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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/23/2026 has been entered.
Applicant' s arguments, filed 2/23/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 2/23/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-20 are the currently pending claims hereby under examination. Claims 1, 6, 11, and 20 have been amended.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 8, 11, and 14 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1, 2, 9, 11, and 15 of U.S. Patent Application No. 18/781767, hereto referred to as Reference, and further in view of Peyman‘551 (US 20190307551 A1), hereto referred as Peyman’551, and further in view of Elsheikh et al. (Elsheikh A, McMonnies CW, Whitford C, Boneham GC. In vivo study of corneal responses to increased intraocular pressure loading. Eye Vis (Lond). 2015 Dec 10;2:20. doi: 10.1186/s40662-015-0029-z. PMID: 26693165), hereto referred as Elsheikh, and further in view of Lai et al. (US 20170280997 A1), hereto referred as Lai.
The analysis as follows (please note the bolded and underlined portions of the entries under the Instant Application, IA, are those portions of the IA claims that the claims of Patent Application 18/781767, Reference, does not have or are different from in some form):
Instant Application (Claim Elements)
Reference (18/781767)
Analysis
Claim 1
An intraocular pressure (IOP) measurement system comprising:
Claim 1: An intraocular pressure (IOP) measurement system comprising:
These elements correspond.
An optical pressure sensor configured to be implanted in the cornea of an eye, wherein the sensor has a sealed cavity and a membrane that is configured to change shape based on the cornea changing shape, the shape of the cornea being substantially a function of IOP of the eye.
Claim 1: 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;
The instant application specifies implantation in the cornea, while the reference only states "an eye" in claim 1. Peyman’551 teaches that pressure sensors can be implanted in the cornea (Peyman’551, ¶[0376]) and that implants can be "surrounded entirely by the stromal tissue of the cornea" (Peyman’551, ¶[0577]). Elsheikh teaches that the shape of the cornea changes as a function of IOP (Elsheikh, Abstract; p. 1–2). When the sensor is placed in the corneal stroma as taught by Peyman’551, the IOP‑induced corneal deformation (Elsheikh) is the immediate mechanical driver of membrane deflection. Thus, the limitation that the membrane is “configured to change shape based on the cornea changing shape” is an obvious variant of the reference’s “membrane that changes shape as a function of intraocular pressure,” as both describe the same physical behavior. It would have been obvious to implant the sensor in the cornea as a less invasive and more stable location that leverages the cornea’s biomechanical response to IOP changes.
An optical transmitter to emit an incident optical beam.
Claim 1: An optical transmitter to emit an incident optical beam to the sensor.
These elements correspond.
A receiver to produce an output signal in response to receiving a plurality of reflections of the incident optical beam from the sensor.
Claim 1: A receiver to produce an interference pattern in response to receiving a plurality of reflections of the incident optical beam from the sensor.
These elements correspond.
A processor configured to estimate the IOP of the eye based on processing the output signal of the receiver and a corneal position parameter, the corneal position parameter being determined based on a relationship between the shape of the cornea and the IOP of the eye
Claim 1: A processor configured to estimate the intraocular pressure of the eye based on processing the projection of the interference pattern.
These elements correspond with respect to the output signal of the receiver, but not the positioning parameter. The reference does not explicitly recite a parameter based on corneal shape. However, Lai teaches determining IOP using a calibrated parameter derived from corneal deformation (Lai, ¶[0055]), and further teaches that corneal curvature changes quantitatively with IOP (Lai, ¶[0042]). Elsheikh teaches that corneal shape is a function of IOP. It would have been prima facie obvious to incorporate such a parameter into the reference system to improve accuracy of IOP estimation. Therefore, the claimed subject matter differs from the reference only by obvious variations.
Claim 3
The system of claim 1 wherein the sensor provides a frequency dependent reflection of the incident optical beam, that changes as a second function of the IOP.
Claim 2: The system of claim 1 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.
These elements correspond (where the first function is the change in shape, second function is the reflection).
Claim 8
The system of claim 1 wherein the optical transmitter and the receiver are integrated within a single housing of a reader
Claim 9: The transmitter, the receiver, and the image sensor are integrated within a single housing of a handheld device.
These elements correspond (where the transmitter is optical as defined in the Reference claim 1).
Claim 11
A method for measuring IOP of an eye, the method comprising:
Claim 11: A method for measuring intraocular pressure of an eye, the method comprising:
These elements correspond.
Emitting an optical beam toward the eye
Claim 11: Emitting an optical beam toward the eye.
These elements correspond.
Detecting, as an output signal, reflections of the optical beam from a pressure sensor that is implanted in a cornea of the eye
Claim 11: Detecting, as an output signal, an interference pattern corresponding to a plurality of reflections of the optical beam from a pressure sensor that is implanted in the eye.
The instant application specifies implantation in a cornea, while the reference only states "the eye” in claim 11. Peyman’551 teaches that pressure sensors can be implanted in the cornea (Peyman’551, ¶[0376]) and that implants can be "surrounded entirely by the stromal tissue of the cornea" (Peyman’551, ¶[0577]). It would have been obvious to implant the sensor in the cornea as a less invasive and more stable location. (see claim 11 below for details)
and that is configured to be actuated based on the cornea changing shape
Elsheikh teaches that the shape of the cornea changes as a function of IOP (Elsheikh, Abstract; p. 1–2, Background). It would have been obvious to modify the art so that the sensor’s membrane changes shape based on the cornea changing shape, wherein the shape of the cornea is substantially a function of IOP of the eye. (see claim 11 below for details)
Processing the output signal to compute an estimate of the IOP of the eye.
Claim 11: Processing the projected interference pattern to compute an estimate of the intraocular pressure of the eye.
These elements correspond.
Claim 14
The method of claim 11, wherein the optical beam comprises an incident optical beam, wherein processing the output signal comprises computing an estimate of frequency dependent impedance presented to the incident optical beam, and wherein the estimate of frequency dependent impedance changes as a function of the IOP.
Claim 15: The method of claim 14 [claim 14—>claim 11] wherein the plurality of reflections are frequency dependent reflections of an incident optical beam that change as a function of the intraocular pressure to produce the interference pattern.
These elements correspond. One of ordinary skill in the art would understand that the incident optical beam is part of the optical beam and understand that both the Reference and IA are describing an estimate of impedance since they are functions and not direct measurements.
Claims 4 and 7 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1 and 6-7 of U.S. Patent Application No. 18/781767, hereto referred to as Reference, and further in view of Peyman‘551 (US 20190307551 A1), hereto referred as Peyman’551, and further in view of Elsheikh et al. (Elsheikh A, McMonnies CW, Whitford C, Boneham GC. In vivo study of corneal responses to increased intraocular pressure loading. Eye Vis (Lond). 2015 Dec 10;2:20. doi: 10.1186/s40662-015-0029-z. PMID: 26693165), hereto referred as Elsheikh, , and further in view of Lai et al. (US 20170280997 A1), hereto referred as Lai, and in view of Phan et al. (Phan, Alex et al. “Design of an Optical Pressure Measurement System for Intraocular Pressure Monitoring.” IEEE sensors journal 18.1 (2018): 61–68. Web.), hereto referred as Phan.
The analysis as follows (please note the bolded and underlined portions of the entries under the Instant Application, IA, are those portions of the IA claims that the claims of Patent Application 18/781767, Reference, does not have or are different from in some form):
Claim 4
The system of claim 3 wherein the sensor comprises a rigid substrate, wherein the membrane comprises a flexible membrane and is attached to the ridged substrate, and wherein an inner surface of the ridged substrate and an inner surface of the flexible membrane define the sealed cavity.
Claim 1: The sensor has a substrate coupled to a membrane that changes shape as a function of intraocular pressure, and the substrate and the membrane define a sealed cavity.
Nearly identical except the IA substrate is defined as rigid and the cavity is defined as the inner surface of the components. Phan teaches a rigid glass substrate and depicts the cavity as being formed from the inner surfaces (Phan, FIG. 3; p.62, Sec. III.A, ¶1). It would have been obvious to make the substrate rigid so as to provide stable dimensionality to the structure and a person of ordinary skill in the art would see that a cavity is implicitly defined by its inner surfaces as shown in Phan.
Claim 7
The system of claim 1 wherein the processor determines, by processing the output signal of the receiver, an optical interference pattern which varies as a second function of the IOP.
Claim 6: The system of claim 1 wherein the processor determines, by processing the projection of the interference pattern, whether the projection of the interference pattern matches a theoretical interference profile to estimate the intraocular pressure.
Claim 7: The system of claim 6 wherein the theoretical interference profile corresponds to a known membrane pressure.
The IA claim states an optical interference pattern varies as a function of IOP, where the reference claim 6 says the projection of the interference pattern matches a theoretical profile and then goes on to state in claim 7 that the theoretical profile corresponds to a known pressure. This shows that the projection of the interference pattern is a function of IOP. And Phan teaches that the projection can be part of the output signal and contains the interference pattern, where it depicts a reader (i.e. receiver) that uses a camera to record the reflections of interference patterns as projections to produce an output signal that is then processed to determine IOP (Phan, FIG. 1, p.64, Sec. IV.B, ¶2) (where the first function is the change in shape, second function is the reflection). It would have been obvious to incorporate this teaching of Phan so as to provide details with respect to the type of optical interference pattern to be determined.
