DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 12 January 2026 and 21 October 2025 have been fully considered but they are not persuasive. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Please see response to arguments below in the present Office action.
Counsel's assertion that "the determining "whether a subject is a candidate at risk of glaucoma" based on several factors cannot practically be performed in the human mind." is merely an argument unaccompanied by evidentiary support, and, thus, is insufficient to rebut Examiner's finding(s). Arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). MPEP § 2145, 716.01(c). Evaluating ophthalmic information and selecting a subject at risk of glaucoma as a candidate constitutes an analysis and judgment that can be performed mentally by a clinician reviewing patient data. Examiner invites the applicant to provide evidence or explanation demonstrating that such an evaluation cannot practically be performed in the human mind or with pen and paper.
In response to the applicant's argument that "More specifically, the amended claims require that a determination unit determines whether the subject is a candidate at risk of glaucoma…," the Examiner traverses. “A determination unit determines whether the subject is a candidate at risk of glaucoma” describes the evaluation or judgement of medical information to reach a diagnostic conclusion. This evaluation can be performed mentally by a clinician reviewing patient data and deciding whether the patient is at risk for glaucoma. Also, the recitation of the generic computer elements do not change the fundamental nature of this evaluation, i.e., analyzing information to make a diagnostic determination. See previous response to argument above and § 101 rejection below in the present Office action for further details.
In response to the applicant's argument that "Amended claim 1 does not…fall within a mathematical concept, a certain method of organizing human activity, or a mental process,… Amended claim 1 is not similar to any idea found by the courts to be abstract…with respect to claim 1" the Examiner traverses. Claim 1 recites a mental process and specifically the analysis of patient information and the resulting selection of a subject as a candidate at risk of glaucoma. Arguments directed to other abstract idea groupings are therefore not responsive to the rejection(s). See § 101 rejection below in the present Office action for further details.
In response to the applicant's argument that "Conventionally, intraocular pressure is checked by blowing air at a subject's cornea…based on the anterior chamber depth, the eye axial length, and the refractive power of the subject's eye. (Specification; para. [0019])," the Examiner traverses. Examiner notes that the features upon which applicant relies (i.e., "Embodiments of the present invention provide for determining whether a subject is a candidate at risk for glaucoma without blowing air over the subject's eye to check for intra-ocular pressure") are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Examiner also reminds the applicant that the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
In response to the applicant's argument that "Such technical explanation is reflected in the claims… Embodiments of the present invention thus provide for an improvement in the technical field of ophthalmologic information processing systems," the Examiner traverses. Selecting a subject for clinical testing, an information acquisition unit/step, measurement by ophthalmologic apparatus, and determination unit/step represent routine and conventional use of generic technology. The computing system performs no improvement to itself or to the operation of the ophthalmologic information processing device or visual test systems. See § 101 rejection below in the present Office action for further details.
In response to the applicant's argument that "Therefore, claim 1 is integrated into the practical application of an improvement to the technical field…The claims are not directed to an abstract idea under both Prong One and Prong Two,…Accordingly, amended claim 1 amounts to the inventive concept…functioning of a computer is one example identified by MPEP 2106.05(I)(A) as amounting to an inventive concept and thus qualifying as significantly more,…Therefore, even if the claims are considered to be directed to an abstract idea… Thus, claims 1 and 7-9 are patent eligible under 35 U.S.C. §101. Reconsideration and withdrawal of this rejection is respectfully requested" the Examiner traverses. See response to previous arguments above and § 101 rejection below in the present Office action for further details.
