Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are:
“a reflection beam reflected from the eyeball and refracted through the reflection unit” as recited in claim 1
The closest support seems to be Fig. 1 element 120 and para 49 of applicant’s specification received on 12/22/2022 (hereafter referred to as applicant’s specification in this office action) which states the following:
“The reflection unit 120 is positioned adjacent to the guide beam irradiation unit. Specifically, the reflection unit 120 is positioned on the same straight line as the guide beam irradiation member 111. In addition, a reflective mirror is formed inside the reflection unit 120 to refract the reflection beam reflected from the eyeball IO and transmit the reflection beam to the image acquisition unit 140.”
Based on these section(s) a reflection unit is understood to be a mirror.
“an image acquisition unit configured to acquire at least one retinal image of a retina of the eyeball” in claim 1
The closest support seems to be Fig. 1 element 140 and para 66 of applicant’s specification which states:
“The image acquisition unit 140 includes a convex lens 141, a filter member 142, a concave lens 143, and an image processing member 144.”
Based on these section(s) an image acquisition unit is understood to be a convex lens, filter, concave lens and image processing member.
“an image mapping unit configured to map the at least one retinal image to construct a macular image which is a full image of a macula of the eyeball” in claim 1
This limitation raises a 112 rejection(s) as outlined below. Please see 112 rejection section below for how this limitation was interpreted.
“an image processing member that is positioned under the concave lens to acquire the at least one retinal image based on the reflection beam dispersed from the concave lens” in claim 9
Closest support appears to be Fig. 1 element 144 and para 70 of applicant’s specification which states the following:
“The image processing member 144 is positioned under the concave lens 143 and acquires at least one retinal image based on the reflection beam dispersed from the concave lens 143. As an example, the image processing member 144 may be CMOS, but is not limited thereto, and any image processing member may be used.”
A CMOS (or complementary Metal-Oxide semiconductor) is understood to be an image sensor. Therefore, a processing member is understood to be any CMOS or any functionally equivalent image sensor.
“refracting a reflection beam reflected from the eyeball and reflecting the reflection beam to an image acquisition unit by a reflection unit” in claim 10
The closest support seems to be Fig. 1 element 120 and para 49 of applicant’s specification received on 12/22/2022 (also referred to as applicant’s specification in this rejection) which states the following:
“The reflection unit 120 is positioned adjacent to the guide beam irradiation unit. Specifically, the reflection unit 120 is positioned on the same straight line as the guide beam irradiation member 111. In addition, a reflective mirror is formed inside the reflection unit 120 to refract the reflection beam reflected from the eyeball IO and transmit the reflection beam to the image acquisition unit 140.”
Based on these section(s) a reflection unit is under stood to be a mirror.
“receiving the reflection beam reflected from the eyeball and refracted through the reflection unit and acquiring at least one retinal image for a retina of the eyeball by an image acquisition unit” in claim 10
The closest support seems to be Fig. 1 element 140 and para 66 of applicant’s specification which states:
“The image acquisition unit 140 includes a convex lens 141, a filter member 142, a concave lens 143, and an image processing member 144.”
Based on these section(s) an image acquisition unit is understood to be a convex lens, filter, concave lens and image processing member.
“mapping the at least one retinal image to construct a macula image, which is an entire image of a macula of the eyeball by an image mapping unit” in claim 10
This limitation raises a 112 rejection(s) as outlined below. Please see 112 rejection section below for how this limitation was interpreted.
“acquiring the at least one retinal image for the retina of the eyeball based on the reflection beam dispersed by an image processing member of the image acquisition unit” in claim 11
Closest support appears to be Fig. 1 element 144 and para 70 of applicant’s specification which states the following:
“The image processing member 144 is positioned under the concave lens 143 and acquires at least one retinal image based on the reflection beam dispersed from the concave lens 143. As an example, the image processing member 144 may be CMOS, but is not limited thereto, and any image processing member may be used.”
A CMOS (or complementary Metal-Oxide semiconductor) is understood to be an image sensor. Therefore, a processing member is understood to be any CMOS or any functionally equivalent image sensor.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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 1-13 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.
