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 7, 15, and 20 are objected to because of the following informalities:
Claim 7: “and wherein” should be added after the semicolon in line 2
Claim 15: the commas after “or” in lines 5 and 6 should be omitted
Claim 20: “a second obtaining module” in line 4 should read “a first obtaining module”
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 1-23 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 1 recites the limitation "the laser ablation" in line 15. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-19 and 21-23 are also rejected because they are dependent on claim 1.
Claim 21 recites “a control host and a computer program stored on the control host, wherein the control host is configured to execute the computer program to implement the steps of the laser ablation method according to claim 1”. Claim 22 recites “a non-transitory computer readable storage medium having a computer program stored thereon, the computer program implementing, when executed by a laser ablation device, the steps of the laser ablation method according to claim 1”. Claim 23 recites “computer program product, comprising a computer program, wherein the computer program implements, when executed by a control host, the steps of the laser ablation method according to claim 1”.
Paragraph [0059] of the specification discloses “In the related art, the laser ablation device can only emit one kind of laser. For a particular lesion region, it requires changing an ablation mode, which involves repeatedly plugging and unplugging of a fiber that emits the laser for replacement”.
Under their broadest reasonable interpretations, claims 21-23 can be interpreted such that the laser ablation device only includes a control host and a computer program executed by the control host. Thus, the invention does not comprise any device that emits a laser, let alone a fiber that needs to be plugged and unplugged, as the specification describes. Therefore, it is unclear as to how a control host executing a computer program can “end the laser ablation” as recited in claim 1, because there is no laser ablation performed in the method.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 23 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because claim 23 is directed to a computer program product comprising computer readable code. The instant specification does not provide a special definition of the computer readable code. Under the broadest reasonable interpretation, computer readable code (or computer readable medium, CRM) comprises transitory signals, which have been found to be non-statutory. See MPEP 2106.03(II).
Claims 1-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Determination as to whether a claim satisfies the criteria for subject matter eligibility is a stepwise process (MPEP 2016).
Step 1: Does the claim fall within a statutory category of invention?
Claim 1 recites a process (method), claim 20 recites a machine (apparatus), claim 21 recites a machine (device), and claim 22 recites a manufacture (non-transitory computer-readable medium), which are within the four statutory categories. Therefore, claims 1-22 are directed to a statutory category of invention.
As explained above, claim 23 does not fall within a statutory category of invention, and is therefore not patent-eligible under 35 U.S.C. 101.
Step 2A, Prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claims 1-22 are directed to an abstract idea.
Claim 1 is directed to a laser ablation method comprising:
determining a corresponding laser ablation mode based on real-time lesion region information at a first time;
obtaining real-time lesion region information at a (i+1)th time, wherein the (i+1)th time is later than an i-th time, and i is a positive integer;
determining whether a conformity index between the real-time lesion region information at the (i+1)th time and expected lesion region information after an i-th laser ablation exceeds a first set threshold; and
determining, in response to that the conformity index between the real-time lesion region information at the (i+1)th time and the expected lesion region information after the i-th laser ablation exceeds the first set threshold, a (i+1)th laser ablation mode according to an expected laser ablation mode of a (i+1)th laser ablation in a laser ablation strategy and the real-time lesion region information at the (i+1)th time, and continuing to determine a next laser ablation mode through repeating the above steps of obtaining and subsequent determining.
Claim 20 is directed to a laser ablation apparatus comprising:
a first processing module, configured to determine a corresponding laser ablation mode based on real-time lesion region information at a first time;
a second obtaining module, configured to obtain real-time lesion region information at a (i+1)th time, wherein the (i+1)th time is later than an i-th time, and i is a positive integer, wherein a lesion region at the (i+1)th time is ablated based on a laser ablation mode at the i-th time; and
a second processing module, configured to determine a (i+1)th laser ablation mode according to a laser ablation strategy and the real-time lesion region information at the (i+1)th time, until a conformity index between real-time lesion region information at a subsequent time and expected lesion region information after a final laser ablation exceeds a first set threshold.
