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 Objections
Claims 3, 26-27, 50-51 and 57 are objected to because of the following informalities:
Regarding claim 3:
Claim 3 is written as follows:
(Original) The electrotherapy system of claim 2, wherein the pair of electrodes is
spatially apart from each other to define an electrode spacing that is larger than 1 mm.
The number 3 of the claim is struck through which creates a clarity issue. This appears to be a typo as nothing else of the claim is struck through. Therefore Claim 3 should be amended as follows:
3. (Original) The electrotherapy system of claim 2, wherein the pair of electrodes is
spatially apart from each other to define an electrode spacing that is larger than 1 mm.
Claim 26 should be amended as follows:
“wherein the current measured during the stimulation is associated with a dying process of the wound and provides an estimate of the healing progress”
Claim 27 should be amended as follows:
“wherein a gradual decrease of the current relates directly to progressive healing of the wound, and the current gradually decreases to 0 when the wound is fully dry.”
Claim 50 should be amended as follows:
“wherein the current is associated with a dying process of the wound”
Claim 51 should be amended as follows:
“wherein a gradual decrease of the current relates directly to progressive healing of the wound, and the current gradually decreases to 0 when the wound is fully dry.”
Claim 57 should be amended as follows:
“detecting biochemical/biophysical parameters associated with the wound site;”
Appropriate correction is required.
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.
Such claim limitation(s) is/are: “means for drug delivery, biochemical/biophysical sensing, and/or closed-loop control of operational parameters” in claim 37.
This means plus function limitation appears to raise 112(b) and/or 112(a) rejections, please see 112 rejection section below for information as to how these limitations have been interpreted for this examination.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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 1-38,48, 50-51 and 54 is 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 "the stimulator" in the limitation “a wireless platform coupled with the pair of electrodes for operable providing power to the stimulator”. There is insufficient antecedent basis for this limitation in the claim.
For this examination “the stimulator” is interpreted as referring to the electrodes as these are elements that are understood to provide stimulation. Applicant should clarify what is being claimed here. Additionally, claims 2-38 are rejected under 35 112(b) as well based on dependency to claim 1.
Regarding claim 15-16:
Claims 15 recites the limitation "the wireless power harvesting unit" in the limitation “wherein the wireless power harvesting unit comprises an antenna for delivering the power to the system”. There is insufficient antecedent basis for this limitation in the claim.
Please note there is antecedent basis for a “power harvesting unit” but not for a “wireless power harvesting unit”. For this examination “the wireless power harvesting unit” is interpreted as referring to “the power harvesting unit” first recited in claim 12. Applicant should clarify what is being claimed here. Additionally, claim 16 is rejected under 35 USC 112(b) as well based on dependency on claim 15.
Regarding claims 16 and 48:
Claims 16 and 48 both recite the limitation:
“wherein the power harvesting unit operates by resonant inductive coupling at a resonance frequency in a range of about 10-15 Mhz, preferably about 13.56 MHz.”
Both claims list numerical ranges recite frequency ranges followed by a more narrow preferred frequency within the same claim. Is the narrowest frequency required or is the more broad range all that is required?
MPEP 2173.05(c) provides a clear example of this being indefinite:
“Examples of claim language which have been held to be indefinite are (A) "a temperature of between 45 and 78 degrees Celsius, preferably between 50 and 60 degrees Celsius".
“Preferably” should be removed and the narrower limitations should be definitively claimed, or the further narrow frequency limitations should be removed from the same claim. For this examination the broader range of frequency is the only required range claimed as this is the broadest reasonable interpretation.
Regarding claims 26-27 and 50-51:
Claim 26 recites the limitation “wherein the current measured during
the stimulation is accociated with a dying process of the wound” and claim 50 recites the limitation “wherein the current is accociated with a dying process of the wound”.
However, claims 27 and 51 which depend on claim 26 and 50 respectively recite “the currently gradually decreases to 0 when the wound is fully dry”. This raises questions should “dying” be “drying” OR should “drying” be “dying”? For this examination “dying” was interpreted to be a typo for “drying” and has been interpreted as such. Applicant should clarify what is being claimed here. Claims 27 and 51 are rejected based on dependency on these claims.
Regarding claims 30 and 54:
Both claims recite the limitation “wherein the electrostimulation reduces the times for closure of excisional splinted wounds by about 30 % or more, compared to those of control and untreated groups”.
This limitation is indefinite because control and untreated groups vary based on an assortment of factors such as age, genetics, type of wound, etc. So, it’s not clear what the metes and bounds are for “about 30% or more” or more precisely 10%-50% or more as “about” is defined as +/- 20% (see pg. 15 line 30 – pg. 16 line 5 in applicant’s disclosure received on 11/14/2024). For this examination, any electric field that improves healing and/or speeds up healing is interpreted as an electrostimulation as recited in claims 30 and 54. Applicant should clarify what is being claimed here.
