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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-16 in the reply filed on 12/15/2025 is acknowledged.
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 t-he later invention.
Claim(s) 1-7, 9-11, 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kao et al. (US 20190224047 A1, hereafter “Kao”) in view of Camras et al. (US 20160058615 A1, hereafter “Camras”), and in further view of Heitzmann et al. (US 20180333296 A1, hereafter “Heitzmann”).
Regarding claim 1, Kao discloses a device for lowering intraocular pressure, the device (1) comprising: a plate comprising a first surface (211) opposite a second surface (212, para. [0046]), wherein the first surface (211) includes interconnected fluid channels (232, para. [0055]).
However, Kao fails to disclose a first coating on the first surface; and a second coating on the second surface.
Camras teaches a similar device in the same field of endeavor a first coating on the first surface (fig. 1, top side of head portion 36, para. [0075]); and a second coating on the second surface (fig. 1, bottom side of head portion 36, para. [0075]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Kao to have a coating as shown in Camras because it can enhance the device by adding an antimicrobial layer, antifibrotic layer, a therapeutic agent, or even a drug-eluting layer (para. [0075]).
However, Kao and Camras fails to disclose wherein at least one of the first surface or the second surface includes a marking that is visible under at least one of visible, ultraviolent, or infrared light for intraoperative or post-operative monitoring.
Heitzmann teaches an ocular implant wherein at least one of the first surface or the second surface includes a marking (positioning element 526, can be an indentation or a visible marker) that is visible under at least one of visible, ultraviolent, or infrared light for intraoperative or post-operative monitoring (para. [0269]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Kao and incorporate the notch as shown in Heitzmann to allow the medical practitioner to achieve the desired orientation of the device during implantation with a visual indicator to align the device as needed (para. [0269]).
Regarding claim 2, the combination of Kao, Camras, and Heitzmann discloses the device of claim 1. Kao further discloses wherein the fluid channels form a hexagonal pattern (fig. 3) with each channel having a height and first width to produce a desired fluid flow rate (para. [0059, 0066, 0075]).
Regarding claims 3 and 4, the combination of Kao, Camras, and Heitzmann discloses the device of claim 1. However, Kao fails to disclose:
(Claim 3) wherein a first portion of the plate has a first thickness and a second portion of the plate has a second thickness;
(Claim 4) wherein the first thickness is greater than the second thickness.
Camras teaches:
(Claim 3) wherein a first portion of the plate (middle portion of head portion 36, fig. 1) has a first thickness and a second portion of the plate (either end portion of head portion 36, fig. 1) has a second thickness;
(Claim 4) wherein the first thickness is greater than the second thickness (fig. 1, para. [0045]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Kao and incorporate the variance in thicknesses of the plate as shown in Camras to create a smooth, continuous transition surface along the outer surface of the device to the surface of the eye (para. [0045]).
Regarding claim 5, the combination of Kao, Camras, and Heitzmann discloses the device of claim 3. Kao further discloses wherein the first portion includes an extension portion (250) and the second portion (240) includes a main body portion (para. [0083]).
Regarding claim 6, the combination of Kao, Camras, and Heitzmann discloses the device of claim 1. Kao further discloses wherein the interconnected fluid channels have dimensions between 10x14 and 12x18 micrometers (para. [0074]) and the plate includes a neck width between 2 and 5 millimeters (extension portion 250, para. [0089]).
Regarding claim 7, the combination of Kao, Camras, and Heitzmann discloses the device of claim 1. Kao further discloses wherein the plate is formed from a ceramic material selected from the group consisting of alumina, silicon nitride, silica, hafnium oxide, titanium nitride, and titanium carbide (para. [0076-0077]).
Regarding claims 9-11, the combination of Kao, Camras, and Heitzmann discloses the device of claim 1, but Kao fails to disclose:
(Claim 9) wherein the first coating is a parylene polymer including at least one of parylene C, parylene D, parylene N, a derivative thereof, or a combination thereof;
(Claim 10) wherein the second coating is aluminum oxide or a parylene polymer (para. [0075]);
(Claim 11) wherein at least one of the first coating or the second coating includes at least one of a biocompatible film, a porous coating, or a lubricious coating.
