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 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 21-28, 32-34, 36-38, 40, and 43-44 are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0057701 Kelleher et al., hereinafter “Kelleher” (cited previously).
Regarding claim 21, Kelleher Embodiment 1 (Figures 3 and 8 showing the application of treatment to one eyelid at a time with half a scleral shield) discloses a system (Figure 3, elements 202 and 260) comprising: a protective scleral cover (Figure 3, element 300) configured to be positioned over at least a cornea to protect an eye of a patient during optical heating (Para 111), the protective scleral cover comprising: a body sized and shaped to be positioned on the eye of the patient (The shape is represented clearly in Figure 2C, element 300 and Para 111, 159-160), wherein the body comprises an inner surface that is concave facing towards the eye and an opposite outer surface (Figure 2C, element 300 is shown to be concave towards the eye and convex on the outer surface towards the eyelids, this is as the shapes are described in para 132 that describes Figure 3, element 140 as being concave, 300 holds the same inner shape), and a tab extending outward from the outer surface (Figure 3, element 262 and Para 111); and a housing (Figure 3, element 202) configured to removably attach to the tab of the protective scleral cover (Para 111 and 82; “The eye treatment device 200 can include a housing 202 coupled with a removable or consumable portion 260” and “scleral shield 300 may be coupled to housing 202 in various manners such as with one or more wires 420, such wires having insulation with sufficient mechanical strength to serve as support arms 262”) in a manner that the housing is configured to: decouple from the tab in a first position; rotate about an axis extending through the eye from the first position to a second position; and couple to the tab in the second position (See Paragraphs 111, 165, 169, and 249; examiner would first like to point that embodiment 1 of Figure 3 and Para 111 that shows that the housing 202 is capable of decoupling from the tab of the scleral cover 260 via coupling element 186. This embodiment also shows application of light to one eyelid at a time, this embodiment also aligns with Figure 8 and Paras 165 and 169. This embodiment specifically states the treatment of one eyelid at a time and “FIG. 8 may easily be adapted for treating the upper eyelid, for example by reversing the orientation of the energy delivery elements while keeping the display 244 and alignment elements in their upright (readable) orientation”; therefore, embodiment 1 is teaching the removal of the housing from tab 262, reversing the scleral shield 300 and the housing to the other eyelid and reattaching at another orientation); wherein the housing comprises: at least one light emitter configured to emit beams of infrared light (Figure 3, element 120 and Para 100, 103, and 129); and an elastomeric waveguide component (Para 92 and 179 and Figure 2C elements 130&140) coupled to the at least one light emitter and structurally arranged to direct the beams of infrared light toward a lower eyelid of the patient for optical heating in the first position and toward an upper eyelid of the patient for optical heating in the second position (Figure 2C, element 120 is coupled to 130 and Para 192; see also embodiment of Figure 8 and Para 169).
Kelleher Embodiment 1 does not disclose an attachment structure secures the tab to the housing, while the protective scleral cover remains in an orientation relative to the eye and wherein the attachment structure comprises a plurality of at least partially horizontally aligned protrusions extending from the protective scleral cover or the housing.
However, Kelleher Embodiment 2 (Figures 16D and 16L showing a full scleral shield with application of energy to both eyelids at the same time) an attachment structure secures the tab to the housing (Figure 3 and 16D, elements 262), while the protective scleral cover remains in an orientation relative to the eye (Figure 16L shows the shield 300 covering the whole eyelid at the same time, this embodiment is showing energy applied by elements 140 at the same time to the upper and lower lids, however, embodiment 1 shows the application of energy to one eyelid at a time by rotating the applicator. Embodiment 2 is brought in to show obviousness of using a single scleral shield that covers the entire eye that has tabs that can disconnect from the housing, so that the shield can remain in place when no treatment is being applied) and wherein the attachment structure comprises a plurality of at least partially horizontally aligned protrusions extending from the protective scleral cover or the housing (Para 16D, element 262 protruding from shield 300).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a scleral shield that remains in the same orientation relative to the eye as taught by Embodiment 2, in Embodiment 1 of Kelleher, in order to treat both eyelids and keeping the eye protected at the same time (Kelleher; Para 168 and 236).
Regarding claim 22, Kelleher discloses the housing further comprises a massaging assembly configured to oscillate the elastomeric waveguide component or the light emitter along a longitudinal axis (Para 181; applied in an axis parallel to the ocular axis therefore longitudinal; see Para 182 for massaging and light emission).
