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 .
Response to Amendment
Receipt is acknowledged of the amendment filed 6/18/2026. Claims 1, 4-5, 10-12 and 119-20 are amended and claims 1-20 are currently pending.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 20 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 20 has been amended to recites “the light emitter includes plurality of LEDs have an adjustable color setting inclusive of blue light, and wherein only one or more LEDs of the plurality of LEDs are configured to selectively emit blue light in response to a user input signal”. The metes and bounds of the limitation cannot be determined. There appears to be a typographical omission in the phrase “the light emitter includes plurality of LEDs have an adjustable color setting inclusive of blue light” such that the subject predicate agreement is improper and is irreconcilable. It is unclear if the light emitter has an adjustable color setting or the plurality of LEDs have an adjustable color setting. Further, the phrase “only one or more LEDs of the plurality of LEDs are configured to selectively emit blue light” provides an unconventional and unclear limitation on the claimed invention as there is not clear meaning of “only … more LEDs of the plurality of LEDs”. It would be clear if the claim recites “only one LED of he plurality of LEDs is configured to emit blue light” or “all LEDs of the plurality of LEDs are configured to emit blue light”, but the current phrasing is not so clear. The indefiniteness preempts further examination on the merits.
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.
Claims 1-8 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over WO 01/49166 to Birchall (hereinafter Birchall) in view of US Pat. 8,353,595 to Mann (hereinafter Mann).
Regarding claim 1, Birchall discloses an ophthalmic visualization tool (Figs. 1-4) for visualizing a vitreous body within a patient's eye, the eye having a pars plana region, the ophthalmic visualization tool comprising: a frame (e.g. eye cup 12 and head 10, Figs. 1, 3, 4) having: an annular body (eye cup 12, Fig. 1, 3, 4) configured to support an optical lens (lens 13, Figs. 1-4); and a flange (head 10, Figs. 1, 3, 4) connected to the annular body, the flange having a first end (proximal to eye cup 12, Fig. 1, 3, 4) and an exterior of the flange at the first end having a first width (Fig. 1, 4) and a second end (distal to eye cup 12, Fig. 1, 3, 4) and the exterior of the flange at the second end having a second width that is larger than the first width (Figs. 1, 4) and the exterior of the flange having a frustoconical shape (Figs. 1, 4), wherein the first end is connected to the annular body (Figs. 1, 4); and a light emitter (LEDs 19, Figs. 1, 4) connected to the flange proximate the second end (Figs. 1, 4), the second width being sized and the light emitter positioned along the flange such that light emitted impinges on being configured to direct light through and passes through the scleral surface at the pars plana region (“LEDs are directed such that the light 'reflexes' or reflections from the cornea are displaced to the temporal quarter or limbal region of the corner and nasal cornea”, Figs. 1, 4) into a vitreous cavity of the eye, at the pars plana region, to thereby uniformly illuminate the vitreous body (“hand held illuminated magnifier similar to those used as low vision aids is modified to provide an illuminated magnifying instrument, for examination of the anterior segment of the eye (conjunctiva, sclera, cornea, iris, pupil and lens) and peri-ocular tissues (eyelid margins, conjunctival and cutaneous surfaces and surrounding skin”).
Birchall discloses the claimed invention as cited above though does not explicitly disclose the second end is configured to rest on a scleral surface of the eye proximate in the pars plana region.
Mann discloses: a flange having a second end, and the second end is configured to rest on a scleral surface of the eye proximate in the pars plana region and a light emitter connected to the flange proximate the second end, the second width being sized and the light emitter positioned along the flange such that light emitted impinges on being configured to direct light through and passes through the scleral surface at the pars plana region (“a cylindrical ring attachment 1 out of a trans-luminescent material is attached to the end 3e of the tube 3c that is facing the eye…is put onto the eye concentrically to the cornea close to the limbus, so that the attachment rests on the eye on the sclera outside of the pupil” and “As the eye has a curvature and as the ring attachment 1 rests on the eye with its face side on the eye, it is advantageous to have a surface area of the face side, which does not form a right angle with the longitudinal axis of the tube 3c. For example, the outer edge of the ring may further protrude towards the eye than the inner edge. Ideally, the face surface of the ring attachment additionally has a curvature, which curvature is adapted to the curvature of an average eye”, Fig. 1; col. 2, ln. 64-col. 3, ln. 37).
