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 Objections
Claims 1, 6, 12, and 17 objected to because of the following informalities:
Claim 1, line 2: “a distal end of a catheter” should read “a distal end of the catheter”.
Claim 1, line 14: “a closed position” should read “the closed position”.
Claim 6, line 2: “a distal end of a catheter” should read “a distal end of the catheter”.
Claim 12, line 2: “a closed position” should read “the closed position”.
Claim 12, line 3: “an open position” should read “the open position”.
Claim 16, line 2: “an opening” should read “the opening”.
Claim 17, line 2: “a closed position” should read “the closed position”.
Claim 17, lines 2-3: “an open position” should read “the open position”.
Appropriate correction is required.
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.
Claims 1-3, 6-8, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Ishikawa et al. (US 2003/0216749) in view of Zoellner (US 2017/0347868).
Regarding claim 1, an invention relating to anastomosis systems, Ishikawa discloses (Figs. 1-10) a method for performing an endoscopic procedure on a patient (Par. 0042 & 0058), the method comprising: inserting a catheter (60) in the patient (Par. 0063), a distal end (see annotated figure below) of the catheter being selectively positioned in a small bowel of the patient (Fig. 10; Par. 0052 & 0063); inserting an endoscope (22) in the patient, a distal end (22a) of the endoscope being selectively positioned in a stomach of the patient based on the selected position of the catheter in the small bowel [i.e. the desired position where the stomach is pierced and the small intestine is pulled through and pierced to insert the catheter] (Par. 0050-0052 & 0063); and actuating a grasping system (18) to extend an end effector (19) for grasping selected tissue of the small bowel at the selected position of the catheter [i.e. grasping tissue of the small bowel where catheter will be inserted into the small bowel] (Par. 0049 & 0053); wherein the end effector includes a first arm and a second arm extending from a connection at a proximal end of the first and second arms (see annotated figure below) and movable between an open position and a closed position (Par. 0049). However, Ishikawa fails to further disclose wherein the first arm and the second arm are arc shaped and form arcuate shaped tissue-engaging surfaces extending proximally from respective distal tips thereof and facing each other such that the first arm and the second arm are configured for atraumatically closing around the small bowel as the first and second arms are actuated to a closed position to enclose the small bowel atraumatically between the arcuate-shaped tissue-engaging surfaces proximal to the distal tips of the first arm and the second arm.
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In the analogous art of tissue graspers, Zoellner teaches (Fig. 5B) wherein a first arm (570) and the second arm (572) are arc shaped [i.e. curvilinear configuration] with and form arcuate shaped tissue-engaging surfaces [i.e. the inner surface of each arm is curvilinear along the longitudinal axis of each arm] extending proximally from respective distal tips (see annotated figure below) thereof and facing each other such that the first arm and the second arm are configured for atraumatically closing around the small bowel [i.e. closing around the small intestine without causing damage to the tissue] as the first and second arms are actuated to a closed position [i.e. close the jaws] to enclose the small bowel atraumatically between the arcuate-shaped tissue-engaging surfaces proximal to the distal tips of the first arm and the second arm (Fig. 6; Par. 0056, 0069-0071, 0097).
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Therefore, 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 Ishikawa to have wherein the first arm and the second arm are arc shaped and form arcuate shaped tissue-engaging surfaces extending proximally from respective distal tips thereof and facing each other such that the first arm and the second arm are configured for atraumatically closing around the small bowel as the first and second arms are actuated to a closed position to enclose the small bowel atraumatically between the arcuate-shaped tissue-engaging surfaces proximal to the distal tips of the first arm and the second arm. Doing so would prevent tissue damage (Par. 0069), as taught by Zoellner.
Regarding claim 2, Ishikawa, as modified by Zoellner, disclose the method according to claim 1. Ishikawa further discloses wherein the catheter is selectively positioned at a first location in the small bowel and the endoscope is selectively positioned at a second location apposing the first location [i.e. a location in proximity to the first location] (Fig. 10).
