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 . 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09 March 2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 35-38 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The new independent claim recites that the actuator causing the deployable element to move distally also urges the movable handle toward the fixed handle. There is no citation provided for these features in the remarks, and the specification does not describe this feature. It appears that Applicant is inferring that because the actuator also moves an (unclaimed) sheath (210, fig. 6) distally with the energizable member (220), where the sheath will cam the jaws closed (fig. 33), that this jaw closure caused by the actuator will therefore also cause the movement of the movable handle toward the fixed handle (which closes the jaws without reference to the deployable element). But the specification discloses that a spring (149, fig. 8) is positioned between the movable handle (40) and the drive bar (142) which attached to the end effectors by a clip (145). In order to move the jaws, the movable handle must overcome some amount of force (applied by flange 46 to the spring and eventually to the clip) before the drive bar moves. Therefore, if the jaws are simply moved, that will move the clip forward (distally) which because of the intervening spring has no necessary relationship to the flange (e.g. pulling the flange) and therefore no necessary relationship to the movement of the handle. That is, while the specification discloses that moving the movable handle toward the fixed handle will close the jaws, the specification does not disclose that moving the jaws will move the movable handle toward the fixed handle, because of the manner in which the drive assembly is constructed.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 35-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dumbauld (US 2005/0113827), in view of Twomey (US 2012/0283727), Hafner (US 2008/0215048) and Ein-Gal (US 2002/0019655).
Regarding claims 35-38, Dumbauld discloses a surgical instrument with a housing (20), an end effector with movable jaws (110, 120) each with electrodes (112, 122) to allow bipolar delivery of energy between the jaws ([0074]). The instrument further includes a drive assembly for opening and closing (i.e. approximating) the jaws by compressing a first movable handle (30) toward a fixed handle of the housing (50). Dumbauld also discloses a deployable element with a distalmost tissue treating portion movable proximally and distally relative to the end effector (154, fig. 1D). The deployable element including constituent parts has a “storage condition,” i.e. any condition in which it is not being used, that is “adjacent” (within the breadth of that term) all the other elements of the end effector including jaw flange (118, fig. 1D). Alternatively, another embodiment of the deployable element (180, figs. 5A-C) having all the previously discussed claim elements includes a storage condition that is more adjacent to the flange than the previous embodiment, including being proximal to the first and second electrodes (fig. 5A). The jaw electrodes are only energizable when the deployable element is in the storage condition ([0086]). The deployable element is actuated by an actuator (70 or 450, figs. 3-4, [0081]). Dumbauld does not disclose an indicator when the jaws are closed, where further compression of the movable handle causes energy to be delivered. Dumbauld also does not disclose that movement of the actuator to move the deployable element distally urges the movable handle toward the fixed handle. Regarding the indicators, such elements are common in the art for a wide range of reasons including an indication that jaws have been closed, such as taught by Twomey ([0054]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the instrument of Dumbauld to include an audible indicator for the jaws-approximated position as taught by Twomey that would produce the predictable result of allowing a user to know that the jaws are in fact closed. Regarding a movable handle position closer to the fixed handle than the jaw-closing position for energizing the electrodes, this is also a common configuration in the electrosurgical forceps art. Hafner, for example, discloses a forceps device with a first compressed position for closing the jaws (shown in figs. 1-2) and a second compressed position for suppling energy to the electrodes on the jaws (via switch 110, [0067]). Whatever amount of movement exists between the closed position and triggering the switch is a threshold amount. Therefore, before the application was filed, it would have been obvious to further modify the instrument of Dumbauld to include any commonly known mechanism of applying energy to the electrodes, including the two compressed handle positions as taught by Hafner, that would produce the predictable result of allowing a user to treat tissue in a desired manner. Regarding the relationship between the jaw actuator (i.e. the movable handle) and the deployable element actuator, the prior art discloses various relationships between movable elements. It has been held that the combination of known elements according to known methods to yield predictable results (MPEP 2141(III)), where there is no evidence that a relationship between the deployable element actuator and the jaw actuator produces an unexpected result. The significant breadth of this limitation is also noteworthy as the claim recites no direct physical relationship between the actuator and the movable handle, only that in some undefined and potentially very indirect manner the actuator cause movement in the movable handle. Ein-Gal discloses an electrosurgical system that includes two movable elements and teaches that the system may be provided with operational modes in which the movable elements are movable together or independently ([0009]). This is understood to be a general teaching that it is beneficial to allow a system with movable elements to have modes that allow a user the option of which elements to move independently or separably, as well as a general disclosure that the level of ordinary skill in the art includes the electrical/mechanical elements necessary for such functionality. Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the system of Dumbauld to include modes for allowing any of the movable elements (the jaws, the knife and/or the deployable element) to be moved independently or relatedly such as taught by Ein-Gal to produce the predictable result of allowing an operator greater choices for how to operate the system. Because the jaws are movable by moving the movable handle, however the mode connects the actuator of the deployable element so as to move the jaws is understood to move the movable handle as well. It is further noted this modification is expressly intended to allow a user to retain the freedom to use the various elements independently as disclosed in Dumbauld (e.g. [0083]).
Allowable Subject Matter
Claims 11, 13, 14, 16-21, 28-34 are allowed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Regarding the general teaching of using a single actuator to move two elements or two actuators to move two elements, see paragraph [0034] of US 2007/0179489 to Dodde. Regarding mechanical elements connecting jaws to a handle in such a way that movement of the mechanical elements will move the handle, see the discussion associated with figures 4 and 6 of US 6,458,130 to Frazier.
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794
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