DETAILED ACTION
Notice to Applicant
This communication is in response to the amendment submitted March 30, 2026. The present application claims priority under 35 U.S.C. §119 to European Patent Application No. 22159795.8, filed March 2, 2022. Claims 1 and 12 are amended. Claims 3 – 4, 7, and 19 were previously cancelled. Claims 21 – 22 are new. Claims 1 – 2, 5 – 6, 8 – 18, and 20 – 22 are pending.
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 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 – 2, 5 – 6, 8 – 18, and 20 – 22 are rejected under 35 U.S.C. 101 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 One
Claims 1 – 2, 5 – 6, 8 – 18, and 20 – 22 are drawn to a method, system, and non-transitory computer-readable storage medium and product, which is/are statutory categories of invention (Step 1: YES).
Step 2A Prong One
Independent claims 1 and 12 – 15 recite generating protocol data of a specific medical process, wherein the specific medical process comprises at least one measurement process, comprising: generating a first structured medical data object based on user-generated medical data, the user-generated medical data being created by a user documenting the specific medical process; generating a second structured medical data object by applying [the] created medical data, the medical data referring to the specific medical process; and generating the protocol data based on the first structured medical data object and the second structured medical data object by merging the first structured medical data object and the second structured medical data object, the protocol data including a third structured data object, the generating including comparing the first and second structured medical data objects to determine deviations.
The recited limitations, as drafted, under their broadest reasonable interpretation, cover certain methods of organizing human activity, as reflected in the specification, which states that “present invention relates to a method for generating protocol data for a specific medical process.” (paragraph 2 of the published specification). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. The present claims cover certain methods of organizing human activity because they address a need “of using expert knowledge and automatic analytic tools for the analysis of measurement data in a more coherent way” (paragraph 10 of the published specification). An alert is provided to a user if a deviation in the protocol generation is determined (paragraphs 68 – 73). Accordingly, the claims recite an abstract idea(s) (Step 2A Prong One: YES).”
Step 2A Prong Two
This judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including:
Claim 1: “electronic”, “automatic processing algorithm”, “automatic”, “the first structured medical data object and the second structured medical data object comprise the same data structure”, “the first structured medical data object and the second structured medical data object comprise a graph structure, and the merging uses graph linking”
Claim 2: “output”
Claims 5, 8, 16: “electronic”
Claims 6, 20: “electronic”, “automatic”, “the automatic processing algorithm comprises an image processing algorithm, the image processing algorithm being applied to the medical image data”
Claims 10, 17: “electronic”, “machine translation of the text-based electronic medical data”
Claim 12: “device”, “an extraction unit configured to generate a first structured medical data object based on user-generated electronic medical data”, “processing unit”, “applying an automatic processing algorithm to automatically created electronic medical data”, “data generation unit”, “the first structured medical data object and the second structured medical data object comprise the same data structure”, “the first structured medical data object and the second structured medical data object comprise a graph structure, and the merging uses graph linking”
Claim 13: “system”, “process unit”, “documentation unit”, “electronic”, “user interface”, “device”
Claim 14: “A non-transitory computer program product comprising instructions which, when executed by a computer, cause the computer to perform”
Claim 15: “A non-transitory computer-readable storage medium comprising instructions which, when executed by a computer, cause the computer to perform”
Claim 21: “third structured medical data object”
Claim 22: “device”, “data generation unit”, “third structured medical data object”
These features are additional elements that are recited at a high level of generality such that they amount to no more than mere instruction to apply the exception using generic computer components. See: MPEP 2106.05(f).
The additional elements are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
The combination of these additional elements is no more than mere instructions to apply the exception using generic computer components. Accordingly, even in combination, 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.
Hence, the 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. Accordingly, the claims are directed to an abstract idea (Step 2A Prong Two: NO).
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, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic components cannot provide an inventive concept. See MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are not integrated into the claim because they are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See: MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The published specification supports this conclusion as follows:
[0065] A computer readable medium such as a memory stick, a hard-disk or other transportable or permanently installed carrier can serve to transport and/or to store the executable parts of the computer program product so that these can be read from a processor unit of a computing system. A processor unit can comprise one or more microprocessors or their equivalents.
