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 § 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.
The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Claims 1, 3, 6, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Nardone (“Nardone”, US 20140142518, included in IDS filed 8/15/2025) in view of Blacker et al (“Blacker”, US 20150005738, included in IDS filed 8/15/2025) and in further view of Doshi et al (“Doshi”, US 20180113984, included in IDS filed 8/15/2025) and in even further view of Haller et al (“Haller”, US 20100198303).
Regarding Claim 1, Nardone teaches an implantable vascular access device comprising:
a fluid reservoir (par 2);
a self-sealing cover disposed over the reservoir (par 2);
an outlet port configured to mate with a catheter, the outlet port fluidically coupled to the fluid reservoir (par 2);
Nardone does not explicitly teach one or more sensors configured to capture physiological data; a coil configured to inductively couple with an interrogation device;
a localization unit electrically coupled to the coil, the localization unit configured to emit a localization signal in response to electrical energy received by the coil, wherein the localization signal is configured to aid identification of the device position while implanted within a patient; and a data communications processor configured to: receive physiological data from the one or more sensors; obfuscate the physiological data: and transmit the obfuscated physiological data to one or more remote computing devices.
Blackner teaches one or more sensors configured to capture physiological data (par 24-28);
wherein the localization signal is configured to aid identification of the device position while implanted within a patient (par 24-28).
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 Nardone with the data monitoring of Blacker because it allows for the automatic adjustment of a catheter if it is out of position (Blacker; par 4).
Nardone and Blackner do not explicitly teach a coil configured to inductively couple with an interrogation device; a localization unit electrically coupled to the coil, the localization unit configured to emit a localization signal in response to electrical energy received by the coil, and a data communications processor configured to: receive physiological data from the one or more sensors; obfuscate the physiological data: and transmit the obfuscated physiological data to one or more remote computing devices.
Doshi teaches obfuscate the physiological data: and transmit the obfuscated physiological data to one or more remote computing devices (par 100-105).
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 Nardone and Blackner with the encryption of Doshi because it provides privacy and security to patient data.
Nardone, Blackner, and Doshi do not explicitly teach a coil configured to inductively couple with an interrogation device; a localization unit electrically coupled to the coil, the localization unit configured to emit a localization signal in response to electrical energy received by the coil, wherein the localization signal is configured to aid identification of the device position while implanted within a patient.
Haller teaches a coil configured to inductively couple with an interrogation device (par 22-27; The interrogation device is the cochlear implant system.);
a localization unit electrically coupled to the coil, the localization unit configured to emit a localization signal in response to electrical energy received by the coil (par 22-27; The localization signal is the telemetry signal. The localization unit is the cochlear implant system.).
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 Nardone, Blackner, and Doshi with the induction coil of Haller because it allows for the transfer of energy with high efficiency.
Regarding Claim 3, Nardone, Blackner, Doshi, and Haller teach the device of claim 1.
Nardone and Blackner do not explicitly teach wherein obfuscating the physiological data comprises: encrypting the physiological data; and parsing the encrypted physiological data into component packets, wherein the component packets are individually unintelligible.
Doshi teaches wherein obfuscating the physiological data comprises: encrypting the physiological data (par 100-105);
and parsing the encrypted physiological data into component packets, wherein the component packets are individually unintelligible (par 100-105; The encrypted information is sent to a server, and therefore parsed into component packets and unintelligible since it is encrypted.).
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 Nardone and Blackner with the encryption of Doshi because it provides privacy and security to patient data.
Regarding Claim 6, Nardone, Blackner, Doshi, and Haller teach the device of claim 1.
Nardone, Blackner, and Doshi do not explicitly teach wherein the coil is an electrically conductive wire.
Haller teaches wherein the coil is an electrically conductive wire (par 63; The Examiner interprets the coil to be the wire, because the claim defines the coil as a wire.).
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 Nardone, Blackner, and Doshi with the induction coil of Haller because it allows for the transfer of energy with high efficiency.
Regarding Claim 10, Nardone, Blackner, Doshi, and Haller teach the device of claim 1.
Nardone, Blackner, and Doshi do not explicitly teach wherein the localization unit includes a radiofrequency transmitter, and the localization signal includes a radiofrequency signal.
