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 09/25/2025 have been fully considered but they are not persuasive.
The applicant argues that the combination of Iwao and Juhasz fails to teach “a light source…configured to emit light in a wavelength range of 401 to 490 nm with an intensity between 1 and 2000 J/cm^2 sufficient to kill microbial cells in or on the subject without DNA damage”. However, Juhasz does teach a wavelength range of 300 nm - 3000 nm which fully encompasses the range in the present invention. The applicant argues that Juhasz only teaches a wavelength of 0.3 um – 3.0 um intended for photodisruption and tissue removal rather than for an antibacterial purpose. However, as the present claims are directed to a system rather than a method, the test for anticipation or obviousness is only whether the prior art is capable of performing the cited function rather than whether it is actually used in that way. In response to applicant's argument that the purpose of the wavelength range in Juhasz is to cause tissue damage rather than disinfection, 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.
In the amended claims, the applicant has added the limitation of an intensity of light required that is not in the original claim set. The prior art of record also teaches this limitation, specifically Stasko teaches a range of 0.5 J/cm^2 - 100 or 2-50 J/cm^2 for the purpose of treating pathogens ([0050]).
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 1,2, and 4-8 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 1 recites the limitation that “the light source is configured to emit light … with an intensity between 1 and 2000 J/cm^2”. However, light intensity measurements depend heavily on the time period over which it is measured, since it is measuring the energy of light delivered to a certain area in a defined period of time and there is not standard baseline for the time since some light sources deliver therapy on the order of milliseconds and others on the order of hours. It is unclear whether this value is the intensity of light delivered in one session and if so, how long is the session? Is it cumulative for a longer period of time such as a week? Such details are crucial to understanding the metes and bounds of this limitation.
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) 1,2,4, and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Iwao et al (JP 2006 116088), Juhasz et al (US5993438A); hereinafter Juhasz, and Stasko et al (US 20210128938 A1); hereinafter Stasko.
Regarding claim 1, Iwao teaches a light therapy device for the disinfection treatment of fungal, bacterial and viral infections in or on a subject,
comprising a base unit (laser supply device 5) and a diffuser cap (diffusion cap 71) provided with a reflector element (concave lens 49, convex lens 24) connected to the base unit, where the base unit has an inner housing (fig 3 part 12), to the upper side of which at least one light source (laser diode 20 as light source) is connected, in the inner housing there is a power supply unit (power source), under which there is a control unit (control box 2), a switch (power switch 8, setting switch 10) is positioned on the lower part of the inner housing (fig 1), breaking through the wall thereof (fig. 3), wherein the inner housing is surrounded by an outer housing (case 12), on the outer housing there are at least two connecting portions (fig 12 [0046]), the connecting portions include an L-shaped slot having a vertical arm and a horizontal arm, the vertical arm and the horizontal arm are the continuation of each other ([0046]); the diffuser cap also includes connecting elements (parts 56 and 57) connected to the lower part of the reflector element (fig 10), and the connecting elements are provided with a locking element comprising at least one pin (fig 10), the locking element fixes the diffuser cap to the connecting portion of the base unit (fig 12). Iwao discloses the claimed invention except for “the light source has two electrical wires: a short leg, which is connected to the power supply unit, and a long leg, which ends between the switch and the control unit, the long leg is provided with an insulating element”. It would have been an obvious matter of design choice to have wires of different sizes because having wires to connect the source at all is implicit and to have a short and long leg, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Iwao fails to teach a particular wavelength range. Juhasz teaches the light source emits light in the wavelength range of 401 to 490 nm (column 2 lines 50-54). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Iwao with Juhasz because there is some teaching, suggestion, or motivation to do so. Juhasz teaches that the wavelength chosen allows the light in the laser beam to pass through the cornea to reach the focal spot. Although the present invention is intended for disinfection, selecting a range that would not affect unintended tissues would be obvious.
The combination of Iwao and Juhasz fails to teach the intensity of the light source. Stasko teaches that the intensity of the light is between 0.5 J/cm^2 - 100 or 2-50 J/cm^2 and the dose of light is repeatably administered to provide a cumulative dose in a range from 1 J/cm^2 to 1000 J/cm^2 over a cumulative time period ([0050]). While this does not encompass the entire range of the present invention (1-2000 J/cm^2), it still covers a key portion of the range and serves the same purpose of disinfection. Selecting an intensity that meets the requirements of the invention of Stasko also meets the requirements of the present invention. 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 Iwao and Juhasz with Stasko because it is obvious to try as it choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. Unless high-intensity light is required for the application such as surgical lasers and ablation, then low-intensity light is commonly used in biomedical applications especially for the skin. This intensity range falls into the low-intensity when considered over the long-time frames typically used for skin treatment.
Regarding claim 2, Iwao, Juhasz, and Stasko teaches the device according to claim 1. Iwao further teaches an additional element between the reflector element and the connecting elements of the diffuser cap (fig 12, parts such as 53a, 60 are between the diffusion cap and the reflector lenses).
Regarding claim 4, the combination of Iwao, Juhasz, and Stasko teaches the device according to claim 1. Iwao further teaches the light source is LED (LED lamp 9).
Regarding claim 5, Iwao, Juhasz, and Stasko teaches the device of claim 2. Stasko further teaches the reflector element is made of medical silicone ([0286] reflective surface may include…silicone). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Iwao with Stasko because there is some teaching, suggestion, or motivation to do so. Stasko discusses how it would be advantageous to have a material that can be tapered since that the device can more easily conform to the surface of the skin ([0293]). Silicone is a biocompatible material that meets this limitation; therefore, it would have been obvious.
Claim(s) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Iwao, Juhasz, and Stasko as applied to claim 2 above, and further in view of Pang et al (US 20210212555 A1); hereinafter Pang.
Regarding claim 6, Iwao, Juhasz, and Stasko teaches the device of claim 2. The combination fails to teach that the reflector element consists of light cables. Pang teaches the reflector element consist of light cables (light cable 15). 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 with Pang because there is some teaching, suggestion, or motivation to do so. Pang suggests that the form factor of the light cables allows for use of the device with elongate medical devices such as endoscopes and catheters ([0064]).
Regarding claim 7, the combination of Iwao, Juhasz, Stasko and Pang teaches the device of claim 6. Pang further teaches the light cables are fixed in the additional element of the diffuser cap ([0064] conveys light to the imager within the camera head 13).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Iwao, Juhasz, and Stasko as applied to claim 1 above, and further in view of Reinhardt et al (US 20200101315 A1); hereinafter Reinhardt. Iwao teaches the device of claim 1. Iwao fails to teach the microcontroller and the microprocessor. Reinhardt teaches the light therapy device according to claim 1, wherein the control unit includes a microcontroller ([0121] microcontroller) and a microprocessor ([0121] microprocessor). 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 with Reinhardt because it would constitute use of a known technique to improve similar devices in the same way. The device of Reinhardt is also a laser for bacterial removal that requires computing capabilities and uses a microprocessor and microcontroller. The device of Iwao requires computing capabilities to complete the functions, therefore it would be obvious to include a microprocessor and a microcomputer that can perform the functions.
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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/D.S.D./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796