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 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: Element 31 (paragraph [0052]) and Element 52 (paragraph [0056]). 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. 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 Objections
Claim 1 is objected to because of the following informalities: The acronym PCB is not defined before being used. Appropriate correction is required. The examiner assumes this means printed circuit board (PCB).
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.
Claim 19 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 19 recites the limitation "the controller" in line 6. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Andrich et al (US Publication 2022/0339466).
Referring to Claim 17, Andrich et al teaches a light mat for a wearable phototherapy system comprising: a lower silicone layer (e.g. Figures 2 and 11 and Paragraph [0092]);an upper silicone layer opposite the lower silicone layer (e.g. Figures 2 and 11 and Paragraph [0092]); a flexible PCB sheet having a plurality of light emitters disposed on the flexible PCB sheet, wherein the flexible PCB sheet is enveloped between the upper silicone layer and the lower silicone layer, with the plurality of light emitters positioned so as to emit light through the upper silicone layer (e.g. Figures 2 and 11 and Paragraphs [0068] and [0092]).
Claim(s) 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chow et al (US Publication 2020/0197721).
Referring to Claim 20, Chow et al teaches a method of treating an infant with the wearable phototherapy system of claim 1 comprising the steps of: providing the wearable phototherapy system (e.g. Figures 1 and 4); positioning a back of an infant on the central spine region of the body member (e.g. Figures 1 and 4); wrapping the first side wing over the infant (e.g. Figures 1 and 4); wrapping the second side wing over the infant (e.g. Figures 1 and 4); securing the first side wing and the second side wing together (e.g. Figures 1 and 4); extending the upper sealing member around a neck of the infant (e.g. Figures 1 and 4); securing the first side of the upper sealing member to an outer surface of the body member (e.g. Figures 1 and 4); sealing the second side of the upper sealing member to the outer surface of the body member (e.g. Figures 1 and 4); energizing the light emitters of the light mat (e.g. Paragraph [0029]).
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.
Claim(s) 1-3, 5-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chow et al (US Publication 2020/0197721) in view of Andrich et al (US Publication 2022/0339466).
Referring to Claim 1, Chow et al teaches a wearable phototherapy system for an infant, comprising: a swaddle assembly( e.g. Figure 1, Element 38), the swaddle assembly comprising: a body member adapted to encircle the infant from a neck region downward, defining a central spine region, a first side wing on a first side thereof and a second side wing on a side opposite the first wing (e.g. Figure 4 illustrates central spine region (near element 104), first side and opposite second side are the left and right of the central region); a pocket panel positioned on an inner surface of the body member overlying at least a portion of the central spine region, defining a cavity with an opening facilitating entry into the cavity, the pocket panel being light permeable (e.g. Figure 4, Elements 92 and Paragraphs [0059], [0072], and [0079]); an upper sealing member including a first side and a second side opposite the first side extending outwardly from a top end of the body member, the first and second sides cooperate to form a central slot adapted to encircle the neck of an infant when the body member encircles the infant (e.g. Figure 4, Element 102); a light mat (e.g. Figure 4, Element 78) comprising: wherein the light mat is insertable through the opening into the cavity defined by the pocket panel and the body member, with plurality of light elements when energized oriented to direct light through the upper silicone layer and the pocket panel (e.g. Figure 4, Elements 78 and Paragraphs [0059], [0072], and [0079]). However, Chow et al does not explicitly disclose a flexible PCB assembly having a plurality light elements organized in a spaced apart manner along the flexible PCB assembly, an upper silicone layer overlying the flexible PCB assembly.
Andrich et al teaches that it is known to use a flexible PCB assembly having a plurality light elements organized in a spaced apart manner along the flexible PCB assembly, an upper silicone layer overlying the flexible PCB assembly as set forth in Figures 1, 2, and 11 and Paragraphs [0068] and [0092] to provide reducing the risk of electricity transfer to the patient and to provide a soft and comfortable surface for the neonate. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Chow et al, with flexible PCB assembly having a plurality light elements organized in a spaced apart manner along the flexible PCB assembly, an upper silicone layer overlying the flexible PCB assembly as taught by Andrich et al, since such a modification would provide the predictable results of to reduce the risk of electricity transfer to the patient and to provide a soft and comfortable surface for the neonate.
Referring to Claim 2, Chow et al in view of Andrich et al teaches the wearable phototherapy system of claim 1 wherein the first side and the second side are adapted to overlie a portion of an outer surface of the body member when encircling the infant, and are releasably attachable to an outer surface of the body member (e.g. Figure 1 and 4). In the alternative, it would have been obvious to one of ordinary skill in the art at the time the invention was made to adjust the dimensions so that the first side and the second side are adapted to overlie a portion of an outer surface of the body member when encircling the infant, since it has been held by the courts that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device, and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), see MPEP 2144.04(IV)(A).
