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.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-3, 8-12 and 60-68 in the reply filed on 26 January 2026 is acknowledged.
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 63 and 65 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 62, the term “limited heat” is a relative term which renders the claim indefinite. The term “limited heat” is not defined by the claim, 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 how much heat is beyond “limited heat.”
Regarding claim 63, the term “minimal damage” is a relative term which renders the claim indefinite. The term “minimal damage” is not defined by the claim, 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 how much damage would have to occur before the damage is no longer “minimal.”
Regarding claim 65, it is not clear what Applicant means by “constant electric field.” In one sense, any electric field is constant as long as it is being generated. In another sense, a constant electric field is impossible because the field strength varies with distance from the conductors from which the field originates. Further, if two electrodes are used to generate the electric field, and the electrodes move, the shape of the electric field changes by definition and so is not constant between the two electrode configurations. On the other hand, it is common in the art to create a substantially uniform electric field when measured at specific at specific locations around electrodes. Because it is not clear what steps are in view, the claim is indefinite.
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, 8, 9, 60-63, 67 and 68 are rejected under 35 U.S.C. 103 as being unpatentable over Yih (US 2022/0151689) in view of Pearson (US 2010/0256628).
Regarding claims 1, 3, 8, 9, 60, 62, 67 and 68, Yih discloses a method for reducing a volume of tissue at the base of the tongue or in the throat or at any number of other locations ([0057]) by enclosing a volume of tissue between two electrodes (fig. 8, 22A or 23, note “any of the device and method embodiments below” in [0057]), the electrodes being located on a device that is inserted, noninvasively, within/through the mouth at least (i.e. where the base of the tongue/throat is located, see e.g. fig. 8). Yih does not disclose the use of irreversible electroporation (IRE). However, Yih teaches that any of several ablation modalities can be used ([0010]), including “any other type or combination of energy modalities” ([0058]). In fact, IRE is commonly used in the art for ablation, having recognized benefits over other ablation modalities such as radiofrequency (RF). Pearson, for example, discloses another tissue shrinking method ([0012]) that uses IRE ([0039]) and teaches that IRE, being non-thermal, has the advantage over thermal modalities such as RF, microwave and cryogen ([0017], note those ablation modalities are also disclosed by Yih such as in [0010]). Pearson also discloses the use of several sequences (pulse trains, [0040]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the method of Yih to employ IRE such as taught by Pearson to produce the predictable result of shrinking tissue at the base of the tongue while avoiding undesirable temperature changes. It is noted that whatever IRE parameters are used to shrink tissue must have been “set”/”selected” at some point because IRE parameters are not randomly generated, where the IRE parameters that result in non-thermal ablation thus result in “limited heat” at the treatment zone.
Regarding claim 61, the method of Yih does not disclose any steps regarding intubation, presumably because a person of ordinary skill in the art would know what options are available to perform a medical procedure. Since there are only two options regarding intubation (yes or no), and the level of ordinary skill in the art includes knowledge of intubation, it would have been obvious to such a person at the time the application was filed was to further modify the method of Yih to include intubation, or to dispense with intubation, to produce the predictable result of treating a patient according to the preferences of a medical professional.
Regarding claim 63, the device of Yih when modified as discussed above does not expressly disclose that the IRE parameters are picked to avoid damage to epithelial tissue. However, Yih does disclose that it may be desirable to avoid damage to epithelial tissue ([0081]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the method of Yih to avoid damage to epithelial tissue, such as taught by Yih, by adjusting whatever ablation modality parameters are being employed, including IRE energy parameters, to produce the predictable result of treating tissue in a desired manner.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Yih and Pearson, further in view of Davalos (US 2019/0069945).
Regarding claim 2, the method of Yih as modified does not disclose the IRE includes a sequency with a frequency from 5kz to infinity. However, the parameters necessary for IRE are commonly known and a matter for a person of ordinary skill in the art to determine based on the factors of a given treatment. Davalos, for example, discloses an electroporation system and teaches a wide range of parameters can be used, including frequences from 1 Hz to 15 GHz ([0072]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the method of Yih to include any commonly known electroporation parameters, including a value over 5 kHz as taught by Davalos, that would produce the predictable result of treating tissue in a desired manner.
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Yih and Pearson, further in view of Davalos and Sano (US 2019/0328445).
