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 Arguments
Applicant’s arguments, filed 12/03/2025, with respect to the rejection of have been fully considered and are persuasive. The 35 USC 101 rejection of claim 12 has been withdrawn.
Applicant’s arguments, filed 12/03/2025, with respect to the 112(b) rejection of claim 1 have been fully considered and are persuasive. The 112(b) rejection of claim 1 has been withdrawn.
Applicant's arguments filed 12/03/2025 regarding the 35 USC 112(b) rejection of have been fully considered but they are not persuasive. The applicant claims that paragraphs [0070],[0077],[0084], [0085], and [0088] provides clarity to the detachable controller, however the above mentioned paragraphs fail to describe the function of the controller. Does it control power, stimulation patterns, timings, all of the above?
Applicant’s arguments, filed 12/03/2025, with respect to the 35 USC 112(b) rejection have been fully considered and are persuasive. The 35 USC 112(b) rejection of claims 11 and 20 has been withdrawn.
Applicant’s arguments, filed 12/03/2025, with respect to the 35 USC 112(d) rejection have been fully considered and are persuasive. The 35 USC 112(d) of claims 3 and 13 has been withdrawn.
Applicant's arguments filed 12/03/2025, regarding the prior art rejections of all the claims have been fully considered but they are not persuasive.
The applicant argues that Ergas does not teach that the elongated slots (retainer loops 450) have a greater elasticity than the sheet itself. However, Ergas teaches that the fastening means 510 is adjustable to allow for a range of user face sizes ([0036]). In the art of wearable devices, it is obvious that making components more elastic makes them more adjustable.
The applicant argues that Ergas fails to teach a secondary transparent silicone sheet, specifically one that projects beyond the periphery of the backing layer. However, as disclosed in a previous office action, Ergas does teach the correct number of layers. It would have been obvious that one of those layers could project beyond the periphery of the backing layer because Ergas teaches that a “protrusion” in the structure in paragraph [0036]. Additionally, the applicant states that the benefit to the protrusion is that ensures “consistent skin coupling during phototherapy or magnetic stimulation”. The protrusion of Ergas provides the same benefit.
The applicant argues that Ergas and Weber fail to teach a “plurality of stimulation elements such as LEDs and magnetic nodes”. Firstly, it was unclear which claim this argument is directed to, however based on the lack of any mention of the specific stimulation elements in claim 1, it is assumed that this argument refers to limitations of claim 6. Regardless, Ergas was not relied on to teach this concept and it was admitted in a prior office action that this limitation is not taught by Ergas. Weber is relied upon to teach this limitation. The phrasing of the limitation states that the PCB includes “a plurality of LEDs, a body sensor, and a plurality of magnetic nodes”. Therefore, the plurality of stimulation elements can be broadly interpreted to mean a plurality of any items from the list, even if it is all of one type. Therefore, a plurality of LEDs meets the requirement to read on the claim.
The applicant argues that the adjunctive circuitry of Weber does not teach the polarity protection circuit because Weber is silent as to how the protection is achieved and doesn’t mention polarity orientation or the like. However, claims 1 and 12 only require that the polarity protection circuit protects said device from damage and does not provide further details, which is taught by the previously cited portions of Weber. There are no further details actually provided in the claims and even if claims 9 and 18 are intended to further describe the polarity protection circuit, those details are taught by Pepitone et al (US 20180221682 A1); hereinafter Pepitone. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the polarity protection circuit) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The applicant claims that the stimulation elements of Weber are not incorporated into a flexible PCB. However, the applicant is reminded that Weber is only relied upon for the stimulation elements themselves and Ergas teaches the flexible PCB. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
The applicant argues that none of the prior art references teach a magnetically detachable controller. However, the disclosure of Pepitone discloses magnetically detachable portions, therefore making a magnetically detachable controller obvious.
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 12 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.
Regarding claim 12, it is stated that the controller is detachably attached to the primary sheet. It is unclear what role the controller plays in the stimulation/treatment process. If it is detachable then it is not necessary for the functioning of the device at all times. Based on the claims, it is unclear what the function of the controller is and what it does that cannot be done by the PCB. Clarity is required as to the function of the controller and the necessity for the functioning of the device.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-8,11,12-17, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ergas et al (US20230033993A1); hereinafter Ergas in view of Weber et al (US 20230211076 A1); hereinafter Weber (both cited previously).
