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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the first and second layers of the therapeutic dressing as recited in claim 5, and the indicator is disposed in the non-adherent portion, and wherein the IC, the sensor, and the at least one stimulating electrode are disposed in the non-adherent portion as recited in claim 10 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
Specification
The disclosure is objected to because of the following informalities:
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the specification does not provide support for the limitation of “the indicator is disposed in the non-adherent portion, and wherein the IC, the sensor, and the at least one stimulating electrode are disposed in the non-adherent portion” as recited in claim 10. Currently the specification on [pg 7 ln 9-10] contrarily states “The IC 150, the sensor 160, the electrode(s) 140, and the indicator 130 (if present) can all be disposed on the adherent portion 120”.
The use of the term Bluetooth®, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Objections
Claims 2, 7, 10, and 16 objected to because of the following informalities:
Claim 2 recites the limitation “the same amount of stimulating current” in lines 2 and 5. These limitation should be amended to recite “a/the same amount of the electrical stimulation” to maintain consistency in the claims.
Claim 7 recites the limitation “with skin of the user” in lines 2 and 5. These limitations should be amended to recite “a/the skin of the user” to properly present the limitaitons.
Claim 10 recites the limitation “the non-adherent portion” in lines 4 and 6. These limitations should be amended to recite “the central non-adherent portion” to maintain consistency in the claims.
Claim 16 recites the limitation “to skin of the user” in line 3. This limitation should be amended to recite “a skin of the user” to properly present the limitation.
Appropriate correction is required.
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.
Claim 14 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 14 contains the trademark/trade name Bluetooth®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe short range wireless connections and, accordingly, the identification/description is indefinite.
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) 1-3, 5, 7-8, 11, 13-16, and 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Toong et al. (US 2021/0268276 A1) (hereinafter Toong).
In regards to claim 1, Toong discloses A therapeutic dressing (110; see [0146]; see figure 13), comprising:
a central non-adherent portion (first and second 1612; see [0146]; see figure 13);
an adherent portion (adhesive portion of 1610; see [0146]; see figure 13) around the central non-adherent portion and comprising an adhesive (see [0146]);
at least one stimulating electrode (1620; see [0146]; see figure 13);
a sensor (1006; see [0024]; see figure 2; 1000 and 1630 are each control systems on a chip/board which generate stimulation through electrodes, and sense said stimulation (see [0024] and [0148]), thus, 1630 is considered to be configured similar to, and comprise the same structures as 1000); and
an integrated circuit (IC) (1630; see [0148]; see figure 13) in operable communication with, and configured to control, the at least one stimulating electrode (see [0148]),
wherein the therapeutic dressing is configured to provide electrical stimulation to a nerve of a user during use via the at least one stimulating electrode (see [0018] and [0070]).
In regards to claim 2, Toong discloses the invention as discussed above.
Toong further discloses wherein the IC (1630) is configured such that the nerve receives the same amount of stimulating current regardless of a size of the user or a resistance of skin or tissue of the user (see [0018] and [0148]), and
wherein the IC comprises a microcontroller (1002; see [0024]; see figure 2; as discussed above, 1630 is considered to be configured similar to, and comprise the same structures as 1000), a power source (1636; see [0147]; see figure 13), and a current-controlled voltage pulse generator (1004; see [0025]; see figure 2) configured to provide the same amount of stimulating current to the nerve regardless of the size of the user or the resistance of the skin or tissue of the user (see [0018] and [0148]).
In regards to claim 3, Toong discloses the invention as discussed above.
Toong further discloses wherein the therapeutic dressing is configured to provide the electrical stimulation to the nerve for a predetermined amount of time before becoming inert (the device applies stimulation during the treatment duration, and then becomes inert after the treatment is over; see [0048-0051]; see figures 4 and 5).
In regards to claim 5, Toong discloses the invention as discussed above.
