CTNF 18/993,415 CTNF 90624 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Objections 07-29-01 AIA Claim 27 objected to because of the following informalities: In line 2, “the attachment body” should read “an attachment body” . Appropriate correction is required. Claim Rejections - 35 USC § 112 07-30-02 AIA The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 07-34-01 Claim 33 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 33 recites the limitation "the first hinge connection includes a first spring configured to bias" and “the second hinge connection includes a second spring configured to bias” in lines 1 and 3. There is insufficient antecedent basis for this limitation in the claim, and “the first hinge connection” and “the second hinge connection” have not been positively recited. For examination purposes, the limitations are not considered part of the claimed invention and will be interpreted as functional language. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – 07-08-aia AIA (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. 07-15 AIA Claim s 16-18, 21-23, 26-32, and 35 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by ASAI (US 2018/0369540) . Regarding claim 16, an invention relating to catheters, Asai discloses (Figs. 7b & 9-10E) a medical device lock capable of use with a thrombectomy system (Abstract), comprising: a body (15, 18, 20a, 38) having a lumen [i.e. the opening in element 22 that element 14 occupies] extending therein (Par. 0059); a first clamping arm [i.e. one of two arms (42)] pivotably coupled to the body; and a second clamping arm [i.e. the other of two arms (42)] pivotably coupled to the body; wherein the first clamping arm may be releasably attached to the second clamping arm to clamp a catheter shaft therebetween, wherein clamping the catheter between the first clamping arm and the second clamping arm maintains the catheter shaft in a substantially linear configuration (Par. 0069-0070, 0086, 0099, 0101). Regarding claim 17, Asai discloses the medical device lock of claim 16. Asai further discloses (Fig. 9) wherein the first clamping arm is coupled to the body via a first hinge connection (44; Par. 0069-0070). Regarding claim 18, Asai discloses the medical device lock of claim 17. Asai further discloses (Fig. 9) wherein the second clamping arm is coupled to the body via a second hinge connection (44; Par. 0069). Regarding claim 21, Asai discloses the medical device lock of claim 16. Asai further discloses wherein the lumen of the body is configured to permit the catheter shaft to extend therethrough (Par. 0059). Regarding claim 22, Asai discloses the medical device lock of claim 16. Asai further discloses (Fig. 10C) wherein the first clamping arm includes a first clamping channel (56) extending along a longitudinal axis of the first clamping arm, wherein the first clamping channel is configured to permit the catheter shaft to be disposed therein (Par. 0099 & 0101). Regarding claim 23, Asai discloses the medical device lock of claim 22. Asai further discloses (Fig. 10C) wherein the second clamping arm includes a second clamping channel (56) extending along a longitudinal axis of the second clamping arm, wherein the second clamping channel is configured to permit the catheter shaft to be disposed therein (Par. 0099 & 0101). Regarding claim 26, Asai discloses the medical device lock of claim 16. Asai further discloses (Fig. 10C) wherein the second clamping arm includes a cradle (64) disposed along a proximal end region of the second clamping arm, wherein the cradle is configured to accept the catheter shaft (Par. 0101). Regarding claim 27, Asai discloses the medical device lock of claim 26. Asai further discloses (Fig. 9) wherein the cradle is longitudinally aligned with the lumen of the attachment body [i.e. aligned along the longitudinal axis of element 12]. Regarding claim 28, Asai discloses the medical device lock of claim 16. Asai discloses (Fig. 7B) further comprising a connector (14) disposed along a distal end region of the body (see annotated figure below). PNG media_image1.png 235 371 media_image1.png Greyscale Regarding claim 29, Asai discloses the medical device lock of claim 28. Asai discloses (Fig. 9) wherein the connector is configured to attach to a manifold (18) of a medical introducer sheath (Par. 0056). Regarding claim 30, Asai discloses the medical device lock of claim 28. Asai discloses wherein releasably attaching the first clamping arm to the second clamping arm to clamp a catheter shaft therebetween prevents the catheter shaft from translating relative to the manifold of the introducer sheath (Par. 0056 & 0069-0071). Regarding claim 31, Asai discloses the medical device lock of claim 30. Asai further discloses wherein the catheter shaft is an outer shaft of a thrombectomy apparatus [i.e. a catheter] (Par. 0054). Regarding claim 32, an invention relating to catheters, Asai discloses (Figs. 7b & 9-10E) a medical device lock capable of