DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
2. Claims 1-20 as originally filed on 12/05/2024 are pending, and have been examined on the merits.
Claim Objections
3. Claims 16 & 20 are objected to because of the following informalities:
a. In claim 16, lines 1-2, the recitation of “wherein the medical system comprising” should instead recite --wherein the medical system comprises--.
b. In claim 16, line 12, the recitation of “positioning the medical device of over a target” should instead recite --positioning the medical device over a target--.
c. In claim 20, line 2, the recitation of “A handle” should instead recite --a handle--.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
4. 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.
5. Claims 1-6, & 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2005/0113867 to Anderhub et al. (“Anderhub”) [made of record in Applicant’s 03/05/25 IDS].
6. Regarding claim 1, Anderhub discloses a medical device comprising:
a handle [see ¶[0029] (“an endoscopic actuator assembly 9 (i.e. a handle portion)”); FIG. 1], including a stationary portion and a movable portion [¶[0029] (“The endoscopic actuator assembly 9 is shown schematically in FIG. 1 as a box, as assembly 9 may be any suitable handle known in the art that controls the actuation of the end effector assembly 11. Suitable handles may include spool/shaft assemblies, scissor-like handles, or any other known handle used in medical or non-medical applications”); ¶[0056] (“Pull wires 14 may be advanced distally using any method known in the art, for example, by pushing on a spool portion of a handle”)];
a shaft, including a sheath [elongate tubular member (12) - ¶[0029]; FIG. 1] and one or more wires [pull wires (14) - ¶[0031]], wherein the sheath [(12)] is coupled to the stationary portion of the handle [¶[0029]], and wherein the one or more wires [(14)] are coupled to the movable portion of the handle [e.g., ¶[0031] (“The pull wires 14 connect to upper forceps assembly 30 and lower forceps assembly 50, and extend through clevis 17 and elongate member 12 to the proximal actuation handle 9”); ¶[0041] (“an actuating pull wire 14 that extends from proximal actuation handle 9”); & ¶[0056] (“For example, pull wires 14 are advanced distally and push on pull wire holes 33, 53, 133, 153 on tang portions 32, 52, 132, 152. The pushing causes tang portions 32, 52, 132, 152 of upper forceps assembly 30 and lower forceps assembly 50 to rotate away from each other and thus cause upper forceps assembly 30 and lower forceps assembly 50 to open. Pull wires 14 may be advanced distally using any method known in the art, for example, by pushing on a spool portion of a handle”)]; and
an end effector [end effector assembly (11) - ¶[0029]] positioned at a distal end of the shaft [¶[0029]; FIG. 1]; and
the end effector [(11)] comprising:
a basket [lower forceps assembly (50) including pouch (16) - ¶[0037]; FIGS. 1, 2C, 5], the basket [(50, 16)] including a rim [cutting portion (155) including cutting edge (157) of insert portion (161) - ¶’s [0036], [0051], [0057]; FIGS. 2A, 3A] extending along an opening [sample receiving hole (158) - ¶[0036]; FIG. 2A] of the basket [(50 16)],
a paddle [upper forceps assembly (30) - ¶[0031]; FIG. 1], and
a hinge [pivot pin (19) of clevis (17) - ¶[0033]], wherein the basket [(50, 16)] and the paddle [(30)] are pivotally connected to the hinge [(19, 17)] [¶[0031]; FIG. 1].
7. Regarding claim 2, Anderhub discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Anderhub further discloses wherein the basket [(50, 16)] is formed from a basket mesh [see ¶[0051] (“Insert portions 141, 161 may be made of a biocompatible metal or any other material suitable for cutting tissue, and may have various thicknesses or configurations, such as a mesh type configuration”)], and wherein the paddle [(30)] is formed from a paddle mesh [¶[0051]] [NOTE: insert portion (161) is a part of lower forceps assembly (50), and insert portion (141) is part of upper forceps assembly (30)].
8. Regarding claim 3, Anderhub discloses all of the limitations of claim 2 for the reasons set forth in detail (above) in the Office Action.
Anderhub further discloses wherein the basket mesh of the basket and the paddle mesh of the paddle are both formed from a non-conductive material [e.g., “plastics” - ¶[0051]].
9. Regarding claim 4, Anderhub discloses all of the limitations of claim 2 for the reasons set forth in detail (above) in the Office Action.
