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 amendments and associated arguments filed 8/4/2025 have been fully considered but they are not persuasive. The claims have been amended to recite that the second surface of the flexible substrate should be “substantially” covered by the eyelid when the eyelid is open. This does not overcome the prior art.
First of all, “substantially covered” is not defined in the original specification as to how much coverage would constitute “substantial” coverage. Furthermore, MPEP 2173.05(b) III. D. explicitly states that “substantially” is a broad term. As such, as long as any subjectively meaningful amount of the second surface of the flexible substrate is covered when the eyelid is even partially open would read on the claim (as the claim does not recite HOW open the eyelid needs to be. It could be 1% open and still read on the claim).
As previously described by the Examiner, when a user is squinting, their eyes could only be barely open. In that case, the substrate of Loudin would most certainly be substantially covered by the eyelid while the eyelids are 1% open when a user is squinting (1% being a mere example). The applicant seems to be arguing that the claimed second surface of the substrate must be covered by the eyelid at all times when the eyelid is completely open. However, the claim is not that specific. As currently recited, as long as any meaningful portion of the second surface of the substrate is covered by the eyelid at any time the eyelid is open, the claim is met. This would include instances where a user/patient has very thin eyes, or even when the user/patient is temporarily squinting, such that the eyelids remain open, but are closer together.
Loudin further discloses that the contact lens is placed over the cornea/conjunctiva of the eye (par. 0032). The “conjunctiva” of the eye covers the white of the eye, and thus includes portions of the eye that are covered by the eyelid when the eyelid is completely open. As such, Loudin discloses that the contact lens is at least partially covered by, and at least partially in contact with, the eyelid when the eyelid is open. Furthermore, when the user/patient is squinting, the eyelids will be closer together yet remain open, such that they cover a portion of the cornea of the eye, as well.
It is also important for the applicant to remember that these are apparatus claims, which are interpreted using the following principles of law:
"To anticipate a claim, a reference must disclose every element of thechallenged claim and enable one skilled in the art to make the anticipatingsubject matter." PPG Indus. Inc. v. Guardian Indus. Corp, 75 F.3d 1558,1566 (Fed. Cir. 1996).
"[T]he patentability of apparatus or composition claims depends onthe claimed structure, not on the use or purpose of that structure." CatalinaMktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801,809 (Fed. Cir.2002).
"It is well settled that the recitation of a new intended use for an oldproduct does not make a claim to that old product patentable." In reSchreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997).
As long as the substrate of the prior art is structurally configured to being substantially covered by an eyelid when the eyes are at least partially open, the claim is met. There is no structural difference currently claimed.
Clearly, Loudin discloses that the substrate has a second surface configured to be at least partially in contact with the eyelid and to be substantially covered by the eyelid when the eyelid is open. All rejections are still considered proper.
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.
Claims 1-11 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Loudin et al. (US 2020/0030615, hereinafter Loudin) in view of Bonmassar et al. (US 2016/0023016, hereinafter Bonmassar).
Regarding claims 1-3, 5, 7-10 and 20 Loudin discloses a stimulation device (i.e., contact lens) to be located underneath an eyelid for treating dry eye (see abstract). The device includes a flexible substrate 112/512, the substrate having an antenna 403 configured to receive electromagnetic energy from a remote control transmitter 401 and having an electronic component 405 (collectively element 510 mounted on a surface) disposed on a second side of the substrate (figures 4-5 and par. 0042-0043). A first electrode trace 518 and a second electrode trace 520 are disposed on and spaced apart on a first side (i.e., juxtaposed with) of the substrate opposite the second side such that the first side faces a sclera and is in contact with the surface of the eye, and the first and second sides are insulated by element 514 (figure 5 and par. 0043). The electrical component is a rectifier that converts electromagnetic energy from the transmitter into electrical power delivered to the electrodes (par. 0042-0043). Loudin discloses that the contact lens is placed over the cornea/conjunctiva of the eye (par. 0032). The conjunctiva of the eye covers the white of the eye, and thus includes portions of the eye that are covered by the eyelid when the eyelid is completely open. As such, Loudin discloses that the contact lens is at least partially covered by, and at least partially in contact with, the eyelid when the eyelid is open. Furthermore, when the user/patient is squinting, the eyelids will be closer together yet remain open, such that they cover a portion of the cornea of the eye, and thus the contact lens, as well. Therefore, Loudin discloses that the substrate has a second surface configured to be at least partially in contact with the eyelid and to be covered by the eyelid when the eyelid is open.
Loudin is silent as to the first and second electrodes having a plurality of prongs with a plurality of slots therebetween for facilitating near-field coupling. The applicant’s specification makes clear in par. 0067 of the original specification that the slots accomplish this goal because they limit the creation of eddy currents. Bonmassar also discloses a stimulation device, and thus is analogous art with Loudin (see abstract). Bonmassar discloses that stimulation electrodes can have a plurality of parallel prongs with a plurality of parallel slots/branches therebetween such that the width between slots is less than a width of each prong and such that prongs can either extend towards or away from a central axis (see figures 5 and 6A and par. 0039). Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to modify Loudin’s electrodes to include a plurality of prongs with a plurality of slots therebetween such that the width between slots is less than a width of each prong and such that prongs can either extend towards or away from a central axis in order to prevent the formation of eddy currents, as taught by Bonmassar (par. 0039 for motivation).
Regarding claim 4, Loudin discloses that the electronic components can be part of an integrated circuit (par. 0043).
Regarding claim 6, the prongs of the first and second electrodes extend in opposing directions along the length of the prongs. The claim does not require the prongs of the first electrode to extend only in a first direction and the prongs of the second electrode to extend only in a second, opposite direction. Instead, the claim requires the that the prongs of both electrodes extend in opposing directions.
Regarding claim 11, the antenna is showed as sealed in figure 12D.
Claims 12-19 are rejected under 35 U.S.C. 103 as being unpatentable over Loudin and Bonmassar in view of Azar et al. (US 2020/0360692, hereinafter Azar).
Regarding claims 12-17, Loudin, as modified and described above, discloses the applicant’s basic invention, but is silent as to the exact structure of the antenna. Azar also discloses a device for treating dry eye (see abstract), and thus is analogous art with Loudin. Azar discloses a flexible substrate with a spiral loop antenna trace 350 for receiving electromagnetic energy to be rectified into electrical power (par. 0042). Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to modify the antenna of Loudin to be a spiral loop antenna, as taught by Azar, as Azar shows a loop antenna to be an art-recognized equivalent for receiving electromagnetic energy to be rectified into electrical power.
Regarding claim18, the antenna is showed as sealed/encapsulated in figure 12D.
Regarding claim 19, as seen in figures 1 and 12 D< the substrate can be bean-shaped.
Conclusion
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 Eric D Bertram whose telephone number is (571)272-3446. The examiner can normally be reached Monday-Friday 8am-6pm Central Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Eric D. Bertram/Primary Examiner, Art Unit 3796