DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment filed on 07/02/26 has been entered in the case. Claims 1-2, 19, 21-25, 51-62 are pending for examination and claims 3-18, 20, 26-50 are cancelled.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 19, 21-25, 51-62 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The limitation “extension member including opposing surfaces substantially perpendicular to the longitudinal axis” is failing to comply with the written description requirement. The extension member 180 has cylindrical shape and longitudinal axis (is equivalent to a center line of the cylindrical tube). The outer, curved surface of a cylindrical tube is parallel to its longitudinal axis. The longitudinal (or central) axis represents an imaginary line running down the exact center of the tube, and the outer cylindrical wall (outer surface) extends perfectly alongside it. For example: the radius R (but not an opposing surface) is perpendicular to the longitudinal axis.
PNG
media_image1.png
342
636
media_image1.png
Greyscale
In other words, the opposing surface of the extension member 180 (groove) substantially parallel (not perpendicular, as recited in the claims 1, 51 & 59) to the longitudinal axis.
For examining purpose, Examiner interprets that extension member including opposing surfaces substantially parallel to the longitudinal axis
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 19, 21-25, 51-62 are rejected under 35 U.S.C. 103 as being unpatentable over Sutherland et al. (US 2008/0004632) in view of Vetter et al. (US 5,269,764).
Regarding claims 1, 51 & 59, Sutherland discloses an apparatus comprising:
a base (a whole unit on a left side in Figs. 12-17, #144 is temporary called as a base) to support a forceps 45 (or a catheter 57/58/62, as shown in Figs. 14-16, can be support a catheter with hemostasis valve, as modified by Vetter below), rotating driven member 47 (small gear), an extension member (hub/handle of the forceps 45 or hub/handle) including opposing surfaces substantially parallel to the longitudinal axis defining an outer circumferential groove (wherein a bracket 148 holds an outer, see marked-up Fig. 13.
Note: with aspect to the limitation, i.e., substantially perpendicular to the longitudinal axis, this limitation involves 112, 1st paragraph issue above. For examining purpose, the Examiner interpreted such as: opposing surfaces substantially parallel to the longitudinal axis defining an outer circumferential groove.
Note: the outer surface of the extension member is as a long narrow depression surface with respect to a flange at proximal end of the extension. Therefore, the outer surface of the extension member is called as an outer circumferential groove.
Note: the limitation “to support a hemostasis valve” is a functional limitation and only requires performing of a function. Therefore, the limitation “a valve body having a longitudinal axis, a rotating driven member, and extension member” is a part of the hemostasis valve or a part of functional limitation. Therefore, the limitation above is also interpreted as a functional limitation. According to the elected Figs. 19-21 of the current application, a hemostasis valve 34 is equivalent to a hub or handle of the catheter. In the prior art Sutherland, the base supports an extension member (hub/handle of a forceps 44 or hub/handle of the catheter 57/58/62). Therefore, the base in Sutherland is capable of supporting a catheter (or equivalent to the claimed “a hemostasis valve”). Also see the modification of Vetter. Sutherland also discloses that the base is used to support a catheter 57/58/62 (e.g., a person skilled in the art would recognize that the catheter 57/58/62 can be provided a hemostasis valve located inside the extension member; or hemostasis valve includes a valve body, as modified by Vetter below) having a longitudinal axis, a rotating driven member 47 and an extension member (a handle/connector of the forceps or a handle/connector of the catheter 57/58/62).
The base 144 comprising:
a first bracket 148 (or 149) defining an insertion opening configured to allow the catheter (or hemostasis-valve catheter, modified by Vetter below) to be received by the first bracket in a radial direction relative to the longitudinal of the forceps/catheter and to be removed from the first bracket in the radial direction relative to the longitudinal axis of the forceps/catheter;
a drive mechanism 42 to rotatable drive the rotating driven member 47 while the forceps is received by the first bracket 148/149;
wherein the insertion opening of the first bracket 148/149 is configured to contact the extension member of the forceps to oppose movement of the forceps along the longitudinal axis, see paras [0056, 0139-0041].
PNG
media_image2.png
629
998
media_image2.png
Greyscale
Sutherland does not disclose that the hemostatic valve (e.g. catheter having a hemostatic valve) being supported by the base.
Note: the limitation “valve body” is a part of the functional limitation. Therefore, it only requires to performing a function.
