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 .
Response to Amendment
Regarding the previous 112(b) rejections over claims 2-3 and 7, the amendments are acknowledged and the 112(b) rejections are withdrawn.
Response to Arguments
Applicant’s arguments, see page 2, filed 12/23/2025, with respect to the 102 rejection(s) of claim(s) 1 under Ulm, III have been fully considered and are persuasive. The examiner agrees that Ulm, III fails to disclose “wherein the distal end region includes a slot extending through the wall from the first lateral side to the second lateral side” as required in claim 1. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of a 103 rejection is made over Ulm, III in view of Starkey et al. (US 5137288).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-10 and 13-16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Ulm, III et al. (US 20190133619) [hereinafter Ulm] in view of Starkey et al. (US 5137288) [hereinafter Starkey].
Regarding claim 1, Ulm, III discloses a hand-held shaft puller (shown in Figs. 32A-45) for engaging a medical device shaft (para. 0145, 0154-0155), comprising:
a handle 302, 322 having a distal end region (interpreted as including comprising distal outer tube 322), a proximal end region (interpreted as region including proximal outer tube 302), and a longitudinal axis (Figs. 32A, 38, para. 0145);
wherein the distal end region includes a first channel (interpreted as channel with proximal and distal tapers that defines space for a distal end of inner tube distal end 344, see annotated Fig. 40 below) extending along the longitudinal axis (Figs. 39, 40, para. 0158), and wherein the first channel includes an engagement surface (interpreted as inner surface of the first channel used to engage inner tube distal end 344, Fig. 40) configured to engage an engagement member disposed on a shaft extending through the first channel (Fig. 40, para. 0158; see note below).
However, Ulm, III fails to disclose wherein the distal end region includes a slot extending through a wall from a first lateral side to a second lateral side, opposite the first lateral side.
Starkey in the same field of endeavor of hand-held shaft pullers for engaging a medical device shaft (Figs. 1-2, col. 1 lines 45-46: “In this invention a wire-gripping handle is provided for attaching to and detaching from wires”) teaches that it is known in the art for handle comprising a distal end region (interpreted as region comprising plastic tubular member 14) and a proximal end region (interpreted as region comprising plastic tubular member 12) to include a slot 16, 20, 26, 30 (The examiner notes that the slots 20 and 30 extend into lumens 16, 26, thereby forming one cohesive slot, see Figs. 1 and 3) extending through a wall (interpreted as the sidewalls of the proximal and distal regions 12, 14) from a first lateral side (interpreted as the side in which the slot begins) to a second lateral side, opposite the first lateral side (interpreted as the side in which the wire 24 sits in) (see Fig. 1, col. 2 lines 55-58: “Longitudinal slot 20 extends through the side wall into first bore 16, and preferably extends across at least both ends 22, 23 of first tubular member 12, and along the entire length thereof” and col. 3 lines 3-7: “Second tubular member 14 defines a sidewall 29 which, in turn, defines a second longitudinal slot 30 extending completely along the length thereof, which slot is proportioned to allow the passage of wire 24 through it from the exterior into the bore 26”) for the purpose of side loading a guidewire (col. 1 lines 28-42 and col. 3 lines 61-65).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proximal and distal regions in Ulm, III to include the slot extending through the wall from the first lateral side to the second lateral side as taught by Starkey in order to increase the ease of mounting the medical shaft within the handle during the loading of the device (col. 4 lines 11-20 of Starkey: “Handle 10 is easily applied at any point along the length of a wire by side mounting, and it is easily removed simply by screwing the respective tubular members 12, 14 apart into a rotary position where the slots 20, 30 are aligned. Then the handle 10 can simply laterally fall off of the wire. Thus, the handle of this invention can be applied, used, and removed at great speed during any desired surgical or other procedure involving a wire that needs to be rotated or otherwise manipulated”).
