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 .
The action is in response to the application filed on 03/14/2024. Claims 1-12 are pending and examined below.
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.
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:
“a prescription module…the prescription model is configured to allow a user to enter a prescription that is used to trigger the analyte detection by the non-invasive device during the surgical care” in claim 1 and 7
“a device module…is able to trigger the analyte detection by the non-invasive device via the device module during the surgical care” in claims 1 and 7
“a guidance module…the guidance module is configured to search for medical guidance based on the patient during the surgical care, and the guidance module is able to trigger the analyte detection by the non-invasive device based on the medical guidance during the surgical care” in claims 1 and 7
“a workflow module…the workflow module is configured to allow a user to select an existing workflow or create a new workflow during the surgical care, and the workflow module is able to trigger the analyte detection by the non-invasive device based on the existing workflow or the new workflow during the surgical care” in claims 1 and 7
“a robot module…the robot module is configured to connect during the surgical care to a surgical robot that is used during the surgical care and that is able to trigger the analyte detection by the non-invasive device via the robot module during the surgical care” in claims 1 and 7
“an OR module…the OR module is configured to allow a user to check-in to the OR module during the surgical care and allow the user to trigger the analyte detection by the non-invasive device via the OR module during the surgical care” in claims 1 and 7.
“a profile module…the profile module is configured to allow a user to enter and/or retrieve patient profile information of the patient from a record or database during the surgical care, check a database for a suggested analyte measurement based on the patient profile information during the surgical care, and trigger the analyte detection by the non-invasive device during the surgical care based on the suggested analyte measurement” in claims 1 and 7.
“a wearable module…the wearable module is configured to connect during the surgical care to a wearable medical device that is worn by the patient during the surgical care, and configured to trigger the analyte detection by the non-invasive device during the surgical care based on data detected by the wearable medical device” in claims 1 and 7.
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.
A prescription module, a device module, a guidance module, a workflow module, a robot module, an OR module, a profile module, and a wearable module are all software programs that are contained within a computer a discussed in paragraph [0045] of the PGPub of the instant Application US 20240306957 A1.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20200187812 A1 (hereinafter referred to as “Leabman”) in view of US 20080058612 A1 (hereinafter referred to as “Ohyu”).
Regarding claims 1-3 and 7-9, Leabman teaches a surgical care patient health monitoring system /method(abstract), comprising:
a non-invasive device (paragraph [0099]; as shown in Figure 10) that includes one or more transmit antennas configured to transmit radio frequency (RF) analyte detection signals from the one or more transmit antennas into a patient during surgical care (Tx; paragraphs [0099]-[0101]; as shown in Figures 10-12), and one or more receive antennas that receive return RF analyte signals that result from the transmitted RF analyte detection signals into the patient during the surgical care (Rx; paragraphs [0099]-[0101]; as shown in Figures 10-12), the non-invasive device is configured to be triggered to perform an analyte detection in the patient using the one or more transmit antennas and the one or more receive antennas during the surgical care (“In an embodiment, the health parameter is blood glucose level. In other embodiments, the health parameter may be blood pressure or heart rate”; paragraph [0129]; Figure 21); but Leabman does not explicitly teach at least one of the following:
(a) a prescription module that is connectable to and able to control operation of the non-invasive device to perform the analyte detection in the patient during the surgical care; the prescription module is configured to allow a user to enter a prescription that is used to trigger the analyte detection by the non-invasive device during the surgical care;
(b) a device module that is connectable to and able to control operation of the non-invasive device to perform the analyte detection in the patient during the surgical care; the device module is connectable during the surgical care to a medical device that is used during the surgical care and that is able to trigger the analyte detection by the non-invasive device via the device module during the surgical care;
(c) a guidance module that is connectable to and able to control operation of the non-invasive device to perform the analyte detection in the patient during the surgical care; the guidance module is configured to search for medical guidance based on the patient during the surgical care, and the guidance module is able to trigger the analyte detection by the non-invasive device based on the medical guidance during the surgical care;
(d) a workflow module that is connectable to and able to control operation of the non-invasive device to perform the analyte detection in the patient during the surgical care; the workflow module is configured to allow a user to select an existing workflow or create a new workflow during the surgical care, and the workflow module is able to trigger the analyte detection by the non-invasive device based on the existing workflow or the new workflow during the surgical care;
(e) a robot module that is connectable to and able to control operation of the non-invasive device to perform the analyte detection in the patient during the surgical care; the robot module is configured to connect during the surgical care to a surgical robot that is used during the surgical care and that is able to trigger the analyte detection by the non-invasive device via the robot module during the surgical care;
(f) an OR module that is connectable to and able to control operation of the non-invasive device to perform the analyte detection in the patient during the surgical care; the OR module is configured to allow a user to check-in to the OR module during the surgical care and allow the user to trigger the analyte detection by the non-invasive device via the OR module during the surgical care;
(g) a profile module that is connectable to and able to control operation of the non-invasive device to perform the analyte detection in the patient during the surgical care; the profile module is configured to allow a user to enter and/or retrieve patient profile information of the patient from a record or database during the surgical care, check a database for a suggested analyte measurement based on the patient profile information during the surgical care, and trigger the analyte detection by the non-invasive device during the surgical care based on the suggested analyte measurement;
(h) a wearable module that is connectable to and able to control operation of the non-invasive device to perform the analyte detection in the patient during the surgical care; the wearable module is configured to connect during the surgical care to a wearable medical device that is worn by the patient during the surgical care, and configured to trigger the analyte detection by the non-invasive device during the surgical care based on data detected by the wearable medical device.
