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 Group I, Species A in the reply filed on 10/8/2025 is acknowledged.
Claim(s) 9, 11-12 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/ species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/8/2025.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the from claim 10: chamber (in addition to the channel) positioned between the eye shell and the synthetic trabecular meshwork tissue must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim(s) 5, 7 is/are objected to because of the following informalities:
Within claim 5, line 1: “synthetic trabecular meshwork” should be replaced with --synthetic trabecular meshwork tissue-- in order to maintain consistent claim terminology throughout the claims (see claim 1, line 7; and claim 4, line 1).
Within claim 7, line 1: “the corneal portion integral” should be replaced with --the corneal portion is integral--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1-8, 10 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Within claim 1, line 2: Applicant claims, “a rigid or semi-rigid eye shell”; Examiner can find no written description for what constitutes a rigidi or semi-rigid eye shell – although both terms are used numerous times within the original disclosure there are no examples of materials would qualify as rigid or semi-rigid nor are there bounds given (such as the young’s modulus) which would define a material as semi-rigid vs flexible. In paragraph [0041] of Applicant’s specifications the focus of eye shell description is in embodiments in which the eye shell is soft/ flexible to mimic real human tissues. Claim(s) 2-8 and 10, which depend from claim 1, inherit all the problems associated with claim 1.
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) 1-2, 6-7, 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over BERNAL (US 2020/0118466 A1) in view of Van Dalen et al. (US 2012/0021397 A1 – as cited by Applicant).
With respect to claim 1:
BERNAL discloses the invention substantially as claimed. Specifically, BERNAL discloses a synthetic eye model (eye model device 100), as can be seen in figs. 1-6 (paragraphs [0030-0031]), comprising:
a rigid or semi-rigid eye shell (resilient material making up a subsection of separable anterior segment 230 including the sclera 272, limbus 286, with or without the cornea 292) (paragraph [0042]);
a synthetic iris base (iris 288) positioned within the eye shell (subsection of separable anterior segment 230 including the sclera 272, limbus 286, with or without cornea 292) (paragraphs [0042-0043]);
an eye core (subsection of ciliary body 276 not including the iris 288) positioned within the eye shell (subsection of separable anterior segment 230 including the sclera 272, limbus 286, with or without cornea 292) and encircling the synthetic iris base (iris 288) (paragraph [0042]),
a schlemm’s canal (paragraph [0042]),
a synthetic trabecular mesh tissue (trabecular mesh framework) (paragraph [0042]).
However, BERNAL does not disclose the specifics of the schlemm’s canal (specifically that the eye core (subsection of ciliary body 276 not including the iris 288) including a channel integral to the eye core (subsection of ciliary body 276 not including the iris 288) configured to replicate Schlemm’s canal of a human eye) nor the location of the synthetic trabecular mesh tissue (trabecular mesh framework) (specifically that it is coupled to the eye shell (subsection of separable anterior segment 230 including the sclera 272, limbus 286, with or without cornea 292) and extends across the channel) (as required by claim 1).
Van Dalen et al. teaches a synthetic eye model (model human eye), as can be seen in fig. 4A, (paragraph [0075]), comprising:
An eye core (area from which iris portions 315a, 315b extend in fig. 3A near ciliary body) including a channel (tubes) integral to the eye core (area from which iris portions 315a, 315b extend in fig. 3A near ciliary body) configured to replicate Schlemm’s canal (paragraph [0075]); and
A synthetic trabecular mesh tissue (trabecular meshwork 410) that extends across the channel (tubes) (paragraph [0075]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include the channel (tubes) and the synthetic trabecular mesh tissue (trabecular meshwork 410) that extends across the channel (tubes), as taught by Van Dalen et al., for the undisclosed details of the schlemm’s canal and the synthetic trabecular mesh tissue (trabecular mesh framework), as disclosed by BERNAL, as the details of the structures should be interchangeable (as both are used to replicate the same structures within a model eye). (PLEASE NOTE: In making the aforementioned combination, the channel (tubes), as taught by Van Dalen et al., would be positioned on the eye core (subsection of ciliary body 276 not including the iris 288) near to the limbus (286) at the base of the iris (288), as disclosed by BERNAL. And the synthetic trabecular mesh tissue (trabecular meshwork 410), as taught by Van Dalen et al., would span the added channel (tubes) of the eye core (subsection of ciliary body 276 not including the iris 288) and be at least indirectly coupled to the eye shell (resilient material making up a subsection of separable anterior segment 230 including the sclera 272, limbus 286, with or without cornea 292), as disclosed by BERNAL and modified by Van Dalen et al..)
