DETAILED ACTION
Examiner’s Note: Prosecution of the application has been taken over by Examiner Kim from previous Examiner Kumar. In accordance with MPEP 704.01, the examiner will give full faith and credit should be given to the search and action of the previous examiner unless there is a clear error in the previous action or knowledge of other prior art. All future communications should be directed to Examiner Kim at the contact information provided at the end of this Office action.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/18/2025 was considered by the examiner.
Claim Objections
Claims 1-7, 9-16, and 18-21 are objected to because of the following informalities:
Claim 1, line 3: “and” should be deleted”;
Claims 2-7, 9-12, 14-16, 18-20: in the preambles, “Claim” should be lowercase;
Claim 6, line 3: “an eye of a patient” should be replaced with –the eye–;
Claim 7, line 2: “an anterior” should be replaced with –the anterior–;
Claim 7, line 2: “an eye” should be replaced with –the eye–;
Claim 10, line 3: “an anterior” should be replaced with –the anterior–;
Claim 13, line 9: “eye,” should be replaced with –eye; and–;
Claim 13, last line: “an eye of a patient” should be replaced with –the eye–;
Claim 19, line 3: “an anterior” should be replaced with –the anterior–;
Claim 21, line 2: “and” should be deleted;
Claim 21, line 3: the comma after “tissue” should be replaced with a semicolon.
Appropriate correction is required
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9 and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 recites “a housing” in line 2. Claim 1 recites “an implant housing” in line 9 and “a sensor housing” in line 14. It is unclear how the housing of claim 9 is related to the housings of claim 9. Is the housing of claim 9 one of the housings of claim 1, or is it a different housing? For the purposes of examination, the recitation in claim 9 will be interpreted to be “the implant housing”. The recitation of “the housing” in line 2 of claim 9 will be interpreted to be “the implant housing”. Claim 18 recites similar limitations, so claim 18 is rejected on similar grounds.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 7, 9-14, and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0275923 A1 (Haffner) in view of US 7,857,782 (Tu), US 2016/0000344 A1 (Cao), and A Dual-Slope Capacitance-to-Digital Converter Integrated in an Implantable Pressure-Sensing System (Oh).
With regards to claims 1, 13, and 21, Haffner teaches an intraocular physiological sensor implant (Fig. 9 and ¶¶ [0097]-[0099] depict an intraocular physiological sensor 900 with an anchoring member 902) comprising: a physiological sensor configured to be located within an anterior chamber of an eye (Fig. 9 and ¶ [0097] depict a head portion 905 which serves as a housing for various electronic components of the sensor (e.g., sensing module, controller module, transmitter, fuel cell, etc.), wherein the head portion 905 is sized and shaped such that it is capable of being located within an anterior chamber of an eye. See analogous sensor device 800 of ¶ [0096] which indicates that the physiological sensor 800 is sized and shaped to be inserted into the anterior chamber of the eye and anchored into trabecular meshwork); and an anchor (Fig. 9 and ¶¶ [0097]-[0098] depict a stem portion 903 and anchoring member 902, the combination of which amounts to the claimed anchor), wherein the anchor comprises a fluid pathway including a fluid inlet disposed on proximal end of the anchor and a fluid outlet disposed on a distal end of the anchor (Fig. 9 and ¶¶ [0097]-[0098] depict one or more fluid inlet ports 909 disposed on a proximal end and one or more fluid outlet ports 906 disposed on a distal end), the fluid outlet configured to be positioned in Schlemm's canal of the eye (Fig. 9 depicts the one or more fluid outlet ports 906 disposed on a distal end. See analogous sensor device 800 of ¶ [0096] which indicates that the outlet ports 806 allow for drainage of the aqueous humor into Schlemm’s canal), and an implant housing connected to the anchor and house the physiological sensor (Fig. 9 and ¶ [0097] depict a head portion 905 connected to the stem portion 903, wherein the head portion 905 houses a sensing module);
Haffner is silent regarding an anchor comprising a penetrating tip and configured to be inserted through a trabecular meshwork of the eye and penetrate scleral tissue.
In a system relevant to the problem of anchoring intraocular implants, Tu teaches an anchor comprising a penetrating tip and configured to be inserted through a trabecular meshwork of the eye and penetrate scleral tissue (Figs. 32-33 and Col. 18, lines 10-29 depict a stent including a barbed or threaded screw-like extension or pin 126 with barbs 128 for anchoring, wherein the extension 126 is advanced through the trabecular meshwork 21 and across Schlemm’s canal 22 and into the back wall 92 of Schlemm’s canal 22 (i.e., scleral tissue)). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the anchor of Haffner to incorporate a penetrating tip and that it is configured to be inserted through a trabecular meshwork of the eye and penetrate scleral tissue as taught by Tu. The motivation would have been to provide a more secure anchoring of the implant (Col. 18, lines 25-26 of Tu).
