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 .
Information Disclosure Statement
The IDS form(s) submitted on 9/16/2025 and 2/28/2025 is/are in compliance with the requirements of the provisions of 37 CFR 1.97. Accordingly, the information disclosure(s) are being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-10, in the reply filed on 9/16/2025 is acknowledged.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2023/0346589 A1 to Grover et al.
In regard to claim 1:
A device (Fig. 1 element 1500) comprising: a sheath (Para. 59 “the removal tool 1600 can include an outer sleeve or guide member (not shown), which further includes a proximal end portion, a distal end portion, an outer surface, an inner surface, and a guide lumen defined by the inner surface.” (Emphasis added)); a probe (Fig. 3 elements 1640 and 1650); a first material (Fig. 2 element 1100); and a first opening (para. 59 “For example, the guide lumen is configured to permit the distal end portion 1642 of the driveshaft 1640 to extend beyond the distal end portion of the guide member and permit the distal end portion 1642 of the driveshaft 1640 to be withdrawn into the distal end portion of the guide member.”) wherein the device has a first configuration ((Para. 59 “the guide member is inserted into the body lumen BL, via the delivery member 1500, prior to the tool member 1650 and the driveshaft 1640 being inserted into the body lumen BL via the guide lumen of the guide member.” First configuration is after insertion of elements 1500 the guide member and element 1650) and a second configuration (Para. 59 “the guide member is inserted into the body lumen BL, via the delivery member 1500, prior to the tool member 1650 and the driveshaft 1640 being inserted into the body lumen BL via the guide lumen of the guide member.” Second configuration is insertion of element 1500 prior to insertion of the guide member), wherein more of the first material is distal the first opening when the device is in the second configuration than when the device is in the first configuration (See para. 59 cited above. 2nd configuration, before insertion of the guide member w/ distal end and first opening (distal opening) into element 1500 within the body lumen, the first opening would be more distal to the first material that in the first configuration when the guide member is inserted into the body lumen ready to use element 1650 upon the first material element 1100), wherein the first material is closer to a second material when the device is in the second configuration than when the device is in the first configuration (Fig. 4, para. 31 “FIG. 4 is a schematic illustration of an enlarged view of a body lumen showing a flushing fluid being directed towards an ablated biomaterial implant according to an embodiment.” (Emphasis added). Flushing fluid considered second material. Para. 10 “In some embodiments, the delivery member is inserted into the body lumen upstream from the implant. In some embodiments, the method includes advancing the rotating distal tip within the body lumen to contact the implant, thereby ablating the implant. In some embodiments, the method includes directing the flush solution to disburse the ablated implant within the body lumen. In some embodiments, the directing the flush solution advances the ablated implant in an upstream to downstream direction within the body lumen”), wherein the probe has a retracted configuration and an advanced configuration (Para. 59 “the guide lumen is configured to permit the distal end portion 1642 of the driveshaft 1640 to extend beyond the distal end portion of the guide member and permit the distal end portion 1642 of the driveshaft 1640 to be withdrawn into the distal end portion of the guide member”. Advanced position is the configuration the driveshaft and tool are advanced to element 1100, and the retracted configuration the tool and shafter are retracted into the guide member.), wherein more of the probe is distal the first opening when the probe is in the advanced configuration than when the probe is in the retracted configuration (Para. 59 “the guide lumen is configured to permit the distal end portion 1642 of the driveshaft 1640 to extend beyond the distal end portion of the guide member and permit the distal end portion 1642 of the driveshaft 1640 to be withdrawn into the distal end portion of the guide member”), wherein when the probe is in the advanced configuration, the probe is movable from a first position to a second position (Fig. 3 “L” Para. 61 “The driveshaft 1640 is further configured to translate longitudinally L relative to a centerline of the driveshaft 1640 to advance the tool member 1650 against, into and/or through the implant 1100”), wherein when the device is in the second configuration and the probe is in the first position, the probe is in contact with the first material (Fig. 3 “L” Para. 61 cited above considered the “against” the implant 1100 position), wherein when the device is in the second configuration and the probe is in the second position, the probe is in contact with the first material or a gap is between the probe and the first material (fig. 2 elements 1640 and 1650 distance to element 1100, forming a gap. Examiner notes this “gap” is not considered require within the claim due to “the prove is in contact with the first material” proceeding the use of “or” in which case the first position and the second position are the same.), and wherein a distal terminal end of the probe is the same distance or a different distance from the first opening when the probe is in the second position than when the probe is in the first position (Para. 61 cited above different distance of “L”. Examiner notes this limitation is not considered required due to the use of “is the same distance or” in which case the first and second positions would be considered the same position.).
