hemostasis valve in the modified system).
Regarding claim 10, Falb as modified discloses the adaptor system of claim 4 further including a catheter (see Falb guide catheter 228, fig. 2) configured to extend through the y-connector hemostasis valve (see Falb [0054], [0062], and [0076], guide catheter 228 is configured to extend from the distal end of the support track 216 into the patient, and in the modified system, this includes the catheter going through the added hemostasis valve of Agrawal; Agrawal teaches that this is possible in [0003] and [0061] where it discusses that interventional instruments such as catheters are meant to be used with and inserted through the valve assembly), wherein the distal end connector is configured to be removably connected to the y-connector hemostasis valve while the catheter is configured to extend through the y-connector hemostasis valve (in the modified system, the distal end connector of Dodson can be removed from the tubes which it connects while other devices are or are not inserted through them; the flanges of device 70 can be separated by the elements which they prevent disconnection from by pivoting the longitudinal axes relative to each other; see claim 6).
Regarding claim 5, Falb as modified discloses the adaptor system of claim 4 wherein the distal end connector includes a first leg and a second leg (see exemplary fig. 18 which is not relied upon; flanges 82 and 30 are each composed of a pair of legs which extend along a curve about the longitudinal axis and extend along the longitudinal axis) configured to flexibly spread apart to receive the non-rotating portion of the y-connector hemostasis valve between the first leg and the second leg (see at least [0088] and [0090]; the flanges are flexible such as to allow the tubes to be held between them) to connect the distal end connector to the non-rotating portion of the y-connector hemostasis valve with a snap fit (in the modified device, the structures would be connected with a snap fit as the flexing of the flanges around the tube to hold it in position would be considered a snap fit; while [0090] discloses that a snap fit is not necessary for strong connection, the flexing of the flanges around the tubing shows that it is the default).
Regarding claim 6, Falb as modified discloses the adaptor system of claim 5 wherein the y- connector hemostasis valve is configured to be removed from the distal end connector by pivoting a longitudinal axis of the adaptor relative to a longitudinal axis of the y- connector hemostasis valve in a non-colinear direction (see annotated fig. 21; the upwardly angled dashed line is pivoted relative to the original longitudinal axis of the hemostasis valve such that the axes are non-colinear; this is how the structures are meant to be separated as it requires that the device of Dodson is removed from the snap fit of the flanges).
Regarding claim 7, Falb as modified discloses the adaptor system of claim 5 wherein the adaptor is configured to be radially connected to the non-rotating portion of the y-connector hemostasis valve in a direction perpendicular to a longitudinal axis of the y-connector hemostasis valve (see annotated fig. 21; the provided arrows shows a direction which the device of Dodson could be applied to the hemostasis valve in the modified system; since the direction of the arrows is at 90 degrees at, or perpendicular to, the provided longitudinal axis of the hemostasis valve, the device is configured as claimed).
Regarding claim 8, Falb as modified discloses the adaptor system of claim 5 wherein a valve of the y-connector hemostasis valve (see Agrawal valve assembly 44, fig. 2) is configured to be opened by moving the outer member in a linear direction with respect to a body of the y-connector hemostasis valve within the opening of the body of the adaptor (see Agrawal [0063]; this distal advancement could happen within the opening of the device in the modified system as the device is shaped to not interfere with plunger 16).
Regarding claim 9, Falb as modified discloses the adaptor system of claim 1 wherein the elongated medical device support track includes a flexible tube (see Falb flexible track 216, fig. 1) having a slit (see Falb slit 286, fig. 10) extending substantially an entire length of the flexible tube (see Falb [0062]).
Regarding claim 47, Falb as modified discloses the adaptor system of claim 1 further comprising: the coupler disposed at the distal end of the elongated medical device support track (see Falb fig. 10); and the hemostasis valve disposed between the coupler and a first catheter (in the modified system, the hemostasis valve of Agrawal is disposed at the distalmost end of sheath clip 256; if flexible tube 216 of Falb was bent when the device was assembled such that distal end 254 was pointed towards guide catheter 228, fig. 5, such as at Y-connector base 238, then the hemostasis valve would be disposed as claimed).
Regarding claim 36, Falb discloses a robotic catheter-based system (assembly of fig. 10) having a robotic drive (robotic drive base 220, fig. 1), which includes hemostasis valves (Y-connector 233, fig. 2 and [0054]) used for prevention of blood bleedback in interventional procedures ([0085]-[0087]) which are configured to be used during operation of the robotic catheter system ([0054] and [0055]) and comprising a coupler (terminal end 254, fig. 10) at a first, distal end of an elongated medical device support track ([0065], end 254 distally terminates flexible track 216) where the coupler is configured to directly couple to other elements (see fig. 10, end 254 couples to sheath clip 256), the elongated medical device support track extending from the robotic drive (see figs. 1 and 10) and being configured to receive a first catheter (see figs. 5 and 16, the claimed first catheter is guide catheter 228). Falb additionally discloses that a guide catheter is configured to proceed distally from the medical device support track ([0076]).
