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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/16/25 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to because of the lack of legibility in Figs. 4a-4h . Applicant could overcome this drawing objection by enhancing the figure pixel quality, making the figures larger, and providing the figures on separate pages (see MPEP § 608.02.V(l): Character of lines, numbers, and letters and 608.02.V(p)(3): number, letters, and reference characters). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 9-17 are objected to because of the following informalities:
Claim 9 line 3 reads “according to delivery profile” and should likely read “according to a delivery profile” to provide proper antecedent basis for delivery profile which has not yet been introduced in the claim language
Each of Claims 10-15 in line 1 read “the device of claim” and should likely read “the [[device]] system of claim” to provide proper reference to the claim from which each of these claims depend
Claim 13 line 4 reads “reservoirs storing the fluid comprising ions” and should likely read “a plurality of reservoirs storing the fluid comprising ions” to provide antecedent basis for the structure of “reservoirs”
Claim 15 lines 2-3 read “so as to form the first type of ions comprising biomolecules or drugs” and should likely read “so as to form [[the]] a first type of ions comprising biomolecules or drugs” to provide antecedent basis for a “first type” of ions which have not yet been introduced in the claim language
Claim 16 line 4 reads “the imaging system” and should likely read “[[the]] an imaging system” to provide proper antecedent basis for imaging system which has not yet been introduced in the claim language
Claim 16 line 18 reads “the control circuit” and should likely read “[[the]] a control circuit” to provide proper antecedent basis for control circuit which has not yet been introduced in the claim language
Claim 16 line 22 reads “the electrodes” should likely read “[[the]] a plurality of electrodes” to provide proper antecedent basis for electrodes which have not yet been introduced in the claim language
Claim 17 line 1 reads “the ions” and should likely read “[[the]] a plurality of ions” to provide proper antecedent basis for ions which have not yet been introduced in the claim language
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.
Claims 1 and all subsequent depending claim recitations of “means for delivering” invoke 112f interpretation as explained below:
Claim 1 line 2: “means for delivering a dose of therapy to a treatment site”. Therefore, claim 1 is interpreted under 112(f) according to the 3-prong test:
Prong 1: means or generic placeholder is recited— “means” has been recited
Prong 2: functional language—for delivering a dose
Prong 3: not modified by other structural language in the claims—no structure is recited for how the means for delivering a dose of therapy functions in order to achieve therapeutic delivery. Only the desired outcome of “delivering a dose” is recited.
According to Applicant’s disclosure under 112(f), the means for delivering a dose of therapy to a treatment site is interpreted as a bioelectronic bandage or equivalent (see [0111] of the current Application’s PGPUB).
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function.
Such claim limitation(s) is/are:
means for delivering the dose in claim 4. Claim 4 recites sufficient structure that the means for delivering comprises a control circuit coupled to a pump
means for delivering the dose in claim 9. Claim 9 recites sufficient structure that the means for delivering comprises a control circuit and an ion pumping system
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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 11 and 18 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 11 recites the limitation "the ion conducting material" in line 8. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the examiner interprets that claim 11 depends from claim 10 instead of claim 9 because claim 10 has proper antecedent basis for “ion conducting material”.
Claim 18 recites the limitation "the wound dermal interface" in line 1. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the examiner interprets that claim 18 depends from claim 16 instead of claim 1 because claim 16 has proper antecedent basis for “wound dermal interface”.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 6-8, 17, 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Toong et al. (U.S. PGPUB No. 2021/0268276), hereinafter Toong.
Regarding claim 1, Toong discloses a system for delivering therapy to a treatment site, comprising:
means for delivering a dose of a therapy to a treatment site (see [0018]: patch used with or without medication and provides electrical stimulation to wound site. See [0094-0098]: iontophoresis delivery via patch, aligning with 112 interpretation above. patch 110, see FIG. 8 provided for immediate reference below and [0082]: “Patch 110 can be implemented by patch 100 previously described.” and therefore portions of the specification describing patch 100 will also be referenced throughout rejections.);
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a sensor (115) configured for sensing the treatment site and outputting data in response thereto (see [0084], [0086], [0116-0122]: sensor data such as images are provided to controller); and
a data-driven controller or data-driven computer (140) configured to control the dose (see [0103-0115]: smart controller and patch control treatment protocol) in a closed loop by (see [0091]: closed loop monitoring):
determining a healing state of the treatment site from the data (see [0116-0124]), and
using the healing state as feedback to update or determine the dose delivered to the treatment site so that the therapy increases a rate of healing of the treatment site and/or the healing state converges to a desired healing state (see [0116-0124]: wound monitoring use data to design treatment protocol to optimize wound healing).
