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 1-4, 9-15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Orszulak (US 2015/0051598), Liu (US 2014/0039473) and Wham (US 2020/0265309)
Regarding claims 1-4, 9 and 12-15, Orszulak discloses a system and method including an end effector with jaws having tissue-contacting/treating surfaces (figs. 1 and 8) and a temperature sensor adjacent to and inwardly spaced from a jaw periphery that either directly or indirectly measures the temperature of the jaw and/or tissue between the jaws (550, fig. 8). The system/method further includes a generator for supplying the tissue-contacting surfaces with treatment energy ([0031]) and for receiving temperature information from the temperature sensor (via the thermal spready control assembly, [0042]). Orszulak teaches that the temperature information is used in real time by the generator to lower power to the tissue-contacting surfaces to “minimize thermal spread” ([0061]) on the basis of a threshold ([0053]). Orszulak does not disclose that temperature information is used to predict that a thermal spread over some undesired (threshold) value will occur, where the generator output is adjusted to prevent the predicted result. However, the prior art (as in the references cited below) is very familiar with prediction and commonly teaches that sensing and prediction of temperature can be performed interchangeably showing that such functions are within the level of ordinary skill in the art and there are no unexpected results associated with either temperature acquisition methodology (where temperature is associated with various results, including thermal spread, depending on the function of the system). Further, the fact that Applicant has not disclosed how exactly the thermal spread is predicted results in an extensive reliance on the level of ordinary skill in the art to enable the invention in the first place. Prior art such as Liu recognizes that predicting a result and controlling a medical system proactively, rather than measuring a result and controlling the system reactively, has the benefit of not subjecting desired outcomes to system processing/output delays ([0107]-[0108]). Liu, even though not an electrosurgical forceps, is reasonably pertinent to the problems faced by the inventor which are the problems, for example, of controlling a system based on feedback data and ensuring that an appropriate temperature is generated by the system. Further, prior art such as Wham teaches that thermal spread predictions based on temperature determinations are within the level of ordinary skill in the art ([0102] which, like Applicant, provides no details on the specific functions employed). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the system/method of Orszulak to include at least a prediction mode where thermal spread is predicted based on the sensed temperature such as taught by Wham, to minimize the effects of processing time and output lag such as taught by Lui, in order to produce the predictable result of preventing thermal spread. It is noted that this mode is understood to be either in place of or in addition to the measurement mode disclosed by the unmodified Orszulak.
Regarding claim 10, the system of Orszulak as modified does not disclose the use of a machine learning algorithm. However, as of the time the application was filed, machine learning algorithms were commonly known for various calculation purposes, including as taught by Wham (abstract). Therefore, before the application was filed, it would have been obvious to further modify the system of Orszulak to include using machine learning algorithms such as taught by Wham for any processor function, including the prediction, that would produce the predictable result of allowing the system to predict thermal spread.
Regarding claims 11 and 20, the system/method of Orszulak as modified does not disclose how far into the future the prediction is made. However, Applicant has not only failed to disclose any specific reason for the claimed range (as opposed to the flat use of a range), but also to disclose how exactly a prediction within the claimed range can be made. At this time the examiner chooses to interpret the specification as relying on the very high level of ordinary skill in the art to enable the invention. But if the purpose of Orszulak as modified is to prevent thermal spread by predicting a temperature that would result in that spread on the basis that the prediction will avoid system lag associated with mere measurement, as discussed above, then it follows that a person of ordinary skill in the art would be able to choose a prediction range that would actually accomplish that purpose. Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the system/method of Orszulak to predict an unwanted thermal spread to any point in the future, including at least 3 seconds, that would produce the predictable result of allowing the system to adjust the output to the electrodes so as to avoid thermal spread.
Claims 5 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Orszulak, Liu, and Wham, further in view of Dodde (US 7,815,641).
Regarding claims 5 and 16, Orszulak as modified does not disclose that the temperature sensor can be positioned on an independent device. However, temperature sensors border on ubiquitous in the art and the fact that Applicant has claimed mutually exclusive configurations of the temperature sensor suggest that where the temperature sensor is located is not associated with unexpected results (within the meaning of MPEP 716.02(a)). Dodde discloses an electrosurgical forceps system and teaches that temperature sensors can be employed on independent devices (note “thermistor holes” in figs. 10-12). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the system/method of Orszulak to include any commonly known type of temperature sensor, including temperature sensor located on an independent device such as taught by Dodde, that would produce the predictable result of allowing the system to have access to information relevant to the desired operation of the system.
Claims 6-8, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Orszulak, Liu, and Wham, further in view of Couture (US 2007/0265616).
Regarding claims 6-8, 17 and 18, Orszulak does not disclose the use of impedance in addition to temperature for predicting thermal spread. It is noted that since impedance chances as the treatment operation progresses, impedance is understood to fall within the broad and undefined phrase “progression status information.” However, thermal spread is a common issue with electrosurgical forceps and the prior art is familiar with influence of thermal spread on various parameters. Couture, for example, teaches that impedance and current are both known to be factors in thermal spread ([0062]). Therefore, before the application was filed, it would have been obvious to further modify the system/method of Orszulak to include in the prediction any parameter commonly known to be associated with thermal spread including the progression status information of impedance that would produce the predictable result of allowing the system to make a more accurate prediction than would be possible with a single parameter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Regarding another generic electrosurgical forceps that uses temperature for feedback-based control to combat thermal spread, see paragraph [0063] of US 2015/0223868 to Brandt. Regarding the general teaching that using sensed temperature or estimated temperature is known, see for example paragraph [0030] of US 2010/0211070 to Subramaniam. Regarding a medical system that predicts a maximum temperature based on measured temperature and other parameters, but also measures the actual temperature as a backup safety mechanism, see discussion associated with figure 10 of US 2011/0077641 to Dunning. Regarding a laser system that uses temperature to predict future temperature for adjusting the output of the laser, see paragraph [0052] of US 2020/0383728 to Hofvander. Regarding use of temperature run through a neural network to predict a future temperature and control the output of RF energy to an electrode on the basis of the predicted temperature, see discussion of the “Predicted Temperature Processor” starting at column 6 line 10 of US 5,906,614 to Stern. Regarding a teaching that the amount of thermal spread from an electrode can be calculated on the basis of make and model of the device, power and duration of the energy source, measured temperature, impedance or other tissue information, see paragraph [0068] of US 2010/0268067 to Razzaque.
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