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.
Claim Rejections - 35 USC § 112
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.
Claim 13 is 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.
Regarding claim 13, there is no antecedent basis for “after interlocking the secondary electrode.”
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 2-5, 7, 8, 13-15, 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Shuman (US 2014/0276764) in view of Swoyer (US 2007/0179496) and Sato (US 2006/0276873).
Regarding claim 2, 7, 8 and 19, Shuman discloses a system for extending/retracting a secondary electrode (115, fig. 3B) contained within a primary electrode (103) that involves numerous method steps according to how an operator would know how to use the system, including extending a sheath containing the electrodes (bronchoscope working channel, fig. 2), moving coupled electrodes so that the primary electrode is at a first location near a reference point (fig. 6B), then extending the secondary electrode to a second location near the reference point (fig. 6C). The system further includes a housing relative to which the electrodes can move (126). Shuman does not disclose locks for the primary and secondary electrode so that the electrodes can be locked after they have been positioned, or that the primary and secondary electrode or locked together. However, locking elements are common in the art and there is no evidence that their use here produces an unexpected result (within the meaning of MPEP 716.02(a)). Swoyer, for example, discloses a method of using an extendable electrode and teaches that once the extendable electrode is in a desired position it “may” be locked in place until ablation is complete ([0055]). The fact that Swoyer says the electrode “may” be locked, and provides no details about how such a mechanism would work, is evidence that a person of ordinary skill in the art would know how to lock relatively movable elements together using any of countless commonly known mechanisms. Further, locking elements together that are otherwise independently movable is also common in the art such as taught by Sato (e.g. via one or more of 16, 43 and 21 in fig. 13). Therefore, before the application was filed, it would have been obvious to provide the system of Shuman with locks for the electrodes relative to the reference point, such as taught by Swoyer, that would produce the predictable result of allowing the method of operating Shuman to include locking the primary electrode and the secondary electrode in desired locations relative to a reference point, and further to provide any two movable elements with an interlock such as taught by Sato, including the primary and secondary electrodes, that would allow a user to move those elements together if desired. It is noted that any conceivable locking mechanism (or set of locking mechanisms) can be considered “an actuator interlock” and requires movement to transition between lock/unlock positions which can be considered first/second (or second/first) positions.
Regarding claim 12, the features discussed above provide the system of Shuman with a host of options for moving the parts of the system, and locking and interlocking various elements of the system. There is not a specific disclosure of all the possible combinations of the steps of using the system, including the claimed sequence of steps. But the entire purpose of providing the various locking elements is to allow a user the option to lock/unlock elements depending on the circumstances and there is no evidence that this combination of using known elements produces an unexpected result (within the meaning of MPEP 2141(III)). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to use any of the features of Shuman when modified as discussed above in any order, including interlocking any one or more movable elements, moving the elements, unlocking the elements, moving elements independently, and relocking one or more elements, followed or interspersed with any other locking/unlocking/moving steps, that would produce the predictable result of placing electrodes in a location in a safe and effective manner according to the preferences of an operator based on the circumstances in which the method is performed.
Regarding claims 3-5 and 13-15, the claims do not recite any details about elements or steps that would require the primary electrode to move a given amount. Therefore, there exists a point for the primary electrode that, after the secondary electrode is extended and locked, would allow the primary electrode to retract some amount. As discussed above, the locks allow the electrodes to be interlocked and locked relative to a point outside the device. Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to move the primary and/or secondary electrodes together or relative to each other at any point during the procedure throughout their respective range of motion, and to then move the primary and/or secondary electrodes together or relative to each other again throughout their respective range of motion, any number of times, locking either or both electrodes wherever within the ranges of motion, and/or at any point during the procedure, that would produce the predictable result of allowing a user to treat tissue in a desired manner. To summarize, the entire purpose of having adjustable elements is so that an operator can adjust the elements depending on the circumstances, including mere preference, so that it would in fact be obvious to adjust the elements to any point and in any order that would produce predictable result of adjusting electrode position relative to tissue according to those circumstances (see also MPEP 2141(III)). It is noted that any conceivable locking mechanism useful for the primary electrode can be considered a “primary release.”
