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 stimulation channels (claim 1), body zones (claim 1), command and/or data entry interface (claim 1) display (claim 1), film (claim 1), branches (claim 6), concave shape (claim 6), self-adhesive support element (claim 6), support element shaped like a frame closed on itself (claim 7), electrodes provided on support element (claim 7), closure layer (claim 8) concave area (claim 8), flexible elements (claim 9), external side extensions of a branch (claim 13), at least two branches (claim 13), terminal (claim 15) and a connection base (claim 15) 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.
In figure 2, the electrode is labeled as 102 and in figure 3 the electrode is labeled 105. Figures 2-3 do not demonstrate “layers” and the drawings are thus confusing. The specification, page 21 recites “layer 100”, annular element 100 and ring 100. It is unclear what element 100 is. Also on page 21 ring is denoted as 104 as is second layer.
Specification
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the applicant’s use.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility application should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase “Not Applicable” should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM.
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR.
(g) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art including information disclosed under 37 CFR 1.97 and 1.98.
(h) BRIEF SUMMARY OF THE INVENTION.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(j) DETAILED DESCRIPTION OF THE INVENTION.
(k) CLAIM OR CLAIMS (commencing on a separate sheet).
(l) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(m) SEQUENCE LISTING. (See MPEP § 2422.03 and 37 CFR 1.821 - 1.825). A “Sequence Listing” is required on paper if the application discloses a nucleotide or amino acid sequence as defined in 37 CFR 1.821(a) and if the required “Sequence Listing” is not submitted as an electronic document either on read-only optical disc or as a text file via the patent electronic system.
Many of the headings are not found in the specification.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “body areas of an organism”, “body zones” and “a patient’s skin”. This language is inconsistent and indefinite. It is suggested that the same language is used consistently.
Claim 2 recites “a patient’s body” it is unclear if this is the same patient or a different patient than recited in claim 1.
Claim 5 recites “a human body” it is unclear if this is the same patient or a different patient than recited in claim 1.
Claim 5 recites “the plurality of electrodes are each born by an independent flexible self-adhesive support element”. It is not clear what “born by” means in this claim language.
Claim 6 recites “wherein said plurality of electrodes is born by a single flexible, self-adhesive support element, which can be fixed in a prefixed position in relation to an anatomy of a human body, said support element having at least two branches which delimit an area at least of concave shape for housing the lesion, said electrodes being each provided on one end of a respective branch, said concave area being configured to house a dressing film.” As with claim 5 the language “born by” is not understood and indefinite.
Claim 7 recites “wherein the plurality of electrodes are born by a flexible self-adhesive support element, wherein said support element is shaped like a frame closed on itself which has a free central area configured to accommodate the lesion, said plurality of electrodes being provided on said support element in two points therefore that are diametrically opposite each other with respect to a center of said support element, and wherein the dressing consists of a film of such shape and size to be at least inscribable inside said support element shaped like a frame.” As with claim 5 the language “born by” is not understood and indefinite.
Claim 9 recites “flexible elements for supporting the electrodes”. It is unclear what applicant intends a “flexible element” to be.
Claim 10 recites “wherein the electrical pulse generator, the control unit, and the command and/or data entry interface and a power source of the electrical pulse generator, the control unit and the command and/or data entry interface, are integrated in a single control device, said single control device being connected or connectable with a connection by electric cables to the plurality of electrodes, said connection being designed to be fixed or to be made with coupling terminals provided at an end of one of the electric cables with a corresponding electrode, the plurality of electrodes being connected in a separable way to corresponding connection terminals provided with said corresponding electrode.” It is believed that this language indicates that there is a single control unit, which includes a pulse generator, command/data entry interface and power source. However the language is idiomatic and difficult to understand and is therefore indefinite.
Claim 13 recites “and consists of one or more external side extensions of a branch of at least two branches of a flexible support element”. This language is not understood and indefinite.
Claim 15 recites “a connection base steadily fixed to said support element”. It is not clear what “steadily fixed” means.
Claim 16 recites “substantially congruent” the metes and bounds of the word “substantially” cannot be determined. Further the language of claim 16 is not understood and is narrative in form and somewhat idiomatic.
