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 § 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) 1-7 and 9-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0215965 Harrah et al., hereinafter “Harrah” (cited previously), in view of US 9,642,513 Levy et al., hereinafter “Levy”.
Regarding claim 1, Harrah discloses a system (Figure 1, element 100) for treating stones (Abstract) in a hollow organ or body passage (Para 30), comprising: an insertion device (Figure 1, element 100) including a shaft (Figure 1, element 102) extending longitudinally from a proximal end (Figure 1, element 106) to a distal end (Figure 1, element 104), the shaft being configured for insertion to a target area within a hollow organ or a body passage (Para 30 and 35) and including a first working channel (Figure 3A, element 114) and a second working channel (Figure 3A, element 112) extending therethrough; and an adapter (Figure 1, element 115) including a proximal portion (Figure 1, element 104) configured to be coupled to the distal end of the shaft (Figure 1, element 104) in a desired alignment (Para 40) and a distal portion (Figure 1, element 105) defining a chamber therein for receiving a target stone to be treated (Para 42; “fluid toward the distal end 105 of distal portion 115 may assist in pushing stone fragments/dust toward the vacuum, e.g., distal opening of second lumen 114”), the proximal portion including an outlet extending through a portion thereof positioned so that, when the adapter is in the desired alignment (Para 47), a fluid supplied to the first working channel is directed out of the adapter via the outlet to an area surrounding the adapter (Figure 3A, element 122; see also Para 42), the adapter further including an inlet channel extending longitudinally through the proximal portion to a first distal opening open to the chamber (Figure 3A, element 114 and Para 42), the inlet channel being configured so that, when negative pressure is applied thereto, the fluid from the area surrounding the adapter is drawn through the first distal opening through the inlet channel to the second working channel (Para 42-43 and 57).
Harrah does not disclose a partition extending across a lumen of the adapter, the partition separating a proximal portion of the adapter from a distal portion of the adapter; the partition and an outer wall of the adapter along the distal portion of the adapter defining a chamber; and the adapter further including an inlet channel extending longitudinally through the proximal portion to a first distal opening in the partition.
However, Levy discloses an endoscope insertion device (Abstract) and teaches a partition extending across a lumen of the adapter (Annotated Figure 2A shows the adapter 200; examiner refers to annotated Figures 2A and 10A that show the partition and the proximal portion. The partition is a physical object that inherently provides separation between the proximal portion shown in Annotated Figure 10A and the distal portion shown in Annotated Figure 2A), the partition separating a proximal portion of the adapter from a distal portion of the adapter (Annotated Figure 2A shows separate components that are separated; proximal portion, including the partition 300 and distal portions 400 and 600); the partition and an outer wall of the adapter along the distal portion of the adapter defining a chamber (Annotated Figure 2A shows the chamber; the chamber is formed from the walls of the adapter on the distal portion and is separated from the proximal portion by the partition shown in Annotated Figures 2A and 10A; therefore the chamber is defined by the distal portion and the partition, chamber is element 640, see also Col. 63, lines 16-21 and Col. 137, lines 32-36); and the adapter further including an inlet channel extending longitudinally through the proximal portion to a first distal opening in the partition (Figure 2A, elements 340, 346, and 344; see Figure 63 that clearly shows the extending of these channels; Col. 27, lines 17-19 and Col. 71, lines 32-37 also show the alignment of the extending channels with the distal portion of the adapter).
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Annotated Figure 2A (Levy)
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Annotated Figure 10A (Levy)
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a partition that separates the proximal and distal portion as taught by Levy, in the invention of Harrah, in order to provide protection to the internal components (Levy; Col. 71, lines 32-37).
Regarding claim 2, Harrah discloses the adapter includes a substantially tubular body extending from a proximal end to a distal end (Figure 2, element 116 and Para 38).
Regarding claim 3, Harrah discloses the outlet includes an aperture extending through a wall along the proximal portion of the adapter (Figure 3A, element 122).
Regarding claim 4, Harrah discloses the adapter includes a device channel extending through the proximal portion to a second distal opening, the second distal opening being open to the chamber (Figure 3A, element 112; see Para 34 that describes the addition of any number of lumens used for a variety of purposes), the device channel configured to receive an energy device (Figure 3A, element 112 receives device 120) therethrough for applying an energy to a target stone received within or against the chamber (Para 53-54, see also Para 42 that shows receiving the fragmented stones).
Harrah does not disclose a partition.