Regarding claim 37:
Claim 37’s limitation:
“means for drug delivery, biochemical/biophysical sensing, and/or closed-loop control of operational parameters” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The best support is pg. 5 lines 25-30 of applicant’s specification received on 11/14/2024 which states:
“In one embodiment, the electrotherapy system further comprises means for drug delivery, biochemical/biophysical sensing, and/or closed-loop control of operational parameters.”
As seen here this section simply repeats what is claimed. Thus, the specification is devoid of adequate structure to perform the claimed function. There is no disclosure of any particular structure, either explicitly or inherently, to perform the process. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For this examination, any structure able deliver drugs, senses biochemical/biophysical properties and/or control operations recite the limitation as claimed.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 37 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. As outlined above, the disclosure is devoid of structure and does not provide adequate structure to perform the claimed functions for the following means plus function limitations:
“means for drug delivery, biochemical/biophysical sensing, and/or closed-loop control of operational parameters” in claim 37.
Thus, the specification does not demonstrate that applicant has made an invention that achieves the claimed function because the invention is not described with sufficient detail that one of ordinary skill in the art can reasonably conclude that the inventor had possession of the claimed invention.
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.
Claim(s) 1, 11, 17-18, 32-37 and 39 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rogers et al (US 20210022609) hereafter known as Rogers.
Independent claims:
Claim 1:
An electrotherapy system [see Fig. 32 and abstract… “Provided are wireless electronic devices for thermally interfacing with a biological tissue.”], comprising:
a pair of electrodes coupled with a region of interest of a subject for providing
electrostimulation thereto [see Fig. 32 element ultrathin sensor/actuator and para 170-171… “Actuating” refers to stimulating, controlling, or otherwise affecting a structure, material or device component. Useful device components for actuating include, but are not limited to, electrode elements” Plurality of electrode elements implies a pair of electrodes]; and
a wireless platform [see Fig. 32 element labelled “Silicone-elastomer substrate”] coupled with the pair of electrodes for operable providing power to the stimulator [see Fig. 32]
Claim 39:
An electrotherapy system [see Fig. 32 and abstract…“Provided are wireless electronic devices for thermally interfacing with a biological tissue.”], comprising:
a stimulator coupled with a region of interest of a subject for providing
electrostimulation thereto [see Fig. 32 element ultrathin sensor/actuator and para 170-171… “Actuating” refers to stimulating, controlling, or otherwise affecting a structure, material or device component. Useful device components for actuating include, but are not limited to, electrode elements”].
Dependent claims:
Regarding claim 11, para 91 of Rogers [see “Any of the devices and methods described herein may further comprise one or more components useful for the application of interest. Examples include, but are not limited to… encapsulating layers”] describes encapsulating layers possibly being included implying this feature is optional indicating Rogers as including embodiments of the system that include electrodes without an encapsulating layer.
Regarding claims 17-18, para 51 of Rogers [see “The wireless electronic device of any of the above embodiments, further comprising an encapsulating layer of PI with a thickness less than 10 μm.”] discloses polyimide (i.e. a type of polymer) encapsulation as claimed.
Regarding claims 32-33: see Fig. 32 of Rogers which discloses a “sheet adhesive” and “silicon adhesive” which is a releasable flexible connector electrically connected and configured for allowing the platform to be positioned as recited in claims 32-33
Regarding claim 34: see Fig. 32 of Rogers which shows the electrodes (sensor/actuator) positioned relative to the platform (silicone elastomer substrate) as claimed.
Regarding claims 35-36, para 328 of Rogers [see “Its rugged, lightweight design allows for continuous use over long time-periods, including up to a 7-day period, with capabilities in power transfer and data transmission directly through a commercially available NFC-enabled smartphone, tablet computer or other portable device.”] and para 333 of Rogers [see “The overall construction enables easy mounting, and advanced electronics designs allow for wireless measurement and readout from an external controller, such as a commercial, NFC-enabled smartphone or tablet computer as shown in FIG. 32 (panels E-F).”] are understood to recite a mobile device that includes an app with graphical user interface operating as recited as claimed in claims 35-36.
Regarding claim 37, para 66 of Rogers [see “the additional sensor is one or more of an optical sensor such as a photodetector, ambient electromagnetic radiation sensor, an accelerometer, a piezoelectric device to measure a skin modulus, an impedance sensor, a motion sensor, or a vibration sensor.”] discloses a means as interpreted as outlined under 112 section above.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 2, 4-8, 12, 15, 19, 28-31, 40, 42-47, 49, 53-55 and 57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rogers in view of Andino et al (US 20030144723) hereafter known as Andino.
