DETAILED ACTION
Claims 1-7 are presented for examination.
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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,893,028. Although the claims at issue are not identical, they are not patentably distinct from each other because claims of the issued patent anticipate the claims in the current application.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,143,372. Although the claims at issue are not identical, they are not patentably distinct from each other because claims of the issued patent anticipate the claims in the current application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the terms “the communication message” on line 2. These terms lack antecedent basis. For the purpose of examination, the claim is being interpreted as reciting “a communication message”.
Claim 1 recites the terms “transforming several of the random bytes” on line 9. It is not clear whether the random bytes are referring to the first count random bytes, to the generated number of random bytes or both. For the purpose of examination, the claim is being interpreted as referring to the first count of random bytes or the generated count of random bytes.
Claim 1 recites “the current control communications state”, “the current medical device communication state” and “the current medical device state”. All these terms lack antecedent basis. The claim is being interpreted as reciting “a current control communications state”, “a current medical device communication state” and “a current medical device state”
Claims 2-7 depend on claim 1 and therefore inherit these rejections.
Claims 2 and 3 recite “the first communications protocol” or “the second communications protocol”, respectively. These terms lack antecedent basis. For the purpose of examination, these claims are being interpreted as reciting “a first communications protocol” or “a second communications protocol”, respectively.
Claim 5 recites the terms “the transformed number” which lacks antecedent basis. For the purpose of examination, it is being interpreted as reciting “the transformed random number”.
Claims 6-7 depend on claim 5 and therefore inherit this rejection.
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 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Carlson et al (US Pub. No.2015/0012057) in view of Park, “Security Mechanism Based on Hospital Authentication Server for Secure Application of Implantable Medical Devices”, July 24, 2014, BioMed Research International, Vol. 2014, Article ID 543051 (provided in Applicant’s IDS) and further in view of “Core System Package, Specification of the Bluetooth System”, Version 5.0, Volume 6, December 06, 2016, pp.2600-2648, hereinafter Bluetooth5.0 (provided in Applicant’s IDS).
Re Claim 1. Carlson discloses a method for controlling a medical device comprising:
applying communications (i.e. programmer 22 may communicate with IMD 16 and another programmer via remote telemetry techniques) [Carlson, para.0070];
Carlson does not explicitly disclose whereas Park does: applying communications threat control to the communications message [by obfuscating clear text data in the communications message] to obtain a threat controlled communications message (i.e. All the commands between IMD and personalized programmer are secured using the
Read-Key, Kr𝑗= 𝑘𝑑𝑓 (𝐾dID, SN𝑗, dID, pID), and
Write-Key, Kw𝑗=𝑘𝑑𝑓 (𝐾dID, SN𝑗, dID, pID, PatientData𝑗, ℎ (Config𝑗)) which are a kind of session keys for the current patient session. Since IMD/physician identification numbers, dID and pID, as well as the current session number, SN𝑗, are used
to derive the session keys, the freshness of each command can be guaranteed to protect from a replay attack. In particular, the patient data PatientData𝑗 and physician’s treatment Conf𝑗 are symmetrically protected against eavesdropping, for patient privacy) [Park, p.8, col.2, section 6.3]
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify Carlson with Park in order to guarantee the authenticity of the patient data collected from IMD and the nonrepudiation of the physician’s treatment [Park, p.2, col.1].
This motivation applies to the remainder of the claim.
