DETAILED ACTION
This office action is in response to the communication received November 24, 2025.
The amendments of claims 1, 10, 12, and 17 are acknowledged.
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 Arguments
Applicant’s arguments that amendments overcome previous 35 USC 112(b) rejections are persuasive and the previous 35 USC 112(b) rejections are withdrawn.
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments regarding claim 12 and Folan, Binmoeller and Gray not disclosing the most recent amendments of claim 12 are persuasive, and explanations on allowability appear below in the Allowable Subject Matter section.
Claim Objections
Claims 12 is objected to because of the following informalities: “is overlaps” should be “overlaps” in line 6 of claim 12. Appropriate correction is required.
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.
Claim(s) 1, 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Nobles et al. (US 6,143,015) in view of Roth et al. (US 2004/0167572).
Regarding claim 1, Nobles discloses a medical device (see Fig. 8), comprising: an elongate tubular body comprising first (see Fig. 8, around part 14) and second end (see Fig. 8, around part 12) portions, the elongate body having a constrained configuration and an unconstrained configuration (see col. 8, lines 9-16, inflated configuration an uninflated configuration); wherein the first end portion of the elongate tubular body is doubled back towards the second end into a retention member 14 such that the first end portion overlaps the elongate tubular body a length greater than a length of the retention member (see Fig. 8).
Nobles does not disclose the elongate tubular body comprising a coating or covering of the retention member and extends beyond the first end portion towards the second end portion along a partial axial length of the medical device.
Roth discloses coating medical devices to minimize or substantially eliminate a biological organism’s reaction to the introduction of the medical device to the organism (see Abstract), the coating fully covering the outer part of the medical device (see Fig. 32). It would have been obvious to a person to coat the medical device of Nobles to minimize or substantially eliminate a biological organism’s reaction to the introduction of the medical device to the organism, as disclosed by Roth, which would result in the full coating of the retention member and coating extending beyond the first end portion to the second end portion along a partial axial length of the medical device.
Regarding claim 5, Nobles and Roth disclose the limitations of claim 1 and further discloses the retention member is fully covered (see rejection of claim 1, full coating of retention member).
Regarding claim 6, Nobles and Roth disclose the limitations of claim 1 and Nobles further discloses the retention member comprises at least one flange (see Fig. 8).
Regarding claim 7, Nobles and Roth disclose the limitations of claim 1 and further disclose the coating or covering extends towards the second end portion along at least 50% of a full axial length of the medical device (see rejection of claim 1 and Fig. 32 of Roth, full covering of medical device teaching of Roth combined with teachings of Nobles explained above).
Regarding claim 8, Nobles and Roth disclose the limitations of claim 1, and Nobles further discloses the elongate tubular body in the unconstrained configuration is configured to facilitate fluid flow without leakage between the second end portion and the retention member (see Fig. 5A).
Regarding claim 9, Nobles and Roth disclose the limitations of claim 1, and Nobles further discloses a second retention member 12 in the unconstrained configuration (see Fig. 8, even when unconstrained the second retention portion would still be there, just deflated).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nobles in view of Roth as applied to claim 1 above, and further in view of Amplatz et al. (US 2009/0210047).
Regarding claim 10, Nobles and Roth teach the limitations of claim 1 but do not disclose the medical device further comprising at least one radiopaque, echogenic, or colored marker.
Amplatz discloses a medical device with an elongate body comprising radiopaque markers to facilitate visualization and positioning of a stent within a lumen (see par. 31). It would have been
obvious to a person having ordinary skill in the art before the effective filing date of the claimed
invention to have the medical device of Nobles and Roth further include radiopaque markers to
facilitate visualization and positioning of the medical device, as disclosed by Amplatz.
Allowable Subject Matter
Claims 13-16 are allowable, claim 12 would be allowable if rewritten to overcome the claim objection in the current office action, and claims 2-4 and 11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claims 2-4, the closest prior art found is Nobles and Roth, which do not disclose the second portion uncovered or an uncovered segment. Roth discloses motivation for a coating to minimize or substantially eliminate a biological organism’s reaction to the introduction of the medical device to the organism and in light of that, one of ordinary skill would not be motivated to partially coat the medical device of Nobles absent hindsight.
Regarding claim 11, the closest prior art found is Nobles and Roth, which do not disclose the medical device is a self-expanding stent. Furthermore, one of ordinary skill in the art would not be motivated to modify the device to be a self-expanding stent as the device is specifically designed to be inflatable (see Abstract) and none self-expanding, and therefore would make the invention inoperable.
Regarding claims 12-16, the closest prior art found is Folan, Binmoeller, and Gray, which do not disclose “the retention member having a doubled back configuration, such that the first end overlaps the elongate body a length greater than a length of the retention member.” While it is well known to have retention members that are created by doubling back to overlap a tubular body, as is shown in Binmoeller, Bruszewski et al. (US 2010/0241218), Shin (US 2013/0012969), and Kim (US 6,007,544), these references do not disclose overlapping a length greater than a length of the retention member. While Nobles discloses such an overlap in Figure 8, this overlap is to allow a cavity to inflate the retention members via tube 20 (col. 8, lines 12-19) and as Binmoeller is directed to a mesh stent that is not inflatable, one of ordinary skill in the art would not be motivated to add features that would help with inflation. Additionally and as explained above with the allowability of claims 2-4, one of ordinary skill also would not look at the medical device of Nobles and modify it in such a way as to the second portion uncovered.
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 ARIANA ZIMBOUSKI whose telephone number is (303)297-4665. The examiner can normally be reached 8:30 - 5:00 PST M-F.
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, REBECCA E EISENBERG can be reached at (571) 270-5879. 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.
/ARIANA ZIMBOUSKI/ Primary Examiner, Art Unit 3781