Regarding claim 2, Toong discloses the system of claim 1, and Toong further discloses wherein the controller implements a real-time data informed algorithm for determining the healing state and the dose in real time as the data is updated and received from the sensor (see [0084], [0086], [0116-0122]: sensor data used by controller, see [0116-0124]: determining healing state from data and see [0047], [0091], [0121-0124]: real time data and analysis).
Regarding claim 3, Toong discloses the system of claim 1, and Toong further discloses wherein the data-driven controller or data-driven computer (140, see FIG. 8) is configured to execute machine learning or artificial intelligence to determine the healing state and the dose using the data as the feedback (see [0116-0124]).
Regarding claim 4, Toong discloses the system of claim 1, and Toong further discloses wherein:
the means for delivering the dose (see [0018]: patch used with or without medication and provides electrical stimulation to wound site. See [0094-0098]: iontophoresis delivery via patch. patch 110, see FIG. 8. See [0141]: patch 110 includes data manager such as in control unit 1002) comprises a control circuit (1000, see FIG. 2 and [0023]) coupled to a pump operable to pump the therapy to the treatment site in response to one or more control signals received from the control circuit (see [0094-0098]: iontophoresis drives/pumps ions to site by voltage applied to a reservoir such as, see [0026-0027]: via controlled electrodes, aligning with applicant disclosure in [0013]: pump is electrodes and reservoir combination), and
the controller (140, see FIG.8) comprises or is coupled to the control circuit (see [0023]: circuit communicates to smartphone).
Regarding claim 6, Toong discloses the system of claim 4, and Toong further discloses wherein: the treatment site comprises a wound (see [0082]: fig. 8 shows patch applied to wound at neck), the healing state comprises at least one of a change in wound size or a rate of healing of the wound (see [0116-0124] and [0170]), and the controller executes a computer vision algorithm to identify and calculate at least one of the size and the rate of healing of the wound (see [0084], [0086], [0116-0122]: sensor data such as images are provided to controller to identify and calculate size/healing of wound by predictive algorithm).
Regarding claim 7, Toong discloses the system of claim 4, and Toong further discloses wherein the machine learning learns how to update the dose and the control signals in real time (see [0084], [0086], [0091], [0116-0124], and [0170]) and/or during a time lapse between the image frames from which the image data is obtained.
Regarding claim 8, Toong discloses the system of claim 1, and Toong further discloses wherein:
the means delivers the dose in response to control signals (see [0103-0124]: smart controller and patch control treatment protocol);
the computer or controller (140) comprises a hardware control circuit (1000, see FIG. 2 executed by circuit such as shown in FIG. 3A-B as described in [0028]) executing the machine learning (see [0023-0027], [0047-0048], and the machine learning: determines a reference signal representing the desired healing state (see 0120-0124]); and updates the control signals using the hardware without an algorithm by comparing the image data to the reference signal (see [0049-0071] & [0170]).
Regarding claim 17, Toong discloses the system of claim 1, and Toong further discloses the system operable to control delivery of the dose so that the ions (ions delivered via iontophoresis, see [0094-0098]) cause re-epithelialization of the treatment site comprising a wound, as characterized by the dose causing transitioning of macrophages in the treatment site to an anti-inflammatory pro- reparative phonotype (away from an inflammatory phenotype) early in the treatment cycle (see [0072-0081]: re-epithelization achieved by enhancing body’s natural process via patch dosing/therapy protocol and [0168]).
Regarding claim 19, Toong discloses a method comprising:
using data driven computing or a data-driven algorithm to output control signals used to control a dose of therapy delivered to a treatment site (see [0103-0115]: smart controller and patch control treatment protocol and [0116-0124]: wound monitoring use data to design treatment protocol to optimize wound healing) in a closed loop (see [0091]: closed loop operation) by:
determining a healing state of the treatment site from data obtained from a sensor (115, see FIG. 8) sensing the treatment site (see [0084], [0086], [0116-0122]: sensor data such as images are provided to controller and then this data allows determination of healing state as in [0116-0124]), and
using the healing state as feedback to determine the control signals used to control the dose delivered to the treatment site so that the therapy increases healing of the treatment site and/or the healing state converges to a desired healing state (see [0116-0124]: wound monitoring use data to design treatment protocol to optimize wound healing such as by modifying stimulation at site).
