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
This Office Action is a response to applicant’s arguments and amendment filed 02/19/2026. Claims 1, 13 and 19-23 are amended. Claims 4, 17-18 and 24-34 are cancelled. Claims 1-3, 5-16 and 19-23 are currently pending.
The objection of claims 1 and 12 is maintained; see below.
The rejection of claims 1-3, 5-16 and 19-23 under 35 U.S.C. 112(b) has been withdrawn due to applicant’s amendment.
Response to Arguments
Applicant’s arguments, see Remarks, filed 02/19/2026, with respect to the rejection(s) of claim(s) 1-3, 5-11, 16 and 19-22 under 35 U.S.C. 102(a)(1) as being anticipated by Hall; claims 12-15 under 35 U.S.C. 103 as being unpatentable over Hall in view of Hart; and claim 23 under 35 U.S.C. 103 as being unpatentable over Hall in view of Marcadis, have been fully considered but are not persuasive, in combination with the amendments to the claims.
1) Applicant argues Hall does not teach comprising a balloon component that has a first end and a second end which engage the catheter tube to envelop the outlet because Hall has a first end that attaches to the inner tube and a second end that attaches to the outer tube (Remarks, pg. 7).
In response to applicant’s first argument, it is respectfully submitted the arguments are narrower than the claim limitations. The claim language does not specify which end engages the catheter tube, and further does not specify what type of engagement is being claimed (e.g. direct or indirect engagement). Further, the instant spec. describes the catheter tube comprising an outer tube 26 and an inner tube 28 (para. [0144]; fig. 3a). The configuration of the inner and outer tube in Hall is consistent with the disclosed configuration of the catheter tube, therefore the claim limitation is met.
2) Applicant further argues Hall does not teach separate walls, and instead teaches a single wall member having different sides and different regions, and never teaches reflected portion 6 is an edge (Remarks, pg. 8).
In response to applicant’s second argument, it is respectfully submitted the arguments are narrower than the claim limitations. The claim language reciting an outer wall, an inner wall, and an edge located between the outer wall and the inner wall does not preclude a membrane with different regions or sides meeting the claim limitation. Further, Hall explicitly describes membrane 2 consisting of an outer wall and an inner wall (col. 4 lines 39-56). Therefore, a region of the membrane on a border of the membrane is considered to have an edge, as discussed below.
3) Applicant further argues seal 32 of Hall does not include any bonding, therefore seal 32 is not a bond zone (Remarks, pgs. 8-9).
In response to applicant’s third argument, it is respectfully submitted the bond zone is interpreted consistent with the instant spec., which describes the bond zone as being formed by direct sealing engagement of the inner wall to the outer wall (paras. [0063] and [0098]). Since the instant spec. describes the bond zone as being formed by sealing, the claim limitation is considered to be met.
4) Applicant further argues Hall does not teach bonding the inner wall to the outer wall in such a way that upon inflation the outer wall moves radially outward relative to the catheter’s longitudinal axis, thereby expanding rather than closing the cavity (Remarks, pg. 9).
In response to applicant’s fourth argument, it is respectfully submitted seal 32 of Hall meets the claimed limitation of at least one bond zone within which the inner wall is bonded directly to the outer wall as discussed above. In addition, Hall discloses walls 4 and 8 being inflated or “ballooning”, and then further discloses the membrane inflated when the inner tube 24 is in the extended position (col. 5 line 67-col. 6 line 14). Therefore, Hall discloses membrane 2 inflated prior to and after movement of inner tube 24, such that inflation of membrane 2 after inner tube 24 moves distally is considered to encompass the inflation state. Accordingly, the cavity is considered to be expanded as membrane 2 moves to the inflated state, because membrane 2 moves radially outwardly during expansion/movement of inner tube 24 as depicted in figs. 1-4 of Hall, such that the claimed limitation is met.
Claim Objections
Claims 1 and 12 are objected to because of the following informalities:
In claim 1, lines 10 and 12, the phrase “the catheter” should read “the catheter tube”, to remain consistent in referring to the catheter tube previously introduced.
In claim 12, line 2, the phrase “each of which” should read “each of the plurality of tethers”.
Appropriate correction is required.
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 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.
Claim(s) 1-3, 5-11, 16 and 19-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hall (US 4324262) (all references previously of record).