Claim Rejections - 35 USC § 103
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 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 1, 3-4, 7-11, 15, 17, and 19-20 are rejected under 35 U.S.C. 103 as obvious over Phan et al. (Phan, Alex et al. “Design of an Optical Pressure Measurement System for Intraocular Pressure Monitoring.” IEEE sensors journal 18.1 (2018): 61–68. Web.), hereto referred as Phan, and further in view of Peyman‘551 (US 20190307551 A1), hereto referred as Peyman’551, and Martola et al. (Martola E, Baum JL. Central and Peripheral Corneal Thickness: A Clinical Study. Arch Ophthalmol. 1968;79(1):28–30.), hereto referred as Martola, as evidence, and further in view of Elsheikh et al. (Elsheikh A, McMonnies CW, Whitford C, Boneham GC. In vivo study of corneal responses to increased intraocular pressure loading. Eye Vis (Lond). 2015 Dec 10;2:20. doi: 10.1186/s40662-015-0029-z. PMID: 26693165), hereto referred as Elsheikh, and further in view of Lai et al. (US 20170280997 A1), hereto referred as Lai.
Regarding claim 1, Phan teaches an intraocular pressure (IOP) measurement system comprises: (Phan, p.62, Sec. 1, ¶7: "a novel pressure measurement approach using an implantable interferometric pressure sensor coupled with a portable hand-held reader", describing an intraocular pressure measurement system); an optical pressure sensor, wherein the sensor has a sealed cavity and a membrane that is configured to change shape (Phan, FIG. 2, p.62, Sec. III A: "The sensor consists of a square flexible silicon nitride (SiN) diaphragm, a rigid glass substrate and a spacer to form a cavity of height h", describing an optical pressure sensor that consists of a flexible membrane and a rigid glass substrate, forming a sealed cavity (Abstract: "hermetically sealed") where the membrane deflects in response to changes in intraocular pressure); an optical transmitter to emit an incident optical beam, (Phan, FIG. 1, p.62, Sec. III A: "Monochromatic light with coherence length Lc > 2h is directed at the sensor cavity", disclosing an optical transmitter that directs monochromatic light (i.e., an incident optical beam)); a receiver to produce an output signal in response to receiving a plurality of reflections of the incident optical beam from the sensor, (Phan, FIG. 6 and p.63, Sec. III A: "Interference of light reflected from the bottom surface of the glass substrate (R1) and the top surface of the diaphragm (R2) results in bright and dark fringes depending on the spacing d(x,y). These interference fringes are captured by the optical readout system and processed to determine pressure changes", describing multiple reflections. Phan implicitly, inherently, or obviously teaches the generation of an output signal because the presence of a processor analyzing the detected optical interference necessarily connotes or at least suggests that a signal must be produced from the reflections for subsequent processing as shown in figure 6 where the reader is connected to the computer); and a processor configured to estimate the IOP of the eye based on processing the output signal of the receiver. (Phan, FIG. 6 and p.64, Sec. V A: "Using image processing algorithms (MATLAB and ImageJ), we analyzed the fringe patterns to determine the maximum deflection of the sensor diaphragm as a function of the applied pressure", explaining that the processor analyzes interference fringe patterns from the received optical signal to determine intraocular pressure, where MATLAB and ImageJ are known computer programs that function via a processor of a computer (shown in figure 6)).
Also regarding claim 1, Phan does not teach that the system comprises an optical pressure sensor configured to be implanted in a cornea of an eye. Rather, Phan teaches a pressure sensor structure (flexible diaphragm, rigid substrate, sealed cavity) that is designed for intraocular pressure measurement and was tested ex-vivo using corneal tissue mounted on an artificial anterior chamber (see above and Phan, FIG. 2; p.62, Sec. III, ¶11; p.64, Sec. IV.D, ¶11). Although Martola provides evidence (Martola, Abstract: cornea thickness "523–660 µm") that the human cornea is thick enough to accommodate a sensor of the dimensions disclosed by Phan (Phan, FIG. 2; p.62, Sec. III.A, ¶11: sensor thickness is 410 µm), Phan does not disclose placing or configuring the sensor within the corneal stroma itself.
Peyman’551 provides explicit teaching that intraocular pressure sensors can be configured for and implanted within the corneal tissue. For example, Peyman’551 describes that “the pressure sensor [is] configured to be implanted in a cornea of the eye... [and] the transmitter device [is] configured to be implanted in the cornea of the eye” (Peyman’551, ¶[0376]). Peyman’551 also discloses that “an intracorneal implant comprising a pressure sensor” may be inserted into a corneal pocket (Peyman’551, ¶[0376]) and that implants can be "surrounded entirely by the stromal tissue of the cornea" (Peyman’551, ¶[0577]). These passages demonstrate that Peyman’551 teaches a pressure sensor configured to be implanted in the cornea, where the sensor includes a structure positioned within the corneal tissue, even if a portion of the sensor (e.g., a needle) extends to another region of the eye for pressure communication. Peyman’551 further describes techniques for creating corneal pockets and cross-linking the corneal stroma to maintain implant stability, confirming feasibility for intracorneal implantation of the pressure sensor within corneal tissue (Peyman’551, ¶[0336]–[0340]; ¶[0507]–[0509]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Phan in view of Peyman’551, in light of Martola, to provide an optical pressure sensor configured to be implanted in a cornea of an eye. The modification would have been straightforward and predictable, as both references address implantable sensors for measuring intraocular pressure, even though they use different sensing mechanisms (optical in Phan and pressure-transducing in Peyman’551), and Martola establishes feasibility of physical implantation. A person of ordinary skill would have found it obvious to implant Phan’s pressure-responsive optical diaphragm in the corneal stroma taught by Peyman’551 (pocket creation/cross-linking; sensor/transmitter configured to be implanted in the cornea) to obtain a stable, biocompatible site that permits free-space optical interrogation through the cornea and continuous IOP estimation. Phan already teaches that the membrane deflects in response to local pressure and is read optically; when implanted in the corneal stroma as taught by Peyman’551, the membrane deflects in response to local mechanical loading from surrounding tissue, yielding a predictable optical signal, from which IOP is determined. Implementing the Phan's sensor stack in a known ocular pocket is a routine packaging/placement choice with a reasonable expectation of success, not a change in principle of operation. Additionally, Phan’s sensor thickness and optical readout are compatible with a corneal pocket; Peyman’551 discloses pocket formation and cross-linking to stabilize intracorneal implants, and Martola shows corneal thickness accommodates devices of this scale. A person of ordinary skill in the art would view this as routine implementation detail, not undue experimentation. The motivation for the combination is that implanting Phan's sensor in the cornea ensures a stable, biocompatible, and intracorneal location that enables accurate, repeatable pressure measurements and minimizes surgical complexity while leveraging the intracorneal environment as a pressure-transmitting medium.
Also regarding claim 1, the modified Phan partially teaches that the optical pressure sensor is configured to change shape based on the cornea changing shape, the shape of the cornea being substantially a function of IOP of the eye. Specifically, the modified Phan teaches that the membrane changes shape as the membrane deflects in response to local mechanical loading from surrounding tissue (Phan, FIG. 2, p. 62-63, Sec. III A-B: "The deflection w(x,y) of a square SiN diaphragm can be determined using the shape function approach presented by Rahman et al."). It also teaches that the environment of the pressure sensor can be the cornea of the eye, such as when the sensor and its transmitter are implanted within the corneal stroma as described above (Peyman’551, ¶[0376]). However, it does not expressly teach that the sensor’s actuation is based on changes in corneal shape as a function of IOP.
Elsheikh teaches that the cornea changes shape as a function of IOP, stating that “The shape of the cornea is a function of a number of structural and biomechanical parameters, the most important of which are the material thickness and stiffness (as measured by the tangent modulus), as well as the IOP” (Elsheikh, Abstract; p. 1–2, Background). Thus, changes in corneal shape occur as a function of IOP. When Phan’s diaphragm-based sensor is implanted within the corneal stroma as taught by Peyman’551, the membrane is mechanically coupled to the surrounding corneal tissue. Because the cornea deforms as a function of intraocular pressure (Elsheikh), the immediate mechanical stimulus for membrane deflection is the IOP-induced deformation of the cornea, such that the membrane deflection corresponds to the cornea changing shape in response to IOP.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Phan in view of Elsheikh so that the sensor’s membrane changes shape based on the cornea changing shape, wherein the shape of the cornea is substantially a function of IOP of the eye. The modification would have been straightforward because Phan’s diaphragm is designed to deflect in response to local pressure and is optically interrogated; Peyman’551 provides an intracorneal environment (pocket/cross-linking) where the local tissue pressure field reflects IOP at the corneal stroma; and Elsheikh teaches that corneal shape depends on IOP, providing the biomechanics bridge. A person of ordinary skill in the art would have been motivated to implement this combination to provide a stable, minimally invasive IOP monitoring configuration that leverages the cornea’s biomechanical response to IOP changes. The benefit would be an implant that accurately tracks IOP in a minimally invasive intracorneal location, reducing surgical risk and improving patient safety while maintaining reliable pressure sensitivity through the corneal deformation response.