Regarding claim 20, Toong discloses the method of claim 19, and Toong further discloses wherein the data-driven computing comprises machine learning executed in software or hardware (see [0116-0124] & [0170]: software/hardware implement AI predictive algorithms to optimize wound therapy), and further comprising delivering the dose by pumping the therapy comprising ions to the treatment site (see [0094-0098]: device used iontophoresis).
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.
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Toong as applied to claim 4 above, and further in view of Chung et al. (U.S. PGPUB No. 2024/0115191), hereinafter Chung.
Regarding claim 5, Toong discloses the system of claim 4, and Toong further discloses wherein the data-driven controller or data-driven computer (140, see FIG. 8) executes machine learning (see [0116-0124]: AI with pattern recognition comparison to real-time date to produce predictive analyses and implements machine-learning algorithms), wherein the machine learning:
maps changes in image data to the control signals previously applied (see at least [0122] of [0116-0124]),
makes a decision whether the healing state should be changed to achieve the desired healing state (see [0116-0124] and [0170]: patch adjusts treatment based on sensor data of wound shape/sizes),
and updates the control signals applied to the pump via the control circuit if necessary in response to the decision (see [0129-0131]: controller updates therapy based on sensed conditions and [0170]: updating treatment regimens such as varying pulsing/intensity/etc. applied by electrodes).
Toong is silent to “the machine learning is executed in a neural network and the parameters of the neural network, comprising the bias and weights applied at each of the one or more layers of the neural network, are updated during a time-lapse between the image frames from which the images data is generated, such that the machine learning learns how to adapt the control signals in real time to obtain the desired healing state.”
However, Chung teaches a system for delivering therapy to a treatment site (see [0015-0017]) comprising a data-driven controller (330, see FIG. 3) configured to execute machine learning (321, see [0066]: 321 is machine learning algorithm such as radial basis function network), wherein the machine learning is executed in a neural network and the parameters of the neural network, comprising the bias and weights applied at each of the one or more layers of the neural network, are updated during a time-lapse between the image frames from which the images data is generated, such that the machine learning learns how to adapt the control signals in real time to obtain the desired healing state (see [0066]: Chung teaches a radial basis function of the machine learning and thus must have the bias and weights applied at the layers of the neural network. The update during a time-lapse between image frames, and adapting the control signals in as much as described by Applicant such as in [0162-0164], and [0215] of the current Application’s PGPUB. Further, see Chung [0062-0064] & [0070] & [0072-0073]: controller uses data to transmit treatment improvements to attached device).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor of the data-driven computer that executes machine learning algorithms as disclosed in Toong to include a machine learning algorithm such as radial basis function network as taught by Chung for the purpose of using a known machine learning algorithm including a neural network for image processing and analysis (see [0066-0067] and [0098]), thus achieving “the machine learning is executed in a neural network and the parameters of the neural network, comprising the bias and weights applied at each of the one or more layers of the neural network, are updated during a time-lapse between the image frames from which the images data is generated, such that the machine learning learns how to adapt the control signals in real time to obtain the desired healing state”.
Claims 9-10 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Toong as applied to claim 1 above, and further in view of Jeong et al. (U.S. PGPUB No. 2020/0316354), hereinafter Jeong.
Regarding claim 9, Toong discloses the system of claim 1, and Toong further discloses wherein the means for delivering the dose comprises: a control circuit (1002 implemented by physical hardware circuit 200, see [0028]: circuit 200 in FIG. 3a-3b implements control unit 1002 of chip 1000 in FIG. 2) programmable to output voltage control signals (see [0028-0042]) controlling the dose of ions according to delivery profile for treating a treatment site (see [0047-0051], [0069-0079], and [0094-0098]); and an ion pumping system (see [0094-0098]) comprising at least one ion channels (see [0096]: when compound provided in patch, the patch must have some kind of channel for compound to leave reservoir) and a plurality of electrodes (320, see FIG. 3B) coupled to the control circuit (as shown in FIG. 3A-B), wherein the ions are pumped through the ion channels to the treatment site in response to the voltage control signals (see [0072-0079], [0084-0089], [0094-0098] and [0130-0131]).
