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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/10/2025 has been entered.
Response to Amendment
In light of Applicant’s amendment, claim(s) 64-67 are amended and claim 68 is/are canceled. Claims 64-67 and 69-72 are now pending examination.
The objections to the claims are withdrawn in light of Applicant’s amendment.
The rejection(s) under 35 U.S.C. 112(b) to claim(s) 64-67 is/are withdrawn in light of Applicant’s amendment.
Response to Arguments
Applicant's arguments filed 10/10/2025 have been fully considered but they are not persuasive.
Regarding claim 64, Applicant argues Batiste does not provide recognition of an off-axis coil (Remarks Page 7). Examiner respectfully disagrees. Although Batiste’s specification does not explicitly disclose the wording of the present claims, the drawings, as annotated, provide the features of the present invention as claimed. According to MPEP 2125.I, “Drawings and pictures can anticipate claims if they clearly show the structure which is claimed. In re Mraz, 455 F.2d 1069, 173 USPQ 25 (CCPA 1972)…. When the reference is a utility patent, it does not matter that the feature shown is unintended or unexplained in the specification. The drawings must be evaluated for what they reasonably disclose and suggest to one of ordinary skill in the art. In re Aslanian, 590 F.2d 911, 200 USPQ 500 (CCPA 1979). See MPEP § 2121.04 for more information on prior art drawings as "enabled disclosures."” As such, the drawings of Batiste provide enough disclosure to anticipate the claims as written. Further, the claimed axis is not specific in regards to location or orientation with respect to the coil, thus, any axis of the coil can be interpreted as the claimed axis. As such, the axis as annotated in the Figures of Batiste is considered the claimed axis.
Regarding the amendments, the support portion was previously designated as a coil, thus now that the claims require the support portion to comprise an elongated coil, the interpretation of the reference is maintained.
Claim Objections
Claims 72 is objected to because of the following informalities:
Claim 72 appears to be written as “wherein the filament cross section 1s round” but should be written as “wherein the filament cross section is round”.
Appropriate correction is required.
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 Shinar et al. (US 20150148837 A1) (previously of record).
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; the elongated coil being configured such that when the elongated coil is compressed, its diameter grows.
However, Shinar is directed to a thrombus filter device and teaches an elongated coil (10) having a pitch which exceeds a diameter thereof (Paragraph 0024; 0113). 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 such that an elongated coil having a pitch which exceeds a diameter thereof; the elongated coil being configured such that when the elongated coil is compressed, its diameter grows, as taught by Shinar, as both references and the claimed invention are directed to thrombotic filters. 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 an elongated coil having a pitch which exceeds a diameter thereof; the elongated coil being configured such that when the elongated coil is compressed, its diameter grows in order for selective filtering of emboli, as the windings or turns of the helix therefore exclude emboli whose size is larger than the distance between consecutive helix turns (Shinar Paragraph 0008).
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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).
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).
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 64-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. US 11202699 B2 in view of Shinar et al.
Regarding claim 64, claim 1 of US 11202699 B2 claims an embolic protection device (EPD) configured for arrangement within a blood vessel (Col 28, line 53-54), the EPD comprising a filament (Col 28, line 55) configured to include:
an un-deployed linear state including a portion configured to fit within a lumen of a needle or a tube (Col 28, line 56-57),
a deployed state wherein the filament automatically forms a helix comprising a support portion and a filter portion (Col 28, line 58-59), and
a pull wire configured to traverse a patient's skin and enable retraction of the device by pulling the device out of the vessel (Col 29, line 12-14),
wherein:
the support portion comprises an elongated coil having a pitch which exceeds a diameter thereof (Col 28, line 63-64), the elongated coil including a first portion having an axis (Col 28, line 62- 63), comprising ,
the filter portion includes a funnel configured to taper in a first direction (Col 29, line 1-2), the funnel also including at least one reducing coil having a center which is off the axis (Col 29, line 2-4),
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 (Col 28, line 65-67),
at least a portion of the elongated coil is configured to resist axial compression of the support portion (Col 29, line 5-6), and
the reducing coil is configured to capture emboli greater than a predetermined size (Col 29, line 7-8).
US 11202699 B2 fails to explicitly claim the elongated coil being configured such that when the elongated coil is compressed, its diameter grows, and support from the walls of the blood vessel, which opposes further compression, is generated.
However, Shinar is directed to a thrombus filter device and teaches an elongated coil (10) having a pitch which exceeds a diameter thereof (Paragraph 0024; 0113). 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.) and support from the vessel walls, which opposes further compression (the coil is formed into a predetermined shape, thus is fully capable of resisting further compression when deployed), is generated (Paragraph 0113).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the claims of US 11202699 B2 such that an elongated coil having a pitch which exceeds a diameter thereof; the elongated coil being configured such that when the elongated coil is compressed, its diameter grows, and support from the vessel walls, which opposes further compression as taught by Shinar, as both are directed to thrombotic filters. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the claims of US 11202699 B2 with the teachings of Shinar by incorporating an elongated coil having a pitch which exceeds a diameter thereof; the elongated coil being configured such that when the elongated coil is compressed, its diameter grows and support from the vessel walls, which opposes further compression in order for selective filtering of emboli, as the windings or turns of the helix therefore exclude emboli whose size is larger than the distance between consecutive helix turns (Shinar Paragraph 0008).
Regarding claim 65, claim 1 of US 11202699 B2 further claims wherein the deployed shape further comprises a stem configured to traverse the vessel wall (Col 29, line 10-11).
Regarding claim 66, claim 1 of US 11202699 B2 further claims a stopper configured to prevent the filament from moving from the vessel lumen outwards through a puncture in the vessel (Col 29, line 15-17).
Regarding claim 67, claim 1 of US 11202699 B2 further claims an anchor configured to engage tissue externally to the vessel lumen (Col 29, line 18-19).
Regarding claim 69, claim 1 of US 11202699 B2 further claims a second reducing coil whose center is off the axis (Col 29, line 24).
Regarding claim 70, claim 2 of US 11202699 B2 further claims wherein a line segment connecting the centers of the reducing coil and the second reducing coil intersects the axis (Col 29, line 25-27).
Regarding claim 71, claim 3 of US 11202699 B2 further claims wherein the filament is made from nitinol (Col 29, line 28-29).
Regarding claim 72, claim 4 of US 11202699 B2 further claims wherein the filament cross section is round, and the diameter of the cross section is in the range of 0.05 and 0.3 mm (Col 29, line 30-32).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZEHRA JAFFRI whose telephone number is (571)272-7738. The examiner can normally be reached 8 AM-5:30 PM.
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/Z.J./Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771