DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. According to the Amendment, filed 04 May 2026, the status of the claims is as follows:
Claims 68, 72, 73, 78, 79, 83, and 84
Claims 69, 70, 74-77, 80, 81, and 85-87 are previously presented; and
Claims 1-67, 71, and 82 are cancelled.
3. The objection to claim 78 because of minor informalities is withdrawn in view of the Amendment, filed 04 May 2026.
Response to Arguments
4. Applicant’s arguments, see Remarks, pp. 7-8, filed 04 May 2026, with respect to the rejection of claims 68-87 under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, i.e. abstract idea, without significantly more, have been fully considered, but they are not persuasive.
Applicant contends, see Remarks, p. 7, the following:
Amended Claims 68 and 79 do not recite mere "mathematical operations" (Step 2A, Prong 1).
The Office Action asserts, "[U]nder broadest reasonable interpretation, these steps are merely mathematical operations that could be done mentally or with the aid of pen and paper". (Office Action at page 3.)
Amended Claims 68 and 79 recite receiving pre-therapy parameters (first IOP and BP) taken over a distinct time interval before therapy applied to a patient eye and post-therapy parameters (second IOP and BP) taken over a distinct time interval after the therapy is applied to the patient eye, using a patient treatment system including a pump. These steps necessarily involve physical sensors (to sense patient IOP and BP), a therapy device, and a treated patient, and thus, cannot be performed mentally or with pen and paper. Accordingly, Applicant respectfully submits Claims 68 and 79 are not judicial exceptions as alleged in the Office Action as they are directed to a system more than mere "mathematical operations".
However, respectfully, this argument is not persuasive. Examiner agrees that the limitations of “receive a pre-therapy parameter including a first indication of intraocular pressure (IOP) in the patient eye over a first time interval and a first indication of blood pressure (BP) from the patient over the first time interval, wherein the first time interval occurs before applying the therapy to the patient eye;” and “receive a post-therapy parameter including a second indication of IOP in the patient eye over a second time interval and a second indication of BP from the patient over the second time interval, wherein the second time interval occurs after apply the therapy to the patient eye;” in claim 1, and “receiving with a processor circuit a pre-therapy parameter including a first indication of intraocular pressure (IOP) in the patient eye over a first time interval and a first indication of blood pressure (BP) from the patient over the first time interval, wherein the first time interval occurs before the therapy is applied to the patient eye;” and “receiving with the processor circuit a post-therapy parameter including a second indication of IOP in the patient eye over a second time interval and a second indication of BP from the patient eye over the second time interval, wherein the second time interval occurs after the therapy is applied to the patient eye;” in claim 79, are not directed to an abstract idea, i.e. mathematical operations. However, these additional limitations add insignificant pre-solution activity to the abstract idea that merely collects data to be used by the mental process. The mental process limitations are:
calculate an IOP difference between the received first and second IOP indications;
calculate a BP difference between the received first and second BP indications, and
generate the OHI value based at least in part on the IOP difference and the BP difference to determine the effect of the applied therapy on the patient eye.
Furthermore, Applicant contends, see Remarks, p. 7, the following:
Amended Claims 68 and 79 integrate calculation into a practical application (Step 2A, Prong 2).
Further, amended Claims 68 and 79 clarify the patient treatment system generates an ocular health index (OHI) value to determine an effect of an applied therapy on the patient eye based on physiological changes attributable to that therapy. Amended Claims 68 and 79 combine hardware, (e.g., a processor circuit) with patient data (e.g,, including indications of patient IOP and BP, collected prior to and after a therapy is applied to a patient eye) to generate an OHI value that is used to determine the effect of the applied therapy on the patient eye.
Applicant respectfully submits that even if Claims 68 and 79 recite a judicial exception, since the OHI "can be useful to clinicians and caregivers to monitor disease progression and patient response to therapy" (Application-as-Filed at [0005]) as described above, Claims 68 and 79 recite a practical application as an indicator for the effectiveness of an eye therapy making them eligible subject matter under 35 U.S.C. §101.