Before the effective filing date of the invention, it would have been obvious to a person of ordinary skill in the art to rest a second surface on scleral surface as taught by Mann with the system as disclosed by Birchall. The motivation would have been to shine line uniformly and annularly through the sclera (col. 2, ln. 64-col. 3, ln. 37).
Regarding claim 2, Birchall discloses the annular body includes a set of tabs configured to engage a perimeter edge of the optical lens (unlabeled tabs of eye cup 12 and head 10 interface, Fig. 4).
Regarding claim 3, Birchall discloses the optical lens (Fig. 4).
Regarding claim 4, Birchall discloses the second width is sized and the light emitter is positioned along the flange such that light emitted along a direction normal to a surface of the light emitter impinges on and passes through the scleral surface at the pars plana region (Fig. 4).
Also, in Mann, the concentric relationship between the ring 1 and the eye necessitate this geometric relationship (Fig. 1).
Before the effective filing date of the invention, it would have been obvious to a person of ordinary skill in the art to provide the geometric relationship between light and eye surface as taught by Mann with the system as disclosed by Birchall. The motivation would have been to shine line uniformly and annularly through the sclera (col. 2, ln. 64-col. 3, ln. 37).
Regarding claim 5, Birchall discloses the light emitter includes a plurality of light emission elements (LEDs 19 and LED 24, Fig. 4) that are annularly arranged along an inner wall of the second end of the flange (Figs. 1, 4).
Regarding claim 6, Birchall discloses the light emitter includes a plurality of light-emitting diodes (LEDs) (LEDs 19, Fig. 4; col. 2, ln. 64-col. 3, ln. 37).
Regarding claim 7, Birchall discloses the LEDs include one or more blue LEDs (Claim 5).
Regarding claim 8, Birchall discloses the claimed invention as cited above though does not explicitly disclose at least one of the LEDs is connected to an optical fiber.
Mann discloses at least one of the LEDs is connected to an optical fiber (“an appropriate coupling device for attaching or screwing a cable that contains the light-conducting fibres is affixed on this short pipe”; col. 2, ln. 64-col. 3, ln. 37).
Before the effective filing date of the invention, it would have been obvious to a person of ordinary skill in the art to provide the claimed illumination structure as taught by Mann with the system as disclosed by Birchall. The motivation would have been to shine line uniformly and annularly through the sclera (col. 2, ln. 64-col. 3, ln. 37).
Regarding claim 19, Birchall discloses an ophthalmic visualization tool (Figs. 1-4) for visualizing a vitreous body within a patient's eye, the eye having a pars plana region, the ophthalmic visualization tool comprising: an optical lens (lens 13, Fig. 4) configured for viewing an anterior, middle, or posterior portion of the vitreous body (“examination of the anterior segment of the eye (conjunctiva, sclera, cornea, iris, pupil and lens)”); a frame (e.g. eye cup 12 and head 10, Figs. 1, 3, 4) having an annular body (eye cup 12, Fig. 1, 3, 4) and a neck portion (portion of eye cup 12 proximal to head 10, Fig. 1, 3, 4), wherein the neck portion is configured to support a perimeter edge of the optical lens (it is noted that Birchall’s neck portion does not support the optical lens singularly but rather in combination; Fig. 4); a flange (head 10, Figs. 1, 3, 4) inclusive of a first end (proximal to eye cup 12, Fig. 1, 3, 4) with a first width and a second end (distal to eye cup 12, Fig. 1, 3, 4) with a second width that is larger than the first width, wherein the first end is connected to the neck portion (Figs. 1, 3, 4); and a light emitter (LEDs 19, Figs. 1, 4) disposed between the second end of the flange having the second width and the scleral surface and configured to direct light into a vitreous cavity of the eye through the scleral surface (“LEDs are directed such that the light 'reflexes' or reflections from the cornea are displaced to the temporal quarter or limbal region of the corner and nasal cornea”, Figs. 1, 4), at the pars plana region, to uniformly illuminate the vitreous body (“hand held illuminated magnifier similar to those used as low vision aids is modified to provide an illuminated magnifying instrument, for examination of the anterior segment of the eye (conjunctiva, sclera, cornea, iris, pupil and lens) and peri-ocular tissues (eyelid margins, conjunctival and cutaneous surfaces and surrounding skin”).
Birchall discloses the claimed invention as cited above though does not explicitly disclose the second end is configured to rest on a scleral surface of the eye proximate in the pars plana region.