Regarding claim 1, Ergas teaches a wearable therapy device ([0008] phototherapy mask), comprising:
a primary sheet ([0026] first layer 100 that constitutes a backing layer) having at least one elongated slot on each side of said primary sheet (fig. 7 part 450 retainer loops), wherein the elasticity of the outer edge of each of said slot is greater than that of said primary sheet ([0034] the fixing straps may be elasticated, [0036] the fastening means 510 is adjustable to allow for a range of user face sizes – makes greater elasticity obvious);
a secondary sheet made of transparent silicon layer ([0032] the skin-contacting layer 300 is formed from a material that is translucent or transparent, [0027] flexible material is silicone) wherein the transparent silicon layer is protruded over said primary sheet ([0026] third layer 300 that constitutes a skin-contacting layer, [0036] protrusion);
a flexible Printed Circuit Board (FPCB) ([0028] flexible printed circuit board 210, electronics second layer 200) situated between said primary sheet and said secondary sheet (fig. 3 part 200).
Ergas fails to teach a plurality of stimulation elements. Weber teaches the said flexible PCB includes plurality of stimulation elements ([0636] stimulation devices). It would have been obvious to modify the wearable device of Ergas with the stimulation elements of Weber because it constitutes combining prior art elements according to known methods to yield predictable results. Wearable and implanted devices with a form factor similar to the base reference of Ergas, commonly have a stimulation element as demonstrated by Weber. Additionally, the reference of Weber combines phototherapy with electrical stimulation reading on that particular aspect of the present invention.
Ergas further teaches a controller detachably attached to the rear side of said primary sheet using a securing mechanism ([0031] electronic layer 200 further includes an electrical connector 230 configured to electrically connect a remote power controller unit 240).
Ergas fails to teach a polarity protection circuit. Weber further teaches said device integrates a polarity protection circuit to protect said device against damage caused by incorrect connection between said controller and said flexible PCB ([0669]-[0670] adjunctive circuitry 3233 provide protection to CPU, battery charging and protection). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Ergas with Weber because there is some teaching, suggestion, or motivation to do so. Weber teaches that using adjunctive circuitry helps provide protection to CPU 3232 and superstructure 3219 ([0069]).
Regarding claim 12, Ergas teaches a method of using a wearable therapy device ([0008] phototherapy mask) comprising the steps of:
a) placing said wearable device to a user body, wherein the said wearable device comprises:
a primary sheet ([0026] first layer 100 that constitutes a backing layer) having at least one elongated slot on each side of said primary sheet (fig. 7 part 450 retainer loops), wherein the elasticity of the outer edge of each of said slot is greater than that of said primary sheet ([0034] the fixing straps may be elasticated, [0036] the fastening means 510 is adjustable to allow for a range of user face sizes – makes greater elasticity obvious);
a secondary sheet made of transparent silicon layer ([0032] the skin-contacting layer 300 is formed from a material that is translucent or transparent, [0027] flexible material is silicone) wherein the transparent silicon layer is protruded over said primary sheet ([0026] third layer 300 that constitutes a skin-contacting layer, [0036] protrusion);
a flexible Printed Circuit Board (FPCB) ([0028] flexible printed circuit board 210, electronics second layer 200) situated between said primary sheet and said secondary sheet (fig. 3 part 200).
Ergas fails to teach a plurality of stimulation elements. Weber teaches the said flexible PCB includes plurality of stimulation elements ([0636] stimulation devices). It would have been obvious to modify the wearable device of Ergas with the stimulation elements of Weber because it constitutes combining prior art elements according to known methods to yield predictable results. Wearable and implanted devices with a form factor similar to the base reference of Ergas, commonly have a stimulation element as demonstrated by Weber. Additionally, the reference of Weber combines phototherapy with electrical stimulation reading on that particular aspect of the present invention.
Ergas further teaches detachably attaching a controller to the rear side of said primary sheet using a securing mechanism ([0031] electronic layer 200 further includes an electrical connector 230 configured to electrically connect a remote power controller unit 240).
Ergas fails to teach a polarity protection circuit. Weber further teaches said device integrates a polarity protection circuit to protect said device against damage caused by incorrect connection between said controller and said flexible PCB ([0669]-[0670] adjunctive circuitry 3233 provide protection to CPU, battery charging and protection). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Ergas with Weber because there is some teaching, suggestion, or motivation to do so. Weber teaches that using adjunctive circuitry helps provide protection to CPU 3232 and superstructure 3219 ([0069]).
Weber further teaches activating the wearable therapy device to deliver therapeutic stimulation to the user through the stimulation elements on the flexible PCB, thereby facilitating the therapeutic session ([0636] stimulation devices, [0816] activating peripherally based terminal electrodes 6012).
Regarding claim 2, the combination of Ergas and Weber teaches the device of claim 1. Ergas further teaches that the primary sheet is shaped as oblong (fig. 5 the shape of the mask is roughly oblong).
