DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
Group I, claims 1-7, drawn to an apparatus, classified in A61B3/103.
Group II, claims 8-9, drawn to a method, classified in A61B3/09.
The inventions are independent or distinct, each from the other because:
Inventions of Group I & II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the apparatus could be used to test an eye with both eyes in focus.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
the inventions have acquired a separate status in the art in view of their different classification;
the inventions have acquired a separate status in the art due to their recognized divergent subject matter;
the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with M. David Galin on June 12, 2026 a provisional election was made with traverse to prosecute the invention of Group I, claims 1-7. Affirmation of this election must be made by applicant in replying to this Office action. Claims 8-9 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement filed August 14, 2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. Specifically, no copy of JP2006122661 was provided. Therefore, this reference has been crossed out and it has not been considered, however the other documents in the information disclosure statement are being considered by the examiner.
The information disclosure statements (IDS) submitted on December 18, 2024 and June 17, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f):
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) because the claim limitations uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are:
“wherein the visual target presenting portion is configured to present the fixation targets while changing an examination distance from the left and right subject eyes to the fixation targets in a predetermined range of the examination distance when an anisometropia is induced, in which one of the left and right subject eyes is maintained in a fully corrected condition and another of the left and right subject eyes is corrected by a predetermined degree from the fully corrected condition, and wherein the controller is configured to control the objective measurement optical system to measure the eye characteristics while the left and right subject eyes binocularly view the fixation targets and acquire refractive values of the left and right subject eyes as objective measurement information” in claim 1;
“the controller is configured to intermittently acquire the objective measurement information at a time when the examination distance has reached a predetermined distance” in claim 2;
“the controller is configured to continuously acquire the objective measurement information while the examination distance is changed in the predetermined range” in claim 3;
“the controller is configured to control the visual target presenting portion” in claim 4;
“the controller is further configured to control the left-eye and right-eye projection optical systems to induce the anisometropia” in claim 4;
“the fusion targets that are depicted in a manner that allows binocular fusion while the left subject eye views the left fixation target and the right subject eye views the right fixation target, and examination targets that are depicted not in a manner that allows binocular fusion while the left subject eye views the left fixation target and the right subject eye views the right fixation target” in claim 5;
“a fixation eye determiner that is configured to determine a fixation eye based on the objective measurement information” in claim 6; and
“the fixation eye determiner is configured to determine a subject eye among the left and right subject eyes as the fixation eye when the subject eye with a difference in a refractive value that is equal to or less than a predetermined threshold, the difference being measured between a refractive value of the subject eye itself and a refractive value at a presentation position of the fixation target when the fixation target is presented, or to determine a subject eye among the left and right subject eyes as the fixation eye when the subject eye causes a larger decrease in a difference between the refractive value of the subject eye itself and the refractive value at a presentation position of the fixation target and when the examination distance is changed from far-point vision to near-point vision” in claim 7.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) applicant may: (1) amend the claim limitations to avoid them being interpreted under 35 U.S.C. 112(f) (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f).
Claim Rejections - 35 USC § 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.
Claims 1-7 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claims 1-7 – the claims are directed to an apparatus. In the claims applicant has several instances of an element that “is configured to” preform a function, raising clarity issues. It is unclear if applicant is requiring a particular use of the device (see MPEP 2173.05(p)) or if applicant is claiming the elements are capable of the various functions (assumed). As an example of language which applicant could use to obviate this rejection the examiner respectfully suggests “wherein the visual target presenting portion is capable of presenting the visual targets while changing an examination distance …” For purposes of examination the examiner the examiner will interpret “is configured to” to be synonymous with “is capable of”.
