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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/10/2024 and 05/01/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of invention (I) and species (A, Fig.1A-2B) drawn to claims 1-10, and withdrawn claims 11-20 as drawn to non-elected invention and species in the reply filed on 03/16/2026 is acknowledged.
Claim Objections
Claim 1 is objected to because of the following informalities: the phrase “to apply a force” in line 6 should be amended to read –configured to apply a force--. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: the phrase “can direct a change” in line 2 should be amended to read –directs a change--. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: the phrase “can be determined” in line 4 should be amended to read –is determined--. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
STEP 1: claim 1 an applanation device. Thus, the claims are directed to a product. which is one of the statutory categories of invention.
STEP 2A PRONG ONE: The claim(s) recite(s) specific limitations/method steps of: determine intraocular pressure in the eye based on the captured plurality of applanation images. This limitation recites a mental process, because the claimed limitation describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). For example, a person could look at the image and determine if an intraocular pressure is low or high. Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A PRONG TWO: claim 1 does not recite additional elements that integrate the judicial exception into a practical application because the claim(s) recite the combination of additional elements/method steps of:
[A2] a housing forming an internal cavity, the housing having an applanator access opening formed in an outer wall thereof, the applanator access opening providing access between the internal cavity and an outside environment;
[B2] an applanator disposed in the internal cavity of the housing, the applanator having a distal tip configured to pass into and through the applanator access opening to apply a force to an eye of a subject located in the outside environment;
[C2] an image-capturing system disposed in the internal cavity of the housing and configured to capture a plurality of applanation images of the eye; and
[D2] a controller
The combination of elements [A2]-[C2] of a housing with an applanator and an image capturing system does not integrate the exception into a practical application of the exception because the use of the housing with applanator and image capturing system is merely adding insignificant extra-solution activity to the judicial exception, e.g. using those elements for mere data gathering (see MPEP 2106.05(g)).
Element [D2] does not integrate the exception into a practical application of the exception because the use of a controller amounts to merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)).
Accordingly, this additional element/step does not integrate the abstract idea into a practical application because the claim limitations fail to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception.
STEP 2B: The claim(s) does/do not include additional structural elements that are sufficient to amount to significantly more than the judicial exception because the claim 1 recite additional elements, such as, [A2] a housing forming an internal cavity, the housing having an applanator access opening formed in an outer wall thereof, the applanator access opening providing access between the internal cavity and an outside environment;
[B2] an applanator disposed in the internal cavity of the housing, the applanator having a distal tip configured to pass into and through the applanator access opening to apply a force to an eye of a subject located in the outside environment;
[C2] an image-capturing system disposed in the internal cavity of the housing and configured to capture a plurality of applanation images of the eye; and
[D2] a controller
The combination of elements [A2]-[C2] of a housing with an applanator and an image capturing system does not amount to significantly more than the judicial exception because the use of the housing with applanator and image capturing system is merely adding insignificant extra-solution activity to the judicial exception, e.g. using those elements for mere data gathering (see MPEP 2106.05(g)). Furthermore, the elements [A2]-[C2] are well-understood, routine, and conventional, as is evidenced by Falck et al (US 2014/0163352), Maggiano et al (US 2016/0029888), and Feldon et al (US 2002/0173712), which all show an applanation device with a housing, applanator, and image-capturing system as claimed in claim 1 evidencing that these elements are well-understood, route, and conventional in the applanation arts.
Element [D2] does not amount to significantly more than the judicial exception because adding a controller is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g. a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine, and conventional activities previously known in the industry (see MPEP 2106.05(d)II). Accordingly, the additional elements individual or in co do not integrate the abstract idea into a practical application as they fail to recite additional element(s) or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Merely adding hardware that performs “‘well understood, routine, conventional activities’ previously known to the industry” will not make claims patent-eligible (In re TLI Communications LLC).
However, claims 4 and 7-9 recite enough limitation that would integrate the abstract idea into a practical application.
When viewed alone or in combination, the limitations of claims 1-10 merely instruct the practitioner to implement the concept of collecting data with routine, conventional activity specified at a high level of generality in a particular technological environment. The inventive concept cannot be furnished by the abstract idea; instead, the application must provide something inventive, beyond mere “well-understood, routine, conventional activity” (Genetic Technologies Limited v. Merial L.L.C.). The additional elements of independent claims when viewed alone or as whole, do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea and does not amount to significantly more than the abstract idea itself. In other words, this claim merely applies an abstract idea to a computer and does not (i) improve the performance of the computer itself (as in McRO, Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
However, claims 4 and 7-9 recite enough limitation that would integrate the abstract idea into a practical application.
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”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Limitation “image-capturing system” in claims 1 and 8, the claim does not recite enough structure that corresponds to the claimed “image-capturing system” to perform the claimed function of capture images. However, the specification discloses a camera (par.61), which can be interpreted as the structure that corresponds to the claimed “image-capturing system”.
