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 .
Response to Amendment
The amendments filed 09 JUNE 2026 have been entered. Claims 1 – 5 and 7 – 20 are pending. Applicant’s amendments have overcome each and every rejection under 35 U.S.C. 112 previously applied in the office action dated 11 MARCH 2026.
Claim Interpretation
Applicant has not made an amendment regarding the 112(f) Claim Interpretations applied in the Office Action dated 11 MARCH 2026. Applicant has not provided any reason to withdraw the 112(f) claim interpretation, so the interpretation detailed in the Office Action dated 11 MARCH 2026 is maintained for the terms “a first diagnostic device”, “a second diagnostic device”, and “interface device” in claims 1, 2, 3, 16, 17, 18, and 20 (and their dependent claims)
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 – 5 and 7 – 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Regarding Claims 1 and 20, the claims recite an apparatus, which is one of the statutory categories of invention (Step 1). The claims are then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong 1).
Regarding Claim 16, the claim recites "an act or step, or series of acts or steps", and is therefore a process, which is a statutory category of invention (Step 1). The claim are then analyzed to determine whether they are directed to any judicial exception (Step 2A, Prong 1).
Each of Claims 1 – 5 and 7 - 20 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 1 – 5 and 7 - 20 recites at least one step or instruction for observations, evaluations, judgments, and opinions, which are grouped as a mental process under the 2019 PEG. The claimed invention involves making observations, evaluations, judgments, and opinions, which are concepts performed in the human mind under the 2019 PEG.
Accordingly, each of Claims 1 – 5 and 7 - 20 recites an abstract idea.
Specifically, Claims 1 – 5 and 7 - 20 recite (underlined are observations, judgments, evaluations, or opinions, which are grouped as a mental process under the 2019 PEG) (additional elements bolded, see Step 2A, prong 2);
Claim 1
(Currently Amended) An ophthalmic system for analyzing data for a procedure, comprising:
a first diagnostic device configured to perform a first diagnostic procedure to measure a physiological parameter of an eye of a patient as a first measurement; and
a second diagnostic device configured to perform a second diagnostic procedure to measure
the physiological parameter of the eye of the patient as a second measurement, the second diagnostic device a different type of diagnostic device than the first diagnostic device; and
a computer comprising:
a memory configured to store procedure information for the procedure, the procedure information including the first measurement and the second measurement of the physiological parameter;
an interface device configured to receive input and provide output; and
one or more processors configured to execute software to:
obtain the first measurement of the physiological parameter of the eye of the patient from the first diagnostic device;
obtain the second measurement of the physiological parameter of the eye from the second diagnostic device;
identify information from the procedure information that is aberrant information, the aberrant information including the first measurement of the physiological parameter and the second measurement of the measured physiological parameter, the first measurement and the second measurement differing from each other beyond a threshold variation;
determine one or more recommendations to address the aberrant information, the one or more recommendations comprising a first recommendation to exclude the physiological parameter and to designate the first diagnostic device or the second diagnostic device as potentially defective; and
provide the aberrant information and the one or more recommendations via the interface device.
Claim 16
A method for analyzing data for a procedure, comprising:
performing, by a first diagnostic device, a first diagnostic procedure to measure a physiological parameter of an eye of a patient as a first measurement of the physiological parameter;
performing, by a second diagnostic device, a second diagnostic procedure to measure the physiological parameter of the eye of the patient as a second measurement of the physiological parameter, the second diagnostic device a different type of diagnostic device than the first diagnostic device;
obtaining, by one or more processors, the first measurement of the physiological parameter of the eye and the second measurement of the physiological parameter of the eye;
storing, by a memory, procedure information for the procedure, the procedure information including the first measurement and the second measurement of the physiological parameter;
receiving, by an interface device, input and providing output;
identifying, by one or more processors configured to execute software, information from the procedure that is aberrant information, the aberrant information including the first measurement of the physiological parameter and the second measurement of the physiological parameter, the first measurement and the second measurement differing from each other beyond a threshold variation;
determining, by the one or more processors, one or more recommendations to address the aberrant information, the one or more recommendations comprising a first recommendation to exclude the physiological parameter and to designate first the diagnostic device or the second diagnostic device as potentially defective; and
providing, by the one or more processors, the aberrant information and the one or more recommendations via the interface device.
