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 Rejections - 35 USC § 102
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) 1-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brenizer et al. (hereinafter “Brenizer”, US 2019/0247619).
Regarding claim 1, Brenizer discloses guide extension catheter (Fig. 1-3) device comprising:
an elongated body (Fig. 3, 300) having a distal portion (Fig. 3, 324), a proximal portion (Fig. 3, portion near 338) , and a middle portion extending (Fig. 3, area between 324 and 338) between the distal portion and the proximal portion (Fig. 3, where the distal area is near 338 and the middle section includes the area between 324 and 338), wherein:
the distal portion (324) comprises a first part (324, distal end) and a second part (325),
the first part (324) is disposed at a distal end of the distal portion (Fig. 3, where 324 is at the end of the distal portion),
the second part (325) is disposed at a proximal end of the distal portion (where 325 extends proximal to part 324),
the first part is cylindrical in shape (Fig. 3, 324, where 324 is cylindrical) and the second part (325) is tapered such that a diameter of a second part proximal end is greater than a diameter of a second part distal end (¶0023], where 325 is a proximally extending portion that is tapered and can have a larger outer diameter than 324); and
a built-in balloon integrated at a first part distal end (¶[0018], where a balloon can be applied to the distal end of the device for treatment).
Regarding claim 2, Brenizer discloses the guide extension catheter device of claim 1 further comprising: a first radio-opaque marker disposed at the first part distal end (¶[0034]); and a second radio-opaque marker disposed at an intersection point of the first part and the second part (¶[0034], where both a first and second band can be present on the proximal section and the distal section).
Regarding claim 3, Brenizer discloses the guide extension catheter device of claim 2, wherein the first radio-opaque marker and the second radio-opaque marker are circular in shape (¶[0034], where the band shape of the radiopaque markers is a circular shape).
Regarding claim 4, Brenizer discloses the guide extension catheter device of claim 1 further comprises a sliding tab (Fig. 3, 330) configured to control sliding movement of the built-in balloon (¶[0029], where 330 can extend the interior portion starting from a proximal end to extend 300).
Regarding claim 5, Brenizer discloses the guide extension catheter device of claim 4, wherein the sliding tab is disposed at the proximal portion (¶[0029], where 330 can start on the proximal portion and move distally to extend 300).
Regarding claim 6, Brenizer discloses the guide extension catheter device of claim 4, wherein the sliding tab is further configured to advance and retract the built-in balloon within and outside the first part distal end (¶[0023], [0029], where 330 facilitates extension and retraction of the required interior portion of the device distally and proximally).
Regarding claim 7, Brenizer discloses he guide extension catheter device of claim 4, wherein the sliding tab is further configured to lock position of the built-in balloon (¶[0029], where the activation of 330 requires a pushing force or a compressive force to unlock and move the tab).
Regarding claim 8, Brenizer discloses the guide extension catheter device of claim 4 further comprises a shaft associated with the built-in balloon, wherein the sliding tab is configured to move the shaft to slide the built-in balloon (¶[0018], [0029], where the balloon treatment portion can be controlled and used with the sliding tab 330).
Regarding claim 9, Brenizer discloses he guide extension catheter device of claim 1, wherein the middle portion comprises a diagonally sliced multi-layered pipe (Fig. 3, where the portion between 324 and 338 has diagonally sliced areas, ¶[0030]).
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.
Claim(s) 10-20 are rejected under 35 U.S.C. 103 as being unpatentable over Brenizer et al. (US 2019/0247619) in view of Ben-Ami (US 2014/0309657).
Regarding claim 10, Brenizer discloses the guide extension catheter device of claim 1, however, Brenizer does not specifically teach wherein the middle portion further comprises a central rod.
Ben-Ami teaches a device for accessing occluded vessels and includes treatment portions on the distal end of the device. Ben-Ami teaches wherein the middle portion further comprises a central rod (¶[0058]). By modifying the device of Brenizer to include a central rod, it would allow for the device to have a wider use by giving the option of being over-the-wire or rapid exchange meaning that the device can accommodate for full length tubular access or quick access on the side depending on the needs of the device (¶[0058], [0101] from Ben-Ami). Additionally, the device of Brenizer already uses a guidewire system that allows for extension of a treatment device, so modifying the device to include two options for the access method of the lumen would only improve the use and variety of use for the device.
Therefore it would have been obvious to one ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Brenizer to include a central rod (¶[0058] from Ben-Ami).
Regarding claim 11, Brenizer and Ben-Ami teach the guide extension catheter device of claim 10, Ben-Ami further teaches wherein the central rod comprises two channels for "Over-the-wire" (OTW) and "Rapid-exchange" (Rx) lumens (¶[0058]).
Regarding claim 12, Brenizer discloses a guide extension catheter (Fig. 1-3) device comprising:
an elongated body (Fig. 3, 300) having a distal portion (Fig. 3, 324), a proximal portion (Fig. 3, portion near 338) , and a middle portion extending (Fig. 3, area between 324 and 338) between the distal portion and the proximal portion (Fig. 3, where the distal area is near 338 and the middle section includes the area between 324 and 338), wherein:
the distal portion (324) comprises a first part (324, distal end) and a second part (325),
the first part (324) is disposed at a distal end of the distal portion (Fig. 3, where 324 is at the end of the distal portion),
the second part (325) is disposed at a proximal end of the distal portion (where 325 extends proximal to part 324),
the first part is cylindrical in shape (Fig. 3, 324, where 324 is cylindrical) and the second part (325) is tapered such that a diameter of a second part proximal end is greater than a diameter of a second part distal end (¶0023], where 325 is a proximally extending portion that is tapered and can have a larger outer diameter than 324); and
a built-in balloon integrated at a first part distal end (¶[0018], where a balloon can be applied to the distal end of the device for treatment); and
Brenizer does not specifically teach a central rod disposed at the middle portion.
