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 Amendments
Regarding the amendment to claims 1, 23, and 34, the cancellation of the “valve” language is acknowledged, and the 112(a) and 112(b) rejections of claims 1, 23, and 34 have been withdrawn.
Regarding the amendment to claim 1, the correction of “a bronchoscope” to “the bronchoscope” is acknowledged and the 112(b) rejection is withdrawn.
Regarding the claim objection claim 30, the amendment has been acknowledged and the claim objection is withdrawn.
Response to Arguments
Independent Claim 1
Applicant’s arguments, see pages 3-4, filed 07/15/2025, with respect to the rejection(s) of claim(s) 1 and 34 under Dillon in view of Austin and claim 23 under Dillon in view of Austin and Fischer have been fully considered and are persuasive. The examiner agrees that modified Dillon fails to disclose or suggest “a radiolucent catheter” and “a compressible part positioned between the distal end and the proximal end of the shaft” as required in claims 1, 23, and 34. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view Dillion in view of Meek et al. (US 6979313), Fan et al. (US 20120150210), and Bagaoisan et al. (US 20140018732).
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Claim 1 (and similarly in claims 23 and 34) recites “at least while (a) a portion of the radiolucent catheter is positioned within the channel of the bronchoscope, (b) the adapter is reversibly attached to the proximal end of the shaft, and (c) the compressible part is not compressed to occlude the radiolucent catheter, a portion of the bronchoscope is positionable between (i) the proximal end of the shaft and (ii) the compressible part, and at least while (a) the portion of the bronchoscope is positioned between the proximal end of the shaft and the compressible part and (b) the balloon is inflated, the compressible part can be compressed to occlude the radiolucent catheter to keep the balloon inflated”. Therefore, the bronchoscope and the compressible part in the occluded and non-occluded state “at least while (a) a portion of the radiolucent catheter is positioned within the channel of the bronchoscope” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-2, 8-10, 23, 31-36 are rejected under 35 U.S.C. 103 as being unpatentable over Dillon et al. (US 20110118546) [hereinafter Dillon] in view of Meek et al. (US 6979313) [hereinafter Meek], Fan et al. (US 20120150210) [hereinafter Fan], and Bagaoisan et al. (US 20140018732) [hereinafter Bagaoisan].
[The examiner notes that the embodiment of Figs. 5A-C is being relied upon in the rejection; however, the embodiment shown in Figs. 1A-H are referenced for like features and method that are not shown in Figs. 5A-C].
Regarding claim 1, Dillon discloses a catheter 500 for insertion into an airway of a patient through a channel of a bronchoscope (Figs. 1A-H, 5A-C, para. 0027-0031, 0040; see note below), the catheter comprising:
a shaft 501 having a distal end (interpreted as end comprising balloon 504) insertable into at the patient (Figs. 1F, 5A, para. 0031) and a proximal end (interpreted as end comprising valve 520) opposite the distal end (Fig. 5A, para. 0040);
an inflatable balloon 504 at the distal end of the shaft 501 (Figs. 5A-C, para. 0040); and
an adaptor 510 reversibly attachable to the proximal end of the shaft and usable, at least while attached to the proximal end of the shaft, to inflate and deflate the balloon (Figs. 5A-C, para. 0025, 0040, 0041).
Dillon further discloses a compressible part of the shaft (para. 0061 of Dillon discloses that the shaft may include “a removable low-profile clamp configured to seal the catheter lumen while allowing passage thereover of an elongate surgical device”) as an alternative to a valve to maintain fluid pressure in the balloon (para. 0030).
However, Dillon fails to explicitly disclose that the compressible part is positioned between the distal end and the proximal end of the shaft, wherein the compressible part is positioned such that -
at least while (a) a portion of the radiolucent catheter is positioned within the channel of the bronchoscope, (b) the adapter is reversibly attached to the proximal end of the shaft, and (c) the compressible part is not compressed to occlude the radiolucent catheter, a portion of the bronchoscope is positionable between (i) the proximal end of the shaft and (ii) the compressible part, and at least while (a) the portion of the bronchoscope is positioned between the proximal end of the shaft and the compressible part and (b) the balloon is inflated, the compressible part can be compressed to occlude the radiolucent catheter to keep the balloon inflated.
