DETAILED ACTION
Response to Amendment
The amendment filed September 16, 2025 has been entered. Claims 9-12 have been amended with claim 21 having been newly added. Claims 9-14 and 21 are currently pending in the application.
Response to Arguments
Applicant’s arguments with respect to the rejection(s) of the amended claim(s) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is set forth below.
Claim Rejections - 35 USC § 103
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.
Claim(s) 9-14 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gerrans et al. (US 2011/0218494) in view of Avneri et al. (US 2014/0296889).
Regarding claim 9, Gerrans et al. discloses a treatment method (¶ [0096]) for causing a physiologically active substance (¶ [0081], chemical or biological drugs) to act on a blood vessel wall (Figure 6A, the surface of bodily cavity 48 on which tumor 50 is located) in a blood vessel (Figure 6A, ¶ [0068], bodily cavity 48 may be a blood vessel), the method comprising:
inflating an inflation body (Fig. 1, balloon 36) in the blood vessel to dispose the inflation body a first distance away from the blood vessel wall (Fig. 8, the distance between the top surface of balloon 36 and the wall on which tumor 50 is located); and
guiding, using the inflation body, the physiological active substance released from an upstream side of the blood vessel relative to the inflation body toward the blood vessel wall (see Figure 8, ¶ [0096], the agent is circulated between the catheter 22 opening 39 and the opening 73). Gerrans fails to disclose a first anchor member which does not block blood flow downstream of the anchor member.
Avneri et al. (henceforth Avneri) teaches (Figure 9B) an anchoring member (anchoring balloon; see e.g., Figures 3A-3E which depict an analogous balloon 31 as anchoring the catheter in the vessel) which further comprises openings in the anchoring member for maintaining blood flow past the anchoring member when inflated to anchor the device in the vessel (¶ [0111]); wherein the anchoring member is radially expanded (via inflation into the vessel wall) to anchor the catheter during a procedure.
It would have been obvious to one of ordinary skill in the art to modify the anchoring balloons of Gerrans to provide the openings therein, as taught by Avneri, for the purpose of maintaining blood flow through the vessel during a procedure as taught by Avneri (¶ [0111]). In addition, it would have been obvious to use the anchoring ballon of Avneri to replace both anchoring balloons of Gerrans so as to provide full blood flow through the vessel and around the device during a procedure while maintaining the function of securing the catheter at the target site within the vessel.
Regarding claim 10, Gerrans et al. discloses the treatment method of claim 9,
and wherein the method further comprises:
radially expanding at least one anchor member (Fig. 1, balloons 32, 34; see balloon in Figure 9B of Avneri which replaces the anchoring balloons of Gerrans in the cited combination) and a second anchor member (replacing both the upstream and downstream anchors of Gerrans in the combination with the bypass anchors of Avneri); and the step of radially expanding to a first outer diameter larger than a second outer diameter of the inflation body when inflated (see Figure 8 of Gerrans and Figures 3A-3E of Avneri for the deployment of the anchoring member).
Regarding claim 11, Gerrans/Avneri teach the treatment method of claim 10,
wherein the inflation body is inflated after the at least one anchor member is radially expanded (¶ [0077]; see also ¶ [0099] of Avneri).
Regarding claim 12, Gerrans/Avneri teach the treatment method of claim 10,
wherein an axis of the first and second anchor members are aligned with a central axis of the blood vessel by expanding the first and second anchor members (see Figure 6A-6B, ¶ [0077], the longitudinal axis of balloon 36 is aligned with the longitudinal axis of bodily cavity 48; see also Figures 3A-3E and 9B of Avneri).
Regarding claim 13, Gerrans further discloses the treatment method of claim 12,
wherein the inflation body is positioned so as to not come into contact with the blood vessel wall (see Figure 8).
Regarding claim 14, Gerrans/Avneri teach the treatment method of claim 13,
wherein the inflation body does not block a blood flow when guiding the physiologically active substance toward the blood vessel wall (see Figure 8, ¶ [0077], ¶ [0096], the balloon 36 does not block fluid from flowing around it, therefore any blood trapped when the chamber 58 is formed can be recirculated along with the agent; see also Figure 9B and ¶ [0111] of Avneri).
Regarding claim 21, Gerrans/Avneri teach wherein the second anchor member does not block a blood flow and allows the blood flow to be maintained from an upstream side to a downstream side of the second anchor member (in the cited combination, both anchoring balloons of Gerrans are replaced with the bypass anchors of Avneri to maintain blood flow through the vessel while the catheter is anchored in placed during a procedure as set forth above).
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 JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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.
/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights