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 Objections
Claims 2 and 10 are objected to because of the following informalities:
In claim 2, “searching a corresponding file” should read --searching for a corresponding file--
In claim 10, “user’s identification information” should read --the user’s identification information--
Appropriate correction is required.
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 3-11 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.
Claim 3 recites the limitation “the file database” in line 4. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, this limitation will be read as --the preset file database-- as recited in claim 2. Dependent claims 4-11 are necessarily rejected as depending upon a rejected base claim.
In claim 5, the scope of “to prompt the user to select” is unclear because it is unclear what the user is prompted to select. For examination purposes, this limitation will be read as wherein the user is prompted to confirm a selection of a set of alternative ablation parameters.
Claim 6 recites the limitation “the complications” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation “the ablation parameters” in line 5. The scope of this limitation is unclear because it is unclear which ablation parameters are referred to. For examination purposes, this limitation will be read as the alternative ablation parameters.
Claim 7 also recites the limitation “the target ablation object” in line 3. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, this limitation will be read as --the ablation object -- as recited in claim 1.
Claim 8 recites the limitations “the ablation operations” and “after ablation operation” in lines 8-9 and 11-12. The scope of these limitations is unclear because they lack antecedent basis, and it is unclear whether they refer to the same quantity. For examination purposes, the limitations will be read as --a cumulative number of ablation operations […] after a most recent ablation operation is completed--.
The scope of claim 11 is unclear because the meaning of “the extracted ablation parameters are not capable of completing parameter configuration of all devices to be configured” and “wherein the target device is not capable of performing parameter configuration by utilizing the extracted ablation parameters” is unclear, and the limitations “the target device” further lacks antecedent basis. For examination purposes, this claim will be read without the stated limitations.
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 and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Brannan (US PGPub No. 2017/0319276) in view of Asconeguy (US PGPub No. 2012/0239019).
Regarding claims 1 and 12, Brannan teaches an ablation parameter configuration method (methods in Figs. 3-4), applied to a computer terminal (Fig. 1: computing device 100; Fig. 2: application 216), comprising:
creating an ablation task in response to a task creation instruction; acquiring a target file to which the task creation instruction points and extracting ablation parameters from the target file, associating the extracted ablation parameters with the ablation task, and recording an association relationship between the ablation parameters and the ablation task (par. 0041: “a user may use computing device 100 to load a treatment plan 400 (FIG. 4) into application 216;” par. 0043: “Treatment plan 400 generally includes selection of a treatment best suited for a given ablation procedure based on the target's tissue type, the target's proximity to other tissue structures, the size of the target, and/or other characteristics of the target, patient, etc. Treatment plan 400 may include measuring and/or varying the thermal dosage to one or more targets during ablation in accordance with a temperature accumulation profile 400A”);
wherein the target file comprises an ablation scheme of an ablation object to which the task creation instruction points (par. 0043: “the selection of treatment plan 400 may include selecting a temperature accumulation profile 400A to plan and prepare for an ablation procedure. For example, if the target is located in a patient's liver, then a user would select the temperature accumulation profile 400A for the liver. If the target was located in the patient's kidney, then a user would select a temperature accumulation profile 400A for the kidney, and so on and so forth. However, the temperature accumulation profiles 400A are not limited to categorization based solely on the location; rather, temperature accumulation profiles 400A may be categorized or sub-categorized according to other characteristics of the target tissue, ablation zone size, proximity of the target to other tissue structures, behavior of the target and adjacent tissue structures when subjected to energy over time, characteristics of the patient, etc”);
acquiring target ablation parameters of a target ablation task to which a task execution instruction points according to the recorded association relationship when the task execution instruction is triggered, and configuring the target ablation parameters into an ablation system (par. 0048: “temperature accumulation profiles 400A of treatment plan 400 (see FIG. 4) are used to automatically adjust energy output, heating/cooling, etc. of the probe 130 (FIG. 1) to provide an appropriate thermal dosage over the course of an ablation procedure based on a treatment plan 400 selected;” examiner interprets energy output and heating/cooling, etc. of the probe as target ablation parameters; see also user interface displayed in Fig. 8 with selected temperature accumulation profile 812 and Start Ablation button as a task execution instruction).
