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 without traverse of Invention I (claims 1-12 and 22) in the reply filed on 1/6/2026 is acknowledged. Claims 13-21 and 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to the nonelected invention II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/6/2026.
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.
Claim(s) 1-2 and 10-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Su et al (EP 2898820 listed as Clarity Medical Systems as citation 9 under foreign patent documents in IDS received on 2/1/2023 and copy provided by applicant) hereafter known as Su.
Independent claim:
Regarding claim 1:
Su discloses:
An ophthalmic system for visualizing an interior of an eye [see Fig. 1 and abstract… “A digital camera that combines the functions of the retinal camera and corneal camera into one, single small, easy to use instrument. The single camera can acquire digital images of a retinal region (9) of an eye, and digital images of a corneal region of the eye. The camera includes a first combination of optical elements for making the corneal digital images.”], comprising:
an illumination system configured to illuminate the interior of the eye [see Fig. 3 element 42 and para 40…. “a light emitting diode (LED) module 42 consists of multiple white color LEDs could be used to provide light for the source 28” ], the illumination system comprising an annular illuminator [see Fig. 2 element 28 and para 38… “Source 28 provides illumination for retinal imaging and can be pulsed or continues. The source 28 is shaped as a ring of light”] configured to direct annular illumination towards the interior of the eye [see para 32-33…. “The rear objective lens 13 when combined with the front objective lens 12 comprises the objective lens set for retinal imaging.”], the annular illumination having an illumination axis [A directed annular illumination implicitly has an axis of some type]; and
a visualization system configured to provide an image of the interior of the eye, the visualization system comprising a plurality of visualization optical elements [see Fig. 1-2 elements 7, 12-13 and para 31… “Oculars 7 are provided for achieving all of the typical visual functions associated with the slit-lamp biomicroscope. Lens 12 is the front objective lens and seals the optical system.” And para 33… “The objective lens is comprised of lens ele-ments 12 and 13.”], the plurality of visualization optical elements comprising:
an objective lens configured to receive light reflected from the interior of the eye [see Fig. 2 elements 12-13 and para 33];
and
oculars configured to transmit the reflected light to yield an image of the interior of the eye, the oculars having an ocular axis [see Fig. 1-2 element 7 and para 40]
Regarding claim 2:
a laser device configured to direct a treatment laser beam towards the interior of the eye [see Fig. 2 element 43A and paras 40 and 44… “Laser 43A is guided to port 43 by an optical fiber 43B and passes through one of the pinholes on the pinhole array 44 that has pinholes of various sizes.”]
Regarding claims 10-11, see para 38… “The source 28 is shaped as a ring of light and the light is injected co-axially by lenses 29 and 30 such that a ring of light is projected onto the eye lens of the patient but outside of the entrance pupil.” Co-axially recites “substantially coincident” and is an angle of 0 degrees which is an angle under broadest reasonable interpretation.
Regarding claim 12:
See Fig. 1 element 3 and para 29 [“The slit lamp 3 provides illumination for examination of the cornea and is adjustable in brightness, color, and width of slit.”]
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable Su in view of Rege et al (WO 2021183637 listed as Vasoptic Medical as citation 22 under foreign patent documents in IDS received on 2/1/2023 with copy provided by applicant) hereafter known as Rege.
Regarding claim 3:
Su discloses the invention substantially as claimed including all the limitations of 1 as outlined above and a laser source configured to provide illumination light [see Fig. 3 element 42 and para 40… “As shown in Fig. 3, a light emitting diode (LED) module 42 consists of multiple white color LEDs could be used to provide light for the source 28. Alternatively other light sources such as flashed Xenon and Halogen could be used. The light is coupled into the entrance of fiber optical cable 39 by a lens 40 after passing through an optical filter 41 to properly adjust the color temperature of the light.”]
However, Su fails to disclose “a plurality of annular optical elements configured to modify the illumination light to yield the annular illumination” as recited by claim 3.
