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 .
Election/Restrictions
Applicant’s election of Species A, Subspecies A1 in the reply filed on 08/19/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Drawings
The drawings are objected to because figure 3 seems to have 2 arrows (coming from the top of the middle tine 106) with no numbers. Also, some reference numbers are not highlighted in the figures. For instance, 110 as cited in paragraph 78 is not shown in the drawing. 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 Objections
Claims 2, 3, 6, 8, 11, 12, 14 are objected to because of the following informalities: Each of the claims state “the step of” with what seems to be a new step or a new substep. For consistency/clarity purposes and to avoid any 112 issues, each new step should be amended to read “a step of” or an amendment of a similar scope. For example, claim 2 lines 1-2 can read “further comprises a . Appropriate correction is required.
Claim 2 is objected to because of the following informalities: for consistency and clarity purposes, and to avoid any antecedent issues, “a frame member” of line 2 should be amended to “[[a]] the frame member” or an amendment of a similar scope. Appropriate correction is required.
Claim 7 is objected to because of the following informalities for consistency and clarity purposes, and to avoid any antecedent issues, lines 2-3 should be amended to read “providing [[a]] the frame member
Claim 7 is objected to because of the following informalities: for consistency and clarity purposes, and to avoid any antecedent issues, lines 6-8 should be amended to read “at least one tine of the plurality of tines coupled to one of [[a]] the frame tension member or a [[a]] the compression member and of [[a]] the actuation tension member or [[a]] the compression member ….” or an amendment of a similar scope. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: The status of the claims should be before the substance of the claims. Claim 8 should read “(original) The…” or an amendment of a similar scope. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: for consistency and clarity purposes, and to avoid any antecedent issues, lines 12 and 13 should be amended to read “[[a]] the frame tension member” and “[[an]] the actuating compression member” respectively or an amendment of a similar scope. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: for consistency and clarity purposes, and to avoid any antecedent issues, line 2 should be amended to read “an actuating member of the at least one actuating members coupled to the ring structure” or an amendment of a similar scope. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the limitation “the step of translating the actuating member further comprises…” in lines 1-2. It would seem the claim is positively reciting a previous step including translating the actuating member. Claim 4 is dependent off of claim 3 which is dependent off of claim 1. However, claim 1 and claim 3 do not claim any step of translating the actuating member. The actuating member is actuated and stabilized but the actuating member does not necessarily translate as previously recited. It is unclear if “the step of translating” is a new step which should read “a step of translating” or if the “actuating/stabilizing step” is a being referenced. Further amendments that clearly recite what step is being positively claimed should be made. For examination purposes, the limitation “the translating step” will be interpreted to be a part of the previous “the actuating step”.
Claim 5 recites the limitation “the step of translating the actuating member further comprises…” in lines 1-2. It would seem the claim is positively reciting a previous step including translating the actuating member. Claim 5 is dependent off of claim 3 which is dependent off of claim 1. However, claim 1 and claim 3 do not claim any step of translating the actuating member. The actuating member is actuated and stabilized but the actuating member does not necessarily translate as previously recited. It is unclear if “the step of translating” is a new step which should read “a step of translating” or if the “actuating/stabilizing step” is a being referenced. Further amendments that clearly recite what step is being positively claimed should be made. For examination purposes, the limitation “the translating step” will be interpreted to be a part of the previous “the actuating step”.
Claim 7 recites the limitation "a tubular conduit coupled to the frame member …" in line 10. Claim 7 is ultimately dependent off of claim 1 which claims “a medical device access conduit”. It would seem from the paragraph 75 and figure 2a,b, that the graft 12 can act as the conduit for fluid flow or access through a lumen. There seems to be just one conduit attached to the frame. It is therefore unclear if the “tubular conduit” of claim 7 is the “medical device access conduit” of claim 1 or another tubular conduit. Amendments should be made to clarify the conduits extending from the frame.
Claim 9 recites the limitation "a tubular conduit coupled to the frame member …" in line 15. Claim 9 already recites “a medical device access conduit” in line 3. It would seem from the paragraph 75 and figure 2a,b, that the graft 12 can act as the conduit for fluid flow or access through a lumen. There seems to be just one conduit attached to the frame extending proximally. It is therefore unclear if the “tubular conduit” is the “medical device access conduit” or another tubular conduit. Amendments should be made to clarify the conduits extending from the frame.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent 5,904,697 to Gifford.
