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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the a first scan in a location of the cornea corresponding to a first time, a second scan in the location of the cornea corresponding to a second time, a first measurement and a second measurement, one or more subsequent scans, at least two scans simultaneously at least two different locations of the cornea, and three scans simultaneously on at least three different locations of the cornea must be shown or the feature(s) canceled from the claim(s). Examiner further notes that several claimed elements (e.g., “a first scan” and “a first measurement”; this is not an exhaustive list) are not clearly linked to the as-filed specification, including the drawings. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Several claimed elements (e.g., “a first scan” and “a first measurement”; this is not an exhaustive list) are not clearly linked to the as-filed specification. Therefore, the as-filed specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o).
Appropriate correction is required.
Claim Objections
Claims 4-9, 12-13, 17, and 19-20 are objected to because of the following informalities:
With respect to Claims 4, 7-9, 12, 17, and 19, the recitation “wherein the performing the/a” is grammatically incorrect. With respect to Claims 5 and 6, the recitation “wherein the determine the” is grammatically incorrect. With respect to Claims 13 and 20, the recitation “wherein the determining the” is grammatically incorrect.
Appropriate correction is required.
Claim Interpretation - 35 USC § 112(f)
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) are: “provide control signals to the OCT scanner to implement the scanning sequence; determine a rate of change of the phase data associated with the plurality of scans…a quantitative parameter of the cornea” in Claim 1 and similarly recited in Claims 10 and 18, “determine a difference between a first measurement and a second measurement…more subsequent measurements” in Claim 4 and similarly recited in Claims 12 and 19, “determine the difference between the first…the second measurement” in Claim 5 and similarly recited in Claims 13 and 20, “determine the rate of change of the phase data corresponds to the plurality of scans” in Claim 6, and “performing a plurality of scans comprises B-M scan mode or M-B scan mode” in Claim 7 and similarly recited in Claims 14 and 15.
Because these claim limitation(s) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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 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 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 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(b)
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 1-20 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.
With respect to Claims 1-20, and notwithstanding the permissible instances, the use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear. Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255, 85 USPQ2d 1654, 1663 (Fed. Cir. 2008); see also United Carbon Co. v. Binney & Smith Co., 317 U.S. 228, 234 (1942) See MPEP §2173.05(g).
In the current instance, Claims 1, 10, and 18 merely recite data-acquisition and data-analysis results (e.g., determining a rate of change, growth constant, diffusion coefficient, and quantitative parameter) without adequately identifying the concrete boundaries of the claimed subject matter, for the claims merely encompass any mechanisms capable of producing the claimed determinations and performances (e.g., including mental evaluation by a human using the collected OCT data). Claims 2, 5-6, 13, and 20 recite limitations (e.g., “includes comparing,” “corresponds to,” and “representative of”) that fail to define the objective relationship between the recited data and intended determinations/results, and thus, the metes and bounds of the scope are ambiguous. Claims 3-4, 8-9, 11-12, 16-17, and 19-20 recite operational steps (e.g., “providing control signals, determining, “comparing”) within system and computer-program product claims, so it is unclear whether these claim limitations define structural characteristics of the claimed apparatus or raise infringement issues regarding mere intended use, operation, and functionality occurring after manufacture. See MPEP 2173.05. Claims 3 and 11 recite “determine an average of the plurality of B-scan OCT images” without specifying how the average is calculated, what image attributes are averaged, or how the resulting average image is utilized. Similarly, Claims 4, 12, and 19 recite “determine a difference between a first measurement and a second measurement, based on the OCT data of the first scan or the second scan,” but the “or” statement makes it unclear whether one scan, the other scan, or both scans are required for the determination. With respect to Claims 1-20, there is no sufficient structure/special acts claimed to achieve the recited determinations/results, for the claims merely state the intended results rather than how they are determined (i.e., for method limitations) or what the structure of the device is (i.e., for apparatus limitations). Since the scope of Claims 1-20 are unclear, a person having ordinary skill in the art would not be able to reasonably ascertain the scope of the instant application. In regards to Claims 1-9 and 18-20, Examiner reminds the applicant that “apparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990).
