DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted by applicant dated 05/29/2024 has been considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“first control unit that…” in claim 1;
“first control unit is configured to…” in claim 1;
“communication unit for …” in claim 1;
“safety device configured to…” in claim 1;
“safety unit configured to…” in claims 2, 3, 5;
“second control unit that …” in claim 5;
“communication unit is configured to …” in claims 7, 20;
“device is further configured to…” in claim 15.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
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 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 1-4, 6-14, 16-17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Fiedler et al. US 2022/0311739 (hereinafter Fiedler), in view of Brand et al. US 2013/0018355 (hereinafter Brand).
As per claim 1, Fiedler teaches a device comprising: a housing; a first control unit that controls the device in operation; and an access control unit that forms at least one interface between the device and the outside world (Fiedler paragraph [0008], [0011], [0013], medical device comprising a control hardware module and a gate control hardware module),
wherein the first control unit is configured also to control the device on a failure of the access control unit, and the control unit and the access control unit are each configured on a separate circuit board arranged in the housing (Fiedler paragraph [0008], [0011], [0013], [0049], medical device comprising a control hardware module and a gate control hardware module. The control hardware module controls components of the medical device)(It is obvious to one of ordinary skill in the art that if/when the gate control hardware module has a failure, the control hardware module still controls the medical device); and
the access control unit furthermore has a communication unit for communication with the outside world (Fiedler paragraph [0008], [0013], [0049], gate control hardware module has interface to communicate with external communication network. Control hardware module has interface to communicate with external communication network); and
a safety device that is formed separately from the communication unit and that is configured to check every communication between the first control unit and the outside world via the interface and only to permit it after a determined technical safety assessment (Fiedler paragraph [0008], [0013], [0033], [0049], gate control hardware module checks all traffic between the control hardware module and the external communication network).
Fiedler does not explicitly disclose a device for preparing a medical fluid and/or for monitoring the preparation of a medical fluid.
Brand teaches a device for preparing a medical fluid and/or for monitoring the preparation of a medical fluid (Brand paragraph [0030], [0032], [0081], dialysis machine).
Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Fiedler of a medical device with a gate control hardware that checks traffic with the teachings of Brand to include dialysis machines with a plurality of interfaces such as a touchscreen in order to protect dialysis machines by including a gate control hardware in the dialysis machines that checks all traffic to/from the outside world to/from the dialysis machines.
As per claim 2, Fiedler in view of Brand teaches the device in accordance with claim 1, wherein the device has at least two separate interfaces between the access control unit and the outside world; and wherein the safety unit is configured to check every communication of the first control unit with the outside world over any interface of the device with the outside world and only to permit it after a determined technical safety assessment (Fiedler paragraph [0008], [0013], [0033], [0049], gate control hardware module checks all traffic between the control hardware module and the external communication network; Brand paragraph [0030], [0032]-[0033], [0081], dialysis machine has a plurality of interfaces to communicate with the outside world (e.g. touchscreen, external network connections).
As per claim 3, Fiedler in view of Brand teaches the device in accordance with claim 2, wherein the safety unit is in communication with the outside world over at least two separate communication paths, with a first communication path coming from the outside first leading to the communication unit and thereupon to the safety unit and a second communication path coming from the outside leading directly to the safety unit and the safety unit being configured to check any communication of the first control unit over the first and second communication paths and only to permit it after a determined technical safety assessment (Fiedler paragraph [0008], [0013], [0049], gate control hardware module has interface to communicate with external communication network. Control hardware module has interface to communicate with external communication network. Fiedler paragraph [0008], [0013], [0033], [0049], gate control hardware module checks all traffic between the control hardware module and the external communication network; Brand paragraph [0030], [0032]-[0033], [0081], dialysis machine has a plurality of interfaces to communicate with the outside world (e.g. touchscreen, external network connections).
