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 .
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.
Claims 1-3, 5, 6, 8, 9 and 10-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Holbrook et al (U.S. Patent Application Publication Number: US 2020/0030618 A1, hereinafter “Holbrook”- APPLICANT CITED).
Regarding claim 1, Holbrook teaches a patient device (i.e. patient personal device e.g. 18 Fig. 6, 7) for a leadless pacemaker (e.g. Fig. 4, [0082], [0096], [0099]) communication system (e.g. Fig. 7), wherein the patient device is configured to receive and transmit data from and to a service device (e.g. 170A Fig. 7, [0073]: remote computer (e.g., a device located with a clinician)) as well as from and to a leadless pacemaker, wherein the patient device comprises:
a first controlling device (i.e. device within the network 162 Fig.7, e.g. [0135]-[0140], [0123]: the patient personal device 18 comprises circuitry and instructions for bidirectional wireless communication with the remote computing device) for controlling communication from and to a service device (i.e. remote computing device e.g. 170A Fig.7) ;
a second controlling device (i.e. computing circuitry 136 Fig. 6 and a read-only memory (ROM) comprising code to be executed on the computing circuitry of the patient personal device e.g. [0123], Note: as claimed in claim 8 and the originally filed specifications) for controlling communication from and to a leadless pacemaker;
wherein the second controlling device is immutable (because of the ROM and processing circuitry, the second controlling device cannot be updated or changed and is thus immutable).
Regarding claim 2, Holbrook teaches the first controlling device is updateable (e.g. [0123]: Holbrook teaches that the patient personal device 18 also comprises memory (RAM) and is configured to obtain data from the remote computer and is therefore updateable).
Regarding claim 3, Holbrook teaches the patient device comprises a first communication transceiver controlled by the first controlling device and serving for receiving and transmitting data from and to a service device in a wireless manner (i.e. device within the network 162 Fig.7, e.g. [0135]-[0140], [0123]: the patient personal device 18 comprises circuitry and instructions for bidirectional wireless communication with the remote computing device).
Regarding claim 5 and 6, Holbrook teaches that the they teach that the patient device comprises an interface between the first controlling device and the second controlling device, wherein the interface only allows a data exchange between the first controlling device and the second controlling device that is limited by an intentionally limited data comprehensibility of the second controlling device and the second controlling device is configured such that it does not allow sending a request to a leadless pacemaker to disable a write protection mechanism of the leadless pacemaker (e.g. [0123],[0124]: the second controlling device is a read only memory that comprises program instructions that, when executed by processing circuitry cause patient personal device 18 to perform the functions ascribed to patient personal device such as transmitting a patient request to processing circuitry 102 of IMD 10 and/or a remote computer, or receiving data from IMD 10 and/or the remote computer and that the patient personal device 18 partitions the virtual and/or physical address space provided by memory 138 into user space 150, allocated for running user processes, and kernel space 152, which is protected and generally inaccessible by user processes. Operating system kernel 152 executes in kernel space 152). Note: the claim does not recite what the interface is and since there is a partitioning of the memory as taught by Holbrook it is interpreted as an interface and the ROM does not allow sending a request to a leadless pacemaker to disable a write protection mechanism of the leadless pacemaker).
Regarding claim 8, Holbrook teaches the second controlling device comprises a computing circuitry (e.g. 136 Fig. 6) and a read-only memory comprising code to be executed on the computing circuitry (e.g. [0123])
Regarding claims 9 and 15, Holbrook teaches a leadless pacemaker communication system, and a method for enabling safe communication between a patient device and a leadless pacemaker comprising:
a service device (e.g. 170A Fig. 7, [0073]: remote computer (e.g., a device located with a clinician) may be used to interrogate IMD 10A to retrieve data) allowing a user interaction for retrieving data from a leadless pacemaker (e.g. Fig. 4, [0082], [0096], [0099]);
a patient device (i.e. patient personal device e.g. 18 Fig. 6, 7) configured to receive and transmit data from and to the service device (e.g. Fig. 7 [0135]-[0140]) as well as from and to a leadless pacemaker (e.g. [0135] Fig. 7),
in particular a patient device according to any of the preceding claims, wherein the patient device comprises:
a first controlling device (i.e. device within the network 162 Fig.7, e.g. [0135]-[0140]) for controlling communication from and to the service device (i.e. remote computing device e.g. 170A Fig.7);
a second controlling device (i.e. computing circuitry 136 Fig. 6 and a read-only memory (ROM) comprising code to be executed on the computing circuitry of the patient personal device e.g. [0123], Note: as claimed in claim 8 and the originally filed specifications) for controlling communication from and to a leadless pacemaker;
wherein the second controlling device is immutable (because of the ROM and processing circuitry, the second controlling device cannot be updated or changed and is thus immutable).
