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 .
Applicant's amendments filed on 04/24/2026 has been received and entered. Currently Claims 11-12, 14-18, and 21-29 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted by applicant dated 03/09/2026 has been considered by the examiner.
Response to Arguments
Applicant argues on pages 7-8 of applicant’s remarks that the cited references does not describe “…enable processing at a lowest use level of the at least one first medical device and/or of the at least one second medical device without authentication in an emergency situation” as recited in the amended claims.
The examiner respectfully disagrees. Suarez teaches authenticating a user to use medical devices ([0021], [0023], [0026]-[0027], [0035]-[0039], [0043], [0045]-[0046], [0052], [0063]-[0065]). In an analogous art, Moalemzadeh teaches accessing a medical device in an emergency situation without authentication (e.g. by providing an override code) and certain information is accessible during the emergency situation ([0095], [0097]). The examiner notes that the term “lowest” in the limitation “lowest use level” is a relative term. One of ordinary skill in the art would recognize that since only certain information is accessible and not all information is accessible, the medical device is enabled at a lowest use level. 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 Suarez of authenticating a user for use of a medical device with the teachings of Moalemzadeh to include accessing a medical device in an emergency situation without authentication in order to allow usage of the medical devices during an emergency situation without the hassle of performing authentication.
Therefore, Suarez in view of Moalemzadeh teaches limitations of the claims.
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:
“authentication apparatus configured to…” in claims 11 and 21.
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 11-12, 14-15, 17-18, 21 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Suarez et al. US 2018/0225432 (hereinafter Suarez), in view of Moalemzadeh US 2021/0022648.
As per claim 11, Suarez teaches a system for granting permission clearance to at least one first medical device of a device complex to adjust settings on the at least one first medical device, the system comprising: an authentication server for performing authentication (Suarez paragraph [0018], server);
the at least one first medical device (Suarez paragraph [0021], medical devices); and
an authentication apparatus, the authentication apparatus and/or the at least one first medical device being configured to perform authentication of at least one user (Suarez paragraph [0033], [0042], [0051]-[0052], receive authentication information for user),
the authentication apparatus and/or the at least one first medical device being further configured to communicate with the authentication server to perform authentication of the at least one first medical device (Suarez paragraph [0033], [0042], [0051]-[0052], send authentication information to server),
the authentication server being configured to enable the at least one first medical device with a user-specific use level based on user data upon successful authentication of the at least one first medical device (Suarez paragraph [0023], [0026], [0043], [0045]-[0046], [0052], [0063]-[0065], authenticate user to use the medical device),
wherein the authentication server is provided and configured to unlock at least one second medical device in communication contact with the at least one first medical device from the device complex (Suarez paragraph [0021], [0026]-[0027], [0035]-[0039], [0043], [0052], server authenticates user and sends instructions to medical devices for use by the user).
Suarez does not explicitly disclose wherein system is provided and configured to enable processing at a lowest use level of at least one first medical device and/or of at least one second medical device without authentication in an emergency situation.
Moalemzadeh teaches wherein system is provided and configured to enable processing at a lowest use level of at least one first medical device and/or of at least one second medical device without authentication in an emergency situation (Moalemzadeh [0095], [0097], access to medical device is provided in emergency situation without authentication, certain information is accessible during an emergency situation) (One of ordinary skill in the art would recognize that since only certain information is accessible and not all information is accessible, the medical device is enabled at a lowest use level).
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 Suarez of authenticating a user for use of a medical device with the teachings of Moalemzadeh to include accessing a medical device in an emergency situation without authentication in order to allow usage of the medical devices during an emergency situation without the hassle of performing authentication.
As per claim 12, Suarez in view of Moalemzadeh teaches the system according to claim 11, wherein the at least one first medical device is an infusion pump (Suarez paragraph [0021], infusion pump).
As per claim 14, Suarez in view of Moalemzadeh teaches the system according to claim 11, wherein the authentication server is provided and configured to unlock the at least one second medical device with the user-specific use level (Suarez paragraph [0021], [0026]-[0027], [0035]-[0039], [0043], [0052], server authenticates user and sends instructions to medical devices for use by the user).
As per claim 15, Suarez in view of Moalemzadeh teaches the system according to claim 11, wherein the authentication server is provided and configured to send an authentication command to the at least one second medical device, wherein the authentication command comprises information (Suarez paragraph [0038], [0047], [0061], [0063]-[0064], server sends authentication command to medical devices).
As per claim 17, Suarez in view of Moalemzadeh teaches the system according to claim 15, wherein the at least one second medical device is provided and configured to store the information (Suarez paragraph [0030], [0035]-[0039], [0046]-[0047], [0061], [0063]-[0064], medical devices store information).
As per claim 18, Suarez in view of Moalemzadeh teaches the system according to claim 17, wherein the information is stored in a test protocol of the at least one second medical device (Suarez paragraph [0023], [0030], [0035]-[0039], [0046]-[0047], [0061], [0063]-[0064], medical devices store information).
As per claim 21, Suarez teaches the system according to claim 11, wherein the at least one first medical device or the authentication apparatus is provided and configured to enter user data and send user data to the authentication server (Suarez paragraph [0030], [0033], [0042], [0051]-[0052], [0063]-[0064], send user data to server).
As per claim 24, Suarez in view of Moalemzadeh teaches the system according to claim 11, wherein a communication connection between the authentication server and the at least one first medical device is configured bidirectionally (Suarez paragraph [0027], [0030], communication between server and medical devices).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Suarez in view of Moalemzadeh, and further in view of Fan et al. US 2020/0336481 (hereinafter Fan).
