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 .
A preliminary amendment has been received on 10/10/2025. Claims 1-17 remain pending in this application.
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.
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.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited 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.
As per claims 3, 9, 10, the claim limitations of “means for receiving motion data comprising at least one motion parameter; and means for determining an estimate PAD status, based at least partly on the motion data” within claim 3, “the means for determining the estimate PAD status comprises ana trained artificial intelligence engine trained according to any of claims” within claim 9, and “means for providing information on the estimate PAD status to at least one recipient” within claim 10 have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because they use means plus function language without reciting sufficient structure to achieve the function.
Since the claim limitations invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claims 3, 9, 10 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 the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
“The means for receiving may, e.g., also be configured to store the received motion data at least partly and/or temporarily until the estimate PAD status is determined. The system may, e.g., be implemented as a remote (cloud-based) server, a system distributed over multiple user devices that may communicate with one another and/or in one or more medical devices that may acquire and/or provide the motion data.” on page 3, lines 28-32,
“…a computing device may be configured to include a processor (or a set of processors) and a memory medium, where the memory medium stores program instructions, where the processor is configured to read and execute the program instructions from the memory medium, where the program instructions are executable to implement any of the various method embodiments described herein (or, any combination of the method embodiments described herein, or, any subset of any of the method embodiments described herein, or, any combination of such subsets). The device may be realized in any of various forms.” on page 11, lines 18-25, and
“…the system 10 is a cloud-based server (system) comprising means for determining 14 an estimate PAD status, based on the motion data, optionally along with the further data.” on page 12, lines 30-32.
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 limitations 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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 6-13, 16-17 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.
In particular, claims 3, 9 and 10 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, but they use means plus function language without reciting sufficient structure to achieve the function. The current specification recites “The means for receiving may, e.g., also be configured to store the received motion data at least partly and/or temporarily until the estimate PAD status is determined. The system may, e.g., be implemented as a remote (cloud-based) server, a system distributed over multiple user devices that may communicate with one another and/or in one or more medical devices that may acquire and/or provide the motion data.” on page 3, lines 28-32, and “…the system 10 is a cloud-based server (system) comprising means for determining 14 an estimate PAD status, based on the motion data, optionally along with the further data.” on page 12, lines 30-32. However, it’s unclear whether the server is the structure to achieve these functions.
Claims 6-8, 11-13 and 16-17 inherit the deficiencies of claim 3 through dependency and are therefore also rejected.
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 3 and 15 is rejected under 35 USC 101 because the claimed invention is directed to non-statutory subject matter.
Claims 3, 6-13, 16-17 and claim 15 are rejected under 35 USC 101 because the invention does not fall within at least one of the four categories of patent eligible subject matter recited in 35 U.S.C. 101 (process, machine, manufacture, or composition of matter).
Claim 3 recites “means for receiving motion data comprising at least one motion parameter; and means for determining an estimate PAD status, based at least partly on the motion data”, claim 9 recites “the means for determining the estimate PAD status comprises ana trained artificial intelligence engine trained according to any of claims”, and claim 10 recites “means for providing information on the estimate PAD status to at least one recipient”. These limitations correspond to software per se and do not define any definite structures.
Claims 6-13, 16-17 inherit the deficiencies of claim 3 through dependency and are therefore also rejected.
Claim 15 is directed to "a computer program” and recites “a computer program for estimation of a peripheral artery disease (PAD) status of a patient, the computer program comprising instructions for: receiving motion data comprising at least one motion parameter; determining an estimate PAD status, based at least partly on the motion data; and optionally providing information on the estimate PAD status to at least one recipient.". The instructions are directed to a software, therefore the system claimed is interpreted to be software per se.
Software per se is not one of the four statutory categories.
Claims 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 1-5 and 14 are drawn to a method which is within the four statutory categories (i.e. process). Claims 3-13 and 16-17 are drawn to a system which is within the four statutory categories (i.e. machine). Claim 15 is drawn to a computer program (see the rejection above).
