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 § 103
Claim(s) 67-70,74-76,80,84-86 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ciulla et al (2016/0166320).
67. (New) A method for using a kidney stone removal system, comprising:
positioning the kidney stone removal system within a kidney of a patient having kidney stones by accessing the kidney via a ureter of the patient, wherein the kidney stone removal system comprises a vacuum lumen defined by a vacuum tube through which suction can be applied; (see at least figure 3 step 304 and figure 2 which shows a vacuum lumen 114)
irrigating the kidney via the kidney stone removal system; (see at least figure 2 which shows an irrigation lumen 112)
fragmenting at least one kidney stone into a plurality of kidney stone fragments using a laser fiber supported within a distal portion of the vacuum tube; (see at least figure 2 which shows laser fiber 120 in vacuum lumen and ¶37)
removing at least a portion of the plurality of kidney fragments through the vacuum lumen (see at least ¶39 which teaches suctioning thru channel 114)
using a passive negative pressure to create outflow; (Ciulla is silent as to using passive negative pressure. However, applicant’s specification, at ¶153, teaches that there can still be a little applied vacuum to create passive outflow. It would have been obvious to use a little applied vacuum with the device of Ciulla since it would reduce energy expenditure and still create a desired outflow, in a predictable manner)
applying suction through the vacuum lumen to remove an additional portion of the plurality of kidney stone fragments.
(as mentioned, fragments are removed via the lumen 114, as shown in figure 2. It is considered to have been obvious to remove laser and continue to apply suction to remove any remaining fragments since, as set forth in at least ¶51 the step of removing the laser can be done before suction is applied, and ¶18 teaches that during the laser process or after removal of the laser from the lumen the ureteroscope may vacuum the resulting particles from the body. By removing the laser from lumen 114 and continuing to vacuum, more suction can be created since a larger space in the lumen 114 will be created after laser removal, and thus more particles can thereby be removed.)
68. (New) The method of claim 67, further comprising withdrawing the laser fiber from the distal portion of the vacuum lumen prior to applying suction through the vacuum lumen to remove an additional portion of the plurality of kidney stone fragments. (as mentioned supra, such step is considered to have been obvious since it would create a larger area in lumen 114 to further vacuum the fragments)
69. (New) The method of claim 67, wherein irrigating the kidney occurs continuously during removing at least a portion of the plurality of kidney fragments through the vacuum lumen using a passive negative pressure to create outflow. (see at least ¶46 which teaches continuous flow and ¶48 which teaches suction and irrigation simultaneously, and step 308 in figure 3)
70. (New) The method of claim 69, wherein irrigating the kidney occurs continuously during applying suction through the vacuum lumen to remove an additional portion of the plurality of kidney stone fragments. (see at least ¶46 which teaches continuous flow and ¶48 which teaches suction and irrigation simultaneously, and step 308 in figure 3)
74. (New) The method of claim 67, wherein removing at least a portion of the plurality of kidney fragments through the vacuum lumen using a passive negative pressure to create outflow removes heated fluid and irrigating the kidney via the kidney stone removal system introduces fluid cooler than the heated fluid. (such is considered to be inherent in the operation of the device of Ciulla since the same structure is used. Further, irrigation fluid from external the body is cooler than the fluid inside the body that has been subject to laser energy)
75. (New) The method of claim 67, wherein irrigating the kidney via the kidney stone removal system occurs at a flow rate independent of a size of the laser fiber. (such step is considered to be inherent since the laser is not in the irrigation lumen and thus irrigation fluid can be injected without regard to the diameter of the laser fiber)
76. (New) A method for using a kidney stone removal system, comprising:
positioning the kidney stone removal system within a kidney of a patient having kidney stones by accessing the kidney via a ureter of the patient, wherein the kidney stone removal system comprises a vacuum lumen defined by a vacuum tube through which suction can be applied; (see at least figure 3 step 304 and figure 2 which shows a vacuum lumen 114)
irrigating the kidney continuously via the kidney stone removal system; (see at least figure 2 which shows an irrigation lumen 112; and at least ¶46 which teaches continuous irrigation)
fragmenting at least one kidney stone into a plurality of kidney stone fragments using a laser fiber supported within a distal portion of the vacuum tube; (see at least figure 2 which shows laser fiber 120 in vacuum lumen and ¶37)
removing at least a portion of the plurality of kidney fragments through the vacuum lumen using a passive negative pressure to create outflow; (see at least ¶43-46 where it is taught that suction is created and the fragments are removed thereby. Further, suctioning is caused by creating a pressure differential so that low pressure area content will be suctioned into high pressure area. To use a passive system to create a pressure differential using passive means would have been obvious since it would result in a predictable effect by known means. That is, by using a passive system, no extra power would have to be used to create the suctioning.)