Toong does not explicitly disclose “a plurality of” ion channels.
However, Jeong teaches a system for delivering therapy to a treatment site (see [0002] and [0010]: for example, a patch) comprising an ion pumping system, wherein the ion pumping system (see FIG.3) comprises a plurality of ion channels (D+, D-, ND channels, see [0046-0048] and [0059]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ion pumping system with at least one channel disclosed in Toong to include a plurality of ion channels as taught by Jeong for the purpose of delivering different types of compounds at the same time (see [0048] and [0059]), thus achieving “a plurality of” ion channels.
Regarding claim 10, the modified system of Toong teaches the device of claim 9, and Toong further discloses wherein the ion pumping system (see [0094-0098]) further comprises:
a housing (bottom layer 1610 to top layer 1640, see FIG. 13 and [0146-0147] in stack-up view of patch) for a plurality of the channels (housing can contain any number of structures including “a plurality of channels”), the channel comprising:
a reservoir storing a fluid comprising the ions (see [0096-0097] and [0130]: hydrogel includes compounds for delivery. For example, see hydrogel reservoir 1626 in FIG. 13: Stack-up view of patch and described in [0147-0148]);
a reference electrode (see [0125-0126]: one common negative electrode) electrically connected to the fluid (such as by process described in [0152]);
an array of control electrodes (see [0125] and [0145]) each comprising an end for positioning at different spatial locations at the treatment site (see [0131-0140]); and
wherein the control circuit is operable to activate the pumping of the ions to one or more predetermined locations in the treatment site, by applying one or more of the voltage control signals between the reference electrode and one or more of the control electrodes associated with the predetermined locations according to the delivery profile (see [0129]: controller adjusts to create combination of stimulation via electrodes by voltage pulses and see [0131], and [0094-0098]).
Toong is silent to “each of” the channels comprising the structural elements and “one of the ion channels connecting the reservoir to the ends of the control electrodes, the one of the ion channels containing an ion conducting material for conducting the ions”.
However, Jeong teaches a system for delivering therapy to a treatment site (see [0002] and [0010]: for example, a patch) comprising an ion pumping system, wherein the ion pumping system (see FIG.3) comprises a housing (1 provided in patch 1P, see [0043-0044]) for a plurality of channels (D+, D-, ND channels, see [0046-0048] and [0059]), each of the channels comprising a reservoir (120, see FIG. 7 showing reservoir of Red I Pad 100 of FIG. 3 and description in [0056]: nutrients in unit cell of 120 mixed with water. See FIG. 13 and [0065] for RED II pad), a reference electrode (see [0056] & [0059]), an array of control electrodes (see [0056] & [0059]), and one of the ion channels connecting the reservoir to the ends of the control electrodes (see [0059-0063]), the one of the ion channels containing an ion conducting material for conducting the ions (see [0059-0063]), wherein a control unit (600, see FIG. 3) is operable to activate the pumping of the ions to one or more predetermined locations in the treatment site (see [0047]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ion pumping system with at least one channel disclosed in Toong to include a plurality of channels with the structural elements as taught by Jeong for the purpose of delivering different types of compounds at the same time (see [0048] and [0059]), thus achieving “each of” the channels comprising the structural elements.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify one of the ion channels disclosed in Toong to connect the reservoir to the end of the control electrode and to contain an ion conducting material for conducting the ions as taught by Jeong for the purpose of improving the efficiency of delivery of nutrients and/or drugs to the skin and ensuring that the amount of nutrients/drugs discharged are uniformly maintained to act as a sort of pump which is capable of controlling the amount moved through the ion exchange membrane (see [0059]), thus achieving “one of the ion channels connecting the reservoir to the ends of the control electrodes, the one of the ion channels containing an ion conducting material for conducting the ions”.