Claim 1’s limitation “an image mapping unit configured to map the at least one retinal image to construct a macular image which is a full image of a macula of the eyeball” and claim 10’s limitation “mapping the at least one retinal image to construct a macula image, which is an entire image of a macula of the eyeball by an image mapping unit”
invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The closest support seems to be Fig. 1 element 150 and paras 72-74 of applicant’s specification. But this support just seems to describe what the image mapping unit does rather than any specific structure or class of structures. Thus, the specification is devoid of adequate structure to perform the claimed function. In particular, the specification merely repeats the placeholder and states the claimed function. Therefore, the claims are indefinite and are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For this examination any type of hardware, software or combination of hardware and software that can perform the function of mapping at least one retinal image to construct a macular image which is a full image of a macula of the eyeball. Claims 2-9 and 11-13 are rejected under 35 USC 112(b) as well based on dependency to claims 1 and 10.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 1-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. As outlined above, the disclosure is devoid of structure and does not provide adequate structure to perform the claimed functions for the following means plus function limitations:
“an image mapping unit configured to map the at least one retinal image to construct a macular image which is a full image of a macula of the eyeball” in claim 1
“mapping the at least one retinal image to construct a macula image, which is an entire image of a macula of the eyeball by an image mapping unit” in claim 10
Thus, the specification does not demonstrate that applicant has made an invention that achieves the claimed function because the invention is not described with sufficient detail that one of ordinary skill in the art can reasonably conclude that the inventor had possession of the claimed invention. Claims 2-9 and 11-13 are rejected under 35 USC 112(a) as well based on dependency to claims 1 and 10.
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.
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) 1-4, 6, and 9-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Artsyukhovich et al (US 20130116670) hereafter known as Artsyukhovich in view Sharma et al (US 10452138) hereafter known as Sharma in view of Zacharias et al (US 20080015553) hereafter known as Zacharias.
Independent claim:
Regarding claim 1:
Artsyukhovich discloses
A laser feedback device for irradiating an eyeball [see Fig. 1 element 100 and para 19… “FIG. 1 illustrates an example system 100 for retinal laser surgery. System 100 includes a fundus camera 110, a real-time fundus camera 120, a retinal laser 130, and a beam guidance system 140.”], comprising:
a guide beam irradiation unit that configured to irradiate a guide beam toward an eyeball of a patient [see Fig. 1 element 140 and para 19… “a beam guidance system 140”];
a laser irradiation unit configured to irradiate a laser toward the eyeball [see Fig. 1 element 130 and para 19…“a retinal laser 130”];
a CMOS image sensor [see Fig. 1 element 122 and para 38…. “The real-time fundus camera may then make adjustments to its targeting of retinal laser 130 if the eye has moved. In some instances, approximately 5 ms may elapse between eye movements due to saccadic movement. The periodic images may be taken at one or more times between eye movements to accurately target the retinal laser 130. A windowing CMOS camera having a high partial frame rate, for example, may be used to provide the rapid (i.e., high frame rate) image capture.”]; and
an image mapping unit configured to map the at least one retinal image to
construct a macular image is a full image of a macula of the eyeball [see Fig. 1 element 124 and para 22-23… “Image processor 124 is adapted to determine a blood vessel pattern based on the retina image from fundus camera 110 and associate the blood vessel pattern with the real-time image.”]
However, Artsyukhovich fails to disclose “a reflection unit positioned adjacent to the guide beam irradiation unit” and Artsyukhovich only discloses a CMOS image sensor; thus, Artsyukhovich fails to fully disclose “an image acquisition unit configured to receive a reflection beam reflected from the eyeball and refracted through the reflection unit and acquire at least one retinal image of a retina of the eyeball”.
Sharma discloses in the analogous art of retinal imaging [see abstract… “An eye tracker characterization system comprising a scanning retinal imaging unit and a controller.”] that a combination of a convex lens, a concave lens and a filter are known elements to optically connect the retina to light and/or imaging devices [see Col. 7 lines 30-45… “In one embodiment, the display unit 205 generates content by modulating amplitudes of light emitted from the light source. For example, the display unit 205 generates content in a negative contrast (e.g., the light source is switched off to write the content onto the retinal region 240) within dim field created by the light source. The optics assembly may include a plurality of optical elements to deliver the content to the retinal region 240. Examples of optical elements may include an aperture, a spherical mirror, a Fresnel lens, a convex lens, a concave lens, a filter, adaptive optics (e.g., a wavefront sensor, deformable mirror), or any other suitable optical element that delivers content to the retinal region 240.”]
