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 Preliminary Amendment, filed 17 October 2023, the status of the claims is as follows:
Claims 68-87 are new; and
Claims 1-67 are cancelled.
Claim Objections
3. Claim 78 is objected to because of the following informalities:
In lines 4-5, “to affect establish a fluid pressure in the cavity” lacks clarity as to what action is being performed (affecting or establishing), and should be amended to “togenerate a fluid pressure in the cavity”.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
4. 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.
5. Claims 68-87 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 68-78 are directed to a “device”, which describes one of the four statutory categories of patentable subject matter, i.e. a machine.
Claims 79-87 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) 68-87, recite the following mental process:
receive 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; and
generate the OHI value based at least in part on the first indication of IOP and the first indication of BP.
Under broadest reasonable interpretation, these steps are merely mathematical operations that could be done mentally or with the aid of pen and paper.
Furthermore, “a processor circuit, in communication with a pump, the processor circuit configured to:” in claim 68, and “with a 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.
The additional limitations “a processor circuit, in communication with a pump, the processor circuit configured to:” in claim 68, and “with a 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 69-78 and 80-87 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.
Claim Rejections - 35 USC § 102
6. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
7. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
8. Claims 68, 70, 79, and 81 are rejected 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”).
As to Claim 68, Falck teaches the following:
A patient treatment system to determine an ocular health index (OHI) value (“ocular perfusion pressure”) for a 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 70, Falck teaches the following:
wherein the OHI value is an indication of ocular perfusion pressure (OPP) (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]).
As to Claim 79, Falck teaches the following:
A method of using a patient treatment system to determine an ocular health index (OHI) value (“ocular perfusion pressure”) for a 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 method comprising:
receiving with a processor circuit (“microprocessor”) 20 (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]) 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) 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
generating 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 81, Falck teaches the following:
wherein generating the OHI value includes generating an indication of ocular perfusion pressure (OPP) (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]).
9. Claims 68, 69, 72-76, 78-80, and 83-86 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Berdahl et al., U.S. Patent Application No. 2018/0279877 A1 (“Berdahl”).
As to Claim 68, Berdahl teaches the following:
A patient treatment system (“apparatus”) 200 to determine an ocular health index (OHI) value for a 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 patient treatment system 200 comprising:
a processor circuit (“control circuit”) 230, in communication with a pump (“pump”) 220 (see “The apparatus 200 can include an goggle enclosure 210, a pump 220 in fluid communication with the goggle enclosure 210, a control circuit 230 in electrical communication with the pump 220, and a locating device 240 connected to the goggle enclosure 210.” in para. [0063]), the processor circuit 230 configured to:
receive 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]); and
generate 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 Claim 69, Berdahl teaches the following:
wherein the processor circuit 230 is configured to determine an indication of glaucoma disease progression based on the OHI value (see “Changes TPD can be positively correlated with diseases of the eye 100. For example, glaucoma can arise from an imbalance between IOP and ICP. An increase in TOP or a decrease in ICP can create a pressure differential across the optic nerve 118. ICP can affect the optic nerve 118, such as in pseudotumor cerebri (idiopathic intracranial hypertension) in which elevated ICP can force the optic nerve to bow forward, such as from a physiologically normal position, and in glaucoma, where reduced ICP can force the optic nerve 118 to cup, such as in cupping of the optic nerve 118, such as because a high IOP and a low ICP can force the optic nerve backwards, such as from a physiologically normal position.” in para. [0040]).
As to Claim 72, Berdahl teaches the following:
wherein the processor circuit 230 is configured to determine the OHI value based at least in part on information about the therapy provided to the patient (see “Adjusting the therapeutic pressure level in the goggle enclosure 210 can include processing one or more feedback signals. Processing a feedback signal can include calculating a composite indication of a physiological parameter, such as where the composite indication can be a function of one or more feedback signals.” in para. [0148]).
As to Claim 73, Berdahl teaches the following:
wherein the therapy applied to the patient eye includes at least one of a goggle-based therapy or a drug delivery therapy (see “The apparatus 200 can provide adjustable control over IOP in a patient eye 100 such as to balance IOP with ICP or otherwise control TPD in the patient eye 100 to treat an abnormal eye condition. In an example, an abnormal eye condition, such as glaucoma, can be treated by using the goggles and pump for drawing a small vacuum to the external surface of the patient eye 100 in the goggle enclosure 210, such as a vacuum of 10-15 mmHg relative to the surrounding ambient atmospheric pressure outside of the goggles, such as to reduce IOP and balance TPD.” in para. [0064]).