However, respectfully, this argument is not persuasive. The additional limitations of “a processor circuit, in communication with a pump, the processor circuit configured to:” in claim 68, and “with a processor circuit” and “with the processor circuit” in claim 79, are merely parts (hardware) of a computer to be used as merely a tool to perform the mental process, and not limitations that integrate the mental process into a practical application. The claims do not recite limitations that describe how the generated OHI value is presented to the user. The OHI value is merely generated in the abstract, and not presented into the real world to have a practical application. Thus, the claims fall short of integrating the mental process into a practical application as the result of the mental process, i.e. the generated OHI value, has not be presented to the clinicians and caregivers to recognize and appreciate the usefulness of the indicator for the effectiveness of an eye therapy.
Lastly, Applicant contends, see Remarks, p. 8, the following:
Amended Claims 68 and 79 recite significantly more than an abstract idea (Step 2B).
The Office Action asserts, "[T]he claims(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception, when considered separately and in combination." (Office Action at page 4.)
Applicant has rephrased Claims 68 and 79 to explain the processor circuit is configured to receive a pre-therapy parameter including indications of a first IOP and BP from the patient collected in a first time interval and a post-therapy parameter including indication of a second IOP and BP collected in a second time interval, to clarify the therapy-effect determination reflected in the claimed subject matter. Applicant notes this ordered combination of elements was indicated as allowable in the Office Action and believes the ordered combination amounts to significantly more than the alleged judicial exception cited above.
However, respectfully, this argument is not persuasive. As stated above, the additional limitations of “receive a pre-therapy parameter including a first indication of intraocular pressure (IOP) in the patient eye over a first time interval and a first indication of blood pressure (BP) from the patient over the first time interval, wherein the first time interval occurs before applying the therapy to the patient eye;” and “receive a post-therapy parameter including a second indication of IOP in the patient eye over a second time interval and a second indication of BP from the patient over the second time interval, wherein the second time interval occurs after apply the therapy to the patient eye;” in claim 1, and “receiving with a processor circuit a pre-therapy parameter including a first indication of intraocular pressure (IOP) in the patient eye over a first time interval and a first indication of blood pressure (BP) from the patient over the first time interval, wherein the first time interval occurs before the therapy is applied to the patient eye;” and “receiving with the processor circuit a post-therapy parameter including a second indication of IOP in the patient eye over a second time interval and a second indication of BP from the patient eye over the second time interval, wherein the second time interval occurs after the therapy is applied to the patient eye;” in claim 79, are not directed to an abstract idea, but are limitations that add insignificant pre-solution activity to the abstract idea that merely collects data to be used by the mental process. Thus, these additional limitations do not recite significantly more than the mental process.
In response to Applicant note that “this ordered combination of elements was indicated as allowable in the Office Action and believes the ordered combination amounts to significantly more than the alleged judicial exception cited above”, the combination of limitations recited in original claims 71 and 78 (now cancelled) were considered in view of the prior art under 35 U.S.C. 102 and 103. However, these limitations (now presented in amended claims 68 and 79) have been considered in a different analysis for statutory subject matter under 35 U.S.C. 101, as discussed above.
5. In the prior Office Action, pp. 24-25, mailed 08 January 2026, dependent claims 71 and 82 were indicated as allowable if rewritten in independent form including all of the limitations of the base claim. Applicant amended claims 68 and 79 to include the allowable subject matter of claims 71 and 82 (now cancelled), respectively. Thus, base claims 68 and 79, along with their dependent claims 69, 70, 72-78, 80, 81, and 83-87, are allowable over the prior art for the reasons stated in the prior Office Action, and the rejection of claims 68, 70, 79, and 81 under 35 U.S.C. 102(a)(1) as being anticipated by Falck, Jr. et al., U.S. Patent Application No. 2011/0087086 A1 (“Falck”), the rejection of claims 68, 69, 72-76, 78-80, and 83-86 under 35 U.S.C. 102(a)(1) as being anticipated by Berdahl et al., U.S. Patent Application No. 2018/0279877 A1 (“Berdahl”), and the rejection of claims 77 and 87 under 35 U.S.C. 103 as being unpatentable over Berdahl, as applied to claims 68 and 79, respectively, above, and further in view of Samee et al., U.S. Patent Application Publication No. 2016/0270656 A1 (“Samee”), are withdrawn.
