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 .
DETAILED ACTION
Applicant’s amendment filed on 06/26/2025, wherein claims 1, 3-4, 43 have been amended.
Claims 1-8, 10, 12-14, 19-22, 27-33, 38, 40-43 are pending and examined herein.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
1) Claims 1-8, 10, 12-14, 19-22, 27-33, 38, 40-43 are rejected under 35 U.S.C. 103 as being unpatentable over Feinbaum et al. (9,867,810, PTO-892 of record), in view of Kaufman (US 8,299,079, PTO-1449), and further in view of Meyer (US 9,089,560, PTO-1449).
Feinbaum et al. teaches treating presbyopia comprising administering topically to the eye of human patient an ophthalmic composition comprising pilocarpine or a pharmaceutically acceptable salt thereof such as pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.01 % w/w to 0.4 % w/w. See abstract; column 2, Embodiments 1, 2; Embodiment 18, column 6; column 17, Embodiment 84; claims 12, 13. It is taught that the composition is effective for correction of presbyopia for up to 24 hours. See column 7, Embodiments 21-25; column 11, Embodiment 41. It is taught that the composition therein reduces the size of the pupil. See column 14, Embodiment 58. It is taught that other drugs such as phentolamine can be used. See column 26, lines 1-2.
Feinbaum et al. does not teach administration of phentolamine mesylate in combination with pilocarpine or pharmaceutically acceptable salt thereof such as pilocarpine hydrochloride.
Kaufman teaches a method for ameliorating or reducing presbyopia of a patient
comprising administering to the eye of the patient a therapeutically effective amount of an ophthalmic preparation comprising one or more parasympathomimetic drugs or one or more cholinesterase inhibitors, or their pharmaceutically acceptable salts, and one or more alpha agonists or antagonists, or their pharmaceutically acceptable salts. See abstract; column 3, lines 36-43. One or more parasympathomimetic drugs is pilocarpine or carbachol or their pharmaceutically acceptable salt thereof. See column 2, lines 39-41; one or more alpha agonist is brimonidine or salt thereof; salt can be hydrochloride salt. See column 2, lines 41-43; column 6, lines 28-40. It is taught that the alpha antagonist is phentolamine or its pharmaceutically acceptable salt which is present in an amount of no more than 2%. See column 2, lines 56-60; column 3, lines 11-17. It is taught that salt can be methane sulfonate i.e teaches mesylate salt. See column 6, lines 50-53. Kaufman teaches a method of treating presbyopia in a patient comprising administering to said eye a therapeutically effective amount of an ophthalmic topical preparation comprising a therapeutically effective amount of pilocarpine, or a pharmaceutically acceptable salt thereof, in an amount of 0.25-1.0% and brimonidine, or a pharmaceutically acceptable salt thereof in an amount of 0.05-0.2%. See column 21-column 22, claims 1, 2, 5, 6.
Meyer teaches a method of improving visual performance in a patient comprising administering an ophthalmic solution comprising phentolamine mesylate. See abstract; claims 1-4, 11; column 1, line 65-column 2, line 15. It is taught that the ophthalmic solution comprises phentolamine mesylate 1% w/v. See column 22 TABLE 3. It is taught that visual performance pertains to the patient’s overall vision quality and includes a patient’s ability to see clearly; it is taught that visual performance can be visual acuity which is a measure of a patient’s ability to see clearly. See column 6, lines 7-40. It is taught that improvement visual performance provided by the method therein is improved visual acuity under photopic conditions, see claim 7; improvement in visual acuity is a two-line improvement in the patient’s vision as measured by the Snellen chart. See column 6, lines 7-40. Meyer also teaches a method of reducing pupil diameter employing the ophthalmic composition therein; see claim 13. It is taught that the method therein results in an increase in eye redness of no more than one grade when measured by the CCLRU Redness Grading Scale compared to the patient’s level of eye redness without receiving said dosage See claim 17. It taught that the daily administration is one eye drop per eye of an ophthalmic solution comprising from 0.5 % (w/v) to 1.0 % (w/v) phentolamine mesylate. See column 7, line 66-column 8, line 3. Meyer teaches in an overlapping patient population that phentolamine is long acting (sufficient to reduce pupil diameter for at least twenty hours) at concentrations of 0.5-1% (i.e 0.25 to 0.5 mg within the claimed range of 0.2 mg to 0.7 mg). See column 9, lines 39-41.