The above combination is silent regarding whether the physiological sensor is configured to sense a pressure, includes a sensing layer, a coil layer comprising an inductive coil, and an integrated circuit layer, and is configured to communicate pressure readings to an external reader, responsive to the external reader being held proximate to an eye of a patient.
In the same field of endeavor of monitoring intraocular pressure, Cao teaches a physiological sensor configured to sense a pressure and includes a sensing layer, a coil layer comprising an inductive coil, and an integrated circuit layer (Fig. 6A and ¶ [0057] depict a vertically stacked implantable device 48 including a pressure transducer wafer 12 (a sensing layer), two vertically stacked coils 58, 60 (which necessarily have an inductance) in a substrate (a coil layer), and a first ASIC wafer 50 (an integrated circuit layer), and is configured to communicate pressure readings to an external reader, responsive to the external reader being held proximate to an eye of a patient (¶ [0017] discloses an external acquisition system for transferring data and power with the telemetry circuit of the device; also see the external base station of ¶ [0051]. The Examiner notes that the transmission via the coil or antenna requires the elements being proximate to each other). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the sensor of Haffner with the pressure sensor as taught by Cao. The motivation would have been to provide long-term stable and continuous IOP measurement profiles for appropriate diagnosis and follow-up therapy (¶ [0008] of Cao).
The above combination is silent regarding whether the implant housing at least partially surrounds the physiological sensor.
In the same field of endeavor of monitoring intraocular pressure, Cao teaches an implant housing at least partially surrounding the physiological sensor (Figs. 7A-7B and ¶ [0044] depict a boat 19 for receiving the stacked device). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the implant housing of Haffner to incorporate that the housing at least partially surrounds the physiological sensor as taught by Cao. The motivations would have been to allow for the housing to secure the sensor while not interfering with the pressure sensing components.
The above combination is silent regarding whether wherein the sensing layer is stacked above the coil layer, wherein the coil layer is stacked above the integrated circuit layer.
In the same field of endeavor of implantable pressure sensors, Oh teaches a sensing layer is stacked above a transmitter layer, and the transmitter layer is stacked above an control layer (Fig. 12 depicts a MEMS Pressure sensor layer stacked above a layer including a radio transmitter layer, wherein the layer including the radio transmitter is stacked above a control layer). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the stacks of Cao of the above combination to incorporate the sensing layer is stacked above the coil layer, wherein the coil layer is stacked above the integrated circuit layer as taught by Oh. Because both structural arrangements of Oh and Cao are capable of being used in pressure sensors, it would have been the simple substitution of one known equivalent element for another to obtain predictable results. Additionally or alternatively, the above modification would have been obvious because it amounts to the rearrangement of parts which would not have modified the operation of the device (In reJapikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) of MPEP 2144.04(VI)(C)) and amounts to an obvious matter of design choice (In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) of MPEP 2144.04(VI)(C)).
The above combination is silent regarding whether the sensing layer is hermetically sealed to a sensor housing that at least partially houses the physiological sensor.
In a system relevant to the problem of housing components of intraocular pressure sensors, Haffner teaches a sensing layer is hermetically sealed to a sensor housing that at least partially houses the components of the physiological sensor (Figs. 27-29 and ¶¶ [0195]-[0198] depict a non-recessed sensor cap 2108 comprising a pressure sensing module 2050, wherein the cap 2108 is hermetically sealed to main body 2102 (sensor housing) which at least partially houses the other components of the sensor (see ¶ [0184] with regards to the IC 2075, and antenna 2085 being located within the main housing 2102)). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensing layer of the above combination to incorporate it is hermetically sealed to a sensor housing that at least partially houses the physiological sensor as taught by Haffner. The motivation would have been to protect the sensor from moisture (¶ [0196] of Haffner).
With regards to claim 2, the above combination teaches or suggests the physiological sensor comprises a pressure sensor at the sensing layer (¶ [0057] of Cao teaches the sensor comprises a pressure transducer wafer 12; ¶ [0048] of Cao indicates the wafer 12 comprises a membrane layer with a capacitive pressure transducer).
With regards to claims 3 and 14, the above combination teaches or suggests the pressure sensor comprises a capacitive pressure sensor (¶ [0048] of Cao indicates the wafer 12 comprises a membrane layer with a capacitive pressure transducer).