Toong further discloses further comprising a first layer (1610; see [0146]; see figure 13) of a dressing material (fabric tape) and a second layer (1640; see [0147]; see figure 13) of the dressing material (fabric tape),
wherein the IC (1630) is sandwiched between the first layer of the dressing material and the second layer of the dressing material (see figure 13),
wherein the sensor is exposed out of the first layer of the dressing material (1610; 110 uses sensors which are electrodes on the skin-facing surface of the patch (See [0131]) and thus, are exposed out of 1610 to be in contact with the skin),
wherein the at least one stimulating electrode (1620) is exposed out of the first layer of the dressing material (1620 exposed out of 1610 through 1612; see figure 13), and
wherein the dressing material is electrically insulating (fabric tape does not conduct electricity and thus, is electrically insulating).
In regards to claim 7, Toong discloses the invention as discussed above.
Toong further discloses wherein the therapeutic dressing is configured such that the sensor is in direct physical contact with skin of the user during use (110 uses sensors which are electrodes on the skin-facing surface of the patch; See [0131]), and
wherein the therapeutic dressing is configured such that the at least one stimulating electrode is in direct physical contact with skin of the user during use (see [0166]).
In regards to claim 8, Toong discloses the invention as discussed above.
Toong further discloses wherein the therapeutic dressing is configured such that the sensor is disposed over a muscle of the user during use (110 is capable of being placed such that 1006 is disposed over a muscle of the user during use, and
wherein the sensor is an electromyography (EMG) sensor (see [0119]).
In regards to claim 11, Toong discloses the invention as discussed above.
Toong further discloses wherein the therapeutic dressing is a single-use, disposable dressing (110 is capable of being disposed of after a single-use; see [0020]).
In regards to claim 13, Toong discloses the invention as discussed above.
Toong further discloses wherein the IC comprises a wireless communication module configured to enable remote modification of one or more stimulation parameters of the electrical stimulation (see [0026] that 1000 (which is configured similarly to 1630) includes 1002 which sends data through antenna 1010 to the external control device, which allows for any necessary adjustments of the functionality of the device to be made remotely (see [0170]).
In regards to claim 14, Toong discloses the invention as discussed above.
Toong further discloses wherein the wireless communication module comprises a Bluetooth integrated circuit (see [0093]).
In regards to claim 15, Toong discloses the invention as discussed above.
Toong further discloses wherein the IC further comprises a digital signal processor (DSP) configured to condition one or more physiological input signals, and wherein the DSP is configured to reduce or eliminate junction-reference artifacts (1000 (which is configured similarly to 1630) includes a data processor within 1002 which processes digital signals (see [0026]); the device monitors and adapts to changes in the impedance of the user’s skin (see [0070]); 1002 can perform operations based on the data such as statistical analysis and trend identification (see [0141]); thus, the data processor can identify, analyze, and condition physiological input signals (impedance values of the user’s skin), and subsequently reduce, and eliminate junction-reference artifacts caused by changes in the conditions of the application of the therapeutic dressing).
In regards to claim 16, Toong discloses the invention as discussed above.
Toong further discloses A method for providing electrical stimulation to a nerve of a user (see [0002] and [0018]), the method comprising:
applying, to skin of the user, the therapeutic dressing according to claim 1 (see discussion above; 110 is applied to the user’s skin; see [0018]); and
using the therapeutic dressing to provide the electrical stimulation to the nerve for a predetermined amount of time (treatment duration; see [0048-0051]).
In regards to claim 18, Toong discloses the invention as discussed above.
Toong further discloses further comprising disposing of the therapeutic dressing after a single use of the therapeutic dressing providing the electrical stimulation to the nerve for the predetermined amount of time (110 is disposable and can be disposed after a single treatment duration if desired; see [0020]).
In regards to claim 19, Toong discloses A method of monitoring a post-operative treatment site (110 may be used to for monitoring a wound site; see [0084]; a wound site including a post-operative treatment wound (i.e. surgical incision)), the method comprising:
applying to the post-operative treatment site a therapeutic dressing (110; see [0146]; see figure 13; 110 is applied to the user’s skin over a wound site; see [abstract]) comprising a circuit (1630; see [0146]; see figure 13) and at least one sensor (1006; see [0024]; see figure 2; 1000 and 1630 are each control systems on a chip/board which generate stimulation through electrodes, and sense said stimulation (see [0024] and [0148]), thus, 1630 is considered to be configured similar to, and comprise the same structures as 1000);
receiving a physiological signal from the at least one sensor of the therapeutic dressing (see [0026]);
transmitting the physiological signal wirelessly to a remote device (data transmitted via 1010 to external control device; see [0026]); and
adjusting one or more stimulation parameters of the therapeutic dressing based on the physiological signal (any necessary adjustments of the functionality of the device to be made remotely based on input data from sensors, or observations from a healthcare professional; see [0170]).
