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 .
This communication is in response to the amendment received on 10/03/2025. Claims 1-3, 5 and 7 remain pending in this application.
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 1-3, 5 and 7 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 1 has been amended to recite “an integrated control device configured to regulate operating parameters of the liquid pump, the parameters including fluid pressure, fluid flow, and/or fluid temperature” and this feature is not described in the Applicant’s specification. Therefore, claim 1 recite a limitation that is a new matter.
Claims 2-3, 5 and 7 incorporate the deficiencies of independent claim 1, through dependency, and are also rejected.
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 1-3, 5 and 7 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, claim 1 has been amended to recite “execute a self-learning module trained on data from prior pre-operative and intra- operative phases to build and refine a patient-specific predictive control model in a post- operative phase, wherein the predictive control model is configured to determine, based on real-time intra-operative data and the stored data, operating parameters of the liquid pump specific to the current patient”, and it’s not clear how the self-learning module being trained. The current specification recites “The classification process corresponds to the established method, and a suitable classificator structure is created for each field of application. Training and validation of the classificator is made by means of data from the clinical environment.” on page 9, lines 3-10 and “Automated acquisition and feedback of device configurations takes place by a central data collection, data analysis and data storage device, a so- called expert system that is accessible from the medical device via a network. This expert system consists of a selection and correlation module, a feed module for rules and expert knowledge with a self-learning sub-module and a data retention module, which assigns, classifies, stores the contents and manages the access to the contents.” on page 6, lines 21-30. It’s not clear which data of the clinical environment being used and how the training of the classificatory being done, and t’s not clear whether the classificatory is the self-learning module.
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 1-3, 5 and 7 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 1:
Claims 1-3, 5 and 7 are drawn to a device (system), which is within the four statutory categories (i.e. machine).
Step 2A, Prong 1:
Claim 1 has been amended to recite:
“A medical fluid pump system for expanding body cavities during a surgical procedure, the system comprising:
a liquid pump, configured to deliver fluid to a body cavity;
an integrated control device configured to regulate operating parameters of the liquid pump, the parameters including fluid pressure, fluid flow, and/or fluid temperature
at least one sensor interface configured to receive intra-operative patient data including fluid pressure of flow data;
a storage unit configured to store a priori medical knowledge, intra-operative data, and post-operative outcome data;
a processing device configured to:
execute a self-learning module trained on data from prior pre-operative and intra- operative phases to build and refine a patient-specific predictive control model in a post- operative phase, wherein the predictive control model is configured to determine, based on real-time intra-operative data and the stored data, operating parameters of the liquid pump specific to the current patient;
transmit said operating parameters to the control device to automatically adjust fluid delivery;
wherein the adjustment of the liquid pump parameters is performed autonomously and dynamically during surgery without intervention from clinical personnel, and the parameters include at least a pressure value based on the patient's age.”
The limitations of “…receive intra-operative patient data including fluid pressure of flow data…; determine, based on real-time intra-operative data and the stored data, operating parameters of the liquid pump specific to the current patient; transmit said operating parameters to the control device to automatically adjust fluid delivery” correspond to “certain methods of organizing human activity” (e.g. this is a method of managing interactions between people, such as a user following rules or instructions). The mere nominal recitation of a generic processing device including a storage unit and generic sensor interface does not take the claim out of the methods of organizing human interactions grouping.
The limitation of “execute a self-learning module trained on data from prior pre-operative and intra- operative phases to build and refine a patient-specific predictive control model in a post- operative phase, wherein the predictive control model is configured to determine, based on real-time intra-operative data and the stored data, operating parameters of the liquid pump specific to the current patient” correspond to mathematical relationships, which falls within the “mathematical concept” grouping of abstract ideas.
Thus, the claim recites an abstract idea.
Claims 2-3, 5 and 7 are ultimately dependent from claim 1 and include all the limitations of claim 1. Therefore, claims 2-3, 5 and 7 recite the same abstract idea. Claims 2-3, 5 and 7 describe a further limitation regarding the basis for determining operating parameters of medical devices. These are all just further describing the abstract idea recited in claim 1, 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 “a liquid pump, configured to deliver fluid to a body cavity; an integrated control device configured to regulate operating parameters of the liquid pump, the parameters including fluid pressure, fluid flow, and/or fluid temperature; at least one sensor interface configured to receive intra-operative patient data including fluid pressure of flow data; a storage unit configured to store a priori medical knowledge, intra-operative data, and post-operative outcome data; a processing device configured to: execute a self-learning module trained on data from prior pre-operative and intra- operative phases to build and refine a patient-specific predictive control model in a post- operative phase…;…automatically adjust fluid delivery…; wherein the adjustment of the liquid pump parameters is performed autonomously and dynamically during surgery without intervention from clinical personnel, and the parameters include at least a pressure value based on the patient's age”, which are hardware or 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)).
