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 .
Applicant’s amendments dated 8/10/26 are hereby entered.
Claim Rejections - 35 USC § 103
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.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over PGPUB US 20170229043 A1 by Huh et al (“Huh”), in view of PGPUB US 20160086517 A1 by Gao et al (“Gao”).
In regard to Claim 1, Huh teaches a microfluidic in vitro cornea device, comprising:
a tear flow chamber comprising an inlet, an outlet, and a cell […] region therebetween;
(see, e.g., interior of F1B, “Tear chamber”; see, e.g., p68 in regard to cell region);
a stromal chamber adjacent to and porously coupled with the tear flow chamber;
(see, e.g., interior of F1B, “Stroma”);
an endothelial chamber adjacent to and porously coupled with the stromal chamber;
(see, e.g., interior of F1B, Endothelium);
an aqueous humor chamber adjacent to and porously coupled with the endothelial chamber;
(see, e.g., p55 in regard to “one or more circular chambers”);
wherein a first porous wall is positioned between the tear flow chamber and the stromal chamber, a second porous wall is positioned between the stromal chamber and the endothelial chamber, and a third porous wall is positioned between the endothelial chamber and the aqueous humor chamber,
(see, e.g., exterior layer of F1B, 103 and p61 (“first porous wall”); see, e.g., exterior layer of F1B, 101 and p104; and see, e.g., exterior layer of F1B, 107);
which is configured as a microfluidic in vitro model of a cornea
(see, e.g., p6).
Furthermore, while Huh teaches incorporating cells as part of the eyelid it may not teach wherein those cells are part of a cell culture region, however, in an analogous reference Gao teaches that feature (see, e.g., p112);
Furthermore, the combination of the cited prior art would have been obvious to one of ordinary skill in the art at the time of filing because the cited prior art includes each element claimed, although not necessarily in a single prior art reference, with the only difference between the claimed invention and the cited prior art being the lack of actual combination of the elements in a single prior art reference; one of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately; and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Specifically, it would have been obvious to have added the cell culture region taught by Gao to the eyelid otherwise taught by Huh, in order to increase the realism of the model.
In regard to Claim 2-4, Huh teaches these limitations. See rejection of Claim 1.
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Huh, in view of Gao, further in view of PATENT US 5827641 A by Parenteau et al (“Parenteau”).
In regard to Claim 11, Huh teaches
wherein: the tear flow chamber includes epithelial cells;
(see, e.g., p112);
[…]
the endothelial chamber includes endothelial cells; and
(see, e.g., p63);
the aqueous humor chamber includes endothelial cells or is devoid of cells;
(see, e.g., p55 in regard to “one or more circular chambers”);
To the extent that the remaining claimed limitations may not be taught by Huh, however, in an analogous reference, Parenteau teaches employing fibroblast cells as part of a stromal analog in an in vitro cornea model (see, e.g., F11B and text regarding same);
Furthermore, the combination of the cited prior art would have been obvious to one of ordinary skill in the art at the time of filing because the cited prior art includes each element claimed, although not necessarily in a single prior art reference, with the only difference between the claimed invention and the cited prior art being the lack of actual combination of the elements in a single prior art reference; one of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately; and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Specifically, it would have been obvious to have employed the cells taught by Parenteau for the structure taught by Huh, in order to increase the realism of the model.
In regard to Claim 12, Huh teaches these limitations (see, e.g., p57) with the exception of “primary human corneal fibroblasts”, however
Furthermore, the combination of the cited prior art would have been obvious to one of ordinary skill in the art at the time of filing because the cited prior art includes each element claimed, although not necessarily in a single prior art reference, with the only difference between the claimed invention and the cited prior art being the lack of actual combination of the elements in a single prior art reference; one of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately; and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Specifically, it would have been obvious to have employed the primary cells as taught by Parenteau for the fibroblasts as taught by Huh, in order to increase the realism of the model.
In regard to Claim 13, Huh teaches these limitations. See, e.g., p57.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Huh, in view of Gao, further in view of PGPUB US 20230136820 A1 by Champ et al (“Champ”).
In regard to Claim 14, to the extent that Huh may fail to specifically to the claimed “viewing window”, however, in an analogous refence Champ teaches employing a viewing window in an anatomical model (see, e.g., p141);
Furthermore, the combination of the cited prior art would have been obvious to one of ordinary skill in the art at the time of filing because the cited prior art includes each element claimed, although not necessarily in a single prior art reference, with the only difference between the claimed invention and the cited prior art being the lack of actual combination of the elements in a single prior art reference; one of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately; and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Specifically, it would have been obvious to have added a viewing window as taught by Champ to the model taught by the otherwise cited prior art, in order to increase the utility of the model.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Huh, in view of Gao, further in view of PGPUB US 20160063898 A1 by Bernal (“Bernal”).
In regard to Claim 15, while Huh teaches tear fluids being injected into the model in order to mimic tear fluid dynamics (see, e.g., p10 and 115) to the extent that Huh may fail to specifically teach the remaining claimed limitations, however, in an analogous reference Bernal teaches this feature (see, e.g., p87);
Furthermore, the combination of the cited prior art would have been obvious to one of ordinary skill in the art at the time of filing because the cited prior art includes each element claimed, although not necessarily in a single prior art reference, with the only difference between the claimed invention and the cited prior art being the lack of actual combination of the elements in a single prior art reference; one of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately; and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Specifically, it would have been obvious to have added the pump system as taught by Bernal to the model taught by the otherwise cited prior art, in order to increase the utility of the model.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Huh, in view of Gao, further in view of PGPUB US 20150206456 A1 by Foster et al (“Foster”).
In regard to Claim 16, while Huh teaches an ophthalmic camera being employed as part of the model (see, e.g., p69) to the extent that Huh may fail to specifically teach the remaining claimed limitations, however, in an analogous refence Foster teaches employing a camera and processor in an anatomical model (see, e.g., p14);
Furthermore, the combination of the cited prior art would have been obvious to one of ordinary skill in the art at the time of filing because the cited prior art includes each element claimed, although not necessarily in a single prior art reference, with the only difference between the claimed invention and the cited prior art being the lack of actual combination of the elements in a single prior art reference; one of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately; and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Specifically, it would have been obvious to have added the features as taught by Foster to the model taught by the otherwise cited prior art, in order to increase the utility of the model.
Allowable Subject Matter
Claims 5-10 and 17-28 are allowed.
Response to Arguments
Applicant’s arguments in its Remarks in regard to the art rejections are addressed by the updated statements of those rejections made supra, which were necessitated by Applicant’s amendments.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 Mike Grant whose telephone number is 571-270-1545. The Examiner can normally be reached on Monday through Friday between 8:00 a.m. and 5:00 p.m., except on the first Friday of each bi-week.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's Supervisory Primary Examiner, Peter Vasat can be reached at 571-270-7625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL C GRANT/Primary Examiner, Art Unit 3715
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