Brannan teaches a microwave ablation system and does not explicitly teach wherein the target ablation parameters are configured into a radio frequency ablation system. However, in an analogous art, Asconeguy teaches a system for ablation that may utilize radiofrequency energy, among other forms of energy delivery for ablation (Fig. 1: ablation system 10; par. 0019: “The treatment region(s) may deliver, for example, cryogenic therapy, radiofrequency energy, electroporation treatment or other energetic transfer with a tissue area in proximity to the treatment region(s), including cardiac tissue, tumors, or other undesired growths or structures”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute Asconeguy’s radiofrequency ablation system for Brannan’s microwave ablation system, since Asconeguy contemplates multiple energy modalities for ablation, and one of ordinary skill in the art could have performed such substitution, and the results would have been predictable, i.e., ablation would be performed using radiofrequency rather than microwave energy.
Claim 12 is rejected for the same reasons as claim 1, because Brannan in view of Asconeguy teaches an ablation parameter configuration device (see Brannan at Fig. 1: computing device 100) comprising software modules (Brannan at Fig. 2: application 216) configured to perform the method steps of claim 1.
Regarding claims 13 and 16, the combination teaches the method of claim 1 as described previously. Brannan further teaches an electronic apparatus comprising a memory and a processor (Fig. 2: computing device 100 with memory 202 and processor 204); the memory storing executable program codes thereon; the processor being electrically coupled to the memory, calling the executable program codes stored on the memory, and executing the ablation parameter configuration method defined in claim 1, and a computer-readable storage medium on which a computer program is stored, characterized in that the computer program, when executed by a processor, implements the ablation parameter configuration method defined in claim 1 (par. 0035: “Memory 202 includes any non-transitory computer-readable storage media for storing data and/or software that is executable by processor 204 and which controls the operation of computing device 100. Processor 204 may be a general purpose processor, a specialized graphics processing unit (GPU) configured to perform specific graphics processing tasks while freeing up the general purpose processor to perform other tasks, and/or any number or combination of such processors”).
Regarding claims 14-15, the combination teaches the device of claim 1 as described previously. The combination further teaches an ablation parameter configuration system comprising a radio frequency ablation system (Asconeguy at Fig. 1: radiofrequency ablation system 10),
a parameter configuration device and ablation control device (Brannan at Fig. 1: computing device 100) and database server (Brannan at par. 0036: “computing device 100 may receive computed tomographic (CT) image data of a patient from a server, for example, a hospital server, internet server, or other similar server”);
the parameter configuration device and ablation control device being configured for executing steps of the ablation parameter configuration method defined in claim 1 (Brannan at par. 0041: “a user may use computing device 100 to load a treatment plan 400 (FIG. 4) into application 216”);
the radio frequency ablation system comprising a radio frequency ablation catheter (Asconeguy at Fig. 1: elongate body 16), a neutral electrode (Asconeguy at par. 0033: “The generator 54 may be operable in one or more modes of operation, including for example: (i) bipolar energy delivery between at least two electrodes 30 or electrically-conductive portions of the medical device 12 within a patient's body, (ii) monopolar or unipolar energy delivery to one or more of the electrodes 30 or electrically-conductive portions on the medical device 12 within a patient's body and through a patient return or ground electrode (not shown) spaced apart from the electrodes 30 of the medical device 12, such as on a patient's skin for example”) and an injection pump (Asconeguy at par. 0032: “the control unit 14 may also include pumps, valves, controllers or the like to recover and/or re-circulate fluid delivered from the fluid supply 50 to the handle 38, the elongate body 16, and/or the fluid pathway(s) of the medical device 12”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute the radiofrequency ablation system components taught by Asconeguy for the corresponding microwave ablation system components taught by Brannan, for the same reasons set forth in the rejection of claim 1.
Claims 2-7, 9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Brannan in view of Asconeguy and further in view of Allison (US PGPub No. 2010/0081971).
Regarding claim 2, Brannan in view of Asconeguy teaches the method of claim 1 as described previously. The combination does not explicitly teach wherein before the step of creating the ablation task in response to the task creation instruction, the method comprises: receiving the task creation instruction that comprises an identification information of the ablation object; the step of acquiring the target file to which the task creation instruction points and extracting ablation parameters from the target file comprising: searching a corresponding file in a preset file database according to the identification information and taking the corresponding file as the target file. However, in an analogous art, Allison teaches a radio frequency treatment method comprising receiving an instruction that comprises an identification information of an ablation object, namely, a patient (par. 0089: “the pre-treatment data set may contain patient identification information, for example a patient's name or medical identification number for archiving and retrieval of the pre-treatment data set to/from the data storage device 408” and par. 0110: “the treatment plan request module 420 can receive one or more unique identifier codes with the transmitted request. Presentation of the one or more unique identifiers can initiate a protocol run by the treatment plan request module 420 to retrieve the data sets corresponding to the one or more unique identifiers”), and searching for a corresponding file in a preset file database according to the identification information and taking the corresponding file as the target file (par. 0092: “If a treatment plan is requested, the treatment plan request module 420 searches data storage device 408 to locate and retrieve 1) the patient-specific pre-treatment data set”),
which is part of an algorithm that assists a medical practitioner in the selection of a treatment plan (par. 0046). 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 the combined reference by incorporating the search and retrieval steps of patient-specific treatment information, as taught by Allison, in order to assist a medical practitioner in the selection of a treatment plan, as taught by Allison.
