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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/23/2023 has been entered.
Response to Amendment
Receipt is acknowledged of the amendment filed 1/23/2026. Claims 1-2, 7-12, 14, 16-17 are amended and claims 1-19 are currently pending.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show structural details encoded in color in colored drawings (e.g. yellow/red circles and lead lines to elements described in the specification). Elements of the drawings that are intended to highlight essential subject matter to provide context to the drawings (i.e. yellow/red circles and lead lines to elements) are not legibly reproduced in black and white versions. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). 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.
The drawings are objected to because “color drawings must be of sufficient quality such that all details in the drawings are reproducible in black and white in the printed patent” (37 C.F.R. 1.84). The red/yellow circles (Figs. 4A, 5A), cones (e.g. Figs. 4A, 5A), and lead lines (Figs. 1A, 4A, 5A, 6A) are illegible in the black and white versions of the colored drawings. 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.
Examiner Notes
In an effort to practice compact prosecution, the following understanding of Applicant’s invention is explained in light of the 35 U.S.C. 112 rejections below. The Examiner’s understand is meant to serve as the context in which the language is rejected as indefinite and failing to comply with the written description requirement.
In correspondence to Fig. 10, Applicant discloses “a method of determining if cornea information may be used for fitting scleral or corneo-scleral lenses” including steps of “[f]rom the cornea topography map, surface patterns (peaks and valleys) are determined, step 1014”, “observe the scleral elevation map (FIG. 1A, 1030) defining the pattern of elevations and depressions (1024), defining scleral patterns based upon their location on a circle 360° around, and their distance from the center of the cornea”, and “correlating scleral shape plot is used to characterize the irregularities of the scleral, see step 1040”. Importantly, this method serves as the basis of determining if there is correlation between cornea and scleral patterns and not fitting a lens to a patient for which corneal and scleral topography was obtained by imaging. In the Applicant’s 1/23/2026 Response, it is argued that there is support for the claimed determining step, characterizing step, and creating step in [0095]-[0096] and [0099]. These cited portions are distinct processed whereby [0095]-[0096] discusses the method of Fig. 10 in which case studies of prior, sampled patients are relied upon to determine whether a correlation of corneal and scleral data exists. Figs. 4, 5, 6 are exemplary images from the case study and do not represent topography data of the individual in need as included in the claimed “method of fitting a sclera or corneo-scleral lens to an individual in need”.
In correspondence to Fig. 11, Applicant discloses “a method of fitting scleral or corneo-scleral lenses using corneal topography” including steps of “[f]rom the cornea topography map, surface patterns are determined, step 1114”, “a correlating cornea shape plot is created (similar to FIG. 4B, see step 1120”, “characterize the irregularities of the cornea, see step 1122” and ultimately “data relating to the characterizations of the irregularities are then used to define the irregularities in the sclera, see step 1130” and “[s]uch data can be used to create scleral or corneo-scleral lens or scleral or corneo-scleral fitting lens sets, step 1136”. Importantly, this method of creating a lens based on sclera irregularities based on a determined “relationship” neither includes plotting scleral surface patterns in need of fitting nor determining a relationship “between the cornea surface patterns and the sclera surface patterns”. If sclera surface patterns of the individual in need are plottable (as required in the claim) and therefore known, it is unclear what steps comprise “determining, at one or more points along a circumference of the eye at a selected radius from a center of the cornea of the eye, a relationship between the cornea surface patterns and the sclera surface patterns”. Further, if sclera surface patterns of the individual in need are plottable 9as required in the claim) and therefore known, it is unclear where Applicant has described characterizing irregularities based on an indirect determination step (i.e. based on a relationship between data) as all characterizing irregularities within obtained data is a directly determination that the data represents an irregularity.
The originally-filed [0099] contains multiple errors in describing Figs. 5B and 6B, though correctly describes Fig. 4B. Applicant describes inferring information about scleral elevations and depressions (e.g. locations of scleral SAG values) based on the elevations and depressions of corneal data alone. Para [0099] incorrectly describes Fig. 5B as providing a lowest corneal point at 90⁰ when the highest corneal point is at 90⁰ and incorrectly describes scleral correspondence as providing a highest point at 90⁰. While this could be described as a two-fold typographical error, the description of Fig. 6B and 6C is more discordant with the data. In [0099], Applicant states “This depression would correspond to the high point on the sclera at around 320° … using only the cornea topography, eye care practitioners would be able to map out an irregularity of a high point at the corresponding point in the sclera”. Whereas in [0082], Applicant states “FIG. 6C shows a sclera on a circumferential shape plot graph 142, at an 8 mm radius that demonstrates no real correlation between the high point of the cone and the scleral shape”. Despite these mistakes in [0099] muddling the correlation between corneal topography and scleral topography and a practitioner’s fidelity in inferring scleral topography from only corneal topography, the methodology of fitting in Fig. 11 is clear and does not include the steps of Fig. 10.
