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 67 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 67, claim 1 (from which claim 67 depends) recites that the tissue is selected from the group “consisting of” tonsils and adenoids. The phrase “consisting of” is a closed group (MPEP 2111.03). Claim 67 also recites that the tissue is selected from a group, but the group now is now “consisting of” a base of the tongue or concha/turbinates. It is not clear what “tissue” is in view in claim 67, for example, whether the claim require one tissue from claim 1 and one tissue from claim 67, or one tissue from the four listed between claims 1 and 67. It is noted that because “consisting of” is a closed list, dependent claims cannot add to that list. However, the claim term “tissue” is also ambiguous in this context and it is unclear whether a single tissue or multiple regions being part of a single “tissue” are in view.
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, 61, 62 and 67 are rejected under 35 U.S.C. 103 as being unpatentable over Yih (US 2022/0151689) in view of Beyar (US 6,378,525) and Pearson (US 2010/0256628).
Regarding claims 1, 3, 8, 9, 62 and 67, 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 specifically discuss treating tonsils or adenoids specifically, although it is reiterated that Yid does provide an open-ended teaching of treating tissue in other locations ([0008]), specifically for the purpose of treating sleep apnea ([0008]). Beyar discloses another method of treating sleep apnea and specifically teaches that the based of the tongue, tonsils and adenoids can all be subject to tissue shrinking via ablative energies (abstract). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the method of Yid to apply tissue-reducing ablation to any area or combination of areas known to relevant to the treatment of sleep apnea, including the base of the tongue, tonsils and/or adenoids as at least taught by Beyar, that would produce the predictable result of treating the sleep apnea of a particular patient. Yih also 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 thermal ablation modalities such as radiofrequency (RF), one of the energies used by Yih. 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 further modify the method of Yih to employ IRE such as taught by Pearson to produce the predictable result of shrinking tissue 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 avoiding heat-induced symptoms 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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Yih, Beyar 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, Beyar 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 of previous Action for examples). 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.
Claims 60 and 63 are rejected under 35 U.S.C. 103 as being unpatentable over Yih, Beyar and Pearson, further in view of Mickelsen (US 2017/0065343).
Regarding claims 60 and 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]). Further, using IRE specifically to avoid damage to epithelial tissue is known in the art, such as taught by Mickelsen ([0030]). 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 electroporation of Yih employ parameters that would avoid damage to epithelial tissue, such as taught by Yih in general and more specifically by Mickelsen, to produce the predictable result of treating specific tissue in a desired manner while leaving collateral tissue unharmed.
Claim 64 is rejected under 35 U.S.C. 103 as being unpatentable over Yih, Beyar 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, Beyar 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, Beyar and 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.
Claims 1, 3, 62 and 67 are rejected under 35 U.S.C. 103 as being unpatentable over Edwards (US 5,738,114) in view of McKernon (US 2017/0156783).
Regarding claims 1, 3, 62 and 67, Edwards discloses a method for reducing a volume of tissue (col. 2 lines 45-54) comprising inserting an ablation device with at least two electrodes (fig. 1) into the mouth or throat (col. 4 lines 34-35), enclosing a tissue volume of interest between at least two electrodes (by inserting the bipolar electrodes into tissue, col. 7 line 25, fig. 6), and ablating the tissue into which the electrodes are inserted. Note also that Edwards discloses the device can be deflectable which would be another manner of enclosing tissue (col. 6 lines 16-26). Edwards further discloses the tissue being treated include the base of tongue (col. 8 lines 4-12), tonsils and adenoids (col. 2 lines 45-54) along with turbinates (col. 4 line 13). Edwards does not disclose the use of irreversible electroporation (IRE, which would involve “setting” all of the IRE parameters since they are not randomly determined). However, Edwards does the use of RF, microwave, ultrasound, coherent light and thermal transfer, while specifically noting the energy is “not limited to” that list (col. 6 lines 39-48). The ablation technology is very familiar with different ablation energies and commonly teaches that they are functionally equivalent (MPEP 2144.06), that is, that the energies can be combined or substituted in a predictable manner. McKernon, for example, explicitly teaches that various ablation technologies, including microwave and RF (two of the technologies discussed by Edwards) along with both thermal and non-thermal IRE, “are well-known for their applicability in treatment, coagulation and/or targeted ablation or treatment of tissue in the human body” ([0003], see also [0039]). Further, when discussing unwanted thermal consequences and cooling systems, McKernon excludes IRE from the discussion ([0003]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the method of Edwards to use any commonly known ablation technology, including but not limited to non-thermal IRE such as taught by McKernon to avoid heat-induced symptoms, that would produce the predictable result of treating tissue in a desired manner.
Response to Arguments
Applicant's arguments filed 03 July 2026 have been fully considered but, to the degree they are relevant to the amended claims, they are not persuasive. The fact that Yih is directed to thermal ablation is insufficient to prevent the modification to a non-thermal ablation because, first, Yih associates no advantage with thermal ablation and does not teach away from non-thermal ablation. For example, Applicant notes Yih includes a cooling mechanism for heat generation in tissue. But Yih also expressly teaches cryogenic energy which would not, by definition, require a cooling mechanism. So, Applicant’s argument could just have easily been made against replacing RF with cryogenic energy which would clearly be unpersuasive. Further, if a non-thermal energy is used by Yih, that would mean the cooling system can be omitted which results in a safer (having less systems that might fail and result in patient harm), cheaper and/or simpler system which are beneficial traits. Second, it must be recognized that obviousness modifications are based on the level of ordinary skill in the art, where it is well established that such a person is “a person of ordinary creativity, not an automaton” (as discussed in MPEP 2141.03(I)). The body of knowledge surrounding ablation is vast in the ablation technology areas and it is extremely common for a reference in the art to provide a very general teaching that one or more types of ablation can be substituted (in addition to the references cited above, see the references cited below). Without an explicit exclusion from a reference for a specific type, open-ended language is understood to include all recognized ablation types are within the capacity of a person of ordinary skill in the art. However, in the interest of compact prosecution, another rejection of the independent claim (and closely associated claims) is presented. Note that both due to time constraints for search and consideration of amendments filed after a non-final rejection, and for the sake of simplicity and brevity, not all the claims are rejected twice.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Regarding another general discussion of the state-of-the-art of ablation modalities, including RF, microwave and cryoablation, into addition to “non-thermal” modalities such as IRE, see paragraph [0011] of US 2016/0184003 to Srimathveeravalli and paragraphs [0003], [0053] (note “and the like,” open-ended language similar to Yih) and [0054] of US 2019/0254735 to Stewart.
Regarding an ablation system which has a specific teaching that non-thermal IRE is better than thermal ablation, while still teaching that thermal ablation can be used, see paragraphs [0021] and [0048] of US 2016/0166310 to Stewart (PFA in this context being IRE, [0005]) which is understood to be a general teaching that while various ablation modalities might have benefits over others, a person of ordinary skill in the art might still be motivated to use any modality for any number of reasons.
Regarding a system for cardiac ablation (a more dangerous and complex operation than treating sleep apnea in the throat) which specifically uses non-thermal IRE, see paragraphs [0002], [0100] and [0113] of US 2016/0113709 to Maor, which is understood to be a teaching that the level of ordinary skill in the art includes the knowledge that IRE is useful for shrinking tissue in a non-thermal manner.
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
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