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, 2, 5, 9, 13, 17, 20-22, 24, 27, 28, 33, 37 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Townley (US 2016/0331459) in view of Muratori (US 2018/0110557) and Levinson (US 2009/0018623).
Regarding claims 1, 2, 5, 17, 21, 22 and 24, Townley discloses a method/system for treating rhinosinusitis ([0038]) within a sino-nasal cavity of a patient (abstract) using an end effector with a plurality of electrodes, at least two of which contact the cavity overlying targeted tissue at a target site ([0066], see also fig. 6A). The method further includes disrupting multiple neural signals ([0032]) proximate to the sphenopalatine foramen (fig. 1C), including the steps of delivering energy in a pulsed treatment pattern ([0066]) to maintain a temperature for ablation (“target temperature,” singular, [0055], see also [0111]). This delivery of energy is intended to treat the nasal condition while “minimizing” or preventing collateral damage ([0111]). The energy delivery is controlled by a controller (fig. 2). The pattern of energy delivery is based on the controller processing identifying properties such as the location of the target tissue or depth of tissue ([0073], [0087]). The pulsed energy treatment pattern comprises data “associated” with any value relevant to the treatment of tissue. That is, the claims do not require the pulsed energy treatment pattern comprises specific parameters, only that the actual parameters are “associated” with treatment time, energy level and temperature. Any conceivable value that is part of a “pulsed energy treatment pattern” is clearly “associated” with any value that causes tissue treatment or results from tissue treatment, including the claimed values. However, in the interest of compact prosecution, it is noted that Townley discloses a very robust set of data that actually is part of the pulsed energy treatment pattern including treatment time ([0047]), energy level (energy amplitude in [0072] and/or energy magnitude in [0045]) and temperature range ([0047], [0055], [0066]) among other parameters which are all predetermined at least in the sense that they are not randomly generated (e.g. duty cycle [0066], impedance [0047] and nerve location/anatomy [0049]). The pattern of energy is delivered in the first place to nerves, which are identified as that type of tissue ([0002], [0048]). Townley further teaches that a subset of the electrodes on a treatment device can be used to deliver non-therapeutic stimulating energy to tissue to sense relevant tissue properties ([0098], [0101]). Townley does not specifically disclose that the consistent temperature range is 60 +/- 0.2 degrees Celsius. However, Townley does disclose an ablation temperature between above body temperature (about 37 degrees Celsius) to 120 degrees Celsius ([0055]), where a temperature under 70° seems preferred ([0095]). Further, very small tolerances of temperature control are common in the art. Muratori discloses an ablation system and teaches that tolerances for temperatures between +/- 0.1-2.0 degrees are known in the art ([0039]). Therefore, before the application was filed, it would have been obvious to modify the method/system of Townley to use any commonly known ablation temperature, including 60 degrees Celsius as taught by Townley within a given treatment time, and to provide that temperature accurately as defined by Muratori to be +/- 0.1 degrees, that would produce the predictable result of applying a desired temperature to tissue for a predetermined amount of time. Townley also does not disclose the use of bang-bang control hardware for maintaining this temperature, where any modulation of the pulsed RF energy would involve the “level and associated duty cycle” of energy (although note that Townley explicitly discloses regulation of a duty cycle to control temperature, [0066]). Many types of control hardware are known in the art and there is no evidence that using a bang-bang controller in this context produces an unexpected result (within the meaning of MPEP 716.02(a)). Prior art such as Levinson recognizes that many controller types can be used to control temperature of ablation (fig. 5), including open loop, bang-bang, and proportional integral derivative ([0054]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the method/system of Townley to use any commonly known control hardware, including bang-bang as taught by Levinson, that would produce the predictable result of generating a desired temperature for ablation.
Regarding claims 9, 13, 28 and 33 whatever the pulsed energy treatment pattern is comprises data that is “associated” with any parameter related to the ablation of tissue, as discussed above, where no parameters are randomly determined. But, in the interest of compact prosecution, Townley does disclose that time and temperature are used to set the pattern ([0047]). Townley further discloses the use of real-time feedback related to temperature and time to control energy delivery ([0047]), where an algorithm is further used to determine efficacy of ablation by comparing sensed data to desired data (which is what “pulsed energy treatment pattern data” is understood to mean rather than being indefinite, [0047], [0089]). Further, Townley as modified to be close to a desired temperature can be considered to disclose a “predetermined temperature range,” i.e. 60 +/- 0.1 degrees Celsius.
Regarding claim 20, the embodiment of Townley discussed above does not specifically disclose that blood vessels are targeted to block blood flow to reduce the function of mucus producing elements. However, another embodiment of Townley does disclose blocking blood vessels in the nose for that purpose ([0056]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the method of Townley to use any steps commonly known to be useful for treating rhinosinusitis, including blocking the vessels that supply blood to overactive tissues, as opposed to producing that result by neuromodulation of the overactive tissues by damaging the nerves, that would produce the predictable result of treating a patient in a desired manner.
Regarding claims 37 and 40, these claims recite purely functional limitations. 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. In this case, the system of Townley is capable of performing the recited functions.
Claims 6 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Townley, Muratori and Levinson, further in view of Johnson (US 2017/0252095).
Regarding claims 6 and 25, the method/system of Townley discloses that sensed data can be correlated to tissue type ([0096]), but does not specifically disclose the use of a neural network. However, use of neural networks is common in the art and Applicant has not disclosed how use of a neural network produces an unexpected result (within the meaning of MPEP 716.02(a)). Further, the fact that Applicant is silent about any of the details of this network requires significant reliance on the level of ordinary skill in the art to enable the invention in the first place. Johnson discloses an ablation device and teaches that machine learning can be used to correlated sensed information to tissue type (abstract), where neural networks are a type of machine learning. Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the method of Townley to use a machine leaning process to correlate sensed information to tissue type such as taught by Johnson, including a neural network, that would produce the predictable result of allowing a user and/or the system to determine tissue type.
Response to Arguments
Applicant's arguments filed 16 September 2026 have been fully considered but they are not persuasive. As noted in the rejections, both in the last Action and more specifically and this Action, the claim language of “associated” is extremely broad and does not require any specific parameter, only that the pulsed energy treatment pattern includes data that is related to (i.e. “associated” with) treatment time, energy level, and temperature range. Each of those values, for example, is associated with the others. In the interest of compact prosecution more specific references to those parameters have been provided (see also the Conclusion below), but this is not a concession to claim scope. Further, the arguments do not address this issue (previously articulated in the rejections) or provide any explanation of why more specifically Applicant understands Townley (as modified) to not disclose the parameters now present in the independent claims in conjunction with the rest of the steps/structures.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Regarding ablation systems that discuss the importance of duration, temperature and amount of energy to ablation (among other relevant values), see paragraph [0009] of US 2014/0276718 to Turovskiy, paragraph [0031] of US 2010/0191142 to Paul, column 3 lines 27-31 of US 5,782,828 to Chen, paragraph [0102] to Callas (US 2012/0226271) and control functions (i)-(xxi) starting at column 13 line 53 of US 7,481,809 to Stern.
THIS ACTION IS MADE FINAL. 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.
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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