Zacharias discloses in the analogous art of ophthalmic laser surgery [see abstract…. “A system and method for delivering therapeutic laser energy onto selected treatment locations of the retina following a predetermined spatial distribution pattern using one single laser beam.”] that a beam-splitter (i.e. a specialized type of mirror which recites a reflection unit) is a known way to optically connect aiming light (i.e. guide beam), laser output (i.e. laser irradiation) and a light sensor (i.e. part of image acquisition unit) together [see para 83… “Laser compartment 104 can enclose an optional aiming light source 106 and a light sensor 108. A beam-splitter/reflector element 110 suitably disposed in the light path optically connects laser output 103, aiming light source 106, light sensor 108 and coupling optics 112.”]
It would have been obvious to one of ordinary skill at the time the invention was filed to include a convex lens, a concave lens and a filter to optically connect the CMOS camera to the retina by including and using a convex lens, concave lens and filter similarly to that disclosed by Sharma (i.e. thereby fully reciting an image acquisition unit as claimed) because this is a known way to optically connect the retina to other elements of a light and/or imaging device in the field of retinal imaging.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Artsyukhovich in view of Sharma by including a beam splitter to optically connect the guide beam irradiation unit and the image acquisition units similarly to that disclosed by Zacharias (i.e. thereby reciting a reflection unit as claimed) because this is a known way to connect these elements in the field of ophthalmic laser surgery.
Independent claim:
Regarding claim 10:
Artsyukhovich discloses:
A laser feedback method using a laser feedback device for irradiating an eyeball [see abstract… “Various systems, processes, and computer program products may be used to perform retinal laser surgery. In particular implementations, systems, processes, and computer program products may include the ability to identify retina blood vessels from a retina image and determine a retina location needing therapy and not substantially intersecting a retina blood vessel.” And Fig. 1 and para 19… “FIG. 1 illustrates an example system 100 for retinal laser surgery. System 100 includes a fundus camera 110, a real-time fundus camera 120, a retinal laser 130, and a beam guidance system 140.”], the laser feedback method comprising:
(a) positioning an eyeball of a patient so that the eyeball is positioned on a same straight line as a guide beam irradiation unit [see Fig. 1 and para 26… “Beam guidance system 140 is adapted to guide light (visible or non-visible) from real-time fundus camera 120 and retinal laser 130 through cornea 152 and lens 154 to specific locations on retina 156 as a beam 142.”];
(b) irradiating a guide beam toward the eyeball by the guide beam irradiation unit [see Fig. 1 element 140 and para 26… “Beam guidance system 140 is adapted to guide light (visible or non-visible) from real-time fundus camera 120 and retinal laser 130 through cornea 152 and lens 154 to specific locations on retina 156 as a beam 142.”];
(c) irradiating a laser toward the eyeball by a laser beam irradiation unit [see Fig. 1 element 130 and para 19…“a retinal laser 130” and para 36… “Laser controller 126 may also instruct retinal laser 130 to fire when the beam guidance system has aligned a beam 132 with the therapeutic location. The instructions may be sent, for example, across a data link 134 (e.g., a bus or local area network). After retinal laser 130 has fired, laser controller 126 may determine another appropriate therapeutic location.”];
(e) acquiring at least one retinal image for a retina of the eyeball by a CMOS camera (i.e. CMOS imaging sensor) [see Fig. 1 element 122 and para 38…. “The real-time fundus camera may then make adjustments to its targeting of retinal laser 130 if the eye has moved. In some instances, approximately 5 ms may elapse between eye movements due to saccadic movement. The periodic images may be taken at one or more times between eye movements to accurately target the retinal laser 130. A windowing CMOS camera having a high partial frame rate, for example, may be used to provide the rapid (i.e., high frame rate) image capture.”]
(f) mapping the at least one retinal image to construct a macula image, which is an entire image of a macula of the eyeball by an image mapping unit [see Fig. 1 element 124 and para 22-23… “Image processor 124 is adapted to determine a blood vessel pattern based on the retina image from fundus camera 110 and associate the blood vessel pattern with the real-time image.”]