Regarding claim 13, the modified system of Toong teaches the device of claim 9, and Toong further discloses wherein the wearable ion pumping system (see [0094-0098]) further comprises: a housing (bottom layer 1610 to top layer 1640, see FIG. 13 and [0146-0147] in stack-up view of patch) housing: reservoir storing the fluid comprising the ions (see [0096-0097] and [0130]: hydrogel includes compounds for delivery. For example, see hydrogel reservoir 1626 in FIG. 13: Stack-up view of patch and described in [0147-0148]), and the ion channel (see [0096]: when compound provided in patch, the patch must have some kind of channel for compound to leave reservoir); and the electrodes electrically connected to the fluid (such as by providing hydrogel to electrode, see [0146-0147]) and the control circuit (see [0146] and process in [0152]) so that the electrodes activate the pumping by applying the voltage control signals to the fluid (see [0094-0098], [0125-0130], and [0170]); and a printed circuit board (PCBA 1630) physically attached to the housing (see [0146-0147]) and comprising the control circuit connected to the electrodes (see [0146]).
Toong is silent to multiple reservoir“s” and multiple ion channel“s” and “the ion channels each loaded with an ion conducting material between the reservoir and the treatment site.”
However, Jeong teaches a system for delivering therapy to a treatment site (see [0002] and [0010]: for example, a patch) comprising an ion pumping system, wherein the ion pumping system (see FIG.3) comprises a housing (1 provided in patch 1P, see [0043-0044]) comprising reservoirs (RED I Pad and Red II pad) storing the fluid comprising the ions (see FIG. 7 showing reservoir of Red I Pad 100 of FIG. 3 and description in [0056]: nutrients in unit cell of 120 mixed with water. See FIG. 13 and [0065] for RED II pad) and ion channels (D+, D-, ND channels, see [0046-0048] and [0059]), the ion channels each loaded with an ion conducting material between the reservoir and the treatment site (see [0059-0063]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ion pumping system with at least one channel disclosed in Toong to include a plurality of reservoirs and a plurality of channels as taught by Jeong for the purpose of delivering different types of compounds at the same time (see [0048] and [0059]), thus achieving multiple reservoir“s” and multiple ion channel“s”.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ion channels taught by Modified Toong to be loaded with an ion conducting material between the reservoir and treatment site as taught by Jeong for the purpose of improving the efficiency of delivery of nutrients and/or drugs to the skin and ensuring that the amount of nutrients/drugs discharged are uniformly maintained to act as a sort of pump which is capable of controlling the amount moved through the ion exchange membrane (see [0059]), thus achieving “the ion channels each loaded with an ion conducting material between the reservoir and the treatment site.”
Regarding claim 14, the modified system of Toong teaches the device of claim 13, but Toong is silent to “wherein: the voltage control signals apply a bias across first one of the electrodes in a first one of the reservoirs and a second one of the electrodes in a second one of the reservoirs, to drive a: flow of a first type of the ions, having a first polarity type, from the first one of the reservoirs to the treatment site through a first one of the ion channels, and a return flow of a second type of the ions from the treatment site and having the first polarity type, to the second one of the reservoirs via a second one of the ion channels, and the ion channels comprise an ion exchange membrane allowing the flow of the ions of the first polarity type to and from the treatment site but blocking flow of ions or charge having a second polarity type (opposite the first polarity type); the first one of the electrodes comprises a working electrode/anode and the second one of the electrodes comprises a counter electrode/cathode, and the voltage control signals drive an electrochemical reaction at the electrodes, and the electrochemical reaction: oxidizes the working electrode to release an electron and the first type of the ions comprising the first polarity type; and consumes an electron at the counter electrode to release a charge having a second polarity type (opposite the first polarity type) that pairs or charge balances with the second type of ions comprising physiological ions.”
