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 .
Claim Objections
Claim 13 is objected to because of the following informalities:
i. Regarding Claim 13, “lithium ion” should be “lithium-ion”.
Appropriate correction is required.
Claim Interpretation
The Examiner notes that the light source, control electronics, and battery of Claim 1 are not positively recited as being a part of the claimed device, merely that the device has a button that could activate such component. For the purposes of expedited prosecution, the Examiner will be applying art to these components as if they were required, but amendments positively reciting these components will be required in future responses if Applicant intends these components to be considered a part of the main device.
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 5, 6, and 12 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.
Regarding Claims 5, 6, and 12, the claims are indefinite as they use the term “about”, and neither the claims nor specification provide guidance as to what defines “about”, i.e. an acceptable variance past the provided ranges. One of ordinary skill would not be aware of the scope of the claims given this lack of information.
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.
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.
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.
Claims 1-3, 5, 7, 9-10, 12, and 14-17 rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20150238774 awarded to Anderson et al, and further in view of U.S. 20150238774 awarded to Tapper et al.
Regarding Claim 1, Anderson teaches a phototherapy treatment device for use with cosmetic treatments (abstract), comprising: a top surface and a bottom surface which form a flexible treatment head (Fig. 3a, bottom surface is the skin side surface, top surface is opposite, Para. 0089, “Further, the light source 12 may optionally include an apron, shield, or safeguard 22 to reduce or prevent accidental use of the light and/or exposure of tissue that is not under a dressing. In some embodiments, the apron, shield, or safeguard 22 may include smart glass or switchable glass, such that it blocks the UV light from reaching the healthy skin. Further, the shield 22 may include a compressible and/or displaceable section or portion, such that the shield may conform to curved surfaces of the body”) a light source (LEDs 26, Fig. 3a), a battery (battery 16, Fig. 3a), and control electronics (controller 18, Fig. 3a); and a replaceable self-adhesive layer (dressing 2, Fig. 3a, Para. 0088, “For example a UV light source may couple to the patient and/or dressing using one or more of: a strap that wraps around the patient's body, a re-usable pressure sensitive adhesive”) disposed on the bottom surface and directly over the light source (Fig. 5) such that when the flexible treatment head is attached to a patient, activation of the light source emits an intensity of light capable of treating an area of skin of the patient (abstract, Fig. 5). Anderson does not teach a button on the device to activate the light source, battery, and control electronics, but does teach the usage of a mobile device to control and activate their treatment device (Para. 0084).
However, in the art of portable phototherapy treatments (abstract), Tapper teaches the usage of a button activating the phototherapy device and associated components that is provided on the portable device (Para. 0110).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Anderson by Tapper, i.e. by using a control button on the device of Anderson as taught in Tapper, for the predictable purpose of simply substituting one known method of a user interface control for another.
Regarding Claim 2, Anderson modified by Tapper makes obvious the phototherapy treatment device according to claim 1. Anderson further teaches wherein the phototherapy treatment device is used for treating at least one of acne (Para. 0057), psoriasis (abstract) and wound healing (Para. 0060).
Regarding Claim 3, Anderson modified by Tapper makes obvious the phototherapy treatment device according to claim 1. Anderson further teaches wherein the self-adhesive layer is substantially transparent to the intensity of light used for a phototherapy treatment (Para. 0012, “The predetermined percentage of UV light may refer to any appropriate predetermined percentage, which may be selected based on the dosage and treatment time. For example, the predetermined percentage may be greater than 20%, greater than 25%, greater than 30%, greater than 35%, greater than 40%, greater than 45%, greater than 50%, greater than 55%, greater than 60%, greater than 65%, greater than 70%, greater than 75%, greater than 80%, greater than 85%, greater than 90%, or greater than 95%, etc.”).
Regarding Claim 5, Anderson modified by Tapper makes obvious the phototherapy treatment device according to claim 1. Anderson further teaches wherein the self-adhesive layer has a light transmission of greater than about 95% of a wavelength of light used in phototherapy treatment (Para. 0012, “The predetermined percentage of UV light may refer to any appropriate predetermined percentage, which may be selected based on the dosage and treatment time. For example, the predetermined percentage may be greater… 95%, etc”).