Falb does not disclose a hemostasis valve with an outer member, the outer member being rotatable during operation of the robotic catheter system, and a non-rotating portion. Agrawal teaches a hemostasis valve (hemostasis valve 10, fig. 2) with an outer member (plunger 16, fig. 2) which is rotatable around a longitudinal axis of the hemostasis valve (see [0063] and see figs. 2 and 7, plunger 16 rotates about a longitudinal axis extending along lumen 52) and a non-rotating portion (side port 18, main body portion 14, and adaptor 12, fig. 2, are non-rotating relative to the longitudinal device of valve 10 when plunger 16 is rotated), where the outer member is rotatable when the non-rotating portion is engaged (see [0063], “The user may then apply a radially applied gripping force to rotate the plunger 16 and the lock nut 38 to further distally advance the plunger 16 and the lock nut 38. When the plunger 16 and the lock nut 38 are in the desired longitudinal position, the threaded engagement of the lock nut 38 and the proximal portion 20 of the main body portion 14 may be sufficient to lock the main body portion 14 in a distally advanced configuration”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the hemostasis valve of Agrawal to the distal end of the medical device support track of Falb distal to the sheath clip for allowing the guide catheter of Falb to pass through a valve to allow for additional interventional devices to be inserted (see Agrawal [0059]-[0061]) and to have provided an ability to flush or infuse contrast through a point distal to the medical device support track such as by using a powered high pressure contrast injector which might not be compatible with the guide catheter holding assembly of Falb (see Agrawal [0059] and [0061] and see Falb fig. 4).
Falb as modified does not disclose an adaptor system for the robotic catheter system as claimed. Dodson teaches an adaptor system (system of fig. 21), the adaptor system comprising: an adaptor (device 70 shown in fig. 21) including a body (body portions 90 and 92, fig. 21, make up the claimed body) defining an opening (space extending between flanges 30 and 82, fig. 21) configured to encompass an outer member (see fig. 21, the opening encompasses an outer member of Y-port feeding adapter 2 where the outer member is the connection of tubes), a distal end connector (the distal most end surface of flange 30, fig. 21) configured to engage a non-rotating portion (see fig. 21, flange 30 engages with outlet conduit 6 and outlet tube 16 which are not rotating portions of adapter 2), and a proximal end connector (the proximal most end surface flange 82’, fig. 21) configured to directly couple with a coupler (see figs. 19 and 21, flange 82’ of fig. 21 is configured to directly couple and come into contact with inlet port 9, which is a coupler, of inlet conduit 8) at a distal end of a medical tube (see figs. 18 and 21, inlet port 9 is at the distal end of conduit 8), wherein the body extends between the distal end connector and the proximal end connector (see fig. 21, the body extends longitudinally between the flanges) and the outer member is not prevented from rotation within the opening when the distal end connector is engaged with the non-rotating portion of the hemostasis valve and the proximal end connector is coupled with the coupler (see fig. 21 and see not relied on exemplary fig. 10; the inserted Y-port feeding adapter 2 is partially rotatable when inserted into the device 70 up until the point at which the Y-branch portions of adapter 2 interfere with the body of the device 70; since no structures are present to prevent rotation, the Y-port adapter is rotatable as claimed). Dodson additionally discloses that its adapter is provided with adjustable lengths to provide a variety of different kinds of medical tubes with separation prevention (see [0103] and [0105]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the adaptor system of Dodson to the robotic catheter system of Falb as modified to have provided the robotic catheter system of Falb with the added hemostasis valve of Agrawal with the prevention of disconnection between components which are locked together (see Dodson [0007] and [0008]) and to have done so with an adjustable length assembly such as to allow for various devices to be inserted or not (Dodson [0103]).
Thus, in the modified system, the adaptor system of Dodson would be used with the robotic system of Falb and the hemostasis valve of Agrawal such that the hemostasis valve of Agrawal is added to the distal end of the coupler of Falb and the adaptor of Dodson extends longitudinally such that it is attached onto the distal most end of the hemostasis valve and the support track of Falb to prevent unintentional disconnection of elements relative to each other. In this modified system, the adaptor of Falb would be configured to allow rotation of the hemostasis valve rotatable portion (plunger 16) such as to allow for closing and opening of the hemostasis valve around the guide catheter of Falb extending through the hemostasis valve and adaptor. Thus, the hemostasis valve of Agrawal would be arranged within the adaptor of Dodson similarly to the Y-port shown in Dodson fig. 21.
{Subsequent references are to Dodson unless otherwise stated.}
Regarding claim 37, Falb as modified discloses the adaptor system of claim 36 wherein the adaptor comprises: a body (body portions 90 and 92, fig. 21, make up the claimed body) defining an opening (space extending between flanges 30 and 82, fig. 21) configured to receive the outer member of the hemostasis valve (see fig. 21, the opening is shaped such that the hemostasis valve of Agrawal in the modified system could be placed into it, and thus it is configured as claimed).
