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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the phrases "an optional bottom lens component” and “optionally one or more buffering agent” renders the claim indefinite because it is unclear whether “a bottom lens component” and “one or more buffering agent” are positively required in claim 1.
Claims 2-20 are rejected by virtue of depending on claim 1.
Regarding claim 20, the phrases “the method of claim 1” renders the claim indefinite because claim 1 recites a device, not a method.
Claim 20 recites the limitation "the ophthalmological disorder, disease, or clinical condition" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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) 1-2, 5-6, 8-12, 14-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Manzo (US 2016/0213514).
Regarding claim 1, Manzo discloses
An ionophoretic ocular delivery device (100, figs. 1A-4 and pars. 0023-0044) comprising:
a first electrode (106a, fig. 1A and par. 0025);
a second electrode (106b, fig. 1A and par. 0025);
a top lens component (102, fig. 1A and par. 0025);
an optional bottom lens component (Examiner notes: claim 1 uses the language “optional”, which makes the limitation “bottom lens component” not positively recited in claim 1. Since the limitation “bottom lens component” is not positively recited in claim 1, Examiner does not interpret that limitation);
one or more therapeutic agent (101, fig. 1A and par. 0025);
optionally one or more buffering agent (Examiner notes: claim 1 uses the language “optionally”, which makes the limitation “one or more buffering agent” not positively recited in claim 1. Since the limitation “one or more buffering agent” is not positively recited in claim 1, Examiner does not interpret that limitation); and
a power source (power source disclosed in par. 0015).
Regarding claim 2, Manzo discloses
The ionophoretic ocular delivery device of claim 1, wherein the first electrode (106a) is configured as an anode; and wherein the second electrode (106b) is configured as a cathode (see pars. 0025 and 0029 for 106a and 106b applying a current to the aqueous solution in the buffer and/or reservoir layer causing an electrolysis reaction resulting in production of charged ions used to electro-repel charged therapeutic compound 101 across the surface of the eye. Therefore, 106a and 106b are configured as an anode and a cathode to apply a current across the surface of the eye).
Regarding claim 5, Manzo discloses
The ionophoretic ocular delivery device of claim 1, wherein the power source is an external power source (see par. 0015 for “external power supply”).
Regarding claim 6, Manzo discloses
The ionophoretic ocular delivery device of claim 1, wherein the power source is an integral power source (see par. 0015 for “stored energy component – a battery”).
Regarding claim 8, Manzo discloses
The ionophoretic ocular delivery device of claim 1, wherein the power source is capable of providing a voltage of about 0.01 V to about 10 V; and wherein the power source is capable of providing a current of about 0.01 mAmp to about 50 mAmp (Examiner notes: the limitation “capable of providing a voltage of … and capable of providing a current of …” is interpreted as functional limitation. Manzo discloses “a voltage source supplying a voltage to an active sacrificial electrode” (par. 0010), “the controller and power management circuit are similarly designed to deliver a constant current, requiring a certain voltage to deliver that current” (par. 0041), “the sensors and/or controller monitor that voltage” (par. 0041). Therefore, the controller and power management circuit are capable of providing a voltage of about 0.01 V to about 10 V and a current of about 0.01 mAmp to about 50 mAmp).
Regarding claim 9, Manzo discloses
The ionophoretic ocular delivery device of claim 1, wherein the top lens component (102) comprises a polymer or a hydrogel (see par. 0025 for 100 comprised of 102 and 100 formed from know biocompatible materials such as polymeric materials, polyethylene terephthalate (“PET”), polymethyl methacrylate (“PMMA”), polyhydroxyethylmethacrylate (“polyHEMA”), a hydrogel, silicon based polymers (e.g., fluoro-silicon acrylate), and/or combinations of these).
Regarding claim 10, Manzo discloses
The ionophoretic ocular delivery device of claim 9, wherein the polymer comprises a polymethyl methacrylate (see par. 0025).
Regarding claim 11, Manzo discloses
The ionophoretic ocular delivery device of claim 1, wherein the therapeutic agent (101) is uniformly distributed within the top lens component (see par. 0029 for 101 being uniformly distributed across the surface of the eye by 106a/106 and 108a/108b, and see par. 0033 for 101 being delivered to the entire ocular surface).
Regarding claim 12, Manzo discloses
The ionophoretic ocular delivery device of claim 1, wherein the therapeutic agent is an opthamological drug (see par. 0008 for ocular iontophoretic delivery of therapeutic compounds).
Regarding claim 14, Manzo discloses
The ionophoretic ocular delivery device of claim 1, wherein the one or more buffering agent is a Good’s buffer (Examiner notes: claim 1 uses the language “optionally”, which makes the limitation “one or more buffering agent” not positively recited in claim 1. Since the limitation “one or more buffering agent” is not positively recited in claim 1, Examiner does not interpret that limitation. Since claim 14 further recites “the one or more buffering agent” which is not positively recited in claim 14, Examiner does not interpret claim 14).
Regarding claim 15, Manzo discloses
The ionophoretic ocular delivery device of claim 14, wherein the Good’s buffer is selected from the group consisting of BES, Bicine, HEPES, HEPPSO, POPSO, and Tricine (Examiner notes: claim 1 uses the language “optionally”, which makes the limitation “one or more buffering agent” not positively recited in claim 1. Since the limitation “one or more buffering agent” is not positively recited in claim 1, Examiner does not interpret that limitation. Since claim 15 further recites “the one or more buffering agent” which is not positively recited in claim 15, Examiner does not interpret claim 15).
