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 .
Election/Restrictions
Claims 4, 10-12, 21-29 and 33-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/26/2026.
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 2 and 3 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. It is unclear what element or elements, if any, these claims are meant to limit in the apparatus claims. No structure has been set forth to provide the functionalities recited in the claims, rendering it unclear whether these are method steps recited in apparatus claims, imply an intended use, or do actually imply some sort of structure.
Claim Rejections - 35 USC § 102/103
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
Claims 1-3 and 14 are rejected under 35 U.S.C. 102(a)(2) as anticipated by Silver et al. (US 2021/0322782, hereinafter “Silver”) or, in the alternative, under 35 U.S.C. 103 as obvious over Silver in view of Gamelin et al. (US 2017/0056686, hereinafter “Gamelin”).
In regards to claim 1, Silver discloses a phototherapy system for treating and preventing infections in tissue of a human or animal (par. 0002, “reduce surgical site infections”), the system comprising:
an optical head unit (Fig. 5, element 10 except for element 6) having a housing (elements 12 and 12’) incorporating circuitry (element 22, par. 0106, “printed circuit board”), the circuitry including a plurality of light emitting diodes (LEDs) (par. 0106, Fig. 5 showing five light sources) being driven to control emission of light from the plurality of LEDs at one or more wavelengths in the light spectrum from approximately 100 nanometers to approximately 10,000 nanometers (par. 0105, “UV-C”; please see attached Wikipedia “ultraviolet” article as evidence that the UV-C band is from 100-280 nm); and
a base (Fig. 5, element 6) that selectively and operatively couples to the optical head unit (par. 0107, via holding pins 14) to provide a consistent distance to a target site and prevent the light emitted from the plurality of LEDs from escaping into an environment surrounding the target site (par. 0107, “formed from a material that is impervious to therapeutic light (such as irradiated acrylic) so as to avoid an impact of therapeutic light on areas of biological tissue 2 that are not intended to be treated”).
Silver discloses a plurality of LEDs (Fig. 5) that are each driven with control circuitry (par. 0106) and so necessarily comprises a plurality of LED drivers (i.e., the portions of the control circuitry that drive each individual LED). Alternatively and additionally, Gamelin in the same field of endeavor of light therapy expressly teaches providing a plurality of LEDs with a plurality of LED drivers (par. 0010) to provide the predictable results of flexibility of controlling each LED individually and facilitate optimization of light emission uniformity (par. 0048). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Silver by providing the plurality of LEDs with a plurality of LED drivers to provide the predictable results of flexibility of controlling each LED individually and facilitate optimization of light emission uniformity.
In regards to claim 2, the plurality of LEDs cease to emit light in response to the optical head unit being detached from the base (par. 0108; “Electronics are operatively associated with the shroud 6 to activate the power source 24 and/or the light source 18 when the shroud 6 comes into contact with the biological tissue 2 to be treated, to allow the power source 24 and/or the light source 18 to be activated”).
In regards to claim 3, the plurality of LEDs are controlled to emit the light for a specified period of time (par. 0106, “A control circuit is operatively associated with PCB 22 so that power source 24 and/or light source 18 can be deactivated after a predetermined treatment period”).
In regards to claim 14, the base has at least one of: an asymmetrical C-shaped cross-sectional profile having an upper portion and a lower portion with the upper portion extending over the lower portion and extending further inwards than the lower portion to define the asymmetrical C-shaped cross-sectional profile; or
a generally truncated cone shape (Fig. 5, element 6) with a bottom opening having a first diameter and a top opening having a second diameter, the first diameter is greater than the second diameter (Fig. 5, element 6).
Claims 5, 9, 13, 16-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Silver in view of Gamelin.
In regards to claim 5, Silver discloses the essential features of the claimed invention except for wherein the plurality of LEDs are arranged in a lattice. However, Gamelin in the same field of endeavor of light therapy teaches providing a plurality of LEDs that are arranged in a lattice (Fig. 1A) to provide the predictable results of producing light of uniform intensity on the targeted surface (par. 0037). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Silver by providing a plurality of LEDs that are arranged in a lattice to provide the predictable results of producing light of uniform intensity on the targeted surface.