For the prosecution on merits, examiner interprets the claimed subject matter described above as introducing optional elements, optional structural limitations, optional expressions, and optional functionality within an optical coherence tomography (OCT) scanning system, method of measuring ocular tissue characteristics of a cornea in real-time at multiple ocular locations, and a computer-program product.
Applicant should clarify the claim limitations as appropriate. Care should be taken during revision of the description and of any statements of problem or advantage, not to add subject-matter which extends beyond the content of the application (specification) as originally filed. If the language of a claim, considered as a whole in light of the specification and given its broadest reasonable interpretation, is such that a person of ordinary skill in the relevant art would read it with more than one reasonable interpretation, then a rejection of the claims under 35 U.S.C. 112, second paragraph, is appropriate. See MPEP 2173.05(a), MPEP 2143.03(I), and MPEP 2173.06.
Proper correction is required to ensure accuracy and consistency in the claims, for the language is so awkward that it renders the claims nearly incomprehensible. The primary purpose of the requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent. It is of utmost importance that patents issue with definite claims that clearly and precisely inform persons skilled in the art of the boundaries of protected subject matter. See MPEP § 2173.
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.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rollins et al. US 20180211383 A1 (herein after "Rollins").
With respect to Claim 1, Rollins discloses an optical coherence tomography (OCT) scanning system for measuring characteristics of ocular tissue of a cornea in a patient’s eye (figs. 1-5), the system comprising:
an OCT scanner (OCT scanner 12; [0018]) configured to implement a scanning sequence (OCT scanner 12 that is configured to implement a scanning sequence; [0018]) via an optical signal (via an optical signal; [0018]) on the ocular tissue (biological tissue or fluid medium; [0018]), the scanning sequence (scanning sequence; [0018]) including performing a plurality of scans (plurality of scan lines, e.g., series of A-scans; [0006], [0018]) of the ocular tissue (biological tissue or fluid medium; [0018]) to obtain OCT data (e.g., phase and amplitude information; [0005]) based on a reflected version (associated with a reflected version; [0005]) of the optical signal (via an optical signal; [0018]), the OCT data (e.g., phase and amplitude information; [0005]) being representative of phase data (phase information; [0005]) of the reflected version (associated with a reflected version; [0005]) of the optical signal (via an optical signal; [0018]); and
a computer (computer or other programmable data processing apparatus; [0052]) including a processor (processor cores of general purpose computer, e.g., scanning controller 16; [0019], [0051]) configured to:
provide control signals (scanning controller 16 configured to provide control signals; [0019]) to the OCT scanner (OCT scanner 12; [0018]) to implement the scanning sequence (OCT scanner 12 that is configured to implement a scanning sequence; [0018]);
determine a rate of change (time-dependent complex-valued change; [0021]) of the phase data (phase information; [0005]) associated with the plurality of scans (plurality of scan lines, e.g., series of A-scans; [0006], [0018]), the rate of change (time-dependent complex-valued change; [0021]) of the phase data (phase information; [0005]) characterizing a change of the reflected version (associated with a reflected version; [0005]) of the optical signal (via an optical signal; [0018]) as a function of time ([0021]);
determine a growth constant (e.g., exponential decay constant as a negative growth constant; [0021]) of the reflected version (associated with a reflected version; [0005]) of the optical signal (via an optical signal; [0018]) based on the rate of change (time-dependent complex-valued change; [0021]) of the phase data (phase information; [0005]);
determine, based on the growth constant (e.g., exponential decay constant as a negative growth constant; [0021]), a diffusion coefficient (diffusion coefficient; [0021]) associated with the cornea (implemented for corneal measurement; [0017]); and
determine, based on the diffusion coefficient (diffusion coefficient; [0021]) associated with the cornea (implemented for corneal measurement; [0017]), a quantitative parameter (quantitative parameter; [0018]) of the cornea (implemented for corneal measurement; [0017]).
Examiner reminds the applicant that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Ex parte Masham, 2 USPQ2d - 164 7 (1987). Examiner further notes that when the structure of a claimed system is the same as that claimed, it must inherently perform the same function. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432. See also Bettcher Industries, Inc. v. Bunzl USA, Inc., 661 F.3d 629, 639-40,100 USPQ2d 1433, 1440 (Fed. Cir. 2011). 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. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. See In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986). See also MPEP § 2112.02.
