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 .
Claim Objections
Claim 16 is objected to because of the following informalities:
Claim 16 is dependent off claim 1, and seems it is to meant to be off claim 11. Otherwise, it is a duplicate of claim 8.
Appropriate correction is required.
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.
Claim(s) 1-6, 8, and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alobaid (US 9283018).
Claim 1, Alobaid discloses a system (Fig. 1) for performing a vertebral augmentation procedure (Fig. 1; abstract), the system comprising: a delivery device (11), the delivery device comprising: an inflation tube (30) having a delivery cannula (30) and an injection port (32), wherein bone cement can flow through the delivery cannula and out of the injection port (Fig. 1; col. 2, lines 2-3); a push tube (24) provided over a proximal portion of the inflation tube (Fig. 1); and a push handle (44); an inflation luer ((tip of 42) for receipt by the push handle (Fig. 1; cols. 1-2), wherein the inflation luer and the push handle are configured for a snap fit connection (these two parts could be snap fit into a holding tray that has a mold similar in shape that flexes just enough to pop/snap the parts into a tray); and an encapsulation balloon (20) configured for receiving bone cement (Fig. 1; cols. 1-2), the encapsulation balloon being provided over a distal portion (Fig. 1; near where 20 points) of the inflation tube such that the port is provided within the encapsulation balloon (Fig. 1; cols. 1-2).
Claim 2, Alobaid discloses the system of claim 1, further comprising an access catheter (14).
Claim 3, Alobaid discloses the system of claim 1, further comprising a balloon tamp (20).
Claim 4, Alobaid discloses the system of claim 1, wherein the encapsulation ballon has an inflated configuration (Fig. 2) and a non-inflated configuration (cols. 2-3), and wherein, in the inflated configuration, the encapsulation balloon includes a plurality of wings (Fig. 2; the proximal end near where 14 points but on the balloon 20 and the distal end near where 18 points but on the balloon 20, are both portions that could be considered “wings”).
Claim 5, Alobaid discloses the system of claim 1, wherein the port is a side port (Figs. 1-3).
Claim 6, Alobaid discloses the system of claim 1, wherein the encapsulation balloon is biodegradable and/or bioresorbable (col. 2, line 24).
Claim 8, Alobaid discloses the system of claim 1, wherein the encapsulation balloon includes an exterior inflatable portion (distal end portion of the balloon) and an interior shaft (14), wherein the interior shaft includes a port (22) configured to align with the injection port (Figs. 1 and 2; col. 2, lines 48-53).
Claim 10, Alobaid discloses the system of claim 8, wherein the port includes a one-way valve (slit 22 acts as a one-way valve; cols. 2, lines 30-34).
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alobaid (US 9283018), in view of Shadduck et al. (US 2010/0262152; “Shadduck”).
Claim 1, Alobaid discloses the system as noted above, wherein the inflation luer and the push handle can mate by any known connection type (col. 2, lines 56-59).
However, Alobaid does not disclose the inflation luer and push handle mating with a snap fit connection.
Shadduck teaches a connecting two parts via a snap fit connection (paragraph [0083]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the connection feature between the inflation luer and the push handle of Alobaid, to be a snap fit connection, as taught by Shadduck, since this is a well-known way to connect two parts of a medical device (paragraph [0083]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alobaid (US 9283018), in view of Weikel et al. (US 7666205; “Weikel”).
Claim 7, Alobaid discloses the system of claim 1.
However, Alobaid does not disclose the balloon including a radiopaque marker.
Weikel teaches a balloon (Fig. 1; 30) that includes a radiopaque marker (col. 11, line 66, col. 12, line 3).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to include the radiopaque marker, as taught by Weikel, to the balloon of Alobaid in order to be able to visualize the balloon under fluoroscopy (col. 11, line 66, col. 12, line 3).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alobaid (US 9283018), in view of Hayes et al. (US 2006/0085022; “Hayes”).
Claim 9, Alobaid discloses the system of claim 8.
However, Alobaid does not disclose the balloon comprising a ridged shape having a distal tip.
