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 .
Response to Amendment
Receipt is acknowledged of the RCE Request dated 2/23/2026. Claims are not amended, claims 26-27 are new, and claims 1-4, 6-12, and 18-21, and 23-27 are currently pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/23/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
As there continues to be disagreement concerning the broadest reasonable interpretation of the claims in light of the Specifications, this section will provide clarity on the scope of invention and how the scope differs from contentions presented by Applicant in the 2/23/2026 Remarks.
Claim 1 recites “a position configured to received therein an upper eyelid wiper of a wearer of the ophthalmic lens”. This language is a structural limitation on the position of the first concavity, though is substantially defined by its function, use, and/or operation with an upper eyelid wiper of a wearer. It is unclear that an artisan would understand how a position (hypothetical) of a concavity would not capable of such function, use, and/or operation. For known lenses that fix orientation of a lens relative to an eye and prohibit further orientations of the lens relative to the eye, it is possible that a concavity would never interact with an upper eyelid wiper to a meaningful extent. Without reciting the particular structure, materials or steps that accomplish the function or achieve the result, all means or methods of resolving the problem may be encompassed by the claim. Ariad Pharmaceuticals., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353, 94 USPQ2d 1161, 1173 (Fed. Cir. 2010) In this instance, for ophthalmic lenses free to re-orient and be re-positioned relative to an eye, the functional language does not further limit the position of the first concavity.
Claim 1 recites “a position configured to received therein a lower eyelid wiper of a wearer of the ophthalmic lens”. This language is a structural limitation on the position of the second concavity, though is substantially defined by its function, use, and/or operation with a lower eyelid wiper of a wearer. It is unclear that an artisan would understand how a position (hypothetical) of a concavity would not capable of such function, use, and/or operation. For known lenses that fix orientation of a lens relative to an eye and prohibit further orientations of the lens relative to the eye, it is possible that a concavity would never interact with a lower eyelid wiper to a meaningful extent. Without reciting the particular structure, materials or steps that accomplish the function or achieve the result, all means or methods of resolving the problem may be encompassed by the claim. Ariad Pharmaceuticals., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353, 94 USPQ2d 1161, 1173 (Fed. Cir. 2010) In this instance, for ophthalmic lenses free to re-orient and be re-positioned relative to an eye, the functional language does not further limit the position of the second concavity.
Claim 1 recites “”wherein a vertical, longitudinal axis extending through the center point of the ophthalmic lens intersects the first concavity at a first point and the second concavity at a second point”. This language is a structural limitation on the location of points of the first and second concavities relative to a center point, though is substantially defined by its function, use, and/or operation relative to a gravitational reference frame. The wearer and wearer’s eye are not bound or fixed within that gravitational reference frame. A lens may or may not be bound or fixed to the eye though there is no requirement within the claim. In other words “vertical, longitudinal axis” under the broadest reasonable interpretation may be taken as referencing a frame of gravity, a frame of the eye of the wearer, and a frame of the lens itself, at least. Applicant’s own lens is not bound to either gravity nor the eye of the wearer, though the disclosure stabilizes the lens within the frame of the eye via the concavities and interactions with the eyelid wiper. The claim language is not so limiting as Applicant’s disclosure as the claim is drawn to the lens alone (i.e. not the lens and wearer) and the functional language limiting the location of the concavities is not so narrowly constructed. In Wichterle, the lens design is agnostic to the orientation of the eyelids and to the orientation of gravity but rather references the optical characteristic and anatomical geometry of the ocular optics. The concavities are defined relative to the astigmatism of the eye and the axis thereof. A person having ordinary skill in the art would understand astigmatism to have no particular relationship to a gravitational reference frame and the axis of astigmatism may be oriented at any angle relative to the wearer eyelids and gravity. For this reason, a person having ordinary skill in the art would understand the functional language limiting the concavity to limit a structure capable of evidencing the claimed locations and vertical, longitudinal axis for an arbitrary orientation (see figure below). This is discussed further in the Response to Arguments section below.