Regarding claim 23, Kelleher discloses at least a portion of the elastomeric waveguide component has a convex shape (Para 92 describes the waveguide as being elements 130 and 140 in Figure 2C, element 140 is convex).
Regarding claim 24, Kelleher discloses the housing further comprises a mechanical coupling feature configured to receive and engage with the tab (Para 111 and Figure 3, element 186).
Regarding claim 25, Kelleher discloses the mechanical coupling feature comprises at least one post to receive and engage with the tab (Para 111 and Figure 3, element 186 shows posts that are connected to housing 200).
Regarding claim 26, Kelleher discloses the tab comprises at least one notch configured to removably attach to the at least one post (Para 111 and Figure 3, element 186 shows two notches that are connected to arm 262).
Regarding claim 27, Kelleher discloses the housing comprises a handle configured to be grasped by a human hand (Para 117 and Figure 8, element 202).
Regarding claim 28, Kelleher discloses the outer surface of the body is configured to reflect the infrared light away from the eye of the patient and towards one of the upper eyelid or the lower eyelid of the patient to shield the eye from the optical heating of the one of the upper eyelid or the lower eyelid (Figure 2E, the outer surface of element 300 comprises a reflective surface 155; see Para 103 and 155; see also Para 169 for “one eyelid at a time” embodiment).
Regarding claim 32, Kelleher discloses the inner surface is configured to be physically separated from the cornea of the patient by a vaulted gap (Para 171 discloses an airgap; but also, examiner would like to include that the natural tear film present in our eyes is inherently forming a gap to separate the device from the cornea).
Regarding claim 33, Kelleher discloses the vaulted gap is sized to keep the cornea below 39 degrees Celsius for between 2 and 5 minutes of the optical heating (Para 137, 188, and 202; this is a statement of intended use, examiner suggests positively reciting the limitations of this claim).
Regarding claim 34, Kelleher discloses the housing (Figure 2D, element 100) further comprises an imaging component (Figure 2D, element 160) configured to obtain images of an eyelid margin of the patient during a treatment procedure (Para 103).
Regarding claim 36, Kelleher discloses the outer surface comprises a reflective material (Figure 2E, the outer surface of element 300 comprises a reflective surface 155; see Para 103 and 155).
Regarding claim 37, Kelleher discloses the housing removably attaches to the tab after the protective scleral cover is positioned (Para 111).
Regarding claim 38, Kelleher discloses the at least one light emitter is one or more LEDs (Para 30 and 111) comprising at least one of: one or more short wave infrared (SWIR) LEDs configured to emit light having a spectral range of 1050 nm - 1200 nm; or one or more infrared LEDs configured to emit light having a center wavelength of approximately 980 nm and a spectral range between 940 nm - 1000 nm (Para 19, 120, 129, and 150).
Regarding claim 40, Kelleher discloses the housing is configured to removably attach to the tab via a mechanical, magnetic, or electrical means (Para 111 and Figure 3, element 186; electrical and mechanical).
Regarding claim 43, Kelleher Embodiment 1 (Figures 3 and 8 showing the application of treatment to one eyelid at a time with half a scleral shield) discloses a system (Figure 3, elements 202 and 260) comprising: a protective scleral cover (Figure 3, element 300) configured to be positioned over at least a cornea to protect an eye of a patient during optical heating (Para 111), the protective scleral cover comprising: a body sized and shaped to be positioned on the eye of the patient (The shape is represented clearly in Figure 2C, element 300 and Para 111, 159-160), wherein the body comprises an inner surface that is concave facing towards the eye and an opposite outer surface (Figure 2C, element 300 is shown to be concave towards the eye and convex on the outer surface towards the eyelids, this is as the shapes are described in para 132 that describes Figure 3, element 140 as being concave, 300 holds the same inner shape), and a tab extending outward from the outer surface (Figure 3, element 262 and Para 111); and a housing (Figure 3, element 202) configured to removably attach to the tab of the protective scleral cover (Para 111 and 82; “The eye treatment device 200 can include a housing 202 coupled with a removable or consumable portion 260” and “scleral shield 300 may be coupled to housing 202 in various manners such as with one or more wires 420, such wires having insulation with sufficient mechanical strength to serve as support arms 262”) in a manner that the housing is configured to: decouple from the tab in a first position; rotate about an axis extending through the eye from the first position to a second position; and couple to the tab in the second position (See Paragraphs 111, 165, 169, and 249; examiner would first like to point that embodiment 1 of Figure 3 and Para 111 that shows that the housing 202 is capable of decoupling from the tab of the scleral cover 260 via coupling element 186. This embodiment also shows application of light to one eyelid at a time, this embodiment also aligns with Figure 8 and Paras 165 and 169. This embodiment specifically states the treatment of one eyelid at a time and “FIG. 8 may easily be adapted for treating the upper eyelid, for example by reversing the orientation of the energy delivery elements while keeping the display 244 and alignment elements in their upright (readable) orientation”; therefore, embodiment 1 is teaching the removal of the housing from tab 262, reversing the scleral shield 300 and the housing to the other eyelid and reattaching at another orientation); wherein the housing comprises: at least one light emitter configured to emit beams of infrared light (Figure 3, element 120 and Para 100, 103, and 129); and an elastomeric waveguide component (Para 92 and 179 and Figure 2C elements 130&140) coupled to the at least one light emitter and structurally arranged to direct the beams of infrared light toward a lower eyelid of the patient for optical heating in the first position and toward an upper eyelid of the patient for optical heating in the second position (Figure 2C, element 120 is coupled to 130 and Para 192; see also embodiment of Figure 8 and Para 169).
