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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on March 11th, 2025 and June 8th, 2026 have been considered by the examiner.
Claim Rejections - 35 USC § 102
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.
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.
Claims 1-3, 6, 9-16, and 20 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sinha (US 2022/0395178).
Regarding claim 1, Sinha discloses an intraocular pressure (IOP) measurement system (Figs. 1-4, [0009], “an example of how to measure IOP using a passive, implanted optical pressure sensor”) comprising:
an optical pressure sensor (1) implantable in an eye ([0013], “optical sensor 1 that has been implanted in the cornea or in the sclera”), wherein the sensor has a substrate (3) coupled to a membrane (5) that changes shape as a function of an intraocular pressure of the eye ([0018], “allows changes in the IOP to sufficiently bend or change the shape of the membrane 5 (via movement of the corneal tissue that surrounds the sensor 1 and that is caused by the changing IOP)”), and the substrate and the membrane define a sealed cavity (6);
an optical transmitter ([0017], “an optical transmitter (Tx)”) to emit an incident optical beam to the sensor (as shown in Fig. 3, Tx emits a beam towards sensor 1);
a receiver ([0017], “an optical receiver (Rx)”) to produce an interference pattern in response to receiving a plurality of reflections of the incident optical beam from the sensor ([0019], “the processor analyzes the signal from the receiver Rx in a spatial sense, to determine or evaluate an interference pattern that is produced by the reflections”);
an image sensor ([0024], “photo-detector, or it may be a one-dimensional or two-dimensional array of photo-detectors”) operable to receive a projection of the interference pattern ([0024], “determining the interference pattern via for example an imaging function being performed upon the signals produced by the array of photo-detectors”); and
a processor ([0019], “processor analyzes the signal from the receiver Rx”) configured to estimate the intraocular pressure of the eye based on processing the projection of the interference pattern ([0019], “processor analyzes the signal from the receiver Rx to interpret the reflections from the sensor 1 into an estimate of the IOP, e.g., in units of mmHg”).
Regarding claim 2, Sinha further discloses wherein the plurality of reflections are frequency dependent reflections of the incident optical beam that change as a function of the intraocular pressure to produce the interference pattern ([0019], “The processor may look for a spectral frequency dependent reflectivity characteristic in the receiver output signal, which can be correlated to how much the sensor 1 is being bent or compressed (by the IOP.)”).
Regarding claim 3, Sinha further discloses wherein the plurality of reflections ([0017], “reflections from at least two surfaces”) comprises a first reflection from an interface between the membrane and the cavity (as shown in Fig. 3, there is a first reflection at the membrane and cavity interface), and a second reflection from the interface between the substrate and the cavity (as shown in Fig. 3, there is a second reflection at the substrate and cavity interface).
Regarding claim 6, Sinha further discloses wherein the processor ([0017], “estimate of the IOP is then determined by an optical measurement processor”) determines, by processing the projection of the interference pattern ([0019], “processor analyzes the signal from the receiver Rx in a spatial sense, to determine or evaluate an interference pattern”), whether the projection of the interference pattern matches a theoretical interference profile to estimate the intraocular pressure ([0019], “the processor analyzes the signal from the receiver Rx in a spatial sense, to determine or evaluate an interference pattern that is produced by the reflections (where the interference pattern changes as a function of bending of the membrane.) The processor may determine an absolute pressure reading as the pressure that is exerted on the sensor”, examiner interprets this to mean the interference pattern received by the processor is analyzed against stored data to determine intraocular pressure).
Regarding claim 9, Sinha further discloses wherein the transmitter (Tx), the receiver (Rx) and the image sensor ([0024], “photo-detector, or it may be a one-dimensional or two-dimensional array of photo-detectors”) are integrated within a single housing of a handheld device ([0023], “The reader 2 may be a handheld device as illustrated in FIG. 4, for example a consumer focused product”).
Regarding claim 10, Sinha further discloses wherein the sensor is implanted in a cornea of the eye ([0014], “a passive optical sensor 1 that has been implanted in the cornea”).
Regarding claim 11, Sinha discloses a method for measuring intraocular pressure of an eye (Figs. 1-4, [0009], “an example of how to measure IOP using a passive, implanted optical pressure sensor”), the method comprising:
emitting an optical beam toward the eye ([0024], “The reader 2 may have an optical lens that focuses the incident optical beam being emitted by the transmitter”);
detecting, as an output signal, an interference pattern corresponding to a plurality of reflections of the optical beam ([0019], “the processor analyzes the signal from the receiver Rx in a spatial sense, to determine or evaluate an interference pattern that is produced by the reflections”) from a pressure sensor (1) that is implanted in the eye (as shown in Fig. 3, reflections from 1 are directed to 2);
projecting the interference pattern to an image sensor ([0024], “photo-detector, or it may be a one-dimensional or two-dimensional array of photo-detectors”, [0024], “determining the interference pattern via for example an imaging function being performed upon the signals produced by the array of photo-detectors”); and
processing the projected interference pattern to compute an estimate of the intraocular pressure of the eye ([0019], “processor analyzes the signal from the receiver Rx to interpret the reflections from the sensor 1 into an estimate of the IOP, e.g., in units of mmHg”).