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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) 2-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0346589 A1 to Grover et al. in view of WO 2024/091496 A1 to Ference et al.
In regard to claim 2:
The device of claim 1, taught by Grover as described in parent claim rejection above.
Grover does not appear to explicitly disclose the remover and/or third configuration. Ference teaches, further comprising a remover (Fig. 9 element 74, Para. 1010 “In some embodiments, prior to exerting the force on the upstream portion of the implant, a guidewire is advanced through the delivery' member and through or around the implant. A microcatheter is advanced over the guidewire and through or around the implant to position a distal end portion of the microcatheter downstream of the implant. A retrieval tool is then advanced through the microcatheter to a position that is downstream of the distal end portion of the microcatheter. The retrieval tool is then transitioned to an expanded configuration and a portion of the implant is engaged. The portion of the implant is extracted from the first body lumen by moving the retrieval tool in an upstream or downstream direction.”), wherein the first material (Fig. 1 element 1110), the second material (non-required limitation due to the use of “and/or”), and/or a third material (non-required limitation due to the use of “and/or”) is closer to the first opening (Para. 1084 “disrupting the structural integrity of the implant 1110 optionally includes advancing a guidewire 1600 through the delivery member 1500 and into the first body lumen 1120”, First opening considered to be the distal opening of element 1510 (catheter portion of element 1500, see para. 1078, and Fig. 2) lumen element 1600 is advanced through) when the device is in a third configuration than when the device is in the second configuration (Para. 1010 “prior to exerting the force on the upstream portion of the implant, … … The portion of the implant is extracted from the first body lumen by moving the retrieval tool in an upstream or downstream direction”(emphasis added). Moving the implant (first material) upstream is considered to move the first material closer to the first opening. Fig. 2 elements 1510).
It would have been obvious to one having ordinary skill in the art prior to the effective date of filing, to modify the occlusion removal tool taught by Grover, to include the remover taught by Ference. This would have been motivated by reducing the volume of flush fluid needed to remove the first material. Ference teaches para. 1087 “With at least a portion of the implant 1110 engaged by the retrieval tool 1700, the retrieval tool 1700 can be moved in upstream direction, as indicated by arrow BB. The upstream movement of the retrieval tool 1700 can be continued until the retrieval tool 1700 and the entangled portion of the implant 1110 is extracted from the entry point 1122”. Mechanically removing a portion of the first material (implant) would reduce the volume of flushing fluid needed to finish removal the first material. Ference teaches the flushing fluid may be toxic or have adverse effects, para. 1004 “In some known systems and methods where a biomaterial is implanted to occlude the vas deferens, the implant can be reversed by supplying a chemical solution to dissolve the implant within the vas deferens. However, such systems and methods require high volumes of dissolving agents, where the dissolving agent may be toxic, and also typically do not restore sperm parameters comparable to pre-implant baseline levels. Sperm parameters may include sperm concentration, total motility, progressive motility, morphology, and/or viability and/or other biomarkers of sperm function/fertility”. Therefore reducing the volume of flushing fluid needed to remove the first material would improve the success rate of the procedure by limiting exposure of the patient to the flushing fluid.
