DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/17/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The amendments filed on 07/17/2026 have been entered. Claims 1, 5-10 have been amended; claims 11-15 have been added. Accordingly, claims 1-15 are pending and under consideration.
Response to Arguments
Applicant's arguments filed on 07/17/2026 have been fully considered but they are not persuasive.
Regarding Applicant’s remarks stating that “For example, with respect to Jacobsen, the Examiner has clearly ignored the overwhelming majority of the teachings of Jacobsen which lauds the benefits of a pressure sensor that is "appropriately exposed to the environment external to or at the other surface of the catheter 10 to be able to appropriately monitor pressure in an area, including the ventricle of a brain" (emphasis added, see paragraph [0031] of Jacobsen). Also, the Office Action, on page 9 states that "[i]t 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 ocular implant of Schieber to incorporate a pressure sensor on the inner surface of a strut area such that it is adjacent an opening as taught by Jacobsen, in order to measure a pressure at or near the holes said body (Par. 32 of Jacobsen)." Applicant has amended independent claim 1 to clarify that the struts are formed of undulating strips along the body. As such, the first pressure sensor is disposed on an inner surface of one of the struts/undulating strips. Here, the Examiner has not met the burden of proving that one of ordinary skill in the art would have been motivated by the teachings of Schieber and Jacobsen to predictably place the pressure sensor on an inner surface of one of the struts and be sure that such a pressure sensor would work when placed in such a location” on page 7 of Applicant’s remarks, Examiner acknowledged the remarks, but respectfully disagrees. Firstly, while Applicant’s recited paragraph 31 of Jacobsen does discuss the pressure measuring of the external environment, according to MPEP 2123.II, it states that "disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments", and/or "Furthermore, "[t]he prior art's mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed....". Therefore, Jacobsen's brief description of an internal pressure sensor compared to the detailed description of an external pressure sensor does not teach away from the claimed invention. In addition to the aforementioned reasoning, placing the pressure sensor would not render the device of Jacobsen or the combined device of Schieber in view of Jacobsen inoperable or unsatisfactory for its intended purpose, because Jacobsen’s pressure sensor would still monitor bodily fluid pressure wherever it is located. Secondly, Applicant’s newly amended limitations regarding undulating strips are hereby rejected by Schieber (see rejection of claims below); therefore, the incorporation of a pressure sensor that is internal and arranged on a strut as taught by Jacobsen (see annotated Fig. 1A below) into the primary device of Schieber would be obvious for one of ordinary skill in the art that the pressure sensor also has to be disposed on the inner surface of one of the struts as claimed in claim 1.
Regarding Applicant’s remarks stating that “The Examiner has not provided any reasoning why one of ordinary skill in the art would predictably position the pressure sensor on the inner surface of a strut/undulating strip where the diaphragm of the pressure sensor faces an elongate open channel of the body. Applicant respectfully submits that one of ordinary skill in the art would predictably have been motivated by the teachings of Schieber and Jacobsen to position the pressure sensor on part of an exterior surface of the body of the ocular implant near one of the openings” on page 7-8 of Applicant’s remarks, Examiner acknowledged the remarks, but respectfully disagrees. See response to arguments above.
Regarding Applicant’s remarks stating that “Also, with respect to Haffner '923 and Pang, Applicant agrees with the Examiner that the combination of Schieber, Jacobsen, Ding, and Haffner '923 does not teach the kit further comprising a second pressure sensor disposed within the trough of the cannula (see Office Action, page 14). As such, the only reference that could conceivably motivate one of ordinary skill in the art to place the second pressure sensor at a base of the open trough is Pang. However, as can be see in paragraph [0078] and Fig. 11 of Pang, the pressure sensors 148 are positioned within a closed distal tip of the cannula 120. The Examiner has not provided any reasoning why one of ordinary skill in the art would predictably position the second pressure sensor at a base of the open trough of a cannula. Also, the Examiner has not provided any reasoning why one of ordinary skill in the art would predictably even add a second pressure sensor when the ocular implant already comprises a first pressure sensor” on page 8 of Applicant’s remarks, Examiner acknowledged the remarks, but respectfully disagrees. The pressure sensor of Pang is disposed within the distal tip of the cannula; therefore, the incorporate of Pang’s pressure sensor will also have to within the open trough distal tip cannula of the combination, more specifically that of Heffner ‘923. See rejection of claims below.