Anderhub further discloses wherein the paddle mesh of the paddle is more rigid than the basket mesh of the basket [e.g., ¶’s [0051] & [0053] (“Pouch 16 may be composed of a material and/or have a wall thickness that allows a desired amount of flexibility and/or compression of pouch 16”)].
10. Regarding claim 5, Anderhub discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Anderhub further discloses wherein the rim [cutting portion (155) including cutting edge (157) of insert portion (161)] is formed from a conductive material [see ¶[0051] (“Insert portions 141, 161 may be made of a biocompatible metal or any other material suitable for cutting tissue, and may have various thicknesses or configurations, such as a mesh type configuration. Examples of various materials suitable for portions 141, 161 include metals (stainless steel, brass, aluminum, cooper, nitinol), composites, plastics, ceramics, glass, Kevlar fibers, and carbons… Cutting portions 135, 155 may be connected to a source of current and heated (e.g., monopolar or bi-polar) to perform electrocautery, and may have different finishes. For example, they may be plated, coated, and/or have a stick or non-stick substance adhering to its surface”)].
11. Regarding claim 6, Anderhub discloses all of the limitations of claim 5 for the reasons set forth in detail (above) in the Office Action.
Anderhub further discloses wherein the rim [cutting portion (155) including cutting edge (157) of insert portion (161)] is configured to be energized with RF energy and is configured to cut through tissue [see ¶[0051] (“Cutting portions 135, 155 may be connected to a source of current and heated (e.g., monopolar or bi-polar) to perform electrocautery, and may have different finishes. For example, they may be plated, coated, and/or have a stick or non-stick substance adhering to its surface”)].
12. Regarding claim 15, Anderhub discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Anderhub further discloses wherein a proximal end of the paddle and a proximal end of the basket are pivotally connected to the hinge [via pivot pin (19) of clevis (17) - ¶[0033]].
Claim Rejections - 35 USC § 103
13. 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.
14. 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.
15. Claims 7-11 & 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Anderhub in view of U.S. Patent Application Publication No. 2022/0095888 to Sharma et al. ("Sharma").
16. Regarding claims 7-9, Anderhub discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Anderhub additionally discloses that the handle [endoscopic actuator assembly (9)] includes an actuator operably connected to the end effector [end effector assembly (11)] via the one or more wires [e.g., ¶[0031] (“The pull wires 14 connect to upper forceps assembly 30 and lower forceps assembly 50, and extend through clevis 17 and elongate member 12 to the proximal actuation handle 9”); ¶[0041] (“an actuating pull wire 14 that extends from proximal actuation handle 9”); & ¶[0056]], wherein… movement of the actuator is configured to transition the end effector from a closed configuration to an open configuration [¶’s [0056] (“once upper forceps assembly 30 and lower forceps assembly 50 are positioned proximate the tissue portion from which a sample is desired, the user actuates a handle portion and upper forceps assembly 30 and lower forceps assembly 50 are opened (i.e. they are separated)”); & [0057]].
Anderhub does not, however, explicitly disclose the following emphasized claim limitations:
[claim 7] wherein the movable portion of the handle includes an actuator operably connected to the end effector via the one or more wires, wherein proximal movement of the actuator is configured to transition the end effector from a closed configuration to an open configuration;
[claim 8] further comprising a biasing element, wherein the biasing element is positioned in the handle and proximal to the actuator, wherein the biasing element is configured to bias the actuator distally to transition the end effector from the open configuration to the closed configuration and maintain the end effector in the closed configuration; and
[claim 9] wherein the biasing element is a spring.
Sharma, in a similar field of endeavor, teaches medical systems, devices, and methods for endoscopic medical procedures, such as articulating one or more medical devices during endoscopic procedures [¶[0002]].
Sharma teaches that it was known in the art to actuate opposing jaws [jaws (1301), (1302)] to an open position [FIG. 13] by moving/pulling an actuator [trigger actuator 124] in the proximal direction to overcome a spring bias mechanism designed to maintain the jaws in the closed position [see, e.g., ¶[0051] (“FIG. 13 illustrates grasper 118 in an open position with jaws 1301, 1302 separated from each other. FIG. 12 shows grasper 118 in a closed positioned with jaws 1301, 1302 clamped together, whereas FIG. 13 shows grasper 118 in an open position. In some examples, pulling trigger actuator 124 may move actuation wire 601 distally and cause grasper 118 to transition from a closed position to an open position, and releasing trigger actuator 124 may pull actuation wire 601 proximally, for example via a spring bias mechanism, and move grasper 118 to a closed position”); FIGS. 12, 13].