As per claim 4, Fiedler in view of Brand teaches the device in accordance with claim 1, wherein the communication unit and the safety unit are implemented as two separate web servers and/or as two separate autonomous parts of a communication module (Fiedler paragraph [0008], [0013], [0049], gate control hardware module has interface to communicate with external communication network. Control hardware module has interface to communicate with external communication network. Fiedler paragraph [0008], [0013], [0033], [0049], gate control hardware module checks all traffic between the control hardware module and the external communication network) (It is obvious that the communication unit and the safety unit are two separate autonomous parts of a communication module. One receives/sends data while the other checks the data).
As per claim 6, Fiedler in view of Brand teaches the device in accordance with claim 1, wherein the safety unit forms a technical safety separation between a first region of the device and a second region of the device, with the first region having the communication unit and the second region having the first, and optionally the second, control unit (Fiedler paragraph [0008], [0013], [0033], [0049], gate control hardware module checks all traffic between the control hardware module and the external communication network).
As per claim 7, Fiedler in view of Brand teaches the device in accordance with claim 1, wherein the communication unit is configured to provide a communication path for network communication (Fiedler paragraph [0008], [0013], [0049], gate control hardware module has interface to communicate with external communication network. Control hardware module has interface to communicate with external communication network).
As per claim 8, Fiedler in view of Brand teaches the device in accordance with claim 1, wherein at least information from the first control unit can be transferred to the outside by means of the first communication path and information from the first control unit can be transferred to the outside by means of the second communication path and/or information can be transferred from the outside to the control unit and/or access to the first safety unit can take place from the outside if the safety unit has determined a technical safety assessment (Fiedler paragraph [0008], [0013], [0049], gate control hardware module has interface to communicate with external communication network. Control hardware module has interface to communicate with external communication network. Fiedler paragraph [0008], [0013], [0033], [0049], gate control hardware module checks all traffic between the control hardware module and the external communication network; Brand paragraph [0030], [0032]-[0033], [0081], dialysis machine has a plurality of interfaces to communicate with the outside world (e.g. touchscreen, external network connections).
As per claim 9, Fiedler in view of Brand teaches the device in accordance with claim 1, furthermore having at least one display unit that is part of the device, wherein the display unit is connected to the first control unit (Fiedler paragraph [0008], [0013], [0049], gate control hardware module has interface to communicate with external communication network. Control hardware module has interface to communicate with external communication network. Fiedler paragraph [0008], [0013], [0033], [0049], gate control hardware module checks all traffic between the control hardware module and the external communication network; Brand paragraph [0030], [0032]-[0033], [0081], dialysis machine has a plurality of interfaces to communicate with the outside world (e.g. touchscreen, external network connections).
As per claim 10, Fiedler in view of Brand teaches the device in accordance with claim 9, wherein inputs with respect to the operation of the device are capable of being actuated by means of the display unit or of an additional input device that is part of the device (Brand paragraph [0032], touchscreen to receive inputs).
As per claim 11, Fiedler in view of Brand teaches the device in accordance with claim 1, wherein the device is a medical device and/or a device for providing medical water or medical solutions (Brand paragraph [0030], [0032], [0081], dialysis machine).
As per claim 12, Fiedler in view of Brand teaches the device in accordance with claim 6, wherein the second region of the device is configured as a medical device and the first region of the device is not configured as a medical device (Fiedler paragraph [0012], segregation between the medically relevant region of the medical device and other region of the medical device; Brand paragraph [0030], [0032], [0081], dialysis machine).
As per claim 13, Fiedler in view of Brand teaches the device in accordance with claim 11, wherein the device is a blood treatment device (Brand paragraph [0030], [0032], [0081], dialysis machine).
As per claim 14, Fiedler in view of Brand teaches the device in accordance with claim 11, wherein the device is a device for water pre-treatment, a reverse osmosis system, a concentrate mixing system, or a technical water control system (Brand paragraph [0030], [0032], [0081], dialysis machine).
As per claim 16, the claim claims a method essentially corresponding to the device claim 1 above, and is rejected, at least for the same reasons.
As per claim 17, Fiedler in view of Brand teaches the method of claim 16, wherein the method is conducted at a clinic or a dialysis center, and the medical fluid is a liquid medium for dialysis (Fiedler paragraph [0009], medical device used at a clinic; Brand paragraph [0081], dialysis machine used at a dialysis ward).