Claim 20
(Currently Amended) An ophthalmic system for analyzing data for a procedure, comprising;
a first diagnostic device configured to perform a first diagnostic procedure to measure a physiological parameter of an eye of a patient as a first measurement; and
a second diagnostic device configured to perform a second diagnostic procedure to measure the physiological parameter of the eye of the patient as a second measurement, the second diagnostic
device a different type of diagnostic device than the first diagnostic device; and
a computer comprising:
a memory configured to store procedure information for the procedure, the procedure comprising a surgical procedure or a diagnostic procedure, the procedure information including the first measurement and the second measurement of the physiological parameter;
an interface device configured to receive input and provide output; and
one or more processors configured to execute software to:
obtain the first measurement of the physiological parameter of the eye of the patient;
obtain the second measurement of the physiological parameter of the eye from the second diagnostic device;
identify information from the procedure information comprising:
aberrant information, the aberrant information comprising (i) a value that departs from one or more predefined values or ranges of values by a threshold amount, and (ii) the first measurement of the physiological parameter and the second measurement of the physiological parameter differing from each other beyond a threshold variation;
an eye measurement that is an indication of a negative outcome with the procedure; and
a medical condition that is incompatible with the procedure;
determine one or more recommendations to address corresponding portions of the procedure information, the one or more recommendations comprising:
a first IOL with which the eye measurement is compatible, the first IOL different from an IOL of the procedure as designated in the procedure information;
an insertion procedure that makes a second IOL compatible with the eye measurement, the insertion procedure different from the procedure as designated in the procedure information;
an IOL formula for calculating IOL parameters that are compatible with the eye measurement;
a third IOL that is compatible with the medical condition, the third IOL different from the IOL of the procedure as designated in the procedure information;
a second IOL formula for calculating IOL parameters that are compatible with the medical condition; and
a recommendation to exclude the physiological parameter and to designate the first diagnostic device or the second diagnostic device as potentially defective;
prioritize the one or more recommendations;
provide the aberrant information and the one or more prioritized recommendations via the interface device;
receive via the interface device a selection of a recommendation of the one or more recommendations;
identify first negative outcome information from the procedure information that is associated with the selected recommendation;
determine one or more next recommendations to address the first negative outcome information for the selected recommendation;
provide the first negative outcome information for the selected recommendation and the one or more next recommendations via the interface device;
receive via the interface device a change in the procedure;
identify second negative outcome information from the procedure information that is associated with for the changed procedure;
determine second one or more next recommendations to address the second negative outcome information for the changed procedure;
provide the second negative outcome information for the changed procedure and the second one or more next recommendations via the interface device
wherein compatibility includes a probability of the negative outcome of the procedure being below a second threshold amount and incompatibility includes the probability of the negative outcome of the procedure being above the second threshold amount.
(observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
These underlined limitations describe a mathematical calculation and/or a mental process, as a skilled practitioner is capable of performing the recited limitations and making a mental assessment thereafter. Examiner notes that nothing from the claims suggests that the limitations cannot be practically performed by a human with the aid of a pen and paper; their knowledge gained from education, background, or experience; or by using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner additionally notes that nothing from the claims suggests an undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps. For example, in Independent Claims 1, 16, and 20, these limitations include:
Observation and judgment to store or remember procedure information for the procedure
Observation and judgment of the first measurement of the physiological parameter of the eye of the patient from the first diagnostic device;
Observation and judgment of the first measurement of the physiological parameter of the eye of the patient
Observation and judgment of the second measurement of the physiological parameter of the eye of the patient from the second diagnostic device;
Observation and judgment to identify information from the procedure information that is aberrant information
Observation and judgment to identify information from the procedure information that is aberrant information
Observation and judgment to think of one or more recommendations to address the aberrant information, the one or more recommendations comprising a first recommendation to exclude the physiological parameter
Observation and judgment to designate the first diagnostic device or the second diagnostic device as potentially defective;
Observation and judgment to recommend designating the diagnostic device as potentially defective (as with writing Out Of Order on a device producing unexpected results);
Observation and judgment of one or more recommendations to address corresponding portions of the procedure information
Observation and judgment of a recommendation to exclude the physiological parameter
Observation and judgment to prioritize the one or more recommendations;
Observation and judgment to communicate the aberrant information and the one or more recommendations via the interface device.
