DETAILED CORRESPONDENCE
Note: This office action is in response to communication filed on 05/15/2025.
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 .
Status of Claims
Claims 1-15 and 20-24 are pending in the application.
Claims 1-15 and 20-24 are examined on the merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Response to Arguments
Applicant’s arguments filed on 05/15/2025 have been fully considered but are moot because the independent claims have been amended and the new ground of rejection does not rely on the same combination references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
With respect to the claim rejection(s) under 35 U.S.C. § 112(a), applicant’s arguments and applicant's amendment(s) to the claim(s) have overcome the claim rejection(s).
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 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.
Claim(s) 1, 6-8, 15, and 20-24 is/are rejected under 35 U.S.C 103 as being unpatentable over Lind (US PGPUB 20150057596) in view of Camras (US PGPUB 20170087016).
Regarding claim 1, Lind discloses a therapeutic device configured to be worn on an eye of a patient (a control system 200: ¶0028 and Figs. 2-7), the therapeutic device (200) comprising:
a housing (a housing 605: ¶0053 and Figs. 6-7) comprising an inlet (an inlet 606: ¶0053 and Figs. 6-7) and an outlet (an outlet 607: ¶0053 and Figs. 6-7), the inlet configured for receiving aqueous humor from the eye (¶0054: the inlet 606 is configured to receive aqueous humor), and the outlet configured for delivering the aqueous humor to a tear film or an exterior surface of the eye (¶0048, 0054, and 0078: the outlet 607 is configured for delivering aqueous humor to a drainage site 212 wherein the drainage site is at any locations in the eye; thus, Lind implicitly discloses the outlet 607 is configured for delivering the aqueous humor to a tear film or an exterior surface of the eye);
a passive pressure relief valve coupled to the housing (a valve 610: ¶0053 and Figs. 6-7), wherein the passive pressure relief valve is configured to open from a default closed configuration to passively regulate a flow rate of the aqueous humor from an ingress of the passive pressure relief valve to an egress of the passive pressure relief valve in response to a pressure of the aqueous humor on the ingress of the passive pressure relief valve exceeding a threshold associated with the default closed configuration (¶0048, 0059-0061, and Figs. 6-7), wherein the passive regulation of the flow rate is configured to change in response to a change of the pressure of the aqueous humor (¶0048).
Lind does not disclose a filter coupled to the housing and positioned between the egress of the passive pressure relief valve and the outlet of the housing, such that the filter is configured to allow passage of fluid from the egress of the passive pressure relief valve through the outlet of the housing along a fluid path extending from the inlet of the housing to the outlet.
In the same field of endeavor, a device to be worn on an eye of a patient, Camras discloses an apparatus for draining aqueous humor from an eye for reducing intraocular pressure (¶0010). Camras further disclose the apparatus comprising a filter coupled a housing and positioned between the egress of the passive pressure relief valve and the outlet of the housing (a filter 40 is engaged with the housing of the head portion 36 subsequent to the flow control device 39: ¶0036, Figs. 4, and 13A), such that the filter 40 is configured to allow passage of fluid from the egress of the passive pressure relief valve through the outlet of the housing along a fluid path extending from the inlet of the housing to the outlet (¶0036-0037).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Lind in view of Camras by incorporating a filter coupled to the housing and positioned between the egress of the passive pressure relief valve and the outlet of the housing, in order to facilitate the regulation of intraocular pressure, reduce the effect of clogging, and reduce debris or relatively large contaminants in the flow path, as suggested in ¶0034 of Camras.
Regarding claim 6, Lind does not disclose an inlet filter coupled to the housing and positioned between the ingress of the passive pressure relief valve and the inlet of the housing.
Camras further discloses an inlet filter coupled to the housing and positioned between the ingress of the passive pressure relief valve and the inlet of the housing (one or more filters 40 is/are disposed in fluid communication between the flow control device 30 and filter 40 is disposed both upstream and downstream of the flow control device 39: ¶0036, 0042, and Fig. 13A).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Lind/Camras in view of Camras by incorporating an inlet filter coupled to the housing and positioned between the ingress of the passive pressure relief valve and the inlet of the housing, in order to facilitate the regulation of intraocular pressure, reduce the effect of clogging, and reduce debris or relatively large contaminants in the flow path, as suggested in ¶0034 of Camras.
