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 and Amendment Filed
Applicant’s response and amendment, filed March 30, 2026, has been entered and made of record.
Previously Set Forth Objections and Rejections
The status of the objections and rejections set forth in the previous Office action (mailed November 28, 2025) is as follows:
The objection to the drawings has been overcome by the filing of a replacement sheet on March 30, 2026.
The objection to the specification has been overcome by amendments to the specification filed on March 30, 2026.
The objection to claim 8 has been overcome by amendments to claim 8 in the response filed March 30, 2026.
The 35 USC 103 rejection of claims 1-20 as being unpatentable over Stigall (U.S. Patent Application Publication No. 2014/0171788) in view of Chu (U.S. Patent Application Publication No. 2022/0280021) and further in view of Baviskar et al. (U.S. Patent Application Publication No. 2024/0358925) is hereby maintained and is reiterated below.
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.
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.
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.
Claims 1-20 is/are rejected under 35 U.S.C. 103 as being obvious over Stigall (U.S. Patent Application Publication No. 2014/0171788) in view of Chu (U.S. Patent Application Publication No. 2022/0280021) and further in view of Baviskar et al. (U.S. Patent Application Publication No. 2024/0358925)
The applied reference of Baviskar et al. has a common inventor and assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
In regard to claims 1, 3, 4, 8, 12, 16-18, Stigall teaches a cannulation system 100 with a sensor wire 110 slidably disposed within a penetrating instrument 120 (see Fig. 1). The sensor wire 110 includes a core wire 155 and a sensor 150 disposed on the distal end (see Fig. 1 and para. 0033). The penetrating instrument 120 has a lumen 178 extending between a sharp distal tip 180 and a proximal end 185 and the sensor wire 110 extends through the lumen 178 and can extend beyond the distal tip 180 (see Fig. 1 and paras. 0035-0037). The sensor wire 110 is able to be reciprocally and axially moveable within the penetrating instrument 120 (see para. 0037) and a connector 170 serves as a handle where the sensor wire 110 is housed within and retracted within the handle (see Figs. 1 and 12). The sensor wire 110 (and the sensor 150 disposed therein – see Fig. 1) may range in diameter from 0.008 inches to 0.040 inches (see para. 0037). Stigall is not specific as to an actuation mechanism for the sensor wire 110. However, Chu teaches a similar medical device with a handle 12 with a shaft advancement device 34 that is used to advance and retract the shafts of a retrieval device 38 and a laser fiber 36 through the main lumen of the device (see Fig. 1 and paras. 0065, 0069 and 0073). Figure 1 shows that the shaft advancement device 34 is positioned within the handle 12. The shaft advancement device 34 thus provides a handle-mounted actuator to advance/retract a cable or shaft within a medical device, thus making it easier for the operator to perform a procedure without having to remove the overall medical device from the patient or make an additional incision, as demonstrated by Chu. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the device of Stigall with the handle-mounted actuator disclosed by Chu in order to equip the device of Stigall with the ability to advance/retract a cable or shaft within a medical device to make it easier for the operator to perform a procedure without having to remove the overall medical device from the patient or make an additional incision. Stigall is silent as to a fluid delivery device coupled to the second or proximal end of the handle 170. However, Baviskar et al. teach a similar medical device with a fluid delivery device in the form of a syringe 110 that couples to the proximal end of a handle (see Figs. 1 and 9B). Provision of a syringe for introducing fluids to the shaft of a medical device is well known in the art, as taught by Baviskar et al., in order to irrigate a surgical site. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the device of Stigall with the syringe-type fluid delivery device disclosed by Baviskar et al., positioned at the proximal end of the handle 170 (also disclosed by Baviskar et al.), in order to equip the device of Stigall with the ability to irrigate a surgical site.