However, Levy teaches a partition (Figure 2A shows the adapter 200; examiner interprets element 300 to be the partition separating the proximal portion 300 from distal pieces 400 and 600).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a partition that separates the proximal and distal portion as taught by Levy, in the invention of Harrah, in order to provide protection to the internal components (Levy; Col. 71, lines 32-37).
Regarding claim 5, Harrah discloses the proximal portion of the adapter includes an alignment feature configured to engage a corresponding portion of a mounting bracket attached to the distal end of the shaft so that the adapter is coupled to the shaft in an operative configuration (Para 40 and 47).
Regarding claim 6, Harrah discloses the distal portion of the adapter has a smaller cross-sectional area than the proximal portion (Figure 3B shows the distal portion 105 being tapered as compared to end 104), and the outlet is configured as an outlet channel extending longitudinally through the proximal portion to a second distal opening (Figure 3B, elements 122).
Harrah does not disclose a partition.
However, Levy teaches a partition (Figure 2A shows the adapter 200; examiner interprets element 300 to be the partition separating the proximal portion 300 from distal pieces 400 and 600).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a partition that separates the proximal and distal portion as taught by Levy, in the invention of Harrah, in order to provide protection to the internal components (Levy; Col. 71, lines 32-37).
Regarding claim 7, Harrah discloses the proximal and distal portions of the adapter are configured to be releasably coupled to one another (Para 8; “For example, the tube may be in fluid communication with a cap located at the distal portion, and the cap may be removably attached to the tube”).
Regarding claim 9, Harrah discloses the proximal portion of the adapter includes a window sized and shaped to receive an imaging system of the insertion device therein so that the chamber is within a field of view of the imaging system (Figure 2, element 116 extends through proximal portion; consider Figure 1, element 170 and Figure 3A, element 124; see also Para 43).
Regarding claim 10, Harrah discloses the chamber includes a tapered surface tapering toward a proximal end of the chamber to funnel one or more stones received therein toward a central axis along which the outlet channel extends (Figure 3B, surface 105 is tapered; surface 105 includes chamber 114 shown in Figure 3A; see also Para 56).
Regarding claim 11, Harrah discloses at least a distal portion of the outlet channel has a non-circular cross-sectional area (Figure 3A, element 112 is non-circular) configured to align an energy device received therein toward a central axis (Figure 3A, element 120 is within a central axis of 112) along which the inlet channel extends so that a negative force may be applied through the inlet channel, about the energy device (Para 42).
Regarding claim 12, Harrah discloses the non-circular cross-sectional area is one of an elliptical shape, an elongated slot, or a cross-shape (Figure 3A, element 112 is an elongated slot; regardless see Para 34 that describes that the lumens 112 and 114 can be in any shape).
Regarding claim 13, Harrah discloses a system (Figure 1, element 100) for treating stones (Abstract) in a hollow organ or body passage (Para 30), comprising: a ureteroscope (Para 29) including a shaft (Figure 1, element 102) extending longitudinally from a proximal end (Figure 1, element 106) to a distal end (Figure 1, element 104), the shaft being configured for insertion to a target area within a hollow organ or a body passage (Para 30 and 35) and including a first working channel (Figure 3A, element 114) and a second working channel (Figure 3A, element 112) extending therethrough; wherein the ureteroscope further comprises an imaging system, including an imager (Figure 1, element 170); and an adapter (Figure 1, element 115) including a proximal portion (Figure 1, element 104) configured to be coupled to the distal end of the shaft (Figure 1, element 104) in a desired alignment (Para 40) and a distal portion (Figure 1, element 105) defining a chamber therein for receiving a target stone to be treated (Para 42; “fluid toward the distal end 105 of distal portion 115 may assist in pushing stone fragments/dust toward the vacuum, e.g., distal opening of second lumen 114”), the proximal portion including an outlet extending through a portion thereof positioned so that, when the adapter is in the desired alignment (Para 47), a fluid supplied to the first working channel is directed out of the adapter via the outlet to an area surrounding the adapter (Figure 3A, element 122; see also Para 42), the adapter further including an inlet channel extending longitudinally through the proximal portion to a first distal opening which is open to the chamber (Figure 3A, element 114 and Para 42), the inlet channel being configured so that, when negative pressure is applied thereto, the fluid from the area surrounding the adapter is drawn through the first distal opening through the inlet channel to the second working channel (Para 42-43 and 57), and wherein the imager extends through such that the chamber is distal to and within a field of view of the imager (Figure 2, element 116 extends through proximal portion; consider Figure 1, element 170 and Figure 3A, element 124; see also Para 43).
