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 .
Amendment
This action is in response to the Amendment filed on 11/5/2025.
Claims 1-7 are pending.
Response to Arguments
Applicant's arguments with respect to claims 1-7 have been fully considered but are moot because the new grounds of rejection as necessitated by the amendments.
Claim Rejections under 35 U. S. C. 103 - U.S. Patent No. 10,695,566 to Do-Hyoung Kim et al. ("Kim") in view of U.S. Patent Publication No. 2019/0344076 Al to Pedro Irazoqui et al. ("Irazoqui").
Independent claim 1 has been amended to now recite
"1. A device for regenerating nerve cells and suppressing immune diseases, the device comprising:
a contact lens comprising a body configured to be worn on a cornea and a
conductive material inserted into the body and serving to induce a microcurrent generated outside the body, wherein the body is comprised of an upper layer, an intermediate layer, and a lower layer, and wherein the intermediate layer is disposed between the upper layer and the lower layer and the conductive material coats the intermediate layer;
a plurality of channels configured to come into close contact with skins
around a user's eyes and to generate a flow of microcurrent on the upper layer of the contact lens worn over each of the user's eyes; and
a signal supply unit configured to supply electrical signals to the plurality of channels."
Applicant’s arguments and amendments have been carefully considered. Upon further search and consideration, the rejection is now withdrawn in view of the amendments.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Upon further search and consideration, the claims are rejected as discussed in the current office action below.
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.
Claims 1 and 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al (U.S. Patent Number: US 10695566 B1, hereinafter “Kim”- PREVIOUSLY CITED) in view of Blum et al (U.S. Patent Application Publication Number: US 2008/0208335 A1, hereinafter “Blum”).
Regarding claims 1 and 4, Kim teaches a device for regenerating nerve cells and suppressing immune diseases, the device (e.g. Col.1 lines 59-65) comprising:
a plurality of channels (e.g. 2111,2112,2121,2122 Figs. 7-9, Col. 9 line 66- col. 10 line 61) configured to come into close contact with skins around eyes and to generate a flow of microcurrent; and
a signal supply unit (e.g. 2130 Fig 7,8, Col. 9 line 66- col. 10 line 61) configured to supply electrical signals to the plurality of channels and
wherein the electrical signals are standardized pulse signals over each of the user's eyes (e.g. Fig. 12 col. 8 lines 37-62).
Kim does not specifically teach a contact lens comprising a body configured to be worn on a cornea and a conductive material inserted into the body and serving to induce a microcurrent generated outside the body, wherein the body is comprised of an upper layer, an intermediate layer, and a lower layer, and wherein the intermediate layer is disposed between the upper layer and the lower layer and the conductive material coats the intermediate layer (the conductive electroactive elements are stacked Note: the method by manufacturing by coating is a product by process limitation);
In a similar field of endeavor, Blum a flexible electro-active lens (e.g. 2 Fig.2 A,B, Fig.4,[0032]) comprising a body configured to be worn on a cornea (e.g. 6 Figs. 2A,B,4,5A-D, 7, [0032]) and a conductive material (e.g. [0041], [0042]: stacked electro-active elements may be activated in response to a control signal from a source external to the electro-active lens. Referring to FIG. 5A, FIG. 5B, FIG. 5C, and FIG. 5D, the electro-active lens may include a receiver, such as, sensing device and/or a memory metal, for receive control signals from a source external to the lens. The control signals may be used to modulate the power applied to each of the elements), inserted into the body and serving to induce a microcurrent generated outside the body, wherein the body is comprised of an upper layer, an intermediate layer, and a lower layer, and wherein the intermediate layer is disposed between the upper layer and the lower layer and the conductive material coats the intermediate layer ([0041]: the electroactive elements are stacked Note: the method by manufacturing by coating is a product by process limitation). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Kim to include a contact lens with a layer of conductive material capable of receiving electrical energy as taught by Blum in order to provide the predictable results of providing a more targeted and effective therapy to the underlying ocular tissue.
Regarding claim 3, Kim in view of Blum teaches the claimed invention as discussed above and Kim further teaches that the plurality of channels comprise:
first and third channels configured to be disposed above user's eyes; and
second and fourth channels configured to be disposed under the user's eyes, wherein electrical signals that are supplied to the first and third channels are different from electrical signals that are supplied to the second and fourth channels (e.g. Figs 7,8, Col. 10 lines 24-40, Fig.12).
Regarding claim 5, Kim in view of Blum teaches the claimed invention as discussed above and Kim further teaches providing standardized pulse waves as discussed above except for the standardized pulse signals being applied at intervals of 500 ms. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device as taught by Kim in view of Blum with the pulse waves being applied at intervals of 500ms, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.050.
In the alternative, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the device as taught by Kim in view of Blum with the pulse waves being applied at intervals of 500ms, because Applicant has not disclosed that the 500 ms intervals provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the standardized pulse wave signal as taught by Kim because it helps in regeneration of damaged corneal nerves and since it appears to be an arbitrary design consideration which fails to patentably distinguish over Kim in view of Blum.
Regarding claims 6 and 7, Kim in view of Blum teaches the claimed invention as discussed above and Kim further teaches providing electrical signals wherein a polarity of the electrical signals that are supplied to the first and third channels are different from a polarity of the electrical signals that are supplied to the second and fourth channels to generate the flow of microcurrent between the first and second channels and between the third and fourth channels and wherein a voltage of the electrical signals that are supplied to the first and third channels are different from a voltage of the electrical signals that are supplied to the second and fourth channels to generate the flow of microcurrent between the first and second channels and between the third and fourth channels (e.g. col 12 line 41-col 13 line 3, Figs.8, 12).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Kim et al (U.S. Patent Number: US 10695566 B1, hereinafter “Kim”- PREVIOUSLY CITED) in view of Blum et al (U.S. Patent Application Publication Number: US 2008/0208335 A1, hereinafter “Blum”) and further in view of Pugh et al (U.S. Patent Application Publication Number: US 2011/0157544 A1, hereinafter “Pugh” -PREVIOUSLY CITED).
Regarding claim 2, Kim in view of Blum teaches the claimed invention as discussed above except for the conductive material is composed of a plurality of conductive fibers, wherein the conductive fibers are in partial contact with each other.
Pugh teaches that it is well known for contact lenses to have conductive material such as carbon fibers (e.g. 0045]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Kim in view of Blum so that the electroactive elements in the lens are made of carbon fibers as taught by Pugh in order to provide the predictable results of have electrodes that are small and also have good conductivity.
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.
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792