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 Amendment
This office action is responsive to the amendment filed on 4/24/2026. As directed by the amendment, the status of the claim(s) are:
Claim(s) 1, 3-5, 9-12 has/have been amended;
Claim(s) 7 is/are cancelled;
Claim(s) 1-6, 8-12 is/are presently pending.
The amendment(s) to the claim(s) is sufficient to obviate the 35 U.S.C. 112(f) interpretation(s) from the previous office action(s).
The amendment(s) to claim(s) 11 is sufficient to overcome the 35 U.S.C. 112 rejection of claim 11 from the previous office action. However, claim 9 amendments do not fix the previously presented 112 rejection. Note also the canceling of claim 7 introduces 112 issues to claim 8. See 112 rejection below.
Response to Arguments
With regard to claim rejections under 35 USC 102 and/or 103, Applicant’s arguments have been fully considered but are moot in light of new grounds of rejection due to claim amendment(s).
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(s) 8, 9 is/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 8 depends from claim 7; but claim 7 is canceled. For examination purposes below, it will be assumed claim 8 depends from claim 1.
Claim 8 recites the limitation "the laminar arrangement" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the laminar arrangement" in line 1. There is insufficient antecedent basis for this limitation in the claim. Note that claim 8 recites “the laminar arrangement”. But the instant claim depends from claim 1.
Claim 9 recites the limitation "the flexible circuit board layer" in line 1. There is insufficient antecedent basis for this limitation in the claim. Note that claim 8 recites “a flexible circuit board layer”. But the instant claim depends from claim 1.
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.
Claim(s) 1-6, 9, 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Savage (US 20040138726 A1; 7/185/2004; cited in previous office action) in view of Asvadi (US 20090030489 A1; 1/29/2009; cited in IDS) and further in view of Vreman (US 6596016 B1; 7/22/2003; cited in IDS; cited in previous office action).
Regarding claim 1, Savage teaches a disposable phototherapy body wrap comprising:
a plurality of light sources mounted on a flexible substrate material (Fig. 1A-2D; Fig. 8A-8C; [0032]-[0033]; the art meets the claim limitation of “disposable” since structurally the art is capable of being disposed of),
wherein each light source is configured to emit light within a therapeutic wavelength range of about 400-500 nm optimized for the treatment of jaundice ([0003]; [0021]; [0033]; [0048]-[0049]; [0061]; In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); MPEP 2144.05.),
wherein the phototherapy body wrap is anatomically shaped to align with predetermined body areas of a person (Fig. 1A-2D; Fig. 8A-8C; Fig. 9A-9C; [0032]-[0033]; [0064]; front and back sections).
Savage does not explicitly teach comprises multiple wrap sections, each section sized and shaped to conform to a predetermined body area. Note that Savage teaches multiple sections for the wrap with front and back body area sections (Fig. 8A-8C; [0064]; front and back sections) which would read on the claim. However, for the sake of clarity of the record, alternatively Asvadi teaches in the same field of endeavor (Abstract) multiple wrap sections, each section sized and shaped to conform to a predetermined body area (Fig. 11; [0044]; [0047]-[0048]). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Savage to include these features as taught by Asvadi because this enables modularity (Fig. 11; [0044]; [0047]-[0048]) and is an obvious duplication of parts and change in shape; MPEP 2144.04.
The combination of Savage and Asvadi teaches wherein the plurality of light sources is oriented to emit therapeutic light inward toward the person (Savage Fig. 2A-2B; Fig. 8A-9C; Asvadi [0011]).
The combination of Savage and Asvadi does not teach wherein the body wrap further comprises at least one light-blocking layer positioned outward of the plurality of light sources to substantially prevent emission of the therapeutic light away from the person. However, Vreman teaches in the same field of endeavor (Abstract; Fig. 7B; Col. 13 lines 45-65 “Phototherapy garment 10 can be considered to be a light-emitting fabric that can be used to make any number of other garments…The garments can also be used together…thereby providing for rapid and efficient reduction of bilirubin levels. Each type of garment shown covers a particular skin region of the patient, for example, the torso, legs, or head. For each region, it is highly preferable that the light-emitting portions of the garment cover the entire circumference of the region, thereby illuminating the largest possible surface area of the region.”) wherein the body wrap further comprises at least one light-blocking layer positioned outward of the plurality of light sources to substantially prevent emission of the therapeutic light away from the person (Vreman Col. 13 lines 15-22 “cover layer may be…opaque material”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Savage and Asvadi to include this feature as taught by Vreman because this enables additional protection and comfort (Col. 13 lines 15-22).
Regarding claim 2, in the combination of Savage, Asvadi, and Vreman, Savage teaches wherein said body wrap is structurally layered to maintain a distance between the plurality of light sources and a person undergoing phototherapy treatment (Fig. 1B; Fig. 3A-5; [0043]; [0053]).