Carlson in view Park does not explicitly disclose whereas Bluetooth5.0 does: applying threat control by obfuscating clear text data in the communications message [Bluetooth5.0, p.2600, Fig.3]; including: generating a random byte; using the random byte as a random key; transforming the random key into a first count of random bytes in a known range; generating a number of random bytes that equals the first count [Bluetooth5.0, p.2648, section 4.5.8.3.4 and Fig.4.38 where prn_e is a random number as indicated in 4.5.8.3.3]; transforming several of the random bytes into a linear feedback shift register (LFSR) seed value (i.e. before whitening or dewhitening, the shift register is initialized with a sequence that is derived from the channel index………… in the following manner: position 0 is set to one, positions 1 to 6 are set to the channel index of the channel used went transmitting or receiving, from the most significant bit in position 1 to the least significant bit in position 6) [Bluetooth5.0, p. 2601, Section 3.2, p.2602, Fig.3.4]; and whitening an input counted string of the clear text data using the LFSR seed value forming obfuscated clear text data in the communications message [Bluetooth5.0, p.2602, Fig.3.4 shows an example of linear feedback shift register to generate data whitening];
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify Carlson in view of Park with Bluetooth5.0 because Carlson states that Bluetooth is an example of local wireless communication techniques that may be employed to facilitate communication between programmer 22 and another computing device include RF communication based on the 802.11 or Bluetooth specification sets [Carlson, para.0123].
This motivation applies to remainder of this claim.
Park further discloses: transmitting the threat controlled communications message based on the current control communications state (i.e. Write-Request {SN𝑗, pID, [Conf𝑗]Kw𝑗,ℎ(Conf𝑗),MAC(Kw𝑗)}command) [Park, p.6, col.2, Fig.4, step 3]; receiving a message based on the current medical device communications state; verifying based on the communications threat control and the current medical device state, that the received message is the same as the threat controlled communications message (i.e. After receiving the Write-Request {SN𝑗, pID,[Conf𝑗]Kw𝑗,ℎ(Conf𝑗),MAC(Kw𝑗)}command, IMD first computes its own Kw𝑗 and verifies the MAC value. A reason to use ℎ (Conf𝑗) instead of Conf𝑗 to generate the Write-Key is for confidentiality of the treatment parameters. If the verification is successful, IMD changes its parameters according to Conf𝑗) [Park, p.6, col.1, Fig.4, step 4];
Bluetooth5.0 further discloses: deobfuscating the obfuscated clear text data including: transforming the random key into a second count of random bytes in a known range [Bluetooth5.0, p.2648, section 4.5.8.3.4 and Fig.4.38 where prn_e is a random number as indicated in 4.5.8.3.3]; transforming at least one of the random bytes into the LFSR seed value (i.e. Before whitening or dewhitening, the shift register is initialized with a sequence that is derived from the channel index………… in the following manner: position 0 is set to one, positions 1 to 6 are set to the channel index of the channel used when transmitting or receiving, from the most significant bit in position 1 to the least significant bit in position 6) [Bluetooth5.0, p. 2601, Section 3.2, p.2602, Fig.3.4, Note: the channel index is based on a random number]; dewhitening the second count of random bytes; and dewhitening the whitened input counted string using the dewhitened second count of random bytes [Bluetooth5.0, p.2601, Section 3.2, p.2602, Fig.3.4] and the LFSR seed value (i.e. Before whitening or dewhitening, the shift register is initialized with a sequence that is derived from the channel index…………in the following manner: position 0 is set to one, positions 1 to 6 are set to the channel index of the channel used went transmitting or receiving, from the most significant bit in position 1 to the least significant bit in position 6) [Bluetooth5.0, p.2601, Section 3.2, p.2602, Fig.3.4];
Carlson further discloses: controlling the medical device based on the message (i.e. controls the delivery of therapy by IMD 16 based on one or more entry actions that are associated with the current state in the state machine (72). The one or more entry actions associated with the current state may be specified by programmable state parameters that are received from an external device e.g. programmer 22. IMD 16 determines whether one or more exit conditions that are associated with the current state are satisfied (74). The one or more exit conditions associated with the current state may be specified by the programmable state parameters that are received from an external device (e.g., programmer 22). If at least one of the exit conditions is satisfied, IMD 16 may proceed to process box 76. If no exit conditions are satisfied, then IMD 16 may repeat decision box 74 until one of the exit conditions is satisfied) [Carlson, para.0136-0137, Fig.6].
