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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/23/2025 has been entered.
Response to Arguments
Applicant’s arguments filed 6/23/2025 with respect to the rejection of Independent Claim 1 under 35 USC 102 as anticipated by US 2014/0180365 A1 have been fully considered and are persuasive. The Examiner agrees that Perryman does not disclose “and to couple a signal inside the body tissue and make use of a signal path between the patches and through the surrounding tissue, to thereby make use of the conductivity of the body tissue” as recited by amended Claim 1. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Okamoto, E., Kato, Y., Seino, K. et al. Interface of data transmission for a transcutaneous communication system using the human body as transmission medium. J Artif Organs 15, 99–103 (2012).
The Examiner respectfully notes that the predominance of Applicant’s arguments pertain to a passive backscatter communication which is not reflected in the claims. Were such passive backscatter communication to be required, the Examiner’s position regarding many of Applicant’s arguments would merit reconsideration.
Applicant’s arguments that “Perryman is incompatible with the required claim 1 features” are otherwise not persuasive. Applicant argues that “Applicant's claimed invention relates to a wireless backscatter communication system, optimized for deep tissue implants, and explicitly excludes energy harvesting during communication.” However, Claim 1 contains no such limitation. Such backscatter as Applicant highlights is recited at Claim 16, for which the Examiner has cited Applicant Admitted Prior Art WO 2018/011235 A1 to Khaleghi et al.
Applicant argues on Pg. 8 of Applicant’s Remarks that “Nothing in Perryman, neither the claims nor the embodiments, discloses any functionality related to data encoding, implant-originated signal modulation, bidirectional links, or signal reception. Perryman is concerned solely with delivering power.” This argument is not persuasive. Claim 1 expressly recites “providing power to the on-body antenna apparatus and/or for handling communications.” As Perryman’s antenna provides power, Perryman reads on Claim 1.
Applicant’s arguments regarding dependent Claims 7, 12, 16-19, 23 and 24 are based solely on Applicant’s arguments regarding Claim 1. Applicant’s arguments regarding dependent Claims 2-6, 8-11, 13-15, and 20-22 are based in part on Applicant’s arguments regarding Claim 1. Applicant’s arguments have been fully considered and are persuasive for the same reasons as explained above with respect to Claim 1. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Okamoto, E., Kato, Y., Seino, K. et al. Interface of data transmission for a transcutaneous communication system using the human body as transmission medium. J Artif Organs 15, 99–103 (2012).
Applicant’s arguments on Pg. 9-10 of Applicant’s Remarks regarding the rejection of Independent Claims 2 and 3 under 35 U.S.C. 103 as being unpatentable over Perryman in view of US 2016/0190698 A1 to Andresen et al. (“Andresen”) have been fully considered but are not persuasive. Applicant argues that “Andresen' s design does not disclose or suggest any antenna system where two patches form a circuit through the body via biological coupling.” However, neither Claims 2 or 3 recite such a narrow requirement.
Applicant’s arguments on Pg. 10-11 of Applicant’s Remarks regarding the rejection of Claims 4-6 and 8 under 35 U.S.C. 103 as being unpatentable over Perryman in view of U.S. Patent Publication No. 2009/0248112 to Mumbru ("Mumbru"). Applicant argues that “Applicant's claims require a non-resonant, dual-patch on-body antenna configuration that lacks a ground plane, and is structured to form a capacitive path through the conductive body medium-not free-space or dielectric-based radiation.” However, none of Claims 4-6 or 8 contain such a limitation.
Applicant’s arguments on Pg. 11-12 of Applicant’s Remarks regarding the rejection of Claim 9 under 35 USC 103 as being unpatentable over Perryman in view of U.S. Patent Publication No. 2014/0031837 to Perryman (“Perryman ‘837”) have been fully considered and are persuasive. Applicant argues that Perryman ‘837’s spacing is between coupling contacts rather than antenna patches, and thus does not reasonably teach such inter-patch spacing as claimed. The Examiner agrees. Therefore, the rejection is withdrawn. However, upon further search and consideration, new grounds of rejection is made in view of Okamoto, E., Kato, Y., Seino, K. et al. Interface of data transmission for a transcutaneous communication system using the human body as transmission medium. J Artif Organs 15, 99–103 (2012).
Applicant’s arguments on Pg. 12-13 of Applicant’s Remarks regarding the rejection of Claims 10 and 22 under 35 U.S.C. 103 as being unpatentable over Perryman in view of US 2009/0004982 A1 to Kim et al. (“Kim ‘982”) have been fully considered but are not persuasive. Applicant argues that “In our invention ‘we use for polarization mismatch control with the implant and also reduce mutual coupling for efficient backscatter self interference control,’” and that “[t]hus, Kim '982 does not teach or suggest the L-shaped radiative antenna structure required in Applicant's claim 10.” The Examiner respectfully disagrees. Such polarization mismatch control is not recited by Claim 10, nor is backscatter.
Applicant’s arguments on Pg. 13-14 of Applicant’s Remarks regarding the rejection of Claims 13 and 14 under 35 USC 103 as unpatentable over Perryman in view of US 2006/0173265 A1 to Kim (“Kim '265”) have been fully considered but are not persuasive. Applicant’s arguments pertain to features that are not recited in the claims. Additionally, the features highlighted by Applicant are unrelated to the structure (i.e., “ten or more pairs,” “each pair being spaced apart”) or selection features recited by Claims 13 and 14.