Regarding claim 1, Hall discloses (see abstract; col. 4 line 35-col. 6 line 40; figs. 1-11) a medical device for use within the human body (abstract, fig. 1), which includes a catheter tube (16, col. 4 lines 39-56; fig. 1) having a distal end and a proximal end (fig. 5), an inflation passage (30, col. 4 line 57-col. 5 line 2 and col. 6 line 55-col. 7 line 16) defined within the catheter tube and having an outlet (fig. 1), at least one balloon module comprising a balloon component (membrane 2) that has a first end (12) and a second end (20) which engage the catheter tube to envelop the outlet (fig. 1), and between which an outer wall (4), an inner wall (8), and an edge (edge formed at 32) between the outer wall and the inner wall (fig. 1), are disposed to define an inflation enclosure (at 10, fig. 1), at least one bond zone (32) within which the inner wall is bonded directly to the outer wall (col. 4 line 57-col. 5 line 2 and col. 5 lines 13-25), and a cavity (at 11) defined within the inner wall (fig. 1), wherein the balloon component is inflatable by inflow of an inflation fluid through an inlet into the inflation enclosure from a deflated state to an inflated state (col. 5 lines 13-25 and col. 6 line 55-col. 7 line 16), wherein the edge is radially spaced from the longitudinal axis of the catheter such that when the balloon component moves from the deflated state to the inflated state, the outer wall and at least part of the inner wall move radially outwardly relatively to the longitudinal axis of the catheter to cause expansion of the cavity (see figs. 1 and 3-4, considered to be radially spaced from longitudinal axis as walls stiffen and balloon when expanding and moving radially outwardly).
Regarding claim 2, Hall discloses the device of claim 1. Hall further discloses wherein the edge is an edge or region of curvature or inflection defining a boundary or transition between the outer wall and the inner wall (fig. 1).
Regarding claim 3, Hall discloses the device of claim 2. Hall further discloses wherein the edge follows a circumferential path (fig. 1).
Regarding claim 5, Hall discloses the device of claim 3. Hall further discloses wherein the edge is mitred, chamfered or bevelled (edge is formed at a slant/incline, considered to be beveled).
Regarding claim 6, Hall discloses the device of claim 5. Hall further discloses wherein the catheter tube has at least one working passage (25, col. 5 lines 3-12).
Regarding claim 7, Hall discloses the device of claim 6. Hall further discloses wherein the catheter tube includes a conduit (24) within which the at least one working passage is defined (fig. 1).
Regarding claim 8, Hall discloses the device of claim 7. Hall further discloses wherein the first end engages the catheter tube and the second end engages the conduit (fig. 1).
Regarding claim 10, Hall discloses the device of claim 7. Hall further discloses wherein the conduit has an inlet disposed at or towards the distal end (distal opening of 25).
Regarding claim 11, Hall discloses the device of claim 7. Hall further discloses wherein the conduit extends beyond the edge of the balloon component as an extending section (depicted in fig. 3).
Regarding claim 16, Hall discloses the device of claim 11. Hall further discloses which includes a conical filter (see spiral pleats 81 of inner wall of membrane, considered to function as a conical filter, fig. 10) which extends between the edge and the extending section (fig. 10).
Regarding claim 19, Hall discloses the device of claim 1. Hall further discloses which the at least one bond zone includes a plurality of bond zones (includes seal/bonding at 32, 18 and 20).
Regarding claim 20, Hall discloses the device of claim 19. Hall further discloses wherein each bond zone of the plurality of bond zones is elongate or circular (see fig. 3 depicting bonds as circular surrounding catheter tube).
Regarding claim 21, Hall discloses the device of claim 19. Hall further discloses wherein each bond zone of the plurality of bond zones is longitudinally, circumferentially, helical, or spirally configured (circumferentially configured, fig. 3).
Regarding claim 22, Hall discloses the device of claim 20. Hall further discloses wherein the elongate bond zones of the plurality of bond zones are straight or take on a V-, W- or chevron shape (note the claim language is further limiting an alternative recitation in claim 20 and is therefore not required).
Regarding claim 1, Hall discloses (see abstract; col. 4 line 35-col. 6 line 40; figs. 1-11), under an alternative interpretation with respect to the first end and the second end, a medical device for use within the human body (abstract, fig. 1), which includes a catheter tube (16, col. 4 lines 39-56; fig. 1) having a distal end and a proximal end (fig. 5), an inflation passage (30, col. 4 line 57-col. 5 line 2 and col. 6 line 55-col. 7 line 16) defined within the catheter tube and having an outlet (fig. 1), at least one balloon module comprising a balloon component (membrane 2) that has a first end (20) and a second end (12) which engage the catheter tube to envelop the outlet (fig. 1), and between which an outer wall (4), an inner wall (8), and an edge (edge formed at 32) between the outer wall and the inner wall (fig. 1), are disposed to define an inflation enclosure (at 10, fig. 1), at least one bond zone (32) within which the inner wall is bonded directly to the outer wall (col. 4 line 57-col. 5 line 2 and col. 5 lines 13-25), and a cavity (at 11) defined within the inner wall (fig. 1), wherein the balloon component is inflatable by inflow of an inflation fluid through an inlet into the inflation enclosure from a deflated state to an inflated state (col. 5 lines 13-25 and col. 6 line 55-col. 7 line 16), wherein the edge is radially spaced from the longitudinal axis of the catheter such that when the balloon component moves from the deflated state to the inflated state, the outer wall and at least part of the inner wall move radially outwardly relatively to the longitudinal axis of the catheter to cause expansion of the cavity (see figs. 1 and 3-4, considered to be radially spaced from longitudinal axis as walls stiffen and balloon when expanding and moving radially outwardly).