Independent claim:
Claim 46:
A method for electrotherapeutic stimulation to a region of interest of a subject [see para 212… “During operation, the sensor acts as a thermal actuator upon application of direct electrical current (Keithley 6220, A Tektronix Co.). The device connects to the current source by bonding to a conductive ribbon (250 μm spacing, 3M) and small PC board (˜2.5 cm×5 cm). With thermal actuation, the resistive sensor undergoes self-heating where the resistance of the sensor linearly increases with temperature per the coefficient of resistance of the metal (Au), FIG. 19.” Thermal activation by electrodes is at least electrotherapeutic stimulation], comprising:
providing a pair of electrodes [see Fig. 32 element ultrathin sensor/actuator and para 170-171… “Actuating” refers to stimulating, controlling, or otherwise affecting a structure, material or device component. Useful device components for actuating include, but are not limited to, electrode elements” Plurality of electrode elements implies a pair of electrodes]; and
applying a voltage to the pair of electrodes for electrostimulation to the region of
interest for predetermined periods of time, wherein the region of interest is a wound site of the subject [see para 126… “Wirelessly measured raw voltage during actuation, overlaid with simultaneously acquired IR data for stable temperature (left) and drifting temperature (right). D.” and para 333…. “Changes in temperature cause changes in resistance (˜5Ω), that result in differential voltage changes (˜500 V) across the arms of the bridge. This differential voltage is amplified by an operational amplifier whose closed-loop gain is set by the choice of feedback resistor (R5). To induce thermal actuation, R2 can be tuned, allowing for precise control of the power dissipated by the sensing arm.” And para 327… “One such opportunity revolves around the precise, and continuous thermal characterization of human skin, with recent embodiments demonstrating the ability to measure temperature, blood flow, skin hydration, wound healing and skin-based pathologies such as cellulitis and sunburn up to depths of several millimeters, over several locations including skin and the fingernail.”]
However, Rogers is silent as to the exact position of the electrodes relative to each other and therefore fails to fully disclose “an outer electrode surrounding the inner electrode” and thus fails to fully disclose “providing a pair of electrodes having an inner electrode attached onto the region of interest and an outer electrode surrounding the inner electrode” and Rogers fails to disclose the voltage is applied “every day until full wound closure” and thus fails to fully disclose “applying a voltage to the pair of electrodes for electrostimulation to the region of interest for predetermined periods of time every day until full wound closure”]
Andino discloses in the analogous art of wound healing [see para 1… “The present invention relates generally to apparatus and methods for facilitating wound healing through the use of electrical stimulation”] that a known electrode configuration includes an inner electrode surrounded by an outer electrode around a wound (i.e. area of interest) that emits a current path between the electrodes as this helps maximize cell recruitment to help with wound healing [see Figs. 2 and 4 element 22 (inner electrode) element 24 (outer electrode) element 60 (wound) and para 41… “Referring to FIG. 2, conductive leads 32 and 34, which connect electrodes 22 and 24 respectively to power supply 40” and para 48… “FIG. 4 demonstrates a view of electrode system 10 placed over wound 60. In this embodiment, electrode system 10 is a disposable, one-time-use bandage that uses a battery and associated circuitry as power supply 40, which is attached to electrode system 10. Appropriate electrical parameters may be selected such that the current generated by the internal circuitry will last for a desired period of time. For example, the desired period of time may be at least as long as the typical amount of time a normal bandage is used on the wound.” And para 24….”Such a pattern of current flow maximizes the recruitment of the necessary cells to the wound location at the appropriate times during the various stages of wound healing.”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Rogers by applying the voltage every day until the wound heals (i.e. thereby fully reciting “providing a pair of electrodes having an inner electrode attached onto the region of interest and an outer electrode surrounding the inner electrode”) because there are a limited number of ways to apply therapy across a healing time frame (i.e. once, never, intermittently until complete healing, or every day until complete healing) and every day until complete healing is one of those limited number of ways.
Additionally, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Rogers by configuring the electrodes to have an inner and outer electrode around wound and to emit an additional current between the electrodes similarly to that disclosed by Andino (i.e. thereby fully reciting “applying a voltage to the pair of electrodes for electrostimulation to the region of interest for predetermined periods of time every day until full wound closure”) because this is a known way to help maximize cell recruitment thereby leading to better wound healing.
Dependent claims:
Regarding claims 2 and 40:
Rogers discloses the invention substantially as claimed including all the limitations of claims 1 and 39 as outlined above and a pair of electrodes [see para 170-171… “Actuating” refers to stimulating, controlling, or otherwise affecting a structure, material or device component. Useful device components for actuating include, but are not limited to, electrode elements”]
However, Rogers is silent as to how the electrodes are configured and therefore fails to disclose “a first electrode attached onto the region of interest and a second electrode surrounding the first electrode” as recited in claims 2 and 40.
