DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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 1-15 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.
Claim 1 recites the limitation “generating acoustic vibrations by activating said transducer for a period of time”, “transmitting said acoustic vibrations to the target site” and “applying said acoustic vibrations to the neural tissue at the target site sufficient to reduce immune system foreign body response in the subject where the electrode contacts the neural tissue at the target site”. It is unclear if the generating, transmitting, and applying steps are different/distinct elements or if these are intended to be the same/corresponding steps. In other words, it is unclear if the claim is attempting to set forth first generating acoustic vibrations, then transmitting said acoustic vibrations and then further applying (e.g. by transmitting) said acoustic vibrations subsequently or if the claim is merely attempting to further define the acoustic vibrations and transmission thereof such that when the acoustic vibrations are generated they are transmitted to the neural tissue at the target site and are sufficient to reduce immune system foreign body response. For examination purposes, it has been interpreted that these may be different steps or the same, however, clarification is required.
The term “about” in claims 3 and 5-8 is a relative term which renders the claim indefinite. The term “about” 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. In this case, it is unclear as to how close to the claimed values/ranges the duration, frequency, spatial temporal average intensity, voltage, duty cycle, and time need to be to be considered “about” the recited values/ranges as the specification uses the term about in three instances without defining what is meant by the term. For examination purposes, it has been interpreted that any value deemed close to the recited values/ranges and sufficient to reduce immune system foreign body response is considered to be “about” said values/ranges, however, clarification is required.
Claims 4 and 10-14 recite the limitation “the target tissue”. There is insufficient antecedent basis for the limitation in the claim. It is therefore unclear if the claim is intending to refer to the target site, the neural tissue, or a different target tissue which has not been defined yet by the claims. For examination purposes, it has been interpreted to mean any target tissue, however, clarification is required.
Claim 8 recites the limitation “activating said transducer for a predetermined period of time comprises (i) turning said transducer on for a time in the range about 1 to 15 minutes, (ii) turning said transducer off for a time in the range about 1 to 15 minutes, and (iii) repeating steps (i) and (ii) from 2 to 10 times”. The limitation is unclear as to whether any of the time ranges are considered to be the predetermined period of time or if these are merely subsets of the predetermined period of time. It is further unclear how turning off the transducer is considered to be included in activating said transducer for a predetermined period of time as the transducer would appear to not be activated during such a time. For examination purposes, it has been interpreted that the method further includes steps i-iii, however, clarification is required.
Claim 9 recites the limitation “wherein activating said transducer for said predetermined period of time comprises turning said transducer on for 5 minutes, then off for 5 minutes, then on for 5 minutes for a total treatment time of 15 minutes”. It is unclear if the turning the transducer on, off, and then on again is attempting to further define the ranges of claim 8 or if these are different instances of turning said transducer on, off, then on again and it is further unclear if the predetermined period of time is the same as the total treatment time or if these are different times. For examination purposes, it has been interpreted to mean they are the same or different, however, clarification is required.
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 1-4, 8-12, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Slayton (US 20130012755 A1), hereinafter Slayton in view of Lewis, JR. et al. (US 20190269943 A1), hereinafter Lewis and NPL Kozai et al. (“Brain Tissue Responses to Neual Implants Impact Signal Sensitivity and Intervention Strategies”), hereinafter Kozai.
Regarding claim 1,
Slayton, teaches a method of reducing foreign body response in a subject from metal implanted in tissue at a target site, said method comprising:
positioning a device (at least fig. 3B-4C (105) and corresponding disclosure in at least [0087]) having a body (see at least fig. 3B-4C (105) examiner notes that a probe necessarily has a body), an ultrasonic transducer ([0061] which discloses ultrasound probe 105 may comprise a therapeutic transducer and a separate imaging transducer), and acoustic coupling medium in communication with the ultrasonic transducer such that the acoustic coupling medium are in contact with the tissue in proximity to the target site ([0083] which discloses medicant can be administered by applying it to the skin above the Roi and can be mixed in a coupling gel or can be used as a coupling gel);
generating acoustic vibrations by activating said transducer for a predetermined period of time ([0034] which discloses step 14 is directing ultrasound energy to the implant and/or native tissue at site and [0061] which discloses Ultrasound probe 105 emits ultrasound energy 120 in ROI 115);
transmitting said acoustic vibrations to the target site ([0061] which discloses ultrasound probe 105 emits ultrasound energy 120 in ROI 115. See also figs. 3B-4C); and
applying said vibrations to the tissue at the target site sufficient to reduce immune system foreign body response in the subject where the electrode contacts the tissue at the target site ([0089] which discloses ultrasound from device 100 could be used during the time of implantation to inhibit infection or enhance ingrowth due to its improved vascular function, and it could also enhance the pharmaceutical effects locally).