The processing device in each step is recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of ranking information based on a determined amount of use) such that it amounts no more than mere instructions to apply the exception using a generic computer component.
The claimed medical device is described in the current specification as “Herein, "networking" means the comprehensive use of information of all relevant data present in the operating room. A "medical device" is every energy-operated or non-energy-operated technical device that is used for diagnostic or therapeutic interaction with the human or animal body. Accessories and disposables are explicitly also referred to as medical devices.” on page 1, lines 12-18, that is as a generic medical device.
Claim 7 has been amended to recite “The system of claim 1, wherein the control device is further configured to: reduce pressure after a defined time above a threshold, initiate fluid rinsing cavity after a defined period, trigger a warning after a defined pressure/time combination, or gradually reduce the set pressure as a function of procedure duration.”, which
The current specification recites “The feedback of device settings to the medical de- vice can be made through a previously established safe connection or as an addressed and encrypted data packet with defined target indication. The reception of the data packet can be acknowledged by the receiving medical device named as target. Certain procedures that are caused by the medical course or for other reasons require a certain reaction of the medical device, can as a rule be recorded in the evaluation module of the expert system. These may be, for example, a reduction of the joint pressure being after a defined time above a reference value, rinsing (exchange of media) of the expanded body cavity after a defined period of time or more complex situations, such as the warning after a certain pressure/time combination (where longer time is put on a level with low pressure, shorter time with high pressure, and a maximum pressure/time limit should not be exceeded) or the gradual reduction of the set pressure with proceeding duration of the procedure or after an adjusted increase above a defined threshold. Further rules are imaginable and can be applied through the device parameters of the server sent from the medical device and answered with device settings adjusted to the incoming data.” on page 13, line 30 to page 14, line 22. The limitations of claim 7 correspond to additional elements that are merely invoked as a tool to apply instructions of the abstract idea in a particular technological environment.
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.
Claims also recite other additional limitations beyond abstract idea, including functions such as obtaining/ storing data from/to a database, displaying (obtaining data via the interface)/transmitting data/notification – are insignificant extra-solution activities (see MPEP 2106.05 (g)), which does not provide a practical application for the 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 elements of using a processing device to perform both determining/classifying 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 1 has been amended to recite “wherein the adjustment of the liquid pump parameters is performed autonomously and dynamically during surgery without intervention from clinical personnel, and the parameters include at least a pressure value based on the patient's age”, which corresponds to well-understood, routine and conventional activity in the field, as evidenced by the newly applied prior art, Varsavsky. In particular, Varsavsky discloses “…infusion device…adjust or otherwise alter control parameters…an autonomous control scheme implemented by the infusion device……” in col. 19, line 63 to col. 20, line 3.
Therefore, claims 1-3, 5 and 7 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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 1-3, 5 and 7 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Varsavsky et al. (hereinafter Varsavsky) (US 10,478,557 B2).
Claim 1 has been amended to recite a medical fluid pump system for expanding body cavities during a surgical procedure, the system comprising:
a liquid pump, configured to deliver fluid to a body cavity (Varsavsky discloses “…infusion pump…” in col. 28, lines 18-37);
an integrated control device configured to regulate operating parameters of the liquid pump, the parameters including fluid pressure, fluid flow, and/or fluid temperature (Varsavsky discloses “…parameters…” in col. 11, lines 24-62 and “pump control module” in col. 38, line 56 to col. 39, line 14);
at least one sensor interface configured to receive intra-operative patient data including fluid pressure of flow data (Varsavsky discloses “…infusion system includes a heart rate sensing arrangement…” in col. 34, line 60 to col. 35, line 19);
a storage unit configured to store a priori medical knowledge, intra-operative data, and post-operative outcome data (Varsavsky discloses “…storage element…” in col. 9, lines 14-44);
a processing device (Varsavsky discloses “…processing circuitry…” in col. 8, lines 28-52) configured to:
execute a self-learning module trained on data from prior pre-operative and intra- operative phases to build and refine a patient-specific predictive control model in a post- operative phase, wherein the predictive control model is configured to determine, based on real-time intra-operative data and the stored data, operating parameters of the liquid pump specific to the current patient (Varsavsky discloses “…to obtain a model for a parameter of interest, the patient modeling process 200 identifies or otherwise determines a subset of the historical data that is predictive of or correlative to the historical values for the parameter of interest for that individual patient and generating a patient-specific model of the parameter of interest for that patient using that predictive subset of variables (tasks 214, 216). In this regard, in exemplary embodiments, the server 106 utilizes machine learning to determine which combination of historical sensor measurement data, historical delivery data, demographics data, environmental data, behavioral data, and other historical parameter data are most strongly correlated to or predictive of the contemporaneous historical values for the parameter of interest, and then determines a corresponding equation for calculating the value of the parameter of interest based on that subset of input variables…” in col. 11, lines 24-62);
transmit said operating parameters to the control device to automatically adjust fluid delivery (Varsavsky discloses “…parameter determination process… initiated automatically…” in col. 13, lines 50-65);
wherein the adjustment of the liquid pump parameters is performed autonomously and dynamically during surgery without intervention from clinical personnel, and the parameters include at least a pressure value based on the patient's age (Varsavsky discloses “…infusion device…adjust or otherwise alter control parameters…an autonomous control scheme implemented by the infusion device……” in col. 19, line 63 to col. 20, line 3).
