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 § 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.
Claims 56, 60-61, and 63-68 are 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 56, “the pressurized inert gas lumen” lacks antecedent basis.
Regarding claim 60, “the flexible housing” lacks antecedent basis. Claim 61 depends on rejected claim 60 and fail to remedy the issues. Therefore, it is also rejected.
Regarding claims 63-68, the claims depend on cancelled claim 1.
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.
Claim(s) 49, 52-53, 60, and 62 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maschke (US 7238178 B2) in view of Leckrone (US 5026367), further in view of Boppart (US 8115934 B2).
Regarding claim 49, Mashke discloses a catheter configured to penetrate a chronic total occlusion (eg. Col. 1, Ln. 35-53, Col. 4, Ln. 30-48), wherein the catheter comprises: a proximal end; a distal end (Eg. Fig. 1, Ln. 3, Ln. 55 – Col. 4, Ln. 20); an imaging fiber configured to transmit imaging data from the distal end of the catheter to the proximal end of the catheter (eg. Claim 1, Col. 3, Ln. 55 – Col. 4, Ln. 48, OCT sensor signaling line that uses a glass fiber line); a laser fiber configured to transmit laser energy from the proximal end of the catheter to the distal end of the catheter (eg. Col. 3, Ln. 55 – Col. 4, Ln. 48, laser radiation device 11); but does not disclose a vacuum lumen configured to transmit a vacuum from the proximal end of the catheter to the distal end of the catheter wherein: the imaging fiber is configured to focus imaging light at a distance D1 from the distal end; the laser fiber is configured to focus the laser energy at a distance D2 from the distal end; and D1 is greater than D2.
Leckrone teaches an angioplasty catheter that uses a suction lumen to remove debris from the blood vessel (Col. 1, Ln. 42 – Col. 2, Ln. 10 Col. 4, Ln. 52 – Col. 5, Ln. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Mashke with the aspiration lumen as taught by Leckrone since applying suction to a lumen for the predictable result of withdrawing debris from the blood vessel is commonly used in the art (eg. Leckrone, Col. 1, Ln. 42 – Col. 2, Ln. 10).
Boppart teaches an OCT system with a laser and OCT system that can have variable focal lengths (eg. Col. 25, Ln. 59 – Col. 26, Ln. 16, Col. 26, Ln. 59 – Col. 27, Ln. 11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Mashke and Leckrone with the varying focal lengths as taught by Boppart since they are both in the realm of OCT imaging and lasers and Mashke purposely puts the OCT sensor in front of the laser emitting device relative to a laser emitting device relative to a laser emitting direction (eg. Mashkle, claim 4). One of ordinary skill would have put the sensor before the laser to be able to visualize the plaque/wall to prevent the laser from accidentally cutting the blood vessel wall instead of the plaque.
Regarding claim 52, the combined invention of Maschke, Leckrone, and Boppart discloses the imaging fiber is configured to transmit optical coherence tomography imaging data (eg. Maschke, Col. 2, Ln. 40 – Col. 3, Ln. 8, Col. 3, L. 55 – Col. 4, Ln. 20).
Regarding claim 53, the combined invention of Maschke, Leckrone, and Boppart discloses the imaging fiber is configured to transmit optical coherence tomography imaging data for the determination of plaque composition real-time to minimize heating of the artery (Eg. Maschke, Col. 2, Ln. 40-61).
Regarding claim 60, the combined invention of Maschke, Leckrone, and Boppart discloses an outer sheath around the flexible housing, wherein the outer sheath extends between the proximal end of the catheter and the distal end of the catheter (eg. Maschke, Col. 3, Ln. 55 – Col. 4, Ln. 20).
Regarding claim 62, the combined invention of Maschke, Leckrone, and Boppart discloses the catheter has an outer diameter of 1.0 mm or less (eg. Leckrone, Col. 7, Ln. 60 – Col. 8, Ln. 7).