Regarding claim 3, Ishikawa, as modified by Zoellner, discloses the method according to claim 1. Ishikawa discloses (Figs. 9B-12) further comprising: creating an opening in the stomach [i.e. pierced portion (92) of stomach] (Par. 0051); grasping the tissue of the small bowel with the grasping system through the stomach opening (Par. 0053); creating an opening in the small bowel (Par. 0053); and delivering an anastomotic device (42A) across the openings (Par. 0064); wherein the device apposes the stomach and small bowel at the respective selected positions and creates a conduit (41) for stomach content to flow therethrough (Par. 0060 & 0064).
Regarding claim 6, an invention relating to anastomosis systems, Ishikawa discloses (Figs. 1-10) a method for performing an endoscopic procedure on a patient (Par. 0042 & 0058), the method comprising: inserting a catheter (60) in the patient (Par. 0063), a distal end (see annotated figure below) of a catheter being selectively positioned in a small bowel of the patient (Fig. 10; Par. 0052 & 0063); inserting an endoscope (22) in the patient, a distal end (22a) of the endoscope being selectively positioned in a stomach of the patient based on the selected position of the catheter in the small bowel [i.e. the desired position where the stomach is pierced and the small intestine is pulled through and pierced to insert the catheter] (Par. 0050-0052 & 0063); and actuating a grasping system (18) to extend an end effector (19) for grasping selected tissue of the small bowel at the selected position of the catheter [i.e. grasping tissue of the small bowel where catheter will be inserted into the small bowel] (Par. 0049 & 0053), the end effector having a first arm and a second arm extending from a proximal end of the first and second arms to respective distal tips (see annotated figure below), and movable between an open position and a closed position (Par. 0049); and moving the portion of the small bowel encompassed and grasped between the first arm and the second arm proximally [i.e. the desired portion is held or pulled by the grasping forceps] (Par. 0051). However, Ishikawa fails to disclose causing the first arm and the second arm to move together to the closed position to atraumatically encompass a portion of the small bowel with only the distal tips of the first arm and the second arm contacting each other, and without pinching the small bowel between the first arm and the second arm.
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In the analogous art of tissue graspers, Zoellner teaches (Fig. 5B) the method step: causing a first arm (570) and a second arm (572) to move together to a closed position [i.e. close the jaws] to atraumatically encompass a portion of the small bowel [i.e. closing around the small intestine without causing damage to the tissue] with only distal tips (see annotated figure below) of the first arm and the second arm contacting each other [i.e. the arms compress the intestine in between until the tips contact as seen in figure 5B. Furthermore, paragraph 0070 details the gap (576) = D+2t, t being a wall thickness of the intestine, and D being a cross sectional dimension of an endoscopic capsule. Paragraph 0071 details the arms being compressed such that the gap (576) = gap (602) +2t, gap (602) being less than D. Hence, the distal tips of the arms would be in contact], and without pinching the small bowel between the first arm and the second arm [i.e. the intestine would be proximal to the distal tips of the arms] (Par. 0056, 0069-0071, 0097).
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Therefore, 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 Ishikawa to have the method step: causing the first arm and the second arm to move together to the closed position to atraumatically encompass a portion of the small bowel with only the distal tips of the first arm and the second arm contacting each other, and without pinching the small bowel between the first arm and the second arm. Doing so would prevent tissue damage (Par. 0069), as taught by Zoellner.
Regarding claim 7, Ishikawa, as modified by Zoellner, discloses the method according to claim 6. Ishikawa further discloses wherein the catheter is selectively positioned at a first location in the small bowel and the endoscope is selectively positioned at a second location apposing the first location [i.e. a location in proximity to the first location] (Fig. 10).
Regarding claim 8, Ishikawa, as modified by Zoellner, discloses the method according to claim 6. Ishikawa discloses (Figs. 9B-12) further comprising: creating an opening in the stomach [i.e. pierced portion (92) of stomach] (Par. 0051); grasping the tissue of the small bowel with the grasping system through the stomach opening (Par. 0053); creating an opening in the small bowel (Par. 0053); and delivering an anastomotic device (42A) across the openings (Par. 0064); wherein the device apposes the stomach and small bowel at the respective selected positions and creates a conduit (41) for stomach content to flow therethrough (Par. 0060 & 0064).