Mann discloses: a flange having a second end, and the second end is configured to rest on a scleral surface of the eye proximate in the pars plana region and a light emitter connected to the flange proximate the second end, the second width being sized and the light emitter positioned along the flange such that light emitted impinges on being configured to direct light through and passes through the scleral surface at the pars plana region (“a cylindrical ring attachment 1 out of a trans-luminescent material is attached to the end 3e of the tube 3c that is facing the eye…is put onto the eye concentrically to the cornea close to the limbus, so that the attachment rests on the eye on the sclera outside of the pupil” and “As the eye has a curvature and as the ring attachment 1 rests on the eye with its face side on the eye, it is advantageous to have a surface area of the face side, which does not form a right angle with the longitudinal axis of the tube 3c. For example, the outer edge of the ring may further protrude towards the eye than the inner edge. Ideally, the face surface of the ring attachment additionally has a curvature, which curvature is adapted to the curvature of an average eye”, Fig. 1; col. 2, ln. 64-col. 3, ln. 37).
Before the effective filing date of the invention, it would have been obvious to a person of ordinary skill in the art to rest a second surface on scleral surface as taught by Mann with the system as disclosed by Birchall. The motivation would have been to shine line uniformly and annularly through the sclera (col. 2, ln. 64-col. 3, ln. 37).
Claims 10-16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over WO 01/49166 to Birchall (hereinafter Birchall) in view of US Pat. 8,353,595 to Mann (hereinafter Mann) and US Pat. No. 8,740,383 to Yates (hereinafter Yates).
Regarding claim 10, Birchall discloses a transscleral illumination system (Figs. 1-4) for visualizing a vitreous body within a patient's eye, the eye having a pars plana region, the transscleral illumination system comprising: an ophthalmic visualization tool (Figs. 1-4) having: an annular body (eye cup 12, Fig. 1, 3, 4) configured to support an optical lens (lens 13, Figs. 1-4); and a flange (head 10, Figs. 1, 3, 4) having a first end (proximal to eye cup 12, Fig. 1, 3, 4) with a first width and a second end (distal to eye cup 12, Fig. 1, 3, 4) with a second width that is larger than the first width and a frustoconical shape (Figs. 1, 4), wherein the first end is connected to the annular body (Figs. 1, 4); and a light emitter (“LEDs are directed such that the light 'reflexes' or reflections from the cornea are displaced to the temporal quarter or limbal region of the corner and nasal cornea”, Figs. 1, 4) connected to the flange to be disposed between the second end of the flange and the scleral surface proximate the second end (Figs. 1, 4), the light emitter such that light emitted impinges on and passes through the scleral surface at the pars plana region into a vitreous cavity of the eye (“hand held illuminated magnifier similar to those used as low vision aids is modified to provide an illuminated magnifying instrument, for examination of the anterior segment of the eye (conjunctiva, sclera, cornea, iris, pupil and lens) and peri-ocular tissues (eyelid margins, conjunctival and cutaneous surfaces and surrounding skin”), at the pars plana region, to thereby uniformly illuminate the vitreous body
Birchall discloses the claimed invention as cited above though does not explicitly disclose the second end is configured to rest on a scleral surface of the eye proximate in the pars plana region.
Mann discloses: a flange having a second end, and the second end is configured to rest on a scleral surface of the eye proximate in the pars plana region and a light emitter connected to the flange proximate the second end, the second width being sized and the light emitter positioned along the flange such that light emitted impinges on being configured to direct light through and passes through the scleral surface at the pars plana region (“a cylindrical ring attachment 1 out of a trans-luminescent material is attached to the end 3e of the tube 3c that is facing the eye…is put onto the eye concentrically to the cornea close to the limbus, so that the attachment rests on the eye on the sclera outside of the pupil” and “As the eye has a curvature and as the ring attachment 1 rests on the eye with its face side on the eye, it is advantageous to have a surface area of the face side, which does not form a right angle with the longitudinal axis of the tube 3c. For example, the outer edge of the ring may further protrude towards the eye than the inner edge. Ideally, the face surface of the ring attachment additionally has a curvature, which curvature is adapted to the curvature of an average eye”, Fig. 1; col. 2, ln. 64-col. 3, ln. 37).
Before the effective filing date of the invention, it would have been obvious to a person of ordinary skill in the art to rest a second surface on scleral surface as taught by Mann with the system as disclosed by Birchall. The motivation would have been to shine line uniformly and annularly through the sclera (col. 2, ln. 64-col. 3, ln. 37).
