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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/19/2025 has been entered.
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.
Claim(s) 1-5, 7-13, 15-20 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shugarman (US Pub 2017/0042529) in view of Stephenson et al. (US Pub 2007/0270657).
With respect to claim 1, Shugarman discloses a speculum (See 4-5 below), comprising: and a flexible eyelid retraction member (fig 4, 10) being a continuous structure (forms a circle or an ellipse (paragraph 16), the retraction member comprising a plurality of interconnected curved surfaces (see fig 4 below) collectively sized to surround an eye (fig 4) of the patient and contact and press outwardly against skin on the exterior of the eye eyelid (fig 5) of the patient to urge the upper and lower eyelids to retract from the eye. With respect to claim 2, Shugarman discloses wherein the plurality of curved surfaces comprise opposing first and second surfaces and opposing third and fourth curved surfaces (fig 4 and paragraph 16, the shape can be elliptical or oval and matching the eye shape) wherein the opposing first and second curved surfaces have a first common radius of curvature and the opposing third and fourth curved surfaces have a common second radius of curvature and wherein the first radius of curvature is different from the second radius of curvature (paragraph 16 the shape can be oval therefor having sections having different radius of curvatures).
With respect to claim 1, Shugarman discloses the claimed invention except for opposing pads comprising an adhesive configured to adhere to skin of a patient with the retraction member engaging the opposing pads.
Stephenson discloses opposing pads (fig 1, 28 and 29) comprising an adhesive (paragraph 11) configured to adhere to skin of a patient (paragraph 11) with the retraction member engaging the opposing pads (on each of opposing retraction members in fig 1) in order to hold the speculum in place and provide additional eye lid and lash support (paragraph 11).
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 device of Shugarman to include opposing pads comprising an adhesive configured to adhere to skin of a patient with the retraction member engaging the opposing pads in view of Stephenson in order to hold the speculum in place and provide additional eye lid and lash support. With respect to claim 3, Shugarman in view of Stephenson discloses wherein the plurality of curved surfaces substantially continuously contact the skin on the exterior of the eyelid (fig 4) wherein a first of the opposing pads is mounted on the third curved surface and a second of the opposing pads is mounted on the fourth curved surface (fig 4 of Shugarman the retractor surfaces are on the 3rd and 4th surfaces while Stephenson places the pads on the retractor surfaces). With respect to claim 4, Shugarman in view of Stephenson discloses wherein upper and lower surfaces (see figs 4 and 5 below 24s curves upward from the bottom) of the flexible eyelid retraction member and the opposing pads curve upwardly (see fig 5 below and Stephenson places the pads of the retractor surface which in Shugarman are 24 which curve upward) above a line defined by lower extremities of the first and second curved surfaces and an apex of the upward curve is located on the opposing third and fourth curved surfaces (see fig 4 below). With respect to claim 5, Shugarman discloses wherein a radius of curvature of the upward curve is greater than the radius of curvature of each of the first, second, third and fourth curved surfaces (See fig 4 below The upward curve 24 is wider than the curved surfaces) and wherein the plurality of curved surfaces are substantially symmetrically disposed relative a common point (paragraph 16, oval shaped). With respect to claim 7, Shugarman in view of Stephenson discloses wherein opposing curved surfaces of the retraction member each connect directly to the opposing pads (pads of Stepheson are connected to the retractor surfaces) wherein the opposing pads are configured to engage exterior skin of the inner and outer ends of the upper and lower eyelids of the patient (fig 5 shows the retractor surfaces engaging the skin of the eye) engaging the exterior of the inner and outer portions of the eye lids and the flexible retraction member is configured to contact the exterior skin of the upper and lower eye lids of the patient above and below the iris (fig 4-5, contacts the skin) and wherein the flexible eyelid retraction member is configured to curve outwardly (fig 5) while in contact with the upper and lower eyelids to continuously contact the exterior of the skin surrounding the eye of the patient (fig 4 and 5 the upper portion is shown in continuously contact).
