DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 5, 2026 has been entered.
The Examiner acknowledges the amendment to claim 1. Claims 1-28 are currently pending, while claims 11-26 remain withdrawn from consideration.
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 .
Response to Arguments
Applicant’s arguments with respect to the rejections of claims 1-10 and 27-28 under 35 USC 103, alleging that Hetling, Essen-Moller, and Verkman fail to teach or suggest the limitations of amended claim 1 reciting, among other things, that the perfusion catheter is positionable adjacent to the ocular surface in a receptacle area created by an everted lower eyelid and in an inferior fornix, that the perfusion catheter is configured to contact a fluid pool in the receptacle area without contacting the ocular surface, and that the measuring electrode is configured to be immersed in the fluid pool contacting the ocular surface, have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claims 1-10 and 28 are 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.
Claim 1 recites the limitation “a measuring electrode operably coupled to the perfusion catheter and configured to be immersed in the fluid pool contacting the ocular surface” at lines 6-7. This limitation renders the claim indefinite as the claim language is unclear as to whether it is the measuring electrode or the fluid pool that is “contacting the ocular surface.” Claims 2-10 and 28 are dependent on claim 1 and inherit the same lack of clarity. Claim 27, although also dependent on claim 1, is not rejected on these grounds as the limitations recited therein render this question moot.
Claim Rejections - 35 USC § 102
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 1-10, 27 and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Felix et al. (“Pro-Secretory Activity and Pharmacology in Rabbits of an Aminophenyl-1,3,5-Triazine CFTR Activator for Dry Eye Disorders”)(cited on IDS of 1/30/2024 and on 892 of 11/14/2025).
Regarding claims 1-2 and 27, Felix et al. teach an ocular surface potential difference (OSPD) system (illustrated in Figure 2A) comprising a perfusion system comprising a perfusion catheter (see at least “Ocular Surface Potential Difference Measurements” at pages 4507-4508; Figure 2A and description of Figure 2) b) a measuring electrode (see at least “Ocular Surface Potential Difference Measurements” at pages 4507-4508 and description of Figure 2) operably coupled to the perfusion catheter and configured to be immersed in the fluid pool contacting the ocular surface; c) a reference needle (see at least “Ocular Surface Potential Difference Measurements” at pages 4507-4508 and Figure 2A) operably coupled to a reference electrode; and d) an electrical measurement device (voltmeter, see at least “Ocular Surface Potential Difference Measurements” at pages 4507-4508 and Figure 2A) operably coupled to the measuring electrode and the reference electrode. The perfusion catheter is configured such that it is capable of being positioned adjacent to an ocular surface in a receptacle area (reservoir formed by eyelids, see description of Figure 2) created by an everted lower eyelid and in an inferior fornix and is configured to contact a fluid pool in the receptacle area without contacting the ocular surface. The limitations regarding the positioning of the perfusion catheter and the measuring electrode of the OSPD system relative to the eyelid and/or the ocular surface are directed to the intended use of the OSPD system. 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.
Regarding claims 3, 7 and 28, Felix et al. teach the perfusion system is configured to serially perfuse the ocular surface with two or more solutions using at least two solution delivery devices coupled to the perfusion catheter (see at least Figure 2A and “For PD recording, solutions (see below) were serially perfused at 10 mL/min through PE-90 plastic tubing using a gravity multireservoir pinch-valve system (ALA Scientific, Westbury, NY, USA) and a variable-flow peristaltic pump (medium flow model; Thermo Fisher Scientific, Fair Lawn, NJ, USA)”, see page 4507).
Regarding claims 4-6, Felix et al. teach a processor/software module coupled to the electrical measurement device to measure OSPD in a subject during perfusion (see at least the computer in Figure 2A).
Regarding claim 8, Felix et al. teach a positioning device operably coupled to the perfusion catheter (adjustable stereotaxic frame, page 4507).
Regarding claims 9-10, Felix et al. teach the measuring electrode is constructed and arranged to measure OSPD changes at the ocular surface, wherein measured OSPD changes are indicative of a condition such as dry eye disease which may be associated with corneal disease, infection, and/or ocular surface lesions.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. WO2019/040919A1, WO2017/112947A1, and WO2017/112951A1 are cited as the references disclose OSPD systems.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Charles A Marmor, II whose telephone number is (571)272-4730. The examiner can normally be reached Monday-Friday 9AM-5PM.
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, Jonathan Moffat can be reached at (571)272-4390. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHARLES A MARMOR II/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights