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 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.
The “control means” of claim 3 and “base means” of claim 37 are being interpreted to invoke section 112(f).
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.
(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.
Claims 1, 2, 5, 18 and 37 are rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by Van Der Zaan-Landwehr Johan et al. (US 2016/0243378, hereinafter “Johan”).
In regards to claims 1 and 37, Johan discloses a phototherapy system for treating and preventing infections in tissue of a human or animal (as the intended use in the preamble does not appear to impart a structural limitation, the examiner is considering Johan’s system as capable of this use), the system comprising:
an optical head unit having a housing (Fig. 1, element 21) including a light source (Fig. 3, elements 6) configured to deliver light at one or more wavelengths in the light spectrum from 100 nanometers to 10,000 nanometers (par. 0091, “300 nm to 1100 nm”); and
a base/base means that selectively and operatively couples to the optical head unit to provide a consistent distance to a target site and prevent the light emitted from the light source from escaping into an environment surrounding the target site (Fig. 1, carrier 11, par. 0057, “for preventing light from escaping between the positioning part and the treatment part when the formations are engaged. This can prevent stray light from escaping”),
wherein the base/base means is configured to at least partially surround the target site (Fig. 1), and wherein the base defines an open-format morphology configured and dimensioned to allow a clinician to work freely on the target site when the optical head unit is decoupled therefrom (par. 0051, “[t]he opening 5 is a hole”; par. 0089, “the opening typically has a maximum linear dimension in the range 3 cm to 15 cm, such as a circle with diameter in this range,” which the examiner is considering a sufficient dimension to allow a clinician to “work freely on the target site”).
In regards to claim 2, the device further comprises an interlock that causes the light source to cease to emit light in response to the optical head unit being detached from the base (par. 0058, “[t]he light treatment device may further comprise a safety device for preventing the light emitter from emitting light when the positioning part and the treatment part are not magnetically coupled together”; par. 0090).
In regards to claim 5, the light source comprises a plurality of LEDs that are arranged in a lattice (Fig. 3, the LEDs are arranged in a regular geometric formation).
In regards to claim 18, at least one of a collimator or a filter is disposed over the plurality of LEDs light source (Fig. 4, walls of the treatment part form a collimator as it narrows the light beam applied by the LEDs and par. 0056 discloses cover 23 can be “translucent” so filters at least some light).
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.
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 9, 13, 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Johan in view of Gamelin et al. (US 2017/0056686, hereinafter “Gamelin”).
In regards to claim 9, Johan 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 Johan 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, Johan 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 Johan 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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Johan in view of Yang et al. (US 2013/0096657, hereinafter “Yang”).
Johan 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 Johan 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 Johan in view of Shah et al. (US 2022/0016439, hereinafter “Shah”). Johan discloses the essential features of the claimed invention, including providing a shutter to control the size and shape of the aperture (Figs. 9-12 and pars. 0073-0080), but does not expressly disclose wherein the optical head unit includes the shutter. However, Shah in the same field of endeavor of light therapy discloses a system wherein the optical head unit 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 Johan 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.
Claims 3, 14 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Johan in view of Silver et al. (US 2021/0322782, hereinafter “Silver”). Johan discloses the essential features of the claimed invention, including utilizing a plurality of LEDs in wavelengths in the UV band “depending on the condition to be treated” (par. 0091), but does not expressly disclose wherein the plurality of LEDs are further comprising control means for causing the light source to emit the light for a specified period of time;
wherein 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 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; or
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 207 nm and 265 nm.
However, Silver in the same field of endeavor of light therapy teaches providing a system wherein the plurality of LEDs are further comprising control means for causing the light source 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”) to provide the predictable results of automatically applying therapy for the appropriate duration without the requirement of user interaction; and
wherein the base has:
a generally truncated cone shape 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. 4) to provide the predictable results of establishing an effective distance and area of therapeutic light treatment relative to the biological tissue to be treated (abstract).
Further, Silver teaches one or more wavelengths at which one or more of the plurality of LEDs emit light covers a range that includes at least one of 235 nm or between 207 nm and 265 nm (100-280 nm, par. 0105), both Johan and Silver disclose that wavelength is a results-effective variable (Johan at par. 0091, “depending on the condition to be treated”; Silver at pars. 0009,0013 as a results-effective variable for treatment or prophylaxis against infectious organisms), 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 Johan by providing a system wherein the plurality of LEDs are further comprising control means for causing the light source to emit the light for a specified period of time to provide the predictable results of automatically applying therapy for the appropriate duration without the requirement of user interaction; wherein the base has a generally truncated cone shape 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 to provide the predictable results of establishing an effective distance and area of therapeutic light treatment relative to the biological tissue to be treated; and one or more wavelengths at which one or more of the plurality of LEDs emit light covers a range that includes at least one of 235 nm or between 207 nm and 265 nm to yield no more than predictable results.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Johan in view of Gerber et al. (US 2016/0082281, hereinafter “Gerber”). Johan discloses the essential features of the claimed invention including providing additional light sources (Figs. 3, 4 and 6 depicting several), 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, Gerber 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 Johan 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 Johan in view of You et al. (US 2019/0175907, hereinafter “You”). Johan 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 Johan 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 Johan in view of Jeong (US 2020/0093945, hereinafter “Jeong”). Johan 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 Johan 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 Johan in view of Piergallini et al. (US 2011/0123958, hereinafter “Piergallini”). Johan 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 Johan 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 Johan in view of Gil et al. (US 2020/0179718, hereinafter “Gil”). Johan 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 Johan 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.
Response to Arguments
Applicant’s arguments with respect to claims 1-3, 5-9, 13-20, 30-32 and 37 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kennedy (US 2007/0185553) is another example of a light therapy device with light containment.
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 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
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