Also regarding claim 1, the modified Phan partially teaches that a processor configured to estimate the IOP of the eye based on a corneal position parameter, the corneal position parameter being determined based on a relationship between the shape of the cornea and the IOP of the eye. Rather, the modified Phan teaches a processor configured to estimate intraocular pressure based on processing an output signal from the optical sensor using a calibration parameter (Phan, FIG. 6; p.64, Sec. V A: “Using image processing algorithms… we analyzed the fringe patterns to determine the maximum deflection of the sensor diaphragm as a function of the applied pressure”; p.64: “A third order polynomial curve fit was performed… to produce a calibration curve… sensitivity… 31 nm/mmHg”). Thus, Phan teaches use of a parameter relating measured deformation to IOP. However, Phan does not expressly teach that the parameter is determined based on a relationship between corneal shape and IOP.
Lai teaches determining intraocular pressure based on corneal deformation using a calibrated relationship between deformation and IOP, wherein a change in corneal curvature due to IOP causes a corresponding measurable change that is correlated with IOP (“the curvature… changes in response to a change in IOP… [and] the change… may be used to determine the change in IOP”; “a correlation between the indicator feature travel distance and IOP… is calibrated…” (Lai, ¶[0055])). Lai further teaches that corneal curvature changes quantitatively with IOP (“the cornea… exhibit[s] approximately 3 µm… change in curvature… for each 1 mmHg intraocular pressure (P) change” (Lai, ¶[0042])), thereby explicitly establishing the relationship between corneal shape and IOP. Thus, Lai explicitly teaches determining IOP using a calibrated parameter derived from the relationship between deformation (shape) and IOP.
Elsheikh teaches that the shape of the cornea is a function of IOP (“The shape of the cornea is a function of… IOP” (Elsheikh, Abstract; p. 1–2)). Accordingly, the deformation used in Lai corresponds to corneal shape changes caused by IOP.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Phan in view of Lai and Elsheikh to use a parameter determined based on the relationship between corneal shape and IOP, because Lai teaches that such a relationship-based parameter can be used to determine IOP from deformation, and Phan provides a processor-based calibration framework for implementing such a parameter in a sensor system. Since the sensor of Phan is implanted in the cornea as taught by Peyman’551, the measured deformation corresponds to deformation of the surrounding corneal tissue, and applying Lai’s relationship-based calibration represents a predictable use of known techniques to improve accuracy of IOP estimation. The benefit would be improved accuracy and reliability of intraocular pressure estimation by accounting for the biomechanical response of the cornea to IOP.
Regarding claim 3, the modified Phan teaches that the sensor provides a frequency dependent reflection of the incident optical beam, that changes as a second function of the IOP (Phan, FIGs. 3, 8; p.62, Sec. III.A, ¶2: “Interference of light reflected from the bottom surface of the glass substrate (R1) and the top surface of the diaphragm (R2) results in bright and dark fringes depending on the spacing d(x,y). These interference fringes are captured by the optical readout system and processed to determine pressure changes”. Phan teaches that the optical sensor produces an interference pattern (frequency dependent reflection) that varies as a function of the pressure applied to the membrane (where the first function is changing shape and the second function is reflecting light as a result of the change in shape); “Monochromatic light with coherence length Lc > 2h is directed at the sensor cavity, and the reflected light is captured and analyzed to determine pressure”, Phan shows that the optical reflection depends on the sensor cavity and changes with pressure (IOP).).
Regarding claim 4, the modified Phan teaches that the sensor comprises a rigid substrate, wherein the membrane comprises a flexible membrane and is attached to the rigid substrate, and wherein an inner surface of the rigid substrate and an inner surface of the flexible membrane define the sealed cavity (Phan, FIG. 4; .62, Sec. III.A, ¶1: "The sensor consists of a square flexible silicon nitride (SiN) diaphragm, a rigid glass substrate and a spacer to form a cavity of height h”, Abstract: “hermetically sealed… sensor”, describing a structure in which a rigid substrate (glass) and a flexible membrane (SiN diaphragm) together define a sealed cavity that changes in response to intraocular pressure).
Regarding claim 7, the modified Phan teaches that the processor determines, by processing the output signal of the receiver, an optical interference pattern which varies as a second function of the IOP (Phan, p.64, Sec. IV.C, ¶2: "As various pressure loads were applied, the interference patterns were captured and processed using MATLAB image analysis algorithms," describing how the system detects and processes an optical interference pattern that varies with intraocular pressure (where the first function is a change in shape and the second function is reflecting light as a result of the change in shape); FIG. 6 illustrates the reader/receiver connected to a computer, supporting the processing of interference patterns for IOP estimation).
Regarding claim 8, the modified Phan teaches that the optical transmitter and the receiver are integrated within a single housing of a reader (Phan, FIGS. 1, 15: illustrating a system where the optical transmitter (light source) and receiver are positioned together within a single device and housing, enabling measurement of the sensor's response in a compact reader setup).
Regarding claim 9, the modified Phan teaches that the reader is a handheld device, and the processor is outside of the handheld device (Phan, FIG. 15: depicting a handheld optical reader used for capturing sensor response; FIG. 6b: illustrates the reader (camera) and processor (computer) as separate units, confirming that the processing occurs outside of the handheld device).
Regarding claim 10, the modified Phan does not teach that the sensor is configured to be implanted in a position in the cornea of the eye that is closer to a limbus of the eye than a visual axis of the eye. Rather, the modified Phan teach that the sensor can be implanted in the cornea of the eye, as discussed above in claim 1, but does not disclose that the sensor is closer to a limbus of the eye than a visual axis of the eye.
Peyman’551 explicitly teaches both (1) a pressure-sensor implant configured to be implanted in the cornea and (2) generic placement guidance that such corneal implants may be positioned in the peripheral cornea away from the visual axis (i.e., closer to the limbus). For example, Peyman’551 teaches that “the implant or implants … can be located at a desired distance … from the corneal periphery, that is located away from the center of the visual axis (i.e., the implant may be off centered, or ring-shaped in the peripheral cornea)” (Peyman ’551, ¶[0293]). In addition, the reference provides figure-specific teachings showing implants “disposed in a cross-linked pocket in the peripheral portion of the cornea that is spaced apart from the central visual axis of the eye so as not to obstruct the central portion of the eye” (Peyman’551, FIG. 38-49; ¶[0106]; see also ¶[0108], ¶[0310]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Phan in view of Peyman'551 to provide a sensor configured to be implanted in a position in the cornea of the eye that is closer to a limbus of the eye than a visual axis of the eye. This modification is both straightforward and predictable, as Peyman'551 illustrates implant placement in the peripheral cornea, spaced from the central visual axis and adjacent to the limbus, to avoid obstructing the central optical zone. The benefit of this combination is optimal sensor positioning for pressure measurement while preserving the patient's visual axis.
Regarding claim 11, Phan teaches a method for measuring IOP of an eye (Phan, p.6, Sec. 1, 17: "a novel pressure measurement approach using an implantable interferometric pressure sensor coupled with a portable hand-held reader", describing an intraocular pressure measurement method), the method comprises: emitting an optical beam toward the eye (Phan, FIG. 1, p.62, Sec. III, 12: "Monochromatic light with coherence length Lc > 2h is directed at the sensor cavity," disclosing an optical transmitter that directs monochromatic light (i.e. incident optical beam) toward the sensor); and processing the output signal to compute an estimate of the IOP of the eye (Phan, FIG. 6 and p.64, Sec. V, 12: "Using image processing algorithms (MATLAB and ImageJ), we analyzed the fringe patterns to determine the maximum deflection of the sensor diaphragm as a function of the applied pressure," explaining that the processor analyzes interference fringe patterns from the received optical signal to determine intraocular pressure, where MATLAB and ImageJ are known computer programs that function via a processor of a computer (shown in figure 6)).
Also regarding claim 11, Phan partially teaches detecting, as an output signal, reflections of the optical beam from the pressure sensor that is implanted in a cornea of the eye. Phan describes a method in which a monochromatic incident optical beam is directed at the intraocular pressure sensor, resulting in a portion of the light being reflected from both the glass substrate and the flexible silicon nitride diaphragm. These multiple reflections create interference patterns that are then captured by the optical readout system and analyzed to determine pressure changes (Phan, FIG. 6; p.63, Sec. III, 13: "Interference of light reflected from the bottom surface of the glass substrate (R1) and the top surface of the diaphragm (R2) results in bright and dark fringes depending on the spacing d(x,y). These interference fringes are captured by the optical readout system and processed to determine pressure changes"). This approach enables the system to detect and process reflections from the sensor surfaces. Although, Martola provides evidence (Martola, Abstract: cornea thickness "523-660 mm") that the human cornea is thick enough to accommodate a sensor of the dimensions disclosed by Phan (Phan, FIG. 2; p.62, Sec. III.A, 11: sensor thickness is 410 µm), Phan does not disclose that the pressure sensor is implanted in a cornea of the eye; rather, Phan's experiments were performed ex vivo using corneal tissue mounted in an artificial anterior chamber (Phan, FIG. 2; p.62, Sec. III, 11; p.64, Sec. IV.D, 11).