Claim Objections
6. Claim 79 is objected to because of the following informalities:
In line 2, “Uthe” is a typographical error, and should be amended to “the”.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
7. 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.
8. Claims 68-70, 72-81, and 83-87 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, i.e. abstract idea, without significantly more.
Step 1 of the Patent Subject Matter Eligibility Guidance (see MPEP 2106.03):
Claims 68-70 and 72-78 are directed to a “system”, which describes one of the four statutory categories of patentable subject matter, i.e. a machine.
Claims 79-81 and 83-87 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 Revised Patent Subject Matter Eligibility Guidance (see MPEP 2106.04 and the 2019 Revised Patent Subject Matter Eligibility Guidance, FR Vol. 84, No. 4, 07 January 2019):
Claim(s) 68-70, 72-81, and 83-87, recite the following mental process:
calculate an IOP difference between the received first and second IOP indications;
calculate a BP difference between the received first and second BP indications, and
generate the OHI value based at least in part on the IOP difference and the BP difference to determine the effect of the applied therapy on the patient eye.
Under broadest reasonable interpretation, these steps are merely mathematical operations that could be done mentally or with the aid of pen and paper.
This judicial exception is not integrated into a practical application because the additional limitations of “receive a pre-therapy parameter including a first indication of intraocular pressure (IOP) in the patient eye over a first time interval and a first indication of blood pressure (BP) from the patient over the first time interval, wherein the first time interval occurs before applying the therapy to the patient eye;” and “receive a post-therapy parameter including a second indication of IOP in the patient eye over a second time interval and a second indication of BP from the patient over the second time interval, wherein the second time interval occurs after apply the therapy to the patient eye;” in claim 1, and “receiving … a pre-therapy parameter including a first indication of intraocular pressure (IOP) in the patient eye over a first time interval and a first indication of blood pressure (BP) from the patient over the first time interval, wherein the first time interval occurs before the therapy is applied to the patient eye;” and “receiving … a post-therapy parameter including a second indication of IOP in the patient eye over a second time interval and a second indication of BP from the patient eye over the second time interval, wherein the second time interval occurs after the therapy is applied to the patient eye;” in claim 79, add insignificant pre-solution activity to the abstract idea that merely collects data to be used by the mental process.
Furthermore, “a processor circuit, in communication with a pump, the processor circuit configured to:” in claim 68, and “with a processor circuit” and “with the processor circuit” in claim 79, are merely parts of a computer to be used as a tool to perform the mental process.
Step 2B of the Patent Subject Matter Eligibility Guidance (see MPEP 2106.05):
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception, when considered separately and in combination.
Analyzing the additional claim limitations individually, the additional limitations that are not directed to the mental process are “receive a pre-therapy parameter including a first indication of intraocular pressure (IOP) in the patient eye over a first time interval and a first indication of blood pressure (BP) from the patient over the first time interval, wherein the first time interval occurs before applying the therapy to the patient eye;” and “receive a post-therapy parameter including a second indication of IOP in the patient eye over a second time interval and a second indication of BP from the patient over the second time interval, wherein the second time interval occurs after apply the therapy to the patient eye;” in claim 1, and “receiving … a pre-therapy parameter including a first indication of intraocular pressure (IOP) in the patient eye over a first time interval and a first indication of blood pressure (BP) from the patient over the first time interval, wherein the first time interval occurs before the therapy is applied to the patient eye;” and “receiving … a post-therapy parameter including a second indication of IOP in the patient eye over a second time interval and a second indication of BP from the patient eye over the second time interval, wherein the second time interval occurs after the therapy is applied to the patient eye;” in claim 79. Such limitations are conventional and routine in the art, and add insignificant pre-solution activity to the abstract idea that merely collects data to be used by the abstract idea.
The additional limitations “a processor circuit, in communication with a pump, the processor circuit configured to:” in claim 68, and “with a processor circuit” and “with the processor circuit” in claim 79, are merely parts of a computer to be used as a tool to perform the mental process, and amounts to computer implementation of the abstract idea.
The additional limitations of dependent claims 69, 70, 72-78, 80, 81, and 83-87 are merely directed to and further narrow the scope of the mental process or further narrow the scope of the additional limitations that do not integrate the mental process into a practical application or are not significantly more than the mental process.