Andino discloses in the analogous art of wound healing [see para 1… “The present invention relates generally to apparatus and methods for facilitating wound healing through the use of electrical stimulation”] that a known electrode configuration includes an inner electrode surrounded by an outer electrode around a wound (i.e. area of interest) that emits a current path between the electrodes as this helps maximize cell recruitment to help with wound healing [see Figs. 2 and 4 element 22 (inner electrode) element 24 (outer electrode) element 60 (wound) and para 41… “Referring to FIG. 2, conductive leads 32 and 34, which connect electrodes 22 and 24 respectively to power supply 40” and para 48… “FIG. 4 demonstrates a view of electrode system 10 placed over wound 60. In this embodiment, electrode system 10 is a disposable, one-time-use bandage that uses a battery and associated circuitry as power supply 40, which is attached to electrode system 10. Appropriate electrical parameters may be selected such that the current generated by the internal circuitry will last for a desired period of time. For example, the desired period of time may be at least as long as the typical amount of time a normal bandage is used on the wound.” And para 24….”Such a pattern of current flow maximizes the recruitment of the necessary cells to the wound location at the appropriate times during the various stages of wound healing.”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Rogers by configuring the electrodes to have an inner and outer electrode around wound and which emits an additional current between the electrodes similarly to that disclosed by Andino (i.e. thereby fully reciting claims 2 and 40) because this is a known configuration that helps maximize cell recruitment thereby leading to better wound healing.
Regarding claims 4-5 see rejection to claim 2 which cites Figs. 2 and 4 of Andino as disclosing the electrode configuration of Rogers in view of Andino which shows electrodes configured and/or capable of being arranged and/or positioned as claimed.
Regarding claims 6-7, see para 191 of Rogers [see “A serpentine electrical interconnect 320 may electrically connect various components to contact pad 330”] which disclose how the electrical elements of Rogers in view of Andino (i.e. understood to include the electrodes) have a serpentine layout as recited in claim 6 and see para 280 of Rogers [see “Each epidermal thermal depth sensor (e-TDS) comprises a thin metal trace (Au, 5-10 μm width) in a circular, coil geometry (radius R), with a pair of serpentine interconnects (Au, less than or equal to 200 μm, such as 100 μm width and length less than or equal to 2.5R, such as about 2R, with resistance <100Ω)”] which discloses a thickness and width as recited in claim 7.
Regarding claim 8:
Rogers in view of Andino discloses the invention substantially as claimed including all the limitations of claims 1-2, 6-7 as outlined above and a first second electrodes with a thickness of 15 microns and a width of 120 microns [see para 280 of Rogers…. “Device structure and operation using a single-layer model: Each epidermal thermal depth sensor (e-TDS) comprises a thin metal trace (Au, 5-10 μm width) in a circular, coil geometry (radius R), with a pair of serpentine interconnects (Au, less than or equal to 200 μm, such as 100 μm width and length less than or equal to 2.5R, such as about 2R, with resistance <100Ω) “]
However, Rogers in view of Andino fails to disclose a flower-like design, therefore Rogers fails to fully disclose “wherein the first electrode includes a serpentine trace with a thickness of 15 μm and width of 120 μm in a flower-like design; and the second electrode adopts a similar serpentine shape with similar thickness and width.” as claimed.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Rogers in view of Andino by making the first and second electrodes in a flower-like design similarly as claimed (i.e. thereby fully reciting claim 8) because absent unpredictable results such a modification is a mere change in shape which has been deemed to be a matter of choice [see In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966)]
Regarding claims: 12, 15, 42-43 and 47:
Paras 328-329 of Rogers discloses electronics design and wireless power transfer (i.e. a power harvesting unit that powers the system and as it is wireless it is understood to recite an antenna of some type) that uses NFC communication (i.e. near field communication) to communicate and be operated by a smart phone or other portable device (i.e. microcontroller unit as claimed). Additionally, based on Fig. 32 of Rogers the electronic components of the platform are all part of a substrate (i.e. a system on a chip) and para 336 of Rogers voltage is measured. Thus, the limitations in claims 12, 15, 42-43 and 47 are recited as claimed.
Regarding claims 19, 28-31:
See rejection to claim 2 above which discloses how Rogers in view of Andino applies a current to recruit cells for wound healing (i.e. adapted for electro therapeutically treating the wound, capability to mimic naturally driven endogenous wound currents and acceleration of closure rate and granulation tissue formation of the wound, reduces time for closure and subduing the pro-inflammatory and stimulating the anti-inflammatory response) which recites these claims.
