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 .
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.
Information Disclosure Statement
The information disclosure statement(s) filed on January 9, 2026 have/has been acknowledged and considered by the examiner. Initialed copies of supplied IDS(s) forms are included in this correspondence.
Response to Amendment
Regarding Applicant’s amendment as it pertains to claim 1 and the alignment adjuster, while the amendment removes the USC 112(f) invocation, the amendment introduces an additional 112(b) regarding the function of the relative position adjustment. See below.
Applicant’s amendment regarding claim 3 and the converter to be a digitizer merely swaps between one USC 112(f) invocation and another.
Applicant’s amendment regarding claim 3, the USC 112(a) issue remains since the digitizer doesn’t include any algorithm to perform the conversion as a computer implemented function.
Applicant’s amendment to claim 7 does not resolve the issue since the computer implemented function continues to lack an algorithm.
Applicant’s remarks as they pertain to the art of Murata are not persuasive. As best as Examiner understands, Applicant doesn’t consider Murata’s pivot point ever lie between Murata’s eye (E) and objective optical system (27).
Murata’s pivot point, like Applicant’s pivot point is the focus the light directed to the eye. Murata does not label the pivot point (focus) but as shown in both Murata Figures 1A,B and 4A,B Murat moves the pivot point from outside the objective, through the objective (27, 27a, 27b, 25) and to the eye (E). As such, the pivot point is provided at a “target position set between the subject eye and the objective optical system”.
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Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
a) a digitizer that samples… (synonymous with means for digitally sampling)…in claim 3.
b) optical path length difference adjuster that adjusts…in claim 4.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 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 1-11 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.
As to claim 1, the claim recites “wherein a relative position between the light guide optical system and the subject eye is adjustable in three-dimensions” which is a function that does not follow from the recited structure (MPEP 2173.05(g)). Specifically, such language is drawn to a function without any indication of how the function is performed. Does the function require some other structure than the splitter, detector, controller, scanner, objective system? Is this a result of operating the device? For purposes of compact prosecution, Examiner will interpret such features as implicit to the device since the human eye is necessarily moveable in three dimensions and thus the relative position between the light guide optical system and eye is adjustable.
Claims 2-11 are rejected as dependent upon claim 1.
Claim 3 limitation “digitizer that samples…and converts” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
Regarding the claim 3 limitation “digitizer that samples…converts” Applicant’s specification does not appear to contain any structure, material for performing the function. Additionally, such converter appears directed to a computer implemented function without the corresponding/sufficient algorithm (MPEP 2181.II.B).
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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 3, 7-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As to claim 3, the claim recites “a digitizer that samples…and converts…” which invokes USC 112(f) as detailed above. Such function appears to be a computer implemented function without the corresponding algorithm (MPEP 2181.II.B - When a claim containing a computer-implemented 35 U.S.C. 112(f) claim limitation is found to be indefinite under 35 U.S.C. 112(b) for failure to disclose sufficient corresponding structure (e.g., the computer and the algorithm) in the specification that performs the entire claimed function, it will also lack written description under 35 U.S.C. 112(a)).
As discussed above, Applicant’s specification fails to disclose the sufficient/necessary algorithm to perform the sampling and conversion of the interference signal via computer algorithm.
As to claim 7, the claim recites “the arithmetic controller analyzes the B-scan data to acquire information representing a tilt of an anterior segment with respect to the fundus” which is a computer implemented function without the corresponding/sufficient algorithm (MPEP 2161.01 - If the specification does not provide a disclosure of the computer and algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention a rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, for lack of written description must be made).
While Applicant’s specification makes references to the NPL of Kim et al.1, such reference is not incorporated by reference, thus such method of determining a tilt (e.g. squint angle (κ)) forms no part of the instant application even if such methodology is used.
Claims 8-10 are rejected as dependent upon claim 7.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-6, 11 are rejected under 35 U.S.C. 102(a1) as being anticipated by Murata et al. (US 2016/0317028 - Murata; of record).
As to claim 1 (as understood), Murata teaches an OCT device (Murata Fig. 1A-9B) comprising
an OCT optical system including
a light splitter that splits light from an OCT light source into measurement light and reference light (Murata Fig. 1A - 15, 15b, 15c; para. [0033]);
a detector that detects a spectral interference signal between the measurement light guided to a subject eye and the reference light (Murata Fig. 1A - 40; para. [0029]),
an arithmetic controller that acquires OCT data based on a signal from the detector (Murata Fig. 1A - 70; para. [0027], [0062]) and controls at least the OCT optical system to execute an OCT data acquisition operation (Murata Fig. 1A - 70; para. [0062]);
a light guide optical system including at least
an optical scanner that scans a tissue of the subject eye with the measurement light (Murata Fig. 1A - 24; para. [0040]),
an objective optical system that is disposed between the optical scanner and the subject eye (Murata Fig. 1A - 27; para. [0038]), and forms a pivot point around which the measurement light passing through the optical scanner is pivoted (Murata Figs. 4A, 4B; para. [0065] - turning position of measurement light being displaced in first and second positions - e.g. corneal vs. retinal positions);
a relative position between the light guide optical system and the subject eye is adjustable in three dimensions (Murata Figs. 1A, 1B - E, 50, 51; para. [0047]);
wherein the arithmetic controller guides the three-dimensional position such that the pivot point is arranged at a target position set between the subject eye and the objective optical system (Murata Fig. 1A, B - 50; pivot (focus/crossing) of light L1 between eye (E) and objective (27) as diver (50) scans the focus from outside the objective (27) to the eye (E); Figs. 4A, 4B), and further executes the OCT data acquisition operation at the target position (Murata Fig. 3; para. [0073], [0078]).
