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.
Claims 24-33, 35 and 36 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 claims 24-33, 35 and 36, the amendment to the preamble of claim 24 has rendered the claim indefinite. Under U.S. practice, method claims (what an invention does) and apparatus claims (what an invention is) are treated differently. The language “A system used to perform a method” makes it unclear exactly what the relationship is between the steps of the method and the structure of the apparatus. For example, the apparatus includes a data processing system that receives temperature and determines a temperature gradient. But those functions have no clear relationship to the steps of claim 10. That is, even though the preamble of claim 24 states that it is a system for performing the method for performing claim 10, the steps of claim 10 are never performed and it is not even clear that the elements of claim 24 could perform the steps of claim 10. This issue could be corrected by stating that the “data processing system” is configured to perform the steps recited by claim 10, as long as there is a clear relationship between the steps of claim 10, receiving the temperature readings and calculating a temperature gradient. Claims 25-33, 35 and 36 depend on claim 24 and are therefore also 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 1-6, 9-18, 21, 22, 24-30 and 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Wittkampf (US 2008/0045943) in view of Zhang (US 2009/0024016).
Regarding claims 1-6, 9, 10, 12-18, 21, 22, 24, 25 and 27, Wittkampf discloses a method/system of treating dysrhythmias in the atria and/or ventricles of the heart (fig. 2, [0034]-[0035]) using at least one ablation catheter (1). Wittkampf further discloses the use of single temperature sensor (e.g. 16 in fig. 3) which can be used for feedback-based control of the ablation energy ([0018]). Wittkampf specifically teaches that excessive heat applied by the ablation catheter can result in unwanted damage to collateral structures such as the AV node ([0003]). Wittkampf does not disclose that the risk of an AV block is predicted based on the change of temperature measured at some undefined distance from an ablation region/site/location/area. However, using temperature to predict outcomes in tissue is extremely common in the art (which is a comment on the level of ordinary skill in the art) and Applicant has not disclosed this step produces an unexpected result (within the meaning of MPEP 716.02(a)). Zhang, as a specific example of that general principle, discloses a temperature monitoring system for use with cardiac ablation which specifically mentions the use of a single temperature sensor such as in Wittkampf is not particularly effective ([0003]). Instead, Zhang teaches that a plurality of temperature sensors (130, which can be thermistors, [0024]) on a plurality of deflectable, curved catheters can be used by a data processing system to create and display an isothermal temperature map on a 3D model of the heart (fig. 5, [0023]) to predict unwanted events including excessive ablation energy applied to regions of the heart ([0019]- [0021], see also [0032] and the discussion associated with figure 5). The map can include both the values of temperature and the change of temperature ([0030], [0032]). Thus, the location at which the temperature is measured includes tissue at least “near” all cardiac tissue. Creating a map of temperatures from multiple temperature sensors includes the creation of a gradient which exists in region encompassing the heart and thus including a path from any point of interest (including a sensitive tissue site) to any other point of interest (including the ablation site). Further, Zhang teaches that the gradient can be used to calculate increases and decreases of temperature based on the gradient in real time ([0030]-[0031]), where the gradient is used for adjusting the ablation ([0023]). Whether or not any particular temperature value indicates any particular occurrence in tissue strictly requires the use of thresholds, that is, a value below which a sensed value means one thing and above which a sensed value means another thing. Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the method/system of Wittkampf to include the structure and steps disclosed by Zhang, including use of change in temperature as detected by a plurality of temperature sensors on a plurality of catheters spaced from the catheter used for ablation to allow a data processing system predict unwanted damage to specific anatomical structures on the basis of change in temperature as displayed on a map, including the AV node as taught by Wittkampf, that would produce the predictable result of a safe and effective cardiac ablation procedure. It is noted that “predict unwanted damage” is understood to include both the display of temperature that results in unwanted damage and a user interpreting temperature information according to what a person of ordinary skill in the art would know since at least some of the claims do not recite what element performs the “prediction” or what that “prediction” is used by the invention to do.
Regarding claim 11, the terminology of the claim is so broad it is almost meaningless. Any part of the sensing catheter(s) of Wittkampf as modified that includes at least one sensor can be considered a “sensor region,” and whatever “sensor region” is “closest” (relative to some undefined other element) to the ablation site can be considered the claimed “sensor region.”