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer topically to an eye of human patient an ophthalmic solution composition comprising pilocarpine in an amount of 0.2 % w/w (0.1 mg), 0.4 % (0.2 mg) w/w or pilocarpine hydrochloride in combination with phentolamine mesylate once per day to treat presbyopia because 1) Kaufman teaches a method for ameliorating or reducing presbyopia of a patient having an eye, comprising administering to the eye a therapeutically effective amount of an ophthalmic preparation comprising one or more parasympathomimetic drugs such as pilocarpine or carbachol or their pharmaceutically acceptable salt thereof or one or more cholinesterase inhibitors, or their pharmaceutically acceptable salts, and one or more alpha agonists or antagonists, or their pharmaceutically acceptable salts, see abstract; column 3, lines 36-43; 2) Kaufman teaches that the alpha antagonist is phentolamine or its pharmaceutically acceptable salt such as mesylate salt, and 3) Meyer teaches a method of improving visual performance in a patient comprising administering an ophthalmic solution comprising 1% w/v of phentolamine mesylate (see abstract; claims 1-4, 11; column 1, line 65-column 2, line 15); it is taught that visual performance can be visual acuity which is a measure of a patient’s ability to see clearly; Meyer teaches that the daily administration is one eye drop per eye of an ophthalmic solution comprising from 0.5 % (w/v) to 1.0 % (w/v) phentolamine mesylate. One of ordinary skill in the art at the time of invention would have been motivated to administer topically to an eye of a patient suffering from presbyopia pilocarpine or pilocarpine hydrochloride in combination with phentolamine mesylate in the form of eye drop once per day to an eye of human patient with presbyopia with reasonable expectation of success of treating presbyopia. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to administer to an eye of a patient suffering from presbyopia pilocarpine in combination with one eye drop of a composition comprising 1% (w/w) phentolamine mesylate solution with reasonable expectation of success of improving visual performance and patient’s ability to see clearly; since Meyer teaches a method of improving visual performance in a patient comprising administering an ophthalmic solution comprising 1% w/v of phentolamine mesylate improves visual performance and includes a patient’s ability to see clearly; Kaufman teaches treating presbyopia employing alpha antagonist phentolamine or its pharmaceutically acceptable salt such as mesylate salt; and Feinbaum et al., Kaufman teaches treating presbyopia comprising administering topically to the eye of human patient an ophthalmic composition comprising pilocarpine or a pharmaceutically acceptable salt thereof such as pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.01 % w/w to 0.4 % w/w.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to determine or optimize parameters such as effective amount of the phentolamine mesylate as in instant claims 1, 33, 40-42 and effective amount of the pilocarpine as in instant claims 3-4, 39, 43 to treat presbyopia.
One having ordinary skill in the art before the effective filing date of the claimed invention was made would have been motivated to determine the effective amount of the phentolamine mesylate as in instant claims 1, 33, 40-42 and effective amount of the pilocarpine as in instant claims 3-4, 39, 43, since the optimization of effective amounts of known agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art.
It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980).
Further, the amount of a specific dosage to administer is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454,456, 105 USPQ 233, 235 (CCPA 1955). The reference teaches that the dosage and administration can be varied. Thus, the reference has recognized these parameters as variables, it would have been customary for an artisan of ordinary skill to determine the optimal dosage in order to best achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of dosage amount would have been obvious at the time of applicant's invention.
Regarding the recitations “wherein the method provides a therapeutic effect against presbyopia for a duration of at least 6 hours” as in instant claims 5, “wherein the method provides a therapeutic effect against presbyopia for a duration of at least 6 hours” as in instant claim 6; “wherein the method provides a therapeutic effect against presbyopia for a duration of at least 12 hours”, as in instant claim 7 “wherein the method provides a therapeutic effect against presbyopia for a duration of at least 12 hours” as in instant claim 8, it is pointed out that these are the properties/result of the compounds on administration, Feinbaum et al. in view of Kaufman, and further in view of Meyer renders obvious topical administration of pilocarpine or pilocarpine hydrochloride in combination with phentolamine mesylate in the amounts as in instant claims once per day to treat presbyopia, the property of such a claimed compounds will also be rendered obvious by the prior art teachings, since the properties, are inseparable from the compounds.