Birchall discloses the claimed invention as cited above though does not explicitly disclose a processor in communication with the light emitter, wherein a setting of the light emitter is controllable via the processor.
Yates discloses a processor in communication with the light emitter, wherein a setting of the light emitter is controllable via the processor (“controller 17 allows for control of which LEDs of LEDs 10 are illuminated, for how long (e.g., various temporal characteristics), and how bright”; col. 9, ll. 57-59).
Before the effective filing date of the invention, it would have been obvious to a person of ordinary skill in the art to provide an illumination processor as taught by Yates with the system as disclosed by Birchall. The motivation would have been to adjust illumination characteristics during applications (col. 9, ll. 57-59).
Regarding claim 11, Birchall discloses the annular body having includes a neck portion, and wherein the neck portion is configured to support a perimeter edge of the optical lens (indirect support of lens 13, Figs. 1, 4). Note: The claim does not require direct physical contact.
Regarding claim 12, Birchall discloses the light emitter includes a plurality of light emission elements that are annularly arranged along an inner wall of the second end of the flange (LEDs 19 and LED 24, Fig. 1 & 4).
Regarding claim 13, Birchall discloses the light emitter includes a plurality of light-emitting diodes (LEDs) (LEDs 19 and LED 24, Fig. 1 & 4).
Regarding claim 14, Birchall discloses the LEDs are configured in an annular arrangement (LEDs 19 and LED 24, Fig. 1 & 4).
Regarding claim 15, Birchall discloses the claimed invention as cited above though does not explicitly disclose at least one of the LEDs is connected to an optical fiber.
Mann discloses at least one of the LEDs is connected to an optical fiber (“an appropriate coupling device for attaching or screwing a cable that contains the light-conducting fibres is affixed on this short pipe”; col. 2, ln. 64-col. 3, ln. 37).
Before the effective filing date of the invention, it would have been obvious to a person of ordinary skill in the art to provide the claimed illumination structure as taught by Mann with the system as disclosed by Birchall. The motivation would have been to shine line uniformly and annularly through the sclera (col. 2, ln. 64-col. 3, ln. 37).
Regarding claim 16, Birchall discloses the claimed invention as cited above though does not explicitly disclose the processor is configured to adjust a setting of the light emitter in response to a user input signal.
Yates discloses the processor is configured to adjust a setting of the light emitter in response to a user input signal (col. 9, ll. 55-61).
Before the effective filing date of the invention, it would have been obvious to a person of ordinary skill in the art to provide an illumination processor as taught by Yates with the system as disclosed by Birchall. The motivation would have been to adjust illumination characteristics during applications (col. 9, ll. 57-59).
Regarding claim 18, Birchall discloses the optical lens, wherein the optical lens is configured as an exchangeable lens configured for viewing an anterior, middle, or posterior portion of the vitreous body (Fig. 4).
Claims 10, 16, 17 are rejected under 35 U.S.C. 103 as being unpatentable over Birchall in view of Mann and US Pat. No. 11,154,193 to Toslak et al. (hereinafter Toslak).
Regarding claim 10, Birchall discloses a transscleral illumination system (Figs. 1-4) for visualizing a vitreous body within a patient's eye, the eye having a pars plana region, the transscleral illumination system comprising: an ophthalmic visualization tool (Figs. 1-4) having: an annular body (eye cup 12, Fig. 1, 3, 4) configured to support an optical lens (lens 13, Figs. 1-4); and a flange (head 10, Figs. 1, 3, 4) having a first end (proximal to eye cup 12, Fig. 1, 3, 4) with a first width and a second end (distal to eye cup 12, Fig. 1, 3, 4) with a second width that is larger than the first width and a frustoconical shape (Figs. 1, 4), wherein the first end is connected to the annular body (Figs. 1, 4); and a light emitter (“LEDs are directed such that the light 'reflexes' or reflections from the cornea are displaced to the temporal quarter or limbal region of the corner and nasal cornea”, Figs. 1, 4) connected to the flange to be disposed between the second end of the flange and the scleral surface proximate the second end (Figs. 1, 4), the light emitter such that light emitted impinges on and passes through the scleral surface at the pars plana region into a vitreous cavity of the eye (“hand held illuminated magnifier similar to those used as low vision aids is modified to provide an illuminated magnifying instrument, for examination of the anterior segment of the eye (conjunctiva, sclera, cornea, iris, pupil and lens) and peri-ocular tissues (eyelid margins, conjunctival and cutaneous surfaces and surrounding skin”), at the pars plana region, to thereby uniformly illuminate the vitreous body
Birchall discloses the claimed invention as cited above though does not explicitly disclose the second end is configured to rest on a scleral surface of the eye proximate in the pars plana region.