Regarding claim 17, the system of Shuman does not include two locks (“primary release” “actuator interlock”) for the primary electrode. However, it has been held that duplication of parts is an obvious modification (MPEP 2144.04(VI)(B)). 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 Shuman to include any number of locks for the primary electrode, including two or more, that would produce the predictable result of allowing the method steps of locking/unlocking the primary electrode.
Claims 6, 10, 11, 16, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Shuman in view of Swoyer and Sato, further in view of Allen (US 2016/0262826).
Regarding claims 6, 10, 11, 16, and 21, the system of Shuman as modified does not disclose pushing a button (i.e. actuator) unlocks the primary electrode, or secondary electrode from the primary electrode. However, pushing buttons to unlock movable elements is common in the art and there is no evidence that using such a feature here produces an unexpected result (within the meaning of MPEP 716.02(a)). Allen discloses a button that when pushed unlocks a movable elements (82, fig. 2A, [0042]-[0043]). 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 Shuman to include any commonly known lock/unlock element for any lock in the system including the primary electrode lock and the secondary electrode lock relative to the primary electrode, including respective buttons for pushing to unlock as taught by Allen, that would produce the predictable result of allowing a user to perform the method steps of locking/unlocking movement of that element (including the primary/second electrode). With such a locking mechanism provided, the secondary electrode need not move with the primary electrode. Any actuator can be considered a “primary actuator” or “secondary actuator.”
Claims 9, 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Shuman in view of Swoyer and Sato, further in view of Dumbauld (US 2007/0078456).
Regarding claim 9, 18 and 20, the system of Shuman as modified does not disclose that the “actuator interlock,” when unlocking the secondary/primary electrode, locks the primary/secondary electrode. However, providing a mechanism to prevent two things from happening at the same time is common in the art. Dumbauld, for example, disclose an electrosurgical system and teaches that a mechanism can be employed from preventing one thing from happening if another thing is happening ([0124]). It has been held that the combination of known elements according to known methods to yield predictable results is an obvious modification (MPEP 2141(III)) where in this case the “known element” is simply the fact that it can be beneficial for two events to be optionally mutually exclusive. 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 Shuman to have any lock mechanism, including but not limited to the lock mechanism for the secondary/primary electrode, to be a mutually exclusive lock mechanism such as taught by Dumbauld, excluding any other movement in the system including but not limited to movement of the primary/secondary electrode, that would produce the predictable result of allowing a user to perform method steps for using the two electrodes in a desired manner. Alternatively, it would have been obvious to further modify the system of Shuman to include a second lock for the secondary/primary electrode, distinct from the locks discussed above, this lock a mutually exclusive lock such as taught by Dumbauld, relative to any other movable part including the primary/secondary electrode, that would produce the predictable result of allowing a user to only lock/unlock the secondary electrode relative to the reference point (as discussed in claim 1), or lock/unlock the primary electrode with respect to the unlock/lock status of the secondary electrode (respectively), that would produce the predictable result of allowing a user multiple method step options for operating the system.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Shuman in view of Swoyer, Sato and Allen, further in view of Ford (US 2005/0288664).
Regarding claim 22, the system of Shuman as modified does not disclose that any of the actuators involve a locking arm and a notch. However, this is one of many commonly known locking mechanisms. Ford, for example, discloses a locking mechanism that includes a locking arm (208, figs. 8-9) and a notch (210). 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 Shuman to include any commonly known locking mechanism, including a locking arm and notch such as taught by Ford, for any of the locking mechanism including the secondary actuator, that would produce the predictable result of allowing a user to perform the method steps of interacting with the second actuator to unlock the secondary electrode.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL WAYNE FOWLER whose telephone number is (571)270-3201. The examiner can normally be reached Monday-Friday (9-5).
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794