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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/20/2026 has been entered.
Claims 8-15 remain pending in this application.
New Matter
The amendment filed 03/20/2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: The newly added recitation of “a control device configured to regulate operating parameters of the fluid pump”, “derive a predictive control model” within claim 8, “processing device is further configured to generate control preset curves based on the derived predictive control model and transmit said curves to the control device” within claim 11 appears to constitute new matter.
In particular, Applicant does not point to, nor was the Examiner able to find, any support for a “a control device configured to regulate operating parameters of the fluid pump”, “derive a predictive control model” within claim 8, “processing device is further configured to generate control preset curves based on the derived predictive control model and transmit said curves to the control device” features within the specification as originally filed. As such, Applicant is respectfully requested to clarify the above issues and to specifically point out support for the newly added limitations in the originally filed specification and claims.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 8-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In particular, claim 8 recites “a control device configured to regulate operating parameters of the fluid pump”, “derive a predictive control model” and claim 11 recites “processing device is further configured to generate control preset curves based on the derived predictive control model and transmit said curves to the control device”. The current specification recites:
“The invention, therefore, relates to a medical engineering apparatus for storing medical data, including
at least one computation unit, consisting of a selection and correlation module, a feed module with self-learning sub-module,
at least one storage unit that stores the measurement data obtained via the interface and/or patient data and that optionally permanently includes at least one data set as a fall-back level,
at least one interface to at least one other medical engineering apparatus, the interface transmitting measurement data and/or patient data to the storage unit,
at least one interface for reading patient information to at least one information system of the hospital (patient record) and/or an image recognition system for reading the patient information,
at least one processing device, in which a priori information present in the storage unit is processed with information obtained via the interface such that operating parameters calculated according to a predetermined criterion are provided via an interface to another medical engineering apparatus.” in [0013].
However, the current specification fails to recite any support for the features of “a control device configured to regulate operating parameters of the fluid pump”, “derive a predictive control model” and “processing device is further configured to generate control preset curves based on the derived predictive control model and transmit said curves to the control device”.
Claims 9-15 incorporate the deficiencies of independent claim 8, through dependency, and are 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 8-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 8-15 are drawn to a system which is within the four statutory categories (i.e. machine).
Step 2A, Prong 1:
Claim 8 recites “collect data,…analyze the collected data … to identify correlations between the intra-operative process data and the clinical treatment success…, determining…based on the derived predictive control model and current patient data, those operating parameters for the fluid pump that are optimized to achieve a maximum clinical treatment success…” and 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 processing and control devices does not take the claim out of the methods of organizing human interactions grouping.
The limitation of “analyze the collected data by means of a self-learning module to identify correlations between the intra-operative process data and the clinical treatment success” is directed to mathematical calculations, which falls within the “mathematical concepts” grouping of abstract ideas.
Thus, the claim recites an abstract idea.
Claims 9-15 are ultimately dependent from claim 8 and include all the limitations of claim 8. Therefore, claims 9-15 recite the same abstract idea. Claims 9-15 describe a further limitation regarding the basis for determining the operating parameters. These are all just further describing the abstract idea recited in claim 8, without adding significantly more.
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.
Step 2A, Prong 2:
This judicial exception is not integrated into a practical application. In particular, claims recite the additional elements that are shown below in the bolded style:
Newly added claim 8 recites a medical engineering system for optimizing surgical procedures, the system comprising:
a fluid pump configured to deliver a fluid into a body cavity of a patient during a surgical procedure;
a control device configured to regulate operating parameters of the fluid pump;
a storage unit; and
a processing device configured to execute a central expert system, the expert system being configured to:
collect and store in the storage unit data from a plurality of previous surgical procedures, the collected data comprising: a) intra-operative process data of the respective procedures, and b) quantified data related to the post-operative clinical treatment success of the respective procedures;
analyze the collected data by means of a self-learning module to identify correlations between the intra-operative process data and the clinical treatment success, and to derive a predictive control model therefrom; and
for a current surgical procedure, determine and transmit to the control device, based on the derived predictive control model and current patient data, those operating parameters for the fluid pump that are optimized to achieve a maximum clinical treatment success; wherein the adjustment of the pump parameters is performed autonomously and dynamically during the procedure.
Newly added claim 9 recites the system of claim 8, wherein the data stored in the storage unit comprises a mixture of anonymized or pseudonymized patient data, anamnesis data, surgical procedure data, device configuration data, and procedural control rules.