Regarding claim 44
See rejection to claim 40 above which discloses how Rogers in view of Andino applies a current to recruit cells for wound healing (i.e. mimic naturally endogenous wound currents) which recites this claim.
Regarding claim 45, see para 328 of Rodgers [see “Its rugged, lightweight design allows for continuous use over long time-periods, including up to a 7-day period, with capabilities in power transfer and data transmission directly through a commercially available NFC-enabled smartphone, tablet computer or other portable device.”] and para 333 of Rodgers [see “The overall construction enables easy mounting, and advanced electronics designs allow for wireless measurement and readout from an external controller, such as a commercial, NFC-enabled smartphone or tablet computer as shown in FIG. 32 (panels E-F).”] which understood to recite a mobile device that includes an app with graphical user interface operating as recited as claimed.
Regarding claims 49 and 53-55, See rejection to claim 46 above which discloses how Rogers in view of Andino applies a current to recruit cells for wound healing (i.e. adapted for electro therapeutically treating the wound, mimics naturally driven endogenous wound currents and acceleration of closure rate and granulation tissue formation of the wound and subduing the pro-inflammatory, reduces time for closure and stimulating the anti-inflammatory response) which recites these claims.
Regarding claim 57:
para 66 of Rogers [see “the additional sensor is one or more of an optical sensor such as a photodetector, ambient electromagnetic radiation sensor, an accelerometer, a piezoelectric device to measure a skin modulus, an impedance sensor, a motion sensor, or a vibration sensor.”] which discloses detecting parameters as claimed.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rogers in view of Andino as applied to claims 1-2 above, and further in view of Prakash et al (WO-2021207516) hereafter known as Prakash
Rogers in view of Andino discloses the invention substantially as claimed including all the limitations of claim 1-2.
However, Rogers in view of Andino fails to disclose “wherein the pair of electrodes is spatially apart from each other to define an electrode spacing that is larger than 1 mm” as recited by claim 3.
Prakash discloses in the analogous art of wound healing [see para 2… “The present disclosure is generally directed to devices and methods for generating and directing an electric current through a wound to promote healing.”] that a known spacing between two electrodes via which electric field is applied to help heal a wound is 10nm-10 mm [see para 29… “The electroceutical dressings can be formed into any of a number of possible shapes, patterns or geometries, depending upon the application and topography of the wound or application site. Any aspect of the wound dressing can be manufactured in a variety of shapes and configurations. … Generally, it is desired to have the conductive anode 106 and conductive cathode 108 as close together as possible without causing an electrical short-circuit. Exemplary feature spacings include, without limitation, from about 10 nm to about 10 mm” and abstract… “Methods of making the dressings and methods of applying an electric current to promote the wound healing process are also disclosed.”].
Since Rogers in view of Andino is silent as to the exact distance between the electrodes and Prakash discloses 10 nm – 10 mm is a known distance with which to space electrodes when using electrical field to heal a wound, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Rogers in view of Andino by spacing the electrodes 10 nm- 10 mm apart similarly to that disclosed by Prakash because this is a known spacing when treating wounds.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Rogers in view of Andino in view of Prakash by spacing the electrodes 1-10mm apart because this is a subset of the range of spacing taught by Rogers in view of Andino in view of Prakash and therefore a subcombination of different combinations of spacing disclosed.
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rogers in view of Andino as applied to claims 1-2 and 12 above, and further in view of Skaribas et al (US 20130296967) hereafter known as Skaribas.
Rogers in view of Andino discloses the invention substantially as claimed including all the limitations of claim 1-2 and 12 as outlined above.
However, Rogers in view of Andino fails to disclose “wherein the wireless platform further comprises a component that serves as an audio or visual indicator of system operation” as recited by claim 13 or “wherein the visual indicator of system
operation is a light-emitting diode (LED)” as recited by claim 14.
Skaribas discloses in the analogous art of electrode-based devices [see abstract… “The device further includes a plurality of electrical electrodes circumferentially disposed along the head band, wherein the plurality of electrodes contacts each of the front portion, the rear portion, the first lateral side, and the second lateral side. The plurality of electrical electrodes is configured to stimulate, with electrical current, at least one of the greater occipital nerve, the lesser occipital nerve, the supraorbital nerve, the supratrochlear nerve, zygomatotemporal nerve, and the auriculotemporal nerve when the electrodes are energized by the power source.”] a visual indicator in the form of a light diode that indicates the power level of a system is acceptable for operation (i.e. visual indicator of system operation) [see para 35… “device 100 also include a low battery indicator (not shown) located near switch 110 within cavity 144, on the separate remote (not shown), or some other suitable location along or within device 100 such that the patient will be alerted when the power level within source 130 has fallen below a level that is acceptable for operating the device 100. The low battery indicator may comprise a visual indicator (e.g., a light emitting diode), an audible indicator, or both.”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Rogers in view of Andino to include a visual indicator of an light emitting diode that provides information as to if the level power is enough for the system to operation similarly to that disclosed by Skaribas (i.e. thereby reciting claims 13-14) as this provide notice of the power level to a user.
