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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 4-16, 49-57 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.
Claim Rejections - 35 USC § 102
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 –
(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.
Claim(s) 1, 5-6, 11,13, 15, 49 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Malek et al. 2020/0069927.
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Noting fig. 68A-68C Malek et al. discloses the invention as claimed comprising: A method of performing a medical procedure at a treatment site in a dural venous sinus (see [0027]) of a brain of a patient, the method comprising: positioning a system ([0087]) of devices into an advancement configuration, the system of devices comprising: a catheter (50) having a catheter lumen (this is an inherent feature), an inner diameter and a distal end; and an inner member (1100) sized and shaped to slide within the catheter lumen (see [0089]), wherein the inner member defines a single lumen and has a distal portion, the distal portion having a first outer diameter that tapers distally (see fig. 68C) to a second outer diameter that is smaller than the first outer diameter, wherein the inner member transitions in flexibility from a proximal end of the inner member to a distal end of the inner member, the distal end of the inner member being more flexible (this is inherent as the inner member must be navigated through the catheter) than the distal end of the catheter, and wherein, when positioned in the
advancement configuration, the inner member extends coaxially through the catheter lumen until the distal portion of the inner member is positioned distal to the distal end of the catheter (see fig. 68 supra); advancing the catheter and the flexible inner member retrograde to a target location distal to a sigmoid sinus (see [0133]) relative to an access point of entry while the system of devices is positioned in the advancement configuration; positioning the catheter at the treatment site in the dural venous sinus ([0134]), the treatment site comprising an occlusion, wherein the catheter inner diameter is about 0.052" (1.321 mm) to about 0.088" (2.235 mm) (see 0096 which states “…The tubing can be formed to have various inner diameters (ID) or outer diameters (OD), for example, based on the intended size or use of the catheter assembly 50. The inner diameter of the reinforcing member 1100 can be about 0.005 inches to about 0.080 inches.” It is inherent that inches translated to the claim sizes in mm and that diameters are applicable to the inner diameter of the catheter which is tubing); removing the inner member from the patient; and treating the occlusion by applying variable aspiration pressure (see [0279]) through the catheter to remove the occlusion and restore outflow of blood from the brain through the dural venous sinus.
Regarding claims 5-6 see [0089] and liner 60 which can include any of various flexible and smooth materials, such as a plastic (PTFE) or other material, and can form the inner or working lumen and see [0180] for durometers.
Regarding claim 11, the device of Malek et al. displays a close fit as illustrated and see e.g. [0027 and 0133] and is capable of navigating through tortuous branched anatomies as claimed.
Regarding claim 13, see fig. 68C supra.
Regarding claims 15-16 Malet et al. discloses the use of guide wires e.g. [0123] and may extend through the entire length of the assembly as illustrated by fig. 68A “80”.
Regarding claim 49, Malek et al. discloses aspirating with pressure (this is done by flushing) and does not disclose crossing into the occlusion (which is the CSF) thus meets the limitations of the claim. See [0133-0314].
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) 7-10, 12, 14 and 50 is rejected under 35 U.S.C. 103 as being unpatentable over Malek et al. 2020/0069927.
Regarding claim 7-10, 12, 14, Malek et al. does not utilize the identical verbiage of the claim e.g. “…configured to extend from outside a patient's body, through a femoral artery, and beyond the sigmoid sinus…” or the claimed measurements and degrees.
It would be obvious to modify the inner member to have this claimed length because Malek et al. states in [0093] “..the various lengths can be configured based upon the medical environment in which the reinforcing member 1100 and catheter will be deployed… In some cases, longer zones at or near the proximal end of the reinforcing member 1100 can help to increase control of the catheter where it will be handled by a user…” and [0096] states that the tubing can be formed to have various inner diameters (ID) or outer diameters (OD), for example, based on the intended size or use of the catheter assembly 50, thus obvious to modify to the claimed sizes and diameters as the objective is to treat venous sinuses and intracranial diseases (see as noted in [0130]).
Regarding claim 50 Malek et al. does not specifically state that the distal end of the catheter is located near a proximal face of the occlusion. It would be obvious to modify the inner member to have this claimed length because Malek et al. to place the distal end of the catheter near the occlusion in order to treat any obstructions.
Allowable Subject Matter
Claims 4, 51-57 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.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art has been disclosed supra, however does not disclose or teach in combination with the limitations of claim 1 e.g. that the method includes a hypotube; wherein removing the inner member from the patient increases aspiration pressure through the catheter before external aspiration is applied through the catheter lumen; wherein the system of devices further comprises a pump fluidly connected to a connector at a proximal end of a guide sheath, the pump configured to apply the variable aspiration pressure and the limitations which depend from claim
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 Suzette Gherbi whose telephone number is (571)272-
4751. The examiner can normally be reached on Monday-Friday 7:00am-3:00pm. 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:/Avww.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Melanie Tyson can be reached on 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 September 3, 2026
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