Slayton fails to explicitly teach the body having an aperture (see at least fig. 1) and the acoustic coupling medium retained within the body between and in communication with the ultrasonic transducer and the aperture such that the aperture and acoustic coupling medium are in contact with the tissue in proximity to the target site.
Lewis, in a similar field of endeavor involving ultrasound, teaches a device having a body (at least fig. 1 and 4 (10) and corresponding disclosure in at least [0091]) with an aperture (see at least fig. 1), a ultrasonic transducer (at least fig. 2C (40) and corresponding disclosure in at least [0093]), and an acoustic coupling medium (at least fig. 1 (30) and corresponding disclosure in at least [0091]) retained within the body between and in communication with the ultrasonic transducer and the aperture such that the aperture and acoustic coupling medium are in contact with the tissue in proximity to the target site ([0092] which discloses the ultrasound coupling medium 30 is designed such that it contacts the ultrasound transducer 40 (see, e.g., FIG. 2C) and surface of a patient's body in the area requiring treatment, imaging, or diagnosis and [0123] In another embodiment, an adhesive fabric 80 may be used to couple the ultrasound coupling adapter 10 to a location on the patient's body and [0105] which discloses the base of the ultrasound coupling adapter 10 (i.e. the portion that contacts the patient's body).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Slayton to include a device as taught by Lewis in order to provide a limited use ultrasound device which cures deficiencies of coupling media which become less transmissive to ultrasound which prevents effective ultrasound treatment and increased risk of injury to the patient ([0005]-[0006]). Such a modification thereby allows for an ultrasound device having a replaceable coupling device which would improve treatment of tissue over time. Additionally/alternatively, such a modification amounts to merely a simple substitution of one known ultrasound device for another yielding predictable results with respect to ultrasound treatment thereby rendering the claim obvious (MPEP 2143).
Slayton further fails to explicitly teach wherein the implant is an electrode is implanted in neural tissue.
Nonetheless, Kozai, in a similar field of endeavor involving medical implants, teaches foreign body response is common in electrodes implanted in neural tissue (pg. 48 which discloses electrodes for amperometry voltammetry and electrophysiological recording offer the ability for basic clinical scientists to record… electrophysiological signals directly from they living, intact brain of animal human subjects.. and implantable devices remain true that their physical insertion into brain tissue causes local injury which in turn initiates a progressive inflammatory tissue response).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the implant of Slayton to be an electrode implanted in neural tissue as taught by Kozai in order to provide additional uses of the method accordingly. Such a modification would therefore allow for accelerated healing of electrodes in neural tissue thereby allowing for neural electrodes implanted in order to prevent or reduce sensing inaccuracy, instability, and failure of such electrodes (Kozai pg. 48). Furthermore, such a modification amounts to merely a simple substitution of one known implant device for another yielding predictable results of accelerated healing thereby rendering the claim obvious (MPEP 2143).
Examiner notes that in the modified method reducing foreign body response in the subject from the electrode implanted in the neural tissue means that positioning the device would be such that the aperture and acoustic coupling are in contact with the neural tissue in proximity to the target site and transmitting said acoustic vibrations to the target site would apply said acoustic vibrations to the neural tissue.
Regarding claim 2,
Slayton further teaches wherein said acoustic vibrations are in the ultrasonic frequency range (Abstract disclosing directing ultrasound energy. See also [0037]).
