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 .
Drawings
In view of replacement drawings filed 06/22/26, the previous drawing objection has been withdrawn.
Response to Arguments
Applicant's arguments filed 06/22/2026 have been fully considered but they are not persuasive.
Applicant argues that the term comprise is open ended and a hinge is a very will-known structural term and thus claim 9 is not indefinite. The examiner disagrees as “comprises” and “used…as” are different. As detailed previously, the eyelet comprises no additional structure that makes or adds a static hinge. Rather the eyelet itself is used as a static hinge. Thus, the term comprises renders the claim indefinite.
Applicant argues that the prior art, specifically Thornton, fail to teach that the length and width of the distal actuating portion opposite the ballon remain substantially the same in a non-actuated and actuated state. The examiner respectfully disagrees for the following reasons. As detailed in the previous rejection and below, the distal actuating portion interpreted by the examiner is “portion past the balloon comprising the forward end (11)” (of Morton). The examiner notes that as seen in Morton the length of said portion (see figure 1 and 2 of Morton) appears substantially the same in the two figures. As such Morton reads to the claimed invention. The examiner further notes that while Applicant challenges that Thornton, combined with Morton however, adjusts the length of the catheter, quoting that the inflation member may act to “reduce the transverse size of the catheter when inflatable member 188 is expanded”, the balloon itself is causing the extension, where the wall length and width, as interpreted by the examiner remains the same. Even if applicant disagrees with said interpretation, the examiner notes that as detailed under para. 0079, the transverse size of the catheter itself is not changed rather, “As inflatable member 188 expands, portion 188a that forms part of outer surface 180b of catheter 180 changes from a first size in FIG. 8A to a second size larger than the first size in FIG. 8B. In this manner, inflatable member 188 asymmetrically elongates outer surface 180b of catheter 180, which, in turn, causes distal end 180a of catheter 180 including first lumen 184 to deflect, as shown in FIG. 8B.”. Based on said disclosure, the outside end (side with balloon) is expanded (or extended), causing the side opposite the balloon to deflect, thus reducing the transverse size. From the examiner’s understanding, the size of the actual wall of the catheter is not changed. As such the examiner notes that both Morton and Thornton read to the claimed limitation.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 9 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 9, the claim requires that the eyelet comprises a static hinge. The examiner notes that this limitation is unclear based on the specification. Applicant’s specification Para. 0047 details that the “drainage eyelets 88 can also be used in this (or any other embodiments) as static hinges to further allow bending of the catheter tip.” Based on said disclosure, the eyelet doesn’t comprise a static hinge, rather is acts as a static hinge, where no other specific structure other than it being an eyelet is provided. As such it is interpreted than an eyelet in bending portion of a catheter would read to said claimed limitation.
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 (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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2,4-5,7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over [Morton US 3811448 in view of Thornton et al. US 2011/0098561, hereafter Morton and Thornton, both provided in the IDS.
Regarding claim 1, Morton discloses a catheter (abstract, figure 1-3) having a non-actuated state (figure 1) and an actuated state (figure 2) and comprising: a catheter shaft (10) having central longitudinal axis extending therethrough (figure 1), a distal actuating portion (portion past balloon comprising forward end (11)), a proximal portion (end opposite distal end), opposing first and second outer walls (figure 3, interpreted as the walls of lumen [passageway] (12)), and an inner wall between the opposing first and second outer walls (interpreted as wall within the passageway forming passageway 14); a drainage section comprising a drainage lumen disposed between the inner wall and the first outer wall (portion with eyelet, where the lumen is the drainage passageway (12)); a drainage eyelet disposed in the drainage section (eyelet (22)); an inflation section comprising an inflation lumen disposed between the inner wall and the second outer wall (inflator fluid passageway (14)); and a balloon at the distal actuating portion of the inflation section in fluid communication with the inflation lumen (balloon (15), column 3 lines 16-21), the balloon offset from the central longitudinal axis of the catheter shaft and having a length and a width (seen extending past the side of the catheter shaft in both deflated (figure 1) and deflated (figure 2) configurations, length and width best seen in figure 2)), the length of the balloon in an actuated state being greater than the length of the balloon in a non-actuated state (see figure 1 and 2).
Morton however fails to specifically disclose that the width of the balloon remaining substantially the same in an actuated state and a non-actuated state.
Thornton teaches a catheter device and is thus considered analogous to the claimed invention. Thornton teaches that the device comprises a rounded balloon (figure 7B) or a different inflated member may be used (188 in figure 8A-8B, see para. 0076-0078). Per paragraph 0077-0078, the member (188) may be a bellows device which restricts the expansion of the element primarily to the longitudinal direction, which may act to reduce the size of the catheter when the inflatable member is inflated. Therefore, as a means to reduce the size of the catheter when inflated, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use a bellows inflatable device as the inflatable device of Morton, as Thornton teaches that bellows inflatable members are suitable in place of rounded balloon inflatable devices to reduce the size of the catheter. Doing so would merely involve the simple substitution of one known element (balloon inflation) for another (bellows inflation device) to obtain predictable results (inflation of the catheter component) and thus a prima facie case of obviousness exists.