Regarding claims 3-7, the combination teaches the method of claim 2 as described previously. Allison further teaches wherein the method further comprises acquiring biological indicator information, historical ablation information and description information of an ablation site of the ablation object when the corresponding file is not found in the file database and searching for at least one set of alternative ablation parameters matching the biological indicator information, historical ablation information and descriptive information in a preset historical ablation database (par. 0093: “The treatment plan request module 420 can also retrieve a plurality of empirically derived and/or a priori data sets (the "model data sets") for comparison to the patient-specific data sets”);
wherein the biological indicator information comprises at least one of the complications, weight, blood pressure within a preset time period, heart rate, blood sugar, blood lipids, vital capacity and oxygen saturation, age and gender of the ablation object (par. 0087: “A pre-treatment data set can include general patient information such as gender, age, height, weight, etc”); the historical ablation information comprises the historical number of ablation operations performed on the ablation object (par. 0042: “The treatment plan can be based on patient-specific information, patient desired treatment results, a priori information and empirically-derived information relating to previously implemented treatments”); and the description information comprises position, size, shape and area of the ablation site (par. 0087: “The pre-treatment data set can also include information characterizing the patient's target region, for example, the target area body position (e.g., abdominal, love handle, hip, buttocks, back, thigh, arms, knees, face, chin, etc.), the outer parameter of the effected region (e.g., shape, size, skin surface area, etc.)”);
acquiring an ablation result information of the target ablation object corresponding to each set of alternative ablation parameters (par. 0165: “a recommended and/or likely post-treatment outcome (e.g., based on a priori and/or empirically derived information)”);
filtering the found alternative ablation parameters according to a matching degree and sorting the found alternative ablation parameters according to the number of matching items and the level of matching degree, the more items with the matching degree greater than a preset matching degree, the higher the ranking (par. 0094: “The predictive modeling module 422 can receive the accumulated set of search results from the invoked treatment plan request module 420 and rank the plurality of model data sets in accordance with a degree of affinity to the 1) pre-treatment data set”);
taking the ablation parameters in the alternative ablation parameters with the highest matching degree as the filtered ablation parameters or taking the ablation parameters in the alternative ablation parameters with the matching degree greater than a preset first matching degree as the filtered ablation parameters (par. 0095: “compared model data sets may be dropped from the accumulated result set when the degree of affinity is below a pre-determined threshold value”); or displaying the sorted alternative ablation parameters and outputting confirmation prompt information to prompt the user to select (par. 0096: “the predictive modeling module 422 can generate a graphical display of one or more of the highest ranked model data sets and/or a combination of model data sets to visually represent a best fit to the patient-specific pre-treatment data set”); and taking the ablation parameters pointed by the user's selection operation as the filtered ablation parameters (par. 0099: “the optimization module 424 can receive instruction from a client computer (e.g., an optimization command) to alter output from the predictive modeling module 422. For example, graphical representation of pre-treatment status and/or post-treatment objective may not represent actual pre-treatment status and/or desired outcome. In this example, optimization module 424 can further query the user for additional information. The optimization module 424 transmits the updated patient-specific data to the predictive modeling module 422 for re-ranking the model data sets”);
associating the filtered ablation parameters with the ablation task, and recording association relationships between the filtered ablation parameters and the ablation task (par. 0101: “upon realizing a final collection of model data sets, the treatment plan formulation module 426 can generate a patient-specific treatment plan to present to the user for implementation with the treatment system 404, such as treatment system 100”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the method of the combined reference by incorporating the various search, retrieval, and ranking features taught by Allison, for the same reasons set forth previously in the rejection of claim 2.
