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.
Note on Claim interpretation
The claims recite substantial functional limitations, that is, limitations that describe what the system is capable of doing. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the preamble, or elsewhere in a claim, then it meets the claim. However, in the interest of compact prosecution and because the pulsed electric field art is relatively small, prior art is at least occasionally used that specifically discloses performing the claimed steps. But as long as some claims merely recite a generator with the capacity to output waveforms with certain parameters (via some undefined “algorithm”), an obviousness rejection on the grounds that it would be obvious to use a generator to output waveforms with any commonly known parameters will always be a possibility.
Priority
It is noted that the effective filing dates for various claims are different. Only claims 1, 6, 7, 9-15, 17, 19 and 20 appear to have the oldest effective filing date of the provisional 63/246,239. There are twelve intervening documents that may be relevant to one or more of the remaining claims which will be sorted out if/when it becomes relevant to a particular prior art reference.
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 7, 8, 15 and 16 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 7, the claim recites that cell death occurs “over a period of 24 hours.” It is not clear, for example, whether the cell death must occur for 24 hours and then stop abruptly, or if the 24-hour period is simply an inclusive time fame. The first case is likely to raise issues under 35 U.S.C. 112(a) for lack of enablement, and the second case is likely to raise issues under 35 U.S.C. 112(d), for failing to limit the structure recited in claim 1 (since cell death depends not only on the waveform generated by the generator but on the manner in which a given type of tissue is being treated). For the purpose of examination this limitation will be understood to require an amount of cell death occurring within 24 hours.
Regarding claims 8 and 16, the term “minimizes” is a relative term which renders the claims indefinite. The term “minimizes” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear by how much the prior art would have to reduce pulsatile mechanical forces on an extracellular matrix to qualify as “minimizes.”
Regarding claim 15, there is no antecedent basis for “cycles.”
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 6 and 7 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Beebe (US 2011/0288545).
Regarding claims 1-3, 6 and 7, Beebe discloses a system for delivering pulsed electric fields ([0023]) to tumors ([0024]), the system including a generator (e.g. claim 6) for supplying the pulsed electric field to an energy delivery body on an instrument ([0030]). The generator includes an “algorithm” that causes cell death by pyroptosis and/or necroptosis, among a teaching that “all types of programmed cell death” are in view ([0021]), where cell death occurs within 24 hours (fig. 8). Beebe also discloses the generator is capable of creating adaptive immunity ([0029]).
Claims 1 and 4-7 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Guo (US 2018/0154142).
Regarding claims 1 and 4-7, Guo discloses a system for treating tumors ([0002]) including a generator (106, fig. 1) connected to an energy delivery body (110) on an instrument (fig. 1). The generator outputs puled electric fields by an “algorithm” ([0004]) for regulated cell death that includes the release of various damage-associated molecular patterns including ATP, HMBG1 and calreticulin ([0165]), where this cell death occurs over 24 hours (e.g. fig. 18A, C). Guo also discloses the generator is capable of creating adaptive immunity ([0002]).
Claims 1-3, 11, 17, 18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Jimenez (US 2021/0212755).
Regarding claims 1-3, 11, 17-18 and 20 Jimenez discloses a system/method of use including a generator, instrument and energy delivery body (fig. 1), where the generator has an “algorithm” that generates packets of biphasic pulses creating electric fields resulting in apoptosis, pyroptosis, necroptosis “and the like” ([0107]) in tumors ([0164])
Claims 1-3 and 6-20 are rejected under 35 U.S.C. 102(a)(2) as being clearly anticipated by Manucherhabadi (US 2021/0315639).
Regarding claims 1-3 and 6-20, Manucherhabadi discloses a system/method of use including a generator, instrument and energy delivery body (fig. 1), where the generator has an “algorithm” that generates packets of biphasic pulses creating electric fields ([0071]) resulting in regulated cell death including apoptosis, necroptosis and/or pyroptosis ([0128]) and includes an adaptive immune response in tumors ([0128]) within 24 hours ([0128], the healing necessarily occurring after the damage). Note also the extensive discussion of pulse parameters in Table 2 which discloses values within the claimed voltage, frequency, number of pulses per packet, packet delay and cycle delay values. There exists a set of parameters (such as disclosed by Applicant and therefore intrinsic to certain waveforms within the disclosed parameter ranges) that would at least “minimize” pulsatile mechanical forces on the extracellular matrix.
Claims 1, 6-17, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Wasson (US 2021/0052882)
Regarding claim 1, 6-17, 19 and 20, Wasson discloses a system/method for treating tumors ([0002]) that includes a generator ([0079]) for supplying a pulsed, biphasic electric field (fig. 1B) to an energy delivery body on an instrument ([0079]) for treating tumors ([0002]). The generator uses an “algorithm” that results in regulated cell death ([0053]) with 24 hours ([0053]), and prompts an adaptive immune response ([0012]). Wasson further discloses a large range of optional parameters for use including a voltage in the range of 0-10kV ([0055]), a frequency in the range of 0 Hz – 100 MHz ([0060]), where the biphasic pulses are in packets from 1-5000 pulses ([0062]), where there can be a delay between the pulses and the packets that range from 1 microsecond to 30 seconds ([0063], note this paragraph includes other delays that could be considered between “cycles”). There exists a set of parameters (such as disclosed by Applicant and therefore intrinsic to certain waveforms within the disclosed parameter ranges) that would at least “minimize” pulsatile mechanical forces on the extracellular matrix.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Regarding another biphasic pulse generator that produces regulated cell death including the release of calreticulin, ATP and MHGB1, see paragraphs [0027] and [0090] of US 2020/0147371 to Pakhomov. Regarding a PEF system and a teaching that the extracellular matrix should be preserved, see paragraphs [0130] and [0137] of US 2016/0213922 to Goldberg and paragraph [0135] of US 2019/0282294 to Davalos.
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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