Step 2A, Prong 1:
Claim 1 recites “inputting a training data set, the training data set comprising a plurality of samples, wherein each sample comprises a ground truth and motion data comprising at least one motion parameter; determining an estimate ground truth based on the motion data of a sample; comparing the estimate ground truth with the ground truth of the sample; and adjusting the artificial intelligence engine at least partly based on the comparing” and claims 3, 14 and 15 recite “receiving motion data comprising at least one motion parameter; determining an estimate PAD status, based at least partly on the motion data; and optionally providing information on the estimate PAD status to at least one recipient”.
These limitations are directed to an abstract idea of “certain methods of organizing human activity”. This is a method of managing interactions between people, such as user following rules and instructions. The mere nominal recitation of a generic computer and user device does not take the claims out of the methods of organizing human interactions grouping. Thus, the claims recite an abstract idea.
The current specification describes the computer as a generic computing device, such as, the specification recites “…a computing device may be configured to include a processor (or a set of processors) and a memory medium, where the memory medium stores program instructions, where the processor is configured to read and execute the program instructions from the memory medium, where the program instructions are executable to implement any of the various method embodiments described herein (or, any combination of the method embodiments described herein, or, any subset of any of the method embodiments described herein, or, any combination of such subsets). The device may be realized in any of various forms.” on page 11, lines 18-25.
After considering all claim elements, both individually and in combination and in ordered combination, it has been determined that the claims do not amount to significantly more than the abstract idea itself.
Claims 2-5, 6-13 and 16-17 are ultimately dependent from claims 1, 3 and include all the limitations of claims 1, 3. Therefore, claims 2-5, 6-13 and 16-17 recite the same abstract idea. Claims 2-5, 6-13 and 16-17 describe a further limitation regarding the basis for determining an estimate PAD status of a patient. These are all just further describing the abstract idea recited in claims 1, 3, without adding significantly more.
Step 2A, Prong 2:
This judicial exception is not integrated into a practical application. In particular, claims recite the additional elements of “artificial intelligence engine”, “a trained artificial intelligence engine”, “a user device configured to receive the information…and comprising a user-interface for outputting the received information”, “a medical sensor for acquiring and providing the motion data, wherein the medical sensor comprises at least one of: an accelerometer, a GPS sensor, a timekeeper, and a position sensor”.
These additional elements correspond to hardware and software elements, these limitations are not enough to qualify as “practical application” being recited in the claims along with the abstract idea since these elements are merely invoked as a tool to apply instructions of the abstract idea in a particular technological environment, and mere instructions to apply/implement/automate an abstract idea in a particular technological environment and merely limiting the use of an abstract idea to a particular field or technological environment do not provide practical application for an abstract idea (MPEP 2106.05(f) & (h)).
Claims also recite other additional limitations beyond abstract idea, including functions such as receiving data from a database, outputting data are insignificant extra-solution activities (see MPEP 2106.05 (g)), which do not provide a practical application for the abstract idea.
Accordingly, 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. The claims are directed to an abstract idea.
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a system (server)using an artificial intelligence engine to perform the determining steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
The claims are not patent eligible.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Alsaleem et al. (hereinafter Alsaleem) (US 2024/0237902 A1).
Claim 1 recites a computer-implemented method for training an artificial intelligence engine for use in estimation of a peripheral artery disease (PAD) status of a patient, the method comprising:
inputting a training data set, the training data set comprising a plurality of samples, wherein each sample comprises a ground truth and motion data comprising at least one motion parameter (Alsaleem; abstract, [0022]-“ training a machine learning model with gait characteristic data extracted from acceleration data for patients known to have PAD and patients that do not have PAD”);
determining an estimate ground truth based on the motion data of a sample (Alsaleem; abstract, [0022]);
comparing the estimate ground truth with the ground truth of the sample (Alsaleem; abstract, [0022]); and
adjusting the artificial intelligence engine at least partly based on the comparing (Alsaleem; abstract, [0022]).
