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 December 17th, 2025, have been entered. Claims 1-16 and 21-24 remain pending in the Application. Claims 3-5 and 12 were previously withdrawn by the Applicant.
Response to Arguments
Examiner would like to note again that the withdrawn claims 3-5 and 12 should be labeled as “withdrawn” in the claims, rather than “original.” Failure to correct this discrepancy again will lead to a non-compliant action under MPEP 714 and 37 CFR 1.121.
Applicant's arguments filed December 17th, 2025, have been fully considered but they are not persuasive.
Regarding the rejection of claims 1 and 21 under Greenhalgh et al. (Pub. No. 2016/0030099), Applicant argues that the slits of Greenhalgh et al. are not linear when the hypotube is unexpanded because the slits are diamond-shaped. Examiner respectfully disagrees. The slits 14 of Greenhalgh et al. do not have any curves and are defined by straight struts 16 in FIG. 2. The description of the slits as linear does not require the slits to be rectangular or of a consistent width for the length of the slit; a linear slit only needs to extend over a straight line, which the slits of 14 do.
Applicant further argues that the struts of Greenhalgh et al. are not disclosed as twisting as the hypotube expands. Examiner respectfully disagrees. Applicant notes that the struts of Greenhalgh et al. rotate relative to each other as the device expands, which occurs by the outer surface of the struts 16 in FIG. 2 rotating to the positions shown in FIG. 1. Since a twist only requires forming a bent, curling, or distorted shape, twisting relative to a surface of the hypotube is satisfied by forming a curled shape relative to the hypotube. FIGs. 1-2 of Greenhalgh et al. illustrate that the initially straight shapes on the outer surface of the hypotube become curved shapes by the expansion of the hypotube, thereby meeting the claim language.
Applicant then argues that the slits are arranged parallel to the longitudinal axis of Greenhalgh et al. as depicted in FIG. 2, and not helically as claimed. Examiner respectfully disagrees. As shown in the Annotated FIG. 2 below, the slits 14 extend in a helical pattern around the device.
PNG
media_image1.png
288
764
media_image1.png
Greyscale
Regarding claim 15, Applicant argues that Kleshinski et al. (Pub. No. 2016/0008003) does not disclose the newly added limitations that the distal end of the control wire is at least partially located within the occlusive device in the constrained configuration and that the distal end is able to be disconnected from the occlusive device while the occlusive device is expanded. Examiner respectfully disagrees. As shown in FIGs. 16A-16B, the distal end of the control wire, labeled as 1634a and 1634b, is within the implant hub 1650 (which is a part of the occlusive device) when sleeve 1632 is still constraining 1634a and 1634b, and when the sleeve 1632 is removed, both 1650 and 1634a-b are able to expand and disengage from each other.
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) 1-2, 6, 11, 13-14, and 21-24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Greenhalgh et al. (Pub. No. 2016/0030099).
Regarding claim 1, Greenhalgh et al. discloses an occlusive device (2; [0049]; FIG. 1), comprising: a hypotube (FIG. 1: 2 is a hypotube) with slits that are linear while the hypotube is unexpanded (FIG. 2: the slits 12 between 16 extend linearly along 2 when 2 has not been expanded; see the Response to Arguments above) and define struts (16; [0051]) that twist relative to a surface of the hypotube (FIG. 1: the struts 16 are expanded away from each other to form slits which have a circumference similar to a circle or diamond) and move apart from each other upon expansion of the hypotube to an increased outer diameter and a final shape ([0049] 2 goes from a radially contracted and longitudinally expanded configuration before deployment to a radially expanded and longitudinally contracted configuration after deployment to the treatment site), the increased outer diameter and the final shape being capable of at least partially occluding a passage through a portion of a body of a subject ([0049] 2 is capable of at least partially occluding a passage after deployment).
Regarding claim 2, Greenhalgh et al. further discloses ends of the hypotube are oriented along a longitudinal axis of the final shape of the hypotube ([0050] distal end 6 and proximal end 8 are oriented along longitudinal axis 4; FIG. 1).