Peyman’551 provides explicit teaching that intraocular pressure sensors can be configured for and implanted within the corneal tissue. For example, Peyman’551 describes that “the pressure sensor [is] configured to be implanted in a cornea of the eye... [and] the transmitter device [is] configured to be implanted in the cornea of the eye” (Peyman’551, ¶[0376]). Peyman’551 also discloses that “an intracorneal implant comprising a pressure sensor” may be inserted into a corneal pocket (Peyman’551, ¶[0376]) and that implants can be "surrounded entirely by the stromal tissue of the cornea" (Peyman’551, ¶[0577]). These passages demonstrate that Peyman’551 teaches a pressure sensor configured to be implanted in the cornea, where the sensor includes a structure positioned within the corneal tissue, even if a portion of the sensor (e.g., a needle) extends to another region of the eye for pressure communication. Peyman’551 further describes techniques for creating corneal pockets and cross-linking the corneal stroma to maintain implant stability, confirming feasibility for intracorneal implantation of the pressure sensor within corneal tissue (Peyman’551, ¶[0336]–[0340]; ¶[0507]–[0509]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Phan in view of Peyman'551, in light of Martola, to provide a method comprising detecting, as an output signal, reflections of the optical beam from the pressure sensor that is implanted in a cornea of the eye. The modification would have been straightforward and predictable, as both references address implantable sensors for measuring intraocular pressure, even though they use different sensing mechanisms (optical in Phan and pressure-transducing in Peyman’551), and Martola establishes feasibility of physical implantation. A person of ordinary skill would have found it obvious to implant Phan’s pressure-responsive optical diaphragm in the corneal stroma taught by Peyman’551 (pocket creation/cross-linking; sensor/transmitter configured to be implanted in the cornea) to obtain a stable, biocompatible site that permits free-space optical interrogation through the cornea and continuous IOP estimation. Phan already teaches that the membrane deflects in response to local pressure and is read optically; when implanted in the corneal stroma as taught by Peyman’551, the membrane deflection is governed by local mechanical loading from surrounding tissue, yielding a predictable optical signal from which IOP is determined. Implementing the Phan's sensor stack in a known ocular pocket is a routine packaging/placement choice with a reasonable expectation of success, not a change in principle of operation. Additionally, Phan’s sensor thickness and optical readout are compatible with a corneal pocket; Peyman’551 discloses pocket formation and cross-linking to stabilize intracorneal implants, and Martola shows corneal thickness accommodates devices of this scale. A person of ordinary skill in the art would view this as routine implementation detail, not undue experimentation. The motivation for the combination is that implanting Phan's sensor in the cornea ensures a stable, biocompatible, and intracorneal location that enables accurate, repeatable pressure measurements and minimizes surgical complexity while leveraging the intracorneal environment as a pressure-transmitting medium.
Also regarding claim 11, the modified Phan partially teaches that the pressure sensor is configured to be actuated based on the cornea changing shape. Specifically, the modified Phan teaches that the membrane changes shape as the membrane deflects in response to local mechanical loading from surrounding tissue (i.e., the portion of the eye to which it is implanted)(Phan, FIG. 2, p. 62-63, Sec. III A-B: "The deflection w(x,y) of a square SiN diaphragm can be determined using the shape function approach presented by Rahman et al."). It also teaches that the environment of the pressure sensor can be the cornea of the eye, such as when the sensor and its transmitter are implanted within the corneal stroma as described above (Peyman’551, ¶[0376]). However, it does not expressly teach that the sensor’s actuation is based on changes in corneal shape as a function of IOP.
Elsheikh teaches that the shape of the cornea is a function of IOP, so changes in corneal shape correspond to changes in IOP (Elsheikh, Abstract; p. 1–2, Background: “The shape of the cornea is a function of a number of structural and biomechanical parameters, the most important of which are the material thickness and stiffness (as measured by the tangent modulus), as well as the IOP”). When Phan’s diaphragm-based sensor is implanted within the corneal stroma as taught by Peyman’551, the membrane is mechanically coupled to the surrounding corneal tissue. Because the cornea deforms as a function of intraocular pressure (Elsheikh), the immediate mechanical stimulus for membrane deflection is the IOP-induced deformation of the cornea, such that the membrane deflection corresponds to the cornea changing shape in response to IOP.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Phan in view of Elsheikh so that the sensor’s membrane changes shape based on the cornea changing shape, wherein the shape of the cornea is substantially a function of IOP of the eye. The modification would have been straightforward because Phan’s diaphragm is designed to deflect in response to local pressure and is optically interrogated; Peyman’551 provides an intracorneal environment (pocket/cross-linking) where the local tissue pressure field reflects IOP at the corneal stroma; and Elsheikh teaches that corneal shape depends on IOP, providing the biomechanics bridge. A person of ordinary skill in the art would have been motivated to implement this combination to provide a stable, minimally invasive IOP monitoring configuration that leverages the cornea’s biomechanical response to IOP changes. The benefit would be an implant that accurately tracks IOP in a minimally invasive intracorneal location, reducing surgical risk and improving patient safety while maintaining reliable pressure sensitivity through the corneal deformation response.
Also regarding claim 11, the modified Phan does not expressly teach processing a parameter to compute an estimate of the IOP of the eye, the parameter being determined based on a relationship between the shape of the cornea and the IOP of the eye. Rather, the modified Phan teaches a processor configured to estimate intraocular pressure based on processing an output signal from the optical sensor using a calibration parameter (Phan, FIG. 6; p.64, Sec. V A: “Using image processing algorithms… we analyzed the fringe patterns to determine the maximum deflection of the sensor diaphragm as a function of the applied pressure”; p.64: “A third order polynomial curve fit was performed… to produce a calibration curve… sensitivity… 31 nm/mmHg”). Thus, Phan teaches use of a parameter relating measured deformation to IOP. However, Phan does not expressly teach that the parameter is determined based on a relationship between corneal shape and IOP.
Lai teaches determining intraocular pressure based on corneal deformation using a calibrated relationship between deformation and IOP, wherein a change in corneal curvature due to IOP causes a corresponding measurable change that is correlated with IOP (“the curvature… changes in response to a change in IOP… [and] the change… may be used to determine the change in IOP”; “a correlation between the indicator feature travel distance and IOP… is calibrated…” (Lai, ¶[0055])). Lai further teaches that corneal curvature changes quantitatively with IOP (“the cornea… exhibit[s] approximately 3 µm… change in curvature… for each 1 mmHg intraocular pressure (P) change” (Lai, ¶[0042])), thereby explicitly establishing the relationship between corneal shape and IOP. Thus, Lai explicitly teaches determining IOP using a calibrated parameter derived from the relationship between deformation (shape) and IOP.
Elsheikh teaches that the shape of the cornea is a function of IOP (“The shape of the cornea is a function of… IOP” (Elsheikh, Abstract; p. 1–2)). Accordingly, the deformation used in Lai corresponds to corneal shape changes caused by IOP.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Phan in view of Lai and Elsheikh to use a parameter determined based on the relationship between corneal shape and IOP, because Lai teaches that such a relationship-based parameter can be used to determine IOP from deformation, and Phan provides a processor-based calibration framework for implementing such a parameter in a sensor system. Since the sensor of Phan is implanted in the cornea as taught by Peyman’551, the measured deformation corresponds to deformation of the surrounding corneal tissue, and applying Lai’s relationship-based calibration represents a predictable use of known techniques to improve accuracy of IOP estimation. The benefit would be improved accuracy and reliability of intraocular pressure estimation by accounting for the biomechanical response of the cornea to IOP.
Regarding claim 15, the modified Phan teaches that the sensor comprises a rigid substrate and a flexible membrane attached to the rigid substrate that define a sealed cavity (Phan, p.62, Sec. III.A, ¶1: "The sensor consists of a square flexible silicon nitride (SiN) diaphragm, a rigid glass substrate and a spacer to form a cavity of height h”, Abstract: “hermetically sealed… sensor”, describing a structure in which a rigid substrate (glass) and a flexible membrane (SiN diaphragm) together define a sealed cavity that changes in response to intraocular pressure).
Regarding claim 17, the modified Phan teaches that the optical beam comprises an incident optical beam wherein the rigid substrate is transparent to the incident optical beam and wherein the flexible membrane is reflective of the incident optical beam (Phan, p.62, Sec. III, ¶1: “The sensor consists of a square flexible silicon nitride (SiN) diaphragm, a rigid glass substrate and a spacer to form a cavity of height h”, and FIG. 3: depicts a clear glass substrate with light being transmitted through it to a reflective diaphragm, disclosing that the rigid substrate is transparent to the incident optical beam and that the flexible membrane (diaphragm) is reflective of the incident optical beam used for optical interrogation).