Regarding claim 11, Ishikawa, as modified by Zoellner, discloses the method according to claim 6. Ishikawa discloses further comprising pulling the portion of the small bowel encompassed and grasped between the first arm and the second arm relative to portions of the small bowel on either side of and not encompassed by the first arm and the second arm [i.e. the desired portion is held or pulled by the grasping forceps] (Fig. 4; Par. 0051 & 0053).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Ishikawa et al. (US 2003/0216749) in view of Zoellner (US 2017/0347868) as applied to claim 1 above, and further in view of Gartner et al. (US 2007/0027456).
Regarding claim 5, Ishikawa, as modified by Zoellner, discloses the method according to claim 1. Ishikawa further discloses (Fig. 1) wherein the end effector is actuatable relative to an actuating mechanism [i.e. a ring (18a) and slider (18b) structures], such that the first and second arms are actuated between an unconstrained open position [i.e. opened] in response to relative movement between the actuating mechanism, and a constrained closed position [i.e. closed] in response to relative movement between the actuating mechanism (Par. 0049). However, Ishikawa fails to further disclose wherein the end effector is actuatable relative to a sheath, such that the first and second arms are actuated between an unconstrained open position in response to the end effector extending out of the sheath, and a constrained closed position in response to the end effector retracting within the sheath.
In the analogous art of tissue graspers, Gartner teaches (Figs. 1-2 & 10-12) an end effector (120) is actuatable relative to a sheath (122), such that the first and second arms (124) are actuated between an unconstrained open position [i.e. open position] in response to the end effector extending out of the sheath, and a constrained closed position [i.e. closed position] in response to the end effector retracting within the sheath (Par. 0043-0046).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the actuating mechanism of Ishikawa that is a ring and slider structure, for the actuating mechanism of Gartner that is a control [i.e. knob, trigger, or slide] and grasper lumen [i.e. sheath] since these mechanisms perform the same function of actuating legs of a grasper system between the open position and closed position. Simply substituting one actuating mechanism for another would yield the predicable result of movement of the legs of the end effector between the open and closed positions. See MPEP 2143.
Claims 10 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Ishikawa et al. (US 2003/0216749) in view of Zoellner (US 2017/0347868) as applied to claim 6 above, and further in view of Gartner et al. (US 2007/0027456).
Regarding claim 10, Ishikawa, as modified by Zoellner, discloses the method according to claim 6. Ishikawa further discloses (Fig. 1) wherein the end effector is actuatable relative to an actuating mechanism [i.e. a ring (18a) and slider (18b) structures], such that the first and second arms are actuated between an unconstrained open position [i.e. opened] in response to relative movement between the actuating mechanism, and a constrained closed position [i.e. closed] in response to relative movement between the actuating mechanism (Par. 0049). However, Ishikawa fails to further disclose wherein the end effector is actuatable relative to a sheath, such that the first and second arms are actuated between an unconstrained open position in response to the end effector extending out of the sheath, and a constrained closed position in response to the end effector retracting within the sheath.
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In the analogous art of tissue graspers, Gartner teaches (Figs. 1-2 & 10-12) an end effector (120) is actuatable relative to a sheath (122), such that the first and second arms (124) are actuated between an unconstrained open position [i.e. open position] in response to the end effector extending out of the sheath, and a constrained closed position [i.e. closed position] in response to the end effector retracting within the sheath (Par. 0043-0046).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the actuating mechanism of Ishikawa that is a ring and slider structure, for the actuating mechanism of Gartner that is a control [i.e. knob, trigger, or slide] and grasper lumen [i.e. sheath] since these mechanisms perform the same function of actuating legs of a grasper system between the open position and closed position. Simply substituting one actuating mechanism for another would yield the predicable result of movement of the legs of the end effector between the open and closed positions. See MPEP 2143.
Regarding claim 12, Ishikawa, as modified by Zoellner, discloses the method of claim 6. Ishikawa discloses (Fig. 1) further comprising actuating the grasping system by moving the first arm and the second arm between a closed position [i.e. closed] in response to relative movement between an actuating mechanism (18a-b; Par. 0049), and an open position [i.e. opened] in response to relative movement between an actuating mechanism (18a-b; Par. 0049). However, Ishika fails to further disclose comprising actuating the grasping system by moving the first arm and the second arm between a closed position, at least partially drawn into a flexible sheath, and an open position, outside the flexible sheath.