However, Jeong teaches a system for delivering therapy to a treatment site (see [0002] and [0010]: for example, a patch) comprising an ion pumping system (see FIG. 3 with reservoir of Red I pad and Red II pad) wherein: the voltage control signals apply a bias across first one of the electrodes (see [0056] & [0059]: i.e.: electrodes 1010 in FIG. 8/9) in a first one of the reservoirs (red I pad, see FIG.7) and a second one of the electrodes (see [0065]: redi I pad has same structure, including electrodes, as in red I pad/fig. 7-9) in a second one of the reservoirs (red II pad, see FIG. 13), to drive a: flow of a first type of the ions, having a first polarity type, from the first one of the reservoirs to the treatment site through a first one of the ion channels (see [0045-0048] and [0056-0063]), and a return flow of a second type of the ions from the treatment site and having the first polarity type, to the second one of the reservoirs via a second one of the ion channels (see arrow from Red I pad to red II pad in FIG. 3 and [0056-0063]), and the ion channels (delivering D+, D-, DN) comprise an ion exchange membrane (1020, see FIG. 10 and [0061]) allowing the flow of the ions of the first polarity type to and from the treatment site but blocking flow of ions or charge having a second polarity type (opposite the first polarity type) (see [0061]: flow of ions determined by membranes and dictate a one way flow preference for one type of ion); the first one of the electrodes comprises a working electrode/anode (see FIG. 10 and [0061]) and the second one of the electrodes comprises a counter electrode/cathode (see FIG. 13 and [0065]), and the voltage control signals drive an electrochemical reaction at the electrodes (see [0056-0065]), and the electrochemical reaction: oxidizes the working electrode to release an electron and the first type of the ions comprising the first polarity type; and consumes an electron at the counter electrode to release a charge having a second polarity type (opposite the first polarity type) that pairs or charge balances with the second type of ions comprising physiological ions (see FIG. 3 and [0056-0065]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to have combined the control system for the ion pumping system disclosed in Toong with the ion pumping system comprising multiple reservoirs and ion channels for directing electrons of certain polarity types in controllable flow patterns by way of the arranged membranes, channels, and electrodes taught in Jeong.
A person of ordinary skill in the art could have combined the elements (Toong discloses a control system for applying voltage across an ion pumping system formed in a patch to optimize wound therapy over time. Jeong teaches an ion pumping system using a controller for delivering a certain polarity of drugs/ions across a patch device having membranes, channels, and electrodes.) as claimed by known methods (patch-like devices are known to include layers/membranes as disclosed in Toong, such as at least FIG. 13, and Jeong) with no change to the respective functions (both devices use controllers to deliver treatment via ion pumps to the skin). Further, the combination would yield nothing more than predictable results (Toong’s device selectively delivering ions as taught by Jeong via the patch-like device to the skin) to one of ordinary skill in the art, thus achieving “wherein: the voltage control signals apply a bias across first one of the electrodes in a first one of the reservoirs and a second one of the electrodes in a second one of the reservoirs, to drive a: flow of a first type of the ions, having a first polarity type, from the first one of the reservoirs to the treatment site through a first one of the ion channels, and a return flow of a second type of the ions from the treatment site and having the first polarity type, to the second one of the reservoirs via a second one of the ion channels, and the ion channels comprise an ion exchange membrane allowing the flow of the ions of the first polarity type to and from the treatment site but blocking flow of ions or charge having a second polarity type (opposite the first polarity type); the first one of the electrodes comprises a working electrode/anode and the second one of the electrodes comprises a counter electrode/cathode, and the voltage control signals drive an electrochemical reaction at the electrodes, and the electrochemical reaction: oxidizes the working electrode to release an electron and the first type of the ions comprising the first polarity type; and consumes an electron at the counter electrode to release a charge having a second polarity type (opposite the first polarity type) that pairs or charge balances with the second type of ions comprising physiological ions.”
Regarding claim 15, the modified system of Toong teaches the device of claim 13, but Toong is silent to “wherein the fluid comprises a solution comprising a biochemical or drug ionized (e.g., by protonation) by the solution, so as to form the first type of ions comprising biomolecules or drugs.”
However, Jeong teaches a system for delivering therapy to a treatment site (see [0002] and [0010]: for example, a patch) comprising an ion pumping system, wherein the ion pumping system (see FIG.3) has a reservoir (i.e.: RED I pad) containing a fluid (see FIG. 7 and [0056]: pad 120 has nutrients/drugs mixed with water), wherein the fluid comprises a solution comprising a biochemical or drug ionized (e.g., by protonation) (D+, D-, ND, see FIG. 3 and [0045-0048]) by the solution (see [0056]), so as to form the first type of ions comprising biomolecules or drugs (i.e.: D+/D-, see [0045-0048]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid disclosed in Toong to comprise a biochemical or drug ionized (e.g., by protonation) by the solution so as to form a first type of ions as taught by Jeong for the purpose of forming the fluid as a high concentration electrolyte that is more effectively delivered to the skin for treatment (see [0056]), thus achieving “wherein the fluid comprises a solution comprising a biochemical or drug ionized (e.g., by protonation) by the solution, so as to form the first type of ions comprising biomolecules or drugs.”