Given Anderhub’s explicit teaching that the endoscopic actuator assembly (9) may be any suitable handle known in the art that controls the actuation of the end effector assembly (11), including any other known handle used in medical or non-medical applications [see ¶[0029]], it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Anderhub to utilize a known, art-recognized actuator assembly/configuration, such as, e.g., one wherein the movable portion of the handle includes an actuator operably connected to the end effector via the one or more wires, wherein proximal movement of the actuator is configured to transition the end effector from a closed configuration to an open configuration; [one] further comprising a biasing element…, wherein the biasing element is configured to bias the actuator distally to transition the end effector from the open configuration to the closed configuration and maintain the end effector in the closed configuration; and wherein the biasing element is a spring, all as taught by Sharma, since such a modification amounts merely to the simple substitution of one known actuator assembly for another, yielding only predictable results [the opening and closing of opposing jaws] to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Finally, while Sharma does not explicitly teach that “the biasing element is positioned in the handle and proximal to the actuator” [as required by claim 8], it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Anderhub and Sharma such that the biasing element be placed in the handle proximal to the actuator, since such a modification constitutes a mere rearrangement of parts, which is an example directed to a common practice which the court has held normally requires only ordinary skill in the art, and is hence considered a routine expedient.
See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice). In the instant case, positioning the biasing spring of Anderhub/Sharma either proximal or distal to the actuator [trigger (124)] would not have modified the operation of the device, as the biasing spring would still be configured bias the jaws in the closed position.
17. Regarding claim 10, the combination of Anderhub and Sharma teaches all of the limitations of claim 7 for the reasons set forth in detail (above) in the Office Action.
Anderhub further teaches wherein during a transition from the closed configuration to the open configuration and a transition from the open configuration and the closed configuration, only one of the basket and the paddle pivots about the hinge while the other of the basket and the paddle remains stationary [see ¶[0063] (“In other embodiments, there may be various alternate method steps that may be executed. For example, upper and lower forceps assemblies 30, 50 may be individually actuated (i.e. only one jaw moves to open and close the assembly 11) and/or one jaw may be stationary and the other movable”)].
18. Regarding claim 11, the combination of Anderhub and Sharma teaches all of the limitations of claim 7 for the reasons set forth in detail (above) in the Office Action.
Anderhub further teaches wherein during a transition from the closed configuration to the open configuration and a transition from the open configuration and the closed configuration, both the basket and the paddle are configured to pivot about the hinge [e.g., ¶’s [0056], [0057]].
19. Regarding claim 16, Anderhub teaches a method of using a medical system, wherein the medical system compris[es]: an insertion device [endoscope - ¶[0055]] including a working channel [working channel of endoscope - ¶[0055]] and an medical device [forceps and collection assembly (10) - ¶[0055]] receivable within the working channel [¶[0055] (“An endoscope with a working channel first is placed into the body, for example, a tissue tract, using a method known in the art. Forceps and collection assembly 10 then is inserted into the working channel of the endoscope to the endoscope distal end. During insertion, upper forceps assembly 30 and lower forceps assembly 50 are closed”)], the medical device [(10)] including an end effector [end effector assembly (11) - ¶[0029]] positioned at a distal end of a shaft [elongate tubular member (12) - ¶[0029]; FIG. 1] of the medical device; the end effector [(11)] comprising: a basket [lower forceps assembly (50) including pouch (16) - ¶[0037]; FIGS. 1, 2C, 5], the basket [(50, 16)] including a rim [cutting portion (155) including cutting edge (157) of insert portion (161) - ¶’s [0036], [0051], [0057]; FIGS. 2A, 3A] extending along an opening [sample receiving hole (158) - ¶[0036]; FIG. 2A] of the basket [(50 16)], the rim [cutting portion (155) including cutting edge (157) of insert portion (161)] configured to