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 .
2. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 112
3. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
4. Claims 2-7 and 11, as well as claims 8-10 and 12-13 based on their dependencies to claims 2-7, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
5. Claim 2 recites the limitation "the front end of the housing" in line 2. There is insufficient antecedent basis for this limitation in the claim. There is no recitation of a front end of the housing in any previous claims, rendering the claim indefinite.
6. Claim 2 recites the limitation "the front end of the shaft rod member" in line 4. There is insufficient antecedent basis for this limitation in the claim. There is no recitation of a front end of the shaft rod member in any previous claims, rendering the claim indefinite.
7. Claim 3 recites the limitation "the front end of the inner sleeve" in lines 2-3 and 6. There is insufficient antecedent basis for this limitation in the claim. There is no recitation of a front end of the inner sleeve in any previous claims, rendering the claim indefinite.
8. Claim 3 recites the limitation "the tail ends of both the first jaw and the second jaw" in lines 5-6. There is insufficient antecedent basis for this limitation in the claim. There is no recitation of a tail end of the jaws in any previous claims, rendering the claim indefinite.
9. Claim 3 recites the limitation "the two ends of the second hinge pin" in line 7. There is insufficient antecedent basis for this limitation in the claim. There is no recitation of any end of the second hinge pin in any previous claims, rendering the claim indefinite.
10. Claim 3 recites the limitation "the guide slot" in line 8. There is insufficient antecedent basis for this limitation in the claim. Previously in claim 3, there is the limitation “guide slots are disposed on side portions…”, but the singular recitation of ‘the guide slot’ makes it unclear as to which guide slot is being referred to, or both guide slots. Therefore, the claim is rendering indefinite.
11. Claim 4 recites the limitation "the tail end of the inner sleeve" in line 4. There is insufficient antecedent basis for this limitation in the claim. There is no recitation of a tail end of the inner sleeve in any previous claims, rendering the claim indefinite.
12. Claim 5 recites the limitation "the inner wall of the housing" in line 3. There is insufficient antecedent basis for this limitation in the claim. There is no recitation of an inner wall of the housing in any previous claims, rendering the claim indefinite.
13. Claims 5, 6 and 11 also recite ‘the inner wall of the housing’, like claim 4; therefore, they are rendered indefinite for the same reasons above.
14. Claim 6 recites the limitation "the tail end of the push block" in line 2. There is insufficient antecedent basis for this limitation in the claim. There is no recitation of a tail end of the push block in any previous claims, rendering the claim indefinite.
15. Claim 7 recites the limitation "the tail end of the locking rod" in line 7. There is insufficient antecedent basis for this limitation in the claim. There is no recitation of a tail end of the locking rod in any previous claims, rendering the claim indefinite.
16. Proper correction is required.
Claim Rejections - 35 USC § 102
17. 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.
18. Claims 1, 2, 4, 5, 12, 14, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abbott WO 2016/100650 (herein referred to as “Abbott”).