In regards to claim 20, Toong discloses a method for providing electrical stimulation to a nerve of a user (see [0018]), the method comprising:
applying, to skin of the user, a therapeutic dressing (110; see [0146]; see figure 13; 110 is applied to the skin of the user; see [0018]) comprising at least one stimulating electrode (1620; see [0146]; see figure 13), a sensor (1006; see [0024]; see figure 2; 1000 and 1630 are each control systems on a chip/board which generate stimulation through electrodes, and sense said stimulation (see [0024] and [0148]), thus, 1630 is considered to be configured similar to, and comprise the same structures as 1000), and an integrated circuit (IC) (1630; see [0148]; see figure 13) in operable communication with, and configured to control, the at least one stimulating electrode (see [0018] and [0070]);
receiving and utilizing EMG signal feedback to confirm neural stimulation (sensors include EMG sensors which provide EMG signal feedback and confirm neural stimulation which change with wound healing; see [0119]);
adjusting stimulation parameters of the therapeutic dressing, based on the EMG signal feedback, to deliver or maintain optimal stimulation according to a predetermined protocol (any necessary adjustments of the functionality of the device to be made remotely based on input data from sensors (including the EMG signal feedback) to maintain the prescribed treatment; see [0170]; see also figures 4-5).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 4, 9, 12 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toong et al. (US 2021/0268276 A1) (hereinafter Toong).
In regards to claim 4, Toong discloses the invention as discussed above.
Toong further discloses wherein the predetermined amount of time is based on: characteristics of a wound of the nerve of the user; characteristics of the user; or both (treatment regimens can be automatically adjusted for wound geometries (characteristics of the wound and the wound of the nerve) upon initial application as well as downstream as the environment changes (e.g., changing impedances, degree of user comfort, etc.) (characteristics of the user); see [0170]).
Toong does not explicitly disclose wherein the predetermined amount of time is in a range of from 2 minutes to 180 minutes.
However, Toong teaches patch 110 can vary treatment durations from minutes to hours to days, and can adjust treatment upon inputs from sensors (e.g., temperature sensors, optical sensors to detect wound size and closure rates, etc.) (see [0170]). Thus, the predetermined amount of time for the provision of electrical stimulation to the nerve is considered to be a result effective variable in that changing the predetermined amount of time affects the ability of the electrical stimulation to promote wound healing by increasing vascularization (and vascular endothelial growth factor, VEGF, expression), promoting regeneration of defective peripheral nerves, increasing collagen deposition, enhancing cell migration and integrative repair function, and by forcing a necessary bacteriostatic state (see [0168]). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the predetermined amount of time of Toong as it involves only adjusting the duration of a treatment disclosed to require adjustment, and because the claimed range of the predetermined amount of time lies inside the range of minutes to days as taught by Toong.
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the predetermined amount of time of electrical stimulation disclosed by Toong by adjusting the predetermined amount of time to be 2 minutes to 180 minutes as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation” In re Aller, 220 F.2d 454, 456, 105 USPQ 223, 235 (CCPA 1955) (see MPEP 2144.05 II A). Such a modification would add the benefit of ability of the electrical stimulation to promote wound healing by increasing vascularization (and vascular endothelial growth factor, VEGF, expression), promoting regeneration of defective peripheral nerves, increasing collagen deposition, enhancing cell migration and integrative repair function, and by forcing a necessary bacteriostatic state (see [0168]) as needed.
