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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/06/2026 has been entered.
Claim Objections
Claim 1 is objected to because of the following informalities: Line 14 reading “wherein the a priori data” should read --wherein the priori data--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 1-7 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.
Lines 18-20 of Claim 1 reading "wherein the processing unit is further configured to: perform a compatibility check to determine whether disposables selected for a specific surgical case are compatible with the computed operating parameters" lacks support in the specification and figures. Likewise, Lines 26-27 of Claim 1 reading a medical device “configured to automatically record vital patient data during a medical treatment and transfer the recorded data to a secondary storage unit for later evaluation" lacks support in the specification and figures. Claims 2-6 are rejected by virtue of their dependence on Claim 1. Appropriate correction and/or clarification is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Mollstam (USPGPub 2015/0290387) in view of Stewart et al. (USPGPub 2005/0277890) and McPherson et al. (USPGPub 2013/0293353).
Re Claim 1, Mollstam teaches a medical device (1) (Mollstam Fig. 1) for use in minimally invasive surgery (MIS), comprising: at least one interface (19) configured to communicate with at least one other medical device (18, 21), and to transmit measurement data and/or patient data (Mollstam ¶ 0155 - "wherein the first fluid pump device and/or the second fluid pump device is adapted to control the pressure in the body cavity 3 based on said control signal received from the control unit 19"); at least one storage unit configured to: store operating parameters derived from the measurement data received via the at least one interface (19) (Mollstam ¶ 0155 teaching a storage component "wherein the control signal is derived by processing the signal from the blood pressure measuring device 20 by using a correlation factor and/or an adjustment factor and/or a compensation value, stored in the device"); and permanently store at least one fallback data set of predetermined operating parameters (Mollstam ¶ 0144 - describing a default target pressure, DP-dt that is automatically adjusted to meet pressure requirements).
Mollstam further teaches at least one processing unit operatively coupled to the at least one interface (19) and configured to: receive the measurement data and/or patient data compute operating parameters of the medical device (1) based on the measurement data and/or patient data (Mollstam ¶ 0155 - wherein control unit 19 processes signals from a measuring device 20 "by using a correlation factor and/or an adjustment factor, and/or a compensation value, comprises or equals multiplying the signal with the correlation factor and/or the adjustment factor, and/or the compensation value respectively); select a priori data according to a predetermined criterion (Mollstam ¶ 0144 - device 1 operates with a specific DP that is a product of several parameters), wherein the priori data comprises patient characteristics (Mollstam ¶ 0144 - teaching systemic blood pressure for the patient under surgery) and/or surgery type (Mollstam ¶ 0002 - “applications of this procedure include: Transurethral resection (TUR), Laparascopy, enteroscopy, colonoscopy, sigmoidoscopy, proctoscopy, cytoscopy, arthoscopy, etc., 0144 - teaching choice of procedure); and incorporate the selected priori data into the computation of the operating parameters (Mollstam ¶ 0144 - describing a first and second parameters that are incorporated into computation of the operating parameters); wherein the medical device (1) is further configured to: operate in a gentle mode that modifies the computed operating parameters to optimize performance for pain reduction and patient comfort in cases classified as sensitive (Mollstam ¶ 0032, 0125 describing optimizing pressure in the body cavity based on control signals received from an individual's body cavity); regulate operation of the medical device (1) based on the computed operating parameters (Mollstam ¶ 0155).
However, Mollstam fails to teach wherein the medical device is configured to automatically record vital patient data during a medical treatment and transfer the recorded data to a secondary storage unit for later evaluation. Stewart teaches a fluid infusion medical device configured based on measurement data and/or patient data (Stewart ¶ 0006, 0026-0029; Abstract), wherein vital patient data during a medical treatment is automatically recorded and transferred to a further storage unit (data from identifier 18 is automatically transferred and stored in memory of device 12) for later evaluation (Mollstam ¶ 0026-0029, 0054 - volume history) for tracking an amount of infused drug to a patient (Mollstam ¶ 0054). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the medical device of Mollstam to be configured to automatically record vital patient data during a medical treatment and transfer the recorded data to a secondary storage unit for later evaluation as disclosed by Stewart for tracking an amount of infused drug to a patient (Mollstam ¶ 0054).
Mollstam also fails to teach wherein the processing unit is further configured to: perform a compatibility check to determine whether disposables selected for a specific surgical case are compatible with computed operating parameters. McPherson teaches a medical device comprising a processing unit (McPherson ¶ 0025), the processing unit further configured to perform a compatibility check to determine whether disposables selected for a specific surgical case are compatible with computed operating parameters (McPherson ¶ 0035-0038, 0054), wherein the processing unit prevents reuse of the medical device if the specific use is determined to be an unsafe or not permitted (McPherson ¶ 0039). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the processing unit of Mollstam to perform a compatibility check to determine whether disposables selected for a specific surgical case are compatible with computed operating parameters as disclosed by McPherson wherein the processing unit prevents reuse of the medical device if the specific use is determined to be an unsafe or not permitted (McPherson ¶ 0039).
Re Claim 2, Mollstam in view of Stewart and Mollstam teach all of the limitations of Claim 1. Mollstam teaches wherein the medical device (1) is a fluid pump Mollstam Fig. 1).
