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
Claims 4 and 20 are objected to because of the following informalities:
Claims 4 and 20 are objected to for having typographical errors where the claims each recite “the longitudinal axis” and should instead each recite “a longitudinal axis” to clarify the antecedent basis for the claimed longitudinal axis.
Appropriate correction is required.
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 11 is 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 11, the claim is indefinite where it is not clear how the multiple flaps and bands present in the claim are meant to be related, especially where Applicant’s Specification does not appear to disclose a single embodiment having multiple flaps and bands as appears to be required by the claim. For the purposes of compact prosecution, Examiner has understood the claim to require only a single flap and band such that the claim reads “The catheter of claim 10, further comprising a band positioned on the catheter and an attachment element attaching the flap to the band, wherein the guiding device presses the flap outwardly away from the side opening to create a gap for exit from the lumen
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, 2, 6, and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McFerran (US 20050065498, henceforth McFerran).
Regarding claim 1, McFerran discloses a catheter (catheter 10, fig. 1) comprising a proximal opening (the opening at the proximal end of hub and strain relief assembly 18, fig. 1), a distal opening (the opening at the distal end of distal end 16, fig. 1), a lumen (lumen 30, fig. 2) extending through the catheter ([0025]) and a side opening (guidewire port 44, fig. 4) forming a rapid exchange port ([0032]) dimensioned and configured for insertion of a guiding device through the side opening ([0032]) and a seal (polymer sheath 50, fig. 6), the seal movable between a closed position to reduce leakage through the side opening ([0037]) and an open position ([0037]-[0039]), wherein the seal is movable to an open position by the guiding device (see [0037], a guidewire alone can be used to open valve 56 of the seal).
{Examiner notes that the guiding device is not positively recited and is only functionally recited, and thus dependent claims which place further limitations on the guiding device are also functional limitations and not positively recited.}
Regarding claim 2, McFerran discloses the catheter of claim 1 wherein the guiding device is a guidewire (guidewire 72, fig. 8, and see [0037]).
Regarding claim 6, McFerran discloses the catheter of claim 1 wherein the catheter comprises a proximal body portion (the portion of sheath 42 proximal to opening 44, fig. 8) and a distal body portion (the portion of sheath 42 distal to opening 44, fig. 8), the proximal body portion is connected to the distal body portion by a connecting tube (polymer sheath 50 is a tube which connects the portions, see fig. 8), wherein the seal is formed in the connecting tube (since sheath 50 is the connecting tube and the seal, the seal is formed in the connecting tube as claimed).
Regarding claim 9, McFerran discloses the catheter of claim 1 wherein the guiding device is configured to extend through a dilator (guidewire sheath 66, which is considered to be a dilator as it is a tubular member insertable into a catheter with an outer diameter capable of dilating an incision, and note that guidewire 72, which is the guiding device as claimed, is shown extending through sheath 66 in fig. 8) positioned in the lumen of the catheter (see fig. 8).
{Examiner notes that this claim does not positively recite a dilator, but rather functionally requires that the guiding device is functionally capable of extending through a dilator which is positioned in the lumen of the catheter; guidewire sheath 66 is called out to demonstrate this functional capability. }
Claim(s) 1, 2, 8, and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wijeratne et al. (US Pat. No. 6036670, henceforth Wijeratne).
Regarding claim 1, Wijeratne discloses a catheter (assembly of fig. 1) comprising a proximal opening (the opening at the proximal end of hub assembly 12, fig. 1), a distal opening (the opening at the distal end of distal tip 25, fig. 1), a lumen (the hollow interior of catheter 16, fig. 2) extending through the catheter (see figs. 1 and 2 and see Col. 4 lines 37-53) and a side opening (guidewire port 26, fig. 2) forming a rapid exchange port see fig. 2) dimensioned and configured for insertion of a guiding device through the side opening (see Col. 4 lines 54-63) and a seal (seal area 38, fig. 1), the seal movable between a closed position to reduce leakage through the side opening and an open position (see Col. 5 lines 42-67), wherein the seal is movable to an open position by the guiding device (see Col. 5 lines 42-67).