Meek in same field of endeavor of balloon catheters further teaches that it is known in the art to utilize a clamp at a compressible part of the shaft such that the compressible part can transition from a state of not being compressed by the clamp to occlude the catheter (Fig. 1, col. 2 lines 13-17) to a state of being compressed by the clamp to occlude the catheter and to keep the balloon inflated (Fig. 1, col. 6 lines 12-17).
Fan in the same field of endeavor of balloon catheters 1700 (Fig. 17, para. 0076) teaches that it is known in the art to position a clamp 1781 between a distal end and a proximal end of a shaft 1710 (Fig. 17, para. 0076-0077).
In light of these teachings, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the location of the low-profile clamp and compressible part in Dillon to be positioned between the proximal and distal ends of the shaft (Fig. 17, para. 0076 of Fan), as taught by Fan, such that the clamp compresses the shaft to occlude the shaft of the catheter (Fig. 1, col. 2 lines 13-17 of Meek), as taught by Meek, since such a modification is a rearrangement of parts and since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975). MPEP 2144.04 VI. C.
The combination of Dillon in view of Meek and Fan would result in a product wherein the clamp of Dillon (para. 0061) is positioned between the distal end and the proximal end of the shaft, as taught by Fan, (Fig. 17, para. 0076 of Fan) such that,
at least while (a) a portion of the catheter is positioned within the channel of the bronchoscope (see note below; Figs. 1A-H, para. 0027, 0030-0031 of Dillon), (b) the adapter 510 is reversibly attached to the proximal end of the shaft (Figs. 5A-B, para. 0040 of Dillon), and (c) the compressible part is not compressed to occlude the catheter (The examiner notes that para. 0061 of Dillon discloses that the clamp is removable, and therefore is capable of being removed to not compress the shaft to occlude the catheter. Meek further taught that removal of the clamp removes the occlusion of the catheter (Fig. 1, col. 2 lines 13-17 of Meek), a portion of the bronchoscope is positionable between (i) the proximal end of the shaft and (ii) the compressible part (Figs. 1C-F, para. 0030-0031 of Dillon), and
at least while (a) the portion of the bronchoscope is positioned between the proximal end of the shaft and the compressible part (see note below, Figs. 1A-H, para. 0027, 0030-0031 of Dillon) and (b) the balloon is inflated (Figs. 1B-C, 5A-C, para. 0029-0030, 0040-0041), the compressible part can be compressed to occlude the catheter to keep the balloon inflated (para. 0061 of Dillon; Fig. 1, col. 6 lines lines 12-17 of Meek).
However, modified Dillon fails to disclose wherein the catheter is radiolucent.
Bagaoisan teaches that it is known in the art to provide a tubular element 101 with multiple segments/markers 106 comprised of radiolucent material (para. 0039 teaches that “the materials used for any of the system components could be rendered radiopaque or radiolucent as desired”) along a length of the tubular member for the purpose of visualization under x-rays, fluoroscopy, computed tomography, ultrasound, direct visualization, infrared modalities, electromagnetic positioning systems or the like (para. 0114).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the catheter in modified Dillon to include the radiopaque markers of Bagaoisan in order to enable easier direct visualization of the device during a procedure by a user (para. 0114 of Bagaoisan).
Note: “for insertion into an airway of a patient through a channel of a bronchoscope” is interpreted as functional language that recites intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, the catheter of Dillon is for insertion into a body lumen of a patient through a channel of an elongate surgical device such as a duendoscope, endoscope, other camera or image-capturing device, etc. (para. 0033). Therefore, the catheter of Dillon is capable for insertion into an airway of a patient through a channel of a bronchoscope. Since the device of modified Dillon includes all of the structure required in claim for insertion into the airway of the patient through the channel of the bronchoscope, the device of modified Dillon meets the functional limitations of the claim.
Note: “at least while (a) a portion of the catheter is positioned within the channel of the bronchoscope, (b) the adapter is reversibly attached to the proximal end of the shaft, and (c) the compressible part is not compressed to occlude the catheter, a portion of the bronchoscope is positionable between (i) the proximal end of the shaft and (ii) the compressible part, and at least while (a) the portion of the bronchoscope is positioned between the proximal end of the shaft and the compressible part and (b) the balloon is inflated, the compressible part can be compressed to occlude the catheter to keep the balloon inflated” is interpreted as functional language that recites intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, modified Dillon discloses all of the structure required in claim 1 to meet the functional claim language of the claim such as the catheter comprising the shaft, the compressible part positioned between the proximal and distal ends of the shaft and configured to transition between the compressed and non-compressed state, the reversible attached adapter, and the balloon. The combination of Dillon in view of Fan and Meek necessitates a balloon catheter device capable of meeting the functional language and intended use of the claim. Since, the device of modified Dillon meets the structural limitations required in claim 1, the device of modified Dillon also meets the functional limitations of claim 1.
