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 .
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Harant et al. (US 10761348 B2) in view of Ek et al. (US 10363411 B2).
Regarding Claim 1, Harant teaches an ophthalmic device (Abstract) comprising:
a reservoir ('Lower chamber 116', fig.4, col.21, ll.7-8) having an interior configured to hold a therapeutic ("fluid", col.2, ll.60);
a metal electrode ("Sensor 150 may comprise...ion specific microelectrodes", col.23, ll.4-8) configured to cover an opening of the reservoir 116 ("The erodible insert material may comprise first polymer chains configured to dissolve and travel through the body of the contact lens and second polymer chains configured to erode from the material and remain within the cavity", col.24, ll.55-59); and
a body comprising a hydrogel-based material ("hydrogel of the contact lens body", col.23, ll.63) configured to encapsulate the reservoir 116 and the metal electrode 150, wherein electrodissolution is enhanced by chloride ions ("The insert material may comprise a salt such as sodium chloride, sodium carbonate, potassium chloride", col.37, ll.15-17).
Harant fails to teach a metal electrode configured to cover an opening of the reservoir and to receive an electrical signal that electrodissolves the metal electrode to release the therapeutic from the reservoir. Ek teaches a metal electrode configured to cover an opening of the reservoir and to receive an electrical signal that electrodissolves the metal electrode to release the therapeutic from the reservoir ("The electrode matrix element consists of or comprises a material dissolvable and/or degradable in the tissue, that is, in a body fluid", (col.4, ll.20-22); "Upon insertion of the microelectrode of the invention into tissue, either as such or comprised by a bundle of electrodes or an array of electrodes or electrode bundles, and the dissolution or degradation of the electrode matrix element by body fluid and, in the case of an electrode bundle or an array of electrodes or electrode bundles, the (additional) dissolution of the bundle or array matrix or matrices by body fluid, an electrode of the invention is transformed into an microelectrode disposed in soft tissue", col.4, ll.48-57).
Therefore, 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 lens of Harant such that a metal electrode would be configured to cover an opening of the reservoir and to receive an electrical signal that electrodissolves the metal electrode to release the therapeutic from the reservoir as taught by Ek, in order to increase the contact with surrounding cells and decrease the impedance of the electrode (col.11, ll.36-47).
Regarding Claim 2, Harant teaches the hydrogel-based material is permeable to the chloride ions ("When placed on the eye, the contact lens 100 permeability allows the lens 100 to hydrate the eye with cavity liquid 112", col.20, ll.6-9; "The solutes may have a molecular weight such that diffusion of the solutes through the boundary of the cavity and permeation through the lens body may be controlled", col.46, ll.34-37).
Regarding Claim 3, Harant teaches a boost layer ("FIG. 37A shows an insert made of sodium chloride", col.18, ll.31-32) located proximal to the metal electrode 150 configured to supply the chloride ions to enhance the dissolution ("The insert dissolves in the hydration medium, typically physiological saline leaving a cavity filled with saline", col.19, ll.19-22; “The insert materials were tested for the ability to form a thin film-like insert (for example by spreading a thin layer of a hydrated insert material and allowing it to form a dry film through evaporation)”, col.53, ll.34-37; see figs. 36A-36B for insert film 140a; fig.3A).
Harant fails to teach the metal electrode configured to supply the chloride ions to enhance the electrodissolution. Ek teaches the metal electrode configured to supply the chloride ions to enhance the electrodissolution ("The electrode matrix element consists of or comprises a material dissolvable and/or degradable in the tissue, that is, in a body fluid", (col.4, ll.20-22); "Upon insertion of the microelectrode of the invention into tissue, either as such or comprised by a bundle of electrodes or an array of electrodes or electrode bundles, and the dissolution or degradation of the electrode matrix element by body fluid and, in the case of an electrode bundle or an array of electrodes or electrode bundles, the (additional) dissolution of the bundle or array matrix or matrices by body fluid, an electrode of the invention is transformed into an microelectrode disposed in soft tissue", col.4, ll.48-57).
Therefore, 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 lens of Harant such that the metal electrode would be configured to supply the chloride ions to enhance the electrodissolution as taught by Ek, in order to increase the contact with surrounding cells and decrease the impedance of the electrode (col.11, ll.36-47).
