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 .
Response to Amendment
Claims 1-20, 25 and 33 are canceled.
Claims 21 and 31 are amended.
Claims 21-24 and 26-32, and 34-37 are pending.
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 21-24 and 26-32, and 34-37 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. Claim 21 and similarly 31 recite “storing at least one operating parameter limit of an intended use of the medical-technical device” (emphasis added). While applicant has cited Par. 41 of the specification to support said limitation, notably “expected lifetime (lifetime limit or operating parameter limit that is known and stored in the data system)”, that still does not support “operating parameter limit of an intended use of the medical-technical device” the limit described in the specification is a usage limit, not an intended use of the medical-technical device. “intended use” is much broader i.e. covering a multitude of ways of using the device rather than an expected lifetime of the device. Further examiner notes that “original” claim 25 is not part of the original disclosure. In addition, Claim 21 and similarly 31 recite the amended limitation “by applying a predefined use profile corresponding to a planned medical procedure;”. While applicant cites Par. 41 for said limitation no such support is found. Further while the specification does describe in Par. 51 of the pg-pub, “a usage profile of the device”, this does not support “by applying a predefined use profile corresponding to a planned medical procedure” as no such planned medical procedure is described nor is applying a predefined use profile described.
In addition, claim 30 and similarly 36 recite “wherein the step of outputting the indication based on the determined risk of failure includes a control signal configured to trigger a shutdown, maintenance prompt, or operational restriction of the medical-technical device”. While applicant points to Par. 57, specifically “"[a]n intra-operative failure of such a component is to be prevented for understandable reasons. By the method according to the invention, it is secured that the medical-technical devices are not (or cannot be) further used, when it can be expected that further usage exceeds the limit values. By the method according to the invention, it is furthermore possible to enable, in due time before reaching the parameter limits, maintenance or replacement." (emphasis added)”, this does not provide support for “trigger a shutdown, maintenance prompt, or operational restriction of the medical-technical device” as it does not describe triggering a shut down, nor does “enable, in due time before reaching the parameter limits, maintenance” provide support for a control signal configure to trigger a maintenance prompt as no such prompt or controlling is described. The recitation in the specification of “it is secured that the medical-technical devices are not (or cannot be) further used, when it can be expected that further usage exceeds the limit values” does not support a control signal configured to trigger operational restriction of the medical-technical device, as no such controller triggering of operation restriction is described.
Further, claim 32 recites “minimally invasive surgical procedures”, while applicant cites Par. 31 specifically, “The medical-technical device may be, for instance, a liquid pump for laparoscopy, arthroscopy, hysteroscopy, uroscopy, or an insufflation device” for support, the limited list does not provide support for all and any “minimally invasive surgical procedures” as claimed.
Claims 22-24, 26-30, 32 and 34-37 are rejected based on their inherited deficiencies.
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 21-24 and 26-32, and 34-37 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 21 and similarly in claim 31 recite(s) “A method for predicting failure of a medical-technical device” and ‘simulating… a future operational scenario of the medical-technical device based on the stored at least one operating parameter by applying a predefined use profile corresponding to a planned medical procedure; comparing the simulated future operational scenario with the at least one operating parameter limit; determining, based on the comparison, whether a risk of failure exists for the medical-technical device in the simulated future operational scenario;’ which are directed to mathematical calculations and/or mental processes as evidenced by the calculating likelihood, i.e. probability.