Claim(s) 9-10, 16, 20-21, 24-27, 41, 48, 50-51 and 56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rogers in view of Andino as applied to claims 1-2, 12, 15, 19, 39-40 and 46-47 above, and further in view of Campbell et al (US 20140200626) hereafter known as Campbell.
Regarding claims 9-10 and 41:
Rogers in view of Andino discloses the invention substantially as recited in claims 1-2 and 39-40 as outlined above.
However, Rogers in view of Andino discloses using electrodes with gold material and therefore fails to disclose “wherein the pair of electrodes is bioresorbable and biocompatible” as recited by claims 9 and 41, or “wherein the pair of electrodes is formed of a bioresorbable conductive material comprising molybdenum (Mo), zinc (Zn), iron (Fe), tungsten (W), magnesium (Mg), AZ31B (3 wt% Al and 1 wt% Zn) Mg alloy, and/or other bioresorbable conductive materials” as recited by claim 10.
Campbell discloses in the analogous art of implantable medical devices that implantable devices are known to be made of bioresorbable and biocompatible materials including magnesium which is for the purpose of controlling the period of time of treatment by the device [see para 47… “Most, if not all, of the components of the implantable medical device are composed of materials having predictable and controllable resorption within a patient upon implantation. Accordingly, the target duration of the function life of the device may be a function of the expected period of treatment. The transience of function may be controlled either by incorporating one or more bioresorbable components within the circuit of the device itself or by including a bioresorbable protective encapsulation coating configured to degrade over a programmed period of time, after which the circuit is compromised and ceases function.” And claims 18-21… “wherein one or more components of the circuit comprises a material selected from the group consisting of Mg, Mg alloys, MgO, Zn, W, Fe, Si, SiO.sub.2, and combinations thereof.”]
It would have been obvious to one having ordinary skill at the time the invention was filed to modify Rogers in view of Andino by making the electrodes out of the bioresorbable and biocompatible magnesium material similarly to that disclosed by Campbell (i.e. thereby reciting 9-10 and 41) because this provides the advantage of further controlling the duration of a treatment.
Regarding claims 16 and 48:
Rogers in view of Andino discloses the invention substantially as claimed including all the limitations of claims 1-2, 12, 15 and 46-47 as outlined above which includes a wireless power harvesting unit.
However, Rogers in view of Andino is silent as to the frequency used by the wireless power harvesting unit and thus, fails to disclose “wherein the power harvesting unit operates by inductive coupling at a resonance frequency in a range of about 10-15 Mhz, preferably about 13.56 MHz” as recited by claims 16 or “wherein the power harvesting unit operates by resonant inductive coupling at a resonance frequency in a range of about 10-15 Mhz, preferably about 13.56 MHz” as recited by claim 48.
Campbell discloses in the analogous art of implantable medical devices [see abstract… “The invention generally relates to an implantable, tunable, and bioresorbable medical device for nerve stimulation within a body of a patient for pain management.”] 13.56 MHz is a known resonant transmission frequency used for wireless inductive charging [para 97… “The proof-of-concept nerve stimulator system was designed to receive wireless power via resonant inductive coupling from an external controller 104 in the form of a PCB-based transmitter operating at a transmission frequency within the 13.56 MHz ISM band.”]
Since Rogers in view of Andino is silent as the frequency used and Campbell discloses 13.56 Mhz is a known resonance frequency used for wireless inductive charging, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Rogers in view of Andino by using a frequency of 13.56 Mhz similarly to that disclosed by Campbell.
Regarding claims 20-21:
Rogers in view of Andino discloses the invention substantially as claimed including all the limitations of claim 1-2, 12 and 19 as outlined above. Additionally, as discussed in rejection to claim 2 above, Rogers in view of Andino discloses applying a current to recruit cells which is understood to have a structure to mimic in vivo conditions including those over adipose tissue as recited in claim 21.