In the analogous art of tissue graspers, Gartner teaches (Figs. 1-2 & 10-12) comprising actuating a grasping system (120) by moving a first arm and the second arm (124) between a closed position [i.e. closed position], at least partially drawn into a flexible sheath (122; Par. 0056), and an open position [i.e. open position], outside the flexible sheath (Par. 0043-0046).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the actuating mechanism of Ishikawa that is a ring and slider structure, for the actuating mechanism of Gartner that is a control [i.e. knob, trigger, or slide] and grasper lumen [i.e. flexible sheath] since these mechanisms perform the same function of actuating legs of a grasper system between the open position and closed position. Simply substituting one actuating mechanism for another would yield the predicable result of movement of the legs of the end effector between the open and closed positions. See MPEP 2143.
Regarding claim 13, Ishikawa, as modified by Zoellner and Gartner, discloses the method of claim 12. Ishikawa, as modified by Zoellner and Gartner discloses (Fig. 4) further comprising navigating the flexible sheath into a natural orifice [i.e. mouth] of the patient, into the stomach of the patient, and through an opening (92) created in the stomach to grasp the small bowel of the patient [Note, Gartner’s teachings provide Ishikawa’s grasper system, which is navigated into a natural orifice of the patient, into the stomach of the patient, and through an opening created in the stomach to grasp the small bowel of the patient, with the flexible sheath. Hence, the combination obviates the method step of: navigating the flexible sheath into a natural orifice of the patient, into the stomach of the patient, and through an opening created in the stomach to grasp the small bowel of the patient] (Par. 0044 & 0049-0053).
Claims 14, 16-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ishikawa et al. (US 2003/0216749) in view of Gartner et al. (US 2007/0027456) and Zoellner (US 2017/0347868).
Regarding claim 14, an invention relating to anastomosis systems, Ishikawa discloses (Figs. 1-10) a method for performing an endoscopic procedure on a patient (Par. 0042 & 0058), the method comprising: navigating a grasping system (18) into a natural orifice [i.e. mouth] of the patient, into the stomach (90) of the patient, and through an opening (92) created in the stomach to grasp the small bowel (94) of the patient (Par. 0044 & 0049-0053); actuating the grasping system to extend an end effector (19) to grasp a selected portion of the small bowel between a first arm and a second arm (see annotated figure below) of the end effector (Par. 0049 & 0053), the first arm and the second arm extending from a proximal end of the first and second arms to respective distal tips (see annotated figure below), and movable between an open position [i.e. opened], in which the selected portion of the small bowel may be positioned between the first arm and the second arm, and a closed position [i.e. closed] (Par. 0049 & 0053); and moving the selected portion of the small bowel encompassed and grasped between the first arm and the second arm [i.e. the desired portion is held or pulled by the grasping forceps] (Par. 0051). Also, Ishikawa discloses (Fig. 1) comprising actuating the grasping system by moving the first arm and the second arm between a closed position [i.e. closed] in response to relative movement between an actuating mechanism (18a-b; Par. 0049), and an open position [i.e. opened] in response to relative movement between an actuating mechanism (18a-b; Par. 0049). However, Ishikawa fails to disclose the method steps of: navigating a flexible sheath into a natural orifice of the patient, into the stomach of the patient, and through an opening created in the stomach to grasp the small bowel of the patient; and causing the first arm and the second arm to move together from the open position to the closed position to atraumatically encompass the selected portion of the small bowel between arcuate surfaces of the first arm and the second arm, and with the distal tips of the first arm and the second arm contacting each other distal to the selected portion of the small bowel, and without pinching the small bowel between the first arm and the second arm.