In regard to claim 3:
Grover teaches a device (Fig. 1 element 1500) comprising: a sheath (Para. 59 “the removal tool 1600 can include an outer sleeve or guide member (not shown), which further includes a proximal end portion, a distal end portion, an outer surface, an inner surface, and a guide lumen defined by the inner surface.” (Emphasis added)); and a probe (Fig. 3 elements 1640 and 1650), wherein the probe is advanceable relative to the sheath (para. 59 “For example, the guide lumen is configured to permit the distal end portion 1642 of the driveshaft 1640 to extend beyond the distal end portion of the guide member and permit the distal end portion 1642 of the driveshaft 1640 to be withdrawn into the distal end portion of the guide member.”), wherein when the probe is in an advanced position, the probe is an advanced distance from the sheath (para. 59 “For example, the guide lumen is configured to permit the distal end portion 1642 of the driveshaft 1640 to extend beyond the distal end portion of the guide member and permit the distal end portion 1642 of the driveshaft 1640 to be withdrawn into the distal end portion of the guide member.”), and wherein when the advanced distance is greater than or equal to a threshold distance (“L” considered to be advanced distance, para. 61 “The driveshaft 1640 is further configured to translate longitudinally L relative to a centerline of the driveshaft 1640 to advance the tool member 1650 against, into and/or through the implant 1100.”, distance from “guide member” against implant 1100 considered to be the threshold distance).
Grover does not appear to explicitly teach the indicator as claimed. Ference discloses the advanced position of the probe comprises an indicator (“load sensor” and its indication, see para. 135 to follow) to a user that the device has access to a target site (para. 135 “In some embodiments, the sensor(s) of the control device is a load sensor. The load sensor is configured to detect a condition in which the distal end portion is in contact with the implant based at least in part on a stiffness of the implant. The control device produces an indication of contact between the distal end portion and the implant based on the detection by the load sensor” the implant considered to be the target site. The sheath considered to have access to said target site as the distal end portion is in contact with it”).
It would have been obvious to one having ordinary skill in the art prior to the effective date of filing, to modify the probe taught by Grover, to include the indicator taught by Ference. This would have been motivated by Ference Fig. 17, and para. 1116 “depicts a method 50 for determining when to deliver the second removal fluid RF2 to move the remnant portion 1116 downstream to the second body lumen 1130… method 50 includes determining a length Li (FIG. 11) of the implant 1110 (e.g., the length of the implant at time of implantation and prior to the delivery of the first removal fluid RFi). The mass of the implant 1110 can, for example, be determined based on the recorded (e.g., in a medical record) volume of the hydrogel dispensed at time of implantation to form the implant 1110 and the observed diameter inner diameter of the first body lumen 1120 during implantation. At step 52, the method 50 includes advancing the delivery member 2500 within the first body lumen 1120 and into contact with the implant 1110 prior to delivering the first removal fluid RF 1, as depicted in FIG. 11. At step 53, the method 50 includes determining a first insertion length of the delivery member 2500 on a condition that the delivery member 2500 is in contact with the first implant. At step 54, the method 50 includes determining a second insertion length of the delivery member 2500 on a condition that the delivery member is in contact with the implant 1110 after the separation of the eroded portion 1117….…In other words, the second removal fluid RF2 can be delivered to move the remnant portion 1116 downstream once the length of the remnant portion 1116 has been reduced to an amount that is predicted to be responsive to the force (e.g., to move) applied by the second removal fluid RF2.”). This is considered motivation as it would result in a more complete removal of the first material and therefore and improved removal.
In regard to claim 4:
The device of claim 3, taught by Grover in view Ference as described in parent claim rejection above.
Grover teaches, wherein when the advanced distance is greater than or equal to the threshold distance, (“L” considered to be advanced distance, para. 61 “The driveshaft 1640 is further configured to translate longitudinally L relative to a centerline of the driveshaft 1640 to advance the tool member 1650 against, into and/or through the implant 1100.”, distance from “guide member” against implant 1100 considered to be the threshold distance).
Grover does not appear to explicitly teach the indicator as claimed. Ference teaches the advanced position of the probe comprises an indicator (“load sensor”, see para. 135 below) to the user that the sheath and/or a port has access to the target site (para. 135 “In some embodiments, the sensor(s) of the control device is a load sensor. The load sensor is configured to detect a condition in which the distal end portion is in contact with the implant based at least in part on a stiffness of the implant. The control device produces an indication of contact between the distal end portion and the implant based on the detection by the load sensor” the implant considered to be the target site. The sheath considered to have access to said target site as the distal end portion is in contact with it”).
