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 .
Response to Arguments
Applicant's arguments filed 03/07/2025 have been fully considered but they are not persuasive.
Applicant argues that Hetling is not directed to the claimed invention as Hetling teaches something different than the claimed invention. Further, Applicant argues that the previously used prior art references are nonanalogous to each other in addition to being nonanalogous to the claimed invention. Moreover, Applicant argues that with respect to the Hetling reference, it is unnecessary to perfuse the eye because the electrodes contact the eye directly.
The Examiner respectfully finds Applicant's arguments to be unpersuasive. In response to Applicant's arguments that the Hetling reference is not directed to the claimed invention, the Examiner respectfully disagrees. Hetling teaches an apparatus and methods for mapping retinal function wherein an electrode array device is used to detect electrical potentials of a retina of an eye at a plurality of locations on the anterior surface of an eye (see Hetling, abstract, par 0033, 0040-0041, fig. 2). Therefore, Hetling is directed to the claimed invention because Hetling teaches detecting potential differences in an eye.
As noted by Applicant, Hetling discloses a contact lens with electrodes in contact with the cornea of the eye, or having a number of holes through which the electrode may be placed into contact with the cornea, or into which an electrode may be placed with a conductive hydrogel or other conductive liquid (see Hetling, figs. 11-12B, par 0035, 0038). As further noted by Applicant, Essen-Moller discloses a catheter system. The catheter system of Essen-Moller is used to perfuse a solution around an electrical wire of a potential difference measurement device, that is used to measure potential differences across a tissue. This addresses a similar problem as the claimed invention and as Hetling because potential difference measurements of a tissue are obtained, wherein perfusion of a solution through a perfusion catheter is used to measure the potential differences across tissue. As such, Essen-Moller is reasonably pertinent to the problem faced by the inventors of the instant application and therefore qualifies as analogous prior art. See MPEP 2141.01(a).
Regarding Applicant's arguments that the combination of prior art references is improper because in Hetling, it is unnecessary to perfuse a contact lens with anything because the electrodes are in contact with the cornea directly, and that an introduction of any outside liquid may interfere with direct measurement, the Examiner disagrees with this argument. Hetling explicitly teaches that an electrically conductive connection is made between a conductive trace (i.e., a metallic film or wire that is connected to an electrode) (see Hetling, par 0034) and the anterior surface of the eye using a conductive liquid such as hydrogel, saline, or natural tears (see Hetling, par 0035). Essen-Moller teaches the perfusion catheter contains saline solution for perfusing on an Ag/AgCl electrode such that a constant ionic environment is provided around the Ag/AgCl electrode, and since the Ag/AgCl electrode has a constant ionic environment (i.e., acts as an indifferent, or reference electrode), the electrode is able to distinctly detect gastrointestinal potential difference measurements (see Essen-Moller, Col. 2, lines 1-42). This would be useful in the reference of Hetling as Hetling 1) already uses a conductive liquid such as a saline solution, therefore the conductive liquid used is a saline solution and 2) the perfusion of the saline solution (i.e., the conductive liquid) through the contact lens of Hetling would maintain a constant ionic environment around the electrode so that potential difference measurements are better detected.
Moreover, regarding the bodily incorporation of Essen-Moller into Hetling, Hetling describes that each measuring electrode comprises a cylindrical through-hole formed in the lens substrate adjacent to an un-insulated portion of its corresponding conductive trace, and each through-hole is filled with the conductive liquid (see Hetling, par 0035). The measuring electrode of Hetling can be coupled with the perfusion catheter of Essen-Moller, that is appropriately sized to fit within the through-holes formed in the lens substrate, such that each measuring electrode is perfused with saline during measurement (i.e., the perfusion catheter of Essen-Moller is coupled with the measuring electrode of Hetling as opposed to the Ag/AgCl electrode as in Essen-Moller, see Essen-Moller, abstract, Col. 2, lines 1-28, see fig. 1). The use of Hetling as modified is analogous to the claimed invention because Hetling as modified by Essen-Moller discloses measuring potential differences in an eye of a subject using a perfusion catheter and a measuring electrode. The information obtained from such potential difference measurements can be useful for studying, diagnosing, or monitoring the progression of ocular diseases (see Hetling, par 0002). See 35 USC 103 Rejections below.