Kelleher Embodiment 1 does not disclose the protective scleral cover remains in an orientation relative to the eye.
However, Kelleher Embodiment 2 (Figures 16D and 16L showing a full scleral shield with application of energy to both eyelids at the same time) the protective scleral cover remains in an orientation relative to the eye (Figure 16L shows the shield 300 covering the whole eyelid at the same time, this embodiment is showing energy applied by elements 140 at the same time to the upper and lower lids, however, embodiment 1 shows the application of energy to one eyelid at a time by rotating the applicator. Embodiment 2 is brought in to show obviousness of using a single scleral shield that covers the entire eye that has tabs that can disconnect from the housing, so that the shield can remain in place when no treatment is being applied).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a scleral shield that remains in the same orientation relative to the eye as taught by Embodiment 2, in Embodiment 1 of Kelleher, in order to treat both eyelids and keeping the eye protected at the same time (Kelleher; Para 168 and 236).
Regarding claim 44, Kelleher Embodiment 1 (Figures 3 and 8 showing the application of treatment to one eyelid at a time with half a scleral shield) discloses an ophthalmic device (Figure 3, elements 202 and 260) comprising: (Figure 3, element 202) configured to removably attach to the tab of the protective scleral cover (Para 111 and 82; “The eye treatment device 200 can include a housing 202 coupled with a removable or consumable portion 260” and “scleral shield 300 may be coupled to housing 202 in various manners such as with one or more wires 420, such wires having insulation with sufficient mechanical strength to serve as support arms 262”) in a manner that the housing is configured to: decouple from the tab in a first position; rotate about an axis extending through the eye from the first position to a second position; and couple to the tab in the second position (See Paragraphs 111, 165, 169, and 249; examiner would first like to point that embodiment 1 of Figure 3 and Para 111 that shows that the housing 202 is capable of decoupling from the tab of the scleral cover 260 via coupling element 186. This embodiment also shows application of light to one eyelid at a time, this embodiment also aligns with Figure 8 and Paras 165 and 169. This embodiment specifically states the treatment of one eyelid at a time and “FIG. 8 may easily be adapted for treating the upper eyelid, for example by reversing the orientation of the energy delivery elements while keeping the display 244 and alignment elements in their upright (readable) orientation”; therefore, embodiment 1 is teaching the removal of the housing from tab 262, reversing the scleral shield 300 and the housing to the other eyelid and reattaching at another orientation); wherein the housing comprises: at least one light emitter configured to emit beams of infrared light (Figure 3, element 120 and Para 100, 103, and 129); and an elastomeric waveguide component (Para 92 and 179 and Figure 2C elements 130&140) coupled to the at least one light emitter and structurally arranged to direct the beams of infrared light toward a lower eyelid of the patient for optical heating in the first position and toward an upper eyelid of the patient for optical heating in the second position (Figure 2C, element 120 is coupled to 130 and Para 192; see also embodiment of Figure 8 and Para 169); and wherein the protective scleral cover is configured to be positioned over at least a cornea (Para 160) to protect the eye of the patient during optical heating (Para 160, also note that this is an intended use statement), the protective scleral cover comprising: a body sized and shaped to be positioned on the eye of the patient (The shape is represented clearly in Figure 2C, element 300 and Para 111 and 160), wherein the body comprises an inner surface that is concave facing towards the eye and an opposite outer surface (Figure 2C, element 300 is shown to be concave towards the eye and convex on the outer surface towards the eyelids, this is as the shapes are described in para 132 that describes Figure 3, element 140 as being concave, 300 holds the same inner shape), and the tab extending outward from the outer surface (Figure 3, element 262 extending from outer surface of 300).
