DETAILED ACTION
Notices to Applicant
This communication is a final rejection. Claims 1-7, 9-12, 14-16, and 18-20, as filed 11/292025, are currently pending and have been considered below.
Priority is generally acknowledged as shown in the bibliographic data sheet with the earliest filing date being 09/16/2022.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis 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.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim elements in this application that use the word “means” (or “step for”) are presumed to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
The claim limitations “information receiving unit,” “dose receiving unit,” “treatment plan establishing unit,” and “treatment plan determining unit” have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder “unit” coupled with functional language “receiving,” “establishing,” or “determining” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claims 1-7, 9-12, 14-16, and 18-20 have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that these limitations are only used functionally with no indication of structure. For purposes of examination, the examiner interprets the units as conceptual processing units of a computer. For example, a “dose receiving unit” is a computer capable of receiving data.
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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.
Claims 1-7, 9-12, 14-16, and 18-20 are 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 the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1
The claim(s) recite(s) subject matter within a statutory category as a process, machine, and/or article of manufacture which recite:
1. A computer-implemented system for determining a tumor treatment plan using dose based on impulse, the system comprising:
an information receiving unit implemented by a processor configured to (general purpose computer) classify organs and a tumor of a medical image stored in a memory (abstract idea – mental process), and the information receiving unit receives three-dimensional image information including the organs and the tumor acquired from the scanner, and receives, from a storage device, physical property information including electrical conductivity and permittivity for the medical image (additional element – data gathering);
a dose receiving unit implemented by the processor to receive a prescription dose information based on the impulse to the tumor (additional gathering – data gathering);
a candidate treatment plan establishing unit comprising a processor-executable module configured to generate (general purpose computer) at least one treatment plan of candidate treatment plans numerically calculating an electric field distribution within the medical image using the physical property information and determining a set of treatment parameters including number of treatment electrodes, position of the treatment electrodes, treatment frequency, treatment voltage or current density and treatment time using the information received from the information receiving unit and the dose receiving unit (abstract idea – mental process); and
a treatment plan determining unit configured to select, by execution of a stored program on the processor, the treatment plan from among the candidate treatment plans (abstract idea – mental process); and
a non-transitory computer-readable medium storing program instructions that, when executed by the processor of the system, cause the system to perform the operations of the information receiving unit, the dose receiving unit, the candidate treatment plan establishing unit, and the treatment plan determining unit, (general purpose computer)
wherein the at least one treatment plan has different values of at least one of the number of treatment electrodes, the position of the treatment electrodes and the treatment time (abstract idea – mental process).
Claim 1 is presented as an exemplary claim but the same analysis applies to the other independent claims.
Step 2A Prong One
The broadest reasonable interpretation of these steps includes mental processes such as making a treatment plan with various attributes and determining a treatment plan which can each be performed by a clinician thinking about various plans and choosing an appropriate one. Other than reciting generic computer terms like various processors and computer instructions, nothing in the claims precludes the italicized portions from practically being performed in the mind. Additionally, calculating an electric field distribution within a medical image using physical property information is a mental process and a mathematical process.
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims. For example, claims 2-6 recite further abstract ideas, namely, mathematical concepts. Claims 7 and 9-11 add further detail to the mental processes of claim 1.
Step 2A Prong Two
This judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements:
amount to mere instructions to apply an exception. For example, various units implemented by processors classifying organs and a tumor or making a treatment plan amounts to invoking computers as a tool to perform the abstract idea, see applicant’s specification [0159] and FIG. 11, see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea. For example, receiving three-dimensional image information including the organs and the tumor, and to receive physical property information including electrical conductivity and permittivity for the medical image; a dose receiving unit receiving a prescription dose information based on the impulse to the tumor amounts to mere data gathering or selecting a particular data source or type of data to be manipulated, see MPEP 2106.05(g))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. For example, claim recites additional limitations which amount to invoking computers as a tool to perform the abstract idea. Claim recites additional limitations which add insignificant extra-solution activity to the abstract idea which amounts to mere data gathering. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, other than the abstract idea per se amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields. For example, amounts to receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i), performing repetitive calculations, Flook, MPEP 2106.05(d)(II)(ii), electronic recordkeeping, Alice Corp., MPEP 2106.05(d)(II)(iii), and/or storing and retrieving information in memory, Versata Dev. Group, MPEP 2106.05(d)(II)(iv).