Regarding claim 12, Sinha further discloses wherein processing the output signal comprises performing an interferometric image processing algorithm ([0019], “the processor analyzes the signal from the receiver Rx in a spatial sense, to determine or evaluate an interference pattern that is produced by the reflections (where the interference pattern changes as a function of bending of the membrane.)”).
Regarding claim 13, Sinha further discloses wherein the interferometric image processing algorithm analyzes the projected interference pattern ([0017], “estimate of the IOP is then determined by an optical measurement processor”) and matches the projected interference pattern to a theoretical interference pattern ([0019], “the processor analyzes the signal from the receiver Rx in a spatial sense, to determine or evaluate an interference pattern that is produced by the reflections (where the interference pattern changes as a function of bending of the membrane.)”) that corresponds to a known pressure to determine the intraocular pressure of the eye ([claim 7], “wherein the processor determines, by processing the output signal of the receiver, an optical interference pattern which varies as a function of the IOP”).
Regarding claim 14, Sinha further discloses wherein the sensor comprises a rigid substrate (3) and a flexible membrane (5) attached to the substrate that define a sealed cavity (6).
Regarding claim 15, Sinha further discloses wherein the plurality of reflections are frequency dependent reflections of an incident optical beam ([0019], “a spectral frequency dependent reflectivity characteristic in the receiver output signal”) that change as a function of the intraocular pressure to produce the interference pattern ([0019], “which can be correlated to how much the sensor 1 is being bent or compressed (by the IOP.)”).
Regarding claim 16, Sinha further discloses wherein the plurality of reflections ([0017], “reflections from at least two surfaces”) comprises a first reflection from an interface between the flexible membrane and the cavity (as shown in Fig. 3, there is a first reflection at the membrane and cavity interface), and a second reflection from the interface between the substrate and the cavity (as shown in Fig. 3, there is a second reflection at the substrate and cavity interface).
Regarding claim 20, Sinha further discloses wherein the sensor is implanted in a cornea of the eye ([0014], “a passive optical sensor 1 that has been implanted in the cornea”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 4-5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Sinha (US 2022/0395178) in view of Hastings (US 2011/0160561).
Regarding claim 4, Sinha discloses as is set forth in claim 1 rejection above but does not specifically disclose wherein the interference pattern comprises a number of concentric rings and the number of concentric rings is a function of a shape of the membrane.
However Hastings, in the same field of endeavor because both teach a pressure measurement system, teaches wherein the interference pattern (Figs. 3A and 4A) comprises a number of concentric rings (as shown in Figs. 3A and 4A, the interference pattern has concentric rings) and the number of concentric rings is a function of a shape of the membrane ([0112], “The materials and dimensions of the flexible membrane allow a number of periods in the interference pattern 300 and sufficient deflection to detect clinically important changes in intraocular pressure.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have the intraocular pressure (IOP) measurement system of Sinha with the wherein the interference pattern comprises a number of concentric rings and the number of concentric rings is a function of a shape of the membrane as taught by Hastings, for the purpose of detecting clinically important changes in intraocular pressure ([0112]).
Regarding claim 5, Sinha discloses as is set forth in claim 1 rejection above but does not specifically disclose wherein the interference pattern comprises a number of concentric rings and each ring of the number of concentric rings comprises a position that is a function of the shape of the membrane.
However Hastings, in the same field of endeavor because both teach a pressure measurement system, teaches wherein the interference pattern (Figs. 3A and 4A) comprises a number of concentric rings (as shown in Figs. 3A and 4A, the interference pattern has concentric rings) and each ring of the number of concentric rings ([0111], “separation of these rings depends on the curvature of the flexible membrane 202 surface”) comprises a position that is a function of the shape of the membrane ([0112], “The materials and dimensions of the flexible membrane allow a number of periods in the interference pattern 300 and sufficient deflection to detect clinically important changes in intraocular pressure.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have the intraocular pressure (IOP) measurement system of Sinha with the wherein the interference pattern comprises a number of concentric rings and each ring of the number of concentric rings comprises a position that is a function of the shape of the membrane as taught by Hastings, for the purpose of detecting clinically important changes in intraocular pressure ([0112]).
Regarding claim 7, Sinha discloses as is set forth in claim 6 rejection above but does not specifically disclose wherein the theoretical interference profile corresponds to a known membrane pressure.
However Hastings, in the same field of endeavor because both teach a pressure measurement system, teaches wherein the theoretical interference profile corresponds to a known membrane pressure ([0026], “the resulting interference pattern corresponds to intraocular pressure”, examiner interprets the resulting interference pattern to correspond to the theoretical interference pattern since the resulting interference pattern corresponds to intraocular pressure).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have the intraocular pressure (IOP) measurement system of Sinha with the wherein the theoretical interference profile corresponds to a known membrane pressure as taught by Hastings, for the purpose of detecting clinically important changes in intraocular pressure ([0112]).
Claims 8 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Sinha (US 2022/0395178) in view of Choo (US 2013/0165762).