Regarding claim 3, in the combination of Savage, Asvadi, and Vreman, Savage teaches wherein the plurality of light sources comprise light-emitting diodes (LEDs) ([0015]; [0043]; [0032]).
Regarding claim 4, in the combination of Savage, Asvadi, and Vreman, Savage does not teach wherein the intensity of the light from the plurality of light sources can be controlled and varied across the said wrap. Note Savage teaches controlling light source to control intensity ([0062]-[0063]). However, Vreman teaches in the same field of endeavor (Abstract) wherein the intensity of the light from the plurality of light sources can be controlled and varied across the said wrap (Col. 8 lines 49-53; Col. 9 lines 20-25; Col. 13 lines 35-44). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Savage, Asvadi, and Vreman to include this feature as taught by Vreman because this enables independent control of different light portions (Col. 13 lines 35-44).
Regarding claim 5, in the combination of Savage, Asvadi, and Vreman, Savage teaches further comprising an additional piece that extends underneath the person undergoing phototherapy treatment (Fig. 2B-2C, there is a pillow underneath infant; Fig. 9A-9C, there is a piece under infant).
Regarding claim 6, the combination of Savage, Asvadi, and Vreman teaches wherein the body wrap is shaped in alignment with predetermined body areas of the person comprising several sections, each intended to cover/wrap a different body area (Savage Fig. 8A-8C; [0064]; front and back sections; Asvadi Fig. 11; [0044]; [0047]-[0048]; Vreman Fig. 7B; Col. 13 lines 45-65 “Phototherapy garment 10 can be considered to be a light-emitting fabric that can be used to make any number of other garments…The garments can also be used together…. Each type of garment shown covers a particular skin region of the patient, for example, the torso, legs, or head. For each region, it is highly preferable that the light-emitting portions of the garment cover the entire circumference of the region, thereby illuminating the largest possible surface area of the region.”).
Regarding claim 9, in the combination of Savage, Asvadi, and Vreman, Savage teaches wherein the laminar arrangement (interpreted in light of instant specification [0069] and instant Fig. 8A-8B; Savage Fig. 2A-2D; Fig. 8A-8C) prevents direct contact and provides electricity and thermal isolation between the flexible circuit board layer and the body of the patient, thus ensuring the patient's safety and comfort (Fig. 1B; Fig. 3A-5; Fig. 7; Fig. 9A-9C; [0053]-[0054]; [0067]; For the purposes of examination, Applicant is reminded that this is a product claim. Intended use/functional language does not require that reference specifically teach the intended use of the element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.).
Regarding claim 11, in the combination of Savage, Asvadi, and Vreman, Vreman teaches wherein the body wrap is comprises at least one opaque or light-absorbing layer positioned outward of the plurality of light sources and configured to block or absorb outwardly directed therapeutic light, thereby reducing exposure of surrounding areas (Col. 13 lines 15-22 “cover layer may be…opaque material”).
Regarding claim 12, the combination of Savage, Asvadi, and Vreman teaches wherein the body wrap comprises combination of inward-facing light sources (Savage Fig. 2A-2B; Fig. 8A-9C; Asvadi [0011]; Vreman Fig. 5-7C), opaque outer layers (Vreman Col. 13 lines 15-22 “cover layer may be…opaque material”), and sealed wrap edges (Savage Fig. 2C, 20; [0036]; Asvadi Fig. 11; [0045] “zippers”; Vreman Fig. 6-7C; Col. 13 lines 25-30 “zippers or other fasteners”) that cooperate to confine therapeutic light within the wrap, thereby enabling mask-free phototherapy treatment (the combination of Savage, Asvadi, and Vreman as cited structurally meets this limitation; For the purposes of examination, Applicant is reminded that this is a product claim. Intended use/functional language does not require that reference specifically teach the intended use of the element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Savage, Asvadi, and Vreman as applied to claim 1 above, in view of Alden (US 6743249 B1; 6/1/2004; cited in previous office action), and further in view of Hammond (US 20100179469 A1; 7/15/2010; cited in previous office action).
Regarding claim 8, in the combination of Savage, Asvadi, and Vreman, Savage teaches laminar arrangement (interpreted in light of instant specification [0069] and instant Fig. 8A-8B; Savage Fig. 2A-2D; Fig. 8A-8C).
In the combination of Savage, Asvadi, and Vreman, Savage does not teach
a flexible circuit board layer;
an ancillary thermal pad layer, which disperses and thereby moderates the heat generated by the flexible circuit board layer;
a transparent silicone layer deployed on the flexible circuit board layer for passing the therapeutic light toward the patient’s body while electrically and thermally isolating between the patient and the flexible circuit board layer.
