DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are:
“power management unit” in claims 24, 26, 28, 34, 36, 40, 41, 43. “Power management unit” has been interpreted as a piezoelectric receiver or RF antenna, as stated in the specification (page 6, lines 10-16).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 24, 26-27, 34, 39, 42-43 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.
Regarding claims 24, 26, 34, and 43, the terms “optimal efficiency” and “optimal power efficiency” are relative terms which render the claims indefinite. The terms “optimal efficiency” and “optimal power efficiency” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. “Optimal” is a subjective term that can be defined in several different ways; for example, optimal could mean using as little power as possible but potentially limiting the quality of therapy, using as much power as necessary to ensure a high quality of therapy, etc.
The term “energy longevity management” in claim 27 is a relative term which renders the claim indefinite. The term “energy longevity management” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. “Longevity” is subjective and can be defined in several ways; for example, should the device disable a power consuming component so the device can last hours, days, weeks, etc.?
Regarding claims 24, 39, 42, the phrase "such as" renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 24-26, 28-29, 39-43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arbabian et al. (US Pre-Grant Publication 2017/0125892), hereinafter ‘Arbabian’.
Regarding claim 24, Arbabian teaches a micro device (base unit 100) (See Fig. 1, [0004], implants are miniaturized to sub-mm scale) for implantation into biological tissue, the micro device comprising:
a power management unit (Fig. 12, main path) arranged to receive a wireless signal (Fig. 12, VOC), such as an ultrasonic signal, from an external source ([0095], US signal provided by external device) and to generate an electric power output accordingly (Fig. 12, IOUTmax);
a plurality of electrical power consuming components ((implantable packages); [0089],) powered by the electric power output, the power consuming components comprising at least one controllable light source arranged to generate light in a controllable time-varying manner ([0093], light sources used for optogenetics); and
an electric regulator circuit (LDO) (see Fig. 12) to regulate electric current applied to the at least one controllable light source so as to provide a predetermined total electric load of the power management unit [0113] for optimal efficiency of transferring power to the plurality of electrical power consuming components ([0110], target threshold/ranges).
Regarding claim 25, Arbabian teaches the device of claim 24, further comprising:
wherein the electric regulator circuit is arranged to regulate electric current applied to the at least one controllable light source in a closed-loop manner (see Fig. 12, main path is closed), so as to regulate a total current applied to all of the electrically power consuming components [0110].
Regarding claim 26, Arbabian teaches the device of claim 24, further comprising:
an impedance matching circuit ((matching network), Fig. 28) connected to the power management unit to provide optimal power efficiency [0142], wherein the impedance matching circuit has fixed components (Fig. 28).
Regarding claim 28, Arbabian teaches the device of claim 24, further comprising:
comprising a wireless receiver (communication circuit (105)) separate from the power management unit (power circuit (130)) (See Fig. 1) and being arranged to receive data for controlling at least one of the plurality of electrically power consuming components ([0072], operate based on various inputs).
Regarding claim 29, Arbabian teaches the device of claim 24, further comprising:
wherein the at least one controllable light source is arranged for optogenetic stimulation ([0093], optogenetics).
Regarding claim 39, Arbabian teaches the device of claim 24, further comprising:
wherein the plurality of electrically power consuming components comprises a sensor arranged to measure neural activity and/or a physical parameter of the biological tissue, such as temperature or pressure ([0015], sensor for neural recording, temperature/pressure sensing).
Regarding claim 40, Arbabian teaches the device of claim 24, further comprising:
wherein the power management unit and the electric regulator circuit are implemented on an integrated circuit die ([0070], integrated circuit).
Regarding claim 41, Arbabian teaches the device of claim 24, further comprising:
wherein the power management unit comprises a piezoelectric transducer (unlabeled) arranged to receive an ultrasonic signal and to generate the electric power output accordingly (Fig. 10) [0105].
Regarding claim 42, Arbabian teaches the device of claim 24, further comprising:
having a total volume of less than 1 mm3, such as less than 0.5 mm3, such as less than 0.2 mm3 ([0030], 0.7mm x 0.7mm x 1mm which is .49 mm3; [0135], dimensions can be further scaled down).
