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.
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-10, drawn to an ablation system, classified in A61B 18/1815.
II. Claims 11-14, drawn to an ablation system, classified in A61B 2018/00642.
III. Claims 15-20, drawn to a method, classified in A61B 2018/00577.
The inventions are distinct, each from the other because of the following reasons:
Inventions I and II are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because it does not require all of the specifically-claimed ‘computing device instructions/steps’. The subcombination has separate utility such as for displaying feedback (which is not claimed in the combination).
The examiner has required restriction between combination and subcombination inventions. Where applicant elects a subcombination, and claims thereto are subsequently found allowable, any claim(s) depending from or otherwise requiring all the limitations of the allowable subcombination will be examined for patentability in accordance with 37 CFR 1.104. See MPEP § 821.04(a). Applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Inventions I & III and II & III are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the apparatuses as claimed can be used to practice another and materially different process, such as a process that targets a different area (e.g. an external target).
Restriction for examination purposes as indicated is proper because all these inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because at least the following reason(s) apply: the groupings have acquired a separate status in the art as shown by their different classification, their recognized divergent subject matter, and their differing field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
During a telephone conversation with Nathan Weber on January 8, 2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-10. Affirmation of this election must be made by applicant in replying to this Office action. Claims 11-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Objections
Claim 9 is objected to because of the following informalities: In line 5, “determined” should be replaced with -determination-. Appropriate correction is required.
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.
Claim(s) 1, 2, 5, and 7-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen, U.S. 2021/0361353 (hereinafter Chen).
Regarding claim 1, Chen discloses (note figs. 2-3) an ablation system comprising: an ablation device including: a radiating antenna (120) configured to apply microwave ablation energy to a target within a patient to ablate the target (note paragraph 32); and a fiber (222) including Bragg gratings (224) formed along a length thereof and configured to reflect light therefrom (note paragraph 36); a computing device (note paragraphs 4 and 37) necessarily including a processor and memory storing instructions which, when executed by the processor, cause the computing device to: calculate temperature measurements based on the reflected light during application of microwave ablation energy to the target (note paragraph 33); and extrapolate the temperature measurements calculated to generate an ablation volume in real time (note paragraphs 48 and 52).
Regarding claim 2, Chen discloses (see above) a system further comprising a display operably coupled to the computing device, wherein the computing device is configured to cause the display to display a progression of the ablation volume in real time (note paragraphs 48-52).
Regarding claim 5, Chen discloses (see above) a system wherein the Bragg gratings are etched into the fiber (note paragraph 36).
Regarding claim 7, Chen discloses (see above) a system wherein the ablation device is a rigid microwave ablation device configured to be percutaneously inserted through tissue to access the target (note paragraph 35).
Regarding claim 8, Chen discloses (see above) a system wherein the computing device is necessarily configured to generate the ablation volume ‘based on’ the extrapolated temperature measurements, a total amount of microwave ablation energy applied, and a duration of energy application (note paragraphs 48-52 – i.e., the generated volume is necessarily dependent on all of these).
Regarding claim 9, Chen discloses (see above) a system wherein the computing device is configured to: determine an expected ablation zone geometry to be formed by the ablation device based on a model of the ablation device; and extrapolate the temperature measurements based on the expected ablation zone geometry determination (note paragraph 50).
Regarding claim 10, Chen discloses (see above) a system wherein the expected ablation zone geometry is capable of being substantially spherically shaped, and the computing device is necessarily configured to extrapolate the temperature measurements ‘based on’ this shape.
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(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Keidar, U.S. 2004/0147920 (hereinafter Keidar).
Regarding claim 3, Chen discloses (see above) an ablation system wherein the computing device is configured to display a feedback image of ablation volume. However, Chen fails to explicitly disclose that the computing device is configured to cause the display to overlay the ablation volume onto an image of the target within the patient. Keidar teaches a similar system comprising a computing device that is configured to cause a display to overlay an ablation volume onto an image (i.e., map) of a target within a patient (note paragraph 11). It is well known in the art that this feedback configuration would facilitate the visualization of the progression of ablation, thereby resulting in increased safety and efficiency. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the system of Chen to comprise a computing device that is configured to cause the display to overlay the ablation volume onto an image of the target within the patient in order to increase safety and efficiency.
Regarding claim 4, Chen discloses (see above) an ablation system wherein the computing device is configured to display a feedback image of the expected/estimated ablation zone. However, Chen fails to explicitly disclose that the computing device is configured to cause the display to overlay the expected/estimated ablation zone onto an image of the target within the patient, along with the progression of the ablation volume. Keidar teaches a similar system comprising a computing device that is configured to cause a display to overlay an expected/predicted ablation zone onto an image (i.e., map) of a target within a patient, along with the progression of an ablation volume (note paragraph 11). It is well known in the art that this feedback configuration would facilitate the visualization of the progression of ablation, thereby resulting in increased safety and efficiency. Therefore it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the system of Chen to comprise a computing device that is configured to cause the display to overlay the expected/estimated ablation zone onto an image of the target within the patient (along with the progression of the ablation volume) in order to increase safety and efficiency.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Dolgonos, U.S. 2019/0247118 (hereinafter Dolgonos).
Regarding claim 6, Chen discloses (see above) an ablation system comprising a rigid microwave ablation device. However, Chen fails to explicitly disclose an ablation system comprising a flexible microwave ablation device. Dolgonos teaches a similar system comprising a microwave device (note paragraph 6), wherein “the probe may be rigid, semi-rigid, or flexible depending upon the designed means for introducing the needle antenna to the target tissue” (note paragraph 25). It is well known in the art that these different probe configurations are widely considered to be interchangeable (as can be seen by the embodiments in Dolgonos). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the system of Chen to comprise a flexible (or semi-rigid) microwave ablation device. This is because this modification would have merely comprised a simple substitution of interchangeable probe configurations in order to produce a predictable result (see MPEP 2143).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
U.S. 2020/0069192 (Sanborn).
U.S. 2014/0025066 (Kerr).
U.S. 2014/0336637 (Agrawal).
U.S. 2007/0156212 (Saxena).
U.S. 7,048,732 (Ellingsen).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS ANTHONY GIULIANI whose telephone number is (571)270-3202. The examiner can normally be reached Mon - Fri 9:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794
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