Regarding claim 10, Holbrook further teaches a leadless pacemaker operatively coupled to the patient device (e.g. Figs. 4,7, [0082], [0096], [0099]).
Regarding claim 11, Holbrook teaches the service device (e.g. 170A Fig. 7, [0073]: remote computer (e.g., a device located with a clinician) may be used to interrogate IMD 10A to retrieve data) is a service center device being remotely located from the patient device and comprising software for obtaining data from a leadless pacemaker.
Regarding claims 12 and 14, Holbrook teaches that the patient device18 is a smartphone (e.g. [0043]) and also teaches an access point device 160 that is also a smartphone (e.g. [0136]: collocated with the patient and that can access information from the IMD in response from the patient, clinician or network) and therefore they teach that the service center device (e.g. 170A Fig. 7) is configured to establish a connection to the patient device ( e.g. 18 Fig.7) with the help of the mobile device (in the patient device or via the network e.g. 162 e.g. Fig. 7 ) as an intermediate service device.
Regarding claim 13, Holbrook teaches that the service device (e.g. 0170A Fig. 7) is a mobile device being located in proximity to the patient device and comprising software for obtaining data from a leadless pacemaker (e.g. [0138]: smartphone, tablet or other smart device located with a clinician, by which the clinician may program, receive alerts from, and/or interrogate IMD 10).
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Holbrook et al (U.S. Patent Application Publication Number: US 2020/0030618 A1, hereinafter “Holbrook” - APPLICANT CITED) in view of Kothandaraman (U.S. Patent Application Publication Number: US 2015/0073498 A1, hereinafter “Kothandaraman”).
Regarding claim 4, Holbrook teaches the claimed invention as discussed above and while they teach that the patient device communicates with the leadless pacemaker to receive and transmit data and is controlled by the instructions stored in the second controlling device (i.e. ROM), they do not specifically teach that the patient device comprises a second communication transceiver that is controlled by the second controlling device and serving for receiving and transmitting data from and to a leadless pacemaker in an inductive manner.
In a similar field of endeavor, Kothandaram teaches a mobile device (e.g. 150 Fig. 3A, 3B, [0023]) that comprises a wireless transmitter for using long-range cellular telephony protocols ( e.g. [0025]) as well as a second communication transceiver (i.e. NFC magnetic inductive coupling antenna e.g. 151 Fig. 3C) for receiving and transmitting data from and to an implantable medical device in an inductive manner ( e.g. [0026]: the mobile device 150 contains NFC telemetry circuitry 153 (which comprises part of the circuitry used to operate the mobile device 150). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the patient device in the teachings of Holbrook to include a second NFC communication transceiver for receiving and transmitting data in an inductive manner as taught by Kothandaraman in order to provide the predictable results of ensuring that the system is more user friendly and secure.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Holbrook et al (U.S. Patent Application Publication Number: US 2020/0030618 A1, hereinafter “Holbrook” - APPLICANT CITED) in view of Ye et al (U.S. Patent Application Publication Number: US 2002/0161763 A1, hereinafter “Ye”).
Regarding claim 7, Holbrook teaches the claimed invention as discussed above except for the second controlling device being configured such that it assigns an attribute to any data request being provided from the first controlling device, wherein the attribute classifies the data request to which it is assigned as originating from a remote device.
Ye teaches that a computer system that sends and receives data to and from a network and monitors, evaluates, and classifies the incoming data that defines an attribute variable (e.g. [0029], [0030]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the second controlling device in the teachings of Holbrook to be configured to assign attributes to data requests and classify incoming data requests as taught by Ye in order to provide the predictable results of improve security of the system.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Rondoni et al (U.S. Patent Application Publication Number: US 2020/0086128 A1, hereinafter “Rondoni”) teaches a communication platform such as a smartphone (e.g. 0036]) that implements secure communications between a medical device and a trusted authority (TA) service provider (e.g. Abstract).
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792