be energized with RF and configured to cut through tissue when energized [see ¶[0051] (“Cutting portions 135, 155 may be connected to a source of current and heated (e.g., monopolar or bi-polar) to perform electrocautery, and may have different finishes. For example, they may be plated, coated, and/or have a stick or non-stick substance adhering to its surface”)], a paddle [upper forceps assembly (30) - ¶[0031]; FIG. 1], a hinge [pivot pin (19) of clevis (17) - ¶[0033]], wherein the basket [(50, 16)] and the paddle [(30)] are pivotally connected to the hinge [(19, 17)] [¶[0031]; FIG. 1], an actuator [endoscopic actuator assembly (9) - ¶[0029]; FIG. 1] configured to transition the end effector [(11)] from a closed position to an open position [e.g., ¶[0031] (“The pull wires 14 connect to upper forceps assembly 30 and lower forceps assembly 50, and extend through clevis 17 and elongate member 12 to the proximal actuation handle 9”); ¶[0041] (“an actuating pull wire 14 that extends from proximal actuation handle 9”); & ¶[0056] (“For example, pull wires 14 are advanced distally and push on pull wire holes 33, 53, 133, 153 on tang portions 32, 52, 132, 152. The pushing causes tang portions 32, 52, 132, 152 of upper forceps assembly 30 and lower forceps assembly 50 to rotate away from each other and thus cause upper forceps assembly 30 and lower forceps assembly 50 to open. Pull wires 14 may be advanced distally using any method known in the art, for example, by pushing on a spool portion of a handle”)]… the method comprising:
delivering the medical device to a treatment site [via the endoscope - ¶[0055]];
positioning the medical device of over a target [¶’s [0056]-[0057]];
energizing the medical device to at least partially sever the target [¶[0057] & ¶[0051]];
capturing the target at least partially within the basket [¶’s [0057]-[0058]]; and
removing the target from the treatment site [¶’s [0059]-[0061]].
BIASING ELEMENT
Anderhub teaches that the endoscopic actuator assembly (9) may be any suitable handle known in the art [see ¶[0029] (“The endoscopic actuator assembly 9 is shown schematically in FIG. 1 as a box, as assembly 9 may be any suitable handle known in the art that controls the actuation of the end effector assembly 11. Suitable handles may include spool/shaft assemblies, scissor-like handles, or any other known handle used in medical or non-medical applications”); ¶[0056] (“Pull wires 14 may be advanced distally using any method known in the art, for example, by pushing on a spool portion of a handle”)]].
Anderhub does not, however, teach:
a biasing element configured to transition the end effector from the open position to the closed position.
Sharma, in a similar field of endeavor, teaches medical systems, devices, and methods for endoscopic medical procedures, such as articulating one or more medical devices during endoscopic procedures [¶[0002]].
Sharma teaches that it was known in the art to actuate opposing jaws [jaws (1301), (1302)] to an open position [FIG. 13] by moving/pulling an actuator [trigger actuator 124] in the proximal direction to overcome a spring bias mechanism designed to maintain the jaws in the closed position [see, e.g., ¶[0051] (“FIG. 13 illustrates grasper 118 in an open position with jaws 1301, 1302 separated from each other. FIG. 12 shows grasper 118 in a closed positioned with jaws 1301, 1302 clamped together, whereas FIG. 13 shows grasper 118 in an open position. In some examples, pulling trigger actuator 124 may move actuation wire 601 distally and cause grasper 118 to transition from a closed position to an open position, and releasing trigger actuator 124 may pull actuation wire 601 proximally, for example via a spring bias mechanism, and move grasper 118 to a closed position”); FIGS. 12, 13].
Given Anderhub’s explicit teaching that the endoscopic actuator assembly (9) may be any suitable handle known in the art that controls the actuation of the end effector assembly (11), including any other known handle used in medical or non-medical applications [see ¶[0029]], it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Anderhub to utilize a known, art-recognized actuator assembly/configuration, such as, e.g., one wherein a biasing element is configured to transition the end effector from the open position to the closed position, since such a modification amounts merely to the simple substitution of one known actuator assembly for another, yielding only predictable results [the opening and closing of opposing jaws] to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
20. Regarding claim 17, the combination of Anderhub and Sharma teaches all of the limitations of claim 16 for the reasons set forth in detail (above) in the Office Action.