Claim 2 recites the computer-implemented method of claim 1, wherein the ground truth comprises the PAD status (Alsaleem; abstract, [0022]).
Claim 3 recites a system for estimation of a peripheral artery disease (PAD) status of a patient, the system comprising:
means for receiving motion data comprising at least one motion parameter (Alsaleem; [0023], [0025]); and
means for determining an estimate PAD status, based at least partly on the motion data (Alsaleem; [0021], [0033]).
Claim 4 has been amended to recite the computer-implemented method of claim 1, wherein the at least one motion parameter comprises at least one of: a walking distance measure, a walking pause measure, a step measure, and a posture measure (Alsaleem; [0009]).
Claim 5 has been amended to recite the computer-implemented method of claim 1, wherein the estimate PAD status comprises a medical classifier (Alsaleem; [0022]).
Claim 6 has been amended to recite the system of any of claim 3, wherein determining an estimate PAD status is based at least partly on a comparison of the motion data with predetermined reference data comprising at least one predetermined reference motion parameter and a predetermined reference PAD status (Alsaleem; [0020]-[0022]).
Claim 7 recites the system of claim 6, wherein the comparison of the motion data comprises a comparison of at least one individual motion parameter of the motion data (Alsaleem; [0020]-[0022]).
Claim 8 has been amended to recite the system of claim 6, wherein the comparison comprises a comparison between an aggregate motion score based on a plurality of motion parameters and a reference motion score based on a plurality of predetermined reference motion parameters (Alsaleem; [0025]).
Claim 9 has been amended to recite the system of claim 3, wherein the means for determining the estimate PAD status comprises a trained artificial intelligence engine (Alsaleem; abstract, [0006]).
Claim 10 has been amended to recite the system of claim 3, further comprising means for providing information on the estimate PAD status to at least one recipient (Alsaleem; [0025]).
Claim 11 recites the system of claim 10, further configured to provide the information on the estimate PAD status according to a predetermined schedule and/or when at least one motion parameter and/or the PAD status fulfills a predetermined criterion (Alsaleem; [0025]).
Claim 12 has been amended to recite the system of claim 10, further comprising a user device configured to receive the information on the estimate PAD status and comprising a user-interface for outputting the received information (Alsaleem; [0025]).
Claim 13 has been amended to recite the system of claim 3, further comprising a medical sensor for acquiring and providing the motion data, wherein the medical sensor comprises at least one of: an accelerometer, a GPS sensor, a timekeeper, and a position sensor (Alsaleem; [0006]-[0007]).
Claim 14 recites a method for estimation of a peripheral artery disease (PAD) status of a patient, the method comprising:
receiving motion data comprising at least one motion parameter (Alsaleem; [0025]);
determining an estimate PAD status, based at least partly on the motion data (Alsaleem; [0021], [0033]); and
optionally providing information on the estimate PAD status to at least one recipient (Alsaleem; [0025]).
Claim 15 recites a computer program for estimation of a peripheral artery disease (PAD) status of a patient, the computer program comprising instructions for:
receiving motion data comprising at least one motion parameter (Alsaleem; [0025]);
determining an estimate PAD status, based at least partly on the motion data (Alsaleem; [0021], [0033]); and
optionally providing information on the estimate PAD status to at least one recipient (Alsaleem; [0025]).
Newly added claim 16 recites the system of claim 3, wherein the at least one motion parameter comprises at least one of: a walking distance measure, a walking pause measure, a step measure, and a posture measure (Alsaleem; [0009]).
Newly added claim 17 recites the system of claim 3, wherein the estimate PAD status comprises a medical classifier (Alsaleem; [0022]).
Conclusion
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/DILEK B COBANOGLU/ Primary Examiner, Art Unit 3687
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