Regarding claim 38, Falb as modified discloses the adaptor system of claim 37 wherein the adaptor comprises: a first connector (the distal most end surface of flange 30, fig. 21) at a first end of the body (the distal end of the body, see fig. 21), the first connector configured to engage a portion of the hemostasis valve to connect the adaptor to the hemostasis valve (see fig. 21, flange 30 and the distal most end surface thereof engages with outlet conduit 6 and outlet tube 16 which are not rotating portions of adapter 2; in the modified system, flange 30 would be engaging with the distal end portion of the hemostasis valve of Agrawal).
Regarding claim 39, Falb as modified discloses the adaptor system of claim 38 wherein the hemostasis valve is a y-connector hemostasis valve (see Agrawal fig. 2) and the first connector is configured to be removably connected to the non-rotating portion of the y-connector hemostasis valve (see fig. 21, flange 30 engages with outlet conduit 6 and outlet tube 16 which are not rotating portions of adapter 2; in the modified system, flange 30 would be engaging with the distal end portion of the hemostasis valve of Agrawal, which is attached to side port 18, main body portion 14, and adaptor 12, fig. 2, which do not rotate relative to the longitudinal axis of the hemostasis valve when plunger 16 of Agrawal is rotated during use).
Regarding claim 40, Falb as modified discloses the adaptor system of claim 39 wherein the first connector includes a first leg and a second leg (see exemplary fig. 18 which is not relied upon; flanges 82 and 30 are each composed of a pair of legs which extend along a curve about the longitudinal axis and extend along the longitudinal axis) configured to flexibly spread apart to receive the non-rotating portion of the y-connector hemostasis valve between the first leg and the second leg (see at least [0088] and [0090]; the flanges are flexible such as to allow the tubes to be held between them) to connect the first connector to the non-rotating portion of the y-connector hemostasis valve with a snap fit (in the modified device, the structures would be connected with a snap fit as the flexing of the flanges around the tube to hold it in position would be considered a snap fit; while [0090] discloses that a snap fit is not necessary for strong connection, the flexing of the flanges around the tubing shows that it is the default).
Regarding claim 41, Falb as modified discloses the adaptor system of claim 39 wherein the first connector is configured to be connected about an outer surface of the portion of the y- connector hemostasis valve that is non-rotating (in the modified device, the distal most end surface of flange 30, fig. 21, is configured as claimed as it would be connected to the exterior surface of side port 18, main body portion 14, and adaptor 12 as claimed when the flange is snapped onto adaptor 12 to provide the flexible track 216 of Falb and the hemostasis valve of Agrawal with separation prevention due to the addition of the device 70 of Dodson).
Regarding claim 42, Falb as modified discloses the adaptor system of claim 38 wherein the adaptor comprises: a second connector (the proximal most end surface of flange 82’, fig. 21) at a second end of the body (the proximal end of the body, see fig. 21), the second connector configured to operatively connect the adaptor to the elongated medical device support track (in the modified system, flange 82’ is configured as claimed where it is the surface which connects device 70 of Dodson to track 216 of Falb).
Regarding claim 43, Falb as modified discloses the adaptor system of claim 42 wherein the elongated medical device support track includes a flexible tube (see Falb flexible track 216, fig. 1) having a slit (see Falb slit 286, fig. 10) extending along a length of the flexible tube (see Falb [0062]), and the second connector is configured to engage the coupler to operatively connect the adaptor to the elongated medical device support track (in the modified system, flange 82’ is configured as claimed where it is the surface which connects device 70 of Dodson to track 216 and terminal end 254 thereof, see fig. 10, of Falb).
Regarding claim 44, Falb as modified discloses the adaptor system of claim 36 wherein a longitudinal axis of the adaptor is configured to be co-axial with a longitudinal axis of the hemostasis valve (see annotated fig. 21; the provided dashed axis is the longitudinal axis of the hemostasis valve in the modified system, and the solid line with bracket ends is the longitudinal axis of the adaptor, with the axes being coaxial).
Regarding claim 45, Falb as modified discloses the adaptor system of claim 36 further comprising: a clip (see Falb sheath clip 256, fig. 10) configured to releasably engage with the elongated medical device support track (see Falb clip 256 is considered to be engaged when it is only connected to collar 250 as shown in fig. 2 and does not have the tube of flexible track 216 inserted into it as in [0063]), the clip being further configured to automatically disengage from the elongated medical device support track when an end of the clip contacts the robotic drive (clip 256 disengages with collar 250 automatically as controlled by the robotics of the device which insert the tube of flexible track 216 into it; this insertion involves the distal end 254 of flexible track 216, which is in contact with the robotic drive, contacting the engagement portion 260 at its proximal end as seen in fig. 9).
Regarding claim 48, Falb as modified discloses the adaptor system of claim 36 further comprising: the coupler disposed at the first end of the elongated medical device support track (see Falb fig. 1); and the hemostasis valve disposed between the coupler and a second catheter (in the modified system, the hemostasis valve of Agrawal is disposed at the distalmost end of sheath clip 256; if flexible tube 216 of Falb was bent when the device was assembled such that distal end 254 was pointed towards guide catheter 228, fig. 5, such as at Y-connector base 238, then the hemostasis valve would be disposed as claimed).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 36 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 SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p 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.
/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
Prosecution Insights