Regarding claim 6 (and its dependent 7), insofar as it is understood, “the controller comprises a fixation eye determiner that is capable of determin[[e]]ing a fixation eye based on the objective measurement information” raises clarity issues. The specification defines “a fixation eye” under anisometropia condition is the “in focus” eye. It is unclear if the fixation eye is determined (objectively) by measurements when an anisometropia condition is caused by the ophthalmologic apparatus (assumed) or is when an ophthalmologic apparatus is not caused by the ophthalmologic apparatus. For purposes of examination the examiner will use “the controller comprises a fixation eye determiner that is capable of determin[[e]]ing a fixation eye based on the objective measurement information when the ophthalmologic apparatus induces anisometropia.”
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 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sakurada US Patent Application Publication 2016/0345824.
Regarding claim 1 Sakurada discloses an ophthalmologic apparatus (title e.g. figure 1 ophthalmologic apparatus 1) comprising: a visual target presenting portion (abstract “target presenting part” e.g. figure 2 first and second target presenting parts 122L & 122R) that is capable of1 presenting fixation targets to left and right subject eyes (axiomatic e.g. “target presenting part is configured to selectively present a plurality of visual targets to the subject's eye”), respectively (e.g. via 122L & 122R); an objective measurement optical system (abstract “objective measurement part” e.g. first and second objective measurement parts 123L & 123R) that is capable of objectively measuring eye characteristics of the left and right subject eyes (axiomatic e.g. abstract “objective measurement part is configured for performing objective refraction measurement of the subject's eye”), respectively (e.g. via 123L & 123R); and a controller that is capable of controlling the objective measurement optical system (inter alia paragraph [0060] “[u]nder the control of the control system (described later), the measuring head 100 is configured to automatically perform … objective optometry measurement”), wherein each of the fixation targets comprises a fusion target (inter alia paragraph [0055] “fusion target”) that is depicted in a manner that allows binocular fusion while the left and right subject eyes respectively view the fixation targets (axiomatic e.g. paragraph [0060] discusses preforming a binocular balance test), wherein the visual target presenting portion is capable of presenting the fixation targets while changing an examination distance from the left and right subject eyes to the fixation targets in a predetermined range of the examination distance when an anisometropia is induced (inter alia paragraph [0050] “lens 57 is used to perform fixation and fogging of the subject's left eye EL”), in which one of the left and right subject eyes is maintained in a fully corrected condition and another of the left and right subject eyes is corrected by a predetermined degree from the fully corrected condition, and wherein the controller is capable of controlling the objective measurement optical system to measure the eye characteristics while the left and right subject eyes binocularly view the fixation targets and acquire refractive values of the left and right subject eyes as objective measurement information (inherent that ophthalmologic apparatus 1 is capable of being used this way, given separately controlled left and right optometry units 120L & 120R with individually controlled optical element applying parts 121L & 121R, target presenting parts 122L & 122R and objective measuring parts 123L & 123R).
Regarding claim 2 Sakurada discloses the ophthalmologic apparatus according to claim 1, as set forth above. Sakurada further discloses wherein the controller is capable of intermittently acquiring the objective measurement information at a time when the examination distance has reached a predetermined distance (inherent that ophthalmologic apparatus 1 is capable of measuring at a point in time e.g. see paragraph [0060]).
Regarding claim 3 Sakurada discloses the ophthalmologic apparatus according to claim 1, as set forth above. Sakurada further discloses wherein the controller is capable of continuously acquiring the objective measurement information while the examination distance is changed in the predetermined range (inherent that ophthalmologic apparatus 1 is capable of measuring at a distance e.g. see paragraph [0060]).