Note: “configured to engage an engagement member disposed on a shaft extending through the first channel” is interpreted as functional language due to the “configured to” language. Therefore, the engagement member introduced in claim 1 is not positively claimed and interpreted as a functional component, not a structural component, that the engagement surface of the first channel is capable of engaging. As claimed, Ulm, III discloses all of the structure provided in the limitation to necessitate the functional language i.e. the engagement surface of the first channel (Fig. 40, para. 0158 of Ulm, III). Furthermore, Ulm, III discloses inner tube distal end 344 comprising a clamp 392 that is designed to engage the engagement surface of the first channel and is disposed on a shaft (interpreted as pull wire 356) extending through the first channel (see Fig. 40, para. 0158 of Ulm, III). Therefore, the engagement surface of the first channel is capable of engaging an engagement member disposed on a shaft extending through the first channel. The examiner notes that a recitation of the intended use of the claimed invention and/or functionality of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
PNG
media_image1.png
206
337
media_image1.png
Greyscale
Annotated Fig. 40 of Ulm, III
Regarding claim 2, modified Ulm, III discloses wherein a proximal face is configured to engage the engagement member disposed along an inner shaft of a thrombectomy system (see annotated Fig. 40 [a] of Ulm, III below, para. 0145; see note below regarding “configured to” language).
Note: “configured to engage an engagement member disposed along an inner shaft of a thrombectomy system” is interpreted as functional language due to the “configured to” language. Therefore, the engagement member and the inner shaft introduced in claim 2 is not positively claimed and interpreted as functional components, not structural components, that the proximal face of the first channel is capable of engaging. As claimed, modified Ulm, III discloses all of the structure provided in the limitation to necessitate the functional language i.e. the proximal face of the first channel (see annotated Fig. 40 [a] of Ulm, III below). For example, modified Ulm, III discloses inner tube distal end 344 comprising a clamp 392 that is designed to engage the proximal surface of the first channel and is disposed on a shaft (interpreted as pull wire 356) of a thrombectomy system (see annotated Fig. 40 [a] of Ulm, III below, para. 0145, 0158). Therefore, the proximal face of the first channel is capable of engaging the engagement member disposed along an inner shaft of a thrombectomy system. The examiner notes that a recitation of the intended use of the claimed invention and/or functionality of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
PNG
media_image2.png
198
341
media_image2.png
Greyscale
Annotated Fig. 40 [a] of Ulm, III
Regarding claim 3, modified Ulm, III discloses wherein the inner shaft includes a distal end region coupled to a flexible tube of the thrombectomy system (The examiner notes that “the inner shaft” is not positively claimed, see note above for the rejection of claim 2. Therefore, “a distal end region of the inner shaft” and “a flexible tube of the thrombectomy system” are also not positively claimed. As stated above, since modified Ulm, III discloses all of the structural components needed to necessitate the functional language of the claim, the claim is met; see Figs. 15B-C, para. 0145 which disclose that the pull wire 352 includes a distal region coupled to a flexible delivery catheter 208 of the thrombectomy system and is therefore capable of performing the function.).
Regarding claim 4, modified Ulm, III discloses wherein the first channel includes a first diameter at a first longitudinal position along the first channel and a second diameter at a second longitudinal position along the first channel (see annotated Fig. 40 [b] below of Ulm, III).
PNG
media_image3.png
247
310
media_image3.png
Greyscale
Annotated Fig. 40 [b] of Ulm, III
Regarding claim 5, modified Ulm, III discloses wherein the handle is configured to be grasped by one hand (Fig. 32A, para. 0146 of Ulm)
Regarding claim 6, modified Ulm, III discloses further comprising a second channel (interpreted as channel with threads 394, Figs. 37, 40) longitudinally aligned with the first channel (see annotated Fig. 40 above, para. 0158 of Ulm, III).
Regarding claim 7, modified Ulm, III discloses wherein the first channel and the second channel are longitudinally aligned to permit the inner shaft to extend along both the first channel and the second channel in a substantially straight configuration (see annotated Fig. 40 above and see Figs. 39-40 of Ulm, III).
Regarding claim 8, modified Ulm, III discloses wherein the engagement member includes a pull-ring (The examiner notes that “the engagement member” is not positively claimed, see note above for the rejection of claim 1. Therefore, “a pull-ring” is also not positively claimed. As stated above, since Ulm, III discloses all of the structural components needed to necessitate the functional language of the claim, the claim is met; see Figs. 38-39, 42-43, para. 0155-0157 which disclose that the inner tube distal end 344 comprising the clamp 392 includes an annular body that is used to pull wire proximally and distally and therefore could be interpreted as a pull-ring.)
Regarding claim 9, modified Ulm, III discloses wherein the slot 16, 20, 30, 26 is configured to accept an insert therein (Fig. 1 of Starkey; see note below).
