DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 29 December 2025 has been entered.
Applicant's response has been fully considered. Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 Status
Claims 1-22 are currently pending and under exam herein.
Claims 21-22 are newly added.
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 1-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Any newly recited portions herein are necessitated by claim amendment and the analysis has not diverged from the previous Final Office Action..
The instant rejection reflects the framework as outlined in the MPEP at 2106.04:
Framework with which to Evaluate Subject Matter Eligibility:
(1) Are the claims directed to a process, machine, manufacture or composition of matter;
(2A) Prong One: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea;
Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and
(2B) If the claims do not integrate the judicial exception, do the claims provide an inventive concept.
Framework Analysis as Pertains to the Instant Claims:
(1) Evaluation:
With respect to step (1): yes, the claims 1-22 are directed to a computer-implemented method, apparatus, and non-transitory processor readable medium.
(2A)(1) Evaluation
With respect to step (2A)(1), the claims recite abstract ideas. The MPEP at 2106.04(a)(2) further explains that abstract ideas are defined as:
mathematical concepts (mathematical formulas or equations, mathematical relationships and mathematical calculations);
certain methods of organizing human activity (fundamental economic practices or principles, managing personal behavior or relationships or interactions between people); and/or
mental processes (procedures for observing, evaluating, analyzing/ judging and organizing information).
With respect to the instant claims, under the (2A)(1) evaluation, the claims are found herein to recite abstract ideas that fall into the grouping of mental processes (in particular procedures for observing, analyzing and organizing information) and/or mathematical concepts (in particular mathematical relationships).
Under the broadest reasonable interpretation, the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See MPEP 2111.
Claim steps to abstract ideas are as follows:
Claim 1:
identifying, with one or more processors, a gross tumor volume for the three-dimensional model… wherein steps directed to identification are those that are mental, as they merely require observation of data by assessment of given three-dimensional model and deriving from said data a volume. Alternatively, said operations are directed to mathematical processes, as calculations of volume are defined as such. As such, the step directed to a mental process and/or mathematical process.
identifying, with the one or more processors, a primary clinical target volume for the three-dimensional model… wherein steps directed to identification are those that are mental, as they merely require observation of data by assessment of given three-dimensional model and deriving from said data a volume. Alternatively, said operations are directed to mathematical processes, as calculations of volume are defined as such. As such, the step directed to a mental process and/or mathematical process.
identifying, with the one or more processors, a predictive clinical target volume for the three-dimensional model… wherein steps directed to identification are those that are mental, as they merely require observation of data by assessment of given three-dimensional model and deriving from said data a volume. Alternatively, said operations are directed to mathematical processes, as calculations of volume are defined as such. As such, the step directed to a mental process and/or mathematical process.
determining, with the one or more processors, a plurality of transducer layouts for delivering tumor treating fields to the subject, wherein steps directed to “determining”, given their plain meaning, are those which are mental in nature wherein one can make a determination of a layout based on appropriate data (assumed to be the volumetric data from recited previous limitations. Beyond the plain meaning of “determine” there are no specific steps recited such that making a determination is anything other than a mental operation.
calculatingthe three-dimensional model of the subject and the predictive clinical target volume, wherein calculating the tumor treating fields dosages for the plurality of transducer layouts comprises simulating applying alternating electric fields to the three-dimensional model of the subject for each of the plurality of transducer layouts wherein the step of generating dosages is a mental operation that physicians would engage in when making a decision based on how to treat a tumor, i.e. “generate dosages for the transducer layouts”. No other specifics are claimed that would preclude said interpretation herein. Further said operation of “simulating” is not claimed in a manner such that said operation requires any more than steps to artificially trial currents onto a model to replicate behavior and therefore is abstract. No further steps, for example, for specific rules and patterns for simulation interaction are claimed.
selecting, with the one or more processors, at least one transducer layout from the plurality of transducer layouts for delivering tumor treating fields…wherein steps directed to “selection” are those that are mental wherein one may make an informed “selection” based on the identified data.
Each of the above steps are given their broadest reasonable interpretation (BRI) and given their plan meaning, absent any further limitations for “identifying” and “selecting”.