In response to the applicant's argument that "Walsh does not disclose each and every limitation of amended claim 1,… Although Walsh describes use of an optical coherence tomography instrument, Walsh does not disclose "an ophthalmologic apparatus including,…" as recited in amended claim 1," the Examiner traverses. Walsh discloses an ophthalmologic information processing system (system 100, 3050; [0301], figs. 1, 21) for selecting a subject at risk of glaucoma as a candidate (system 100, 3050 indicates that the patient is at risk of suffering from a glaucoma condition; [0301]),…a refractive power of the subject's eye (determining refractive errors for each eye of the subject; [0077]; e.g., computer system 104 configured to use corneal Z-offset in combination with other parameters to determine and/or calculate refractive error of the eyes; [0316]) included in the measurement information (information related to ophthalmic condition received via input device 3055 of system 3050; [0276]). Examiner reminds the applicant that ‘“The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)).’ See MPEP § 2123. See also § 102(a)(1) rejection below in the present Office action for further details.
Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which they think the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
Drawings
The applicant’s drawings submitted are acceptable for examination purposes.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-5 and 8-9 rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (e.g., mental processes, mathematical concepts, etc.) without significantly more. The claim(s) recite(s) selecting a subject at risk of glaucoma as a candidate, an information acquisition unit/step performed by a generic computer that acquires measurement information of an eye of the subject measured by an ophthalmologic apparatus; and a determination unit/step performed by a generic computer that determines whether the subject is a candidate at risk of glaucoma based on an anterior chamber depth of the subject included in the measurement information acquired. This judicial exception is not integrated into a practical application because the claims are directed to an abstract idea with additional generic computer elements, for the generically recited computer elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. The claim(s) do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations only store and retrieve information in memory, for these are well-understood, routine, conventional computer functions as recognized by the court decisions listed in MPEP § 2106.05(d).
Furthermore, ‘claims do recite a mental process when they contain limitations that can practically be performed in the human mind, including for example, observations, evaluations, judgments, and opinions, e.g., selecting/determining a subject at risk of glaucoma as a candidate. Examples of claims that recite mental processes include: a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016);’ See MPEP § 2106.04(a)(2).
Selecting a subject for clinical testing, an information acquisition unit/step, measurement by ophthalmologic apparatus, and determination unit/step represent routine and conventional use of generic technology. The computing system performs no improvement to itself or to the operation of the ophthalmologic information processing device or visual test systems. Therefore, the claim does not recite any improvement to the underlying functioning of visual testing technology, to OCT systems, or to computer hardware, for the claim instead recites the application of known AI techniques to a medical context. ‘Limitations that the courts have found not to be enough to qualify as “significantly more” when recited in a claim with a judicial exception include: i. Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer (e.g., a computer; an ophthalmologic apparatus including, in a single device, measurement functions for the subject's anterior chamber depth, axial length, and refractive power;), as discussed in Alice Corp., 573 U.S. at 225-26, 110 USPQ2d at 1984 (See MPEP § 2106.05(f)); ii. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (See MPEP § 2106.05(d));’ See MPEP § 2106.05.
Thus, there is no transformation of a physical object, no improved technological performance, and no meaningful limitation confining the abstract idea (involving mental processes, mathematical modeling, and data analysis in a medical context) to a particular implementation beyond generic computer components. See MPEP § 2106.05(d). Accordingly, Claims 1-5 and 8-9 are rejected under 35 U.S.C. 101.
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: “measurement functions for the subject's anterior chamber depth, axial length, and refractive power” and “determines whether the subject is a candidate at risk of glaucoma based on an anterior chamber depth of the subject included in the measurement information” in Claims 1, and 8-9, “acquires measurement information of an eye of the subject measured by an ophthalmologic apparatus” in Claims 1 and 8, “determines that the subject is the candidate at risk of glaucoma when the anterior chamber depth of the subject is less than 2 mm” in Claim 2, “determination unit performs a stepwise determination” in Claim 3, “determination unit assigns greater weight to the axial length than to the refractive power, and assigns greater weight to the anterior chamber depth than to both the refractive power and the axial length to perform a stepwise determination” in Claim 4, and “determination unit determines in a stepwise manner whether the subject is the candidate at risk of glaucoma, giving greater weight to the axial length than to the refractive power, and giving greater weight to the anterior chamber depth than to both the refractive power and the axial length” in Claim 5.
