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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 16 February 2026 has been entered.
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 58 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 58, there is no antecedent basis for “the cryogenic fluid removal lumen.”
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 49, 50 and 52 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Apffelstaedt (US 2005/0240073).
Regarding claims 49, 50 and 52, Apffelstaedt discloses a method for treating tumor margin including the steps of surgically removing a tumor in a manner that results in an exposed tissue surface (figs. 1-2), inserting a spheroidal shell, at the end of a shaft, that has an interior volume and heat transfer surface for contacting the exposed surface (fig. 3), and circulating a 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).
Claim 55 is rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Carroll (US 6,471,693).
Regarding claim 55, while this claim is also rejected below using prior art closer to Applicant’s invention, it is extremely broad and so is rejected here using different prior art. Carrol discloses a probe with a shaft (110b, fig. 1), a shell with an interior volume (inside of 7, see also 3a-b in fig. 4) and an exterior surface (outside of 7), a temperature sensor located on the exterior surface (5a-b) and a supply lumen for delivering fluid to the interior volume (2). All the other language in this claim directed to how the device is used (e.g. “for ablating a marginal tissue region in a surgically crated tissue cavity”) is functional language. 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. The probe of Carroll could be used in the manner claimed and so reads on the claim. It is noted that obviousness rejections over claims 55-60 using a broader interpretation would be simple (see Babkin below which has most of the elements), but additional rejections beyond those below are not made in the interest of simplicity and brevity.
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.
Claim 51 is rejected under 35 U.S.C. 103 as being unpatentable over Apffelstaedt 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 system 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 53 and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Apffelstaedt in view of Trumer (US 2020/0138499).
Regarding claims 53 and 54, the system of Apffelstaedt does not disclose the manner in which cooling fluid is generated because a person of ordinary skill in the art would know how to implement that ablation modality (Apffelstaedt does not describe the specific details of how heat, radiofrequency, chemical agents [0011] or even lasers [0043] are used for the same reason). Trumer can be considered a generic cryosurgical ablation device and teaches that cryogenic temperatures may be created by using fluid cooled by a JT nozzle released into an interior volume at the treatment end of the device ([0068]). 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)). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the system of Apffelstaedt to use any commonly known mechanism for creating cryogenic temperatures, including by use of a JT nozzle for cooling fluid released into the interior volume at the distal end of the device as taught by Trumer, that would produce the predictable result of cooling tissue in a desired manner.
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). Further, these lumens terminate in a shell comprising three concentric walls that define the interior volume that receives the circulating 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, lumens and associated elements taught by Krimsky, that would produce the predictable result of a system that can be used for ablating a tumor margin.
Response to Arguments
Applicant's arguments filed 16 February 2026 have been fully considered but they are not persuasive. Applicant’s arguments are incorrect as a matter of fact. Applicant states “All cited references teach in situ cryotherapy of intact tumors as an alternative to surgery” (page 5 of the remarks). Applicant further states that “Apffelstaedt treats intact tumors in situ via cryotherapy.” But Applicant has not provided any citations to Apffelstaedt in support of either of these assertions, and cannot because no such citations exist. The first sentence of the abstract of Apffelstaedt states “Devices and methods are provided to administer treatment to walls of either naturally occurring cavities or cavities generated by the resection of tissue such as tumors…” (emphasis added). The first sentence of the Field of the Invention section reads “this invention relates generally to methods and devices for applying physical agents such as radiation, heat, cold, electrofrequency or chemical agents, such as thrombolytic and cytostatic medications, to body cavities, including natural body cavities and wound cavities resulting from resection of a tumor, and more particularly to methods and devices to ensure tissue contact and conformance to a non-deformable body introduced to a wound cavity, resulting from resection of a tumor” (emphasis added). Paragraph [0032] includes the statement “Methods to treat conformed body cavities tissues can use individual or combination of physical agents including but not limited to, radiation, heat, cold, electrofrequency or chemical agents, such as thrombolytic and cytostatic medications” (emphasis added). The first figure of the publication shows a tumor (12), the second figure shows the cavity that remains when the tumor is removed (14), and third figure shows the device inserted into the cavity (18). The first claim reads “a non-deformable body having a head portion shaped configured to be positioned within a body cavities resulting from removal of a tumor….” Apffelstaedt discusses at length the reason for the invention is the potential for unwanted cells to remain in the body after removal of a tumor mass, those cells being killed by treatment of the cavity after removal of the tumor (e.g. [0011], [0065]). So, far from “teach[ing] in situ cryotherapy of intact tumors as an alternative to surgery” as asserted by Applicant, Apffelstaedt’s invention is expressly and entirely directed to treatment of the cavity that remains after the surgical removal of a tumor, including by the use of cryogenic temperatures.
Conclusion
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