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Claim 1 recites “wherein the second concavity is configured to enable an approximately equal interaction with the lower eyelid wiper during upgaze and downgaze”. This language is a structural limitation on the overall lens geometry and/or material and/or factors influencing “interaction”, though is substantially defined by its function, use, and/or operation between the lower eyelid wiper and the second concavity. Under the broadest reasonable interpretation of this language, “an approximately equal interaction” includes movement of the lower eyelid in proximity to the second concavity that includes physical contact or the absence thereof while interacting with portions of the second concavity (e.g. concavity slopes). In Wicherle, the concavities are shaped such that they are cylindrical (i.e. circular in cross-section) and thus movement of the eyelid across the cylindrical concavity includes physical interaction with a circular slope and general cylindrical extension in a first direction and physical interaction with the same circular slope in a second direction (see below). The figure below depicts the eyelid wiper movement (not location) relative to the cylindrical concavities.
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Allowable Subject Matter
Claim 26 would be allowable if rewritten to overcome the rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
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.
Claim 26 is 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 26 recites “each of the first concavity and the second concavity has a depth normal to the convex front surface at its deepest point of about 30 microns to about 50 microns”. There is no fixed, clear “normal to the convex front surface” as the convex front surface provides “a substantially uniform radius of curvature” and local concavities having varied slopes. Thus a depth defined according to a normal for a surface with infinite number of normal vectors does not clearly define the metes and bounds of the claim. In light of the disclosure, it appears that Applicant intends to limit the depth of the concavity as the distance between a hypothetical surface of a lens with the same “substantially uniform” curvature and the point located farthest from the hypothetical surface, as measured orthogonally from the hypothetical surface. This measurement would be consistent with the geometry shown in Applicant’s Fig. 3, depicting a symmetry point 302 and a hypothetical lens surface 304.
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Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 6-12, 18-19, 21, 23 and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pat. 4,256,369 to Wichterle (hereinafter Wichterle).
Regarding claim 1, Wichterle discloses an ophthalmic lens, comprising: a convex front surface (front surface, Figs. 1-4) having a substantially uniform radius of curvature (“a toric central portion 2 having a maximum radius curvature R1 in the plane passing through to section lines A--A, and a minimum curvature in the plane passing through the section lines B--B”, Figs. 1-4) other than at a location of a first concavity and a second location of a second concavity therein (“two roughly cylindrically concave strips 3 extend parallel to the plane of minimum curvature on either side of the toric portion 2 being spaced from each other distance corresponding to the width of the optical zone, i.e., at least 4 mm, but preferably 7-9 mm”, Figs. 1-4), and a rear surface (rear surface, Fig. 1-4) that opposes the front surface and defines a thickness therebetween, and wherein the concavity is dispose at a position configured to receive therein an upper eyelid wiper of a wearer of the ophthalmic lens (“two roughly cylindrically concave strips 3 extend parallel to the plane of minimum curvature on either side of the toric portion 2 being spaced from each other distance corresponding to the width of the optical zone, i.e., at least 4 mm., but preferably 7-9 mm”, “transition zones are preferably between 0.5 to 2 mm”, “shaping produces only minimum irritation to the eye and its lids by the outer surface of the lens”; cols. 3-4), wherein the second concavity is disposed at a position configured to receive therein a lower eyelid wiper of the wearer of the ophthalmic lens (“two roughly cylindrically concave strips 3 extend parallel to the plane of minimum curvature on either side of the toric portion 2 being spaced from each other distance corresponding to the width of the optical zone, i.e., at least 4 mm., but preferably 7-9 mm”, “transition zones are preferably between 0.5 to 2 mm”, “shaping produces only minimum irritation to the eye and its lids by the outer surface of the lens”; cols. 3-4), wherein a vertical, longitudinal axis extending through the center point of the ophthalmic lens intersects the first concavity at a first point and the second concavity at a second point (Figs. 1-2), and wherein the second concavity is configured to enable an approximately equal interaction with the lower eyelid wiper during upgaze and downgaze (R3 is circular and therefore inherently exhibits equal curvatures for upgaze and downgaze, Figs. 1-4; col. 3, ln. 4-col. 4, ln. 28).
The claim requires “an approximately equal interaction with the lower eyelid wiper during upgaze and downgaze”. A person having ordinary skill in the art would understand movement of eyelid wipers to vary during downgaze and upgaze and to not be limited as purely inferior or superior to a starting/primary position. While the Applicant’s cited references evidences movement of the lower eyelid 3-4mm inferior to a primary position during downgaze, the more relevant inquiry is the relative motion between the pupil and the eyelid during downgaze and upgaze and not the relative motion of the eyelid to a primary position. Movement of the eyelids relative to the pupil accounts for a means by which the eye interacts with the ophthalmic lens concavities. When there is movement of the eyelids relative to the ophthalmic lens, there is interaction with surfaces based, at least in part, on the slope of the surfaces. In the case of the Wichterle lens and cylindrical concavities, slopes of the surfaces within the concavities are at least “approximately equal” on account of the definition of a cylinder. With approximately equal cylindrical slopes interacting with the eyelids during relative motion toward the center of the ophthalmic lens and away from the center of the ophthalmic lens, the Wichterle lens is inherently capable of the claimed function/operation.
