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.
Claims 2 and 17-20 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.
Regarding claim 2, it is not clear what the relationship is between the plurality of resistors in claim 2 and the at least one resistor in claim 1, not least because both groups of resistors are in the same location. This is assumed to fundamentally be an indefiniteness issue so a rejection under 35 U.S.C. 112(a) is not made at this time (since the specification discloses only one group of resistors in this location, 2908, fig. 29).
Regarding claim 17-20, it is not clear what the relationship is between the plurality of switches in claim 17 and the at least one switch in claim 16. The issue is exacerbated by claim 18 because there is no antecedent basis in that claim for “the at least one switch of the plurality of switches.”
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, 3-7, 9-14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Stewart (US 2019/0030328) in view of Fischbach (US 2023/0329769).
Regarding claims 1, 3-7, 9-14 and 16, Stewart discloses a common type of ablation system including a pulse generator for electroporation ([0057], see also [0068]) connected to a plurality of electrodes (18, e.g. fig. 11) through a switching unit with a plurality of switches (16, [0077], fig. 1) to control the polarity of each electrode for generating electric fields ([0075]-[0077], see also [0095], note subsets of electrodes having the two polarities in e.g. fig. 11). Stewart does not disclose a resistor coupled between the switching unit and the electrodes (although it is noted that all parts of any system are “coupled to” each other). However, using resistors borders on ubiquitous in the electrosurgical arts for countless purposes, including limiting the current applied to the electrode, and there is no evidence that using such a common electrical component “coupled to” other common electrical components to produce an unclaimed result, produces an unexpected result (within the meaning of MPEP 716.02(a)). Fischbach discloses another electroporation system that includes a plurality of electrodes (408, fig. 5) each of which is connected by switches (412, 414, 416) to at least one generator (404, 402), where there are several different resistors (430) which are all “coupled to” all the other electrical components of the system, including some which are between the generator and the switch and some which are between the switch and the electrode for limiting current ([0074]). Therefore, before the application was filed, it would have been obvious to modify the system of Stewart to include resistors for any commonly known purpose anywhere such resistors are known to be useful for that purpose, including resistors for limiting current between each switch and each electrode such as taught by Fischbach, to produce the predictable result of an electrosurgical generator that can function in a safe, effective and/or desired manner.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Stewart and Fischbach, further in view of Alleyne (US 6,468,274).
Regarding claims 2, Stewart as modified does not disclose the resistors are in the “ablation device.” However, the prior art recognizes current limiting resistors can be located anywhere in the electrical pathway and there is no evidence that locating them in the ablation device produces an unexpected result. Alleyne, for example, teaches that current limiting resistors can be located in the generator, the cable between the generator and the device, or the device (col. 29 line 60 to col. 30 line 16). 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 Stewart to have current limiting elements anywhere they are known to be functional, including in the ablation device as taught by Alleyne, that would produce the predictable result of providing current limiting to the system.
Claims 8, 15 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Stewart and Fischbach, further in view of Vaynberg (US 2014/0309628) and Li (US 2019/0329033).
Regarding claims 8 and 15, Stewart as modified does not disclose a particular value for the resistors, presumably because a person of ordinary skill in the art would be able to choose an appropriate value for the desired function. More importantly, Stewart does not disclose the specific intent of current limiting is to maintain a current value for the electrodes within some range. However, using resistors associated with electrodes to limit current in a manner that results in substantially uniform current delivery from the electrodes is common in the art. Vaynberg, for example, discloses an electrosurgical system that discloses a plurality of switches (1124, fig. 4) connected to a plurality of electrodes (1126) and a plurality of resistors (1125). Vaynberg also does not disclose the resistance of the resistors, again because such values are well within the level of ordinary skill in the art, but does specifically note the purpose of the resistors is to limit current, specifically for the purpose of distributing current homogeneously to the electrodes ([0209]), where “homogeneously” is understood to be a difference at least close to 0% between the highest and lowest current electrode. While the resistance value is understood to be a matter for a person of ordinary skill in the art to determine, in the interest of compact prosecution, it is noted that values that fall entirely within the claimed range are known in the art for use in resistors for limiting current, such 500-4000 ohms as taught by Li ([0036]). 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 Stewart to include current limiting resistors for any commonly known purpose, including a current difference between electrodes around 0% such as taught by Vaynberg, by using any commonly known resistance value associated with current limiting, including 500-4000 ohms as taught by Li, that would produce the predictable result of ensuring a consistent current output from the electrodes.
Regarding claim 17-20, Stewart as modified (discussed above with respect to one or more of claims 3-8 and 11-15) discloses all the elements except one or more/plurality of switches are in the device. However, placing switches in devices is common in the art and there is no evidence that where the switches are located produces an unexpected result. Vaynberg discloses a similar system and teaches that the switches and resistors can be located in the device ([0201]). 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 Stewart to include the switches anywhere they would be functional, including the device as taught by Vaynberg, that would produce the predictable result of allowing a user to control which electrodes are active.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Regarding another electroporation system with a plurality of electrodes having independent polarities, where there is no circuit diagram indicating that the level of ordinary skill in the art encompasses generators, switches and electrodes, see paragraph [0117] of US 2018/0214202 to Howard. Regarding another reference that does disclose a positive/negative pulse switching structure, see figure 9 of US 2023/0172659 to Olson. Regarding the use of current limiting resistors associated with a plurality of electrodes, where the resistance is listed at between 500-50,000 omhs, see figure 9 and column 10 lines 22-25 of US 5,366,443 to Eggers.
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