[0321] In addition, or alternative, to that discussed above, units and/or devices according to one or more example embodiments may be implemented using hardware, software, and/or a combination thereof. For example, hardware devices may be implemented using processing circuitry such as, but not limited to, a processor, Central Processing Unit (CPU), a controller, an arithmetic logic unit (ALU), a digital signal processor, a microcomputer, a field programmable gate array (FPGA), a System-on-Chip (SoC), a programmable logic unit, a microprocessor, or any other device capable of responding to and executing instructions in a defined manner. Portions of the example embodiments and corresponding detailed description may be presented in terms of software, or algorithms and symbolic representations of operation on data bits within a computer memory. These descriptions and representations are the ones by which those of ordinary skill in the art effectively convey the substance of their work to others of ordinary skill in the art. An algorithm, as the term is used here, and as it is used generally, is conceived to be a self-consistent sequence of steps leading to a desired result. The steps are those requiring physical manipulations of physical quantities. Usually, though not necessarily, these quantities take the form of optical, electrical, or magnetic signals capable of being stored, transferred, combined, compared, and otherwise manipulated. It has proven convenient at times, principally for reasons of common usage, to refer to these signals as bits, values, elements, symbols, characters, terms, numbers, or the like.
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with routine, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent claim(s) 2, 5 – 6, 8 – 11, 16 – 18, and 20 – 22 when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
Claim Rejections - 35 USC § 103
Claim(s) 1 – 3, 5 – 10, 12 - 17, and 20 rejected under 35 U.S.C. 103 as being unpatentable over Glottmann et al., herein after Glottmann (U.S. Publication Number 2020/0043600 A1) in view of Giataganas et al., herein after Giataganas (U.S. Patent Number 11,189,379 B2) were withdrawn in the Office Action mailed December 29, 2025.
Claim(s) 11 and 18 rejected under 35 U.S.C. 103 as being unpatentable over Glottmann et al., herein after Glottmann (U.S. Publication Number 2020/0043600 A1) in view of Giataganas et al., herein after Giataganas (U.S. Patent Number 11,189,379 B2) further in view of Xie et al., herein after Xie (U.S. Publication Number 2020/0160993 A1) were withdrawn in the Office Action mailed December 29, 2025.
Response to Arguments
Applicant's arguments filed March 30, 2026 have been fully considered but they are not persuasive. The Applicant’s arguments have been addressed in the order in which they were presented.
Claim Rejections under 35 USC § 101
The Applicant argues the present claims are patent eligible because the claims do not recite methods of organizing human activity. The Examiner disagrees. Under its broadest reasonable interpretation, the Applicant’s claims are an abstract idea that falls into the grouping of “Certain Methods of Organizing Human Activity” which covers fundamental economic principles or practices, commercial or legal interactions, or managing personal behavior or relationships or interactions between people. The Examiner respectfully submits that the MPEP 2106.04(a)(2) recites that “Certain Methods of Organizing Human Activity” include managing personal behavior or relationships or interactions between people, including social activities, teaching, and following rules or instructions. The present claims recite the abstract idea of generating protocol data of a specific medical process. The present claims recite generating a first medical data object based on user generated data based on the user documenting the specific medical process, generating a second medical data object referring to the specific medical process, generating protocol data including a third medical data object, which is a comparison of the first and second medical objects to determine deviations, and providing an alert output for a user based on the deviation detection, where the user is preferably an expert. These features describe interactions with people, thus “Certain Methods of Organizing Human Activity”, where an alert is output for a user (as disclosed in dependent claim 2). Thus, if a claim limitation, under its broadest reasonable interpretation, covers interactions with people, but for the recitation of generic components, then it is still in the “Certain Methods of Organizing Human Activity” grouping.
The Applicant argues the claims integrate any alleged judicial exception into a practical application. The Examiner respectfully disagrees. The additional elements of the present claims fail to integrate the exception into a practical application of the exception. The 2019 PEG defines the phrase “integration into a practical application” to require an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception. For example, the 2019 PEG guidelines recite limitations that are indicative of integration into a practical application when recited in a claim with a judicial exception include:
Improvements to the functioning of a computer, or to any other technology or technical field, as discussed in MPEP 2106.05(a);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for disease or medical condition – see Vanda Memo
Applying the judicial exception with, or by use of, a particular machine, as discussed in MPEP 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP 2106.05(c); and
Applying 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, as discussed in MPEP 2106.05(e) and the Vanda Memo issued in June 2018.
The present claims fail to demonstrate an improvement to the functioning of a computer or to any other technology or technical field. Thus, Applicant’s argument is not persuasive, and the rejection is maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINE K RAPILLO whose telephone number is (571)270-3325. The examiner can normally be reached Monday - Friday 7:30 - 4 pm.
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/KRISTINE K RAPILLO/Examiner, Art Unit 3682
/ROBERT A SOREY/Primary Examiner, Art Unit 3682
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