Regarding Claim 4, Harant teaches the boost layer ("insert made of sodium chloride", col.18, ll.31-32) comprises a material with a high water solubility with the metal electrode 150 that enables storage of a chloride containing material ("The external solution may be an aqueous solution 204 containing the therapeutic agent 330 such that as the internal cavity 110 comes to equilibrium with the external storage solution, the therapeutic agent 330 diffuses across the lens body 120 into the cavity 110. The storage solution may be of such a concentration, temperature, composition, or any comparable parameter or combination of parameters that the rate of diffusion can be controlled to load the cavity 110 with the desired amount of therapeutic agent 330", col.40, ll.39-48).
Harant fails to teach the boost layer comprises a material with a high water solubility configured to create a gap layer. Ek teaches the boost layer comprises a material with a high water solubility configured to create a gap layer with the metal electrode 150 that enables storage of a chloride containing material ("two or more matrix-embedded electrodes and/or electrode bundles disposed in parallel or about in parallel can be joined by a substantially solid array matrix or glue that can dissolve in or be degraded by an aqueous medium such as a body fluid but also in a body fluid rich in fat such as nerve tissue. The array matrix must be biocompatible. Suitable materials include...alkali salts", col.14, ll.4-15).
Therefore, 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 lens of Harant such that the boost layer would comprise a material with a high water solubility configured to create a gap layer as taught by Ek, in order to increase the contact with surrounding cells and decrease the impedance of the electrode (col.11, ll.36-47).
Regarding Claim 5, Harant teaches the boost layer ("insert made of sodium chloride", col.18, ll.31-32) comprises a solid salt comprising the chloride ions ("salts (including sodium chloride)", col.53, ll.33-34).
Regarding Claim 6, Harant teaches the hydrogel-based material comprises a hydrogel having a high chloride permeability ("When placed on the eye, the contact lens 100 permeability allows the lens 100 to hydrate the eye with cavity liquid 112", col.20, ll.6-9; "The solutes may have a molecular weight such that diffusion of the solutes through the boundary of the cavity and permeation through the lens body may be controlled", col.46, ll.34-37), and
wherein the boost layer ("insert made of sodium chloride", col.18, ll.31-32) comprises a material with a high water solubility ("The insert was made of a biocompatible soluble uncross-linked polyvinyl alcohol, called Solublon®, grade GA. This particular grade of Solublon® is soluble in cold water and studies of dissolution of Solublon® in water at room temperature", col.46, ll.14-18) and/or a solid salt.
Regarding Claim 7, Harant teaches the boost layer ("insert made of sodium chloride", col.18, ll.31-32) is configured to dissolve to form a local enhanced chloride environment that leads to an increase in a speed of the dissolution (Abstract; col.37, ll.56 through col.38, ll.27).
Harant fails to teach a local enhanced chloride environment that leads to an increase in a speed of the electrodissolution. Ek teaches a local enhanced chloride environment that leads to an increase in a speed of the electrodissolution ("The electrode matrix element consists of or comprises a material dissolvable and/or degradable in the tissue, that is, in a body fluid", (col.4, ll.20-22); "Upon insertion of the microelectrode of the invention into tissue, either as such or comprised by a bundle of electrodes or an array of electrodes or electrode bundles, and the dissolution or degradation of the electrode matrix element by body fluid and, in the case of an electrode bundle or an array of electrodes or electrode bundles, the (additional) dissolution of the bundle or array matrix or matrices by body fluid, an electrode of the invention is transformed into an microelectrode disposed in soft tissue", col.4, ll.48-57).
Therefore, 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 lens of Harant such that a local enhanced chloride environment would be formed that leads to an increase in a speed of the electrodissolution as taught by Ek, in order to increase the contact with surrounding cells and decrease the impedance of the electrode (col.11, ll.36-47).