Observing input information and communicating an output
Observation and judgment a selection of a recommendation of the one or more recommendations;
Observation and judgment of first negative outcome information from the procedure information that is associated with the selected recommendation;
Observation and judgment of one or more next recommendations to address the first negative outcome information for the selected recommendation;
Observation and judgment to communicate the first negative outcome information for the selected recommendation and the one or more next recommendations;
Observation and judgment of a change in the procedure;
Observation and judgment of second negative outcome information from the procedure information that is associated with the changed procedure;
Observation and judgment of second one or more next recommendations to address the second negative outcome information for the changed procedure;
Observation and judgment to calculate IOL parameters that are compatible with the medical condition;
Observation and judgment to calculate IOL parameters that are compatible with the eye measurement;
Observation and judgment to communicate the second negative outcome information for the changed procedure and the second one or more next recommendations via the interface device
all of which are grouped as mental processes under the 2019 PEG.
Similarly, Dependent Claims 2 – 15 and 17 – 19 include the following abstract limitations, in addition the aforementioned limitations in Independent Claims 1, 16, and 20 (underlined observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG):
identify negative outcome information from the procedure information that is associated with a negative outcome of the procedure for the selected recommendation (or for the changed procedure)
Observation and judgment of negative outcome information from the procedure information that is associated with a negative outcome of the procedure for the selected recommendation (or for the changed procedure)
determine one or more next recommendations to address the negative outcome information for the selected recommendation (or for the changed procedure)
Observation and judgment of one or more next recommendations to address the first negative outcome information for the selected recommendation (or for the changed procedure);
provide the negative outcome information for the selected recommendation (or for the changed procedure) and the one or more next recommendations.
Observation and judgment to communicate the negative outcome information for the selected recommendation (or for the changed procedure) and the one or more next recommendations;
present the prioritized one or more recommendations.
communicate the prioritized one or more recommendations.
identify an eye measurement in the procedure information that is an indication of a negative outcome with the procedure
Observation and judgment of an eye measurement in the procedure information that is an indication of a negative outcome with the procedure
receive a selection of an intraocular lens (IOL) to be used in the procedure
Observation and judgment of a selection of an intraocular lens (IOL) to be used in the procedure
determine that the IOL, based on the eve measurement, has a probability for the negative outcome with the procedure above a threshold amount;
Observation and judgment that the IOL, based on the eve measurement, has a probability for the negative outcome with the procedure above a threshold amount;
adjust the one or more recommendations to include a second IOL with which the probability for the negative outcome is below the threshold amount based on the eye measurement
Observation and judgment to adjust the one or more recommendations to include a second IOL with which the probability for the negative outcome is below the threshold amount based on the eye measurement
obtain information indicating a medical condition of the patient that is an indication of a negative outcome with the procedure as designated in the procedure information
Observation and judgment of information indicating a medical condition of the patient that is an indication of a negative outcome with the procedure as designated in the procedure information
Identifying negative outcome information from the procedure information that is associated with a negative outcome of the procedure for the selected recommendation (or the changed procedure);
Observation and judgment of negative outcome information from the procedure information that is associated with a negative outcome of the procedure for crucial for the selected recommendation (or the changed procedure);
determining one or more next recommendations to address the crucial negative outcome information for the selected recommendation (or the changed procedure);
Observation and judgment of one or more next recommendations to address the crucial negative outcome information for the selected recommendation (or the changed procedure);
Providing the negative outcome information for the selected recommendation (or the changed procedure) and the one or more next recommendations;
Observation and judgment to communicate the negative outcome information for the selected recommendation (or the changed procedure) and the one or more next recommendations;
Providing the negative outcome information for the changed procedure from the procedure information that is associated with the selected recommendation;
Observation and judgment of first negative outcome information from the procedure information that is associated with the selected recommendation;
presenting the prioritized one or more recommendations
Observation and judgment to present the prioritized one or more recommendations
As claimed, the aforementioned limitations are mental processes that would be performed by a biomedical, medical, or engineering professional using their education, background, and experience, and a pen and paper.