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 1-5, and 8-9 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 1-5, and 8-9, 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, "determines whether the subject is a candidate at risk of glaucoma based on an anterior chamber depth of the subject included in the measurement information" in Claims 1, and 8-9 recites functional language, for the claim limitations merely recite a description of a problem to be solved or a function or result achieved by the invention. This limitation merely recites a result without specifying how this “determination” is performed. There is no defined algorithm, rule, threshold, comparison, functions, or specific processing recited for evaluation and it simply states the outcome of the analysis without reciting sufficient structure and/or operative steps for performing the determination that achieves this result. Thus, this limitation is purely functional and result-oriented. In regard to Claims 1-5, 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).
With respect to Claims 1-5, and 8-9, a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011), Katz, 639 F.3d at 1318, 97 USPQ2d at 1749 (citing IPXL Holdings v. Amazon.com, Inc., 430 F.3d 1377, 1384, 77 USPQ2d 1140, 1145 (Fed. Cir. 2005).
In the current instance, "an ophthalmologic information processing system for selecting a subject at risk of glaucoma as a candidate" in Claim 1, “an ophthalmologic information processing program for selecting a subject at risk of glaucoma as a candidate by using an ophthalmologic apparatus and a computer,” in Claim 8, and “an ophthalmologic information processing method for selecting a subject at risk of glaucoma as a candidate using an ophthalmologic apparatus and a computer” in Claim 9, recite an apparatus and methods of using the apparatus within apparatus and method/process claim limitations. Thus, it is unclear whether infringement occurs when one creates a system that allows for selection of a subject at risk of glaucoma as a candidate, or whether infringement occurs when a subject at risk of glaucoma is actually selected as a candidate. See Ex parte Lyell, 17 USPQ2d 1548 (Bd. Pat. App. & Inter. 1990) & MPEP § 2173(p).
With respect to Claims 1 and 8, the recitation “measurement information of an eye of the subject measured by an ophthalmologic apparatus” seems to be ambiguous in definition. It is unclear how the limitation(s) should be interpreted and it is unclear as to what the metes and bounds of the above claim limitations are and would be needed to meet the above claim limitations. In the instant case, it is unclear whether the measurement information is measured by the same ophthalmologic apparatus of the instant application, for “an ophthalmologic apparatus” is already recited prior in the claims and with proper antecedent basis (e.g., see “an ophthalmologic apparatus including, in a single device…an information acquisition unit, located in one of the computer or the ophthalmologic apparatus, that acquires measurement information of an eye of the subject measured by an ophthalmologic apparatus” in as-filed Claim 1). This creates ambiguity regarding when the measurement information is acquired and if the measurement information is preset data or being acquired within the device of the instant application. Thus, a person having ordinary skill in the art would not be able to reasonably ascertain the scope of invention.
With respect to Claims 4 and 5, the recitation(s) “wherein the determination unit assigns greater weight to the axial length than to the refractive power, and assigns greater weight to the anterior chamber depth than to both the refractive power and the axial length to perform a stepwise determination as to whether the subject is the candidate at risk of glaucoma” in Claim 4 and “the determination unit determines in a stepwise manner whether the subject is the candidate at risk of glaucoma, giving greater weight to the axial length than to the refractive power, and giving greater weight to the anterior chamber depth than to both the refractive power and the axial length” in Claim 5 include relative terminology which render the claim(s) indefinite. The term(s) “assigns/giving greater weight” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree(s), and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. These limitations recite relative terminology without defining the magnitude, scale, or method by which the weights are determined or applied. Furthermore, these claims provide no objective standard, numerical relationship between the parameters, or algorithm for how the comparative weighting is implemented in the “stepwise determination/manner.” It is unclear how much greater the weighting must be, how the stepwise determination is actually performed, or whether these parameters are dependent or independent on one another when adjusting the weight and/or importance. Since a person having ordinary skill in the art would not be able to reasonably ascertain the boundaries of these limitations, the anterior chamber depth, refractive power, and axial length measurement information of the subject are also rendered indefinite by the use of “assigns/giving greater weight.”