applying suction through the vacuum lumen to remove an additional portion of the plurality of kidney stone fragments. (as mentioned, fragments are removed via the lumen 114, as shown in figure 2. It is considered to have been obvious to remove laser and continue to apply suction to remove any remaining fragments since, as set forth in at least ¶51 the step of removing the laser can be done before suction is applied, and ¶18 teaches that during the laser process or after removal of the laser from the lumen the ureteroscope may vacuum the resulting particles from the body. By removing the laser from lumen 114 and continuing to vacuum, more suction can be created since a larger space in the lumen 114 will be created after laser removal, and thus more particles can thereby be removed.)
80. (New) A method for using a kidney stone removal system, comprising:
positioning the kidney stone removal system within a kidney of a patient having kidney stones by accessing the kidney via a ureter of the patient, wherein the kidney stone removal system comprises a vacuum lumen defined by a vacuum tube through which suction can be applied; (see at least figure 3 step 304 and figure 2 which shows a vacuum lumen 114)
irrigating the kidney continuously via the kidney stone removal system; (see at least figure 2 which shows an irrigation lumen 112; and at least ¶46 which teaches continuous irrigation)
fragmenting at least one kidney stone into a plurality of kidney stone fragments using a laser fiber stably supported within a distal portion of the vacuum tube; (see at least figure 2 which shows laser fiber 120 in vacuum lumen and ¶37. Further, the laser is considered to be stably supported in the lumen 114 otherwise it would move around inside the lumen and the laser process would not be as accurate if the laser was unstably supported in the lumen)
removing at least a portion of the plurality of kidney fragments through the vacuum lumen using a passive negative pressure to create outflow; (see at least ¶43-46 where it is taught that suction is created and the fragments are removed thereby. Further, suctioning is caused by creating a pressure differential so that low pressure area content will be suctioned into high pressure area. To use a passive system to create a pressure differential using passive means would have been obvious since it would result in a predictable effect by known means. That is, by using a passive system, no extra power would have to be used to create the suctioning.)
applying suction through the vacuum lumen to remove an additional portion of the plurality of kidney stone fragments. (as mentioned, fragments are removed via the lumen 114, as shown in figure 2. It is considered to have been obvious to remove laser and continue to apply suction to remove any remaining fragments since, as set forth in at least ¶51 the step of removing the laser can be done before suction is applied, and ¶18 teaches that during the laser process or after removal of the laser from the lumen the ureteroscope may vacuum the resulting particles from the body. By removing the laser from lumen 114 and continuing to vacuum, more suction can be created since a larger space in the lumen 114 will be created after laser removal, and thus more particles can thereby be removed.)
84. (New) The method of claim 80, wherein removing at least a portion of the plurality of kidney fragments through the vacuum lumen using a passive negative pressure to create outflow removes heated fluid and irrigating the kidney via the kidney stone removal system introduces fluid cooler than the heated fluid. (such is considered to be inherent in the operation of the device of Ciulla since the same structure is used. Further, irrigation fluid from external the body is cooler than the fluid inside the body that has been subject to laser energy)
85. (New) The method of claim 80, wherein irrigating the kidney via the kidney stone removal system occurs at a flow rate independent of a size of the laser fiber. (such step is considered to be inherent/obvious since the laser is not in the irrigation lumen and thus irrigation fluid can be injected without regard to the diameter of the laser fiber)
86. (New) The method of claim 80, further comprising withdrawing the laser fiber from the distal portion of the vacuum lumen prior to applying suction through the vacuum lumen to remove an additional portion of the plurality of kidney stone fragments. (as mentioned supra, such step is considered to have been obvious since it would create a larger area in lumen 114 to further vacuum the fragments)
Claim(s) 71-73,77-79,81-83 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ciulla et al (2016/0166320) and Weissmuller et al (5,095,889).