However, Artsyukhovich fails to disclose “(d) refracting a reflection beam reflected from the eyeball and reflecting the reflection beam to an image acquisition unit by a reflection unit” and Artsyukhovich only discloses a CMOS image sensor; thus, Artsyukhovich fails to fully disclose the step of “(e) receiving the reflection beam reflected from the eyeball and refracted through the reflection unit and acquiring at least one retinal image for a retina of the eyeball by an image acquisition unit”
Sharma discloses in the analogous art of retinal imaging [see abstract… “An eye tracker characterization system comprising a scanning retinal imaging unit and a controller.”] that a combination of a convex lens, a concave lens and a filter are known elements to optically connect the retina to light and/or imaging devices [see Col. 7 lines 30-45… “In one embodiment, the display unit 205 generates content by modulating amplitudes of light emitted from the light source. For example, the display unit 205 generates content in a negative contrast (e.g., the light source is switched off to write the content onto the retinal region 240) within dim field created by the light source. The optics assembly may include a plurality of optical elements to deliver the content to the retinal region 240. Examples of optical elements may include an aperture, a spherical mirror, a Fresnel lens, a convex lens, a concave lens, a filter, adaptive optics (e.g., a wavefront sensor, deformable mirror), or any other suitable optical element that delivers content to the retinal region 240.”]
Zacharias discloses in the analogous art of ophthalmic laser surgery [see abstract…. “A system and method for delivering therapeutic laser energy onto selected treatment locations of the retina following a predetermined spatial distribution pattern using one single laser beam.”] that a beam-splitter (i.e. a specialized type of mirror which recites a reflection unit) is a known way to optically connect aiming light (i.e. guide beam), laser output (i.e. laser irradiation) and a light sensor (i.e. part of image acquisition unit) together [see para 83… “Laser compartment 104 can enclose an optional aiming light source 106 and a light sensor 108. A beam-splitter/reflector element 110 suitably disposed in the light path optically connects laser output 103, aiming light source 106, light sensor 108 and coupling optics 112.”]
It would have been obvious to one of ordinary skill at the time the invention was filed to include a convex lens, a concave lens and a filter to optically connect the CMOS camera to the retina similarly to that disclosed by Sharma (i.e. thereby fully reciting an image acquisition unit as claimed) because this is a known way to optically connect the retina to elements of a light and/or imaging device in the field of retinal imaging.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Artsyukhovich in view of Sharma by including a beam splitter to optically connect the guide beam irradiation unit and the image acquisition units similarly to that disclosed by Zacharias (i.e. thereby reciting a reflection unit as claimed and fully disclose steps (d) and (e)) because this is a known way to connect these elements in the field of ophthalmic laser surgery.
Dependent claims:
Regarding claim 2, see paras 31 and 39-42 of Artsyukhovich [see in particular… “image processor 124 may determine the reflectivity of a therapeutic location on a retina before retinal laser 130 is activated and adjust the laser shot based on this determination” and “The therapeutic effect provided to a retina location may be determined by the degree of whitening that occurs due to a laser shot, and whitening can be correlated with reflectivity.”] which disclose adjusting the laser shot (i.e. changing irradiation angle and irradiation position) and the retinal image (i.e. retinal image at a different angle and position) based on the reflectivity and/or whitening of the retina. Thereby, Artsyukhovich in view of Sharma in view of Zacharias recites claim 2 as claimed.
Regarding claims 3-4 and 12
Artsyukhovich in view of Sharma in view of Zacharias discloses the invention substantially as claimed including all the limitations of claims 1-2 and 10 as outlined above and retina imaging and retinal mapping of blood vessels and “(f1) receiving the at least one retinal image by the image mapping unit” of claim 12 [para 31… “In FIG. 2A, the real-time fundus camera has processed image data from fundus camera 110 to determine a retina blood vessel pattern 210. In FIG. 2B, real-time fundus camera 120 has registered blood vessel pattern 210 with a real-time image of eye 150.” And abstract… “computer program products may include the ability to identify retina blood vessels from a retina image and determine a retina location needing therapy and not substantially intersecting a retina blood vessel.” Element 124 (i.e. image processor of element 120) is the image mapping unit.]