Harrah does not disclose the adapter includes a partition extending across a lumen of the adapter and separating the chamber from the outlet, and wherein the chamber is distal to the partition and the outlet is proximal to the partition; the imager extends through the partition.
However, Levy discloses an endoscope insertion device (Abstract) and teaches the adapter includes a partition extending across a lumen of the adapter (Figure 2A shows the adapter 200; examiner interprets element 300 to be the partition separating the proximal portion 300 from distal pieces 400 and 600) and separating the chamber from the outlet (Figure 3A, examiner will consider element 340 to be the chamber and 640 is the outlet, see also Col. 66, lines 65-67 and Col. 67, lines 1-3), and wherein the chamber is distal to the partition and the outlet is proximal to the partition (Figure 3A, examiner will consider element 340 to be the chamber and 640 is the outlet; the partition is element 200); the imager extends through the partition (Figure 2A, element 116 includes an image sensor that travels down cover 300, to front optical assembly 256).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a partition that separates the proximal and distal portion as taught by Levy, in the invention of Harrah, in order to provide protection to the internal components (Levy; Col. 71, lines 32-37).
Regarding claim 14, Harrah discloses a laser fiber (Figure 3A, element 112 receives device 120 and Para 29) configured to be inserted through a third working channel of the ureteroscope (Figure 3A shows 3 lumens 114, 124, and laser lumen 112) to laser stones received within or against the chamber (Para 53-54, see also Para 42 that shows receiving the fragmented stones), the third working channel extending through the proximal portion to a second distal opening that is open to the chamber (Figure 1, 3A and Para 47).
Regarding claim 15, Harrah discloses wherein the imaging system is configured to facilitate navigation of the distal end of the shaft to the target area (Figure 2, element 116 extends through proximal portion; consider Figure 1, element 170 and Figure 3A, element 124; see also Para 31, 43, and 53).
Regarding claim 16, Harrah discloses a method for treating ureteral or kidney stones (Abstract) comprising: inserting (Para 53) a scope device (Figure 1, element 100), with an adapter (Figure 1, element 115) coupled to a distal end (Figure 1, element 104) of a shaft (Figure 1, element 102) of the scope device, to a target area within a patient’s body (Para 30 and 35), the scope device comprising an imaging system including an imager (Figure 1, element 170), the adapter including a proximal portion (Figure 1, element 104) configured to be coupled to the distal end of the shaft (Figure 1, element 104) and a distal portion (Figure 1, element 105) defining a chamber therein (Para 42; “fluid toward the distal end 105 of distal portion 115 may assist in pushing stone fragments/dust toward the vacuum, e.g., distal opening of second lumen 114”), the proximal portion including an outlet in fluid communication with a first working channel of the scope device (Figure 3A, element 122; see also Para 42) and an inlet channel extending longitudinally through the proximal portion to a distal opening which is open to the chamber (Figure 3A, element 114 and Para 42); and wherein the imager extends through such that the chamber is distal to and within a field of view of the imager (Figure 2, element 116 extends through proximal portion; consider Figure 1, element 170 and Figure 3A, element 124; see also Para 43); applying a negative pressure through a second working channel of the scope device so that a target stone is suctioned into or against a portion of the chamber (Para 42-43 and 57); applying a laser energy to the target stone (Figure 3A, element 112 receives device 120 and Para 29 and 53); and supplying a fluid to the target area via the outlet to provide a continuous fluid circulation from the outlet, proximally through the chamber and the second working channel to remove any stone particles and heat resulting from a lasering of the target stone from the chamber (Para 29, 50, and 55-56).
Harrah does not disclose the adapter includes a partition extending across a lumen of the adapter and separating the chamber from the outlet, and wherein the chamber is distal to the partition and the outlet is proximal to the partition; the imager extends through the partition.
However, Levy discloses an endoscope insertion device (Abstract) and teaches the adapter includes a partition extending across a lumen of the adapter (Figure 2A shows the adapter 200; examiner interprets element 300 to be the partition separating the proximal portion 300 from distal pieces 400 and 600) and separating the chamber from the outlet (Figure 3A, examiner will consider element 340 to be the chamber and 640 is the outlet, see also Col. 66, lines 65-67 and Col. 67, lines 1-3), and wherein the chamber is distal to the partition and the outlet is proximal to the partition (Figure 3A, examiner will consider element 340 to be the chamber and 640 is the outlet; the partition is element 200); the imager extends through the partition (Figure 2A, element 116 includes an image sensor that travels down cover 300, to front optical assembly 256).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a partition that separates the proximal and distal portion as taught by Levy, in the invention of Harrah, in order to provide protection to the internal components (Levy; Col. 71, lines 32-37).