Applicant’s arguments on Pg. 14-15 of Applicant’s Remarks regarding the rejection of Claim 11 under 35 USC as unpatentable over US 2020/0091608 to Alpman (“Alpman”) have been fully considered but are not persuasive. Applicant argues that “[t]he use of different polarization angles in Alpman serves a distinct purpose-beamforming and stream multiplexing-which is not applicable to the low-frequency, near-field backscatter communication context of the claimed invention.” However, “low-frequency, near-field backscatter communication” is not recited by the claims, which are far broader.
Applicant’s arguments on Pg. 15-16 of Applicant’s Remarks regarding the rejection of Claims 20-21 under 35 U.S.C. §103 as being unpatentable over Perryman in view of US 2007/0288066 A1 to Christman (“Christman”) have been fully considered but are not persuasive. Applicant argues that “the Christman reference, even when combined with Perryman, fails to teach or suggest the claimed features involving passive sensor-derived data transmission via a body-coupled, backscatter-based communication system.” However, such “passive sensor-derived data transmission via a body-coupled, backscatter-based communication system” is not required by the claims. Applicant’s arguments are thus not persuasive.
Applicant’s arguments regarding the rejection of Claim 3 under 35 USC 112(b) have been fully considered and are persuasive. The Examiner agrees that Applicant’s amendments have resolved the cited antecedent basis issues. Accordingly, the rejection has been withdrawn.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 1, and Claims 2-24 by dependency, are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding Independent Claim 1, Claim 1 recites “wherein the on-body antenna apparatus comprises a pair of patch antennas arranged to be placed on the surface of the body spaced apart from one another and to couple a signal inside the body tissue and make use of a signal path between the patches and through the surrounding tissue, to thereby make use of the conductivity of the body tissue to form an antenna circuit that is coupled by the body tissue around and between the patch antennas.” This limitation appears to require that the pair of antennae actually be arranged to form an antenna circuit that is coupled by the body tissue. The configuration must include body tissue: a configuration that did not include body tissue would not read on Claim 1. Claim 1 thus impermissibly encompasses a human organism.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5, 8 and 9, and Claim 6 by dependency, 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
Claim 5 recites the broad recitation “in the range 50 MHz to 1400MHz,” and the claim also recites “optionally in the range 100 MHz to 800 MHz” which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 8 recites the broad recitation “in the range 5 mm to 100 mm,” and the claim also recites “optionally 10 mm to 50mm” which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 9 recites the broad recitation “in the range 5 mm to 60 mm,” and the claim also recites “optionally 10 mm to 40 mm” which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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, 9, 12 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2014/0180365 A1 to Perryman et al. (“Perryman”) in view of Okamoto, E., Kato, Y., Seino, K. et al. Interface of data transmission for a transcutaneous communication system using the human body as transmission medium. J Artif Organs 15, 99–103 (2012) (“Okamoto”).
Regarding Independent Claim 1, Perryman discloses:
A system for wireless transmission of data and/or power using an on-body antenna apparatus and an implant device inside the body, the system comprising: (Abstract, “A wearable device for facilitating neurophysiological treatment of a patient harboring an implanted neural stimulator is provided. The wearable device includes a transmitting antenna configured to accept one or more input signals and to transmit one or more electromagnetic signals to a neural stimulator that is implanted in a patient's body.”);
the implant device, which is for use within the body and comprises an implant antenna arranged to receive wirelessly transmitted power and/or to wirelessly transmit data; (Para. [0069], “The microwave field stimulator is connected to the embedded transmitting antenna, which transmits a radio frequency (RF) signal to an implanted receiving antenna within the tissue of the patient, on the skin of the patient, or within an article of clothing close to the body of the patient.”);
the on-body antenna apparatus, which is arranged to transmit power and/or data acting as a radiative antenna at radio frequencies, wherein the on-body antenna apparatus comprises a pair of patch antennas arranged to be placed on the surface of the body spaced apart from one another and to … form an antenna circuit that is coupled by the body tissue around and between the patch antennas; and (Para. [0108], “FIG. 19 illustrates a semi-cylindrical array of antennas that are used to transmit power to the implant. The semi-cylindrical antenna array is comprised of smaller patch antennas that act as a single antenna to transmit RF energy to an implanted lead. The smaller antennas are arranged to direct or steer the energy directly to the implant. The smaller antennas have small space between them to improve the flexibility of the WAA and conformity of the antennas to the body. Each antenna is moldable and would conform to the back and body of the user;” Para. [0119]; Paras. [0084] through [0085] and [0112] through [0114]);
an antenna control system for providing power to the on-body antenna apparatus and/or for handling communications between the on-body antenna apparatus and the implant antenna, wherein the antenna control system is arranged to drive the on-body antenna apparatus. (Para. [0072], “The structural wearable antenna assembly holds the battery, embedded control panel, embedded microwave field stimulator, and the embedded transmitting antenna;” Para. [0079], “A control panel may include button-switches to control neurostimulation settings, and a sliding switch that chooses the setting that is being controlled by the switches;” Paras. [0080] through [0083]).
Perryman does not disclose:
couple a signal inside the body tissue and make use of a signal path between the patches and through the surrounding tissue, to thereby make use of the conductivity of the body tissue to
Okamoto describes “Interface of data transmission for a transcutaneous communication system using the human body as transmission medium” (Title). Okamoto is analogous art.