Regarding claim 8, Sinha discloses as is set forth in claim 1 rejection above but does not specifically disclose wherein the transmitter and the receiver are integrated within a reader and the reader is operable to read the optical pressure sensor when the reader and the sensor are positioned within a volume between 10 to 100 times greater than a volume of 2 mm×2 mm×0.2 mm.
However Choo, in the same field of endeavor because both teach a pressure measurement system, teaches wherein the transmitter ([0040], “excitation beam 140”) and the receiver ([0040], “reflected light 150”) are integrated within a reader (110, as shown in Fig. 1A, transmitter and emitter are integrated into 110) and the reader is operable to read the optical pressure sensor when the reader and the sensor are positioned within a volume between 10 to 100 times greater than a volume of 2 mm×2 mm×0.2 mm ([0054], “the 100 .mu.m diameter implant to generate strong reflective optical signals that can be detected from a remote distance over 20 cm”, examiner interprets this to mean the reader 110 and sensor 130 are located within a volume between 10 to 100 times 2 mm×2 mm×0.2 mm since the reader is 20 cm away from the sensor which has a diameter of 0.1 mm).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have the intraocular pressure (IOP) measurement system of Sinha with the wherein the transmitter and the receiver are integrated within a reader and the reader is operable to read the optical pressure sensor when the reader and the sensor are positioned within a volume between 10 to 100 times greater than a volume of 2 mm×2 mm×0.2 mm as taught by Choo, for the purpose of detecting reflections over greater distances ([0054]).
Regarding claim 17, Sinha discloses as is set forth in claim 11 rejection above but does not specifically disclose wherein the emitting and the detecting are performed by a transmitter and a receiver, and the transmitter, the receiver and the pressure sensor are positioned within a volume of between 10 to 100 times greater than a volume of 2 mm×2 mm×0.2 mm during measuring.
However Choo, in the same field of endeavor because both teach a pressure measurement system, teaches wherein the emitting and the detecting (110, as shown in Fig. 1A, transmitter and emitter are integrated into 110) are performed by a transmitter ([0040], “excitation beam 140”) and a receiver([0040], “reflected light 150”), and the transmitter, the receiver and the pressure sensor are positioned within a volume of between 10 to 100 times greater than a volume of 2 mm×2 mm×0.2 mm during measuring ([0054], “the 100 .mu.m diameter implant to generate strong reflective optical signals that can be detected from a remote distance over 20 cm”, examiner interprets this to mean the reader 110 and sensor 130 are located within a volume between 10 to 100 times 2 mm×2 mm×0.2 mm since the reader is 20 cm away from the sensor which has a diameter of 0.1 mm).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have the intraocular pressure (IOP) measurement system of Sinha with the wherein the emitting and the detecting are performed by a transmitter and a receiver, and the transmitter, the receiver and the pressure sensor are positioned within a volume of between 10 to 100 times greater than a volume of 2 mm×2 mm×0.2 mm during measuring as taught by Choo, for the purpose of detecting reflections over greater distances ([0054]).
Regarding claim 18, modified Sinha teaches as is set forth in claim 17 rejection above and Sinha further discloses wherein the transmitter (Tx), the receiver (Rx) and the image sensor ([0024], “photo-detector, or it may be a one-dimensional or two-dimensional array of photo-detectors”) are integrated within a single housing of a handheld device ([0023], “The reader 2 may be a handheld device as illustrated in FIG. 4, for example a consumer focused product”).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Sinha (US 2022/0395178) in view of Choo (US 2013/0165762), further in view of Hastings (US 2011/0160561).
Regarding claim 19, modified Sinha teaches as is set forth in claim 18 rejection above but does not specifically disclose further comprising a projector integrated within the single housing of the handheld device to project the interference pattern to the image sensor.
However Hastings, in the same field of endeavor because both teach a pressure measurement system, teaches further comprising a projector (Fig. 1, element 110) integrated within the single housing of the handheld device ([0088], “the assembly containing the detector 106 must be considered. The assembly may be at least one of a handheld unit”) to project the interference pattern to the image sensor ([0068], “The objective lens 110 performs at least one of the functions of collecting light from the intraocular pressure sensor 101 and forming an image of the intraocular pressure sensor 101 on the detector 106”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have the intraocular pressure (IOP) measurement system of Sinha in view of Choo with the further comprising a projector integrated within the single housing of the handheld device to project the interference pattern to the image sensor as taught by Hastings, for the purpose of detecting clinically important changes in intraocular pressure ([0112]).
Conclusion
The prior art made of record and not relied upon are considered pertinent to applicant’s disclosure. Shau (US 2017/0181626), Phan (US 2017/0251921), Fleischman (US 6,994,672), teach an intraocular pressure (IOP) measurement system comprising: an optical pressure sensor implantable in an eye, wherein the sensor has a substrate coupled to a membrane that changes shape as a function of an intraocular pressure of the eye, and the substrate and the membrane define a sealed cavity.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW Y LEE whose telephone number is (571)272-3526. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pinping Sun can be reached at (571) 270 - 1284. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW Y LEE/Examiner, Art Unit 2872 23 June 2026
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