Regarding the recitations in claims 10, 12, “wherein the method results in an improvement in near-vision visual acuity characterized by at least a two-line improvement in the patient's vision measured using a vision chart”; “wherein the method results in an improvement in near-vision visual acuity characterized by at least a three-line improvement in the patient's vision measured using a vision chart”, it is pointed out that these are the properties/result of the compounds on administration, Feinbaum et al. in view of Kaufman, and further in view of Meyer renders obvious topical administration of pilocarpine or pilocarpine hydrochloride in combination with phentolamine mesylate in the amounts as in instant claims once per day to treat presbyopia, the property of such a claimed compounds will also be rendered obvious by the prior art teachings, since the properties, are inseparable from the compounds.
Regarding the recitations in claims 13-14, “wherein the patient experiences an increase in eye redness of no more than one grade measured using the CCLRU Redness Grading Scale compared to the patient's level of eye redness without receiving said dosage of phentolamine mesylate”….., it is pointed out that these are the properties/result of the compounds on administration, Feinbaum et al. in view of Kaufman, and further in view of Meyer renders obvious topical administration of pilocarpine or pilocarpine hydrochloride in combination with phentolamine mesylate in the amounts as in instant claims once per day to treat presbyopia, the property of such a claimed compounds will also be rendered obvious by the prior art teachings, since the properties, are inseparable from the compounds.
Regarding the recitations in claims 19-20, “wherein the patient experiences the effect of having a pupil diameter of less than 2.6 mm in the eye that received said dosage when measured under photopic conditions”, it is pointed out that these are the properties/result of the compounds on administration, Feinbaum et al. in view of Kaufman, and further in view of Meyer renders obvious topical administration of pilocarpine or pilocarpine hydrochloride in combination with phentolamine mesylate in the amounts as in instant claims once per day to treat presbyopia, the property of such a claimed compounds will also be rendered obvious by the prior art teachings, since the properties, are inseparable from the compounds.
Regarding the recitations in claims 21-22, “wherein as a result of the administering the patient experiences the effect of having a pupil diameter of less than 2.4 mm in the eye that received said dosage when measured under photopic conditions”, it is pointed out that these are the properties/result of the compounds on administration, Feinbaum et al. in view of Kaufman, and further in view of Meyer renders obvious topical administration of pilocarpine or pilocarpine hydrochloride in combination with phentolamine mesylate in the amounts as in instant claims once per day to treat presbyopia, the property of such a claimed compounds will also be rendered obvious by the prior art teachings, since the properties, are inseparable from the compounds.
One of ordinary skill in the art at the time of invention would have been motivated to the particular treatment regimen such as phentolamine mesylate is administered to the eye no more than once per day as in instant claims; “wherein the dosage of phentolamine mesylate is administered at or near the bedtime of the patient” as in instant claims 29-30; wherein pilocarpine is administered after the administration of phentolamine mesylate as in instant claims 31-32 because the optimization of result effect parameters e.g., dosage range, dosing regimens, dosing duration is obvious as being within the skill of the artisan, involving merely routine skill in the art.
Response to Arguments
Applicant's arguments and Affidavit filed by Alan Meyer on 07/11/2024 have been fully considered but they are not persuasive as discussed above, and those found below.
Applicant’s arguments that the amendment overcomes the contention that “unexpected results do not apply across the entire range….” have been considered, but not found persuasive. It is pointed out that instant claim 1 recites “about 0.125 mg to about 0.25 mg” of pilocarpine and 0.2 mg to 0.7 mg of phentolamine mesylate. The unexpected results are employing 0.5 mg of phentolamine mesylate and 0.13 mg (0.25 %) of pilocarpine hydrochloride. Further instant claims recite “about 0.25 mg” of pilocarpine (0.5 %) which can be greater than 0.5 % of pilocarpine; and for example 1% pilocarpine (~0.5 mg) caused over-reduction of pupil diameter that actually impaired visual performance, thus, the alleged unexpected results do not apply across the entire claimed range of “about 0.1 mg to about 0.25 mg” of pilocarpine, since there is no data provided for about 0.25 mg (0.5 % pilocarpine or greater; since about can be 0.6 % or 0.7 % etc.) in combination with 0.5 mg of phentolamine mesylate. Furthermore, Meyer teaches in an overlapping patient population that phentolamine is long acting (sufficient to reduce pupil diameter for at least twenty hours) at concentrations of 0.5-1% (i.e 0.25 to 0.5 mg within the claimed range of 0.2 mg to 0.7 mg). See column 9, lines 39-41. Thus, longer duration with the combination is not clearly unexpected, since phentolamine was known from Meyer to be long-acting (i.e reasonably expected that pupil reduction would be of longer duration when using the combination of phentolamine and pilocarpine vs. pilocarpine alone).
