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 .
DETAILED ACTION
Claims 19-38 are presented for examination.
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)(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.
Claims 19-29, 31-36, and 38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chizeck et al (US Pub. 2015/0295949; hereinafter Chizeck).
As per claim 19, Chizeck discloses A surgical system for use in a surgical procedure [para 0019; surgical procedures; para 0020; surgical system] comprising:
a surgical device [para 0020; surgical manipulator];
a communication module [para 0019; a communication network]; and
a control circuit electrically coupled with the communication module [Fig. 3; para 0013; a security device], wherein the control circuit is configured to:
detect a security violation or an unauthorized interaction to the surgical device via the communication module at least one of before, during, or after the surgical procedure commences [para 0019, 0021, 0023-0026; monitoring or detecting attempt to jam, disrupt or even take over the communication network between the surgeon and the manipulator; lack of authentication; para 0029-0032; security system; monitoring system; timely and reliable detection of any discrepancy between an authorized and spoofed operator; 0037-0039, 0041-0046; identifying a dangerous command from a presumed operator]; and
cause the surgical device to generate a response to the security violation or the unauthorized interaction [para 0050-0051, 0055, 0074; generating a notification to the operator that feedback is unreasonable; 0121; security reports; para 0036; the system can generate alerts about the attack].
As per claim 31, Chizeck discloses a surgical system for use in a surgical procedure [para 0019; surgical procedures; para 0020; surgical system] comprising:
a surgical device [para 0020; surgical manipulator];
a communication module [para 0019; a communication network]; and
a control circuit electrically coupled with the communication module [Fig. 3; para 0013; a security device], wherein the control circuit is configured to:
detect a security violation or an unauthorized interaction to the surgical device via the communication module at least one of before, during, or after the surgical procedure commences [para 0019, 0021, 0023-0026; monitoring or detecting attempt to jam, disrupt or even take over the communication network between the surgeon and the manipulator; lack of authentication; para 0029-0032; security system; monitoring system; timely and reliable detection of any discrepancy between an authorized and spoofed operator; 0037-0039, 0041-0046; identifying a dangerous command from a presumed operator];
cause the surgical device to generate a response to the security violation or the unauthorized interaction [para 0050-0051, 0055, 0074; generating a notification to the operator that feedback is unreasonable; 0121; security reports; para 0036; the system can generate alerts about the attack]; and
store a record of the security violation or the unauthorized interaction in a memory unit of the control circuit [Abstract; para 0007, 0039, 0061-0062; a reality rules database (RRDB)].
As per claim 38, Chizeck discloses a method for a surgical procedure [para 0019; surgical procedures; para 0020; surgical system] comprising:
electrically coupling a control circuit with a communication module [Fig. 3; para 0013; a security device], wherein the control circuit is configured to:
detect a security violation or an unauthorized interaction to the surgical device via the communication module at least one of before, during, or after the surgical procedure commences [para 0019, 0021, 0023-0026; monitoring or detecting attempt to jam, disrupt or even take over the communication network between the surgeon and the manipulator; lack of authentication; para 0029-0032; security system; monitoring system; timely and reliable detection of any discrepancy between an authorized and spoofed operator; 0037-0039, 0041-0046; identifying a dangerous command from a presumed operator];
cause the surgical device to generate a response to the security violation or the unauthorized interaction [para 0050-0051, 0055, 0074; generating a notification to the operator that feedback is unreasonable; 0121; security reports; para 0036; the system can generate alerts about the attack];
detect at least one subsequent security violation or at least one subsequent unauthorized interaction to the surgical device after the security violation or the unauthorized interaction [para 0019, 0021, 0023-0026; monitoring or detecting attempt to jam, disrupt or even take over the communication network between the surgeon and the manipulator; lack of authentication; para 0029-0032; security system; monitoring system; timely and reliable detection of any discrepancy between an authorized and spoofed operator; 0037-0039, 0041-0046; identifying a dangerous command from a presumed operator]; and
cause the surgical device to generate another response to the at least one subsequent security violation or the at least one subsequent unauthorized interaction [para 0050-0051, 0055, 0074; generating a notification to the operator that feedback is unreasonable; 0121; security reports; para 0036; the system can generate alerts about the attack].
As per claim 20, Chizeck discloses wherein detecting the security violation or the unauthorized interaction to the surgical device comprising: detecting an attack or a hack to the surgical device [para 0021; attempt to jam; 0022; attacks; 0024; jamming attack].
As per claim 21, Chizeck discloses wherein detecting the security violation or the unauthorized interaction to the surgical device comprising: detecting a pairing attempt to the surgical device from an unauthorized device [para 0020-0022; wireless connection].
As per claim 22, Chizeck discloses wherein detecting the security violation or the unauthorized interaction to the surgical device comprising: detecting an unauthorized activation of the surgical device [para 0078; malicious activates are detected].
As per claim 23, Chizeck discloses wherein the control circuit is further configured to: store a record of the security violation or the unauthorized interaction in a memory unit [Abstract; para 0007, 0039, 0061-0062; a reality rules database (RRDB)].
As per claims 24 and 36, Chizeck discloses further comprising: a user interface electrically coupled with the control circuit [para 0134, 0135, 0137; user interface], wherein the control circuit is further configured to: cause the user interface to issue an alert [para 0035; generating alerts; para 0137; user interface can be configured to send and/or receive data].