The limitations of determining a corresponding laser ablation mode, determining whether a conformity index exceeds a first set threshold, and determining a (i+1)th laser ablation mode, as drafted, under their broadest reasonable interpretations, are merely mental processes, because these steps are akin to having a doctor or other human actor performing these operations with pen and paper. For example, “determining a corresponding laser ablation mode based on real-time lesion region information at a first time” encompasses nothing more than a human actor mentally evaluating lesion region information and drawing a conclusion about the corresponding laser ablation mode.
The limitation of “obtaining real-time lesion region information” encompasses nothing more than a human actor collecting these pieces of information by hand.
Therefore, claim 1 recites an abstract idea.
Claims 2-19 and 21-22 depend on claim 1. These dependent claims only recite additional features of the analysis described in claim 1, which may also be performed by a human actor mentally and using a pen and paper. For example, claim 6 recites “adjusting…the expected laser ablation mode” and “maintaining…a laser ablation mode”, which encompasses nothing more than a human actor evaluating the gathered information and deciding which action to take as a result.
Therefore, claims 1-22 recite an abstract idea.
Step 2A, Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?
This judicial exception is not integrated into a practical application.
Claim 20 only recites the additional limitations “a first processing module” and “a second processing module”. Claim 21 recites “a control host”. Claim 22 recites “a non-transitory computer readable storage medium”. These additional elements are recited at a high level of generality (i.e. most generic computers would be known to have these components). Paragraphs [0127]-[0130] describe the processing modules at a high level of generality. These generic processor and memory limitations are no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Therefore claim 20 does not integrate the judicial exception into a practical application.
Claim 20 recites the additional limitation “a second obtaining module”, which amounts to no more than mere pre-solution activity of data gathering. Therefore the claimed generic obtaining module element does not integrate the judicial exception into a practical application.
Thus, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Therefore, the claims are directed to an abstract idea. As described above, dependent claims 2-19 only recite other limitations of determining a laser ablation mode, which may be done mentally by a human actor and/or with a pen and paper.
Step 2B: Does the claim include additional elements that are sufficient to amount to significantly more than the judicial exception?
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
As explained above with respect to the integration of the judicial exception into a practical application (Step 2A, Prong 2), the additional elements of using computer components to perform the process steps amounts to no more than mere instructions to apply the judicial exception using generic computer elements. The structural elements recited in claim 20 are “a first processing module” and “a second processing module”. These additional elements are recited at a high level of generality (i.e. most generic computers would be known to have these components). Paragraphs [0127]-[0130] of the specification describes the processing modules at a high level of generality, and only provides conventional, well-known computing functions that do not add meaningful limits to practicing the abstract idea.
Claim 20 recites the additional limitation “a second obtaining module”. As discussed above with respect to integration of the abstract idea into a practical application (Step 2A, Prong 2), the additional element of an obtaining module to collect data amounts to no more than mere pre-solution activity of data gathering. This pre-solution activity of data gathering using MRI during an ablation procedure (as described in paragraph [0120] of the specification) is well-understood, routine, and conventional in the field of ablation technology. For example, see de Senneville et al. (MR thermometry for monitoring tumor ablation. 2007. https://doi.org/10.1007/s00330-007-0646-6), which describes known methods of mapping of temperature and thermal dose during ablation therapy. Therefore, the claimed generic obtaining module and computer processing elements are all well-understood, routine, and conventional in the field of ablation technology.
As explained above in view of 35 U.S.C. 112(b), claims 21-23 can be interpreted such that the laser ablation device only includes a control host and a computer program executed by the control host. In claim 1, the limitation of “determining a corresponding laser ablation mode” can be interpreted as “determining which laser ablation mode to use”, and not as actually changing the laser ablation mode (e.g. plugging and unplugging of fibers as described in specification paragraphs [0058]-[0059]). Therefore, “determining a laser ablation mode” encompasses nothing more than a human actor evaluating collected data and deciding which laser ablation mode to use.
Therefore, claims 1-23 are not patent-eligible under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim Rejections - 35 USC § 102
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.
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 1-8, 10, 12-14, and 16-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ben-Haim et al. (US 20200060757 A1), hereinafter Ben-Haim.