Rege discloses in the analogous art of ophthalmology [see para 3… “The subject technology relates to imaging regions of tissue. In particular, the subject technology relates to illuminating and acquiring images of a fundus of an eye.”] an ophthalmic imaging device that includes one or more lenses (i.e. a plurality of annular optical elements) that are configured to modify the illumination light to yield the annular illumination [see para 21… “The apparatus, embodied as an ophthalmic imaging device (called "OID" hereafter), may use coherent illumination that is generated by any type of laser source, and any type of camera to acquire image data.” And see para 36… “an OID can include one or more axicon lenses configured to shape a coherent light beam that focuses to an annular shape on the cornea and lens and then spreads to effect substantially uniform illumination of the fundus.”] including axicon lenses [see para 36… “an OID can include one or more axicon lenses configured to shape a coherent light beam that focuses to an annular shape on the cornea and lens and then spreads to effect substantially uniform illumination of the fundus.”] and speckle patterns [see para 43… “the OID may be configured for implementing laser speckle contrast imaging (LSCI) and producing "LSCI output data". LSCI refers to the imaging of speckle patterns caused by laser light scattered by the tissue, and the subsequent processing of these speckle patterns to assess blurring in the imaged speckle patterns to obtain information about movement of the scattering particles.”] and that the components of this device (understood to include the lenses or annual optical elements) are adjustable [see para 37… “The OID can be designed either as different embodiments that are customized for the application but employ the principles disclosed herein, or as a single embodiment that contains adjustable components providing for use in both humans and animals and for one or more diseases or conditions.”] for the purpose of allowing the device to use multiple illumination modalities thereby allowing the device to capture a number of different types of data in the form of different imaging data [see para 22… “Use of multiple illumination modalities permits the OID to capture one or more of reflectance images, absorption spectroscopic images, fluorescence images, and LSCI images with or without mydriatic agents.”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Su by including a plurality adjustable annular optical elements including axicons and a configuration that provides light as a laser beam with a speckle pattern similarly to that disclosed by Rege for the purpose of allowing Su to capture a number of different types of data in the form of different imaging data.
Regarding claim 4, see rejection to claim 3 above which discloses a configuration to provide the illumination light as a laser beam with a speckle pattern.
Regarding claim 5:
Su in view of Rege discloses the invention substantially as claimed including all the limitations of claims 1 and 3 as outlined above including a plurality of axicons (i.e. a first and second axicon)
However, Su in view of Rege fails to disclose “a first axicon configured to transform the illumination light into an annular distribution of light” and “a second axicon configured to modify the annular distribution of light to yield the annular illumination” as recited by claim 5
It would have been obvious to one having ordinary skill in the art at the time invention was filed to modify Su in view of Rege to achieve said claimed limitations of a first axicon configured to transform the illumination light into an annular distribution of light” and “a second axicon configured to modify the annular distribution of light to yield the annular illumination” as recited by claim 5 because as explained previously Su in view of Rege a plurality (i.e. at least two) of axicons are known elements for delivering the illumination light in annular manner; therefore, absent unpredictable results, one of ordinary skill would expect to achieve the claimed combination through routine experimentation through the application of known factors to achieve a known result when optimizing imaging.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Su in view of Rege as applied to claims 1 and 3 above, and further in view of Roorda et al (WO 2007050743) hereafter known as Roorda.
Su in view of Rege discloses the invention substantially as claimed including all the limitations of claims 1 and 3 above. Also, Su in view of Rege discloses a need to address spherical aberrations in the design of the device [see para 18 of Su… “The optical system has two different entrance pupils, one located at the lens of the patient's eye for operation in retina mode and another near the front objective lens for operation in the cornea mode. The optical design corrects spherical and achromatic aberrations in both configurations.”]
However, Su in view of Rege fails to disclose “an axicon configured to transform the illumination light into an annular distribution of light; and” or “a spherical lens configured to modify the annular distribution of light to yield the annular illumination.” as recited by claim 6.
Roorda discloses in the analogous art of illuminating optical systems [see pg. 1 lines 5-15… “The present disclosure relates to microscopy, specifically to an illuminating optical system that illuminates a sample using total internal reflection.”] that axicons used with spherical lenses are known optical elements used when addressing design factors such as optical aberrations or color corrections [see pg. 16 lines 15-20…. “Positive lenses 2 and 4 could be replaced by a single lens. The stationary axicon 5 could be integrated into a surface of a positive spherical lens. The design limiting factors are optical aberrations, color correction and space considerations.”].
