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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 July 9, 2026, has been entered.
Claims 1-19 are currently pending, with claims 8-15 withdrawn from consideration.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-7 and 16-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. There is insufficient support in the specification for the limitation of the anchor being pivotally attached to the expandable frame and the anchor bending through a range of more than 90 degrees with respect to the longitudinal axis of the expandable frame to thereby pivot the anchor relative to the expandable frame as recited in amended claim 1.
There is support for the anchor being attached to the expandable frame through a tab or support frame that allows the anchor to bend through a range of more than 90 degrees (see Figs 5-6 for example). Applicant specifically points to page 14, lines 1-5 for support:
“Tab 37 and frame 38 function in allowing anchor 18 to elastically bend from a
position in which penetrating portion 44 is pointed radially outward (Figures 1A-B and
4-5) at 90 degrees (Figures 4-5) or less (e.g., 30-60 degrees) as is shown in Figures 1A-
B to a position in which penetrating portion 44 is pointed about parallel to a longitudinal
axis of device 10 (Figures 3 and 6).”
Thus, there is support for bending, but not the claimed pivoting or a pivot point. For the purpose of examination, the pivotal attachment is interpreted broadly to include an attachment that allows for the claimed bending.
Claims 2-7 and 16-19 are rejected due to their dependency on claim 1.
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 comprising a tissue penetrating portion (152 or 154), said at least one anchor pivotally attached to said frame via a support frame (anchor arms 152, 154 pivotally attached to collar 150 and housing 121 and cooperatively attached through anchor slot 170 of housing 121 to the expandable frame 110; para [0051] – expandable frame 110 is welded or otherwise fixed to support frame 121 and the support frame is movably attached to the at least one anchor 152 or 154, thus the at least one anchor is attached to the expandable frame via the support frame), said 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 to thereby pivot or bend said at least one anchor relative to 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 July 9, 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 pivotally attached to the expandable frame via the claimed support frame, such that the support frame allows the anchor to pivot relative to the expandable frame from a first parallel position to a second position where the anchor elastically bends through a range of more than 90 degrees relative to the longitudinal axis of the expandable frame.
As noted above, there is insufficient support in the specification for the limitation of the anchor being pivotally attached to the expandable frame and the anchor bending through a range of more than 90 degrees with respect to the longitudinal axis of the expandable frame to thereby pivot the anchor relative to the expandable frame as recited in amended claim 1.
There is support for the anchor being attached to the expandable frame through a tab or support frame that allows the anchor to bend through a range of more than 90 degrees (see Figs 5-6 for example). Applicant specifically points to page 14, lines 1-5 for support:
“Tab 37 and frame 38 function in allowing anchor 18 to elastically bend from a
position in which penetrating portion 44 is pointed radially outward (Figures 1A-B and
4-5) at 90 degrees (Figures 4-5) or less (e.g., 30-60 degrees) as is shown in Figures 1A-
B to a position in which penetrating portion 44 is pointed about parallel to a longitudinal
axis of device 10 (Figures 3 and 6).”
Thus, there is support for bending, but not the claimed pivoting or a pivot point. For the purpose of examination, the pivotal attachment is interpreted broadly to include an attachment or coupling that allows for the claimed bending.
Krumpelmann teaches the anchor (anchor arms 152, 154) is pivotally attached to the collar 150 and housing 121 and is cooperatively attached through anchor slot 170 of housing 121 to the expandable frame 110. The expandable frame 110 is welded or otherwise fixed to the support frame 121 and the support frame is movably attached to the at least one anchor 152 or 154 allowing for the claimed bending or pivoting of the anchor with respect to the support frame, (para [0051]). Thus, the at least one anchor (152 or 154) is attached or coupled to the expandable frame (110) via the support frame (121) in a pivotal arrangement allowing for the claimed bending of the anchor with respect to the support frame.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the structure of the support tab 37 and support frame 38 allowing for the claimed attachment and bending between the anchor and expandable frame to differentiate from the bending attachment between Krumpelmann’s anchor and expandable frame) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2020/0268533 discloses a tissue anchoring device comprising an expandable frame (formed by strut segments 57) and at least one anchor (142) pivotally attached to the expandable frame via a support frame (end region 130 with slit 141) that allows the anchor to elastically bend with respect to the longitudinal axis of the expandable frame to thereby pivot the anchor relative to the expandable frame from a first parallel position to a second position pointing radially outward from the expandable frame (Fig 6).
US 2005/0240259 discloses a tissue anchoring device comprising an expandable frame (strut 13 of framework) having at least one anchor (barb 12) pivotally attached to the frame via a support frame (anchoring element 11) (Figs 1-2).
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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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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/KATHERINE M RODJOM/Primary Examiner, Art Unit 3771
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