Haller teaches wherein the localization unit includes a radiofrequency transmitter, and the localization signal includes a radiofrequency signal (par 40; par 22-27; The localization signal is the telemetry signal. The localization unit is the cochlear implant system.).
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 Nardone, Blackner, and Doshi with the induction coil of Haller because it allows for the transfer of energy with high efficiency.
Claims 2 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Nardone, Blacker, Doshi and Haller in view of Rickert et al (“Rickert”, US 20150173215).
Regarding Claim 2, Nardone, Blackner, Doshi, and Haller teach the device of claim 1.
Nardone, Blackner, Doshi, and Haller do not explicitly teach wherein the localization unit comprises a light source and wherein the localization signal comprises light emitted from the light source.
Rickert teaches wherein the localization unit comprises a light source and wherein the localization signal comprises light emitted from the light source (par 10; par 14; par 51).
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 Nardone, Blackner, Doshi, and Haller with the light or infrared communication of Rickert because a more energy-efficient and interference-free transmission at higher data rates is enabled (Rickert; par 10).
Regarding Claim 8, Nardone, Blackner, Doshi, and Haller teach the device of claim 1.
Nardone, Blackner, Doshi, and Haller do not explicitly teach wherein the localization unit includes one or more magnets, and the localization signal includes a magnetic field generated by the one or more magnets.
Rickert teaches wherein the localization unit includes one or more magnets, and the localization signal includes a magnetic field generated by the one or more magnets (par 20-23).
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 Nardone, Blackner, Doshi, and Haller with the light or infrared communication of Rickert because a more energy-efficient and interference-free transmission at higher data rates is enabled (Rickert; par 10), and because a very efficient coupling to the sender or to the sender-sided induction coil is enabled (Rickert; par 21).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Nardone, Blacker, Doshi and Haller in view of Kim et al (“Kim”, US 20180043168).
Regarding Claim 4, Nardone, Blackner, Doshi, and Haller teach the device of claim 3.
Nardone, Blackner, Doshi, and Haller do not explicitly teach wherein encrypting the physiological data includes one or more of: symmetric-key encryption or asymmetric-key encryption.
Kim teaches wherein encrypting the physiological data includes one or more of: symmetric-key encryption or asymmetric-key encryption (par 25).
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 Nardone, Blackner, Doshi, and Haller with the symmetric encryption of Kim because it provides high efficiency and speed.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Nardone, Blacker, Doshi and Haller in view of Ghovanloo et al (“Ghovanloo”, US 20080169872).
Regarding Claim 7, Nardone, Blackner, Doshi, and Haller teach the device of claim 1.
Nardone, Blackner, Doshi, and Haller do not explicitly teach wherein the coil is inductively coupled to a second coil of the interrogation device to facilitate wireless energy transmission between the coil and the interrogation device.
Ghovanloo teaches wherein the coil is inductively coupled to a second coil of the interrogation device to facilitate wireless energy transmission between the coil and the interrogation device (par 18).
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 Nardone, Blackner, Doshi, and Haller with the inductive link of Ghovanloo because it allows for the transfer of energy between devices wirelessly (Ghovanloo; par 18).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Nardone, Blacker, Doshi and Haller in view of Single et al (“Single”, US 5941905).
Regarding Claim 9, Nardone, Blackner, Doshi, and Haller teach the device of claim 1.
Nardone, Blackner, Doshi, and Haller do not explicitly teach wherein the localization unit includes a speaker configured to emit an audible sound, and the localization signal includes the audible sound emitted.
Single teaches wherein the localization unit includes a speaker configured to emit an audible sound, and the localization signal includes the audible sound emitted (Col. 2 lines 64-67; Col. 3 lines 1-7).
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 Nardone, Blackner, Doshi, and Haller with the sound emission of Single because it lets a user know if an implant is functioning properly (Single; Col. 2 lines 64-67; Col. 3 lines 1-7).
Allowable Subject Matter
Claims 11-20 are allowed.