Regarding claims 3 and 13, the combination of Ergas and Weber teaches the device of claim 1 and the method of claim 12. Ergas further teaches said elongated slots enable the user to connect multiple said devices using at least one strap made of elastic material ([0034] The fixing straps 440 may be elasticated and/or may fasten by means of a fastening clip, hook and loop, buckle or other fastening means capable of releasably connecting to/cooperating with the retainer loops 450 to secure the mask 400 to the user's face.).
Regarding claim 5, the combination of Ergas and Weber teaches the device of claim 1. Ergas further teaches a gap is forged between the outer periphery of the said primary sheet and outer periphery of said secondary sheet (fig. 4 demonstrates that the primary sheet and the secondary sheet have a gap).
Regarding claims 6 and 15, the combination of Ergas and Weber teaches the device of claim 1 and the method of claim 12. Ergas further teaches the flexible printed circuit board includes a plurality of Light Emitting Diodes (LEDs) ([0030] In various embodiments, the light sources 220 are LEDs), a body sensor and a plurality of magnetic nodes.
Regarding claims 7 and 16, the combination of Ergas and Weber teaches the device of claim 6 and the method of claim 15. Ergas further teaches that the LEDs are emitting red and infrared light ([0030] the light sources 220 are LEDs capable of emitting light with at least one wavelength between 300 nm and 1200 nm. In various preferred embodiments, the LEDs are capable of emitting light with at least one wavelength between 420 nm and 1080 nm – these wavelengths encompass both red and infrared light).
Regarding claims 8 and 17, the combination of Ergas and Weber teaches the device of claim 6 and the method of claim 15. Ergas further teaches the flexible PCB has edges and corners made in a round shape to prevent breakage (fig. 4,5).
Regarding claims 11 and 20, the combination of Ergas and Weber teaches the device of claim 1 and the method of claim 12. Weber further teaches said device is wirelessly connected with a user's external communication device which enables said user to control said device from said external communication device (the device may be remotely powered and/or employ wireless communication… the device may be controlled via external data telemetry).
Claim(s) 4 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Ergas and Weber as applied to claims 1 and 12 above, and further in view of Schwarz et al (US 20230241384 A1); hereinafter Schwarz (cited previously).
The combination of Ergas and Weber teaches the device of claim 1 and the method of claim 12. The combination fails to teach using a different material to alter the elasticity of the outer edges. Schwarz teaches that the elasticity of said outer edges is increased by incorporating, but not limited to, adding a different material or filing less material ([0128] it is possible to fasten the flexible pads 4 to the face by at least one fastening mechanism - a band or felt which may be made from an elastic material). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination of Ergas and Weber with the teachings of Schwarz because there is some teaching, suggestion, or motivation to do so. Schwarz teaches that the elasticity makes the mask adjustable for an individual face ([0128]).
Claim(s) 9,10,18, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Ergas and Weber as applied to claim 1 and 12 above, and further in view of Pepitone et al (US 20180221682 A1); hereinafter Pepitone (cited previously).
Regarding claims 9 and 18, the combination of Ergas and Weber teaches the device of claim 1 and the method of claim 12. The combination fails to teach using a plurality of magnetic poles to hold the controller in place in electrical connection with the PCB. Pepitone teaches the securing mechanism comprises;
a plurality of poles to securely hold the controller and establishing the electrical connection between said controller and said flexible PCB ([0031] corresponding magnets 62,64… engage and magnetically join, thereby securing the pace plate 40 on the headband 20); and,
a cavity to restrict movement of said controller during affixing of said controller with said primary sheet (see fig. 1 - there is a recess in which the magnets are contained).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination of Ergas and Weber with the teachings of Pepitone because there is some teaching, suggestion, or motivation to do so, Pepitone teaches “the face plates 40 are each removable from the headband 20 to allow interchanging of different face plates. In order to allow for easy and quick removal and replacement” ([0031]). While Pepitone discusses exchanging a different part than the present invention, the logical extension is that using a system of corresponding magnets allows for simple and easy removal and replacement of whatever parts are being connected.
Regarding claims 10 and 19, the combination of Ergas, Weber, and Pepitone teach the device of claim 9 and the method of claim 18. Pepitone further teaches the plurality of poles as described in claim 9 are connected to the plurality of magnetic nodes to facilitate magnetization, enabling magnetic coupling between the controller and the plurality of poles ([0031] corresponding magnets 62,64… engage and magnetically join, thereby securing the pace plate 40 on the headband 20).
Conclusion
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 Dhrasti SNEHAL Dalal whose telephone number is (571)272-0780. The examiner can normally be reached Monday - Thursday 8:30 am - 6:00 pm, Alternate Friday off, 8:30 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl 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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/D.S.D./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796