Accordingly, as indicated above, each of the above-identified claims recite an abstract idea.
Step 2A, Prong 2
The above-identified abstract ideas in Independent Claims 1, 16, and 20 (and their dependent Claims) are not integrated into a practical application under 2019 PEG because the additional elements (identified above in Claims 1 – 5 and 7 - 20), either alone or in combination, generally link the use of the above-identified abstract ideas to a particular technological environment or field of use. More specifically, within the independent Claims 1, 16, and 20 and their dependent claims, the additional elements of:
first diagnostic device
second diagnostic device
computer
memory
interface device
one or more processors
Additional elements recited include a “first and second diagnostic device” to each “perform a diagnostic procedure”, “computer”, a “memory” to “store”, an “interface device” to “receive” and “one or more processors” to “execute” in independent claims 1, 16 and 20 and their dependent claims. These components are recited at a high level of generality. These generic hardware component limitations for the “first diagnostic device”, “second diagnostic device”, “computer”, “memory”, “interface device”, and “one of more processors” are no more than mere instructions to apply the exception using generic computer components. As such, these additional elements do not impose any meaningful limits on practicing the abstract idea.
Further additional elements from Claims 1 – 5 and 7 – 20 include pre-solution activity limitations, such as:
a first diagnostic device configured to perform a first diagnostic procedure to measure a physiological parameter of an eye of a patient as a first measurement; and
a second diagnostic device configured to perform a second diagnostic procedure to measure
the physiological parameter of the eye of the patient as a second measurement, the second diagnostic device a different type of diagnostic device than the first diagnostic device
the procedure comprising a surgical procedure or a diagnostic procedure, the procedure information including the first measurement and the second measurement of the physiological parameter;
an interface device configured to receive input and provide output; and
one or more processors configured to execute software
aberrant information, the aberrant information comprising (i) a value that departs from one or more predefined values or ranges of values by a threshold amount, and (ii) the first measurement of the physiological parameter and the second measurement of the physiological parameter differing from each other beyond a threshold variation;
the aberrant information including the first measurement of the physiological parameter and the second measurement of the measured physiological parameter, the first measurement and the second measurement differing from each other beyond a threshold variation;
an eye measurement that is an indication of a negative outcome with the procedure; and
a medical condition that is incompatible with the procedure;
a first IOL with which the eye measurement is compatible, the first IOL different from an IOL of the procedure as designated in the procedure information;
an insertion procedure that makes an IOL compatible with the eye measurement, the insertion procedure different from an initial insertion procedure as designated in the procedure information
an insertion procedure that makes a second IOL compatible with the eye measurement, the insertion procedure different from the procedure as designated in the procedure information;
the given IOL different from an IOL of the procedure as designated in the procedure information
a third IOL that is compatible with the medical condition, the third IOL different from the IOL of the procedure as designated in the procedure information;
wherein compatibility includes a probability of the negative outcome of the procedure being below a threshold amount and incompatibility includes the probability of the negative outcome of the procedure being above the threshold amount.
aberrant information comprising second aberrant information, the second aberrant information comprising a second instance in which a given measurement of the measured physiological parameter differs from one or more previous measurements of the measured physiological parameter by a second threshold variation amount.
the one or more recommendations further comprising: an IOL that is compatible with the medical condition.
the one or more recommendations further comprising: an IOL formula for calculating IOL parameters that are compatible with the medical condition.
the procedure comprising a surgical procedure.
the first diagnostic device comprising a topographer, a wavefront aberrometer, an optical coherence tomography (OCT) device, a biometry or retina imaging device, or a Scheimpflug imaging device
These pre-solution measurement elements are insignificant extra-solution activity, setting up the parameters of the system, and serve as data-gathering for the subsequent steps.
