DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Subgroup IIB, claims 1-9, 12-22 and 24, and withdrawn claims 10-11, 23 and 25-27 in the reply filed on April 2, 2026 is acknowledged.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 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) 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):
(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). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) 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). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) 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) 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) 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) because the claim limitations 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 limitations are:
“at least one optical element configured to direct the scanning beam: in claim 1;
‘a first scanning element configured to direct the scanning beam” in claim 1;
‘a second scanning element configured to direct the scanning beam” in claim 1;
“the detector is configured to generate scan data of the retina of the eye comprising a plurality of line scans using the at least one optical element, and a portion of the at least one optical marker is included in each line scan of the plurality of line scans to indicate an alignment of the line scan relative to another line scan of the plurality of line scans” in claim 1;
“a line start sensor disposed in an optical path of the scanning beam and configured to output a signal to the detector to record a new line scan each time the scanning beam is directed to the line start sensor by the first scanning element” in claim 2;
“the plurality of line scans is generated by scanning the retina along a first direction using the first scanning element and positions of the plurality of line scans are varied along a second direction orthogonal to the first direction using the second scanning element” in claim 4;
“one or more processing units and one or more memory units storing thereon instructions that, when executed by the one or more processing units, cause the one or more processing units to: receive the scan data generated by the SLO; detect a plurality of optical marker portions in the plurality of line scans of the scan data that each correspond to the optical marker; and generate a final scan of the eye by aligning the plurality of line scans relative to each other based upon the detected optical marker portions” in claim 9;
“a module for optical coherence tomography (OCT) imaging including optics for OCT imaging that are operatively coupled with the SLO” in claim 12
“generating, by a detector, scan data for the retina comprising a plurality of line scans captured via the second scanning element and a second scanning element using the at least one optical element, wherein a portion of the at least one optical marker is included in each line scan of the plurality of line scans to indicate an alignment of the line scan relative to another line scan of the plurality of line scans” in claim 17;
“detecting a plurality of optical marker portions in the plurality of line scans of the scan data that each correspond to the optical marker” in claim 22;
“generating a final scan of the eye by aligning the plurality of line scans relative to each other based upon the detected optical marker portions” in claim 22; and
“performing optical coherence tomography (OCT) in parallel with operating the SLO, such that an output of the SLO is used for tracking movement of the eye in performing the OCT” in claim 24.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) they 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 these limitations interpreted under 35 U.S.C. 112(f) applicant may: (1) amend the claim limitations to avoid them being interpreted under 35 U.S.C. 112(f) (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f).
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 1-5, 8, 17-18, 21-22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Brown et al. US Patent Application Publication 2015/0216408 in view of Sakai et al. US Patent 5,153,417.
Regarding claim 1 Brown discloses a scanning laser ophthalmoscope (title e.g. figures 2-6 & 8 scanning laser ophthalmoscope/SLO 10) for scanning a retina of an eye (abstract “for imaging the retina of an eye”), comprising: a light source (abstract e.g. source 12) emitting a scanning beam (abstract e.g. beam 13); a detector (e.g. detector 510); at least one optical element configured to direct the scanning beam (abstract e.g. scan relay device 18 ); a first scanning element (abstract e.g. first scanning element 14) configured to direct the scanning beam between the light source (e.g. 12) and the at least one optical element (e.g. 18); and a second scanning element (abstract e.g. second scanning element 16) configured to direct the scanning beam with respect to the at least one optical element (e.g. 18), wherein the detector is configured to generate scan data of the retina of the eye comprising a plurality of line scans using the at least one optical element (axiomatic e.g. paragraph [0081] “photodetector 510, which can be used to generate a detailed SLO image”).
Brown does not disclose at least one optical marker disposed at a predetermined region of the at least one optical element, and a portion of the at least one optical marker is included in each line scan of the plurality of line scans to indicate an alignment of the line scan relative to another line scan of the plurality of line scans.