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.
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) 1-2 & 4-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 20080294066 --as previously cited--, hereinafter referenced as "Hetling" in view of US Patent 5551425 --as previously cited--, hereinafter referenced as "Essen-Moller".
With respect to claim 1, Hetling teaches an ocular surface potential difference (OSPD) system (i.e., an electrode array that measures eye surface potentials) (see Hetling, par 0033-0040, 0078, 0091, fig. 13), comprising:
a measuring electrode 504 (i.e., a recording electrode) (see Hetling, par 0033-0040, 0091, fig. 13);
a reference needle operably coupled to a reference electrode 513 (see Hetling, par 0091, fig. 13);
and an electrical measurement device 506 (i.e., an amplifier connected to a signal processor) operably coupled to the measuring electrode and the reference electrode (see Hetling, par 0033, 0039, 0073, 0087-0088, 0091, fig. 13).
Hetling does not teach that the OSPD system comprises a perfusion system comprising a perfusion catheter configured to be positionable adjacent to an ocular surface.
Essen-Moller teaches a potential difference measurement device and perfusion pressure catheter that comprises a perfusion lumen that perfuses saline around an electrode wire of the potential difference measurement device that is used to measure the potential difference across the gastrointestinal wall of a patient (see Essen-Moller, abstract, Col. 2, lines 1-28, see fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Hetling such that the measuring electrode is used in conjunction with a perfusion system comprising a perfusion catheter configured to be positionable adjacent to an ocular surface (i.e., the perfusion system is appropriately sized to fit in the through-holes formed on the lens substrate of Hetling) (see Hetling, par 0035) because that would improve the system of Hetling by perfusing the ocular surface with a saline solution that maintains a constant ionic environment around the measuring electrode of Hetling such that it is able to accurately measure the potential difference of its surroundings (i.e., the ocular surface) (see Essen-Moller, Col. 2, lines 1-28).
With respect to claim 2, Hetling in view of Essen-Moller teaches the ocular surface potential difference system of claim 1. Hetling further teaches the electrical measurement device 506 comprises a voltmeter (i.e., the electrical measurement device measures voltage) (see Hetling, par 0019, 0039, 0041, 0104).
With respect to claim 4, Hetling in view of Essen-Moller teaches the ocular surface potential difference system of claim 1. Hetling further teaches the system comprises a processor 146 coupled to the electrical measurement device (see Hetling, par 0033, 0037, 0039-0040, 0069, 0071-0073, fig. 11).
With respect to claim 5, Hetling in view of Essen-Moller teaches the ocular surface potential difference system of claim 4. Hetling in view of Essen-Moller further teaches the processor 146 (see Hetling, par 0033, 0037, 0039-0040, 0044, 0069, 0071-0073, fig. 11) is configured to measure OSPD (i.e., the potential difference across the ocular surface) in a subject during perfusion (see Essen-Moller, Col. 2, lines 1-28).
With respect to claim 6, Hetling in view of Essen-Moller teaches the ocular surface potential difference system of claim 4. Hetling in view of Essen-Moller further teaches the system comprises a software module associated with the processor, wherein the software module is configured to measure OSPD in a subject during perfusion (see Hetling, par 0039, 0078, 0104, Essen-Moller, Col. 2, lines 1-28).
With respect to claim 7, Hetling in view of Essen-Moller teaches the ocular surface potential difference system of claim 1. Hetling in view of Essen-Moller teaches the perfusion system further comprises at least two solution delivery devices fluidically coupled to the perfusion catheter (i.e., a perfusion pump 21 and a tube 23) (see Essen-Moller, Col. 2, lines 54-64, fig. 1).