Regarding claim 4 Sakurada discloses the ophthalmologic apparatus according to claim 1, as set forth above. Sakurada further discloses wherein the controller is capable of controlling the visual target presenting portion (inter alia paragraph [0065] “the control device 200 performs the display control of the LCD 53, the operation control of movable lens drive units 83L and 83R for driving the movable lens 57 in the optical axis direction, and the like. The control device 200 further performs the operation control of VCC lens drive units 84L and 84R for rotating the VCC lens 59 about the optical axes of of the target projection optical systems 32L and 32R respectively”), wherein the visual target presenting portion comprises a left-eye projection optical system that is capable of presenting a left fixation target of the fixation targets to the left subject eye (e.g. 122L), and a right-eye projection optical system that is capable of presenting a right fixation target of the fixation targets to the right subject eye (e.g. 122R), and wherein the controller is further capable of controlling the left-eye and right-eye projection optical systems to induce the anisometropia (inherent that ophthalmologic apparatus 1 is capable of being used this way, given separately controlled left and right optometry units 120L & 120R with individually controlled optical element applying parts 121L & 121R and target presenting parts 122L & 122R e.g. see paragraphs [0050 & 0065]).
Regarding claim 5 Sakurada discloses the ophthalmologic apparatus according to claim 1, as set forth above. Sakurada further discloses wherein the left and right fixation targets (e.g. 122L & 122R) respectively comprise the fusion targets that are depicted in a manner that allows binocular fusion while the left subject eye views the left fixation target and the right subject eye views the right fixation target (inter alia paragraph [0055] “fusion target” & paragraph [0060] discusses preforming a binocular balance test), and examination targets (inter alia paragraphs [0050-51] “visual targets”) that are depicted not in a manner that allows binocular fusion while the left subject eye views the left fixation target and the right subject eye views the right fixation target (implicit for proper operation).
Regarding claim 6 Sakurada discloses the ophthalmologic apparatus according to claim 1, as set forth above. Sakurada further discloses wherein the controller comprises a fixation eye determiner that is capable of determining a fixation eye based on the objective measurement information when the ophthalmologic apparatus induces anisometropia (inherent that the controller would identify which eye is corrected and which is fogged for proper operation).
Regarding claim 7 Sakurada discloses the ophthalmologic apparatus according to claim 6, as set forth above. Sakurada further discloses , wherein the fixation eye determiner is capable of determining a subject eye among the left and right subject eyes as the fixation eye when the subject eye with a difference in a refractive value that is equal to or less than a predetermined threshold, the difference being measured between a refractive value of the subject eye itself and a refractive value at a presentation position of the fixation target when the fixation target is presented, or to determine a subject eye among the left and right subject eyes as the fixation eye when the subject eye causes a larger decrease in a difference between the refractive value of the subject eye itself and the refractive value at a presentation position of the fixation target and when the examination distance is changed from far-point vision to near-point vision (inherent that the controller would identify which eye is corrected and which is fogged for proper operation).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Troilo et al. “Accommodation and the Visual Regulation of Refractive State in Marmosets” Optom Vis Sci. 2009 January; 86(1): E31–E39; in regards to steps of taking an objective measurement after inducing anisometropia.
Bharadwaj et al. “The Effect of Lens-Induced Anisometropia on Accommodation and Vergence during Human Visual Development” Investigative Ophthalmology & Visual Science, May 2011, Vol. 52, No. 6, pp 3595-3603; in regards to steps of taking an objective measurement after inducing anisometropia.
Yukimori et al. US Patent Application Publication 2023/0309814; in regards to an ophthalmologic apparatus includes an objective measurement optical system and a projection system that is configured to present at a fixation target a predetermined presentation position and apply fog to the subject eye; and a controller that is configured to control the objective measurement optical system and projection system, see figures 1-4.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to George G King whose telephone number is (303)297-4273. The examiner can normally be reached 9-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/George G. King/Primary Examiner, Art Unit 2872 June 12, 2026
1 It has been held that the recitation that an element is "capable of" performing a function is not a positive limitation but only requires the ability to so perform. It does not constitute a limitation in any patentable sense; In re Hutchison, 69 USPQ 138. Also see Intel Corp. v. U.S. Int'l Trade Comm’n, 946 F.2d 821, 832, 20 USPQ2d 1161, 1171 (Fed. Cir. 1991), MPEP 2114. IV and MPEP 2173.05(g).
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