Okamoto teaches:
couple a signal inside the body tissue and make use of a signal path between the patches and through the surrounding tissue, to thereby make use of the conductivity of the body tissue (Abstract, “We have been developing a new transcutaneous communication system (TCS) that uses the human body as an electrical conductive medium. We studied an interface circuit of the TCS in order to optimize the leading data current into the human body effectively.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Perryman with the teachings of Okamoto (i.e., to modify the device of Perryman such that it uses a human body as a transmission conductor in the manner of Okamoto) in order to facilitate “stable communication between an implanted artificial organ and external monitor outside the body” (Okamoto at Pg. 102, Left Column, Fifth Paragraph).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2014/0180365 A1 to Perryman et al. (“Perryman”) in view of Okamoto, E., Kato, Y., Seino, K. et al. Interface of data transmission for a transcutaneous communication system using the human body as transmission medium. J Artif Organs 15, 99–103 (2012) (“Okamoto”) as applied to Claim 1 above in view of US 2014/0031837 A1 to Perryman et al. (“Perryman ‘837”).
Regarding Claim 9, the combination of Perryman and Okamoto renders obvious the entirety of Claim renders obvious the entirety of Claim 1 as explained above.
The combination of Perryman and Okamoto does not disclose:
wherein the patch antennas are arranged to be placed with a spacing between the patch antennas in the range 5 mm to 60 mm, optionally 10 mm to 40 mm
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Perryman and Okamoto such that the size of the space between patch antennas is in the range 5 mm to 60 mm because such a modification entails a mere change in size, which is a common practice which the court has held normally requires only ordinary skill in the art and hence is considered a routine expedient. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955); MPEP 2144.04(IV)(A)
Regarding Claim 12, the combination of Perryman and Okamoto renders obvious the entirety of Claim renders obvious the entirety of Claim 1 as explained above.
Perryman additionally discloses:
wherein the on-body antenna apparatus comprises a multiple pairs of patches forming an array (Para. [0108], “FIG. 19 illustrates a semi-cylindrical array of antennas that are used to transmit power to the implant. The semi-cylindrical antenna array is comprised of smaller patch antennas that act as a single antenna to transmit RF energy to an implanted lead.”).
Regarding Claim 23, the combination of Perryman and Okamoto renders obvious the entirety of Claim renders obvious the entirety of Claim 1 as explained above.
Perryman additionally discloses:
A method including use of the system of claim 1 for wireless transmission of data and/or power between the on-body antenna apparatus and the implant device. (Para. [0003], “A wearable device for facilitating neurophysiological treatment of a patient harboring an implanted neural stimulator is provided.”).
Use of Perryman’s device as described at Para. [0003] results in performance of such a method as claimed.
Regarding Claim 24, the combination of Perryman and Okamoto renders obvious the entirety of Claim renders obvious the entirety of Claim 23 as explained above.
Perryman additionally discloses:
comprising using the implant device to gather medical information at one or more locations within the patient's body, and then transmitting this information out of the body via the wireless communications between the implant device and the on-body antenna apparatus. (Para. [0104], “The conductive fabric is then used transmit an RF signal directly to the implant at various locations on the body where fabric is found, including but not limited to: lumbar, thorax, stomach, chest, shoulder, arm, forearm, leg, foot, hand, neck, buttocks, etc.;” Para. [0116], “FIG. 27 is an example circuit that can be used to inform the user that RF energy is being transmitted. An indicator light is build into the control panel of the belt. This indicator light illuminates when the belt is transmitting energy to the implant. This indicator light is independent from the “power on” indicator. If the microwave field stimulator is not able to transmit power to the transmitting antenna, the indicator light will not illuminate. This indicator light will remain illuminated as long as RF energy is transmitted out of the embedded antenna.”)
Perryman’s implant transmits information regarding whether it is receiving appropriate signals to perform neurostimulation. If no such signals are being received, Perryman’s device does not perform neurostimulation. Whether neurostimulation is being performed is such “medical information” as claimed when the term is afforded its broadest reasonable interpretation.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over 35 U.S.C. 103 as being unpatentable over previously cited US 2014/0180365 A1 to Perryman et al. (“Perryman”) in view of Okamoto, E., Kato, Y., Seino, K. et al. Interface of data transmission for a transcutaneous communication system using the human body as transmission medium. J Artif Organs 15, 99–103 (2012) (“Okamoto”) as applied to Claim 1 above in view of US 2016/0190698 A1 to Andresen et al. (“Andresen”).
Regarding Claim 2, the combination of Perryman and Okamoto renders obvious the entirety of Claim renders obvious the entirety of Claim 1 as explained above.
The combination of Perryman and Okamoto does not disclose:
wherein the on- body antenna apparatus is arranged to couple RF energy to a conductive human body medium using a gap capacitance, and hence is arranged to be placed on the surface of the body with a gap between the patch antennas and the surface of the body.
Andresen describes a “Patch antenna assembly” (Title). Andresen is analogous art.