Regarding claim 1, Ben-Haim discloses a laser ablation method (Fig. 12, paragraph [0483], "a method of real-time use, with optional adjustment, of an ablation plan"; paragraph [0404], "The particular ablation segment is formed (and/or is planned to be formed) by the operation of an ablation modality (e.g., ... laser ablation ... ) acting on tissue which is targeted for ablation"), comprising:
determining a corresponding laser ablation mode (paragraph [0489], "At block 132, in some embodiments, the system 1100 characterizes parameters such as ablation probe position and settings of the actual ablation operation performed ... the new state of tissue in the lesioned region is modeled, based on actual ablation position and parameters, and on data previously configured for thermal simulation") based on real-time lesion region information at a first time (paragraph [0489], "at block 134, in some embodiments, the lesion actually created is itself characterized, for example, by the analysis of dielectric measurements and/or temperature readings. In some embodiments, at block 134, lesion effectiveness, ablation line effectiveness, and/or ablation segment effectiveness are estimated");
obtaining real-time lesion region information at a (i+1)th time, wherein the (i+1)th time is later than an i-th time, and i is a positive integer (paragraph [0489]);
determining whether a conformity index between the real-time lesion region information at the (i+1)th time and expected lesion region information after an i-th laser ablation exceeds a first set threshold (paragraph [0491], "block 136 may include a determination as to whether or not the resulting estimated ablation segment effectiveness (corresponding, in some embodiments, to block 2106 of FIG. 14A) indicates that an effective ablation segment has been formed (e.g., by placement of the most recent sub-lesion), and/or will be formed if the next sub-lesion is created as already planned");
determining, in response to that the conformity index between the real-time lesion region information at the (i+1)th time and the expected lesion region information after the i-th laser ablation exceeds the first set threshold, a (i+1)th laser ablation mode according to an expected laser ablation mode of a (i+1)th laser ablation in a laser ablation strategy and the real-time lesion region information at the (i+1)th time (paragraphs [0492]-[0493], "If the plan is to remain unchanged, flow continues at block 140. For example, if the ablation segment effectiveness estimator result indicates an effective ablation segment is being and/or has been produced, the flowchart continues with block 140. ... Otherwise, at block 138, in some embodiments, the ablation plan is adjusted"), and continuing to determine a next laser ablation mode through repeating the above steps of obtaining and subsequent determining (paragraph [0502], "if an ablation line estimator (e.g., estimator 1804) estimates that the line is not effective, the flowchart returns to block 130 or block 138"); and
ending the laser ablation in response to that the conformity index between the real-time lesion region information at the (i+1)th time and the expected lesion region information after the i-th laser ablation does not exceed the first set threshold (paragraph [0502]).
Regarding claim 2, Ben-Haim discloses the laser ablation method according to claim 1, as explained above. Ben-Haim further discloses that, prior to determining the corresponding laser ablation mode based on the real-time lesion region information at the first time, the method further comprises: obtaining initial lesion region information of a user and corresponding laser ablation strategy (paragraph [0485], "The flowchart begins (after production or receiving of an ablation plan)"; ),
wherein the laser ablation strategy comprises a quantity of laser ablation, an expected laser ablation mode corresponding to each laser ablation (paragraph [0175], "An ablation plan optionally comprises the definition of ablation parameters along the ablation line (for example, frequency, total energy delivered, power and/or timing)"), and expected lesion region information after each laser ablation (paragraph [0188], "an ablation plan may include the order of ablations, for example, where ends of a looping line of ablation should meet, and/or placement and/or timing of sub-lesions to take advantage of previously existing lesions and/or recent administration of ablation energy").