Regarding claim 2, modified Dillon discloses wherein the shaft 501 comprises an air channel 524 extending between the proximal end and the distal end of the shaft (Fig. 5A, para. 0040 of Dillon) and wherein via the adaptor 510 is usable, at least while attached to the proximal end of the shaft, to inflate and deflate the balloon via. the air channel (Figs. 5A-C; para. 0031, 0033, 0040-0041 of Dillon).
Regarding claim 4, modified Dillon discloses wherein the tip is steerable within the airway using a force applied to the proximal end of the catheter (Figs. 1A-H; para. 0027-0028 of Dillon).
Regarding claims 8-10, modified Dillon discloses wherein the adaptor 510 (see note below) comprises a two-way stop cock or switching lock (not labeled but shown in Fig. 4A of Dillon in between syringe 490 and connector end 412) to keep air trapped in the balloon at least while the balloon is inflated (para. 0034; note it is well known in the art to use a two-way stop cock to manually regulate fluid flow by stopping or restoring said fluid flow) and is configured to connect to a syringe 490 such that the syringe is usable to push air into the catheter or into the air channel to inflate the balloon (Fig. 4A, para. 0034 of Dillon)
Note: Para. 0030 of Dillon discloses that the features of the adapters shown in Figs. 4A-8 may be combined, para. 0040 discloses that the adapter 510 is shown as a very basic hub, but may alternatively be embodied as a manifold. Para. 0034 of Dillon discloses a removable hub embodied as a manifold 410, see Fig. 4A.).
Regarding claim 32, modified Dillon discloses wherein, while the adapter is reversibly attached to the proximal end portion of the shaft and a portion of the radiolucent catheter is positioned within the channel of the bronchoscope, a distal end of the bronchoscope is positionable between (i) the proximal end portion and (ii) the compressible part (Figs. 1F-G, para. 0030-0031 of Dillon discloses that a distal end of an endoscope is positionable between the proximal end of the catheter and the distal end of the catheter. Since Modified Dillon in discloses the compressible part is positioned between the proximal and distal ends of the catheter, the endoscope would also be positionable over the compressible part).
Regarding claim 33, modified Dillon discloses wherein, while the portion of the radiolucent catheter is positioned within the channel of the bronchoscope and the adapter is reversibly attached to the proximal end of the shaft, a distal end of the bronchoscope is moveable over the compressible part from (i) a first side of the compressible part nearest the distal end of the shaft to (ii) a second side of the compressible part nearest the proximal end of the shaft (Figs. 1F-G, para. 0030-0031 of Dillon discloses that a distal end of an endoscope is moveable a first side nearest the distal end (end comprising balloon 504, see Fig. 5A of Dillon) of the catheter to a second side nearest the proximal end (end attached to adapter 510, see Fig. 5A of Dillon) of the shaft. Since modified Dillon discloses the compressible part positioned between the proximal and distal ends of the shaft (Fig. 17, para. 0076-0077 of Fan), the endoscope would also be positionable over the compressible part from (i) the first side of the compressible part nearest the distal end of the shaft to (ii) the second side of the compressible part nearest the proximal end of the shaft).
Regarding claim 36, modified Dillon discloses wherein: the compressible part can be transitioned between an unclamped state and a clamped state (Fig. 1, col. 2 lines 13-17 and col. 6 lines 12-17 of Meek);
to occlude the radiolucent catheter, the compressible part can be transitioned from the unclamped state to the clamped state (Fig. 1, col. 2 lines 13-17 and col. 6 lines 12-17 of Meek); and
at least when the balloon is inflated and the compressible part is in the clamped state, the compressible part can be transitioned from the clamped state to the unclamped state to permit flow of air between the proximal end portion of the shaft and the balloon (Fig. 1, col. 2 lines 13-17 and col. 6 lines 12-17 of Meek).
