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
Response to Arguments
The replacement drawings overcome the previously drawing objections. Additionally, the cancelation of claim 14 overcomes the previous rejection under 35 USC 112(b).
Applicant’s arguments with respect to the prior art rejections against the claims have been considered but are moot in view of the new grounds of rejection. The arguments rely on the claim amendments, particularly to the change of “two or more electrodes” to “exactly three electrodes”.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 and 6-7 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Samant et al. (WO 2023/065029).
Samant discloses systems for generating and delivering electrical stimulation to a user’s body, such as to one or more target muscles on the body (see paragraph 6). Specifically, Samant teaches a system for positioning electrodes on muscle groups, comprising:
An electrode sheet (see flexible body 142 in Fig. 1, paragraph 54), a flexible circuit (see paragraph 53, “Circuit board 182 may be any suitable circuit board, such as a printed circuit board (PCB), a rigid-flex circuit board, and more”), and exactly three electrodes (see exactly three electrodes 149 in Figure 6);
Wherein the flexible circuit is coupled to the electrodes sheet (see Figure 5, illustrating circuit board 182 contained therein connector 170, which is shown on flexible body 142 within Figures 8-10);
Wherein the three electrodes are coupled to the electrode sheet (see exactly three electrodes configured directly on the flexible body 142 in each of Figures 6 and 9); and
Wherein the three electrodes are pre-arranged on the electrode sheet to activate a rectus femoris muscle group and a vastus medialis muscle group (it is noted that the arrangement of the three electrodes on the flexible body 142 as illustrated by Samant is fully capable of activating the rectus femoris and vastus medialis muscle groups, which would depend on how the flexible body 142 is applied to the patient).
With regard to the immediately preceding paragraph, it is noted that Section 2114(II) of the MPEP states (with emphasis in the original), “’Apparatus claims cover what a device is, not what a device does.’ Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990).” Section 2114(II) of the MPEP states, “A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987.” With regard to the last wherein clause of claim 1, the electrodes being pre-arranged on the electrode sheet to activate certain muscle groups is only going to activate those muscle groups if it is used in a particular manner. For example, if the system of claim 1 is applied to the arm of a user, it will be unlikely to activate the muscle groups that are claimed.
Regarding claim 2, figure 6 illustrates a first electrode, second electrode and third electrode. With regard to the second and third wherein clauses, the same citations from MPEP 2114(II) presented above for claim 1 are directly relevant again. Additionally, the device shown in Figure 6 is capable of being placed on a person such that, for example, the top electrode of Figure 6 and one of the two bottom electrodes may reside over the rectus femoris muscle group, while the other one of the two bottom electrodes would then reside over the vastus medialis muscle group. This is, again, dependent upon how the device is applied to the user’s thigh, but again it is noted that “’Apparatus claims cover what a device is, not what a device does.’ Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990).”
Regarding claim 3, paragraph 54 teaches that “electrode pads 149 (and/or an exterior surface of second wall 176) may include an outer adhesive layer and/or define an adhesive surface of flexible body 142 to facilitate attachment to the target treatment site.”
Regarding claim 6, see Figure 10 of Samant illustrating controller coupler 170 and stimulator device/controller 110, which are shown on an opposite side of the flexible body 142 as compared to the electrodes (see Figure 1, and all figures illustrating the device attached to a person).
Regarding claim 7, Samant teaches in paragraph 53 that “Electrode plate 184, and particularly apertures 186, may be configured to interact with (e.g., receive) the plurality of pins 119 via the corresponding apertures on first connection interface 178, in response to stimulator device 110 connecting with connector device 170. For example, the one or more apertures 186 on electrode plate 184 may define electrical contacts that are configured to receive the plurality of pins 119 through first wall 174, and the corresponding apertures on second connection interface 177 may be configured to receive the plurality of pins 119 therein via apertures 186 on electrode plate 184.”
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.
Claims 4-5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Samant in view of Baldwin et al. (WO 2022/271614).
Samant is described above with respect to claim 3. However, Samant teaches that the adhesive is in relation to the electrodes or wall 176 (see paragraph 54). Samant does not teach adhesive with regard to the non-electrode parts of the flexible body 142.
Regarding claim 4, 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) and a flexible circuit (see “(B) Metal” and “(C) Dielectric” in Figure 7; see paragraph 61-62 regarding conductive traces 124), and electrodes (see Figure 2 for an example; see paragraph 55). 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.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize adhesive either directly on the electrodes (as in Samant) or on the areas other than the electrodes (as taught by Baldwin), because the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results (KSR, 550 U.S. at 416, 82 USPQ2d at 1395). These are the only two options for applying adhesive to such a device, and the use of either option yields the predictable result of adherence of the device to the patient.