19. Regarding Claim 1, Abbott teaches a safe high-frequency electrotome surgical instrument (Fig. 1), comprising
a housing (Fig. 1, ref num 12),
a shaft rod member (Fig. 1, ref num 16),
a jaw assembly (Fig. 1, ref num 18; Fig. 3, ref nums 20a/20b),
a control wrench (Fig. 1, ref num 26),
a blade (Fig. 3, ref num 110; para 0097, “the end effector assembly 18 optionally includes a blade, knife, or cutting implement 110”), and
a control button (Fig. 1, ref num 120),
wherein the control wrench controls opening and closing of the jaw assembly through a jaw control mechanism (para 0075, “The movable handle member 26 is coupled to the end effector assembly 18 via a drive assembly 34 in order to transition the jaws 20 between their respective open and closed configurations in response to the movable handle member 26 moving between its initial and actuated positions”; Fig. 2, ref num 34)
the control button drives the blade to move for cutting through a blade control mechanism (para 0097, “such that actuation of the trigger 120, e.g., by a finger of a user of the surgical device 10, results in deployment of the blade 110 in order to cut tissue”; Fig. 6, ref num 114; para 0098, “the drive collar 114 is connected to the trigger 120”); the moving direction of the control wrench is consistent with that of the control button (see Figs. 3, 6, 8, and 9, ref nums 26 and 120 move in the same direction), and
a locking mechanism (Fig. 5, ref num 130) is disposed between the control wrench and the control button (see Fig. 5, ref num 130 is between ref num 26 and 120);
the locking mechanism is composed of a locking lug boss (Fig. 5, ref num 132) and an inverted buckle (Fig. 5, ref num 134; para 0099, “arms 132 engage with and support a locking feature or projection 134 projecting eccentrically from the trigger 120 capable of being clamped with the lug boss”);
the locking lug boss is disposed on the control wrench (Fig. 5, ref num 132 is disposed on ref num 26 via ref num 86);
the inverted buckle is disposed on the control button or is disposed on a triggering connecting rod of the blade control mechanism (Fig. 5, ref num 134 is disposed on ref num 120);
in a first state, the jaw assembly is opened, and the locking lug boss is clamped with the inverted buckle, such that the control button is not movable (Figs. 19 and 20B, ref num 132 is clamped with ref num 134; para 0099, “When the movable handle member 26 is in the initial position, e.g., as shown in Figures 2 and 19, the lock (blocking) arms 132 engage with and support a locking feature or projection 134 projecting eccentrically from the trigger 120 in order to prevent rotation of the trigger 120 about the pivot 122 due to interference of the feature 134 with the lock arms 132”);
in a second state, the jaw assembly is closed, and the locking lug boss is separated from the inverted buckle, such that the control button is movable to drive the blade for cutting (see Figs. 20A and 21, ref num 132 is separated from ref num 134; para 0100); and
after the control wrench is turned back, the locking lug boss is re-clamped with the inverted buckle (para 0102, “It is additionally noted that the lock arms 132 are arranged to return the blade 110 to the retracted position when the movable handle member 26 is moved back to the initial position from the actuated position. That is, movement of the lock arms 132 toward the initial (distal) position from the actuated (proximal) position will cause the arms 132 to encounter the feature 134 and force rotation of the trigger 120, via engagement with the arms 132, back to its initial position and thereby retract the blade 110 as force transfer member 112 is pulled proximally via linkage 126 and collar 114”).
20. Regarding Claim 2, Abbott teaches the shaft rod member extends forward from the front end of the housing and defines a longitudinal axis (Fig. 3, ref num 16 extends from ref num 12 and defines a longitudinal axis); the shaft rod member comprises an inner sleeve and an outer sleeve (see Figs. 1-3, ref num 16 has an outer sleeve; para 0109, “the passage or lumen formed through the shaft” indicates an inner sleeve); the jaw assembly is disposed at the front end of the shaft rod member (Figs. 1 and 3, ref num 18 is at front end of ref num 16); and the blade is disposed inside the inner sleeve (Fig. 12, ref num 110 is within the inner sleeve of ref num 16; para 0109, “the passage or lumen formed through the shaft can include a guide 166… the guide 166 includes… a blade channel 170”; para 0097, “The cutting blade 110 is located at the distal end of a force transfer member 112, e.g., a drive ribbon, bar, rod, etc., that extends through the shaft 16”).
21. Regarding Claim 14, Abbott teaches a convex post is disposed on the control wrench (Fig. 3 and 5, ref num 28), the convex post is located above the locking lug boss (see Fig. 5, ref num 28 is above ref num 132); a concave portion matching the convex post is disposed on the triggering connecting rod (402); the convex post and the concave portion of the triggering connecting rod form an auxiliary turnback mechanism; and when the control wrench is turned back, the convex post abuts against the concave portion of the triggering connecting rod, and drives the triggering connecting rod to be synchronously turned back, wherein the control button is synchronously turned back with the triggering connecting rod (para 0100-0102).
22. Regarding Claim 15, Abbott teaches the control wrench is an enclosed annular structure (see Figs. 3 and 5).
Claim Rejections - 35 USC § 103
23. 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 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.
24. Claims 3-5 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Abbott and in view of Worrell U.S. 2018/0271553 (herein referred to as “Worrell”).