It would have been obvious to one having ordinary skill in the art prior to the effective date of filing, to modify the probe taught by Grover, to include the indicator taught by Ference. This would have been motivated by Ference Fig. 17, and para. 1116 “depicts a method 50 for determining when to deliver the second removal fluid RF2 to move the remnant portion 1116 downstream to the second body lumen 1130… method 50 includes determining a length Li (FIG. 11) of the implant 1110 (e.g., the length of the implant at time of implantation and prior to the delivery of the first removal fluid RFi). The mass of the implant 1110 can, for example, be determined based on the recorded (e.g., in a medical record) volume of the hydrogel dispensed at time of implantation to form the implant 1110 and the observed diameter inner diameter of the first body lumen 1120 during implantation. At step 52, the method 50 includes advancing the delivery member 2500 within the first body lumen 1120 and into contact with the implant 1110 prior to delivering the first removal fluid RF 1, as depicted in FIG. 11. At step 53, the method 50 includes determining a first insertion length of the delivery member 2500 on a condition that the delivery member 2500 is in contact with the first implant. At step 54, the method 50 includes determining a second insertion length of the delivery member 2500 on a condition that the delivery member is in contact with the implant 1110 after the separation of the eroded portion 1117….…In other words, the second removal fluid RF2 can be delivered to move the remnant portion 1116 downstream once the length of the remnant portion 1116 has been reduced to an amount that is predicted to be responsive to the force (e.g., to move) applied by the second removal fluid RF2.”). This is considered motivation as it would result in a more complete removal of the first material and therefore and improved removal.
In regard to claim 5:
The device of claim 3, taught by Grover in view Ference as described in parent claim rejection above.
Grover teaches, wherein the sheath comprises a sheath lumen (Para. 59 “the removal tool 1600 can include an outer sleeve or guide member (not shown), which further includes a proximal end portion, a distal end portion, an outer surface, an inner surface, and a guide lumen defined by the inner surface.” (Emphasis added)), and wherein more of the probe is distal the sheath lumen when the probe is in the advanced configuration than when the probe is in a retracted configuration (Para. 59 “the guide lumen is configured to permit the distal end portion 1642 of the driveshaft 1640 to extend beyond the distal end portion of the guide member and permit the distal end portion 1642 of the driveshaft 1640 to be withdrawn into the distal end portion of the guide member”. Para. 61 “The driveshaft 1640 is further configured to translate longitudinally L relative to a centerline of the driveshaft 1640 to advance the tool member 1650 against, into and/or through the implant 1100”. Probe elements 1640 and 1650 have “L” more distal to the sheath lumen in the advance configuration than the retracted configuration).
In regard to claim 6:
The device of claim 3, taught by Grover in view Ference as described in parent claim rejection above.
Grover teaches the advanced distance (Fig. 3 “L”, para. 61 “The driveshaft 1640 is further configured to translate longitudinally L relative to a centerline of the driveshaft 1640 to advance the tool member 1650 against, into and/or through the implant 1100.”.)
Grover does not expressly disclose wherein the advanced distance is measured along a straight line between a distal terminal end of the sheath and a distal terminal end of the probe. It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to cause the device of Grover to have a the advanced distance measured along a straight line between a distal terminal end of the sheath and a distal terminal end of the probe, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Grover would not operate differently with the claimed the advanced distance is measured along a straight line between a distal terminal end of the sheath and a distal terminal end of the probe and since Grover teaches an advancing distance L the device would function appropriately having the claimed the advanced distance is measured along a straight line between a distal terminal end of the sheath and a distal terminal end of the probe. Further, applicant places no criticality on the range claimed, indicating different examples of measuring the advanced distance (specification pp. 298 “Figure 20 illustrates that the probe 55 can be moved (e.g., advanced) a distance D5 (also referred to as the deployed distance D5, the advanced distance D5, the advancing distance D5, or any other similar term) beyond the conduit 52. The distance D5 can be, for example, the distance that the probe 55 is advanced beyond the distal end opening (e.g., the opening 50z) of the device 50. The distance D5 can be, for example, the distance that the probe 55 is advanced beyond the opening 50z to position the probe 55 in the probe second configuration