However, Alden teaches in the same field of endeavor (Abstract; Col. 1 lines 42-50) wherein the laminar arrangement comprises:
a flexible circuit board layer (Col. 1 line 35 “flexible ‘circuit board’”);
an ancillary thermal pad layer, which disperses and thereby moderates the heat generated by the flexible circuit board layer (Col. 3 line 36 “heat dissipating layer”; Col. 7 lines 15-28);
a transparent silicone layer deployed on the flexible circuit board layer for passing the therapeutic light toward the patient’s body while electrically and thermally isolating between the patient and the flexible circuit board layer (Col. 1 lines 37-39 “silicone cover”; Col. 7 lines 15-28; For the purposes of examination, Applicant is reminded that this is a product claim. Intended use/functional language does not require that reference specifically teach the intended use of the element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.).
Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Savage, Asvadi, and Vreman to include these features as taught by Alden because this enables structure of flexible light device to be placed on body for therapy (Fig. 10-11; Col. 1 lines 35-52).
The combination of Savage, Asvadi, Vreman, and Alden does not teach a PVC laminate deployed above the flexible circuit board layer to complete the electrical isolation thereof;
a fabric laminate deployed above the PVC laminate to block undesired light emission; and
However, Vreman teaches in the same field of endeavor (Abstract) a PVC laminate deployed above the flexible circuit board layer to complete the electrical isolation thereof (Col. 7 lines 10-29 “vinyl” reads on PVC; Col. 7 lines 64-67 “vinyl”);
a fabric laminate deployed above the PVC laminate to block undesired light emission (Col. 13 lines 15-23 “substantially opaque material, such as cotton or synthetic fiber material”).
Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Savage, Asvadi, Vreman, and Alden to include these features as taught by Vreman because this enables easy cleaning/sterilization (Col. 7 lines 11-25) and decorations for baby clothing/blankets (Col. 13 lines 15-23).
The combination of Savage, Asvadi, Vreman, and Alden does not teach a nonwoven fabric layer utilized for providing comfortable padding and as hygiene means for preventing the spread of bacteria and infections. However, Hammond teaches in the same field of endeavor (Fig. 5; [0003]; [0083]) a nonwoven fabric layer utilized for providing comfortable padding and as hygiene means for preventing the spread of bacteria and infections ([0029] “The covering 114 may provide comfort for a patient using the phototherapy device 100 particularly if the patient is lying on the phototherapy device 100. The covering 114 may provide protection to the phototherapy device, keeping dirt and fluid off of the device and providing a cushion to protect the phototherapy device from impact. The covering may be one of a woven fabric, nonwoven fabric, or plastic film.”; For the purposes of examination, Applicant is reminded that this is a product claim. Intended use/functional language does not require that reference specifically teach the intended use of the element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Savage, Asvadi, Vreman, and Alden to include this feature as taught by Hammond because this enables protecting the device ([0029]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Savage, Asvadi, and Vreman as applied to claim 1 above, and further in view of Behler (US 20200139152 A1; 5/7/2020; cited in previous office action).
Regarding claim 10, in the combination of Savage, Asvadi, and Vreman, Savage does not teach a temperature sensor positioned on or adjacent to the flexible substrate material and configured to generate a temperature signal representative of wrap temperature; and a controller comprising processor-based control circuitry and stored instructions, the controller being operatively connected to the temperature sensor and to the plurality of light sources, and configured to:
deactivate electrical power supplied to the plurality of light sources when the temperature signal exceeds a predetermined threshold or when the temperature is outside of a predetermined range; and,
resume the supply of electrical power once the temperature returns to the acceptable range.
Note that Asvadi teaches temperature based feedback control ([0051]). However, Behler teaches in the same field of endeavor (Fig. 1; [0017]) a temperature sensor positioned on or adjacent to the flexible substrate material and configured to generate a temperature signal representative of wrap temperature (Fig. 4; [0005]-[0006]; [0017]-[0018]); and a controller comprising processor-based control circuitry and stored instructions, the controller being operatively connected to the temperature sensor and to the plurality of light sources ([0018]; [0024]), and configured to:
deactivate electrical power supplied to the plurality of light sources when the temperature signal exceeds a predetermined threshold or when the temperature is outside of a predetermined range (Fig. 4; [0005]-[0006]; [0017]-[0018]); and,
resume the supply of electrical power once the temperature returns to the acceptable range (Fig. 4; [0005]-[0006]; [0017]-[0018]).
Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Savage, Asvadi, and Vreman to include these features as taught by Behler because this ensures user does not overheat (Fig. 4; [0005]; [0017]).
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 Jonathan T Kuo whose telephone number is (408)918-7534. The examiner can normally be reached M-F 10 a.m. - 6 p.m. PT.
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/JONATHAN T KUO/Primary Examiner, Art Unit 3792
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