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
Applicant’s election of Group I and Species A in the reply filed on 7/6/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. It is noted that applicant inadvertently/incorrectly identified the claims of Group II as 22-23, when no such claims exist. Instead, the claims of Group II are 15-19 (as identified in the restriction requirement mailed 5/7/2026). Therefore, claims 1-14 are pending examination.
Claim Interpretation
Under the broadest reasonable interpretation, the limitations related to the active and inactive periods of time for the “array of light-emitting devices” are met by any of the light emitting devices within the array being active or inactive, i.e. a subset of light sources within the array. For example, if the array includes three different types of light sources (A, B and C), the claim language is met by just A being on (while B and C are off), then just B being on (while A and C are off) and then just C being on (while A and B are off). i.e. A is active, then A (or C) is/are inactive, then C is active. Stated differently, the claims do not require that ALL of the lights to be simultaneously all on, then all off, then all on again (although this is encompassed by the claim language). Additionally, pulsing of any individual light source (either together with other light source or by itself) would read on the claim language, e.g. pulsing any/all of light sources A, B or C (on/off/on repetitively) would read on the claim language.
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 13 and 14 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.
These claims recite “the second set of light emitting devices”, however there are three different “second set of light emitting devices”, i.e. “of the first color”, “of the second color” and “of IR light emitting devices”. Therefore, it’s unclear which of the three “second set of light emitting devices” this is referring to or if this is intended to refer to the “second cluster of light emitting devices”.
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.
Claims XXX are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0067086 to Tedford (Tedford ‘086) in view of US 2016/0067087 to Tedford (Tedford ‘087) and further in view of US 2017/0127932 to Walsh or US 4,740,072 to Griffin et al.
[Claim 1] Tedford ‘086 discloses a device (Figs. 1-3) for aiding patients with macular degeneration (at least Pars 0006, 0009 and 0043-51) the device comprising:
a visor (patient interface 104 and eyepiece 106) including:
an array of light-emitting devices (light engine 420, Fig. 4, including “one or more light sources 422a, 422b, 422c”) comprising:
a controller (programmable controller, e.g. 750, Fig. 7) that controls activation of the array of light-emitting devices such that (Pars 0079-85):
the array of light-emitting devices is active for a first period of time;
after the array of light-emitting devices is active for the first period of time, the array of light-emitting devices is inactive for a second period of time; and
after the array of light-emitting devices is inactive for the second period of time, the array of light-emitting devices is active for a third period of time.
Regarding the claimed active and inactive times, Tedford ‘086 discloses “for example, the programmable controller can execute a treatment program that includes a set of activation times or periods during which each of the light sources is in an emitting state and a set of inactivation times or periods during which the light source is in a non-emitting state” Par 0080. And, “the programmable controller includes a logic circuit, a clock coupled to the logic circuit, and an interface coupled to the logic circuit. The clock of at least some embodiments provides a timing signal to the logic circuit so that the logic circuit can monitor and control timing intervals of the applied light. Examples of timing intervals include, but are not limited to, total treatment times, pulse width times for pulses of applied light, and time intervals between pulses of applied light. In at least some embodiments, the light source can be selectively turned on and off to reduce the thermal load on the eye or ocular tissue and to deliver a selected irradiance to particular areas of the eye or other ocular tissue” Par 0094. As well as, “the device is operated so that two or more of the light sources generate light simultaneously. In other embodiments, the device operates to deliver light from a single light source at any given time, although the light sources may be turned on and off in any suitable light delivery sequence” Par 0070. Lastly, “for example, a desired frequency of light energy emission (e.g., every 24 hours), duration of light energy emission (e.g., for 5 minutes), irradiance of light energy emission (e.g., from 1 mW to 10 mW), irradiation pattern or order of light source activity (e.g., a sequence of emission of light energy in those embodiments comprising more than one light source), and other parameters can be preprogrammed into the programmable controller. For pulsed light dosimetry, the treatment parameters can also include duty cycle, pulse shape, repetition rate, pulse width or irradiance per pulse for pulsed light dosimetry.” Par 0082. At the very least, these citied paragraphs of Tedford ‘086, as a well as the document as a whole, teaches/suggests a controller that controls the array of light sources such that the claimed active, inactive and then active period are provided; see explanation above, in the claim interpretation section.