Claim 19:
identify a gross tumor volume for the three-dimensional model… wherein steps directed to identification are those that are mental, as they merely require observation of data by assessment of given three-dimensional model and deriving from said data a volume. Alternatively, said operations are directed to mathematical processes, as calculations of volume are defined as such. As such, the step directed to a mental process and/or mathematical process.
identify a primary clinical target volume for the three-dimensional model… wherein steps directed to identification are those that are mental, as they merely require observation of data by assessment of given three-dimensional model and deriving from said data a volume. Alternatively, said operations are directed to mathematical processes, as calculations of volume are defined as such. As such, the step directed to a mental process and/or mathematical process.
identify a predictive clinical target volume for the three-dimensional model… wherein steps directed to identification are those that are mental, as they merely require observation of data by assessment of given three-dimensional model and deriving from said data a volume. Alternatively, said operations are directed to mathematical processes, as calculations of volume are defined as such. As such, the step directed to a mental process and/or mathematical process.
determine a plurality of transducer layouts for delivering tumor treating fields to the subject, wherein steps directed to “determine”, given their plain meaning, are those which are mental in nature wherein one can make a determination of a layout based on appropriate data (assumed to be the volumetric data from recited previous limitations. Beyond the plain meaning of “determine” there are no specific steps recited such that making a determination is anything other than a mental operation.
calculatethe three-dimensional model of the subject and the predictive clinical target volume, wherein calculating the tumor treating fields dosages for the plurality of transducer layouts comprises simulating applying alternating electric fields to the three-dimensional model of the subject for each of the plurality of transducer layouts wherein the step of generating dosages is a mental operation that physicians would engage in when making a decision based on how to treat a tumor, i.e. “generate dosages for the transducer layouts”. No other specifics are claimed that would preclude said interpretation herein. Further said operation of “simulating” is not claimed in a manner such that said operation requires any more than steps to artificially trial currents onto a model to replicate behavior and therefore is abstract. No further steps, for example, for specific rules and patterns for simulation interaction are claimed.
select at least one transducer layout from the plurality of transducer layouts for delivering tumor treating fields…wherein steps directed to “selection” are those that are mental wherein one may make an informed “selection” based on the identified data.
Each of the above steps are given their broadest reasonable interpretation (BRI) and given their plan meaning, absent any further limitations for “identifying” and “selecting”.
Claim 20:
identify a gross tumor volume for the three-dimensional model… wherein steps directed to identification are those that are mental, as they merely require observation of data by assessment of given three-dimensional model and deriving from said data a volume. Alternatively, said operations are directed to mathematical processes, as calculations of volume are defined as such. As such, the step directed to a mental process and/or mathematical process.
identify a primary clinical target volume for the three-dimensional model… wherein steps directed to identification are those that are mental, as they merely require observation of data by assessment of given three-dimensional model and deriving from said data a volume. Alternatively, said operations are directed to mathematical processes, as calculations of volume are defined as such. As such, the step directed to a mental process and/or mathematical process.
identify a predictive clinical target volume for the three-dimensional model… wherein steps directed to identification are those that are mental, as they merely require observation of data by assessment of given three-dimensional model and deriving from said data a volume. Alternatively, said operations are directed to mathematical processes, as calculations of volume are defined as such. As such, the step directed to a mental process and/or mathematical process.
determine a plurality of transducer layouts for delivering tumor treating fields to the subject, wherein steps directed to “determine”, given their plain meaning, are those which are mental in nature wherein one can make a determination of a layout based on appropriate data (assumed to be the volumetric data from recited previous limitations. Beyond the plain meaning of “determine” there are no specific steps recited such that making a determination is anything other than a mental operation.
calculatethe three-dimensional model of the subject and the predictive clinical target volume, wherein calculating the tumor treating fields dosages for the plurality of transducer layouts comprises simulating applying alternating electric fields to the three-dimensional model of the subject for each of the plurality of transducer layouts wherein the step of generating dosages is a mental operation that physicians would engage in when making a decision based on how to treat a tumor, i.e. “generate dosages for the transducer layouts”. No other specifics are claimed that would preclude said interpretation herein. Further said operation of “simulating” is not claimed in a manner such that said operation requires any more than steps to artificially trial currents onto a model to replicate behavior and therefore is abstract. No further steps, for example, for specific rules and patterns for simulation interaction are claimed.
select at least one transducer layout from the plurality of transducer layouts for delivering tumor treating fields…wherein steps directed to “selection” are those that are mental wherein one may make an informed “selection” based on the identified data.