Regarding claim 6, Greenhalgh et al. further discloses a filler within an interior of the hypotube ([0091] 2 can be filled with a filler).
Regarding claim 11, Greenhalgh et al. further discloses the struts include first struts (FIGs. 45-46: struts 16 that are close to the center of 2) in a first portion of the hypotube that move a first distance apart from each other upon expansion of the hypotube (FIGs. 45-46: struts 16 that are close to the center of 2 move a first distance apart when 2 expands) and second struts (FIGs. 45-46: struts 16 that are close to the ends of 2) in a second portion of the hypotube that move a second distance apart from each other upon expansion of the hypotube (FIGs. 45-46: struts 16 that are close to the ends of 2 move a second distance when 2 expands), the first distance being greater than the second distance (FIGs. 45-46: the center struts 16 expand a greater amount than the end struts to go from the cylindrical delivery shape to the spherical deployed shape).
Regarding claim 13, Greenhalgh et al. further discloses the final shape is a substantially spherical shape (FIG. 1: the deployed shape of 2 is spherical).
Regarding claim 14, Greenhalgh et al. further discloses the final shape has a length of at least 6 mm ([0047] FIG. 1 has a length scale in mm, which shows the length of 2 is at least 6 mm) and an outer diameter of at least 6 mm ([0047] FIG. 1 has a length scale in mm, which shows the outer diameter of 2 is at least 6 mm).
Regarding claim 21, Greenhalgh et al. discloses an occlusive device (2; [0049]; FIG. 1), comprising:
a hypotube (FIG. 1: 2 is a hypotube) with an expandable section ([0049] 2 is the expandable section) including slits that are linear (FIG. 2: 14 are linear), extend helically around the hypotube, (14; Annotated FIG. 2 below: 14 are helically oriented around 4; [0052]) and define struts that are helically oriented while the hypotube is unexpanded (16; Annotated FIG. 2: 16 are helically oriented around 4) and twist relative to a surface of the hypotube (FIG. 1: the struts 16 are expanded away from each other to form slits which have a circumference similar to a circle or diamond) and move apart from each other upon expansion of the hypotube to an increased outer diameter and a final shape upon deployment to a target location within a body of a subject ([0049] 2 goes from a radially contracted and longitudinally expanded configuration before deployment to a radially expanded and longitudinally contracted configuration after deployment to the treatment site), the increased outer diameter and the final shape being capable of at least partially occluding a passage through a portion of the body of the subject ([0049] 2 is capable of at least partially occluding a passage after deployment).
PNG
media_image1.png
288
764
media_image1.png
Greyscale
Regarding claim 22, Greenhalgh et al. further discloses the increased outer diameter is about 6 mm ([0047] FIG. 1 has a length scale in mm, which shows the outer diameter of 2 is at least 6 mm).
Regarding claim 23, Greenhalgh et al. further discloses the increased outer diameter is about 8 mm ([0047] FIG. 1 has a length scale in mm, which shows the outer diameter of 2 is at least 8 mm).
Regarding claim 24, Greenhalgh et al. further discloses the final shape is a substantially spherical shape (FIG. 1: the deployed shape of 2 is spherical).
Claim(s) 15 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kleshinski et al. (Pub. No. 2016/0008003).