Hayes teaches a balloon (Fig. 1B) comprising a ridged shape (31) having a distal tip (34).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to include the ridged shape, as taught by Hayes, with the balloon of Alobaid, in order to decrease the size of the balloon during insertion (paragraph [0044]).
Claim(s) 11-12, 14, and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alobaid (US 9283018), in view of Tilson et al. (US 2015/0141917; “Tilson”).
Claim 11, Alobaid discloses a system (Fig. 1) for performing a vertebral augmentation procedure (Fig. 1; abstract), the system comprising: a delivery catheter (30), the delivery catheter comprising: a central tube (30) having a distal end (end near the balloon 20) and a proximal end (end near the hub 42), and a longitudinal axis (axis running through the middle of the device from the proximal end to the distal end); a distal tip assembly (tip at the balloon) provided at the distal end (Fig. 1), the distal tip assembly including a port (32), wherein bone cement can flow through the central, to the distal tip assembly, and out of the port tube (Fig. 1; cols. 2-3); a dispensing tip (42), wherein the dispensing tip is configured for receiving a cement cannula (Fig. 1; opening at the top of 42 allows for this; cols. 2-3); and a handle (44) removably coupled to the central tube and configured to receive the dispensing tip (Fig. 1; cols. 2-3); and an encapsulation balloon (20) configured for receiving bone cement (Fig. 1; cols. 2-3), wherein the encapsulation balloon is provided over the distal tip assembly (Fig. 1).
However, Alobaid does not disclose the balloon having a star-shape when inflated.
Tilson teaches a balloon (Figs. 21A-21B) that has a star-shaped profile (Figs. 21A-21B; profile you would see looking down the longitudinal axis) when viewed from directions parallel to the longitudinal axis (Figs. 21A-2B; paragraphs [0239]-[0243]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the balloon shape of Alobaid, to include the star-shape, as taught by Tilson, in order to reinforce the balloon (paragraphs [00239]-[00243]).
Claim 12, Alobaid in view of Tilson discloses the system of claim 11, Alobaid discloses wherein the handle comprises an internal slot (the lumen of 44) and two interlocking parts (Fig. 1; distal portion of 44 and proximal portion of 44).
Claim 14, Alobaid in view of Tilson discloses the system of claim 11, Alobaid discloses wherein the encapsulation balloon is biodegradable and/or bioresorbable (col. 2, line 24).
Claim 16, Alobaid in view of Tilson discloses the system of claim 11, Alobaid discloses wherein the encapsulation balloon includes an exterior inflatable portion (distal end portion of the balloon) and an interior shaft (14), wherein the interior shaft includes a port (22) configured to align with the injection port (Figs. 1 and 2; col. 2, lines 48-53).
Claim 17, Alobaid in view of Tilson discloses the system of claim 16, Tilson teaches wherein the star-shaped profile includes a plurality of wings (Figs. 21A-21B; paragraphs [0239]-[0243]).
Claim 18, Alobaid in view of Tilson discloses the system of claim 16, Alobaid discloses wherein the port includes a one-way valve (slit 22 acts as a one-way valve; cols. 2, lines 30-34).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alobaid (US 9283018), in view of Tilson et al. (US 2015/0141917; “Tilson”), in further view of Liu et al. (US 7811291; “Liu”).
Claim 13, Alobaid in view of Tilson discloses the system of claim 11.
However, they do not disclose the system comprising a cement cannula as required by the claim.
Liu teaches a system (Fig. 4) comprising a cement cannula (10), the cement cannula comprising a central cannula (10), a handle (18), and a distal tip (distal end that 10 points to), wherein the distal tip engages with the dispensing tip of the delivery catheter (Fig. 4).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the cement cannula, as taught by Liu, to the system of Alobaid in view of Tilson, in order to easily connect the system to a pre-existing cement source (Fig. 4; col. 7, lines 35-67).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alobaid (US 9283018), in view of Tilson et al. (US 2015/0141917; “Tilson”), in further view of Shadduck et al. (US 2010/0262152; “Shadduck”).
Claim 15, Alobaid in view of Tilson disclose the system of claim 11.