Note: “wherein the slot is configured to accept an insert therein” is interpreted as functional language due to the “configured to” language. Therefore, the insert introduced in claim 9 is not positively claimed and interpreted as a functional component, not a structural component of the device, that the slot is capable of accepting. As claimed, Starkey teaches all of the structure provided in the limitation to necessitate the functional language i.e. the slot (interpreted as slots 20 and 30 which extends into lumens 16, 26, thereby forming one cohesive slot to accept an element such as an insert, see Figs. 1 and 3; col. 3 lines 61-63: “As shown in FIG. 3, a wire 24 may be placed into the respective bores 16, 26 by rotating the respective tubular members 12, 14 until their longitudinal slots 20, 30 align”. ). Therefore, the slot is capable of accepting an insert therein. The examiner notes that a recitation of the intended use of the claimed invention and/or functionality of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 10, modified Ulm, III discloses wherein the insert is configured to engage the engagement member (see note above in regards to “the insert” not being positively claimed in claim 9. Since, modified Ulm, III discloses the all the structure necessary to perform the function as recited in claim 10 i.e. the slot capable of accepting the insert as stated above in claim 9, the claim limitation of claim 10 is met).
Regarding claim 13, Ulm, III discloses a hand-held shaft puller for engaging a shaft of a thrombectomy system (shown in Figs. 32A-45, para. 0145, 0154-0155), comprising:
a handle 302, 322 having a distal end region (interpreted as including comprising distal outer tube 322), a proximal end region (interpreted as region including proximal outer tube 302) and a longitudinal axis (Figs. 32A, 38, para. 0145);
wherein the distal end region includes a first channel (interpreted as channel with proximal and distal tapers that defines space for an inner tube distal end 344=, see annotated Fig. 40 above) extending along the longitudinal axis (Figs. 39, 40, para. 0158);
wherein the proximal end region includes a second channel (interpreted as inner lumen of proximal outer tube 302) longitudinally aligned with the first channel (Fig. 39, para. 0146, 0149);
wherein the first channel includes a proximal face (see annotated Fig. 40 [a] of Ulm, III above, para. 0145) configured to engage a pull-ring disposed on an inner shaft extending through the first channel (see note below);
wherein a distal end region of the inner shaft is coupled to a proximal end of a flexible tube of the thrombectomy system (The examiner notes that “the inner shaft” is not positively claimed, see below in regards to functional language interpretation. Therefore, “a distal end region of the inner shaft” and “a flexible tube of the thrombectomy system” are also not positively claimed. As stated below, since Ulm, III discloses all of the structural components needed to necessitate the functional language of the claim, the claim is met; see Figs. 15B-C, para. 0096, 0103, 0125, 0145 which disclose that the pull wire 352 includes a distal region coupled to a flexible delivery catheter 208 of the thrombectomy system and is therefore capable of performing the function).
However, Ulm, III fails to disclose wherein the distal end region includes a slot extending through a wall from a first lateral side to a second lateral side, opposite the first lateral side.
Starkey in the same field of endeavor of hand-held shaft pullers for engaging a medical device shaft (Figs. 1-2, col. 1 lines 45-46: “In this invention a wire-gripping handle is provided for attaching to and detaching from wires”) teaches that it is known in the art for a handle comprising a distal end region (interpreted as region comprising plastic tubular member 14) and a proximal end region (interpreted as region comprising plastic tubular member 12) to include a slot 16, 20, 26, 30 (The examiner notes that the slots 20 and 30 extend into lumens 16, 26, thereby forming one cohesive slot, see Figs. 1 and 3) extending through a wall (interpreted as the sidewalls of the proximal and distal regions 12, 14) from a first lateral side (interpreted as the side in which the slot begins) to a second lateral side, opposite the first lateral side (interpreted as the side in which the wire 24 sits in) (see Fig. 1, col. 2 lines 55-58: “Longitudinal slot 20 extends through the side wall into first bore 16, and preferably extends across at least both ends 22, 23 of first tubular member 12, and along the entire length thereof” and col. 3 lines 3-7: “Second tubular member 14 defines a sidewall 29 which, in turn, defines a second longitudinal slot 30 extending completely along the length thereof, which slot is proportioned to allow the passage of wire 24 through it from the exterior into the bore 26”) for the purpose of side loading a guidewire (col. 1 lines 28-42 and col. 3 lines 61-65).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proximal and distal regions in Ulm, III to include the slot extending through the wall from the first lateral side to the second lateral side as taught by Starkey in order to increase the ease of mounting the medical shaft within the handle during the loading of the device (col. 4 lines 11-20 of Starkey: “Handle 10 is easily applied at any point along the length of a wire by side mounting, and it is easily removed simply by screwing the respective tubular members 12, 14 apart into a rotary position where the slots 20, 30 are aligned. Then the handle 10 can simply laterally fall off of the wire. Thus, the handle of this invention can be applied, used, and removed at great speed during any desired surgical or other procedure involving a wire that needs to be rotated or otherwise manipulated”).