With regards to claim 7, the above combination teaches or suggests the fluid inlet is configured to reside in an anterior chamber of an eye (Fig. 9 and ¶¶ [0097]-[0098] of Haffner depict one or more fluid inlet ports 909 disposed on a proximal end. See analogous sensor device 800 of ¶ [0096] of Haffner which indicates that the aqueous humor flows into Schlemm’s canal, which means that the inlet is in an anterior chamber), and wherein the fluid outlet is configured to reside in Schlemm's canal of the eye, such that aqueous humor flows from the anterior chamber to Schlemm's canal via the fluid pathway (Fig. 9 of Haffner depicts the one or more fluid outlet ports 906 disposed on a distal end. See analogous sensor device 800 of ¶ [0096] of Haffner which indicates that the outlet ports 806 allow for drainage of the aqueous humor into Schlemm’s canal)
With regards to claims 9 and 18, the above combination teaches or suggests the anchor is either coupled to the housing or integrally formed with the housing (Fig. 9 and ¶¶ [0097]-[0098] of Haffner depict a stem portion 903 and anchoring member 902 coupled or integrally formed with the head portion 905 .
With regards to claims 10 and 19, the above combination teaches or suggests the anchor is configured to pierce the trabecular meshwork of the eye, such that the intraocular physiological sensor is retained in an anterior chamber of the eye, adjacent to the trabecular meshwork (Fig. 9 of Haffner depicts the sensor 900. See analogous sensor device 800 of ¶ [0096] of Haffner which indicates that implant is anchored to the trabecular meshwork and is in the anterior chamber of the eye).
With regards to claims 11 and 20, the above combination teaches or suggests the anchor further includes a plurality of physical standoffs (Figs. 32-33 and Col. 18, lines 10-29 of Tu depict a stent including a barbed or threaded screw-like extension or or pin 126 with barbs 128, wherein the threads or barbs are physical standoffs).
With regards to claim 12, the above combination is silent regarding whether the physiological sensor comprises a glucose sensor.
In a related embodiment for monitoring physiological parameters, Haffner teaches a physiological sensor comprising a glucose sensor (Fig. 3 and ¶ [0073] depicts a physiological sensor 300 comprising an electrochemical fuel cell 310 for measuring glucose). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the physiological sensor of the above combination to incorporate a glucose sensor as taught by Haffner. The motivation would have been to provide a more complete diagnostic picture of the patient. Additionally or alternatively, the motivation would have been to measure glucose in non-immunologically privileged parts of the body (¶ [0049] of Haffner).
Claims 4 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Haffner in view of Tu, Cao, and Oh, as applied to respective claims 3 and 14 above, and further in view of US 2002/0115920 A1 (Rich).
With regards to claims 4 and 15, the above combination is silent regarding whether the capacitive pressure sensor comprises a flexible diaphragm electrode spaced apart from a counter electrode.
In a system relevant to the problem of detecting intraocular pressure, Rich teaches a capacitive pressure sensor comprises a flexible diaphragm electrode spaced apart from a counter electrode (¶ [0034] and Fig. 1 depict a capacitive pressure sensor 18 comprising a diaphragm 64 (which has a moveable electrode) and a fixed electrode 66). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the capacitive pressure sensor of the above combination with the capacitive pressure sensor comprising a flexible diaphragm electrode spaced apart from a counter electrode as taught by Rich. Because both elements are capable of monitoring a pressure, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
Claims 5-6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Haffner in view of Tu, Cao, and Oh, as applied to respective claims 1 and 13 above, and further in view of US 2016/0051145 A1 (Rickard)
With regards to claims 5 and 16, the above combination is silent regarding whether the coil layer includes a looped coil, configured to communicate with an external reader.
In a system relevant to the problem of interrogating an implant, Rickard teaches a looped coil, configured to communicate with an external reader (¶¶ [0072]-[0073] depict a looped antenna which is configured to communicate with an external reader). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coil of the coil layer of the above combination to incorporate that it is a looped coil configured to communicate with an external reader as taught by Rickard. Because both the coils of Cao and Rickard are configured to transmit data, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
With regards to claim 6, the above combination teaches or suggests the physiological sensor communicates physiological readings to the external reader, responsive to the external reader being held proximate to an eye of a patient (¶¶ [0072]-[0073] of Rickard depict a looped antenna which is configured to communicate with an external reader when the external reader is in proximity to the implant)
Response to Arguments
Applicant’s arguments with respect to the 35 USC 103 rejections set forth in the Non-Final Rejection mailed 11/06/2026 have been 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. A new ground(s) of rejection is made in view of US 2014/0275923 A1 (Haffner) in view of US 7,857,782 (Tu), US 2016/0000344 A1 (Cao), and A Dual-Slope Capacitance-to-Digital Converter Integrated in an Implantable Pressure-Sensing System (Oh).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
MEMS-based wireless intraocular pressure sensors (Blue) teaches a vertically stacked intraocular pressure sensor comprising a sensing layer sealed to a sensor housing that at least partialy houses the physiological sensor (Fig. 14.17 depicts a pressure sensor layer sealed to a parylene housing).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL C KIM whose telephone number is (571)272-8637. The examiner can normally be reached M-F 8:00 AM - 5:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.C.K./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
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