Limitation “force-adjustment mechanism” in claim 4, the claim does not recite enough structure that corresponds to the claimed. a torsional spring or torsional spring mechanism (par.54), which can be interpreted as the structure that corresponds to the claimed “force-adjustment mechanism”.
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 § 102
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(s) 1, 3, 5, 6 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Falck et al (US 2014/0163352).
As to claim 1, Falck teaches an applanation device (tonometer 100, par.29, fig.8-11), comprising:
a housing forming an internal cavity (housing 100 has an internal cavity where applanator 130 and arm 132 moves therein, par.29-33, fg.8-11), the housing having an applanator access opening (opening at the outer front wall of housing 100 wherein 130/132 is inserted therein, par.29-33, fig.8-11) formed in an outer wall thereof, the applanator access opening providing access between the internal cavity and an outside environment (the opening provides access from the internal cavity to the outside/environment, as best seen in fig.10);
an applanator (applanator 130 and arm 132 disposed in housing 100, par.29, fig.8-11) disposed in the internal cavity of the housing, the applanator having a distal tip (the distal tip extending out from 132, fig.8-11) configured to pass into and through the applanator access opening to apply a force to an eye of a subject located in the outside environment (par.29-30);
an image-capturing system disposed in the internal cavity of the housing and configured to capture a plurality of applanation images of the eye (active pixel sensor array 50 captures images of the eye, par.28-30, fig.11); and
a controller (microprocessor 70, par.27-32, fig.11) configured to receive the plurality of applanation images captured by the image-capturing system and determine intraocular pressure in the eye based on the captured plurality of applanation images (microprocessor 70 tends to the IOP and other calculations from inputs by active pixel sensor array 50, par.27-32, fig.11).
As to claim 3, Falck teaches the applanation device, wherein the applanator further comprises: a lever arm (shaft extending between 132 and 145, par.30-33, fig.11) having a first end (top section of shaft, as best seen in fig.11), a second end (bottom section of the shaft, as best seen in fig.11), and a fulcrum (140, fig.11) disposed therebetween; and
a counterweight (counterbalanced by a mass 145, par.32, fig.11) disposed on a second side of the fulcrum, more proximate to the second end than the first end, wherein the distal tip is disposed on a first side of the fulcrum, more proximate to the first end than the second end (the distal tip of applanator 130 is considered to be disposed on the first side of 140 via the connection of 132, which 130 is connected to, at the top end of the lever arm, as best seen in fig.11).
As to claim 5, Falck teaches the applanation device, further comprising: a force-adjustment mechanism (coil 150; Fig 11, par.30-33) associated with the housing, the force-adjustment mechanism being in communication with the applanator (coil 150 is used to apply a desired amount of force to the eye via applanator 130, wherein coil 150 is shown to be in communication with applanator 130 via the lever extending to 132 and 132) and the force-adjustment mechanism being configured to change an amount of the force being applied to the eye (microprocessor 70 is taught to control the force applied by coil 150, wherein the microprocessor 70 is considered capable of adjusting the force applied by coil 150, par.32-33).
As to claim 6, Falck teaches the applanation device, wherein the controller is further configured to be in communication with the applanator such that the controller can direct a change in an amount of the force being applied to the eye (the microprocessor 70 is taught to control the force applied by coil 150, wherein the microprocessor 70 is considered capable of adjusting the force applied by coil 150, which changes the force applied to the eye by the applanator 130, par.30-32, fig.11).
As to claim 10, Falck teaches the applanation device, wherein the housing provides for the applanation device to be a portable, handheld applanation device (tonometer 100 is handheld portable device that can be held with handle 110, abstract, par.4, par.25, and par.28-29, fig.8-11).
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.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being obvious over Falck et al (US 2014/0163352).
Falck teaches the invention substantially as claimed above, wherein the force applied to the eye by the distal tip of the applanator is a constant force (for a duration of time during which the plurality of applanation images of the eye are captured (par.30-33, fig.11), wherein microprocessor 70 is taught to control the force applied by coil 150 to press the applanator 130 against the eye of the patient, wherein the microprocessor 70 is reasonably considered to be able to cause the coil 150 to apply a constant force while the applanator 130 is pressed against the eye of the patient (par.26). Falck failed to explicitly teach for a duration of time during which the plurality of applanation images of the eye are captured. However, it is well known in the art that routine experimentation and various engineering design choices could have been made to have arrived at for a duration of time during which the plurality of applanation images of the eye are captured (Note: the device taught in Fig 8-11 is reasonably considered to be used similarly to the device taught in Fig 1-7, wherein the force reaches a predetermined value in which IOP is calculated - using the pixel sensor 50 to take multiple images at the constant force over a period of time is then of the ordinary skill in the art). Accordingly, it would have been obvious to one of ordinary skill in the art to have arrived at for a duration of time during which the plurality of applanation images of the eye are captured, in order to ensure proper intraocular pressure measurements, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art, In re Aller, 105 USPQ 233.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being obvious over Falck et al (US 2014/0163352), in view of Siegenthaler et al (US 2009/0131779).
