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 .
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-7 and 10-21 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Devashree et al (2020/0281658).
Referring to claims 1 and 14, Devashree et al teaches a method of planning a microwave ablation procedure and a processor comprising: uploading a pretreatment scan to a control system of an energy delivery system (paragraph 0013); displaying the pretreatment scan on a display of the control system (paragraphs 0050, 0054 and 0068-0070); analyzing the pretreatment scan and identifying a target tissue region that includes a disorder (paragraphs 0056, 0069-0070); creating and graphically displaying a digital target area on the pretreatment scan and relative to the target tissue region (paragraphs 0013, 0070-0074); planning and graphically depicting on the pretreatment scan a target path for one or more planned ablation probes relative to the target tissue region (paragraph 0013, 0074-0075; creating a planned ablation zone for each of the one or more planned ablation probes based on one or more user-selected parameters (paragraphs 0013-0015, 0082-0084); placing one or more actual ablation probes in the subject patient relative to the target tissue region (paragraphs 0014, 0056 and 0103); obtaining a probe scan of a subject patient that detects the one or more actual ablation probes (paragraphs 0049 and 0104); and assigning the planned ablation zone for the one or more planned ablation probes to the one or more actual probes (paragraphs 0061 and 0097-0099) (Figures 1-12B).
Referring to claim 2, Devashree et al teaches wherein the disorder comprises at least one of a tumor associated with tissue, an organ, a gland, a blood vessel, bone, and any combination thereof (paragraphs 0010, 0011 and 0043).
Referring to claim 3, Devashree et al teaches wherein creating the digital target area comprises digitally drawing the digital target area on the pretreatment scan (paragraph 0084).
Referring to claims 4 and 15, Davashree et al teaches wherein planning the target path for the one or more planned ablation probes comprises: setting a distal end of the one or more planned ablation probes at or within the digital target area; setting a proximal end of the one or more planned ablation probes at a location proximal to the digital target area and outside of a body of the subject patient; and generating and graphically depicting a line extending between the distal and proximal ends (paragraphs 0074; Figures 12A).
Referring to claims 5, 16 and 17, Davashree et al teaches wherein graphically depicting broken portions of the line corresponding to portions of the target path that reside behind, or in front of, a plane of the pretreatment scan; graphically depicting solid portions of the line corresponding to portions of the target path that reside in the plane of the pretreatment scan; calculating a distance from the distal end to a point at which the target path exits a skin of the subject patient; and displaying a numerical value of the distance on the pretreatment scan (paragraphs 0088, 0110; Figure 11A).
Referring to claims 6, 7 and 18, Davashree et al teaches identifying and displaying one or more critical pathway regions along the target path for at least one of the one or more planned ablation probes and wherein the one or more critical pathway regions are selected from the group consisting of a dense or high-density area, vasculature, a major organ, a collecting system in the kidney, portions of the lung, and any combination thereof (paragraph 0088).
Referring to claims 10 and 19, Davashree et al teaches creating the planned ablation zone for each planned ablation based on a type of tissue or organ in which the digital target area is located (paragraphs 013-0015, 0019, 0061 and 0068-0070).
Referring to claims 11 and 20, Davashree et al teaches obtaining the probe scan of the subject patient comprises: uploading the probe scan to the control system; overlaying placement of the one or more actual ablation probes on the pretreatment scan; and comparing placement of the one or more actual ablation probes against the digital target area and the target path of the one or more planned ablation probes (paragraph 0088, 0104-0109).
Referring to claims 12 and 13, Davashree et al teaches wherein assigning the planned ablation zone for the one or more planned ablation probes to the one or more actual probes comprises: matching the one or more actual ablation probes to the one or more planned ablation probes based on a matching algorithm; and transferring the one or more user-selected parameters of the planned ablation zones to the one or more actual ablation probes; adjusting the one or more user-selected parameters and thereby altering a size of the planned ablation zone relative to the digital target area (paragraph 0088, 0104-0109; Figures 1-12B).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 8 and 9 rejected under 35 U.S.C. 103 as being unpatentable over Devashree et al (2020/0281658) as applied to claim 1 above, and further in view of Andrea Borsic (2019/0371474).