Regarding claim 3,
Slayton further teaches wherein said acoustic vibrations are pulsed, having a duration in the range of about 5 to 200 milliseconds ([0061] which discloses ultrasound probe 105 is capable of emitting ultrasound energy 120 for variable time periods or to pulse the emission over time, such as, for example, those time intervals described herein. [0036] which discloses the amount of time ultrasound energy is applied at these levels to create a lesion varies in the range from approximately 1 millisecond to several minutes. However, a range can be from about 1 millisecond to about 5 minutes, or from about 1 millisecond to about 1 minute, or from about 1 millisecond to about 30 seconds, or from about 1 millisecond to about 10 seconds, or from about 1 millisecond to about 1 second, or from about 1 millisecond to about 0.1 seconds, or about 0.1 seconds to about 10 seconds, or about 0.1 seconds to about 1 second, or from about 1 millisecond to about 200 milliseconds, or from about 1 millisecond to about 0.5 seconds. Such a range of 2 millisecond to several minutes including 1 millisecond to about 200 milliseconds includes a duration between 5 to 200 milliseconds).
Regarding claim 4,
wherein applying said acoustic vibrations to the target site includes applying at least one of a frequency and intensity sufficient to stimulate release of at least one endogenous neurotrophic factor in the target tissue ([0052] which discloses ultrasound energy is deposited at site, which can stimulate a change in at least one of concentration and activity of one or more of the following: Adrenomedullin (AM), Autocrine motility factor, Bone morphogenetic proteins (BMPs), Brain-derived neurotrophic factor (BDNF), Epidermal growth factor (EGF)…. Nerve growth factor (NGF) and other neurotrophies…. and/or any other growth factor not listed herein, and combinations thereof).
Regarding claim 8,
Slayton, as modified, teaches the elements of claim 1 as previously stated. Slayton further teaches wherein activating said transducer for a predetermined period of time comprises (i) turning said transducer on for a time in the range about 1 to 15 minutes ([0036] which discloses the amount of time ultrasound energy is applied at these levels varies in the range from approximately 1 millisecond to several minutes. A range can be from about 1 millisecond to about 5 minutes)
Slayton further teaches repeatedly performing directing of the ultrasound energy to the site for example when the results of step 30 are not found to be acceptable based on imaging the site (see fig. 1 and [0049]), thus reasonably teaches turning off said transducer (i.e. turning off during determining step and targeting step before directing ultrasound energy to the site again in step 14), and turning said transducer on for a time in the range of about 1 to 5 minutes as disclosed in at least [0035], however, fails to explicitly teach turning said transducer off for a time in the range about 1 to 15 minutes.
Nonetheless, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Slayton, as currently modified, to include turning off said transducer for a time in the range of about 1 to 15 minutes in order to provide sufficient timing for determining whether desired results of therapeutic effects have occurred and to reduce any heating which may occur between activations of the transducer. Such a modification amounts to merely routine optimization of a waiting/rest period between transmission of ultrasound energy with predictable results related to ultrasound treatment thereby rendering the claim obvious.
Regarding claim 9,
Slayton, as modified, teaches the elements of claim 8 as previously stated. Slayton, as currently modified, further teaches wherein activating said transducer for said predetermined period of time comprises turning said transducer on for 5 minutes ([0036] which discloses the amount of time ultrasound energy is applied at these levels varies in the range from approximately 1 millisecond to several minutes. A range can be from about 1 millisecond to about 5 minutes), turning said transducer off for 5 minutes (see modification above where as modified 1 to 15 minutes of time would include 5 minutes), and turning said transducer on for 5 minutes ([0036] A range can be from about 1 millisecond to about 5 minutes) for a total treatment time of 15 minutes.
Regarding claim 10,
Slayton, as modified, teaches the elements of claim 8 as previously stated. Slayton, as currently modified, fails to explicitly teach repeating steps (b) through (d) once every day during the week following implantation of the electrode in the target tissue.
