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 52-54, 56 and 58-60 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 52 and 56, the claim recites that the shell has a generally spheroidal or ovoidal shape. It is unclear what the relationship is between this limitation and the limitation in claim 49 and 55 (respectively) which recites that the heat transfer surface being generally spheroidal or ovoidal and convex, where the heat transfer surface is the outer part of the shell.
Regarding claim 58, first, it is unclear what the relationship is between the cryogenic fluid removal lumen recited in claim 58 and the cryogenic fluid removal lumen recited in claim 55. Second, it is not clear what the relationship is between the supply lumen and the removal lumen(s) in claim 58 since claim 55 already recites that the supply lumen is disposed concentrically about the removal lumen.
Regarding claims 53, 54, 59 and 60, it is unclear if the “cooling fluid” recited in these claims is the same as the “cryogenic cooling fluid” recited in claim 49 or 55.
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 49, 50 and 52-54 are rejected under 35 U.S.C. 103 as being unpatentable over Apffelstaedt (US 2005/0240073) in view of Milder (US 5,281,215).
Regarding claims 49, 50 and 52, Apffelstaedt discloses a method for treating a tissue cavity created by surgery including the steps of surgically removing a tumor in a manner that results in an exposed tissue surface (figs. 1-2, abstract, [0065]), inserting a spheroidal, convex shell, at the end of a shaft, that has an interior volume and spheroidal, convex outer heat transfer surface for contacting a circumferential area of the tissue cavity (fig. 3), and providing a cryogenic cooling fluid through the interior volume for to ablate the exposed surface until a predetermine end point occurs such as treatment duration or “cooling profile” (claims 37-39, 47 and 50, note sterilization of tumor bed via cold temperatures in [0011], see also [0035] regarding the use of liquid nitrogen which has a boiling point of about -196°C). Because the cooling fluid is at a temperature that sterilizes the tumor bed ([0011]), the cooling fluid is a cryogenic cooling fluid. Apffelstaedt does not disclose the specific structures for circulating the cryogenic cooling fluid at least because such elements are extremely common in the art and well within the level of ordinary skill in the art. Apffelstaedt also does not disclose the specific details of numerous other disclosed ablation modalities including RF energy ([0011]), heat energy ([0011]) or laser energy (claim 7) which is evidence that the level of ordinary skill in the art encompasses the rudimentary structures necessary for sterilizing tissue using those types of energy. Milder discloses a cryogenic ablation device and teaches that an inner fluid removable lumen (14, fig. 4) and a concentrically outer supply lumen (16) are used to supply an interior volume (34) with cryogenic fluid. It has been held that the combination of known elements according to known methods to yield predictable results is an obvious modification (MPEP 2141(III)), where in this case the known elements are simply the lumens necessary to allow cryogenic cooling fluid to be supplied and removed from an interior volume. Therefore, before the application was filed, it would have been obvious to modify the method of Apffelstaedt to use any commonly known structures for supplying a cavity with cryogenic cooling fluid, including the concentric supply and removal lumens as taught by Milder, that would produce the predictable result of allowing cryogenic temperatures to be generated in the shell for sterilizing a surgically created tissue cavity.
Regarding claims 53 and 54, the method of Apffelstaedt as modified does not disclose that the cooling fluid is cooled as it is released into the interior volume by Joule-Thomson expansion. However, this is a common structure for creating cool temperatures. In fact, Milder discloses both that cooling fluid can be merely circulated to reach cool temperatures (as discussed with respect to fig. 1, col. 4 lines 20-45) or that cooling fluid can be passed through a Joule-Thomson nozzle to create cool temperatures within the chamber (as discussed with respect to fig. 4), indicating that they are functional equivalents (MPEP 2144.06). Therefore, before the application was filed, it would have been obvious to further modify the method of Apffelstaedt to include any commonly known mechanism for generating cool temperatures, including Joule-Thomson expansion into the interior volume such as taught by Milder, that would produce the predictable result of allowing a user to treat tumor margines in a desired manner.
Claim 51 is rejected under 35 U.S.C. 103 as being unpatentable over Apffelstaedt and Milder, further in view of Babkin (US 2010/0168725).