{Examiner notes that the guiding device is not positively recited and is only functionally recited, and thus dependent claims which place further limitations on the guiding device are also functional limitations and not positively recited.}
Regarding claim 2, Wijeratne discloses the catheter of claim 1 wherein the guiding device is a guidewire (guidewire 28, fig. 1).
Regarding claim 8, Wijeratne discloses the catheter of claim 1 wherein the seal is formed in a tube (transition tube 32, fig. 2) positioned in the lumen of the catheter (see fig. 2), the tube having a coil (coil member 31, fig. 2) embedded in the wall (see fig. 2 and see Col. 5 lines 42-56).
Regarding claim 10, Wijeratne discloses the catheter of claim 1 wherein the seal comprises a flap (see fig. 2, guidewire port 26 includes a flap where outer body tube 22 overlaps with transition tube 32 as shown) movably positioned over the opening (see Col. 4 lines 54-63 and see Col. 5 lines 42-56) and movable by the guiding device for exit of the guiding device through the side opening (see Col. 4 lines 54-63).
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) 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over McFerran (US 20050065498, henceforth McFerran) as applied to claim 1 above, and further in view of Whiting et al. (US 20070083168, henceforth Whiting).
Regarding claim 3, McFerran discloses the catheter of claim 1.
McFerran does not disclose the catheter in combination with a dilator, the dilator positioned within the lumen of the catheter and having a guiding surface adjacent the side opening, the guiding surface guiding the guiding device toward the side opening of the catheter. Whiting teaches a dilator (stabilizer sheath 204, fig. 17A), the dilator positioned within a lumen of a catheter (see fig. 19) and having a guiding surface (deflective surface 212, fig. 17A) adjacent a side opening (see fig. 17A, side port 210 is a side port which is in communication with the inner lumen of the catheter and is configured to allow a guiding device to pass through it, see Abstract and [0011]), the guiding surface guiding the guiding device toward the side opening of the catheter (see the description of deflective surface 62 in [0133], the deflective surface of the chosen embodiment is similarly shaped and configured).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have inserted the dilator of Whiting into the catheter of McFerran for reliably guiding the guidewire to the side port (see at least [0133] and [0151]) and for allowing easier viewing of the catheter assembly with ultrasound during in vivo use (see at least [0131]).
Regarding claim 4, McFerran as modified by Whiting discloses the catheter of claim 3 wherein the guiding surface comprises a ramped surface (see Whiting fig. 17A, the surface is ramped as claimed) angled away from the longitudinal axis toward the side opening (see Whiting fig. 17A, the surface is formed as claimed, and note that the longitudinal axis is coaxial with inner lumen 206).
Claim(s) 5, 7, and 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over McFerran (US 20050065498, henceforth McFerran) as applied to claims 1 and 6 above, respectively, and further in view of Gerberding (US Pat. No. 6475187, henceforth Gerberding).
Regarding claim 5, McFerran discloses the catheter of claim 1 wherein the seal comprises a tube (polymer sheath 50 is a tube as shown in fig. 6 and as described in [0036]) having a side opening (control valve 56, fig. 6) and connecting a first portion of the catheter (the portion of sheath 42 proximal to opening 44, fig. 8) with a second portion of the catheter (the portion of sheath 42 distal to opening 44, fig. 8).
