Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant’s arguments and amendments, filed 28 March 2025, with respect to the 35 USC 112 and 103 rejection(s) of claim(s) 10-20 have been fully considered. Applicants argue that the prior citations in the prior Office Action to the cited prior art do not teach the new added limitations in the pending claim Amendments. But the new limitations were not considered in the prior Office Action as they were not recited. However, upon further search and consideration, Halevy appears to teach the amended claims.
Claims 21-23 are newly added. Claims 10-23 are examined on the merits.
Claim Rejections - 35 USC § 103
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.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 10-11 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Halevy (US 6663589) in view of Hanuka (US 20120136324).
Regarding claim 10, Halevy discloses a catheter system for connection to a vessel contained within a body, vessel including an internal lumen 202 and wall 204 (col 7, lines 25-30, figure 3) comprising an anchor (260, figure 3) configured to be implanted and fixed to an external surface of the vessel wall (figure 3 on surface of the passage which is on the exterior, col 7, lines 49-66, the anchor is on the inside of the body as depicted in figure 3), the anchor includes a first lock device (266, figure 3, col 7, lines 49-66) forming an extended void (void interior to the ring and projections of the anchor, col 7, lines 48-57); and
a drain tube (200, figure 3, conduit can be used for draining, col 5, lines 27-29) having a distal end with a plurality of side holes (218, 214) and a tip opening (218, col 8, lines 25-35), the drain tube includes a second lock device (220, figure 3, col 7, lines 49-66) mating in the extended void of the first lock device (figure 3) thereby forming a substantially watertight connection between the inside of the drain tube and the internal reservoir (col 7, lines 49-66, Inflating balloon 220 and inserting rods 266 into passage 202 also expands web 269 and establishes a seal between both sides of web 269, preventing fluid flow between the proximal and the distal ends of catheter 200), the drain tube includes a channel (212, figure 3, channel is separate from the passage 216) configured to trigger the second lock device to mate with the first lock device by filling the extended void of the first locking device (col 7, lines 49-66).
Halevy does not disclose the anchor is mounted independent of the drain tube.
Hanuka discloses a tubing device and fixation element relatively pertinent to problem posed by Applicant of allowing separation of the tubing element with a fixation element. Hanuka teaches an anchor (5) capable of being mounted independent to the drain tube (2) via inflation of the balloon (25) ([0147]).
Hanuka provides the separate anchor to implant the sleeve and allow the open pathway for the insertion of the closure tubing ([0147]), the balloon allows the device to not migrate after being inserted. It would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify Halevy with the separable Hanuka anchor in order to allow an open passageway while inserting the device.
Further, it has been held In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961) (The claimed structure, a lipstick holder with a removable cap, was fully met by the prior art except that in the prior art the cap is "press fitted" and therefore not manually removable. The court held that "if it were considered desirable for any reason to obtain access to the end of [the prior art’s] holder to which the cap is applied, it would be obvious to make the cap removable for that purpose."). In this case one of ordinary skill in the art would make the anchor separable from the drain tube since it is desirable to obtain access to the catheter to check for the lodging or accumulation of any material between the tip of the catheter and the ring of the anchor that would otherwise cause inadequate pressure applied to the walls to anchor the catheter.
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Regarding claim 11, Halevy further discloses an external cap (proximal portion of tube 210 outside of the body) connected to the drain tube outside the body, external cap encloses a first conduit (216, figure 3) for draining the vessel via the drain tube and a second conduit (212, figure 3) that is a channel (the channel is separate from the passage 216) connected to the second lock device (col 7, lines 49-66), wherein the second lock device is actuated via the second conduit to activate locking mate with the first lock device forming the substantially watertight connection (col 7, lines 49-66).
Claim Rejections - 35 USC § 103
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.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 12 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Halevy in view of Hanuka further in view of Sommerich (US 2004/0243064).
Regarding claim 12, Halevy and Hanuka do not teach a sleeve having an extension for circling the drain tube and a flange.
Sommerich discloses access devices in the same field of endeavor as the Applicant. Sommerich teaches a sleeve (12) having an extension for circling the drain tube (sleeve 12 encloses catheter 50, figure 2) and a flange (16).
Sommerich provides the sleeve to reduce microbial contamination from the surrounding tissue (abstract). It would have been obvious to a person of ordinary skill in the art to modify the cited prior art with Sommerich to prevent contamination. Therefore, it would have been obvious to one skilled in the art at the time of the invention to modify Halevy with the sleeve of Sommerich to prevent contamination of the catheter with potential bacteria from surrounding tissue thus lowering contamination.
Claim 13-14, 16-17, 20 and 23 are rejected under pre-AIA 35 U.S.C. 103(a) as unpatentable over Gill (US 2005/0251174) in view of Keast and further in view of Hanuka (US 2012/0289815).
Regarding claim 13, Gill discloses a method of tissue bonding for a catheter comprising the steps of implanting an anchor (3410 and 3430, figure 141) with a central channel (central channel of the anchor) with internal extended void (void inside 3430) as a first lock device (figure 141-144, [0324]) to an external wall (wall of bladder) of a drain vessel (2) inside the body, the drain vessel forms a reservoir internally within the external wall (figure 141, the wall forms the external wall for the bladder).
guiding a drain tube (3510, figure 142, [0329]) through the central channel of the anchor ([0324-0327], figure 141) and extend to the inside of the drain vessel inside the body (figure 141-144), the drain tube includes an activation channel (3511, figure 143, the channel is separate from the main passage) and locking the drain tube to the anchor via a second locking device (3520) of the drain tube, the activation channel ([0329-0330]) is triggered to activate the second lock device to conform the internal extended void of the first lock device, to thereby form a substantially watertight seal between an inside of the drain tube to inside of the drain vessel ([0330], [0332]).