This judicial exception is not integrated into a practical application because “a processing unit” and “storing the sensed at least one operating parameter on a memory, the memory including at least one operating parameter limit associated with an intended use of the medical-technical device;” are considered to be simply implementing the abstract idea on a computer. The elements of “sensing, during operation of the medical-technical device, at least one operating parameter of at least one wear-prone component using at least one sensor;” and “outputting an indication based on the determined risk of failure” are considered to be data gathering and outputting steps required to use the correlation do not add a meaningful limitation to the method as they are insignificant extra-solution activity. The element of “at least one wear-prone component” and “a medical-technical device” is considered to be a nominal or token extra-solution component of the claim, and is nothing more than an attempt to generally link the method to a particular technological environment.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because “a processing unit” and “storing the sensed at least one operating parameter on a memory, the memory including at least one operating parameter limit associated with an intended use of the medical-technical device;” are considered to be well-understood, routine, conventional computer functions as recognized by the court decisions listed in MPEP § 2106.05(d). The elements of “sensing, during operation of the medical-technical device, at least one operating parameter of at least one wear-prone component using at least one sensor;” and “outputting an indication based on the determined risk of failure” are considered to be insignificant extra-solution activity to the judicial exception per MPEP 2106.05(g)(ii), well-understood, routine and conventional in the field per MPEP 2106.05(d), the additional elements amount to nothing more than a recitation of the words “apply it” MPEP 2106.05(f)(1) also see MPEP 2106.05(a)(II)(iii) “Gathering and analyzing information using conventional techniques and displaying the result”. The elements of “at least one wear-prone component” and “a medical-technical device” are considered to be generally linking the use of a judicial exception to a particular technological environment or field of use per MPEP 2106.05(h) “Flook established that limiting an abstract idea to one field of use or adding token post solution components did not make the concept patentable” and well-understood, routine, conventional activities previously known to the industry per MPEP 2106.05(d)(see US 20190357873 A1, US 20070156285 A1, US 20190376991 A1).
Claims 22-24, 32, and 35 are not integrated into a practical application or include additional elements that are sufficient to amount to significantly more than the judicial exception because they are considered to be generally linking the use of a judicial exception to a particular technological environment or field of use per MPEP 2106.05(h) “Flook established that limiting an abstract idea to one field of use or adding token post solution components did not make the concept patentable” and well-understood, routine, conventional activities previously known to the industry per MPEP 2106.05(d)(see US 20190357873 A1, US 20070156285 A1, US 20190376991 A1).
Claims 28 and 37 are not integrated into a practical application or include additional elements that are sufficient to amount to significantly more than the judicial exception because it is considered to be simply implementing the abstract idea on a computer and well-understood, routine, conventional computer functions as recognized by the court decisions listed in MPEP § 2106.05(d).
Claim 26-27, 29-30 and 34-36 is not integrated into a practical application or include additional elements that are sufficient to amount to significantly more than the judicial exception because they are considered to be are considered to be data gathering and outputting steps required to use the correlation do not add a meaningful limitation to the method as they are insignificant extra-solution activity and adding insignificant extra-solution activity to the judicial exception per MPEP 2106.05(g)(ii), well-understood, routine and conventional in the field per MPEP 2106.05(d), the additional elements amount to nothing more than a recitation of the words “apply it” MPEP 2106.05(f)(1) also see MPEP 2106.05(a)(II)(iii) “Gathering and analyzing information using conventional techniques and displaying the result”.
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 21, 26-28, 31, and 35-37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by UEBLER (US 20190357873 A1).
In claim 21, UEBLER discloses a method for predicting failure of a medical-technical device (Par. 2 “a medical device” Fig. 1, 10), the method comprising: sensing, during operation of the medical-technical device, at least one operating parameter (Par. 11, 134 “output parameter”) of at least one wear-prone component using at least one sensor (Par. 134 “sensor”, Par. 11, 109, 134 “failure or malfunction of one or several components”, “electrical and/or mechanical components”); storing the sensed at least one operating parameter on a memory (Par. 134 “memory”, Par. 71 “data may be stored by one or more computer readable recording mediums”, Par. 104 “difference between a standard value and an actual output parameter exceeds a threshold value”), the memory including at least one operating parameter limit associated with an intended use of the medical-technical device (Par. 104 “difference between a standard value and an actual output parameter exceeds a threshold value”, Par. 134 “the sensor detects an oscillation of a magnet used by a magnetic imaging device” “a deviation of the measured parameter from a default value”); simulating, by a processing unit (Par. 66), a future operational scenario of the medical-technical device based on the stored at least one operating parameter (Par. 73 “acts and symbolic representations of operations [e.g., in the form of flow charts, flow diagrams, data flow diagrams, structure diagrams, block diagrams, etc.] that may be implemented in conjunction with units and/or devices discussed in more detail below”) by applying a predefined use profile corresponding to a planned medical procedure (Par. 90 “creating a virtual model by using the virtual components, wherein the virtual model corresponds to the medical device”, Par. 88 “operation of the medical device”); comparing the simulated future operational scenario with the at least one operating parameter limit (Par. 104 “difference between a standard value and an actual output parameter exceeds a threshold value”); determining, based on the comparison, whether a risk of failure exists for the medical-technical device in the simulated future operational scenario (Par. 110 “risk for the malfunction is provided for an individual medical device”); and outputting an indication based on the determined risk of failure (Fig. 1 32, Par. 2 “predicting a malfunction”, Par. 119 “informed about the probability that the warning message is caused by a specific defect” examiner considers said probability to be functionally equivalent to said percentage).