However, Ohyu, a medical information system teaches, at least one of the following:
(a) a prescription module that is connectable to and able to control operation of the non-invasive device to perform the analyte detection in the patient during the surgical care; the prescription module is configured to allow a user to enter a prescription that is used to trigger the analyte detection by the non-invasive device during the surgical care;
(b) a device module that is connectable to and able to control operation of the non-invasive device to perform the analyte detection in the patient during the surgical care; the device module is connectable during the surgical care to a medical device that is used during the surgical care and that is able to trigger the analyte detection by the non-invasive device via the device module during the surgical care ();
(c) a guidance module that is connectable to and able to control operation of the non-invasive device to perform the analyte detection in the patient during the surgical care; the guidance module is configured to search for medical guidance based on the patient during the surgical care, and the guidance module is able to trigger the analyte detection by the non-invasive device based on the medical guidance during the surgical care;
(d) a workflow module that is connectable to and able to control operation of the non-invasive device to perform the analyte detection in the patient during the surgical care; the workflow module is configured to allow a user to select an existing workflow or create a new workflow during the surgical care, and the workflow module is able to trigger the analyte detection by the non-invasive device based on the existing workflow or the new workflow during the surgical care (the system assesses a patients level of arousal, and determines if they are fully awake (part of a flow of surgery) based on biometric information such as blood pressure; paragraph [0224]-[0225]);
(e) a robot module that is connectable to and able to control operation of the non-invasive device to perform the analyte detection in the patient during the surgical care; the robot module is configured to connect during the surgical care to a surgical robot that is used during the surgical care and that is able to trigger the analyte detection by the non-invasive device via the robot module during the surgical care;
(f) an OR module that is connectable to and able to control operation of the non-invasive device to perform the analyte detection in the patient during the surgical care; the OR module is configured to allow a user to check-in to the OR module during the surgical care and allow the user to trigger the analyte detection by the non-invasive device via the OR module during the surgical care (“a stage identification unit 9 decides the type of performed medical act and the time instant of performance on the basis of the biomedical information acquired by the measured value acquisition unit 1” (thus is capable of determining/checking in on a stage of surgery, performed in an operation room; paragraph [0038]);
(g) a profile module that is connectable to and able to control operation of the non-invasive device to perform the analyte detection in the patient during the surgical care; the profile module is configured to allow a user to enter and/or retrieve patient profile information of the patient from a record or database during the surgical care, check a database for a suggested analyte measurement based on the patient profile information during the surgical care, and trigger the analyte detection by the non-invasive device during the surgical care based on the suggested analyte measurement (paragraphs [0038]-[0039]);
(h) a wearable module that is connectable to and able to control operation of the non-invasive device to perform the analyte detection in the patient during the surgical care; the wearable module is configured to connect during the surgical care to a wearable medical device that is worn by the patient during the surgical care, and configured to trigger the analyte detection by the non-invasive device during the surgical care based on data detected by the wearable medical device. It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Leabman, to determine have additional modules for performing specific medical related tasks, as taught by Ohyu, because doing so adds additional functionality based on biometric parameters that are determined by the non-invasive device of Leabman.
Regarding claims 4 and 10, Leabman, in view of Ohyu, teaches further comprising an analog-to-digital converter connected to the one or more receive antennas (has an analog to digital converter; paragraph [0080]; as taught by Leabman).
Regarding claims 5 and 11, Leabman, in view of Ohyu, teaches wherein the at least one of (a)-(h) is physically separate from the non-invasive device (the noninvasive device is an rf sensor device; abstract; as taught by Leabman; the sensor 1 is separate from the surgical recording system 12 (the profile module) as shown in Figure 1; as taught by Ohyu).
Regarding claims 6 and 12, Leabman, in view of Ohyu, teaches wherein the two or more of (a)-(h) are together in an admin network (parts of software (which is part of a computer); paragraph [0039}).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABID A MUSTANSIR whose telephone number is (408)918-7647. The examiner can normally be reached M-F 10 am to 6 pm Pacific Time.
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, Jason Sims can be reached at 571-272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ABID A MUSTANSIR/ Examiner, Art Unit 3791