The “first diagnostic device”, “second diagnostic device”, “computer”, “memory”, “interface device”, and “one of more processors” as recited in independent Claims 1, 16 and 20 and their dependent claims are generically recited computer and hardware elements which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract ideas identified above in independent Claims 1, 16, and 28 (and their dependent claims) are not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed system and method merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer processor as claimed. In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract ideas identified above in in Independent Claims 1, 16, and 20 (and their dependent claims) are not integrated into a practical application under the 2019 PEG.
Accordingly, Independent Claims 1, 16, and 20 (and their dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B –
None of Claims 1 - 5 and 7 - 20 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: “first diagnostic device”, “second diagnostic device”, “computer”, “memory”, “interface device”, and “one of more processors” as recited in independent Claims 1, 16, and 20 and their dependent claims.
The additional elements of the “first diagnostic device”, “second diagnostic device”, “computer”, “memory”, “interface device”, and “one of more processors” in Claims 1 – 5 and 7 - 20, as discussed with respect to Step 2A Prong Two, amounts to no more than mere instructions to apply the exception using generic computer and hardware components. The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per applicant’s specification, the “first diagnostic device” and “second diagnostic device” are described generically in [0025] of the Instant Specification with “A diagnostic device 24 may be any suitable device that measures one or more features of an eye. Examples of diagnostic devices include topographers, wavefront aberrometers, optical coherence tomography (OCT) devices with applicability for 2D and 3D, biometry or retina imaging devices, Scheimpflug imaging devices, or other devices that measure a feature of an eye.” The “first diagnostic device” and “second diagnostic device” are shown as generic box element “diagnostic devices 24” in Figure 1.
Per applicant’s specification, the “computer” is described generically in [0043] “component (such as computers 20 and 103) of the systems and apparatuses disclosed herein may include an interface, logic, and/or memory, any of which may include computer hardware and/or software” and that it may incorporate “an interface” from via which it “can receive input to the component and/or send output from the component”. It is shown as a generic box element “computer” 20 in Fig 1.
Per applicant’s specification, the “memory” is generically described in [0045] “A memory can store information and may comprise tangible, computer- readable, and/or computer-executable storage medium”, followed by a list of possible generic memory options, including “Random Access Memory (RAM), Read Only Memory (ROM) , mass storage medica, and removable storage media. It is shown as a generic box element “memory 32” in Fig. 1.
Per applicant’s specification, the “interface device” is generically described in [0043] “Examples of an interface device include input and/or output devices, such as a keyboard, mouse, touchpad, touchscreen, microphone, computer display, foot pedal, gesture sensor, and/or speaker.” It is shown as “interface 31” in Figure 1.
Per applicant’s specification, the “one or more processors” is generically described in [0044] “Examples of such an electronic device include a computer, processor, microprocessor (e.g., a Central Processing Unit (CPU)), and computer chip.” It is shown as a generic box element “processors 30” in Fig. 1.
There is nothing particular to the structures of each the “first diagnostic device”, “second diagnostic device”, “computer”, “memory”, “interface device”, and “one of more processors” that deems it more than well-understood, routine, or conventional.
Accordingly, in light of Applicant’s specification, the claimed terms “first diagnostic device”, “second diagnostic device”, “computer”, “memory”, “interface device”, and “one of more processors” are reasonably construed as a generic computing devices or hardware. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the “first diagnostic device”, “second diagnostic device”, “computer”, “memory”, “interface device”, and “one of more processors”. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 1 – 5 and 7 - 20 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the apparatuses and method of Claims 1 – 5 and 7 - 20 are directed to applying an abstract idea as identified above on a general-purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 1 – 5 and 7 - 20 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements for Step 2A Prong 2 in independent Claims 1, 16, and 20 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1 – 5 and 7- 20 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1 – 5 and 7- 20 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1 – 5 and 7- 20 are not patent eligible and rejected under 35 U.S.C. 101.
Response to Arguments
Applicant's arguments filed 06 JUNE 2026 have been fully considered but they are not persuasive.
