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 .
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 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.
Response to Amendment
Acknowledgement is made to the amendment received 12/15/2025.
Acknowledgement is made to the amendment of claims 1-2, 11-12, and 18.
Acknowledgement is made to the cancellation of claims 3-4 and 13-14.
Acknowledgement is made to the withdrawal of claims 6, 9-10, 16, and 18-20.
Any claims listed above as cancelled have sufficiently overcome any rejections set forth in any of the prior office actions.
Any claims listed above as withdrawn have been withdrawn from further consideration by the examiner, as these claims are drawn to a non-elected invention.
Claims 1-2, 5, 7-8, 11-12, 15, and 17 are pending as rejected below. A complete action on the merits appears below.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 7-8, 11-12 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Kladakis (US 20070276415 A1) in view of Kiedrowski (US 20210052147 A1).
Regarding claim 1, Kladakis teaches a medical device (Abstract) comprising:
an elongated shaft portion (Fig. 4; delivery assembly 124); and
an expansion body (Fig. 12; occluder 70) provided at a distal portion of the shaft portion, the expansion body configured to be expandable and contractable in a radial direction of the expansion body ([0011]- [0012]),
wherein the shaft portion includes a central shaft (Fig. 12; catch member 50) extending along an axial direction of the expansion body;
the expansion body includes a plurality of wire portions (Fig. 5-8; proximal petals 82 and distal petals 72) configured to be expandable and contractable in the radial direction,
each of the plurality of wire portions includes a proximal side outward projection portion (Fig. 5-8; proximal portion 40) protruding outward in the radial direction ([0036]), a distal side outward projection portion (Fig. 5-8; distal portion 20) located closer to a distal side than the proximal side outward projection portion and protruding outward in the radial direction ([0036]), and an inward projection portion protruding inward in the radial direction between the proximal side outward projection portion and the distal side outward projection portion (Fig. 5-8; the portion between the proximal portion and the distal portion is shown as projecting inward relative to the proximal portion and the distal portion), the each of the plurality of wire portions having a valley shape in the radial direction of the expansion body formed from the inward projection portion, the proximal side outward projection portion and the distal side outward projection portion, the inward projection portion forming a bottom of the valley shape ([0036] teaches that each of the proximal petals 82 and the distal petals 72 originate from the central tube at one end),
the inward projection portion includes a contact portion (Fig. 5-8 & 12; central tube 78) that comes into contact with the central shaft when the expansion body is contracted in the radial direction with a storage sheath (Fig. 12; delivery sheath 200),
an opening portion is formed in the contact portion of the inward projection portion (Fig. 12; the connection member 78, also referred to as central tube 78, is taught as being a tube and as having threads 79),
a protruding portion (Fig. 12; threads 152) is formed in the central shaft (Fig. 12; the catch member 50 is taught as including external threads 152), and when the expansion body is contracted, at least a part of the protruding portion enters an inside of the opening portion, and comes into contact with the opening portion ([0053]),
wherein the contact portion of the inward projection portion includes an outer edge portion (Fig. 12; central tube 78 is shown as being a tube having proximal and distal edge portions), and
wherein when the proximal side outward projection portion in an expanded state is contracted and stored within the storage sheath from a proximal side of the proximal side outward projection portion the outer edge portion of the contact portion of the inward projection portion comes into contact with the protruding portion of the central shaft so as to be slidable in the axial direction of the expansion body ([0053] discuss the threads 79 as cooperating with the threads 152 of the catch member 50, this movement from an expanded state to a contracted state can be shown best in Fig. 7 and 12 where in Fig. 7 the catch member 50 is shown as having pass by the connection member 78, and therefore, by the threads 79 of connection member 78 in a proximal direction to produce the expanded configuration of the occluder 70 and in Fig. 12 the catch member 50 is shown as having passed by the connection member 78 in a distal direction).
Kladakis further teaches the contact portion including an outer edge portion as being a screw member for threadable attachment (Abstract, [0012], [0036], [0053]).