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 ophthalmologic information processing system, ophthalmologic information processing program, and ophthalmologic information processing method.
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.
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.
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 1-5, and 8-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Walsh et al. US 20110299034 A1 (herein after "Walsh").
With respect to Claim 1, Walsh discloses an ophthalmologic information processing system (system 100, 3050; [0301], figs. 1, 21) for selecting a subject at risk of glaucoma as a candidate (system 100, 3050 indicates that the patient is at risk of suffering from a glaucoma condition; [0301]), the ophthalmologic information processing system (system 100, 3050; [0301], figs. 1, 21) comprising:
a computer (computer system of system 100, 3050; [0301]; fig. 1);
an ophthalmologic apparatus (optical coherence tomography system 3050; [0275]) including, in a single device (present invention relates to utilization of optical coherence tomography, in conjunction with one or more display devices, one or more input devices, and a central processor to perform multitude of ophthalmic diagnostic tests and other testing in one single, small instrument that are currently completed by many separate instruments; [0006]), measurement functions for the subject’s anterior chamber depth (system 100, 3050 measures anterior chamber depth or corneal thickness of a user; [0302]), axial length (computer system 104 of system 100 as seen in fig. 1 including corneal Z-offset in combination with retinal Z-offset utilized to determine axial length of the eye; [0316]), and refractive power (auto-focus system for automatically determining refractive errors for each eye of the subject, processing module configured to perform refractive error analysis based on optical coherence tomography measurements; [0077]; e.g., computer system 104 configured to use corneal Z-offset in combination with other parameters to determine and/or calculate refractive error of the eyes; [0316]);
an information acquisition unit (self-administered OCT test; [0301], information received by input device 3055 of system 3050; [0277]), located in one of the computer (computer system of system 100, 3050; [0301]; fig. 1) or the ophthalmologic apparatus (optical coherence tomography system 3050; [0275]), that acquires measurement information (information related to ophthalmic condition received via input device 3055 of system 3050; [0276]) of an eye of the subject (self-administered OCT test performed on patients, information utilized for screening glaucoma; [0301]) measured by an ophthalmologic apparatus (optical coherence tomography system 3050; [0275]; OCT measurement obtained by OCT systems positioning Z-offset adjustment stage 290 and utilizing adjustable optics 210; [0303-307]); and
a determination unit (output device 102, 3105 of system 100, 3050; figs. 1, 21), located in one of the computer (computer system of system 100, 3050; [0301]; fig. 1) or the ophthalmologic apparatus (optical coherence tomography system 3050; [0275]), that determines whether the subject is a candidate at risk of glaucoma (thickness or depth to be used in comparisons or as output; [0306] & measurements utilized to determine that patient is suffering from condition e.g., narrow-angle glaucoma; [0309]) based on an anterior chamber depth of the subject (measure the anterior chamber depth or a corneal thickness of a user; [0304]) included in the measurement information (information related to ophthalmic condition received via input device 3055 of system 3050; [0276]) acquired (measured data may be loaded from a storage component; [0304]) by the information acquisition unit (self-administered OCT test; [0301], information received by input device 3055 of system 3050; [0277]) and either an axial length of the subject (computer system 104 of system 100 as seen in fig. 1 including corneal Z-offset in combination with retinal Z-offset utilized to determine axial length of the eye; [0316]) included in the measurement information (information related to ophthalmic condition received via input device 3055 of system 3050; [0276]) or a refractive power of the subject's eye (determining refractive errors for each eye of the subject; [0077]; e.g., computer system 104 configured to use corneal Z-offset in combination with other parameters to determine and/or calculate refractive error of the eyes; [0316]) included in the measurement information (information related to ophthalmic condition received via input device 3055 of system 3050; [0276]).