Referring to Claim 3, Chow et al in view of Andrich et al teaches the wearable phototherapy system of claim 1 wherein at least one of the first side wing and the second side wing are adapted to overlie the other of the first side wing and the second wing when encircling the infant, and wherein the first side wing and the second side wing are releasably attachable to each other (e.g. Figure 1 and 4).
In the alternative, it would have been obvious to one of ordinary skill in the art at the time the invention was made to adjust the dimensions so at least one of the first side wing and the second side wing are adapted to overlie the other of the first side wing and the second wing when encircling the infant, since it has been held by the courts that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device, and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), see MPEP 2144.04(IV)(A).
Referring to Claim 5, Chow et al in view of Andrich et al teaches the wearable phototherapy system of claim 1 further comprising a lower sealing member extending from a bottom end of the body member opposite the upper sealing member (e.g. Figure 4, Element 104).
Referring to Claim 6, Chow et al in view of Andrich et al teaches the wearable phototherapy system of claim 5 wherein the lower sealing member is releasably attachable to an outer surface of the upper sealing member when encircling an infant so as to cover seal a lower end of the swaddle assembly (e.g. Figure 4, Element 104).
Referring to Claim 7, Chow et al in view of Andrich et al teaches the wearable phototherapy system of claim 6 wherein the lower sealing member includes an openings extending therethrough (e.g. Figures 1 and 4). However, Chow et al does not disclose the lower sealing member includes a plurality of openings.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to include a plurality of openings since it has been held that mere duplication of essential working parts of a device involves only routine skill in the art. See MPEP 2144.04(VI)(B).
Referring to Claim 8, Chow et al in view of Andrich et al teaches the wearable phototherapy system of claim 1 wherein the pocket panel of the body member comprises a mesh member that is one of transparent and translucent (e.g. Paragraph [0072] and Figure 4, Element 96).
Referring to Claim 9, Chow et al in view of Andrich et al teaches the wearable phototherapy system of claim 1 further comprising a controller, the controller being electrically coupled to the light mat and adapted to selectively energize the light elements of the light mat (e.g. Paragraph [0048]).
Referring to Claim 10, Chow et al in view of Andrich et al teaches the wearable phototherapy system of claim 9 wherein the controller is wired to the light mat about a lower end thereof (e.g. Paragraph [0048] and Figure 4).
Referring to Claim 11, Chow et al in view of Andrich et al teaches the wearable phototherapy system of claim 1 except wherein the light mat further includes a lower silicone layer, wherein the upper silicone layer and the lower silicone layer cooperatively envelope the flexible PCB sheet therebetween.
Andrich et al teaches that it is known to use the light mat further includes a lower silicone layer, wherein the upper silicone layer and the lower silicone layer cooperatively envelope the flexible PCB sheet therebetween as set forth in Figures 2 and 11 and Paragraph [0092] to provide simplifying cleaning, and limits the surface area that can harbor bacteria, while protecting the LEDs from impact, liquids (from the infant, or otherwise), and cleaning materials and abrasives. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Chow et al, with the light mat further includes a lower silicone layer, wherein the upper silicone layer and the lower silicone layer cooperatively envelope the flexible PCB sheet therebetween as taught by Andrich et al, since such a modification would provide the predictable results of simplifying cleaning, and limits the surface area that can harbor bacteria, while protecting the LEDs from impact, liquids (from the infant, or otherwise), and cleaning materials and abrasives.
Referring to Claim 12, Chow et al in view of Andrich et al teaches the wearable phototherapy system of claim 11 except wherein the upper silicone layer includes a cavity aligning with each of at least a plurality of the light emitters, so as to overlay the same.
Andrich et al teaches that it is known to use the upper silicone layer includes a cavity aligning with each of at least a plurality of the light emitters, so as to overlay the same as set forth in Figures 9 and 10 to provide allowing the flexible light emitting pad to more easily wrap around an infant. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Chow et al, with the upper silicone layer includes a cavity aligning with each of at least a plurality of the light emitters, so as to overlay the same as taught by Andrich et al, since such a modification would provide the predictable results of allowing the flexible light emitting pad to more easily wrap around an infant.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chow et al (US Publication 2020/0197721) in view of Andrich et al (US Publication 2022/0339466) as applied to claim 1 above, and further in view of Masu et al (CN 103638605), cited in IDS dated 9/4/2025.
Referring to Claim 4, Chow et al in view of Andrich et al teaches the wearable phototherapy system of claim 1 wherein the pocket panel extends toward the first side wing and wherein the pocket panel extends toward a second wing side, so as to be adapted to at least partially encircle the infant (e.g. Figure 4).
Masu et al teaches that it is known to use the pocket panel extends toward the first side wing a distance beyond the first side of the upper sealing member and wherein the pocket panel extends toward a second wing side a distance beyond the second side of the upper sealing member as set forth in Figure 1 to provide increased treatment by providing more continuously covering of the patient’s body surface. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Chow et al, with the pocket panel extends toward the first side wing a distance beyond the first side of the upper sealing member and wherein the pocket panel extends toward a second wing side a distance beyond the second side of the upper sealing member as taught by Masu et al, since such a modification would provide the predictable results of increased treatment by providing more continuous covering of the patient’s body surface.
