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 .
Response to Amendment
This Action is in response to the Amendment filed January 5, 2026 in response to the restriction/election requirement dated 11/05/2025.
Claims 1-6 are canceled.
Claims 21-26 are added.
Claims 7-26 are pending.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 7-20 in the reply filed on 01/05/2026 is acknowledged. New claims 21-23 and 24-26 depend from original claim 13 and 20, respectively. Thus, claims 7-26 are examined.
Priority
Claims 7-26 are deemed to have an effective priority date of November 11, 2022.
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 plurality of flexible electrodes positioned between the upper and lower insole layers of claims 22 and 25 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. The Examiner notes that electrodes 12/15, 16 are positioned between “upper layer 10” and “overlay 18” in Figs. 3 and 10 where “upper layer 10” includes at least one window where the PPG sensor is positioned. However, those depictions do not show electrodes positioned between an upper layer with a window at which the PPG sensor is positioned and a lower layer as the overlay is not a lower layer.
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 one sheet forming an upper insole layer and a lower insole layer of claims 21 and 24, and the one-piece electrode assembly of claims 23 and 26 must be shown or the feature(s) canceled from the claim(s). How is an upper insole layer and a lower insole layer formed of one sheet? How are electrodes disposed within a one piece-electrode assembly? Fig. 7 shows that its electrode 15 has a cross-section of two pieces (13 and 14). No new matter should be entered.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: electrodes 6A (paragraph [0041] of originally filed specification (OFS)).
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “22” has been used to designate both a portion of a lower assembly (reference numeral 22 with an arrow pointing to the Fig. between reference numerals “30” and “38” in Fig. 13) and a top view of a bottom layer of a wearable insole (reference numeral without an arrow or line in the upper left hand side of Fig. 13).
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: in paragraph [0005], line 12, the recitation of “Other embodiment further include” is awkward. The noun “embodiment” does not agree with the plural verb “include”.
Appropriate correction is required.
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 claim language of claims 21-16 is not found in the OFS. The Examiner notes that canceled claims 1-6 also includes language that is not in the OFS.
Claim Objections
Claims 13, 17, and 20 are objected to because of the following informalities:
In line 11 of claim 13, there appears to be a typographical error as the line recites “stimulate the patient’s food”, which the Examiner believes should be --patient’s foot--.
In line 1 of claim 17, there appears to be a typographical error as the body of the claim begins: “I further comprising”. Appropriate correction is required.
In line 9 of claim 20, there appears to be a typographical error as the line recites “stimulate the patient’s food”, which the Examiner believes should be --patient’s foot--.
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.
Claims 21-23 and 24-26 are 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.
Regarding claims 21 and 24, Fig. 3 is an exploded view of a wearable insole and illustrates an “upper assembly 20” formed of multiple sheets of material that forms an “upper layer 10 “and an “overlay 18”; and a “lower assembly 22 formed of multiple sheets of material including a “lower layer 11” and an “overlay 26”. The PPG sensors 5 are located in the lower assembly 22 and are positioned in at least one window in the upper layer 10 of the upper assembly 20. Thus, one of ordinary skill in the art, reading the instant specification, would have recognized that a shoe insole includes multiple sheets forming an upper assembly and multiple sheets forming a lower assembly where the upper assembly includes a window at which the PPG sensor is positioned. How is an upper insole layer and a lower insole layer formed of one sheet? The OFS does not describe how that embodiment is achieved. Nor do the drawings illustrate such an embodiment.
With respect to claims 22 and 25, the plurality of flexible electrodes are positioned between the upper and lower insole layers/assemblies. Similar to above, there are no drawings illustrating this embodiment, one of ordinary skill in the art, reading the instant specification, would recognize that the plurality of flexible electrodes are positioned between sheets of an upper insole layer assembly as shown in Figs. 3 and 10, or are an electrode assembly as shown in Figs. 7-8 sandwiched between an upper layer and an overlay. Would one of ordinary skill in the art consider overlay 18 a lower insole layer? Would one of ordinary skill in the art position electrodes within one sheet of material? Neither the OFS not the drawings provide any guidance.
