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 § 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 16-17 are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Fructus (US 2014/0118518).
Regarding Claim 16, Fructus discloses:
A method performed by a computing system, to which a medical device is removably connectable to, for use during a medical procedure, the method comprising:
detecting a connection of the medical device to the computing system (see Paragraph 0064), the medical device including a secure memory (23) storing usage data in a plurality of data fields (see Paragraph 0040, for example, indicating that the memory 23 includes multiple data fields), the plurality of data fields including one or more usage metric fields corresponding to one or more usage metrics and an expiration data field (see Paragraphs 0042 and 0070 mentioning date and time and Paragraphs 0043-0044 mentioning indicating adding flags for each use; see Paragraph 0048 where there is an identifier that is recorded such that connection with another instrument is prevented, this is considered a maximum allowed value of one);
determining the medical device is not expired based on the usage data received from the secure memory of the medical device upon connection (see Paragraphs 0064-0065 discussing reading the memory to determine prior use);
processing and causing display of image data received from an imaging device of the medical device (Paragraph 0080 and throughout the disclosure, images are displayed on 15);
iteratively:
obtaining the one or more usage metrics associated with the medical device (see Paragraph 0065 discussing how the control unit determines the presence of a flag);
writing the one or more usage metrics to the secure memory of the medical device for storage as part of the usage data, the writing causing initially null or zero values of the one or more usage metric fields corresponding to the one or more usage metrics to be one or more of populated or incremented according to the one or more usage metrics obtained (see Paragraphs 0042-0043, for example, where metrics such as time and date of the beginning and end of connection and usage flags are recorded such that a new device will not have any usage time and any “flag” will be null or zero as the device has not yet been used).;
comparing the one or more usage metrics to one or more corresponding usage metric limits (see Paragraph 0065, for example, discussing reading the memory to determine whether or not there is a flag); and
determining whether the medical device is expired based on the comparison (see Paragraph 0065, the control unit determines whether or not a flag is present, which indicates prior use);
in response to determining the medical device is expired, writing an expiration value to the secure memory of the medical device for storage as part of the usage data, the writing causing the expiration data field to be updated to indicate an expired status of the medical device (see Paragraph 0044 indicating that upon determining a flag already exists, the flag is modified to indicate a second use of the instrument); and
after the medical device is determined to be expired, continuing to process and cause display of the image data received from the imaging device of the medical device without interruption until the medical device is disconnected from the computing system (see Paragraph 0044 indicating that the device may be reused; also see Paragraph 0009 where one of the problems the reference is addressing is limiting use to a predetermined duration; the reference focuses on connections such that once a flag is created, the device continues to operate until it is disconnected),
wherein, upon a next connection of the medical device to the computing system or another computing system, the computing system or the other computing system determines the medical device is expired based on the usage data received from the secure memory of the medical device upon the next connection, and fails to process and cause display of any image data received from the imaging device of the medical device (see Paragraph 0066, for example, the control unit prevents reuse under certain circumstances; also, the control unit does not allow reuse unless the practitioner overrides the control unit, the Examiner considers this to also read on the claims as failing to process and display the image data in that the control unit does not perform this function upon subsequent connections).
Regarding Claim 17, Fructus discloses wherein the plurality of data fields further includes one or more usage metric limit fields storing one or more maximum allowed values representing the one or more corresponding usage metric limits, and wherein comparing the one or more usage metrics to the one or more corresponding usage metric limits comprises: receiving the one or more maximum allowed values representing the one or more corresponding usage metric limits from the secure memory; and comparing one or more current values of the one or more usage metrics obtained to the one or more maximum allowed values (see Paragraph 0048 where there is an identifier that is recorded such that connection with another instrument is prevented, this is considered a maximum allowed value of one).
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 1-9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Fructus (US 2014/0118518).