Further to steps that include “machine learning”, (claim 12), when given the broadest reasonable interpretation in light of the specification, the machine is merely an algorithmic mathematical calculation process that computes neural network parameters using a series of mathematical calculations. The Specification supports the plain meaning of such in the Specification generally calls out “machine learning” as an example of a predictive model [0021]; [0064].
Claims 2-18 include recitations that further limit recited judicial exception in claim 1. Specifically those recitations include: volume limitations of claim 2-5; approximation definitions at claim 6; types of volumes at claim 8-9; data for volume determinations at claims 10-11; way in which a volume was determined at claim 12; further limitations to identifications at claims 13-18, including calculation steps. Claim 21 is directed to using a predictive model (math) that includes a trained machine learning model wherein said model is an algorithmic mathematical mode and no steps of training are actively claimed herein.
As discussed above, the abstract ideas recited in the claims are evaluated under the Broadest Reasonable Interpretation (BRI) and determined herein to each cover performance either in the mind and/or performance by mathematical operation because they cover concepts performed by math or in the mind. See MPEP 2106.04(a)(2), subsection II.
Further, see MPEP § 2106.04(a)(2), subsection III. The courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation (see, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674: noting that the claimed "conversion of [binary-coded decimal] numerals to pure binary numerals can be done mentally," i.e., "as a person would do it by head and hand."); Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1139, 120 USPQ2d 1473, 1474 (Fed. Cir. 2016): holding that claims to a mental process of "translating a functional description of a logic circuit into a hardware component description of the logic circuit" are directed to an abstract idea, because the claims "read on an individual performing the claimed steps mentally or with pencil and paper"). Nor do the courts distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. As the Federal Circuit has explained, "[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind" (see Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016): holding that computer-implemented method for "anonymous loan shopping" was an abstract idea because it could be "performed by humans without a computer").
With respect to “mathematical concepts” in the claims: (see MPEP § 2106.04(a)(2), subsection I: including a mathematical relationship between enhanced directional radio activity and antenna conductor arrangement (i.e., the length of the conductors with respect to the operating wave length and the angle between the conductors), Mackay Radio & Tel. Co. v. Radio Corp. of America, 306 U.S. 86, 91, 40 USPQ 199, 201 (1939): while the litigated claims 15 and 16 of U.S. Patent No. 1,974,387 expressed this mathematical relationship using a formula that described the angle between the conductors, other claims in the patent (e.g., claim 1) expressed the mathematical relationship in words); as well as organizing information and manipulating information through mathematical correlations (in Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014). The patentee in Digitech claimed methods of generating first and second data by taking existing information, manipulating the data using mathematical functions, and organizing this information into a new form. The court explained that such claims were directed to an abstract idea because they described a process of organizing information through mathematical correlations, like Flook's method of calculating using a mathematical formula. 758 F.3d at 1350, 111 USPQ2d at 1721). Therefore, volume determinations and predictive mathematics includes mathematical relationships, and thus, constitute abstract ideas.
(2A)(2) Evaluation
Because the claims do recite judicial exceptions, direction under (2A)(2) provides that the claims must be examined further to determine whether they integrate the abstract ideas into a practical application (MPEP 2106.04(d). A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception. This is performed by analyzing the additional elements of the claim to determine if the abstract idea is integrated into a practical application (MPEP 2106.04(d).I.; MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the abstract idea, the claim is said to fail to integrate the abstract idea into a practical application (MPEP 2106.04(d).III).