With respect to Claim 2, Walsh discloses the ophthalmologic information processing system (system 100, 3050; [0301], figs. 1, 21) of claim 1, wherein the determination unit (output device 102, 3105 of system 100, 3050; figs. 1, 21) determines that the subject is the candidate at risk of glaucoma (in the instance of narrow-angle glaucoma, smaller anterior chamber depths are associated with the condition; [0302]) when the anterior chamber depth of the subject is less than 2 mm (threshold may include an anterior chamber depth of about 2.1 mm, 2.0 mm, 1.5 mm or 1.0 mm; [0302]) and the axial length of the subject is 26.5 mm or greater (if the axial length of the eye is greater than 25 mm then the subject/patient is at a higher risk for various eye diseases or abnormalities; [0320]), or when the anterior chamber depth of the subject is less than 2 mm (threshold may include an anterior chamber depth of about 2.1 mm, 2.0 mm, 1.5 mm or 1.0 mm; [0302]) and the refractive power of the subject's eye is stronger than -8 D (computer system 104 of system 100 as seen in fig. 1 configured to determine whether the refractive errors for both eyes is greater than -10 diopters in the myopic range and less than +5 diopters in the hyperopic range, greater than -10 diopters inclusive of exceeding -8 D; [0323]).
With respect to Claim 3, Walsh discloses the ophthalmologic information processing system (system 100, 3050; [0301], figs. 1, 21) of claim 1, wherein the determination unit (output device 102, 3105 of system 100, 3050; figs. 1, 21) performs a stepwise determination (at step 3020, an ophthalmic output is determined based on the optical coherence tomography measurements; [0284]) using the anterior chamber depth (system 100, 3050 measures anterior chamber depth or corneal thickness of a user; [0302]), the axial length (computer system 104 of system 100 as seen in fig. 1 including corneal Z-offset in combination with retinal Z-offset utilized to determine axial length of the eye; [0316]), and the refractive power (determining refractive errors for each eye of the subject; [0077]; e.g., computer system 104 configured to use corneal Z-offset in combination with other parameters to determine and/or calculate refractive error of the eyes; [0316]) to determine whether the subject is the candidate at risk of glaucoma (measurements utilized to determine that patient is suffering from condition e.g., narrow-angle glaucoma; [0309]).
With respect to Claim 4, Walsh discloses the ophthalmologic information processing system (system 100, 3050; [0301], figs. 1, 21) of claim 3, wherein the determination unit (output device 102, 3105 of system 100, 3050; figs. 1, 21) assigns greater weight to the axial length than to the refractive power (corneal Z-offset in combination with retinal Z-offset used to determine axial length, computer system 104 configured to use corneal Z-offset in combination with other parameters to determine and/or calculate refractive error; [0316]), and assigns greater weight to the anterior chamber depth than to both the refractive power and the axial length (e.g., information may indicate a particular ophthalmic measurement of interest like an anterior chamber depth or a concerning feature, may indicate a current ophthalmic measurement and/or a threshold of the measurement, threshold may be absolute or relative; [0297]) to perform a stepwise determination (system 100, 3050 measures and compares user’s ophthalmic information to determine whether user is suffering from or is at risk of suffering from a glaucoma condition; [0302]) as to whether the subject is the candidate at risk of glaucoma ([0309]).