The claim requires “wherein a vertical, longitudinal axis extending through the center point of the ophthalmic lens intersects the first concavity at a first point and the second concavity at a second point”. A person having ordinary skill in the art would understand that language to limit the use and function of the structure and would not differentiate the apparatus over prior art apparatuses used differently. The orientation of the axes and concavities in Wichterle’s contact lens address astigmatism in the eye, but the claimed invention is not patentably distinct from the prior art device.
Regarding claim 2, Wichterle discloses the concavity is configured to provide rotational stability and/or position control for the ophthalmic lens (Figs. 1-4). This claimed functionality is a structural characteristic of an elongated lens concavity interacting with the eyelid wipe, as disclosed in cited portions of Wichterle.
Regarding claim 3, Wichterle discloses wherein the second concavity is defined by a second sloped surface of decreasing thickness on a first side and a third sloped surface of decreasing thickness on a second side meeting along a second thinned zone, wherein a thickness of said lens along said second thinned zone is less than a thickness at said convex front surface surrounding said second concavity (second cylindrical concavity 3, Fig. 1-4).
Regarding claim 4, Wichterle discloses the radial distance between the center point of the ophthalmic lens and the first concavity is between about 4 millimeters (mm) and about 4.5 mm (“central toric surface occupies a inner part of the lens of a band 8 mm wide and about 10 mm long”). This disclosure requires the cylindrical concavity to have a portion at 4mm from center.
Regarding claim 6, Wichterle discloses the first sloped surface of the first concavity is farther from the center point of the ophthalmic lens than the second sloped surface, which is nearer to the center point of the ophthalmic lens (Fig. 1 & 2). Slope would have been understood by a person having ordinary skill in the art to be defined according to a reference line or plane. The claim is silent as to a reference and thus the broadest reasonable interpretation of the claim extends to arbitrary references.
In the annotated drawing of Wichterle’s Fig. 2 below, lines tangent to portions of concavities are depicted for illustration purposes. Further, arbitrary axes “x” and “y” are provided for illustrations purposes. A same Tangent 1 can be said to be steep relative to the x-axis and not as steep relative to the y-axis. The same is true of Tangent 2. This illustrates that arbitrary references may make any particular surface slope “steep” relative to any other slope.
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Regarding claim 7, Wichterle discloses the first sloped surface has a steeper slope than the second sloped surface (Figs. 1 & 2). See notes above.
Regarding claim 8, Wichterle discloses the second sloped surface has a steeper slope than the first sloped surface (Figs. 1 & 2). See notes above.
Regarding claim 9, Wichterle discloses a length of the first sloped surface is greater than a length of the second sloped surface (Figs. 1 & 3). As the claimed length is not further defined, beyond being associated with a first and second sloped surface, Wichterle anticipates the claim by matching arbitrary lengths of the first and second sloped surfaces to the features of the claimed invention.
Regarding claim 10, Wichterle discloses a length of the second sloped surface is greater than the length of the first sloped surface (Figs. 1 & 3). As the claimed length is not further defined, beyond being associated with a first and second sloped surface, Wichterle anticipates the claim by matching arbitrary lengths of the first and second sloped surfaces to the features of the claimed invention.
Regarding claim 11, Wichterle discloses the first concavity has a width of about 0.8 millimeters (mm) to about 1.2 mm (“outer convex surface has a peripheral ring in the form of a sphere of radius 8.5 mm. The circumferential ring is then continuously linked with the central toric surface in part directly, and in part by means of two parallel moonshaped strips, the shape of which is slightly concave cylindric in the main. The central toric surface occupies a inner part of the lens of a band 8 mm wide and about 10 mm long.”). These dimensions would result in a concavity approximately 4mm wide, thus having the claimed width.