Claim(s) 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chow et al (US Publication 2020/0197721) in view of Andrich et al (US Publication 2022/0339466) as applied to claim 1 above, and further in view of Harel et al (US Publication 2024/0325778).
Referring to Claim 13-15, Chow et al in view of Andrich et al teaches the wearable phototherapy system of claim 1 except wherein the light mat further defines an upper body region and a lower body region, both regions being spaced apart from each other with a connector portion extending therebetween, the connector portion being narrower than each of the upper body region and the lower body region; the upper body region defines a central portion coupled to the connector portion, a first upper wing on one side thereof and a second upper wing on an opposite side thereof; the lower body region defines a central portion coupled to the connector portion, a first lower wing on one side thereof and a second lower wing on an opposite side thereof. Harel et al teaches that it is known to use the light mat further defines an upper body region and a lower body region, both regions being spaced apart from each other with a connector portion extending therebetween, the connector portion being narrower than each of the upper body region and the lower body region; the upper body region defines a central portion coupled to the connector portion, a first upper wing on one side thereof and a second upper wing on an opposite side thereof; the lower body region defines a central portion coupled to the connector portion, a first lower wing on one side thereof and a second lower wing on an opposite side thereof as set forth in Figure 3 to provide cost and energy can be saved by using fewer lights and in a position that corresponds to the shape of a newborn baby (e.g. Paragraph [0062]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Chow et al, with the light mat further defines an upper body region and a lower body region, both regions being spaced apart from each other with a connector portion extending therebetween, the connector portion being narrower than each of the upper body region and the lower body region; the upper body region defines a central portion coupled to the connector portion, a first upper wing on one side thereof and a second upper wing on an opposite side thereof; the lower body region defines a central portion coupled to the connector portion, a first lower wing on one side thereof and a second lower wing on an opposite side thereof as taught by Harel et al, since such a modification would provide the predictable results of cost and energy can be saved by using fewer lights and in a position that corresponds to the shape of a newborn baby.
Referring to Claim 16, Chow et al in view of Andrich et al and Harel et al teaches the wearable phototherapy device of claim 15 wherein the controller is attached to a lower end of the central portion of the lower body region (e.g. Figure 4).
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Andrich et al (US Publication 2022/0339466) in view of Harel et al (US Publication 2024/0325778) and Chow et al (US Publication 2020/0197721).
Referring to Claims 18-19, Andrich et al teaches the light mat of claim 16, except wherein the light mat further defines an upper body region and a lower body region, both regions being spaced apart from each other with a connector portion extending therebetween, the connector portion being narrower than each of the upper body region and the lower body region; the upper body region defines a central portion coupled to the connector portion, a first upper wing on one side thereof and a second upper wing on an opposite side thereof; the lower body region defines a central portion coupled to the connector portion, a first lower wing on one side thereof and a second lower wing on an opposite side thereof; and wherein the controller is attached to a lower end of the central portion of the lower body region. Harel et al teaches that it is known to use the light mat further defines an upper body region and a lower body region, both regions being spaced apart from each other with a connector portion extending therebetween, the connector portion being narrower than each of the upper body region and the lower body region; the upper body region defines a central portion coupled to the connector portion, a first upper wing on one side thereof and a second upper wing on an opposite side thereof; the lower body region defines a central portion coupled to the connector portion, a first lower wing on one side thereof and a second lower wing on an opposite side thereof as set forth in Figure 3 to provide cost and energy can be saved by using fewer lights and in a position that corresponds to the shape of a newborn baby (e.g. Paragraph [0062]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Andrich et al, with the light mat further defines an upper body region and a lower body region, both regions being spaced apart from each other with a connector portion extending therebetween, the connector portion being narrower than each of the upper body region and the lower body region; the upper body region defines a central portion coupled to the connector portion, a first upper wing on one side thereof and a second upper wing on an opposite side thereof; the lower body region defines a central portion coupled to the connector portion, a first lower wing on one side thereof and a second lower wing on an opposite side thereof as taught by Harel et al, since such a modification would provide the predictable results of cost and energy can be saved by using fewer lights and in a position that corresponds to the shape of a newborn baby.
Chow et al teaches that it is known to use the controller is attached to a lower end of the central portion of the lower body region as set forth in Figure 4 to provide making it easier to swaddle the infant without having the cable in the way which make it easier to flexible encircle the infant and make adjustments. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Andrich et al, with the controller is attached to a lower end of the central portion of the lower body region as taught by Chow et al, since such a modification would provide the predictable results of making it easier to swaddle the infant without having the cable in the way which make it easier to flexible encircle the infant and make adjustments.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Gardner (US Publication 2006/0100675) discloses encapsulating the LEDs in silicone both above and below the substrate 22.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William J Levicky/Primary Examiner, Art Unit 3796
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