Sakai teaches a similar laser scanning device (abstract “scanning laser beam in two-dimensional directions, and for guiding the scanning light beam to a photo-detector along the same path after the scanning light beam is reflected” e.g. figures 4-5 & 8) including a light source (e.g. laser beam source 201) emitting a scanning beam (e.g. laser beam L); a detector (e.g. photo-detector 211 or 226); at least one optical element (e.g. hologram disk 205) configured to direct the scanning beam (inter alia abstract “hologram receiving a scanning light beam in sequence from a scanning light beam source for directing the scanning light beam”); a first scanning element (e.g. mirror 209) configured to direct the scanning beam between the light source (e.g. 201) and the at least one optical element (e.g. 205); and a second scanning element (e.g. polygonal reflecting mirror assembly 207) configured to direct the scanning beam with respect to the at least one optical element (e.g. column 4 lines 56-58 “laser beam L going out from the hologram disk 205 is reflected by a polygonal reflecting mirror assembly 207”); and further teaches at least one optical marker disposed at a predetermined region of the at least one optical element (e.g. plurality of circumferentially spaced opaque marks 205c), and a portion of the at least one optical marker is included in each line scan of the plurality of line scans to indicate an alignment of the line scan relative to another line scan of the plurality of line scans (inter alia column 5 lines 37-44 “opaque marks 205c at positions corresponding in position to the leading ends (start) and the trailing ends (end) of the respective scanning lines. The marks 205 are detected by the photo-interrupter 212 so that the leading and trailing ends of each scanning line is detected”) for the purpose of detecting the start and end of the scan lines (inter alia column 5 lines 37-44). Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention for the scanning laser ophthalmoscope as disclosed by Brown to have at least one optical marker disposed at a predetermined region of the at least one optical element, and a portion of the at least one optical marker is included in each line scan of the plurality of line scans to indicate an alignment of the line scan relative to another line scan of the plurality of line scans as taught by Sakai for the purpose of detecting the start and end of the scan lines.
Regarding claim 2 the combination of Brown as modified by Sakai discloses the SLO of claim 1, as set forth above. Brown does not disclose it is further comprising a line start sensor disposed in an optical path of the scanning beam and configured to output a signal to the detector to record a new line scan each time the scanning beam is directed to the line start sensor by the first scanning element.
Sakai further teaches a line start sensor (e.g. photo-interrupter 212) disposed in an optical path of the scanning beam and configured to output a signal to the detector to record a new line scan each time the scanning beam is directed to the line start sensor by the first scanning element (inter alia column 5 lines 37-44 “opaque marks 205c at positions corresponding in position to the leading ends (start) and the trailing ends (end) of the respective scanning lines. The marks 205 are detected by the photo-interrupter 212 so that the leading and trailing ends of each scanning line is detected”). for the purpose of detecting the start and end of the scan lines (inter alia column 5 lines 37-44). Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention for the scanning laser ophthalmoscope as disclosed by the combination of Brown as modified by Sakai to have a line start sensor disposed in an optical path of the scanning beam and configured to output a signal to the detector to record a new line scan each time the scanning beam is directed to the line start sensor by the first scanning element as further taught by Sakai for the purpose of detecting the start and end of the scan lines.
Regarding claim 3 the combination of Brown as modified by Sakai discloses the SLO of claim 2, as set forth above. Brown further discloses wherein the detector is operatively coupled with the light source (inherent since the detected reflected light is light from the source).
Regarding claim 4 the combination of Brown as modified by Sakai discloses the SLO of claim 1, as set forth above. Brown further discloses wherein the plurality of line scans is generated by scanning the retina along a first direction using the first scanning element and positions of the plurality of line scans are varied along a second direction orthogonal to the first direction using the second scanning element (inter alia paragraph [0062, 0065 & 0142] “first scanning mirror 14 and the second scanning mirror 16 axes are arranged to create a two-dimensional collimated light scan, in the form of a raster scan pattern of the laser beam 13 … alignment of the first and second scanning mirrors may be orthogonal”).
Regarding claim 5 the combination of Brown as modified by Sakai discloses the SLO of claim 1, as set forth above. Brown does not disclose it is further comprising an optical filter disposed between the detector and the first scanning element and configured to filter the scanning beam to be received by the detector.
Sakai further teaches (e.g. figure 4) an optical filter (e.g. bandpass filter 210) disposed between the detector (e.g. 211) and the first scanning element (e.g. 209) and configured to filter the scanning beam to be received by the detector (column 6 lines 1-6 “the reflected laser beam is reflected by a reflecting mirror 209 toward a bandpass filter 210 which transmits light having a particular band of frequencies. The reflected laser beam finally is focused on a photo-detector 211”) for the purpose of producing an electrical data signal (column 6 lines 3-6). Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention for the scanning laser ophthalmoscope as disclosed by the combination of Brown as modified by Sakai to have an optical filter disposed between the detector and the first scanning element and configured to filter the scanning beam to be received by the detector as further taught by Sakai for the purpose of producing an electrical data signal.
Regarding claim 8 the combination of Brown as modified by Sakai discloses the SLO of claim 1, as set forth above. Brown does not disclose wherein the at least one optical marker includes a plurality of optical markers, the plurality of optical markers including: a line-start optical marker defining a first end of the line scans, and a line-end optical marker defining a second end of the line scans.