McFerran does not disclose the catheter comprising an elastic material placed over the tube, wherein the guiding device presses against the elastic material to move the elastic material to provide a gap for exit of the guiding device through the side opening of the catheter. Gerberding teaches a catheter (catheter 10, fig. 1) having a seal (the portion of the catheter shown in fig. 14) comprising a tube (distal inner tube 104, fig. 14) and a side opening (side port 124, fig. 13) and comprising an elastic material (valve 200, fig. 15, which is elastic as in Col. 12 lines 59-67 and Col. 13 lines 10-13) placed over the tube (see fig. 14), wherein a guiding device presses against the elastic material to move the elastic material to provide a gap for exit of the guiding device through the side opening (see Col. 13 lines 8-13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the valve of Gerberding to the seal of McFerran as Gerberding teaches the use of such a valve to be beneficial in preventing blood or the like from entering the lumen during the procedure (see Gerberding Col. 13 lines 25-38).
Regarding claim 7, McFerran discloses the catheter of claim 6 having an opening in the connecting tube (control valve 56, fig. 6).
McFerran does not disclose the catheter further comprising an elastic material positioned over an opening in the connecting tube, a portion of the elastic material movable toward the side opening by the guiding device to create a gap for exit of the guiding device from the lumen. Gerberding teaches a catheter (catheter 10, fig. 1) having a seal (the portion of the catheter shown in fig. 14) comprising a tube (distal inner tube 104, fig. 14) and a side opening (side port 124, fig. 13) and comprising an elastic material (valve 200, fig. 15, which is elastic as in Col. 12 lines 59-67 and Col. 13 lines 10-13) positioned over an opening (see fig. 14), a portion of the elastic material movable toward the side opening by the guiding device to create a gap for exit of the guiding device from the lumen (see Col. 13 lines 8-13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the valve of Gerberding to the seal of McFerran as Gerberding teaches the use of such a valve to be beneficial in preventing blood or the like from entering the lumen during the procedure (see Gerberding Col. 13 lines 25-38).
Regarding claim 10, McFerran discloses the catheter of claim 1.
McFerran does not disclose the catheter wherein the seal comprises a flap movably positioned over the opening and movable by the guiding device for exit of the guiding device through the side opening. Gerberding teaches a catheter (catheter 10, fig. 1) having a seal (the portion of the catheter shown in fig. 14) comprising a tube (distal inner tube 104, fig. 14) and a side opening (side port 124, fig. 13) wherein the seal comprises a flap (flap 204, fig. 15) movably positioned over the opening (see Col. 13 lines 8-13) and movable by a guiding device for exit of the guiding device through the side opening (see Col. 13 lines 8-13, the guiding device is the guidewire which provides the taught pressure).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the valve of Gerberding to the seal of McFerran as Gerberding teaches the use of such a valve to be beneficial in preventing blood or the like from entering the lumen during the procedure (see Gerberding Col. 13 lines 25-38).
Regarding claim 11, McFerran as modified by Gerberding discloses the catheter of claim 10 further comprising a band (from Gerberding: see attachment region 202, fig. 15, which is a band) positioned on the catheter (from Gerberding: see arrangement of fig. 14) and an attachment element (from Gerberding: see fig. 15, the junction between attachment region 202 and flap 204 is an attachment element as claimed) attaching the flap to the band (from Gerberding: see fig. 15), wherein the guiding device presses the flap outwardly away from the side opening (from Gerberding: see fig. 14, the flap is pushed outward from the vessel wall which the catheter is positioned in away from the side hole port) to create a gap for exit from the lumen and the side opening (from Gerberding: see fig. 14).
Regarding claim 12, McFerran discloses the catheter of claim 1.
McFerran does not disclose the catheter wherein the catheter further comprises an inner polymeric liner, the liner movable by the guiding device to create a gap for exit of the guiding device through the side opening. Gerberding teaches a catheter (catheter 10, fig. 1) having a side opening (side port 124, fig. 13) wherein the catheter further comprises an inner polymeric liner (distal inner tube 104, fig. 13, which is polymeric as taught in Col. 11 lines 42-50 where it is taught that tube 104 is plastic which is a polymer), the liner movable by a guiding device to create a gap for exit of the guiding device through the side opening (see Col. 13 lines 8-13, the guiding device is the guidewire which provides the taught pressure).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added an inner polymeric liner which is movable by a guiding device as in Gerberding to the catheter of McFerran as adding a guide wire lumen is taught to allow for the guide wire to have its position maintained during withdrawal of the catheter without requiring the use of a long guidewire or an extension wire (see Gerberding Col. 3 lines 9-18).