Andresen teaches:
wherein the on- body antenna apparatus is arranged to couple RF energy to a conductive human body medium using a gap capacitance, and hence is arranged to be placed on the surface of the body with a gap between the patch antennas and the surface of the body (Para. [0006], “The patch antenna assembly may be configured such that the reflection ratio of at least 10 dB is maintained with an air gap and without gel coupling between the signal metal layer and the subject's skin. The capacitance adjustment pad may be configured to adjust the resonant frequency of the patch antenna assembly to be matched at the resonant frequency of the RF signal generator;” Para. [0027], “Particularly, the patch antenna can operate with an air gap between a top surface of the patch antenna assembly and the subject's skin.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Perryman with the teachings of Andresen (i.e., to modify the device of Perryman such that it is couplable via gap capacitance as taught by Andresen) in order to allow the device to operate in the absence of direct contact with the subject’s skin (Andresen at Para. [0027]).
Regarding Claim 3, the combination of Perryman, Okamoto and Andresen renders obvious the entirety of Claim renders obvious the entirety of Claim 2 as explained above.
Andresen additionally discloses:
wherein the gap between the body surface and the patch antennas is in the range 0.5 mm to 5 mm (Para. [0088], “The patch antenna assembly 400 may be configured such that the reflection ratio at the operating frequency of the antenna assembly is maintained when the antenna assembly is positioned between zero to 2 centimeters, or more particularly, between zero to 1 centimeter, away from the patient's skin.”).
The claimed range of “0.5 mm to 5 mm” lies inside Andresen’s disclosed range of “between zero to 1 centimeter.” “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” MPEP 2144.05(I), citing In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Although Andresen does not expressly disclose the claimed range of “0.5 mm to 5 mm,” it would have been obvious for a person of ordinary skill in the art to select the claimed range from within Andresen’s disclosed range of “between zero to 1 centimeter” because such a selection from within Andresen’s range would be likely to succeed.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Perryman with the teachings of Andresen (i.e., to modify the device of Perryman such that it is couplable via such a gap as taught by Andresen) in order to allow the device to operate in the absence of direct contact with the subject’s skin (Andresen at Para. [0027]).
Claims 4-6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2014/0180365 A1 to Perryman et al. (“Perryman”) in view of Okamoto, E., Kato, Y., Seino, K. et al. Interface of data transmission for a transcutaneous communication system using the human body as transmission medium. J Artif Organs 15, 99–103 (2012) (“Okamoto”) as applied to Claim 1 above in view of US 2009/0248112 A1 to Mumbru et al. (“Mumbru”).
Regarding Claim 4, the combination of Perryman and Okamoto renders obvious the entirety of Claim renders obvious the entirety of Claim 1 as explained above.
The combination of Perryman and Okamoto does not disclose:
wherein the on-body antenna apparatus is a broadband antenna that has an antenna bandwidth covering Medical Implant Communication Service (MICS) bands and also being appropriate for wideband/ultrawideband applications
Mumbru describes a “Wireless Implantable Medical Device” (Title). Mumbru is analogous art.
Mumbru discloses:
wherein the on-body antenna apparatus is a broadband antenna that has an antenna bandwidth covering Medical Implant Communication Service (MICS) bands and also being appropriate for wideband/ultrawideband applications (Paras. [0121] through [0122], “In some cases, the antenna integrated in the wireless implantable medical device will operate in at least one frequency band comprised in the range from approximately 300 MHz up to approximately 6 GHz, with any subinterval within that range included. Preferably, one or more of the ISM (industrial, scientific, medical) frequency bands of the radioelectric spectrum will be used. In some preferred embodiments, the wireless implantable medical device will be capable of operating at one, two, three or more of the frequency bands typically used for telemetry services, such as for instance and without limitation: Medical Implant Communication Systems (MICS) bands, like for example the 402-405 MHz band.”)
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Perryman with the teachings of Mumbru (i.e., to modify the device of Perryman to operate in the frequency bands of Mumbru) in order to conform to “frequency bands typically used for telemetry services” (Mumbru at Para. [0121]).
Regarding Claim 5, the combination of Perryman and Okamoto renders obvious the entirety of Claim renders obvious the entirety of Claim 1 as explained above.
The combination of Perryman and Okamoto does not disclose:
being arranged to operate with data and/or power transmission at frequencies in the range 50 MHz to 1400MHz, optionally in the range 100 MHz to 800 MHz
Mumbru describes a “Wireless Implantable Medical Device” (Title). Mumbru is analogous art.
Mumbru discloses:
being arranged to operate with data and/or power transmission at frequencies in the range 50 MHz to 1400MHz, optionally in the range 100 MHz to 800 MHz (Paras. [0121] through [0126], “In some cases, the antenna integrated in the wireless implantable medical device will operate in at least one frequency band comprised in the range from approximately 300 MHz up to approximately 6 GHz, with any subinterval within that range included. … In some preferred embodiments, the wireless implantable medical device will be capable of operating at one, two, three or more of the frequency bands typically used for telemetry services, such as for instance and without limitation: [(1]) Medical Implant Communication Systems (MICS) bands, like for example the 402-405 MHz band. [(2)] Wireless Medical Telemetry Services (WMTS) bands, like for example the 608-614 MHz band, the 139-1400 MHz band, or the 1427-1432 MHz band. [(3)] Industrial, Scientific, Medical (ISM) unlicensed bands, like for example the 915 MHz ISM band (902-928 MHz), 2.4 GHz ISM band (2400-2500 MHz), or 5.7 GHz ISM band (5650-5925 MHz). [(4)] Unlicensed general telemetry bands, like for example the 433.05-434.79 MHz band, or the 868-870 MHz band [(5)] VHF and UHF bands, like for example the UHF PLMRS bands from 450 to 470 MHz.”).