With respect to Claim 2, Rollins discloses the system (figs. 1-5) of claim 1, wherein the OCT data (e.g., phase and amplitude information; [0005]) is representative of an amplitude change (amplitude information; [0005]) of the reflected version (associated with a reflected version; [0005]) of the optical signal (via an optical signal; [0018]).
With respect to Claim 3, Rollins discloses the system (figs. 1-5) of claim 1, wherein the scanning sequence (OCT scanner 12 that is configured to implement a scanning sequence; [0018]) comprises B-M Mode scanning ([0020]) wherein the OCT scanner (OCT scanner 12; [0018]) is configured to:
perform a plurality of B-scan OCT images corresponding to two-dimensional, cross-sectional images (plurality of A-scans can correspond to multiple sequential measurements in a given scan time that are each evaluated separately and comparatively; [0020]) of the ocular tissue (biological tissue or fluid medium; [0018]);
perform a plurality of M-mode OCT images (M-mode images; [0020]); and
determine an average (utilizing short and independent temporal windows and averaging the resulting diffusivity, motion artifacts can be substantially mitigated; [0042]) of the plurality of B-scan OCT images (plurality of A-scans can correspond to multiple sequential measurements in a given scan time that are each evaluated separately and comparatively; [0020]).
With respect to Claim 4, Rollins discloses the system or claim 3, wherein the performing the plurality of scans (plurality of scan lines, e.g., series of A-scans; [0006], [0018]) of the ocular tissue (biological tissue or fluid medium; [0018]) comprises:
perform a first scan (multiple sequential measurements in a given scan time; [0020]) in a location (OCT image data corresponding to multiple pixels of the given region of the tissue or fluid medium; [0020]) of the cornea (implemented for corneal measurement; [0017]) corresponding to a first time ([0020]);
perform a second scan ([0020]) in the location ([0020]) of the cornea (implemented for corneal measurement; [0017]) corresponding to a second time ([0020]);
determine a difference between a first measurement and a second measurement (signal processing algorithm including calculation of time-dependent complex-valued change, such as first-order correlation, associated with ensemble of samples associated with tissue or fluid medium; [0021]), based on the OCT data (e.g., phase and amplitude information; [0005]) of the first scan or the second scan ([0020]);
perform one or more subsequent scans ([0020]) in the location ([0020]) corresponding to one or more subsequent times ([0020]); and
determine the optical signal (via an optical signal; [0018]) based on an average value of the difference between the first measurement and the second measurement and one or more differences between the first measurement and one or more subsequent measurements (autocorrelation, via Stokes-Einstein equation, ensemble average both in space and in time; [0023-24]).
With respect to Claim 5, Rollins discloses the system (figs. 1-5) of claim 4, wherein the determine the difference between the first measurement and the second measurement (multiple sequential measurements in a given scan time; [0020]) includes comparing (signal processing algorithm including calculation of time-dependent complex-valued change, such as first-order correlation, associated with ensemble of samples associated with tissue or fluid medium; [0021]) an amplitude or a phase of the first measurement to the amplitude or phase of the second measurement (e.g., phase and amplitude information; [0005]).
With respect to Claim 6, Rollins discloses the system (figs. 1-5) of claim 1, wherein the determine the rate of change (time-dependent complex-valued change; [0021]) of the phase data (phase information; [0005]) corresponds to the plurality of scans (plurality of scan lines, e.g., series of A-scans; [0006], [0018]).
With respect to Claim 7, Rollins discloses the system (figs. 1-5) of claim 1, wherein the performing a plurality of scans (plurality of scan lines, e.g., series of A-scans; [0006], [0018]) comprises B-M scan mode or M-B scan mode (plurality of A-scans can correspond to multiple sequential measurements in a given scan time that are each evaluated separately and comparatively, e.g., as B-scans, M-mode images; [0020]).
With respect to Claim 8, Rollins discloses the system (figs. 1-5) of claim 1, wherein the performing a plurality of scans (plurality of scan lines, e.g., series of A-scans; [0006], [0018]) comprises performing at least two scans ([0006], [0018-20]) simultaneously (can execute method of scanning serially and concurrently; [0047]; figs. 4-5) at least two different locations (OCT image data corresponding to multiple pixels of the given region of the tissue or fluid medium, e.g., up to the entire surface of the media; [0020]) of the cornea (implemented for corneal measurement; [0017]).