Regarding claim 26, any temperature sensor is “configured to” measure temperature anywhere the sensor can be located. In this case, therefore, the temperature sensors of Wittkampf can measure the temperature radially around the circumference of the catheter.
Regarding claims 28-30, the system of Wittkampf does not specifically disclose the use of a “computer screen” for displaying the model and temperature gradients which are also used for control purposes. However, a “computer screen” is both extremely common and well within the level of ordinary skill in the art and Applicant has not disclosed that using such a trivial and common feature produces an unexpected result. Therefore, before the application was filed, it would have been obvious to modify the system of Wittkampf to display any information relevant to the procedure on any commonly known display device, including a “computer screen,” that would produce the predictable result of allowing a user to see the information.
Regarding claim 35, whether an electrode has a specific polarity depends on the source of energy to which the electrode is attached. Therefore, since the claim recites no source of energy, nor, for example, independent leads, there exists some hypothetical source which would allow any catheter to be considered a “multipolar catheter.” If Applicant understands the invention to be a multipolar catheter, the language can be clarified, although based on the specification it seems the polarity of the catheter does not produce an unexpected result.
Regarding claim 36, all the catheters shown in both Wittkampf and Zhang are curved and are thus considered to meet the broad “circular orientation” language. If Applicant understands the invention to be a catheter in a circle, the language can be clarified, although based on the specification it seems the shape does not produce an unexpected result.
Claims 7, 8, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Wittkampf and Zhang, further in view of Avitall (US 2012/0143177).
Regarding claims 7, 8, 19 and 20, the method of Wittkampf does not disclose that a temperature rate is calculated based on the gradient where the rate is used to determine the risk of overheating a particular region of tissue (i.e. a rate compared to a threshold). However, it is well established that both temperature and rate of temperature change are useful for determination of overheating such as taught by Avitall ([0067]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to derive any value from the gradient commonly known to be relevant to whether tissue is ablated or not in the method of Wittkampf, including both the temperature and the acceleration of temperature a taught by Avitall, that would produce the predictable result of ablating tissue that is desired to be ablated and not ablating tissue that is not desired to be ablated.
Claims 23 and 31-33 are rejected under 35 U.S.C. 103 as being unpatentable over Wittkampf and Zhang, further in view of Wrublewski (US 6,174,309).
Regarding claims 23 and 31, the method of Wittkampf does not disclose that the temperature is calculated based on impedance. Impedance always includes at least a voltage measurement and the claim does not actually recite the step of collecting EMGs. Further, both the calculation of temperature and impedance are “based on” not only the material of the electrodes but the material of any electrically or thermally conductive element/tissue that is part of the electrical or thermal pathway being investigated (respectively). Further, Applicant has made it abundantly clear that it makes no meaningful difference how the temperature is acquired, stating that other commonly known temperature sensors could be used for the same purpose ([0055]) and failing to describe in any detail how exactly this calculation from voltage to impedance to temperature would work (presumably because those steps are commonly known in the art). Zhang further discloses electrophysiological electrodes for collecting voltage information ([0033]) and Wrublewski generally agrees with Applicant that temperature from temperature sensors and temperature from impedance are known in the art (col. 3 lines 25-37). Therefore, before the application was filed, it would have been obvious to further modify the method of Wittkampf to include electrodes as taught by Zhang for collecting the information necessary to calculate impedance including voltage for the purpose of determining impedance and then temperature as taught by Wrublewski to produce the predictable result of allowing the user and/or the system to know the temperature of tissue. It is noted that the electrodes are “configured to” do anything that electrodes can do including mapping.
Regarding claim 32 and 33, the fact that Applicant has claimed mutually exclusive species of the invention suggests that neither produces an unexpected result. As noted by Wrublewski above, temperature sensors can be discrete or function as voltage/impedance sensors, where Zhang discloses discrete electrodes and temperature sensors as discussed above with respect to claim 1. Therefore, before the application was filed, it would have been obvious to modify the system of Wittkampf to have any commonly known electrode/temperature sensor arrangement, including the electrodes as the temperature sensors such as taught by Wrublewski or electrodes as discrete from the temperature sensors as taught by Zhang that would produce the predictable result of functional temperature sensors and electrodes.
Claims 1, 10 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Wittkampf (US 2008/0045943) in view of Nields (US 8,556,888).