Regarding claim 2, Hall discloses the device of claim 1. Hall further discloses wherein the edge is an edge or region of curvature or inflection defining a boundary or transition between the outer wall and the inner wall (fig. 1).
Regarding claim 3, Hall discloses the device of claim 2. Hall further discloses wherein the edge follows a circumferential path (fig. 1).
Regarding claim 5, Hall discloses the device of claim 3. Hall further discloses wherein the edge is mitred, chamfered or bevelled (edge is formed at a slant/incline, considered to be beveled).
Regarding claim 6, Hall discloses the device of claim 5. Hall further discloses wherein the catheter tube has at least one working passage (25, col. 5 lines 3-12).
Regarding claim 7, Hall discloses the device of claim 6. Hall further discloses wherein the catheter tube includes a conduit (24) within which the at least one working passage is defined (fig. 1).
Regarding claim 9, Hall discloses the device of claim 7. Hall further discloses wherein the first end engages the conduit and the second end engages the catheter tube (fig. 1).
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.
Claim(s) 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Hall in view of Hart (US 6183492 B1).
Regarding claim 12, Hall discloses the device of claim 11.
However, Hall fails to disclose wherein the balloon module includes a plurality of tethers, each of which extend between the edge and the extending section.
Hart teaches (col. 6 line 18-col. 8 line 25; figs. 18-29), in the same field of endeavor, a medical device (figs. 18-21) comprising a balloon module (511) including a plurality of tethers (704), each of which extend between an edge (516) and an extending section (505), for the purpose of fixing chamber 700 in the radial plane, and also fixing the radial plane at a preferred operative position along the shaft (col. 8 lines 7-25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hall to further include a plurality of tethers each extending between the edge and the extending section of tube 24, in order to better control the radial plane in which membrane 2 extends during operation, such that a preferred operative position along the intermediate tube is obtained as walls 4 and 8 of the membrane 2 move during expansion, which would allow control over how far out membrane 2 expands radially as inner tube 24 is maneuvered, based on the suggestions and teachings of Hart (col. 8 lines 7-25).
Regarding claim 13, Hall (as modified) teaches the device of claim 12. Hall (as modified) further teaches wherein the tethers of the plurality of the tethers are equally circumferentially spaced relatively to one another (fig. 27 of Hart).
Regarding claim 14, Hall (as modified) teaches the device of claim 13. Hall (as modified) further teaches wherein the tethers extend between the edge and the extending section in an oblique direction (see tethers extending at an angle, fig. 27 of Hart).
Regarding claim 15, Hall (as modified) teaches the device of claim 14. Hall (as modified) further teaches wherein the tethers converge at a tubular neck adapted to be bonded to an outer surface of the extending section (see tethers 704 converging at neck of shaft 505 of Hart, combination considered to further teach tether converging at neck of inner tube 24 of Hall).
Claim(s) 23 is rejected under 35 U.S.C. 103 as being unpatentable over Hall in view of Marcadis (US 5487730).
Regarding claim 23, Hall discloses the device of claim 20.
However, Hall fails to disclose wherein the plurality of bond zones includes a pair of elongate bond zones that intersect or join to provide an X-shaped bond zone, or a zig-zag bond zone or an S shape bond zone or a sinusoidal bond zone.
Marcadis teaches (col. 8 lines 34-50; figs. 14-16), in the same field of endeavor, a medical device comprising a pair of elongate bond zones intersecting or joining to provide a zig-zag bond zone (figs. 14-15), in order to provide a relatively large area of surface contact between the retention means and interior surface of the coronary sinus (col. 8 lines 42-50).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hall to further include a pair of the bond zones in a zig-zag shape, in order to provide a larger area of surface contact between the device and the tissue, based on the teachings of Marcadis (col. 8 lines 42-50).
Conclusion
THIS ACTION IS MADE FINAL. 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 BRIGID K BYRD whose telephone number is (571)272-7698. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/BRIGID K BYRD/Examiner, Art Unit 3771