Regarding claim 3, Ben-Haim discloses the laser ablation method according to claim 2, as explained above. Ben-Haim further discloses that, prior to obtaining the initial lesion region information of the user and the corresponding laser ablation strategy, the method further comprises:
receiving digital image information of the user (paragraph [0252], "patient-specific anatomy comprise 3-D imaging data (for example, MRI, CT, NMR, and/or data from another imaging modality) describing and/or displaying patient-specific anatomy"; paragraph [0206]);
performing multimodal three-dimensional modeling based on the digital image information to obtain a three-dimensional model of the user (paragraph [0221], "The anatomical imaging data may serve as a basis for geometrical structure and/or modeling of internal organs of the patient");
receiving a marking operation for a position of a tissue in the three-dimensional model to determine the initial lesion region information of the user, wherein the tissue comprises a lesion (paragraph [0190], "expected results of an ablation plan are presented to a user a priori, for example, as an ablation line indication presented together with a 3-D model of the target tissue"), nerve fiber tracts (paragraph [0220], "data from the NM modality may be used to infer the location of autonomous nervous system components (e.g., one or more ganglion plexi) designated for treatment on the dataset from the CT modality"), a brain partition, and a blood vessel;
receiving a marking operation for a position of a tissue in the three-dimensional model to determine the initial lesion region information of the user, wherein the tissue comprises a lesion (paragraph [0190], "expected results of an ablation plan are presented to a user a priori, for example, as an ablation line indication presented together with a 3-D model of the target tissue"; paragraph [0345], "Stroke or documented brain MR lesions post ablation"), nerve fiber tracts (paragraph [0220], "data from the NM modality may be used to infer the location of autonomous nervous system components (e.g., one or more ganglion plexi) designated for treatment on the dataset from the CT modality"), a brain partition (paragraph [0345], "Stroke or documented brain MR lesions post ablation"), and a blood vessel (paragraph [0193], "the indication may be “surrounding a root of a pulmonary vein” (additionally or alternatively, the root of a plurality of veins, of another blood vessel, or any other relationship between anatomical landmark and lesion form suitable to the application)"; paragraphs [0222], [0251]);
determining the laser ablation strategy based on the initial lesion region information and the expected lesion region information (paragraph [0178], "determining a final ablation plan comprises iteratively adjusting these plan features to approach more optimal results, and/or generating a selection of alternative plans from which the most optimal result is chosen"; paragraph [0397]).
Regarding claim 4, Ben-Haim discloses the laser ablation method according to claim 3, as explained above. Ben-Haim further discloses:
receiving the marking operation for the position of the tissue in the three-dimensional model (paragraph [0190], "the method comprises providing (for example, to a lesion planning system) an indication of the planned target form. Optionally, the indication comprises showing a line of planned ablation together with a 3-D representation of the target anatomical structure"),
determining whether there is a non-ablation region (paragraph [0242], "lesion placement criteria exclude and/or limit lesioning from entering certain regions of the lesioned surface itself"; paragraph [0189], "the ablation plan takes into account (and is formulated to avoid damaging) the patient-specific positions of anatomical structures subject to collateral damage"; paragraph [0197], "safety constraints are also imposed on the plan: for example, to prevent collateral damage to sensitive structures"), and
marking the non-ablation region in response to that there is a non-ablation region (paragraph [0357], "effectiveness constraints include regions where lesioning should be avoided (avoided regions 1513)").
Regarding claim 5, Ben-Haim discloses the laser ablation method according to claim 3, as explained above. Ben-Haim further discloses that determining the corresponding laser ablation mode based on the real-time lesion region information at the first time comprises:
obtaining the real-time lesion region information at the first time (paragraph [0489], "at block 134, in some embodiments, the lesion actually created is itself characterized, for example, by the analysis of dielectric measurements and/or temperature readings. In some embodiments, at block 134, lesion effectiveness, ablation line effectiveness, and/or ablation segment effectiveness are estimated"); and
determining an expected laser ablation mode of a first laser ablation in the laser ablation strategy as the laser ablation mode in response to that a conformity index between the real-time lesion region information at the first time and the initial lesion region information is less than a second set threshold (paragraph [0491], "At block 136, in some embodiments, a determination is made as to whether or not the plan is still being followed as currently defined and/or whether the lesion is effective. In some embodiments, block 136 may include a determination as to whether or not the resulting estimated ablation segment effectiveness (corresponding, in some embodiments, to block 2106 of FIG. 14A) indicates that an effective ablation segment has been formed (e.g., by placement of the most recent sub-lesion), and/or will be formed if the next sub-lesion is created as already planned").
