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 Invention I, claims 1-10 and 16-20 in the reply filed on June 8, 2026 is acknowledged. Claims 11-15 are withdrawn from consideration.
Information Disclosure Statement
It is noted that the IDS filed March 14, 2025 appears to have an incorrect listing. Specifically, the IDS lists US 20160189750 as Dong et al. The name of patentee or applicant does not match the cited document. It appears the cited document is supposed to be US 20160189570 (Dong et al.) which has been considered.
Claim Objections
Claim 20 is objected to because of the following informalities:
In claim 20, line 2, “that include inner” should read “that includes inner”.
Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 5, 6, 8-10, and 16-17 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Slabber et al. (US PGPub 20230237932), hereinafter referred to as Slabber.
With regard to claim 1, Slabber teaches a model eye unit (Abstract; Paragraphs 0077, 0080-0081; “eye model”) comprising:
a lens assembly removably attached to an anterior scleral casing (Figs. 2B, 2C, 3B; Paragraphs 0081-0083, 0094 teach the model includes a corneal dome and core including various lens aspects and features wherein the corneal dome is removably attached to an outer scleral dome (Fig 2B, ref 26)); and
a middle section removably coupled to the anterior scleral casing (Figs. 2B, 2C, 3B; Paragraphs 0081-0083 teach the model includes an inner core which is removably attached to the outer scleral dome by a horizontal step or land supporting the outer dome);
wherein the middle section is removably and height adjustably coupled to a posterior scleral section (Figs. 2A, 2B, 2C, 3B; Paragraphs 0081-0083 teach the model can include a lower body and/or mounting base encasing the core with the outer scleral dome wherein the height of the corneal dome can be adjusted); and
wherein the lens assembly includes a cornea lens (Fig. 2a; Paragraphs 0081, 0083, “corneal dome”).
With regard to claim 2, Slabber further teaches wherein the lens assembly includes an iris disc (Figs 3A, 3B; Paragraph 0094 teaches the model may incorporate a simulated flat iris disk).
With regard to claim 5, Slabber further teaches wherein the lens assembly includes a thin film disc (Figs. 3A-B, Ref 70; Paragraph 0086-0087 teaches the model can include a sheet/film/wrap (thin film disc)).
With regard to claim 6, Slabber further teaches wherein the iris disc includes a trabecular mesh-like edge (Figs. 2B, 3A-B; Paragraph 0086-0087 teaches the model can include a sheet/film/wrap which is shown to create an edge of the iris disc and simulates a trabecular meshwork).
With regard to claim 8, Slabber further teaches wherein the middle section and the anterior scleral casing form a water tight interface (Paragraph 0150 teaches the eye components can create a water-tight anterior chamber).
With regard to claim 9, Slabber further teaches wherein the posterior scleral section includes a slip tube that is mated with a posterior section (Figs 16A-B; Paragraphs 0081, 0158, 0164 teaches the model includes a cavity or recess (slip tube) that can be mated with a mount or post oof a base (posterior section)).
With regard to claim 10, Slabber further teaches further comprising a suction cup removably coupled to the posterior scleral section (Figs. 16A-B; Paragraphs 0164, 0167 teach the assembled eye model can be screwed, snapped, or magnetically secured (removably coupled) via the posterior section to a base/mount wherein the mount can be a suction cup).
Claim(s) 1-4 and 8 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Sheehy et al. (US 6,485,142), hereinafter referred to as Sheehy.