As to claims 23 and 26, an electrode assembly may be printed on a substrate (paragraph [0032]). Thus, a one-piece electrode is disclosed. But, it is not apparent from the detailed description and the drawings how “electrodes are disposed within a one-piece electrode assembly”. Thus, one of ordinary skill in the art would not have recognized that the instant specification reasonably conveys 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 of claims 21-23 and 24-26.
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 7-26 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 7, line 11, recites the conditional preposition “if”, which renders the scope of the claim indefinite as it is unclear if the step of providing power is required to meet the claim. The use of “if” includes both positive and negative scenarios, and in negative scenarios, the providing step in line 11 is not required. The Examiner recommends replacing “if” with --when--.
Claim 7 recites “predefined criteria” without an article in lines 12 and 13. It is unclear whether this “predefined criteria” is the same for both recitations, or, if a different “predefined criteria” is being used. Thus, the scope of claim 7 is indefinite.
Claims 10-11, line 2, recite the conditional preposition “if”, which renders the scope of the claim indefinite as it is unclear if the step of providing heat is required to meet the claims. The use of “if” includes both positive and negative scenarios, and in negative scenarios, the providing step in line 2 is not required. The Examiner recommends replacing “if” with --when--.
Claim 11 recites “predefined criteria” twice without an article in line 3. It is unclear whether this “predefined criteria” is the same for both recitations in line 3, or, if a different “predefined criteria” is being used. Thus, the scope of claim 11 is indefinite.
Claim 13, line 5, and claim 20, line 4 include the connector “such that” that renders the phrase following the connector indefinite as “such” connotes “of the kind, character, degree” which does not mean that the phrase following the connector is required for the claim. The Examiner suggests the connector “so that”.
Claim 14, line 10, recites the conditional preposition “if”, which renders the scope of the claim indefinite as it is unclear if the step of providing power is required to meet the claim. The use of “if” includes both positive and negative scenarios, and in negative scenarios, electrical power being provided in line 10 is not required. The Examiner recommends replacing “if” with --when--; and reciting a “computing device” or a controller that determines whether the perfusion index and/or SpO2 are/is acceptable.
Claim 14 recites “predefined criteria” twice without an article in lines 11 and 12. It is unclear whether this “predefined criteria” is the same for both recitations, or, if a different “predefined criteria” is being used. Thus, the scope of claim 14 is indefinite.
Claims 21 and 24 recite that the “resilient shoe insole includes one or more sheets of resilient material to form an upper insole layer and a lower insole layer”. Paragraph [0030] of the OFS states that The Examiner notes that the OFS does not provide antecedent basis for the language of original claims 2-6, now canceled. Accordingly, the scope of the claim is indefinite because it is unclear how a sheet can form two layers based on the instant specification.
With respect to claims 22 and 25, the recitation of the plurality of flexible electrodes are positioned between the upper and lower insole layers/assemblies is indefinite because it is unclear to what the upper insole layer and the lower insole layer are. Similar to above, there are no drawings illustrating this embodiment. Thus, the scope of the claims is indefinite.
As to claims 23 and 26, the recitation of the plurality of electrodes are disposed in a one-piece electrode assembly” renders the scope of the claim indefinite. What is the one-piece electrode assembly, and how it is the plurality of flexible electrodes part of the one-piece assembly? Are “a plurality of electrodes” of the one-piece assembly additional electrodes, or, are they meant to refer back to the plurality of flexible electrodes? This limitation is not apparent from the detailed description and the drawings. Thus, the scope of claims 23 and 26 is indefinite.