With respect to the instant recitations, the claims recite the following additional elements:
Claims 1 and 20 recite the following additional elements:
obtaining, with one or more processors, a three-dimensional model of the subject, the model comprising voxels wherein the additional element of “obtaining” a model is an insignificant extra-solution activity that amounts to mere data gathering incidental to the claim steps. The additional element are mere data gathering because all uses of the judicial exception require the use of the obtained model. See MPEP 2106.05(g). As such, said steps are insignificant extra-solution activity.
computer-implementation; non-transitory processor readable medium (claim 20)
Claim 19:
obtain a three-dimensional model of the subject, the model comprising voxels wherein the additional element are insignificant extra-solution activity that amounts to mere data gathering incidental to the claim steps. The additional element are mere data gathering because all uses of the judicial exception require the use of the obtained model. See MPEP 2106.05(g). As such, said steps are insignificant extra-solution activity.
apparatus; memory; processor
Dependent claims recite steps that further limit the recited additional elements in the claims. Claim 22 is claimed to “output” which is extra-solution activity of “apply it” herein.
Further with respect to the additional elements in the instant claims, those steps directed to data gathering perform functions of collecting the data needed to carry out the abstract idea. Data gathering does not impose any meaningful limitation on the abstract idea, or on how the abstract idea is performed. Data gathering steps are not sufficient to integrate an abstract idea into a practical application. (MPEP 2106.05(g).
Further steps herein directed to additional elements of “processor; computer; storage medium etc…” do not describe any specific computational steps by which the “computer parts” perform or carry out the abstract idea, nor do they provide any details of how specific structures of the computer, such as the computer-readable recording media, are used to implement these functions. The claims state nothing more than a generic computer which performs the functions that constitute the abstract idea. Hence, these are mere instructions to apply the abstract idea using a computer, and therefore the claim does not integrate that abstract idea into a practical application. The courts have weighed in and consistently maintained that when, for example, a memory, display, processor, machine, etc… are recited so generically (i.e., no details are provided) that they represent no more than mere instructions to apply the judicial exception on a computer, and these limitations may be viewed as nothing more than generally linking the use of the judicial exception to the technological environment of a computer. (see MPEP 2106.05(f)).
Step 2B: Do Claims Provide an Inventive Concept Assessment
The claims are lastly evaluated using the (2B) analysis, wherein it is determined that because the claims recite abstract ideas, and do not integrate that abstract ideas into a practical application, the claims also lack a specific inventive concept. Applicant is reminded that the judicial exception alone cannot provide the inventive concept or the practical application and that the identification of whether the additional elements amount to such an inventive concept requires considering the additional elements individually and in combination to determine if they provide significantly more than the judicial exception. (MPEP 2106.05.A i-vi).
With respect to the instant claims, the additional elements of data gathering described above do not rise to the level of significantly more than the judicial exception. As directed in the Berkheimer memorandum of 19 April 2018 and set forth in the MPEP, determinations of whether or not additional elements (or a combination of additional elements) may provide significantly more and/or an inventive concept rests in whether or not the additional elements (or combination of elements) represents well-understood, routine, conventional activity. Said assessment is made by a factual determination stemming from a conclusion that an element (or combination of elements) is widely prevalent or in common use in the relevant industry, which is determined by either a citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s).
With respect to the instant claims, the steps to obtaining “data” in the form of a three-dimensional model is an element that is routine, well-understood and conventional in the art. The Specification discloses the models are obtained from medical image data such as x-ray images, MRI, CT images, ultrasound images. Save for any particular new way of getting said image data and “modeling” said data, said activity is step that is conventional practice in the field of medical imaging and medical imaging assessment. For example, the review prior art to Guo et al. (Cancer (2022) Vol. 14:23 pages) discloses that electric field intensity and array locations may be optimized from models based on MRI from patients (section 3, page 8). Further, Guo et al. detail TTField treatment over multiple years making it a well-known practice in the art. Further, art to Trusheim et al. (CNS Oncol. (2017) Vol. 6:pages 29-43) disclose that NovoTAL software is the standard of care for TTField planning and delivery including getting image data models (e.g., page 30, col. 2).