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Response to arguments
Applicant's arguments filed 11/29/2025 have been fully considered and are discussed below.
Regarding the subject matter ineligibility rejections, Applicant argues that the claimed invention is not directed to one or more mental processes (Step 2A Prong One) because they “[r]elate to specific systems and methods for implementing technical operations of receiving three- dimensional medical image data and classifying organ and tumor of medical image stored in memory; receiving physical property information including conductivity and permittivity; numerically computing electric field distributions; generating candidate treatment plans; selecting a treatment plan; thus, a finding that the claims are directed to some fundamental concept that threatens to tie up ‘well-understood, routine, and conventional concepts in existing computer technology’ is false.” Remarks pages 13-16. These arguments are not persuasive. Applicant appears to be arguing that, notwithstanding any claimed mental processes such as making treatment plans, the claimed invention is not directed to an abstract idea because the mental processes are not “fundamental concept[s] that threate[n] to tie up well-understood, routine, and convention concepts.” The question of whether the abstract idea is a fundamental concept that would pre-empt certain ideas is not the test of Step 2A Prong One. The MPEP states, “For Step 2A Prong One, the rejection should identify the judicial exception by referring to what is recited (i.e., set forth or described) in the claim and explain why it is considered an exception. For example, if the claim is directed to an abstract idea, the rejection should identify the abstract idea as it is recited (i.e., set forth or described) in the claim and explain why it is an abstract idea.” MPEP 2106.07(a). The MPEP further provides an example explanation: “The claim recites the step of comparing collected information to a predefined threshold, which is an act of evaluating information that can be practically performed in the human mind. Thus, this step is an abstract idea in the "mental process" grouping.” MPEP 2106.07(a)(I). In this case, the Examiner stated that various limitations of the claimed invention set forth and describe mental processes such as making a treatment plan with various attributes and determining a treatment plan which can each be performed by a clinician thinking about various plans and choosing an appropriate one. The claimed determinations are not so complex that they cannot practicably be performed mentally.
Applicant argues that the claimed invention integrates any abstract idea into a practical application (Step 2A Prong Two) because “the system uses specific, tangible computer components to improve a technical field—computer-implemented medical treatment planning.” Remarks pages 16-17. This is not persuasive because it is a result (i.e., a better treatment plan) rather than improvement to technical itself. The claimed invention arguably improves the content of a medical recommendation by using steps that are practicably performed in the mind of a clinician or mathematical concepts which is an improvement to the abstract ideas themselves rather than an improvement to computer functionality or the underlying medical device(s).
Applicant argues that the claimed invention amounts to significantly more than any abstract idea (Step 2B) because the steps are not “widely accepted and used in the field of pattern search by use of generic computers” and instead us “a special purpose computer” “with specific programming instructions.” Remarks pages 17-18. First, the Examiner never made a finding that the abstract ideas were well-understood, routine, and conventional. The non-abstract elements of the claim (i.e., the additional elements) are generic computing components that amount to “apply it”. Applicant’s advocacy for a narrow interpretation of the processor is not persuasive because the hardware limitations in the claims do not reflect an unconventional arrangement that provides a technical solution to a technical problem or some kind of novel hardware solution. If the claimed invention actually required novel hardware solutions beyond general-purpose computers, the examiner would expect to find those solutions set forth in the specification such that they would provide structural support for the functionally claimed limitations. No such support is found. Thus the eligibility rejections are maintained.
The prior art rejections are withdrawn in light of claim amendments that incorporate subject matter determined to be free from prior art such as from dependent claim 8 (see Non-Final Rejection dated 07/01/2025).
The 112(b) rejections are withdrawn in light of claim amendments that clarify the structure of the units.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA BLANCHETTE whose telephone number is (571)272-2299. The examiner can normally be reached on Monday - Thursday 7:30AM - 6:00PM, EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid Merchant, can be reached on (571) 270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSHUA B BLANCHETTE/ Primary Examiner, Art Unit 3624