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
Regarding the 101 rejection, the amendments overcome the rejection and the rejection has been withdrawn.
Regarding the prior art rejections and allowable subject matter, the examiner thanks the applicant for including the allowable subject matter into the independent claims. However, upon the examiner’s allowability review, the examiner found that figure 24 of the primary reference reads upon the allowable subject matter in a 102 type rejection. Thus, the examiner must make this rejection and withdraw the allowable subject matter. The examiner is making this rejection non-final since the subject matter in claim 19 was previously presented.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 5-8,11-14, and 20 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Irazoqui et al. (WO 2017/223387); hereinafter referred to as “Irazoqui”. For the purpose of examination, USPGPub. No. 2019/0344076 A1, which is a national stage application of the WO 2017/223387 above, has been used for the prior art rejections below.
Regarding claim 1, Irazoqui discloses a system for treating an eye of a patient comprising: a lens (e.g. see figure 24 element 2400, [0164]) that is configured for positioning on the eye of the patient, the lens having an inner surface that is positionable against the eye and an outer surface that is opposite the inner surface (e.g. [0164]); a first conductive component lens (e.g. see figure 24 element 2410, [0164]-[0167]) that is positioned on the lens; a second conductive component lens (e.g. see figure 24 element 2412, [0164]-[0167]) that is positioned on the lens and that is separated and electrically insulated from the first conductive component (e.g. see [0167]), the first conductive component and the second conductive component being positioned on the lens so that when the lens is positioned on the eye, the first conductive component or the second conductive component is positioned adjacent a limbus of the eye (e.g. see figure 24, “limbus”); and an electrical source (e.g. see [0165], “WPT coil”) that provides electrical energy (e.g. see [0165], “time-varying electromagnetic fields from a WPT coil”) to the first conductive component or the second conductive component to induce a current (e.g. see [0165]) within the eye between the first conductive component and the second conductive component and thereby deliver electromagnetic energy to target tissue within the eye to therapeutically treat the target tissue (e.g. see figure 24, [0165], figure 14, [0137]. NOTE: [0165] discloses “By positioning the inner electrode 2412 and outer electrode 2410 in that manner, each stimulus coil 2402 is advantageously positioned to deliver the stimulus signal (time-varying electromagnetic field) to ocular structures”), wherein: the first conductive component and the second conductive component comprise an electrode pair (e.g. see figure 24 elements 2410, 2412); the lens includes between 5 and 40 electrode pairs that are arranged and spaced apart on the lens in an annular configuration; and adjacent electrode pairs are separated by a circumferential gap (e.g. see figure 24, elements 2410, 2412. Note: There are 8 pairs of electrodes that are in an annular configuration spaced apart by circumferential gaps).
Regarding claim 3, Irazoqui discloses the first conductive component (e.g. see figure 24 element 2410, [0164]-[0167]) and the second conductive component (e.g. see figure 24 element 2412, [0164]-[0167]) comprise electrodes that electrically contact the eye and that deliver a resistive current through tissue of the eye between the electrodes (e.g. see [0121]).
Regarding claims 5 and 12, Irazoqui discloses the first conductive component and the second conductive component are employed to image at least a portion of the eye via electrical impedance tomography (e.g. see [0164]-[0167]. Note: This is a this is a functional use limitation of a system claim that the conductive components (electrodes) are capable of and/or configured to perform. In particular, the stimulation electrodes are capable of sensing electrical signals in addition to generating electrical signals as both sensing and stimulation electrodes are just conductive pieces of metal).
Regarding claim 6, Irazoqui discloses the therapeutic treatment of the target tissue comprises reducing an intraocular pressure of the eye for treatment of glaucoma (e.g. see [0002], [0008]).
Regarding claim 7, Irazoqui discloses the lens comprises a flexible printed circuit board (e.g. see [0237], [0239], [0245]).
Regarding claim 8, Irazoqui discloses a lens or eye mask for treating an eye of a patient comprising: a flexible printed circuit board (PCB) (e.g. see [0237], [0239], [0245]) that is configured to fit over at least a portion of a surface of the eye (e.g. see [0164]); a plurality of electrode pairs that are arranged on the flexible PCB (e.g. see figure 24, elements 2410, 2412. Note that there are 8 pairs of electrodes); and an electrical source (e.g. see [0165], “WPT coil”) that provides electrical energy to each electrode pair of the plurality of electrode pairs; wherein: each electrode pair is configured to create a near electromagnetic field within the eye (e.g. see [0165]); a spacing between electrodes of each electrode pair is controlled to achieve a predetermined penetration depth of the near electromagnetic field within the eye (e.g. see [0165] which discloses “By positioning the inner electrode 2412 and outer electrode 2410 in that manner, each stimulus coil 2402 is advantageously positioned to deliver the stimulus signal (time-varying electromagnetic field) to ocular structures (including but not necessarily limited to the ciliary body and canal of Schlemm) in order to effectuate the desired reduction in aqueous humor inflow and/or increase in aqueous humor outflow in order to reduce elevated IOP within the eye according to the disclosed techniques”); and the near electromagnetic field is configured to therapeutically treat target tissue of the eye (e.g. see [0165]), wherein the lens includes between 5 and 40 electrode pairs that are arranged and spaced apart on the lens in an annular configuration; and adjacent electrode pairs are separated by a circumferential gap (e.g. see figure 24, elements 2410, 2412. Note: There are 8 pairs of electrodes that are in an annular configuration spaced apart by circumferential gaps).