Regarding claim 9, the combination teaches the method of claim 3 as described previously. The combination further teaches wherein before the step of configuring the target ablation parameters into the radio frequency ablation system, the method further comprises: displaying the target ablation parameters (Brannan at Fig. 8: ablation zone 806, power settings 814, dimensions 808), and marking the target ablation parameters obtained through matching on a display interface according to a preset marking method (Allison at par. 0097: “the second graphical image can be a graphical display of one or more of the highest ranked model data sets (e.g., from the highest ranked model data set, a composite of a plurality of highly ranked model sets, etc.), wherein the model data sets are ranked according to a level of affinity to the patient specific objective post-treatment data set”); modifying the target ablation parameters according to the user's modification operation on the display interface, and executing the step of configuring the target ablation parameters into the radio frequency ablation system based on the modified target ablation parameters (Brannan at par. 0055: “a button 814 allowing the user to select a power setting for ablation probe 130, and a button 816 allowing the clinician to increase or decrease the size of the ablation zone based on the selected ablation zone chart”).
Regarding claim 11, the combination teaches the method of claim 9 as described previously. Allison teaches the limitations of this claim, as best understood in the manner described previously in the rejection of the claim under 35 U.S.C. 112(b), for the same reasons set forth previously in the prior art rejection of claim 3.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Brannan in view of Asconeguy and Allison, and further in view of Piron et al. (US PGPub No. 2016/0067007), hereinafter Piron.
Brannan in view of Asconeguy and Allison teaches the method of claim 7 as described previously. As previously described in the rejection of claim 6, Allison further teaches wherein the biological indicator information comprises at least one of the complications, weight, blood pressure within a preset time period, heart rate, blood sugar, blood lipids, vital capacity and oxygen saturation, age and gender of the ablation object; the historical ablation information comprises the historical number of ablation operations performed on the ablation object; and the description information comprises position, size, shape and area of the ablation site.
Allison further teaches wherein the ablation result information comprises desired post-treatment outcomes, including a corresponding cumulative number of ablation operations (par. 0107: “the treatment plan formulation module 426 utilizes a priori and empirically-derived information to account for applicator edge effects (i.e., temperature differences between the middle of the applicator plate and the edge of the applicator plate), and effects of more than one treatment sessions (e.g., adjacent target regions, overlapping target regions, etc.)”) and the size, shape, and area of the ablation site after a most recent ablation operation is completed (par. 0098: “the first and second graphical images can include representation of the pretreated target region and desired post-treatment result, respectively, in three-dimensions”), but the combination does not explicitly teach wherein the post-treatment outcome information includes the survival time of the ablation object. However, in an analogous art, Piron teaches a method of searching archival post-treatment outcome data related to a surgical procedure wherein the post-treatment outcome data includes survival time of the patient (par. 0303: “previously described tumor size estimates may be associated with disease prevalence information. The latter information is another metadata that can be used as search criteria to identify other patients in the archival data set. Such identified information can be used to infer possible outcome of the current surgical procedure, such as survival period and quality of life after surgery”). 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 the combined reference by including survival time of the patient in the analyzed post-treatment outcome data, as taught by Piron, since all the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art, i.e., one skilled in the art would have recognized that the survival period taught by Piron would provide another metric by which to rank the model data sets according to desired post-treatment outcomes.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Brannan in view of Asconeguy and Allison, and further in view of Lu (US PGPub No. 2020/0008875).
Brannan in view of Asconeguy and Allison teaches the method of claim 9 as described previously, but the combination does not teach wherein before the step of modifying the target ablation parameters according to the user's modification operation on the display interface, the method further comprises: acquiring the user's identification information; determining whether the user has been pre-authorized according to the acquired identification information and a preset authorization information; and executing the step of modifying the target ablation parameters according to the user's modification operation when the user is pre-authorized. However, in an analogous art, Lu teaches an ablation planning method wherein a user may only edit an ablation plan after passing a credential check to ensure that the clinician is permitted to access the patient data (par. 0072: “prior to any method disclosed herein for performing ablation planning and/or performance, the credential check (step S80 of FIG. 13) may be performed to make sure that the clinician is permitted to access patient data and communication with other clinicians. Once the clinician passes the credential check (S80), then the clinician has access to the image source (see step S81 of FIG. 13), and may search or select a patient or case file (see step S82 of FIG. 13). Once the patient or case file is retrieved in step S82, the clinician may study the case (see step S83 of FIG. 13), and may determine whether edit(s) to an existing procedure plan (e.g., an ablation plan, a radiotherapy plan, etc.) are required or not (see step S84 in FIG. 13)”). 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 the combined reference by providing a credential check step, as taught by Lu, in order to ensure that the user is permitted to access the patient data, as taught by Lu.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVINA E LEE whose telephone number is (571)272-5765. The examiner can normally be reached Monday through Friday between 8:00 AM and 5:30 PM (ET).
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/D.E.L./Examiner, Art Unit 3794