Regarding claim 34, Dillon discloses a catheter 500 (Figs. 5A-C, 0040), comprising:
a shaft 501 having a distal end portion (interpreted as portion comprising balloon 504) insertable into at the patient (Figs. 1F, 5A, para. 0031) and a proximal end portion (interpreted as portion comprising valve 520) opposite the distal end portion (Fig. 5A, para. 0040), and a middle section between the distal end portion and the proximal end portion (see Fig. 5A, para. 0040);
an inflatable balloon 504 at the distal end portion of the shaft 501 (Figs. 5A-C, para. 0040); and
an adaptor 510 reversibly attachable to the proximal end portion of the shaft and usable, at least while attached to the proximal end of the shaft, to inflate and deflate the balloon (Figs. 5A-C, para. 0025, 0040, 0041).
Dillon further discloses a compressible part (para. 0030, 0061 of Dillon discloses that the shaft may include “a removable low-profile clamp configured to seal the catheter lumen while allowing passage thereover of an elongate surgical device” as an alternative to the valve).
However, Dillon fails to explicitly disclose that the compressible part, at least when the balloon is inflated, can be clamped to occlude the radiolucent catheter to keep the balloon inflated and is positioned between the distal end and the proximal end of the shaft, wherein the compressible part is positioned such that,
at least while (a) a portion of the radiolucent catheter is positioned within a channel of a bronchoscope and (b) the adapter is reversibly attached to the proximal end portion of the shaft, a distal end of the bronchoscope is movable over the compressible part from (i) a first side of the compressible part nearest the distal end portion of the shaft to (ii) a second side of the compressible part nearest the proximal end portion of the shaft.
Meek in same field of endeavor of balloon catheters further teaches that it is known in the art to utilize a clamp at a compressible part of the shaft such that the compressible part, at least when the balloon is inflated, can be clamped to occlude the catheter to keep the balloon inflated (Fig. 1, col. 2 lines 13-17 and col. 6 lines 12-17).
Fan in the same field of endeavor of balloon catheters 1700 (Fig. 17, para. 0076) teaches that it is known in the art to position a clamp 1781 between a distal end and a proximal end of a shaft 1710 (Fig. 17, para. 0076-0077).
In light of these teachings, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the location of the low-profile clamp and compressible part in Dillon to be positioned between the proximal and distal ends of the shaft (Fig. 17, para. 0076 of Fan), as taught by Fan, such that the clamp compresses the shaft to occlude the shaft of the catheter to maintain inflation (Fig. 1, col. 2 lines 13-17 of Meek), as taught by Meek, since such a modification is a rearrangement of parts and since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975). MPEP 2144.04 VI. C.
The combination of Dillon in view of Fan and Meek would result in a product wherein the clamp of Dillon (para. 0061) is positioned between the distal end and the proximal end of the shaft, as taught by Fan, (Fig. 17, para. 0076 of Fan) such that,
at least while (a) a portion of the catheter is positioned within the channel of the bronchoscope (see note below; Figs. 1A-H, para. 0027, 0030-0031 of Dillon), (b) the adapter 510 is reversibly attached to the proximal end of the shaft (Figs. 5A-B, para. 0040 of Dillon), and (c) the compressible part is not compressed to occlude the catheter (The examiner notes that para. 0061 of Dillon discloses that the clamp is removable, and therefore is capable of being removed to not compress the shaft to occlude the catheter. Meek further taught that removal of the clamp removes the occlusion of the catheter (Fig. 1, col. 2 lines 13-17 of Meek), a distal end of the bronchoscope is movable over the compressible part (i) a first side of the compressible part nearest the distal end of the shaft to (ii) a second side of the compressible part nearest the proximal end of the shaft (Figs. 1F-G, para. 0030-0031 of Dillon discloses that a distal end of an endoscope is moveable a first side nearest the distal end (end comprising balloon 504, see Fig. 5A of Dillon) of the catheter to a second side nearest the proximal end (end attached to adapter 510, see Fig. 5A of Dillon) of the shaft. Since modified Dillon discloses the compressible part positioned between the proximal and distal ends of the shaft (Fig. 17, para. 0076-0077 of Fan), the endoscope would also be positionable over the compressible part from (i) the first side of the compressible part nearest the distal end of the shaft to (ii) the second side of the compressible part nearest the proximal end of the shaft).
a portion of the bronchoscope is positionable between (i) the proximal end of the shaft and (ii) the compressible part (Figs. 1C-F, para. 0030-0031 of Dillon), and
at least while (a) the portion of the bronchoscope is positioned between the proximal end of the shaft and the compressible part (see note below, Figs. 1A-H, para. 0027, 0030-0031 of Dillon) and (b) the balloon is inflated (Figs. 1B-C, 5A-C, para. 0029-0030, 0040-0041), the compressible part can be compressed to occlude the catheter to keep the balloon inflated (para. 0061 of Dillon; Fig. 1, col. 6 lines 12-17 of Meek).