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In the analogous art of tissue graspers, Gartner teaches (Figs. 1-2 & 10-12) comprising actuating a grasping system (120) by moving a first arm and the second arm (124) between a closed position [i.e. closed position], at least partially drawn into a flexible sheath (122; Par. 0056), and an open position [i.e. open position], outside the flexible sheath (Par. 0043-0046).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the actuating mechanism of Ishikawa that is a ring and slider structure, for the actuating mechanism of Gartner that is a control [i.e. knob, trigger, or slide] and grasper lumen [i.e. flexible sheath] since these mechanisms perform the same function of actuating legs of a grasper system between the open position and closed position. Simply substituting one actuating mechanism for another would yield the predicable result of movement of the legs of the end effector between the open and closed positions. See MPEP 2143. Note, Gartner’s teachings provide Ishikawa’s grasper system, which is navigated into a natural orifice of the patient, into the stomach of the patient, and through an opening created in the stomach to grasp the small bowel of the patient, with the flexible sheath. Hence, the combination obviates the method step of: navigating the flexible sheath into a natural orifice of the patient, into the stomach of the patient, and through an opening created in the stomach to grasp the small bowel of the patient.
In the analogous art of tissue graspers, Zoellner teaches (Fig. 5B) the method step: causing a first arm (570) and a second arm (572) to move together from an open position [i.e. open the jaws] to a closed position [i.e. close the jaws] to atraumatically encompass the selected portion of the small bowel [i.e. closing around the small intestine without causing damage to the tissue] between arcuate surfaces [i.e. the inner surface of each arm is curvilinear along the longitudinal axis of each arm] of the first arm and the second arm, and with distal tips (see annotated figure below) of the first arm and the second arm contacting each other distal to the selected portion of the small bowel [i.e. the arms compress the intestine in between until the tips contact which is distal to the small intestine as seen in figure 5B. Furthermore, paragraph 0070 details the gap (576) = D+2t, t being a wall thickness of the intestine, and D being a cross sectional dimension of an endoscopic capsule. Paragraph 0071 details the arms being compressed such that the gap (576) = gap (602) +2t, gap (602) being less than D. Hence, the distal tips of the arms would be in contact], and without pinching the small bowel between the first arm and the second arm [i.e. the intestine would be proximal to the distal tips of the arms] (Par. 0056, 0069-0071, 0097).
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Therefore, 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 Ishikawa, in view of Gartner, to have the method step of: causing the first arm and the second arm to move together from the open position to the closed position to atraumatically encompass the selected portion of the small bowel between arcuate surfaces of the first arm and the second arm, and with the distal tips of the first arm and the second arm contacting each other distal to the selected portion of the small bowel, and without pinching the small bowel between the first arm and the second arm. Doing so would prevent tissue damage (Par. 0069), as taught by Zoellner.
Regarding claim 16, Ishikawa, as modified by Gartner and Zoellner, discloses the method according to claim 14. Ishikawa discloses (Figs. 9B-12) further comprising: creating an opening in the stomach [i.e. pierced portion (92) of stomach] (Par. 0051); grasping the tissue of the small bowel with the grasping system through the stomach opening (Par. 0053); creating an opening in the small bowel (Par. 0053); and delivering an anastomotic device (42A) across the openings (Par. 0064); wherein the device apposes the stomach and small bowel at the respective selected positions and creates a conduit (41) for stomach content to flow therethrough (Par. 0060 & 0064).
Regarding claim 17, Ishikawa, as modified by Gartner and Zoellner, discloses the method of according to claim 14. Ishikawa, as modified by Gartner and Zoellner, discloses further comprising actuating the end effector by extending the end effector between a closed position within the flexible sheath and an open position distally outside the flexible sheath [i.e. actuating a grasper between open and closed positions via flexible sheath, see Gartner paragraphs 0043-0046].
Regarding claim 19, Ishikawa, as modified by Gartner and Zoellner, discloses the method according to claim 14. Ishikawa discloses further comprising pulling the selected portion of the small bowel encompassed and grasped between the first arm and the second arm relative to portions of the small bowel on either side of and not encompassed by the first arm and the second arm [i.e. the desired portion is held or pulled by the grasping forceps] (Fig. 4; Par. 0051 & 0053).
Regarding claim 20, Ishikawa, as modified by Gartner and Zoellner, discloses the method of claim 14. Ishikawa discloses further comprising pulling the selected portion of the small bowel towards the stomach to create an anastomosis between the stomach and the selected portion of the small bowel (Par. 0052-0056).
