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 .
Terminal Disclaimer
The terminal disclaimer filed on 1/28/26 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent 10376146 and US Patent 11510573 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Objections
Claim 33 is objected to because of the following informalities: there is a missing period at the end. Appropriate correction is required.
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 15, 19, 21-23, 29, and 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over “Pendo” (US 7,323,142) in view of “Colvin” (US 6,304,766).
Regarding claims 15 and 29, Pendo teaches an implantable device (“embodiments of the present invention to be implanted into a human body for extended periods of time,” col. 5, lines 25-27) comprising:
a communication system (e.g., 14; “once the signals have been digitized by the electronics…they may be sent to other devices for operation or other processing,” col. 4, lines 59-61);
a sensor (e.g., 12; col. 4, lines 32-39); and
a monolithic substrate (16) comprising an integrated sensor circuit configured to process input from the sensor into a form conveyable by a communication system (“the electronics may take the form of an integrated circuit (IC), such as, for example, an ASIC, a microcontroller, or a microprocessor,” col. 9, lines 5-8; “analog signals received from the sensing element on the sensing element side 12 of the substrate 16 may be digitized by the ASIC on the electronics side 14 of the substrate 16…once the signals have been digitized by the electronics…they may be sent to other devices for operation or other processing,” col. 4, lines 49-61), and a power supply (“a capacitor may be used in connection with the IC. The capacitor may serve as a power supply, ”col. 11, lines 45-46), wherein:
the communication system is located on a first face of the monolithic substrate and the sensor is located on a second face of the monolithic substrate, the first face being on an opposite side of the monolithic substrate from the second face [col. 4, l. 32 to col. 5, l.50; sensors 12 on one face and electronics 14 on the opposite face and vias passing between them];
the sensor comprises a functionalized layer integrated into the monolithic substrate wherein the functionalized layer comprises a hydroqel or polymer matrix having an enzyme catalyst incorporated therein [col. 4, ll. 40-44: “the sensing element may be a glucose sensor utilizing a glucose oxidase enzyme as a catalyst”; col.13, ll.31-52: “the surface … may be coated … spin coated using a polymer such as hydroxyethel methacholate (HEMA) or polyhydroxyethel methacholate (PHEMA). This coating may form the basis of an electrolyte layer …” – i.e., in-situ polymer coating / curing / immobilization steps and electrode structures reads on a functionalized hydrogel/polymer sensor layer “integrated into” the substrate];
wherein the device is configured to be powered for an interval of time corresponding to a period of time when energy is available, such that the device transitions from a non-powered state to a powered state upon availability of energy and transitions from the powered state to the non-powered state upon cessation of energy availability [col. 11, ll. 45-48; use of a capacitor to hold voltage between pulses indicating intermittent powering is contemplated].
Pendo teaches all limitations of claim 15 except for an RF antenna-based power reception and RF telemetry arrangement for delivering energy from an external source to the on-substrate electronics and for transmitting processed sensor information to an external detector.
Colvin teaches a similar implantable device (“sensor 10 to be implanted into the human body,” col. 5, lines 61-62) comprising: a communication system (transmitter 42); a sensor (detector 20); and a substrate (70) comprising a power supply (power source 40) configured to receive energy from an external source (“the sensor can be powered…by an inductor coil 56 that is housed in an appropriately configured instrument (not shown) positioned near the sensor,” col. 7, lines 54-60), wherein: the communication system is located on a first face of the substrate and the sensor is located on a second face of the monolithic substrate (Fig. 1), the first face being on an opposite side of the monolithic substrate from the second face (transmitter 42 and detector 20 are on opposite sides of the substrate, Fig. 1), wherein the device is configured to be powered for an interval of time corresponding to a period of time when energy is received by the power supply, such that the device transitions from a non-powered state to a powered state upon receiving energy and transitions from the powered state to the non-powered state upon cessation of energy reception [col. 7, l. 51 to col. 8, l. 23; the device is powered when the external electromagnetic field is present and not powered when the field is absent]; and the communication system comprises an RF antenna (transmitter 42 is an inductor configured to transmit 50 MHz radio waves, col. 7, lines 51-66).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Pendo to incorporate an RF antenna as the communication system on the one side of the substrate opposite the sensor and a power supply configured to receive energy from an external source and configured to power the implantable device. Since Pendo doesn’t teach the details of how signals may be sent out (“once the signals have been digitized by the electronics…they may be sent to other devices for operation or other processing,” col. 4, lines 59-61), one would be motivated to look at known communication systems, such as the RF transmitter 42 of Colvin. One may be further motivated to use an inductor as a power source as a substitute for Pendo’s capacitor, since it was known in the art to use an externally powered inductor to power an implantable sensor (Colvin: Fig. 1). Colvin further teaches that this arrangement allows the implantable sensor to be fully self-contained without any electrical leads (“a sensor…may be wholly self-contained…no electrical leads extend into or out of the sensor body,” col. 7, par. 35-39).