However, Rogers in view of Andino fails to disclose “wherein the pair of electrodes is designed to support levels of electrical conductivity and interface impedances that are necessary for electrotherapy and wound monitoring over several weeks of use in a thin, flexible, and stretchable construct that naturally bioresorbs into the healed tissue to eliminate the need for surgical retrieval” as recited by claim 20
Campbell discloses in the analogous art of implantable medical devices that implantable devices are known to be made of bioresorbable and biocompatible materials including magnesium which is for the purpose of controlling the period of time of treatment by the device [see para 47… “Most, if not all, of the components of the implantable medical device are composed of materials having predictable and controllable resorption within a patient upon implantation. Accordingly, the target duration of the function life of the device may be a function of the expected period of treatment. The transience of function may be controlled either by incorporating one or more bioresorbable components within the circuit of the device itself or by including a bioresorbable protective encapsulation coating configured to degrade over a programmed period of time, after which the circuit is compromised and ceases function.” And claims 18-21… “wherein one or more components of the circuit comprises a material selected from the group consisting of Mg, Mg alloys, MgO, Zn, W, Fe, Si, SiO.sub.2, and combinations thereof.”]
It would have been obvious to one having ordinary skill at the time the invention was filed to modify Rogers in view of Andino by making the electrodes out of the bioresorbable and biocompatible magnesium material similarly to that disclosed by Campbell (i.e. thereby reciting 20) because this provides the advantage of further controlling the duration of a treatment.
Regarding claims 24-25, para 223 of Rogers [see “As previously stated, thermal actuation of the resistive sensor causes an increase in its temperature. The temperature increases rapidly for short durations (i.e. 2 s) of thermal actuation (measurement time) and increases incrementally at longer durations (i.e. >40 s)”] discloses how durations for actuating (i.e. applying stimulation) can be adjusted (i.e. customizable). This indicates structural capability to apply voltage for predetermined periods including until wound closure and the predetermined periods are customizable as recited in claims 24-25.
Regarding claims 26-27 and 50-51, para 66 of Rogers [see “The wireless electronic device of embodiments 43, wherein the additional sensor is one or more of an optical sensor such as a photodetector, ambient electromagnetic radiation sensor, an accelerometer, a piezoelectric device to measure a skin modulus, an impedance sensor, a motion sensor, or a vibration sensor.”] discloses impedance measurements which are understood to be associated with a drying process of the wound, provides an estimate of the healing process and is a signature of drying of the wound as recited by claims 26 and 50 and as it the wound gets dryer the impedance is understood to drop to 0 as recited by claims 27 and 51.
Regarding claim 56:
Rogers in view of Andino discloses the invention substantially as recited in claims 1-2 and 39-40 as outlined above.
However, Rogers in view of Andino discloses using electrodes with gold material and therefore fails to disclose “wherein the inner electrode is eliminable completely from the wound site of the subject through natural chemical/biochemical processes of hydrolysis and/or metabolic actions, over a subsequent timeframe following completion of electrotherapy” as recited by claim 56.
Campbell discloses in the analogous art of implantable medical devices that implantable devices are known to be made of bioresorbable and biocompatible materials including magnesium (i.e. inner electrode is eliminable completely from the wound site of the subject through natural chemical/biochemical processes of hydrolysis and/or metabolic actions, over a subsequent timeframe) for the purpose of controlling the period of time of treatment by the device [see para 47… “Most, if not all, of the components of the implantable medical device are composed of materials having predictable and controllable resorption within a patient upon implantation. Accordingly, the target duration of the function life of the device may be a function of the expected period of treatment. The transience of function may be controlled either by incorporating one or more bioresorbable components within the circuit of the device itself or by including a bioresorbable protective encapsulation coating configured to degrade over a programmed period of time, after which the circuit is compromised and ceases function.” And claims 18-21… “wherein one or more components of the circuit comprises a material selected from the group consisting of Mg, Mg alloys, MgO, Zn, W, Fe, Si, SiO.sub.2, and combinations thereof.”]
It would have been obvious to one having ordinary skill at the time the invention was filed to modify Rogers in view of Andino by making the electrodes out of the bioresorbable and biocompatible magnesium material similarly to that disclosed by Campbell (i.e. thereby reciting claim 56) because this provides the advantage of further controlling the duration of a treatment.
Claim(s) 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rogers in view of Andino in view of Campbell as applied to claims 1-2, 12, 15, 19-21 above, and further in view of Vidyasagar et al (US 20210283081) hereafter known as Vidyasagar.
Rogers in view of Andino in view of Campbell discloses all the limitations of claims 1-2, 12, 15, 19-21 and wherein the inner electrode is eliminable completely from the wound site of the subject through natural chemical/biochemical processes of hydrolysis and/or metabolic actions, over a subsequent timeframe following completion of electrotherapy [see rejection to claim 20 above which disclose the device as being made of material that is reabsorbed by the body which is understood to be performed by hydrolysis and/or metabolic actions]
However, Rogers in view of Andino in view of Campbell fails to disclose “wherein the inner electrode is fixed on the wound site by a sutured splint ring structure” as recited by claim 23.