25. Regarding Claim 3, Abbott teaches the jaw assembly comprises a first jaw disposed at the front end of the inner sleeve (Fig. 12, ref num 20a is disposed at front end of inner sleeve, i.e., ref num 46) and a second jaw disposed at the front end of the outer sleeve (Fig. 12, ref num 20b is disposed at front end of ref num 16); the first jaw is hingedly connected to the second jaw through a first hinge pin (Fig. 12, ref num 54; para 0087); guide slots are disposed on side portions of the tail ends of both the first jaw and the second jaw (Fig. 12, ref nums 50 and 52); the front end of the inner sleeve is connected to the first jaw through a second hinge pin (Fig. 12, ref num 48); the two ends of the second hinge pin are movably clamped in the guide slots (see Figs. 12 and 13; ref num 48 is movable within ref nums 50 and 52; para 0076); and the inner sleeve drives the first jaw and the second jaw to be opened and closed by moving longitudinally (para 0076 and 0078 describes longitudinal movement of ref num 46 to open and close jaws).
Abbott fails to teach the guide slot(s) is enclosed through a baffle.
Worrell teaches an instrument of analogous art (Fig. 1), wherein the device comprises a jaw assembly (Fig. 1, ref num 50), comprising a guide slot (Fig. 6B, ref num 65; para 0061, “a slot or guide 65”). The guide slot is enclosed through a baffle (Figs. 6A-6C, ref num 61; para 0062, “the slot or guide 65 formed in the proximal member 61”). This configuration facilitates the movement of the hinge/pin (para 0061). 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 Abbott to include a baffle, as this produces the same expected result of facilitating the movement of the hinge pins as well as the jaws.
26. Regarding Claim 4, Abbott teaches the jaw control mechanism comprising (Fig. 2, ref num 34) a closing connecting rod (Fig. 2, ref num 36), a push block (Figs. 2 and 3, ref num 40), and a jaw spring (Fig. 2, ref num 38); the push block is sleeved on the inner sleeve (Fig. 2, ref num 40 is on ref num 46), and abuts against the jaw spring that is sleeved at the tail end of the inner sleeve (Fig. 2, ref num 40 abuts ref num 38 at proximal end of ref num 46); and the control wrench (Fig. 2, ref num 26) is connected to the push block through the closing connecting rod (see Fig. 2, ref num 26 is connected to ref num 40 via ref num 36; para 0075) and drives the push block and the inner sleeve to move longitudinally and synchronously (para 0075).
27. Regarding Claim 5, Abbott teaches a push-block guide slot defining the moving direction of the push block (para 0075; Fig. 2, ref num 44) is disposed on the inner wall of the housing (Fig. 2, ref num 40 is located on the inner wall of the housing), and the push block is slidably clamped in the push-block guide slot (para 0075).
28. Regarding Claim 12, Abbott teaches a blade holder of the blade (Fig. 12, ref num 112) is inserted into the inner sleeve (see Fig. 12, ref num 112 is inserted into inner sleeve of ref num 16; para 0109); and the blade is movably clamped in a movable slot between the first jaw and the second jaw (para 0109, “a blade channel 170”; Fig. 12, ref num 110 is in slot ref num 170 between ref nums 20a/20b).
29. Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Abbott and Worrell, and further in view of De Córdoba U.S. 2023/0285069 (herein referred to as “De Córdoba”).
30. Regarding Claim 6, Abbott fails to teach a jaw reset spring abuts against the tail end of the push block; and the jaw reset spring is clamped in a limiting slot on the inner wall of the housing.
De Córdoba teaches an instrument of analogous art (Fig. 1), wherein the instrument comprises a push block (Fig. 4A, ref num 199) and a jaw reset spring (Fig. 4A, ref num 155), wherein the jaw reset spring abuts against an end of the push block (see Fig. 4A, ref num 155 abuts ref num 199). The jaw reset spring is also clamped in a limiting slot on the inner wall of the housing (see Fig. 4A, ref num 155 is clamped within a slot of ref num 122; para 0056). The jaw reset spring facilitates the opening of the jaws, i.e., resetting them (para 0056). 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 Abbott to include a jaw reset spring in order to facilitate the opening of the jaws when needed.
31. Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Abbott and in view of Shelton U.S. 2015/0136835 (herein referred to as “Shelton”).
32. Regarding Claim 7, Abbott teaches a wrench locking mechanism (Fig. 3, ref num 90) is disposed between the bottom portion of the control wrench and the housing (see Fig. 3, ref num 90 is between the bottom portion of ref num 26 and ref num 12); the wrench locking mechanism comprises a locking block located on the side portion of the control wrench (Fig. 3, ref num 92) and a locking rod located inside the housing (Fig. 3, ref num 94); a clamping slot containing a sliding guide surface is formed on the surface of the locking block (Fig. 3, ref num 96; para 0095, “The cam 92 includes a slot or groove 96…”); a limiting slot is disposed inside the housing (Fig. 3, ref num 98); the locking rod moves elastically along the limiting slot (Fig. 3, ref num 94 moves along ref num 98; para 0095).
Abbott fails to teach the tail end of the locking rod is pivotally connected to the housing; and there is a protruding portion at the front end of the locking rod, so that the locking block is enabled to drive, through movement relative to the locking rod, the protruding portion to slide along the clamping slot.
Shelton teaches an electrotome surgical instrument of analogous art (Fig. 1), wherein the instrument comprises a control wrench (Fig. 1, ref num 130) and a wrench locking mechanism (Fig. 1, ref num 210). The wrench locking mechanism comprising a locking rod (Fig. 1, ref num 211) with a protruding portion (Fig. 1, ref num 212). The tail end of the locking rod is pivotally connecting to the housing (Fig. 1, ref num 211 is pivotally connected to housing, ref num 102/107; para 0368, “he knife lockout system 210 comprise a knife lockout bar 211 that is pivotally supported within the pistol grip portion 107 of the handle assembly 100”), so that a locking block of the control wrench (Fig. 12 and 13, the control wrench, ref num 130, acts as the ‘locking block’) is enabled to drive, through movement relative to the locking rod, the protruding portion to slide along a clamping slot (see movement of ref num 212 within a slot via the movement of ref num 130 and 211). This movement facilitates the lockout mechanism to engage/disengage depending on the desired treatment (para 0368 and 0371, describes movement in regards to whether the jaws move/clamp in open or closed positions, as well as movement of the knife). 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 Abbott to having the locking rod pivotally connected to the housing; and a protruding portion at the front end of the locking rod, so that the locking block is enabled to drive, through movement relative to the locking rod, the protruding portion to slide along the clamping slot, since this configuration and movement facilitates the same desired outcome of manipulating the blade and jaws for the desired treatment.
33. Regarding Claim 8, Abbott fails to teaches a concave guide surface is formed on the surface of the clamping slot (para 0095, “The cam 92 includes a slot or groove 96 through which the cam follower 94 traverses as the movable handle member 26 is actuated toward the fixed handle member 24. The cam follower 94 is secured at the end of a cantilevered element 98 that is arranged to enable the cam follower 94 at the free end of the cantilevered element 98 to follow the groove 96”); an inward protruding portion is formed on the middle portion of the clamping slot (Fig. 5, ref num 98); when the protruding portion slides along the guide surface to the inward bending portion, the locking block and the locking rod are locked (para 0095); and when the protruding portion slides out of the inward bending portion, the locking block and the locking rod are unlocked (para 0095).
34. Regarding Claim 9, Abbott fails to teach elastic members abut against the upper and lower sides along the pivot direction of the locking rod on the side wall of the housing.
Shelton teaches elastic members (Fig. 1, ref num 28) abut against the upper and lower sides along the pivot direction of the locking rod on the side wall of the housing (see Fig. 1, ref num 218 abuts the upper and lower directions of ref num 211). This configuration facilitates the lockout mechanism to engage/disengage depending on the desired treatment (para 0368 and 0371, describes movement in regards to whether the jaws move/clamp in open or closed positions, as well as movement of the knife). 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 Abbott to having elastic members abutting the locking rod since this facilitates the same desired outcome of manipulating the blade and jaws for the desired treatment.
35. Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Abbott and Worrell, and further in view of Stamm U.S. 2022/0183744 (herein referred to as “Stamm”).
36. Regarding Claims 10 and 11, Abbott fails to teach two conductive rings are respectively mounted outside the outer sleeve; and the two conductive rings are electrically connected to the first jaw and the second jaw through conducting wires, respectively (claim 10); wherein conductive sheets slidably abut against the two conductive rings, respectively; the two conductive sheets are fixedly disposed on the inner wall of the housing, and are connected to a power supply through conducting wires, respectively; a knob is disposed at the front end of the housing; and the knob is fixedly connected to the outer sleeve and drives the outer sleeve to rotate synchronously (claim 11).
Stamm teaches an instrument of analogous art (Fig. 1), comprising an outer sleeve (Fig. 1, ref num 100) and two conductive rings (Fig. 20, ref num 424 and 426) mounted outside the outer sleeve (see Fig. 20, ref num 424 and 426 are around ref num 414, which ref num 100 extends through; para 0141), such that the two conductive rings are electrically connected to the first jaw and the second jaw through conducting wires, respectively (para 0146, “The electrical connection between first and second spring contacts 432, 434 and inner and outer contact rings 424, 426, respectively, electrically connects lead wires 910, 920 with lead wires 754, 794, thus enabling the conduction of energy, e.g., electrosurgical energy, from the generator to electrically-conductive plates 750, 790 of jaw members 720, 760, respectively, for treating tissue grasped therebetween (see FIGS. 7-9)”). Stamm also teaches conductive sheets slidably abut against the two conductive rings (Fig. 18, ref nums 755 and 795; para 0144), respectively; the two conductive sheets are fixedly disposed on the inner wall of the housing (see Figs. 2 and 3), and are connected to a power supply through conducting wires (Fig. 18, ref nums 754, 794), respectively; a knob is disposed at the front end of the housing; and the knob is fixedly connected to the outer sleeve and drives the outer sleeve to rotate synchronously (Fig. 2, ref num 410; para 0141, “Rotation of rotation wheel 410 rotates shaft 100 relative to housing 200”). This connects the jaws to the power source for treatment (para 0143-0144), and rotates the outer sleeve to guide the jaws to the target site (para 0141). 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 Abbott to include two conductive rings and a knob, as this produces the same expected result of providing energy to the jaws and providing the advantage of rotating the jaws at the target site.
37. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Abbott and Worrell, and further in view of Green U.S. 5,383,881 (herein referred to as “Green”).
38. Regarding Claim 13, Abbott fails to teach the blade control mechanism further comprises a blade feeding clip and a blade reset spring; the blade feeding clip is connected to the blade holder; the blade reset spring is sleeved on the inner sleeve, and abuts against the blade feeding clip; the control button is connected to the blade feeding clip through the triggering connecting rod; a button guide slot is disposed inside the housing; and the control button slides along the button guide slot and controls the blade feeding clip to move along the inner sleeve to drive the blade to move.
Green teaches an instrument of analogous art (Fig. 1) comprising a blade control mechanism (Fig. 2), which comprises a blade feeding clip (Fig. 4, ref num 78) and a blade reset spring (Fig. 2, ref num 72), the blade feeding clip is connected to the blade holder (Figs. 2 and 4, ref num 78 is connected to ref num 32) and the blade reset spring is sleeved on the inner sleeve and abuts against the blade feeding clip (Fig. 2, ref num 72 within inner sleeve; see Figs. 2 and 4, ref nums 78 and 32). The control button is connected to the blade feeding clip through the triggering connecting rod (Fig. 3, ref num 16 is connected to ref num 78 via ref num 164; Col 10, lines 48-67 – Col. 11, lines 1-5). A button guide slot is disposed inside the housing (see Figs. 3 and 17-19, ref num 16 has a guide slot); and the control button slides along the button guide slot to control the blade feeding clip to move alone the inner sleeve to drive the blade to move (Col. 10, lines 48-67 – Col. 11, lines 1-5). This achieves the same expected result of moving the blade; 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 Abbott to include the structures configured above in order to produce the same expected result of moving the blade.
Conclusion
39. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794