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
In response to the amendment filed on 3/2/2026, claim 8 has been cancelled, claim 21 has been newly added, and thus claims 1-7 and 9-21 are pending.
Response to Arguments
Applicant’s arguments with respect to claims 1, 17 and 20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claims 1-5, 7, 9-13, and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over US 6379329 B1 Naglreiter et al. (hereinafter Naglreiter) in view of US 5451204 Yoon.
Regarding claim 1, Naglreiter discloses an occlusion system for occluding a treatment site (col. 1 line 13-15, line 64 – col. 2 line 55), comprising:
a balloon (54,56 of balloon assembly 52, Fig. 2-5) in fluid communication with an inflation lumen (lumen of inner tubular member 10, Fig. 1) (col. 4 line 33-39, 60 – col. 5 line 12),
wherein an adhesive-absorbing membrane (col. 2 line 32-55, outer balloon 54 is made of a porous material) is in fluid communication with an adhesive lumen (lumen of outer tubular member 4, Fig. 1) (col. 4 line 33-39, 60 – col. 5 line 4, col. 5 line 36-52), and
wherein diffusion of an adhesive (78, Fig. 8-10) through the adhesive-absorbing membrane exposes at least a portion of the adhesive to an outer surface of the adhesive-absorbing membrane of the balloon (abstract, col. 5 line 36-52).
Naglreiter is silent on the adhesive-absorbing membrane disposed on an outer surface of the balloon.
However, Yoon teaches a device used in endoscopic surgery (abstract, col. 1 line 23-30) that comprises an expandable balloon (22, Fig. 1-2) and an adhesive-absorbing membrane (24, Fig. 1-2; col. 4 line 54 – col. 5 line 42, adhesive-absorbing membrane is made of an absorbent material and is capable of absorbing an adhesive) disposed on an outer surface of the balloon (as seen in Fig. 1-2, col. 5 line 34-42).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Naglreiter with the teachings of Yoon to have the adhesive-absorbing membrane disposed on an outer surface of the balloon in order to increase the external size or surface area of the device utilizing an absorbent material while minimizing the quantity of absorbent material required as disclosed by Yoon (col. 2 line 21-23).
Regarding claim 2, the combination of Naglreiter and Yoon teaches the limitations of claim 1, and Naglreiter further discloses wherein at least a portion of the inflation lumen is positioned within at least a portion of the adhesive lumen (col. 2 line 1-4, the inner tubular member is coaxially disposed within the outer tubular member).
Regarding claim 3, the combination of Naglreiter and Yoon teaches the limitations of claim 1, and Naglreiter further discloses wherein the adhesive lumen extends into a distal portion of the balloon (as seen in Fig. 1-3).
Regarding claim 4, the combination of Naglreiter and Yoon teaches the limitations of claim 1, and Naglreiter further discloses wherein the balloon comprises a depression (see Fig. 7, a depression is formed at the distal portion of the balloon between outer balloon 54 and inner balloon 56) and wherein the adhesive-absorbing membrane is positioned disposed over the depression (the modification of Naglreiter with Yoon would have the adhesive-absorbing membrane disposed over the depression of the balloon).
Regarding claim 5, the combination of Naglreiter and Yoon teaches the limitations of claim 4, and Naglreiter further discloses wherein the depression is located at a distal portion of the balloon (see Fig. 7, a depression is formed at the distal portion of the balloon between outer balloon 54 and inner balloon 56).
Regarding claim 7, the combination of Naglreiter and Yoon teaches the limitations of claim 1, and Naglreiter further discloses wherein the adhesive-absorbing membrane comprises a plurality of pores (col. 2 line 32-55, outer balloon 54 is made of a porous material).
Regarding claim 9, the combination of Naglreiter and Yoon teaches the limitations of claim 1, and Yoon further discloses wherein the adhesive-absorbing membrane is disposed over a distal portion of the balloon (as seen in Fig. 1-2, col. 5 line 34-42).
Regarding claim 10, the combination of Naglreiter and Yoon teaches the limitations of claim 1, and Naglreiter further discloses wherein the inflation lumen comprises an outer catheter (inner tubular member 4, Fig. 1).