Regarding Claim 1, Fructus discloses:
A computing system, comprising:
at least one memory (control unit 20 includes instructions and operates like a standard processing unit; memory is almost certainly included, but see below for discussion as to why this is obvious) configured to store instructions; and
at least one processor (20) configured to execute the instructions to perform operations to monitor usage of a medical device removably connected to the computing system (see Paragraph 0041, for example, discussing how the processor is used to identify utilization data; discussion of the processor can be found throughout the disclosure), the operations comprising:
detecting a connection of the medical device to the computing system (Paragraph 0039 and throughout the disclosure, the processor detects connection of the medical device to the system);
determining the medical device is not expired based on usage data received from a secure memory (23) of the medical device upon connection (see Paragraph 0065, the control unit determines whether or not a flag is present, which indicates prior use);
processing and causing display of image data received from an imaging device of the medical device (20 acts with 14/15 to display the images from the imaging device);
iteratively:
obtaining one or more usage metrics associated with the medical device (see Paragraph 0065 discussing how the control unit determines the presence of a flag);
writing the one or more usage metrics to the secure memory of the medical device for storage as part of the usage data (see Paragraphs 0069-0070, for example, discussing storing and updating the utilization data);
comparing the one or more usage metrics to one or more corresponding usage metric limits (see Paragraph 0065, for example, discussing reading the memory to determine whether or not there is a flag); and
determining whether the medical device is expired based on the comparison (see Paragraphs 0065 and 0071 discusses determining expiration based on the existence of a flag);
in response to determining the medical device is expired, writing an expiration value to the secure memory of the medical device for storage as part of the usage data (see Paragraph 0044 indicating that upon determining a flag already exists, the flag is modified to indicate a second use of the instrument); and
after the medical device is determined to be expired, continuing to process and cause display of the image data received from the imaging device of the medical device without interruption until the medical device is disconnected from the computing system (see Paragraph 0044 indicating that the device may be reused; also see Paragraph 0009 where one of the problems the reference is addressing is limiting use to a predetermined duration; the reference focuses on connections such that once a flag is created, the device continues to operate until it is disconnected),
wherein, upon a next connection of the medical device to the computing system or another computing system, the computing system or the other computing system determines the medical device is expired based on the usage data received from the secure memory of the medical device upon the next connection, and fails to process and cause display of any image data received from the imaging device of the medical device (see Paragraph 0066, for example, the control unit prevents reuse under certain circumstances; also, the control unit does not allow reuse unless the practitioner overrides the control unit, the Examiner considers this to also read on the claims as failing to process and display the image data in that the control unit does not perform this function upon subsequent connections).
The Examiner notes that the reference does not technically make any mention of memory related to the control unit. However, the control unit is a standard processing unit with complex instructions. These instructions are commonly stored in memory. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include memory in the control unit to store the instructions the control unit performs. Such a configuration uses standard components (memory) to store instructions as is known in the art.
Regarding Claim 2, Fructus further discloses wherein the secure memory of the medical device includes a data structure comprising a plurality of data fields for storing the usage data (see Paragraph 0040, for example, indicating that the memory 23 includes multiple data fields).
Regarding Claim 3, Fructus further discloses wherein the plurality of data fields includes one or more usage metric fields corresponding to the one or more usage metrics, wherein values of the one or more usage metric fields initially written to the secure memory at a time of manufacturing of the medical device are one or more of null or zero values, and wherein writing the one or more usage metrics to the secure memory of the medical device comprises: causing the values of the one or more usage metric fields corresponding to the one or more usage metrics to be one or more of populated or incremented according to the one or more usage metrics obtained (see Paragraphs 0042-0043, for example, where metrics such as time and date of the beginning and end of connection and usage flags are recorded such that a new device will not have any usage time and any “flag” will be null or zero as the device has not yet been used).
Regarding Claim 4, Fructus further discloses wherein the plurality of data fields further includes one or more usage metric limit fields storing one or more maximum allowed values representing the one or more corresponding usage metric limits for the one or more usage metrics (see Paragraph 0048 where there is an identifier that is recorded such that connection with another instrument is prevented, this is considered a maximum allowed value of one).
