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
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.
Claim(s) 1-4, 6-8, 16-19 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Peeters (US 20200082139)
Peeters discloses
1. A medical device, comprising:
a medical tool (par. 36, 132: band-aid, drug package, any product, …);
a controller (52) connected to the medical tool, the controller configured to receive an activation signal from a remote control (par. 69: “Said leads 54 can terminate in tiny printable micro-heaters 56 located in a zone R that can be overlaid for example with a temperature sensitive ink with micro patterns 60 that appear only upon activation of said micro - heaters 56. A plurality of one - time use micro-heaters 56 can be printed and create optical zones that are sequential and indicate how many times the NFC tag has been read in transit … The use of NFC sensors and printed sensor leads 54 to determine for example if an item has been opened or tampered with is well known. Reference is made to U.S. Pat. Nos. 7,148,803; 7,969,307 and 10,271,738”; the activation signal comes from the power signal from an external wireless device); and
an activation label (2) connected to the medical tool and having an activation code required for activating the medical device, wherein the activation label comprises a temperature sensitive part (par. 35, 45, 65, 69: ring or area with multiple zones each with s temperature sensor) configured to change appearance at a predetermined temperature condition (par. 37, 47-50, 52-53, 70, 88: the code and colors are to read by a wireless phone to authenticate the label and to activate the tool by at least validating the genuineness of the label and the tool)
2.1, wherein the activation label comprises a coating of a temperature sensitive material locally treated with the predetermined temperature condition to display the activation code (Figs. 1-5).
3.1, wherein the temperature sensitive part is configured to change appearance to a first appearance at a first predetermined temperature condition and to change appearance to a second appearance at a second predetermined temperature condition (par. 35, 45, 65, 69: ring or area with multiple zones each with temperature sensor).
4.1, wherein the activation label comprises a coating of a temperature sensitive material that is configured to change appearance to a first appearance at a first predetermined temperature condition and to change appearance to a second appearance at a second predetermined temperature condition and/or wherein the activation label comprises a first temperature sensitive part configured to change appearance at a first predetermined temperature condition and a second temperature sensitive part configured to change appearance at a second predetermined temperature condition (par. 35, 45, 65, 69: ring or area with multiple zones each with temperature sensor).
6.1, wherein packaging of the medical device comprises a label indicating whether the predetermined temperature condition has been reached (par. 36, 43, 64, 69, 79, 132).
7.1, wherein the activation code is displayed in letters and digits, as a bar code, or as a QR-code (Figs. 1-5, par. 52, 55, 61+).
8.1, wherein the medical tool is a physiological sensor and/or a medical tool for subcutaneous insertion (par. 36, 132, 81, 87-89, 157-158, 175-178).
16. Use of a remote control to activate a medical device of claim 1 (see discussion regarding claims above.)
17.1, wherein the temperature sensitive part is configured to mask at least part of the activation code if the predetermined temperature condition is reached (par. 64, 78-79: temperature sensitive inks that reveal an optical code only at a given temperature).
18.17, wherein the temperature sensitive part is configured to entirely mask the activation code if the predetermined temperature condition is reached (par. 64, 78-79).
19.17, wherein the temperature sensitive part is configured to irreversibly mask at least part of the activation code if the predetermined temperature condition is reached ([0041] The changes in the optical properties of the optical sensors 8 can be reversible, meaning bidirectional, permanent, threshold initiated changes or any combination thereof)
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.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peeters (US 20200082139)
Re claim 5.1, Peeters is silent to the activation label is hidden from the view of a user before unpacking of the medical device.
However, Peeters also discloses the label can be in any product such as band-aid, skin care products and can be shipped in a package (par. 36, 59, 132, 159).
It would have been obvious to one of ordinary skill in the art before the effective date the invention was made that the label that is attached to the product cannot be seen until the shipping package is opened as is also well known in the art.
Claim(s) 9-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peeters (US 20200082139) in view of Landherr (US 20230381525)
9. A medical device activation system, comprising: the medical device of claim 1; and a remote control configured to determine information allowing determination of the activation code from the activation label and send an activation signal to the medical device based on the activation code
(par. 37, 47-50, 52-53, 70, 88: the code and colors are to read by a wireless phone to authenticate the label and to activate the tool by at least validating the genuineness of the label and the tool; par. 65, 75, 98-103: keys are used for added security;
Peeters is silent to the send an activation signal to the medical device based on the activation code;
Landherr discloses [0081] In various embodiments herein, a data bearing tag herein used to establish secure communication between the medical device and an external communication device can be disposed on or in the packaging unit. In various embodiments, the data bearing tag can arranged so that it is inoperative until the packaging unit is opened. By way of example, in the context of an optical data bearing tag, the tag can be blocked from view until the packaging unit is opened. In the context of a data bearing tag that may communicate via wireless electromagnetic modalities (such as radio frequency-based communication or inductive based communication) the tag can be blocked from communication using electromagnetic shielding or the like. In this manner, the data bearing tag can only be utilized to facilitate secure communication between the medical device and an external communication device only when the packaging unit is opened. [0085] In various embodiments, the data bearing tag can include data in the form of a character string. In various embodiments, the data bearing tag can include data in the form of a password or a token. In various embodiments, the data bearing tag can include data in the form of at least one of a cryptography key (such as a key for use with a Public/Private key encryption architecture) or a digital certificate. [0093] It will be appreciated that multiple types of external communication devices are contemplated herein … the external communication device can be a personal patient communicator or a programmer device. [0114] In some embodiments, the security data (conveyed by the data bearing tag or otherwise) needed to establish secure communications can also be used for other purposes. For example, in some embodiments, the security data can be used to authorize/enable specific functionality on the part of the external communication device. In some embodiments, the security data can be used to unlock certain functionality of the external communication device (for example putting the implanted device into an MRI-safe operating mode). In some embodiments, the security data can be used to cause the implanted medical device to accept a predetermined set of programming commands (such as putting the implanted device into an MRI-safe operating mode) from the external communication device.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective date the invention was made to incorporate the teachings of Landherr so that the key or password encoded in the QR code can be used to enable secure communication between the programming device thereby enabling the medical device to operate as programmed by the programmer.
10. A medical device activation system according to claim 9, wherein the information allowing determination of the activation code is determined from the activation label by optical scanning (Peeters, par. 37, 47-50, 52-53, 70, 88; Landherr, Fig. 4, par. 81, 85, 93, 114).
11. Use of the medical device activation system of claim 9 to activate the medical device (see discussion regarding claims above.).
12. The medical device activation system of claim 9, further comprising a processor configured to receive the information allowing determination of the activation code and generate a confirmation signal to allow activation of the medical device (Landherr, Fig. 4, par. 113: processors in devices 104, 108 communicate to each other using the code and handshake confirmation signal).
Re claims 13-15, see discussion regarding claims above.
Conclusion
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/THIEN T MAI/ Primary Examiner, Art Unit 2876
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