Regarding claim 51, Apffelstaedt does not disclose monitoring isotherms to control ablation depth. However, this is common in the art, where Apffelstaedt does teach a specific depth of ablation is contemplated (e.g. claims 48-49). Babkin discloses a cryosurgical system and teaches that ablation depth can be controlled by using monitored isotherms (fig. 1b, 2b and 3b, [0038]). Further Babkin explicitly teaches this allows an ablation of a tumor margin ([0042]) and is thus directly related to the tumor cavity ablation disclosed by Apffelstaedt. That is, both systems are concerned with not just removal of a tumor (physically or by ablation), but with removal of problematic tissue immediately adjacent to the tumor. Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the method of Apffelstaedt to include controlling ablation depth by monitoring isotherms, as taught by Babkin, to produce the predictable result of killing cells in a given range from the tumor cavity.
Claims 55-60 are rejected under 35 U.S.C. 103 as being unpatentable over Apffelstaedt in view of Swanson (US 2005/0251122) and Krimsky (US 2020/0015878).
Regarding claims 55-60, Apffelstaedt discloses all the features discussed above but does not disclose the details of the cryogenic embodiment or a temperature sensor on the shell. Regarding the temperature sensor, such elements are common in the art and there is no evidence that providing one on the shell produces an unexpected result (as defined in MPEP 716.02(a)). The fact that Applicant does not show or describe this sensor anywhere other than the originally filed claims, and so does not describe how the sensed temperature information is even used, is evidence of the opposite. Swanson can be considered a generic cryosurgical system and teaches that providing temperature sensors on a treatment element (446, 448, fig. 44) allows a more accurate measure of tissue temperature ([0149]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the tissue-treating shell of Apffelstaedt to include temperature sensors as taught by Swanson to produce the predictable result of allowing a user or control system to know the tissue temperature adjacent to the shell. Regarding the circulating structure, Krimsky discloses an outer supply lumen (256 in fig. 2) concentrically around a fluid removal lumen (258). These lumens must be separate from each other by definition (i.e. if they are to perform simultaneous supply/removal functions as described). Further, these lumens terminate in a shell comprising three concentric walls that define the interior volume that receives the circulating fluid (the three walls in distal portion 30 that define the circulation path for the fluid, fig. 2). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the generally spheroidal shell of Apffelstaedt to use any commonly known structure for producing cryogenic temperatures, including the concentric walls of the treatment portion and concentric supply/removal lumens as taught by Krimsky, that would produce the predictable result of a system that can be used for ablating a tumor margin with cryogenic temperatures.
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. While it is not entirely clear what Applicant’s goal is in referencing a temperature of -135° C in the remarks, since that limitation is not in the claims it is not addressed in the rejections. It is noted, though, that this value is within commonly known cryosurgical temperature ranges. Damasco (US 2003/0055416), for example, teaches that Joule-Thomson nozzles can be used to create temperatures of around -150°C ([0045]).
It is noted, further, that it is not clear from the remarks why Applicant regards the amendments to claim 55 to define around the prior art cited in the previous rejection under 35 U.S.C. 103. While the language has a different scope, Apffelstaedt clearly treats a circumferential area of a tissue cavity with a generally spheroidal heat transfer surface, and Krimsky clearly shows a fluid removal lumen in the shaft, fluidly connected to an interior volume and concentrically within a supply lumen. The obviousness of combining known structures according to known methods to yield predictable results is well established (MPEP 2141(III) and there is no evidence that the use of concentric supply/removal lumens does anything other than what a person of ordinary skill in the art would expect. Further, as noted above, the fact that Apffelstaedt does not even bother to show which specific mechanism is used to generate sterilizing temperatures is strong evidence that any commonly known mechanism would work for that purpose. While uncommon, prior art teaching that “it does not matter what structure is used to produce this common result” cannot be ignored.
It is conceivable that some of the embodiments shown in Applicant’s figures may have details that the prior art does not disclose for this type of device. For example, figure 2 appears to show two physically distinct circulation paths, separated by a central, longitudinal element. Krimsky does not disclose physically separated circulation paths. However, between the fact that Applicant’s specification appears to be silent on the exact manner in which the flow paths are physically separated, and the fact that a prior art search has not been conducted for such a feature specifically, it cannot be determined whether that unclaimed feature would be a patentable distinction over the prior art. Further, again without making any comment about patentability, it is noted that the steps and structures associated with the coaxial suction channel shown in figure 5 remain unclaimed. An updated search is always required where new claim language is submitted.
Conclusion
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.
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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