In claim 26, UEBLER discloses wherein the step of outputting an indication includes generating an alert if the simulated future operational scenario exceeds the at least one operating parameter limit (Par. 171-173 “in particular any warning message 31 generated by the medical device software, to the simulated malfunction of the at least one virtual component 21; [0172] Repeating (f) steps (c) to (e) for a plurality of different simulated malfunctions and [0173] feeding a warning message generated by the medical device software 30 to the knowledge base 50, and in response the knowledge base 50 provides a probability value 51, wherein the probability value 51 specifies a probability for a malfunction of a certain component 11”).
In claim 27, UEBLER discloses wherein the indication includes a visual display of a remaining usable life, a number of remaining cycles, or a likelihood of failure expressed as a percentage (Par. 104 “information about a deviation of a specific or several different specific output parameters from the corresponding default value. Such warning messages are evidently most useful in providing maintenance service, since they allow providing service, e.g. replacing defective components, before complete failure and resulting downtime of the medical device”, Par. 132 “machine learning system suggests to change the maintenance interval when one or several warning messages indicate a failure of a component or sub-unit of the medical device in the near future”, Par. 161 “machine learning system 40 might provide a probability 51 that a total failure occurs within a defined time interval to the operator 35 of the medical device 10”).
In claim 28, UEBLER discloses updating the at least one stored operating parameter limit upon replacement of the wear-prone component (Par. 101, 104, 158).
In claim 30, UEBLER discloses wherein the step of outputting the indication based on the determined risk of failure includes a control signal configured to trigger a shutdown, maintenance prompt (Par. 103 “The warning message is forwarded or sent to a server, in particular to a central managing server, that, for example, coordinates the maintenance, and the message is then displayed on a screen”), or operational restriction of the medical-technical device.
In claim 31, UEBLER discloses a medical-technical system (Par. 2 “a medical device” Fig. 1, 10) comprising: at least one sensor configured to sense (Par. 134 “sensor”), during operation, an operating parameter (Par. 11, 134 “output parameter”) of at least one wear-prone component of the medical-technical device (Par. 11, 109, 134 “failure or malfunction of one or several components”, “electrical and/or mechanical components”); a memory (Par. 134 “memory”) configured to store the sensed operating parameter and at least one operating parameter limit associated with an intended use of the medical-technical device (Par. 71 “data may be stored by one or more computer readable recording mediums” Par. 104 “difference between a standard value and an actual output parameter exceeds a threshold value”); a processor (Par. 66) configured to simulate a future operational scenario of the medical-technical device based on the stored operating parameter (Par. 73 “acts and symbolic representations of operations [e.g., in the form of flow charts, flow diagrams, data flow diagrams, structure diagrams, block diagrams, etc.] that may be implemented in conjunction with units and/or devices discussed in more detail below”), compare the simulated future operational scenario with the stored operating parameter limit (Par. 104 “difference between a standard value and an actual output parameter exceeds a threshold value”) by applying a predefined use profile corresponding to a planned medical procedure (Par. 90 “creating a virtual model by using the virtual components, wherein the virtual model corresponds to the medical device”, Par. 88 “operation of the medical device”); and determine a risk of failure based on the comparison (Par. 110 “risk for the malfunction is provided for an individual medical device” Par. 104 “difference between a standard value and an actual output parameter exceeds a threshold value”); and an interface (Par. 103 “displayed on a screen”) configured to output an indication based on the determined risk of failure (Fig. 1 32, Par. 2 “predicting a malfunction”, Par. 119 “informed about the probability that the warning message is caused by a specific defect” examiner considers said probability to be functionally equivalent to said percentage).
