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 Amendment
The claims filed on April 13th, 2026, have been entered. Claims 1-24 remain pending in the Application. Claims 15-20 were previously withdrawn by the Applicant.
Response to Arguments
Applicant's arguments filed April 13th, 2026, have been fully considered but they are not persuasive.
First, regarding the drawing objection, Applicant does not acknowledge or respond to the points made in the Non-Final Rejection dated January 12th, 2026, the Final Rejection dated July 22nd, 2025, and the Non-Final Rejection dated February 25th, 2025, and continues to copy and paste the same reply that does not address the issues that make the drawings illegible and unacceptable. Therefore, the drawing objection is upheld and repeated below.
Second, Applicant argues that Cragg et al. (Pub. No. 2015/0039020) does not disclose the limitation “each strut being rotated about a longitudinal axis of the strut with a portion of a first edge of the edges of the strut rotated outwardly and a portion of a second edge of the edges of the strut rotated inwardly” because [0311-313] discuss that the strut endings 1215e and hooks 1217e rotate about their longitudinal axes, but not necessarily the entire strut. Examiner respectfully disagrees. The statement in [0313] is “when expanded, the ratio of strut width/thickness causes the struts and the hooks to twist approximately 90 degrees.” The disclosure does not say that only the strut endings 1215e rotate, and in the context of describing both ends 1211e and 1215e of the struts in FIGs. 13D-13E, the rotation occurs along the length of the strut. Whether that rotation is also used to disengage the occlusion device from the attachment member does not prevent the struts from satisfying the limitation.
Third, Applicant argues that Casey et al. (Pub. No. 2019/0000492) in view of Nguyen et al. (Pub. No. 2017/0259042) does not disclose the limitation “each strut being rotated about a longitudinal axis of the strut with a portion of a first edge of the edges of the strut rotated outwardly and a portion of a second edge of the edges of the strut rotated inwardly” because while Nguyen et al. teaches the distal tips 438 extending from an anchor 437 may twist helically, Nguyen et al. does not teach or suggest that the struts defining anchor 437 may also rotate about their longitudinal axes. Examiner disagrees. [0306] states that the distal tips 438 (shown in FIG. 88R) are sufficiently flexible to allow the distal tips to twist helically, which is in the context of allowing for interlocking the distal tips together. For the distal tips to interlock together from a helical twist, based on their configuration in FIG. 88R, they would need to rotate about their own longitudinal axes, thereby satisfying the claim limitation.
Drawings
The drawings are objected to because lines, numbers, and letters are not uniformly thick and well defined; and numbers and reference characters are not plain and legible for all figures. This applies to shading. Solid black shading areas are not permitted, except when used to represent par graphs or colors. See for example, Figures 1A-1B, 3A-3E, and 4. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-6, 8-14, and 21-24 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Cragg et al. (Pub. No. 2015/0039020).
Regarding claim 1, Cragg et al. discloses an occlusive device (1200e; FIGs. 13A-13E; [0296]), comprising:
a hypotube formed from a metal ([0306] 1200e is formed by laser cutting a nitinol hypotube), the hypotube comprising an expandable section (1202e, 1204e) including struts (1210e) that are parallel to each other in a constrained state (FIG. 13B: 1210e are parallel to each other in the constrained state) that self-expands to an expanded state having an increased outer diameter (FIG. 13A: 1200e expands to a larger diameter in 120e and 1204e), each strut including edges (FIGs. 13A-13B: 1210e have outer surfaces and inner surfaces that comprise their edges), an outer surface (FIG. 13A: 1210e have an outer surface) and an inner surface (FIG. 13A: 1210e have an inner surface), with the outer surface defined by an outer surface of the hypotube (FIG. 13A: 1210e have an outer surface, which is also the outer surface of 1200e) and the inner surface defined by an inner surface of the hypotube (FIG. 13A: 1210e have an inner surface, which is also the inner surface of 1200e),
in the expanded state:
portions of the struts are separate from each other to define openings (FIG. 13A: 1210e have openings formed between them),
each strut being rotated about a longitudinal axis of the strut with a portion of a first edge of the edges of the strut rotated outwardly and a portion of a second edge of the edges of the strut rotated inwardly ([0313] when expanded, the struts twist approximately 90 degrees, which causes their outer surfaces to rotate inwardly and their inner surfaces to rotate outwardly),
each opening of the openings including opposed ends that taper outwardly toward a central portion of a length of the opening (FIG. 13A: the openings have diamond shapes with points towards their centers),
the expandable section assumes a final shape (FIG. 13A) that differs from a shape of the constrained state upon deployment of the occlusive device to a target location within a body of the subject (FIGs. 13A-13B: the constrained shape is cylindrical while the expanded state is an hourglass),
the increased outer diameter and the final shape capable of at least partially occluding flow through a blood vessel of the body of the subject ([0314] 1206e can be covered in a membrane thick enough to facilitate occlusion).