With regard to claim 1, Sheehy teaches a model eye unit (Abstract; Col 2, lines 43-53; “functional replica of the human eye”) comprising:
a lens assembly removably attached to an anterior scleral casing (Figs. 1-3; Col 3, lines 36-67 teach artificial eye includes a lens holder including a plurality of lenses (lens assembly) which can be removably disposed in an opening of the anterior portion of the container (anterior scleral casing)); and
a middle section removably coupled to the anterior scleral casing (Figs. 1-3; Col 3, lines 36-67 teach artificial eye includes a lens holder (middle section) including a plurality of lenses which can be removably disposed in an opening of the anterior portion of the container (anterior scleral casing) and removably attached);
wherein the middle section is removably and height adjustably coupled to a posterior scleral section (Figs. 1-3; Col 3, lines 36-67 teach artificial eye includes a lens holder (middle section) which is attached to the casing including the posterior portion of the casing wherein the distance of the lens holder can be adjusted relative to the interior surface of the posterior portion (heigh adjustably)); and
wherein the lens assembly includes a cornea lens (Figure 3, Ref 46; Col 3, lines 42-49 teach the artificial eye includes a first lens simulating the human cornea).
With regard to claim 2, Sheehy further teaches wherein the lens assembly includes an iris disc (Fig 3, Ref 54; Col 3, lines 42-49 teach the artificial eye includes an aperture disk simulating a human iris).
With regard to claim 3, Sheehy further teaches wherein the lens assembly includes an intraocular lens (Fig 3, Ref 48; Col 3, lines 42-49 teach the artificial eye includes a second lens simulating the human lens (intraocular lens)).
With regard to claim 4, Sheehy further teaches wherein the lens assembly includes an intraocular lens holding disc (Fig 3; Col 3, lines 36 – Col 4, line 8 teach the artificial eye includes a lens holder which includes backing rings (intraocular lens holding disc) that support the lenses including the second lens (intraocular lens)).
With regard to claim 8, Sheehy further teaches wherein the middle section and the anterior scleral casing form a water tight interface (Col 4, lines 9-36 teach the container can be filled with a fluid and forms fluid tight seals).
With regard to claim 16, Slabber teaches a model eye unit (Abstract; Paragraphs 0077, 0080-0081; “eye model”) comprising:
a lens assembly removably attached to an anterior scleral casing via a first set of ridges (Figs 2B, 3A-4B; Paragraphs 0080-0082, 0087 teach and show the corneal dome is held in place by the scleral dome (anterior scleral casing) including an edge (first set of ridges)); and
a middle section removably coupled to the anterior scleral casing via a second set of ridges (Figs 2B, 3A-4B; Paragraphs 0080-0082, 0087 teach and show the core includes sheet anchors/O-rings or other such anchors (second set of ridges) which are in contact with the corneal dome and scleral dome thereby removably coupling the core to the scleral dome);
wherein the middle section is removably and height adjustably coupled to a posterior scleral section via a threaded interface (Figs. 2A, 2B, 2C, 3B; Paragraphs 0081-0083 teach the model can include a lower body and/or mounting base encasing the core with the outer scleral dome wherein the height of the corneal dome can be adjusted and the core is attached to the outer dome in part by an attachment screw attached to a threaded bore (threaded interface) of the core); and
wherein the lens assembly includes a cornea lens (Fig. 2a; Paragraphs 0081, 0083, “corneal dome”).
With regard to claim 17, Slabber further teaches wherein the lens assembly includes an iris disc (Fig 3, Ref 54; Col 3, lines 42-49 teach the artificial eye includes an aperture disk simulating a human iris).
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.
Claim(s) 3-4, 7, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Slabber in view of Sheehy.
With regard to claims 3 and 4, Slabber may not explicitly teach wherein the lens assembly includes an intraocular lens [claim 3] and wherein the lens assembly includes an intraocular lens holding disc [claim 4]. However, Sheehy, as discussed above, teaches an artificial eye including a lens holder including backing rings supporting a second lens simulating a human lens (intraocular lens) (Fig 3; Col 3, lines 36 – Col 4, line 8).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Slabber to incorporate the teachings of Sheehy by substituting the lens holder and lenses of Sheehy for the iris and central screw of Slabber, as both references and the claimed invention are directed to eye models simulating a human eye including fluid. One of ordinary skill in the art would modify Slabber by substituting the central screw, iris, and corresponding features with the lens holder of Sheehy to act as the attachment point of the core to the horizontal floor by modifying the threaded bore of the core for the threads of the lens holder. One of ordinary skill in the art would expect such a modification to work as the models are similar systems/devices and would provide the expected result of allowing Slabber to work as a functional model including simulating human eye reaction to radiation. Upon such modification, the method and system of Slabber would include wherein the lens assembly includes an intraocular lens [claim 3] and wherein the lens assembly includes an intraocular lens holding disc [claim 4]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Sheehy with Slabber’s system and method in order to provide further realism to the eye model and provide the functionality of the eye model receiving light or radiation through the lenses.