Vetter discloses a hemostasis valve 10 (in Fig. 1) including a valve body 12 having a longitudinal axis, an extension member14 or/and 24 defining an outer circumferential groove (a long narrow depression surface 14). The outer surface 24 of the extension member 24 also includes outer circumferential grooves 24, see Fig. 1.
Since a hub/handle in Sutherland has same cylindrical configuration (or elongated member) as a hub/handle/connector 10 of the hemostasis valve in Vetter, therefore, the purpose disclosed by Vetter would have been recognized in the pertinent art of Sutherland.
A person having ordinary skill in the art would have easily recognizes that modifying the apparatus of Sutherland with providing a catheter (named as a hemostasis valve) including a valve body, as taught by Vetter, would provide the benefits of using hemostasis valve being provided in the robot system for leaking-proof introduction of a catheter or other device into the vascular system or elsewhere in the body of a patient.
Note: the limitation “to support a hemostasis valve including a valve body having a longitudinal axis rotating driven member and an extension member defining an outer circumferential groove” and the limitation “is configured to interact with the outer circumferential groove to support the extension member as the extension member rotates and to oppose movement of the hemostasis valve in two directions along the longitudinal axis” are functional limitations and only require performing a function.
Analysis #1: the functional limitation, i.e., the base, “to support a hemostasis valve including a valve body having a longitudinal axis rotating driven member and an extension member defining an outer circumferential groove”, the base 144 in Sutherland supports a forceps 45 in Fig. 13 (or a catheter 57/58 as shown in Figs. 14-15). Therefore, the base 144 can support the catheter/hemostasis valve 10 of Vetter (wherein the catheter/hemostasis valve 10 includes a valve body therein).
Analysis #2: the functional limitation, i.e., the insertion opening of the first bracket, “is configured to interact with the outer circumferential groove to support the extension member as the extension member rotates and to oppose movement of the hemostasis valve in two directions along the longitudinal axis” are functional limitations and only require performing a function. In this case, the insertion opening of the bracket 148/149 in Sutherland is holding an extension member the forceps 45 or an extension member of the catheter 57/58. Therefore, the insertion opening of the bracket 148/149 in Sutherland is capable of interacting or holding with an outer circumferential groove at extension member of the hemostasis valve 10 of Vetter to support the extension member as the extension member rotates and to contact the opposing surfaces defining the outer circumferential groove to oppose movement of the hemostasis valve in two directions along the longitudinal axis.
PNG
media_image3.png
779
1214
media_image3.png
Greyscale
Note: the limitations in claims 51 & 59 are being rejected using same analysis as noted above in regard to the claim 1. In addition, the claims 51 & 59 require a circumferential groove member (instated of an extension member). As shown in the marked-up figs in the rejection in claim 1 above, a circumferential groove defines as a long narrow depression surface. Vetter clearly shows that the hemostasis valve including a valve body and a circumferential groove, see marked-up figure above.
With respect to the limitation, i.e., the insertion opening of the first bracket is configured to contact the extension member or groove member, is considered as functional limitation. In this case, it would have been obvious to one having ordinary skill in the art at the time the invention was made to an insertion opening being interacted/contacted the extension/groove member, since it has been held that rearranging parts of an invention involves only routine skill in the art with a purpose of providing more support or stability during using.
As for claim 59, Sutherland in view of Vetter discloses all claimed subject matter as required. Please see the rejection in claim 1 above. Sutherland discloses that the base comprising a motor (e.g., robotic arm motor drives, para [0053], or piezoelectric motor, para [0058]. In addition, a motor device is inherently included in the robotic system) configured to rotational drive the drive mechanism.
Regarding claims 2 & 52, Sutherland in view of Vetter discloses all claimed subject matter as required. Sutherland discloses that the drive mechanism 42 is rotatable about first axis. As best as understood, the first bracket 149 is formed as a clip and therefore, the bracket/clip 149 has three insertion openings (e.g., 2 insertion openings at top & bottom; the third opening is located on the right side, see Fig. 13 below) the insertion opening (at top or bottom) faces in horizontal direction and therefore, the top or bottom insertion opening faces in a direction nonparallel to the first axis. In addition, the insertion opening is located in a direction that nonparallel to the first axis is considered as rearrangement parts.