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 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Schieber et al. US 2009/0082862 A1 (previously cited, hereinafter Schieber), as cited in the IDS, in view of Jacobsen US 2016/0287111 A1 (previously cited, hereinafter Jacobsen), Ding et al. US 2014/0275923 A1 (previously cited, hereinafter Ding), Haffner et al. US 2014/0275923 A1 (previously cited, hereinafter Haffner ‘923), and Pang et al. US 2009/0306585 A1 (previously cited, hereinafter Pang).
Regarding claim 1, Schieber discloses an ocular implant kit 236 (Fig. 8 – ocular implant 236), the ocular implant kit 236 (Fig. 8) comprising:
an ocular implant 236 (Fig. 8 – ocular implant 236) adapted to reside at least partially in a portion of Schlemm's canal of an eye (Par. 11 – “the ocular implant being adapted to be disposed within a canal of Schlemm in a human eye”), the ocular implant 236 (Fig. 8) comprising:
a body 200 (Fig. 8 and Par. 54 – body 200) having an inner surface (Fig. 8 – the interior surface of implant 236 that defines channel 242);
a plurality of openings 228, 230 (Fig. 8 and Par. 52 – first opening 228, second opening 230, and “additional openings shown in Fig. 8”) and struts 220, 222 (Fig. 8 and Par. 52 – first strut 220 and second strut 222, and other similar struts along the longitudinal length of implant 236) formed of undulating strips (Fig. 8 – struts 220, 222, and the remaining struts form wavy side walls/strips, and Par. 22 – “The ocular implant includes a first frame comprising a first strut and a second strut. In the exemplary embodiment of FIG. 3A, each strut undulates in a circumferential direction”) along the body 236 (Fig. 8).
However, Schieber does not disclose a first pressure sensor disposed on the inner surface of one of the struts adjacent one of the openings, the first pressure sensor comprising a diaphragm facing an elongate open channel of the body; and a cannula defining a passageway extending from a proximal end to a distal end, the cannula having an open trough, wherein the open trough comprises a second pressure sensor disposed at a base of the open trough, and wherein the passageway is configured to receive the ocular implant.
Jacobsen, in the same field of endeavor of implant and implant system (Par. 7), teaches a first pressure sensor 30b (Fig. 1A – pressure sensor 30b) disposed on the inner surface (Par. 35 – “the sensor 30-30b… may be formed on an internal surface that forms the lumen 17…”) of one of the struts (see annotated Fig. 1A below – pressure sensor 30b on the surface of the annotated strut area) adjacent one of the openings 20 (Fig. 1A – pressure sensor 30b is also adjacent a hole 20 on the right or left, and Par. 32 – “the pressure sensor 30-30b may measure a pressure at or near the holes 20…”).
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Annotated Fig. 1A of Jacobsen
Ding, in the same field of endeavor of MEMS pressure sensing elements (Abstract), teaches the first pressure sensor 300 (Fig. 4 – sensing element 300) comprising a diaphragm 309 (Fig. 4 – diaphragm 309).
Haffner ‘923, in the same field of endeavor of implantable intraocular sensor (Abstract), teaches a cannula (Fig. 13 and Par. 162 – a hollow needle) defining a passageway (Fig. 13, Fig. 14A-14B, and Par. 162 – inside the shaft of the needle) extending from a proximal end (see annotated Fig. 13 below – break line on the left indicates an elongated portion of the needle on the other side, implying a “proximal end of the cannula”) to a distal end (see annotated Fig. 13 below – “distal end of cannula”), the cannula (Fig. 13 and Par. 162 – needle) having an open trough 2150 (Fig. 13 – trough being the beveled opening 2150 at the tip of the hollow needle), and wherein the passageway is configured to receive the ocular implant (Par. 162 – “delivery instrument for a sensor/shunt… The sensor/shunt can be loaded inside of the shaft of the needle for delivery through the eye”, and Par. 148 – “The beveled or spatula shape can include a recess to contain the sensor/shunt”).