Newly added claim 10 recites the system of claim 8, further comprising at least one interface configured to receive patient data from a hospital information system (HIS) and/or an electronic patient record.
Newly added claim 11 recites the system of claim 8, wherein the processing device is further configured to generate control preset curves based on the derived predictive control model and to transmit said curves to the control device.
Newly added claim 12 recites the system of claim 8, wherein the central expert system is further configured to, when deriving the predictive control model, consider rules originating from medical guidelines or expert protocols.
Newly added claim 13 recites the system of claim 8, wherein the control device is further configured to perform at least one of the following actions: reducing pressure after a defined time above a threshold; initiating a rinsing of the body cavity after a defined period; triggering a warning after a defined pressure/time combination; or gradually reducing the set pressure as a function of procedure duration.
Newly added claim 14 recites the system of claim 8, wherein the operating parameters comprise at least one of a fluid pressure and/or a fluid flow.
Newly added claim 15 recites the system of claim 9, wherein the operating parameters comprise at least one of a fluid pressure and/or a fluid flow.
These limitations are directed 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, such as the feature of “operating parameters…are optimized to achieve a maximum clinical treatment success” is insignificant application (see MPEP 2106.05 (g)), which does 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 processing device and a self-learning module to perform analyzing data and determining operating parameters 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 feature of “analyze the collected data by means of a self-learning module to identify correlations between the intra-operative process data and clinical treatment success, and to derive a predictive control model thereform…determine the operating parameters…” is found to be a well-understood, routine and conventional activity in the field, as evidenced by the article published on IEEE Transactions on parallel and distributed systems, titled “Patient Infusion Pattern based Access Control Schemes for Wireless Insulin Pump System” by Hei et al (hereinafter Hei), published in 2015.
In particular Hei discloses “a super vised learning method”, “…To learn these normal patterns, the regressions are designed to analyze infusion dosage history and predict future infusion dosages…” on page 3108, par. 3.
Hence, the claims are not patent eligible.
Response to Arguments
Applicant's arguments filed 03/20/2026 have been fully considered. Applicant’s arguments will be addressed below in the order in which they appear.
Arguments about 35 USC 101 rejection:
Applicant argues that the newly added claims are not directed to an abstract idea of a mental process or certain methods of organizing human activity, and the current claims recite a machine-based system that operates on physical inputs and produces physical control outputs.
In response, Examiner submits that an updated rejection has been provided for the newly added claims and as indicated in the rejection above, the claim limitations of “collect data,…analyze the collected data … to identify correlations between the intra-operative process data and the clinical treatment success…, determining…based on the derived predictive control model and current patient data, those operating parameters for the fluid pump that are optimized to achieve a maximum clinical treatment success…” are directed to an abstract idea of “certain methods of organizing human activity”, where the physical components, such as the fluid pump, control device, and the processing device are not a part of the abstract idea rejection.
Applicant argues that claim 8 integrates the abstract idea into a practical application, by providing " A predictive control model is derived from correlations between intra-operative data and post-operative clinical outcomes; and " That model is used during a current surgical procedure to determine and transmit operating parameters to a control device; " The system then autonomously and dynamically adjusts a fluid pump based on those parameters.”. Applicant argues that this constitutes a direct application of the analysis to control a physical device in real time, thereby affecting the operation of a medical apparatus and the conditions within a patient's body.
In response, Examiner submits that the feature of “derive a predictive control model” is not recited/described in the current specification and therefore, is objected for being a new matter. Thei feature also has been rejected under 35 USC 112, first paragraph for failing to comply with the written description requirement. Additionally, the features of autonomously and dynamically adjusting the pump parameters correspond to additional elements, that 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.
Applicant argues that the newly added claims provide a specific improvement in the field of medical engineering systems, by use of post-operative clinical outcome data as feedback signal for optimizing intra-operative device control.
In response, Examiner submits that determining pump parameters based on analyzed data (including post operative clinical success of the respective procedures) is not directed to an improvement to the technology. This feature may be an improvement to the outcome for the operating parameters to be transmitted to the control device (the pump), but it’s not an improvement to the technology itself.
Arguments about 35 USC 102 rejection:
Applicant’s arguments, see Remarks, filed 03/20/2026, with respect to 35 USC 102 rejection of claim have been fully considered and are persuasive. The rejection has been withdrawn.
Conclusion
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/DILEK B COBANOGLU/Primary Examiner, Art Unit 3687
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