Regarding claim 19, Colvin further teaches the power supply comprises a second RF antenna (power source 40 is an inductor, col. 7, lines 51-52). Colvin teaches power generating using an inductor and radio frequency is well known (“a power generating mode and a signal transmitting mode. These and other telemetry schemes will be familiar to those having skill in the art, as such techniques are used relatively commonly, e.g., … radio frequency identification,” col. 8, lines 16-23).
Regarding claims 21 and 31, Pendo teaches at least one interconnect electrically connecting the sensor to the communication system, the interconnect going through the monolithic substrate (“vias 18 are pathways through the body of the substrate that allow for electrical contact between an array of electrodes…on the sensing side 12 of the substrate 16 and electronics on the electronics side 14 of substrate 16,” col. 4, lines 65-67-col. 5, lines 1-3).
Regarding claim 22, Pendo teaches the at least one interconnect is cylindrical (e.g., Fig. 10).
Regarding claims 23 and 32, Pendo teaches the sensor is a glucose sensor (col. 4, lines 41-42).
Claims 16, 20 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Pendo and Colvin as applied to claim 15 and 29 above, and further in view of Fey (US 7,071,546).
Regarding claims 16 and 33, Pendo in view of Colvin do not explicitly teach or suggest the monolithic substrate has a height less than 200 microns. Fey teaches analogous art related to integrated circuit substrates and minimizing the size of the package (“facilitating minimization of the volume and customization of the three dimensional package size to conform to the available internal space within a housing, e.g., one used in an implantable device,” Abstract). Fey teaches a substrate can be as thin as 10 microns (col. 4, lines 55-56).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Pendo in view of Colvin such that the monolithic substrate has a height less than 200 microns. One would be motivated to do so in order to miniaturize to facilitate site delivery and implantation [generally, it is also desirable to miniaturize implantable devices], and Fey teaches existing technologies that allow an integrated sensor substrate to be as thin as 10 microns (col. 4, lines 55-56).
Regarding claim 20, Pendo in view of Colvin do not explicitly teach or suggest the monolithic substrate is a CMOS die. Fey teaches CMOS fabrication of integrated substrates (“using different fabrication techniques, different types of transistors, e.g., bipolar, CMOS, etc. can be mixed,” col. 3, lines 36-40).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Pendo in view of Colvin such that the monolithic substrate is a CMOS die as taught by Fey in order to optimally utilize associated advantages (col. 3, lines 40-41).
Claims 17-18 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Pendo in view of Colvin as applied to claims 15 and 29 above, and further in view of Zhou (US 2005/0261563).
Regarding claims 17 and 30, Pendo in view of Colvin do not explicitly teach or suggest the communication system further comprises a modulator and an output driver. Zhou teaches an analogous implantable glucose bio-sensor system (on-chip transponder 100, Fig. 1a; Abstract) using radio frequency communication system (RF transmitter 500) comprising an RF antenna (RF transmitter antenna 501). Zhou teaches the communication system further comprises a modulator (modulator 580) and an output driver (amplifiers 520 and/or 530, Fig. 4; “second transmitter amplifier 520…is configured to…generate a second amplified signal 512 having a desired power level that is preferably sufficient for reliable transmission to the remote transponder 800,” par. 66).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Pendo in view of Colvin to comprise a modulator and output driver in the communication system. Since Pendo and Colvin generally teach that data is transmitted but don’t teach the details of how signals are processed for transmission (“once the signals have been digitized by the electronics…they may be sent to other devices for operation or other processing,” Pendo col. 4, lines 59-61; transmitter 42 is an inductor configured to transmit 50 MHz radio waves, Colvin, Jr. col. 7, lines 51-66), one would be motivated to look at known communication systems, such as Zhou’s. Since this technology is well known, this modification should be within the ordinary skill in the art (“a power generating mode and a signal transmitting mode. These and other telemetry schemes will be familiar to those having skill in the art, as such techniques are used relatively commonly, e.g., … radio frequency identification,” Colvin col. 8, lines 16-23).