However, modified Dillon fails to disclose that the catheter is radiolucent.
Bagaoisan teaches that it is known in the art to provide a tubular element 101 with multiple segments/markers 106 comprised of radiolucent material (para. 0039 teaches that “the materials used for any of the system components could be rendered radiopaque or radiolucent as desired”) along a length of the tubular member for the purpose of visualization under x-rays, fluoroscopy, computed tomography, ultrasound, direct visualization, infrared modalities, electromagnetic positioning systems or the like (para. 0114).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the catheter in modified Dillon to include the radiopaque markers of Bagaoisan in order to enable easier direct visualization of the device during a procedure by a user (para. 0114 of Bagaoisan).
Note: “at least while (a) a portion of the catheter is positioned within a channel of a bronchoscope” is interpreted as functional language that recites intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, the catheter of Dillon is for insertion into a body lumen of a patient through a channel of an elongate surgical device such as a duendoscope, endoscope, other camera or image-capturing device, etc. (para. 0033). Therefore, the catheter of Dillon is capable being positioned within a channel of a bronchoscope. Since the device of modified Dillon includes all of the structure required in claim for insertion into the airway of the patient through the channel of the bronchoscope, the device of modified Dillon meets the functional limitations of the claim.
Note: “at least while (a) a portion of the catheter is positioned within a channel of a bronchoscope and (b) the adapter is reversibly attached to the proximal end portion of the shaft, a distal end of the bronchoscope is movable over the compressible part or the valve from (i) a first side of the compressible part or the valve nearest the distal end portion of the shaft to (ii) a second side of the compressible part or the valve nearest the proximal end portion of the shaft” is interpreted as functional language that recites intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, modified Dillon discloses all of the structure required in claim 34 to meet the functional claim language of the claim such as the catheter comprising the shaft, the valve positioned between the proximal and distal ends of the shaft and configured to transition between the open and closed state, the reversible attached adapter, and the balloon. The combination of Dillon in view of Meek, Fan, and Kobel necessitates a balloon catheter device capable of meeting the functional language and intended use of the claim. Since, the device of modified Dillon meets the structural limitations required in claim 34, the device of modified Dillon also meets the functional limitations of claim 34.
Regarding claim 35, modified Dillon discloses wherein: the compressible part can be transitioned between an unclamped state and a clamped state (Fig. 1, col. 2 lines 13-17 and col. 6 lines 12-17 of Meek);
to occlude the radiolucent catheter, the compressible part can be transitioned from the unclamped state to the clamped state (Fig. 1, col. 2 lines 13-17 and col. 6 lines 12-17 of Meek); and
at least when the balloon is inflated and the compressible part is in the clamped state, the compressible part can be transitioned from the clamped state to the unclamped state to permit flow of air between the proximal end portion of the shaft and the balloon (Fig. 1, col. 2 lines 13-17 and col. 6 lines 12-17 of Meek).
Claims 3 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Dillon et al. (US 20110118546) [hereinafter Dillon] in view of Meek et al. (US 6979313) [hereinafter Meek], Fan et al. (US 20120150210) [hereinafter Fan], and Bagaoisan et al. (US 20140018732) [hereinafter Bagaoisan], as applied to claim 1 above, and further in view of Kolbel (US 10426484).
Regarding claims 3 and 19, Modified Dillon discloses all the limitations set forth above in claim 1. Dillon further discloses wherein the distal end of the catheter includes a soft tip (Fig. 1C, para. 0027). However, Modified Dillon fails to disclose wherein the shaft is made of a semi-rigid plastic.
Kolbel in the same field of endeavor teaches a balloon catheter comprising a shaft formed from a semi-rigid material (col. 4 lines 48-53) for the purpose of enhancing the pushability and/or torqueability of the shaft without risk of buckling or kinking (col. 4 lines 48-53).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the shaft in modified Dillon to include the semi-rigid material of Kolbel in order to enhance the pushability and/or torqueability of the shaft without risk of buckling or kinking (col. 4 lines 48-53 of Kolbel) when navigating through a body lumen.