Claim(s) 13, 15, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over McFerran (US 20050065498, henceforth McFerran) as applied to claim 1 above, and further in view of Besser et al. (US 20190275296, henceforth Besser).
Regarding claim 13, McFerran discloses the catheter of claim 1.
McFerran does not disclose the catheter wherein the catheter has a distal deflection zone deflectable by axial movement of a first wire. Besser teaches a catheter (catheter 100’, fig. 7) wherein the catheter has a distal deflection zone (curvable section 104’, fig. 10) deflectable by axial movement of a first wire (first pull wire P1, fig. 7, and see [0083]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the steering wire assembly of Besser to the catheter of McFerran for providing the catheter with steerability of its own to navigate tortuous patient anatomy in regions of vessel curvature (Besser [0004]).
Regarding claim 15, McFerran as modified by Besser (henceforth McFerran as modified) discloses the catheter of claim 13 wherein the first wire is offset from a longitudinal axis of the catheter (from Besser: see fig. 7, first pull wire P1 is offset from a longitudinal axis of the catheter which is centered in the catheter) and is attached to a pull ring (pull ring 110, fig. 7), and pulling of the first wire deflects the distal deflection zone initially in the direction of the first wire (from Besser: [0083]), wherein the pull ring and first wire are substantially within a wall of the catheter (from Besser: [0083]).
Regarding claim 16, McFerran as modified discloses the catheter of claim 13 wherein the first wire is a push wire (see Besser [0088] and fig. 7, first pull wire P1 is a push wire as denoted by the double sided arrows) offset from a longitudinal axis of the catheter (from Besser: see fig. 7, first pull wire P1 is offset from a longitudinal axis of the catheter which is centered in the catheter) and pushing of the first wire deflects the distal deflection zone initially opposite the first wire (see Besser [0089], pushing the pull wire causes deflection away from the wire).
Claim(s) 14 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over McFerran (US 20050065498, henceforth McFerran) and Besser et al. (US 20190275296, henceforth Besser) as applied to claim 13 above, and further in view of Intoccia et al. (US 20080300462, henceforth Intoccia).
Regarding claim 14, McFerran as modified by Besser, henceforth McFerran as modified, discloses the catheter of claim 13.
McFerran as modified does not disclose the catheter wherein the catheter has a proximal deflection zone positioned proximal of the distal zone and deflectable by a second wire. Intoccia teaches a catheter (assembly of fig. 3) having a distal deflection zone (first active deflection section 64, fig. 2) deflectable by a first pull wire (pull wire 30, [0058]) and a proximal deflection zone (second active deflection section 66, fig. 2) positioned proximal of the distal zone (see fig. 2, the proximal direction is the direction closer to handle 20 and further from distal end 62) and deflectable by a second wire (pull wire 28, [0060]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added multiple deflection zones controlled by multiple steering wires as in Intoccia to the modified device of McFerran to allow for deflection of the catheter about multiple planes (see Intoccia [0048]).
Regarding claim 17, McFarren as modified discloses the catheter of claim 14 further comprising a distal pull ring (this is pull ring 110 of fig. 7 of Besser), and the first wire attached to the distal pull ring (see Besser fig. 7), the proximal and distal deflection zones being independently deflectable (see Intoccia [0048]).
McFarren as modified does not explicitly disclose a proximal pull ring, or that the second wire is attached to the proximal pull ring. However, Besser teaches pull rings to be known attachment methods for pull wires to be mounted in deflection sections (Besser [0086]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a second, proximal pull ring at the proximal deflection zone and to have attached the second steering wire added from Intoccia in the modified device to this proximal pull ring as claimed as Besser teaches that pull rings are known methods of attachment for pull wires in deflection zones (Besser [0068]) and because such a modification would have yielded the same, predictable result of a deflectable pull wire being mounted into the catheter wall of the proximal deflection zone such that the second wire could be pulled to cause a desired deflection.