With respect to Claim 9, Rollins discloses the system (figs. 1-5) of claim 8, wherein the performing a plurality of scans (plurality of scan lines, e.g., series of A-scans; [0006], [0018]) comprises performing three scans (e.g., 25,000 A-lines can be collected to reduce noise by averaging; [0020]) simultaneously (can execute method of scanning serially and concurrently; [0047]; figs. 4-5) on at least three different locations (OCT image data corresponding to multiple pixels of the given region of the tissue or fluid medium, e.g., up to the entire surface of the media; [0020]) of the cornea (implemented for corneal measurement; [0017]).
With respect to Claim 10, Rollins discloses a method of measuring ocular tissue characteristics of a cornea in real-time at multiple ocular locations (figs. 1-5), the method comprising:
at an optical coherence tomography (OCT) device (PhD-OCT system 10; [0018]):
performing a plurality of scans (plurality of scan lines, e.g., series of A-scans; [0006], [0018]) of the ocular tissue (biological tissue or fluid medium; [0018]) of the cornea (implemented for corneal measurement; [0017]) to obtain OCT data (e.g., phase and amplitude information; [0005]) representative of an OCT signal (E is complex OCT signal, having both real and imaginary parts; [0023-24]) including phase data and amplitude data (e.g., phase and amplitude information; [0005]); at a computer (computer or other programmable data processing apparatus; [0052]) coupled to the OCT device (PhD-OCT system 10; [0018]):
determining a rate of change (time-dependent complex-valued change; [0021]) of the amplitude data or the phase data associated (e.g., phase and amplitude information; [0005]) with the plurality of scans (plurality of scan lines, e.g., series of A-scans; [0006], [0018]), the rate of change (time-dependent complex-valued change; [0021]) of the phase data or the amplitude data (e.g., phase and amplitude information; [0005]) characterizing a change of a reflected version (associated with a reflected version; [0005]) of the optical signal (via an optical signal; [0018]) as a function of time ([0021]);
determining a growth constant (e.g., exponential decay constant as a negative growth constant; [0021]) of the reflected version (associated with a reflected version; [0005]) of the optical signal (via an optical signal; [0018]) based on the rate of change (time-dependent complex-valued change; [0021]) of the amplitude data or the phase data (e.g., phase and amplitude information; [0005]);
determining, based on the growth constant (e.g., exponential decay constant as a negative growth constant; [0021]), a diffusion coefficient (diffusion coefficient; [0021]) associated with the ocular tissue (biological tissue or fluid medium; [0018]); and
determining, based on the diffusion coefficient (diffusion coefficient; [0021]) associated with the ocular tissue (biological tissue or fluid medium; [0018]), a quantitative parameter (quantitative parameter; [0018]) of the ocular tissue (biological tissue or fluid medium; [0018]).
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. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. See In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986). See also MPEP § 2112.02.
With respect to Claim 11, Rollins discloses the method (figs. 1-5) of claim 10, wherein the plurality of scans (plurality of scan lines, e.g., series of A-scans; [0006], [0018]) comprise B-M Mode scanning ([0020]), and wherein the OCT device (PhD-OCT system 10; [0018]) is further configured to:
performing a plurality of B-scan OCT images corresponding to two-dimensional, cross-sectional images (plurality of A-scans can correspond to multiple sequential measurements in a given scan time that are each evaluated separately and comparatively; [0020]) of the cornea (implemented for corneal measurement; [0017]);
performing a plurality of M-mode OCT images (M-mode images; [0020]); and
determining an average (utilizing short and independent temporal windows and averaging the resulting diffusivity, motion artifacts can be substantially mitigated; [0042]) of the plurality of B-scan OCT images (plurality of A-scans can correspond to multiple sequential measurements in a given scan time that are each evaluated separately and comparatively; [0020]).