Camras further discloses a pore size of the filter 40 (¶0034); however, Lind/Camras does not disclose a pore size of the inlet filter is at least two times larger than a pore size of the filter.
Absent a showing of criticality, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Lind/Camras by making/having a pore size of the inlet filter at least two times larger than a pore size of the filter, motivated by the desires to control flow rate and reduce debris, as it has been held that scaling up or down of an element which merely requires a change in size is generally considered as being within the ordinary skill in the art (See MPEP § 2144.04 (IV) (A)). Furthermore, in light of In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), “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.” (MPEP § 2144.04). In the instant case, the device of Lind/Camras would not operate differently with the claimed pore size ratio and the filter and the inlet filter are still able to facilitate the regulation of intraocular pressure, reduce the effect of clogging, and/or reduce debris.
Regarding claim 7, Lind does not disclose the pore size of the inlet filter is between 8 µm and 0.4 µm.
Camras further discloses a pore size of the filter 40 is greater than 0.5 µm (¶0034; the taught pore size range overlaps with the claimed pore size range) for the benefit of reducing debris or relatively large contaminants (¶0034).
Absent a showing of criticality, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Lind/Camras in view of Camras by making/having the pore size of the inlet filter between 8 µm and 0.4 µm, in order to reduce debris or relatively large contaminants, as suggested in ¶0034 of Camras and as it has been held that scaling up or down of an element which merely requires a change in size is generally considered as being within the ordinary skill in the art (See MPEP § 2144.04 (IV) (A)).
Regarding claim 8, Lind does not disclose the pore size of the filter is between 100 nm and 200 nm.
Camras further discloses a pore size of the filter 40 is 0.5 µm or less (¶0034; the taught pore size range overlaps with the claimed pore size range) for the benefit of reducing debris or relatively large contaminants (¶0034).
Absent a showing of criticality, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Lind/Camras in view of Camras by making/having the pore size of the inlet filter between 100 nm and 200 nm, in order to minimize or prevent bacterial migration therethrough, as suggested in ¶0034 of Camras and as it has been held that scaling up or down of an element which merely requires a change in size is generally considered as being within the ordinary skill in the art (See MPEP § 2144.04 (IV) (A)).
Regarding claim 15, Lind further discloses the housing defines a flat profile (Figs. 6-7) and the height of the device is less than 5 mm (the height/thickness of the device is 2 mm: ¶0078; thus, the taught height is within the claimed height).
Absent a showing of criticality, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Lind/Camra by making the height of the device less than 5 mm, in order to have a device configured to fit within the eye, as suggested in ¶0078 of Lind and as it has been held that scaling up or down of an element which merely requires a change in size is generally considered as being within the ordinary skill in the art (See MPEP § 2144.04 (IV) (A)).
Lind does not disclose the passive pressure relief valve and the filter comprise flat surfaces arranged in parallel between the inlet of the housing and the outlet of the housing.
Camras further discloses the passive pressure relief valve and the filter comprise flat surfaces arranged in parallel between the inlet of the housing and the outlet of the housing (Fig. 13A).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Lind/Camras in view of Camras by arranging the passive pressure relief valve and the filter parallel between the inlet of the housing and the outlet of the housing, in order to suitably control flow rate and reduce debris, as suggested in ¶0034 of Camras.
Regarding claim 20, Lind further discloses a pressure differential between the inlet and the outlet is substantially equal to a pressure differential between a pressure of an interior portion of the eye and a pressure at the tear film or the exterior surface of the eye (¶0026 and 0048: pressure differential between the anterior chamber and the drainage site wherein the drainage site is at any locations in the eye).
Regarding claim 21, Lind further discloses the passive regulation of the flow rate by the passive pressure relief valve allows for the passive pressure relief valve to entirely maintain an inlet pressure relative to a pressure at the tear film or the exterior surface of the eye (¶0052).
Regarding claim 22, Lind does not explicitly teach the passive pressure relief valve configured to passively regulate flow in a reverse direction. However, since the missing recitation sets forth the intended manner of using the passive pressure relief valve without adding patentable weight to the structural limitations of the passive pressure relief valve and Lind discloses all the claimed structural limitations, the passive pressure relief valve of Lind is expected to be capable of passively regulating flow in a reverse direction.