Regarding claim 11, the combination of Naglreiter and Yoon teaches the limitations of claim 10, and Naglreiter further discloses wherein the balloon is releasably attached to the outer catheter by a detachment mechanism (50, Fig. 1, 2-5, col. 3 line 33-37).
Regarding claim 12, the combination of Naglreiter and Yoon teaches the limitations of claim 10, and Naglreiter further discloses wherein the adhesive lumen comprises an inner catheter (outer tubular member 10, Fig. 1).
Regarding claim 13, the combination of Naglreiter and Yoon teaches the limitations of claim 1, and Naglreiter further discloses further comprising a valve assembly (58, Fig. 2) positioned within the balloon so as to separate a proximal portion of the balloon from a distal portion of the balloon (as seen in Fig. 4-10, the valve 58 separates the inner distal surface from the inner proximal surface of the balloon – if the valve were absent, the proximal portion and the distal portion of the balloon would come in contact if squeezed together).
Regarding claim 16, the combination of Naglreiter and Yoon teaches the limitations of claim 1, and Naglreiter further discloses wherein the adhesive lumen is in fluid communication with a distal portion of an interior of the balloon (as seen in Fig. 4-5).
Regarding claim 17, Naglreiter discloses a balloon (54,56 of balloon assembly 52, Fig. 2-5) for occluding a treatment site (col. 1 line 13-15, line 64 – col. 2 line 55), comprising:
a proximal portion for receiving an inflation fluid (seen in Fig. 4-5, 6-10, col. 4 line 16-39, 60 – col. 5 line 12, inner balloon 56 is inflated with inflation fluid from a proximal portion of the balloon);
a distal portion (as seen in Fig. 4-5);
and an adhesive-absorbing membrane (col. 2 line 32-55, outer balloon 54 is made of a porous material), wherein diffusion of an adhesive (78, Fig. 8-10) through the adhesive-absorbing membrane exposes at least a portion of the adhesive to an outer surface of the adhesive-absorbing membrane of the balloon (abstract, col. 5 line 36-52).
Naglreiter is silent on the adhesive-absorbing membrane disposed over the distal portion.
However, Yoon teaches a device used in endoscopic surgery (abstract, col. 1 line 23-30) that comprises an expandable balloon (22, Fig. 1-2) and an adhesive-absorbing membrane (24, Fig. 1-2; col. 4 line 54 – col. 5 line 42, adhesive-absorbing membrane is made of an absorbent material and is capable of absorbing an adhesive) disposed on an outer surface of the balloon (as seen in Fig. 1-2, col. 5 line 34-42).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Naglreiter with the teachings of Yoon to have the adhesive-absorbing membrane disposed over the distal portion in order to increase the external size or surface area of the device utilizing an absorbent material while minimizing the quantity of absorbent material required as disclosed by Yoon (col. 2 line 21-23).
Regarding claim 18, the combination of Naglreiter and Yoon teaches the limitations of claim 17, and Naglreiter further discloses further comprising an inflation lumen fluidly connected to the proximal portion (lumen of inner tubular member 10, Fig. 1) (col. 4 line 33-39, 60 – col. 5 line 12).
Regarding claim 19, the combination of Naglreiter and Yoon teaches the limitations of claim 18, and Naglreiter further discloses further comprising an adhesive lumen fluidly connected to the distal portion (lumen of outer tubular member 4, Fig. 1) (col. 4 line 33-39, 60 – col. 5 line 4, col. 5 line 36-52).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Naglreiter in view Yoon as applied to claim 1 above, and further in view of US 20150374483 A1 Janardhan et al. (hereinafter Janardhan).
Regarding claim 6, the combination of Naglreiter and Yoon teaches the limitations of claim 1.
The combination is silent on wherein the adhesive-absorbing membrane comprises a plurality of fibers forming a series of interlocking loops.