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Surti et al. (US 2011/0257668) in view of Gartner et al. (US 2007/0027456) and Zoellner (US 2017/0347868).
Regarding claim 14, an invention relating to anastomosis systems, Surti discloses (Figs. 1-2) a method for performing an endoscopic procedure on a patient (Par. 0010), the method comprising: navigating a grasping system (24) into a natural orifice [i.e. mouth] of the patient, into the stomach (40) of the patient, and through an opening (42) created in the stomach to grasp the small bowel (50) of the patient (Par. 0028); actuating the grasping system to extend an end effector to grasp a selected portion (54) of the small bowel [i.e. moving the grasping system through the mouth to the target tissue via the endoscope, and opening and closing the grasping system to engage said tissue] between a first arm and a second arm (see annotated figure below) of the end effector, the first arm and the second arm extending from a proximal end of the first and second arms to respective distal tips (see annotated figure below), and movable between an open position, in which the selected portion of the small bowel may be positioned between the first arm and the second arm, and a closed position [Note, the grasping system is a forcep with jaws that open and close] (Par. 0026 & 0028); and moving the selected portion of the small bowel encompassed and grasped between the first arm and the second arm (Par. 0029).
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However, Surti fails to disclose the method steps of: navigating a flexible sheath into a natural orifice of the patient, into the stomach of the patient, and through an opening created in the stomach to grasp the small bowel of the patient; and causing the first arm and the second arm to move together from the open position to the closed position to atraumatically encompass the selected portion of the small bowel between arcuate surfaces of the first arm and the second arm, and with the distal tips of the first arm and the second arm contacting each other distal to the selected portion of the small bowel, and without pinching the small bowel between the first arm and the second arm.
In the analogous art of tissue graspers, Gartner teaches (Figs. 1-2 & 10-12) comprising actuating a grasping system (120) by moving a first arm and the second arm (124) between a closed position [i.e. closed position], at least partially drawn into a flexible sheath (122; Par. 0056), and an open position [i.e. open position], outside the flexible sheath (Par. 0043-0046).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the actuating mechanism of Surti, for the actuating mechanism of Gartner that is a control [i.e. knob, trigger, or slide] and grasper lumen [i.e. flexible sheath] since these mechanisms perform the same function of actuating legs of a grasper system between the open position and closed position. Simply substituting one actuating mechanism for another would yield the predicable result of movement of the legs of the end effector between the open and closed positions. See MPEP 2143. Also, 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 Surti to have the grasping system comprising a flexible sheath. Doing so would provide means for actuating the end effector arms open and close that has steering capability which is simple to operate and control (Par. 0044 & 0056), as taught by Gartner. Note, Gartner’s teachings provide Surti’s grasper system, which is navigated into a natural orifice of the patient, into the stomach of the patient, and through an opening created in the stomach to grasp the small bowel of the patient, with the flexible sheath. Hence, the combination obviates the method step of: navigating the flexible sheath into a natural orifice of the patient, into the stomach of the patient, and through an opening created in the stomach to grasp the small bowel of the patient.
In the analogous art of tissue graspers, Zoellner teaches (Fig. 5B) the method step: causing a first arm (570) and a second arm (572) to move together from an open position [i.e. open the jaws] to a closed position [i.e. close the jaws] to atraumatically encompass the selected portion of the small bowel [i.e. closing around the small intestine without causing damage to the tissue] between arcuate surfaces [i.e. the inner surface of each arm is curvilinear along the longitudinal axis of each arm] of the first arm and the second arm, and with distal tips (see annotated figure below) of the first arm and the second arm contacting each other distal to the selected portion of the small bowel [i.e. the arms compress the intestine in between until the tips contact which is distal to the small intestine as seen in figure 5B. Furthermore, paragraph 0070 details the gap (576) = D+2t, t being a wall thickness of the intestine, and D being a cross sectional dimension of an endoscopic capsule. Paragraph 0071 details the arms being compressed such that the gap (576) = gap (602) +2t, gap (602) being less than D. Hence, the distal tips of the arms would be in contact], and without pinching the small bowel between the first arm and the second arm [i.e. the intestine would be proximal to the distal tips of the arms] (Par. 0056, 0069-0071, 0097).
