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 .
Terminal Disclaimer
The terminal disclaimer filed on 7/7/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US 11202699 B2 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Amendment
In light of Applicant’s amendment, claim(s) 64 and 72 are amended and claim 68 was previously canceled. Claims 64-67 and 69-72 are now pending examination.
The objections to the claims are withdrawn in light of Applicant’s amendment.
Response to Arguments
Applicant’s arguments, filed 6/30/2026, with respect to the rejection(s) of claim(s) 64 under U.S.C. 103 have been fully considered and are persuasive. Examiner agrees the rejection fails to explicitly disclose the amended limitation “wherein the pitch Z is greater than 1.5 times the diameter D”. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Batiste in view of Auth.
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.
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.
Claim(s) 64-67, 69-72 is/are rejected under 35 U.S.C. 103 as being unpatentable over Batiste (US 20080183206 A1)(noted on IDS) in view of Auth (US 5695507 A).
Regarding claim 64, Batiste discloses an embolic protection device (EPD) configured for arrangement within a blood vessel (Paragraph 0012; 0053), the EPD comprising a filament (800+900) configured to include:
an un-deployed linear state including a portion configured to fit within a lumen of a needle (400) (Figure 9; Paragraph 0013; 0049-50),
a deployed state wherein the filament automatically forms a helix comprising a support portion (labeled in Annotated Figure 14) and a filter portion (labeled in Annotated Figure 14) (Figure 13-15; Paragraph 0052), and
a pull wire (1200) configured to traverse a patient’s skin and enable retraction of the device by pulling the device out of the vessel (Figure 13; Paragraph 0054),
wherein:
the support portion comprises an elongated coil (labeled in Annotated Figure 14), the elongated coil including a first portion (labeled in Annotated Figure 14) having an axis (labeled in Annotated Figure 14) (Figure 14),
the first portion comprising an elongated coil having a pitch (Figure 13-15; Paragraph 0052),
the filter portion includes a funnel (the labeled filter portion tapers, thus is considered a funnel) configured to taper in a first direction, the funnel also including at least one reducing coil (labeled in Annotated Figure 14) having a center which is off the axis (Annotated Figure 14; Paragraph 0052),
the support portion is configured to at least one of orientate the filter portion within a blood vessel and secure the EPD relative to the blood vessel (Paragraph 0053),
at least a portion of the elongated coil is configured to resist axial compression of the support portion (Paragraph 0052), and support from the walls of the blood vessel, which opposes further compression, is generated (the coil is formed into a predetermined shape, thus is fully capable of resisting further compression when deployed) (Paragraph 0052-53), and
the reducing coil is configured to capture emboli greater than a predetermined size (Figure 15- 16; Paragraph 0055).
Batiste fails to explicitly disclose an elongated coil having a pitch which exceeds a diameter thereof, wherein the pitch Z is greater than 1.5 times the diameter D; the elongated coil being configured such that when the elongated coil is compressed, its diameter grows.
However, Auth is directed to a thrombus removal device and teaches an elongated coil (53) having a pitch which exceeds a diameter thereof, wherein the pitch of the coil is from about 1 times to 8 times, more preferably 4 times the mean diameter of the coil, which encompasses the claimed range of “greater than 1.5 times the diameter D” (Col 8, line 16-18). As a result, the elongated coil would be fully capable of being configured such that when the elongated coil is compressed, its diameter grows (Applicant’s spec states the pitch exceeding the diameter of the coil would result in resisting axial compression because initial compression of the elongated coil causes the coil diameter to increase [0051], thus this property would allow the modified coil of Batiste with Shinar to exhibit a similar capability.).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Batiste to include an elongated coil having a pitch which exceeds a diameter thereof, wherein the pitch Z is greater than 1.5 times the diameter D, as taught by Auth, as both references and the claimed invention are directed to thrombus devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Batiste with the teachings of Auth by incorporating an elongated coil having a pitch which exceeds a diameter thereof, wherein the pitch Z is greater than 1.5 times the diameter D in order to maintain larger clots in the wire to prevent them from becoming downstream emboli (Auth Col 2 line 19-24).
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Regarding claim 65, Batiste further discloses wherein the deployed state further comprises a stem (labeled in Annotated Figure 14) configured to traverse the wall of the blood vessel (Figure 14; Paragraph 0054).
Regarding claim 66, Batiste further discloses a stopper (1300) configured to prevent the filament from moving from a lumen of the blood vessel outwards through a puncture in the blood vessel (Figure 14; Paragraph 0054) (the fixation device 1300 prevents movement of the filter in its entirety, thus would be fully capable to prevent the filament from moving from the vessel lumen outwards through a puncture in the vessel.
Regarding claim 67, Batiste further discloses an anchor (1300) configured to engage tissue externally to a lumen of the blood vessel (Figure 14; Paragraph 0054).
Regarding claim 69, Batiste further discloses a second reducing coil (labeled in Annotated Figure 14) whose center is off the axis (Figure 14).
Regarding claim 70, Batiste further discloses wherein a line segment (labeled in Annotated Figure 14) connecting the centers of the reducing coil and the second reducing coil intersects the axis (Annotated Figure 14).
Regarding claim 71, Batiste further discloses wherein the filament is made from nitinol (Paragraph 0051).
Claim(s) 72 is/are rejected under 35 U.S.C. 103 as being unpatentable over Batiste in view of Auth as applied to claim 64 above, and further in view of Shinar et al. (US 20150148837 A1) (previously of record).
Regarding claim 72, Batiste discloses the EPD of claim 64, and further discloses wherein the filament cross section is round (Paragraph 0051), but fails to explicitly disclose the diameter of the cross section is in the range of 0.05 and 0.3 mm.
However, Shinar is directed to a thrombus filter device and teaches the diameter of the cross section of a filament is in the range of 0.05 and 0.3 mm (Paragraph 0111; 0120).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Batiste such that the diameter of the cross section of a filament is in the range of 0.05 and 0.3 mm, as taught by Shinar, as both references and the claimed invention are directed to blood filter devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Batiste with the teachings of Shinar by incorporating the diameter of the cross section of a filament is in the range of 0.05 and 0.3 mm in order to prevent blood coagulation (Shinar Paragraph 0111).
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.
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/Z.J./Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
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