71. (New) The method of claim 67, wherein the laser fiber is supported within the distal portion of the vacuum tube by a movable guide. (Ciulla is silent as to a guide. Weissmuller teach such a guide (element 8) that allows the laser to be axially displaceable, see at least abstract. It would have been obvious to use such with the device of Ciulla since it would provide predictable results such as being able to adjust the laser to the optimum distance from the kidney stone for energy transmission, as taught in at least the abstract. Weissmuller supports the laser using the guide including within the distal portion of the lumen it is in so that it is stable and can thereby more effectively apply energy to the stone)
72. (New) The method of claim 71, further comprising flow gaps defined by spaces between the moveable guide and the vacuum tube and wherein kidney stone fragments are removed via the flow gaps. (the guide of Weissmuller when used in the lumen 114 of Ciulla would not take up the entire space, and thus suction can still be used to clear the fragments via the gaps)
73. (New) The method of claim 71, further comprising moving the movable guide back and forth while removing at least a portion of the plurality of kidney fragments through the vacuum lumen using a passive negative pressure to create outflow. (Weismuller is silent as to moving the guide while removing kidney fragments. However, such step is considered to have been obvious since it would yield the predictable result of causing turbulence, as taught in at least ¶46 of Ciulla , that will keep the stone fragments in suspension and thus be more effectively suctioned out)
77. (New) The method of claim 76, wherein the laser fiber is supported within the distal portion of the vacuum tube by a movable guide. (Weissmuller teach such a guide (element 8) that allows the laser to be axially displaceable, see at least abstract. It would have been obvious to use such with the device of Ciulla since it would provide predictable results such as being able to adjust the laser to the optimum distance from the kidney stone for energy transmission, as taught in at least the abstract. Weissmuller supports the laser using the guide including within the distal portion of the lumen it is in so that it is stable and can thereby more effectively apply energy to the stone)
78. (New) The method of claim 77, further comprising flow gaps defined by spaces between the moveable guide and the vacuum tube and wherein kidney stone fragments are removed via the flow gaps. (the guide of Weissmuller when used in the lumen 114 of Ciulla would not take up the entire space, and thus suction can still be used to clear the fragments via the gaps)
79. (New) The method of claim 77, further comprising moving the movable guide back and forth while removing at least a portion of the plurality of kidney fragments through the vacuum lumen using a passive negative pressure to create outflow. (such step is considered to have been obvious since it would yield the predictable result of causing turbulence that will keep the stone fragments in suspension and thus be more effectively suctioned out)
81. (New) The method of claim 80, wherein the laser fiber is supported within the distal portion of the vacuum tube by a movable guide. (Weissmuller teach such a guide that allows the laser to be axially displaceable, see at least abstract. It would have been obvious to use such with the device of Ciulla since it would provide predictable results such as being able to adjust the laser to the optimum distance from the kidney stone for energy transmission, as taught in at least the abstract. Weissmuller supports the laser using the guide including within the distal portion of the lumen it is in so that it is stable and can thereby more effectively apply energy to the stone)
82. (New) The method of claim 81, further comprising flow gaps defined by spaces between the moveable guide and the vacuum tube and wherein kidney stone fragments are removed via the flow gaps. (the guide of Weissmuller when used in the lumen 114 of Ciulla would not take up the entire space, and thus suction can still be used to clear the fragments via the gaps)
83. (New) The method of claim 81, further comprising moving the movable guide back and forth while removing at least a portion of the plurality of kidney fragments through the vacuum lumen using a passive negative pressure to create outflow. (such step is considered to have been obvious since it would yield the predictable result of causing turbulence that will keep the stone fragments in suspension and thus be more effectively suctioned out)
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 67-86 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 12,329,399. Although the claims at issue are not identical, they are not patentably distinct from each other because at least one claim of the present application is merely a broadening over at least one claim of the ‘399 patent. Re application claim 67, see patent claim 1. Re application claim 68, see patent claim 2. Re application claim 69, see patent claim 3. Re application claim 70, see patent claim 4. Re application claim 71, see patent claim 5. Re application claim 72, see patent claim 6. Re application claim 73, see patent claim 7. Re application claim 74, see patent claim 8. Re application claim 75, see patent claim 9. Re application claim 76, see patent claim 11. Re application claim 77, see patent claim 12. Re application claim 78, see patent claim 13. Re application claim 79, see patent claim 14. Re application claim 80, see patent claim 16. Re application claim 81, see patent claim 17. Re application claim 82, see patent claim 18. Re application claim 83, see patent claim 19. Re application claim 84, see patent claim 20. Re application claim 85, see patent claim 21. Re application claim 86, see patent claim 22.
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/Scott M. Getzow/Primary Examiner, Art Unit 3792