With respect to Claim 5, Walsh discloses the ophthalmologic information processing system (system 100, 3050; [0301], figs. 1, 21) of claim 4, wherein when the anterior chamber depth of the subject is less than 2mm (threshold may include an anterior chamber depth of about 2.1 mm, 2.0 mm, 1.5 mm or 1.0 mm; [0302]), the axial length of the subject is 26.5 mm or greater (if the axial length of the eye is greater than 25 mm then the subject/patient is at a higher risk for various eye diseases or abnormalities; [0320]), and the refractive power of the subject's eye is stronger than -8D (computer system 104 of system 100 as seen in fig. 1 configured to determine whether the refractive errors for both eyes is greater than -10 diopters in the myopic range and less than +5 diopters in the hyperopic range, greater than -10 diopters inclusive of exceeding -8 D; [0323]), or when the anterior chamber depth of the subject is less than 2mm (threshold may include an anterior chamber depth of about 2.1 mm, 2.0 mm, 1.5 mm or 1.0 mm; [0302]) and the axial length of the subject is 26.5 mm or greater (if the axial length of the eye is greater than 25 mm then the subject/patient is at a higher risk for various eye diseases or abnormalities; [0320]), or when the anterior chamber depth of the subject is less than 2mm (threshold may include an anterior chamber depth of about 2.1 mm, 2.0 mm, 1.5 mm or 1.0 mm; [0302]) and the refractive power of the subject's eye is stronger than -8 D (computer system 104 of system 100 as seen in fig. 1 configured to determine whether the refractive errors for both eyes is greater than -10 diopters in the myopic range and less than +5 diopters in the hyperopic range, greater than -10 diopters inclusive of exceeding -8 D; [0323]), the determination unit (output device 102, 3105 of system 100, 3050; figs. 1, 21) determines in a stepwise manner (system 100, 3050 measures and compares user’s ophthalmic information to determine whether user is suffering from or is at risk of suffering from a glaucoma condition; [0302]) whether the subject is the candidate at risk of glaucoma ([0309]), giving greater weight to the axial length than to the refractive power (corneal Z-offset in combination with retinal Z-offset used to determine axial length, computer system 104 configured to use corneal Z-offset in combination with other parameters to determine and/or calculate refractive error; [0316]), and giving greater weight to the anterior chamber depth than to both the refractive power and the axial length (e.g., information may indicate a particular ophthalmic measurement of interest like an anterior chamber depth or a concerning feature, may indicate a current ophthalmic measurement and/or a threshold of the measurement, threshold may be absolute or relative; [0297]).
With respect to Claim 8, Walsh discloses an ophthalmologic information processing program for selecting a subject at risk of glaucoma as a candidate ([0301]) by using an ophthalmologic apparatus (optical coherence tomography system 3050; [0275]) and a computer (computer system of system 100, 3050; [0301]; fig. 1), the ophthalmologic apparatus (optical coherence tomography system 3050; [0275]) including, in a single device (present invention relates to utilization of optical coherence tomography, in conjunction with one or more display devices, one or more input devices, and a central processor to perform multitude of ophthalmic diagnostic tests and other testing in one single, small instrument that are currently completed by many separate instruments; [0006]), measurement functions for the subject's anterior chamber depth (system 100, 3050 measures anterior chamber depth or corneal thickness of a user; [0302]), axial length (computer system 104 of system 100 as seen in fig. 1 including corneal Z-offset in combination with retinal Z-offset utilized to determine axial length of the eye; [0316]), and refractive power (determining refractive errors for each eye of the subject; [0077]; e.g., computer system 104 configured to use corneal Z-offset in combination with other parameters to determine and/or calculate refractive error of the eyes; [0316]), the ophthalmologic information processing program causing the computer (computer system of system 100, 3050; [0301]; fig. 1) to perform:
an information acquisition step ([0301]) in which an information acquisition unit (self-administered OCT test; [0301], information received by input device 3055 of system 3050; [0277]) of the computer (computer system of system 100, 3050; [0301]; fig. 1) acquires measurement information (information related to ophthalmic condition received via input device 3055 of system 3050; [0276]) of an eye of the subject (self-administered OCT test performed on patients, information utilized for screening glaucoma; [0301]) measured by an ophthalmologic apparatus (optical coherence tomography system 3050; [0275]; OCT measurement obtained by OCT systems positioning Z-offset adjustment stage 290 and utilizing adjustable optics 210; [0303-307]); and
a determination step ([0301]) in which a determination unit (output device 102, 3105 of system 100, 3050; figs. 1, 21) of the computer (computer system of system 100, 3050; [0301]; fig. 1) determines whether the subject is a candidate at risk of glaucoma (thickness or depth to be used in comparisons or as output; [0306] & measurements utilized to determine that patient is suffering from condition e.g., narrow-angle glaucoma; [0309]) based on an anterior chamber depth of the subject (measure the anterior chamber depth or a corneal thickness of a user; [0304]) included in the measurement information (information related to ophthalmic condition received via input device 3055 of system 3050; [0276]) acquired (measured data may be loaded from a storage component; [0304]) by the information acquisition unit (self-administered OCT test; [0301], information received by input device 3055 of system 3050; [0277]) and on the subject's axial length (computer system 104 of system 100 as seen in fig. 1 including corneal Z-offset in combination with retinal Z-offset utilized to determine axial length of the eye; [0316]) and the refractive power of the subject's eye (determining refractive errors for each eye of the subject; [0077]; e.g., computer system 104 configured to use corneal Z-offset in combination with other parameters to determine and/or calculate refractive error of the eyes; [0316]) included in the measurement information (information related to ophthalmic condition received via input device 3055 of system 3050; [0276]).
