DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 16 is 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). The claim language “…wherein the tissue is associated with a spinal column…” positively recites the human body. It is suggested to use language such as “adapted for,” “configured to,” etc. Correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 2, 4-9, 12-13, 16-19 & 21 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hastings et al. (US 2009/0234407) in view of Chow et al. (‘Evaluation of Cardiovascular Stents as Antennas for Implantable Wireless Applications’).
Claim 2.
An implantable stimulator…
E.G. Hastings et al. teaches a wireless electrode assembly 210 including electrodes 250/260, {[0049]-[0067] & (Figs. 2, 4-5)}.
…one or more electrodes configured to apply stimulation pulses…
E.G. Hastings et al. teaches electrodes 250/260, which deliver electrostimulation, [0062]-[0063]
…and a circuit coupled to the electrodes…configured to generate stimulation pulses
E.G. Hastings et al. teaches a logic 216, rectifier 213, switch 217, filter 209, etc. ([0052]-[0063]), and stimulus control logic generates desired waveform ([0055]-[0063]).
Hastings et al. teaches circuitry coupled to the one or more electrodes and configured to generate stimulation pulses, including logic 216, rectifier 213, switch 217, filter 209, blocking device 218 and shunt 219 (Fig 2). Hastings further teaches that stimulus control logic 216 is configured to generate a desired electrostimulation waveform for application to the electrodes ([0052]-[0063]).
However, Hastings et al. does not expressly teach that the first antenna receives an input signal from a second antenna through electrical radiative coupling. Chow et al. teaches wireless transfer of electrical energy via radiative RF propagation using an implanted antenna and an external antenna (Figs 2(b) and 5), wherein RF energy received by the implanted antenna is converted to DC power by an RF rectifier to power implanted electronic circuitry (pp. 2524-2529). Accordingly, Chow teaches the claimed first antenna receiving, from a second antenna through electrical radiative coupling, an input signal containing electrical energy.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the implantable stimulator of Hastings et al. to employ the electrical radiative coupling taught by Chow et al. for transferring electrical energy from an external antenna to an implanted antenna. Chow expressly teaches that radiative RF power transfer provides efficient wireless powering of implanted electronics while offering greater operating distance, reduced alignment sensitivity, and improved orientation immunity compared to inductive coupling. Incorporating Chow’s radiative energy transfer technique would have predictably improved the transfer of electrical energy to the implanted circuitry while preserving Hastings’ intended function of generating and delivering stimulation pulses. Such substitution of one known wireless energy transfer technique for another to obtain is recognized advantages would have been a predictable use of prior art elements according to their established functions, as contemplated by KSR Int’l Co. v. Teleflex Inc, 550 U.S. 398, 417 (2007).
Claim 4.
The implantable stimulator of claim 2, further comprising a lumen configured to accommodate a navigating stylet.
E.G. Hastings et al. teaches an implantable electrostimulation electrode assembly configured for intravascular delivery through a delivery catheter, including assemblies sized for minimally invasive implantation ([0032]-[0034], [0049]-[0051] & (Fig 4A-4D).
Note: The electrode assembly is configured to pass through the lumen of a delivery catheter, thereby inherently accommodating a navigating stylet under the broadest reasonably interpretation, [0101].
Claim 5.
…one or more antenna coupling contacts…waveform condition circuitry…conducting wires…waveform conditioning circuitry uses electrical energy contained in the input signal to create stimulation pulses.
E.G. Hastings et al. teaches wireless electrostimulation electrode assembly including inductive pickup 212 electrically coupled to stimulus control logic 216 through conductive circuitry and associated circuitry form waveform conditioning circuitry that uses received electrical energy to generate desired electrostimulation waveforms ([0052]-[0063]), (Fig.2 ).
Claim 6.
…waveform conditioning circuitry includes diodes, resistors and/or capacitors
E.G. Hastings et al. teaches rectifiers 213 (diodes), blocking device 218 including a capacitor, shunt device 219 including a resistor and tuning capacitor 211 ([0059]-[0063], Fig 2.
Claim 7.
…wherein the implantable stimulator has a cylindrical or semi-cylindrical shape.
E.G. Hastings et al. teaches elongated wireless electrostimulation electrode assemblies configured for intravascular implantation within blood vessels and heart chambers, {[0049]-[0051] & (Figs. 4-7)}
Additionally, Chow et al. teaches cylindrical stent-based implantable antenna assemblies having a generally cylindrical configuration for implantation within blood vessels [(pp. 2524-2526) & (Fig. 2)]. Chow et al. further evidences that cylindrical implantable wireless electrode/antenna structures were well known in the art.
Claim 8.
…external coating of biocompatible polymer including PMMA, PDMS, parylene, polyurethane, PTFE or polycarbonate.
E.G. Hastings et al. teaches implantable electrostimulation assemblies encapsulated within protective biocompatible materials suitable for implantation [0057].
Claim 9.
…wherein the one or more electrodes comprise a cylindrical or semi-cylindrical array.
E.G. Hastings et al. discloses multiple electrodes disposed on elongated implantable electrostimulation assemblies configured for implantation within blood vessels {[0050]-[0051], [0138] & (Fig 14)}.
Additionally, Chow et al. teaches cylindrically implantable stent-based electrode/antenna structures implanted within vascular tissue [(pp. 2524-2526) & (Fig. 2)].
Claim 12.
…wherein the one or more electrodes are comprise at least one of platinum, platinum-iridium, gallium-nitride, etc.