However, Kladakis fails to teach the outer edge portion as being two outer edge portions interposing the opening portion in a width direction, the width direction being a direction orthogonal to the axial direction of the expansion body and being a direction orthogonal to the radial direction of the expansion body.
Kiedrowski teaches a medical device having a channel part, a connecting element having a fastening element, and a sliding element (Abstract, [0022], [0037]).
Kiedrowski further teaches the fastening element as being in a form from any of a plurality of known forms, such as a thread to form a screw or a tongue-and-groove ([0010], [0017]).
Therefore, it would have been obvious to a person having ordinary skill before the effective filing date to have substituted the screw catch mechanism for threadable attachment as is taught by Kladakis with the element for providing attachment as is taught by Kiedrowski as both elements perform the same function of attaching elongated slidable elements and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06(II).
Regarding claim 2, Kladakis teaches the medical device according to claim 1, wherein the opening portion and/or the protruding portion extend in the axial direction ([0036], [0053]).
Regarding claim 7, Kladakis teaches the medical device according to claim 1, wherein the opening portion is a non-through recessed portion ([0036], [0053]).
Regarding claim 8, Kladakis teaches the medical device according to claim 1, further comprising: an axially orthogonal cross section of an outer peripheral surface of the central shaft is a substantially circular shape, and the protruding portion is a part of the outer peripheral surface of the central shaft ([0036], [0053]).
Regarding claim 11, Kladakis teaches a medical device (Abstract) comprising:
an elongated shaft (Fig. 4; delivery assembly 124);
an expansion body (Fig. 12; occluder 70) on at a distal portion of the shaft, the expansion body configured to be expandable and contractable in a radial direction of the expansion body ([0011]- [0012]), the shaft includes a central shaft (Fig. 12; catch member 50) extending along an axial direction of the expansion body;
the expansion body includes four wire portions (Fig. 5-8; proximal petals 82 and distal petals 72) configured to be expandable and contractable in the radial direction, each of the four wire portions includes a proximal side outward projection portion (Fig. 5-8; proximal portion 40) protruding outward in the radial direction, a distal side outward projection portion (Fig. 5-8; distal portion 20) located closer to a distal side than the proximal side outward projection portion and protruding outward in the radial direction ([0036]), and an inward projection portion protruding inward in the radial direction between the proximal side outward projection portion and the distal side outward projection portion (Fig. 5-8; the portion between the proximal portion and the distal portion is shown as projecting inward relative to the proximal portion and the distal portion), the each of the four wire portions having a valley shape in the radial direction of the expansion body formed from the inward projection portion, the proximal side outward projection portion and the distal side outward projection portion, the inward projection portion forming a bottom of the valley shape ([0036] teaches that each of the proximal petals 82 and the distal petals 72 originate from the central tube at one end)
the inward projection portion includes a contact portion (Fig. 5-8; central tube) that comes into contact with the central shaft when the expansion body is contracted in the radial direction within a storage sheath (Fig. 12; delivery sheath 200);
an opening portion is formed in at least one of the contact portion of the inward projection portion (Fig. 12; the connection member 78, also referred to as central tube 78, is taught as being a tube and as having threads 79);
a protruding portion (Fig. 12; threads 152) is formed in the central shaft (Fig. 12; the catch member 50 is taught as including external threads 152) and
when the expansion body is contracted, at least a part of the protruding portion enters an inside of the opening portion, and comes into contact with the opening portion ([0053]): and
wherein the contact portion of the inward projection portion includes an outer edge portion (Fig. 12; central tube 78 is shown as being a tube having proximal and distal edge portions), and
wherein when the proximal side outward projection portion in an expanded state is contracted and stored within the storage sheath from a proximal side of the proximal side outward projection portion, the two outer edge portions of the contact portion of the inward projection portion comes into contact with the protruding portion of the central shaft so as to be slidable in the axial direction of the expansion body ([0053] discuss the threads 79 as cooperating with the threads 152 of the catch member 50, this movement from an expanded state to a contracted state can be shown best in Fig. 7 and 12 where in Fig. 7 the catch member 50 is shown as having pass by the connection member 78, and therefore, by the threads 79 of connection member 78 in a proximal direction to produce the expanded configuration of the occluder 70 and in Fig. 12 the catch member 50 is shown as having passed by the connection member 78 in a distal direction).