Regarding claim 23, Lind further discloses the passive regulation of the flow rate by the passive pressure relief valve allows for the therapeutic device to maintain a pressure at the inlet independent of a bleb at the outlet (¶0052).
Regarding claim 24, Lind further discloses the passive pressure relief valve (610) further comprises a valve opening (a sealing portion 615: ¶0055 and Figs. 6-7) when in the open configuration, the size of the valve opening configured to change in response to the change of the pressure of the aqueous humor (¶0055-0056).
Claim(s) 2-4 is/are rejected under 35 U.S.C 103 as being unpatentable over Lind (US PGPUB 20150057596) in view of Camras (US PGPUB 20170087016), as applied to claim 1 above, and further in view of Ludin (US PGPUB 20140276341).
Regarding claims 2-4, Lind in view of Camras discloses the filter but fails to specify one or more electrodes coupled to the housing adjacent to the filter and in fluid communication with the filter; and electronic circuitry coupled to the housing and configured to apply a voltage to the one or more electrodes to remove a filter cake from a surface of the filter; the one or more electrodes comprises a first electrode and a second electrode, and wherein the filter is positioned between the first electrode and the second electrode; and the first electrode, the second electrode, and the filter comprise a same footprint.
In an analogous art for being directed to solve the same problem, removing blockages in a fluid circuit, Ludin discloses a system for transporting a bodily fluid (Abstract) comprising one or more electrodes (one or more conductors, or wires 215: ¶0042 and Figs. 3A-3H) coupled to a housing (a catheter system 200: ¶0041 and Fig. 2) adjacent to a part of a fluid circuit (a catheter 205: ¶0041 and Figs. 3A-3H) and in fluid communication with the part of the fluid circuit (Figs. 3A-3H); and electronic circuitry (a transmission circuit 470: ¶0051 and Figs. 4A-4C) coupled to the housing (Figs. 4A-4C) and configured to apply a voltage to the one or more electrodes (electromagnetic generator 225 can provide an energetic signal: ¶0051) to remove an occlusion from a surface of the fluid circuit part (energy excites the cells of the occlusion 450 causing them to heat and eventually vaporize: ¶0051); wherein the one or more electrodes (215) comprises a first electrode and a second electrode (Figs. 3A-3H), and wherein the filter (an inner lumen 310: ¶0044 and Figs. 3A-3H) is positioned between the first electrode and the second electrode (Figs. 3A-3H); wherein the first electrode, the second electrode, and the filter comprise a same footprint (Figs. 3A-3H).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Lind/Camras in view Ludin by incorporating one or more electrodes as claimed, in order to remove blockages in the fluid circuit while preventing unintended damage to the tissues surrounding the occlusion, as suggested in ¶0008 of Ludin.
Claim(s) 5 is/are rejected under 35 U.S.C 103 as being unpatentable over Lind (US PGPUB 20150057596) in view of Camras (US PGPUB 20170087016) and Ludin (US PGPUB 20140276341), as applied to claim 2 above, and further in view of Field (US PGPUB 20130144202).
Regarding claim 5, Lind/Camras/Ludin does not disclose an antenna coupled to the housing and in electrical communication with the electronic circuitry, wherein the antenna is configured to wirelessly receive electromagnetic energy, and provide an electrical current to the electronic circuitry.
In the same field of endeavor, a device to be worn on an eye of a patient, Field discloses an intraocular pressure control system (Abstract) comprising a pressure relief valve (¶0068) comprising an antenna coupled to the housing and in electrical communication with the electronic circuitry. Field further discloses the antenna is configured to wirelessly receive electromagnetic energy, and provide an electrical current to the electronic circuitry (¶0022-0025).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Lind/Camras/Ludin in view of Field by incorporating an antenna coupled to the housing and in electrical communication with the electronic circuitry, in order to allow for wireless charging and data transmission, as suggested in ¶0022-0025 of Field.
Claim(s) 9-11 is/are rejected under 35 U.S.C 103 as being unpatentable over Lind (US PGPUB 20150057596) in view of Camras (US PGPUB 20170087016), as applied to claim 6 above, and further in view of Field (US PGPUB 20130144202).