Mumbru’s range of “139-1400 MHz” overlaps the claimed range of “50 MHz to 1400MHz.” “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” MPEP 2144.05(I), citing In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Although Mumbru does not expressly disclose the claimed range of “50 MHz to 1400MHz,” it would have been obvious for a person of ordinary skill in the art to select the claimed range from within Mumbru’s disclosed range of “139-1400 MHz” because such a selection from within Mumbru’s range would be likely to succeed.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Perryman with the teachings of Mumbru (i.e., to modify the device of Perryman to operate in the frequency bands of Mumbru) in order to conform to “frequency bands typically used for telemetry services” (Mumbru at Para. [0121]).
Regarding Claim 6, the combination of Perryman, Okamoto and Mumbru renders obvious the entirety of Claim 5 as explained above.
Perryman does not disclose:
being configured for transmissions in a MICS band including frequencies in one or more bands known for medical implant use in the range 400 MHz-460 MHz
Mumbru further teaches:
being configured for transmissions in a MICS band including frequencies in one or more bands known for medical implant use in the range 400 MHz-460 MHz (Paras. [0121] through [0126], “In some cases, the antenna integrated in the wireless implantable medical device will operate in at least one frequency band comprised in the range from approximately 300 MHz up to approximately 6 GHz, with any subinterval within that range included. … In some preferred embodiments, the wireless implantable medical device will be capable of operating at one, two, three or more of the frequency bands typically used for telemetry services, such as for instance and without limitation: [(1]) Medical Implant Communication Systems (MICS) bands, like for example the 402-405 MHz band. [(2)] Wireless Medical Telemetry Services (WMTS) bands, like for example the 608-614 MHz band, the 139-1400 MHz band, or the 1427-1432 MHz band. [(3)] Industrial, Scientific, Medical (ISM) unlicensed bands, like for example the 915 MHz ISM band (902-928 MHz), 2.4 GHz ISM band (2400-2500 MHz), or 5.7 GHz ISM band (5650-5925 MHz). [(4)] Unlicensed general telemetry bands, like for example the 433.05-434.79 MHz band, or the 868-870 MHz band [(5)] VHF and UHF bands, like for example the UHF PLMRS bands from 450 to 470 MHz.”).
Mumbru’s ranges of “402-405 MHz” and “433.05-434.79 MHz” both overlap the claimed range of “400 MHz-460 MHz” “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” MPEP 2144.05(I), citing In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Although Mumbru does not expressly disclose the claimed range of “400 MHz-460 MHz,” it would have been obvious for a person of ordinary skill in the art to select the claimed range from within Mumbru’s disclosed ranges of “402-405 MHz” and “433.05-434.79 MHz” because such a selection from within Mumbru’s range would be likely to succeed.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of Perryman and Okamoto with the teachings of Mumbru (i.e., to modify the device of Perryman to operate in the frequency bands of Mumbru) in order to conform to “frequency bands typically used for telemetry services” (Mumbru at Para. [0121]).
Regarding Claim 8, the combination of Perryman, Okamoto and Mumbru renders obvious the entirety of Claim 5 as explained above.
Perryman additionally discloses:
wherein the on-body antenna patches have maximum dimensions in the range 5 mm to 100 mm, optionally 10 mm to 50 mm (Para. [0072], “The structural wearable antenna assembly can have a width within a range from 0.2 inch to 5.0 inches.”).
Perryman’s disclosed “.2 inch” equates to 5.08 mm, and Perrryman’s “5.0 inches” equates to 127 mm.
Perryman’s disclosed range overlaps the claimed range. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” MPEP 2144.05(I), citing In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Although Perryman does not expressly disclose “5 mm to 100 mm,” it would have been obvious for a person of ordinary skill in the art to select from Perryman’s range of 0.2 inch to 5.0 inches (i.e., 5.08 mm to 127 mm) the range of “5 mm to 100 mm” because doing so would result in a high probability of success given Perryman’s disclosure.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0180365 A1 to Perryman et al. (“Perryman”) as applied to Claim 1 above in view of previously cited Non-Patent Literature: Gary Breed, "The Fundamentals of Patch Antenna Design and Performance; "High Frequency Electronics, March 2009, Pg. 48-51 (“Breed”) as evidenced by Non-Patent Literature: Ali Ibraheem, “Intrabody Propagation Channel Investigation Using Electrically Coupled Loop Antenna;” Progress in Electromagentic Research M, Vol. 40, 57-67, 2014 (“Ibraheem”) and MAILADIL T. SEBASTIAN, "MEASUREMENT OF MICROWAVE DIELECTRIC PROPERTIES AND FACTORS AFFECTING THEM;" Dielectric Materials for Wireless Communication; Pg. 11, 2008 (“Mailadil”).
Regarding Claim 7, the combination of Perryman and Okamoto renders obvious the entirety of Claim renders obvious the entirety of Claim 1 as explained above.
The combination of Perryman and Okamoto does not disclose:
“wherein the maximum dimension of the patch antennas is less than 20% of the wavelength in free space at the intended operating frequency of the system”
Breed describes “The Fundamentals of Patch Antenna Design and Performance” (Title). Breed is thus analogous art.