With respect to claims 1-22, the computer-related elements or the general purpose computer do not rise to the level of significantly more than the judicial exception. Further exemplified in the prior art above teaching that computing elements are routine, well-understood and conventional in the art. The specification also notes that computer processors and systems, as example, are commercially available or widely used. The additional elements are set forth at such a high level of generality that they can be met by a general purpose computer. Therefore, the computer components constitute no more than a general link to a technological environment, which is insufficient to constitute an inventive concept that would render the claims significantly more than an abstract idea (see MPEP 2106.05(b)I-III).
Dependent claims have been analyzed with respect to step 2B and none of these claims provide a specific inventive concept, as they all fail to rise to the level of significantly more than the identified judicial exception.
For these reasons, the claims, when the limitations are considered individually and as a whole, are rejected under 35 USC § 101 as being directed to non-statutory subject matter.
Response to Applicant’s Arguments
1. Applicant states that, “claim 1 recites, in part, "calculating, with the one or more processors, tumor treating fields dosages for the plurality of transducer layouts based on the three-dimensional model of the subject, wherein calculating the tumor treating fields dosages for the plurality of transducer layouts comprises simulating applying alternating electric fields to the three-dimensional model of the subject for each of the plurality of transducer layouts." As such, claim 1 is not directed to a "mental process" or a "mathematical concept," as asserted by the Office Action”. Applicant includes that, “claim 1 recites features that cannot be practically performed in the human mind. For example, claim 1 recites "calculating... tumor treating fields dosages for the plurality of transducer layouts based on the three-dimensional model of the subject and the predictive clinical target volume, wherein calculating the tumor treating fields
dosages for the plurality of transducer layouts comprises simulating applying alternating electric fields to the three-dimensional model of the subject for each of the plurality of transducer layouts" and these recitations cannot be practically performed in the human mind” and further provides that US Patent publications 2020/0023179 and 2021/0196943 disclose calculating tumor field dosages by numerical simulations using finite element methods. Applicant lastly states that, “calculating the tumor treating fields dosages requires "solving complex algorithms using large data sets associated with the subject and, as such, require the use of a computer apparatus, as the human mind is not capable of performing the required calculations." Application, paragraph [0029]. Therefore, claim 1 does not recite a mental process.
It is respectfully submitted that this is not persuasive, as has been set forth previously. As in the above rejection, steps directed generically to identifying…a predictive clinical target volume for a three-dimensional model…and calculating…tumor treating fields dosages…are mental operations/mathematical operations that one could readily engage in by observing the data from said model and making the appropriate calculations therein. There is nothing beyond the plain meaning of said words to indicate otherwise, even given the recitation of computer-implementation. Paragraph [0029], referenced by Applicant includes directed to “calculate” dosages for TTFields, further lending to the evidence that steps of generating dosages are performed by calculation. The fact that a computer is used to perform the calculation is not relevant, as any computer may be operational to perform mathematical operation, no matter how complex, as that is the role of computing. The tool (computer) functions to perform said operation and is not, as such, changed by any calculation herein.
2. Applicant states that, “claim 1 recites more than a mere mathematical concept” and that “claim 1 is only based on or involves such so-called mathematical concepts” In particular, claim 1 additionally recites, “identifying, with the one or more processors. A predictive clinical target volume for the three-dimensional model” and “selecting…at least one transducer layout…for delivering tumor treating fields…” and thus only involves or is based on mathematical concept.
It is respectfully submitted that this is not persuasive. As outlined above for each claim element, the rejection describes why each of the claims herein either are directed to judicially recited exceptions of mental operation and/or mathematical concepts. For example, claim steps such as “calculating” tumor treating fields dosages…based on the three-dimensional model…and the predictive target volume, wherein calculating the tumor treating fields dosages…comprises simulating applying alternating electric fields…” are steps whereby calculations of said operation are performed using mathematics. The Specification, for example discloses said operations wherein clinical target volume for a three-dimensional model is identified [0018] and predictive clinical target volumes [0020] may include volumes and further wherein dosages for volumes are calculated [0027]. TTFields dosages are calculated as described in USPG PUB 2020/0023179 and 2021/0196943, wherein said references include disclosure of at the very least, finite element analysis. As such there is no other way to interpret the operations of volume calculations and finite element calculations that as being mathematical concepts. The claims are rooted in mathematical operations by which identification and calculations are the focus and as such the claims and recited to the application of mathematical and/or mental operations and not simply just relying on operations for ancillary operation.