Regarding claim 43, Arbabian teaches a micro device for implantation into biological tissue ([0004], miniaturized implants) (base unit (100), Fig. 1), where power consumption can be managed (Fig. 12, main path), further comprising:
providing a wireless signal (Fig. 12, VOC) from an external source ([0095], US signal provided by external device) to a power management unit of the micro device;
powering (Fig. 12, IOUTmax) electrically power consuming components of the micro device based on electric power from the power management unit ([0089], implantable packages); and
regulating an electric current applied to at least one controllable light source using an electric regulator circuit (Fig. 12, LDO) so as to provide a predetermined total electric load of the power management unit [0113] for optimal power efficiency ([0110], target threshold/ranges).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 27, 30, 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over Arbabian et al. (US Pre-Grant Publication 2017/0125892) in view of Denison et al. (US Pre-Grant Publication 2011/0125077), hereinafter ‘Denison’.
Regarding claim 27, Arbabian teaches the device of claim 24, further comprising:
wherein the electrical regulator circuit is arranged to modify the power supply to at least one power consuming component when there is low power (Fig. 12, auxiliary path) (Fig. 37, auxiliary low-power path) for energy longevity management at the micro device.
Arbabian does not teach disabling the power consuming component when there is a lack of power.
Denison teaches an implantable medical system for light therapy (claim 11), the device further comprising:
wherein the electrical regulator circuit is arranged to disable at least one power consuming component (Fig. 16, adjusting delivery of the light (206)) ([0172], ceasing delivery of light) for energy longevity management at the micro device ([0083], managing power flow).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Arbabian to incorporate the teachings of Denison to include disabling the power component. Doing so would allow for the device to manage power flow, as recognized by Denison [0083].
Regarding claim 30, Arbabian teaches the device of claim 24, further comprising:
wherein said plurality of electrical power consuming components comprises a second controllable light source ([0093], multiple light sources).
Arbabian does not teach that the light sources generate light at different wavelengths.
Denison teaches an implantable medical system for light therapy (claim 11), the device further comprising:
wherein the first and second controllable light sources are arranged to generate light at different wavelengths (Fig. 10, LEDs 132A, 132B) ([0117], opsin activation/inhibition wavelengths).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Arbabian to incorporate the teachings of Denison to include two light sources generating light at different wavelengths. Doing so would allow for the tuning of the LEDs/light sources to follow a selected treatment program, as recognized by Denison [0115].
Regarding claim 34, Arbabian and Denison teach the device of claim 30, further comprising:
wherein the electric regulator circuit (Arbabian, LDO) (see Fig. 12) is arranged to regulate electric current applied to both of the first and second controllable electric light sources (Dension, multiple light sources, see Fig. 10) so as to provide the predetermined total electric load of the power management unit for optimal power efficiency (Arbabian, Fig. 12, IOUTmax).
The combination of Arbabian and Dension teaches an electric regulator circuit that controls multiple light sources. Therefore, the combination, as proposed in the rejection of claim 30 (see above), would meet the claim limitation of controlling both light sources.
Regarding claim 35, Arbabian and Denison teach the device of claim 30. Arbabian teaches the device comprising:
wherein the electric regulator circuit comprises a load regulator (power recovery and regulation circuit (215)) arranged to drive the first controllable light source (see Fig. 2, [0074]).
Arbabian does not teach a digital to analog convertor that drives the second light source.
Denison teaches an implantable medical system for light therapy (claim 11), the device further comprising:
a current Digital to Analog Converter (see Fig. 10, DAC converter (122)) arranged to drive the second controllable light source [0117].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Arbabian to incorporate the teachings of Denison to include a digital to analog convertor that drives the second light source. Doing so would allow for the appropriate signal processing for generation of a current used to control the light sources, as recognized by Denison [0117]. Furthermore, it would have been obvious to try (selecting from the limited number of predictable solutions of either a digital or an analog driving signal) using a digital to analog convertor with the reasonable expectation that providing an analog signal as opposed to a digital signal would effectively drive the light sources of the proposed combined device. See MPEP 2143 (I)(E).
Regarding claim 36, Arbabian and Denison teach the device of claim 35. Arbabian teaches the device comprising:
wherein the load regulator is arranged to adapt a current to the first controllable light source in order to provide said predetermined total electric load of the power management unit (power recovery and regulation circuit (215)) ([0074], regulates power provided to aspects of circuit),
and/or wherein the load regulator is arranged to drive the first controllable light source, when electric power is available from the power management unit ([0074], regulates power provided to aspects of circuit),
and/or wherein the load regulator is arranged to drive the second controllable light source based on a received command ([0180], interprets commands and relays to controller circuit) (see Fig. 42).