On the issue of the metes and bounds of “create” in the claim language “creating a sclera or corneo-scleral lens or sclera or corneo-scleral fitting lens comprising a shape based on the sclera irregularities of said sclera of said individual”, the plain meaning of create is inconsistent with the use in the Specifications. The Oxford English Dictionary defines “create” as “to make, form, set up, or bring into existence (something which has not existed before); to produce (a work of imagination or invention; an artefact)”. In [0100] of Applicant’s disclosure, creating is synonymous with an eye care professional knowing where a scleral irregularity would be located based only on cornea topography and thus fitting the lens to the eye with the irregularity. In the more convention meaning of “create”, the eye care professional fitting the lens to the eye with irregularities is not creating the lens but rather utilizing a created lens (e.g. selecting the created lens, prescribing the created lens, applying the created lens to the eye, and/or evaluating comfort and performance of the applied created lens). Otherwise in the disclosure, it is clear that the case study in correlation between corneal topography and scleral topography may be used to design a finite number of lenses from which a practitioner may prescribe for a patient. In terms of a method inclusive of obtaining an individual’s corneal topography and creating a lens based on scleral irregularities of the individual, based on a determined relationship between cornea surface patterns and sclera surface patterns of the individual, the scope of the step includes merely providing a manufactured lens.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-14 and 16-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “a method of fitting a sclera or a corneo-scleral lens to an individual in need, the method comprising the steps of obtaining, via a topography imaging device, a corneal topography of an eye of the individual in need of sclera or corneo-scleral lens fitting; plotting one or more surface patterns of a cornea of said individual in need of sclera or corneo-scleral lens fitting; plotting one or more surface patterns of a sclera of the eye of said individual in need of sclera or corneo-scleral lens fitting; determining, at one or more points along a circumference of the eye at a selected radius from a center of the cornea of the eye, a relationship between the cornea surface patterns and the sclera surface patterns, characterizing, based on the determined relationship and a position of a highest elevation of the cornea, sclera irregularities; and creating a sclera or corneo-scleral lens or sclera or corneo-scleral fitting lens comprising a shape based on the sclera irregularities of said sclera of said individual” (emphasis added). Applicant does not evidence possession of the claimed determining and characterizing steps in the context of plotting scleral surface patterns of an individual in need. Applicant provides support for obtaining cornea topography (1012 of Fig. 10 and 1112 of Fig. 11), plotting corneal patterns (1014 of Fig. 10 and 1120 of Fig. 11), plotting scleral patterns (1030 and 1038 of Fig. 10), and determining relationships between a highest corneal elevation and sclera irregularities (1048, 1050, and 1052 of Fig. 10), and characterizing scleral irregularities (1040 of Fig. 10 and 1130 of Fig. 11). The characterizing of scleral irregularities in Figs. 10 and 11 are substantively different as the characterizing in Fig. 10 merely includes determining plot shapes of scleral data and characterizing in Fig. 11 is an inference based on a correlation between corneal topography and scleral irregularities based only on corneal topography data. The collection of claimed steps appears to be a muddled fusion of steps for determining whether scleral irregularities may be determined from corneal data alone and actual use of the assumption that corneal data indicated scleral irregularities. Examination on the merits is pre-empted, though the following proposed amendment hopefully illuminates Examiner’s argument by clearly distinguishing between Applicant’s methods included in Figs. 10 and 11.
1. (Currently Amended) A method of determining if cornea information may be used for fitting scleral or corneo-scleral lenses and of fitting a sclera or a corneo-scleral lens to an individual in need, the method comprising the steps of:
obtaining, via a topography imaging device, a plurality of corneal patterns based on corneal topography of respective eyes;
obtaining, via the topography imaging device, a plurality of scleral patterns based on scleral topography of the respective eyes;
determining a correlation exists between elevations and/or depressions of said corneal patterns and irregularities of said scleral patterns, based on comparing said corneal patterns with said scleral patterns,
obtaining, via a topography imaging device, a corneal topography of an eye of the individual in need of sclera or corneo-scleral lens fitting;
plotting one or more surface patterns of a cornea of said individual in need of sclera or corneo-scleral lens fitting;
determining a highest elevation of the cornea of said individual in need of sclera or corneo-scleral lens fitting based on the one or more surface patterns,
mapping scleral irregularities [[characterizing,]] based on the [[determined relationship]] correlation between corneal patterns and scleral patterns and the position of the highest elevation of the cornea of said individual in need of sclera or corneo-scleral lens fitting [[, sclera irregularities]]; and
[[creating]] providing a sclera or corneo-scleral lens or sclera or corneo-scleral fitting lens comprising a shape based on the sclera irregularities of said sclera of said individual.