Re Claim 2. Carlson in view of Park and Bluetooth5.0 discloses the method of claim 1, wherein the first communications protocol comprises a remote interface specification protocol (i.e. programmer 22 may communicate with IMD 16 and another programmer via remote telemetry techniques) [Carlson, para.0070].
Re Claim 3. Carlson in view of Park and Bluetooth5.0 discloses the method of claim 1, wherein the second communications protocol comprises a service component architecture (SCA) protocol (i.e. the user interfaces described in this disclosure may support one or more of the following features: ability to drag and drop states from a pre-defined "toolbox" of common states; ability to customize the icons and images associated with states; ability to customize a state using a "state-builder;" ability to draw custom states and draw links between states; ability to define the conditions (e.g., from a variety of sources such as sensors, timers, etc.) that cause a state transition; ability to configure the actions that occur when a state is entered (stimulation changes); ability to save and recall templates and previously created algorithms; ability to create a table report of the created algorithm states and transitions; and ability to allow a user to follow a wizard-like user-interface to facilitate algorithm development) [Carlson, para.0252].
Re Claim 4. Carlson in view of Park and Bluetooth5.0 discloses the method of claim 1, Park further discloses: wherein the communications threat control comprises a challenge-response authentication process [Park, p.10, Table 1, line 2, “CR with shared secret”, where CR is an acronym for challenge-response, as indicated in the footnote].
The same motivation to combine with Park, as in claim 1 above, applies.
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Carlson in view of Park and Bluetooth 5.0, as applied to claim 1, further in view of Rasmussen et al “Proximity-based Access Control for Implantable Medical Devices”, in Proceedings of the 16th ACM Conference on Computer and Communications Security CCS09, November 9-13, 2009, provided in Applicant’s IDS.
Re Claim 5. Carlson in view of Park and Bluetooth5.0 discloses the method as in claim 4, Carlson in view of Park does not explicitly disclose whereas Rasmussen does: wherein the challenge-response authentication process comprises: picking a random number; the random number to a receiver; transforming the random number according to an algorithm known to a transmitting entity and a receiving entity; cryptographically securely processing the transformed number and creating a receiver processed number and a transmitter processed number; checking that the receiver processed number and the transmitter processed number are equal [Rasmussen, p.3, Fig.1, section 3.1].
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify Carlson-Park-Bluetooth5.0 with Rasmussen because Park states that his proposed session key generation is similar to Rasmussen’s: the session key between IMD and programmer is generated based on the Diffie-Hellman key exchange in [6] [Park, p.10, col.1, where the reference [6] cited in Park is Rasmussen].
Re Claim 6. Carlson in view of Park and Bluetooth5.0 and Rasmussen discloses the method of claim 5, Rasmussen further discloses: wherein the cryptographically secure processing comprises hashing (i.e. The modification to the protocol would then be to replace the MAC function with a regular hash function) [Rasmussen, p.5, col.2, section 4.2].
The same motivation to combine Carlson-Park-Bluetooth5.0 with Rasmussen, as in claim 5 above, applies.
Re Claim 7. Carlson in view of Park and Bluetooth5.0 and Rasmussen discloses the method of claim 5, Rasmussen further discloses: wherein the cryptographically secure processing comprises encryption (i.e. in order to let the device know that a key was successfully established, the prover sends a final message to the verifier containing a message authentication code (MAC) of the two nonces Np and Nv) [Rasmussen, p.3, col.2, section 3.1].
The same motivation to combine Carlson-Park-Bluetooth5.0 with Rasmussen, as in claim 5 above, applies.
Prior art made of record however not relied upon includes:
Holden et al (US Pub.No.2016/0036949) describes various communication techniques for communication between a mobile computing device and an accessory. An accessory protocol that is generic to the mobile computing device can be used for some communication. An application executing at the mobile computing device can communicate with the accessory using an application communication protocol. In some embodiments, the application communication protocol can be different from the accessory communication protocol.
Conclusion
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/NOURA ZOUBAIR/Primary Examiner, Art Unit 2434
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