Note: “configured to engage a pull-ring disposed on an inner shaft extending through the first channel” is interpreted as functional language due to the “configured to” language. Therefore, the pull-ring and the inner shaft introduced in claim 13 are not positively claimed and interpreted as a functional component, not a structural component, that the proximal face of the first channel is capable of engaging. As claimed, Ulm, III discloses all of the structure provided in the limitation to necessitate the functional language i.e. the proximal face of the first channel (see annotated Fig. 40 [a] of Ulm, III above). For example, Ulm, III discloses a pull ring (interpreted as the inner tube distal end 344 comprising clamp 392 since the inner tube distal end 344 comprises an annular body used to pull a pull wire proximally and distally; para. 0155-0157) that is designed to engage the proximal surface of the first channel and is disposed on a shaft (interpreted as pull wire 356) of a thrombectomy system (see annotated Fig. 40 [a] of Ulm, III below, para. 0145). Therefore, the proximal face of the first channel is capable of engaging a pull-ring disposed along an inner shaft extending through the first channel. The examiner notes that a recitation of the intended use of the claimed invention and/or functionality of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 14, modified Ulm, III discloses wherein the first channel (see annotated Fig. 40 above) and the second channel (interpreted as lumen of proximal outer tube 302) are longitudinally aligned to permit the inner shaft (see note above in claim 13 in regards to the inner shaft not being positively claimed) to extend along both the first channel and the second channel in a substantially straight configuration (see Figs. 33B, 39, 43 of Ulm, III).
Regarding claim 15, modified Ulm, III discloses wherein the slot 16, 20, 30, 26 is configured to accept an insert therein (Fig. 1 of Starkey; see note below).
Note: “wherein the slot is configured to accept an insert therein” is interpreted as functional language due to the “configured to” language. Therefore, the insert introduced in claim 9 is not positively claimed and interpreted as a functional component, not a structural component of the device, that the slot is capable of accepting. As claimed, Starkey teaches all of the structure provided in the limitation to necessitate the functional language i.e. the slot (interpreted as slots 20 and 30 which extends into lumens 16, 26, thereby forming one cohesive slot to accept an element such as an insert, see Figs. 1 and 3; col. 3 lines 61-63: “As shown in FIG. 3, a wire 24 may be placed into the respective bores 16, 26 by rotating the respective tubular members 12, 14 until their longitudinal slots 20, 30 align”. ). Therefore, the slot is capable of accepting an insert therein. The examiner notes that a recitation of the intended use of the claimed invention and/or functionality of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 16, modified Ulm, III discloses wherein the insert is configured to engage the pull-ring (see note above in regards to “the insert” not being positively claimed in claim 15. Since, modified Ulm, III discloses the all the structure necessary to perform the function as recited in claim 16 i.e. the slot capable of accepting the insert as stated above in claim 15, the claim limitation of claim 16 is met).
Regarding claim 19, modified Ulm, III discloses wherein a distal end of the flexible tube is coupled to an outer shaft (See note above in rejection 13 in regards to the flexible tube not being positively claimed. The examiner further notes that since the flexible tube is not positively claimed, “an outer shaft” is also not positively claimed. As stated above, since modified Ulm, III discloses all of the structural components needed to necessitate the functional language of the claim, the claim is met.), and wherein the inner shaft is positioned within at least a portion of the outer shaft (See note above in the rejection of claim 13 in regards to the inner shaft not being positively claimed. As stated above, since modified Ulm, III discloses all of the structural components needed to necessitate the functional language of the claim, the claim is met).
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 LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 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, Elizabeth Houston can be reached at 571-272-7134. 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.
/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771
Prosecution Insights