Regarding claim 2, Cragg et al. further discloses the hypotube self-expands to the increased outer diameter and the final shape upon exposure to a condition within the body of the subject ([0408-410] the occlusion device is tested by be placed in water simulating internal human body temperature to show the level of expansion caused by that level of heat).
Regarding claim 3, Cragg et al. further discloses the hypotube self-expands to the increased outer diameter and the final shape upon exposure to body temperature ([0408-410] the occlusion device is tested by be placed in water simulating internal human body temperature to show the level of expansion caused by that level of heat).
Regarding claim 4, Cragg et al. further discloses the hypotube comprises a shape memory material ([0306] the device is formed from nitinol).
Regarding claim 5, Cragg et al. further discloses the shape memory material comprises nitinol ([0306] the device is formed from nitinol).
Regarding claim 6, Cragg et al. further discloses the increased outer diameter of the hypotube is at least 100% of a constrained outer diameter of the hypotube (FIGs. 13A-13B: the outer diameter of 1200e after expansion is greater than, and therefore at least 100% of, the outer diameter of 1200e before expansion).
Regarding claim 8, Cragg et al. further discloses the hypotube in the final shape will occlude at least about 75% of a cross-sectional area of a passage through the blood vessel or duct of the body of the subject ([0219] the occlusive device can occlude at least 98% of fluid flow through the blood vessel).
Regarding claim 9, Cragg et al. further discloses the hypotube in the final shape will occlude at least about 80% of a cross-sectional area of a passage through the blood vessel or duct of the body of the subject ([0219] the occlusive device can occlude at least 98% of fluid flow through the blood vessel).
Regarding claim 10, Cragg et al. further discloses the hypotube in the final shape will occlude at least about 85% of a cross-sectional area of a passage through the blood vessel or duct of the body of the subject ([0219] the occlusive device can occlude at least 98% of fluid flow through the blood vessel).
Regarding claim 11, Cragg et al. further discloses the hypotube in the final shape will occlude at least about 90% of a cross-sectional area of a passage through the blood vessel or duct of the body of the subject ([0219] the occlusive device can occlude at least 98% of fluid flow through the blood vessel).
Regarding claim 12, Cragg et al. further discloses a filler ([0162] the delivery systems can include radiopaque fillers) within a lumen of the hypotube (in view of [0362], the occlusion devices can include radiopaque bands which have a diameter equal to or less than the diameter of the hypotube; thus one of ordinary skill in the art would understand that radiopaque bands having a smaller diameter than the hypotube are within the lumen of the hypotube, and where the radiopaque markers can take different forms, such as the radiopaque filler described in [0162]).
Regarding claim 13, Cragg et al. further discloses the filler comprises an absorbent material ([0162] a radiopaque filler absorbs radio frequencies).
Regarding claim 14, Cragg et al. further discloses the filler comprises a radiopaque material ([0162] the fillers can be radiopaque).
Regarding claim 21, Cragg et al. further discloses each opening has a diamond shape (FIG. 13A: the openings are diamond-shaped).