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Their collective functions merely provide computer implementation of the abstract idea using collected data without: improvement to the functioning of a computer or to any other technology or technical field; applying the mental process with, or by use of, a particular machine; effecting a transformation or reduction of a particular article to a different state or thing; applying or using the mental process in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment; or adding a specific limitation other than what is well-understood, routine, conventional activity in the field.
Allowable Subject Matter
9. Claims 68-70, 72-81, and 83-87 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 101, set forth in this Office Action.
10. The following is a statement of reasons for the indication of allowable subject matter:
As to Claim 68, Falck teaches the following:
A patient treatment system to determine … an ocular health index (OHI) value (“ocular perfusion pressure”) generated for the patient eye (see “A tonometer used for estimating ocular perfusion pressure preferably includes a microprocessor that can control operations and manage the data generated, can make whatever calculations are necessary, and can use look-up tables and make data comparisons to produce outputs usable to an operator. The goals of the inventive way of estimating ocular perfusion pressure include speed and convenience using an available tonometer, low cost and reliability, and providing substantially improved information to a clinician examining the health of the eye and the vascular system supplying it.” in para. [0006]), the patient treatment system comprising:
a processor circuit (“microprocessor”) 20, in communication with a pump (“tonometer”) 10 (see “Tonometer 10 presses surface 11 more forcefully against cornea 12 to raise the IOP within the eye. The increasing IOP is represented by the inclined portion 24 of the signal shown in FIG. 4. Microprocessor 20 collects from detector 15 information on ocular pulse amplitude (OPA), which is the height of a systolic pulse 22 above a diastolic base line 21.” in para. [0020]) … , the processor circuit 20 configured to:
receive … a first indication of intraocular pressure (IOP) in the patient eye over a first time interval (see “It begins with low pressure measures of intraocular pressure (IOP) made while surface 11 is pressed lightly against cornea 12. The pressure of surface 11 against cornea 12 is preferably small enough for this purpose not to increase IOP values within the eye being examined. The IOP measures include diastolic values 21 and systolic values 22 (FIG. 4), which appear each time a pulse occurs in a central retinal artery of an eye being examined. Tonometer 10 calculates an MIOP from signal region 23 generated during low pressure force of surface 11 against cornea 12. The MIOP value is preferably made by multiplying the diastolic value 21 by 2, adding the systolic value 22, and dividing by 3. An MIOP value for a normal healthy eye is about 16 mm Hg.” in para. [0013]) and a first indication of blood pressure (BP) (“mean central retinal artery pressure (MCRAP)”) from the patient over the first time interval (see “The microprocessor then multiplies MIOP by the multiplier to produce the estimate of MCRAP.” in para. [0016]; and see “The MCRAP estimate reached by the method described above and illustrated in FIG. 1 can be corroborated by an MCRAP estimate based on brachial blood pressures. These can be measured for each arm of a person and preferably entered into microprocessor 20, which then calculates 60% of the brachial pressures of each arm. The microprocessor can then compare the measured MCRAP estimate with the brachial blood pressure estimate of MCRAP to see whether discrepancies exist.” in para. [0018]; and see “This fact, together with information on expected upper and lower ranges, is used by microprocessor 20 to calculate an initial estimate of mean central retinal artery pressure (MCRAP).” in para. [0021]), … and
…
generate the OHI value based at least in part on the [first indication of IOP and the first indication of BP] (see “A reliable estimate of MCRAP and a measure of mean intraocular pressure (MIOP) can then produce an estimate of ocular perfusion pressure simply by subtracting MIOP from MCRAP.” in para. [0011]; and see “For a normal healthy eye and normal blood pressure, the estimate of MCRAP is reached, and microprocessor 20 calculates ocular perfusion pressure by subtracting mean IOP from MCRAP. Measurements of MIOP and OPA that depart from normal can lead to different MCRAP estimates and to different perfusion pressure estimates that can be investigated further.” in para. [0021]).
