Prosecution Insights
Last updated: October 04, 2026
Application No. 18/774,349

Method of Accessing A Vascular Site With A Multi-Directional Steerable Catheter

Non-Final OA §DP
Filed
Jul 16, 2024
Priority
Oct 19, 2015 — continuation of 14/887,203 +3 more
Examiner
AHMED, TASNIM M
Art Unit
Tech Center
Assignee
Biocardia Inc.
OA Round
1 (Non-Final)
81%
Grant Probability
Favorable
1-2
OA Rounds
7m
Est. Remaining
86%
With Interview

Examiner Intelligence

Grants 81% — above average
81%
Career Allowance Rate
364 granted / 449 resolved
+21.1% vs TC avg
Moderate +5% lift
Without
With
+5.2%
Interview Lift
resolved cases with interview
Typical timeline
2y 9m
Avg Prosecution
28 currently pending
Career history
470
Total Applications
across all art units

Statute-Specific Performance

§101
1.8%
-38.2% vs TC avg
§103
39.7%
-0.3% vs TC avg
§102
30.2%
-9.8% vs TC avg
§112
21.5%
-18.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 449 resolved cases

Office Action

§DP
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 . Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-24 and 32 of U.S. Patent No. 11,141,568 in view of Rosenman et al (US 2006/0135961). Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims anticipate the instant claims as follows: Instant Patent 11141568 1. A method of accessing a target site in a first iliac artery of a patient, said method comprising the steps of: providing a steerable catheter comprising: a tube having a proximal end, a distal end, and a lumen extending therebetween, said tube having a first segment proximate said distal end and a second segment that extends proximally from said first segment toward said proximal end, a first pull wire disposed within a first side lumen of the tube and a second pull wire disposed within a second side lumen of the tube, and extending from the distal end to the proximal end of the tube, said first and second pull wires comprising first and second wound segments which are wound about a longitudinal axis of the tube in the second segment of the tube, with the first wound segment and the second wound segment dispersed circumferentially about the longitudinal axis of the tube; wherein the wound segments are configured to reduce whipping when the tube is rotated around the longitudinal axis of the tube, a handle fixed to the tube, said handle comprising: means for selectively tensioning the first pull wire without tensioning the second pull wire, or tensioning the second pull wire without tensioning the first pull wire, to provide bidirectional steering of the deflectable segment; inserting the steerable catheter through a second iliac artery of the patient and over an iliac bifurcation of the patient until the first segment of the tube is disposed proximate the target site in the first iliac artery of the patient, in a curved configuration; and operating one or both of the pull wires to deflect the first segment of the tube around the iliac bifurcation to advance the first segment into the first iliac artery and toward the target site. 20. A method of accessing a target site in a vessel of a patient, said method comprising the steps of: providing a steerable catheter comprising: a tube (2) having a proximal end (4), a distal end (5), and a lumen extending therebetween, said tube (2) having a first segment (2d) proximate said distal end and second segment (2w) that extends proximally from said first segment (2d) toward said proximal end, a first pull wire (12) disposed within a first side lumen of the tube (2) and a second pull wire (13) disposed within a second side lumen of the tube (2), and extending from the distal end (5) to the proximal end (4) of the tube (2), said first and second pull wires comprising first and second wound segments (12w, 13w) which are wound about a longitudinal axis of the tube in the second segment (2w) of the tube, with the first wound segment (12w) and the second wound segment (13w) dispersed circumferentially about the longitudinal axis of the tube (2); wherein the wound segments (12w, 13w) are configured to reduce whipping when the tube (2) is rotated around the longitudinal axis of the tube (2), a handle (3) fixed to the tube (2), said handle comprising: means for selectively tensioning the first pull wire without tensioning the second pull wire, or tensioning the second pull wire without tensioning the first pull wire, to provide bidirectional steering of the deflectable segment; inserting the steerable catheter into a vessel of the patient, and navigating the steerable catheter through the vessel of the patient until the first segment of the tube is disposed proximate the target site and the second segment is disposed across a curve in the vessel; and operating one or both of the pull wires to deflect the first segment of the tube; and rotating the tube about the long axis of the tube (2) while the steerable catheter is disposed within the vessel. The method of the patent claims is silent regarding “a target site in a first iliac artery of a patient.” However, Rosenman teaches a steerable guide catheter (Figs. 1-2), thus being in the same field of endeavor, that is used to access an internal iliac artery during a graft procedure (¶0049). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have used the method of the patent claims to access a first iliac artery in a patient at a bifurcation as taught by Rosenman in order to treat a desired area of a patient, as recognized by Rosenman. Instant 2 3 4 5 6 7 Patent 20 21 22 23 24 32 Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 12,036,371 in view of Rosenman et al (US 2006/0135961). Although the claims at issue are not identical, they are not patentably distinct from each other because patent claim 1 teaches each and every element of instant claim 1 but is silent regarding ““a target site in a first iliac artery of a patient.” However, Rosenman teaches a steerable guide catheter (Figs. 1-2), thus being in the same field of endeavor, that is used to access an internal iliac artery during a graft procedure (¶0049). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have used the method of the patent claims to access a first iliac artery in a patient at a bifurcation as taught by Rosenman in order to treat a desired area of a patient, as recognized by Rosenman. The other elements of the claim are anticipated as follows: Instant 1 2 3 4 5 6 7 Patent 1 2 3 4 5 6 7 Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time. 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, Bhisma Mehta can be reached at (571)272-3383. 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. /TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783
Read full office action

Prosecution Timeline

Jul 16, 2024
Application Filed
Sep 22, 2026
Non-Final Rejection mailed — §DP (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
81%
Grant Probability
86%
With Interview (+5.2%)
2y 9m (~7m remaining)
Median Time to Grant
Low
PTA Risk
Based on 449 resolved cases by this examiner. Grant probability derived from career allowance rate.

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