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Annotated Fig. 13 of Haffner ‘923
Pang, in the same field of endeavor of implantable cannula (Title), teaches a second pressure sensor 148C (Fig. 1A and Fig. 11 – pressure sensor 148C) disposed at a base of the cannula 120 (Fig. 1A, Fig. 11 – cannula 120, and Par. 78 – “the pressure sensor 148 can be placed… inside the cannula 120 and at its distal tip (as illustrated by the placement of pressure sensor 148C in FIG. 11”).
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 ocular implant of Schieber to incorporate a pressure sensor on the inner surface of a strut such that it is adjacent an opening as taught by Jacobsen, in order to measure a pressure at or near the holes said body (Par. 32 of Jacobsen). The pressure sensor located at such a location can maximize information relevant for navigation or long-term monitoring, or both (Par. 29 of Jacobsen).
It also 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 pressure sensor of the combination to further have the pressure sensor comprising a diaphragm as taught by Ding, so that the deflection of the diaphragm containing piezoresistors can be detected and output an electrical signal representative of the applied pressure (Par. 1 of Ding). This type of pressure sensing is known in the art (Par. 1 of Ding), and it is important in measuring the intraocular pressure of a patient receiving ophthalmic treatment. Once the modification is made as discussed, the diaphragm 309 of Ding will be exposed to the inner surface of the ocular implant of the combined device, such that intraocular pressure can be applied onto the diaphragm as seen in Fig. 8 of Ding for an exemplary demonstration. Therefore, the limitation “a diaphragm facing an elongate open channel of the body” is met.
Furthermore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have applied and combined the cannula of Haffner ‘923 to the device of Schieber, Jacobsen, and Ding, in order to yield predictable result of delivering the ocular implant to a patient’s eye. Since the cannula of Haffner ‘923 is known to use in conjunction with an ocular implant, applying said cannula to the ocular implant of the combined device would still result in a delivery system that assists in positioning the ocular implant in a human eye. MPEP 2143.D.
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 combined device to further include a second pressure sensor within the cannula and at its distal tip as taught by Pang, in order to measure pressure at the site of administration (Par. 51 of Pang). Said placement of the second sensor is also advantageous because it prevents flow-related pressure drops inside the cannula 120 from causing an error in the pressure reading (Par. 78 of Pang). Once the combination is made as discussed, the second pressure sensor of Pang will be disposed within and at the distal tip of the combined cannula. As established above, the distal tip of cannula comprises a trough 2150 (Fig. 13 of Haffner ‘923), therefore, the internal second pressure sensor upon combination will be placed within said trough 2150. Thus, the limitation “disposed within at a base of the open trough” is met.
Regarding claim 2, Schieber in view of Jacobsen in view of Ding in view of Haffner ‘923 in view of Pang suggests the invention of claim 1. The combination further discloses wherein the first pressure sensor 30b (Fig. 1A of Jacobsen) further comprises a first substrate 310 (Fig. 4 and Par. 17 of Ding – layer 310) comprising a layered silicon substrate 310 (Fig. 4 and Par. 17 of Ding – thick silicone layer 310) and a cavity 311 (Fig. 4 and Par. 17 of Ding – thick silicon layer 310 where a cavity 311 is formed), the diaphragm 309 (Fig. 4 of Ding) being disposed over the cavity 311 (Fig. 4 of Ding – diaphragm 309 deposited over cavity 311), and a second substrate comprising a semiconductor wafer 308 (Fig. 4 and Par. 17 of Ding – thin silicon layer 308, which is a semiconducting layer).
Examiner notes that once the modification is made as discussed in claim 1, the sensor structure of Ding will be incorporated in its entirety into the pressure sensor of the combined device, thus the limitation is met.
Regarding claim 3, Schieber in view of Jacobsen in view of Ding in view of Haffner ‘923 in view of Pang suggests the invention of claim 1. However, the combination currently does not disclose wherein the first pressure sensor includes an antenna for transmitting data from the first pressure sensor to a remote location.