As to Claim 74, Berdahl teaches the following:
wherein the therapy applied to the patient eye is the goggle-based therapy (see “The apparatus 200 can provide adjustable control over IOP in a patient eye 100 such as to balance IOP with ICP or otherwise control TPD in the patient eye 100 to treat an abnormal eye condition. In an example, an abnormal eye condition, such as glaucoma, can be treated by using the goggles and pump for drawing a small vacuum to the external surface of the patient eye 100 in the goggle enclosure 210, such as a vacuum of 10-15 mmHg relative to the surrounding ambient atmospheric pressure outside of the goggles, such as to reduce IOP and balance TPD.” in para. [0064]).
As to Claim 75, Berdahl teaches the following:
wherein the processor circuit 230 is configured to determine the OHI value based at least in part on information about the goggle-based therapy provided to the patient (see “Adjusting the therapeutic pressure level in the goggle enclosure 210 can include processing one or more feedback signals. Processing a feedback signal can include calculating a composite indication of a physiological parameter, such as where the composite indication can be a function of one or more feedback signals.” in para. [0148]).
As to Claim 76, Berdahl teaches the following:
wherein the therapy applied to the patient eye is the drug delivery therapy (see para. [0078]).
As to Claim 78, Berdahl teaches the following:
a goggle (“goggle enclosure”) 210, configured to fit over the patient eye to form a cavity (“cavity”) 212 over the patient eye (see “The apparatus 200 can include an goggle enclosure 210, a pump 220 in fluid communication with the goggle enclosure 210, a control circuit 230 in electrical communication with the pump 220, and a locating device 240 connected to the goggle enclosure 210. In an example, the apparatus 200 can include one or more enclosures 210, such as to form a set of goggles that can be located over the eyes 100 of a patient for diagnosing or treating for an eye condition. In an example, an image processor circuit can include at least one of the control circuit 230 or a VAD image processor circuit.” in para. [0063]; and see “The goggle enclosure 210 placed against the patient can include or define a cavity 212 between the goggle enclosure 210 and the patient.” in para. [0065]); and
a pump, in communication with the cavity, configured to affect establish a fluid pressure in the cavity (see “Referring again to FIG. 2, the pump 220 can be in fluid communication with the cavity 212 of the goggle enclosure 210, such as through a tube 222.” in para. [0074]).
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 for a 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]); and
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 Claim 80, Berdahl teaches the following:
wherein generating the OHI value includes generating an indication of glaucoma disease progression based on the OHI value (see “Changes TPD can be positively correlated with diseases of the eye 100. For example, glaucoma can arise from an imbalance between IOP and ICP. An increase in TOP or a decrease in ICP can create a pressure differential across the optic nerve 118. ICP can affect the optic nerve 118, such as in pseudotumor cerebri (idiopathic intracranial hypertension) in which elevated ICP can force the optic nerve to bow forward, such as from a physiologically normal position, and in glaucoma, where reduced ICP can force the optic nerve 118 to cup, such as in cupping of the optic nerve 118, such as because a high IOP and a low ICP can force the optic nerve backwards, such as from a physiologically normal position.” in para. [0040]).
As to Claim 83, Berdahl teaches the following:
wherein generating the OHI value includes generating the OHI value based at least in part on information about the therapy provided to the patient (see “Adjusting the therapeutic pressure level in the goggle enclosure 210 can include processing one or more feedback signals. Processing a feedback signal can include calculating a composite indication of a physiological parameter, such as where the composite indication can be a function of one or more feedback signals.” in para. [0148]).
As to Claim 84, Berdahl teaches the following:
wherein generating the OHI value includes generating the OHI value with a therapy applied to the patient eye, the therapy including at least one of a goggle-based therapy or a drug delivery therapy (see “The apparatus 200 can provide adjustable control over IOP in a patient eye 100 such as to balance IOP with ICP or otherwise control TPD in the patient eye 100 to treat an abnormal eye condition. In an example, an abnormal eye condition, such as glaucoma, can be treated by using the goggles and pump for drawing a small vacuum to the external surface of the patient eye 100 in the goggle enclosure 210, such as a vacuum of 10-15 mmHg relative to the surrounding ambient atmospheric pressure outside of the goggles, such as to reduce IOP and balance TPD.” in para. [0064]).
