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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
automatic shutdown mechanism in claim 10; structure found in e.g. instant Fig. 1, power supply/control unit; Fig. 13, controller 620; instant specification [0081] “controller”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are:
hygiene means in claim 8; the instant claim recites structure of “nonwoven fabric layer” to perform this function.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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) 9, 11 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 9 recites the limitation "the laminar arrangement" in line 1. There is insufficient antecedent basis for this limitation in the claim. Note that claim 7 recites “a 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 11 recites “wherein the wrap is designed to minimize exposure of the surrounding areas to the LED light.” This is functional language that renders the instant claim indefinite since no structure is recited and the language only states a problem solved or a result obtained; and one of ordinary skill in the art would not know from the claim terms what structure or steps are encompassed by the claim; MPEP 2173.05(g); MPEP 2114. Also, the limitation “minimize” is a relative term which renders the claim indefinite. The term “minimize” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim Rejections - 35 USC § 102
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 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) 1-3, 5-7, 9, 11-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Savage (US 20040138726 A1; 7/185/2004).
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 optimized for the treatment of jaundice ([0003]; [0021]; [0033]; [0061]),
wherein the phototherapy body wrap is anatomically shaped to align with predetermined body areas of a person, thereby covering a large surface area of the body (Fig. 1A-2D; Fig. 8A-8C; Fig. 9A-9C; [0032]-[0033]).
Regarding claim 2, 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, Savage teaches wherein the plurality of light sources comprise light-emitting diodes (LEDs) ([0015]; [0043]; [0032]).
Regarding claim 5, 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, Savage 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 (Fig. 8A-8C; [0064]; front and back sections).
Regarding claim 7, Savage teaches wherein the body wrap is configured in a laminar arrangement configured to enable light transfer towards the patient and to isolate the body of the patient underneath (interpreted in light of instant specification [0069] and instant Fig. 8A-8B; Savage Fig. 2A-2D; Fig. 8A-8C).
Regarding claim 9, Savage teaches wherein the laminar arrangement prevents direct contact and provide electricity and heat 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, Savage teaches wherein the wrap is designed to minimize exposure of the surrounding areas to the LED light (Fig. 2A-2D; Fig. 8A-9C; compare to structure of instant Fig. 1-7, Fig. 13-15; reference is similar/same structure as instant disclosure’s and thus inherently meets the functional limitations; MPEP 2114.
Regarding claim 12, Savage teaches teach wherein the wrap is configured to block emitted light from escaping the confines of the wrap, allowing for mask-free treatment of a patient (Fig. 2A-2D; Note that Savage teaches wrap that surrounds infant and with light on interior would meet the instant claim limitation (Fig. 2A-2D), especially since Fig. 2D depicts mask-free treatment, both the caretaker and infant do not wear masks).
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(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Savage as applied to claim 1 above, in view of Vreman (US 6596016 B1; 7/22/2003; cited in IDS).
Regarding claim 4, 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 to include this feature as taught by Vreman because this enables independent control of different light portions (Col. 13 lines 35-44).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Savage as applied to claim 7 above, in view of Alden (US 6743249 B1; 6/1/2004), further in view of Vreman (US 6596016 B1; 7/22/2003; cited in IDS), and further in view of Hammond (US 20100179469 A1; 7/15/2010).
Regarding claim 8, Savage does not teach wherein the laminar arrangement comprises:
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 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 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 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, Alden, and Vreman 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, Alden, and Vreman 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 as applied to claim 1 above, in view of Behler (US 20200139152 A1; 5/7/2020).
Regarding claim 10, Savage does not teach a built-in temperature probe configured to monitor the temperature of the wrap during use; and
an automatic shutdown mechanism operatively connected to the temperature probe, wherein the mechanism is configured to deactivate the light sources when the temperature exceeds a predetermined threshold, thereby ensuring safety by preventing overheating.
However, Behler teaches in the same field of endeavor (Fig. 1; [0017]) a built-in temperature probe configured to monitor the temperature of the wrap during use (Fig. 4; [0005]-[0006]; [0017]-[0018]); and
an automatic shutdown mechanism operatively connected to the temperature probe, wherein the mechanism is configured to deactivate the light sources when the temperature exceeds a predetermined threshold, thereby ensuring safety by preventing overheating (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 to include these features as taught by Behler because this ensures user does not overheat (Fig. 4; [0005]; [0017]).
Conclusion
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