Regarding claim 12, Wichterle the first concavity has a length of about 5 millimeters (mm) to about 6 mm (“outer convex surface has a peripheral ring in the form of a sphere of radius 8.5 mm. The circumferential ring is then continuously linked with the central toric surface in part directly, and in part by means of two parallel moonshaped strips, the shape of which is slightly concave cylindric in the main. The central toric surface occupies a inner part of the lens of a band 8 mm wide and about 10 mm long.”, Fig. 1). These dimensions would result in a concavity approximately as long as the central convex, toric region, i.e. 10mm.
Regarding claim 18, Wichterle discloses the ophthalmic lens is a toric lens (Abstract).
Regarding claim 19, Wichterle discloses wherein the ophthalmic lens is a spherical lens (“a peripheral ring in the form of a sphere of radius 8.5 mm”).
Regarding claim 21, Wichterle discloses the ophthalmic lens is an aspheric lens (toric, Abstract).
Regarding claim 23, Wichterle discloses the first concavity is defined by a first sloped surface on a first side directed inward toward said rear surface and a second sloped surface on a second side directed inward toward said rear surface, said first sloped surface and second sloped surface meeting along a thinned zone, wherein a thickness of said lens along said thinned zone is less than a thickness of said lens at said convex front surface surrounding the first concavity (cylindrical concavities, Figs. 1-4).
Regarding claim 28, Wichterle discloses the second concavity is symmetric (cylindrical concavities with circular cross-section of radius R3, Fig. 2) such that respective widths of opposing sloped surfaces defining the second concavity are about the same (a portion of a cylinder necessarily exhibits about equal widths of surfaces about a point/line, Fig. 2). In the illustration below, the extent and orientation of the circular cross section of the cylindrical concavity is shown as varying in order to demonstrate that for any orientation and extent of the circular cross-section there is a point/line of symmetry across which two widths can be said to be “about the same” as claimed.
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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.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Wichterle in view of US Pat. No. 11,022,816 to Bailey et al. (hereinafter Bailey).
Regarding claims 20, Wichterle discloses the claimed invention as cited above though does not explicitly disclose a multifocal lens.
Bailey discloses the ophthalmic lens is a multifocal lens (col. 1, ln. 55-col. 2, ln. 7).
Before the effective filing date of the invention, it would have been obvious to a person of ordinary skill in the art to provide the claimed additional functionality of the ophthalmic lenses as taught by Bailey with the system as disclosed by Wichterle. The motivation would have been to provide additional functionalities, inherent to the claimed features recited, to the toric ophthalmic lens of Wichterle. For example, providing a multi-focal lens permits the lens to provide multiple focuses to the wearer and the tinted lenses are known to enhance lens cosmetics.
Claims 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Wichterle in view of US Pat. 5,422,687 to Tanaka et al. (hereinafter Tanaka).
Regarding claims 24 and 25, Wichterle discloses the claimed invention as cited above though does not explicitly disclose the first location touches an edge of the ophthalmic lens at a first point and a second point and the second location touches the edge of the ophthalmic lens at a third point and a fourth point.
Tanaka discloses the first location (location of thinned regions 18, Fig. 4) touches an edge of the ophthalmic lens at a first point and a second point (Fig. 4) and the second location (location of thinned regions 18, Fig. 4) touches the edge of the ophthalmic lens at a third point and a fourth point (Fig. 4).
Before the effective filing date of the invention, it would have been obvious to a person of ordinary skill in the art to extend thinned regions to ophthalmic lens edge locations as taught by Tanaka with the system as disclosed by Wichterle. The motivation would have been to avoid an additional process of grinding a lens edge to provide rotational stability (Wichterle, col. 1) and to increase lens stability via eyelid interaction (col. 7, ll. 35-41).
Response to Arguments
Applicant's arguments filed 2/23/2026 have been fully considered but they are not persuasive.
On page 7 of the Remarks, Applicant argues “there is no vertical line that can intersect both strips 3” and “Wichterle is mostly silent on eyelid interaction, from FIG. 1, it appears that both strips either touch both of the upper and lower eyelids or neither do, depending on the size of the peripheral ring portion 1”. Examiner respectfully disagrees. The Claim Interpretation section above details the breadth of “vertical” as would be understood by a person having ordinary skill in the art. In summary, there is no fixed “vertical” orientation for a lens that is free to be used according to the astigmatism axis of the eye. Wichterle defines the cylindrical concavities relative to the optical characteristic of the eye and thus explicitly allows for varied orientations of the disclosed lenses relative to “vertical”. Additionally, Wichterle discloses a specific, cylindrical shape to the concavities which necessarily read on the functional language limitation regarding eyelid wiper interaction as the concavities are symmetrical and thus eyelid movement in opposite directions would have substantially symmetrical physical contact and thus “interaction”. Lastly, Wichterle discloses “projections can not irritate the eye-lid but permanently show the position of cylindric axis” and “shaping produces only minimum irritation to the eye and its lids by the outer surface of the lens” – reading on the required “approximately equal interaction”.