However, Artsyukhovich in view of Sharma in view of Zacharias fails to disclose constructing a macular image and therefore fails to fully disclose “wherein the
image mapping unit constructs the macula image by mapping the at least one retinal image based on at least one of an optic nerve, a blood vessel, and a discolored region of the eyeball captured as the at least one retinal image.” as recited by claim 3, “wherein the at least one retinal image and the macula image includes include the irradiation position of the laser, and the image mapping unit records the irradiation position of the laser” as recited by claim 4 or “(f2) mapping the at least one retinal image based on at least one of an optic nerve, a blood vessel, and a discolored region of the eyeball captured as the at least one retinal image by the image mapping unit; and constructing the macula image based on the at least one retinal image mapped by the image mapping unit” as recited by claim 12.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Artsyukhovich in view of Sharma in view of Zacharias to have the image mapping unit construct and map an image of blood vessels of the macula including the irradiation position of the laser because the macula is a part of the retina; therefore a macula map is a subset a retina map which as outlined above is disclosed by Artsyukhovich in view of Sharma in view of Zacharias; therefore a macula map is a subcombination of combinations disclosed by Artsyukhovich in view of Sharma in view of Zacharias.
Regarding claim 6:
Artsyukhovich in view of Sharma in view of Zacharias discloses the invention substantially as claimed including all the limitations of claim 1 as outlined above.
However, Artsyukhovich in view of Sharma in view of Zacharias fails to disclose “wherein when the laser is irradiated while the guide beam is irradiated to the eyeball, the image acquisition unit acquires the at least one retinal image” as recited by claim 6.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Artsyukhovich in view of Sharma in view of Zacharias to acquire the retinal image while the laser irradiates the eyeball and the guide beam irradiates the eyeball (i.e. the missing limitation) because there are only a limited number of possible times to acquire the retinal image relative these steps (i.e. acquire an image before irradiating the eyeball with the laser and guide beam, acquire an image after irradiating the eyeball with the laser and guide beam or acquire an image while irradiating the eyeball with the laser and guide beam) and acquiring an image while irradiating the eyeball with the laser and guide beam is one of those limited number of possible choices.
Regarding claim 9 and 11
Artsyukhovich in view of Sharma in view of Zacharias discloses the invention substantially as claimed including all the limitations of claims 1 and 10 as outlined above. Also, Artsyukhovich in view of Sharma in view of Zachariasa discloses an image acquisition unit includes and/or uses a convex lens, concave lens, filter and image processing member (i.e. an image sensor) as outlined these claims above.
However, Artsyukhovich in view of Sharma in view of Zacharias fails to disclose the exact order these elements are configured /used relative to each other and the other elements. Therefore, Artsyukhovich in view of Sharma in view of Zacharias fails to fully disclose “a convex lens that is positioned under the reflection unit to receive and focus the reflection beam refracted by the reflection unit”, “a filter member that is positioned under the convex lens to filter the reflection beam focused by the convex lens”, “a concave lens that is positioned under the filter member to disperse the reflection beam filtered by the filter member”, “an image processing member that is positioned under the concave lens to acquire the at least one retinal image based on the reflection beam dispersed from the concave lens” or “wherein the convex lens, the filter member, the concave lens, and the image processing member are disposed to be perpendicular to the guide beam irradiation unit, the reflection unit, and the laser irradiation unit.” as recited by claim 9. Also, Artsyukhovich in view of Sharma in view of Zacharias fails to fully disclose the steps of “(e1) focusing the reflection beam by a convex lens of the image acquisition unit”, “(e2) filtering the reflection beam focused by a filter member of the image acquisition unit, “(e3) dispersing the reflection beam filtered by a concave lens of the image acquisition unit”, “(e4) acquiring the at least one retinal image for the retina of the eyeball based on the reflection beam dispersed by an image processing member of the image acquisition unit” or “wherein the at least one retinal image includes an irradiation position of the laser.” as disclosed by claim 11.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Artsyukhovich in view of Sharma in view of Zacharias to achieve the recited combination of limitations/steps recited in claims 9 and 11 because as explained above Artsyukhovich in view of Sharma in view of Zacharias discloses all the structures for the combination of limitations/steps, therefore absent
unpredictable results one of ordinary skill would expect to achieve the claimed feature
through routine experimentation through the application of known factors to achieve a
known result.