While Tedford ‘086 discloses an array of light sources all having different colors/wavelengths (Pars 0065-68 and 0108-115), the reference fails to explicitly teach a first cluster and a second cluster, as claimed, i.e. one cluster of light emitting devices for each eye. However, in the same field of endeavor, specifically a light therapy device for the treatment of macular degeneration (at least Par 0010), Tedford ‘087 discloses (Figs. 2A-B):
a first cluster of the light-emitting devices (right array 208; Pars 0068-71 and 0120-126) including:
a first set of light-emitting devices of a first color (210a, e.g. 590 nm, which is yellow/orange; Par 0120);
a first set of light-emitting devices of a second color (210b, e.g. 670 nm, which is red; Par 0120 ); and
a first set of infrared (IR) light-emitting devices (210c, e.g. 810 nm or 1064 nm, which are both infrared; Par 0120); and
a second cluster of the light-emitting devices including (left array 208; Pars 0068-71 and 0120-126, which is a duplicate/replica of the right array, discussed above):
a second set of light-emitting devices of the first color (210a);
a second set of light-emitting devices of the second color (210b); and
a second set of IR light-emitting devices (210c);
Therefore, it would have been obvious to one of ordinary skill in the art to substitute the light array taught by Tedford ‘086 for the light array taught by Tedford ‘087, as a simple substitution of one known light array for another to obtain predictable results, i.e. provide light of different colors/wavelengths to each eye. It is emphasized that Tedford ‘087 teaches the same/similar controller as Tedford ‘086 that controls the timing and sequence/pattern of the light emission (at least Pars 0091-94 and 0105 of Tedford ‘087)
Tedford ‘086 and Tedford ‘087 are discussed above, but fail to explicitly teach a base with posts and a visor housing with apertures corresponding to the posts of the base such that the visor couples to the base via the apertures and the posts. However, analogous art references Walsh or Griffin, which are in the same field of endeavor (providing light to a patient’s eye for medical purposes) and/or pertinent to the problem being solved (designing devices where patient’s place their eyes to receive light for medical purposes), teach/suggest such a configuration.
Specifically, Walsh (Figs. 1, 2a and 2b) discloses a similar visor (mask 100), i.e. equivalent to the eyepiece/interface taught by Tedford ‘086, that is connected to a base (medical device 112) via posts (flanges 164, one on each side of the mask, therefore interpreted as two posts) and apertures (slots 116). While the figures show that the posts/flanges are on the visor/mask and the apertures/slots are on the base. Walsh explicitly teaches “the flange 164 can be on the medical device 112 and the slot 116 can be on the mask 100.” (Par 0041). It is noted that Tedford ‘086 specifically discloses an embodiment where the visor/eyepiece/mask is detachable from the base (Figs. 3A-B; Par 0064). Therefore, it would have been obvious to one of ordinary skill in the art modify the device taught by Tedford ‘086 and Tedford ‘087, specifically modify the removable visor/eyepiece of Tedford ‘086, to have posts on the base and apertures in the visor that receive the posts so that the visor couples to the base via the apertures and posts, as taught by Walsh, as a simple substitution of one known removable attachment mechanism for another known removable attachment mechanism to obtain predictable results, i.e. to make a visor/eyepiece detachable/removable from a base.
Alternatively, Griffin (Figs. 1 and 10) discloses a visor/eyepiece (10) that is attached to a base (12) via posts and apertures (pivot connection 148 on each side of the device). The examiner contends that inherently the pivot connection includes a post and aperture, as claimed, in order to pivot. However, if applicant disagrees, the examiner takes official notice that the claimed post (or pin)/aperture configuration is commonly known and used to provide pivoting connections, like the one taught by Griffin. Therefore, it would have been obvious to one of ordinary skill in the art to modify the device taught by Tedford ‘086 and Tedford ‘087 to include the posts and apertures in the claimed configuration, as taught by Griffin, in order to provide a small, compact and portable device with a pivoting base that allows proper positioning of the device to easily accommodate a patient’s eyes during the medical procedure, as taught by Griffin.