Claims 23, 27-30, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Dillon et al. (US 20110118546) [hereinafter Dillon] in view of Meek et al. (US 6979313) [hereinafter Meek], Fan et al. (US 20120150210) [hereinafter Fan], Bagaoisan et al. (US 20140018732) [hereinafter Bagaoisan], and Fischer et al. (US 20170189644) [hereinafter Fischer].
[The examiner notes that the embodiment of Figs. 5A-C is being relied upon in the rejection; however, the embodiment shown in Figs. 1A-H are referenced for like features and method that are not shown in Figs. 5A-C].
Regarding claim 23, Dillon discloses a system (Figs. 1A-H, 5A-C, para. 0027-0031, 0040) comprising:
an elongate surgical device (duendoscope 152 or endoscope 160) having a channel (Figs. 1A-B, 1F, para. 0027, 0031); and
a catheter 500 dimensioned to fit within the channel (Figs. 1A-H, 5A-C, para. 0027-0031, 0040), the catheter including:
a shaft 501 having a distal end portion (interpreted as portion comprising balloon 504) insertable into at the patient (Figs. 1F, 5A, para. 0031) and a proximal end portion (interpreted as portion comprising a proximal end of the shaft) opposite the distal end portion (Fig. 5A, para. 0040);
a balloon 504 at the distal end portion of the shaft 501 (Figs. 5A-C, para. 0040); and
an adaptor 510 reversibly attachable to the proximal end portion of the shaft and configured, at least while reversibly attached to the proximal end portion of the shaft, to facilitate inflation and deflation of the balloon (Figs. 5A-C, para. 0025, 0040, 0041).
Dillon further discloses a compressible part (para. 0030, 0061 of Dillon discloses that the shaft may include “a removable low-profile clamp configured to seal the catheter lumen while allowing passage thereover of an elongate surgical device” as an alternative to the valve).
However, Dillon fails to explicitly disclose that the compressible part, at least when the balloon is inflated, can be clamped to occlude the radiolucent catheter to keep the balloon inflated and is positioned between the distal end and the proximal end of the shaft, wherein the compressible part is positioned such that,
at least while (a) a portion of the radiolucent catheter is positioned within a channel of a bronchoscope and (b) the adapter is reversibly attached to the proximal end portion of the shaft, a distal end of the bronchoscope is movable over the compressible part from (i) a first side of the compressible part nearest the distal end portion of the shaft to (ii) a second side of the compressible part nearest the proximal end portion of the shaft.
Meek in same field of endeavor of balloon catheters further teaches that it is known in the art to utilize a clamp at a compressible part of the shaft such that the compressible part, at least when the balloon is inflated, can be clamped to occlude the catheter to keep the balloon inflated (Fig. 1, col. 2 lines 13-17 and col. 6 lines 12-17).
Fan in the same field of endeavor of balloon catheters 1700 (Fig. 17, para. 0076) teaches that it is known in the art to position a clamp 1781 between a distal end and a proximal end of a shaft 1710 (Fig. 17, para. 0076-0077).
In light of these teachings, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the location of the low-profile clamp and compressible part in Dillon to be positioned between the proximal and distal ends of the shaft (Fig. 17, para. 0076 of Fan), as taught by Fan, such that the clamp compresses the shaft to occlude the shaft of the catheter to maintain inflation (Fig. 1, col. 2 lines 13-17 of Meek), as taught by Meek, since such a modification is a rearrangement of parts and since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975). MPEP 2144.04 VI. C.
Dillon further discloses that the catheter is dimensioned and configured to be inserted through a channel of an elongate surgical device such as a duendoscope, endoscope, other camera or image-capturing device, etc. (para. 0033), However, Dillon does not expressly disclose a bronchoscope.
Fischer in the same field of endeavor teaches a dilation balloon device in the same field of endeavor wherein the dilation balloon is coupled to endoscopes such as bronchoscopes for the purpose of navigating the device through a patient’s airways and lungs (Figs. 6-7, abstract, para. 0003, 0070). Therefore, it is understood by one of ordinary skill in the art that a bronchoscope is a type of endoscope used to visualize the device in the body (para. 0068).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the elongate surgical device of Dillon to be a bronchoscope as taught by Fischer, particularly since Fischer teaches that a bronchoscope is a type of endoscope, Dillon discloses that the device inserted through a working channel of an elongate surgical device, and such a modification would yield the predictable result of providing the user with means to visualize the device in the body (para. 0068).