Regarding claims 11, Irazoqui discloses the electrode pairs are arranged on the flexible PCB so that when the eye mask is positioned on the eye, each electrode pair is positioned near a limbus of the eye (e.g. see figure 24, elements 2410, 2412, “limbus”) so that the near electromagnetic field within the eye therapeutically targets a ciliary body or ciliary processes (e.g. see [0136]-[0137]).
Regarding claim 12, Irazoqui discloses one or more sensory electrodes that are configured to image at least a portion of the eye via electrical impedance tomography (e.g. see figure 24, elements 2410, 2412. Note: This is a functional use limitation of a system claim that the prior art is capable of and/or configured to perform).
Regarding claims 13 and 20, Irazoqui discloses each electrode pair of the plurality of electrode pairs includes one or more sensory electrodes, and wherein each electrode pair and one or more sensory electrodes form an electrode group that is able to simultaneously provide an electrical energy based treatment and measure or sense one or more parameters of the electrical energy based treatment (e.g. see figure 43, “pressure sensor”, [0092], [0099], [0103]. Note from figure 43 the pressure sensor is an electric sensor).
Regarding claim 14, see the rejection for claims 1 and 8 above.
Claim(s) 10 and 18 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Irazoqui et al. (WO 2017/223387); hereinafter referred to as “Irazoqui” as evidenced by the National Library of Medicine link: https://pmc.ncbi.nlm.nih.gov/articles/PMC12133147/.
Regarding claims 10 and 18, Irazoqui discloses the spacing between each electrode of each electrode pair is between 0.1 and 5 mm (e.g. see [0137], [0139], [0141]. According to https://pmc.ncbi.nlm.nih.gov/articles/PMC12133147/, the “limbus is a thin strip of approximately 1–1.5 mm in width”. Thus the electrodes are separated by the disclosed distance since they are on either side of the Limbus).
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.
Claim(s) 2 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Irazoqui as applied to claim 1 above, and further in view of Luttrull et al. (Pub. No.: US 2017/0232269 A1); hereinafter referred to as “Luttrull”.
Regarding claims 2 and 9, Irazoqui discloses the electromagnetic energy will cause the temperature to rise of the electrodes (e.g. see [0228]-[0233]) but is silent as to the electromagnetic energy therapeutically treats the target tissue by heating the target tissue.
Luttrull teaches it is known to use such a modification as set forth in [0168], [0171] to create a thermal time-course temperature spike in the target tissue sufficient to activate or produce heat shock proteins in the cells of the target tissue without damaging the target tissue itself (e.g. see [0168]). The system and process of Luttrull could target the trabecular mesh work as treatment for glaucoma, accomplished by another customized treatment field template ([0109]). Moreover, treatment of retinal tissue using SDM, as explained above, in eyes with advanced open-angle glaucoma have shown improved key measures of optic nerve and ganglion cell function, indicating a significant neuroprotective effect of this treatment (0109]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to use electromagnetic energy to heat the tissue as taught by Luttrull in the system/method of Irazoqui, since said modification would provide the predictable results of a thermal time-course temperature spike in the target tissue sufficient to activate or produce heat shock proteins in the cells of the target tissue without damaging the target tissue itself for the effective treatment of glaucoma.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Irazoqui as applied to claim 1 above, and further in view of Suaning (Patent No.: US 6,458,157 B1).
Regarding claim 4, Irazoqui discloses the claimed invention except for the first conductive component and the second conductive component comprise a pair of capacitors, wherein an insulative material is positioned between each capacitor and the eye, and wherein the pair of capacitors deliver a displacement current through tissue of the eye between the pair of capacitors. Suaning teaches that it is known to use such a modification as set forth in figure 6 elements Cap 1 and Cap 2, column 8 lines 7-12, column 15 lines 48-50 to provide a reduced apparatus size that still balances electrical current (e.g. see column 8 lines 7-12, column 15 lines 48-50). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use capacitors in the retinal stimulator as taught by Suaning in the system of Irazoqui, since said modification would provide the predictable results of a reduced apparatus size that still balances electrical current.
Conclusion
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/P.C.E/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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