On page 7 and 8 of the Remarks, Applicant argues “Wichterle makes clear that the purpose of these strips is merely to provide smooth geometric transitions between lens regions, not to interact with eyelids in a stabilizing or gaze-dependent manner” and “[n]othing in Wichterle discloses first and second sloped surfaces, differing surface widths, or any concavity geometry engineered for eyelid-wiper interaction during different gaze positions”. Examiner agrees with this description of Wichterle, though this is not understood as pointing to errors in the rejection as the purpose of the invention and the motivation of design do not appear as a limitation on the structure of the apparatus.
In Section II of the Remarks, Applicant argues Wichterle teaches away from eyelid-interaction-based stabilization. The rejection above provides evidence that the structure of the Wichterle lens anticipates the structure of the claimed apparatus. From MPEP 2131.05: "Arguments that the alleged anticipatory prior art is ‘nonanalogous art’ or ‘teaches away from the invention’ or is not recognized as solving the problem solved by the claimed invention, [are] not ‘germane’ to a rejection under section 102." Twin Disc, Inc. v. United States, 231 USPQ 417, 424 (Cl. Ct. 1986) (quoting In re Self, 671 F.2d 1344, 213 USPQ 1, 7 (CCPA 1982)). See also State Contracting & Eng’ g Corp. v. Condotte America, Inc., 346 F.3d 1057, 1068, 68 USPQ2d 1481, 1488 (Fed. Cir. 2003)
In Section II of the Remarks, Applicant argues for the merits of newly added Claim 26 as differentiating the invention over prior art. Examiner acknowledges that the underlying concept of specifying the invention in terms of the depth of the concavities differentiates over the cited prior art and could be allowable if claimed definitely.
On page 9 of the Response, Applicant argues “Applicants' own specification affirmatively demonstrates that the claimed behavior is not inherent, but instead the result of deliberate geometric design”. Firstly, Examiner acknowledges that Applicant discloses embodiments clearly distinct in geometric design from the cited prior art (i.e. Wichterle). However the symmetry of the slopes of the concavity provide for the approximately equal interaction of the eyelid wiper as the eyelid wiper moves across the concavity. The same symmetry is inherently true for a cylindrical concavity. The shape of a cylinder is symmetrical across various planes of intersection and thus a moving eyelid necessarily interacts approximately equally on either side of the intersection plane (i.e. plane of symmetry). This is entirely consistent with Applicant’s disclosure. In addition to this, Applicant provides for (1) asymmetrical designs, and (2) transitions from the concavity to the adjacent portions of the front surface having uniform radius that both provide approximately equal interactions. Wichterle is silent about asymmetrical shapes and is silent as to the geometry of the transition between the cylindrical concavities to adjacent lens portions. In this way, Wichterle does not disclose the same geometric lens design as Applicant. The claims are given their broadest reasonable interpretation, however, and the scope of invention is far broader than the specific embodiment and geometric design shown in Fig. 3-4.
Applicant argues “approximately equal lower-eyelid interaction during upgaze and downgaze is achieved only when a symmetric concavity with intentionally matched sloped-surface geometry is provided”. Examiner respectfully disagrees. The scope of invention under the broadest reasonable claim interpretation is far broader than Applicant’s specific eyelid interaction. While Applicant requires an evidentiary showing of inherency, the evidence of inherency s the Applicant’s own disclosure. The issue is not whether a symmetrical concavity would inherently provide approximately equal interactions during upgaze and downgaze, but rather the metes and bounds of the “equal interaction”.
Regarding Section IV of the Remarks, Applicant addresses functional language in the Claim Interpretation section above. While the language is not considered “merely reciting orientation of intended use”, the language is an indirect and broad structural limitation that is anticipated by a structure that is capable of the function, operation, and/or use.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER J STANFORD whose telephone number is (571)270-3337. The examiner can normally be reached 8AM-4PM PST M-F.
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/CHRISTOPHER STANFORD/Primary Examiner, Art Unit 2872