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 .
Examiner’s Note
Please note that the case has been transferred and the Examiner of record has changed. All subsequent papers filed in response to actions received from the Office should be addressed to Examiner GILLIAN REGLAS, AU 1632.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-10) in the reply filed on 8/14/2026 is acknowledged.
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as
being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was
made without traverse in the reply filed on 8/14/2026.
Accordingly, claims 1-20 are pending and claims 1-10 have been examined herein.
Priority
The instant claims herein are examined utilizing the accepted effective filing date of 6/2/2023 for the basis of any prior art rejections.
Claim Interpretation
Claim 5 recites, inter alia, “wherein the coating is configured to bind to a tracer at any regions of said coating not covered by the plurality of endothelial cells”. The examiner is interpreting this limitation to be an intended result of the coating when coated by endothelial cells. Absent evidence to the contrary, the coating as describe in the art rejections below would have this function.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 8 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “healthy” in claim 8 is a relative term which renders the claim indefinite. The term “healthy” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term “Schlemm’s canal cells” as in claim 8 is rendered indefinite by the use of the term “healthy.” For the purpose of compact prosecution, the examiner is interpreting “healthy” SCs cell as primary SC cells exhibiting normal genotype and phenotype.
It is noted that any interpretation of the claims set forth above does not relieve Applicant of the responsibility of responding to rejections made based on said interpretations. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejections and art may be readily applied in a subsequent final Office action.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vulto et al (US20220017846A1, 11/27/2019; published 1/20/2022) in view of Yang et al (IVOS, June 2015; Vol. 56) as evidenced by Li et al (bioRxiv, 28 April 2026; p. 1-35).
Regarding claim 1, Vulto teaches a microfluidic device for assessing mechanical strain on cells comprising a microfluidic network, the microfluidic network comprising: a base, a microfluidic channel, and a cover; wherein the base comprises a non-porous diaphragm forming at least part of an inner surface of the microfluidic channel and wherein the microfluidic channel comprises a sub-volume defined at least in part by the diaphragm and by a capillary pressure barrier in the microfluidic channel (see Abstract, claim 1 of Vulto).
Vulto continues to teach that the microfluidic network contains biological or biomimetic material including one or more of: gel, extracellular matrix or scaffold provided for example in the first sub-volume and epithelial or endothelial cells lining the microfluidic channel (see claim 15 of Vulto).
Regarding claim 1-3, Vulto teaches that the base, also referred to herein as the base layer, or bottom substrate, is preferably formed from a substantially rigid material, such as glass (para 91).
Regarding claim 3-5, Vulto teaches that many suitable gels can be used such as gelatin (para 169) (regarding claim 5, see claim interpretation above).
Regarding claim 1 and 6, Vulto teaches that the diaphragm contains ferromagnetic particles (see claim 7 of Vulto).
Vulto does not teach that:
the endothelial cells comprise a plurality of pores.
Regarding i), Yang teaches investigation of the Schlemm’s canal endothelial cells functions using a three-dimensional microfluidic model (title).
Regarding claims 1 and 7-8, Yang teaches that Human Schlemm’s canal endothelial cells (HSCEC) and human dermal lymphatic microvascular endothelial cells (HLMEC) were cultured on collagen type I gel scaffold (2.5mg/mL) in microfluidic devices.
Yang continues to teach that the microfluidic-based assay was able to be used to study Schlemm’s canal endothelial barrier functions and giant vacuole (GV) formation under physiologically relevant basal-to-apical transendothelial flow and their responses to drug treatment (“Purpose”).
Regarding claim 9, while Yang does not use glaucomatous cells in the microfluidic device, it does teach that the system creates a “trabecular outflow pathway-on-a-chip" and offers innovative ways to study cellular physiology and biomechanics of normal and glaucomatous HSCEC in the future (“Conclusion”).
Regarding claim 10, the teachings of Li are relied upon as providing evidence that Schlemm’s canal endothelial cells have transcellular pores. Specifically, Li teaches that Schlemm’s Canal (SC) is an endothelial-lined vessel whose cells display phenotypic characteristics of both vascular and lymphatic endothelia (Introduction, para 1). The SC inner wall endothelium facilitates aqueous humor outflow by forming openings in its monolayer which are of two distinct types: paracellular pores, which open at cell-cell junctions, and transcellular pores, which typically develop through giant vacuole-associated transcellular channels within individual SC endothelial cells. This evidences that the Schlemm’s cells as taught by Yang have transcellular pores.
Therefore, it would have been obvious prior to the effective filing date of the instantly claimed invention to create a microfluidic device containing endothelial cells as taught by Vulto, where the endothelial cells are Schlemm’s canal endothelial cells as taught by Yang, to arrive at the instantly claimed invention. Yang shows Schlemm’s canal endothelial cells can be successfully used in a microfluidic device. One of ordinary skill would have been motivated to simply substitute one known element [endothelial cells of Vulto] for another [Schlemm’s endothelial cells of Yang] with a reasonable expectation of advantageously study Schlemm’s canal endothelial barrier functions and giant vacuole (GV) formation under physiologically relevant basal-to-apical transendothelial flow and their responses to drug treatment as taught by the prior art.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GILLIAN C REGLAS whose telephone number is (571)270-0320. The examiner can normally be reached M-F 9-5.
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, Peter Paras Jr can be reached at (571) 272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/G.R./Examiner, Art Unit 1632
/DAVID A MONTANARI/Examiner, Art Unit 1632
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