In regards to claim 9, Silver discloses the essential features of the claimed invention except for wherein the circuitry further comprises: a non-transitory computer-readable medium storing instructions; and a processor that executes the instructions to output drive signals to the LED drivers to control an operation of the plurality of LEDs. However, Gamelin in the same field of endeavor of light therapy teaches providing a system wherein the circuitry further comprises: a non-transitory computer-readable medium storing instructions; and a processor that executes the instructions to output drive signals to the LED drivers to control an operation of the plurality of LEDs (pars. 0055, 0057) to provide the predictable results of remote control, subject-specific treatment, and flexibility of therapy conditions (par. 0057). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Silver by providing a system wherein the circuitry further comprises: a non-transitory computer-readable medium storing instructions; and a processor that executes the instructions to output drive signals to the LED drivers to control an operation of the plurality of LEDs to provide the predictable results of remote control, subject-specific treatment, and flexibility of therapy conditions.
In regards to claims 13, 16 and 17, Silver discloses the essential features of the claimed invention except for wherein the LED drivers provide variable current to one or more of the plurality of LEDs to irradiate the target site with a homogeneous distribution of the light emitted from the plurality of LEDs; wherein different sets of the plurality of LEDs are controlled by different ones of the plurality of LED drivers; or wherein the plurality of LEDs are calibrated to emit the light with homogeneous light distribution with a spatial uniform density within ten percent (10%).
However, Gamelin in the same field of endeavor of light therapy teaches providing a system wherein the LED drivers provide variable current to one or more of the plurality of LEDs to irradiate the target site with a homogeneous distribution of the light emitted from the plurality of LEDs (par. 0048); and wherein different sets of the plurality of LEDs are controlled by different ones of the plurality of LED drivers (par. 0048) to provide the predictable results of facilitating optimization of light emission uniformity (par. 0048).
Further, Gamelin expressly teaches that the light calibration is a results-effective variable and desirable to maximize light distribution uniformity (par. 0048) and it has been held that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Silver by providing a system wherein the LED drivers provide variable current to one or more of the plurality of LEDs to irradiate the target site with a homogeneous distribution of the light emitted from the plurality of LEDs; and wherein different sets of the plurality of LEDs are controlled by different ones of the plurality of LED drivers to provide the predictable results of facilitating optimization of light emission uniformity; and wherein the plurality of LEDs are calibrated to emit the light with homogeneous light distribution with a spatial uniform density within ten percent (10%) to yield no more than predictable results.
In regards to claim 18, Silver discloses the essential features of the claimed invention except for wherein at least one of a collimator or a filter is disposed over the plurality of LEDs. However, Gamelin in the same field of endeavor of light therapy teaches providing a collimator or a filter that is disposed over the plurality of LEDs (par. 0043) to provide the predictable results of transmitting light in only a specific range (par. 0043). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Silver by providing a collimator or a filter that is disposed over the plurality of LEDs to provide the predictable results of transmitting light in only a specific range.
In regards to claim 20, Silver discloses the essential features of the claimed invention, including providing therapy in the overlapping UV-C band (100-280 nm, par. 0105), but does not expressly disclose the one or more wavelengths at which one or more of the plurality of LEDs emit light is at least one of 235 nm or between approximately 207 nm and approximately 265 nm. However, Silver recognizes that wavelength is a results-effective variable for treatment or prophylaxis against infectious organisms (pars. 0009, 0013) and it has been held that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Silver by providing the claimed wavelength ranges to provide no more than predictable results.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Silver (or Silver and Gamelin) in view of Yang et al. (US 2013/0096657, hereinafter “Yang”).