Regarding claim 16, Manzo discloses
The ionophoretic ocular delivery device of claim 1, wherein the first electrode comprises gold, a gold alloy, silver, a silver alloy, platinum, a platinum alloy, a conductive polymer, or mixtures thereof; and wherein the second electrode comprises gold, a gold alloy, silver, a silver alloy, platinum, a platinum alloy, a conductive polymer, or mixtures thereof (see par. 0040 for electrode comprising silver).
Regarding claim 17, Manzo discloses
The ionophoretic ocular delivery device of claim 16, wherein the first electrode and the second electrode comprise substantially identical materials (see fig. 1a and par. 0025 for 106a and 106b being electrodes of the first conductive layer; see par. 0029 for electrodes 106a and 106b used to apply a current to the aqueous solution causing an electrolysis reaction. Since 106a and 106b together forming the first conductive layer and together performing the same function, 106a and 106b comprise substantially identical materials).
Regarding claim 18, Manzo discloses
A method of treating an ophthalmological disorder, disease, or clinical condition comprising administering one or more therapeutic agent using the ionophoretic ocular delivery device of claim 1, thereby treating the ophthalmological disorder, disease, or clinical condition (see par. 0008, see also pars. 0009-0017).
Claim(s) 1, 4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Higuchi et al. (EP 1 807 149. Examiner notes: see attached NPL for the Google translate of this patent)
Regarding claim 1, Higuchi discloses
An ionophoretic ocular delivery device (pars. 0041 and 0067) comprising:
a first electrode (first electrode assembly in par. 0067);
a second electrode (second electrode assembly in par. 0067);
a top lens component (component of 20, fig. 2 and pars. 0018, 0067, 0074. See also pars. 0041 and 0067 for the device being used in the eye);
an optional bottom lens component (Examiner notes: claim 1 uses the language “optional”, which makes the limitation “bottom lens component” not positively recited in claim 1. Since the limitation “bottom lens component” is not positively recited in claim 1, Examiner does not interpret that limitation);
one or more therapeutic agent (agent in par. 0041);
optionally one or more buffering agent (Examiner notes: claim 1 uses the language “optionally”, which makes the limitation “one or more buffering agent” not positively recited in claim 1. Since the limitation “one or more buffering agent” is not positively recited in claim 1, Examiner does not interpret that limitation); and
a power source (electrical current source in par. 0074).
Regarding claim 4, Higuchi discloses
The ionophoretic ocular delivery device of claim 1, wherein the first electrode is configured as an outer concentric electrode; and wherein the second electrode is configured as an inner concentric electrode (see fig. 2 and par. 0074 for device 20 having multiple electrode assemblies 22 and 24 arranged in a concentric “bullseye” pattern, with 22 shown as an outer concentric electrode and 24 shown as an inner concentric electrode).
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.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Manzo (US 2016/0213514) in view of Olson (US 2019/0381274).
Regarding claim 3, Manzo discloses the ionophoretic ocular delivery device of claim 1, as set forth above, except for wherein the first electrode is configured as one or more first spot electrode.
However, Olson teaches a medical device comprising one or more spot electrodes (figs. 7-8).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Manzo to be spot electrodes, as taught by Olson. Doing so would be a simple substitution of one know element (Manzo electrode) for another (spot electrode) to obtain predictable results (applying current to the aqueous solution).
Claim(s) 7, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Manzo (US 2016/0213514) in view of Otts et al. (US 2018/0101027).
Regarding claim 7, Manzo discloses the ionophoretic ocular delivery device of claim 5, as set forth above, except for wherein the integral power source is a water-activated battery.
However, Otts teaches the power source being a water-activated battery (par. 0089).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Manzo’s power source to be a water-activated battery, as taught by Otts, for the purpose of allowing the device to continue operating with exposure to human tears (par. 0089).
Regarding claim 19, Manzo discloses the method of claim 18, as set forth above, except for wherein using the ionophoretic ocular delivery device comprises applying an electric field to the ionophoretic ocular delivery device for a period of from about 0.5 hours to about 2 hours.
However, Otts teaches the power source delivering 1 microamp of current for 1 hour (par. 0074).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Manzo’s power source to deliver 1 microamp of current for 1 hour, as taught by Otts, for the purpose of delivering a suitable operating voltage to an incorporated electrical circuit while being placed in the eye.
Claim(s) 13, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Manzo (US 2016/0213514) in view of Cochran et al. (US 2003/0215448).
Regarding claim 13, Manzo discloses the ionophoretic ocular delivery device of claim 12, as set forth above, except for wherein opthamological drug is a glaucoma therapeutic agent, an ocular hypertension therapeutic agent, or a combination thereof.
However, Cochran teaches compositions treating glaucoma (par. 0193) using ionophoretic administration (par. 0169).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Manzo’s therapeutic agent to be glaucoma therapeutic agent, as taught by Cochran, for the purpose of treating glaucoma (par. 0193 of Cochran).
Regarding claim 20, Manzo discloses the method of claim 1, as set forth above, except for wherein the ophthalmological disorder, disease, or clinical condition is selected from glaucoma, ocular hypertension, inflammation, keratitis, dry eye, uveitis, ophthalmological bacterial infection, ophthalmological fungal infection, macular edema, macular degeneration, herpetic conjunctivitis, blepharitis, retinal neovascularization, choroidal neovascularization, diabetic retinopathy, and combinations thereof.
However, Cochran teaches compositions treating glaucoma (par. 0193) using ionophoretic administration (par. 0169).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Manzo’s therapeutic agent to be glaucoma therapeutic agent, as taught by Cochran, for the purpose of treating glaucoma (par. 0193 of Cochran).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO 892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DUNG T ULSH whose telephone number is (571)272-9894. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DUNG T ULSH/Primary Examiner, Art Unit 3783
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