Gill does not teach implanting the anchor mounted to an exterior surface of the drain vessel and locking the drain tube to the anchor to form a substantially watertight seal between anchor and drain tube. The Gill anchor has holes and does not necessarily surround the balloon when inflated.
Keast discloses a tissue bonding device which teaches implanting the anchor (392, figures 3A-3G) mounted and extends to the exterior surface of the drain vessel.
Keast provides the extended anchor in order to fully secure the anchor to the vessel walls ([0132]). It would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify Gill with Keast by extending the anchor to reach the exterior of the vessel as taught by Keast to fully secure the anchor to the vessel walls ([0132]).
Gill does not teach locking the drain tube to the anchor to form a substantially watertight seal between anchor and drain tube.
Hanuka discloses a tubing device and fixation element relatively pertinent to problem posed by Applicant of allowing separation of the tubing element with a fixation element. Hanuka teaches an anchor (5) that completely surrounds the balloon 25 and thus forms a substantial watertight seal ([0134]).
Hanuka provides the cap and sleeve in order to properly seal and affix the device ([0150]) It would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify Gill with the anchor shape of Hanuka anchor in order to seal the cavity while also affixing the device to anchor.
Regarding claim 14, Gill discloses the step of locking reversibly (deflating and inflating the balloon ([0324-0327]) connect the drain tube to anchor (balloon 3520 when inflated presses between straps 3430 exerting pressure on the walls and seal off the bladder opening [330]).
Regarding claim 16, Gill discloses the step of guiding and locking are performed after implantation (inserting the catheter and then inflating the balloon [0327]).
Regarding claim 17, Gill further discloses the vessel is a bladder (2) which is inside the body but does not teach the anchor is bonded inside the body solely to the external surface of the bladder.
Keast discloses a tissue bonding device which teaches implanting the anchor (392, figures 3A-3G) inside the body that solely to an external surface and opposing the reservoir of the bladder in the implanting.
Keast provides the extended anchor in order to fully secure the anchor to the vessel walls ([0132]). It would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify Gill with Keast by extending the anchor to reach the exterior of the vessel as taught by Keast to fully secure the anchor to the vessel walls ([0132]) The resulting device would be an anchor that extends to the exterior of the bladder.
Regarding claim 20, Gill discloses the anchor is removable (equivalent part 1430 may be removed [0282]). The anchors are dissolvable ([0365]) which makes the device necessarily replaceable.
Regarding claim 23, Gill does not teach wherein the anchor comprises a silicone body with a porous polymer-coated outer surface. Gill teaches the channel with expanded void to receive the second lock device (figure 141) and configured for extra-peritoneal fixation of the vessel wall (bladder implantation).
Keast discloses an anchor for use in the body as an implant teaches wherein the anchor comprises a silicone body ([0127]) with a porous polymer-coated outer surface ([0127]).
Keast provides different materials to allow a desirable characteristic of the anchor ([0127]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Gill with the materials of Keast to obtain desirable characteristics of the anchor.
Claim 15, 18 and 19 are rejected under pre-AIA 35 U.S.C. 103(a) as unpatentable over Gill in view of Keast further in view of Hanuka further in view of Sommerich.
Regarding claims 15 and 18-19, the cited prior art discloses the invention as claimed in claim 13, however does not teach shielding the drain tube and transcutaneous layers by a sleeve to prevent microbial.
Sommerich is directed to a percutaneous access device relatively pertinent to the field of endeavor as Applicant as it is an implantation device. Sommerich teaches a transcutaneous sleeve (12, figure 2) having a flange (16) extending laterally from an upper edge of a transcutaneous extension of the sleeve (figure 4). Sommerich teaches the step of shielding the drainage tube ([0024]). The sleeve is replaceable as the entire device is replaceable ([0020]).
Sommerich provides the sleeve to reduce microbial contamination from the surrounding tissue (abstract). It would have been obvious to one of ordinary skill in the art to modify the cited prior art with Sommerich to prevent contamination. Therefore, it would have been obvious to one skilled in the art at the time of the invention to modify Gill with the sleeve of Sommerich to prevent contamination of the catheter with potential bacteria from surrounding tissue thus lowering contamination.
Claim 21-22 are rejected under pre-AIA 35 U.S.C. 103(a) as unpatentable over Halevy in view of Hanuka further in view of Keast.
Regarding claim 21, Halevy and Hanuka do not teach wherein the anchor comprises a silicone body with a porous polymer-coated outer surface. Halevy discloses the channel with expanded void to receive the second lock device and configured for extra-peritoneal fixation of the vessel wall (figure 3, implanted within the body, does not have to be pertioneal).
Keast discloses an anchor for use in the body as an implant teaches wherein the anchor comprises a silicone body ([0127]) with a porous polymer-coated outer surface ([0127]).
Keast provides different materials to allow a desirable characteristic of the anchor ([0127]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Halevy with the materials of Keast to obtain desirable characteristics of the anchor.
Regarding claim 22, the limitation “vessel is a bladder” is a statement of intended use. Halevy and Keast discloses the all the structures of claims 21 and thus is capable of performing the intended use of being used in a bladder.
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 KAI H WENG whose telephone number is (571)272-5852. The examiner can normally be reached on M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached on (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KAI H. WENG
Primary Examiner
Art Unit 3761
/KAI H WENG/Primary Examiner, Art Unit 3781