As per claim 19, Fiedler in view of Brand teaches the device in accordance with claim 1, furthermore having at least one display unit that is part of the device and that is configured as a screen, wherein the display unit is connected to the first control unit (Fiedler paragraph [0008], [0011], [0013], medical device comprising a control hardware module and a gate control hardware module; Brand paragraph [0030], [0032]-[0033], [0081], dialysis machine having a touchscreen that displays settings of the machine).
Claims 5 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Fiedler in view of Brand, and further in view of Michalik US 2013/0315785.
As per claim 5, Fiedler in view of Brand teaches the safety unit furthermore being configured to check every communication of the control unit with the outside world (Fiedler paragraph [0008], [0013], [0033], [0049], gate control hardware module checks all traffic between the control hardware module and the external communication network).
Fiedler in view of Brand does not explicitly disclose furthermore having a second control unit that controls device in emergency operation, with the second control unit being configured on a separate, board arranged in housing.
Michalik teaches furthermore having a second control unit that controls device in emergency operation, with the second control unit being configured on a separate, board arranged in housing (Michalik paragraph [0031], emergency override).
Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Fiedler in view of Brand of a dialysis machine with the teachings of Michalik to include an emergency override in order to provide an override of the dialysis machine during an emergency. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Michalik of an emergency override with the teachings of Fiedler in view of Brand to include a gate control hardware that checks traffic in order to check the traffic to/from the emergency override of the dialysis machine.
As per claim 18, Fiedler in view of Brand and Michalik teaches the device in accordance with claim 5, furthermore having at least one display unit that is part of the device and that is configured as a screen, wherein the display unit is connected to the first control unit and also to the second control unit (Fiedler paragraph [0008], [0011], [0013], medical device comprising a control hardware module and a gate control hardware module; Brand paragraph [0030], [0032]-[0033], [0081], dialysis machine having a touchscreen that displays settings of the machine; Michalik paragraph [0031], emergency override).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Fiedler in view of Brand, and further in view of Kopperschmidt et al. US 2010/0168640 (hereinafter Kopperschmidt).
As per claim 15, Fiedler in view of Brand teaches the device in accordance with claim 1.
Fiedler in view of Brand does not explicitly disclose wherein device is further configured to detect a parameter of medical fluid, which is optionally pure medical water, by means of at least one sensor, with the sensor either being a component of the device or being connected to the device via a line.
Kopperschmidt teaches wherein device is further configured to detect a parameter of medical fluid, which is optionally pure medical water, by means of at least one sensor, with the sensor either being a component of the device or being connected to the device via a line (Kopperschmidt paragraph [0025], [0027], [0029], [0033]-[0034], [0042], dialysis machine comprising sensors to detect a parameter of medical fluid).
Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Fiedler in view of Brand of dialysis machines with the teachings of Kopperschmidt to include dialysis machine comprising sensors to detect a parameter of medical fluid because the results would have been predictable and resulted in the dialysis machines comprising sensors to detect a parameter of medical fluid.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Fiedler in view of Brand, and further in view of Demers et al. US 2009/0095679 (hereinafter Demers).
As per claim 20, Fiedler in view of Brand teaches the device in accordance with claim 1.
Fiedler in view of Brand does not explicitly disclose wherein communication unit is configured to provide a communication path for network communication such that the communication unit hosts a web site by means of a web server and/or hosts a cloud service and/or provides a connection to a cloud server.
Demers teaches wherein communication unit is configured to provide a communication path for network communication such that the communication unit hosts a web site by means of a web server and/or hosts a cloud service and/or provides a connection to a cloud server (Demers paragraph [0450]-[0451], treatment device includes embedded web server).
Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Fiedler in view of Brand of dialysis machines with the teachings of Demers to include a treatment device that includes embedded web server because the results would have been predictable and resulted in the dialysis machines having an embedded web server.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY TSANG whose telephone number is (571)270-7959. The examiner can normally be reached M-F 9am - 5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Farid Homayounmehr can be reached at (571) 272-3739. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HENRY TSANG/ Primary Examiner, Art Unit 2495
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