PC2. The distance D5 can be measured, for example, from the probe distal end 55de to the conduit distal end 52de. The distance D5 can be measured, for example, from the probe tip 56 to the conduit distal terminal end 52dte and/or from the probe tip 56 to the opening 50z (e.g., the opening 50z that the probe 55 can be advanced through). For example, figure 20 illustrates that the distance D5 can be measured from the probe tip 56 to the longitudinal center of the opening 5Oz. The distance D5 can be, for example, measured along the probe center longitudinal axis A3. The distance D5 can be, for example, 0.0 cm-30.0 cm, or more narrowly, 0.0 cm-20.0 cm, or more narrowly, 0.0 cm-15.0 cm, or more narrowly, 0.0 cm-10.0 cm, or more narrowly, 0.0 cm-5.0 cm, including, for example, every 0.1 cm increment within these ranges (e.g., 0.0 cm, 5.0 cm, 10.0 cm, 15.0 cm, 20.0 cm, 30.0 cm). The upper bound of these ranges for the distance DS (e.g., 30.0 cm, 20.0 cm,10.0cm,5.0 cm) can be, for example, the maximum distance that the probe 55 can be advanced out of the conduit 52. As another example, there may not be a maximum distance that the probe 55 can be advanced out of the conduit 52, in which case the upper bound of the above ranges for the distance D5 may not be the maximum distance that the probe 55 can be advanced out of the conduit 52. For example, the distance D5 can be the distance that the user advances the probe55 beyond and/or out of the conduit 52, whereby the distance D5 may or may not also be the maximum distance that the probe 55 is capable of being advanced beyond and/or out of the conduit 52”).
In regard to claim 7:
The device of claim 3, taught by Grover in view Ference as described in parent claim rejection above.
Grover teaches, advance distance (Fig. 3 “L”, para. 61 “The driveshaft 1640 is further configured to translate longitudinally L relative to a centerline of the driveshaft 1640 to advance the tool member 1650 against, into and/or through the implant 1100.”.)
Grover does not expressly disclose wherein the advanced distance is measured between a distal terminal end of the sheath and a distal terminal end of the probe. It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to cause the device of Grover to have a the advanced distance is measured between a distal terminal end of the sheath and a distal terminal end of the probe, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Grover would not operate differently with the claimed advanced distance measured from the distal terminal end of the sheath to the distal end of the probe and since Grover teaches an advancing distance L the device would function appropriately having the claimed the advanced distance is measured along a straight line between a distal terminal end of the sheath and a distal terminal end of the probe. Further, applicant places no criticality on the range claimed, indicating different examples of measuring the advanced distance (specification pp. 298 “Figure 20 illustrates that the probe 55 can be moved (e.g., advanced) a distance D5 (also referred to as the deployed distance D5, the advanced distance D5, the advancing distance D5, or any other similar term) beyond the conduit 52. The distance D5 can be, for example, the distance that the probe 55 is advanced beyond the distal end opening (e.g., the opening 50z) of the device 50. The distance D5 can be, for example, the distance that the probe 55 is advanced beyond the opening 50z to position the probe 55 in the probe second configuration PC2. The distance D5 can be measured, for example, from the probe distal end 55de to the conduit distal end 52de. The distance D5 can be measured, for example, from the probe tip 56 to the conduit distal terminal end 52dte and/or from the probe tip 56 to the opening 50z (e.g., the opening 50z that the probe 55 can be advanced through). For example, figure 20 illustrates that the distance D5 can be measured from the probe tip 56 to the longitudinal center of the opening 5Oz. The distance D5 can be, for example, measured along the probe center longitudinal axis A3. The distance D5 can be, for example, 0.0 cm-30.0 cm, or more narrowly, 0.0 cm-20.0 cm, or more narrowly, 0.0 cm-15.0 cm, or more narrowly, 0.0 cm-10.0 cm, or more narrowly, 0.0 cm-5.0 cm, including, for example, every 0.1 cm increment within these ranges (e.g., 0.0 cm, 5.0 cm, 10.0 cm, 15.0 cm, 20.0 cm, 30.0 cm). The upper bound of these ranges for the distance DS (e.g., 30.0 cm, 20.0 cm,10.0cm,5.0 cm) can be, for example, the maximum distance that the probe 55 can be advanced out of the conduit 52. As another example, there may not be a maximum distance that the probe 55 can be advanced out of the conduit 52, in which case the upper bound of the above ranges for the distance D5 may not be the maximum distance that the probe 55 can be advanced out of the conduit 52. For example, the distance D5 can be the distance that the user advances the probe55 beyond and/or out of the conduit 52, whereby the distance D5 may or may not also be the maximum distance that the probe 55 is capable of being advanced beyond and/or out of the conduit 52”).