The combination of Dillon in view of Meek, Fan, and Fischer discloses wherein the compressible part is positioned between the distal end portion and the proximal end portion of the shaft (as taught by Fan, Fig. 17, para. 0076-0077) such that, while the adapter 510 of Dillon is reversibly attached to the proximal end portion of the shaft (Figs. 5A-B, para. 0040 of Dillon), at least a portion of the bronchoscope is positionable over the proximal end portion of the shaft and between (i) the proximal end of the shaft and (ii) the compressible part (Figs. 1C-F, para. 0030-0031 of Dillon; see note above in claims 1 and 34 about functional language).
However, modified Dillon fails to disclose that the catheter is radiolucent.
Bagaoisan teaches that it is known in the art to provide a tubular element 101 with multiple segments/markers 106 comprised of radiolucent material (para. 0039 teaches that “the materials used for any of the system components could be rendered radiopaque or radiolucent as desired”) along a length of the tubular member for the purpose of visualization under x-rays, fluoroscopy, computed tomography, ultrasound, direct visualization, infrared modalities, electromagnetic positioning systems or the like (para. 0114).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the catheter in modified Dillon to include the radiopaque markers of Bagaoisan in order to enable easier direct visualization of the device during a procedure by a user (para. 0114 of Bagaoisan).
Note: “at least while (a) a portion of the catheter is positioned within a channel of a bronchoscope” is interpreted as functional language that recites intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, the catheter of Dillon is for insertion into a body lumen of a patient through a channel of an elongate surgical device such as a duendoscope, endoscope, other camera or image-capturing device, etc. (para. 0033). Therefore, the catheter of Dillon is capable being positioned within a channel of a bronchoscope. Since the device of modified Dillon includes all of the structure required in claim for insertion into the airway of the patient through the channel of the bronchoscope, the device of modified Dillon meets the functional limitations of the claim,
Regarding claim 25, modified Dillon discloses wherein the adaptor 510 (see note below) is configured to reversibly receive a syringe 490 such that the syringe is usable to push air into the radiolucent catheter to inflate the balloon (Fig. 4A, para. 0034 of Dillon); and the adapter 510 (see note below) includes a two-way stop cock (not labeled but shown in Fig. 4A of Dillon in between syringe 490 and connector end 412) to keep air trapped in the balloon at least while the balloon is inflated (para. 0034; note it is well known in the art to use a two-way stop cock to manually regulate fluid flow by stopping or restoring said fluid flow).
Note: Para. 0030 of Dillon discloses that the features of the adapters shown in Figs. 4A-8 may be combined, para. 0040 discloses that the adapter 510 is shown as a very basic hub, but may alternatively be embodied as a manifold. Para. 0034 of Dillon discloses a removable hub embodied as a manifold 410, see Fig. 4A.).
Regarding claim 27, Modified Dillon discloses all of the limitations set forth above in claim 1.
However, Modified Dillon does not expressly disclose that the radiolucent catheter has a diameter of 1 mm to 2.5 mm for the embodiment of Figs. 5A-C.
In para. 0060, Dillon discloses another embodiment (Figs. 10, 10A-B) of a catheter 1000 used for the same purpose and function as the embodiment shown in Fig. 4A (para. 0059), wherein the catheter has a diameter of 0.053 inches or 1.35 mm, which is within the claimed range of 1 mm to 2.5 mm.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter in the embodiment of Figs. 5A-C of Dillon to include the diameter of the embodiment shown in Figs. 10, 10A-B, particularly since Dillon teaches that it is a known configuration for a catheter used for insertion into a body lumen of a patient through a channel of an elongate surgical device.
Regarding claim 29, modified Dillon discloses wherein, while the adapter is reversibly attached to the proximal end portion of the shaft and a portion of the radiolucent catheter is positioned within the channel of the bronchoscope, a distal end of the bronchoscope is positionable between (i) the proximal end portion and (ii) the compressible part (Figs. 1F-G, para. 0030-0031 of Dillon discloses that a distal end of an endoscope is positionable between the proximal end portion of the catheter and the middle portion of the catheter. Since Modified Dillon in discloses the compressible part positioned in the middle section, the endoscope would also be positionable over the compressible part).