Regarding Claim 8, Harant teaches a method comprising:
positioning an ophthalmic device on an eye of a subject (Abstract),
wherein the ophthalmic device ('contact lens 100', fig.1B, col.19, ll.33) comprises:
a reservoir ('Lower chamber 116', fig.4, col.21, ll.7-8) having an interior configured to hold a therapeutic ("fluid", col.2, ll.60);
a metal electrode ("Sensor 150 may comprise...ion specific microelectrodes", col.23, ll.4-8) ("The erodible insert material may comprise first polymer chains configured to dissolve and travel through the body of the contact lens and second polymer chains configured to erode from the material and remain within the cavity", col.24, ll.55-59); and
a body comprising a hydrogel-based material ("hydrogel of the contact lens body", col.23, ll.63) configured to encapsulate the reservoir 116 and the metal electrode 150; and
applying an electrical signal to the electrode 150 so that the electrode 150 undergoes dissolution to release the therapeutic,
wherein the dissolution is enhanced by chloride ions ("The insert material may comprise a salt such as sodium chloride, sodium carbonate, potassium chloride", col.37, ll.15-17).
Harant fails to teach a metal electrode configured to cover an opening of the reservoir and to receive an electrical signal that electrodissolves the metal electrode to release the therapeutic from the reservoir. Ek teaches a metal electrode configured to cover an opening of the reservoir and to receive an electrical signal that electrodissolves the metal electrode to release the therapeutic from the reservoir ("The electrode matrix element consists of or comprises a material dissolvable and/or degradable in the tissue, that is, in a body fluid", (14); "Upon insertion of the microelectrode of the invention into tissue, either as such or comprised by a bundle of electrodes or an array of electrodes or electrode bundles, and the dissolution or degradation of the electrode matrix element by body fluid and, in the case of an electrode bundle or an array of electrodes or electrode bundles, the (additional) dissolution of the bundle or array matrix or matrices by body fluid, an electrode of the invention is transformed into an microelectrode disposed in soft tissue", (15)).
Therefore, 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 lens of Harant such that a metal electrode would be configured to cover an opening of the reservoir and to receive an electrical signal that electrodissolves the metal electrode to release the therapeutic from the reservoir as taught by Ek, in order to increase the contact with surrounding cells and decrease the impedance of the electrode (col.11, ll.36-47).
Regarding Claim 9, Harant teaches the hydrogel-based material is permeable to the chloride ions ("When placed on the eye, the contact lens 100 permeability allows the lens 100 to hydrate the eye with cavity liquid 112", col.20, ll.6-9; "The solutes may have a molecular weight such that diffusion of the solutes through the boundary of the cavity and permeation through the lens body may be controlled", col.46, ll.34-37).
Regarding Claim 10, Harant teaches the ophthalmic device further comprises a boost layer ("FIG. 37A shows an insert made of sodium chloride", col.18, ll.31-32) proximal to the metal electrode 150 to supply the chloride ions to enhance the electrodissolution ("The insert dissolves in the hydration medium, typically physiological saline leaving a cavity filled with saline", col.19, ll.19-22).
Regarding Claim 11, Harant teaches dissolving the boost layer ("insert made of sodium chloride", col.18, ll.31-32) with water from the eye of the subject diffused through the hydrogel-based material ("The external solution may be an aqueous solution 204 containing the therapeutic agent 330 such that as the internal cavity 110 comes to equilibrium with the external storage solution, the therapeutic agent 330 diffuses across the lens body 120 into the cavity 110. The storage solution may be of such a concentration, temperature, composition, or any comparable parameter or combination of parameters that the rate of diffusion can be controlled to load the cavity 110 with the desired amount of therapeutic agent 330", col.40, ll.39-48).
Regarding Claim 12, Harant teaches creating a local chloride environment between at least a portion of the metal electrode 150 and the hydrogel-based material ("hydrogel of the contact lens body", col.23, ll.63) (col.37, ll.56 through col.38, ll.27), wherein the local chloride environment enhances the electrodissolution of the metal electrode 150 (col.37, ll.56 through col.38, ll.27).
Regarding Claim 13, Harant teaches creating the local chloride environment further comprises creating a concentration of chloride greater than or equal to a concentration of chloride in saline from the eye of the subject (col.40, ll.23-50; col.41, ll.18-46; col.53, ll.27-44).
Regarding Claim 14, Harant teaches the boost layer ("insert made of sodium chloride", col.18, ll.31-32) increases the speed of the electrodissolution (col.37, ll.56 through col.38, ll.27) by:
dissolving in the presence of water ("The soft contact lens material comprises a sufficient amount of cross-linking to provide structure to the lens and shape the cavity, and allows water and solutes to diffuse in and out of the cavity in order to establish equilibrium of the cavity with the external environment of the lens body", col.3, ll.11-16).