Breed discloses:
“wherein the maximum dimension of the patch antennas is less than 20% of the wavelength in free space at the intended operating frequency of the system” (Pg. 48, Left Col., Last Paragraph through Right Col., First Paragraph, “…the basic configuration is shown in Figure 1, where l is then length (relative to the feedpoint) and w is the width. In the simplest configuration, l = w = λeff/2, or an electrical one-half wavelength, including the shortening effect of the dielectric constant (εr) of the material between the patch and the conducting surface (or substrate) below.”).
Ibraheem states at Pg. 59, Table 1 that the dielectric constant of skin in the MICS band is 49.85.
Mailadil states at Pg. 11, Equation (2.1) that the shortening effect of the dielectric constant referenced by Breed is equal to the wavelength in free space divided by the square root of the dielectric constant. For a dielectric constant of 49.85, this amounts to less than 20% of the wavelength in free space.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Perryman and Okamoto with the teachings of Breed (i.e., to limit a maximum dimension of the patch antennas to less than 20% of the wavelength in free space at the intended operating frequency of the system) in order to benefit from the flat profile and reduced weight of such a device as compared to other antennas (Breed at Pg. 48, First Paragraph).
Claims 10 and 22 is rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2014/0180365 A1 to Perryman et al. (“Perryman”) in view of Okamoto, E., Kato, Y., Seino, K. et al. Interface of data transmission for a transcutaneous communication system using the human body as transmission medium. J Artif Organs 15, 99–103 (2012) (“Okamoto”) as applied to Claim 1 above in view of previously cited U.S. Patent Publication No. 2009/0004982 A1 to Kim et al. (“Kim ‘982”).
Regarding Claim 10, the combination of Perryman and Okamoto renders obvious the entirety of Claim renders obvious the entirety of Claim 1 as explained above.
The combination of Perryman and Okamoto does not disclose:
wherein the patch antennas include: a first flat conductive patch, such as a rectangular patch, for placement on the body surface; and an additional flat conductive patch extending away from the first flat conductive patch such that the patch antennas have an L-shape in cross section
Kim ‘982 describes “A portable device for data communication using a body as a conductor to transmit data to a receiver…” (Abstract). Kim is thus analogous art.
Kim ‘982 discloses:
“wherein the patch antennas include: a first flat conductive patch, such as a rectangular patch, for placement on the body surface; and an additional flat conductive patch extending away from the first flat conductive patch such that the patch antennas have an L-shape in cross section” (Fig. 6(c), “transmitting electrodes 253 and 254”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Perryman and Okamoto with the teachings of Kim ‘982 (i.e., to employ in the device of Perryman such L shaped patches as taught by Kim ‘982) in order to increase contact area (Kim ‘982 at Para. [0072]).
Regarding Claim 22, the combination of Perryman and Okamoto renders obvious the entirety of Claim renders obvious the entirety of Claim 1 as explained above.
The combination of Perryman and Okamoto does not disclose:
wherein the implant device is a capsule endoscope.
Kim ‘982 describes “A portable device for data communication using a body as a conductor to transmit data to a receiver…” (Abstract). Kim is thus analogous art.
Kim ‘982 discloses:
wherein the implant device is a capsule endoscope (Para. [0052], “FIG. 3 illustrates an internal structure of a capsule type endoscope used as a sensor in accordance with an exemplary embodiment.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Perryman and Okamoto with the teachings of Kim ‘982 (i.e., to modify Perryman’s implant device for incorporation into such a capsule endoscope as taught by Kim ‘982 rather than using Perryman’s implant device in conjunction with a neurostimulation device) facilitate communication of data without use of a wire (Kim ‘892 at Para. [0004]).
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2014/0180365 A1 to Perryman et al. (“Perryman”) in view of Okamoto, E., Kato, Y., Seino, K. et al. Interface of data transmission for a transcutaneous communication system using the human body as transmission medium. J Artif Organs 15, 99–103 (2012) (“Okamoto”) as applied to Claim 1 above in view of previously cited U.S. Patent Publication No. 2006/0173265 A1 to Kim et al. (“Kim ‘265”).
Regarding Claim 13, the combination of Perryman and Okamoto renders obvious the entirety of Claim renders obvious the entirety of Claim 12 as explained above.
The combination of Perryman and Okamoto does not disclose:
wherein the array comprises ten or more pairs of patches, with each pair being spaced apart from adjacent pairs; and wherein the antenna control system is arranged to select one pair of patches within the array of pairs to use in relation to data or power communications with the implant device.
Kim ‘265 describes a “Method and apparatus for receiving data in human body communication system” (Title). Kim ‘265 is thus analogous art.
Kim ‘265 discloses:
“wherein the array comprises ten or more pairs of patches, with each pair being spaced apart from adjacent pairs” (Fig. 3, “Receiving electrode 2, … Receiving Electrode N”).
Kim ‘265 does not specifically describe “ten or more” such patches. However, Kim describes the potential to incorporate any number of such patches. It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention “ten or more” such patches because such a modification amounts to mere duplication of parts. “[M]ere duplication of parts has no patentable significance unless a new and unexpected result is produced” MPEP 2144.04(VI)(B), citing In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Perryman and Okamoto with the teachings of Kim ‘265 (i.e., to include ten or more pairs of patches) in order to facilitate determination of the devices position upon movement (Para. [0023]).