Sakai further teaches wherein the at least one optical marker (e.g. 205c) includes a plurality of optical markers (e.g. plurality of circumferentially spaced opaque marks 205c), the plurality of optical markers including: a line-start optical marker defining a first end of the line scans, and a line-end optical marker defining a second end of the line scans (inter alia column 5 lines 37-41 “opaque marks 205c at positions corresponding in position to the leading ends (start) and the trailing ends (end) of the respective scanning lines) for the purpose of detecting the start and end of the scan lines (inter alia column 5 lines 37-44). Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention for the scanning laser ophthalmoscope as disclosed by the combination of Brown as modified by Sakai to have the at least one optical marker includes a plurality of optical markers, the plurality of optical markers including: a line-start optical marker defining a first end of the line scans, and a line-end optical marker defining a second end of the line scans as further taught by Sakai for the purpose of detecting the start and end of the scan lines.
Regarding claims 17-18 and 21-22, under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986) see MPEP 2112.02. Since claims 17-18 and 21-22 recite the normal use of the device in claims 1, 5 and 8-9, respectively, claims 17-18 and 21-22 are rejected as inherent.
Regarding claim 24 the combination of Brown as modified by Sakai discloses the method of claim 17, as set forth above. Brown further discloses it is further comprising performing optical coherence tomography (OCT) in parallel with operating the SLO (inter alia abstract “An optical coherence tomography (OCT) system (900) is combined with the SLO, the OCT system providing OCT reference and sample beams. The OCT sample beam (902) propagates along the same optical path as of the SLO collimated light through the scan transfer device.” e.g. figures 4-6 optical coherence tomography/OCT system 900), such that an output of the SLO is used for tracking movement of the eye in performing the OCT (paragraph [0083] “The scanning laser ophthalmoscope may provide high resolution images and retinal tracking before, during and after the OCT scan”).
Claims 6-7 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Brown et al. US Patent Application Publication 2015/0216408 in view of Sakai et al. US Patent 5,153,417 and in further view of Hammer et al. US Patent Application Publication 2011/0234978.
Regarding claims 6-7 the combination of Brown as modified by Sakai discloses the SLO of claim 5 including scan data that includes one or more portions corresponding to the at least one optical marker, as set forth above. Brown and Sakai do not disclose or teach wherein the optical filter is configured to filter a reflected light from the eye and allow a fluorescent light to pass through the optical filter and thereby be received by the detector, as further required by claim 6; or further comprising a beam splitter and a second detector configured to receive the reflected light before being filtered out by the optical filter, thereby obtaining scan data via the second detector, as further required by claim 7.
Hammer teaches a similar scanning device (title e.g. see figure 2) including optical components capable of operating in a SLO mode and an OCT mode (abstract); and further teaches the optical filter (e.g. wavelength selection filter 239) is configured to filter a reflected light from the eye (e.g. beam 242) and allow a fluorescent light to pass through the optical filter and thereby be received by the detector (inter alia paragraph [0054] “239 can be a barrier (notch) filter to remove all wavelengths except fluorescence on the PMT detector”) for the purpose of separating excitation and emission beams (inter alia paragraph [0054]), and further comprising a beam splitter (e.g. beamsplitter 217) and a second detector (e.g. detection device 120) configured to receive the reflected light before being filtered out by the optical filter, thereby obtaining scan data via the second detector (e.g. see figure 2) for the purpose of generating an image (e.g. see figure 2 AOSLO image 102). Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention for the scanning laser ophthalmoscope as disclosed by the combination of Brown as modified by Sakai to have the optical filter is configured to filter a reflected light from the eye and allow a fluorescent light to pass through the optical filter and thereby be received by the detector; and further comprising a beam splitter and a second detector configured to receive the reflected light before being filtered out by the optical filter, thereby obtaining scan data via the second detector as taught by Hammer for the purpose of separating excitation and emission beams and generating an image.
Regarding claims 19-20, under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986) see MPEP 2112.02. Since claims 19-20 recite the normal use of the device in claims 6-7, respectively, claims 19-20 are rejected as inherent.
Claims 9 and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Brown et al. US Patent Application Publication 2015/0216408 in view of Sakai et al. US Patent 5,153,417 and in further view of Amma et al. US Patent Application Publication 2021/0100450.
Regarding claim 9 Brown further discloses an ophthalmic imaging system (title e.g. figure 8) comprising: the SLO of claim 1 including detecting a plurality of optical marker portions in the plurality of line scans of the scan data that each correspond to the optical marker (as ser forth above); the scan data generated by the SLO ; and generate a final scan of the eye by aligning the plurality of line scans relative to each other based upon the detected optical marker portions (axiomatic, e.g. paragraphs [0081 & 0137] “generate a detailed SLO image”).