Claims 31-33, 37 are rejected under 35 U.S.C. 103 as being unpatentable over Arbabian et al. (US Pre-Grant Publication 2017/0125892) in view of Denison et al. (US Pre-Grant Publication 2011/0125077) further in view of Toshinobu et al. (Japanese Patent Publication 2019092532), hereinafter ‘Toshinobu’. Paragraph numbers used for citation purposes are from the provided English translation of the original patent application (JP 2017221712).
Regarding claim 31, Arbabian and Denison teach the device of claim 30. Denison teaches the device comprising:
wherein the first controllable light source comprises a Light Emitting Diode arranged to generate blue light ([0084], LED tuned to blue light wavelength).
Arbabian and Denison do not teach the second light source comprising an LED that generates red light.
Toshinobu teaches a photodynamic therapy system [0011], the device further comprising:
and wherein the second controllable light source comprises a Light Emitting Diode arranged to generate red light [0018].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Arbabian and Denison to incorporate the teachings of Toshinobu to additionally include an LED that generates red light. Doing so would allow for the providing of photodynamic therapy, as recognized by Toshinobu [0004].
Regarding claim 32, Arbabian, Denison, and Toshinobu teach the device of claim 31. Denison teaches the device comprising:
wherein the first and second controllable light sources are arranged for dual color optogenetics ([0043], optogenetic modulation).
Regarding claim 33, Arbabian and Denison teach the device of claim 30. Arbabian teaches the device comprising:
wherein the first controllable light source is arranged for one of: optogenetics ([0093, optogenetics), optical triggering of drug delivery ([0016], release of a drug), and wherein the second controllable light source is arranged for one of: optogenetics ([0093], optogenetics), optical triggering of drug delivery ([0016], release of a drug).
Arbabian and Denison do not teach the light sources being arranged for photodynamic therapy.
Toshinobu teaches a photodynamic therapy system [0011].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Arbabian and Denison to incorporate the teachings of Toshinobu to include light sources arranged for photodynamic therapy. Doing so would allow for the providing of photodynamic therapy, as recognized by Toshinobu [0004].
Regarding claim 37, Arbabian teaches the device of claim 24, further comprising:
a third controllable light source ([0093], multiple light sources) arranged for optogenetics ([0093], optogenetics) or for optical triggering of drug delivery [0016],
and wherein the third controllable light source is arranged for optical triggering of drug delivery [0016].
Arbabian does not teach first and second controllable light sources arranged for optogenetics/photodynamic therapy at different wavelengths of light, and a third light source arranged for photodynamic therapy.
Denison teaches an implantable medical system for light therapy (claim 11) and Toshinobu teaches a photodynamic therapy system [0011], further comprising:
a third controllable light source arranged for photodynamic therapy (Toshinobu, [0011]),
preferably wherein the first and second controllable light sources are arranged for optogenetics or photodynamic therapy (Toshinobu, [0011]) at different wavelengths of light (Denison, [0117], opsin activation/inhibition wavelengths).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Arbabian to incorporate the teachings of Denison and Toshinobu to include light sources arranged for photodynamic/optogenetic therapy at different wavelengths of light. Doing so would allow for the providing of photodynamic therapy, as recognized by Toshinobu [0004], and the tuning of the light sources to follow a selected treatment program, as recognized by Denison [0115].
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Arbabian et al. (US Pre-Grant Publication 2017/0125892) in view of Toshinobu et al. (Japanese Patent Publication 2019092532) further in view of Chiu et al. (US Pre-Grant Publication 2013/0296977), hereinafter ‘Chiu’.
Regarding claim 38, Arbabian teaches the device of claim 24, further comprising:
wherein the at least one controllable light source is arranged for optogenetics [0093].
Arbabian does not teach a light source arranged for photodynamic therapy or an electrode for stimulation of biological tissue.
Toshinobu teaches a photodynamic therapy system [0011] and Chiu teaches an implanted stimulator device [0023], further comprising:
an electrode (Chiu, electrodes (180)) arranged for controllable electric stimulation of biological tissue (Chiu, [0071]),
and wherein the at least one controllable light source is arranged for photodynamic therapy (Toshinobu, [0011]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Arbabian to incorporate the teachings of Toshinobu and Chiu to include a light source arranged for photodynamic therapy and an electrode for tissue stimulation. Doing so would allow for the providing of photodynamic therapy, as recognized by Toshinobu [0004], and a delivery mechanism for the therapy/electric stimulation, as recognized by Chiu [0079].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Degenaar et al. (US Pre-Grant Publication 2017/0143985) teaches an implantable optogenetic neural stimulation system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH L OKONAK whose telephone number is (571)272-1594. The examiner can normally be reached Monday-Friday 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.L.O./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792