Re Claim 3, Mollstam in view of Stewart and Mollstam teach all of the limitations of Claim 2. Mollstam teaches wherein the fluid pump is an insufflator or a liquid pump (Mollstam ¶ 0032).
Re Claim 4, Mollstam in view of Stewart and Mollstam teach all of the limitations of Claim 1. Mollstam teaches wherein the at least one interface (19) transmits measurement data of a blood pressure measurement device (20) (Mollstam ¶ 0155).
Re Claim 5, Mollstam in view of Stewart and Mollstam teach all of the limitations of Claim 1. Mollstam teaches wherein the operating parameters being controlled comprise fluid pressure, fluid flow, and/or fluid temperature (Mollstam ¶ 0140-0141).
Re Claim 6, Mollstam in view of Stewart and Mollstam teach all of the limitations of Claim 1. Mollstam fails to teach wherein the medical device acquires patient information pre-operatively by a data interface to a patient management system. Stewart teaches wherein the fluid infusion medical device (10) (Stewart Fig. 1) acquires patient information pre-operatively by a data interface (20) to a patient management system (12) (Stewart ¶ 0026-0029) in order to reduce the risk of error in the delivery of fluids to a patient or in matching the appropriate therapy to the patient (Stewart ¶ 0004). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the medical device of Mollstam to comprise acquiring patient information pre-operatively by a data interface to a patient management system as disclosed by Stewart, in order to reduce the risk of error in the delivery of fluids to a patient or in matching the appropriate therapy to the patient (Stewart ¶ 0004).
Re Claim 7, Mollstam in view of Stewart and Mollstam teach all of the limitations of Claim 1. Mollstam in view of Stewart fail teach wherein the compatibility check is further based on an automatic recognition of the disposables, and wherein the automatic recognition is performed using at least one of an RFID chip or visual recognition by image processing. McPherson teaches the processing unit configured to perform a compatibility check being further based on an automatic recognition of the disposables, and wherein the automatic recognition is performed using an RFID chip (120d) (McPherson ¶ 0035-0038, 0054), wherein the processing unit prevents reuse of the medical device if the specific use is determined to be an unsafe or not permitted (McPherson ¶ 0039). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the processing unit of Mollstam in view of Stewart such that the compatibility check is further based on an automatic recognition of the disposables, and wherein the automatic recognition is performed using at least one of an RFID chip or visual recognition by image processing (McPherson ¶ 0039).
Response to Arguments
Applicant’s arguments filed 02/06/2026 with respect to 112 indefinite rejection of Claims 1-6 and claim objection of Claim 1 have been fully considered and are persuasive. Due to clarifying amendments, the 112 indefinite rejection of Claims 1-6 and claim objection of Claim 1 are hereinafter withdrawn.
Applicant's arguments filed 02/06/2026 have been fully considered but they are not persuasive. Applicant’s arguments directed to 112 new matter rejections begin on Page 4 of the response. There, applicant argues the limitation "wherein the processing unit is further configured to: perform a compatibility check to determine whether disposables selected for a specific surgical case are compatible with the computed operating parameters" supported on Page 17 Lines 15-18. Examiner recommends referring to PGPub paragraphs in the future. PGPub paragraph 0081 is directed to optimum insufflation whereas the present case is directed to medical devices in general. Applicant’s claim is far more broad than what the specification gives support for. With regard to the limitation “a medical device [...] configured to automatically record vital patient data during a medical treatment and transfer the recorded data to a secondary storage unit for later evaluation.” Applicant argues support for this limitation is found at Page 30 Lines 10-16 of the specification. However, this citation does not provide support for the automatic portion of the aforementioned limitation.
On Page 6 of the response, applicant’s arguments turn to 103 rejections. In the third full paragraph, applicant argues the prior art fails to teach “perform a compatibility check to determine whether disposables selected for a specific surgical case are compatible with the computed operating parameters.” Examiner now relies upon prior art McPherson to teach said limitation. Therefore, this particular argument is hereinafter moot. Applicant then argues the prior art fails to teach the limitation reading “operate in a gentle mode that modifies the computed operating parameters to optimize performance for pain reduction and patient comfort in cases classified as sensitive.” Applicant argues Mollstam paragraphs 0032 and 0125 fail to support this limitation, stating “Mollstam's teaching is a general optimization strategy applicable to all procedures.” However, optimization based perfusion pressure in the blood vessels by the body cavity is highly dependent upon age, with increasing pressure as one ages. Dictating how the device operates based perfusion pressure in the blood vessels by the body cavity implies a different set of control logic for children in relation to adults.
With regard to clarification of priori data, Mollstam teaches priori data including patient characteristics (Mollstam ¶ 0144 - teaching systemic blood pressure for the patient under surgery) and/or surgery type (Mollstam ¶ 0002 - “applications of this procedure include: Transurethral resection (TUR), Laparascopy, enteroscopy, colonoscopy, sigmoidoscopy, proctoscopy, cytoscopy, arthoscopy, etc., 0144 - teaching choice of procedure) and incorporates this data in the computation of the operating parameters (Mollstam ¶ 0144 - describing a first and second parameters that are incorporated into computation of the operating parameters).
Conclusion
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/WILLIAM R FREHE/Examiner, Art Unit 3783 /REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781