Regarding claim 18, Zhou further teaches the modulator comprises a control circuit (modulation control input 584 and/or message control line 708) and a pulse width modulator (“the modulator 580 impresses (i.e., modulates via pulse-code modulation) the processed data in the data signal 462 onto the radio carrier,” par. 67).
Claims 24-26 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Pendo in view of Colvin as applied to claim 15 above, and further in view of He (US 7,620,438).
Regarding claim 24, Pendo in view of Colvin teach the implantable device according to claim 15 (see rejection of claim 15 above). Pendo teaches that signals may be sent to other devices, but does not explicitly teach or suggest the structure of the other devices (“once the signals have been digitized by the electronics…they may be sent to other devices for operation or other processing,” col. 4, lines 59-61). Colvin teaches an external device comprising a power transmitter (“coil 56 generates the electromagnetic wave 54 … to induce a current in the inductor 40,” col. 8, lines 4-6) and a detector (receiver 60) that receives information from the communication system of the implantable device (“transmitter 42, as an inductor, generates an electromagnetic field 58…that can be detected by external receiver 60,” col. 7, lines 60-65).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Pendo in view of Colvin such that the implantable device receives power from and communicates with an external device comprising a power transmitter and a detector. One would be motivated to do so in order generate power in the inductor of the implantable device and to transmit information for further processing (“the sensor can be powered…by an inductor coil 56 that is housed in an appropriately configured instrument (not shown) positioned near the sensor,” Colvin, Jr. col. 7, lines 54-60; “once the signals have been digitized by the electronics…they may be sent to other devices for operation or other processing,” Pendo col. 4, lines 59-61).
Pendo and Colvin Jr. do not explicitly teach or the external device comprises a power source and a processor connected to the power transmitter and the power source, the processor configured to pulse power to the implantable device by activating the power transmitter only for an interval of time. He teaches an analogous bio-sensor system comprising a sensor (sensor unit 101 with transmitter unit 102) and an external device (receiver unit 104, Fig. 3) that have bi-directional RF communication (col. 3, lines 29-30) and are inductively coupled (col. 8, lines 13-15). The external device comprises a power source (301), a power transmitter (magnetic field radiator section 307), and a processor (timer unit 313; “the second section of receiver 104 is a data processing section,” col. 3, line 39) connected to the power transmitter and the power source (Fig. 3), the processor configured to pulse power to the implantable device by activating the power transmitter only for an interval of time (“timer unit 313 is operatively coupled to the power source 301…and may be configured to control power supply in the magnetic field generator unit 300,” col. 6, lines 58-63; “timer unit 313 may be programmed to a time period…such that magnetic field generator unit 300 is configured to be turned on continuously when the RF signals are received by the RF receiver antenna,” col. 8, lines 5-8; various components of receiver 104 can receive data, are programmable, and control activity in the receiver unit and can be interpreted as a processor), and a detector (RF receiver antenna 308).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Pendo in view of Colvin to comprise a power source and processor in the external device. Since Colvin teaches that an external device generates power in the implanted device (“coil 56 generates the electromagnetic wave 54 … to induce a current in the inductor 40,” col. 8, lines 4-6) but doesn’t teach the details of the external device, one would be motivated to look at known external devices for powering an implant, such as He’s. Since this technology is well known, this modification should be within the ordinary skill in the art (“a power generating mode and a signal transmitting mode. These and other telemetry schemes will be familiar to those having skill in the art, as such techniques are used relatively commonly, e.g., … radio frequency identification,” Colvin, Jr. col. 8, lines 16-23).
Regarding claim 25, He teaches a communication link to transmit information from the implantable device (link between receiver unit 104 and data processing terminal 105, Fig. 1; data processing terminal may be further connected to a data network, col. 3, lines 61-64) and operably linked to the detector either directly or through the processor (receiver unit 104 and data processing terminal 105 can be wired or wirelessly connected, col. 3, line 60-61).
Regarding claim 26, He teaches a display operably connected to the processor (“data processing terminal 105…incorporate the functions of the receiver 104 including data processing,” col. 4, lines 22-25; data processing terminal 105 may be a laptop or PDA, which comprise displays, col. 3, lines 56-58).
