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 amendment filed January 27, 2026 has been entered. Claims 1-19 are currently pending. Claims 8-11 have been previously withdrawn from consideration.
New claims 12-15 are dependent upon withdrawn claim 8 and are also drawn to the withdrawn embodiment of Invention II, a method of securing a graft to tissue. In accordance with the election on October 20, 2025 as noted in the November 5, 2025 Office Action, claims 12-15 are withdrawn from further consider by the examiner as being drawn to a non-elected invention.
Currently claims 1-7 and 16-19 are under examination.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1-7 and 16-19 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Krumpelmann et al. (US 2021/0161664, hereinafter “Krumpelmann”).
Regarding claim 1, Krumpelmann discloses a tissue anchoring device (Fig 1) comprising an expandable frame (110) having a proximal end and a distal end (para [0038]) and at least one anchor having a tissue penetrating portion (152 or 154) attached to said frame, said at least one anchor attached to said expandable frame via a support frame (anchor slot 170 of housing 121) (para [0051] – expandable frame is welded or otherwise fixed to support frame and the support frame is movably attached to the at least one anchor, thus the at least one anchor is attached to the expandable frame via the support frame) configured to allow said at least one anchor (152/154) to elastically bend through a range of more than 90 degrees with respect to a longitudinal axis of said expandable frame from a first position (Fig 2B) where said tissue penetrating portion points in a direction parallel to said longitudinal axis of said expandable frame to a second position (Fig 2C) where said tissue penetrating portion points radially outward from said expandable frame (para [0046-0047]).
Regarding claim 2, wherein said at least one anchor comprises a restraining element (barb arms sleeves 162, 164 of housing 121) configured to restrain said tissue penetrating portion of said at least one anchor at a first configuration for delivery into a tissue (Fig 2B), and wherein moving of said restraining element along said at least one anchor releases said tissue penetrating portion to a second configuration for securement to a tissue (Fig 2C) (para [0049] – relative movement of restraining element along said anchor when anchor advanced through restraining element).
Regarding claim 3, wherein said tissue penetrating portion includes two tissue-penetrating prongs (152, 154).
Regarding claim 4, wherein said restraining element maintains said two tissue-penetrating prongs (152, 154) juxtaposed throughout their length when in said first configuration for delivery into said tissue (Fig 2B) (para [0049]).
Regarding claim 5, wherein said two tissue-penetrating prongs (152, 154) are deflected away from each other when said restraining element (barb arms sleeves 162, 164 of housing 121) is moved along said anchor (Fig 2C) (para [0049]).
Regarding claim 6, wherein said restraining element (barb arms sleeves 162, 164 of housing 121) is a restraining sleeve (Figs 2B-C) (para [0049]).
Regarding claim 7, wherein said tissue penetrating portion comprises a stop (151) configured to prevent movement of said restraining sleeve (barb arms sleeves 162, 164 of housing 121) over a tissue penetrating tip of said tissue penetrating portion (Figs 2B-2C; para [0049]).
Regarding claim 16, wherein the tissue anchoring device is configured to anchor a device to tissue (Fully capable of anchoring a device to tissue since “the distal ends 153, 155 are beveled or otherwise sharpened to enable the barb arms to cut through tissue” – para [0047]. It is noted the device is not positively recited).
Regarding claim 17, wherein the device comprises a graft or stent graft and the tissue anchoring device is configured to anchor the graft or the stent graft to the tissue within a vasculature (Fully capable of anchoring a device, including a graft or stent graft, to tissue since “the distal ends 153, 155 are beveled or otherwise sharpened to enable the barb arms to cut through tissue” – para [0047]. It is noted the device is not positively recited.)
Regarding claim 18, wherein the device comprises a valve for cardiovasculature and the tissue anchoring device is configured to anchor the valve to the tissue within the cardiovasculature (Fully capable of anchoring a device, including a valve for cardiovasculature, to cardiovascular tissue since “the distal ends 153, 155 are beveled or otherwise sharpened to enable the barb arms to cut through tissue” – para [0047]. It is noted the device is not positively recited.).
Regarding claim 19, wherein the tissue anchoring device is configured to anchor the device to the tissue of an aorta (Fully capable of anchoring a device to aortic tissue since “the distal ends 153, 155 are beveled or otherwise sharpened to enable the barb arms to cut through tissue” – para [0047]. It is noted the device is not positively recited.) .
Response to Arguments
Applicant’s arguments, see amendment, filed January 27, 2026, with respect to the rejection of claims 1-7 on the ground of nonstatutory double patenting as being unpatentable over claims 3-4 of US Patent No. 11, 896,509, have been fully considered and are persuasive. The patent claims recite “the tissue penetrating portion of said at least one anchor is pointed at an angle of 45-70 degrees with respect to a longitudinal axis of said expandable frame (claim 3) and fails to recite “said support frame configured to allow said at least one anchor to elastically bend through a range of more than 90 degrees with respect to a longitudinal axis of said expandable frame” (amended instant claim 1). The rejection has been withdrawn.
Applicant’s arguments, see amendment, filed January 27, 2026, with respect to the rejection of claims 1, 2, and 6 under 35 USC 102(a)(1) as anticipated by Clerc et al. (US 2013/0172983), have been fully considered and are persuasive. The rejection has been withdrawn.
Applicant's arguments, see amendment, filed January 27, 2026, with respect to the rejection of claims 1-7 under 35 USC 102(a)(2) as anticipated by Krumpelmann et al. (US 2021/0161664), have been fully considered but they are not persuasive.
Applicant argues Krumpelmann fails to teach the anchor assembly 120 is configured to elastically bend through a range more than 90 degrees, much less via a support frame separate from frame 110. Rather, Applicant argues Krumpelmann teaches it is barb arms 152, 154 that transition between the linear configuration and a curved configuration. The Examiner notes the anchor assembly 120 includes barb arms 152, 154 and thus clearly has at least a portion that transitions from the claimed first and second positions. In the updated interpretation of Krumpelmann in light of the amended claims, barb arms 152, 154 are interpreted as the “at least one anchor” comprising a tissue penetrating portion (tip of 152, 154) and are attached to the expandable frame (110) via a support frame (anchor slot 170 of housing 121), wherein the support frame is “configured to allow said at least one anchor (152/154) to elastically bend through a range of more than 90 degrees with respect to a longitudinal axis of said expandable frame from a first position where said tissue penetrating portion points in a direction parallel to said longitudinal axis of said expandable frame (Fig 2B) to a second position where said tissue penetrating portion points radially outward from said expandable frame (Fig 2C)”. (para [0047])
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 KATHERINE MARIE RODJOM whose telephone number is (571)272-3201. The examiner can normally be reached Monday - Thursday 8-5.
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/KATHERINE M RODJOM/Primary Examiner, Art Unit 3771