Anderhub further teaches wherein during the positioning step, one of the basket and the paddle is positioned about one side of the target and the other of the basket and the paddle is position about another opposite side of the target [¶’s [0056]-[0057]].
21. Regarding claim 18, the combination of Anderhub and Sharma teaches all of the limitations of claim 16 for the reasons set forth in detail (above) in the Office Action.
Anderhub does not explicitly teach:
after the capturing step, de-energizing the rim after receiving the target within the basket.
However, it is the Examiner’s position that it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Anderhub and Sharma to, after the capturing step, de-energize the rim after receiving the target within the basket, as the skilled artisan would be motivated to ensure that no unintended tissue is inadvertently cut or thermally damaged by an electrically “active” rim as the device is retracted/withdrawn or otherwise moved within the body. Switching off the current source after capture would have been entirely routine.
22. Regarding claim 19, the combination of Anderhub and Sharma teaches all of the limitations of claim 18 for the reasons set forth in detail (above) in the Office Action.
While Anderhub teaches introduction of the medical device via an endoscope, Anderhub does not explicitly teach:
during the capturing step, visualizing the capturing of the target via a camera of the medical system.
Sharma further teaches that it was known for an endoscope to include a camera for enabling visualization of a target area during a procedure [see, e.g., ¶[0036] (“Endoscope 101 may include a handle 102, actuators 104, and a body 107 extending from handle 102 to a distal end 108. A working channel 106 may extend from a working channel port 103 positioned on the handle 102 to an opening at distal end 108. Distal end 108 of endoscope 101 may also include a camera 105, and movement of distal end 108 and functionality of camera 105 may be controlled via one or more actuators 104 on handle 102. Medical device 110 may be configured to be inserted into working channel 106 of endoscope 101”); and ¶[0060] (“In operation of medical device system 100, a user may first insert endoscope 101 into a body of a patient and position distal portion 108 proximate to a target area within the patient's body. A user may visualize the target area using a camera 105 of endoscope 101”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Anderhub and Sharma to include, during the capturing step, visualizing the capturing of the target via a camera of the medical system, since use of a camera to visualize the target area during capture would facilitate the procedure for a surgeon by ensuring/confirming a successful capture of the target prior to withdrawal of the working device.
23. Regarding claim 20, Anderhub teaches a medical system comprising:
[a] handle, including an actuator [see ¶[0029] (“an endoscopic actuator assembly 9 (i.e. a handle portion)”); FIG. 1]…;
a shaft [elongate tubular member (12) - ¶[0029]; FIG. 1], including at least one wire [pull wires (14) - ¶[0031]], wherein a proximal end of the at least one wire is coupled to the actuator [e.g., ¶[0031] (“The pull wires 14 connect to upper forceps assembly 30 and lower forceps assembly 50, and extend through clevis 17 and elongate member 12 to the proximal actuation handle 9”); ¶[0041] (“an actuating pull wire 14 that extends from proximal actuation handle 9”); & ¶[0056]]; and
a medical device [forceps and collection assembly (10) - ¶[0055]] including an end effector [end effector assembly (11) - ¶[0029]], the end effector [(11)] positioned at a distal end of the shaft [¶[0029]; FIG. 1]and coupled to a distal end of the at least one wire [¶[0056]], the end effector [(11)] comprising:
a basket [lower forceps assembly (50) including pouch (16) - ¶[0037]; FIGS. 1, 2C, 5], the basket [(50, 16)], the basket [(50, 16)] including a rim [cutting portion (155) including cutting edge (157) of insert portion (161) - ¶’s [0036], [0051], [0057]; FIGS. 2A, 3A] extending along an opening [sample receiving hole (158) - ¶[0036]; FIG. 2A] of the basket [(50 16)],
a paddle [upper forceps assembly (30) - ¶[0031]; FIG. 1], and
a hinge [pivot pin (19) of clevis (17) - ¶[0033]], wherein the basket [(50, 16)] and the paddle [(30)] are pivotally connected to the hinge [(19, 17)] [¶[0031]; FIG. 1] at a proximal end of the basket and a proximal end of the paddle [via pivot pin (19) of clevis (17) - ¶[0033]];
wherein movement of the actuator from a first position to a second position on the handle transitions the end effector from a closed configuration to an open configuration [¶’s [0056] (“once upper forceps assembly 30 and lower forceps assembly 50 are positioned proximate the tissue portion from which a sample is desired, the user actuates a handle portion and upper forceps assembly 30 and lower forceps assembly 50 are opened (i.e. they are separated)”); & [0057]].