Haffner ‘923, in another embodiment and in the same field of endeavor of implantable intraocular sensor (Abstract), teaches wherein the first pressure sensor 2000 (Fig. 20 – intraocular pressure sensor 2000) includes an antenna 2085 (Fig. 20 – wireless transmitter/antenna 2085) for transmitting data from the first pressure sensor 2000 to a remote location (Par. 182 – “the transmitter/antenna 2085 can be used to wirelessly transmit pressure measurements stored in the measurement storage module 2060 to an external reader 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 pressure sensor of the combined device to further include an antenna as taught by Haffner ‘923, in order to wirelessly transmit intraocular pressure measurements to an external device (Par. 182 of Haffner ‘923). This allows for further data analysis of pressure readings on a separate device and quickly detect any pressure abnormality of the eye.
Regarding claim 4, Schieber in view of Jacobsen in view of Ding in view of Haffner ‘923 in view of Pang suggests the invention of claim 3. The combination further discloses wherein the data is automatically transmitted from the remote location (Par. 182 of Haffner ‘923 – external reader device) to a second remote device (Par. 182 of Haffner ‘923 – a pair of eyeglasses worn by the patient; data can be wirelessly transferred to an external reader device, and to an external reader device integrated into a pair of eyeglasses; Examiner notes that Par. 93 of Haffner ‘923 also teaches data is automatically sent to a doctor’s office).
Examiner notes that once the combination is made as discussed in claim 3, the antenna of Haffner ‘923 and its ability to transmit data is incorporated in its entirety to the combined device. Thus, the limitation is met.
Regarding claim 5, Schieber in view of Jacobsen in view of Ding in view of Haffner ‘923 in view of Pang suggests the invention of claim 1. However, the combination further does not disclose further comprising a third pressure sensor disposed adjacent to a proximal end of the ocular implant.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have duplicated the pressure sensor of the combination, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. Furthermore, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See MPEP 2144. 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 combination to further add another pressure sensor, in order to measure the pressure at the insertion site and produce a redundancy system should other pressure sensors fail.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the position of the third pressure sensor to so it was adjacent to a proximal end of the ocular implant, since this claimed position of the pressure does not change the sensor ability to measure pressure within the ocular environment. Since applicant has not given any criticality to why the position of the sensor disclosed has any importance to the function of the claimed device, the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding claim 6, Schieber in view of Jacobsen in view of Ding in view of Haffner ‘923 in view of in view of Pang suggests the invention of claim 1. However, the combination of does not disclose wherein the second pressure sensor comprises a micro-electro-mechanical system (MEMS) pressure sensor and includes an antenna for transmitting data from the second pressure sensor to a remote location.
Haffner ‘923, in another embodiment and in the same field of endeavor of implantable intraocular sensor (Abstract), teaches the pressure sensor 2000 (Fig. 20) comprises a micro-electro-mechanical system (MEMS) pressure sensor 2050 (Fig. 20 and Par. 176 – pressure sensing module 2050 includes a microelectromechanical system (MEMS)) and includes an antenna 2085 (Fig. 20 – antenna) for transmitting data (Par. 182 – antenna 2085 can be used to wirelessly transmit pressure measurements) from the second pressure sensor 2000 to a remote location (Par. 182 – “the transmitter/antenna 2085 can be used to wirelessly transmit pressure measurements stored in the measurement storage module 2060 to an external reader 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 second pressure sensor of the combined device to further include a MEMS pressure sensor and an antenna as taught by Haffner ‘923, so that the membrane inside the MEMS sensor can be used to measure intraocular pressure via displacement (Par. 176 of Haffner ‘923) and pressure data can be transmitted wirelessly to another location for download/evaluation (Par. 182 of Haffner ‘923). The use of MEMS sensors is particularly advantageous in this setting because during surgery, fluid constantly enters and exits the cannula, which can create a force high enough to move the surrounding environment/components, such as a membrane of a MEMS sensor. Therefore, MEMS sensor can record the displacement of its membrane and convert the measurements into flow pressure, ocular pressure, etc. One of ordinary skill in the art would have recognized said characteristic of a MEMS sensor and implemented it into the combined device to accurately measure pressures at the surgical site. Furthermore, transmitting data to a remote location as taught by Haffner ‘923 allows further data analysis of pressure readings on a separate device and quickly detect any pressure abnormality of the eye.