Regarding 35 U.S.C. 101 Rejections
Applicant argues at [Page 12, Paragraph 1] that claims 1 – 5 and 7 – 20 are not directed to an abstract idea but to a specific improvement in computer-aided ophthalmic surgical technology that solves a technical problem rooted in machine interoperability and data integrity. There is nothing particular recited in the claims about data integrity from the diagnostic devices that is outside the realm of processing by a human surgeon with the aid of their time, education, background, and experience. The comparison for data integrity could be as simple as noting that no data arrived into the system from the second diagnostic device, therefore it differs from that of the first diagnostic device beyond a threshold variation. Further, a surgeon’s education, background, experience, and training with diagnostic devices would include evaluating whether the result from a diagnostic device does not make sense for the measurement it is taking. For example, if one keratometer outputs a result of 59281.0D, and the other gives 43.0 D, the 59281.0D is very unexpected result in comparison (which can be easily made in the human mind). The claims recite a series of limitations that encompass an abstract idea of manipulating variables obtained from electronic components used in a usual way, and that variable manipulation can be accomplished with the aid of time, equations, and paper. The argument is not persuasive.
Applicant argues at [Page 12, Paragraphs 2] – [Page 13, Top] that when viewed as a whole, the claims are directed to a specific improvement in an existing technology, not an abstract idea, with a specific system architecture with a first and second diagnostic device of a different type, obtain a measurement from each, and automatically perform a cross-validation. Applicant further argues that the “automatic ingestion, parsing, and integration of raw data streams from two different types of specialized hardware devices” is not practically performed in the human mind. There is nothing in particular recited that specifies the nature of the data from the broadly-recited “diagnostic devices”. Further, there is nothing particularly recited that indicates that the hardware devices are specialized, beyond being used for diagnostic purposes. It is within the scope of the claims that each diagnostic device could process raw electric signals on-board the respective diagnostic device, then pass a numeric value result to the processor (or a human looking at a numeric output from each with their eyes). It is well within the ability of a human to read an output result from two machines measuring the same parameter to determine if they are the same or not. It is a routine operation for a surgeon to error-check a plan prior to surgery, including noting if diagnostic tools appear to be providing unexpected results due to defect. There is nothing particularly recited that improves the function of either of the diagnostic devices. The result is “one or more recommendations comprising a first recommendation to exclude the physiological parameter and to designate the first diagnostic device or the second diagnostic device as potentially defective”, which requires no action on the part of the machine or the user, merely provides a suggestion that the diagnostic device might be defective and that it could be a good idea to exclude the data from that device. The invention does not fix the defects, nor does it positively perform a concrete action based on the presence of defects. The argument is not persuasive.
Applicant argues at [Page 13, 1st Full Paragraph] that the claimed invention provides a tangible improvement to the technological field of computer-aided surgical planning because it “automatically detects and flags inconsistencies between different diagnostic machines” to provide a more reliable and verified dataset to prevent the system from generating a potentially dangerous or inaccurate surgical plan. There is nothing particularly recited that improves the function of either of the diagnostic devices, nor that the dataset is actually improved. The result is “one or more recommendations comprising a first recommendation to exclude the physiological parameter and to designate the first diagnostic device or the second diagnostic device as potentially defective”, which requires no action on the part of the machine or the user, merely provides a suggestion that the diagnostic device might be defective and that it could be a good idea to exclude the data from that device. The invention does not fix the defects, nor does it positively perform a concrete action based on the presence of defects, including positively preventing the system from generating a potentially dangerous of inaccurate surgical plan. It merely presents a suggestion to the user that this information should be considered.
Further, there is nothing particular recited in the claims that indicates that the human cannot access the necessary information to make a comparison to discover faulty diagnostic equipment with the aid of their time, education, background, and experience. It is a routine operation for a surgeon to error-check a plan prior to surgery. The claims recite a series of limitations that encompass an abstract idea of manipulating variables obtained from electronic components used in a usual way, and that variable manipulation can be accomplished with the aid of time, equations, and paper. Further, From MPEP 2106.05(a): It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). The argument is not persuasive.
Applicant argues at [Page 13, 2nd Full Paragraph] – [Page 14, Top] that the ordered combination of elements recited in the claims is unconventional because there was no 35 U.SC. 102 or 103 rejection applied, and there is a computer acting as a data arbiter for a collection of disparate physical hardware. Applicant argues that this is similar to BASCOM.