As per claim 25, Chizeck discloses wherein causing the surgical device to generate the response comprising: causing the user interface to issue the alert [para 0035; generating alerts; para 0137; user interface can be configured to send and/or receive data].
As per claims 26 and 34, Chizeck discloses wherein the alert comprises a visual alert and/or an audible alert [para 0050, 0088, 0094, 0098; visual feedback; auditory feedback].
As per claims 27 and 35, Chizeck discloses wherein the control circuit is further configured to: detect at least one subsequent security violation or at least one subsequent unauthorized interaction to the surgical device after the security violation or the unauthorized interaction [para 0019, 0021, 0023-0026; monitoring or detecting attempt to jam, disrupt or even take over the communication network between the surgeon and the manipulator; lack of authentication; para 0029-0032; security system; monitoring system; timely and reliable detection of any discrepancy between an authorized and spoofed operator; 0037-0039, 0041-0046; identifying a dangerous command from a presumed operator]; and cause the surgical device to generate another response to the at least one subsequent security violation or the at least one subsequent unauthorized interaction [para 0050-0051, 0055, 0074; generating a notification to the operator that feedback is unreasonable; 0121; security reports; para 0036; the system can generate alerts about the attack].
As per claim 28, Chizeck discloses wherein causing the surgical device to generate the response comprising: terminating all external communication to the surgical device via the communication module [para 0075; stop the remotely operable device; para 0078, 0122; a safe stop].
As per claim 29, Chizeck discloses wherein causing the surgical device to generate the response comprising: only accepting authenticated and encrypted requests to the surgical device via the communication module [para 0139; authenticated communications].
As per claim 32, Chizeck discloses wherein detecting the security violation or the unauthorized interaction to the surgical device comprising one or more of: detecting an attack or a hack to the surgical device [para 0021; attempt to jam; 0022; attacks; 0024; jamming attack]; detecting a pairing attempt to the surgical device from an unauthorized device [para 0020-0022; wireless connection]; or detecting an unauthorized activation of the surgical device [para 0078; malicious activates are detected].
As per claim 33, Chizeck discloses further comprising: a user interface electrically coupled with the control circuit [para 0134, 0135, 0137; user interface], wherein the control circuit is further configured to: cause the user interface to issue an alert, wherein causing the surgical device to generate the response comprising: causing the user interface to issue the alert [para 0035; generating alerts; para 0137; user interface can be configured to send and/or receive data].
As per claim 36, Chizeck discloses wherein causing the surgical device to generate the response comprising one or more of: terminating all external communication to the surgical device via the communication module [para 0075; stop the remotely operable device; para 0078, 0122; a safe stop]; or only accepting authenticated and encrypted requests to the surgical device via the communication module [para 0139; authenticated communications].
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 30 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Chizeck et al (US Pub. 2015/0295949; hereinafter Chizeck) in view of Vendely et al (US Pub. 2017/0055987; hereinafter Vendely).
As per claims 30 and 37, Chizeck discloses the invention substantially. Though Chizeck does not specifically disclose regarding the surgical device being a surgical staple, it is well known in the art. Vendely (in the same endeavor, i.e., a surgical device) clearly discloses that a surgical device comprising a surgical stapler [Abstract; para 0079, 0166; claim 1]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the cited references as both are directed to field of surgery utilizing a surgical device.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
C. US-20160057152 discloses that a security device can receive a plurality of commands to control a remotely-operable device in a remote environment.
D. US-20140068770 discloses a method for securing remotely-operated devices utilized in commercial application, involving identity of operator based on signature using security device, and generating identity report comprising identity of operator.
E. US-5842173 discloses remote access via modem-based repeaters so that properly authorized users from remote location, such as doctors’ office, nearby hospitals, and so on can check the availability of surgical devices, operating suites, and the progress of surgery in real time.
F. US-20150223890 discloses a medical cart application distribution wherein when a smart medical cart is repaired, a technician or repairman can replace a part with a third party part or unauthorized part. The third party part or unauthorized part may not be fully compatible with the other systems, subsystems, or devices of the smart medical cart. By authenticating a repaired, maintained, exchanged, replaced, and/or upgraded part, the smart medical card can ensure full compatibility.
G. US-20140266591 discloses systems and methods for a population of devices each associated with an RFID tag. This way, the systems and methods may safeguard against attack whereby compromise of a single tag will not compromise the entire population of devices and may reduce or eliminate the use of inappropriate surgical devices during a surgical procedure.
N. CN-104706395 discloses that a surgical device may be a surgical stapler, a surgical cutter, a surgical stapler-cutter, a linear surgical stapler, a linear surgical stapler-cutter, a circular surgical stapler, a circular surgical stapler-cutter, a surgical clip applier, a surgical clamp bandage, a surgical clamping device, a vessel expanding device, a lumen expanding device, a scalpel, a fluid delivery device or any other type of surgical appliance for, each of these configured for handheld electromechanical surgical device driven by power to actuate and manipulation.
O. JP-2010535365 discloses a surgical procedure wherein in an embodiment, the encryption realized between the reader and the RFID tag is the cloning of the RFID tag, which is a form of security violation associated with unauthorized reading and reuse of the RFID tag commands.
P. WO-2007016101 discloses methods and systems using electronic identifiers to transmit and receive data for configuring and data-populating a surgical device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SURESH K SURYAWANSHI whose telephone number is (571)272-3668. The examiner can normally be reached M-F 8:00-5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kenneth M Lo can be reached at 5712729774. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SURESH SURYAWANSHI/Primary Examiner, Art Unit 2116
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