Regarding 13:
Artsyukhovich in view of Sharma in view of Zacharias discloses the invention substantially as claimed including all the limitations of claim 10 as outlined above.
However, Artsyukhovich in view of Sharma in view of Zacharias fails to disclose “acquiring, by the image acquisition unit, an image obtained by capturing a position of the guide beam before the step (c).” as recited by claim 13.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Artsyukhovich in view of Sharma in view of Zacharias to
acquire, by the image acquisition unit, an image obtained by capturing a position of the guide beam before irradiating a laser toward the eyeball (i.e. step (c)) (i.e. the missing limitation) because there are only a limited number of possible times to acquire an image relative to when the eyeball is irradiated with the laser (i.e. irradiate with the laser before the imaging, irradiate with the laser after the imaging or irradiate with the laser while imaging) and acquiring an image before irradiating the eyeball with the laser (i.e. step c) is one of those limited number of possible choices.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Artsyukhovich in view of Sharma in view of Zacharias as applied to claim 1 above, and further in view of Shacham et al (US 20180369020) hereafter known as Shacham.
Artsyukhovich in view of Sharma in view of Zacharias discloses the invention substantially as claimed including all the limitations of claim 1 as outlined above.
However, Artsyukhovich in view of Sharma in view of Zacharias fails to disclose “wherein the laser irradiates only a pigment epithelium including a pigment cell and a choroid of the retina” as recited by claim 5.
Shacham discloses in the analogous art of ophthalmic laser surgery [see abstract… “A method of treating ophthalmic tissues of the body by the application of multiple laser pulses”] specifically targeting only retinal pigment cells and choroid (i.e. understood to include pigment cells and choroid of the retina) using a laser based on the melanin contain of the pigment cells and choroid because this helps provide a therapeutic benefit that helps minimize damage while treating the eye with a laser [see para 23-24… “In order to avoid complications associated with the destructiveness characteristic of a conventional millisecond continuous wave laser photocoagulation, which causes significant collateral thermal damage, complications such as scotomas, lesion enlargement, subretinal or chorodial neovascularization, fibrosis or progressive visual field loss, it is one aspect of the present invention to provide a subthreshold laser therapy to provide a similar therapeutic effect of lasers while minimizing the damaging effects of lasers. Subthreshold refers to photocoagulation or photodamage that is insufficient to produce evidence of retinal damage in standard exam such as for example visual examination. It is believed that the therapeutic benefit of subthreshold laser therapy is driven by inducing thermal stress on the Retinal Pigment Epithelium (RPE) cells which are one of the potential absorbers of the laser energy mainly due to their melanin content (other laser energy absorbers may be the choroid as well as the hemoglobin in blood). This thermal stress of the RPE, it is believed, activates the therapeutic cellular cascade.”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Artsyukhovich in view of Sharma in view of Zacharias to only target the pigment epithelium including a pigment cell and a choroid of the retina when treating the eye with a laser similarly to that disclosed by Shacham for the purpose of triggering a therapeutic effect to thereby minimizing damage to the retina during laser treatment.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Artsyukhovich in view of Sharma in view of Zacharias as applied to claims 1 above, and further in view of Schuele et al (WO 2015147925) hereafter known as Schuele.
Regarding claim 7:
Artsyukhovich in view of Sharma in view of Zacharias discloses the invention substantially as claimed including all the limitations of claim 1 as outlined above.
However, Artsyukhovich in view of Sharma in view of Zacharias is silent as to all the details of the laser irradiation unit and therefore fails to fully disclose “a laser irradiation member that is positioned parallel to the reflection unit and irradiates the laser toward the eyeball”, “a laser control member that controls an operation of the laser”, “a connection member that electrically connects the laser irradiation member and the laser control member” or “wherein the laser control member controls the operation of the laser irradiated from the laser irradiation member as an operation signal is transmitted to the laser irradiation member through the connection member” as recited by claim 7.