Regarding claim 19, the modified Phan teaches that the emitting and the detecting are performed by electronics that are integrated within a single housing of a reader, wherein the reader is a handheld device, and the method further comprises transmitting a digital version of the output signal to a digital processor that is outside of the handheld device, the digital processor performing the processing of the output signal to compute the estimate of the IOP of the eye (Phan, p.65, Sec. D, ¶1: "A portable handheld reader was designed and built to capture the response of the sensor. The unit consists of an objective lens, a beam splitter, a 635 nm LED light source, a 5 nm bandpass filter, and a camera," disclosing a handheld device that performs emitting and detecting with the electronics for the camera and light source; FIG. 6b: depicts the reader electronically connected to as separately housed computer, where the digital processor and analysis programing is located to compute the IOP (p.64, Sec. V, ¶2)).
Regarding claim 20, Phan teaches that a method for measuring IOP of an eye (Phan, p.6, Sec. 1, 17: "a novel pressure measurement approach using an implantable interferometric pressure sensor coupled with a portable hand-held reader", describing an intraocular pressure measurement method), the method comprises: emitting an optical beam toward the eye (Phan, FIG. 1, p.62, Sec. III, 12: "Monochromatic light with coherence length Lc > 2h is directed at the sensor cavity," disclosing an optical transmitter that directs monochromatic light (i.e. incident optical beam) toward the sensor); detecting, as an output signal, reflections of the optical beam from the pressure sensor (Phan, FIG. 6 and p.63, Sec. III, 13: "Interference of light reflected from the bottom surface of the glass substrate (R1) and the top surface of the diaphragm (R2) results in bright and dark fringes depending on the spacing d(x,y). These interference fringes are captured by the optical readout system and processed to determine pressure changes", describing detecting multiple reflections from the pressure sensor); and processing the output signal to compute an estimate of the IOP of the eye (Phan, FIG. 6 and p.64, Sec. V, 112: "Using image processing algorithms (MATLAB and ImageJ), we analyzed the fringe patterns to determine the maximum deflection of the sensor diaphragm as a function of the applied pressure," explaining that the processor analyzes interference fringe patterns from the received optical signal to determine intraocular pressure, where MATLAB and ImageJ are known computer programs that function via a processor of a computer (shown in figure 6)).
Also regarding claim 20, Phan does not teach implanting a pressure sensor into a cornea of the eye. Rather, Phan teaches a sensor structure (flexible diaphragm, rigid substrate, sealed cavity) that is designed for intraocular pressure measurement and was tested ex-vivo using corneal tissue mounted on an artificial anterior chamber (Phan, FIG. 2; p.62, Sec. III, 11; p.64, Sec. IV.D, 11). Although Martola provides evidence (Martola, Abstract: cornea thickness "523-660 mm") that the human cornea is thick enough to accommodate a sensor of the dimensions disclosed by Phan (Phan, FIG. 2; p.62, Sec. III.A, 11: sensor thickness is 410 µm), Phan does not disclose placing or configuring the sensor within the corneal stroma itself. Peyman’551 provides explicit teaching that intraocular pressure sensors can be configured for and implanted within the corneal tissue. For example, Peyman’551 describes that “the pressure sensor [is] configured to be implanted in a cornea of the eye... [and] the transmitter device [is] configured to be implanted in the cornea of the eye” (Peyman’551, ¶[0376]). Peyman’551 also discloses that “an intracorneal implant comprising a pressure sensor” may be inserted into a corneal pocket (Peyman’551, ¶[0376]) and that implants can be "surrounded entirely by the stromal tissue of the cornea" (Peyman’551, ¶[0577]). These passages demonstrate that Peyman’551 teaches a pressure sensor configured to be implanted in the cornea, where the sensor includes a structure positioned within the corneal tissue, even if a portion of the sensor (e.g., a needle) extends to another region of the eye for pressure communication. Peyman’551 further describes techniques for creating corneal pockets and cross-linking the corneal stroma to maintain implant stability, confirming feasibility for intracorneal implantation of the pressure sensor within corneal tissue (Peyman’551, ¶[0336]–[0340]; ¶[0507]–[0509]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Phan in view of Peyman’551, in light of Martola, to provide a method comprising implanting a pressure sensor into a cornea of the eye. The modification would have been straightforward and predictable, as both references address implantable sensors for measuring intraocular pressure, even though they use different sensing mechanisms (optical in Phan and pressure-transducing in Peyman’551), and Martola establishes feasibility of physical implantation. A person of ordinary skill would have found it obvious to implant Phan’s pressure-responsive optical diaphragm in the corneal stroma taught by Peyman’551 (pocket creation/cross-linking; sensor/transmitter configured to be implanted in the cornea) to obtain a stable, biocompatible site that permits free-space optical interrogation through the cornea and continuous IOP estimation. Phan already teaches that the membrane deflects in response to local pressure and is read optically; when implanted in the corneal stroma as taught by Peyman’551, the membrane deflection is governed by local mechanical loading from surrounding tissue, yielding a predictable optical signal from which IOP is determined. Implementing the Phan's sensor stack in a known ocular pocket is a routine packaging/placement choice with a reasonable expectation of success, not a change in principle of operation. Additionally, Phan’s sensor thickness and optical readout are compatible with a corneal pocket; Peyman’551 discloses pocket formation and cross-linking to stabilize intracorneal implants, and Martola shows corneal thickness accommodates devices of this scale. A person of ordinary skill in the art would view this as routine implementation detail, not undue experimentation. The motivation for the combination is that implanting Phan's sensor in the cornea ensures a stable, biocompatible, and minimally invasive intracorneal location that enables accurate, repeatable pressure measurements and minimizes surgical complexity while leveraging the intracorneal environment as a pressure-transmitting medium.
Also regarding claim 20, the modified Phan partially teaches that the pressure sensor is configured to be actuated based on the cornea changing shape. Specifically, the modified Phan teaches that the membrane changes shape as the membrane deflects in response to local mechanical loading from surrounding tissue (i.e., the portion of the eye to which it is implanted)(Phan, FIG. 2, p. 62-63, Sec. III A-B: "The deflection w(x,y) of a square SiN diaphragm can be determined using the shape function approach presented by Rahman et al."). It also teaches that the environment of the pressure sensor can be the cornea of the eye, such as when the sensor and its transmitter are implanted within the corneal stroma as described above (Peyman’551, ¶[0376]). However, it does not expressly teach that the sensor’s actuation is based on changes in corneal shape as a function of IOP.
Elsheikh teaches that the shape of the cornea is a function of IOP, so changes in corneal shape correspond to changes in IOP (Elsheikh, Abstract; p. 1–2, Background: “The shape of the cornea is a function of a number of structural and biomechanical parameters, the most important of which are the material thickness and stiffness (as measured by the tangent modulus), as well as the IOP”). When Phan’s diaphragm-based sensor is implanted within the corneal stroma as taught by Peyman’551, the membrane is mechanically coupled to the surrounding corneal tissue. Because the cornea deforms as a function of intraocular pressure (Elsheikh), the immediate mechanical stimulus for membrane deflection is the IOP-induced deformation of the cornea, such that the membrane deflection corresponds to the cornea changing shape in response to IOP. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Phan in view of Elsheikh so that the sensor’s membrane changes shape based on the cornea changing shape, wherein the shape of the cornea is substantially a function of IOP of the eye. The modification would have been straightforward because Phan’s diaphragm is designed to deflect in response to local pressure and is optically interrogated; Peyman’551 provides an intracorneal environment (pocket/cross-linking) where the local tissue pressure field reflects IOP at the corneal stroma; and Elsheikh teaches that corneal shape depends on IOP, providing the biomechanics bridge. A person of ordinary skill in the art would have been motivated to implement this combination to provide a stable, minimally invasive IOP monitoring configuration that leverages the cornea’s biomechanical response to IOP changes. The benefit would be an implant that accurately tracks IOP in a minimally invasive intracorneal location, reducing surgical risk and improving patient safety while maintaining reliable pressure sensitivity through the corneal deformation response.
Also regarding claim 20, the modified Phan does not expressly teach processing a parameter to compute an estimate of the IOP of the eye, the parameter being determined based on a relationship between the shape of the cornea and the IOP of the eye. Rather, the modified Phan teaches a processor configured to estimate intraocular pressure based on processing an output signal from the optical sensor using a calibration parameter (Phan, FIG. 6; p.64, Sec. V A: “Using image processing algorithms… we analyzed the fringe patterns to determine the maximum deflection of the sensor diaphragm as a function of the applied pressure”; p.64: “A third order polynomial curve fit was performed… to produce a calibration curve… sensitivity… 31 nm/mmHg”). Thus, Phan teaches use of a parameter relating measured deformation to IOP. However, Phan does not expressly teach that the parameter is determined based on a relationship between corneal shape and IOP.
Lai teaches determining intraocular pressure based on corneal deformation using a calibrated relationship between deformation and IOP, wherein a change in corneal curvature due to IOP causes a corresponding measurable change that is correlated with IOP (“the curvature… changes in response to a change in IOP… [and] the change… may be used to determine the change in IOP”; “a correlation between the indicator feature travel distance and IOP… is calibrated…” (Lai, ¶[0055])). Lai further teaches that corneal curvature changes quantitatively with IOP (“the cornea… exhibit[s] approximately 3 µm… change in curvature… for each 1 mmHg intraocular pressure (P) change” (Lai, ¶[0042])), thereby explicitly establishing the relationship between corneal shape and IOP. Thus, Lai explicitly teaches determining IOP using a calibrated parameter derived from the relationship between deformation (shape) and IOP.