3. With respect to Step 2A, Prong, Two, Applicant states that the claims are patent eligible under 35 U.S.C. § 101 because the claims integrate the judicial exception into a practical application. Applicant includes that, “in particular, claim 1 is directed to the practical application of providing for tumor treating fields (TTFields) treatment, which may reduce the needs for further radiation treatment by the subject. Applicant further includes recitations from the Specification discussing the TTFields treatment planning and treatment. Lastly, Applicant includes that to this end, claim 1 recites, in part, "determining, with the one or more processors, a plurality of transducer layouts for delivering tumor treating fields to the subject" and "generating, with the one or more processors, tumor treating fields dosages for the plurality of transducer layouts based on the predictive clinical target volume." Further, using the "plurality of transducer layouts" and the "tumor treating fields dosages for the plurality of transducer layouts," claim 1 recites "selecting, with the one or more processors, at least one transducer layout from the plurality of transducer layouts for delivering tumor treating fields to the subject based on the primary clinical target volume, the predictive clinical target volume, and the tumor treating dosages for the plurality of transducer layouts." Thus, claim 1 integrates the asserted abstract idea into a practical application.
As stated in previous Office Actions, this is not persuasive. The claims do not contain any “integration” of the recited judicial exceptions into a practical application. The steps directed to determining, with the one or more processors, a plurality of transducer layouts for delivering tumor treating fields and generating, with the one or more processors, tumor treating fields dosages, are steps that are, themselves directed to the judicial exceptions (see rejection above). As such, the judicial exceptions cannot integrate themselves. Rather, it is the steps that are in addition that are considered either alone, or in combination for integration into a practical application. It is noted that there are no active steps of actually “delivering treatment” or “treating with a dosage”, for example, and as such, those steps are maintained as directed to abstract ideas wherein the “determining” is for the purpose of delivering treatment and wherein no actual treatment is performed. It is suggested that if the claims include actual “treating” steps or “delivering dosages’ as determined, then the claims may be considered to include steps that integrate the practical applications and may be patent eligible, as such.
4. Applicant responds to the above by further stating that, “the Office Action asserts that these arguments are unpersuasive because claim 1 allegedly recites steps that are the judicial exception and, as such, does not integrate the asserted abstract idea into a practical application. Office Action, page 19. To support the assertion, the Office Action points to the recitations of "determining, with the one or more processors, a plurality of transducer layouts for delivering tumor treating fields to the subject" and the previously recited "generating, with the one or more processors, tumor treating fields dosages for the plurality of transducer layouts based on the predictive clinical target volume." Office Action, page 19. The Office Action further asserts that the claims need to recite the actual tumor treating fields treatment in order to integrate the judicial exception into a practical application. Office Action, page 19.
Additionally, Applicant states that, “Claim 1, in fact, integrates the alleged judicial exception into a practical application by providing a particular improvement in medical technology with respect to providing for TTFields treatment. In particular, claim 1 is directed to the practical application of providing for TTFields treatment, which may reduce the needs for further radiation treatment by the subject. With this improvement in medical technology in predicting where a tumor in a subject will progress, TTFields treatment may be applied, which may reduce a need for further radiation treatment by the subject. The Applicant respectfully asserts that this improvement in medical technology is laudable and that claim 1 clearly integrates the alleged judicial exception into a practical application. Further, while the Applicant appreciates the Office Action's suggestion to recite the actual TTFields treatment in claim 1, the Applicant is not required to do so because claim 1 already recites patent eligible subject matter. As discussed in M.P.E.P., "[a]pplying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition" has been found by the courts to be indicative of an integrated practical application, which is what the Office Action proposes. M.P.E.P. § 2106.04(d)(II). However, the M.P.E.P. also states that "[a]pplying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception" has also been found by the courts to be indicative of an integrated practical application. M.P.E.P. § 2106.04(d)(II). Further, "even in the situation where the individually-viewed elements do not add significantly more or integrate the exception, those additional elements when viewed in combination may render the claim eligible." M.P.E.P. § 2106.5(e)”.