Additionally and/or alternatively, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the predetermined amount of time of the electrical stimulation to the nerve as disclosed by Toong from minutes to days to 2 minutes to 180 minutes as applicant appears to have placed no criticality on the claimed range contrarily stating “(t)he duration of stimulation can be predetermined, for example based on the specific surgical procedure and/or patient/user characteristics. The stimulation can last for an amount of time in a range of, for example, 1 minute to 600 minutes (or any value, about any value, or subrange therein)” (see Specification [pg 2 ln 25-30]) which discloses the predetermined time can be values of time which are not encompassed by the claimed range (i.e. 181 minutes to 600 minutes) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
In regards to claim 9, Toong discloses the invention as discussed above.
Toong does not disclose the first and second stimulating electrode (1620) comprises a positive stimulating electrode and a negative stimulating electrode.
However, Toong teaches a second embodiment of the therapeutic dressing (102; see [0082]; see figure 8) which comprises at least one stimulating electrode (114; see [0082]; see figure 8); wherein the at least one stimulating electrode comprises a positive stimulating electrode and a negative stimulating electrode (see [0082]) for the purpose of creating a lateral electric field across the wound (see [0088]) and to minimize leakage currents which minimizes uncomfortable stimulation sensations (see [0126]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the at least one stimulating electrode as disclosed by Toong to be a positive stimulating electrode and negative stimulating electrode pair as taught by the second embodiment of the therapeutic dressing of Toong in order to have provided an improved pair of stimulating electrodes that would add the benefit of creating a lateral electric field across the wound (see [0088]) which minimizes leakage currents and minimizes uncomfortable stimulation sensations (see [0126]).
In regards to claim 12, Toong discloses the invention as discussed above.
Toong further discloses wherein the IC comprises at least one battery (1636; see [0147]; see figure 13), and
wherein the IC is in operable communication with, and configured to control, the sensor (1006; see [0024]; see figure 2).
Toong does not disclose the IC comprises a voltage multiplier.
However, Toong discloses that the therapeutic dressing may include a boosted voltage circuit (200; see [0028]; see figure 3a) which may be controlled by the control unit 1002 which is configured similarly to 1630; wherein the boosted voltage circuit includes a voltage multiplier (voltage doubler; see [0037]) for the purpose of doubling the high voltage output, and reduce voltage stress on the circuitry (see [0037]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the IC of the therapeutic dressing as disclosed by Toong and to have included the boosted voltage circuit and associated voltage multiplier as taught by Toong in order to have provided an improved IC of the therapeutic dressing that would add the benefit of doubling the high voltage output, and reduce voltage stress on the circuitry (see [0037]).
In regards to claim 17, Toong discloses the invention as discussed above.
Toong further discloses wherein the predetermined amount of time is based on: characteristics of a wound of the nerve of the user; characteristics of the user; or both (treatment regimens can be automatically adjusted for wound geometries (characteristics of the wound and the wound of the nerve) upon initial application as well as downstream as the environment changes (e.g., changing impedances, degree of user comfort, etc.) (characteristics of the user); see [0170]).
Toong does not explicitly disclose wherein the predetermined amount of time is in a range of from 2 minutes to 180 minutes.
However, Toong teaches patch 110 can vary treatment durations from minutes to hours to days, and can adjust treatment upon inputs from sensors (e.g., temperature sensors, optical sensors to detect wound size and closure rates, etc.) (see [0170]). Thus, the predetermined amount of time for the provision of electrical stimulation to the nerve is considered to be a result effective variable in that changing the predetermined amount of time affects the ability of the electrical stimulation to promote wound healing by increasing vascularization (and vascular endothelial growth factor, VEGF, expression), promoting regeneration of defective peripheral nerves, increasing collagen deposition, enhancing cell migration and integrative repair function, and by forcing a necessary bacteriostatic state (see [0168]). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the predetermined amount of time of Toong as it involves only adjusting the duration of a treatment disclosed to require adjustment, and because the claimed range of the predetermined amount of time lies inside the range of minutes to days as taught by Toong.
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the predetermined amount of time of electrical stimulation disclosed by Toong by adjusting the predetermined amount of time to be 2 minutes to 180 minutes as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation” In re Aller, 220 F.2d 454, 456, 105 USPQ 223, 235 (CCPA 1955) (see MPEP 2144.05 II A). Such a modification would add the benefit of ability of the electrical stimulation to promote wound healing by increasing vascularization (and vascular endothelial growth factor, VEGF, expression), promoting regeneration of defective peripheral nerves, increasing collagen deposition, enhancing cell migration and integrative repair function, and by forcing a necessary bacteriostatic state (see [0168]) as needed.