Silver discloses the essential features of the claimed invention, except for wherein the plurality of LEDs form a hexagonal perimeter. However, Yang in the same field of endeavor of light therapy teaches a system wherein the plurality of LEDs form a hexagonal perimeter (Fig. 4) to provide the predictable results of uniform illumination so that therapeutic light can uniformly illuminate a site to be treated (par. 0031). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Silver by providing a plurality of LEDs that form a hexagonal perimeter to provide the predictable results of uniform illumination so that therapeutic light can uniformly illuminate a site to be treated.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Silver (or Silver and Gamelin) in view of Shah et al. (US 2022/0016439, hereinafter “Shah”). Silver discloses the essential features of the claimed invention except for wherein the base includes a shutter that controls an aperture through which the light emitted by the plurality of LEDs passes, wherein the shutter controls at least one of a size of the aperture or a geometry of the aperture. However, Shah in the same field of endeavor of light therapy discloses a system wherein the base includes a shutter that controls an aperture through which the light emitted by the plurality of LEDs passes, wherein the shutter controls at least one of a size of the aperture or a geometry of the aperture (par. 0056, opening and closing a shutter is necessarily altering a size or geometry of an aperture) to provide the predictable results of more accurately and precisely administering the therapeutic dose of energy (par. 0056). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Silver by providing a system wherein the base includes a shutter that controls an aperture through which the light emitted by the plurality of LEDs passes, wherein the shutter controls at least one of a size of the aperture or a geometry of the aperture to provide the predictable results of more accurately and precisely administering the therapeutic dose of energy.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Silver (or Silver and Gamelin) in view of Gerber et al. (US 2016/0082281, hereinafter “Gerber”). Silver discloses the essential features of the claimed invention including providing additional light sources (par. 0011), but does not expressly disclose wherein the base further comprises: a light source to deliver light into the base; wherein the base is configured to at least partially surround the target site and diffuse the light inwards and downwards toward the target site. However, Yang in the same field of endeavor of light therapy devices teaches providing a base that further comprises: a light source to deliver light into the base; wherein the base is configured to at least partially surround the target site and diffuse the light inwards and downwards toward the target site (Fig. 1E) to provide the predictable results of disinfection and illumination of a surgical site to allow a user to perform a task in good view (par. 0012). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Silver by providing a base that further comprises: a light source to deliver light into the base; wherein the base is configured to at least partially surround the target site and diffuse the light inwards and downwards toward the target site to provide the predictable results of disinfection and illumination of a surgical site to allow a user to perform a task in good view.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Silver (or Silver and Gamelin) in view of You et al. (US 2019/0175907, hereinafter “You”). Silver discloses the essential features of the claimed invention except for wherein a temperature of a bottom of the base remains at less than 40 Celsius during operation of the circuitry. However, You in the same field of endeavor of light therapy teaches providing a system wherein a temperature of a bottom of the base remains at less than 40 Celsius during operation of the circuitry (par. 0185) to provide the predictable results of maintaining temperature similar to the human body and thus avoiding adverse effects (par. 0185). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Silver by providing a system wherein a temperature of a bottom of the base remains at less than 40 Celsius during operation of the circuitry to provide the predictable results of maintaining temperature similar to the human body and thus avoiding adverse effects.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Silver (or Silver and Gamelin) in view of Jeong (US 2020/0093945, hereinafter “Jeong”). Silver discloses the essential features of the claimed invention except for wherein the housing of the optical head unit has a fluid tight seal. However, Jeong in the same field of endeavor of light therapy teaches providing a system wherein the housing of the optical head unit has a fluid tight seal (pars. 0067, 0106, 0107) to provide the predictable results of preventing water, cosmetics, and the like from penetrating the housing and degrading performance (pars. 0067, 0106). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Silver by providing a system wherein the housing of the optical head unit has a fluid tight seal to provide the predictable results of preventing water, cosmetics, and the like from penetrating the housing and degrading performance.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Silver (or Silver and Gamelin) in view of Piergallini et al. (US 2011/0123958, hereinafter “Piergallini”). Silver discloses the essential features of the claimed invention except for a gel pad disposed on a bottom of the base to conform to contours of the tissue surrounding the target site. However, Piergallini in the same field of endeavor of light therapy teaches providing a gel pad disposed on a bottom of the base to conform to contours of the tissue surrounding the target site (Figs. 3 and 4) to provide the predictable results of light therapy in conjunction with a photoactivated composition (par. 0075). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Silver by providing a gel pad disposed on a bottom of the base to conform to contours of the tissue surrounding the target site to provide the predictable results of light therapy in conjunction with a photoactivated composition.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Silver (or Silver and Gamelin) in view of Gil et al. (US 2020/0179718, hereinafter “Gil”). Silver discloses the essential features of the claimed invention except for wherein the light emitted by the plurality of LEDs irradiates the target site to achieve over ninety percent pathogen inactivation in under five minutes. However, Gil in the same field of endeavor of light therapy teaches wherein the light emitted by the plurality of LEDs irradiates the target site to achieve over ninety percent pathogen inactivation in under five minutes (par. 0029) to provide the predictable results of therapy that is sufficient to kill/disable pathogens but prevent damage to the skin. The examiner is considering the disclosure of killing/disabling pathogens to constitute killing/disabling 100% of the pathogens. Alternatively and additionally, Gil recognizes that therapy dose is a results-effective variable and it has been held that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Silver by providing a system wherein the light emitted by the plurality of LEDs irradiates the target site to achieve over ninety percent pathogen inactivation in under five minutes to provide the predictable results of therapy that is sufficient to kill/disable pathogens but prevent damage to the skin and yield no more than predictable results.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lin (US 2015/0045702) is another example of a light therapy device with a base element.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571)270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792