Regarding claim 7, Schieber in view of Jacobsen in view of Ding in view of Haffner ‘923 in view of Pang suggests the invention of claim 1. However, the combination does not disclose wherein the open trough has a depth dimension that is deeper than a width of the ocular implant.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the open trough has a depth dimension that is deeper than a width of the ocular implant, in order to fit the particular procedure being done since this claimed dimension of the trough does not change the its ability to receive and container the ocular implant. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (Par. 142 of Applicant’s PG-PUB), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Regarding claim 8, Schieber in view of Jacobsen in view of Ding in view of Haffner ‘923 in view of Pang suggests the invention of claim 1. The combination further discloses wherein the first pressure sensor 30b (Fig. 1A of Jacobsen) is positioned on the inner surface of the first strut 220 (Fig. 8 of Schieber modified by Fig. 1A of Jacobsen), wherein the inner surface of the first strut 220 (Fig. 8 of Schieber) faces an inner surface of a second strut 222 (Fig. 8 of Schieber) opposite the first strut 220 (Fig. 8 of Schieber).
Examiner notes that once the modification is made as discussed in claim 1, the first pressure sensor of Jacobsen will be incorporated into the ocular implant of Schieber, including its position being on the annotated strut area, as seen in the annotated Fig. 1A of Jacobsen above. Thus, the limitation is met.
Regarding claim 9, Schieber in view of Jacobsen in view of Ding in view of Haffner ‘923 in view of Pang suggests the invention of claim 1. The combination further discloses wherein the second pressure sensor 148C (Fig. 1A of Pang, and Fig. 11 of Pang) is configured to provide an instantaneous pressure reading during implantation (Par. 78 of Pang – “A pressure sensor 148 located in or on the cannula 120 can be used to measure and monitor the local pressure at the injection site. For example, if knowledge of the injection-site pressure is required during infusion”, and Par. 104 – “When the fluid experiences an extremely high (i.e., abnormal) pressure (e.g., due to an unexpected force during operation or implantation, etc.)…”, which relies on the instantaneous reading of pressure sensor during operation) of the ocular implant 236 (Fig. 8 of Schieber).
Examiner notes that once the combination is made as discussed in claim 1, the second pressure sensor 148C at the trough of the cannula as taught by Pang will be incorporated into the combined device, including its ability to monitor pressure at implantation/operation stage. Thus, the limitation is met.
Regarding claim 10, Schieber in view of Jacobsen in view of Ding in view of Haffner ‘923 in view of Pang suggests claim 5. The combination further discloses wherein the ocular implant 236 (Fig. 8 of Schieber) further comprises spines 202, 204 (Fig. 8 of Schieber – first and second spine 202, 204) connecting adjacent strut 220, 222 (Fig. 8 of Schieber, and Par. 51 of Schieber – “a first strut 220 that extends between first spine 202 and second spine 204…”), wherein the third pressure sensor is disposed adjacent to the proximal end of the ocular implant 236 (Fig. 8 of Schieber; upon modification as discussed in claim 5).
However, the combination does not currently disclose wherein the third pressure sensor is disposed on an inner surface of one of the spines, and the third pressure sensor comprises a diaphragm facing the elongate open channel of the body.
Ding, in the same field of endeavor of MEMS pressure sensing elements (Abstract), teaches the pressure sensor 300 (Fig. 4 – sensing element 300) comprising a diaphragm 309 (Fig. 4 – diaphragm 309).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the position of the third pressure sensor to be on an inner surface of one of the spines, since this claimed position of the pressure sensor does not change its ability to measure pressure within the ocular environment. Since applicant has not given any criticality to why the position of the sensor disclosed has any importance to the function of the claimed device, the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
It also 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 third pressure sensor of the combination to further have the pressure sensor comprising a diaphragm as taught by Ding, so that the deflection of the diaphragm containing piezoresistors can be detected and output an electrical signal representative of the applied pressure (Par. 1 of Ding). This type of pressure sensing is known in the art (Par. 1 of Ding), and it is important in measuring the intraocular pressure of a patient receiving ophthalmic treatment. Once the modification is made as discussed, the diaphragm 309 of Ding will be exposed to the inner surface of the ocular implant of the combined device, such that intraocular pressure can be applied onto the diaphragm as seen in Fig. 8 of Ding for an exemplary demonstration. Therefore, the limitation “a diaphragm facing an elongate open channel of the body” is met.
