The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Specification
The disclosure is objected to because of the following informalities:
Paragraph 5: It is believed that the last sentence should be amended as follows: “In some embodiments, the electrodes include a mirror and/or identical configuration for the right and left [[knee]] thighs.”
Paragraph 53 (and similar term throughout): The last sentence of paragraph 53 reads “In some embodiments, parameter holes include holes that are within 3 holes of the pattern edge”. It is unclear if this is term was intended, or if the intended term was “perimeter”. This term appears as “parameter holes” in numerous locations after paragraph 53 as well and all iterations of the term should be corrected if it is changed.
Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to clearly label layers 1, 2, 3, 4, 5, 6 or 7 as described in the specification (see paragraphs 56-62). Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). 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 Rejections - 35 USC § 112
Second Paragraph
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 is rejected because “each thigh sheet” in line 3 is indefinite. Line 2 of claim 14 states “a thigh sheet” in reference to “an electrode sheet” from claim 1. Since there is only a single electrode sheet, which is not pluralized in claim 14, it is unclear what is meant by “each thigh sheet”.
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 1 and 6-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zabaleta et al. (US Patent Pub. No. 2021/0386993).
Zabaleta discloses a system for positioning electrodes on muscle groups (see paragraph 2 for general discussion of muscle stimulation, see paragraph 63 for explicit teaching of the invention of Zabaleta for use in muscle stimulation), comprising:
an electrode sheet (see paragraph 42; “The electrode 9 is made of different elements disposed in a layered configuration. In a lower layer, the electrode 9 has a substrate that may be made of a plastic material, for example, polyethylene terephthalate (PET) or polyamide.”),
a flexible circuit (see paragraph 43, and see Figures 2A and 2B illustrating the flexible circuitry of the device),
two or more electrodes (see Figures 2A and 2B illustrating electrodes 91 labeled as numbers 1-16 and A, B, C and D; also see paragraph 41 which states “The electrode or electrode patch 9 comprises, among other things, a plurality of electrode pads 91. Therefore, the electrode or electrode patch 9 is a multi-pad electrode.”);
wherein the flexible circuit is coupled to the electrode sheet (see Figures 2A and 2B);
wherein the two or more electrodes are coupled to the electrode sheet (see Figures 2A and 2B again); and
wherein the two or more electrodes are positioned on the electrode sheet to each activate a different muscle (due to the different locations of the electrode pads 91 across the length of the substrate, the device will inherently be capable of stimulating /activating different muscle groups, depending on the specific location of the body to which the device is applied, especially with respect to the embodiment shown in Figure 8C).
Regarding claim 6, “The socket 8 is for housing another element of the device 100, in particular a stimulator 1” (see paragraph 44 and Figures 1A, 2A and 2B). “FIG. 2A shows an assembly 20 comprising a socket 8… FIG. 2B shows a different view—back view—of the assembly 20” (see paragraph 46). As shown in the back view of Figure 2B, this is the side on which the electrodes are positioned, exemplified by the fact that the labels of electrodes 91 (i.e., 1-16 and A, B, C, and D) are properly readable in this figure. It can be seen that the socket 8 is forward facing in Figure 2A. Therefore, the socket 8 is on the opposite side of the electrodes sheet than the two or more electrodes.
Regarding claim 7, it can be seen in Figure 1A that the socket comprises a raised portion, as shown in this exploded view of Figure 1A:
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Regarding claim 8, Zabaleta teaches a “garment 10” (see Figure 1A) and states that “the garment 10 can be manufactured with flexible materials or fabrics that adapt to the shape of the user's body or limb” (see paragraph 40). “[T]he garment 10 has fastening means, for example at its ends, for securement of the garment around a user's body segment (forearm, upper arm, thigh, shank, among others)” (see paragraph 40). “The garment 10 is provided with a locking system 11. In a particular example, the locking system 11 may be a magnetic-guided locking system” (see paragraph 61), thereby reading on “the flexible garment is configured to secure to itself when wrapped around the user’s limb.”
Regarding claim 9, the garment of Zabaleta comprises a main body portion (i.e., the portion with the hollow area 60), with two oppositely positioned extending arms:
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Regarding claims 10-11, “The socket 8 is for housing another element of the device 100, in particular a stimulator 1” (see paragraph 44 and Figures 1A, 2A and 2B), where the socket 8 reads on the claimed “a controller coupler”. The socket comprises raised portions within which are found recesses 81 and 82 on the top and recess 83 on the bottom. “In the shown embodiment, the stimulator 1 has two flanges 17, 18 (see for example FIG. 5A) configured to match corresponding recesses 81, 82 (see for example FIG. 1 or FIG. 5A) in socket 8. Besides, the socket 8 has a recess 83 configured to match a corresponding protrusion 19 in the stimulator 1 (see for example FIGS. 6A and 6B)… As shown in FIG. 7, the socket 8 has an additional protrusion 84 on its inner surface that matches the switch 32 in the stimulator 1 when the stimulator is housed in the socket, in such a way that the protrusion 84 presses the switch 32. In other words, the stimulator 1 can only be switched on when it is housed in a socket 8” (see paragraph 59). In other words, all of these protrusions and recesses guide controller inputs from a controller (i.e., stimulator 1) to controller contacts on the electrode sheet (see Figure 5B and paragraph 60), as claimed. Additionally, “The garment 10, such as textile or fabric garment, defines a hollow area 60 of substantially the same size and shape as the socket 8. The hollow area is designed to receive the socket 8…when the assembly 20 is put together with the garment 10, … the socket 8 shows up through the hollow area 60 of the garment 10, leaving the socket 8 ready to receive the stimulator 1” (see paragraph 44).