Ben-Ami teaches wherein the middle portion further comprises a central rod (¶[0058]). By modifying the device of Brenizer to include a central rod, it would allow for the device to have a wider use by giving the option of being over-the-wire or rapid exchange meaning that the device can accommodate for full length tubular access or quick access on the side depending on the needs of the device (¶[0058], [0101] from Ben-Ami). Additionally, the device of Brenizer already uses a guidewire system that allows for extension of a treatment device, so modifying the device to include two options for the access method of the lumen would only improve the use and variety of use for the device.
Therefore it would have been obvious to one ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Brenizer to include a central rod (¶[0058] from Ben-Ami).
Regarding claim 13, the combined device of Brenizer and Ben-Ami teaches the guide extension catheter device of claim 12, Brenizer further teaches further comprising: a first radio-opaque marker disposed at the first part distal end (¶[0034]); and a second radio-opaque marker disposed at an intersection point of the first part and the second part (¶[0034], where both a first and second band can be present on the proximal section and the distal section).
Regarding claim 14, the combined device of Brenizer and Ben-Ami teaches the guide extension catheter device of claim 13, Brenizer further teaches wherein the first radio-opaque marker and the second radio-opaque marker are circular in shape (¶[0034], where the band shape of the radiopaque markers is a circular shape).
Regarding claim 15, the combined device of Brenizer and Ben-Ami teaches the guide extension catheter device of claim 12, Brenizer further teaches further comprises a sliding tab (Fig. 3, 330) configured to control sliding movement of the built-in balloon (¶[0029], where 330 can extend the interior portion starting from a proximal end to extend 300).
Regarding claim 16, the combined device of Brenizer and Ben-Ami teaches the guide extension catheter device of claim 15, Brenizer further teaches wherein the sliding tab is disposed at the proximal portion (¶[0029], where 330 can start on the proximal portion and move distally to extend 300).
Regarding claim 17, the combined device of Brenizer and Ben-Ami teaches the guide extension catheter device of claim 15, Brenizer further teaches wherein the sliding tab is further configured to advance and retract the built-in balloon within and outside the first part distal end (¶[0023], [0029], where 330 facilitates extension and retraction of the required interior portion of the device distally and proximally).
Regarding claim 18, the combined device of Brenizer and Ben-Ami teaches the guide extension catheter device of claim 15, Brenizer further teaches wherein the sliding tab is further configured to lock position of the built-in balloon (¶[0029], where the activation of 330 requires a pushing force or a compressive force to unlock and move the tab).
Regarding claim 19, the combined device of Brenizer and Ben-Ami teaches the guide extension catheter device of claim 12, Brenizer further teaches wherein the middle portion comprises a diagonally sliced multi-layered pipe (Fig. 3, where the portion between 324 and 338 has diagonally sliced areas, ¶[0030]).
Regarding claim 20, Brenizer discloses a method for manufacturing (Abstract, ¶[0025]-[0026]) a guide extension catheter device (Fig. 1-3, the method comprising:
providing an elongated body (Fig. 3, 300) having a distal portion (Fig. 3, 324), a proximal portion (Fig. 3, portion near 338), and a middle portion extending (Fig. 3, area between 324 and 338) between the distal portion and the proximal portion (Fig. 3, where the distal area is near 338 and the middle section includes the area between 324 and 338), wherein:
the distal portion (324) comprises a first part (324, distal end) and a second part (325),
the first part (324) is disposed at a distal end of the distal portion (Fig. 3, where 324 is at the end of the distal portion),
the second part (325) is disposed at a proximal end of the distal portion (where 325 extends proximal to part 324),
the first part is cylindrical in shape (Fig. 3, 324, where 324 is cylindrical) and the second part (325) is tapered such that a diameter of a second part proximal end is greater than a diameter of a second part distal end (¶0023], where 325 is a proximally extending portion that is tapered and can have a larger outer diameter than 324);
integrating a built-in balloon at a first part distal end (¶[0018], where a balloon can be applied to the distal end of the device for treatment); and
Brenizer does not specifically teach disposing a central rod at the middle portion.
Ben-Ami teaches wherein the middle portion further comprises a central rod (¶[0058]). By modifying the device of Brenizer to include a central rod, it would allow for the device to have a wider use by giving the option of being over-the-wire or rapid exchange meaning that the device can accommodate for full length tubular access or quick access on the side depending on the needs of the device (¶[0058], [0101] from Ben-Ami). Additionally, the device of Brenizer already uses a guidewire system that allows for extension of a treatment device, so modifying the device to include two options for the access method of the lumen would only improve the use and variety of use for the device.
Therefore it would have been obvious to one ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Brenizer to include a central rod (¶[0058] from Ben-Ami).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HADEN M RITCHIE whose telephone number is (703)756-1699. The examiner can normally be reached M-F 8am-5:30pm.
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/HADEN MATTHEW RITCHIE/Examiner, Art Unit 3783 /BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783