E.G. Hastings et al. teaches implantable electrostimulation electrodes fabricated from conventional implantable electrode materials suitable for chronic tissue stimulation ([004]-[0051]).
Under the broadest reasonable interpretation, one of ordinary skill would have understood implantable stimulation electrodes to be fabricated from conventional biocompatible conductive materials, including platinum and platinum-iridium, which were well known for chronic implantable stimulation devices.
Claim 13.
…wherein the circuit is flexible and placed proximal to the one or more electrodes.
E.G. Hastings et al. teaches electrostimulation circuitry integrated within the implantable electrode assembly immediately adjacent the electrodes {[0050]-[0063] & (Fig 2)}.
Claim 16.
…wherein the tissue is associated with a spinal column.
E.G. Selection of a particular stimulation site, including tissue associated with the spinal column, constitutes selection of a known anatomical location for performing the disclosed electrostimulation and would have been an obvious matter of design choice.
Claim 17.
…wherein the first antenna comprises a conductive trace.
E.G. Hastings et al. teaches an inductive antenna 206 and inductive pickup 212 formed as conductive traces on implant circuitry {[0052]-[0057] & (Fig. 2)}.
Claim 18.
…wherein the first antenna comprises a conductive wire.
E.G. Hastings et al. teaches a wire loop [0052].
Claim 19.
…receiving electrical energy at an implanted antenna to generate stimulation pulses for implanted electrodes…
E.G. Hastings et al. receiving electrical energy at an implanted antenna to generate stimulation pulses for implanted electrodes ([0052]-[0063]).
Hastings et al. does not expressly teach receiving an input signal through electrical radiative coupling.
Chow et al. teaches RF radiative coupling between an external antenna and implanted antenna for wireless powering of implanted electronics [(pp. 2524-2529) & (Fig 2(b))].
The reason to combine is the same rationale as independent claim 2.
Claim 21.
Claim 21 is rejected for substantially the same reasons set forth above with respect to claim 2, which are incorporated herein by reference. Claim 21 further recites an external device including the second antenna configured to transmit through electrical radiative coupling. Hastings et al. teaches an external controller/transmitter 220 physically separate from the implanted assembly ([0048], [0052]-[0056], Fig 2) and Chow et al. teaches an external antenna radiatively transmitting RF energy to an implanted antenna for wireless powering [(pp. 2524-2529) & (Fig 2(b)).
Claims 3 & 20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hastings et al. (US 2009/0234407) and Chow et al. (‘Evaluation of Cardiovascular Stents as Antennas for Implantable Wireless Applications’), as applied to claims 2, 4-9, 12-13, 16-19 & 21, in view of one having ordinary skill in the art.
Hastings et al. discloses the steps of steering, introducing, advancing, etc. a delivery catheter to a location within the heart of a patient, wherein the electrostimulation electrode assembly is housed within said catheter [0106], in which the examiner is interpreting the disclosed delivery catheter introduced into the patient as providing the claimed introducer, except said delivery catheter performing the claimed introducer does not have a diameter no larger than gauge 13. It would have been obvious to one having ordinary skill in the art at the time the invention was made to utilize a delivery catheter having a diameter no larger than gauge 13, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim Objections
Claims 10-11 & 14 are 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.
The prior art of record, Hastings et al., alone or in combination with Chow et al., teaches implantable wireless electrostimulation systems and wireless power transfer to implantable devices. However, the prior art fails to teach or reasonably suggest the specific structural limitations recited in claims 10-11 & 14. More particularly, the prior art fails to teach or suggest:
Claim 10: One or more electrodes comprising one to sixteen electrodes, each having longitudinal length of about 1.0 mm to 6.0 mm and a width of about 0.4 mm to 3.0 mm;
Claim 11: One or more electrodes being between about 1 mm and 6 mm apart and having a combined surface area of between 0.8 mm² and 60.0 mm²; and
Claim 14: A circuit that is sufficiently flexible to bend over a radius of under 0.5 mm.
Although Hastings et al. generally discloses implantable electrostimulation electrodes and Chow et al. generally discloses wireless implant structures and antennas, neither reference, nor their combination, teaches or suggests the foregoing specific dimensional and mechanical limitations, nor does the prior art establish that such limitations would have been obvious design choices or recognized result-effective variables. Accordingly, the claimed subject matter of claims 10-11 and 14 is considered to be novel and nonobvious over the prior art of record.
Response to Arguments
Applicant's arguments filed May 11, 2026 have been fully considered but they are not persuasive
The applicant contends that Hastings et al. fails to disclose receiving an input signal from a second antenna through electrical radiative coupling and that the cited reference relies on inductive coupling rather than the claimed arrangement. However, the current rejection is based on Hastings et al. in view of Chow et al., not Hastings et al. alone. As explained in the above rejection, Chow et al. expressly teaches an implanted antenna configured to receive RF energy transmitted by a physically separate external antenna through electromagnetic (electrical radiative) coupling to wirelessly power implanted electronics. It would have been obvious to one of ordinary skill in the art to incorporate Chow’s wireless radiative power transfer technique into Hastings et al. implantable electrostimulation system to achieve predictable wireless power delivery while eliminating wired connections, thereby improving implant flexibility and reducing the need for implanted power sources. See KSR Int’l Teleflex INC., 550 U.S. 398 (2007).
The Applicant has not presented persuasive evidence that the combined teachings fail to disclose or render obvious the claimed subject matter.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796
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