From MPEP § 2106.05 I: Although the courts often evaluate considerations such as the conventionality of an additional element in the eligibility analysis, the search for an inventive concept should not be confused with a novelty or non-obviousness determination. See Mayo, 566 U.S. at 91, 101 USPQ2d at 1973 (rejecting “the Government’s invitation to substitute §§ 102, 103, and 112 inquiries for the better established inquiry under § 101”). As made clear by the courts, the “‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter.” Intellectual Ventures I v. Symantec Corp., 838 F.3d 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. 2016) (quoting Diamond v. Diehr, 450 U.S. at 188–89, 209 USPQ at 9). See also Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1151, 120 USPQ2d 1473, 1483 (Fed. Cir. 2016) (“a claim for a new abstract idea is still an abstract idea. The search for a § 101 inventive concept is thus distinct from demonstrating § 102 novelty.”). In addition, the search for an inventive concept is different from an obviousness analysis under 35 U.S.C. 103. See, e.g., BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1350, 119 USPQ2d 1236, 1242 (Fed. Cir. 2016) (“The inventive concept inquiry requires more than recognizing that each claim element, by itself, was known in the art. . . . [A]n inventive concept can be found in the non-conventional and non-generic arrangement of known, conventional pieces.”)
Looking to BASCOM, The claims of BASCOM Global Internet Serv., Inc. v. AT&T Mobility LLC recite filtering schemes, filtering elements, and filtering schemes, and “exclusive lists” regarding allowing network access requests that improve the functioning of a computer itself. There is nothing particularly recited in the instant claims that improves the functioning of a computer itself. The computer acting “as a data arbiter” to receive information from two pieces of hardware is merely inputting a plurality of signals, which is well-understood, routine and conventional action for a processor. There is nothing particularly-recited that improves the functioning of the computer itself. The argument is not persuasive.
Applicant argues at [Page 14, 1st Full Paragraph] that the claims use a mathematical process (comparison) within a larger technological process to achieve a specific tangible recommendation to designate the first or second diagnostic device as defective as a specific, actionable hypothesis. There is nothing particularly recited that improves the function of either of the diagnostic devices. The result is a “one or more recommendations comprising a first recommendation to exclude the physiological parameter and to designate the first diagnostic device or the second diagnostic device as potentially defective”, which requires no action on the part of the machine or the user, merely provides a suggestion that the diagnostic device might be defective and that it could be a good idea to exclude the data from that device. The invention does not fix the defects, nor does it positively perform a concrete action based on the presence of defects. The argument is not persuasive.
Applicant argues at [Page 14, 2nd Full Paragraph] that the claims provide a specific improvement to the functioning of the surgical system because they include two distinct and different types of diagnostic devices to measure the same physiological parameter of an eye. The limitations including the first and second diagnostic device measuring the first and second measurement, “a first diagnostic device…different type of diagnostic device than the first diagnostic device” are recited as pre-solution data gathering activity for the subsequently-recited abstract ideas. The first and second diagnostic devices are determined in Step 2A – Prong 2 as a generic diagnostic devices performing well-understood, routing, and conventional routine steps for a generic “diagnostic device” of “measuring a physiological parameter or an eye of a patient as a measurement”. There is nothing particularly recited that positively improves the function of the first and second diagnostic devices themselves. The argument is not persuasive.
Applicant summarily argues at [Page 14, Bottom] that the amended claims are not directed to an abstract idea, and if they were, they recite a clear inventive concept which makes claims 1 – 5 and 7 – 20 patent eligible under 35 U.S.C. 101. Based on the 35 U.S.C 101 analysis herein and the discussion of arguments above, Claims 1 – 5 and 7 – 20 do not qualify as eligible subject matter under 35 U.S.C. 101. The argument is not persuasive.
Conclusion
THIS ACTION IS MADE FINAL. 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 MELISSA J MONTGOMERY whose telephone number is (571)272-2305. The examiner can normally be reached Monday - Friday 7:30 - 5:00 ET.
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, Alexander Valvis can be reached at (571) 272 - 4233. 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.
/MELISSA JO MONTGOMERY/Examiner, Art Unit 3791
/JUSTIN XU/Primary Examiner, Art Unit 3791
Prosecution Insights