Since Su in view of Rege is directed to using apparatus designs that address spherical aberrations, and Roorda discloses a spherical lens with an axicon are known structures for correcting optical aberrations (i.e. includes spherical aberrations), it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Su in view of Rege by including the additional use of a spherical lens with the axicon because this is a known structure used to treat a known problem of spherical aberrations.
It would have been obvious to one having ordinary skill in the art at the time invention was filed to modify Su in view of Rege in view of Roorda to achieve said claimed limitations of “an axicon configured to transform the illumination light into an annular distribution of light and “a spherical lens configured to modify the annular distribution of light to yield the annular illumination.” as recited by claim 6 because as explained previously Su in view of Rege in view of Roorda discloses axicons and spherical lenses are known elements for delivering the illumination light and discloses a need to address spherical aberrations in the design of the device; therefore, absent unpredictable results, one of ordinary skill would expect to achieve the claimed combination through routine experimentation through the application of known factors to achieve a known result when optimizing imaging.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Su in view of Rege as applied to claims 1 and 3 above, and further in view of Razali et al (WO 2021006815) hereafter known as Razali.
Su in view of Rege discloses the invention substantially as claimed including all the limitations of claims 1 and 3 as outlined above. Also, Su in view of Rege discloses a need to address chromatic aberrations in the design of the device [see para 18 of Su… “The optical system has two different entrance pupils, one located at the lens of the patient's eye for operation in retina mode and another near the front objective lens for operation in the cornea mode. The optical design corrects spherical and achromatic aberrations in both configurations.”]
However, Su in view of Rege fails to disclose “an achromatic lens configured to focus the annular illumination” as recited by claim 7.
Razali discloses in the analogous art of ophthalmology [see abstract… “An automated slit lamp with computer program parts, comprising imaging optics, imaging optics control, microcontroller with microcomputer interface, first computer program module for automated movements and automatic image acquisition, lighting optics, lighting optics control, and second computer program module for eye screening”] that an achromatic lens is a known way to correct chromatic aberrations [see para 48… “The objective lens 302 may be achromatic in order to reduce chromatic aberrations as much as possible. The objective lens 302 may have a diameter ranging from 40 mm to 50 mm, and preferably the objective lens may have a diameter of 50 mm.”]
Since Su in view of Rege is directed to reducing chromatic aberrations and Razli discloses a chromatic lens is a known element to reduce chromatic aberrations, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Su in view of Rege to include the use of an achromatic lens similar to that disclosed by Razli to focus the annular illumination because this is a known structure that has a known effect in achieving Su in view of Rege’s desired reduction in chromatic aberrations.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable Su in view of Yates et al (US 20140232985) hereafter known as Yates.
Su discloses the invention substantially as claimed including all the limitations of claim 1 as outlined above.
However, Su fails to disclose the annular illuminator as comprising “an illumination ring, the illumination ring comprising a plurality of lights disposed about the illumination ring” as recited by claim 9.
Yates discloses in the analogous art of ophthalmology [see para 2… “The present invention is directed to an improved device for retinal examination and related methods”] an illumination ring comprising a ring of LEDs with different wavelengths (i.e. a plurality of lights) to allow for different imaging of retinal function [see Fig. 5 element 11 (i.e. illumination ring) and elements 10 (i.e. lights) and para 53… “Another embodiment of the present invention provides a handheld lens 11 utilizing a ring of light-emitting diodes (LEDs) to provide illumination to the retina 101 and is illustrated in FIG. 5. The illustrated embodiment provides ring illumination directly within handheld lens 11 using a ring of LEDs 10. LEDs 10 may be high intensity white, infrared, or colored. Utilizing different types of LEDs allows for imaging of either red free, infrared, or fluorescent dyes which are commonly used to evaluate retinal function.”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Su by including an illumination ring with LEDs with a different wavelength similarly to that disclosed by Yates (i.e. thereby reciting claim 9) for the purpose of allowing for different imaging of retinal function.
Claim(s) 8 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Su in view of Herekar et al (US 20080015660) hereafter known as Herekar.
Regarding claim 8:
Su discloses the invention substantially as claimed including all the limitations of claim 1 as outlined above. Additionally, Su discloses the annular illuminator as comprising “a laser source configured to provide an illumination light” [see Fig. 2 element 43A and paras 40 and 44… “Laser 43A is guided to port 43 by an optical fiber 43B and passes through one of the pinholes on the pinhole array 44 that has pinholes of various sizes.”].