However, Janardhan teaches a vascular treatment device (paragraph 3, 6) wherein an adhesive-absorbing membrane (100, Fig. 1a, distal portion 100 is porous, paragraph 613) comprises a plurality of fibers forming a series of interlocking loops (paragraph 772, the distal portion 100 includes a knitted structure (e.g., produced by interlocking a series of loops of the filaments to create the distal portion 100)).
It should be understood that Naglreiter and Janardhan are known references in the art that teach filtration membranes (abstract, col. 5 line 36-52 of Naglreiter; paragraph 613 of Janardhan); and the examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted the adhesive-absorbing membrane of Naglreiter modified with Yoon with the adhesive-absorbing membrane of Janardhan, and the results of the substitution would have been predictable and resulted in the modified adhesive-absorbing membrane of modified Naglreiter with Yoon being able to function as intended to properly allow the balloon to expand and perfuse liquid therethrough. The examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Naglreiter in view of Yoon as applied to claim 13 above, and further in view of US 20030220666 A1 Mirigian et al. (hereinafter Mirigian) and further in view of US 20200015827 A1 Anderson et al. (hereinafter Anderson).
Regarding claim 14, the combination of Naglreiter and Yoon teaches the limitations of claim 13. Additionally, Naglreiter discloses a valve assembly comprising a first valve (62, Fig. 2-3) configured to seal around the inflation lumen (seen in Fig. 3-4, lumen of inner tubular member 10 extends into the balloon through catheter adapter (50) and is in fluid communication with the balloon).
The combination is silent on wherein the valve assembly is comprised of a second valve configured to seal around the adhesive lumen.
However, Mirigian teaches an embolic balloon and delivery system (abstract, paragraph 1, 4-5) comprising a check valve (228, Fig. 4b-d, 5b-d, paragraph 34) that is a duck-bill type or flapper type similar to the valve (62) of Naglreiter. The check valve of Mirigian is configured to seal around the inflation lumen (lumen 211 of catheter 200, Fig. 4a-c; this equates to the adhesive lumen of Naglreiter) and helps retain inflation liquid in the interior of the balloon (214) (paragraph 34).
Furthermore, Anderson teaches a similar occlusion device (abstract, paragraph 3) that comprises two valves: a first valve (232, Fig. 13; this equates to the valve 62 of Naglreiter) configured to seal around an inflation lumen (lumen 288 of inflation catheter 278; this equates to the inflation lumen of Naglreiter) (Fig. 13, paragraph 107-109), and a second valve (272, Fig. 13) configured to seal around an adhesive lumen (lumen 290 exiting distal region 280 of inflation catheter 278) (Fig. 13, paragraph 110-111). Thus, Anderson teaches a valve assembly comprising two valves for regulating liquid flow into an inner balloon and an outer balloon.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modification of Naglreiter with Yoon with the teachings of Mirigian and Anderson to incorporate a second valve into the valve assembly of modified Naglreiter with Yoon such that it is configured to seal around the adhesive lumen in order to retain the adhesive liquid in the balloon and prevent the backflow of liquid into adjacent inflation catheters (paragraph 34 of Mirigian). The combination above makes it obvious to put the valve of Mirigian in the passageway (60) of modified Naglreiter with Yoon proximal to the outlet (64) so that the valve closes around the catheter adapter (50) to prevent the fluid from flowing back through.
Regarding claim 15, as discussed above, it would have been obvious to modify the valve assembly of modified Naglreiter with Yoon to incorporate the second valve as taught by Mirigian and Anderson. Additionally, the combination teaches wherein the first valve (62 of Naglreiter) and the second valve (228 of Mirigian) are arranged in a linear passage (60 of Naglreiter) (as discussed above, the check valve of Mirigian is placed in the passageway (60) of Naglreiter in a linear fashion. Therefore, the combination makes obvious the limitations above).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Naglreiter in view of Yoon, and further in view of Mirigian and further in view of Anderson.
