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 20 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 20, the amendments to the claims have produced a contradiction in claim 20. Claim 12 and 19 both recite that the first position of the interlock lever is the position in which the primary and secondary electrodes are coupled together. But claim 20 recites that in the first position, the secondary electrode can be moved to the second location and the primary electrode cannot be moved. It is not clear how the primary electrode can move relative to the secondary electrode if the interlock lever is in the position which interlocks the primary and secondary electrodes. It also makes it unclear what the limitation “interlock” requires. It is noted this claim bears some similarity to claim 9, but claim 9 recites the unlocked second position, not the locked first position, allows relative movement of the electrodes. Because every reasonable interpretation of this claim results in a contradiction, the claim cannot be searched or rejected using prior art because the prior art clearly will not teach or suggest a contradiction.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 18 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 17, from which claim 18 depends, has been amended to incorporate substantially the same subject matter as claim 18 such that claim 18 does not further limit the subject matter of claim 17. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 12-15, 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), Sato (US 2006/0276873) and Shlain (US 5,460,629).
Regarding claim 2, 7, 8 and 19, Shuman discloses a system for extending/retracting a secondary electrode (105, 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 second electrode is operated by a connection to a sleeve (122 defines a cavity that holds the 105, [0092], and therefore can be considered a sleeve). 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 any part of the primary electrode and any part of the secondary electrode (including the sleeve) in desired locations relative to a reference point, and further to provide any two movable elements with an interlock including the clamp(s) such as taught by Sato, including the primary and secondary electrodes, that would allow a user to move those elements together if desired. Shuman as modified does not disclose the use of an interlock lever movable in a guide slot to lock(clamp)/unlock(unclamp) any of the movable elements, including the primary and secondary electrodes. However, using a movable actuator in a slot for locking/unlocking elements is common in the art and there is no evidence that the use of such an actuator here produces an unexpected result. It has been held that both the combination of known elements according to known methods to yield predictable results and the simple substitution of one known element for another (both discussed in MPEP 2141(III)), where in this case the “known element” is a slot with a locking actuator. Shlain discloses a medical device and teaches that a lever (25) can be movable in a slot (54, fig. 1) between a locked (distal) and unlocked (proximal) positions. 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 modify the lock/clamp actuator for any of the movable elements, including the primary/secondary electrodes, to be any commonly known lock/clamp actuator, including a lever in a slot as taught by Shlain, that would produce the predictable result of allowing a user to lock the movable elements in a desired position.
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.”
Claims 6, 10, 11, 16, 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Shuman in view of Swoyer, Sato and Shlain, 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 additional 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. Either the lever or the button can be considered the “secondary actuator.”
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. Shlain, as discussed above, discloses a locking arm and a locking notch (28, 54, fig. 1). 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 Shlain, 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.
Claims 9, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Shuman in view of Swoyer, Sato and Shlain, further in view of Dumbauld (US 2007/0078456).
Regarding claim 9, 17 and 18, the system of Shuman as modified does not disclose that the interlock lever, when unlocking the secondary/primary electrode, locks the primary/secondary electrode relative to a housing. 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]), both relative to a housing (20, fig. 1A). 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 for locking elements relative to a housing 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. This modification is understood to allow only one electrode to be moved at a time when the electrodes are not interlocked, which includes when either electrode is in the first or second location (which the reader will note is not the same as the first or second position).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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