In the proposed claim above, the methods of Figs. 10 and 11 have been combined in order to clarify the previously claimed “relationship between the cornea surface patterns and the sclera surface patterns” and connect that relationship to creating and/or providing a lens to an individual that has been imaged. Dependent Claims 2-13 (1/23/2026 Claims) ought to more clearly limit plots and plot features of case study eyes versus plots and plot features of eyes of the individual in need of lens fitting. Dependent Claim 14 (1/23/2026 Claims) is addressed with a separate grounds for rejection below. Dependent Claim 16-19 (1/23/2026 Claims) are reworded and included in the proposed amendment to Claim 1 and therefore could be substantially canceled.
Claim 14 recites “said step of creating a sclera or corneo-scleral lens to fit the sclera of said individual is a first sclera or corneo-scleral lenses of a first sclera, and the method includes further comprises: designing a second shape of a second sclera or corneo-scleral lens or sclera or corneo- scleral fitting based on sclera irregularities of a second sclera of said individual, and providing said individual with the first and the second sclera or corneo-scleral lenses, wherein the first sclera or corneo-scleral lens is configured to fit the first sclera and the second sclera or corneo-scleral lens is configured to fit the second sclera of said individual” As the claim limits the designing and providing to a second sclera of the individual, it is not believed that Applicant’s intention is to capture trial lenses. It is believed that Applicant’s intention is to provide a lens for a second sclera of the same individual, meaning a second sclera of a second eye of the same individual. There is no disclosure corresponding to these steps of designing and providing. It is unclear if the metes and bounds of the claim capture repeating the steps recited in Claim 1 for a second sclera and second cornea, or if there is another methodology for designing and providing sclera or corneo-scleral lenses. Applicant did not evidence possession of this method at the time of invention. Dependent Claim 15 fails to remedy the deficiency of the base claim.
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 1-14 and 16-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “a method of fitting a sclera or a corneo-scleral lens to an individual in need, the method comprising the steps of obtaining, via a topography imaging device, a corneal topography of an eye of the individual in need of sclera or corneo-scleral lens fitting; plotting one or more surface patterns of a cornea of said individual in need of sclera or corneo-scleral lens fitting; plotting one or more surface patterns of a sclera of the eye of said individual in need of sclera or corneo-scleral lens fitting; determining, at one or more points along a circumference of the eye at a selected radius from a center of the cornea of the eye, a relationship between the cornea surface patterns and the sclera surface patterns, characterizing, based on the determined relationship and a position of a highest elevation of the cornea, sclera irregularities; and creating a sclera or corneo-scleral lens or sclera or corneo-scleral fitting lens comprising a shape based on the sclera irregularities of said sclera of said individual” (emphasis added). The determining and characterizing steps in the context of plotting scleral surface patterns of an individual in need does not clearly define the metes and bounds of the claimed invention. In the Specifications, Applicant provides supporting disclosure for obtaining cornea topography (1012 of Fig. 10 and 1112 of Fig. 11), plotting corneal patterns (1014 of Fig. 10 and 1120 of Fig. 11), plotting scleral patterns (1030 and 1038 of Fig. 10), and determining relationships between a highest corneal elevation and sclera irregularities (1048, 1050, and 1052 of Fig. 10), and characterizing scleral irregularities (1040 of Fig. 10 and 1130 of Fig. 11). The characterizing of scleral irregularities in Figs. 10 and 11 are substantively different from the characterizing in Fig. 10 as the characterizing merely includes determining plot shapes of scleral data. Characterizing in Fig. 11 is an inference based on a correlation between corneal topography and scleral irregularities based only on corneal topography data of an individual in need. The collection of claimed steps appears to be a muddled fusion of steps for determining whether scleral irregularities may be determined from corneal data alone and actual use of the assumption that corneal data indicated scleral irregularities. With the claim plotting surface patterns of a sclera of the individual, there are no clear metes and bounds of the determining and characterizing steps as claimed. Examination on the merits is pre-empted, though the proposed amendment provided above hopefully illuminates Examiner’s argument by clearly distinguishing between Applicant’s methods included in Figs. 10 and 11.