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Therefore, 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 Surti, in view of Gartner, to have the method step of: causing the first arm and the second arm to move together from the open position to the closed position to atraumatically encompass the selected portion of the small bowel between arcuate surfaces of the first arm and the second arm, and with the distal tips of the first arm and the second arm contacting each other distal to the selected portion of the small bowel, and without pinching the small bowel between the first arm and the second arm. Doing so would prevent tissue damage (Par. 0069), as taught by Zoellner.
Regarding claim 15, Surti, as modified by Gartner and Zoellner, disclose the method according to claim 14. Surti, as modified by Gartner and Zoellner, discloses (Figs. 1-2) further comprising extending the flexible sheath through an endoscope (22) and into the patient's stomach (Par. 0028). Note, Gartner’s teachings provide Surti’s grasper system, which extends through the endoscope, with the flexible sheath. Hence, the combination obviates the method step of: extending the flexible sheath through an endoscope and into the patient's stomach.
Claims 18 is rejected under 35 U.S.C. 103 as being unpatentable over Ishikawa et al. (US 2003/0216749) in view of Gartner et al. (US 2007/0027456) and Zoellner (US 2017/0347868) as applied to claim 17 above, and further in view of McClellan et al. (US 2003/0158563).
Regarding claim 18, Ishikawa, as modified by Gartner and Zoellner, discloses the method of claim 17. However, the combination fails to explicitly disclose further comprising navigating the end effector into the patient in a withdrawn constrained position within the flexible sheath.
In the analogous art of tissue graspers, McClellan teaches a grasper maintained in the unextended position within a tubular element during the insertion step in order to prevent damage to the components of the grasper and to facilitate insertion of the device (Par. 0051).
Therefore, 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 Ishikawa, in view of Gartner and Zoellner, to have the method step of: navigating the end effector into the patient in a withdrawn constrained position within the flexible sheath. Doing so would prevent damage to the components of the grasper and to facilitate insertion of the device (Par. 0051), as taught by McClellan.
Allowable Subject Matter
Claims 4 and 9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Concerning claim 4, prior art reference Ishikawa fails to disclose wherein the catheter includes projections that are acted upon by peristaltic motion to propel the catheter to the selected position in the small bowel. Prior art reference Reydel (US 2002/0156454) discloses wherein the catheter includes projections that are acted upon by peristaltic motion to propel the catheter to the selected position in the small bowel (Abstract). Modifying the prior art to include the missing limitations wouldn't have been obvious because the modification would only be motivated by hindsight and would possibly render the device inoperable because Ishikawa’s catheter is guided to the stomach via a guide (12; Fig. 3A; Par. 0048-0051 & 0058-0059), so the catheter would not be deployed for peristaltic motion to act on the catheter. Also, if Ishikawa’s catheter is modified by Reydel’s teachings, the peristaltic motion acting on the projections could cause unwanted movement during the anastomosis procedure in the stomach.
Concerning claim 9, prior art reference Ishikawa fails to disclose wherein the catheter includes projections that are acted upon by peristaltic motion to propel the catheter to the selected position in the small bowel. Prior art reference Reydel (US 2002/0156454) discloses wherein the catheter includes projections that are acted upon by peristaltic motion to propel the catheter to the selected position in the small bowel (Abstract). Modifying the prior art to include the missing limitations wouldn't have been obvious because the modification would only be motivated by hindsight and would possibly render the device inoperable because Ishikawa’s catheter is guided to the stomach via a guide (12; Fig. 3A; Par. 0048-0051 & 0058-0059), so the catheter would not be deployed for peristaltic motion to act on the catheter. Also, if Ishikawa’s catheter is modified by Reydel’s teachings, the peristaltic motion acting on the projections could cause unwanted movement during the anastomosis procedure in the stomach.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Chima Igboko whose telephone number is (571)272-8422. The examiner can normally be reached on Monday-Friday 9:00am-6:00pm.
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/CHIMA U IGBOKO/ Examiner, Art Unit 3771
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