PNG
media_image4.png
364
480
media_image4.png
Greyscale
Regarding claims 19 & 53, Sutherland in view of Vetter discloses all claimed subject matter as required. Sutherland discloses that a support which is affixed to the base, see Fig. 1A; a linear actuator to which the support is affixed (e.g., a linear drive mechanism is designed to provide accurate insertion and targeting of a cannula and introducer, para [0056]); the linear actuator having a linear axis along which the linear actuator maybe advanced or retracted in a continuous or incremental manner; and
a bed side (Fig. 1A) support to which the linear actuator is slidingly affixed to allow the linear actuator to move relative to the bedside support; wherein movement of the linear actuator causes the support and the base to move along the linear axis of the linear actuator.
Regarding claims 21 & 54, Sutherland discloses that the driven member 47 includes a gear, and the extension member (as included in the hemostasis valve, as modified by Vetter) rotates with the driven member 47 and is proximate to the driven member 47.
Regarding claims 22-23, 55-56, Sutherland discloses that the gear 47 and the extension member (as modified by Barry). Sutherland does not disclose that the gear 47 is located at extension member are formed as a single component. In addition, it would have been obvious to one having ordinary skill in the art at the time the invention was made to obtain the gear and the rotating connected integrally being formed a single component, since it has been held that constructing a formerly integral structure (or separate structure, i.e., the gear being removably coupled to the rotating connector) in various elements involves only routine skill in the art.
Regarding claims 24 & 57, Sutherland discloses that a second bracket 148 defining a second insertion opening configured to allow the catheter 57/58 (or the hemostasis valve, as modified by Vetter) to be received by the second bracket in the radial direction and to be removed from the second bracket in the radial direction, and wherein the second bracket 148 comprises a surface configured to oppose movement of the hemostasis valve along the longitudinal axis.
Regarding claims 25 & 58, Sutherland discloses that the insertion opening of the first bracket is configured to prohibit movement of the forceps (or the hemostasis valve, as modified by Vetter) in a distal direction parallel to the longitudinal axis.
Regarding claim 60, Sutherland discloses that a wall having a first bracket 149; wherein the wall extends in direction parallel to the longitudinal axis of the forceps (or the hemostasis valve, as modified by Vetter), when the forceps (or the hemostasis valve) is secured to the base.
Regarding claim 61, Sutherland discloses that a second bracket 148; wherein the drive mechanism 42 is positioned between the first bracket 149 and the second bracket 148.
Regarding claim 62, Sutherland discloses that the drive mechanism 42 is configured to drive a driven surface of the removable hemostasis valve (because the gear 47 is located on the forceps (or the removable hemostasis valve, as modified by Vetter).
Response to Arguments
Applicant's arguments filed 07/02/26 have been fully considered but they are not persuasive.
1) Applicant argues on page 9 of the Remarks 07/02/26 that:
PNG
media_image5.png
170
764
media_image5.png
Greyscale
In response, Examiner acknowledges that the tool support mechanism 148 prevents an upper flange (see marked-up figure below) to move in downward direction. However, the moving of actuator 149 in longitudinal direction that moving the tool 26 along to the longitudinal direction. In other words, the tool 26 can not move in downwardly by itself. Instead of that the tool 26 moves in longitudinal direction by the actuator 149.
PNG
media_image6.png
537
892
media_image6.png
Greyscale
In addition, Sutherland states in para [0133] that: actuation of the tool is effected by moving the actuator 149 longitudinally of the axis 42. For this purpose, the actuator 149 is mounted on a slide 43 carried in a track 44 and driven by a suitable mechanism along the track 44 so as to accurately locate the position of the actuator 149 along the length of the tool. In other words, the tool 26 is moving in longitudinal direction (forward/backward directions) by the actuator 149.
2) Applicant argues on page 9 of the Remarks 07/02/26 that:
PNG
media_image7.png
135
757
media_image7.png
Greyscale
In response, Sutherland states in para [0131] that: the end effector is shown in FIGS. 12 through 17. The tool 26 is mounted on its upper end in the role actuator 148 so as to extend downwardly therefrom to the tip 40. The upper end of the tool is supported while allowing some side to side and front to back movement of the tool relative to the actuator 148. Based on the statement in para [0131] above, the tool (or a hemostasis valve, as modified by new prior art Vetter) is moving in at least two directions, i.e., rotating side-by-side, and front and back movement.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached M-F 7:30 am-4:00 pm.
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, Michael Tsai can be reached at 571-270-5246. 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.
/QUYNH-NHU H. VU/ Primary Examiner, Art Unit 3783
Prosecution Insights