With regard to claim 7, Slabber may not explicitly teach wherein the posterior scleral section includes a syringe opening. However, Sheehy further teaches wherein the scleral section includes a syringe opening (Fig. 2; Col 3, lines 5-14; Col 4, lines 28-36 teach the container includes an opening through which fluid can be inserted into the container which a syringe would be obvious to one of ordinary skill in the art). Sheehy may not explicitly teach the opening in on the posterior portion, but such a modification of moving the opening from the anterior portion to a posterior portion would be obvious to one of ordinary skill in the art as a design choice per MPEP 2144.04 and In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) and In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) in part as moving the location would not modify the operation of the device.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Slabber to incorporate the teachings of Sheehy by substituting the lens holder and lenses of Sheehy for the iris and central screw of Slabber, closing the cavity of the core with the lower body as shown in Fig 2A (Ref 30), and incorporating an opening in the lower body/posterior portion for allowing fluid insertion, as both references and the claimed invention are directed to eye models simulating a human eye including fluid. One of ordinary skill in the art would modify Slabber by substituting the central screw, iris, and corresponding features with the lens holder of Sheehy to act as the attachment point of the core to the horizontal floor by modifying the threaded bore of the core for the threads of the lens holder. One of ordinary skill in the art would expect such a modification to work as the models are similar systems/devices and would provide the expected result of allowing Slabber to work as a functional model including simulating human eye reaction to radiation. One of ordinary skill in the art would further modify Slabber by creating an opening on the lower body such that fluid could be inserted into the cavity in the core. Upon such modification, the method and system of Slabber would include wherein the posterior scleral section includes a syringe opening. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Sheehy with Slabber’s system and method as both references teach creating fluid-tight cavities/containers and in order to provide further realism to the eye model by allowing for the interior of the eye model to be filled with fluid to simulate the aqueous humor of the human eye (Sheehy Col 4, lines 18-35).
With regard to claim 18, Slabber may not explicitly teach further comprising a removable plug forming water tight seal with an opening in the posterior scleral section. However, Sheehy further teaches the container includes an opening through which fluid can be inserted into the container wherein the opening can be filled with a removably disposed plug (Figs. 1 and 2; Col 3, lines 5-14; Col 4, lines 28-36). Sheehy may not explicitly teach the opening in on the posterior portion, but such a modification of moving the opening from the anterior portion to a posterior portion would be obvious to one of ordinary skill in the art as a design choice per MPEP 2144.04 and In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) and In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) in part as moving the location would not modify the operation of the device.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Slabber to incorporate the teachings of Sheehy by substituting the lens holder and lenses of Sheehy for the iris and central screw of Slabber, closing the cavity of the core with the lower body as shown in Fig 2A (Ref 30), and incorporating an opening in the lower body/posterior portion for allowing fluid insertion, as both references and the claimed invention are directed to eye models simulating a human eye including fluid. One of ordinary skill in the art would modify Slabber by substituting the central screw, iris, and corresponding features with the lens holder of Sheehy to act as the attachment point of the core to the horizontal floor by modifying the threaded bore of the core for the threads of the lens holder. One of ordinary skill in the art would expect such a modification to work as the models are similar systems/devices and would provide the expected result of allowing Slabber to work as a functional model including simulating human eye reaction to radiation. One of ordinary skill in the art would further modify Slabber by creating an opening on the lower body such that fluid could be inserted into the cavity in the core and using a removable plug to seal the opening to retain the liquid in the model and complete the water/fluid-tight seal of the model. Upon such modification, the method and system of Slabber would include further comprising a removable plug forming water tight seal with an opening in the posterior scleral section. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Sheehy with Slabber’s system and method as both references teach creating fluid-tight cavities/containers and in order to provide further realism to the eye model by allowing for the interior of the eye model to be filled with fluid to simulate the aqueous humor of the human eye (Sheehy Col 4, lines 18-35).
