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 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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/22/2025 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed 05/22/2025 (“Amendment”). Claims 13, 19, 20, 23, and 28 are currently under consideration. The Office acknowledges the amendments to claims 13 and 23, as well as the cancellation of claims 15-17 and 25-27. Claims 14, 18, and 24 remain withdrawn.
The objection(s) to the drawings, specification, and/or claims, the interpretation(s) under 35 USC 112(f), and/or the rejection(s) under 35 USC 101 and/or 35 USC 112 not reproduced below has/have been withdrawn in view of the corresponding amendments.
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 Objections
Claims 13 and 23 are objected to because of the following informalities:
Regarding claims 13 and 23, the recitations of “of at least one or more detection points” should instead read –at at least one or more detection points--.
Further regarding claim 23, the recitation of “properties base on” should instead read –properties based on--. Appropriate correction is required.
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.
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”) (such as “excitation means” (Fig. 2, part 102), “detection means” (Fig. 9), “surface wave processing means” (CPU as described in ¶ 0059, carrying out described algorithms), “ocular physical property determination means” (CPU as described in ¶ 0059, carrying out described algorithms), and “modulation means” (Fig. 2, modulator 201a)) 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.
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 13, 19, 20, 23, and 28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 13, 19, and 20 are directed to a “device,” which describes one of the four statutory categories of patentable subject matter, i.e., a machine. Claims 23 and 28 are directed to a “method,” which describes one of the four statutory categories of patentable subject matter, i.e., a process.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claims 13 and 23 recite (“set forth” or “describe”) the abstract idea of a mental process, substantially as follows:
analyzing the surface wave, determining physical properties of the eyeball based on the analyzing, determining at least one of phase change and delay time of the surface wave, determining at least one of phase velocity and group velocity of the surface wave based on at least one of the phase change and delay time of the surface wave and calculating eyeball physical properties based on at least one of the phase velocity and group velocity of the surface wave.
The analyzing, determining, and calculating steps can be practically performed in the human mind, with the aid of a pen and paper, but for performance on a generic computer, in a computer environment, or merely using the computer as a tool to perform the steps. If a person were to see a printout of the surface wave, they would be able to observe its morphology or other features and perform analysis, determinations, and calculations based thereon. There is nothing to suggest an undue level of complexity in the surface wave data so as to prohibit mental processing. Therefore, a person would be able to perform the analyzing and calculating mentally or with pen and paper.
Prong Two: Claims 13 and 23 do not include additional elements that integrate the mental process into a practical application. Therefore, the claims are “directed to” the mental process. The additional elements merely:
recite the words “apply it” (or an equivalent) with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g. surface wave processing means, ocular physical property determination means, computer-implemented, etc.), and
add insignificant extra-solution activity (the pre-solution activity of: using excitation means and detection means to obtain a surface wave, with a particular frequency range specified for the excitation means).
As a whole, the additional elements merely serve to gather and feed information to the abstract idea, while generically implementing it on a computer. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. Nothing is done with the calculated physical property. No improvement to the technology is evident. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 13 and 23 do not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above.
Dependent Claims
The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely
further describe the pre-solution activity (or the structure used for such activity) (e.g. types of detection means (claims 19 and 28), arrangement with respect to a center of corneal curvature (claim 20), etc.).
Taken alone and in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. They also do not add anything significantly more than the abstract idea. Their collective functions merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves another technology or technical field, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 13, 19, 23, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2018/0193194 (“Haeggstrom”) in view of US Patent Application Publication 2020/0315570 (“Ambrozinski”) and US Patent Application Publication 2014/0350397 (“Lewis”).
Regarding claim 13, Haeggstrom teaches [a] non-contact type ocular physical property measuring device (¶ 0024), comprising: an excitation means that excites at least one or more excitation points on an eyeball using an irradiation wave to generate a surface wave on a surface of an eye to be examined (¶ 0010, producing an excitation pressure pulse formed by nonlinear waves to generate a surface wave), …; a detection means that detects the surface wave generated by the excitation means of at least one or more detection points (¶ 0010, detecting the surface wave), which are different from the excitation points (¶ 0028, wave dispersion, ¶ 0071, etc.), on the eyeball; a surface wave processing means that analyzes the surface wave detected by the detection means (¶ 0027, advanced methods to process measurement information); and an ocular physical property determination means that determines physical properties of the eyeball based on the analyzing result by the surface wave processing means (Abstract, ¶ 0024, etc., extracting pressure information to measure intraocular pressure), wherein: the surface wave processing means determines at least one of phase change and delay time of the surface wave (¶ 0050, calculating surface-wave velocity based on a difference in arrival times); and the ocular physical property determination means determines at least one of phase velocity and group velocity of the surface wave based on at least one of the phase change and delay time of the surface wave and calculates eyeball physical properties base on at least one of the phase velocity and group velocity of the surface wave (¶¶s 0050, 0054, etc., calculating surface-wave velocity, which is either phase velocity or group velocity, and calculating eyeball physical properties (such as corneal thickness) based thereon).