However, Su fails to disclose the annular illuminator as comprising “a spatial light modulator configured to modify the illumination light to yield the annular illumination.” As recited by claim 8.
Herekar discloses in the analogous art of ophthalmic phototherapy [see abstract… “Method and apparatus for performing oculoplasty including applying a photosensitizer solution to a human eye surface includes defining a treatment region within the human eye surface. The treatment region is associated with a predetermined spatial pattern. The method further includes irradiating the treatment region with controlled photoactivating radiation.” And para 27… “Embodiments of the present invention provide methods and techniques that include oculoplasty and keratoplasty, which is a subset of oculoplasty, and non-thermal non-invasive (no-cut) molecular resizing/collagen shrinkage, refractive index and biomechanical modulation via crosslinking of ocular tissues (such as cornea, sclera, ciliary body, lens, TM, and the like) by photochemically affecting the underlying collagen. Novel lithographic exposure techniques for precise ocular patterning, controlled depth of effect, and online metered photosensitizer spraying are included according to some embodiments.”] an ocular treatment system that includes a pixel based spatial light modulator configured to generate different patterns (i.e. “a spatial light modulator configured to modify the illumination light to yield the annular illumination;”) on the eye for the purpose of irradiating the eye with a predetermined spatial pattern of light [see Fig. 1A and see paras 22-23… “The ocular treatment system 100 also includes an ultraviolet/blue source 120, a collimating lens 122, a pixel-based spatial light modulator 124, a projection lens 126, and a turning mirror 128. Depending on the particular embodiment, either pulsed light, CW light, or a combination thereof is utilized during treatment. Radiation from the ultraviolet/blue source is focused by collimating lens 124 to illuminate pixel-based spatial light modulator 124. Additional details of the pixel-based spatial light modulator 124 are provided throughout the present specification and more particularly below. Utilizing the ocular treatment system 100, the human eye 110 is treated with photosensitizer from storage tank 130 utilizing orifice 134 and then irradiated with a predetermined spatial pattern through control of the pixel-based spatial light modulator 124 through the use of control electronics (not shown).”].
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Su’s device by including a spatial light modulator with individually addressable pixels that apply light onto the eye similarly to that disclosed by Herekar (i.e. thereby fully reciting the annular illuminator as claimed) as this will allow for use to apply different spatial patterns of light on the eye.
Independent claim:
Regarding claim 22:
Su discloses:
An ophthalmic system for visualizing an interior of an eye [see Fig. 1 and abstract… “A digital camera that combines the functions of the retinal camera and corneal camera into one, single small, easy to use instrument. The single camera can acquire digital images of a retinal region (9) of an eye, and digital images of a corneal region of the eye. The camera includes a first combination of optical elements for making the corneal digital images.”], comprising:
an illumination system configured to illuminate the interior of the eye [see Fig. 3 element 42 and para 40…. “a light emitting diode (LED) module 42 consists of multiple white color LEDs could be used to provide light for the source 28”], the illumination system comprising an annular illuminator [see Fig. 2 element 28 and para 38… “Source 28 provides illumination for retinal imaging and can be pulsed or continues. The source 28 is shaped as a ring of light”] configured to direct annular illumination towards the interior of the eye [see para 32-33…. “The rear objective lens 13 when combined with the front objective lens 12 comprises the objective lens set for retinal imaging.”], the annular illumination having an illumination axis [A directed annular illumination implicitly has an axis of some type];
a visualization system configured to provide an image of the interior of the eye, the visualization system [see Fig. 1-2 elements 3, 7, 12-13 and para 31… “Oculars 7 are provided for achieving all of the typical visual functions associated with the slit-lamp biomicroscope. Lens 12 is the front objective lens and seals the optical system.” And para 33… “The objective lens is comprised of lens ele-ments 12 and 13.” and para 29… “The slit lamp 3 provides illumination for examination of the cornea and is adjustable in brightness, color, and width of slit.”] comprising a slit lamp microscope [see Fig. 1-2 element 3 and para 29…“The slit lamp 3 provides illumination for examination of the cornea and is adjustable in brightness, color, and width of slit.”], the slit lamp microscope comprising a plurality of visualization optical elements [see Fig. 1-2 elements 7, 12-13 and para 31… “Oculars 7 are provided for achieving all of the typical visual functions associated with the slit-lamp biomicroscope. Lens 12 is the front objective lens and seals the optical system.” And para 33… “The objective lens is comprised of lens ele-ments 12 and 13.”], the plurality of visualization optical elements comprising:
an objective lens configured to receive light reflected from the interior of the eye [see Fig. 1-2 elements 12-13 and para 33]; and
oculars configured to transmit the reflected light to yield an image of the interior of the eye, the oculars having an ocular axis [see Fig. 1-2 element 7 and para 40]; and
a laser device configured to direct a treatment laser beam towards the interior of the eye [see Fig. 2 element 43A and paras 40 and 44… “Laser 43A is guided to port 43 by an optical fiber 43B and passes through one of the pinholes on the pinhole array 44 that has pinholes of various sizes.”],
the annular illuminator comprising:
a laser source configured to provide an illumination light [see Fig. 2 element 43A and paras 40 and 44… “Laser 43A is guided to port 43 by an optical fiber 43B and passes through one of the pinholes on the pinhole array 44 that has pinholes of various sizes.”]
However, Su fails to disclose a spatial light modulator as claimed. Therefore, Su fails to fully disclose: “the annular illuminator comprising:
a laser source configured to provide illumination light with a speckle pattern and a plurality of annular optical elements configured to modify the illumination light to yield the annular illumination, the optical elements comprising: a first axicon configured to transform the illumination light into an annular distribution of light, a second axicon or a spherical lens configured to modify the annular distribution of light to yield the annular illumination, and an achromatic lens configured to focus the annular illumination; or
a laser source configured to provide an illumination light and a spatial light modulator configured to modify the illumination light to yield the annular illumination; or
an illumination ring comprising a plurality of lights disposed about the illumination
ring.” as recited by claim 22.
Herekar discloses in the analogous art of ophthalmic phototherapy [see abstract… “Method and apparatus for performing oculoplasty including applying a photosensitizer solution to a human eye surface includes defining a treatment region within the human eye surface. The treatment region is associated with a predetermined spatial pattern. The method further includes irradiating the treatment region with controlled photoactivating radiation.” And para 27… “Embodiments of the present invention provide methods and techniques that include oculoplasty and keratoplasty, which is a subset of oculoplasty, and non-thermal non-invasive (no-cut) molecular resizing/collagen shrinkage, refractive index and biomechanical modulation via crosslinking of ocular tissues (such as cornea, sclera, ciliary body, lens, TM, and the like) by photochemically affecting the underlying collagen. Novel lithographic exposure techniques for precise ocular patterning, controlled depth of effect, and online metered photosensitizer spraying are included according to some embodiments.”] an ocular treatment system that includes a pixel based spatial light modulator configured to generate different patterns (i.e. “a spatial light modulator configured to modify the illumination light to yield the annular illumination;”) on the eye for the purpose of irradiating the eye with a predetermined spatial pattern of light [see Fig. 1A and see paras 22-23… “The ocular treatment system 100 also includes an ultraviolet/blue source 120, a collimating lens 122, a pixel-based spatial light modulator 124, a projection lens 126, and a turning mirror 128. Depending on the particular embodiment, either pulsed light, CW light, or a combination thereof is utilized during treatment. Radiation from the ultraviolet/blue source is focused by collimating lens 124 to illuminate pixel-based spatial light modulator 124. Additional details of the pixel-based spatial light modulator 124 are provided throughout the present specification and more particularly below. Utilizing the ocular treatment system 100, the human eye 110 is treated with photosensitizer from storage tank 130 utilizing orifice 134 and then irradiated with a predetermined spatial pattern through control of the pixel-based spatial light modulator 124 through the use of control electronics (not shown).”].
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Su’s device by including a spatial light modulator with individually addressable pixels that apply light onto the eye similarly to that disclosed by Herekar (i.e. thereby fully reciting the annular illuminator as claimed) as this will allow for use to apply different spatial patterns of light on the eye.
Conclusion
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SEBASTIAN X LUKJAN
/SXL/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792