Nonetheless, it would have been obvious to a person having ordinary skill in the art to have repeated steps (b) through (d) once every day during the week following implantation of the electrode in the target tissue as part of a routine optimization to ensure that healing at the site of implantation of the electrode is performed as desired. Such a modification would have predictable results of obtaining desired healing affects to the target site by providing repeated ultrasound vibrations to the target site each day as needed until such desired healing has been reached.
Regarding claim 11,
Slayton, as modified, teaches the elements of claim 8 as previously stated. Slayton, as currently modified, fails to explicitly teach repeating steps (b) through (d) one of: (i) once every other day during the second week following implantation of the electrode in the target tissue, and (ii) once every three days following implantation of the electrode in the target tissue.
Nonetheless, it would have been obvious to a person having ordinary skill in the art to have repeated steps (b) through (d) once every other day during the second week or once every three days during the second week following implantation of the electrode in the target tissue as part of a routine optimization to ensure that healing at the site of implantation of the electrode is performed as desired. Such a modification would have predictable results of obtaining desired healing affects to the target site by providing repeated ultrasound vibrations to the target site once every other or every third day as needed until such desired healing has been reached.
Regarding claim 12,
Slayton further teaches wherein applying said acoustic vibrations comprises creating an acoustic of said acoustic vibrations at the target site, said acoustic field surrounding at least a portion of the implant implanted in the target tissue (see at least figs. 4A-4B and corresponding disclosure in at least [0087] which discloses ultrasound energy 120 is directed to at least one of site 190 and implant 222)
Regarding claim 14,
Slayton, as modified, teaches the elements of claim 12 as previously stated. Slayton further teaches further comprising creating overlapping acoustic fields of said vibrations at the target site (See at least fig. 1 where directing ultrasound energy to the site is repeated when results are not acceptable per step 30. Examiner notes that repeating of the directing of ultrasound energy would create overlapping acoustic fields of said vibrations at the target site), at least one of (i) the overlapping portion of said acoustic fields surrounding at least a portion of the implant implanted in the target tissue (see at least figs. 4A-4B in which the acoustic field surrounds at least a portion of the implant where the overlapping portion (i.e. repeated directing of ultrasound energy) is located)
Regarding claim 15,
Slayton further teaches further comprising modulating said acoustic field by changing one of: (i) frequency of acoustic vibrations ([0059] which discloses ultrasound probe 105 can also be configured for temporal control, such as through adjustment and optimization of drive amplitude levels, frequency, waveform selections, e.g., the types of pulses, bursts or continuous waveforms, and timing sequences and other energy drive characteristics to control thermal ablation of tissue. Other temporal control can include but are not limited to full power burst of energy, shape of burst, timing of energy bursts, such as, pulse rate duration, continuous, delays, etc., change of frequency of burst, burst amplitude, phase, apodization, energy level, or combinations thereof)
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Slayton, Lewis, and Kozai as applied to claim 1 above, and further in view of Mishelevich et al. (US 20140194726 A1), hereinafter Mishelevich and McInnes et al. (US 20150174387 A1), hereinafter McInnes.
Regarding claim 5,
Slayton teaches the elements of claim 1 as previously stated. Slayton further teaches wherein activating said transducer comprises operating said transducer at a frequency in the range of about 200 kHz to 5 MHz ([0037] which discloses the frequency of the ultrasound energy can be in a range from about 0.1 MHz to about 100 MHz, or from about 0.1 MHz to about 50 MHz, or from about 1 MHz to about 50 MHz or about 0.1 MHz, to about 30 MHz, or from about 10 MHz to about 30 MHz, or from about 0.1 MHz to about 20 MHz, or from about 1 MHz to about 20 MHz, or from about 20 MHz to about 30 MHz) ,
Slayton, as modified, fails to explicitly teach operating said transducer at a spatial peak temporal average intensity in the range of about .01 to 2.5 W/cm2, voltage in the range of about 100 to 600 V, and duty cycle percentage in the range of about .5% to 20%.
