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 confirmation election without traverse of election on group claims (1-7 and 10) in the reply filed on 06/03/2026 is acknowledged.
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 1-6, 10 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huh WO 2016065312 (and as evidenced by Science Direct article “Hydrogel”).
Claim 1: The Huh reference provides a teaching of a component of a model for simulating surgery upon the eye (see page 25 line 10-15 eye model for practicing and/or performing robotic ocular surgery and/or LASIK eye surgery), comprising:
an anterior portion sized and dimensioned to form at least a corneal portion of the model (see page 17 last paragraph showing a model that include the cornea), including a surface that is transparent (see FIG. 8B showing a transparent model when the eyelid is open) and elastically deformable (see page 9 line 5-15 scaffold 101 deformable material with 3D curvature), and
shaped like the cornea of a natural eye represented by the model (see paragraph 18 line 1-10 producing models that have the same curvature of a human cornea) , the surface including a material that has hydrophilic properties corresponding to the hydrophilic properties of the natural eye (see paragraph 9 line 15-25 showing different model construction material that has been identified in Applicant’s specification as hydrophilic for example polyvinyl alcohol (PVA); see page 10 line 3-8 “polyvinyl alcohol) or polyethylene glycol (PEG) [see page 13 line 23 “polyethylene glycol”] ).
The Huh reference is silent on the teaching of whereby the surface becomes lubricious when water is introduced to the surface, due to the hydrophilic properties. However, Applicant’s specification states that a “Hydrophilic surfaces of the disclosure, in the presence of water, create a thin layer of water between the two sliding surfaces (e.g. a puncturing or cutting instrument, and the cornea), acting as a lubricant, thus reducing the effective coefficient of friction” [see Applicant’s specification page 9 line 20-25]. Since, the Huh reference already teaches a model made from the same material that the applicant’s specification identified as hydrophilic (see page 9 line 15-18 the model 101 composed of hydrogel and page 10 line 3-8 “polyvinyl alcohol) or polyethylene glycol (PEG) [see page 13 line 23 “polyethylene glycol”]); then it would inherently contain the limitation of “whereby the surface becomes lubricious when water is introduced to the surface, due to the hydrophilic properties”.
With respect to the applicant’s amendment of “… the model configured to simulate irrigation of the eye during a surgical procedure”, “… when the surface is irrigated with water during simulation of a surgical procedure” and “… to facilitate insertion of a surgical instrument, and the water uniformly covers the surface without beading to provide a clear surgical field”. The examiner takes the position that these limitations are directed to the intended use of the limitation that do not results in a structural differences between the Huh prior art and the current claim limitation. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this particular case, the Huh reference without being modified can perform the function of “… the model configured to simulate irrigation of the eye during a surgical procedure”, “… when the surface is irrigated with water during simulation of a surgical procedure” and “… to facilitate insertion of a surgical instrument, and the water uniformly covers the surface without beading to provide a clear surgical field”.
Claim 2: The Huh reference provides a teaching wherein the anterior portion includes a body formed from a hydrophilic material (see page 9 line 15-18 the model 101 composed of hydrogel1).
Claim 3: The Huh reference provides a teaching of wherein the material having hydrophilic properties is a hydrogel (see page 9 line 15-18 the model 101 composed of hydrogel.).
Claim 4: The Huh reference provide a teaching of wherein the hydrogel is selected from the group consisting of polyvinyl alcohol (PVA) (see page 10 line 3-8 “polyvinyl alcohol).
Claim 5: The Huh reference provides a teaching of wherein the hydrophilic material is a polymer selected from the group consisting of polyvinylpyrrolidone (PVP) (see page 13 line 24 “polyvinyl pyrrolidone“), polyethylene glycol (PEG) [see page 13 line 23 “polyethylene glycol”]).
Claim 6: The Huh reference provides a teaching of wherein the component is formed from a material that is hydrophobic, the component being treated after being formed to render the material at the surface of the component hydrophilic (see page 15 line 30 – page 16 line 5 treating the material with hydrogel material).