Elsheikh teaches that the shape of the cornea is a function of IOP (“The shape of the cornea is a function of… IOP” (Elsheikh, Abstract; p. 1–2)). Accordingly, the deformation used in Lai corresponds to corneal shape changes caused by IOP.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Phan in view of Lai and Elsheikh to use a parameter determined based on the relationship between corneal shape and IOP, because Lai teaches that such a relationship-based parameter can be used to determine IOP from deformation, and Phan provides a processor-based calibration framework for implementing such a parameter in a sensor system. Since the sensor of Phan is implanted in the cornea as taught by Peyman’551, the measured deformation corresponds to deformation of the surrounding corneal tissue, and applying Lai’s relationship-based calibration represents a predictable use of known techniques to improve accuracy of IOP estimation. The benefit would be improved accuracy and reliability of intraocular pressure estimation by accounting for the biomechanical response of the cornea to IOP.
Claims 5-6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Phan et al. (Phan, Alex et al. “Design of an Optical Pressure Measurement System for Intraocular Pressure Monitoring.” IEEE sensors journal 18.1 (2018): 61–68. Web.), hereto referred as Phan, and further in view of Peyman‘551 (US 20190307551 A1), hereto referred as Peyman’551, and Martola et al. (Martola E, Baum JL. Central and Peripheral Corneal Thickness: A Clinical Study. Arch Ophthalmol. 1968;79(1):28–30.), hereto referred as Martola, as evidence, and further in view of Elsheikh et al. (Elsheikh A, McMonnies CW, Whitford C, Boneham GC. In vivo study of corneal responses to increased intraocular pressure loading. Eye Vis (Lond). 2015 Dec 10;2:20. doi: 10.1186/s40662-015-0029-z. PMID: 26693165), hereto referred as Elsheikh, and further in view of Lai et al. (US 20170280997 A1), hereto referred as Lai, and Araci et al. (Araci, Ismail E et al. “An Implantable Microfluidic Device for Self-Monitoring of Intraocular Pressure.” Nature medicine 20.9 (2014): 1074–1078. Web.), hereto referred as Araci, as evidence.
The modified Phan teaches claim 1 as described above.
Regarding claim 5, the modified Phan does not expressly teach that the sealed cavity is a gaseous cavity. Rather, the modified Phan discloses an intraocular pressure sensor with a hermetically sealed cavity formed between a rigid substrate and a flexible diaphragm (Phan, p.62, Sec. III.A, ¶1). The sensor relies on interferometric optical measurement, meaning changes in cavity spacing influence the interference pattern of reflected light. However, it does not specify the internal medium of the cavity, leaving it unclear whether the cavity is gas-filled, fluid-filled, or a vacuum. One skilled in the art would recognize that a gas-filled cavity is the most practical and expected choice for an interferometric pressure sensor. A vacuum-sealed cavity would not allow for proper diaphragm deflection, as there would be no counteracting force within the cavity to allow for controlled movement. A fluid-filled cavity would introduce refractive index variations, which could distort interferometric measurements and reduce optical clarity. Additionally, a fluid-filled cavity would dampen diaphragm movement, making the sensor less responsive to small pressure changes. In contrast, a gas-filled cavity enables predictable and sensitive diaphragm deflection, ensuring accurate, repeatable pressure measurement without interference from unwanted optical or mechanical effects. Further supporting this understanding, Araci demonstrates that gas-filled cavities have been previously utilized in intraocular pressure sensors, providing evidence that gas-filled cavities were known and expected in the field (Araci, p.61074, Results, ¶1). This reinforces the conclusion that one skilled in the art would recognize a gas-filled cavity as the most suitable choice for Phan’s sensor to achieve stable and sensitive IOP measurements without interference from fluid dynamics or vacuum-related diaphragm constraints. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have further modified the modified Phan in view of Araci to explicitly state that the cavity is gas-filled, as doing so would optimize diaphragm deflection and maintain the integrity of the interferometric measurement. A gas-filled cavity ensures that intraocular pressure changes can be accurately transduced into diaphragm movement, while avoiding the optical and mechanical drawbacks of other potential cavity mediums. The use of a gas-filled cavity improves the sensor’s accuracy and longevity by preventing optical distortion and maintaining consistent diaphragm responsiveness over time. This ensures stable, reliable IOP measurements without interference from intraocular fluid absorption or pressure equalization issues that could arise in a fluid-filled or vacuum-sealed cavity.
Regarding claim 6, the modified Phan teaches that an outside surface of the rigid substrate faces the optical transmitter, and an outside surface of the membrane is configured to face a portion of the eye more posterior than the sensor (Phan, FIG. 2: illustrating the sensor’s configuration where the incident optical beam from the transmitter first contacts the rigid glass substrate, while the flexible membrane faces away from the transmitter and is subjected to intraocular pressure. This depiction confirms that the outside surface of the rigid substrate aligns with the transmitter, and the outside surface of the membrane interfaces with the eye’s internal pressure environment).
Regarding claim 16, the modified Phan does not expressly teach that the sealed cavity is a gaseous cavity. Rather, the modified Phan discloses an intraocular pressure sensor with a hermetically sealed cavity formed between a rigid substrate and a flexible diaphragm (Phan, p.62, Sec. III.A, ¶1). The sensor relies on interferometric optical measurement, meaning changes in cavity spacing influence the interference pattern of reflected light. However, it does not specify the internal medium of the cavity, leaving it unclear whether the cavity is gas-filled, fluid-filled, or a vacuum. One skilled in the art would recognize that a gas-filled cavity is the most practical and expected choice for an interferometric pressure sensor. A vacuum-sealed cavity would not allow for proper diaphragm deflection, as there would be no counteracting force within the cavity to allow for controlled movement. A fluid-filled cavity would introduce refractive index variations, which could distort interferometric measurements and reduce optical clarity. Additionally, a fluid-filled cavity would dampen diaphragm movement, making the sensor less responsive to small pressure changes. In contrast, a gas-filled cavity enables predictable and sensitive diaphragm deflection, ensuring accurate, repeatable pressure measurement without interference from unwanted optical or mechanical effects. Further supporting this understanding, Araci demonstrates that gas-filled cavities have been previously utilized in intraocular pressure sensors, providing evidence that gas-filled cavities were known and expected in the field (Araci, p.61074, Results, ¶1). This reinforces the conclusion that one skilled in the art would recognize a gas-filled cavity as the most suitable choice for Phan’s sensor to achieve stable and sensitive IOP measurements without interference from fluid dynamics or vacuum-related diaphragm constraints. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have further modified the modified Phan in view of Araci to explicitly state that the cavity is gas-filled, as doing so would optimize diaphragm deflection and maintain the integrity of the interferometric measurement. A gas-filled cavity ensures that intraocular pressure changes can be accurately transduced into diaphragm movement, while avoiding the optical and mechanical drawbacks of other potential cavity mediums. The use of a gas-filled cavity improves the sensor’s accuracy and longevity by preventing optical distortion and maintaining consistent diaphragm responsiveness over time. This ensures stable, reliable IOP measurements without interference from intraocular fluid absorption or pressure equalization issues that could arise in a fluid-filled or vacuum-sealed cavity.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Phan et al. (Phan, Alex et al. “Design of an Optical Pressure Measurement System for Intraocular Pressure Monitoring.” IEEE sensors journal 18.1 (2018): 61–68. Web.), hereto referred as Phan, and further in view of Peyman‘551 (US 20190307551 A1), hereto referred as Peyman’551, and Martola et al. (Martola E, Baum JL. Central and Peripheral Corneal Thickness: A Clinical Study. Arch Ophthalmol. 1968;79(1):28–30.), hereto referred as Martola, as evidence, and further in view of Elsheikh et al. (Elsheikh A, McMonnies CW, Whitford C, Boneham GC. In vivo study of corneal responses to increased intraocular pressure loading. Eye Vis (Lond). 2015 Dec 10;2:20. doi: 10.1186/s40662-015-0029-z. PMID: 26693165), hereto referred as Elsheikh, and further in view of Lai et al. (US 20170280997 A1), hereto referred as Lai, and further in view of Lee et al. (Lee, Jeong Oen et al. “A Microscale Optical Implant for Continuous in Vivo Monitoring of Intraocular Pressure.” Microsystems & nanoengineering 3.1 (2017): 17057-. Web.), hereto referred as Lee.
The modified Phan teaches claims 1 and 11 as described above.