Claim 2 has been amended to recite the system of claim 1, further comprising:
a module configured to identify medical devices employed in the pre-operative phase
module configured to generate control preset curves based on the priori knowledge;
a module configured to transmit intra-operative data to a database system or the medical engineering apparatus;
module configured to generate control present curves based on intra-operative data;
a module configured to generate parameter adjustments based on intra-operative data,
a module configured to transmit post-operative data for storage;
a module configured to incorporate rules derived from medical guidelines or expert protocols (Varsavsky; col. 21, line 60 to col. 22, line 14).
Claim 3 has been amended to recite the system of claim 1, wherein the stored data include a mixture of anonymized or pseudonymized patient data, anamnesis data, surgical procedure data, device configuration data, post-operative assessments, and procedural control rules (Varsavsky; col. 9, lines 14-44).
Claim 5 has been amended to recite the system of claim 1, wherein the sensor interface is configured to receive blood pressure measurement data and/or electronic patient record (Varsavsky; col. 10, lines 16-21).
Claim 7 has been amended to recite the system of claim 1, wherein the control device is further configured to:
reduce pressure after a defined time above a threshold,
initiate fluid rinsing cavity after a defined period,
trigger a warning after a defined pressure/time combination, or gradually reduce the set pressure as a function of procedure duration (Varsavsky; col. 41, lines 20-52).
Response to Arguments
Applicant's arguments filed 10/03/2025 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed below in the order in which they appear.
Arguments about 35 USC 101 rejection:
Applicant argues that claim 1 has been amended to recite “a medical fluid pump system with a liquid pump delivering fluid to a body cavity; hardware elements; a self-learning module that builds a predictive control model and dynamically adjusts pump parameters during surgery”, and claims are not directed to an abstract idea, but a concrete medical device system with structural components.
In response, Examiner submits that these features are not part of the abstract idea, but they are directed to additional elements (see the rejection above). The limitations of “…receive intra-operative patient data including fluid pressure of flow data…; determine, based on real-time intra-operative data and the stored data, operating parameters of the liquid pump specific to the current patient; transmit said operating parameters to the control device to automatically adjust fluid delivery” correspond to an abstract idea of “certain methods of organizing human activity”. The features of “a medical fluid pump system with a liquid pump delivering fluid to a body cavity; hardware elements; a self-learning module that builds a predictive control model and dynamically adjusts pump parameters during surgery” are directed to additional elements that are hardware or 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.
Applicant argues that claim limitations provide a technological improvement over conventional pump systems that require manual adjustments by clinicians during procedures. Applicant argues that this approach represents a technological improvement over prior pumps and is not “well-understood, routine and conventional”.
In response, Examiner submits that an updated rejection has been provided above and accordingly: Claim 1 has been amended to recite “wherein the adjustment of the liquid pump parameters is performed autonomously and dynamically during surgery without intervention from clinical personnel, and the parameters include at least a pressure value based on the patient's age”, which corresponds to well-understood, routine and conventional activity in the field, as evidenced by the newly applied prior art, Varsavsky. In particular, Varsavsky discloses “…infusion device…adjust or otherwise alter control parameters…an autonomous control scheme implemented by the infusion device……” in col. 19, line 63 to col. 20, line 3. Therefore, claims are not directed to an improvement in the technology.
Arguments about 35 USC 103 rejection:
Applicant’s arguments with respect to claims 1-3, 5 and 7 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 DILEK B COBANOGLU whose telephone number is (571)272-8295. The examiner can normally be reached 8:30-5:00 ET.
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/DILEK B COBANOGLU/Primary Examiner, Art Unit 3687