With respect to Claim 12, Rollins discloses the method (figs. 1-5) of claim 10, wherein the performing the plurality of scans (plurality of scan lines, e.g., series of A-scans; [0006], [0018]) of the cornea (implemented for corneal measurement; [0017]) comprises:
performing a first scan (multiple sequential measurements in a given scan time; [0020]) in a location (OCT image data corresponding to multiple pixels of the given region of the tissue or fluid medium; [0020]) of the cornea (implemented for corneal measurement; [0017]) corresponding to a first time ([0020]);
performing a second scan ([0020]) in the location ([0020]) of the cornea (implemented for corneal measurement; [0017]) corresponding to a second time ([0020]);
determining a difference between a first measurement and a second measurement of the first scan or the second scan (signal processing algorithm including calculation of time-dependent complex-valued change, such as first-order correlation, associated with ensemble of samples associated with tissue or fluid medium based on phase and amplitude information PH; [0021]);
performing one or more subsequent scans ([0020]) in the location ([0020]) corresponding to one or more subsequent times ([0020]); and
determining the OCT signal (E is complex OCT signal, having both real and imaginary parts; [0023-24]) based on an average value of the difference between the first measurement and the second measurement and one or more differences between the first measurement and one or more subsequent measurements (autocorrelation, via Stokes-Einstein equation, ensemble average both in space and in time; [0023-24]).
With respect to Claim 13, Rollins discloses the method (figs. 1-5) of claim 12, wherein the determining the difference between the first measurement and the second measurement (multiple sequential measurements in a given scan time; [0020]) includes comparing (signal processing algorithm including calculation of time-dependent complex-valued change, such as first-order correlation, associated with ensemble of samples associated with tissue or fluid medium; [0021]) an amplitude or a phase of the first measurement to the amplitude or phase of the second measurement (e.g., phase and amplitude information; [0005]).
With respect to Claim 14, Rollins discloses the method (figs. 1-5) of claim 10, wherein performing the plurality of scans (plurality of scan lines, e.g., series of A-scans; [0006], [0018]) comprises M-B scan mode (plurality of A-scans can correspond to multiple sequential measurements in a given scan time that are each evaluated separately and comparatively, e.g., as B-scans, M-mode images; [0020]).
With respect to Claim 15, Rollins discloses the method (figs. 1-5) of claim 10, wherein performing the plurality of scans (plurality of scan lines, e.g., series of A-scans; [0006], [0018]) comprises B-M scan mode (plurality of A-scans can correspond to multiple sequential measurements in a given scan time that are each evaluated separately and comparatively, e.g., as B-scans, M-mode images; [0020]).
With respect to Claim 16, Rollins discloses the method (figs. 1-5) of claim 10, wherein performing the plurality of scans (plurality of scan lines, e.g., series of A-scans; [0006], [0018]) comprises performing at least 2 scans ([0006], [0018-20]) simultaneously (can execute method of scanning serially and concurrently; [0047]; figs. 4-5) at least two different locations (OCT image data corresponding to multiple pixels of the given region of the tissue or fluid medium, e.g., up to the entire surface of the media; [0020]) of the cornea (implemented for corneal measurement; [0017]).
With respect to Claim 17, Rollins discloses the method (figs. 1-5) of claim 10, wherein the performing a plurality of scans (plurality of scan lines, e.g., series of A-scans; [0006], [0018]) comprises performing three scans (e.g., 25,000 A-lines can be collected to reduce noise by averaging; [0020]) simultaneously (can execute method of scanning serially and concurrently; [0047]; figs. 4-5) simultaneously (can execute method of scanning serially and concurrently; [0047]; figs. 4-5) on at least three different locations (OCT image data corresponding to multiple pixels of the given region of the tissue or fluid medium, e.g., up to the entire surface of the media; [0020]) of the cornea (implemented for corneal measurement; [0017]).