Regarding claim 6, Ben-Haim discloses the laser ablation method according to claim 1, as explained above. Ben-Haim further discloses that determining the (i+1)th laser ablation mode according to the expected laser ablation mode of the (i+1)th laser ablation in the laser ablation strategy and the real-time lesion region information at the (i+1)th time comprises:
adjusting, in response to that a conformity index between the expected lesion region information at the (i+1)th time in the laser ablation strategy and the real-time lesion region information at the (i+1)th time is less than a third set threshold, the expected laser ablation mode of the (i+1)th laser ablation according to the real-time lesion region information at the (i+1)th time, to obtain the corresponding laser ablation mode (paragraphs [0492]-[0493], "If the plan is to remain unchanged, flow continues at block 140. For example, if the ablation segment effectiveness estimator result indicates an effective ablation segment is being and/or has been produced, the flowchart continues with block 140. ... Otherwise, at block 138, in some embodiments, the ablation plan is adjusted"); and
maintaining, in response to that the conformity index between the expected lesion region information at the (i+1)th time and the real-time lesion region information at the (i+1)th time is greater than or equal to the third set threshold, a laser ablation mode at the i-th time as the laser ablation mode at the (i+1)th time (paragraph [0492], "If the plan is to remain unchanged, flow continues at block 140. For example, if the ablation segment effectiveness estimator result indicates an effective ablation segment is being and/or has been produced, the flowchart continues with block 140").
Regarding claim 7, Ben-Haim discloses the laser ablation method according to claim 1, as explained above. Ben-Haim further discloses that the expected lesion region information comprises an area of a lesion region (paragraph [0361], "Ablation line effectiveness parameters 1700 may include indications of structure of an ablation line (e.g., depth, size, volume of tissue etc.)"), and wherein the area of the lesion region after the (i+1)th laser ablation is smaller than the area of the lesion region after the i-th laser ablation (paragraph [0496], "Deviation from an expected effect of an ablation operation (as measured, for example, from dielectric measurements of sub-lesion extent)").
Regarding claim 8, Ben-Haim discloses the laser ablation method according to claim 1, as explained above. Ben-Haim further discloses that the laser ablation mode comprises at least one of a laser wavelength (paragraph [0175], frequency as an ablation parameter is analogous to wavelength), an ablation timing sequence (paragraph [0175], "An ablation plan optionally comprises the definition of ablation parameters along the ablation line (for example...timing)"), a laser output power (paragraph [0175], "An ablation plan optionally comprises the definition of ablation parameters along the ablation line (for example...power...)"), a laser irradiation manner (paragraph [0175], "An ablation plan optionally specifies movements of an ablation probe more particularly—for example, from what start point, in what order, to what end point, at what angle, and/or with what timing between movements"), or a laser irradiation position (paragraph [0175], "an ablation plan includes specification of where ablation is to occur; optionally defined as a line or path, an area, and/or a volume"; paragraph [0493], "Adjustment may be made in any parameter of the ablation plan to adjust, for example: to a deviation from the previously planned timing and/or placement of sub-lesions"; see also paragraphs [0188]).
Regarding claim 10, Ben-Haim discloses the laser ablation method according to claim 8, as explained above. Ben-Haim further discloses that any two laser ablation modes have different laser wavelengths (paragraph [0171], "the system suggests alternative plans to help adjust for the effects of edema—for example, suggesting a different order of ablations, different timing, and/or different operating settings (power, time, frequency, phase) for the ablation modality"; paragraph [0296], "Upon an operator selecting the position of the next ablation operation (such as: next lesion position), the ablation monitoring and/or treatment system optionally applies an estimator to predict effectiveness of the result using not only the current settings, but also other settings available from within current conditions—for example, different power levels, times of ablation, frequencies, phases, angles of approach and the like").
Regarding claim 12, Ben-Haim discloses the laser ablation method according to claim 2, as explained above. Ben-Haim further discloses that the real-time lesion region information comprises real-time temperature information of a lesion region (paragraph [0489], "at block 134, in some embodiments, the lesion actually created is itself characterized, for example, by the analysis of dielectric measurements and/or temperature readings"), and the laser ablation method further comprises:
controlling, in response to that the real-time temperature information is greater than a preset temperature threshold, an optical fiber assembly for outputting the laser to be cooled until subsequent real-time temperature information is not greater than the preset temperature threshold (paragraph [0289], "As examples of plan modulation, ablation intensity (power, and/or time of ablation energy deliver) is optionally increased for a larger tissue thickness, and/or reduced for a higher than expected intra-lesioning temperature"; paragraph [0243], "Exclusion may be defined such that no heating or cooling of an at-risk tissue can rise above (or fall below) a certain temperature threshold, e.g., according to a simulated ablation operation").