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. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986).
With respect to Claim 9, Walsh discloses an ophthalmologic information processing method for selecting a subject at risk of glaucoma as a candidate using an ophthalmologic apparatus (optical coherence tomography system 3050; [0275]) and a computer ([0301]) the ophthalmologic apparatus (optical coherence tomography system 3050; [0275]) including, in a single device (present invention relates to utilization of optical coherence tomography, in conjunction with one or more display devices, one or more input devices, and a central processor to perform multitude of ophthalmic diagnostic tests and other testing in one single, small instrument that are currently completed by many separate instruments; [0006]), measurement functions for the subject's anterior chamber depth (system 100, 3050 measures anterior chamber depth or corneal thickness of a user; [0302]), axial length (computer system 104 of system 100 as seen in fig. 1 including corneal Z-offset in combination with retinal Z-offset utilized to determine axial length of the eye; [0316]), and refractive power (determining refractive errors for each eye of the subject; [0077]; e.g., computer system 104 configured to use corneal Z-offset in combination with other parameters to determine and/or calculate refractive error of the eyes; [0316]), the ophthalmologic information processing method comprising:
an information acquisition step ([0301]) in which an information acquisition unit (self-administered OCT test; [0301], information received by input device 3055 of system 3050; [0277]) of the computer (computer system of system 100, 3050; [0301]; fig. 1) acquires measurement information (information related to ophthalmic condition received via input device 3055 of system 3050; [0276]) of an eye of the subject (self-administered OCT test performed on patients, information utilized for screening glaucoma ([0301]); measured by the ophthalmologic apparatus (optical coherence tomography system 3050; [0275]; OCT measurement obtained by OCT systems positioning Z-offset adjustment stage 290 and utilizing adjustable optics 210; [0303-307]); and
a determination step ([0301]) in which a determination unit (output device 102, 3105 of system 100, 3050; figs. 1, 21) of the computer (computer system of system 100, 3050; [0301]; fig. 1) determines whether the subject is a candidate at risk of glaucoma (thickness or depth to be used in comparisons or as output; [0306] & measurements utilized to determine that patient is suffering from condition e.g., narrow-angle glaucoma; [0309]) based on an anterior chamber depth of the subject (measure the anterior chamber depth or a corneal thickness of a user; [0304]) included in the measurement information (information related to ophthalmic condition received via input device 3055 of system 3050; [0276]) acquired (measured data may be loaded from a storage component; [0304]) by the information acquisition unit (self-administered OCT test; [0301], information received by input device 3055 of system 3050; [0277]) and on the subject's axial length (computer system 104 of system 100 as seen in fig. 1 including corneal Z-offset in combination with retinal Z-offset utilized to determine axial length of the eye; [0316]) and the refractive power of the subject’s eye (determining refractive errors for each eye of the subject; [0077]; e.g., computer system 104 configured to use corneal Z-offset in combination with other parameters to determine and/or calculate refractive error of the eyes; [0316]) included in the measurement information (information related to ophthalmic condition received via input device 3055 of system 3050; [0276]).
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. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/K MUHAMMAD/Examiner, Art Unit 2872 06 March 2026
/SHARRIEF I BROOME/Primary Examiner, Art Unit 2872