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Toong in view of Jeong as applied to claim 10 above, and further in view of DeShazo et al. (U.S. PGPUB No. 2021/0252291), hereinafter DeShazo.
Regarding claim 11, the modified system of Toong teaches the device of claim [[9]] 10, and Toong discloses further comprising a battery (1012, see FIG. 2 and battery 260 in FIG. 3A powers the circuit) coupled to the control circuit for powering the device (see [0024]: 1012 is a battery on the chip or battery 260 and see [0030]: battery input into circuit comes from battery 1012 in FIG. 2), wherein the control circuit further comprises: a microcontroller or processor (see [0141]: control unit 1002 is a processor); a memory (see [0043]); and a program stored in the memory and executed by the microcontroller or processor to output the voltage control signals to the electrodes so as to drive a current of the ions through the ion conducting material to and/or from the treatment site (see [0043], [0047], [0094-0098], [0104-0107], [0112-0115]) .
Modified Toong is silent to “a digital to analog converter (DAC);” and a program stored in the memory and executed by the microcontroller or processor “for commanding the DAC” to output the voltage control signals to the electrodes so as to drive a current of the ions through the ion conducting material to and/or from the treatment site.
However, DeShazo teaches a system for delivering therapy to a treatment site (see [0030]) comprising a control circuit (404&406, see FIG. 4) with a microcontroller or processor (see [0058]); a digital to analog converter (DAC) (426, see [0064]); and a program stored in a memory (see [0058-0063]) and executed by the microcontroller or processor for commanding the DAC to output a voltage control signals to a plurality of electrodes (412, see [0058-0064]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor disclosed in Toong to include a digital to analog converter and the processor commanding the DAC to output the voltage control signals to the electrodes as taught by DeShazo for the purpose of generating a digitally-programmed analog voltage level as an output signal for controlling the feedback loops of the device (see [0064]), thus achieving “a digital to analog converter (DAC);” and “a program stored in the memory and executed by the microcontroller or processor for commanding the DAC to output the voltage control signals to the electrodes so as to drive a current of the ions through the ion conducting material to and/or from the treatment site.”
Regarding claim 12, the modified system of Toong teaches the device of claim 11, and Toong further discloses wherein: the control circuit further comprises one or more resistors (see 232 in FIG. 3A) connected for sensing a current (see [0030]: current measuring resistor 232) associated with pumping of the ions and used to measure the dose, so that: the current flowing through the resistors generates sense voltages used to measure the dose (see [0026-0038]: how voltages are sensed and see [0094-0098]: voltage is indicative of pumping of ions), and the sense voltages can be read by an analog to digital controller in the microcontroller/processor (see [0026] and [0130-0133]: ADC integrated into controller) or by external probes.
Claims 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Toong as applied to claim 1 above, and further in view of Gellman et al. (U.S. PGPUB No. 2022/0079509), hereinafter Gellman.