Regarding claim 28, He teaches the external device is a consumer electronics device (“receiver unit 104 may be integrated with an infusion device,” col. 4, line 4; or receiver unit 104 and data processing terminal 105 may be combined, col. 4, lines 22-25, and data processing terminal can include laptops or PDAs, col. 3, lines 56-58).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Pendo in view of Colvin and He as applied to claim 24 above, and further in view of Rabinovitz (WO 2013/018094).
Regarding claim 27, Pendo in view of Colvin and He do not teach or suggest a detector array that receives information from the communication system of the implantable device. Rabinovitz teaches a sensing capsule (100) that is placed in the body and communicates with an external receiver (receiver 21, Fig. 5). Rabinovitz teaches the receiver can include an antenna array to improve signal reception and allow localization of the in vivo device 100 (par. 98). Although Rabinovitz teaches a swallowable capsule (“a device according to some embodiments may be a capsule,” par. 56), the teachings related to wireless communication between a device in the body and an external device are relevant and analogous to the implanted devices of Pendo in view of Colvin and He.
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Pendo in view of Colvin and He to have a detector array. One would be motivated to do so because Rabinovitz teaches this improves signal reception and allows localization of the in vivo sensing device (par. 98). Although Rabinovitz teaches a swallowable capsule (pars. 56, 58), the teachings may be used to improve Pendo in view of Colvin and He in the same way. Rabinovitz teaches communication is done via radio waves (par. 100), which further indicates that this modification could be applied to the combination of Pendo in view of Colvin and He.
Response to Arguments
Applicant’s submissions of amended Abstract and Specification have been considered and previous objections are withdrawn.
Applicant's arguments filed 1/28/26 have been fully considered but they are not persuasive.
Regarding Applicant’s argument about “integrated into the substrate”, Examiner submits the following. Pendo discloses the key elements that the claims require: (a) a glucose enzyme-based sensing element [col. 4, ll.40-44]; and (b) polymer/hydrogel coating processes and materials used as functional layers on the sensing side [col.13, l.31+: “the surface of the board that has been electroplated may be coated… spin coated using a polymer such as hydroxyethel methacholate (HEMA) or polyhydroxyethel methacholate (PHEMA). This coating may form the basis of an electrolyte layer …”]. Pendo describes preparing polymer coatings, adding buffer drops, and treating the polymer surface — all consistent with forming a sensor functional layer based on a hydrogel or similar polymer matrix on the sensing face. Pendo also explicitly links the substrate-side electrode to enzyme-based electrochemical sensing [col. 4, l.63+: via arrangement corresponding to working/counter/reference electrodes interacting with an enzyme catalyst]. Taken together, these disclosures support the position that Pendo teaches a polymer/hydrogel-based sensor layer applied to the sensing face and the use of glucose oxidase for glucose sensing — i.e., an enzyme-loaded polymer functional layer used in the sensing assembly.
Furthermore, the claim limitation “functionalized layer integrated into the monolithic substrate” is reasonably read to cover a polymer/hydrogel layer formed on or as part of the substrate surface during fabrication [e.g., spin-coated and cured so the polymer layer becomes part of the completed substrate assembly]. This is consistent with Applicant’s own specification definition that components are “monolithically integrated and therefore such components are not adhered and/or secured via mechanical means” which does not exclude polymer layers that are formed in situ to produce a permanent, integral layer on the substrate that is not mechanically adhered.
Regarding Applicant’s argument about “interval based powering”, Examiner submits the following. The claimed language is functional and broad – it encompasses devices that are powered during a period when energy is received and unpowered otherwise. This is ordinary consequence of providing a remote-excitation [i.e., inductive or RF] power receiver or antenna: when the external power field is present the receiver produces power [device transitions to powered state]; when the external field ceases the receiver no longer provides power [device transitions to non-powered state]. Colvin explicitly teaches powering an implantable device by operation of an external field [col. 2, l.35+: “a power source, e.g. an inductor, which powers the source of radiation using external means”; col.7, l.51+: describing coil 56, induction, and switching between power and telemetry modes]. Thus, Colvin directly teaches the claimed concept that the device is powered during the time energy is provided from the external field and that it is unpowered when the field is absent
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tse Chen whose telephone number is (571)272-3672. The examiner can normally be reached M-F 7-3 EST.
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/TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791