Haeggstrom does not appear to explicitly teach wherein the irradiation wave emitted from the excitation means is a continuous wave of an aerial ultrasonic wave whose basic frequency ranges from 20 KHz to 200 KHz or a burst wave having more than 10 waves of the aerial ultrasonic wave (although ¶ 0030 does describe using an ultrasonic measurement technique, and ¶ 0010 mentions an excitation pressure pulse).
Ambrozinski teaches using an irradiation wave that is e.g. a burst aerial ultrasonic wave whose basic frequency is greater than or equal to 20 kHz (¶¶s 0009, 0017, 0049, 0051, 0052, etc. – also see ¶ 0056, a burst signal, ¶¶s 0044, 0045, etc., describe an ultrasound pulse, etc.). Ambrozinski also teaches measurement of surface wave velocity based on phase change or delay time (¶¶s 0076, 0084, etc.).
Lewis teaches emitting a burst ultrasound wave having tens of cycles, e.g. 50 cycles (¶ 0195, Fig. 31), and an alternative that uses a continuous ultrasound wave (Fig. 32 and related description).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use an ultrasonic frequency such as e.g. 20 kHz in Haeggstrom as in Ambrozinski, since 20 kHz is an ultrasonic frequency as already contemplated by Haeggstrom, and is known to be desirable for use in non-contact measurements of IOP, including measurements based on surface waves (Ambrozinski: Abstract, ¶ 0080, etc., thus achieving a predictable result). It would have been obvious to use a continuous wave or a burst wave having more than 10 cycles, as in Lewis, since these are known alternatives (Lewis: Figs. 31 and 32 and related descriptions), and for the purpose of increasing resolution (Lewis: ¶ 0198).
Regarding claim 23, Haeggstrom teaches [a] computer-implemented non-contact type ocular physical property measuring method (¶ 0024), comprising: exciting at least one or more excitation points on an eyeball using an irradiation wave to generate a surface wave on a surface of an eye to be examined (¶ 0010, producing an excitation pressure pulse formed by nonlinear waves to generate a surface wave), …; detecting the surface wave generated by the excitation means of at least one or more detection points (¶ 0010, detecting the surface wave), which are different from the excitation points (¶ 0028, wave dispersion, ¶ 0071, etc.), on the eyeball; analyzing the surface wave as detected (¶ 0027, advanced methods to process measurement information); determining physical properties of the eyeball based on the surface wave as analyzed (Abstract, ¶ 0024, etc., extracting pressure information to measure intraocular pressure); determining at least one of phase change and delay time of the surface wave (¶ 0050, calculating surface-wave velocity based on a difference in arrival times); and determining at least one of phase velocity and group velocity of the surface wave based on at least one of the phase change and delay time of the surface wave and calculating eyeball physical properties base on at least one of the phase velocity and group velocity of the surface wave (¶¶s 0050, 0054, etc., calculating surface-wave velocity, which is either phase velocity or group velocity, and calculating eyeball physical properties (such as corneal thickness) based thereon).
Haeggstrom does not appear to explicitly teach wherein the irradiation wave is emitted during the exciting of the one or more excitation points on the eyeball as a continuous wave of an aerial ultrasonic wave whose basic frequency ranges from 20 KHz to 200 KHz or a burst wave having more than 10 waves of this aerial ultrasonic wave (although ¶ 0030 does describe using an ultrasonic measurement technique, and ¶ 0010 mentions an excitation pressure pulse).
Ambrozinski teaches using an irradiation wave that is a continuous aerial ultrasonic wave whose basic frequency is greater than or equal to 20 kHz (¶¶s 0009, 0017, 0049, 0051, 0052, etc.). Ambrozinski also teaches measurement of surface wave velocity based on phase change or delay time (¶¶s 0076, 0084, etc.).
Lewis teaches emitting a burst ultrasound wave having tens of cycles, e.g. 50 cycles (¶ 0195, Fig. 31), and an alternative that uses a continuous ultrasound wave (Fig. 32 and related description).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use an ultrasonic frequency such as e.g. 20 kHz in Haeggstrom as in Ambrozinski, since 20 kHz is an ultrasonic frequency as already contemplated by Haeggstrom, and is known to be desirable for use in non-contact measurements of IOP, including measurements based on surface waves (Ambrozinski: Abstract, ¶ 0080, etc., thus achieving a predictable result). It would have been obvious to use a continuous wave or a burst wave having more than 10 cycles, as in Lewis, since these are known alternatives (Lewis: Figs. 31 and 32 and related descriptions), and for the purpose of increasing resolution (Lewis: ¶ 0198).