Kelleher Embodiment 1 does not disclose the protective scleral cover remains in an orientation relative to the eye.
However, Kelleher Embodiment 2 (Figures 16D and 16L showing a full scleral shield with application of energy to both eyelids at the same time) the protective scleral cover remains in an orientation relative to the eye (Figure 16L shows the shield 300 covering the whole eyelid at the same time, this embodiment is showing energy applied by elements 140 at the same time to the upper and lower lids, however, embodiment 1 shows the application of energy to one eyelid at a time by rotating the applicator. Embodiment 2 is brought in to show obviousness of using a single scleral shield that covers the entire eye that has tabs that can disconnect from the housing, so that the shield can remain in place when no treatment is being applied).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a scleral shield that remains in the same orientation relative to the eye as taught by Embodiment 2, in Embodiment 1 of Kelleher, in order to treat both eyelids and keeping the eye protected at the same time (Kelleher; Para 168 and 236).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0057701 Kelleher et al., hereinafter “Kelleher”, in view of WO 2019033415 Du et al., hereinafter “Du” (cited previously).
Regarding claim 29, Kelleher discloses the body comprises a biocompatible acrylic material (Para 216 and 242).
Kelleher does not disclose a titanium dioxide additive incorporated within the biocompatible acrylic material.
However, Du discloses a contact lens that protects the eye from heat (Para 6 and 8) and teaches a titanium dioxide additive incorporated within the biocompatible acrylic material (Para 15, 17, and 34).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have included titanium oxide as part of the biocompatible material of the scleral cover as taught by Du, in the invention of Kelleher, in order to include refractive index properties to the cover (Du; Para 15).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0057701 Kelleher et al., hereinafter “Kelleher”, in view of US 4,198,714 Jensen et al., hereinafter “Jensen” (cited previously).
Regarding claim 30, Kelleher discloses the outer surface (Figure 3, outer surface of element 300).
Kelleher does not disclose a dielectric coating, wherein the dielectric coating is more transmissive in visible light wavelengths than infrared wavelengths.
However, Jensen discloses a lens that protects the eye from certain wavelengths of light (Col. 3, lines 3-8) and teaches a dielectric coating (Col. 5, lines 26-32), wherein the dielectric coating is more transmissive in visible light wavelengths than infrared wavelengths (Col. 5, lines 39-50).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have included a dielectric coating as taught by Jensen, in the invention of Kelleher, in order to have selective transmittance to wavelengths of light and protect the eye (Jensen; Col. 3, lines 3-8 and Col. 5, lines 39-50).
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0057701 Kelleher et al., hereinafter “Kelleher”, in view of US 2016/0258964 Zhang et al., hereinafter “Zhang” (cited previously).
Regarding claim 31, Kelleher discloses the inner surface (Figure 3, inner surface of element 300).
Kelleher does not disclose the inner surface comprises a Hydra- PEG coating.
However, Zhang discloses contact lenses that are capable of being exposed to light (Abstract and Para 35) and teaches the inner surface comprises a Hydra- PEG coating (Para 94).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have included a Hydra-PEG coating as taught by Zhang, in the invention of Kelleher, in order to enhance the biocompatibility and inhibit the growth of biofilm (Zhang; Para 94).
Response to Arguments
Applicant’s arguments have been fully considered but are moot because the new ground of rejection.
The 102 rejection on record has been overcome, however examiner still applied a single reference 103 rejection as stated above.
Examiner wants to also make a note of Para 249 of Kelleher that specifically states “that parts mixed with one embodiment are interchangeable with other embodiments; one or more parts from a depicted embodiment can be included with other depicted embodiments in any combination”.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYA ZIAD BAKKAR whose telephone number is (313)446-6659. The examiner can normally be reached on 7:30 am - 5:00 pm M-Th.
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/AYA ZIAD BAKKAR/
Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796