Claims 8-9, 12, and 15-19 are rejected because they depend from an indefinite claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 7 recites providing electrical power to the at least one electrode when the perfusion index is acceptable according to predefined criteria. Providing power to the electrode adjacent a foot would inherently provide heat to the patient’s foot. Claim 10 recites “providing heat to the patient’s foot if the perfusion index is not acceptable”. Thus, it is unclear how claim 10 further limits claim 7. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 7, 10-12, 14, and 17-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication No. 2019/0240475 to Lawson et al. (hereinafter referred to as “Lawson”).
Referring to claim 7, Lawson discloses a method of treating a wound (e.g., title and abstract), the method comprising: securing a wearable article comprising at least one photoplethysmography (PPG) sensor and at least one electrode to a foot of a patient (e.g., paragraphs [0056]-[0058]: patch or covering configured in the shape of a boot that starts at the knee and encloses the foot conforms to a person’s limb where sensor or sensors 18 may be co-located with and/or integrated with the covering and may include an optical blood flow sensor 18 and at least one electrode; [0061]: suitable blood flow/blood volume sensors include photoplethysmography (PPG)-blood flow sensors to determine blood oxygen saturation and to compute blood volume); causing at least one photoplethysmography (PPG) sensor of the wearable article to be positioned adjacent to the foot (see Fig. 1C); causing at least one electrode of the wearable article to be positioned adjacent a wound on the foot (e.g., paragraphs [0044] and [0076]:electrodes attach to a person’s limb at or near the damaged skin (wound)) where the wound is a diabetic foot ulcer); determine a perfusion index utilizing data from the at least one photoplethysmography (PPG) sensor (e.g., paragraph [0061]: PPG sensor determine the percentage of hemoglobin in the blood that is saturated with oxygen from which the blood volume/flow can be calculated); determine an SpO2 estimation utilizing data from the at least one PPG sensor (e.g., paragraph [0061]); providing electrical power to the at least one electrode if: 1) the perfusion index is acceptable according to predefined criteria, and 2) the SpO.sub.2 estimation is not acceptable according to predefined criteria (this step is not required when the perfusion index is not acceptable).
Regarding claim 14, Lawson discloses a wearable article for monitoring and healing foot wounds (e.g., title and abstract) comprising at least one photoplethysmography (PPG) sensor (e.g., paragraphs [0056]-[0058]: patch or covering 16 conforms to a person’s limb where sensor or sensors 18 may be co-located with and/or integrated with the covering and may include an optical blood flow sensor 18; [0061]: suitable blood flow/blood volume sensors include photoplethysmography (PPG)-blood flow sensors to determine blood oxygen saturation and to compute blood volume) and at least one electrode (e.g., paragraphs [0056]-[0058]: patch or covering conforms to a person’s limb where sensor or sensors 18 may be co-located with and/or integrated with the electrode) to a foot of a patient (e.g., paragraph [0056]: the covering or patch may be configured in the shape of a boot that starts at the knee and encloses the foot, see Fig. 1C); wherein at least one photoplethysmography (PPG) sensor of the wearable article to be positioned adjacent to the foot (see Fig. 1C); wherein the at least one electrode of the wearable article is positioned adjacent a wound on the foot (e.g., paragraphs [0044] and [0076]:electrodes attach to a person’s limb at or near the damaged skin (wound)) where the wound is a diabetic foot ulcer); wherein the at least one photoplethysmography (PPG) sensor is capable of providing data for at least (1) determining an SpO2 estimation and (2) calculating a perfusion index (e.g., paragraph [0061] where a perfusion index is a blood flow or volume calculation); and wherein electrical power is capable of being provided to the at least one electrode if: 1) the perfusion index is acceptable according to predefined criteria, and 2) the SpO2 estimation is not acceptable according to predefined criteria.
With respect to claim 10, Lawson discloses the method of claim 7, including: providing heat to the patient's foot if the perfusion index is not acceptable according to the predefined criteria (this step is not required when the perfusion step acceptable).
As to claim 11, Lawson discloses the method of claim 7, including: providing heat to the patient's foot if: 1) the perfusion index is acceptable according to predefined criteria, and 2) the SpO2 estimation is not acceptable according to predefined criteria (this step is not required when the perfusion index is not acceptable).