Regarding claims 19 and 28, Haeggstrom-Ambrozinski-Lewis teaches all the features with respect to the corresponding claims 13 and 23, as outlined above. Regarding claim 19, Haeggstrom-Ambrozinski-Lewis further teaches wherein the detection means detects a surface wave using one of an ultrasonic reflection method, an optical triangulation method, a confocal method of optical coaxial light beams having multiple wavelengths, a Fourier domain optical interferometer using an optical heterodyne method, or a vibration detection by a laser Doppler interferometer (Haeggstrom: Abstract, acoustic reflectivity, ¶ 0030, ultrasonic; Ambrozinski: Abstract, reflected ultrasound).
Claim 28 is rejected in like manner.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Haeggstrom-Ambrozinski-Lewis in view of US Patent Application Publication 2013/0144171 (“Watson”).
Regarding claim 20, Haeggstrom-Ambrozinski-Lewis teaches all the features with respect to claim 13, as outlined above. Haeggstrom-Ambrozinski-Lewis does not appear to explicitly teach wherein the excitation means and the detection means are arranged such that an intersection of an irradiation axis of the excitation means and a detection axis of the detection means coincides with the center of corneal curvature (although see Haeggstrom: Figs. 7, 9, 10, etc.).
Watson teaches aligning an ultrasonic scanner with the center of curvature of the corneal or lens surface (¶¶s 0061, 0069, 0179, 0224, etc., Fig. 5A, etc.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to irradiate with respect to the center of corneal curvature in the combination as in Watson for the purpose of being able to image the surface of interest (Watson: ¶¶s 0061, 0179, 0224, etc.).
Response to Arguments
Applicant’s arguments filed 05/22/2025 have been fully considered.
In response to the arguments regarding the rejections under 35 USC 103, they are not persuasive. However, a new grounds of rejection has been made in view of Ambrozinski and Lewis to provide further detail.
Haeggstrom teaches creating a surface wave via ultrasonic excitation. Although the excitation frequency is not explicit, the ultrasonic range is 20 kHz and greater. Thus, Haeggstrom itself teaches the contemplated frequency range. Ambrozinski is cited for explicit evidence. Regarding the type of ultrasound wave, Lewis teaches that continuous and burst waves are both usable.
In response to the arguments regarding complex structure and low excitation efficiency, etc., they are not relevant since they are not tied to the claim language.
In response to the carrier wave of Ariga, it is submitted that a carrier wave can still generate a surface wave. Applicant’s arguments regarding vibration data in Ariga are also not persuasive because Applicant’s own disclosure contemplates detection of vibration. See claim 19, vibration detection. And the surface wave itself is a mechanical wave that is a vibration.
Applicant argues that the particular frequency is what results in surface waves. The Office notes that because the art uses the same frequency, it also generates surface waves. And, this frequency is apparently what results in no vibration of the eyeball (although it is unclear how Applicant can maintain this in view of e.g. claim 19 as noted above). Nothing in the claim precludes actually vibrating the eyeball.
Regarding Applicant’s other distinctions, they are not persuasive. The art teaches the particular excitation frequency, and also teaches the creation of surface waves. Applicant should not disregard that Haeggstrom uses ultrasonic waves. And, its method of calculating intraocular pressure is irrelevant because Applicant does not claim the method.
In response to the arguments regarding the rejections under 35 USC 101, they are not persuasive. The Office has already noted that the surface wave can be received, in e.g. graphical form, to then be analyzed by the human mind. The Office has not stated that a human observes the surface wave as it travels along the eye. The Office has also not stated that the claims include a limitation of printing out the data of the surface wave. Rather, that particular element of the claim has simply been noted as directed to extra-solution activity, which is not part of the abstract idea. Whether a computer obtains the data or it is provided to a human in e.g. written form, the subsequent steps (those of the abstract idea) can be performed in the human mind. A human is able to analyze, determine, calculate, etc. There is nothing about e.g. the analyzing or determining steps that precludes human processing, even in combination. And, the Office has not stated that the excitation of the eyeball is part of the abstract idea. I.e., that is not what is done by the human mind.
The determination of velocity and the calculation of physical properties are not a practical application of the abstract idea because they are elements of the abstract idea themselves. An improved algorithm would still be ineligible. The practical application must be provided by additional elements, and not those of the abstract idea.
There is no inventive concept for the same reasons as explained above. The particular excitation frequencies are not inventive because they are the frequencies of all ultrasonic radiation. And, the art also contemplates using frequencies that specifically generate surface waves in the cornea.
Thus, all claims remain rejected.
Conclusion
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791