In claim 35, UEBLER discloses wherein the interface includes a display configured to show a failure likelihood as a percentage or as a number of remaining operational cycles (Par. 104 “information about a deviation of a specific or several different specific output parameters from the corresponding default value. Such warning messages are evidently most useful in providing maintenance service, since they allow providing service, e.g. replacing defective components, before complete failure and resulting downtime of the medical device”, Par. 132 “machine learning system suggests to change the maintenance interval when one or several warning messages indicate a failure of a component or sub-unit of the medical device in the near future”, Par. 161 “machine learning system 40 might provide a probability 51 that a total failure occurs within a defined time interval to the operator 35 of the medical device 10”).
In claim 36, UEBLER discloses wherein the processor is further configured to generate a shutdown command or maintenance recommendation if the simulated future operational scenario exceeds the stored operating parameter limit (Par. 103 “The warning message is forwarded or sent to a server, in particular to a central managing server, that, for example, coordinates the maintenance, and the message is then displayed on a screen”).
In claim 37, UEBLER discloses wherein the memory is further configured to be updated upon component replacement to reset wear data (Par. 101, 104, 158).
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.
Claim(s) 22-24, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over UEBLER in view of Rudorfer (US 20190376991 A1).
In claim 22, UEBLER does not explicitly disclose wherein the medical-technical device is a liquid pump for laparoscopy, arthroscopy, hysteroscopy, uroscopy, or an insufflation device.
Rudorfer teaches wherein the medical-technical device is a liquid pump (Par. 3, Par. 15 “pump”) for laparoscopy, arthroscopy, hysteroscopy, uroscopy, or an insufflation device (Par. 15 “aspiration/dispense system” examiner considers to be equivalent to a insufflation device).
Therefore, it would have been obvious to one of ordinary skill in the art before the invention was filed to have wherein the medical-technical device is a liquid pump for laparoscopy, arthroscopy, hysteroscopy, uroscopy, or an insufflation device based on the teachings of Rudorfer in view of Uebler in order to reduced mean time to repair (Rudorfer Par. 16) thus leading to an improved system.
In claim 23, UEBLER does not explicitly disclose wherein the at least one wear-prone component is an electric motor.
Rudorfer teaches wherein the at least one wear-prone component is an electric motor (Par. 15, 20 “motors, or other electrical components”).
Therefore, it would have been obvious to one of ordinary skill in the art before the invention was filed to have wherein the at least one wear-prone component is an electric motor based on the teachings of Rudorfer in view of Uebler in order to reduced mean time to repair (Rudorfer Par. 16) thus leading to an improved system.
In claim 24, UEBLER does not explicitly disclose wherein the at least one operating parameter comprises at least one of:(i) current drawn by the motor, (ii) rotational speed of the motor, (iii) temperature, (iv) vibration, or (v) operating duration.
Rudorfer teaches wherein the at least one operating parameter comprises at least one of:(i) current drawn by the motor, (ii) rotational speed of the motor, (iii) temperature, (iv) vibration, or (v) operating duration (Par. 20 “flow” “vibration”, “noise”).
Therefore, it would have been obvious to one of ordinary skill in the art before the invention was filed to have wherein the at least one operating parameter comprises at least one of:(i) current drawn by the motor, (ii) rotational speed of the motor, (iii) temperature, (iv) vibration, or (v) operating duration based on the teachings of Rudorfer in view of Uebler in order to reduced mean time to repair (Rudorfer Par. 16) thus leading to an improved system.