As to claim 1, Gifford discloses a method for making a medical device access opening in a wall of an anatomical structure (col. 13 ll. 12-30), comprising the steps of: a. positioning a frame member (101) having a plurality of tines (105) projecting distally from the frame against an outer wall surface of the anatomic structure (150), the anatomic structure having an inner wall and an outer wall (figure 4); b. penetrating the plurality of tines into and past the inner wall of the anatomic structure (figure 5b); c. actuating the plurality of tines to bear against the inner wall of the anatomic structure and axially compress the frame against the outer wall of the anatomic structure (figure 5c,d); and d. creating a medical device access passageway (figure 5g) through a medical device access conduit (148/102) coupled to the frame member (figure 1, 5g, 7c). The coupling member/graft vessel is the conduit where a medical device can be passed therethrough.
As to claim 2, Gifford discloses wherein step of positioning the frame member further comprises the step of providing a frame member having a ring structure (104, figure 1) and the plurality tines project helically from a distal surface of the ring structure (figure 1).
As to claim 3, Gifford discloses wherein the actuating step further comprises the step of stabilizing an actuating member (108, 109, 110) coupled to the ring frame member and to the plurality of tines (col. 14 ll. 27-44, col. 19 ll. 18-24). The legs are actuated by the movement of 108/109/110 which can read on the actuating member. The legs are then stabilized after actuated.
As to claim 4, Gifford discloses the step of translating the actuating member further comprises the step of applying a compressive force to the ring member (figure 5a-d col. 19 ll. 18-24). Advancing the outer tube over the anchor member 101 can read on applying a compressive force.
As to claim 5, Gifford discloses step of stabilizing the actuating member such that the actuating member translates along a longitudinal axis of the ring frame member (figure 5a-d).
As to claim 6, Gifford discloses the step of stabilizing the actuating member further includes the step of maintaining the actuating member substantially parallel to a circumferential axis of the ring structure (figure 5d). The portion 108 is maintained parallel to the circumferential axis.
Claims 1-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication 7,063,711 to Loshakove.
As to claim 1, Loshakove discloses a method for making a medical device access opening in a wall of an anatomical structure (col. 2 ll. 47-62), comprising the steps of: a. positioning a frame member (200, figure 5) having a plurality of tines (224, see annotated figure I below) projecting distally from the frame against an outer wall surface of the anatomic structure (see annotated figure II below), the anatomic structure having an inner wall and an outer wall (see annotated figure II below); b. penetrating the plurality of tines into and past the inner wall of the anatomic structure (figure 6b); c. actuating the plurality of tines to bear against the inner wall of the anatomic structure and axially compress the frame against the outer wall of the anatomic structure (figure 6b); and d. creating a medical device access passageway (see annotated figure II below) through a medical device access conduit (see annotated figure II below, the conduit or a similar insertion tool 140 with conduit 142 as seen in figure 4a,b, which will deliver the embodiment of figure 5 ) coupled to the frame member (see annotated figure II below).
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As to claim 2, Loshakove discloses wherein step of positioning the frame member further comprises the step of providing a frame member having a ring structure (222, figure 5, see annotated figure II above, the frame will be similar to the ring structure of figure 122 as seen in figure 1d, col. 16 ll. 16-25) and the plurality tines project helically from a distal surface of the ring structure (figure 1d, 5).
As to claim 3, Loshakove discloses wherein the actuating step further comprises the step of stabilizing an actuating member (see annotated figure I above, 227) coupled to the ring frame member and to the plurality of tines (col. 16 ll. 30-34). Once deployed, the device is stabilized.
As to claim 4, Loshakove discloses the step of translating the actuating member further comprises the step of applying a compressive force to the ring member (figure 6a,b).
As to claim 5, Loshakove discloses step of stabilizing the actuating member such that the actuating member translates along a longitudinal axis of the ring frame member (figure 6a,b the spike will move as it is pressed, the movement will have a vector along the longitudinal axis).
As to claim 6, Loshakove discloses the step of stabilizing the actuating member further includes the step of maintaining the actuating member substantially parallel to a circumferential axis of the ring structure (figure 5, 6a,b).