Regarding claims 9-10, Lind/Camras does not disclose a pump configured to pump the aqueous humor toward the inlet filter and a pressure sensor configured to monitor a pressure of the aqueous humor; and electronic circuitry configured to: receive sensor data from the pressure sensor; and provide electrical power to the pump based on the sensor data.
Field further discloses an intraocular pressure control system (Abstract) comprising: a pump 514 (¶0060 and Fig. 5) configured to pump the aqueous humor (¶0086); and the pressure relief valve (¶0068) further comprising: a pressure sensor (a first sensor: ¶0008) configured to monitor a pressure of the aqueous humor ("detect pressure in the anterior chamber": ¶0008) and electronic circuitry (a power source 205, an IOP sensor system 210, a processor 215, a memory 220, a data transmission module 225, and a valve system 230: ¶0021 and Fig. 2) configured to: receive sensor data from the pressure sensor (¶0024); and provide electrical power to the pump based on the sensor data (¶0071).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Lind/Camras in view of Field by incorporating a pump, a pressure sensor and electronic circuitry, in order to deliberately create an overpressure when needed to clear a bleb or other obstruction, as suggested in ¶0077 of Field.
Regarding claim 11, Lind/Camras/Field does not disclose the housing further comprises a second inlet configured for receiving the aqueous humor from an interior portion of the eye and to direct the aqueous humor into the pump.
However, the second inlet is a duplication of parts and does not yield a new and unexpected result. It has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device Lind/Camras/Field by duplicating an inlet configured for receiving the aqueous humor from the interior of the eye and to direct the aqueous humor into the pump, motivated by the desires to increase fluid flow, as it has been held that the mere duplication of parts has no patentable significance unless a new and unexpected result is produced (see MPEP § 2144.04 (VI) (B)).
Claim(s) 12-14 is/are rejected under 35 U.S.C 103 as being unpatentable over Lind (US PGPUB 20150057596) in view of Camras (US PGPUB 20170087016), as applied to claim 1 above, and further in view of Dos Santos (US PGPUB 20130211313).
Regarding claims 12-14, Lind/Camras does not disclose the passive pressure relief valve includes a spring-biased membrane configured to open to allow passage of the aqueous humor in response to the pressure at the ingress of the passive pressure relief valve exceeding an opening pressure associated with the spring-biased membrane, and wherein the threshold is associated with a spring force of the spring-biased membrane; wherein the spring-biased membrane includes a spiral-cut spring region surrounding a sealing membrane region; and wherein the passive pressure relief valve further includes a first body defining the ingress and a second body defining the egress, wherein the spring-biased membrane further comprises a flange clamped between the first body and the second body.
In the same field of endeavor, a system for use in ophthalmic treatments, Dos Santos discloses a control system 200 comprising a passive pressure relief valve 300 (¶0034 and Fig. 3). Dos Santos further discloses the passive pressure relief valve includes a spring-biased membrane (a corrugated membrane 340: ¶0040 and Fig. 3) configured to open to allow passage of the aqueous humor in response to the pressure at the ingress of the passive pressure relief valve exceeding an opening pressure associated with the spring-biased membrane (¶0040), and wherein the threshold is associated with a spring force of the spring-biased membrane (¶0027); wherein the spring-biased membrane includes a spiral-cut spring region surrounding a sealing membrane region (corrugation zone 430 surrounds a central zone 440: ¶0047 and Fig. 4); and wherein the passive pressure relief valve further includes a first body defining the ingress and a second body defining the egress (¶0041 and Fig. 3), wherein the spring-biased membrane further comprises a flange (a peripheral zone 400: ¶0041 and Fig. 4) clamped between the first body and the second body (sandwiched between the walls of the housing section 360 and the walls of housing section 370: ¶0041 and Fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Lind/Camras in view of Dos Santos by having the passive pressure relief valve comprising a spring-biased membrane configuration, in order to provide a greater degree of control over the membrane deflection profile in response to pressure differentials across the membrane, as suggested in ¶0027 of Dos Santos.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NHU Q TRAN whose telephone number is (571)272-2032. The examiner can normally be reached Monday-Thursday 8:00-5:00 (PST).
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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.
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/NHU Q. TRAN/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781