Regarding claim 13, Ben-Haim discloses the laser ablation method according to claim 12, as explained above. Ben-Haim further discloses that the preset temperature threshold is determined by the initial lesion region information (paragraph [0243], "Exclusion may be defined such that no heating or cooling of an at-risk tissue can rise above (or fall below) a certain temperature threshold, e.g., according to a simulated ablation operation. ... Optionally, a functional criterion is used: for example, a plan which includes heating for more than T seconds at energy Y by a probe within X mm is preferably excluded").
Regarding claim 14, Ben-Haim discloses the laser ablation method according to claim 12, as explained above. Ben-Haim further discloses: obtaining real-time temperature information (paragraph [0214], "The intercepted signals may be analyzed by system 1100, for example, to perform real-time tissue measurements (e.g., ... temperature"; paragraph [0540], "any sub-lesion an ablation line (e.g., an initial sub-lesion) is measured for calibration"), and obtaining a three-dimensional temperature distribution map of the real-time temperature information based on the three-dimensional model of the user (paragraph [0530], "obtaining real-time temperature information, and obtaining a three-dimensional temperature distribution map of the real-time temperature information based on the three-dimensional model of the user").
Regarding claim 16, Ben-Haim discloses the laser ablation method according to claim 1, as explained above. Ben-Haim further discloses that the real-time lesion region information comprises: a plurality of pieces of target region information (paragraph [0210], "system 1100 includes a sensor interface 1126 for communicating with one or more sensors 1128, which may be in the body or external to the body; for example, for measuring electrical and/or thermal parameters, for example, impedance and/or conductivity and/or thermal conductivity and/or heat capacity and/or metabolic heat generation of the blood, the myocardium, and/or other tissues"; paragraph [0489], "the lesion actually created is itself characterized, for example, by the analysis of dielectric measurements and/or temperature readings"), and
the method further comprises: determining the laser ablation mode corresponding to each target region information (paragraph [0493], "the ablation plan is adjusted. Adjustment may be made in any parameter of the ablation plan to adjust, for example: ... to a deviation from an expected effect of a lesioning operation (as measured, for example, from dielectric measurements of lesion extent)").
Regarding claim 17, Ben-Haim discloses the laser ablation method according to claim 1, as explained above. Ben-Haim further discloses that the real-time lesion region information comprises boundary information of a lesion region (paragraph [0192], "lesion effectiveness or ablation line effectiveness may be monitored (e.g., by an estimator) during an ablation in progress (for example, based on dielectric property and/or thermal measurements)"), and
the method further comprises: determining in real time whether the boundary information exceeds a preset boundary threshold (paragraph [0502], "At block 140, in some embodiments, a determination is made as to whether or not the ablation plan has been adequately completed (e.g., according to completion of the planned sequence of steps, and/or based on verification measurements of the actual lesion)").
Regarding claim 18, Ben-Haim discloses the laser ablation method according to claim 1, as explained above. Ben-Haim further discloses displaying, in real time, the real-time lesion region information at each time and the conformity index between the real-time lesion region information at each time and the expected lesion region information through a three-dimensional model (paragraph [0486], "as the actual ablation probe is moved, its motions (measured, for example, by system 1100 of FIG. 1A) are shown also in a live presentation of the views of FIG. 13A and/or FIG. 13B. In some embodiments, the display is adjusted to also include anatomically realistic tissue coloring and/or responsiveness to ablation probe contact and/or to the effects of ablation itself").
Regarding claim 19, Ben-Haim discloses the laser ablation method according to claim 1, as explained above. Ben-Haim further discloses color-marking the real-time lesion region information in a three-dimensional model, wherein the real-time lesion region information corresponding to each time has a different marking color from the expected lesion region information (paragraphs [0509]-[0511]).