Regarding claim 5, Samant teaches that “electrode device 140 may include one or more additional interior layers disposed between the opposing outer layers, such as an insulation film 154 serving as a protective insulating layer made from non-conductive materials” (see paragraph 59). This teaches non-conducive portions. Additionally, Samant teaches printing of conductive materials (see paragraphs 57-58). However, Samant does not explicitly teach printing the electrodes. It is noted that Figure 7 of Baldwin illustrates “(C) Dielectric” that is located under the metal conductive traces. Additionally, paragraph 2 on page 25 of Baldwin 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 three electrodes [(per the combination with Samant]) 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). Additionally, the electrodes 149 of Samant are grids (see Figure 6).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Samant in view of Kanetsuna et al. (WO 2016/189798).
Samant is described above with regard to claim 1. However, Samant does not explicitly teach a garment that wraps around the patient’s limb.
Regarding claim 8, Kanetsuna teaches an electrical stimulation device, comprising: an electrode part (see Abstract; see electrode part 30 in Figure 5), and Kanetsuna teaches that “the inventors confirmed that the training effect of the quadriceps muscle is improved if electrical stimulation can be applied across the rectus femoris, lateral vastus and medial vastus” (see paragraph “[14]”). “According to the electrical stimulation device, the electrode part is easy to fit on the target site. For this reason, the adhesiveness of the electrode part with respect to an object site | part is further improved.” In addition to adhesive, Figures 1-3 and 8 illustrate a wrap that may be used with the electrode part(s) (e.g., “The electrical stimulation device 1 includes a plurality of supporters 10 that are attached to a thigh 200 that is an example of a target region of the body”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize a wrap to apply electrodes to a patient’s limb, as taught by Kanetsuna, as a functional alternative to adhesives as taught by Samant, because the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results (KSR, 550 U.S. at 416, 82 USPQ2d at 1395). As taught by Kanetsuna, “since the detection unit and the electrode unit are fixed to the target site when the supporter is attached to the target site, the detection unit and the electrode unit are not easily detached from the target site” (see paragraph “[9]”), which is the same result of the use of adhesive as taught by Samant.
Regarding claim 9, Figure 3 of Kanetsuna illustrates a main body portion 12 in the middle, a “left” extending arm 13 and a “right “extending arm 11.
Claims 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Samant in view of Kanetsuna as applied to claim 9 above, and further in view of Zabaleta et al. (US Patent Pub. No. 2021/0386993).
Samant in combination with Kanetsuna is described above with regard to claim 9. Figure 10 of Samant illustrates a controller coupler 170 and stimulator device/controller 110. Also, Samant teaches in paragraph 53 that “Electrode plate 184, and particularly apertures 186, may be configured to interact with (e.g., receive) the plurality of pins 119 via the corresponding apertures on first connection interface 178, in response to stimulator device 110 connecting with connector device 170. For example, the one or more apertures 186 on electrode plate 184 may define electrical contacts that are configured to receive the plurality of pins 119 through first wall 174, and the corresponding apertures on second connection interface 177 may be configured to receive the plurality of pins 119 therein via apertures 186 on electrode plate 184.” This reads on lines 3-4 of claim 10.
While Kanetsuna teaches a wrap used for attaching electrode parts to a person, there is no discussion of a controller attachment portion having an aperture in the main body portion of the wrap. This is because Kanetsuna provides the controller 100 connected to the wrap via wires and therefore, separate from the wrap (see Figure 7).
Regarding claims 10-11, 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). Zabaleta teaches that “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 “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).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to provide a system in which the controller is integrally part of the wrapping body, as taught by Zabaleta, as an alternative to the controller being connected separately via wiring as taught by Kanetsuna. By doing so, the device is all self-contained and there is no chance of wires getting tangled or caught on nearby objects, or cut and causing the device to become useless.
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). It is noted also that Samant teaches a single controller 110 that is connected to each of the three electrodes (i.e., directly connected to the top electrode of Figure 6 and connected to each bottom electrode via traces 156); therefore it is inherent or obvious that this one controller controls all three electrodes.
Conclusion
The following prior art is herein made of record is considered pertinent to applicant's disclosure, but not relied upon in the rejections above:
de Oliveira et al. (US Patent Pub. No. 2017/0281935).
De Oliveira discloses equipment for muscular performance recovery in patients (see Abstract). Specifically, de Oliveira teaches a system for positioning electrodes on muscle groups, comprising: … exactly three electrodes (see main electrode 6 and two satellite electrodes 8; see Figure 5). Paragraph 44 teaches that target muscles include the rectus femoris, vastus medialis and vastus laterallis.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JAMES KISH/ Primary Examiner, Art Unit 3792
Prosecution Insights