With further respect to claim 12 and in regard to claims 2 and 20, Chu teaches that the retrieval device 338 may be spooled around a shelf located on a rotation disk 365 or may be spooled within a channel extending into the surface of the rotation disk 365 (see para. 0140). Spooling of the cable would be advantageous so that slack in the cable does not become tangled either on itself or on other parts of the device. As with the combination of Stigall and Chu above, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the device of Stigall with rotation disk 365 (spool) disclosed by Chu in order to equip the device of Stigall with the ability to capture and contain the slack in the sensor wire 110 so that it does not become tangled either on itself or on other parts of the device. In regard to claims 5, 6, 13 and 14, Chu teaches that the shaft advancement device 334 may include a spring 355 resting in a channel located on the rotation disk 365 such that once the rotation cap 386 on rotation disk 365 is released, the spring 355 may expand thereby rotating the rotation cap 386 in a counterclockwise direction and retracting the retrieval wire 339 proximally (see para. 0141). Spring 355 thus functions as a tab that engaged with the rotation disk 365 to move the retrieval wire 339 into a retracted or spooled. This would be advantageous when the procedure is completed and the medical device is being withdrawn or prior to the start of the procedure as the device is being inserted and placed into position. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the device of Stigall with the spring 355 within the rotation disk 365 in order to equip the device of Stigall with the ability to lock the sensor wire 110 in a retracted position as when the procedure is completed and the medical device is being withdrawn or prior to the start of the procedure as the device is being inserted and placed into position. In regard to claim 7, see para. 0034 of Stigall. In regard to claim 9, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to utilize the combined invention of Stigall in view of Baviskar et al. (see above) such that the fluid delivery device is activated after the sensor wire 110 is withdrawn from the lumen 178 in order to provide the ability to flush the surgical site once the sensor wire 110 has been removed. In regard to claim 10, see para. 0032 of Stigall. In regard to claims 11, 15 and 19, rotation cap 386 of Chu is depressed and released (see para. 0141) and thus functions as a button.
Response to Arguments
Applicant's arguments filed March 30, 2026 have been fully considered but they are not persuasive.
Applicant argues that Stigall is not a general-purpose needle insertion device and structurally integrating a fluid delivery pathway into Stigall’s lumen 178 would disrupt the precise acoustic conditions at the distal transducer (see page 9 of the response filed 3/30/26). Applicant also argues that Stigall contemplates a second, longer intravascular-sensing wire 1200 thus demonstrating that Stigall is an ultrasound-based vessel sensing and access system and not a fluid delivery platform (see page 9 of the response filed 3/30/26). Applicant admits that Stigall discloses that connector 170 can be disconnected to allow the advancement of an irrigation catheter over the sensor wire 110 or in place of the sensor wire 110, but this advancement occurs after the connector 170 has been disconnected from the ultrasound system (after the sensing function has concluded) (see page 9 of the response filed 3/30/26). Thus, it is a post-access substitution, not a permanent structural integration of a fluid delivery device into Stigall’s handle (see pages 9-10 of the response filed 3/30/26). Applicant also argues that the lumen 178 is specifically designed to seal against fluid entry and placing a fluid delivery pathway in communication with lumen 178 would alter the architecture upon which Stigall’s angle-dependent Doppler measurement depends, thus rendering Stigall unsatisfactory for its intended purpose (see page 10 of the response filed 3/30/26). Applicant further argues that the combination of Stigall and Baviskar is impermissible hindsight (see pages 10-11 of the response filed 3/30/26). Applicant also argues that the actuation mechanism of Chu is specifically designed for use with a flexible ureteroscope and Stigall employs a rigid, penetrating instrument and thus a skilled artisan would have no reason to look to a flexible ureteroscope accessory for actuation design guidance (see page 11 of the response filed 3/30/26).
As to applicant’s arguments regarding Stigall, it is immaterial that Stigall is not a general-purpose needle insertion device or that Stigall teaches the use of a second, longer intravascular-sensing wire. It only matters whether or not the structure of Stigall meets the claimed limitations. It is further noted that claim 1 does not recite a fluid delivery device within the needle -- only a fluid delivery device coupled to the handle – and there are no recitations about permanent structural integration of the fluid delivery device. Although the claims are interpreted in light of the specification, applicant’s arguments and limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In addition, independent claims 12 and 17 do not recite any type of fluid delivery device. Furthermore, as recognized by applicant, Stigall discloses that connector 170 can be disconnected to allow the advancement of an irrigation catheter over the sensor wire 110 or in place of the sensor wire 110 (see para. 0034). Thus, Stigall contemplates the infusion of fluid within the lumen 178 when the sensor wire 110 is in place and the addition of a fluid delivery device does not render Stigall unsatisfactory for its intended purpose. In response to applicant's argument regarding Baviskar, that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). As to applicant’s arguments regarding Chu, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Stigall and Chu are both within the medical arts and teachings regarding flexible medical devices are equally applicable to teachings regarding rigid medical devices. Furthermore, the sensor wire 110 of Stigall (which is what would be spooled or coiled) is flexible and thus the actuation mechanism of Chu would be additionally applicable.
Conclusion
THIS ACTION IS MADE FINAL. 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 BEVERLY MEINDL FLANAGAN whose telephone number is (571)272-4766. The examiner can normally be reached Mon-Fri 7:30AM to 5:00PM.
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, Linda Dvorak can be reached at 571-272-4764. 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.
/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
Prosecution Insights