Vidyasagar discloses in the analogous art of wound healing that sutured split rings are used prevent wound contraction [see para 74… “FIG. 21 shows the results of wound healing studies” and “To prevent wound contracture, a silicon O-ring was used as a splint and held in place by interrupted sutures. AA-ORS or saline was used in transparent occlusive dressing of the wounds. The dressing was changed every day after measuring the wound area using calipers.”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Rogers in view of Andino in view of Campbell by placing the device including the inner electrode on a sutured splint ring structure around the wound similarly to that disclosed by Vidyasagar because this help prevent wound contracture.
Claim(s) 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rogers in view of Campbell.
Rogers discloses the invention substantially as claimed including all the limitations of claim 1 as outlined above. Additionally, Rogers discloses a wherein the electrotherapy system is a wireless, and battery-free electrotherapy system [see paras 328-329 of Rogers which discloses electronics design and wireless power transfer (i.e. wireless and battery free)]
However, Rogers fails to disclose that the “electrotherapy system is a bioresorbable” as claimed.
Campbell discloses in the analogous art of implantable medical devices that implantable devices are known to be made of bioresorbable and biocompatible materials including magnesium which is for the purpose of controlling the period of time of treatment by the device [see para 47… “Most, if not all, of the components of the implantable medical device are composed of materials having predictable and controllable resorption within a patient upon implantation. Accordingly, the target duration of the function life of the device may be a function of the expected period of treatment. The transience of function may be controlled either by incorporating one or more bioresorbable components within the circuit of the device itself or by including a bioresorbable protective encapsulation coating configured to degrade over a programmed period of time, after which the circuit is compromised and ceases function.” And claims 18-21… “wherein one or more components of the circuit comprises a material selected from the group consisting of Mg, Mg alloys, MgO, Zn, W, Fe, Si, SiO.sub.2, and combinations thereof.”]
It would have been obvious to one having ordinary skill at the time the invention was filed to modify Rogers by making the system out of the bioresorbable and biocompatible magnesium material similarly to that disclosed by Campbell (i.e. thereby reciting “electrotherapy system is a bioresorbable”) because this provides the advantage of further controlling the duration of a treatment.
Claim(s) 52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rogers in view of Andino as applied to claim 46 above, and further in view of Prakash.
Rogers in view of Andino discloses the invention substantially as claimed including all the limitations of claim 46 and applying a voltage of between 1mV-9V [see para 42 of Andino which discloses a supplied electric field of Rogers in view of Andino…see “Power supply 40 may be configured to apply a voltage that is anywhere between 1 mV and 9 V.”]
However, Rogers in view of Andino is silent as to the distance and/or strength of the electric fields used and therefore fails to disclose “wherein the electrostimulation results in an electric field strength of about 1 m V /mm or more near the inner electrode and in regions of adipose tissue between the outer and inner electrodes, which is sufficient to cause migration of human keratinocyte cells to accelerate wound healing processes” as recited by claim 52.
Prakash discloses in the analogous art of wound healing [see para 2… “The present disclosure is generally directed to devices and methods for generating and directing an electric current through a wound to promote healing.”] that a known spacing between two electrodes via which electric field is applied to help heal a wound is 10nm-10 mm [see para 29… “The electroceutical dressings can be formed into any of a number of possible shapes, patterns or geometries, depending upon the application and topography of the wound or application site. Any aspect of the wound dressing can be manufactured in a variety of shapes and configurations. … Generally, it is desired to have the conductive anode 106 and conductive cathode 108 as close together as possible without causing an electrical short-circuit. Exemplary feature spacings include, without limitation, from about 10 nm to about 10 mm” and abstract… “Methods of making the dressings and methods of applying an electric current to promote the wound healing process are also disclosed.”].
Since Rogers in view of Andino is silent as to the exact distance between the electrodes and Prakash discloses 10 nm – 10 mm is a known distance with which to space electrodes when using electrical field to heal a wound, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Rogers in view of Andino by spacing the electrodes 10 nm- 10 mm apart similarly to that disclosed by Prakash because this is a known spacing when treating wounds.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Rogers in view of Andino in view of Prakash by adjusting the voltage to produce an electric field with 1 mV/mm (i.e. thereby reciting claim 52) because this is a subcombination of different combinations of voltages and distances disclosed by Rogers in view of Andino in view of Prakash.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Fried et al (US 20160184596) hereafter known as Fried. Fried discloses in the analogous art of implantable stimulation devices [see Fig. 1A and abstract and para 16] a device with electrodes on a system-on-chip with near-field communication [see para 15].
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SEBASTIAN X LUKJAN
/SXL/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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