Additionally and/or alternatively, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the predetermined amount of time of the electrical stimulation to the nerve as disclosed by Toong from minutes to days to 2 minutes to 180 minutes as applicant appears to have placed no criticality on the claimed range contrarily stating “(t)he duration of stimulation can be predetermined, for example based on the specific surgical procedure and/or patient/user characteristics. The stimulation can last for an amount of time in a range of, for example, 1 minute to 600 minutes (or any value, about any value, or subrange therein)” (see Specification [pg 2 ln 25-30]) which discloses the predetermined time can be values of time which are not encompassed by the claimed range (i.e. 181 minutes to 600 minutes) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toong in view of Hansen et al. (US 2021/0205141 A1) (hereinafter Hansen).
In regards to claim 6, Toong discloses the invention as discussed above.
Toong does not disclose wherein the dressing material is a polymer dressing material.
However, Hansen teaches an analogous therapeutic wound dressing (2; see [0153]; see figure 1) which comprises an analogous IC (217; see [0158]; see figure 5) and electrode (204; see [0153]; see figure 5) which are sandwiched between a first layer and second layer (150 and 206; see [0152-0153]) of dressing material (polyurethane film; see [0038] and [0045]) which is electrically insulating (polyurethane films are electrically insulating); wherein the dressing material is a polymer dressing material (see [0038] and [0045]) for the purpose of providing a material which is water impermeable but vapor permeable (see [0038]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the dressing material of the first and second layers as disclosed by Toong and to have utilized the polyurethane film material for the dressing material of the first and second layers as taught by Hansen in order to have provided improved first and second layers that would add the benefit of providing a material which is water impermeable but vapor permeable (see [0038]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toong in view of Zhang et al. (US 2023/0248962 A1) (hereinafter Zhang).
In regards to claim 10, Toong discloses the invention as discussed above.
Toong further discloses wherein the IC (1630), the sensor (1006), and the at least one stimulating electrode (1620) are disposed in the non-adherent portion (see figure 13).
Toong does not disclose further comprising an indicator configured to indicate a function of the IC and/or the at least one stimulating electrode during use, wherein the indicator is disposed in the non-adherent portion.
However, Zhang teaches an analogous dressing (10; see [0086]; see figure 1a) for applying transcutaneous electrical stimulation (see title) comprising an analogous IC (70; see [0094]; see figure 1a) and at least one stimulation electrode (50; see [0089]; see figure 2a); further comprising an indicator (242; see [0128]; see figure 5) configured to indicate a function of the IC and/or the at least one stimulating electrode during use (see [0128]) for the purpose of indicating the state or condition of the control unit (see [0128]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the therapeutic dressing as disclosed by Toong and to have included the indicator as taught by Zhang in order to have provided an improved therapeutic dressing that would add the benefit of providing a means for indicating the state or condition of the control unit (see [0128]).
Toong as now modified by Zhang does not explicitly disclose wherein the indicator is disposed in the non-adherent portion.
However, such a modification is held to be obvious since it has been held that "a mere rearrangement of parts was held to be an obvious matter of design choice" In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (See MPEP 2144.04 VI C). In the instant case Applicant's specification has not disclosed that the indicator being disposed in the non-adherent portion provides an advantage, is used for a particular purpose, or solves a stated problem, and contrarily discloses that the indicator may not be included in the therapeutic dressing at all (“the therapeutic dressing 100 can include an indicator 130… The IC 150, the sensor 160, the electrode(s) 140, and the indicator 130 (if present) can all be disposed on the adherent portion 120” See specification [pg 7 ln 9-10]) which discloses that not only is the indicator optional, but the aforementioned structures can all be located on the adherent portion. Therefore, the specific configuration is considered not critical to the functionality of Applicant's device and is considered to be a design choice obvious to one of ordinary skill in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL MILLER whose telephone number is (571)270-5445. The examiner can normally be reached Mon-Fri 8am-4pm.
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/DANIEL A MILLER/Primary Examiner, Art Unit 3786
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