Regarding claim 22, Cragg et al. discloses an occlusive device (1200e; FIGs. 13A-13E; [0296]), comprising a hypotube formed from a metal ([0306] 1200e is formed by laser cutting a nitinol hypotube), comprising:
an expandable section (1202e, 1204e) including struts (1210e) that are parallel to each other in a constrained state (FIG. 13B: 1210e are parallel to each other in the constrained state) that self-expands to an expanded state having an increased outer diameter (FIG. 13A: 1200e expands to a larger diameter in 120e and 1204e), in which portions of the struts separate from each other to define openings (FIG. 13A: 1210e have openings formed between them), each strut of the expandable section rotated about a longitudinal axis of the strut with an edge of the strut rotated outwardly ([0313] when expanded, the struts twist approximately 90 degrees, which causes their outer surfaces to rotate inwardly and their inner surfaces to rotate outwardly), and the expandable section assumes a final shape (FIG. 13A) that differs from a shape of the constrained state upon deployment of the occlusive device to a target location within a body of the subject (FIGs. 13A-13B: the constrained shape is cylindrical while the expanded state is an hourglass), the increased outer diameter and the final shape capable of at least partially occluding flow through a blood vessel of the body of the subject ([0314] 1206e can be covered in a membrane thick enough to facilitate occlusion); and
a filler ([0162] the delivery systems can include radiopaque fillers) within a lumen of the hypotube (in view of [0362], the occlusion devices can include radiopaque bands which have a diameter equal to or less than the diameter of the hypotube; thus one of ordinary skill in the art would understand that radiopaque bands having a smaller diameter than the hypotube are within the lumen of the hypotube, and where the radiopaque markers can take different forms, such as the radiopaque filler described in [0162]).
Regarding claim 23, Cragg et al. further discloses the filler comprises an absorbent material ([0162] a radiopaque filler absorbs radio frequencies).
Regarding claim 24, Cragg et al. further discloses the filler comprises a radiopaque material ([0162] the fillers can be radiopaque).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 4-5, and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Casey et al. (Pub. No. 2019/0000492) in view of Nguyen et al. (Pub. No. 2017/0259042).
Regarding claim 1, Casey et al. discloses an occlusive device (3020; FIG. 59; [0201]), comprising:
a hypotube formed from a metal ([0197] the device is made from laser cutting a nitinol tube), the hypotube comprising an expandable section (3021, 3022) including struts (3007, 3008) that are parallel to each other in a constrained state ([0195] when in the delivery configuration, the struts will be pressed together in a parallel state) that self-expands to an expanded state having an increased outer diameter ([0195] both proximal and distal sections expand after deployment), each strut including edges (FIG. 58: 3007 and 3008 have edges), an outer surface (FIG. 58: 3007 and 3008 have outer surfaces) and an inner surface (FIG. 58: 3007 and 3008 have inner surfaces), with the outer surface defined by an outer surface of the hypotube (FIG. 58: the outer surface of 3020 is the same as the outer surface of 3007 and 3008) and the inner surface defined by an inner surface of the hypotube (FIG. 58: the inner surface of 3020 is the same as the inner surface of 3007 and 3008),
in the expanded state:
portions of the struts are separate from each other to define openings (FIG. 59: 3007 and 3008 separate from each other to have openings),
each opening of the openings including opposed ends that taper outwardly toward a central portion of a length of the opening (FIG. 59: the openings in the struts are diamond-shaped),
the expandable section assumes a final shape ([0201] the spiral shape of the proximal portion 3021) that differs from a shape of the constrained state upon deployment of the occlusive device to a target location within a body of the subject ([0201] the spiral shape of the proximal portion 3021 is straightened in the delivery configuration),
the increased outer diameter and the final shape capable of at least partially occluding flow through a blood vessel of the body of the subject (FIG. 59: 3020 are capable of occluding at least part of a blood vessel upon deployment).
Casey et al. does not explicitly disclose each strut being rotated about a longitudinal axis of the strut with a portion of a first edge of the edges of the strut rotated outwardly and a portion of a second edge of the edges of the strut rotated inwardly.
Nguyen et al. teaches in the same field of endeavor of clot retrieval devices (Abstract), and discloses a hypotube (437; [0304]; FIG. 88R) comprising struts ([0305] 437 can comprise at least two different types of struts, ending in distal tips 438), where each strut being rotated about a longitudinal axis of the strut with a portion of a first edge of the edges of the strut rotated outwardly and a portion of a second edge of the edges of the strut rotated inwardly ([0306] 438 can be twisted helically during use) for the purpose of engaging and removing obstructive material from a body lumen ([0306]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the struts of Casey et al. to twist, as taught by Nguyen et al., for the purpose of engaging and removing obstructive material from a body lumen.
Regarding claim 4, Casey et al. further discloses the hypotube comprises a shape memory material ([0197] the device is made from laser cutting a nitinol tube).
Regarding claim 5, Casey et al. further discloses the shape memory material comprises nitinol ([0197] the device is made from laser cutting a nitinol tube).
Regarding claim 7, Casey et al. as modified further discloses the final shape comprises a coil (Casey et al. [0201] 3021 has a spiral shape when expanded, which is equivalent to a coil).
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 JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
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, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JRM/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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