Referring to claims 8 and 9, Devashree et al fails to teach user-selected parameters. Borsic teaches an analogous method of planning a microwave ablation procedure comprising wherein the one or more user-selected parameters are selected from the group consisting of a length of the one or more planned ablation probes, a model of the one or more planned ablation probes, a desired ablation time, and a desired power output for the one or more planned ablation probes and adjusting the one or more user-selected parameters of at least one of the one or more planned ablation probes and thereby altering a size of the planned ablation zone (paragraphs 0048-0049). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of planning a microwave ablation procedure, as taught by Devashree et al, to select one or more user-selected parameters, as taught by Borsic, in order to allow the operator to modify the procedure to various surgical needs.
Response to Arguments
Applicant's arguments filed April 14, 2026 have been fully considered but they are not persuasive. The examiner maintains that Devashree et al teaches assigning the planned ablation zone for the one or more planned ablation probes to the one or more actual probes (paragraphs 0061 and 0097-0099) (Figures 1-12B). Devashree et al states “[s]tep 306 includes creating a preliminary ablation plan (pre-operative plan) to determine where to put the probes 116” in paragraph 0061 and discusses this at length in paragraph 0098. Paragraph 0098 states that “the ablation application 228 causes the suite monitor 126 to overlay a virtual model of the probe guide 112 and planned probe trajectories on the displayed probe guide scan. The probe guide 112 comes with an arc guide and the displayed virtual probe guide 112 includes a virtual arc guide”. Furthermore, paragraph 0098 teaches “the ablation application 228 may receive adjustments to the planned trajectory based on, for example, real or calculated organ motion while the skin entry point is maintained the same as the center of the registered probe guide 112”. Paragraphs 0099 further teaches repositioning the probe if the planned ablation zone is not within the reachable area.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., assigning planned ablation zones to actual probes after placement) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claim does not require that the assigning of the planned ablation zones for the one or more planned ablation probes to the one or more actual probes occurs after placement. As written the specific sequence is not required in the claims as argued by applicant. Furthermore, only one ablation probe is required by the claim.
Referring specifically to the arguments with regard to claims 12 and 21, the examiner respectfully disagrees. Paragraph 0088 of Devashree discusses matching the one or more actual ablation probes to the one or more planned ablation probes based on a matching algorithm based on a matching algorithm. Devashree et al teaches transferring the one or more user selected parameters of the planned ablation zones to the one or more actual ablation probes (paragraphs 0105-0109). Devashree et al states in paragraph 0105 that “[a]t step 912, the ablation application 228 displays an image showing the actual trajectory traveled by the probe 116 into the patient 12 overlain with the proposed (planned) trajectory set out in the ablation plan created in step 306” and goes on to discuss transferring to one or more user selected parameters (in this case depth and/or number of probes) of the planned ablation zones to the one or more actual ablation probes at length in paragraphs 0108 and 0109).
Referring to arguments beginning on page 13, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Borsic teaches an analogous method of planning a microwave ablation procedure comprising wherein the one or more user-selected parameters are selected from the group consisting of a length of the one or more planned ablation probes, a model of the one or more planned ablation probes, a desired ablation time, and a desired power output for the one or more planned ablation probes and adjusting the one or more user-selected parameters of at least one of the one or more planned ablation probes and thereby altering a size of the planned ablation zone (paragraphs 0048-0049) that is advantageous because this allows the operator to modify the procedure to various surgical needs. Applicant’s arguments state on page 15, that the applied references focus on pre-procedure planning and real-time guidance during insertion, not post placement assignment of ablation zones, however this is not currently being claimed.
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 SAMANTHA M GOOD whose telephone number is (571)270-7480. The examiner can normally be reached Mon to Wed, 7am to 3pm.
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, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SAMANTHA M GOOD/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
Prosecution Insights