Mann discloses: a flange having a second end, and the second end is configured to rest on a scleral surface of the eye proximate in the pars plana region and a light emitter connected to the flange proximate the second end, the second width being sized and the light emitter positioned along the flange such that light emitted impinges on being configured to direct light through and passes through the scleral surface at the pars plana region (“a cylindrical ring attachment 1 out of a trans-luminescent material is attached to the end 3e of the tube 3c that is facing the eye…is put onto the eye concentrically to the cornea close to the limbus, so that the attachment rests on the eye on the sclera outside of the pupil” and “As the eye has a curvature and as the ring attachment 1 rests on the eye with its face side on the eye, it is advantageous to have a surface area of the face side, which does not form a right angle with the longitudinal axis of the tube 3c. For example, the outer edge of the ring may further protrude towards the eye than the inner edge. Ideally, the face surface of the ring attachment additionally has a curvature, which curvature is adapted to the curvature of an average eye”, Fig. 1; col. 2, ln. 64-col. 3, ln. 37).
Before the effective filing date of the invention, it would have been obvious to a person of ordinary skill in the art to rest a second surface on scleral surface as taught by Mann with the system as disclosed by Birchall. The motivation would have been to shine line uniformly and annularly through the sclera (col. 2, ln. 64-col. 3, ln. 37).
Birchall discloses the claimed invention as cited above though does not explicitly disclose a processor in communication with the light emitter, wherein a setting of the light emitter is controllable via the processor.
Toslak discloses a processor in communication with the light emitter, wherein a setting of the light emitter is controllable via the processor(“time, duration, and intensity of each of the one or more light sources in the light source 102 may be controlled by a pre-programmed instructions stored in the light source 102 or may be controlled by the instructions from the controller 110 via communication with the controller 110”; col. 4, ln. 65-col. 5, ln. 8).
Before the effective filing date of the invention, it would have been obvious to a person of ordinary skill in the art to provide an illumination processor as taught by Yates with the system as disclosed by Birchall. The motivation would have been to adjust illumination characteristics during applications (col. 4, ln. 65-col. 5, ln. 8).
Regarding claim 16, Birchall discloses the claimed invention as cited above though does not explicitly disclose the processor is configured to adjust a setting of the light emitter in response to a user input signal.
Toslak discloses the processor is configured to adjust a setting of the light emitter in response to a user input signal (“the red light source 204, the green light source 206, and the blue light source 208 may sequentially emit red light, green light, and blue light respectively” and “time, duration, and intensity of each of the one or more light sources in the light source 102 may be controlled by a pre-programmed instructions stored in the light source 102 or may be controlled by the instructions from the controller 110 via communication with the controller 110”; col. 4, ln. 65-col. 5 , ln. 15).
Before the effective filing date of the invention, it would have been obvious to a person of ordinary skill in the art to provide an illumination processor as taught by Yates with the system as disclosed by Birchall. The motivation would have been to adjust illumination characteristics during applications (col. 4, ln. 65-col. 5 , ln. 15).
Regarding claim 17, Birchall discloses the claimed invention as cited above though does not explicitly disclose the setting of the light emitter includes a color of the light emitter, and wherein the user input signal is a requested color of the light emitter.
Toslak discloses the setting of the light emitter includes a color of the light emitter, and wherein the user input signal is a requested color of the light emitter (“the red light source 204, the green light source 206, and the blue light source 208 may sequentially emit red light, green light, and blue light respectively” and “time, duration, and intensity of each of the one or more light sources in the light source 102 may be controlled by a pre-programmed instructions stored in the light source 102 or may be controlled by the instructions from the controller 110 via communication with the controller 110”; col. 4, ln. 65-col. 5 , ln. 15).
Before the effective filing date of the invention, it would have been obvious to a person of ordinary skill in the art to provide an illumination processor as taught by Yates with the system as disclosed by Birchall. The motivation would have been to adjust illumination characteristics during applications (col. 4, ln. 65-col. 5 , ln. 15).
Response to Arguments
Applicant’s arguments with respect to claims 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
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 CHRISTOPHER J STANFORD whose telephone number is (571)270-3337. The examiner can normally be reached 8AM-4PM PST M-F.
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/CHRISTOPHER STANFORD/Primary Examiner, Art Unit 2872
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