Any claim not specifically mentioned in the above rejections is also rejected in that all claims are dependent upon claim 1 which is rejected. It is noted that the claims, in general, are written in a narrative form and are not clear and are therefore indefinite.
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.
Claims 1-10 and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Bogie et al. US 2020/0061379 in view of Athanasiou et al. US 2015/0050234 and further in view of McErlean et al. US 2021/0128932.
Regarding claim 1 as understood: Bogie disclose an electrical pulse generator 130 (“control module”, figures 1-4 paragraphs 0053), the control module provides a series of “electrical stimulations” to a wound (considered to be electrical pulses; paragraph 0019) the stimulation parameters are controlled or adjusted by the control module and include voltage, duration, intensity and frequency, these values are considered to be prefixed values which (paragraph 0056). Thus the control module of Bogie includes a signal generator as well as control features. Each trace 132 (figures 1-4) operably connects to the control module and is considered to be a channel/trace connected for each electrode120/120a (figures 1-4), the stimulation is delivered from the control module, through each trace and then to the electrode, the channels/traces are shown as independent. The electrodes are operably attached to a patients skin surrounding a wound (paragraph 0044), the wound is the predetermined body zone, the electrodes then apply stimulation around the wound, the electrodes are fixed at a specific spacing (paragraph 0057) which is specific to wound size. The electrodes are shown diametrically opposed in figures 1A and 33. The control module includes, a user interface with a keyboard, touchscreen or dials (paragraph 0056) to control stimulation parameters (paragraph 0056). In the Bogie design there is a dressing layer positioned on a wound side of the substrate (paragraph 0003).
However, Bogie does not disclose that the dressing layer consists of a film comprising a solution of povidone iodine and sodium alginate to apply to a lesion. Athanasiou however teaches of an antiseptic which includes a matrix of alginate and iodopoviodine dispersed in the alginate matrix (abstract). The device of Athanasiou is described as a self-supporting film (paragraph 0009) useful for wound dressing produced with sodium alginate as a matrix with PVPI dispersed in the material (paragraph 0025). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to replace or modify the substrate of Bogie with the self-supporting film which includes sodium alginate as a matrix with PVPI dispersed in the material, as taught by Athanasiou, in order to provide an antiseptic and biodegradable composite material for wound healing (paragraph 0001 of Athanasiou).
Bogie/Athanasiou discloses the claimed invention however Bogie/Athanasiou does not disclose FREMS stimulation. McErlean however teaches of using FREMS to stimulate the immune system (paragraph 0134). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Bogie/Athanasiou to include that the electrical stimulation is FERMS, as taught by McErlean, in order to stimulate the immune system.
Regarding claim 2 as understood: Bogie discloses that the electrodes are spaced from the wound bed (paragraph 0044), meaning that the electrodes do not lie on or over the wound. The electrodes are spaced from each other by greater than two inches if the wound is a 2x2 inch wound (paragraph 0057). Bogie thus discloses the claimed invention except for the electrodes spaced at least 1cm from the edge of the wound. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to set the spacing of the electrode to 1cm or less from the wound boundary, 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.
Regarding claim 3 as understood: Bogie/Athanasiou discloses the claimed invention. Athanasiou further discloses that the dressing consists of sodium alginate, PVPI and glycerol (paragraph 0025). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Bogie/Athanasiou to further include glycerol, as taught by Athanasiou, in order to add a plasticizer.
Regarding claim 4 as understood: Bogie/Athanasiou discloses the claimed invention. Athanasiou further discloses that the dressing consists of sodium alginate, PVPI and glycerol (paragraphs 0018 and 0025). Therefore Bogie/Athanasiou discloses the claimed invention except for sodium alginate at a concentration of 4.6-5.2% and PVPI at a concentration of 1.3-1.9% and glycerol at a concentration of 1.3-2.3 all weight per volume. It would have been obvious to one having ordinary skill in the art at the time the invention was made to include sodium alginate at a concentration of 4.6-5.2% and PVPI at a concentration of 1.3-1.9% and glycerol at a concentration of 1.3-2.3 all weight per volume, 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.