Regarding Claim 5, Fructus further discloses wherein comparing the one or more usage metrics to the one or more corresponding usage metric limits comprises: receiving the one or more maximum allowed values representing the one or more corresponding usage metric limits from the secure memory; and comparing one or more current values of the one or more usage metrics obtained to the one or more maximum allowed values (see Paragraph 0048; the value of the identifier that prevents reuse is compared to the value of the current device).
Regarding Claim 6, Fructus further discloses wherein the plurality of data fields further includes an expiration data field, and wherein writing the expiration value to the secure memory of the medical device causes the expiration data field to be updated to indicate an expired status of the medical device (see Paragraphs 0043 and 0069 discussing how the system creates a flag related to usage).
Regarding Claim 7, Fructus further discloses wherein the one or more usage metrics include one or more of: an amount of usage time, a number of connections, a date and time of a first connection of the medical device to any computing system, or a date and time of a most recent connection to the computing system (see Paragraphs 0042 and 0070 mentioning date and time and Paragraphs 0043-0044 mentioning indicating adding flags for each use).
Regarding Claim 8, Fructus further discloses wherein the one or more corresponding usage metric limits include a usage time limit, a connection limit, or a time since first connection limit (the flags are a connection limit and the memory includes a use-by date).
Regarding Claim 9, Fructus further discloses wherein the computing system further comprises a real time clock, the one or more usage metrics include at least an amount of usage time, and obtaining the one or more usage metrics comprises: using the real time clock to obtain a current value for the amount of usage time from the connection of the medical device to the computing system (see Paragraphs 0042 and 0070 mentioning date and time).
Regarding Claim 12, Fructus further discloses in response to determining the medical device is expired, generating and causing a notification to be displayed by a display device associated with the computing system, wherein the notification indicates the medical device is expired (see Paragraphs 0065-0066 indicating that the control unit displays a warning to the user based on the prior use of the device).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Fructus (US 2014/0118518) in view of Talbert et al. (US 2011/0238977).
Fructus discloses the invention substantially as claimed as stated above.
Regarding Claims 10 and 11, Fructus does not explicitly disclose wherein writing the one or more usage metrics to the secure memory of the medical device comprises: encrypting the one or more usage metrics transmitted to the secure memory via a data communication channel established between the computing system and the secure memory; and wherein the secure memory prevents unauthorized access to and alteration of the one or more usage metrics written to the secure memory of the medical device. Using encryption, especially in the medical field, is well-known. Talbert teaches encrypting the data to avoid tampering or unintended use (see Paragraph 0074). This includes encrypting the communication data streams and components (see Paragraphs 0134-0136). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Fructus to include encryption. Such a modification incorporates well-known technology into an existing device to prevent unwanted tampering or access to sensitive information.
Allowable Subject Matter
Claims 18-20 are allowed.
Claims 13-15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance:
The primary reason the claims are allowable over the prior art is that the prior art fails to disclose or render obvious the claimed computing system and method. Claim 13 requires determining a loss as data as the metric for expiration. Fructus makes no mention of data loss in this way. The medical device may be disconnected from the system, but the Examiner does not equate this to data loss. There being no teaching to modify the reference to include the feature, the claims overcome the prior art.
Claim 18 focuses on usage time as the means for determining expiration. Fructus mentions tracking usage time, but there is no clear statement that this is an expiration event. Fructus is more concerned with connection occurrences. In Fructus’s Background, there is mention that it is known in the art to limit usage time, but in that case, the device simply turns off. Applicant’s invention allows the continuing processing and displaying of images even after the usage expiration event. Only upon the following connection is the device prevented from processing and displaying images.
For at least these reasons, the claims overcome the prior art.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY JAY NEAL whose telephone number is (313)446-4878. The examiner can normally be reached Mon-Fri 7:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY J NEAL/ Primary Examiner, Art Unit 3795
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