Schuele discloses in the analogous art of ophthalmic laser surgery [see para 2… “The field of the present invention generally relates to laser surgery systems, and more particularly, to systems and methods for imaging and treating the eye.”] that a known configuration for a laser irradiation unit [see Fig. 2 element 12 and para 163… “laser assembly 12”] includes a laser irradiation member that irradiates the laser toward the eyeball [see Fig. 12 element 32 and para 97... “laser 32”], a laser control member that controls an operation of the laser [see para 86… “The laser assembly 12 may include control and conditioning components.”] and a connection member that electrically connects the laser irradiation member and the laser control member, wherein the laser control member controls the operation of the laser irradiated from the laser irradiation member as an operation signal is transmitted to the laser irradiation member through the connection member [inherently for the control to operate a laser there needs to be some type of electrical connection that provides a signal between the two].
Since Artsyukhovich in view of Sharma in view of Zacharias is silent as to all the details of laser irradiation unit, and Schuele discloses a known laser irradiation unit configuration it would have been obvious to one having ordinary skill at the time the invention was filed to modify Artsyukhovich in view of Sharma in view of Zacharias to include a laser irradiation member, a laser control member and a connection member similarly to that of Schuele as this is a known configuration in the field of ophthalmic laser surgery.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Artsyukhovich in view of Sharma in view of Zacharias in view of Schuele to place the laser irradiation member parallel to the reflection unit (i.e. thereby fully reciting claim 7) because Artsyukhovich in view of Sharma in view of Zacharias discloses all the structures for the combination, therefore absent unpredictable results one of ordinary skill would expect to achieve the claimed feature through routine experimentation through the application of known factors to achieve a known result.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Artsyukhovich in view of Sharma in view of Zacharias in view of Schuele as applied to claims 1 and 7 above, and further in view of Charles et al (US 20090093798) hereafter known as Charles
Artsyukhovich in view of Sharma in view of Zacharias in view of Schuele discloses the invention substantially as claimed including all the limitations of claims 1 and 7 as outlined above.
However, Artsyukhovich in view of Sharma in view of Zacharias in view of Schuele is silent as to all the details of the guide beam irradiation unit and thus fails to disclose a “a guide beam irradiation member that irradiates the guide beam toward the eyeball”, “a guide beam body that is coupled to the guide beam irradiation member, generates the guide beam and delivers the guide beam to the guide beam irradiation member “ or “wherein the guide beam irradiation member, the reflection unit, and the laser beam irradiation member are positioned to be parallel to each other” as recited by claim 8.
Charles discloses in the analogous art of ophthalmic laser surgery [see abstract…“An ophthalmic treatment system and method for performing therapy on target tissue in a patient's eye. A delivery system delivers treatment light to the patient's eye and a camera captures a live image of the patient's eye.”] that a known configuration for a guide beam irradiation unit [see Fig. 1 elements 20 and 68] includes an alignment light source (i.e. “a guide beam irradiation member that irradiates the guide beam toward the eyeball”) [see Fig. 1 element 20 and para 16… “Alignment light (for an aiming beam or alignment pattern) is created using an alignment light source 20, which may be controlled by control electronics 22 via an input/output device 24.”] and a delivery system (i.e. a “a guide beam body that is coupled to the guide beam irradiation member, generates the guide beam and delivers the guide beam to the guide beam irradiation member “) [see Fig. 1 element 68 and para 22… “a delivery system 68 that can be controlled to deliver the alignment/treatment patterns to the intended target tissue.”].
Since Artsyukhovich in view of Sharma in view of Zacharias in view of Schuele is silent as to all the details of its guide beam irradiation unit, and Charles discloses a known guide beam irradiation unit configuration, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Artsyukhovich in view of Sharma in view of Zacharias in view of Schuele’s guide beam irradiation unit to include a guide beam irradiation member and guide beam body similar to that of Charles as this is a known configuration in the field of ophthalmic laser surgery.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Artsyukhovich in view of Sharma in view of Zacharias in view of Schuele in view of Charles to place the guide beam irradiation member, the reflection unit, and the laser beam irradiation member parallel to each other (i.e. thereby fully reciting claim 8), because Artsyukhovich in view of Sharma in view of Zacharias in view of Schuele in view of Charles discloses all the structures for the combination, therefore absent unpredictable results one of ordinary skill would expect to achieve the claimed feature through routine experimentation through the application of known factors to achieve a known result.
Conclusion
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SEBASTIAN X LUKJAN
/SXL/Examiner, Art Unit 3792
/William J Levicky/Primary Examiner, Art Unit 3796