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
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-7 and 10, drawn to an eye model, classified in G09B23/30.
II. Claims 8-9, 11-20, drawn to method of making or forming an eye model, classified in B33Y80/00.
Inventions I and II are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case, the product made can be made using a different process by extrusion or a molding and the process of making in group II can be used to create a different organ model (e.g.: heart model).
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
Since the structure of group I does not require a specific process of making; a search of the structure of group I will be distinct from a search for the process of making in group II.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Paul Bianco on 02/10/2026 a provisional election was made without traverse to prosecute the invention of group I, claims 1-7 and 10. Affirmation of this election must be made by applicant in replying to this Office action. Claims 8, 11-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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 and 10 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”.
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”.
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.
Conclusion
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)