With respect to claims 12 and 19, Lawson discloses the method of claim 7 and the wearable article of claim 14, wherein: providing electrical power to the at least one electrode includes controlling at least one parameter selected from the group consisting of: a pulse duration of a voltage supplied to the at least one electrode, a peak electrical current supplied to the at least one electrode, a waveform of a voltage supplied to the at least one electrode, and a frequency of a voltage supplied to the at least one electrode (e.g., paragraphs [0009] and [0035]: pulse generator is configured to generate a plurality of electrical impulses to deliver electrical stimulation to subject through at least one electrode where the duration is controlled by monitoring blood flow; and [00114]: control unit for electrical stimulation can manipulate variables comprising at least one of waveform, pulse duration, pulse width, and intensity).
As to claim 17, Lawson discloses the wearable article of claim 14, further comprising an electrical heating system capable of providing heat to the patient's foot if the perfusion index is not acceptable according to the predefined criteria (e.g., paragraphs [0007]: the device may include a heating component, which is configured to heat a limb; [0052]: device 10 may include a separate heating component 14. Such as an electric heating coil, an electronic heater, a Peltier device, or heated fluid, or chemical warmers, which may be controlled by control unit 12; [0056]-[0057]: device 10 includes a patch of fabric or covering with a heating component where the covering can enclose the foot – with respect to the conditional “if” clause, Lawson’s device is capable of performing that function).
With respect to claim 18, Lawson discloses the wearable article of claim 14 including: an electrical heating system capable of providing heat to the patient's foot if: 1) the perfusion index is acceptable according to predefined criteria, and 2) the SpO2 estimation is not acceptable according to predefined criteria (e.g., paragraphs [0007]: the device may include a heating component, which is configured to heat a limb; [0052]: device 10 may include a separate heating component 14. Such as an electric heating coil, an electronic heater, a Peltier device, or heated fluid, or chemical warmers, which may be controlled by control unit 12; [0056]-[0057]: device 10 includes a patch of fabric or covering with a heating component where the covering can enclose the foot – with respect to the conditional “if” clause, Lawson’s device is capable of performing that function).
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.
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.
Claims 8-9 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Lawson.
With respect to claims 8 and 15, Lawson discloses the method of claim 7 and the wearable article of claim 14, when the perfusion index is not acceptable, but does not expressly disclose that the predefined criteria for the perfusion index comprises a perfusion index above 0.4%. However, Lawson does disclose that blood flow or perfusion is monitored to control the treatment endpoint (e.g., paragraph [0035]); that the control unit 12 supplies/provides electrical power to electrodes 11 (e.g., paragraphs [0046] and [0052]: in addition to warming using electrodes, device 10 may include a separate heating component 12 also controlled by control unit 12); that control unit 12 may be configured to adjust the applied heat based on sensor readings, blood flow, blood flow volume, temperature, and provide closed loop feedback control (e.g., paragraphs [0060], [0070], [0074]); and that blood flow can be used in real-time to monitor wound healing and serve as control inputs to the device (e.g., paragraphs [0116]; and [0130]-[0131]: the indicators of wound healing are blood perfusion, chemical concentration, a gas amount, wound size or combinations thereof). With respect to the perfusion index being above 0.4%, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method as taught by Lawson so that the perfusion index is acceptable according to predefined criteria when the perfusion index above 0.4% , since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and Applicant does not appear to provide criticality for the blood perfusion index value (e.g., paragraph [0042] of the OFS: it will be understood that other values for the perfusion index may be utilized if appropriate and the present disclosure is not limited to any specific perfusion index criteria).