However, they do not disclose the handle receiving the dispensing tip in a snap fit connection.
Shadduck teaches a connecting two parts via a snap fit connection (paragraph [0083]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the connection feature between the handle and dispensing tip of Alobaid in view of Tilson, to be a snap fit connection, as taught by Shadduck, since this is a well-known way to connect two parts of a medical device (paragraph [0083]).
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Murdoch et al. (US 2021/0015531; “Murdoch”), in view of Shadduck et al. (US 2010/0262152; “Shadduck”).
Claim 19, Murdoch discloses a system (Fig. 2) for performing a vertebral augmentation procedure (Fig. 2; abstract; paragraph [0109]), the system comprising: a cement encapsulation system (230, 240, etc.) comprising: a cement reservoir (230) having a proximal end (upper end) and a reservoir distal tip (near where 221 points); a syringe (242) for removing air; and a tube (202); a catheter delivery system (250 and down) comprising: a delivery catheter (outer tube), the delivery catheter comprising: a central tube (220) having a distal end (bottom end) and a proximal end (upper end); a catheter distal tip assembly (Figs. 2-3; tip at the balloon) provided at the distal end (Fig. 2), the distal tip assembly including a port (Fig. 5, 278), wherein bone cement can flow through the central tube, to the distal tip assembly (Fig. 5), and out of the port (Fig. 6); and a handle (Fig. 2; 250) removably coupled to the central tube (Fig. 2); wherein the cement reservoir is removably coupled to the delivery catheter (paragraph [0118]); and an encapsulation balloon (Fig. 3; 262) configured for receiving bone cement (paragraph [0118]), wherein the encapsulation balloon is provided over the catheter distal tip assembly (Figs. 2-7), the encapsulation balloon having an inflated configuration (paragraph [0129]) and a non-inflated configuration (Fig. 3; paragraph [0129]), and wherein, in the inflated configuration, the encapsulation balloon includes a plurality of wings (Figs. 12A-15D; paragraph [0129]; at least the diamond shape in Fig. 15B can be considered to have wings, but some of the other shapes mentioned also have portions that point out like wings rather than just being one smooth outer surface like a sphere or cylinder).
However, Murdoch does not disclose the system having a stopcock.
Shadduck teaches a cement delivery system that utilizes a stopcock (Fig. 1; 148).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to includes a stopcock, as taught by Shadduck, between any of the input portions of the system of Murdoch, in order to have a safety valve to allow or discontinue flow of any material (Fig. 1; paragraph [0070]).
Claim 20, Murdoch in view of Shadduck discloses the system of claim 19, Shadduck teaches wherein the cement reservoir (Fig. 1; 114) is removably coupled to the delivery catheter via the stopcock (Fig. 1).
Response to Arguments
In regards to claim 1, it still seems Alobaid can read on the claim limitation. Note how the limitation is not positively reciting the snap fit connection between the inflation luer and the push handle. However, an alternate rejection using Shadduck to teach a snap fit connection has been laid out in the rejections above.
Claim 11 was worded in a manner that Alobaid did not teaches. However, Tilson is now being relied upon.
In regards to claim 19 amendments, it still seems Murdoch reads on the claim limitations. “Wings” is still kind of broad. In the current invention the star like shape has wing when viewed down the longitudinal axis. However, “wings” can simply mean two separate portions. Kind of like the white house has east and west wings. Therefore, it is like portions that branch off from the main portion. So even in Fig. 5 of Murdoch there is a wing of the balloon 262 that is above one of the ports 290 and there is a second wing/portion/segment that is below the other port 290. Regardless, the rejection above uses the shapes mentioned in paragraph [0129] to teach wings on the balloon 262. For instance, a diamond shape has angled portions that look more like wings per se. Despite all of that Tilson teaches the star-shape, while Tilson is not necessary to be relied upon for claims 1 and 19.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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 Zade Coley whose telephone number is (571)270-1931. The examiner can normally be reached M-F (9-5) PT.
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/Zade Coley/Primary Examiner, Art Unit 3775