As to Claim 85, Berdahl teaches the following:
wherein generating the OHI value includes generating the OHI value with the goggle-based therapy (see “The apparatus 200 can provide adjustable control over IOP in a patient eye 100 such as to balance IOP with ICP or otherwise control TPD in the patient eye 100 to treat an abnormal eye condition. In an example, an abnormal eye condition, such as glaucoma, can be treated by using the goggles and pump for drawing a small vacuum to the external surface of the patient eye 100 in the goggle enclosure 210, such as a vacuum of 10-15 mmHg relative to the surrounding ambient atmospheric pressure outside of the goggles, such as to reduce IOP and balance TPD.” in para. [0064]).
As to Claim 86, Berdahl teaches the following:
wherein generating the OHI value includes generating the OHI value with the drug delivery therapy (see para. [0078]).
Claim Rejections - 35 USC § 103
10. 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
11. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
12. Claims 77 and 87 are rejected 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”).
As to Claims 77 and 87, Berdahl teaches the subject matter of claims 68 and 79, respectively, above. Berdahl does not teach the following:
a patient interface configured to identify a field of vision of the patient wherein the patient interface includes at least one of a virtual reality (VR) headset or other head-mounted system; and
receiving information from a patient interface configured to identify a field of vision of the patient to determine or update the OHI value.
However, Samee teaches the following:
a patient interface (“augmented (or virtual) reality display device”) 62 configured to identify a field of vision (“images in the eye of the user for the user's viewing”) of the patient wherein the patient interface 62 includes at least one of a virtual reality (VR) headset or other head-mounted system (“display lens”) 106 (see “As described above and shown in FIG. 5, the ophthalmic device may include an augmented (or virtual) reality display device (62) that includes a display lens (106) and a light source configured to project light (38) that is directed into the eyes of a user to form images in the eye of the user for the user's viewing. In various embodiments, this display device comprises a waveguide stack that received light from a fiber scanning display disposed at the edge of the waveguide and couples the light out of the waveguide from the backside thereof to the wearer's eyes. In the case where the display device is an augmented reality display device, the ophthalmic device may also direct ambient light from the surrounding world, e.g., light from in front of the user, to the eyes of the user through display lens (106). This light may, for example, be transmitted through the waveguide stack to the wearer's eye. As discussed above, the display device (62) may also comprise one or more adaptable optics or variable focus elements (VFEs). As described above, the adaptable optics may be an optical element that can be dynamically altered so as to alter the wavefront incident thereon. For example, the adaptable optic may be a reflective optical element such as a deformable mirror or a transmissive optical element such as a dynamic lens, such as described above in FIGS. 10B-10E.” in para. [1533], and fig. 5).
Thus, it would have been obvious for one of ordinary skill in the art at the time the present application was effectively filed to modify Berdahl’s system to include a patient interface configured to identify a field of vision, as taught by Samee, in order to provide the following technological advantage (see Samee, para. [0011]):
Additional example embodiments are provided below. Note that structures for various health analyses and/or therapies may coexist in the same health system. Moreover, as disclosed herein, the same feature may be applied to facilitate multiple health analyses and/or therapies. For example, structures used for delivering medication may also be utilized for various diagnostics, as disclosed herein. Consequently, health systems according to some embodiments may include various combinations of the structural features disclosed herein, including combinations of features disclosed under different headings. In addition, the health system may be configured to perform various combinations of the health analyses and therapies disclosed herein, including those disclosed under different headings.
Allowable Subject Matter
13. Claims 71 and 82 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 101, set forth in this Office Action.
14. The following is a statement of reasons for the indication of allowable subject matter:
As to Claim 71, neither Falck, Berdahl nor the prior art of record teaches the patient treatment system of base claim 69, including the following, in combination with all other limitations of the base claim:
wherein the processor circuit is configured to:
receive the first indication of intraocular pressure (IOP) in the patient eye over the first time interval and the first indication of a blood pressure (BP) from the patient over the first time interval, wherein the first time interval occurs prior to applying a therapy to the patient eye;
receive 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 applying the therapy to the patient eye;
determine an IOP difference between the received first and second indications of IOP;
determine a BP difference between the received first and second indications of BP; and
generate the OHI value based at least in part on the determined IOP difference and the determined BP difference to determine an effect of the therapy on the patient eye.
As to Claim 82, 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 includes receiving the first indication of intraocular pressure (IOP) in the patient eye over the first time interval and the first indication of a blood pressure (BP) from the patient over the first time interval, wherein the first time interval occurs prior to applying a therapy to the patient eye; and,
the method further comprising:
receiving 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 applying the therapy to the patient eye;
determining an IOP difference between the received first and second indications of IOP;
determining a BP difference between the received first and second indications of BP, and
generating the OHI value based at least in part on the determined IOP difference and the determined BP difference to determine an effect of the therapy on the patient eye.
Conclusion
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/NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 12/10/2025