As to claims 9 and 16, Lawson discloses the method of claim 8 and the wearable article of claim 14, but does not expressly disclose that the predefined criteria for the SpO2 comprises an SpO2 level above 92%. Lawson does disclose using blood flow/blood volume sensors such as photoplethysmography (PPG)-blood flow sensors to determine the percentage (%) of hemoglobin in the blood that is saturated with oxygen (SpO2) (e.g., paragraph [0061]). With respect to the percentage value of SpO2, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method as taught by Lawson so that the predefined criteria for SpO2 comprises an SpO2 level above 92%, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and Applicant does not appear to provide criticality for the SpO2 value (e.g., paragraph [0043] of the OFS: Other predefined SpO2 level criteria may also be utilized, and the present disclosure is not limited to a specific SpO2 criteria).
Claims 13, 20-22 and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Lawson in view of US Patent Application Publication No. 2022/0265996 to Lawson et al. (EFD: at least 08/27/2020 and hereinafter referred to as “Lawson ‘996).
With respect to claims 13 and 20, Lawson discloses the method of claim 7 and the wearable article of claim 14, wherein the at least one PPG sensor and the plurality of flexible electrodes are operably connected to a monitoring unit that is configured to actuate at least one of the plurality of flexible electrodes to stimulate the patient's foot at or adjacent the wound base, at least in part, on information from the at least one PPG sensor (e.g., paragraphs [0044]: device 10 monitors damaged tissue, such as a wound, and includes at least two or more rubber electrodes 11 for attaching to a person’s limb at or near the damaged skin to apply electrical stimulation; [0056]-[0058]: patch or covering 16 configured in the shape of a boot that starts at the knee and encloses the foot conforms to a person’s limb where sensor or sensors 18 may be co-located with and/or integrated with the covering where a sensor may include an optical blood flow sensor 18 and the covering 16 of the device has at least one electrode; [0061]: suitable blood flow/blood volume sensors include photoplethysmography (PPG)-blood flow sensors to determine blood oxygen saturation and to compute blood volume; and [0070]: control unit 12 controls the delivery of electrical stimulation provided by the electrodes based on the sensor signals including blood flow, which is obtained by the PPG sensor), but does not expressly disclose that the wearable article comprises a resilient insole, and the at least one PPG sensor is positioned on an upper side of the resilient insole; the at least one electrode comprises a plurality of flexible electrodes positioned on the resilient shoe insole at locations that are selected such that at least one of the plurality of flexible electrodes is positioned adjacent to a wound on the patient's foot when the patient's foot is positioned on the upper side of the resilient shoe insole. However, Lawson ‘996, in a related art: apparatuses, systems, and methods for the treatment of damaged tissue, teaches a resilient insole with an electrical stimulation circuit positioned on an upper side of the resilient insole (e.g., paragraphs [0109]-[0110]: insole 114 may be formed from a pad of flexible material; [0075]: electrodes 40 may be rubber electrodes (i.e., flexible); [0119]: electrodes 140 are positioned at or near damaged skin (wound) to apply electrical stimulation to underlying tissue). Accordingly, one of ordinary skill in the art would have recognized the benefits of a resilient insole with flexible electrodes placed on the upper side of insole to treat a wound or damaged skin on the patient’s foot in view of the teachings of Lawson ‘996. Consequently, one of ordinary skill in the art would have modified the form of the wearable article of Lawson to include a resilient insole, wherein the at least one PPG sensor is positioned on an upper side of the resilient insole in view of the teachings of Lawson ‘996 that electrode are placed on an upper side of the resilient insole and the teachings of Lawson that the PPG sensor can be integrated with the electrode, and because the combination would have yielded a predictable result: a wearable article for treating diabetic foot ulcers in the form of an insole.