Claim 5 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding Claim 5, the closest prior art of record Nardone (US 20140142518, included in IDS filed 8/15/2025) in view of Blacker et al (US 20150005738, included in IDS filed 8/15/2025) and in further view of Doshi et al (US 20180113984, included in IDS filed 8/15/2025) and in even further view of Haller et al (US 20100198303) does not teach an implantable vascular access device comprising: a fluid reservoir; a self-sealing cover disposed over the reservoir; an outlet port configured to mate with a catheter, the outlet port fluidically coupled to the fluid reservoir; one or more sensors configured to capture physiological data; a coil configured to inductively couple with an interrogation device; a localization unit electrically coupled to the coil, the localization unit configured to emit a localization signal in response to electrical energy received by the coil, wherein the localization signal is configured to aid identification of the device position while implanted within a patient; and a data communications processor configured to: receive physiological data from the one or more sensors; obfuscate the physiological data: and transmit the obfuscated physiological data to one or more remote computing devices; wherein obfuscating the physiological data comprises: encrypting the physiological data; and parsing the encrypted physiological data into component packets, wherein the component packets are individually unintelligible; wherein obfuscating the physiological data further comprises arranging the component packets into a data stream interspersed with filler packets containing non-physiological data, and wherein transmitting the obfuscated physiological data comprises transmitting the data stream to one or more remote computing devices wherein the filler packets have a predetermined data size; and/or wherein the filler packets are interspersed into the data stream according to a predetermined pattern.
Regarding Claims 11-17, the closest prior art of record Nardone (US 20140142518, included in IDS filed 8/15/2025) in view of Blacker et al (US 20150005738, included in IDS filed 8/15/2025) and in further view of Doshi et al (US 20180113984, included in IDS filed 8/15/2025) and in even further view of Haller et al (US 20100198303) does not teach a system for monitoring the health of a patient, the system comprising: an interrogation device; and an implantable vascular access device, including: a housing configured to be implanted within a human patient, the housing containing a reservoir; a septum adjacent the reservoir and configured to receive a needle therethrough for delivery of a fluid to the reservoir; a sensing element coupled to the housing and configured to obtain physiological measurements; a coil composed of an electrically conductive wire; and a localization unit electrically coupled to the coil, the localization unit configured to emit a localization signal in response to electrical energy received by the coil, wherein the localization signal is configured to aid identification of the device position while implanted within a patient at least one controller configured to be communicatively coupled to the sensing element, wherein the at least one controller is further configured to: obtain the physiological measurements via the sensing element while the housing is implanted within the patient; determine at least one physiological parameter based on the physiological measurements; compare the at least one physiological parameter to a predetermined threshold; and based on the comparison, provide an indication of the patient's health.
Regarding Claims 18-20, the closest prior art of record Nardone (US 20140142518, included in IDS filed 8/15/2025) in view of Blacker et al (US 20150005738, included in IDS filed 8/15/2025) and in further view of Doshi et al (US 20180113984, included in IDS filed 8/15/2025) and in even further view of Haller et al (US 20100198303) does not teach a method for monitoring the health of a patient, the method comprising: obtaining physiological measurements of the patient via a sensing element coupled to a vascular access device while the vascular access device is implanted within the patient, the vascular access device further including a housing containing a reservoir, a septum adjacent the reservoir, a sensing element coupled to the housing and configured to obtain physiological measurements, a coil configured to inductively couple with an interrogation device, a localization unit electrically coupled to the coil, the localization unit configured to emit a localization signal in response to electrical energy received by the coil, wherein the localization signal is configured to aid identification of the device position while implanted within a patient; determining at least one physiological parameter based on the physiological measurements; comparing the at least one physiological parameter to a predetermined threshold; and based on the comparison, providing an indication of the patient's health.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Pesach et al (US 20100286467, included in IDS filed 8/15/2025), Abstract - Embodiments of the present invention are directed to systems, apparatuses, devices and methods for improving, modifying and/or stabilizing pharmacokinetic and/or pharmacodynamic profile of a drug infused into the tissue by a catheter and absorbed into the blood or lymphatic system. In some embodiments, infusion sets provide fluid and electrical connection between a catheter assembly/treatment element and at least one of a fluid source and a second source.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAQIUL AMIN CHOUDHURY whose telephone number is (571)272-2482. The examiner can normally be reached Monday-Friday 7:30 AM - 5:30 PM.
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/RAQIUL A CHOUDHURY/Examiner, Art Unit 2444
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