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over McFerran (US 20050065498, henceforth McFerran) in view of Whiting et al. (US 20070083168, henceforth Whiting).
Regarding claim 19, McFerran discloses a system comprising: a) a catheter (catheter 10, fig. 1) having a proximal opening (the opening at the proximal end of hub and strain relief assembly 18, fig. 1), a distal opening (the opening at the distal end of distal end 16, fig. 1), a lumen (lumen 30, fig. 2) extending through the catheter ([0025]) and a side opening (guidewire port 44, fig. 4) forming a rapid exchange port ([0032]) dimensioned and configured for insertion of a guiding device through the side opening ([0032]).
McFerran does not disclose the system comprising b) a dilator, the dilator positioned within the lumen of the catheter and having a guiding surface adjacent the side opening, the guiding surface guiding the guiding device toward the side opening of the catheter. Whiting teaches a dilator (stabilizer sheath 204, fig. 17A), the dilator positioned within a lumen of a catheter (see fig. 19) and having a guiding surface (deflective surface 212, fig. 17A) adjacent a side opening (see fig. 17A, side port 210 is a side port which is in communication with the inner lumen of the catheter and is configured to allow a guiding device to pass through it, see Abstract and [0011]), the guiding surface guiding the guiding device toward the side opening of the catheter (see the description of deflective surface 62 in [0133], the deflective surface of the chosen embodiment is similarly shaped and configured).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have inserted the dilator of Whiting into the catheter of McFerran for reliably guiding the guidewire to the side port (see at least [0133] and [0151]) and for allowing easier viewing of the catheter assembly with ultrasound during in vivo use (see at least [0131]).
Regarding claim 20, McFerran as modified by Whiting discloses the system of claim 19 wherein the guiding surface comprises a ramped surface (see Whiting fig. 17A, the surface is ramped as claimed) angled away from the longitudinal axis toward the side opening (see Whiting fig. 17A, the surface is formed as claimed, and note that the longitudinal axis is coaxial with inner lumen 206).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over McFerran (US 20050065498, henceforth McFerran) in view of Whiting et al. (US 20070083168, henceforth Whiting) as applied to claim 19 above, and further in view of Intoccia et al. (US 20080300462, henceforth Intoccia) and Besser et al. (US 20190275296, henceforth Besser).
Regarding claim 22, McFerran as modified discloses the system of claim 19.
McFerran as modified does not disclose the system wherein the catheter has a first and second independently deflectable detachment zones, wherein the first and second detachment zones each have a pull ring and a pull wire connected to the pull ring. Intoccia teaches a catheter (assembly of fig. 3) having first and second independently deflectable detachment zones (first active deflection section 64, fig. 2, and second active deflection section 66, fig. 2, respectively), wherein the first and second detachment zones each have pull wires (pull wire 30, [0058], and pull wire 28, [0060], respectively).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added multiple deflection zones controlled by multiple steering wires as in Intoccia to the modified device of McFerran to allow for deflection of the catheter about multiple planes (see Intoccia [0048]).
McFerran as modified does not disclose the first and second zones each having a pull ring, or that the pull wires connected to the pull rings. Besser teaches pull rings to be known attachment methods for pull wires to be mounted in deflection sections (Besser [0086]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a pull ring at each of the respective zones and to have attached the steering wires added from Intoccia in the modified device to the respective pull rings as claimed as Besser teaches that pull rings are known methods of attachment for pull wires in deflection zones (Besser [0068]) and because such a modification would have yielded the same, predictable result of a deflectable pull wire being mounted into the catheter wall of the proximal deflection zone such that the pull wire could be pulled to cause a desired deflection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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