Regarding claim 5 as understood: Bogie disclose that the electrodes are received within openings (paragraph 0004) in the dressing layer, the dressing layer includes an adhesive 108 (figure 1A) which is affixed to skin.
Regarding claim 6 as understood: Bogie discloses that the electrodes 120 (figure 1A) placed in holes 122 (figure 1A), which is considered to be “born by”. Bogie further disclose that the electrodes 120 placed through layers 104/106/108. Layers 104/106 therefore support the electrodes 120 in place, this can be a support element supporting the electrodes. The branches can be considered to be the left and right side of figures 1A and 1B and they fix the electrodes in position under their respective conductors 132. The adhesive layer 108 creates a frame as is seen in figure 1B. The wound would lie between the electrodes 120 (figure 1A) which houses the dressing.
Regarding claim 7 as understood: Bogie discloses that the electrodes 120 (figure 1A) placed in holes 122 (figure 1A), which is considered to be “born by” the substrate 102 (figure 1A), this substrate is made self-adhesive with the use of adhesive 108 (figures 1A-1B), as is seen in figure 1B the adhesive 108 creates a frame, no adhesive is on the electrodes, sensors or absorbent layer between the electrodes. The electrodes are spaced apart on separate ends of the device and are considered to be diametrically opposed, the dressing is held against the wound.
Regarding claim 8 as understood: Bogie discloses a top layer 104 which is considered to be a closure layer which overlaps support elements 102/106, this layer does not adhere to the wound.
Regarding claim 9 as understood: Bogie discloses a series of flexible elements 104/102 (figures 1A and 1B) for supporting the dressing with sizes configured for wounds of differing sizes (paragraph 0057).
Regarding claim 10 as understood: Bogie discloses that the control module 130 (figures 1-4) which delivers the therapy and thus includes a pulse generation as well as a user interface (0056) which has a keyboard for data entry, a touchscreen which is a display (paragraph 00546) and a battery (paragraph 0045). This is shown throughout the drawings as a single unit. Conductors 132 (figures 1A and 1B) connect to the electrodes 120 through vias 134 in the substrate 102 (figures 1A and 1B), the conductors also connect to the control module 130.
Regarding claim 14 as understood: Bogie discloses that the conductors 132 (figures 1A and 1B) are integrated into the substrate 102 (paragraph 0046).
Regarding claim 15 as understood: Bogie discloses that the support element 102 (“substrate”, figures 1A and 1B) has terminals (where the conductors e132 enter the control module 130 (figures 1A and 1B) for connecting the conductors to the electrodes, the connection base is considered to be the round circle seen in figure 1B (unlabeled but shown in figure 1B and round circles at the end of each conductor 132).
Regarding claim 16 as understood: Bogie discloses that the support element 102 is shaped to delimit the area between electrodes which can be considered a window, the frame is considered to be adhesive 108, the adhesive is a singular layer of film. The control device 130 is removable with the removal of the adhesive.
Regarding claim 17 as understood: Bogie discloses a combination of support elements 102/104/106 (figures 1A and 1B) for the electrodes 120 (two are shown in figures 1A and 1B), the control device 130 is also supported by these layers, the final layer 104 covers the flexible element.
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Bogie et al. US 2020/0061379 in view of Athanasiou et al. US 2015/0050234 and further in view of McErlean et al. US 2021/0128932 and further in view of Franco et al. WO 2019/166965
Regarding claims 11-13 as understood: Bogie/Athanasiou discloses the claimed invention however Bogie/Athanasiou does not disclose that the control device is provided with a wearable element. Franco however teaches of a similar device which includes pocket 940, which can be closed via flap 690 (figure 9) which houses a generator, considered to be a signal generator, the signal generator can be removed from the pocket (figure 9). Franco discloses two branches one housing 390 and the other housing 950. It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Bogie/Athanasiou to include a pocket to house an electronic/control device, as taught by Franco, in order to remove the control device when needed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Binner et al. US 2018/0093106 discloses an electrically powered patch which is removable and self-adhesive (abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAULA J. STICE whose telephone number is (303)297-4352. The examiner can normally be reached Monday - Friday 7:30am -4pm MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl H Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796