Brown does not disclose and one or more processing units and one or more memory units storing thereon instructions that, when executed by the one or more processing units, cause the one or more processing units to process the data.
Sakai further teaches data processing and control circuits (column 6 lines 17-27 “printed-circuit boards 213, 214 include … a signal processing circuit for processing signals from the photo-interrupter 212, an amplifier circuit for amplifying signals from the photo-detector 211 … are connected to the control circuit 4”) for the purpose of processing and amplifying signals (column 6 lines 17-27). Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention for the scanning laser ophthalmoscope as disclosed by the combination of Brown as modified by Sakai to have one or more processing units that process the data as further taught by Sakai for the purpose of processing and amplifying signals.
Sakai does not teach one or more memory units storing thereon instructions that to be executed by the one or more processing units.
Amma teaches a similar scan system (title, e.g. figure 1 ophthalmic scanning system 10) including an SLO (inter alia paragraph [0026] “first imaging modality 12 is a scanning laser ophthalmoscope … uses a laser light beam to scan across the retina in a raster pattern to illuminate successive elements of the retina … light reflected from each retinal point is captured by a photomultiplier. The output of the photomultiplier is recorded and displayed … to produce high-contrast, detailed images of the retina”) and one or more processors (e.g. at least one central processing unit 1508); and further teaches one or more memory units (e.g. system memory 1512) storing thereon instructions that to be executed by the one or more processing units (inter alia paragraph [0025] “1512 that stores instructions that, when executed by the at least one central processing unit”) for the purpose of perform one or more methods and functions (paragraph [0025]), such as producing high-contrast, detailed images of the retina (paragraph [0026]). Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention for the scanning laser ophthalmoscope as disclosed by the combination of Brown as modified by Sakai to have one or more memory units storing thereon instructions that to be executed by the one or more processing units as taught by Amma for the purpose of perform one or more methods and functions, such as producing high-contrast, detailed images of the retina.
Regarding claim 12 the combination of Brown as modified by Sakai and Amma discloses the system of claim 9, as set forth above. Brown further discloses it is further comprising a module for optical coherence tomography (OCT) imaging including optics for OCT imaging that are operatively coupled with the SLO (inter alia abstract “An optical coherence tomography (OCT) system (900) is combined with the SLO, the OCT system providing OCT reference and sample beams. The OCT sample beam (902) propagates along the same optical path as of the SLO collimated light through the scan transfer device.” e.g. figures 4-6 optical coherence tomography/OCT system 900).
Regarding claim 13 the combination of Brown as modified by Sakai and Amma discloses the system of claim 12, as set forth above. Brown further discloses wherein the optics for OCT are coupled with the SLO at a location between the light source and the first scanning element (e.g. figure 4 900 between 13 & 14).
Regarding claim 14 the combination of Brown as modified by Sakai and Amma discloses the system of claim 12, as set forth above. Brown further discloses wherein the optics for OCT are coupled with the SLO at a location between the first scanning element and the at least one optical element (e.g. figure 5 900 between 14 & 18).
Regarding claim 15 the combination of Brown as modified by Sakai and Amma discloses the system of claim 12, as set forth above. Brown further discloses wherein the optics for OCT are coupled with the SLO at the second scanning element (e.g. figure 6 900 between 18 & 16).
Regarding claim 16 the combination of Brown as modified by Sakai and Amma discloses the system of claim 12, as set forth above. Brown and Sakai do not disclose or teach wherein the SLO, the optics for OCT, and at least one of the one or more processing units are enclosed within a common housing. Amma further teaches (e.g. figure 1) wherein the SLO (e.g. 12), the optics for OCT (e.g. second imaging modality 14 is an optical coherence tomography/OCT imaging modality), and at least one of the one or more processing units (e.g. 15) are enclosed within a common housing (e.g. housing 18) for the purpose of having a single instrument (paragraph [0024]). Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention for the scanning laser ophthalmoscope as disclosed by the combination of Brown as modified by Sakai and Amma to have the SLO, the optics for OCT, and at least one of the one or more processing units are enclosed within a common housing as further taught by Amma for the purpose of having a single instrument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Rogers et al. US Patent Application Publication 2008/0088852; in regards to a similar device including using a filter to separate fluorescence, e.g. see figure 11 and paragraph [0071].
Lin et al. US Patent Application Publication 2016/0270647; in regards to a similar device including using a filter to separate fluorescence, e.g. see figure 1 and paragraph [0035].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to George G King whose telephone number is (303)297-4273. The examiner can normally be reached 9-5.
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/George G. King/Primary Examiner, Art Unit 2872 April 15, 2026
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