In the proposed claim above, the methods of Figs. 10 and 11 have been combined in order to clarify the previously claimed “relationship between the cornea surface patterns and the sclera surface patterns” and connect that relationship to creating and/or providing a lens to an individual that has been imaged. Dependent Claims 2-13 (1/23/2026 Claims) ought to more clearly limit plots and plot features of case study eyes versus plots and plot features of eyes of the individual in need of lens fitting. Dependent Claim 14 (1/23/2026 Claims) is addressed with a separate grounds for rejection below. Dependent Claim 16-19 (1/23/2026 Claims) are reworded and included in the proposed amendment to Claim 1 and therefore could be substantially canceled.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pat. No. 9,421,721 to Gemoules (hereinafter Gemoules).
Regarding claim 1, Gemoules discloses a method of fitting a sclera or a corneo-scleral lens to an individual in need (Fig. 2; col. 5, ll. 8-63), the method comprising the steps of obtaining, via a topography imaging device (Fig. 1), a corneal topography (capture sagittal images 201, Fig. 2-3; col. 5, ll. 8-col. 6, ln. 29) of an eye of the individual in need of sclera or corneo-scleral lens fitting; plotting one or more surface patterns of a cornea (“a set of back surface curves are created” 203, Figs. 2-3A; col. 5, ll. 8-col. 6, ln. 29) of said individual in need of sclera or corneo-scleral lens fitting; plotting one or more surface patterns of a sclera (“a haptic surface curve is created for each lens curve to create a set of haptic surface curves” 205, Figs. 2-3A; col. 5, ll. 8-col. 6, ln. 29) of the eye of said individual in need of sclera or corneo-scleral lens fitting; determining, at one or more points along a circumference of the eye at a selected radius from a center of the cornea of the eye, a relationship between said the cornea surface patterns and said the sclera surface patterns (back surface curves and haptic surface curves provided with blend surface 207 and combine in 208, Figs. 2-3A; col. 5, ll. 8-col. 6, ln. 29); characterizing, based on the determined relationship and a position of a highest elevation of the cornea, sclera irregularities (back surface curves and haptic surface curves provided with blend surface 207, Figs. 2-3A; col. 5, ll. 8-col. 6, ln. 29); and creating a sclera or corneo-scleral lens or sclera or corneo-scleral fitting lens comprising a shape based on the sclera irregularities of said sclera of said individual (“the haptic surface, the blend surface, and the optical surface are combined to form a lens surface” in 208 and “the lens is cut by a lathe using the text file” in 214, Figs. 2-3A; col. 5, ll. 8-col. 6, ln. 29).
This rejection is based on the broadest reasonable interpretation of the claims and specifically that collecting corneal and scleral data as shown in Gemoules necessarily provides for determining a relationship between cornea surface patterns and sclera surface patterns and characterization of sclera irregularities based on the determined relationship and a position of a highest elevation of the cornea in the data analyzed. The t-spline modeling technique disclosed by Gemoules based on back surface curves and haptic surface curves inherently accounts for irregularities that would exist in the imaged eye.
Response to Arguments
Applicant's arguments filed 1/23/2026 have been fully considered but they are not persuasive.
On page 6 of the Remarks, Applicant repeats the argument that the drawing objections are in error as the USPTO issued a petition decision granting Applicant’s request. The petition request was on the basis of meeting the requirements of 37 CFR 1.84(a)(2)(i-iii). The petition decision on 12/08/2022 explicitly notes the granting of the petition should not be construed as a determination that the drawings are free of statutory and/or formal defects and the examiner is charged with determining whether the application complied with applicable formal requirements under 37 CFR 1.84, for example.
On pages 6-12 of the Remarks, Applicant argues that the amended claims comply with 35 U.S.C. 112 and the written description requirement. This is substantively addressed in the Examiner Notes and the new 35 U.S.C. 112 sections above. On page 11, Applicant specifically argues that a portion of [0099] teaching a correlation between a highest point elevation in the cornea and the lowest point depression in the sclera exists and eye care professions would be able to map scleral irregularities and thus the Applicant describes “comparing a corneal pattern with a scleral pattern of a single individual to determine and characterize irregularities”. Examiner respectfully disagrees. While the data shown in Figs. 4A-4C are for an individual and not representative of an aggregation of data from a case study, the data are from a case study and not an implementation of a fitting method (see [0079]) and thus are not that which is claimed. Further, the data of Fig. 4C explicitly includes scleral data (see [0080].[0095]) and therefore does not represent data involved in a method using only cornea topography.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER J STANFORD whose telephone number is (571)270-3337. The examiner can normally be reached 8AM-4PM PST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ricky Mack can be reached at (571)272-2333. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER STANFORD/Primary Examiner, Art Unit 2872