Kim ‘265 additionally discloses:
“and wherein the antenna control system is arranged to select one pair of patches within the array of pairs to use in relation to data or power communications with the implant device” (Para. [0012], “In order to achieve the above-mentioned object, a method for receiving data in a human body communication system in accordance with the present invention comprise the steps of: selecting a pair of receiving electrodes sequentially among plural receiving electrodes; processing a voltage value of the selected pair of receiving electrodes and storing it in a memory; performing a predetermined operations for values stored in the memory to select an optimum pair of receiving electrodes; and performing image processing for a value corresponding to the optimum pair of receiving electrodes among the values stored in the memory.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Perryman and Okamoto with the teachings of Kim ‘265 (i.e., to configure the antenna control system to Perryman such that it selects a pair of electrodes in the manner of Kim ‘265) in order to select an antenna pair with the best performance (Kim ‘265 at Para. [0012]).
Regarding Claim 14, the combination of Perryman, Okamoto and Kim ‘265 renders obvious the entirety of Claim 13 as explained above.
Kim ‘265 additionally discloses:
“wherein the antenna control system is arranged to conduct a searching operation by switching between the pairs to find the pair of patch antennas giving the best connection to the implant device” (Para. [0012], “In order to achieve the above-mentioned object, a method for receiving data in a human body communication system in accordance with the present invention comprise the steps of: selecting a pair of receiving electrodes sequentially among plural receiving electrodes; processing a voltage value of the selected pair of receiving electrodes and storing it in a memory; performing a predetermined operations for values stored in the memory to select an optimum pair of receiving electrodes; and performing image processing for a value corresponding to the optimum pair of receiving electrodes among the values stored in the memory.”).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2014/0180365 A1 to Perryman et al. (“Perryman”) in view of Okamoto, E., Kato, Y., Seino, K. et al. Interface of data transmission for a transcutaneous communication system using the human body as transmission medium. J Artif Organs 15, 99–103 (2012) (“Okamoto”) as applied to Claim 1 above in view of US 2020/0091608 A1 to Alpman et al. (“Alpman”).
Regarding Claim 11, the combination of Perryman and Okamoto renders obvious the entirety of Claim renders obvious the entirety of Claim 1 as explained above.
Perryman additionally discloses:
wherein the on-body antenna apparatus comprises multiple pairs of patches (Para. [0108], “FIG. 19 illustrates a semi-cylindrical array of antennas that are used to transmit power to the implant. The semi-cylindrical antenna array is comprised of smaller patch antennas that act as a single antenna to transmit RF energy to an implanted lead.”).
The combination of Perryman and Okamoto does not disclose:
with different polarisation angles.
Alpman describes “Millimeter wave (mmWave) technology, apparatuses, and methods that relate to transceivers, receivers, and antenna structures for wireless communications…” (Abstract). Alpman is analogous art.
Alpman teaches:
with different polarisation angles. (Para. [0864], “In some aspects antenna arrays may be implemented with various types of polarities, such as vertical, horizontal and circular polarizations. As an example, when antenna arrays are implemented for vertical polarity and horizontal polarity, the transmitted polarity at a given time, and therefore which antenna or array is firing at a given time, may be algorithmically controlled based on an indication of the polarity of the signal received with greatest strength at the wireless user device, hence intelligent;” (Para. [0971], “More specifically, a first transceiver can be used to process a first data stream for transmission or reception via the first phased array 6208 (using a first type of antenna polarization), and a second transceiver can be used to process a second data stream for transmission or reception via the second phased array 6222 (using a second type of antenna polarization).”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Perryman and Okamoto with the teachings of Alpman (i.e., to modify the device of Perryman such that it uses different polarization angles in its pairs of patches) in order to facilitate processing of separate data streams (Alpman at Para. [0971]).
Regarding Claim 15, the combination of Perryman, Okamoto and Alpman renders obvious the entirety of Claim 11 as explained above.
Alpman further teaches:
wherein the antenna control system is arranged to feed respective pairs of patch antennas using a dual polarization scheme. (Para. [0971], “More specifically, a first transceiver can be used to process a first data stream for transmission or reception via the first phased array 6208 (using a first type of antenna polarization), and a second transceiver can be used to process a second data stream for transmission or reception via the second phased array 6222 (using a second type of antenna polarization).”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Perryman with the teachings of Alpman (i.e., to modify the device of Perryman such that it control system uses such a dual polarization scheme as taught by Alpman) in order to facilitate processing of separate data streams (Alpman at Para. [0971]).
Claims 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2014/0180365 A1 to Perryman et al. (“Perryman”) in view of Okamoto, E., Kato, Y., Seino, K. et al. Interface of data transmission for a transcutaneous communication system using the human body as transmission medium. J Artif Organs 15, 99–103 (2012) (“Okamoto”) as applied to Claim 1 above in view of Applicant Admitted Prior Art WO 2018/011235 A1 to Khaleghi et al. (“Khaleghi”).
Regarding Claim 16, the combination of Perryman and Okamoto renders obvious the entirety of Claim renders obvious the entirety of Claim 1 as explained above.
The combination of Perryman and Okamoto does not disclose:
wherein the implant device is capable of wireless transmission of data, the implant device includes a data source for providing the data to be transmitted to the on-body antenna, and the wireless transmission of data by the implant is done using a backscatter communication technique.
Khaleghi describes a “Medical implant with wireless communication” (Title). Khaleghi is analogous art.