With regard to claim 19, Slabber, as modified, further teaches further comprising a suction cup removably coupled to the posterior scleral section (Figs. 16A-B; Paragraphs 0164, 0167 teach the assembled eye model can be screwed, snapped, or magnetically secured (removably coupled) via the posterior section to a base/mount wherein the mount can be a suction cup) and the removable plug (see prior art rejection of claim 18 above), but may not explicitly teach wherein the removable plug is positioned vertically above the suction cup. However, as the mounting of the model of Slabber occurs at the bottom of the model as seen in figures 16A-17C, it would have been obvious to one of ordinary skill in the art to arrange the opening to be above the connection point with the base and thereby positioned vertically above the suction cup as a matter of design choice as supported by MPEP 2144.04 and In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) and In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) in part as moving the location would not modify the operation of the device.
With regard to claim 20, Slabber may not explicitly teach wherein the threaded interface is a double sided threaded interface that includes inner threads and outer threads. However, Sheehy further teaches the lens holder is threaded both on an inner side for receiving a piece for securing the lenses and on an outer side for adjusting the location and positioning of the lenses withing the container (Fig. 3; Col 3, lines 50-58; Col 4, lines 1-17).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Slabber to incorporate the teachings of Sheehy by substituting the lens holder and lenses of Sheehy for the iris and central screw of Slabber and applying the teaching of the core having both inner and outer threading as a means for adjusting the height of the corneal dome, as both references and the claimed invention are directed to eye models simulating a human eye including fluid. One of ordinary skill in the art would modify Slabber by substituting the central screw, iris, and corresponding features with the lens holder of Sheehy to act as the attachment point of the core to the horizontal floor by modifying the threaded bore of the core for the threads of the lens holder. One of ordinary skill in the art would expect such a modification to work as the models are similar systems/devices and would provide the expected result of allowing Slabber to work as a functional model including simulating human eye reaction to radiation. One of ordinary skill in the art would further modify Slabber by modifying the core to have the inner threading as detailed in Slabber and outer threading in place of the O-rings/sheet anchors to secure the corneal dome and anterior scleral dome in order to provide the functionality for adjusting the height of the corneal dome and the lenses relative to the corneal dome and the base. Upon such modification, the method and system of Slabber would include wherein the threaded interface is a double sided threaded interface that includes inner threads and outer threads. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Sheehy with Slabber’s system and method in order to provide the functionality of adjusting the height/positioning of the corneal dome and lenses relative to each other, the core, and the base/lower body/posterior scleral dome.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sheehy in view of legal precedent.
With regard to claim 7, Sheehy further teaches wherein the scleral section includes a syringe opening (Fig. 2; Col 3, lines 5-14; Col 4, lines 28-36 teach the container includes an opening through which fluid can be inserted into the container which a syringe would be obvious to one of ordinary skill in the art). Sheehy may not explicitly teach the opening in on the posterior portion, but such a modification of moving the opening from the anterior portion to a posterior portion would be obvious to one of ordinary skill in the art as a design choice per MPEP 2144.04 and In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) and In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) in part as moving the location would not modify the operation of the device. Upon such modification, Sheehy would teach wherein the posterior scleral section includes a syringe opening.
Conclusion
Accordingly, claims 1-10 and 16-20 are rejected and claims 11-15 are withdrawn from consideration.
The Examiner recommends the Applicant inquire with regard to scheduling an Examiner interview to discuss the application and furthering prosecution.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CORRELL T FRENCH whose telephone number is (571)272-8162. The examiner can normally be reached M-Th 7:30am-5pm; Alt Fri 7:30am-4pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kang Hu can be reached at (571)270-1344. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CORRELL T FRENCH/Examiner, Art Unit 3715
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