use with a thrombectomy system (Abstract), comprising: a body (15, 18, 20a, 38) having a distal end region, a proximal end region and a lumen [i.e. the opening in element 22 that element 14 occupies (Par. 0059)] extending therein (see annotated figure below); a first clamping arm [i.e. one of two arms (42)] coupled to the proximal end region of the body, wherein the first clamping arm is configured to pivot about a first spring-loaded hinge connection (44; Par. 0069-0070); and a second clamping arm [i.e. the other of two arms (42)] coupled to the proximal end region of the body, wherein the second clamping arm is configured to pivot about a second spring-loaded hinge connection (44; Par. 0069-0070); wherein the first clamping arm may be releasably attached to the second clamping arm to clamp a catheter shaft between the first clamping arm and the second clamping arm in a locked configuration, and wherein clamping the catheter between the first clamping arm and the second clamping arm maintains the shaft in a substantially linear configuration (Par. 0069-0070, 0086, 0099, 0101). PNG media_image2.png 283 395 media_image2.png Greyscale Regarding claim 35, an invention relating to catheters, Asai discloses (Figs. 7b & 9-10E) a method of securing a portion of a thrombectomy system relative to an introducer (Abstract), the method comprising: positioning the introducer within a body vessel of a patient (Par. 0030), the introducer including a shaft (16) coupled to a manifold (18); securing a medical device lock (15) to the manifold of the introducer (Par. 0056 & 0059), the medical device lock including: a body (22) having a lumen [i.e. space occupied by element 14] extending therein (Par. 0059); a first clamping arm [i.e. one of two arms (42)] pivotably coupled to the body; and a second clamping arm [i.e. the other of two arms (42)] pivotably coupled to the body; wherein the first clamping arm may be releasably attached to the second clamping arm; and advancing an outer catheter (14) of the thrombectomy system through the lumen of the medical device lock body, through the manifold of the introducer and into the lumen of the introducer; attaching the first clamping arm to the second clamping arm such that the outer catheter is clamped between the first clamping arm and the second clamping arm, and wherein clamping the outer shaft between the first clamping arm and the second clamping arm prevents the outer catheter from translating relative to the introducer (Par. 0059, 0069-0070, 0086, 0099, 0101) . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-22-aia AIA Claim s 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over ASAI (US 2018/0369540) as applied to claim 18 above, and further in view of Ponzi et al. (US 2006/0058738) . Regarding claims 19-20, Asai discloses the medical device lock of claim 18. Asai fails to further disclose wherein the first hinge connection includes a first spring configured to bias the first clamping arm in an unlocked configuration [ Claim 19 ]; and wherein the second hinge connection includes a second spring configured to bias the second clamping arm in the unlocked configuration [ Claim 20 ]. In the same field of endeavor, which is catheters, Ponzi teaches (Figs 3-6) wherein a first hinge connection (72) includes a first spring (82) configured to bias a first clamping arm (40) in an unlocked configuration; and wherein a second hinge connection (74) includes a second spring (82) configured to bias a second clamping arm (42) in the unlocked configuration (Par. 0006, 0025, 0033-0034). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Asai to have wherein the first hinge connection includes a first spring configured to bias the first clamping arm in an unlocked configuration [ Claim 19 ]; and wherein the second hinge connection includes a second spring configured to bias the second clamping arm in the unlocked configuration [ Claim 20 ]. Doing so would bias the clamp towards the open position [i.e. unlocked position] (Par. 0006-008), as taught by Ponzi . 07-22-aia AIA Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over ASAI (US 2018/0369540) as applied to claim 23 above, and further in view of Fleming et al. (US 2018/0317956) . Regarding claim 24, Asai discloses the medical device lock of claim 23. Asai further discloses (Figs. 10C) wherein the first clamping channel, the second clamping channel or both the first clamping channel and the second clamping channel includes a gel material disposed thereon as a friction reduction member (Par. 0101). However, Asai fail to disclose the second clamping channel or both the first clamping channel and the second clamping channel includes a silicone pad disposed thereon. In the same field of endeavor, which is catheters, Fleming teaches a lubricious film, such as silicone, can be added to the inner liner to reduce friction between the inner liner and the outer layer (Par. 0032). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the gel material of Asai, for the silicone pad of Fleming since these mechanisms perform the same function of reducing friction. Simply substituting one friction reduction member for another would yield the predicable result of reduced friction within the channel. See MPEP 2143 . 07-22-aia AIA Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over ASAI (US 2018/0369540) as applied to claim 16 above, and further in view of Ponzi et al. (US 2006/0058738) . Regarding claim 25, Asai discloses the medical device lock of claim 16. Asai fails to further disclose wherein the first clamping arm includes a locking member disposed along a proximal end region of the first clamping arm, and wherein the locking member is configured to releasably engage a portion of the second clamping arm. In the same field of endeavor, which is catheters, Ponzi teaches (Figs. 3-5) wherein a first clamping arm (42) includes a locking member (86) disposed along a proximal end region of the first clamping arm, and wherein the locking member is configured to releasably engage a portion of the second clamping arm (Par. 0028-0033). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Asai to have wherein the first clamping arm includes a locking member disposed along a proximal end region of the first clamping arm, and wherein the locking member is configured to releasably engage a portion of the second clamping arm. Doing so would ease release of the catheter from the arms (Par. 0030), as taught by Ponzi . 07-22-aia AIA Claim s 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over ASAI (US 2018/0369540) as applied to claim 32 above, and further in view of Ponzi et al. (US 2006/0058738) . Regarding claim 33, Asai discloses the medical device lock of claim 32. Asai fails to further disclose wherein the first hinge connection includes a first spring configured to bias the first clamping arm in an unlocked configuration, and wherein the second hinge connection includes a second spring configured to bias the second clamping arm in the unlocked configuration. In the same field of endeavor, which is catheters, Ponzi teaches (Figs 3-6) wherein a first hinge connection (72) includes a first spring (82) configured to bias a first clamping arm (40) in an unlocked configuration, and wherein a second hinge connection (74) includes a second spring (82) configured to bias a second clamping arm (42) in the unlocked configuration (Par. 0006, 0025,0033-0034). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Asai to have wherein the first hinge connection includes a first spring configured to bias the first clamping arm in an unlocked configuration, and wherein the second hinge connection includes a second spring configured to bias the second clamping arm in the unlocked configuration. Doing so would bias the clamp towards the open position [i.e. unlocked position] (Par. 0006-008), as taught by Ponzi. Regarding claim 34, Asai discloses the medical device lock of claim 32. Asai fails to further disclose wherein the first clamping arm includes a locking member disposed along a proximal end region of the first clamping arm, and wherein the locking member is configured to releasably engage a portion of the second clamping arm in the locked configuration. In the same field of endeavor, which is catheters, Ponzi teaches (Figs. 3-5) wherein a first clamping arm (42) includes a locking member (86) disposed along a proximal end region of the first clamping arm, and wherein the locking member is configured to releasably engage a portion of the second clamping arm in the locked configuration (Par. 0028-0033). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Asai to have wherein the first clamping arm includes a locking member disposed along a proximal end region of the first clamping arm, and wherein the locking member is configured to releasably engage a portion of the second clamping arm in the locked configuration. Doing so would ease release of the catheter from the arms (Par. 0030), as taught by Ponzi. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Chima Igboko whose telephone number is (571)272-8422. The examiner can normally be reached on Monday-Friday 9:00am-6:00pm. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho, at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /C.U.I/ Examiner, Art Unit 3771 /ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 May 5, 2026 Application/Control Number: 18/993,415 Page 2 Art Unit: 3771 Application/Control Number: 18/993,415 Page 3 Art Unit: 3771 Application/Control Number: 18/993,415 Page 4 Art Unit: 3771 Application/Control Number: 18/993,415 Page 5 Art Unit: 3771 Application/Control Number: 18/993,415 Page 6 Art Unit: 3771 Application/Control Number: 18/993,415 Page 7 Art Unit: 3771 Application/Control Number: 18/993,415 Page 8 Art Unit: 3771 Application/Control Number: 18/993,415 Page 9 Art Unit: 3771 Application/Control Number: 18/993,415 Page 10 Art Unit: 3771
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