Regarding claim 12, it is re-iterated that ““The garment 10… defines a hollow area 60 of substantially the same size and shape as the socket 8” (see paragraph 44). Additionally, it is clear from Figures 1A, 5A and 6A that the stimulator 1 is the same shape as the socket 8.
Regarding claim 13, Zabaleta teaches that “In use of the device 100, when the stimulator 1 coupled to the socket 8, output pins 33 of the stimulator 1 are electrically connected to the conductive paths 93 of the electrode 9, 9A, 9B, and therefore electrically connected to respective electrode pads 91” (see paragraph 46).
Claims 1-5 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baldwin et al. (WO 2022/271614).
Baldwin discloses a multi-electrode pad for transcutaneous stimulation (see Title) and taught for use in “activating muscles for strengthening or rehabilitation” (see paragraph 44). Particularly, the device of Baldwin includes an electrode sheet (see “(A) Flexible Substrate” in Figure 7; see paragraph 52 “The multi-electrode pad 102 can be formed using a substrate 120”, also paragraphs 53-54), a flexible circuit (see “(B) Metal” and “(C) Dielectric” in Figure 7; see paragraph 61-62 regarding conductive traces 124), and two or more electrodes (see Figure 2 for an example; see paragraph 55). Figure 7 illustrates that the make-up of the multi-electrode pad is such that the flexible substrate is combined with the flexible circuit and electrodes to result in the multi-electrode pad of Baldwin. Regarding the positioning of the “two or more electrodes on the electrode sheet to each activate a different muscle group”, it is noted that Figures 2 and 5 illustrate exemplary positioning of electrodes on a sheet and two electrodes at non-adjacent positions would be capable of stimulating different muscle groups depending on how and where the sheet is applied to a patient.
Regarding claims 2-4, Baldwin teaches that “the multi-electrode pad 102 can be attached to the patient's skin with an adhesive so that the multi-electrode pad 102 can adhere to the patient's skin such that contact between the one or more electrodes on the multi-electrode pad can be maintained during patient movement or skin deformation” (see paragraph 51) and “As shown in FIG. 9, … adhesive 904 can be applied to areas other than the electrodes” (see paragraph 67). With regard to claim 4 stating that the “sheet is configured to not wrap completely around a user limb”, Figure 8 illustrates the device on the back of the neck.
Regarding claim 5, it is noted that Figure 7 illustrates “(C) Dielectric” that is located under the metal conductive traces. Additionally, paragraph [0002] on page 25 teaches that “At 1504, a skeleton of an insulating flexible substrate can be cut in a shape surrounding the locations for printed conductive traces and electrodes.” Therefore, this reads on “wherein at least a portion of each of the two or more electrodes on the electrode sheet comprise a conductive material printed on the non-conductive portion”, such that the flexible substrate is non-conductive and the electrodes are printed thereon.
Regarding claim 15, Baldwin teaches that “one or more conductive metal inks can be screen printed onto the substrate at B. The printed conductive metal inks can define the electrode sites, conductive traces, and connections (for the connector, which are ends of the conductive traces) within the multi-electrode pad” (see paragraph 65); thereby teaching that the electrodes include a conductive material, which are printed onto the substrate (i.e., the claimed “electrode sheet”). As shown in Figures 2, 4, and 5, the electrodes can be arranged in a pattern that includes a grid and it is noted that “The patterns can be chosen based on a type of tissue being stimulated” (see paragraph 57).
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.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Zabaleta, as evidenced by KenHub (https://www.kenhub.com/en/library/anatomy/the-quadriceps-femoris-muscle).
Zabaleta is described above in the rejection of claim 1. It is noted that Zabaleta teaches that the garment may be used to attach the electrodes to “a user’s body segment (forearm, upper arm, thigh, shank, among others). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application, if not inherent, that when the device of Zabaleta is around a user’s thigh, it would comprise electrodes over all three of the below illustrated muscles (as found at https://www.kenhub.com/en/library/anatomy/the-quadriceps-femoris-muscle), since it would be wrapped around more than half of the thigh, if not the entirety of it.
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES KISH whose telephone number is (571)272-5554. The examiner can normally be reached M-F 10:00a - 6p EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES KISH/ Primary Examiner, Art Unit 3792