With respect to Claim 18, Rollins discloses a computer-program product (figs. 1-5) comprising
a non-transitory computer-usable medium (computer program product e.g., a non-transitory computer readable medium; [0050]) having computer-readable program code (computer program product having instructions executable by a processor; [0050]) embodied therein, the computer-readable program code adapted to be executed ([0050]) by one or more processors (one or more processor cores of general purpose computer, e.g., scanning controller 16; [0019], [0051]) to implement a method (PhD-OCT method; [0017]) comprising:
receiving, from an optical coherence tomography (OCT) device (PhD-OCT system 10; [0018]), OCT data (e.g., phase and amplitude information; [0005]) representative of an optical signal (via an optical signal; [0018]) including phase and amplitude information (e.g., phase and amplitude information; [0005]), the OCT data (e.g., phase and amplitude information; [0005]) being generated by performing a plurality of scans (plurality of scan lines, e.g., series of A-scans; [0006], [0018]) of a cornea (implemented for corneal measurement; [0017]);
determining a rate of change (time-dependent complex-valued change; [0021]) of amplitude data or phase data (e.g., phase and amplitude information; [0005]) associated with the plurality of scans (plurality of scan lines, e.g., series of A-scans; [0006], [0018]), the rate of change (time-dependent complex-valued change; [0021]) of the phased data or amplitude data (e.g., phase and amplitude information; [0005]) characterizing a change of a reflected version (associated with a reflected version; [0005]) of the optical signal (via an optical signal; [0018]) as a function of time ([0021]);
determining a growth constant (e.g., exponential decay constant as a negative growth constant; [0021]) of the reflected version (associated with a reflected version; [0005]) of the optical signal (via an optical signal; [0018]) based on the rate of change (time-dependent complex-valued change; [0021]) of the amplitude data or the phase data (e.g., phase and amplitude information; [0005]);
determining, based on the growth constant (e.g., exponential decay constant as a negative growth constant; [0021]), a diffusion coefficient (diffusion coefficient; [0021]) associated with the cornea (implemented for corneal measurement; [0017]); and
determining, based on the diffusion coefficient (diffusion coefficient; [0021]) associated with the cornea (implemented for corneal measurement; [0017]), a quantitative parameter (quantitative parameter; [0018]) of the cornea (implemented for corneal measurement; [0017]).
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. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. See In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986). See also MPEP § 2112.02.
With respect to Claim 19, Rollins discloses the computer-program product (figs. 1-5) of claim 18, wherein:
the performing the plurality of scans (plurality of scan lines, e.g., series of A-scans; [0006], [0018]) of the cornea (implemented for corneal measurement; [0017]) includes:
performing a first scan (multiple sequential measurements in a given scan time; [0020]) in a location (OCT image data corresponding to multiple pixels of the given region of the tissue or fluid medium; [0020]) of the cornea (implemented for corneal measurement; [0017]) corresponding to a first time ([0020]), and
performing a second scan ([0020]) in the location ([0020]) of the cornea (implemented for corneal measurement; [0017]) corresponding to a second time ([0020]); and the method (PhD-OCT method; [0017]) further includes:
determining a difference between a first measurement and a second measurement (signal processing algorithm including calculation of time-dependent complex-valued change, such as first-order correlation, associated with ensemble of samples associated with tissue or fluid medium; [0021]), based on OCT data (e.g., phase and amplitude information; [0005]) of the first scan or the second scan ([0020]);
providing, to the OCT device (PhD-OCT system 10; [0018]), control signals (scanning controller 16 configured to provide control signals; [0019]) to perform one or more subsequent scans ([0020]) in the location ([0020]) corresponding to one or more subsequent times ([0020]); and
determining the OCT signal (E is complex OCT signal, having both real and imaginary parts; [0023-24]) based on an average value of the difference between the first measurement and the second measurement and one or more differences between the first measurement and one or more subsequent measurements (autocorrelation, via Stokes-Einstein equation, ensemble average both in space and in time; [0023-24]).
With respect to Claim 20, Rollins discloses the computer-program product (figs. 1-5) of claim 19, wherein the determining the difference between the first measurement and the second measurement (multiple sequential measurements in a given scan time; [0020]) includes comparing (signal processing algorithm including calculation of time-dependent complex-valued change, such as first-order correlation, associated with ensemble of samples associated with tissue or fluid medium; [0021]) an amplitude or a phase of the first measurement to the amplitude or phase of the second measurement (e.g., phase and amplitude information; [0005]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Yi et al. US 20180256025 A1 discloses devices, methods, and systems of functional optical coherence tomography substantially similar to that of the claimed invention.
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/K MUHAMMAD/Examiner, Art Unit 2872 03 June 2026
/SHARRIEF I BROOME/Primary Examiner, Art Unit 2872
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