Claim(s) 51, 63, 65-67 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maschke (US 7238178 B2) in view of Leckrone (US 5026367), further in view of Boppart (US 8115934 B2), further in view of Mitchell (US 6395000 B1).
Regarding claim 51, the combined invention of Maschke, Leckrone, and Boppart discloses the invention of claim 49, but does not disclose the laser fiber is configured to transmit laser energy from an Erbium-doped yttrium aluminum garnet laser (Er:YAG) laser.
Mitchell teaches an ablation catheter with an Er:Yag laser (Eg. Col. 1, Ln. 10-65, Col. 2, Ln. 29-40, Col. 3, Ln. 40-50, Col. 5, Ln. 55-65).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Maschke, Leckrone, and Boppart with the Er:YAG laser as taught by Mitchell since Er:YAG is a known laser source used in the art for ablation.
Regarding claim 63, the combined invention of Maschke, Leckrone, and Boppart, and Mitchell discloses the laser fiber emits electromagnetic energy with a pulse repetition rate of 25 Hz - 1 kHz (Eg. Mitchell, Col. 2, Ln. 39-47).
Regarding claim 65, the combined invention of Maschke, Leckrone, and Boppart, and Mitchell discloses the laser fiber emits electromagnetic energy with a wavelength of 2.94 um (Eg. Mitchell, Col. 3, Ln. 40-50).
Regarding claim 66, the combined invention of Maschke, Leckrone, and Boppart, and Mitchell discloses the laser fiber emits electromagnetic energy with a pulse energy of 1 mJ to 100 mJ (Eg. Mitchell, Col. 4, Ln. 29-50).
Regarding claim 67, the combined invention of Maschke, Leckrone, and Boppart, and Mitchell discloses the laser fiber emits electromagnetic energy with a pulse energy of approximately 5 mJ (Eg. Mitchell, Col. 4, Ln. 29-50).
Claim(s) 54-55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maschke (US 7238178 B2) in view of Leckrone (US 5026367), further in view of Boppart (US 8115934 B2), further in view of Crowley (US 6364840 B1).
Regarding claim 54, the combined invention of Maschke, Leckrone, and Boppart discloses a sheath (eg. Maschke, Col. 2, Ln. 62 – Col. 3, Ln. 21) but does not disclose it being configured to transmit a torque from the proximal end of the catheter to the distal end of the catheter.
Crowley teaches an imaging catheter with a drive shaft that uses coils to transmit torque for rotating imaging elements (eg. Col. 6, Ln. 43-63).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Maschke, Leckrone, and Boppart with the torque coils as taught by Crowley since both are in the realm of imaging catheters and would to provide the predictable result of being able to steer the imaging components to better capture images of the tissues.
Regarding claim 55, the combined invention of Maschke, Leckrone, Boppart, and Crowley discloses the sheath is a multi-filar flexible sheath (eg. Crowley, Abstract, Col. 6, Ln. 43-62, Col. 10, Ln. 34 – Col. 11, Ln. 15).
Claim(s) 56-57, 59, and 61 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maschke (US 7238178 B2) in view of Leckrone (US 5026367), further in view of Boppart (US 8115934 B2), further in view of Kittrell (US 5693043).
Regarding claim 56, the combined invention of Maschke, Leckrone, and Boppart discloses a flexible housing extending from the proximal end of the catheter to the distal end of the catheter, wherein: the flexible housing comprises a first lumen and a second lumen; the imaging fiber extends through the first lumen; the laser fiber extends through the second lumen; and the vacuum lumen extends through the flexible housing (eg. Col. 1, Ln. 43-56 flexible, Fig. 2-6, 13-14 Col. 4, Ln. 15 – Col. 5, Ln. 20, multiple lumens for each tool), but does not disclose an inert gas lumen configured to transmit an inert gas from the proximal end of the catheter to the distal end of the catheter.