It is respectfully submitted that this is not persuasive. It continues to be maintained that the instant claims fail to include any such steps whereby there is a practical application of actual “treatment” using TTfields. It is not disputed whatsoever that the technology is not useful or laudable, even. However, what is not present in the instant claims are steps, either individually or in combination, that practically apply the recited judicial exceptions. Those elements would come from the additional elements, of which only includes the steps of “obtaining…a three-dimensional model…” and “computer-implementation” herein. As stated above, those steps are not one that provide any integration or practical application for the recited judicial exceptions in the claims.
It is also pointed out that there are no steps in the instant claims directed to any particular treatment or prophylaxis for a disease or medical condition in the context of the Vanda Pharmaceuticals decision. The instant claims fail to claim any active recitation of a “treatment” as relied upon and discussed in the MPEP at 2106.04(d)(2), wherein “Vanda’s claims used the recited law of nature to more safely treat the patients with the drug, thereby reducing the patient’s risk of QTc prolongation. 887 F.3d at 1135, 126 USPQ2d at 1280”. (emphasis added).
5. Applicant finally includes that “when claim 1 is viewed as a whole and when all of the elements are viewed in combination, claim 1 is clearly patent eligible. In particular, claim 1 is directed to the practical application of providing for TTFields treatment, which may reduce the needs for further radiation treatment by the subject, and does so by providing a "method for selecting at least one transducer layout for delivering tumor treating fields to a subject”, and then listing the limitations of claim 1, concluding that the improvement is in “predicting of where a tumor will progress”.
It is respectfully submitted that this it not persuasive. Steps that would provide for a practical application herein include those of “obtaining” data and “computer” implementation. Those are not either alone or in combination steps that provide for any practical application for the reasons as already set forth in the above action and in previous Office Actions.
Lastly, it is noted that there are no active steps of actually “delivering treatment” or “treating with a dosage”, for example, and as such, those steps are maintained as directed to abstract ideas wherein the “determining” is for the purpose of delivering treatment and wherein no actual treatment is performed. It is suggested that if the claims include actual “treating” steps or “delivering dosages’ as determined, then the claims may be considered to include steps that integrate the practical applications and may be patent eligible, as such.
Conclusion
No claims are allowed.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114.
Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
Inquiries
Papers related to this application may be submitted to Technical Center 1600 by facsimile transmission. Papers should be faxed to Technical Center 1600 via the PTO Fax Center. The faxing of such papers must conform to the notices published in the Official Gazette, 1096 OG 30 (November 15, 1988), 1156 OG 61 (November 16, 1993), and 1157 OG 94 (December 28, 1993) (See 37 CFR § 1.6(d)). The Central Fax Center Number is (571) 273-8300.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lori A. Clow, whose telephone number is (571) 272-0715. The examiner can normally be reached on Monday-Thursday from 11:00AM to 9:00PM ET.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Karlheinz Skowronek can be reached on (571) 272-9047.
Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to (571) 272-0547.
Patent applicants with problems or questions regarding electronic images that can be viewed in the Patent Application Information Retrieval system (PAIR) can now contact the USPTO’s Patent Electronic Business Center (Patent EBC) for assistance. Representatives are available to answer your questions daily from 6 am to midnight (EST). The toll free number is (866) 217-9197. When calling please have your application serial or patent number, the type of document you are having an image problem with, the number of pages and the specific nature of the problem. The Patent Electronic Business Center will notify applicants of the resolution of the problem within 5-7 business days. Applicants can also check PAIR to confirm that the problem has been corrected. The USPTO’s Patent Electronic Business Center is a complete service center supporting all patent business on the Internet. The USPTO’s PAIR system provides Internet-based access to patent application status and history information. It also enables applicants to view the scanned images of their own application file folder(s) as well as general patent information available to the public.
/Lori A. Clow/ Primary Examiner, Art Unit 1687