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As to claim 2, Murata teaches all the limitations of the instant invention as detailed above with respect to claim 1, and Murata further teaches a measurement range in a depth direction in the OCT data (Murata Fig. 1A - 34, 34a; para. [0053]; Figs. 4A,B - 34; Fig. 1A - 11, 40; para. [0027], [0093]-[0094]), wherein in a case where the OCT data acquisition operation is executed at the target position, the arithmetic controller controls adjustment of the measurement range such that the measurement range includes a cornea to a fundus of the subject eye (Murata Fig. 3; Figs. 4A, B; Fig. 6; para. [0053], [0093]-[0094]).
As to claim 3, Murata teaches all the limitations of the instant invention as detailed above with respect to claim 2, and Murata further teaches a wavelength-swept light source that is the OCT light source (Murata Fig. 1A - 11; para. [0027], [0093]), a digitizer that samples the spectral interference signal output from the detector (Murata Fig. 1A - 40; para. [0031], [0093]), and converts the spectral interference signal from an analog signal to a digital signal (Murata Fig. 1A - 40; para. [0031], [0093]), wherein the measurement range is adjustable in at least any one of the wavelength-swept light source or the digitizer (Murata para. [0093]-[0094]), and the arithmetic controller controls a sweep frequency of the wavelength-swept light source or a sampling rate of the spectral interference signal in the converter such that the measurement range is longer than an axial length of the subject eye (Murata Fig. 3; Fig. 6; para. [0093]-[0094]).
As to claim 4, Murata teaches all the limitations of the instant invention as detailed above with respect to claim 2, and Murata further teaches the adjustment measurement range includes at least an optical path length difference adjuster that adjusts an optical path length difference between the measurement light and the reference light (Murata Fig. 1A - 34, 34a).
As to claim 5, Murata teaches all the limitations of the instant invention as detailed above with respect to claim 1, and Murata further teaches configured to adjust a focus position of the measurement light (Murata Fig. 1A - 23a; para. [0041]), wherein at the target position, the arithmetic controller adjusts the focus position of the measurement light to a first focus position to acquire first OCT data (Murata Fig. 1A - 23a; para. [0041]), further adjusts the focus position to a second focus position different from the first focus position acquires second OCT data (Murata Fig. 1A - 23a; para. [0041]), and acquires synthetic OCT data by synthesizing the first OCT data and the second OCT data (Murata Fig. 1A - 23a; para. [0041]).
As to claim 6, Murata teaches all the limitations of the instant invention as detailed above with respect to claim 1, and Murata further teaches wherein the arithmetic controller executes the OCT data acquisition operation at the target position such that B-scan data of the OCT data includes a cornea, an iris, and a fundus of the subject eye (Murata Fig. 3; para. [0059]).
As to claim 11, Murata teaches all the limitations of the instant invention as detailed above with respect to claim 1, and Murata further teaches the pivot point is arranged at the target position set between the subject eye and the objective optical system such that the measurement light is incident on the subject eye while moving away from an optical axis of the objective optical system (Murata Figs. 1A,B; Figs. 4A,B - for a pivot point located between eye (E) and objective (27, 25), the rays are divergent into the eye (i.e. move away from the optical axis); additionally, scanner (24) scans the beam across the eye which also movement away from the optical axis).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Murata as applied to claim 6 above, and further in view of Kim et al. (Full ocular biometry through dual-depth whole-eye optical coherence tomography; herein Kim)1.
As to claims 7-8, Murata teaches all the limitations of the instant invention as detailed above with respect to claim 6, but doesn’t specify that arithmetic controller analyzes the B-scan data to acquire information representing a tilt/squint angle of the subject eye.
In the same field of endeavor Kim teaches analyzing B-scan OCT data to determine a tilt/squint angle (Kim Figs. 1, 3, 4, 8, 9; Abstract). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to determine a tilt/squint angle (e.g. κ) since, as taught by Kim, such information is well known in the art for the purpose of gathering such information for ophthalmic surgery (Kim Abstract).
As to claim 9, Murata in view of Kim teaches all the limitations of the instant invention as detailed above with respect to claim 8, and Murata further teaches the cornea and crystalline lens in the OCT data include at least a corneal luminous point and a crystalline lens luminous point (Murata Fig. 3; Fig. 6), and the arithmetic controller obtains the physiological squint angle based at least on a positional relationship between the corneal luminous point, the crystalline lens luminous point, and a fovea centralis on the fundus in the B-scan data (Kim Fig. 8, 9; Section 3.4).
As to claim 10, Murata teaches all the limitations of the instant invention as detailed above with respect to claim 7, and Kim teaches the arithmetic controller analyzes the B-scan data to acquire the information representing the tilt of the anterior segment with respect to the fundus, based on a positional relationship between a pupil center based on an end portion of the iris and a fovea centralis on the fundus (Kim Figs. 1, 3, 4, 8, 9; Abstract).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Makihira et al. (US 9,170,087; 2013/0258349) are cited as additional examples of 3D movement elements of ophthalmic OCTs.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY W WILKES whose telephone number is (571)270-7540. The examiner can normally be reached M-F 8-4 (Pacific).
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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/ZACHARY W WILKES/Primary Examiner, Art Unit 2872 February 9, 2026
1 Hyung-Jin Kim, et al. “Full ocular biometry through dual-depth whole-eye optical coherence tomography” Biomedical Optics Express Vol. 9, Issue 2, pp. 360-372 (2018)