Regarding claim 15, Kleshinski et al. discloses a delivery system (1600; [0092]; FIGs. 16A-16B) for an occlusive device (implant including implant hub 1650), comprising:
a delivery device (1632) with a lumen (FIG. 16A: 1632 has a lumen); and
a control wire (1636) positionable within the lumen of the delivery device (FIG. 16A: 1636 is partially within 1632) and including a distal end (1634a-b) with a shape that enables the distal end to engage and release the occlusive device (FIGs. 16A-16B: 1634a-b releasably engage 1650) and has:
a constrained configuration while the distal end of the control wire is at least partially located within the occlusive device (FIG. 16A: 1634a-b are within keyholes 1652a,1652b of occlusive device) and the lumen of the delivery device (FIG. 16A: 1634a-b is within the lumen of 1632 and is restrained), the constrained configuration of the distal end engaging the interior of the occlusive device (sidewalls of keyholes considered part of the interior of the occlusive device since they are radially inward of the radially exterior surface of the occlusive device) to facilitate movement of the occlusive device along at least a portion of a length of the lumen of the delivery device ([0092] in the deflected state, 1634a-b are engaged within keyholes 1652a-b of 1650 so that when 1636 is advanced, 1650 is also advanced); and
an expanded configuration while the distal end is advanced outside of the lumen of the delivery device (FIG. 16B: 1634a-b is advanced outside of the lumen of 1632), the distal end able to be disconnected from the occlusive device while the occlusive device is expanded and the distal end is in the expanded configuration ([0092-94] in the relaxed state when 1632 has been withdrawn from over 1634a-b and 1650, 1634a-b and 1650 can expand and disconnect as 1634a-b move through keyholes 1652a-b; FIG. 16B).
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) 7-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Greenhalgh et al. in view of Herbert et al. (Pub. No. 2018/0296222).
Regarding claim 7, Greenhalgh et al. discloses the invention as claimed in claim 6, as discussed above. Greenhalgh et al. does not explicitly disclose the filler comprises an absorbent material.
Herbert et al. teaches in the same field of endeavor of occlusive devices ([0130] 10 can be used for occlusion in vascular or non-vascular regions; FIG. 1) and discloses filling a tubular body (12; [0169]) with an absorbent material ([0169] swellable hydrogel infused with drugs) for the purpose of providing better occlusion by closing the gaps in the tubular body and providing medicinal treatment through therapeutic drugs which are released over time ([0169]
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the filler in Greenhalgh et al. to include an absorbent material, as taught by Herbert et al., for the purpose of providing better occlusion by closing the gaps in the tubular body and providing medicinal treatment through therapeutic drugs which are released over time.
Regarding claim 8, Greenhalgh et al. as modified further discloses the filler further comprises another substance (Greenhalgh et al. [0091] the fillers can have additional therapeutic agents; Herbert et al. [0169] the hydrogel can be infused with drugs).
Regarding claim 9, Greenhalgh et al. as modified further discloses the another substance, when present within the body of the subject, elutes from the absorbent material over time (Greenhalgh et al. [0091] the therapeutic agents can be gradually dispersed from the degradation of the fillers over time; Herbert et al. [0169] the hydrogel degrades over time to release the infused drugs).
Regarding claim 10, Greenhalgh et al. as modified further discloses the another substance comprises a treatment (Greenhalgh et al. [0091] the therapeutic agents help to treat the body, such as promoting tissue growth; Herbert et al. [0169] the drugs can provide a variety of treatment options depending on the situation).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kleshinski et al.
Regarding claim 16, Kleshinski et al. discloses the invention as claimed in claim 15, as discussed above. Kleshinski et al. does not disclose a slider associated with the delivery device and the control wire in a manner that facilitates movement of the control wire distally and proximally through the lumen of the delivery device, though Kleshinski et al. does disclose that the delivery device is retracted proximally relative to the control wire ([0092-94] 1632 is retracted proximally relative to 1636 to allow the paddles 1634 to expand radially outward and release 1650; FIG. 16B).
A second embodiment of Kleshinski et al. discloses using a slider component to move three wires relative to each other for the purpose of setting an initial condition where the wires are locked in place and cannot move relative to each other, followed by selective release through the retraction of one of the wires relative to the other wires ([0071]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the first embodiment of Kleshinski et al. to make use of a slider component, as taught by the second embodiment of Kleshinski et al., for the purpose of keeping 1636 and 1650 locked together during delivery, followed by retraction of 1632 to selectively decouple 1636 and 1650. This modification would have the slider component associated with the delivery device, as the slider component retracts 1632, and with the control wire, as 1632 is moved relative to 1636, and since the slider component moves the lumen of 1632 relative to 1636, 1636 is moved distally and proximally through the lumen of 1632.
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.
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.
/JRM/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771