As to claims 21 and 24, Lawson in view of Lawson ‘996 teaches the method of claim 7 and the wearable article of claim 14, wherein: that the resilient shoe insole includes one or more sheets of resilient material to form an upper insole layer and a lower insole layer (e.g., paragraphs [0109]-[0110]: insole 114 may be formed from a pad of flexible material; [0054]: the flexible pad may be formed from two or more layers of material [upper and lower insole layer]; and [0111]: insole 114 includes a bottom side 116a for resting on the inner surface of sole 112d and a tissue facing surface 116b [upper insole layer]); wherein the upper insole layer includes at least one window through the upper insole layer (e.g., paragraphs [0111]-[0112]: insole 114 may include one or two regions 116c, 116c’;comprising a recess that extends through the insole); and at least one light source is positioned in the at least one window (e.g., paragraphs [0113]: light sources 130 are located in one or both recesses). Accordingly, one of ordinary skill in the art would have recognized the benefits of an insole with an upper pad layer comprising recesses/windows through which light sources can be positioned in view of the teachings of Lawson ‘996. Consequently, one of ordinary skill in the art would have modified the method and wearable article of Lawson in view of Lawson ‘996 to further include an insole pad of at least an upper layer and a bottom layer where the upper layer has a recess in view of the teachings of Lawson ‘996 that such was a well-known structure for treatment of damaged skin in the foot area. One of ordinary skill in the art would have further modified the method and wearable article of Lawson so that the PPG sensor taught by Lawson is positioned in the at least one window in view of the teachings of Lawson ‘996 that light sources can be positioned there and PPG sensor have light sources, and because the combination would have yielded a predictable result.
As to claims 22 and 25, Lawson in view of Lawson ‘996 teaches the method of claim 7 and the wearable article of claim 14, wherein: the plurality of flexible electrodes are positioned between the upper and lower insole layers (as these claims are best understood, paragraphs [0112] and [0119] of Lawson ‘996: electrodes 140 are located in insole 114 to apply electrical stimulation to tissue and are covered by layer 112b). One of ordinary skill in the art would have modified the method and wearable article of Lawson in view of Lawson ‘996 to position the flexible electrodes of Lawson between upper and lower insole layers in view of the teachings of Lawson ‘996 that such was a well-known structure for treatment of damaged skin in the foot area.
Claims 23 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Lawson in view of Lawson ‘996 as applied to claims 22 and 25 above, and further in view of US Patent No. 5,323,650 to Fullen et al. (hereinafter referred to as “Fullen”).
Lawson in view of Lawson ‘996 teaches the method of claim 7 and the wearable article of claim 14, wherein: the plurality of flexible electrodes are disposed within a one-piece electrode assembly having a base region and a plurality of electrodes (as best understood, paragraphs [0119] and Fig. 5 of Lawson ‘996: electrodes 140 are connected via unnumbered electrical leads to an unnumbered base and an electrical connector 116e as illustrated in Fig. 5). Lawson in view of Lawson ‘996 differs from the claimed invention in that the unnumbered electrical leads are not expressly taught as being “traces”. However, Fullen, in a related art: system for measuring forces in the foot, teaches that it was well-known in the foot medical art to use conductive trace layer 122 to electrically connect sensors/electrodes to the electronic circuit module (e.g., column 5, line 49-column 6, line 3 and 6, lines 21-29 of Fullen). Accordingly, one of ordinary skill in the art would have recognized the benefit of connecting electrodes to the base via at least one trace in view of the teachings of Fullen. Consequently, one of ordinary skill in the art would have modified the method and wearable article of Lawson in view of Lawson ‘996 to further modify the electrical leads interconnecting electrodes 140 with a base, as taught by Lawson in view of Lawson ‘996, so that an electrical trace layer is employed in view of the teaches of Fullen that such was a well-known structure for electrode to base electrical connections in the foot area, and because the combination would have yielded a predictable result.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Application Publication No. 2018/0021375 to Cohen is directed to tissue healing including wounds of the skin such as diabetic ulcers (e.g., paragraphs [0001] and [0291] where inadequate blood circulation occurs (e.g., paragraphs [0292]-[0293]) and describes conventional wound treatment as warming (therapeutic heat) and electrical stimulation (e.g., paragraph [0301]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE M VOORHEES whose telephone number is (571)270-3846. The examiner can normally be reached Monday-Friday 8:30 AM to 4:30 PM.
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/CATHERINE M VOORHEES/Primary Examiner, Art Unit 3792