BIASING ELEMENT
Anderhub teaches that the endoscopic actuator assembly (9) may be any suitable handle known in the art [see ¶[0029] (“The endoscopic actuator assembly 9 is shown schematically in FIG. 1 as a box, as assembly 9 may be any suitable handle known in the art that controls the actuation of the end effector assembly 11. Suitable handles may include spool/shaft assemblies, scissor-like handles, or any other known handle used in medical or non-medical applications”); ¶[0056] (“Pull wires 14 may be advanced distally using any method known in the art, for example, by pushing on a spool portion of a handle”)]].
Anderhub does not, however, teach:
a biasing element; [and]
wherein the biasing element urges the actuator toward the first position on the handle to transition the end effector from the open configuration to the closed configuration.
Sharma, in a similar field of endeavor, teaches medical systems, devices, and methods for endoscopic medical procedures, such as articulating one or more medical devices during endoscopic procedures [¶[0002]].
Sharma teaches that it was known in the art to actuate opposing jaws [jaws (1301), (1302)] to an open position [FIG. 13] by moving/pulling an actuator [trigger actuator 124] in the proximal direction to overcome a spring bias mechanism designed to maintain the jaws in the closed position [see, e.g., ¶[0051] (“FIG. 13 illustrates grasper 118 in an open position with jaws 1301, 1302 separated from each other. FIG. 12 shows grasper 118 in a closed positioned with jaws 1301, 1302 clamped together, whereas FIG. 13 shows grasper 118 in an open position. In some examples, pulling trigger actuator 124 may move actuation wire 601 distally and cause grasper 118 to transition from a closed position to an open position, and releasing trigger actuator 124 may pull actuation wire 601 proximally, for example via a spring bias mechanism, and move grasper 118 to a closed position”); FIGS. 12, 13].
Given Anderhub’s explicit teaching that the endoscopic actuator assembly (9) may be any suitable handle known in the art that controls the actuation of the end effector assembly (11), including any other known handle used in medical or non-medical applications [see ¶[0029]], it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Anderhub to utilize a known, art-recognized actuator assembly/configuration, such as, e.g., one with a biasing element, wherein the biasing element urges the actuator toward the first position on the handle to transition the end effector from the open configuration to the closed configuration, since such a modification amounts merely to the simple substitution of one known actuator assembly for another, yielding only predictable results [the opening and closing of opposing jaws] to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
24. Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Anderhub.
25. Regarding claim 12, Anderhub discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
While Anderhub teaches that the basket [(16)] has a generally elliptical shape [e.g., as shown in FIGS. 1, 2C, & 5], Anderhub does not explicitly teach:
wherein the basket includes a hemi-ellipsoid shape.
Anderhub does, however, teach that the basket may have various configurations/shapes [see, e.g., ¶[0053] (“pouch 16 may have various alternate configurations. For example, pouch 16 may have other shapes and may be composed of any suitable biocompatible material”)].
Given that basket (16) is already of a generally elliptical shape, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Anderhub such that the basket include whatever similar shape was desired, including, e.g., a hemi-ellipsoid shape, since such a modification constitutes a mere change in shape, which is an example directed to a common practice which the court has held normally requires only ordinary skill in the art, and is hence considered a routine expedient. See In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant).
26. Regarding claim 13, Anderhub (as modified) teaches all of the limitations of claim 12 for the reasons set forth in detail (above) in the Office Action.
Anderhub further teaches wherein the paddle is sized and shaped to cover the opening of the basket [clearly seen in FIGS. 5-6].
27. Regarding claim 14, Anderhub (as modified) teaches all of the limitations of claim 13 for the reasons set forth in detail (above) in the Office Action.
Anderhub further teaches wherein the opening [sample receiving hole (158)] includes an elliptical shape [shown in FIG. 2A].
Conclusion
28. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bradford C. Blaise whose telephone number is (571)272-5617. The examiner can normally be reached on Monday - Friday 8 AM-5 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached on 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADFORD C. BLAISE/Primary Examiner, Art Unit 3794
Prosecution Insights