Regarding claim 20, Naglreiter discloses an occlusion system for occluding a treatment site (col. 1 line 13-15, line 64 – col. 2 line 55), comprising:
an outer catheter (4, Fig. 1);
a balloon (54,56 of balloon assembly 52, Fig. 2-5) attached to a distal portion of the outer catheter (col. 3 line 33-37);
an inner catheter (10, Fig. 1) disposed radially within the outer catheter (col. 2 line 1-4), wherein the inner catheter extends into an interior of the balloon (Fig. 1, col. 4 line 33-39, 60 – col. 5 line 12, the lumen of inner catheter is in fluid communication with interior of the balloon and therefore extends into it);
an adhesive-absorbing membrane (col. 2 line 32-55, outer balloon 54 is made of a porous material);
a first valve (62, Fig. 2-3) for selectively sealing around the outer catheter (seen in Fig. 3-4, lumen of outer catheter extends into the balloon through catheter adapter (50) and is in fluid communication with the balloon).
Naglreiter is silent on the adhesive-absorbing membrane disposed over a distal portion of the balloon, and a second valve for selectively sealing around the inner catheter.
However, Yoon teaches a device used in endoscopic surgery (abstract, col. 1 line 23-30) that comprises an expandable balloon (22, Fig. 1-2) and an adhesive-absorbing membrane (24, Fig. 1-2; col. 4 line 54 – col. 5 line 42, adhesive-absorbing membrane is made of an absorbent material and is capable of absorbing an adhesive) disposed on an outer surface of the balloon (as seen in Fig. 1-2, col. 5 line 34-42).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Naglreiter with the teachings of Yoon to have the adhesive-absorbing membrane disposed over the distal portion of the balloon in order to increase the external size or surface area of the device utilizing an absorbent material while minimizing the quantity of absorbent material required as disclosed by Yoon (col. 2 line 21-23).
Furthermore, Mirigian teaches an embolic balloon and delivery system (abstract, paragraph 1, 4-5) comprising a check valve (228, Fig. 4b-d, 5b-d, paragraph 34) that is a duck-bill type or flapper type similar to the valve (62) of Naglreiter. The check valve of Mirigian is configured to seal around the inflation lumen (lumen 211 of catheter 200, Fig. 4a-c; this equates to the inner catheter of Naglreiter) and helps retain inflation liquid in the interior of the balloon (214) (paragraph 34).
Furthermore, Anderson teaches a similar occlusion device (abstract, paragraph 3) that comprises two valves: a first valve (232, Fig. 13; this equates to the valve 62 of Naglreiter) configured to seal around an inflation lumen (lumen 288 of inflation catheter 278; this equates to the outer catheter of Naglreiter) (Fig. 13, paragraph 107-109), and a second valve (272, Fig. 13) configured to seal around an adhesive lumen (lumen 290 exiting distal region 280 of inflation catheter 278) (Fig. 13, paragraph 110-111). Thus, Anderson teaches a valve assembly comprising two valves for regulating liquid flow into an inner balloon and an outer balloon.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modification of Naglreiter with Yoon with the teachings of Mirigian and Anderson to incorporate a second valve into the valve assembly of Naglreiter such that it is configured to seal around the inner catheter in order to retain the adhesive liquid in the balloon and prevent the backflow of liquid into adjacent inflation catheters (paragraph 34 of Mirigian). The combination above makes it obvious to put the valve of Mirigian in the passageway (60) of Naglreiter proximal to the outlet (64) so that the valve closes around the catheter adapter (50) to prevent the fluid from flowing back through.
Allowable Subject Matter
Claim 21 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The following is a statement of reasons for the indication of allowable subject matter: No prior art references alone or in combination with other references teaches each and every limitation of the claim. The closest art of record is Naglreiter in view of Yoon.
Regarding claim 21, the combination of Naglreiter and Yoon teaches the limitations of claim 4. However, the combination does not teach wherein the adhesive lumen comprises an inner catheter and wherein, in a delivery configuration, a distal portion of the inner catheter forms a spiral within the depression of the balloon.
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 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 KHOA TAN LE whose telephone number is (703)756-1252. The examiner can normally be reached Monday - Friday 8am - 4:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KHOA TAN LE/Examiner, Art Unit 3771 /MOHAMED G GABR/Primary Examiner, Art Unit 3771
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