As to claim 7, Loshakove discloses the step of positioning the frame member further comprises the step of providing a frame member having a frame member having one of a frame tension member or a frame compression member projecting therefrom (see annotated figure I above); at least one actuating member connected to the frame member by a stabilizing member and one of an actuating tension member or an actuating compression member and movable relative to the frame member in a substantially co-planar manner (see annotated figure I above); at least one tine coupled to one of a frame tension member or a frame compression member and one of an actuating tension member or an actuating compression member (see annotated figure I above), whereby axial movement of the frame member relative to the at least one actuating member imparts movement to the at least one tine (col. 16 ll. 32-35); and a tubular conduit (the conduit as seen in the annotated figure II above) coupled to the frame member and projecting proximally from the frame member.
As to claim 8, Loshakove discloses the step of actuating the plurality of tines further comprises the step of creating a hemostatic fluid flow coupling between the tubular conduit and the anatomic structure (figure 6b).
As to claim 9, Loshakove a method for making a fluid coupling to an anatomical structure having an inner wall and outer wall thereof (col. 2 ll. 47-62, see annotated figure II above), comprising the steps of: a. positioning a frame member (200, figure 5) having a medical device access conduit (a similar delivery device 140 comprising 142 which deploys 200, col. 16 ll. 16-25 ) coupled thereto, the frame member comprising a ring structure (222, see annotated figure I above) against the outer wall of the anatomical structure (figure 6a,b) the ring structure comprised of a plurality of tines assemblies (see annotated figure I above), each of the tine assemblies comprising one of frame tension member or a frame compression member extending distally from the ring structure therefrom (see annotated figure I above), at least one actuating member (see annotated figure I above) connected to the frame member by a stabilizing member (see annotated figure I above) and of an actuating tension member or an actuating compression member (see annotated figure I above) and movable relative to the frame member, at least one of plurality of tines (224, see annotated figure I above), each of the plurality of tines being coupled to one of the frame tension member or a frame compression member and one of an actuating tension member or an actuating compressing member, whereby axial movement of the ring structure relative to the at least one actuating member imparts movement to the at least one tine (col. 16 ll. 32-35), a tubular conduit (see annotated figure II above) couped to an inner wall of the ring structure and projecting proximally from the ring structure; b. penetrating the plurality of tines into and past the inner wall of the anatomic structure (figure 6b); c. actuating the plurality of tines to bear against the inner wall of the anatomic structure and axially compress the frame against the outer wall of the anatomic structure (figure 6b); and d. creating an opening in the anatomic structure through the outer wall and inner wall of the anatomic structure sufficient to allow passage of a medical device through the tubular conduit and ring structure (figure 6b).
As to claim 10, Loshakove discloses the plurality of tines project helically from a distal surface of the ring structure (figure 1d, 5, col. 16 ll. 16-25). The tines 224 will be similarly helically arranged as seen as the tines 124 in figure 1d.
As to claim 11, Loshakove discloses wherein the actuating step further comprises the step of stabilizing an actuating member (see annotated figure I below, 227) coupled to the ring frame member and to the plurality of tines (col. 16 ll. 30-34). Once deployed, the device is stabilized.
As to claim 12, Loshakove discloses the steps of applying a compressive force to the ring member and actuating the actuating member (figure 6a,b, col. 16 30-35).
As to claim 13, Loshakove discloses step of actuating the actuating member further comprises the step of stabilizing the actuating member (figure 6a,b). Once the device is deployed, the actuated member is stabilized.
As to claim 14, Loshakove discloses the step of stabilizing the actuating member further includes the step of maintaining the actuating member substantially parallel to a circumferential axis of the ring structure (figure 5, 6a,b).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent 5,234,447 to Kaster, U.S. Patent 6,179,849 to Yencho, U.S. Patent 6,979,338 to Loshakove, U.S. Patent Publication 2003/0212418 to Yencho, U.S. Patent Publication 2005/0080437 to Wright, U.S. Patent Publication 2006/0069401 to Wright, U.S. Patent Publication 2012/0215238 to Borghi, and U.S. Patent Publication 2024/0315725 to Mitchell all disclose similar devices capable of disclosing, rendering obvious, and/or providing evidence on the claims of record.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached Monday - Friday 9am - 5pm.
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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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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771
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