Regarding claim 17, Harrah discloses the laser energy is provided via a laser fiber (Figure 3A, element 112 receives device 120 and Para 29) inserted distally through the shaft to the chamber via one of a device channel extending through the proximal portion of the adapter in communication with the chamber (Figure 3A shows 3 lumens 114, 124, and laser lumen 112) and the inlet channel of the adapter (Figure 3A, element 114).
Regarding claim 18, Harrah discloses relocating the target stone, which is suctioned within or against the chamber, to a desired location within the patient’s body for lasering (Para 62).
Regarding claim 19, Harrah discloses supplying the fluid to the target area to provide the continuous fluid circulation includes managing the fluid circulation to control a pressure within the target area resulting from at least one of flushing or relocating at least one of the target stone or stone particles (Para 29, 42, 50, and 55-56).
Regarding claim 20, Harrah discloses capturing at least one of stones, stone fragments, or particles too large to pass proximally through an outlet channel within the chamber for removal from the patient’s body (Para 42-43).
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0215965 Harrah et al., hereinafter “Harrah”, in view of US 9,642,513 Levy et al., hereinafter “Levy”, further in view of WO 2020/223429 Ghani et al., hereinafter “Ghani” (cited previously).
Regarding claim 8, Harrah discloses the distal portion of the adapter (Figure 1, element 105)
Harrah does not disclose the distal portion of the adapter is formed of a translucent material.
However, Ghani discloses a system/method to treat kidney stones using a ureteroscope (Abstract) and teaches the distal portion of the adapter is formed of a translucent material (Page 18, lines 9-12).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed an adapter formed of a translucent material as taught by Ghani, in the invention of Harrah, in order to allow light to be transmitted through the tip for visualization (Ghani; Page 18, lines 9-12).
Response to Arguments
Applicant’s arguments have been fully considered but are moot because the new ground of rejection.
Examiner would like to add a few comments to the rejection made above. Considering Annotated Figures 2A and 10A, examiner believes that they offer a lot in common to applicants claims and specification. The partition shown in the figures contains an inlet channel 340 that extends across the partition shown in annotated Figure 10A, this inlet channel connects to the chamber 640 separated by the partition. This is similar to applicants Figure 1 disclosure that shows an inlet channel 112 that extends through the partition 154 and leads to chamber 116. Examiner would like to add that applicants Figure 1 seems to differ from Levy in the fact that the partition sits in the middle between the distal chamber 116 and the proximal shaft 104. The claims don’t recite that, instead the claims recite “a partition extending across a lumen of the adapter, the partition separating a proximal portion of the adapter from a distal portion of the adapter”, in which examiner still believes Levy does. However, how Levy differs is that it discloses the partition being one with the proximal portion. Therefore, if it is recited that the partition sits between the proximal and distal portion, examiner believes that kind of amendment would overcome reference Levy.
Another suggestion that can make the claims a lot clearer and more concise is avoiding the terms “proximal portion” and “distal portion”. The words proximal and distal equate to no more than sides of a device, like saying left and right. Therefore an examiner can interpret a proximal portion to simply mean the right end or left end of a device, and that’s exactly what was done in Levy. The chamber as shown by applicants Figure 1 should be the front of the adapter blocked from the shaft via a partition (assuming to allow the stone to stay in the front and not travel down the shaft), however, with the confusion of the distal and proximal end in the claims, under BRI, examiner can interpret distal and proximal as needed to work with the reference, therefore allowing examiner to use Levy and interpret the chamber on the distal end to be on the back end of the adapter, instead of the front. If worded properly examiner does not believe Levy would read on these claims because their configuration is the opposite as that shown in Figure 1 (Chamber being on the back end of the adapter instead of the front). In this current application the partition sits in between these two “portions” however, the claim really confuses that. When examining applicants Figure 1, the partition 154 simply sits between the chamber 116 (on the distal end) and end that connects to the shaft (on the proximal end). The partition contains all the elements necessary to use this device. Examiner suggests adding amendments to the claims that clears that up and avoiding the over use of proximal and distal for better clarity.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYA ZIAD BAKKAR whose telephone number is (313)446-6659. The examiner can normally be reached on 7:30 am - 5:00 pm M-Th.
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/AYA ZIAD BAKKAR/
Examiner, Art Unit 3796
/ANKIT D TEJANI/Primary Examiner, Art Unit 3796
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