Regarding claims 10-12, the method of Yih as modified does not specifically disclose the range of values used to ablate tissue using IRE. However, IRE parameters are commonly known and well within the level of ordinary skill in the art. In the order claimed: Pearson discloses a voltage range (which understood to include positive and negative pulse amplitudes) from 100-10,000 volts ([0040]), Davalos discloses a frequency in the range of 1Hz to 15GHz ([0072]) and further includes positive and negative voltages of various values including 400 volts ([0059]), and Sano discloses an electroporation system which uses biphasic pulses with each polarity having a width of 0.1-100 microseconds ([0024]). The rest of the values (inter pulse delay, number of pulses, number of bursts, inter burst delay) all include 0 as a possible value. However, it is noted that even if some non-zero value were required, these values are common (see conclusion below for example). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the method of Yih to include any IRE parameters commonly known for ablation, including any of the values disclosed by Pearson, Davalos and Sano, including bipolar pulses with a given frequency, voltage, pulse width, amplitude, pulse delay, pulse number, burst number and burst delay (including, where appropriate, 0) that would produce the predictable result of treating tissue in a desired manner.
Claim 64 is rejected under 35 U.S.C. 103 as being unpatentable over Yih and Pearson, further in view of Goble (US 2005/0090819).
Regarding claim 64, Yih does not disclose the use of one of various types of masks for providing anesthesia or oxygen. However, using a mask for either of both of those purposes is common in the art such as taught by Goble ([0043]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the method of Yih to include any commonly known elements associated with surgery, including a mask for delivering anesthesia such as taught by Goble, that would produce the predictable result of a safe and effective medical procedure.
Claim 65 is rejected under 35 U.S.C. 103 as being unpatentable over Yih and Pearson, further in view of Cadossi (US 2018/0001085).
Regarding claim 65, the method of Yih does not disclose amending IRE parameters to maintain a constant electric field in view of the positions of the electrodes. However, it is very well understood that the distance between electrodes is directly relevant to the electric field created between those electrodes. Cadossi discloses an electroporation method and teaches that the parameters used to generate IRE can be adjusted based on the electrode spacing to produce a desired electric field (abstract). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the method of Yih to include accounting for electrode distance when generating the electric field such as taught by Cadossi, to produce the predictable result of ensuring that IRE energy is always applied to tissue in a desired manner during the medical procedure.
Claim 66 is rejected under 35 U.S.C. 103 as being unpatentable over Yih in view of Pearson, further in view of Latimer (US 2015/0018816).
Regarding claim 66, the method of Yih does not disclose measuring a gripping force between the electrodes. However, measuring gripping force in medical devices that grip is common in the art. Latimer, for example, discloses a device with jaws and teaches the use of sensors for determining gripping force which can be used to control the delivery of energy ([0013]). Therefore, before the application was filed, it would have been obvious to further modify the method of Yih to include determining the pressure between the electrodes to allow a control system/user to make informed decisions about the medical procedure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Stewart (US 2017/0035499) discloses an IRE system that uses at least two bursts, each burst having 80 pulses, an inter pulse delay of 0-4 microseconds, and an inter burst delay of 5-30,000 microseconds, along with positive and negative pulses between 300-4000 volts and a pulse width of 1-15 microseconds (all in [0046]). Regarding another IRE system that discloses parameters with ranges that at least overlap with the claimed ranges, see discussion associated with figures 12-15 of US 2019/0336198 to Viswanathan. Regarding the use of a face mask for delivering oxygen, see paragraph [0381] to Ella (US 2004/0260209). Regarding a forceps device with a general teaching the device can be used in treating tonsils and adenoids, see paragraph [0017] to Goble (US 2005/0124987). Regarding another IRE system for reducing the size of tissue which teaches the advantages of non-thermal IRE over RF, see paragraphs [0026] and [0085] of Long (US 2011/0160514). Regarding another system for shrinking tissue in the throat using energy passed between electrodes, see the abstract of Garito (US 6,620,156). Regarding the general teaching that IRE parameters have wide ranges because they must be picked based on many factors, such that choosing appropriate parameters within given ranges is within the level of ordinary skill in the art, see for example paragraph [0015] of Zarins (US 2014/0018880). Regarding an IRE/microwave/RF/ultrasound system that includes a teaching to avoid damage to epithelial layer of tissue by controlling the depth of ablation energy delivery, see paragraphs [0137], [0191], [0288] and [0348]-[0350] of Clark (US 2016/0058502).
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