Harant fails to teach that when dissolved, increasing an amount of charge transferred from the applied current to the metal electrode at a time. Ek teaches when dissolved, increasing an amount of charge transferred from the applied current to the metal electrode at a time (col.5, ll.30-54; col.34, ll.39-58).
Therefore, 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 lens of Harant such that when dissolved, increasing an amount of charge transferred from the applied current to the metal electrode at a time as taught by Ek, in order to increase the contact with surrounding cells and decrease the impedance of the electrode (col.11, ll.36-47).
Regarding Claim 15, Harant teaches applying an electrical signal to the metal electrode to begin dissolution ("The erodible insert material may comprise first polymer chains configured to dissolve and travel through the body of the contact lens and second polymer chains configured to erode from the material and remain within the cavity", col.24, ll.55-59); and
dissolving the metal electrode 150 by dissolution (col.37, ll.56 through col.38, ll.27); and
releasing the therapeutic from the reservoir to diffuse across the hydrogel body into the eye ("The erodible insert material may comprise first polymer chains configured to dissolve and travel through the body of the contact lens and second polymer chains configured to erode from the material and remain within the cavity", col.24, ll.55-59).
Harant fails to teach applying an electrical signal to the metal electrode to begin electrodissolution; dissolving the metal electrode by electrodissolution. Ek teaches applying an electrical signal to the metal electrode to begin electrodissolution; dissolving the metal electrode by electrodissolution ("The electrode matrix element consists of or comprises a material dissolvable and/or degradable in the tissue, that is, in a body fluid", (col.4, ll.20-22); "Upon insertion of the microelectrode of the invention into tissue, either as such or comprised by a bundle of electrodes or an array of electrodes or electrode bundles, and the dissolution or degradation of the electrode matrix element by body fluid and, in the case of an electrode bundle or an array of electrodes or electrode bundles, the (additional) dissolution of the bundle or array matrix or matrices by body fluid, an electrode of the invention is transformed into an microelectrode disposed in soft tissue", col.4, ll.48-57).
Therefore, 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 lens of Harant to apply an electrical signal to the metal electrode to begin electrodissolution; to dissolve the metal electrode by electrodissolution as taught by Ek, in order to increase the contact with surrounding cells and decrease the impedance of the electrode (col.11, ll.36-47).
Regarding Claim 16, Harant teaches depositing a boost layer ("insert made of sodium chloride", col.18, ll.31-32) proximal the metal electrode 150 by at least pattern transfer ("the salt wafers were formed with a tool with a patterned surface which left imprinted patterns 360 on the inner walls of the lens cavity 110 as shown in FIG. 37B", col.54, ll.28-31).
Regarding Claim 17, Harant teaches dissolving the boost layer ("insert made of sodium chloride", col.18, ll.31-32) further comprises:
increasing an amount of chloride ions proximal the metal electrode 150 ("the pressure sensing zone 230 comprising a pressure sensor coupled to the electrodes with a circuit to increase optical power of the liquid crystal material in response to eyelid pressure sensed with the pressure sensor", col.22, ll.44-49). Harant fails to teach the amount of chloride ions is proportional to the amount of current generated at a time. Ek teaches the amount of chloride ions is proportional to the amount of current generated at a time (col.5, ll.30-54; col.34, ll.39-58).
Therefore, 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 lens of Harant such that the amount of chloride ions is proportional to the amount of current generated at a time as taught by Ek, in order to increase the contact with surrounding cells and decrease the impedance of the electrode (col.11, ll.36-47).
Regarding Claim 18, Harant fails to teach the applying electrical signal further comprises starting the electrodissolution once a charge transfer limit is reached. Ek teaches the applying electrical signal further comprises starting the electrodissolution once a charge transfer limit is reached (col.41, ll.44-64).
Therefore, 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 lens of Harant such that the applying electrical signal further comprises starting the electrodissolution once a charge transfer limit is reached as taught by Ek, in order to increase the contact with surrounding cells and decrease the impedance of the electrode (col.11, ll.36-47).
Regarding Claim 19, Harant teaches treating an eye disease with the therapeutic (col.12, ll.44-65).
Regarding Claim 20, Harant teaches the eye disease is glaucoma (col.12, ll.44-65).
Conclusion
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/RACHEL O'CONNELL/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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