Regarding claim 12, the modified Phan does not expressly teach that processing the output signal comprises performing a spectroscopy algorithm. Rather, the modified Phan discloses an optical system for measuring intraocular pressure through interference patterns generated by a sensor diaphragm (Phan, FIG. 8, Abstract, p.64, Sec. V, ¶2). The interference pattern shifts based on the diaphragm's deflection due to pressure changes. However, it does not explicitly disclose performing a spectroscopy algorithm on the received optical signal. While Phan's system relies on optical interference, it does not teach direct spectral decomposition or wavelength-dependent analysis to determine intraocular pressure. Lee, who investigates a sensor for determining IOP, provides additional details on analyzing spectral signatures of light reflected from a pressure-sensitive membrane, where specific wavelengths correspond to different intraocular pressures (Lee, p.64, Fig. 2b). Lee’s system explicitly performs spectral analysis of reflected light to determine intraocular pressure. The spectral decomposition in Lee enables precise IOP estimation through wavelength-specific resonance shifts. One skilled in the art would have found it obvious before the effective filing date of the claimed invention to modify Phan in view of Lee to process the output signal by performing a spectroscopy algorithm. The use of spectroscopy in intraocular pressure measurement is well-documented, and Phan’s optical interference patterns inherently contain spectral information that can be further analyzed using the methodologies in Lee. Given that both references deal with optical IOP sensing, integrating spectral analysis into Phan’s system would have been a logical extension to improve measurement accuracy and reliability. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have further modified the modified Phan to include performing a spectroscopy algorithm on the received optical signal, as described in Lee. The method of claim 11 wherein processing the output signal comprises performing a spectroscopy algorithm would have been a predictable and beneficial enhancement based on known optical measurement techniques. The motivation to combine Phan and Lee arises from the benefits of spectral analysis in improving intraocular pressure sensing. Spectral decomposition provides increased accuracy, reduces sensitivity to noise, and enhances measurement consistency. By applying Lee’s spectroscopy techniques to Phan’s interferometric system, one skilled in the art would achieve a more precise and robust intraocular pressure measurement system, making the combination of these references a clear and logical step in advancing the technology.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Phan et al. (Phan, Alex et al. “Design of an Optical Pressure Measurement System for Intraocular Pressure Monitoring.” IEEE sensors journal 18.1 (2018): 61–68. Web.), hereto referred as Phan, and further in view of Peyman‘551 (US 20190307551 A1), hereto referred as Peyman’551, and Martola et al. (Martola E, Baum JL. Central and Peripheral Corneal Thickness: A Clinical Study. Arch Ophthalmol. 1968;79(1):28–30.), hereto referred as Martola, as evidence, and further in view of Elsheikh et al. (Elsheikh A, McMonnies CW, Whitford C, Boneham GC. In vivo study of corneal responses to increased intraocular pressure loading. Eye Vis (Lond). 2015 Dec 10;2:20. doi: 10.1186/s40662-015-0029-z. PMID: 26693165), hereto referred as Elsheikh, and further in view of Lai et al. (US 20170280997 A1), hereto referred as Lai, and further in view of Fleischman et al. (US 20070129623 A1), hereto referred as Fleischman.
The modified Phan teaches claim 11 as described above.
Regarding claim 14, the modified Phan does not expressly teach that the optical beam comprises an incident optical beam, wherein processing the output signal comprises computing an estimate of frequency dependent impedance presented to the incident optical beam, and wherein the estimate of frequency dependent impedance changes as a function of the IOP. Rather, the modified Phan’s system uses a monochromatic incident optical beam directed at the sensor cavity, and the reflected beam is analyzed to detect phase shifts and interference patterns (Phan, Abstract, p.3, Sec. III.A, Eq. 1). The phase shift equation demonstrates that the optical response is frequency-dependent and varies as a function of intraocular pressure. However, it does not explicitly compute an estimate of frequency-dependent impedance presented to the incident optical beam, instead deriving pressure from interference and phase analysis. Fleischman, in contrast, explicitly teaches a resonant sensor system in which the impedance varies in response to intraocular pressure changes (Fleischman, ¶[0030]). While Fleischman does not use an optical system, its method for impedance computation is broadly applicable to frequency-dependent sensing modalities. One skilled in the art would have found it obvious to apply Fleischman’s impedance estimation techniques to the output of Phan’s optical system, enabling computation of an estimate of frequency-dependent impedance presented to the incident optical beam, with the estimate changing as a function of IOP. This modification is a routine extension of the prior art, given the analogous nature of optical and impedance-based frequency-dependent sensing. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have further modified the modified Phan’s optical interrogation method to include processing the output signal to compute an estimate of frequency dependent impedance presented to the incident optical beam, as taught by Fleischman, such that the estimate changes as a function of IOP. This adaptation follows well-established principles in optical and impedance-based sensing, where changes in optical response correlate with impedance variations. The motivation to combine Phan and Fleischman arises from the benefits of frequency-dependent impedance estimation in enhancing intraocular pressure measurements. Optical sensors, such as Phan’s, inherently produce frequency-dependent phase shifts, and Fleischman’s impedance-based techniques provide an established method for converting such variations into impedance-based readings. By applying Fleischman’s impedance estimation techniques to Phan’s optical system, one skilled in the art would achieve a more accurate and robust intraocular pressure measurement method, making this combination a logical and predictable improvement in the field.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Phan et al. (Phan, Alex et al. “Design of an Optical Pressure Measurement System for Intraocular Pressure Monitoring.” IEEE sensors journal 18.1 (2018): 61–68. Web.), hereto referred as Phan, and further in view of Peyman‘551 (US 20190307551 A1), hereto referred as Peyman’551, and Martola et al. (Martola E, Baum JL. Central and Peripheral Corneal Thickness: A Clinical Study. Arch Ophthalmol. 1968;79(1):28–30.), hereto referred as Martola, as evidence, and further in view of Elsheikh et al. (Elsheikh A, McMonnies CW, Whitford C, Boneham GC. In vivo study of corneal responses to increased intraocular pressure loading. Eye Vis (Lond). 2015 Dec 10;2:20. doi: 10.1186/s40662-015-0029-z. PMID: 26693165), hereto referred as Elsheikh, and further in view of Lai et al. (US 20170280997 A1), hereto referred as Lai, and further in view of Hastings et al. (US 20180344158 A1), hereto referred as Hastings.
The modified Phan teaches claim 11 as described above.
Regarding claim 18, the modified Phan does not teach that the emitting, the detecting, and the processing are performed by electronics that are integrated within a single housing of a reader. Rather, the modified Phan discloses a hand help reader that contains a lens, beam splitter, light source, bandpass filter, and camera (Phan, FIGs 1, 15 and p.65, Sec. D, ¶1). This system is responsible for both illuminating the sensor and capturing the reflected optical signal, meaning that the emission, detection, and initial signal processing occur within a single device housing. However, it does not explicitly disclose that the processor itself is housed within the same unit. Hastings, who looks at optical interrogation of an implantable intraocular pressure sensor, explicitly describes a fully integrated system where the light source, lens, beam splitter, modulator, filter, detector, and processing device are all contained within a single housing (Hastings, Fig. 1, ¶[0065]). The processor receives and analyzes the optical signal to estimate intraocular pressure, ensuring that all critical components are integrated into a single compact device. One skilled in the art would have found it obvious before the effective filing date of the claimed invention to modify Phan’s system by integrating the processor within the same housing, as described in Azar. The integration of all necessary components into a single unit is a well-known design consideration for portability, ease of use, and system reliability. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have further modified the modified Phan to include emitting, detecting, and processing within a single housing of a reader, as described in Azar. This adaptation follows well-established engineering practices for compact biomedical devices and optical sensor integration. The motivation to combine Phan and Azar arises from the advantages of a fully integrated system, such as reducing external wiring complexity, improving signal fidelity by minimizing transmission losses, and enhancing device portability. By incorporating Azar’s processor integration into Phan’s system, one skilled in the art would achieve a more efficient and compact intraocular pressure measurement device, making this combination a logical and predictable improvement.
Allowable Subject Matter
Claims 2 and 13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 2 and 13 depend from independent claims, 1 and 11 respectively, and further recite that "the sensor is entirely implantable within the cornea so that the sensor is entirely embedded in the cornea" (i.e., fully contained within corneal tissue without extending into other regions such as the anterior chamber).
The prior art of record, including Phan, Peyman’551, Martola, Elsheikh, and Lai, fails to teach or suggest, alone or in combination, a pressure sensor that is entirely embedded within the corneal tissue.
Peyman’551 teaches an intracorneal implant comprising a pressure sensor (¶[0376]) and describes placement within a corneal pocket, however, Peyman’551 further discloses embodiments in which the pressure sensor includes a needle extending into the anterior chamber to facilitate pressure measurement. Thus, Peyman’551 does not clearly teach or suggest a pressure sensor that is fully confined within the corneal stroma without any portion extending beyond the cornea.
Additionally, the remaining prior art of record does not remedy this deficiency. Phan does not disclose intracorneal implantation, Martola is directed to corneal thickness and feasibility rather than sensor configuration, and Lai relates to external (contact lens-based) sensing approaches rather than implanted sensors. None of these references teach or suggest modifying the known systems to provide a pressure sensor that is entirely embedded within the corneal tissue.
Accordingly, the prior art fails to teach or suggest the limitation of a pressure sensor being entirely embedded within the cornea as recited in claims 2 and 13. Therefore, claims 2 and 13 would be allowable if rewritten in independent form including all of the limitations of the base claims and any intervening claims.