The examiner notes that per the 06/22/26 amendments, claim 2 was brought into claim 1. As detailed under the response to arguments, Morton and Thornton, as previously combined teach that the length and width of the distal actuating portion opposite of the balloon remains substantially the same in a non-actuated state and an actuated state. The examiner notes that as seen in Morton figure 1 and 2, the distal end of the catheter opposite the balloon remains the same size, as the inflatable member is the only component which changes size. Further, as detailed under the response to arguments, the wall opposite the balloon of Thornton is not changing size, rather the balloon side wall is asymmetrically lengthening, causing a deflection in the opposite wall. Thus, the size of the wall itself is not changing, just moving.
Regarding claim 4, Morton and Thornton teach the catheter of claim 1, wherein the balloon comprises a single balloon (Morton figure 1,2).
Regarding claim 5, Morton and Thornton teach the catheter of claim 1, wherein the balloon is disposed on an exterior surface of the inflation section at the distal actuating portion (Morton figure 1 and 2 where the balloon is seen on the outside of the curvature of the catheter).
Regarding claim 7, Morton and Thornton teach the catheter of claim 1, wherein the drainage eyelet is located proximal to the distal actuating portion, distal to the distal actuating portion, or within the distal actuating portion. The examiner notes that as seen in figure 2 of Morton, when actuated the end of the catheter bends, where the eyelet is located within the bending section and is thus interpreted to be (within the distal actuating portion). The examiner notes that as the eyelet is located near the bending section it is also interpreted to be proximal to the actuating portion, and as the eyelet is located on the distal most end of the shaft it is further interpreted to be distal to the actuating bending portion.
Regarding claim 8, Morton and Thornton teach the catheter of claim 1, wherein the drainage eyelet comprises a plurality of drainage eyelets. The examiner notes that while Morton only depicts one drainage opening in the figures, column 3 lines 1-12 disclose that there may be “one or more drainage openings formed in the tube wall adjacent the forward end”. As such it is interpreted that Morton discloses a plurality of drainage openings. As such it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device seen in the figures of Morton to have multiple drainage openings, as Morton teaches that “one or more” drainage openings may be formed in the catheter.
Regarding claim 9, Morton and Thornton teach the catheter of claim 1, wherein the eyelet comprises a static hinge. The examiner notes that detailed under the interpretation of said limitation under 112b and eyelet in a bending drainage section would read to the claimed limitation. Said eyelet (22) of Morton thus reads to the claimed limitation. Should applicant disagree, "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Therefore, as applicant’s eyelet acts as the hinge (hinge is not provided as a structure), where the prior art teaches the same structural limitations (eyelet in a drainage section, where said section bends upon inflation of an inflation device), it is interpreted that the eyelet of Morton reads to the claimed limitation.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morton in view of Thornton and further in view of Crocker et al. US 2003/0028211, hereafter Crocker .
Regarding claim 13, Morton and Thornton teach the catheter of claim 1, but fail to specifically teach the device further comprising a first semi-rigid stiffener disposed adjacent to or embedded within a side of the balloon closest to the drainage section at the distal actuating portion, the first semi-rigid stiffener configured to promote axial lengthening of the balloon while limiting or preventing radial expansion of the balloon and promotes patency of the drainage lumen.
Crocker teaches an insertion catheter comprising a balloon (para. 0002,0008) and is thus considered analogous to the claimed invention. Crocker teaches that, as seen in figures 2 and 3, expansion limiting bands (40 and 44) may be provided on the exterior surface of the balloon (para. 0046) as a means to control inflation of the balloon (para. 0046,0047) where said structures are made from nondistensible materials (para. 0043) to aid in limiting expansion. Therefore, as a means to further control inflation of the balloon as desired, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the balloon of Morton and Thornton with at least a nondistensible expansion limiting band. Doing so would merely involve combining prior art elements according to known methods to yield predictable results (The being expansion prevention) and thus a prima facie case of obviousness exists.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morton in view of Thornton and further in view of Horzewski et al. US 5873865, hereafter Horzewski .
Regarding claim 20, Morton and Thornton teach the catheter of claim 1, but fail to specifically teach wherein the distal actuating portion has a spiral configuration.
Horzewski teaches a catheter device and is thus considered analogous to the claimed invention. Horzewski teaches that the device may comprises a spiral shape, at the location where the drainage holes are located (See figure 2), where said spiral shape allows for the catheter to allows for the shaft to remain in contact with the selected surface structure for treatment (column 6, lines 5-22). Therefore, as a means to retain the catheter within an opening, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the shape of the distal end of the catheter of Morton to be spiral shaped, as Horzewski teaches that spiral shaped catheters are known to be suitable in the art.
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 Matthew Wrubleski whose telephone number is (571)272-1150. The examiner can normally be reached M-F 8:00-4:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 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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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781
/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
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