Regarding claim 30, modified Dillon discloses wherein, while the portion of the radiolucent catheter is positioned within the channel of the bronchoscope and the adapter is reversibly attached to the proximal end of the shaft, a distal end of the bronchoscope is moveable over the compressible part from (i) a first side of the compressible part nearest the distal end of the shaft to (ii) a second side of the compressible part nearest the proximal end of the shaft (Figs. 1F-G, para. 0030-0031 of Dillon discloses that a distal end of an endoscope is moveable a first side nearest the distal end (end comprising balloon 504, see Fig. 5A of Dillon) of the catheter to a second side nearest the proximal end (end attached to adapter 510, see Fig. 5A of Dillon) of the shaft. Since modified Dillon discloses the compressible part positioned between the proximal and distal ends of the shaft (Fig. 17, para. 0076-0077 of Fan), the endoscope would also be positionable over the compressible part from (i) the first side of the compressible part nearest the distal end of the shaft to (ii) the second side of the compressible part nearest the proximal end of the shaft).
Regarding claim 37, modified Dillon discloses wherein: the compressible part can be transitioned between an unclamped state and a clamped state (Fig. 1, col. 2 lines 13-17 and col. 6 lines 12-17 of Meek);
to occlude the radiolucent catheter, the compressible part can be transitioned from the unclamped state to the clamped state (Fig. 1, col. 2 lines 13-17 and col. 6 lines 12-17 of Meek); and
at least when the balloon is inflated and the compressible part is in the clamped state, the compressible part can be transitioned from the clamped state to the unclamped state to permit flow of air between the proximal end portion of the shaft and the balloon (Fig. 1, col. 2 lines 13-17 and col. 6 lines 12-17 of Meek).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Dillon et al. (US 20110118546) [hereinafter Dillon] in view of Meek et al. (US 6979313) [hereinafter Meek], Fan et al. (US 20120150210) [hereinafter Fan], and Bagaoisan et al. (US 20140018732) [hereinafter Bagaoisan] as applied to claim 1 above, and further in view of Barthel (US 20100274084).
Regarding claim 12, modified Dillon discloses all of the limitations set forth above in claim 1. However, modified Dillon fails to disclose wherein the balloon, when inflated, has a diameter of 5 mm to 20 mm.
Barthel in the same field of endeavor teaches a balloon catheter for insertion into a body lumen of a patient through a channel of an endoscope (para. 0029 and 0031). Barthel further teaches that the typical range of diameters for a dilation balloon used within an endoscope is generally about 6 to 19 mm with a more preferred range of 12-18 mm (para. 0029 and 0031).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon in modified Dillon to include the diameter of Barthel, particularly since Barthel teaches that it is known in the art that the typical range of diameters for a dilation balloon used within an endoscope is within the claimed diameter range of 5 mm to 20 mm and therefore there is a reasonable expectation of success.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Dillon et al. (US 20110118546) [hereinafter Dillon] in view of Meek et al. (US 6979313) [hereinafter Meek], Fan et al. (US 20120150210) [hereinafter Fan], Bagaoisan et al. (US 20140018732) [hereinafter Bagaoisan], and Fischer et al. (US 20170189644) [hereinafter Fischer] as applied to claim 23 above, and further in view of Harshman et al. (US 20160310210) [hereinafter Harshman].
Regarding claim 26, modified Dillon discloses all of the limitations set forth above in claim 23. However, modified Dillon fails to disclose wherein the catheter has a length that is at least twice the length of the channel of the bronchoscope.
Harshman in the same field of endeavor teaches a balloon catheter assembly 100 (Fig. 2, para. 0016) inserted through a bronchoscope 200 (Fig. 5, para. 0058), wherein the catheter has a length that is at least twice the length of the channel of the bronchoscope (para. 0083 discloses that the bronchoscope as a working length of 40 to about 80 cm and the total length of the balloon catheter device is 55 to about 100 cm) for the purpose of ensuring that the shaft of the balloon catheter assembly efficiently extends through and out the bronchoscope.
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the length of the catheter in modified Dillon to be at least twice the length of the channel of the bronchoscope, as taught by Harshman in order to ensure that the shaft of the balloon catheter assembly efficiently extends through and out the bronchoscope.
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.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771