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 § 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 1-3, 6, 7, 9 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Garito (US 7,935,110) in view of Houbolt (US 2008/0004611).
Regarding claims 1-3, 6, 7, 9 and 22, Garito discloses an electrosurgical device with a primary electrode assembly comprising a single, contiguous, rectangular conductive element (30, figs. 1, 4) at the distal end of an elongate member (10). Garito does not disclose a secondary assembly. However, using electrode pairs to determine tissue contact is common in the art. Houbolt discloses a skin treatment device similar to Garito and teaches that a rectangular tissue treatment area is surrounded around an entire periphery of the treatment area by more than 4 pairs of electrodes (43, fig. 2) which are used to, independent of treatment, determine tissue contact ([0049]-[0051]). 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)). Therefore, before the application was filed, it would have been obvious to provide the tissue treating area of Garito with a plurality of impedance sensing electrode pairs around a periphery of the tissue treating area, such as taught by Houbolt, that would produce the predictable result of allowing a user to know whether or not the device contacts tissue at those locations.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Garito and Houbolt, further in view of Hettel (US 2017/0164999).
Regarding claim 5, Garito does not disclose an electrode set for a core of the electrode assembly. However, using tissue contact sensors for the core of an electrode is fairly common in the art such as taught by Hettel (38, fig. 2). Further, duplication of parts has been held to be 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 provide the core of the electrode assembly of Garito with a contact sensor, such as taught by Hettel, using any number of the impedance-measuring electrodes taught by Houbolt, that would produce the predictable result or allowing a user or a system to know whether or not the device contacts tissue at those locations.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Garito and Houbolt, further in view of Govari (US 2017/0156791).
Regarding claim 10, it is not clear what the relationship is between the surface area of primary electrode assembly and the surface area of secondary electrode assembly of Garito when modified. However, producing ablation electrodes to be significantly larger than sensing electrodes is common in the art. Govari, for example, discloses that the ablation electrode surface area can be as much as 1o times the sensing electrode surface area ([0013]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the device of Garito to include any commonly known ratio of ablation electrode to sensing electrode, including at least double as taught by Govari, that would produce the predictable result of a functional ablation/sensing device.
Claims 1-3, 6, 7, 9, 21-25, 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Bernaz (US 5,849,009) in view of Houbolt.
Regarding claims 1-3, 6, 7, 9, 21-25 and 27-29, Burnaz discloses an electrosurgical device with a primary electrode assembly comprising a single, contiguous, rectangular, serpentine conductive element (12, fig. 1) at the distal end of an elongate member (11). Burnaz does not disclose a secondary assembly. However, using electrode pairs to determine tissue contact is common in the art. Houbolt discloses a skin treatment device similar to Burnaz and teaches that a rectangular tissue treatment area is surrounded around an entire periphery of the treatment area by more than 4 pairs of electrodes (43, fig. 2) which are used to, independent of treatment, determine tissue contact ([0049]-[0051]). 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)). Therefore, before the application was filed, it would have been obvious to provide the tissue treating area of Burnaz with a plurality of impedance sensing electrode pairs around a periphery of the tissue treating area, such as taught by Houbolt, that would produce the predictable result of allowing a user to know whether or not the device contacts tissue at those locations.
Claims 5 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Burnaz and Houbolt, further in view of Hettel.
Regarding claims 5 and 26, Burnaz does not disclose an electrode set for a core of the electrode assembly. However, using tissue contact sensors for the core of an electrode is fairly common in the art such as taught by Hettel (38, fig. 2). Further, duplication of parts has been held to be 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 provide the core of the electrode assembly of Burnaz with a contact sensor, such as taught by Hettel, using any number of the impedance-measuring electrodes taught by Houbolt, that would produce the predictable result or allowing a user or a system to know whether or not the device contacts tissue at those locations.
Claims 10 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Burnaz and Houbolt, further in view of Govari.
Regarding claims 10 and 30, it is not clear what the relationship is between the primary electrode assembly and the secondary electrode assembly of Garito when modified. However, producing ablation electrodes to be significantly larger than sensing electrodes is common in the art. Govari, for example, discloses that the ablation electrode surface area can be as much as 1o times the sensing electrode surface area ([0013]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the device of Garito to include any commonly known ratio of ablation electrode to sensing electrode, including at least double as taught by Govari, that would produce the predictable result of a functional ablation/sensing device.
Response to Arguments
Applicant’s arguments with respect to 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Regarding a teaching that energy should be supplied to an electrode only when tissue contact is sufficient, see paragraph [0053] of US 2009/0093864 to Anderson (which applies the energy automatically on contact, [0007]) and paragraphs [0031] and [0046] of US 2013/0289679 to Eckhouse. Regarding another device which uses a plurality of tissue contact sensors around the periphery of an ablation electrode, see paragraph [0026] of US 2004/0176754 to Island which also teaches that treatment can be inhibited based on the contact sensors.
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.
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794