In claim 34, UEBLER does not explicitly disclose wherein the at least one sensor is configured to measure one or more of. electric current, rotational speed, internal temperature, or vibrational signature.
Rudorfer teaches wherein the at least one sensor is configured to measure one or more of. electric current, rotational speed, internal temperature, or vibrational signature (Par. 20 “flow” “vibration”, “noise”).
Therefore, it would have been obvious to one of ordinary skill in the art before the invention was filed to have wherein the at least one sensor is configured to measure one or more of. electric current, rotational speed, internal temperature, or vibrational signature based on the teachings of Rudorfer in view of Uebler in order to reduced mean time to repair (Rudorfer Par. 16) thus leading to an improved system.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over UEBLER in view of Heldman (US 20140074179 A1).
In claim 29, UEBLER does not explicitly disclose wherein the step of outputting the indication includes transmitting the indication using SMS and/or email.
UEBLER does not explicitly disclose wherein the step of outputting the indication includes transmitting the indication using SMS and/or email.
Heldman teaches wherein the step of outputting the indication includes transmitting the indication using SMS and/or email (Par. 182).
Therefore, it would have been obvious to one of ordinary skill in the art before the invention was filed to have wherein the step of outputting the indication includes transmitting the indication using SMS and/or email based on the teachings of Heldman in view of Uebler in order for the clinician, physician or technician can access them for review (Heldman Par. 182).
Claim(s) 32 is rejected under 35 U.S.C. 103 as being unpatentable over UEBLER in view of Rudorfer and in further view of SILLMAN (US 20070156285 A1).
In claim 32, UEBLER does not explicitly disclose wherein the medical-technical device is configured as a pump for use in minimally invasive surgical procedures.
Rudorfer teaches wherein the medical-technical device is configured as a pump (Par. 15).
SILLMAN teaches wherein the medical-technical device is for use in minimally invasive surgical procedures (Par. 3 “Medical robotic systems such as those used in performing minimally invasive surgical procedures”).
Therefore, it would have been obvious to one of ordinary skill in the art before the invention was filed to have wherein the medical-technical device is configured as a pump as taught by Rudorfer since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable. Further, it would have been obvious to one of ordinary skill in the art before the invention was filed to have for use in minimally invasive surgical procedures as taught by SILLMAN in UEBLER combined with Rudorfer, since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Response to Arguments
Applicant's arguments filed 06/16/2026 have been fully considered but they are not persuasive. Regarding applicants 112 arguments on pages 6-7, the examiner respectfully disagrees. The rejections are maintained for the reasons cited above.
Regarding applicants 101 arguments on pages 8-9, the examiner respectfully disagrees. The cited amended limitation is abstract as described above. While applicant asserts an improvement to “ensuring reliability of a medical device” the claimed “outputting an indication based on the determined risk of failure” does not accomplish said improvement, as some sort of action or change based on the indication would have to happen for there to be an improvement.
Regarding applicants 103 arguments on pages 9-12, the examiner respectfully disagrees. The cited prior art is within the BRI of the current claims. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “predicting future performance under a specific operational load”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In response to applicant's argument that Heldman, Rudorfer and SILLMAN are nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor' s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In these cases, Heldman, Rudorfer and SILLMAN are all in the field of the inventor' s endeavor as they predict failure of medical devices.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 20120297255 A1, SYSTEM AND METHOD TO BETTER ASSURE CORRECT USE OF PRE-PROGRAMMED MEDICAL DEVICES; US 20200388361 A1, ELECTRONIC MEDICAL DATA TRACKING SYSTEM;
THIS ACTION IS MADE FINAL. 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 BRANDON J BECKER whose telephone number is (571)431-0689. The examiner can normally be reached M-F 9:30-5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shelby Turner can be reached at (571) 272-6334. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/B.J.B/ Examiner, Art Unit 2857
/SHELBY A TURNER/ Supervisory Patent Examiner, Art Unit 2857
Prosecution Insights