Claim 10: The Huh reference provide a teaching of a component of a model for simulating surgery upon the eye (see page 25 line 10-15 eye model for practicing and/or performing robotic ocular surgery and/or LASIK eye surgery), comprising:
an anterior portion having a body formed of a hydrophilic material (see page 9 line 15-18 the model 101 composed of hydrogel, a hydrophilic material), the body having a surface portion sized and dimensioned to form at least a corneal portion of the model (see paragraph 18 line 1-10 producing models that have the same curvature and size of a human cornea),
including a surface that is transparent (see FIG. 8B showing a transparent model when the eyelid is open) and elastically deformable (see page 9 line 5-15 scaffold 101 deformable material with 3D curvature), and shaped like the cornea of a natural eye represented by the model (see page 17 last paragraph showing a model that include the cornea).
having a surface including a material that has hydrophilic properties corresponding to the hydrophilic properties of the natural eye (see paragraph 9 line 15-25 showing different model construction material that has been identified in Applicant’s specification as hydrophilic);
The Huh reference is silent on the teaching of whereby the surface becomes lubricious when water is introduced to the surface, due to the hydrophilic properties. However, Applicant’s specification states that a “Hydrophilic surfaces of the disclosure, in the presence of water, create a thin layer of water between the two sliding surfaces (e.g. a puncturing or cutting instrument, and the cornea), acting as a lubricant, thus reducing the effective coefficient of friction” [see Applicant’s specification page 9 line 20-25]. Since, the Huh reference already teaches a model made from the same material that the applicant’s specification identified as hydrophilic (see page 9 line 15-18 the model 101 composed of hydrogel and page 10 line 3-8 “polyvinyl alcohol) or polyethylene glycol (PEG) [see page 13 line 23 “polyethylene glycol”]); then it would inherently contain the limitation of “whereby the surface becomes lubricious when water is introduced to the surface, due to the hydrophilic properties”.
With respect to the applicant’s amendment of “… the model configured to simulate irrigation of the eye during a surgical procedure”, “… when the surface is irrigated with water during simulation of a surgical procedure” and “… to facilitate insertion of a surgical instrument, and the water uniformly covers the surface without beading to provide a clear surgical field”. The examiner takes the position that these limitations are directed to the intended use of the limitation that do not results in a structural differences between the Huh prior art and the current claim limitation. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this particular case, the Huh reference without being modified can perform the function of “… the model configured to simulate irrigation of the eye during a surgical procedure”, “… when the surface is irrigated with water during simulation of a surgical procedure” and “… to facilitate insertion of a surgical instrument, and the water uniformly covers the surface without beading to provide a clear surgical field”.
Claim 22: With respect to the “wherein the hydrophilic material is dried for storage and transport, and is configured to be rehydrated by addition of water to restore hydrophilicity and lubricity when the model is to be used”. The examiner takes the position that this is directed to intended use of the model. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this particular case, the Huh reference without being modified can perform the function of “wherein the hydrophilic material is dried for storage and transport, and is configured to be rehydrated by addition of water to restore hydrophilicity and lubricity when the model is to be used” since the Huh reference teaches the same hydrogel material and would respond the same way when subjected to the same requirement stipulated on claim 22.
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) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Huh WO 2016065312 and in view of Slabber US 20230237932
Claim 7: The Huh reference is silent on the teaching of wherein the anterior portion includes at least a portion of the sclera area posterior to the corneal component.
However, the Slabber reference provides a teaching of wherein the anterior portion includes at least a portion of the sclera area posterior to the corneal component (see paragraph 81 scleral dome 26).
Therefore, 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 Huh reference with the feature of wherein the anterior portion includes at least a portion of the sclera area posterior to the corneal component, as taught by the Slabber reference in order to provide a more realistic and complete model of the eye.