Kladakis further teaches the contact portion including an outer edge portion as being a screw member for threadable attachment (Abstract, [0012], [0036], [0053]).
However, Kladakis fails to teach the outer edge portion as being two outer edge portions interposing the opening portion in a width direction, the width direction being a direction orthogonal to the axial direction of the expansion body and being a direction orthogonal to the radial direction of the expansion body.
Kiedrowski teaches a medical device having a channel part, a connecting element having a fastening element, and a sliding element (Abstract, [0022], [0037]).
Kiedrowski further teaches the fastening element as being in a form from any of a plurality of known forms, such as a thread to form a screw or a tongue-and-groove ([0010], [0017]).
Therefore, it would have been obvious to a person having ordinary skill before the effective filing date to have substituted the screw catch mechanism for threadable attachment as is taught by Kladakis with the element for providing attachment as is taught by Kiedrowski as both elements perform the same function of attaching elongated slidable elements and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06(II).
Regarding claim 12, Kladakis teaches the medical device according to claim 11, wherein one or more of the opening portion and the protruding portion extend in the axial direction ([0036], [0053]).
Regarding claim 17, Kladakis teaches the medical device according to claim 11, further comprising: an axially orthogonal cross section of an outer peripheral surface of the central shaft is a substantially circular shape, and the protruding portion is a part of the outer peripheral surface of the central shaft ([0036], [0053]).
Claims 5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Kladakis (US 20070276415 A1) in view of Kiedrowski (US 20210052147 A1) further in view of Buysman (US 20150011991 A1).
Regarding claim 5, Kladakis as modified teaches the medical device according to claim 1.
However, Kladakis as modified fails to teach the medical device further comprising: an energy transmission element disposed on the wire portion configured to output energy.
Buysman teaches a catheter system having a distal assembly comprising a plurality of distal, proximal and center segments which is configurable between a collapsed configuration and an expanded configuration (Abstract).
Buysman further teaches assembly which is maneuverable between a collapsed configuration for maneuvering and positioning the assembly in the patient and an expanded assembly for operation of a procedure within the patient as including an energy transmission element, such as an electrode on the wire portion to output energy to the tissue and treat the patient tissue ([0054]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the assembly which is configurable between a collapsed configuration and an expanded configuration as having electrodes, as is taught by Buysman, into the occluder which is adjustable between an expanded and compressed state as is taught by Kladakis, to produce the predictable result of using a wire device which expands and collapses inside of a patient so as to treat patient tissue, as is taught by Buysman, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 15, Kladakis as modified teaches the medical device according to claim 11. However, Kladakis as modified fails to teach the medical device further comprising: an energy transmission element disposed on the wire portion configured to output energy.
Buysman teaches a catheter system having a distal assembly comprising a plurality of distal, proximal and center segments which is configurable between a collapsed configuration and an expanded configuration (Abstract).
Buysman further teaches assembly which is maneuverable between a collapsed configuration for maneuvering and positioning the assembly in the patient and an expanded assembly for operation of a procedure within the patient as including an energy transmission element, such as an electrode on the wire portion to output energy to the tissue and treat the patient tissue ([0054]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the assembly which is configurable between a collapsed configuration and an expanded configuration as having electrodes, as is taught by Buysman, into the occluder which is adjustable between an expanded and compressed state as is taught by Kladakis, to produce the predictable result of using a wire device which expands and collapses inside of a patient so as to treat patient tissue, as is taught by Buysman, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the amendments have necessitated new grounds of rejection.
Specifically, applicant’s arguments of the limitations that art not taught by the Chanduszko reference are moot in view of the new rejections under Kladakis and Kiedrowski.
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 extension fee 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 date of this final action.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/L.R.L./Examiner, Art Unit 3794