Camras teaches:
(Claim 9) wherein the first coating is a parylene polymer including at least one of parylene C, parylene D, parylene N, a derivative thereof, or a combination thereof (para. [0075]);
(Claim 10) wherein the second coating is aluminum oxide or a parylene polymer (para. [0075]);
(Claim 11) wherein at least one of the first coating or the second coating includes at least one of a biocompatible film, a porous coating, or a lubricious coating (para. [0075]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Kao to have a coating as shown in Camras because it can enhance the device by adding an antimicrobial layer, antifibrotic layer, a therapeutic agent, or even a drug-eluting layer (para. [0075]).
Regarding claim 13, the combination of Kao, Camras, and Heitzmann discloses the device of claim 1. Kao further discloses wherein the series of fluid channels includes a plurality of open-ended channels that are interconnected to form an intersecting grid pattern of fluid pathways (para. [0061, 0069], figs. 2-3).
Regarding claim 14, the combination of Kao, Camras, and Heitzmann discloses the device of claim 1. Kao further discloses wherein the plate has a core thickness between 300 and 800 nanometers (para. [0050]).
Regarding claim 15, the combination of Kao, Camras, and Heitzmann discloses the device of claim 1, but Kao fails to disclose wherein the plate structure includes at least one notch along a perimeter, the notch being indicative as to whether the first surface or the second surface is visible to a surgeon.
Heitzmann teaches an ocular implant wherein the plate structure includes at least one notch (positioning element 526, can be an indentation) along a perimeter (para. [0269]), the notch being indicative as to whether the first surface or the second surface is visible to a surgeon (para. [0269], rotating the implant so the proper side is facing outward or facing the eye).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Kao and incorporate the notch as shown in Heitzmann to allow the medical practitioner to achieve the desired orientation of the device during implantation with a visual indicator to align the device as needed (para. [0269]).
Regarding claim 16, the combination of Kao, Camras, and Heitzmann discloses the device of claim 1, but Kao fails to disclose wherein the plate structure includes at least one geometric feature for attachment to patient tissue (para. [0222]).
Heitzmann teaches wherein the plate structure includes at least one geometric feature for attachment to patient tissue (para. [0222]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Kao and incorporate the geometric feature as shown in Heitzmann to securely anchor the implant to the intraocular tissue (para. [0222]).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kao (US 20190224047 A1, hereafter “Kao”) in view of Camras (US 20160058615 A1), Heitzmann (US 20180333296 A1), and in further view of Rodstrom et al. (US 20080181930 A1, hereafter “Rodstrom”).
The combination of Kao and Camras discloses the device of claim 1, but fails to disclose wherein the first coating has a thickness of about 0.1 µm to about 10 µm.
Rodstrom teaches a similar ocular implant with a parylene coating wherein the first coating has a thickness of about 0.1 µm to about 10 µm (para. [0026]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the coating thickness of Rodstrom from between 0.5 nanometers and 100 micrometers to between 0.1 and 10 micrometers since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” See MPEP 2114.05. Further, applicant appears to have placed no criticality on the claimed range (see para. [0074] of specification indicating the thickness “may” be within the claimed range).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kao (US 20190224047 A1, hereafter “Kao”) in view of Camras (US 20160058615 A1), Heitzmann (US 20180333296 A1) and in further view of De Juan et al. (US 20070191863 A1, hereafter “De Juan”).
The combination of Kao and Camras discloses the device of claim 1, but the combination fails to disclose wherein the biocompatible film includes polytetrafluoroethylene (PTFE) or enhanced PTFE.
De Juan teaches a glaucoma treatment device wherein the biocompatible film includes polytetrafluoroethylene (PTFE) or enhanced PTFE (para. [0100, 0103]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Kao and incorporate the biocompatible film as shown in De Juan to promote healing of the shunt into the surrounding tissue (para. [0100, 0103]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN A KIM whose telephone number is (703)756-4738. The examiner can normally be reached Monday - Friday 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, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIN A KIM/Examiner, Art Unit 3781
/SUSAN S SU/Primary Examiner, Art Unit 3781 8 January 2026