Mishelevich, in a similar field of endeavor involving neuromodulation, teaches operating a transducer at a frequency in the range of about 200 kHz to 5 MHz ([0044] which discloses the waveform has an acoustic frequency between about 100kHz and about 10 MHz), at a spatial peak temporal average intensity in the range of about .01 to 2.5 W/cm2 ([0044] which discloses a spatial-peak, temporal-average intensity between about 0.0001 mW/cm.sup.2 and about 1 W/cm.sup.2 at the target tissue site (or between 21 mW/cm.sup.2 and 1 W/cm.sup.2 in alternative embodiments) and duty cycle percentage in the range of about .5% to 20% ([0054] which discloses the duty cycle can be less than 50% and can be within a range from about .1% to about 50%).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Slayton to include a spatial-peak temporal average intensity and duty cycle percentage as taught by Mishelevich in order to provide control of energy emission to as to provide one or more of increased up-regulation or increased down regulation with decreased amounts of ultrasound energy to the targeted neural structure (Mishelevich [0015]). Such a modification would thereby provide desired treatment to the subject in a safe and effective manner (Mishelevich [0012])
Slayton, as currently modified, fails to further teach operating said transducer at a voltage in the range of about 100 to 600 V.
McInnes, in a similar field of endeavor involving ultrasound treatment, teaches operating an ultrasound transducer in the range of about 100 to 600 V ([0047] which discloses for ultrasound voltages in the range of 1-1000 V may be required).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified to Slayton, as currently modified, to include voltages as taught by McInnes in order to provide the power requirements desired for the ultimate function of the device (McInnes [0047]). Such a modification further amounts to merely routine optimization to provide the desired power requirements for the ultrasound transducer to function as desired rendering the claim obvious (MPEP 2144).
Regarding claim 6,
Slayton, as modified, teaches the elements of claim 5 as previously stated. Slayton, as modified, further teaches wherein activating said transducer comprises operating said transducer at a frequency in the range of about 1.0 to 2.2 MHz (Slayton [0037]), a spatial peak temporal average intensity in the range of about 0.1 to 2.2 W/cm2 (Mishelevich 0044]), voltage in the range of about 200 to 280 V (McInnes [0047]), and duty cycle percentage in the range of about 2% to 10% (Mishelevich [0054]).
Regarding claim 7,
Slayton, as modified, teaches the elements of claim 6 as previously stated. Slayton, as modified, further teaches wherein activating said transducer comprises operating said transducer at a frequency of about 1.13 MHz (Slayton [0037]), a spatial peak temporal average intensity of about 0.5 W/cm2 (Mishelevich 0044]), voltage of about 280 V (McInnes [0047]), and duty cycle percentage of about 4.2% (Mishelevich [0054]).
Claims 13 is rejected under 35 U.S.C. 103 as being unpatentable over Slayton, Lewis, and Kozai as applied to claim 12 above, and further in view of Hynynen et al. (US 20220233890 A10, hereinafter Hynynen.
Regarding claim 13,
Slayton, as modified, teaches the elements of claim 12 as previously stated. Slayton further teaches wherein said acoustic field comprises a near field and a far field separated by a transition point ([0034] which discloses the ultrasound energy may be directed to a first depth and then directed to a second depth see also [0066]) wherein at least one of (i) said near field and (ii) said far field surrounding at least a portion of the implant implanted in the target tissue (see at least fig. 4b)
Slayton, as modified, fails to explicitly teach wherein the far field has a wider diameter than a near field.
Nonetheless, Hynynen teaches wherein an acoustic field comprises a near field and a far field separated by a transition point (see at least fig. 3C) wherein the far field has a wider diameter than a near field (see at least fig. 3C).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Slayton, as currently modified, to include a near field and a far field as taught by Hynynen in order to provide for overlapping far fields within a spatial region of the brain that permits selection of a focusing target with an extended focusing region (Hynynen [0154]). Such a modification would allow for an extended field for treating the target site as desired.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE L KLEIN whose telephone number is (571)270-5204. The examiner can normally be reached Mon-Fri 7:30-4.
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/BROOKE LYN KLEIN/Examiner, Art Unit 3797