Kittrell teaches a laser catheter that pumps an inert gas to the distal end of the catheter (eg. Col. 14, Ln. 40-57).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Maschke, Leckrone, and Boppart with the inert gas lumen as taught by Kittrell to provide the predictable result of creating a form of lens while also withstanding the high power of laser radiation traversing it (Eg. Kittrell, Col. 14, Ln. 40-57).
Regarding claim 57, the combined invention of Maschke, Leckrone, Boppart, and Kittrell discloses the pressurized inert gas lumen extends through the flexible housing (eg. Kittrell, Fig. 1-2, Col. 12, Ln. 1-55 and Col. 14, Ln. 40-57).
Regarding claim 59, the combined invention of Maschke, Leckrone, Boppart, and Kittrell discloses the inert gas lumen extends through the flexible housing (eg. Kittrell, Fig. 1-2, Col. 12, Ln. 1-55 and Col. 14, Ln. 40-57).
Regarding claim 61, the combined invention of Maschke, Leckrone, Boppart, and Kittrell discloses an inert gas lumen configured to transmit an inert gas from the proximal end of the catheter to the distal end of the catheter, wherein the inert gas lumen extends through the outer sheath (eg. Kittrell, Fig. 1-2, Col. 12, Ln. 1-55 and Col. 14, Ln. 40-57).
Claim(s) 58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maschke (US 7238178 B2) in view of Leckrone (US 5026367), further in view of Boppart (US 8115934 B2), further in view of Kittrell (US 5693043), further in view of McWeeney (US 7922650 B2).
Regarding claim 58, the combined invention of Maschke, Leckrone, Boppart, and Kittrell discloses the invention of claim 56, but does not disclose the flexible housing is a polytetrafluoroethylene (PTFE) extrusion.
McWeeney teaches a catheter with a body made of PTFE (eg. Col. 7, Ln. 19-34, Col. 8, Ln. 15-35).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Maschke, Leckrone, Boppart, and Kittrell to have the housing made of PTFE since it is a commonly used material in the art for constructing catheters (McWeeney, Col. 7, Ln. 19-34, Col. 8, Ln. 15-35).
Claim(s) 64 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maschke (US 7238178 B2) in view of Leckrone (US 5026367), further in view of Boppart (US 8115934 B2), further in view of Ben Oren (US 2014/0031800 A1).
Regarding claim 64, the combined invention of Maschke, Leckrone, and Boppart, Mitchell discloses the invention of claim 49, but does not disclose the laser fiber emits electromagnetic energy with a pulse duration of 20 ps to 1 ms.
Ben Oren teaches a vascular intervention catheter that uses an Er:YAG laser with pulse widths less than 10 ns (eg. Para. 149).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention to have a pulse width of less than 10 ns as taught by Ben Oren since the parameter is well-known in the art for creating a higher power density to ablate calcified plaques (eg. Ben Oren, Para. 149).
Claim(s) 68 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maschke (US 7238178 B2) in view of Leckrone (US 5026367), further in view of Boppart (US 8115934 B2), further in view of Temelkuran (US 2005/0259933 A1).
Regarding claim 68, the combined invention of Maschke, Leckrone, and Boppart discloses the invention of claim 49, but does not disclose laser fiber emits electromagnetic energy with an average power of 1-10 W.
Temelkuran teaches an Er:YAG catheter that for ablating tissue with wattage that can range from about 1 Watt to about 10 Watts or more (eg. Para. 3, 11, 29, 51, 74-76, 81, 85, 87, 183, 204, 247).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Maschke, Leckrone, and Boppart to have a wattage of 1-10+ Watts as taught by Temelkuran since that power range is well-known in the art for ablation procedures (eg. Temelkuran, Para. 3, 11, 29, 51, 74-76, 81, 85, 87, 183, 204, 247).
Conclusion
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/MICHAEL J LAU/Examiner, Art Unit 3796
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