As to Claim 79, Berdahl teaches the following:
A method of using a patient treatment system (“apparatus”) 200 to determine … an ocular health index (OHI) value generated for the patient eye (see “FIG. 2 shows an example of an apparatus 200, such as for applying fluid pressure to an external surface of the eye 100, such for at least one of diagnosing or treating an eye condition, such as can include an abnormal eye condition.” in para. [0062]), the method comprising:
receiving with a processor circuit (“control circuit”) 230 … a first indication of intraocular pressure (IOP) (“indication of IOP”) in the patient eye over a first time interval (see “The pressure transducer local interface can be in electrical communication with the pressure transducer, such as to wirelessly transmit energy to the pressure transducer, such as to power the pressure disk sensor, and wirelessly receive data from the pressure transducer, such as an indication of IOP.” in para. [0093]) and a first indication of blood pressure (BP) (“indication of blood pressure”) from the patient over the first time interval (see “The detector device 508 can include a blood pressure sensor system 508F, such as can include a device that can detect one or more indications of blood pressure, such as by at least one of auscultation, oscillometric, or photoplethysmography (or PPG) detection. An indication of blood pressure can include one or more indications of one or more cardiac cycle blood pressure parameters, such as can include systolic pressure, diastolic pressure, orbital pressure, or episcleral venous pressure, and one or more related parameters, such as heart rate.” in para. [0100]), …;
…
generating the OHI value (“composite characteristic”) based at least in part on the [first indication of IOP and the first indication of BP] (see “An eye characteristic can include a flow characteristic of the eye 100, such as a flow characteristic of a blood vessel of the eye 100. A flow characteristic of a blood vessel of the eye 100 can include at least one of average or other central tendency of velocity of blood flow, such as can be related to levels of TOP and CSF, systolic and diastolic velocity of blood flow, and density of blood flow. Flow characteristics of a blood vessel can change in a periodic fashion, for example, the flow characteristics can be related to the cardiac cycle. Flow characteristics in a blood vessel can be related to IOP, CSF, or both IOP and CSF, such as flow velocities in a vessel can be affected by changes in CSF. A flow characteristic can include a composite characteristic, such as an eye characteristic calculated from one or more eye characteristics. Composite characteristics can include the pulsatility index (PI) and the resistivity index (RI). ICP can be estimated using a method, such as can include measuring venous outflow pressure, measuring central retinal arterial blood flow, and estimating ICP using the venous outflow data and at least one of a pulsatility or resistivity relationship.” in para. [0060]).
As to Claims 68-70 and 72-78, neither Falck, Berdahl nor the prior art of record teaches the patient treatment system of base claim 68, including the following, in combination with all other limitations of the base claim:
… the processor circuit is configured to:
receive a pre-therapy parameter including a first indication of intraocular pressure (IOP) in the patient eye over a first time interval and a first indication of blood pressure (BP) from the patient over the first time interval, wherein the first time interval occurs before applying the therapy to the patient eye;
receive a post-therapy parameter including a second indication of IOP in the patient eye over a second time interval and a second indication of BP from the patient over the second time interval, wherein the second time interval occurs after apply the therapy to the patient eye;
calculate an IOP difference between the received first and second IOP indications;
calculate a BP difference between the received first and second BP indications, and
generate the OHI value based at least in part on the IOP difference and the BP difference to determine the effect of the applied therapy on the patient eye.
As to Claims 80, 81, and 83-87, neither Falck, Berdahl nor the prior art of record teaches the patient treatment system of base claim 79, including the following, in combination with all other limitations of the base claim:
receiving with a processor circuit a pre-therapy parameter including a first indication of intraocular pressure (IOP) in the patient eye over a first time interval and a first indication of blood pressure (BP) from the patient over the first time interval, wherein the first time interval occurs before the therapy is applied to the patient eye;
receiving with the processor circuit a post-therapy parameter including a second indication of IOP in the patient eye over a second time interval and a second indication of BP from the patient eye over the second time interval, wherein the second time interval occurs after the therapy is applied to the patient eye;
calculating an IOP difference between the received first and second IOP indications;
calculating a BP difference between the received first and second BP indications; and
generating the OHI value based at least in part on the IOP difference and the BP difference to determine the effect of the applied therapy on the patient eye.
Conclusion
11. 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.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAVIN NATNITHITHADHA whose telephone number is (571)272-4732. The examiner can normally be reached Monday - Friday 8:00 am - 8:00 am - 4:00 pm.
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/NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 06/25/2026
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