Regarding Claim 7, Anderson modified by Tapper makes obvious the phototherapy treatment device according to claim 1. Anderson further teaches wherein the phototherapy treatment device is configured to be used with a therapeutic agent activatable by exposure to the intensity of light (Para. 0059, “The medicaments described herein may be specifically formulated for the application of energy (such as UV energy) concurrent with the delivery of a topical therapeutic agent (e.g., coal tar, coal tar extract, etc.). In particular, the medicament may be configured so that it is largely transparent to the to the applied energy modality”).
Regarding Claim 8, Anderson modified by Tapper makes obvious the phototherapy treatment device according to claim 1. Anderson does not teach wherein a ratio of a weight (gm) of the phototherapy treatment device to a skin contact area (cm2) is about 2.5 gm/cm2 or less.
The specification discloses the appropriate ranges that apply to the claimed invention on page(s) 4. However, the specification does not disclose that the specifically claimed range(s) of 4.0 gm/cm2 to 1.0 gm/cm2, or in a range of 2.5 gm/cm2 or less is for any particular purpose or to solve any stated problem that distinguishes it from the other ranges disclosed. The specification therefore lacks disclosure of the criticality required by the Courts in providing patentability to the claimed range(s).
In addition to a lack of disclosed criticality in the specification, an obviousness rejection based upon optimization must rely on prior art that discloses the optimized parameter is a result-effective variable. See MPEP 2144.05.
Since Anderson teaches a device’s need to be portable and thin, and thereby lightweight (abstract, Para. 0004), the prior art therefore provides teaching that the need for a small, light device is a variable that achieves a recognized result, and satisfies the above requirement of a result-effective variable in order to set forth an obviousness rejection based on optimization.
Because Applicants fail to disclose that the claimed range(s) of 4.0 gm/cm2 to 1.0 gm/cm2, or in a range of 2.5 gm/cm2 provides a criticality to the invention that separates it from the other ranges in the specification, and the prior art discloses that the necessity of the device being light-weight and portable absent unexpected results, it would therefore have been obvious for one of ordinary skill to discover the optimum workable range(s) of 4.0 gm/cm2 to 1.0 gm/cm2, or in a range of 2.5 gm/cm2 by normal optimization procedures known in the art.
Regarding Claim 9, Anderson modified by Tapper makes obvious the phototherapy treatment device according to claim 1. Anderson further teaches wherein the phototherapy treatment device further comprises a flexible cuff extending around the flexible treatment head to contain the intensity of light and prevent light leakage during application of light to a skin area (shield 22, Para. 0089, “Further, the light source 12 may optionally include an apron, shield, or safeguard 22 to reduce or prevent accidental use of the light and/or exposure of tissue that is not under a dressing. In some embodiments, the apron, shield, or safeguard 22 may include smart glass or switchable glass, such that it blocks the UV light from reaching the healthy skin. Further, the shield 22 may include a compressible and/or displaceable section or portion, such that the shield may conform to curved surfaces of the body”).
Regarding Claim 10, Anderson modified by Tapper makes obvious the phototherapy treatment device according to claim 1. Anderson further teaches wherein the phototherapy treatment device is configured to conform to at least one of curved or contoured shaped skin surfaces (shield 22, Para. 0089, “Further, the light source 12 may optionally include an apron, shield, or safeguard 22 to reduce or prevent accidental use of the light and/or exposure of tissue that is not under a dressing. In some embodiments, the apron, shield, or safeguard 22 may include smart glass or switchable glass, such that it blocks the UV light from reaching the healthy skin. Further, the shield 22 may include a compressible and/or displaceable section or portion, such that the shield may conform to curved surfaces of the body”).
Regarding Claim 12, Anderson modified by Tapper makes obvious the phototherapy treatment device according to claim 1. Anderson further teaches wherein the light source extends around the flexible treatment head and is configured to provide uniform and constant light intensity to the area of skin of the patient during phototherapy treatment (Fig. 3a, Para. 0097, “For example, the medicament may be applied using a dressing, e.g., the medicament may be incorporated into the dressing, and UV light may be applied through the medicament (and any intervening region of the dressing) at a desired dose (e.g., light intensity and duration). Multiple locations may be treated sequentially or simultaneously on the patient's body”).