Regarding claims 1, 10 and 24, Wittkampf discloses a method/system of treating dysrhythmias in the atria and/or ventricles of the heart (fig. 2, [0034]-[0035]) using at least one ablation catheter (1). Wittkampf further discloses the use of single temperature sensor (e.g. 16 in fig. 3) which can be used for feedback-based control of the ablation energy ([0018]). Wittkampf specifically teaches that excessive heat applied by the ablation catheter can result in unwanted damage to collateral structures such as the AV node ([0003]). Wittkampf does not disclose that the risk of an AV block is predicted based on the change of temperature measured at some undefined distance from an ablation region/site/location/area. However, using temperature to predict outcomes in tissue is extremely common in the art (which is a comment on the level of ordinary skill in the art) and Applicant has not disclosed this step produces an unexpected result (within the meaning of MPEP 716.02(a)). Nields discloses an ablation/data processing system and teaches that changes in temperature of a region including areas distant to an ablation site are measured to create gradients during an ablation procedure (see discussion associated with figs. 6A-F) to protect critical structures near the treatment site (col. 7 lines 17-28, col. 27 lines 45-60). While the main embodiment of Nields is directed to sensing temperature by using various imaging technologies, there is a specific teaching that temperature sensors on the thermal catheter or temperature sensors on separate catheters in or around the region may be used to collect temperature information (col. 11 lines 40-45). Nields teaches that energy is adjusted based on the measured temperature changes (col. 25 lines 4-26). Changing energy on the basis that not changing energy would result in a temperature that would damage critical tissue is understood to be a prediction that damage would occur without the change. Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the method/system of Wittkampf to include the structure and steps disclosed by Nields, including the use of a gradient of change in temperature as measured by sensors on separate probes in the region of interest, to determine if critical structures are predicted to be damaged without intervention such as taught by Nields, including the critical structure of an AV node taught by Wittkampf, that would produce the predictable result of not harming a patient with an ablation procedure.
Response to Arguments
Applicant's arguments filed 25 August 2025 have been fully considered but they are not persuasive.
Applicant argues that the rejection takes official notice with respect to the independent claims and is therefore improper. Applicant has misunderstood official notice. The term “official notice” is used for situations where a feature is so well recognized in the prior art that no specific prior art document is used to support a conclusion of obviousness with regard to that feature. But another prior art document is cited in both rejections of the independent claims. Therefore, by definition, official notice is not being relied upon. However, clarifying language has been added to the rejection.
Applicant further discusses clinical trials. It may be true that Applicant’s disclosed system/method and the system/method resulting from the combination of teachings proposed in the rejection are different. But the question here is not whether Applicant has invented something useful and effective, but whether Applicant has claimed something, among other requirements, novel and nonobvious. The independent claims at least are very broad, which is the only alternative interpretation to indefinite. The interpretation is based, as the rejections are, on the level of ordinary skill in the art. For example, the claims do not define exactly what an “ablation site” is, or what “distant” entails. Probably more relevant to the inventive concept, the claims do not explain what “predicting” requires, whether the word “risk” means anything in particular (as opposed to, e.g., “predicting whether the heart will develop a… block”), how a change of temperature is part of that assessment, or how transient or permanent blocks are distinguished in the context of the prediction (ignoring the fact that claim 1 recites those blocks in the alternative). The combination proposed in the rejection is a system/method that includes the claimed features/steps even though it may not include all the inventive aspects disclosed.
Finally, Applicant argues that Zhang teaches away from the step of predicting a risk of AV block. First, teaching away requires the prior art to “criticize, discredit, or otherwise discourage the solution claimed…” (MPEP 2145(X)(D)(1)). Clearly, Zhang is not discouraging anyone from using the systems previously disclosed as part of that invention even if, as is common in the art, there are various advantages and disadvantages to different solutions to various problems. Second, this argument appears to be based on an overly narrow reading of what “predicting a risk” requires, particularly in the context of the known relationship of temperature and tissue damage within the specific field of cardiac ablation. The claim does not, for example, require that “predicting a risk” is a quantitative measure, or in fact that any particular function is applied to the collected data.
It is noted that additional rejections are presented in the interest of compact prosecution. However, since the amount of time available for updated search and consideration of responses to non-final rejections is limited, only the independent claims are addressed in the new rejections.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Regarding a system which uses a plurality of temperatures to generate a “necrosis probability map,” see for example paragraph [0054] of US 2010/0081857 to Georgi.
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