With respect to claim 8, Hetling in view of Essen-Moller teaches the ocular surface potential difference system of claim 1. Hetling in view of Essen-Moller further teaches a positioning device (i.e., through holes 502 that connect the corneal surface to each recording electrode location) (see Hetling, par 0090, figs. 12A & 12B) operably coupled to the perfusion catheter (see Essen-Moller, Col. 2, lines 54-64, fig. 1).
With respect to claim 9, Hetling in view of Essen-Moller teaches the ocular surface potential difference system of claim 1. Hetling further teaches the measuring electrode is constructed and arranged to measure OSPD changes at the ocular surface (i.e., the potential difference across the ocular surface) (see Hetling, par 0033-0040, 0078, 0091, fig. 13), wherein measured OSPD changes are indicative of a condition (see Hetling, par 0026).
Claim(s) 3 & 27-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hetling in view of Essen-Moller as applied to claim 1 above, and further in view of US Patent Application Publication 20190031630 --as previously cited--, hereinafter referenced as "Verkman".
With respect to claims 3 & 28, Hetling in view of Essen-Moller teaches the ocular surface potential difference system of claim 1. Hetling in view of Essen-Moller fails to teach the perfusion system is configured to perfuse the ocular surface with one or more solutions or two or more solutions in series.
Verkman teaches perfusing an ocular surface with different solutions in series to obtain ocular surface potential difference measurements (see Verkman, par 0362, 0372).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Hetling in view of Essen-Moller such that the perfusion system is configured to perfuse the ocular surface with one or more solutions or two or more solutions in series because that would improve the system of Hetling in view of Essen-Moller by permitting the system to evaluate transepithelial chloride channel function of the ocular surface as the different solutions are perfused over the ocular surface (see Verkman, par 0372).
With respect to claim 27, Hetling in view of Essen-Moller teaches the ocular surface potential difference system of claim 1. Hetling in view of Essen-Moller fails to teach the measuring electrode is configured to be free of contact with the ocular surface being measured.
Verkman teaches perfusing an ocular surface with different solutions in series to obtain ocular surface potential difference measurements (i.e., the measuring electrode during ocular surface potential difference measurements is in contact with perfusion fluid, and not in direct contact with the ocular surface) (see Verkman, par 0362, 0372).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Hetling in view of Essen-Moller such that the measuring electrode is configured to be free of contact with the ocular surface being measured because that would improve the system of Hetling in view of Essen-Moller by permitting the system to evaluate transepithelial chloride channel function of the ocular surface as the different solutions are perfused over the ocular surface (see Verkman, par 0372).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hetling in view of Essen-Moller as applied to claim 1 above, and further in view of US Patent Application Publication 20180133478 --as previously cited--, hereinafter referenced as "Caparso".
With respect to claim 10, Hetling in view of Essen-Moller teaches the ocular surface potential difference system of claim 9. Hetling in view of Essen-Moller fails to teach the condition is an ocular surface condition selected from the group consisting of corneal disease, ectasia, keratoconus, an infection, ocular surface lesions, pterygia, ocular surface squamous neoplasia, and conjunctival lymphoma.
Caparso teaches a microstimulator that is configured to be placed within an anatomical structure of a patient for diagnosing an ocular disease or condition of the patient such as corneal diseases including dry eye (see Caparso, par 0047-0048, figs. 1-3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Hetling in view of Essen-Moller such that the system measures OSPD changes indicative of conditions selected from the group consisting of corneal disease, ectasia, keratoconus, an infection, ocular surface lesions, pterygia, ocular surface squamous neoplasia, and conjunctival lymphoma because measuring OSPD changes that identify conditions such as dry eye corneal disease permits the prevention and treatment of such conditions once identified (see Caparso, par 0004-0005, 0010, 0047).
Conclusion
The following is prior art relevant to the instant application:
Non-Patent Literature “Pro-Secretory Activity and Pharmacology in Rabbits of an Aminophenyl-1,3,5-Triazine CFTR Activator for Dry Eye Disorders” (see “Ocular Surface Potential Difference Measurements” section)
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 Destiny J Cruickshank whose telephone number is (571)270-0187. The examiner can normally be reached M-F, 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/D.J.C./Examiner, Art Unit 3791