DETAILED ACTION
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 .
Response to Arguments
Applicant’s arguments with respect to the previous rejection(s) of the claims have been fully considered but are non-persuasive. Applicant contends that the prior art references in combination fail to obviate the claim language “…wherein the digital certificate comprises data identifying the IMD and validating programming data as being authorized for the identified IMD”. Applicant further states that the cited portions of the secondary Wasily reference describe authentication of the source…and do not describe authorization of programming data for a particular IMD. The examiner respectfully disagrees and notes that the rejection is based on the combination of what both references teach – not just what the secondary reference of Wasily teaches.
Haubrich teaches use of a digital certificate with a cryptographic private key in relation to validation data corresponding to the programming data. This programming data is for the purpose of validating the programming data as being authorizing for the identified IMD – as is clear in the cited portion of the rejection – (¶¶ 58 – “numerous encryption/decryption schemes may be used to ensure that a set of remote programming instructions are received only by a correctly targeted IMD”). The secondary reference of Wasily is referenced to disclose and obviate the use of device identifiers as data identifying the IMD of the claim -language (the remarks refer to the same cited portions ¶¶ 117-119). The examiner maintains that the disclosure of the two references and the cited portions with rationale satisfy the claimed language and can be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law. In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992).
Accordingly the rejection is maintained.
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 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.
In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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 of this title, 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 21-28 are rejected under 35 U.S.C. 103 as being unpatentable over Haubrich et al. (US 2009/0281598; hereinafter “Haubrich”) in view of Wasily et al. (US 2019/0036688; hereinafter “Wasily”).
Regarding claim 21, Haubrich teaches a method for management of implantable medical devices (IMDs) performed by a system for management of IMDs, the method comprising: receiving, by one or more processors of one or more remote servers of a system for management of IMDs (e.g. Fig. 1; e.g. ¶¶ 50 – where the central programming instrument inherently comprises one or more processors), programming data from a clinician programmer device, wherein the programming data was created during a programming session between the clinician programmer device and an IMD without a wireless or wired network connection between the clinician programmer device and the one or more remote servers of the system for management of IMDs, the programming session occurring prior to receiving the programming data (e.g. ¶¶ 91 – “IMD state token values may also be stored in an associated EMD and updated periodically or whenever the IMD and EMD are within communication range. As such, the most recent state token values stored by the EMD may be retrieved by the central programming instrument upon establishing a communication link with the EMD, even if communication with the IMD is unavailable at the time of the remote programming session.”); reconciling, by the one or more processors, programming of the IMD programmed with the programming data with data stored by the system for management of IMDs (e.g. ¶¶ 93 – “verification is made at decision step 468 that any critical tokens are unchanged by comparing the current token values to the token values provided with the transferred programming data” – where the examiner notes that the reconciling is the comparison of the token values of the data category changed – see further: e.g. ¶¶ 91 – “IMD state token values may also be stored in an associated EMD and updated periodically or whenever the IMD and EMD are within communication range.”; ¶¶ 92 – “The clinician or user may flag critical tokens that should remain unchanged before enabling implementation of remote programming instructions by the IMD”); generating, by the one or more processors, validation data corresponding to the programming data, wherein the validation data is a digital certificate signed with a cryptographic private key (e.g. ¶¶ 57 – “A digital certificate may be used to authenticate a user identity and deliver a digital signature used to verify that a set of remote programming instructions arrived intact. A public/private key scheme may be used wherein a unique private key is stored on an IMD”; ¶¶ 58 – “numerous encryption/decryption schemes may be used to ensure that a set of remote programming instructions are received only by a correctly targeted IMD”); communicating, by the one or more processors the validation data to the IMD, the validation data configured to enable, by using the cryptographic private key, the IMD to conduct therapeutic operations according to the programming data (where the examiner notes that the IMD inherently/necessarily conducts therapeutic options based on the programming instructions being properly encrypted and received); and delivering, by the IMD, a therapy to a patient based on the programming data subsequent to receiving the validation data, the therapy configured to treat a medical condition of the patient (e.g. ¶¶ 25 – where the examiner notes the device inherently applies the updated and verified programming).
As noted above, Haubrich discloses the use of a cryptographic private key (e.g. ¶¶ 57-58); however, it is unclear whether the digital certificate comprises data identifying the IMD and validating programming data as being authorized for the identified IMD. In the same field of endeavor, Wasily discloses the use of digital certificate encryption and the notorious use of keys including private keys, to identify and verify programming data components during programming (e.g. ¶¶ 117-119). It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention, to apply the known use of private cryptographic keys comprising data identifying the IMD and validating programming data as being authorized for the identified IMD as taught by Wasily, to the known device of Haubrich, in order to further secure communications and avoid unwarranted access to the programming of IMDs.
Regarding claim 22, Haubrich discloses the programming data comprises one or more parameters for controlling a therapy for treating a patient via the IMD, the one or more parameters comprising at least a stimulation pattern (e.g. ¶¶ 89 – “cardiac pacing parameters”).
Regarding claim 23, Haubrich discloses the validation data is communicated to the IMD via the clinician programmer device (e.g. Fig. 1 – where it is clear the clinician programmer device 22 is the only method of communication for the system as a whole, including the central programming instrumentation 32).
Regarding claim 24, Haubrich discloses the validation data is communicated to the IMD via a patient controller device (e.g. ¶¶ 26 – where a plurality of external patient devices may be located in a patient’s home for telemetric communication and programming purposes).
Regarding claim 25, Haubrich discloses the data stored by the system for management of IMDs is received from a patient controller device (e.g. ¶¶ 26 – where a plurality of external patient devices may be located in a patient’s home for telemetric communication and programming purpose and would necessarily store data at least temporarily before transfer to the IMD).
Regarding claim 26, Haubrich discloses the reconciling comprises: comparing the programming data received from the clinician programming device with the data stored by the system for management of IMDs, wherein the data stored by the system for management of IMDs is received from a patient controller device subsequent to generation of the programming data; determining, based on the comparing, whether the programming data corresponds to the data stored by the system for management of IMDs; and generating the validation data in response to a determination that the programming data corresponds to the data stored by the system for management of IMDs (e.g. ¶¶ 91-93 – where the examiner notes that the patient controller device discussed at ¶¶ 26 would be capable of bidirectional communication and the other components would still perform the same steps as referenced with the independent claim).
Regarding claim 27, Haubrich discloses generating revocation data in response to a determination that a particular instance of programming data does not correspond to data stored by the system for management of IMDs; and communicating the revocation data to a particular IMD associated with the particular instance of the programming data to prevent use of the particular instance of the programming data (e.g. Fig. 5A – #225/230).
Regarding claim 28, Haubrich discloses receiving metadata corresponding to the programming data received from the clinician programmer device, wherein the metadata accompanies the programming data and includes information that identifies one or more modifications to parameters of the IMD during the programming session (e.g. ¶¶ 62-63).
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Williams et al. (US 2005/0021969).
Conclusion
Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael D’Abreu whose telephone number is (571) 270-3816. The examiner can normally be reached on 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL J D'ABREU/Primary Examiner, Art Unit 3796
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