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Huh WO 2016065312 and in view of Omata WO 2018097031
Claim 21: The Huh reference is silent on the teaching of an opening configured to receive a surgical instrument, wherein the hydrophilic material is applied within the opening such that the opening becomes lubricated for insertion of the surgical instrument when the hydrophilic material is hydrated.
However, the Omata reference provides a teaching of an opening configured to receive a surgical instrument, wherein the hydrophilic material is applied within the opening such that the opening becomes lubricated for insertion of the surgical instrument when the hydrophilic material is hydrated (see page 9 first complete paragraph item 160 and page 8 first complete paragraph).
Therefore, 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 Huh reference with the feature of an opening configured to receive a surgical instrument, wherein the hydrophilic material is applied within the opening such that the opening becomes lubricated for insertion of the surgical instrument when the hydrophilic material is hydrated, as taught by the Omata reference, in order to provide a realistic eyeball model for user to practice their surgery technique (see page 2 paragraph 7).
Response to Arguments
The applicant argued that the Huh reference does not anticipates the current claim limitation. The applicant argued:
“Though some of the possible materials listed by Huh have hydrophilic properties, Huh also lists a number of materials that the scaffold may be composed of which are hydrophobic. Specifically, Huh states that the scaffold may be composed of a material "copolymerized with hydrophilic or hydrophobic copolymerizing material." See Huh, page 9, lines 15-22. The mere possibility that the scaffold of Huh may be composed of a material with hydrophilic properties is NOT sufficient to anticipate the claimed feature of a model cornea with material that can be either be hydrophilic or hydrophobic. “ The applicant also argued that the current limitation of "the surface including a material that has hydrophilic properties corresponding to the hydrophilic properties of the natural eye; whereby when the surface is irrigated with water during simulation of a surgical procedure, the surface becomes lubricious to facilitate insertion of a surgical instrument, and the water uniformly covers the surface without beading to provide a clear surgical field when water is introduced to the surface, due to the hydrophilic properties" are no longer the taught in the Huh reference. The examiner respectfully disagrees. The examiner notes that the Huh reference provides a teaching of different materials where the eye model can be constructed of. Some of these materials are the same materials that the applicant considered to be hydrophilic material (see rejection of claims 4 and 5). As such, the Huh reference properly anticipates the limitation of claim 1 and 10.
With respect to applicant’s argument that some “hydrogels are naturally hydrophobic”. The examiner respectfully disagrees. Firstly, the examiner would like to point out that the Guo reference is not part of the rejection rationale and no record of it is currently present in the application. The applicant appears to rely on Guo that hydrogels are naturally hydrophobic which is a contradiction from the applicant’s own claim 3 limitation. Applicant’s claim 3 limitation states that “the material having hydrophilic material is a hydrogel”. If the applicant’s argument of “hydrogels are naturally hydrophobic”, then the applicant’s claim 3 limitation is also directed toward a hydrophobic material and the Huh reference can also be applied here. It is more probable that the applicant interpretation of the Guo reference is incorrect2 and is inconsistent with applicant’s own claim limitation. For these reasons, the applicant’s argument are unpersuasive and the rejection under 35 U.S.C 102(a)(1) under Huh is maintained.
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 ROBERT J UTAMA whose telephone number is (571)272-1676. The examiner can normally be reached 9:00 - 17:30 Monday - Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/ROBERT J UTAMA/Primary Examiner, Art Unit 3715
1 Hydrogels are polymeric materials consisting of a sparse network of polymer chains embedded in an aqueous medium. Hydrogels can retain large amounts of water within their intermolecular space due to strong hydrophilicity of the polymer chains and large porosity (as evidenced by science direct hydrogel)
2 The Guo reference states “Here, we report an abnormal swelling of hydrophobic gels in water to form “hydrophobic hydrogels” ”. In summary, the Guo reference states an abnormal/special condition that is not typical in a normal hydrogel.
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