[Claims 3-5] Both Tedford ‘086 (“In RPE cell studies, the use of 590 nm light has been shown to inhibit VEGF expression and thus the use of 590 nm PBM (or another wavelength in the range of 500 to 650 nm) can be useful in the treatment of wet AMD subtype to suppress VEGF protein expression locally in ocular tissue” Par 0038) and Tedford ‘087 (Par 0043) disclose a wavelength for treating macular degeneration that falls within the range 500 nm to 650 nm, which encompasses 505-525 nm. Similarly, Tedford ‘086 (“In at least some embodiments, the selected wavelength is in a range from 600 to 700 nm” Par 0110) and Tedford ‘087 (0121) discloses a wavelength from 600 to 700 nm, which encompasses 625 nm. Lastly, Tedford ‘086 (“n at least some embodiments, the light includes one or more wavelengths between 550 nanometers and 1064 nanometers, or between 590 nanometers and 980 nanometers” Par 0109) and Tedford ‘087 (Par 0120) disclose a wavelength from 590 nm to 980 nm, which encompasses 940 nm. MPEP 2144.05 states “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. Therefore, it would have been obvious to one of ordinary skill in the art to try/choose any of the wavelengths in the ranges disclosed by Tedford ‘086 or Tedford ‘087, as these are wavelengths known to be effective for treating macular degeneration and other ophthalmic diseases/conditions.
[Claims 5 and 6] Figs. 2A and 2B, as well as Pars 0068-70 of Tedford ‘087, make it clear that the three different light sources can emit different wavelengths and “can be arranged in any suitable arrangement such as, for example, a repeating sequence of light sources 210a, 210b, 210c along a row or column or both or along a diagonal, a sequence (that may be repeating) with one row, column, or diagonal of light source 210a followed by a row, column, or diagonal of light source 210b and then a row, column, or diagonal of light source 210c, or any other suitable regular or irregular arrangement” (Par 0070). The examiner contends that this teaching of Tedford ‘087 either explicitly teaches the claimed configuration or give a POSITA ample motivation to arrange the light source in any desired manner, including the order/pattern claimed, as a matter of routine optimization or design choice; see MPEP 2144.04 and 2144.05. Regarding the green light, both Tedford references teach light from 500 to 600, which at the very least encompasses/includes green light (495-570 nm)
[Claims 7 and 8] The examiner contends that any of the visible light sources, i.e. light sources that emit a color, e.g. green, yellow, orange and red, are interpreted as a “warning light emitting device” or a “wait-period indicator”. As discussed above, the position/location of any of the light sources within the array is taught/suggested by Tedford ‘086; see explanation for claims 5 and 6 above. Furthermore, Tedford ‘087 teaches “it will also be understood that the number of light sources emitting different wavelengths is not limited to three, but there can be two, four, five, six, or more different light sources emitting different wavelengths of light”. Therefore, the fourth and/or fifth different colored light source can be interpreted as the warning light or wait-period indicator.
[Claims 9 and 10] As discussed above, in relation to claim 1, Tedford ‘086 discloses a controller that controls all timing aspects of the light therapy, including activation and inactivation times, pulse duration, and intervals between pulses. Therefore, Tedford ‘086 teaches a controller capable of making the claimed time periods equal or it would be obvious for a POSITA to do so, as mere optimization of a result effective variable.
[Claim 11] Tedford ‘086 is silent to the controller being located in the visor. However, this is considered a mere rearrangement of parts and it would be obvious to a POSITA to position/locate the controller anywhere on the device. Additionally or alternatively, Tedford ‘087 discloses a controller within the visor (“The one or more frame casings 212 can include a controller, light source electronics, a battery or any combination thereof within the casing” Par 0068). Therefore, it would have been obvious to one ordinary skill in the art to modify the visor of Tedford ‘086 to include the controller, as taught by Tedford ‘087, as a known location/position for a controller in a similar laser therapy device.
[Claims 13 and 14] As discussed above, in relation to claims 1, 9 and 10, Tedford ‘086 discloses that the activation time periods and pattern of the light emission (whether this entails concurrent/simultaneous emission of two or more light sources or sequential emission) is controlled by the controller. Similarly, Tedford ‘087 teaches the same/similar controller. Therefore, Tedford ‘086 and/or Tedford ‘087 teaches a controller capable of activating the first cluster and second set of light sources at the same time or at opposite times during the first time period. Alternatively, it would be obvious for a POSITA to do so, as mere optimization of a result effective variable.
Allowable Subject Matter
Claim 12 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, i.e. clam 11. The prior art fails to teach or suggest the claimed configuration/arrangement of a visor having a communication port, an ancillary device connected to the visor via the communication port, the ancillary device including additional/different light emitting devices (from the visor) that is controlled by the controller within the visor.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Titmus Vision Screener shows a visor attached to a base via posts/apertures, i.e. pivotable connection.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lynsey C Eiseman whose telephone number is (571)270-7035. The examiner can normally be reached Monday-Thursday and alternating Fridays 7 to 4 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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