Regarding claim 11, Schieber in view of Jacobsen in view of Ding in view of Haffner ‘923 in view of Pang suggests the invention of claim 8. The combination further discloses wherein the first strut 220 (Fig. 8 of Schieber) is shaped as a first undulating strip (Fig. 8 of Schieber – strut 220 forms the right side wavy strip) and the second strut 222 (Fig.8 of Schieber) is shaped as a second undulating strip (Fig. 8 of Schieber – strut 222 forms the left side wavy strip), wherein the first pressure 30b (Fig. 1A of Jacobsen) is position on the inner surface (Fig. 8 of Schieber modified by Fig. 1A of Jacobsen).
However, the combination does not disclose the inner surface of the first undulating strip.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the position of the sensor to so it was disposed on the inner surface of the first undulating strip, since this claimed position of the sensor does not change the sensor ability to measure pressure within the ocular environment. Since applicant has not given any criticality to why the position of the sensor disclosed has any importance to the function of the claimed device, the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding claim 12, Schieber in view of Jacobsen in view of Ding in view of Haffner ‘923 in view of Pang suggests the invention of claim 11. The combination further discloses wherein the first strut 220 (Fig. 8 of Schieber) is unconnected to the second strut 222 (Fig. 8 of Schieber) along a top of the first undulating strip (Fig. 8 of Schieber – left strip) and the second undulating strip (Fig. 8 of Schieber – right strip; left strip and right strip are spaced apart at the top).
Regarding claim 13, Schieber in view of Jacobsen in view of Ding in view of Haffner ‘923 in view of Pang suggests the invention of claim 11. The combination further discloses wherein the first strut 220 (Fig. 8 of Schieber) is unconnected to the second strut 222 (Fig. 8 of Schieber) except along adjacent spines 202, 204 (Fig. 8 of Schieber – first and second spine 202, 204, and Par. 51 of Schieber – “ocular implant 236 comprises a first spine 202 and a second spine 204… a first strut 220 that extends between first spine 202 and second spine 204… that second strut 222 also extends between first spine 202 and second spine 204”) of the ocular implant 236 (Fig. 8 of Schieber).
Regarding claim 14, Schieber in view of Jacobsen in view of Ding in view of Haffner ‘923 in view of Pang suggests the invention of claim 1. The combination further discloses wherein the second pressure sensor 148C (Fig. 1A of Pang) is positioned along the cannula 120 (Fig. 1A of Pang, Fig. 11 of Pang – cannula 120, and Par. 78 of Pang – “the pressure sensor 148 can be placed… inside the cannula 120 and at its distal tip (as illustrated by the placement of pressure sensor 148C in FIG. 11”).
However, the combination does not disclose along a central axis of a cannula.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the position of the second sensor to so it was along the central axis of the cannula, since this claimed position of the sensor does not change the sensor ability to measure pressure within the ocular environment. Since applicant has not given any criticality to why the position of the sensor disclosed has any importance to the function of the claimed device, the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding claim 15, Schieber in view of Jacobsen in view of Ding in view of Haffner ‘923 in view of Pang suggests the invention of claim 14. The combination further discloses wherein the second pressure sensor 148C (Fig. 1A of Pang) is positioned proximal to beveled edges at a distal end of the cannula (Par. 148 of Haffner’ 923 – “the delivery instrument can include a distal end having a spatula shape. The beveled or spatula shape can have a sharpened edge. the beveled or spatula shape can include a recess to contain the sensor/shunt”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hastings et al. US 10,687,704 B2 teaches an ocular implant with a pressure sensor.
Chang et al. US 2022/0249285 A1 teaches an ocular implant for monitoring pressure.
Weibel US 9,289,123 B2 teaches contact lens for measuring intraocular pressure.
Chang et al. US 2015/0279239 A1 teaches an ocular implant with pressure sensors.
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 QUYNH DAO LE whose telephone number is (571)272-7198. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/QUYNH DAO LE/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