Regarding Claim 14, Anderson modified by Tapper makes obvious the phototherapy treatment device according to claim 1. Anderson further teaches wherein the phototherapy treatment device is configured to wirelessly link with a remote device (mobile device 28, Para. 0086, “The memory may further include additional instructions for interacting with the controller and for processing data received from the controller 18. In various embodiments, both the mobile device 28 and the controller 18 include a wired or wireless connection to enable two-way communication between the devices”).
Regarding Claim 15, Anderson modified by Tapper makes obvious a method of treating the area of skin of the patient using the phototherapy treatment device according to claim 1 (Anderson abstract, see rejection to Claim 1 above).
Regarding Claim 16, Anderson modified by Tapper makes obvious a method of treating one or more skin conditions using the phototherapy treatment device according to claim 1 (Anderson abstract, see rejection to Claim 1 above).
Regarding Claim 17, Anderson modified by Tapper makes obvious the method according to Claim 16. Anderson further teaches wherein the one or more skin conditions is at least one of acne (Para. 0057), eczema (Para. 0057), psoriasis (abstract), and inflammation (Para. 0056).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Anderson in view of Tapper as applied to Claim 1 above, and further in view of U.S. Patent Publication 20150079536 awarded to Brawn.
Regarding Claim 4, Anderson modified by Tapper makes obvious the phototherapy treatment device according to claim 1. Anderson teaches the usage of double-sided adhesives (Para. 0088), but not double-sided tape as an adhesive.
However, in the art of phototherapy devices (abstract), Brawn teaches the usage of double-sided tape to adhere a device to the skin of a patient (Para. 0012).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Anderson by Brawn, i.e. by using double-sided tape as the double-sided adhesive, for the predictable purpose of simply substituting one known adhesive for another.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable Anderson in view of Tapper as applied to Claim 1 above, and further in view of attached NPL awarded to Papageorgiou.
Regarding Claim 6, Anderson modified by Tapper makes obvious the phototherapy treatment device according to claim 1. Anderson teaches the treatment of acne (Para. 0057), but does not teach a wavelength between 400-900 nm.
However, in the art of portable phototherapy (abstract), Papageorgiou teaches skin treatment at wavelengths of 415 and 600 nm for the treatment of acne vulgaris (title, abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Anderson by Papageorgiou, i.e. by operating the device of Anderson at the wavelengths of Papageorgiou, for the predictable purpose of using a known technique to improve similar portable phototherapy devices to yield the predictable result of treating further skin conditions.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable Anderson in view of Tapper as applied to Claim 1 above, and further in view of U.S. Patent Publication 20110257585 awarded to Althorpe et al.
Regarding Claim 11, Anderson modified by Tapper makes obvious the phototherapy treatment device according to claim 1. Anderson does not teach wherein the light source is an organic LED
However, in the art of phototherapy, Althorpe teaches wherein the LEDs are OLEDs (Para. 0040).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Anderson by Althorpe, i.e. by using OLEDs in Anderson, for the particular purpose of simply substituting one known type of LED for another.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable Anderson in view of Tapper as applied to Claim 1 above, and further in view of U.S. Patent Publication 20100121252 awarded to Keltner et al, hereinafter Keltner.
Anderson modified by Tapper makes obvious the phototherapy treatment device according to claim 1. Anderson does not teach wherein the battery is a rechargeable lithium ion type battery.
However, in the art of light therapy devices, Keltner teaches the usage of a rechargeable lithium ion battery (Para. 0064, “As used herein, the term "power supply" includes, but is not limited to, one or more lithium batteries, chemical battery cells, super- or ultra-capacitors, fuel cells, secondary cells, thin film secondary cells, button cells, lithium ion cells”, “The power supply 150 may be rechargeable or non-rechargeable”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Anderson by Keltner, i.e. by using a rechargeable lithium ion battery instead of an unspecified battery, as it is merely the simple substitution of one type of battery for another to perform the same function.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jess Mullins whose telephone number is (571)-272-8977. The examiner can normally be reached between the hours of 9:00 a.m. to 5:00 p.m. PST M-F.
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/JLM/
Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
Prosecution Insights