Response to Arguments
Interview Summary
Applicant's remarks filed 2/23/2026, page 8, regarding the interview conducted on 1/27/2026 pertaining to claim 1 have been fully considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. That is, there are new grounds of rejection. The examiner has determined that the combination of Phan, Peyman’551, Martola, Elsheikh, and Lai teaches or renders obvious the amended limitations for the reasons set forth above. Accordingly, the rejection of claims 1, 11, and 20 under 35 U.S.C. § 103 is proper.
Double Patenting
Applicant's arguments filed 2/23/2026, pages 5-6, regarding the previous Non-statutory Double Patenting Rejections of claims 1, 3, 4, 7, 8, 11, and 14 have been fully considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. That is, there are new grounds of rejection.
To the extent Applicant’s argument relies on the presence of a needle in Peyman’551 to assert that the pressure sensor is not implanted in the cornea, such argument is not persuasive with respect to independent claims 1 and 11. The distinction between a device “implanted in an eye” and one “implanted in a cornea” constitutes a selection of a known anatomical location within the eye and represents an obvious variation, as evidenced by Peyman’551 (¶[0376]) teaching implantation of a pressure sensor in the cornea as a known location within the eye. As discussed below those claims require only that the sensor be implanted in a cornea of an eye and do not require that the sensor be entirely embedded within the cornea. Peyman’551 expressly teaches an intracorneal implant comprising a pressure sensor (Peyman’551, [0376]) and placement of the sensor within corneal tissue, even if a portion of the device extends to another region of the eye. Accordingly, Peyman’551 teaches or at least suggests the claimed implantation limitation for purposes of the nonstatutory double patenting analysis.
Further, to the extent that the arguments rely on the amendments to independent claims 1 and 11, including the recitation of a “corneal position parameter … determined based on a relationship between the shape of the cornea and the IOP of the eye,” overcome the nonstatutory double patenting rejection because the ’767 application does not teach these limitations, such arguments are not persuasive. The additional limitation does not render the claims patentably distinct. While the reference does not explicitly recite such a parameter, Lai teaches determining intraocular pressure using a calibrated parameter derived from corneal deformation (Lai, ¶[0055]) and further teaches that corneal curvature changes quantitatively with IOP (Lai, ¶[0042]). Elsheikh teaches that corneal shape is a function of IOP. A person of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the claimed invention to incorporate such a parameter into the reference system to improve accuracy of IOP estimation. Accordingly, the amended limitations represent only obvious variations over the reference and do not render the claims patentably distinct from the claims of the ’767 application.
The provisional double-patenting rejection remains proper because it is based on the copending ’767 application and demonstrates that the presently claimed subject matter represents an obvious variation of the claims in the ’767 application when considered with the current art set. Accordingly, the Applicant’s prior arguments at least concerning the lack of corneal implantation, membrane deformation based on corneal shape as a function of IOP, or a position parameter related to IOP, do not overcome the updated rejection.
However, the arguments in the 35 U.S.C. §103 section (as shown below) in regards to claim 2 are also pertinent to the double patenting rejection of claim 2. These arguments are persuasive. As such, the double patenting rejection of claim 2 has been withdrawn.
35 U.S.C. §103
Applicant's arguments filed 2/23/2026, pages 6-8 and 9-10, regarding the previous 103 Rejections of claims 1, 3-12, and 14-20 have been fully considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. That is, there are new grounds of rejection. Additionally, the following arguments are not persuasive as shown below:
Applicant’s Argument:Applicant argues that Elsheikh is “merely a scientific study” that does not teach an implantable device having “a membrane that is configured to change shape based on the cornea changing shape,” and therefore cannot remedy the deficiencies of the remaining references.
Examiner’s Response:The argument is not persuasive because it does not address the rejection as made. The rejection does not rely on Elsheikh to teach an implantable device. Rather, Phan teaches an implantable interferometric pressure sensor including a sealed cavity and a flexible membrane, and Peyman’551 teaches implantation of a pressure sensor within the corneal stroma (e.g., ¶[0376], “an intracorneal implant comprising a pressure sensor … configured to be implanted in a cornea of the eye”). Elsheikh is relied upon for the factual teaching that the shape of the cornea is a function of intraocular pressure ("The shape of the cornea is a function of … IOP" (Elsheikh, Abstract; p. 1–2)).
When the flexible membrane sensor of Phan is implanted within the corneal stroma as taught by Peyman’551, the membrane is mechanically coupled to the surrounding corneal tissue. Elsheikh teaches that the cornea deforms as a function of IOP. Accordingly, deformation of the cornea results in deformation of the embedded membrane. Thus, the membrane is configured to change shape based on the cornea changing shape, where the corneal shape is substantially a function of IOP, as claimed. This is a direct mechanical consequence of the intracorneal placement and the known biomechanical behavior of the cornea. The rejection is maintained.
Applicant’s Argument:Applicant argues that no reference teaches “a processor configured to estimate the IOP … based on … a corneal position parameter … determined based on a relationship between the shape of the cornea and the IOP of the eye.”
Examiner’s Response:The argument is not persuasive. Lai teaches determining intraocular pressure based on changes in corneal curvature by using a calibrated relationship between deformation and IOP. Specifically, Lai explains that IOP changes induce changes in the curvature of the cornea, and a lens placed on the eye correspondingly changes curvature in response to those corneal changes, such that a feature associated with the lens changes shape, geometry, or position, which is detected and correlated with IOP (“the curvature of the lens changes in response to a change in IOP… [and] the change… may be used to determine the change in IOP”; “a correlation between the indicator feature travel distance and IOP… is calibrated…” (Lai, ¶[0055])). Lai further teaches that corneal curvature changes quantitatively with IOP (“the cornea… exhibit[s] approximately 3 µm… change in curvature… for each 1 mmHg intraocular pressure (P) change” (Lai, ¶[0042])), thereby explicitly establishing the relationship between corneal shape and IOP. Thus, Lai explicitly relies on corneal deformation as the underlying phenomenon and teaches using a parameter derived from the relationship between corneal deformation (shape) and IOP to determine IOP.
Phan teaches estimating IOP using a calibration parameter derived from a relationship between membrane deflection and applied pressure, including a polynomial calibration curve relating deflection to IOP (“A third order polynomial curve fit was performed on the experimental data to produce a calibration curve. The sensitivity of the sensor was determined to be 31 nm/mmHg” (Phan, p. 64)). This parameter is used by the processor together with the detected optical signal to compute IOP, and Phan further teaches that calibration is required for each sensor (“preoperative calibration should be performed on each sensor prior to implantation to account for manufacturing tolerances” (Phan, p. 66)).
Elsheikh teaches that corneal deformation (i.e., corneal shape) is a function of IOP (“The shape of the cornea is a function of … IOP” (Elsheikh, Abstract; p. 1–2)). When the sensor of Phan is implanted within the cornea as taught by Peyman’551, the membrane deformation is governed by deformation of the surrounding corneal tissue. Accordingly, the deformation measured by the sensor corresponds to corneal deformation that results from changes in IOP.
A person of ordinary skill in the art would have understood from Lai that IOP may be determined using a calibrated relationship based on corneal deformation, and would have further recognized that the calibration framework of Phan provides a suitable mechanism for implementing such a relationship in a sensor-based system. It would have been prima facie obvious before the effective filing date of the claimed invention to apply the deformation-based IOP determination approach of Lai to the intracorneal sensor system of Phan as implanted in the cornea per Peyman’551, because Lai teaches that IOP may be determined using a calibrated relationship based on corneal deformation independent of the specific sensor configuration, and both Lai and the present combination rely on the same underlying biomechanical response of the cornea to IOP, thereby enabling accurate conversion of measured deformation into IOP values. The claimed “corneal position parameter” is therefore taught or suggested by the combination. The rejection is maintained.
Applicant's arguments filed 2/23/2026, page 9, regarding the previous 103 Rejections of claims 2 and 13 are persuasive. The previous 103 rejections have been withdrawn.
Applicant’s Argument:Applicant argues that Peyman’551 does not teach a pressure sensor that is entirely embedded in the cornea because the pressure sensor embodiment includes a needle extending into the anterior chamber.
Examiner’s Response:The argument is persuasive with respect to claims requiring that the pressure sensor be entirely embedded within the cornea. While Peyman’551 teaches implantation of a pressure sensor in the cornea, the disclosed pressure sensing embodiment includes a needle extending into the anterior chamber (Peyman’551, ¶[0376]), which indicates that the sensor is not entirely confined within corneal tissue. The prior art of record does not teach or suggest a pressure sensor that is entirely embedded within the cornea as required by claims 2 and 13. Accordingly, claims 2 and 13 are allowable over the prior art of record.
However, independent claims 1, 11, and 20 do not recite that the pressure sensor is entirely embedded within the cornea and do not exclude configurations in which a portion of the sensor extends beyond the cornea. Therefore, Peyman’551 continues to teach or suggest the recited implantation limitations for those claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/AARON MERRIAM/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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