In regard to claim 8:
The device of claim 3, taught by Grover in view Ference as described in parent claim rejection above.
Grover teaches, wherein the sheath comprises a sheath lumen (Para. 59 “the removal tool 1600 can include an outer sleeve or guide member (not shown), which further includes a proximal end portion, a distal end portion, an outer surface, an inner surface, and a guide lumen defined by the inner surface.” (Emphasis added)), advance distance (Fig. 3 “L”, para. 61 “The driveshaft 1640 is further configured to translate longitudinally L relative to a centerline of the driveshaft 1640 to advance the tool member 1650 against, into and/or through the implant 1100.”.)
Grover does not expressly disclose wherein the advanced distance is measured along a straight line between a distal terminal opening of the sheath and a distal terminal end of the probe. It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to cause the device of Grover to have a the advanced distance is measured along a straight line between a distal terminal opening of the sheath and a distal terminal end of the probe, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Grover would not operate differently with the claimed the advanced distance is measured along a straight line between a distal terminal opening of the sheath and a distal terminal end of the probe and since Grover teaches an advancing distance L the device would function appropriately having the claimed the advanced distance is measured along a straight line between a distal terminal opening of the sheath and a distal terminal end of the probe. Further, applicant places no criticality on the range claimed, indicating different examples of measuring the advanced distance (specification pp. 298 “Figure 20 illustrates that the probe 55 can be moved (e.g., advanced) a distance D5 (also referred to as the deployed distance D5, the advanced distance D5, the advancing distance D5, or any other similar term) beyond the conduit 52. The distance D5 can be, for example, the distance that the probe 55 is advanced beyond the distal end opening (e.g., the opening 50z) of the device 50. The distance D5 can be, for example, the distance that the probe 55 is advanced beyond the opening 50z to position the probe 55 in the probe second configuration PC2. The distance D5 can be measured, for example, from the probe distal end 55de to the conduit distal end 52de. The distance D5 can be measured, for example, from the probe tip 56 to the conduit distal terminal end 52dte and/or from the probe tip 56 to the opening 50z (e.g., the opening 50z that the probe 55 can be advanced through). For example, figure 20 illustrates that the distance D5 can be measured from the probe tip 56 to the longitudinal center of the opening 5Oz. The distance D5 can be, for example, measured along the probe center longitudinal axis A3. The distance D5 can be, for example, 0.0 cm-30.0 cm, or more narrowly, 0.0 cm-20.0 cm, or more narrowly, 0.0 cm-15.0 cm, or more narrowly, 0.0 cm-10.0 cm, or more narrowly, 0.0 cm-5.0 cm, including, for example, every 0.1 cm increment within these ranges (e.g., 0.0 cm, 5.0 cm, 10.0 cm, 15.0 cm, 20.0 cm, 30.0 cm). The upper bound of these ranges for the distance DS (e.g., 30.0 cm, 20.0 cm,10.0cm,5.0 cm) can be, for example, the maximum distance that the probe 55 can be advanced out of the conduit 52. As another example, there may not be a maximum distance that the probe 55 can be advanced out of the conduit 52, in which case the upper bound of the above ranges for the distance D5 may not be the maximum distance that the probe 55 can be advanced out of the conduit 52. For example, the distance D5 can be the distance that the user advances the probe55 beyond and/or out of the conduit 52, whereby the distance D5 may or may not also be the maximum distance that the probe 55 is capable of being advanced beyond and/or out of the conduit 52”).
In regard to claim 9:
The device of claim 3, taught by Grover in view Ference as described in parent claim rejection above.