With respect to claim 8, Shugarman discloses a speculum (see figs 4 and 5 below), comprising: and a flexible eyelid retraction member (fig 4, 10) configured to contact second portions of the patient's upper and lower eyelids (figure 5 and fig 4 the portions without retractors portions 24 are shown contacting the eye in fig 4), the first and second portions being discrete from each other and comprising skin on the exterior of the eye lids (fig 4), wherein the flexible eyelid retraction member is a continuous structure (fig 4 and paragraph 16 oval shaped) that curves outwardly (fig 4 and 5, 24 curves outward) to substantially contact skin surrounding an eye socket of the patient. With respect to claim 9, Shugarman discloses wherein the retraction member comprises a plurality of interconnected curved surfaces (See fig 4 below) collectively sized to surround an eye of the patient and press outwardly against the eyelids of the patient to urge the upper and lower eyelids to retract from the eye. With respect to claim 10, Shugarman discloses wherein the plurality of curved surfaces comprise opposing first and second surfaces and opposing third and fourth curved surfaces (fig 4 and paragraph 16, the shape can be elliptical or oval and matching the eye shape) wherein the opposing first and second curved surfaces have a first common radius of curvature and the opposing third and fourth curved surfaces have a common second radius of curvature and wherein the first radius of curvature is different from the second radius of curvature (paragraph 16 the shape can be oval therefor having sections having different radius of curvatures).
With respect to claim 8, Shugarman discloses the claimed invention except for opposing pads configured to contact opposing portions of the eyelids of a patient above and below a iris of an eye of the patient with the retraction member engaging the opposing pads.
Stephenson discloses opposing pads (fig 1, 28 and 29) configured to contact opposing portions of the eyelids of a patient above and below a iris of an eye of the patient (abstract) with the retraction member engaging the opposing pads (fig 1) to hold the speculum in place and provide additional eye lid and lash support (paragraph 11).
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 device of Shugarman to include opposing pads configured to contact first portions of the eyelids of a patient with the retraction member engaging the opposing pads in view of Stephenson in order to hold the speculum in place and provide additional eye lid and lash support. With respect to claim 11, Shugarman in view of Stephenson discloses wherein the first of the opposing pads is mounted on the third curved surface and the second of the opposing pads is mounted on the fourth curved surface (fig 4 of Shugarman the retractor surfaces are on the 3rd and 4th surfaces while Stephenson places the pads on the retractor surfaces). With respect to claim 12, Shugarman in view of Stephenson discloses wherein upper and lower surfaces (see figs 4 and 5 below 24s curves upward from the bottom) of the flexible eyelid retraction member and the opposing pads curve upwardly (see fig 5 below and Stephenson places the pads of the retractor surface which in Shugarman are 24 which curve upward) above a line defined by lower extremities of the first and second curved surfaces and an apex of the upward curve is located on the opposing third and fourth curved surfaces (see fig 4 below). With respect to claim 13, Shugarman discloses wherein a radius of curvature of the upward curve is greater than the radius of curvature of each of the first, second, third and fourth curved surfaces (See fig 4 below The upward curve 24 is wider than the curved surfaces) and wherein the plurality of curved surfaces are substantially symmetrically disposed relative a common point (paragraph 16, oval shaped). With respect to claim 15, Shugarman in view of Stephenson discloses wherein opposing curved surfaces of the retraction member each connect directly to the opposing pads (pads of Stepheson are connected to the retractor surfaces) wherein the opposing pads are configured to engage exterior skin of the inner and outer ends of the upper and lower eyelids of the patient (fig 5 shows the retractor surfaces engaging the skin of the eye) engaging the exterior of the inner and outer portions of the eye lids and the flexible retraction member is configured to contact the exterior skin of the upper and lower eye lids of the patient above and below the iris (fig 4-5, contacts the skin) and wherein the flexible eyelid retraction member is configured to curve outwardly (fig 5) while in contact with the upper and lower eyelids to continuously contact the exterior of the skin surrounding the eye of the patient (fig 4 and 5 the upper portion is shown in continuously contact).
With respect to claim 16, Shugarman discloses a speculum (See figs 4 and 5 below), comprising; and a flexible eyelid retraction member (fig 4, 10), the retraction member being a continuous structure (fig 4 and paragraph 16, oval shaped) that comprises an interconnected (fig 4 and oval shape) plurality of curved surfaces (see fig 4 below) collectively sized to surround an eye of the patient and contact and press against the exterior of the eyelid (fig 4 and fig 5) of the patient and urge the upper and lower eyelids of the patient to retract from the eye (fig 4 and 5), , respectively, and wherein the flexible eyelid retraction member is configured to curve outwardly (fig 5) while in contact with the patient to continuously (fig 4 shows continuous contact) contact exterior skin (fig 4 shows contacting exterior skin) surrounding the eye of the patient. With respect to claim 17, Shugarman discloses wherein the plurality of curved surfaces comprise opposing first and second surfaces and opposing third and fourth curved surfaces (fig 4 and paragraph 16, the shape can be elliptical or oval and matching the eye shape) wherein the opposing first and second curved surfaces have a first common radius of curvature and the opposing third and fourth curved surfaces have a common second radius of curvature and wherein the first radius of curvature is different from the second radius of curvature (paragraph 16 the shape can be oval therefor having sections having different radius of curvatures).