Regarding claim 20, Ben-Haim discloses a laser ablation apparatus (Fig. 1A, paragraph [0205], system 1100), comprising:
a first processing module (Fig. 1A, paragraph [0201], processor 1104), configured to determine a corresponding laser ablation mode (paragraph [0489], "At block 132, in some embodiments, the system 1100 characterizes parameters such as ablation probe position and settings of the actual ablation operation performed ... the new state of tissue in the lesioned region is modeled, based on actual ablation position and parameters, and on data previously configured for thermal simulation") based on real-time lesion region information at a first time (paragraph [0489], "at block 134, in some embodiments, the lesion actually created is itself characterized, for example, by the analysis of dielectric measurements and/or temperature readings. In some embodiments, at block 134, lesion effectiveness, ablation line effectiveness, and/or ablation segment effectiveness are estimated");
a second obtaining module (Fig. 1A, paragraph [0210], sensors 1128), configured to obtain real-time lesion region information at a (i+1)th time, wherein the (i+1)th time is later than an i-th time, and i is a positive integer (paragraph [0489]), wherein a lesion region at the (i+1)th time is ablated based on a laser ablation mode at the i-th time (Fig. 12, paragraph [0486], "At block 130, in some embodiments, a portion of a planned lesion is made (e.g., a sub-lesion comprising ablation from a fixed ablation probe location, or a dragged-out portion of a lesion)"); and
a second processing module (Fig. 1A, paragraph [0201], processor 1104), configured to determine a (i+1)th laser ablation mode according to a laser ablation strategy and the real-time lesion region information at the (i+1)th time, until a conformity index between real-time lesion region information at a subsequent time and expected lesion region information after a final laser ablation exceeds a first set threshold (paragraphs [0492]-[0493], "If the plan is to remain unchanged, flow continues at block 140. For example, if the ablation segment effectiveness estimator result indicates an effective ablation segment is being and/or has been produced, the flowchart continues with block 140. ... Otherwise, at block 138, in some embodiments, the ablation plan is adjusted").
Regarding claim 21, Ben-Haim discloses the laser ablation method according to claim 1, as explained above. Ben-Haim further discloses a control host and a computer program stored on the control host, wherein the control host is configured to execute the computer program to implement the steps of the laser ablation method according to claim 1 (paragraph [0205], "System 1100 may include a program store 1106 storing code, and a processor 1104 coupled to program store 1106 for implementing the stored code").
Regarding claim 22, Ben-Haim discloses the laser ablation method according to claim 1, as explained above. Ben-Haim further discloses a non-transitory computer readable storage medium having a computer program stored thereon, the computer program implementing, when executed by a laser ablation device, the steps of the laser ablation method according to claim 1 (paragraph [0205], "System 1100 may include a program store 1106 storing code, and a processor 1104 coupled to program store 1106 for implementing the stored code").
Regarding claim 23, Ben-Haim discloses the laser ablation method according to claim 1, as explained above. Ben-Haim further discloses a computer program product, comprising a computer program, wherein the computer program implements, when executed by a control host, the steps of the laser ablation method according to claim 1 (paragraph [0205], "System 1100 may include a program store 1106 storing code, and a processor 1104 coupled to program store 1106 for implementing the stored code").
Claim Rejections - 35 USC § 103
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Haim et al. (US 20200060757 A1), hereinafter Ben-Haim, in view of Drown et al. (US 20210338328 A1), hereinafter Drown.
Regarding claim 9, Ben-Haim discloses the laser ablation method according to claim 8, as explained above. Ben-Haim further discloses that any two laser ablation modes have different laser wavelengths (paragraph [0171], "the system suggests alternative plans to help adjust for the effects of edema—for example, suggesting a different order of ablations, different timing, and/or different operating settings (power, time, frequency, phase) for the ablation modality"; paragraph [0296], "Upon an operator selecting the position of the next ablation operation (such as: next lesion position), the ablation monitoring and/or treatment system optionally applies an estimator to predict effectiveness of the result using not only the current settings, but also other settings available from within current conditions—for example, different power levels, times of ablation, frequencies, phases, angles of approach and the like").
Ben-Haim does not explicitly disclose that any two laser ablation modes have different laser wavelengths and quantities of lasers.