Grover teaches, wherein the sheath comprises a sheath lumen (Para. 59 “the removal tool 1600 can include an outer sleeve or guide member (not shown), which further includes a proximal end portion, a distal end portion, an outer surface, an inner surface, and a guide lumen defined by the inner surface.” (Emphasis added)), advance distance (Fig. 3 “L”, para. 61 “The driveshaft 1640 is further configured to translate longitudinally L relative to a centerline of the driveshaft 1640 to advance the tool member 1650 against, into and/or through the implant 1100.”.)
Grover does not expressly disclose wherein the advanced distance is measured between a distal terminal opening of the sheath and a distal terminal end of the probe along a center longitudinal axis of the probe. It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to cause the device of Grover to have a the advanced distance is measured between a distal terminal opening of the sheath and a distal terminal end of the probe along a center longitudinal axis of the probe, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Grover would not operate differently with the advanced distance is measured between a distal terminal opening of the sheath and a distal terminal end of the probe along a center longitudinal axis of the probe and since Grover teaches an advancing distance L the device would function appropriately having the claimed the advanced distance is measured between a distal terminal opening of the sheath and a distal terminal end of the probe along a center longitudinal axis of the probe. Further, applicant places no criticality on the range claimed, indicating different examples of measuring the advanced distance (specification pp. 298 “Figure 20 illustrates that the probe 55 can be moved (e.g., advanced) a distance D5 (also referred to as the deployed distance D5, the advanced distance D5, the advancing distance D5, or any other similar term) beyond the conduit 52. The distance D5 can be, for example, the distance that the probe 55 is advanced beyond the distal end opening (e.g., the opening 50z) of the device 50. The distance D5 can be, for example, the distance that the probe 55 is advanced beyond the opening 50z to position the probe 55 in the probe second configuration PC2. The distance D5 can be measured, for example, from the probe distal end 55de to the conduit distal end 52de. The distance D5 can be measured, for example, from the probe tip 56 to the conduit distal terminal end 52dte and/or from the probe tip 56 to the opening 50z (e.g., the opening 50z that the probe 55 can be advanced through). For example, figure 20 illustrates that the distance D5 can be measured from the probe tip 56 to the longitudinal center of the opening 5Oz. The distance D5 can be, for example, measured along the probe center longitudinal axis A3. The distance D5 can be, for example, 0.0 cm-30.0 cm, or more narrowly, 0.0 cm-20.0 cm, or more narrowly, 0.0 cm-15.0 cm, or more narrowly, 0.0 cm-10.0 cm, or more narrowly, 0.0 cm-5.0 cm, including, for example, every 0.1 cm increment within these ranges (e.g., 0.0 cm, 5.0 cm, 10.0 cm, 15.0 cm, 20.0 cm, 30.0 cm). The upper bound of these ranges for the distance DS (e.g., 30.0 cm, 20.0 cm,10.0cm,5.0 cm) can be, for example, the maximum distance that the probe 55 can be advanced out of the conduit 52. As another example, there may not be a maximum distance that the probe 55 can be advanced out of the conduit 52, in which case the upper bound of the above ranges for the distance D5 may not be the maximum distance that the probe 55 can be advanced out of the conduit 52. For example, the distance D5 can be the distance that the user advances the probe55 beyond and/or out of the conduit 52, whereby the distance D5 may or may not also be the maximum distance that the probe 55 is capable of being advanced beyond and/or out of the conduit 52”).
In regard to claim 10:
The device of claim 3, taught by Grover in view Ference as described in parent claim rejection above.
Grover teaches, wherein the sheath comprises a sheath lumen (Para. 59 “the removal tool 1600 can include an outer sleeve or guide member (not shown), which further includes a proximal end portion, a distal end portion, an outer surface, an inner surface, and a guide lumen defined by the inner surface.” (Emphasis added)), wherein the probe is retractable relative to the sheath (Considered intended use limitation due to use of “retractable”. Probe elements 1640 and 1650 considered fully capable of retracting at least in part into the sheath lumen due to para. 59 “For example, the guide lumen is configured to permit the distal end portion 1642 of the driveshaft 1640 to extend beyond the distal end portion of the guide member and permit the distal end portion 1642 of the driveshaft 1640 to be withdrawn into the distal end portion of the guide member.”).
Conclusion
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/M.A.I./Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783