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 .
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 1-8 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 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 2-8 are rejected by virtue of their dependence on Claim 1. Appropriate correction and/or clarification is required.
Claim 8 is 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. Claim 8 recites the limitation “an assistance system configured to provide feedback of device status information as a guidance recommendation to an anesthesia vital data monitor.” Although applicant’s specification provides support for “an assistance system,” the specification lacks support for this assistance system “configured to provide feedback of device status information as a guidance recommendation to an anesthesia vital data monitor.” 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 and 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).
Claim 8 is 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) as applied to Claim 1, above and further in view of Bibian et al. (USPN 11,565,042).
Re Claim 8, Mollstam in view of Stewart and McPherson teach all of the limitations of Claim 1. Mollstam in view of Stewart and McPherson fail to teach the medical device further comprising an assistance system configured to provide feedback of device status information as a guidance recommendation to an anesthesia vital data monitor. Bibian teaches a medical device (Fig. 9A) comprising an assistance system configured to provide feedback of device status information as a guidance recommendation to an anesthesia vital data monitor (Bibian (Bibian Col. 17 Lines 36-43; Col. 50 Line 35 to Col. 52 Line 32) for the purpose of maintaining a patient in a sedative state (Bibian Col. 28 Lines 5-20). 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 in view of Stewart and McPherson to include an assistance system configured to provide feedback of device status information as a guidance recommendation to an anesthesia vital data monitor as disclosed by Bibian for the purpose of maintaining a patient in a sedative state (Bibian Col. 28 Lines 5-20).
Response to Arguments
Applicant’s arguments filed 06/03/2026 with respect to 112 new matter rejection of Claims 1-7 regarding 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” is hereinafter withdrawn. Applicant refers examiner to PGPub paragraphs 0068 and 0088. Examiner has found these paragraphs are sufficient to provide support for the aforementioned limitation.
Applicant's arguments filed 06/03/2026 have been fully considered but they are not persuasive. At the bottom of Page 4 of the response, applicant’s arguments are directed to the 112 new matter rejection of Claims 1-8 involving 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 refers to PGPub paragraphs 0035 and 0102 for support of the aforementioned limitation. However, these paragraphs are silent as to recording during a medical treatment and transferring the recorded data to a secondary storage unit for later evaluation.
Arguments directed to 103 rejections begin near the top of Page 5 of the response. There, applicant argues secondary reference McPherson “does not teach or suggest the compatibility determination now recited in amended claim 1, nor does it provide a reason to modify the primary reference to arrive at the claimed invention.” Applicant goes on to argue “McPherson is directed to preventing unauthorized reuse of a disposable or limited-use device. As described in McPherson, a device identifier is evaluated to determine whether the device has previously been used, has exceeded an authorized usage limit, or has expired.” However, McPherson PGPub paragraph 0036 explicitly teaches “The device tracking and management system 115 utilizes the identification information to […] determine if the specific delivery device 30 is a viable device (e.g., reusable and/or unused device), a compatible device (e.g., compatible to the specific electrosurgical generator 20) and/or a device that is safe to use (e.g., no manufacturing recalls).” In fact, McPherson is replete with compatibility teachings. At PGPub paragraph 0022, McPherson teaches “viability of the instrument may be related to system compatibility.” At PGPub paragraph 0045, McPherson teaches “information provided to the electrosurgical generator 20 from the read module 110 may include information related to the manufacturing, assembly and testing of the delivery device 30, information related to use of the delivery device 30 and/or information related to the compatibility of the delivery device 30 with the electrosurgical generator 20.” And this is but a mere sampling of the number of compatibility teachings in McPherson.
In the last paragraph of Page 5 and the first paragraph of Page 6, applicant describes in detail the difference between McPherson and the present case, pointing to specific teachings within the specification. However, the claims in the present case are silent to any of these teachings and thus, these arguments are moot. In the third full paragraph of Page 6 of the response, applicant argues the rational for modifying Mollstam with the teachings of McPherson is insufficient. The motivation to modify Mollstam is provided in McPherson PGPub paragraph 0039, where McPherson teaches its processing unit prevents reuse of the medical device if the specific use is determined to be an unsafe or not permitted. Applicant argues the present invention addresses a different problem. However, this has no bearing on the motivation taught by McPherson. McPherson need not provide a solution to the same problem as described in the present case. Applicant next argues modification of Mollstam with the teachings of McPherson is beyond the skill of one of ordinary skill in the art with regard to the present case. Examiner disagrees where both Mollstam and McPherson are analogous prior art. On Page 8 of the response, applicant argues support for Claim 8 is found at PGPub paragraph 0142. However, said paragraph fails to provide support for providing feedback of device status as a guidance recommendation to an anesthesia vital data monitor.
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 WILLIAM R FREHE whose telephone number is (571)272-8225. The examiner can normally be reached 10:30AM-7:30PM.
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/WILLIAM R FREHE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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