However, Drown teaches laser ablation devices and related systems and methods comprising laser outputs with multiple wavelengths (Abstract), wherein any two laser ablation modes have different laser wavelengths and quantities of lasers (paragraphs [0019]-[0020], "The base unit 102 may comprise a laser energy source 108 that provides two or more laser outputs with different wavelengths ... The laser energy source 108 may emit the laser outputs independently of each other. ... some embodiments, the laser energy source 108 may emit the different laser outputs simultaneously. In some embodiments, the laser energy source 108 may cycle between the different laser outputs such that only one laser output is emitted at a time").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ben-Haim with the teachings of Drown so that any two laser ablation modes have different laser wavelengths and quantities of lasers, because doing so enables users to customize the lesion in the patient, enabling them to achieve both large and small lesions (Drown, paragraphs [0013], [0066]).
Regarding claim 11, Ben-Haim discloses the laser ablation method according to claim 8, as explained above. Ben-Haim does not explicitly disclose that any two laser ablation modes have different quantities of lasers.
However, Drown teaches laser ablation devices and related systems and methods comprising laser outputs with multiple wavelengths (Abstract), wherein any two laser ablation modes have different laser wavelengths and quantities of lasers (paragraphs [0019]-[0020], "The base unit 102 may comprise a laser energy source 108 that provides two or more laser outputs with different wavelengths ... The laser energy source 108 may emit the laser outputs independently of each other. ... some embodiments, the laser energy source 108 may emit the different laser outputs simultaneously. In some embodiments, the laser energy source 108 may cycle between the different laser outputs such that only one laser output is emitted at a time").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ben-Haim with the teachings of Drown so that any two laser ablation modes have different quantities of lasers, because doing so enables users to customize the lesion in the patient, enabling them to achieve both large and small lesions (Drown, paragraphs [0013], [0066]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-Haim et al. (US 20200060757 A1), hereinafter Ben-Haim, in view of Tatsui et al. (US 20180368918 A1), hereinafter Tatsui.
Regarding claim 15, Ben-Haim discloses the laser ablation method according to claim 14, as explained above. Ben-Haim does not explicitly disclose that obtaining the real-time temperature information comprises: obtaining the real-time temperature information through parallel imaging, wherein a scanning slice thickness is not less than 3 mm and not greater than 5 mm; or obtaining the real-time temperature information through three-dimensional scanning; or obtaining the real-time temperature information through thin slice scanning, wherein a scanning slice thickness is less than 3 mm.
However, Tatsui teaches a method of laser ablation (paragraph [0053]) comprising obtaining real-time temperature information (paragraph [0054], "The temperature of the tissue in the region of interest (including for example, the target tissue and the surrounding tissue) can be monitored in step 165"), wherein obtaining the real-time temperature information comprises:
obtaining the real-time temperature information through three-dimensional scanning (paragraph [0083], "The acquisition matrix is 256×128 over fields of view of 24 to 32 cm, typically with a single 3-mm slice being acquired every 5-6 seconds, generating a magnitude and phase image, which are read in real time by the treatment workstation"); or
obtaining the real-time temperature information through thin slice scanning, wherein a scanning slice thickness is 3 mm (paragraph [0083], "The acquisition matrix is 256×128 over fields of view of 24 to 32 cm, typically with a single 3-mm slice being acquired every 5-6 seconds, generating a magnitude and phase image, which are read in real time by the treatment workstation").
Although Tatsui does not explicitly disclose that a scanning slice thickness is less than 3 mm, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a scanning slice thickness that is less than 3 mm, for the purpose of obtaining accurate lesion measurements, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Furthermore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ben-Haim with the teachings of Tatsui so that obtaining the real-time temperature information comprises: obtaining the real-time temperature information through three-dimensional scanning; or obtaining the real-time temperature information through thin slice scanning, wherein a scanning slice thickness is less than 3 mm, because doing so allows a precise verification of the accuracy of navigation at a safe stage, where if the surgeons feel the parameters are inaccurate, major damage can be avoided (Tatsui, paragraph [0014]).
Conclusion
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/CHRISTINE SISON/Examiner, Art Unit 3796
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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