With respect to claim 16, Shugarman discloses the claimed invention except for first and second opposing pads with the retraction member configured to connect directly to the opposing pads wherein the first and second opposing pads are configured to engage exterior skin adjacent to inner and outer ends of the upper and lower eyelids while the retraction member contacts the upper and lower eyelids above and below the iris.
Stephenson discloses first and second opposing pads (fig 1, 28 and 29) with the retraction member configured to connect directly to the opposing pads (fig 1 the pads are directly connected to retraction members) to hold the speculum in place and provide additional eye lid and lash support (paragraph 11).
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 device of Shugarman to include first and second opposing pads with the retraction member configured to connect directly to the opposing pads in view of Stephenson in order to hold the speculum in place and provide additional eye lid and lash support. With respect to claim 16, Shugarman in in view of Stephenson discloses wherein the first and second opposing pads are configured to engage exterior skin (fig 4 and 5, 24 of Shugarman with Stephenson teaching the pads going on the retraction surfaces) adjacent to inner and outer ends of the upper and lower eyelids while the retraction member contacts the upper and lower eyelids above and below the iris (fig 4 of Shugarman). With respect to claim 18, Shugarman in view of Stephenson discloses wherein the first of the opposing pads is mounted on the third curved surface and the second of the opposing pads is mounted on the fourth curved surface (fig 4 of Shugarman the retractor surfaces are on the 3rd and 4th surfaces while Stephenson places the pads on the retractor surfaces). With respect to claim 19, Shugarman in view of Stephenson discloses wherein upper and lower surfaces (see figs 4 and 5 below 24s curves upward from the bottom) of the flexible eyelid retraction member and the opposing pads curve upwardly (see fig 5 below and Stephenson places the pads of the retractor surface which in Shugarman are 24 which curve upward) above a line defined by lower extremities of the first and second curved surfaces and an apex of the upward curve is located on the opposing third and fourth curved surfaces (see fig 4 below). With respect to claim 20, Shugarman discloses wherein a radius of curvature of the upward curve is greater than the radius of curvature of each of the first, second, third and fourth curved surfaces (See fig 4 below The upward curve 24 is wider than the curved surfaces) and wherein the plurality of curved surfaces are substantially symmetrically disposed relative a common point (paragraph 16, oval shaped). With respect to claim 22, Shugarman in view of Stephenson discloses wherein opposing curved surfaces of the retraction member each connect directly to the opposing pads (Stephenson shows the pads are directly attached to the retraction member).
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Claim(s) 6, 14 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shugarman in view of Stephenson et al. as applied to claims 1, 8 and 16 above, and further in view of Graether (US Patent 6,675,805).
With respect to claims 6, 14 and 21, Shugarman in view of Stephenson discloses the claimed invention except for wherein the speculum is received by an eye seal of an ocular imaging device and wherein the eye seal comprises a fluid barrier between the speculum and the ocular device.
Graether discloses wherein a speculum (fig 1, 42) is received by an eye seal of an ocular imaging device (col. 1, ll. 14, used with surgical microscope) and wherein the eye seal comprises a fluid barrier (col 1, ll. 53-55 fully isolates) between the speculum and the ocular device to allow for access and viewing during a surgical procedure (col. 1, ll. 9-16).
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 device of Shugarman in view of Stephenson to include wherein the speculum is received by an eye seal of an ocular imaging device and wherein the eye seal comprises a fluid barrier between the speculum and the ocular device in view of Graether in order to allow for access and viewing during a surgical procedure.
Response to Arguments
Applicant’s arguments, see remarks, filed 8/19/2025, with respect to the U.S.C. 112 rejection of claims 5, 13 and 20 have been fully considered and are persuasive. The U.S.C. 112 rejection of claims 5, 13 and 20 has been withdrawn.
Applicant’s arguments with respect to claim(s) 1-22 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/S.J.C/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773