As to claim 4, Falck teaches the invention substantially as claimed above but failed to explicitly teach further comprising: a constant force spring coupled to the lever arm and configured such that the force applied to the eye by the distal tip of the applanator is a constant force.
However, Siegenthaler teaches an analogous applanation tonometer (abstract, fig.1-4), wherein the tonometer comprises a constant force spring coupled to the lever arm and configured such that the force applied to the eye by the distal tip of the applanator is a constant force (spring 18 coupled to lever 40 to control force applied to the eye, par.67-69, fig.1-4).
Since force spring are well-known in the art, so it would have been obvious to one having an ordinary skill in the art before the effective filing date of the invention to include a force spring in Falck’s invention, as spring 18 taught by Siegenthaler’s invention, to be controlled by the microprocessor 70 to control the force being applied to the eye to not harm the eye.
Claim(s) 7-9 is/are rejected under 35 U.S.C. 103 as being obvious over Falck et al (US 2014/0163352), in view of Koziol et al (US 2019/0350456).
As to claim 7, Falck teaches the invention substantially as claimed above but failed to explicitly teach the controller is configured to identify an outer reference circle that is representative of a circumference of the distal tip and an inner circle that is representative of an applanation mire such that a surface area of the applanation mire can be determined.
However, Koziol teaches an analogous tonometer (abstract, fig.1 and 9), wherein the controller is configured to identify an outer reference circle that is representative of a circumference of the distal tip (controller 928 is configured to identify/generate a real-time biprism 802 wherein the outer circumference of the view, or image is the outer circle of the distal tip, fig.8c-d, par.49-52) and an inner circle that is representative of an applanation mire such that a surface area of the applanation mire can be determined, and wherein the intraocular pressure of the eye is determined based on the determined surface area of the applanation mire and an amount of the force applied to the eye (the inner edges of semicircles 821 and 822, taught to be mires aligning mires 821 and 822 allows for assurance of the appropriate area of corneal applanation, wherein properly aligning the mires ensures the appropriate area of corneal applanation further, par.13, teaches determining the measured contact surface area, reasonably considered to be via the mire aligning taught in par.52), and wherein the intraocular pressure of the eye is determined based on the determined surface area of the applanation mire and an amount of the force applied to the eye (determining IOP, par.49-52, fig.8c-9c).
Since eye bi-prism/circle representation of an eye is well-known in the art, so it would have been obvious to one having an ordinary skill in the art before the effective filing date of the invention to include a biprism and/or circle representation of an eye in Falck’s invention, as taught by Koziol’s invention, to better assist a physician in measuring accurate intraocular pressure.
As to claims 8 and 9, Falck teaches the invention substantially as claimed above but failed to explicitly teach the controller is configured to remove from consideration one or more images of the plurality of applanation images captured by the image-capturing system.
However, Koziol teaches removing from consideration one or more images of the plurality of applanation images captured by the image-capturing system to speed up processing time to determine intraocular pressure in the eye (microprocessor 928 to process images obtained by camera 924, wherein the microprocessor 928 is sued to determine when the endpoint of mires 821 and 822 is reached, as taught in par.49-52, Fig 8C-8D, par.6-7, wherein the microprocessor 928 does not compute the IOP of the eye until the microprocessor 928 determines that the endpoint of the mires is reached, such that the other images wherein the endpoint is not reached are considered to be removed from consideration), wherein the controller is configured to remove from consideration one or more images of the plurality of applanation images captured by the image-capturing system based on at least one of: one or more identified contours of the one or more images (the microprocessor 928 is sued to determine when the endpoint of mires 821 and 822 is reached, as taught in para Fig 8C-8D, par.6-7, wherein the microprocessor 928 does not compute the IOP of the eye until the microprocessor 928 determines that the endpoint of the mires is reached, wherein the mires 821 and 822 are considered to be contours, in which the applanation images are removed from consideration if the mires 821 and 822 are not aligned); or one or more starburst ellipses approximated from the one or more images.
Since removing inaccurate images and/or not validated images from IOP determination is well known in the art, so it would have been obvious to one having an ordinary skill in the art before the effective filing date of the invention to remove inaccurate imaged from Falck’s invention, as taught by Koziol’s invention, to determine more accurate and improved IOP measurement.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAY A ABOUELELA whose telephone number is (571)270-7917. The examiner can normally be reached 8-5.
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/MAY A ABOUELELA/Primary Examiner, Art Unit 3791
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