With respect to claim 2:
Further comprising a synthetic cornea (cornea 292), as disclosed by BERNAL, disposed over the eye shell (a subsection of separable anterior segment 230 including the sclera 272, limbus 286, without cornea 292) (Please note: The cornea (292), as disclosed by BERNAL, can be considered part of a combination of structures (including at least a subsection of separable anterior segment 230 including the sclera 272, limbus 286, optionally cornea 292) which make up the eye shell as required by claim 1; however, claim 2 requires the cornea and the eye shell to be separate (in order for the cornea to be disposed over the eye shell). As such, the subsection of separable anterior segment (230) including the sclera (272) and limbus (286) alone is considered to make up the eye shell as claimed, and the cornea (292) to make us the synthetic cornea as claimed. As can be seen the synthetic cornea (cornea 292) is over (on top of) the eye shell (a subsection of separable anterior segment 230 including the sclera 272, limbus 286, without cornea 292).)
With respect to claim 6:
Wherein the rigid or semi-rigid eye shell (a subsection of separable anterior segment 230 including the sclera 272, limbus 286, with or without cornea 292), as disclosed by BERNAL, includes a corneal portion (cornea 292) and a scleral portion (sclera 272) (paragraph [0042]). (Please note: The cornea (292), as disclosed by BERNAL, can be considered part of a combination of structures (including at least a subsection of separable anterior segment 230 including the sclera 272, limbus 286, optionally cornea 292) which make up the eye shell as required by claim 1; however, claim 6 requires the corneal portion and the scleral portion to both be part of the shell. As such, the subsection of separable anterior segment (230) including the sclera (272), limbus (286), AND the cornea (292) is considered to make up the eye shell as claimed; thus the corneal portion (cornea 292) is a portion thereof as claimed.)
With respect to claim 7:
Wherein the corneal portion (cornea 292), as disclosed by BERNAL, is integral (is made from a single piece/ made from the same material as seen in fig. 7) to the scleral portion (sclera 272) (paragraph [0046]).
With respect to claim 10:
Further comprising a chamber (anterior chamber 232), as disclosed by Bernal, positioned between the eye shell (subsection of separable anterior segment 230 including the sclera 272, limbus 286, with or without cornea 292) and the synthetic trabecular meshwork tissue (trabecular meshwork 410), as disclosed by Bernal and modified by Van Dalen et al. (as discussed above).
Allowable Subject Matter
Claim(s) 3-5, 8 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 1st paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter (should Applicant overcome the rejection(s) under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 1st paragraph): Examiner can find no references alone nor in combination which render obvious:
With respect to claim 3:
A synthetic eye model comprising:
An eye shell;
A synthetic iris base positioned within the eye shell;
An eye core position within the eye shell and encircling the synthetic iris base, the eye core including BOTH a channel integral to the eye core configured to replicate Schlemm’s canal of the human eye AND a protrusion adjacent to the channel and being configured to replicate a scleral spur of a human eye; and
A synthetic trabecular meshwork tissue coupled to the eye shell and extending across the channel.
With respect to claim 5:
A synthetic eye model comprising:
An eye shell;
A synthetic iris base positioned within the eye shell;
An eye core position within the eye shell and encircling the synthetic iris base, the eye core including a channel integral to the eye core configured to replicate Schlemm’s canal of the human eye; and
A synthetic trabecular meshwork tissue (comprising the specific material of a hydrogel-based synthetic tissue) coupled to the eye shell and extending across the channel.
With respect to claim 8:
A synthetic eye model comprising:
An eye shell;
A synthetic iris base positioned within the eye shell;
An eye core position within the eye shell and encircling the synthetic iris base, the eye core comprising a plurality of eye core pieces (as opposed to the singular pieces as referenced within the office action), the eye core including a channel integral to the eye core configured to replicate Schlemm’s canal of the human eye; and
A synthetic trabecular meshwork tissue coupled to the eye shell and extending across the channel.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
HARA (US 2009/0291423 A1 – as cited by Applicant) discloses a synthetic eye model with an eye core including a channel configured to replicate Schlemm’s canal. However, HARA does not disclose the channel to be covered by a synthetic trabecular mesh frame work (the canal does not appear to be covered as it is fully enclosed within the eye core itself).
OMATA et al. (US 2020/0135056 A1) discloses a synthetic eye model with an eye core including a channel configured to replicate Schlemm’s canal which is covered by a synthetic trabecular meshwork tissue. However, OMATA et al. does not disclose the synthetic eye model to include the additional required structures of a rigid or semirigid eye shell nor the synthetic iris base (nor the interaction/ positioning of these structures with eye core or the synthetic trabecular meshwork tissue).
Slabber et al. (US 2023/0237932) discloses a synthetic eye model as claimed. However, Slabber et al. does not qualify as prior art (the earliest filing date is Feb 22 2021).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA S PRESTON whose telephone number is (571)270-5233. The examiner can normally be reached M, W: 9-5; T, Th, F: 9-1.
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/REBECCA S PRESTON/ Examiner, Art Unit 3774