Khaleghi teaches:
wherein the implant device is capable of wireless transmission of data, the implant device includes a data source for providing the data to be transmitted to the on-body antenna, and the wireless transmission of data by the implant is done using a backscatter communication technique. (Pg. 2, Ln. 21-26, “Viewed from a first aspect, the invention provides an implant device for use within the body, the implant device comprising: a data source; and an antenna for backscatter communications with an external communication system; wherein the implant device is arranged to control the backscattering properties of the antenna in order to thereby transmit data from the data source to the external communications system; and wherein the antenna has a configuration for backscatter communications that comprises….”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Perryman and Okamoto with the teachings of Khaleghi (i.e., to configure Perryman’s device such that its implant includes a data source and communicates via backscattering in the manner taught by Khaleghi) in order to facilitate wireless data transmission at an adequate rate through body tissue (Khaleghi at Pg. 1, Ln. 24-26).
Regarding Claim 17, the combination of Perryman, Okamoto and Khaleghi renders obvious the entirety of Claim 16 as explained above.
Khaleghi further discloses:
wherein the implant device is arranged to control the backscattering properties of the implant antenna in order to thereby transmit data to the on-body antenna apparatus; and the backscattering properties of the implant antenna are controlled by one or more electrical switch(es) that change the load and/or geometry of the implant antenna (Pg. 5, Ln. 14-20, “Hence, viewed from a second aspect the invention provides an implant device for use within the body, the implant device comprising: a data source; and an antenna for backscatter communications with an external communication system; wherein the implant device is arranged to control the backscattering properties of the antenna in order to thereby transmit data from the data source to the external communications system; and wherein the backscattering properties of the antenna are controlled by one or more electrical switch(es) that change the load and/or geometry of the antenna.”).
Regarding Claim 18, the combination of Perryman, Okamoto and Khaleghi renders obvious the entirety of Claim 17 as explained above
Perryman additionally discloses:
the … antenna having at least two electrodes including two conductive patches that are arranged to be spaced apart when the implant device is in use; (Para. [0002], “Implanted electrodes are used to pass pulsatile electrical currents of controllable frequency, pulse width, and amplitudes. Two or more electrodes are in contact with neural elements, chiefly axons, and can selectively activate varying diameters of axons, with positive therapeutic benefits.”);
Khaleghi additionally discloses:
comprising a non-self-resonant implant antenna for backscatter communications with the on-body antenna apparatus, (Pg. 6, Ln. 13-24).
Regarding Claim 19, the combination of Perryman, Okamoto and Khaleghi renders obvious the entirety of Claim 18 as explained above.
Khaleghi additionally discloses:
wherein the implant device is arranged to control the backscattering properties of the non-self-resonant implant antenna in order to thereby transmit data from the data source to the external communications system; and wherein the implant device is arranged such that the backscattering properties of the non-self-resonant implant antenna are controlled by one or more electrical switch(es) including an electrical switch that is arranged to change the impedance of the non-self-resonant implant antenna by switching between coupling the at least two electrodes via body tissue and coupling the at least two electrodes via a conductive pathway (Pg. 6, Ln. 13-24, “At least one switch of the one or more switches may have the effect of changing the geometry of the antenna. For example, the switch may alternate between a high impedance connection such as an open circuit and a low impedance connection such as a short circuit, and this switch may be located midway along a length of the antenna. In one example the at least one switch alternates between a high impedance connection and a low impedance connection between a ground plane, which may be the ground plane mentioned above in the first aspect, and a point midway along the length of the antenna, optionally there may be more than one switch with these switches spaced apart along the length of the antenna. As set out above the length of the antenna affects its resonant frequency and since the switch effectively changes the length of the antenna by changing the point at which the antenna is coupled to the ground plane then this has a significant effect on the backscatter properties of the antenna.”).
Claims 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2014/0180365 A1 to Perryman et al. (“Perryman”) in view of Okamoto, E., Kato, Y., Seino, K. et al. Interface of data transmission for a transcutaneous communication system using the human body as transmission medium. J Artif Organs 15, 99–103 (2012) (“Okamoto”) as applied to Claim 1 above in view of US 2007/0288066 A1 to Christman et al. (“Christman”).
Regarding Claim 20, the combination of Perryman and Okamoto renders obvious the entirety of Claim renders obvious the entirety of Claim 1 as explained above.
The combination of Perryman and Okamoto does not disclose:
wherein the implant device is a medical implant device and includes one or more sensor(s) for gathering data for medical use
Christman describes “A system for enabling telemetry in implantable medical devices…” (Abstract). Christman is analogous art.
Christman teaches:
wherein the implant device is a medical implant device and includes one or more sensor(s) for gathering data for medical use (Para. [0035], “The illustrated system also includes sensor circuitry 440 that is coupled to at least one sensor 445. The controller circuit 405 processes sensor data from the sensor circuitry and delivers a therapy responsive to the sensor data.)
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Perryman and Okamoto with the teachings of Christman (i.e., to further include such a sensor as taught by Christman in the device of Perryman) in order to facilitate wireless transmission of sensed physiological data (Christman at Para. [0002]).
Regarding Claim 21, the combination of Perryman Okamoto and Christman renders obvious the entirety of Claim 20 as explained above.
Christman additionally discloses:
wherein the one or more sensor(s) are connected to a data source of the implant device in order to provide information used to generate data that is transmitted from the data source to the on-body antenna system (Para. [0035], “The illustrated system also includes sensor circuitry 440 that is coupled to at least one sensor 445. The controller circuit 405 processes sensor data from the sensor circuitry and delivers a therapy responsive to the sensor data.)
Conclusion
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/C.J.M./Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796