Regarding claim 16, Toong discloses an intelligent wound care management system comprising the system of claim 1 (see [0082]: “Patch 110 can be implemented by patch 100 previously described.” and therefore portions of the specification describing patch 100 will also be referenced throughout rejections. See also [0141]: patch 110 includes data manage such as control unit 1002), comprising:
a wound dermal interface (112, see fig. 8) for attaching the device to the treatment site (see [0082]: 112 is adhesive layer of the patch);
an imaging system (see [0026]: sensors can include optical sensors & [0116-0122]: sensor data such as images are provided to controller) coupled to the treatment site positioned for measuring the dose and/or a healing state of the treatment site and outputting healing data in response thereto (see [0026], [0116-0122], & [0170]: optical sensors for detecting wound size/closure rates/etc. provide data to smart controller for analysis);
the computer (140) comprising one or more processors (see [0082]: 140 is a smart phone and smartphone has a processor) configured for executing the machine learning to determine scheduling of the control voltages applied to the electrodes in response to the alarm signal and outputting prediction data (see [0116-0124]: voltage increased/decreased according to pattern recognition/predictive algorithm in real time and is therefore also “configured to” determine control voltages applied to the electrodes in response to any other data, such as “to the alarm signal”);
a power management system comprising a power source (116, see [0082]) coupled to the device, for distributing power to the device (see [0112-0115]);
a data management system (data processing in 1002 of device chip, see FIG.2 and [0023-0027]: control unit for communicating with smartphone such as in FIG. 8. See also [0142]) configured for storing the healing data (see [0116] & [0121-0123]: smart phone, patch, or cloud/ personal computer can all perform function of data management system storing data);
a communications system (communications in 1002 of device chip, see FIG. 2 and/or antenna 1010) for transmitting the healing data to the data management system (see [0023-0027] & [0116-0122]: data transfer to cloud); and
the control circuit (1000, see FIG. 2 and [0023]) comprising or coupled to a control microcontroller unit (1002), the control microcontroller unit (1002) operably coupled to:
the power management system to activate or deactivate power distribution to the device (see [0035]: controller checks power within desired range and does not allow activation of power unless within range. See also [0143-0144]) based on the prediction data outputted from the predictive algorithm (see [0038-0042]: controller using all feedback data to control power decision and [0122]: predictive algorithms/AI included in feedback data);
the electrodes (1008, see FIG.2 or electrode pairs 114 in FIG. 8 and [0082]) to control application of the control voltages (see [0023-0027] & [0070-0071]) based on the prediction data outputted from the predictive algorithm (see [0116-0122]);
the communication system (communications in 1002 of device chip, see FIG. 2) to control transmission of healing data to the data management system (see [0023-0027], [0116] & [0121-0123]).
Toong discloses using the device to monitor and execute a desired treatment protocol (see [0120-0124]) to achieve a desired healing state (see [0170]), but Toong is silent to “an alarm system coupled to the sensors, the alarm system comprising one or more processors configured for determining whether the healing data is within an acceptable range for the treatment and outputting an alarm signal indicating whether the healing data is within the acceptable range or not.”
However, Gellman teaches an intelligent wound care management system (see [0002]) comprising a wound dermal interface with sensors (see [0067]: wound dressing with sensors), and an alarm system coupled to the sensors (see [0067]: alarm system provided on control unit coupled to sensors), the alarm system comprising one or more processors configured for determining whether the healing data is within an acceptable range for the treatment and outputting an alarm signal indicating whether the healing data is within the acceptable range or not (see [0067]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the control circuit including processor for monitoring and executing a desired treatment protocol via sensed data disclosed in Toong to include an alarm system coupled to the sensors for outputting alarm signals as taught by Gellman for the purpose of providing visual and audible alerts to the user in response to a potentially dangerous condition such as indicating a potential infection (see [0067] & [0076]), thus achieving “an alarm system coupled to the sensors, the alarm system comprising one or more processors configured for determining whether the healing data is within an acceptable range for the treatment and outputting an alarm signal indicating whether the healing data is within the acceptable range or not.”
Regarding claim 18, the modified system of Toong teaches the system of claim [[1]] 16, and Toong further discloses wherein the wound dermal interface (112, see fig. 8) comprises a bandage, dressing, adhesive (see [0082]: 112 is adhesive layer of the patch for attaching to skin), patch, or other mechanism for attaching the device to the treatment site and/or covering the treatment site.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Jiang et al. (U.S. PGPUB No. 2024/0350797) discloses a system for delivering therapy to a treatment site, comprising:
means for delivering a dose of a therapy to a treatment site (wireless smart bandage, see Figure 1A provided for immediate reference below and [0082]: voltage pulse is therapy dose);
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a sensor (sensors on 154, see Figure1f) configured for sensing the treatment site and outputting data in response thereto (see [0071-0073] & [0075]); and
a data-driven controller or data-driven computer (computer in 152, see Figure 1f) configured to control the dose in a closed loop by (see [0072-0075]):
determining a healing state of the treatment site from the data (see [0010]), and
using the healing state as feedback to update or determine the dose delivered to the treatment site so that the therapy increases a rate of healing of the treatment site and/or the healing state converges to a desired healing state (see [0010], [0068-0070] & [0087-0089]: continuous monitoring to return to “unwounded state”/ healing state).
Edlund et al. (U.S. PGPUB No. 2024/0249406) teaches machine learning in image data systems to optimize wound healing
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE VOKES whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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/KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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