As per claim 16, Suarez in view of Moalemzadeh teaches the system according to claim 15, wherein the information comprises at least a user name and the user-specific use level (Suarez paragraph [0038], [0047], [0061], [0063]-[0064], server sends authentication command to medical devices including username information and use level information).
Suarez in view of Moalemzadeh does not explicitly disclose information comprises time stamp.
Fan teaches information comprises time stamp (Fan paragraph [0123], [0157], timestamp).
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 Suarez in view of Moalemzadeh of sending an authentication command to medical devices with the teachings of Fan of sending a request including a timestamp of the request because the results would have been predictable and resulted in the authentication command having a timestamp of when the command was generated.
Claims 22-23 and 25-29 are rejected under 35 U.S.C. 103 as being unpatentable over Suarez in view of Moalemzadeh, in view of Stanley et al. US 2022/0361755 (hereinafter Stanley).
As per claim 22, Suarez in view of Moalemzadeh teaches the system according to claim 11.
Suarez in view of Moalemzadeh does not explicitly disclose wherein at least one first medical device is provided and configured to display a code, which is provided and configured to output a device identification of the at least one first medical device by scanning via authentication apparatus.
Stanley teaches wherein at least one first medical device is provided and configured to display a code, which is provided and configured to output a device identification of the at least one first medical device by scanning via authentication apparatus (Stanley paragraph [0071], [0073], [0093], display QR code which includes device ID).
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 Suarez in view of Moalemzadeh of authenticating and using medical devices with the teachings of Stanley to include a medical device displaying a QR code encoding its device ID and scanning the QR code to obtain the ID because the results would have been predictable and resulted in the medical devices displaying QR codes encoded their device IDs and obtaining the IDs by scanning the QR codes.
As per claim 23, Suarez in view of Moalemzadeh and Stanley teaches the system according to claim 22, wherein the code is a quick response (QR) code or a barcode (Stanley paragraph [0071], [0073], [0093], display QR code which includes device ID).
As per claim 25, Suarez teaches a method for granting a permission clearance to at least one first medical device of a device complex in order to adjust settings on the at least one first medical device of a device complex, the method comprising the steps of: entering user data into an authentication apparatus and/or the at least one first medical device (Suarez paragraph [0033], [0042], [0051]-[0052], receive authentication information for user);
sending the user data to an authentication server unit (Suarez paragraph [0033], [0042], [0051]-[0052], send authentication information to server);
performing an authentication on the at least one first medical device (Suarez paragraph [0023], [0026], [0043], [0045]-[0046], [0052], [0063]-[0065], authenticate user to use the medical device);
granting the permission clearance and assigning a user-specific use level (Suarez paragraph [0023], [0026], [0043], [0045]-[0046], [0052], [0063]-[0065], authenticate user to use the medical device);
unlocking, by the authentication server, at least one second medical device in communication contact with the at least one first medical device from the device complex (Suarez paragraph [0021], [0026]-[0027], [0035]-[0039], [0043], [0052], server authenticates user and sends instructions to medical devices for use by the user).
Suarez does not explicitly disclose enabling processing at a lowest use level of at least one first medical device and/or of at least one second medical device without authentication in an emergency situation.
Moalemzadeh teaches enabling processing at a lowest use level of at least one first medical device and/or of at least one second medical device without authentication in an emergency situation (Moalemzadeh [0095], [0097], access to medical device is provided in emergency situation without authentication, certain information is accessible during an emergency situation) (One of ordinary skill in the art would recognize that since only certain information is accessible and not all information is accessible, the medical device is enabled at a lowest use level).
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 Suarez of authenticating a user for use of a medical device with the teachings of Moalemzadeh to include accessing a medical device in an emergency situation without authentication in order to allow usage of the medical devices during an emergency situation without the hassle of performing authentication.
Suarez in view of Moalemzadeh does not explicitly disclose entering a device identification of at least one first medical device into authentication apparatus.
Stanley teaches entering a device identification of at least one first medical device into authentication apparatus (Stanley paragraph [0071], [0073], [0093], scan QR code which includes device ID).
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 Suarez in view of Moalemzadeh of authenticating and using medical devices with the teachings of Stanley to include a medical device displaying a QR code encoding its device ID and scanning the QR code to obtain the ID because the results would have been predictable and resulted in the medical devices displaying QR codes encoded their device IDs and obtaining the IDs by scanning the QR codes.
As per claim 26, Suarez in view of Moalemzadeh and Stanley teaches the method according to claim 25, wherein the at least one first medical device is an infusion pump (Suarez paragraph [0021], infusion pump).
As per claim 27, Suarez in view of Moalemzadeh and Stanley teaches the method according to claim 25, wherein the user data is a user name and password or biometric data (Suarez paragraph [0033], [0042], [0051]-[0052], receive authentication information for user).
As per claim 28, Suarez in view of Moalemzadeh and Stanley teaches the method according to claim 25, wherein the device identification is entered by scanning a code displayable on the at least one first medical device (Suarez paragraph [0021]; Stanley paragraph [0071], [0073], [0093], scan QR code which includes device ID).
As per claim 29, Suarez in view of Moalemzadeh and Stanley teaches the method according to claim 25, further comprising the steps of: sending an authentication command to at least one second medical device (Suarez paragraph [0038], [0047], [0061], [0063]-[0064], server sends authentication command to medical devices);
storing received information of the authentication command in the at least one second medical device (Suarez paragraph [0030], [0035]-[0039], [0046]-[0047], [0061], [0063]-[0064], medical devices store information); and
using the at least one second medical device according to a received use level (Suarez paragraph [0021], [0026]-[0027], [0035]-[0039], [0043], [0052], server authenticates user and sends instructions to medical devices for use by the user).
Conclusion
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 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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