Applicant argues that “Declaration also provides results showing that topical administration of a 0.5 mg dose of phentolamine mesylate (1 drop of a 1% w/w phentolamine mesylate solution) in combination with one drop of a 0.25% pilocarpine hydrochloride solution reduced pupil diameter to within the range of from 1.8 mm to 2.1 mm, and did so for over 3 hours……… this unexpected result stands in contrast to the experiment using 0.25% pilocarpine hydrochloride solution alone, in which the minimum measured pupil diameter was 2.0 mm, and the pupil reduction effects of the 0.25% pilocarpine hydrochloride solution wore off such that pupil diameter had enlarged to 2.7 mm after 3 hours, which is 58% of the way back to the baseline pupil measurement of 3.2 mm (i.e., before administration of 0.25% pilocarpine hydrochloride solution). (Declaration, Paragraph 9.) A 0.5 mg dose of phentolamine mesylate on its own was unable to achieve pupil reduction in an amount sufficient to achieve a pupil diameter in the range of 1.8 mm to 2.1 mm under photopic conditions. (Declaration, Paragraph 14.) Topical administration of a 0.5 mg dose of phentolamine mesylate (1 drop of a 1% w/w phentolamine mesylate solution) in combination with sequential administration of pilocarpine hydrochloride solutions having a concentration of 0.05%, 0.1%,0.2%, or 0.3% pilocarpine hydrochloride did not result in over-reduction of the subject's pupil diameter. (Declaration, Paragraphs 21 and 22……”. Applicant’s arguments have been considered. It is pointed out that when pilocarpine alone 0.25 % Table 2 is used the pupil is 15.6% smaller at 3h compared to 0h. The trend for the combination (0.25 % pilocarpine + 1% phentolamine) (Table 5) shows the same trend – big pupil constriction at 1 hour that relaxes some by hour 3, 12.5% smaller at 3h compared to 0h in the phentolamine pre-treated eye of Table 5. That is the effect on administration of the combination (0.25 % pilocarpine + 1% phentolamine) (Table 5) appears to be a less than additive effect or w/in error the same. Further, results for 0.25% pilocarpine (corresponding to ~0.13 mg assuming a drop volume of 0.05 ml) are not commensurate in scope with claim 1, which recites “an amount ranging from about 0.1 mg to about 0.25 mg” and 0.2 mg to 0.7 mg of phentolamine mesylate. 1% pilocarpine (~0.5 mg) caused over-reduction of pupil diameter that actually impaired visual performance, thus, the alleged unexpected results do not apply across the entire claimed range of “about 0.1 mg to about 0.25 mg” of pilocarpine which can be greater than 0.5 % of pilocarpine (since about can be 0.6 % or 0.7 % etc.).
Further Applicant’s remarks that “long duration of time over which the measured pupil diameter was within the range of 1.8 mm to 2.1 mm was an unexpected result”, it is pointed out that applicant did not demonstrate why this effect is greater than the sum of each of the effects taken separately. Since the combination involved two different drugs, and two doses rather than one, the results are not clearly greater than those which would have been expected from the prior art to an unobvious extent (MPEP 716.02(a)(I)). Thus, there is no evidence that pilocarpine “wore off” more quickly when administered alone.
Furthermore, Meyer teaches in an overlapping patient population that phentolamine is long acting (sufficient to reduce pupil diameter for at least twenty hours) at concentrations of 0.5-1% (i.e 0.25 to 0.5 mg within the claimed range of 0.2 mg to 0.7 mg). See column 9, lines 39-41. Thus, longer duration with the combination is not clearly unexpected, since phentolamine was known from Meyer to be long-acting (i.e reasonably expected that pupil reduction would be of longer duration when using the combination of phentolamine and pilocarpine vs. pilocarpine alone).
Applicant’s remarks that “There being no experimental results in the Cited References showing what would happen when phentolamine mesylate is topically administered to the eye of a human patient in combination with pilocarpine or a pharmaceutically acceptable salt thereof topically administered to said eye of the human patient, let alone any experimental results showing what would happen when Applicant's claimed dose of phentolamine mesylate is topically administered to the eye of a human patient in combination with pilocarpine or a pharmaceutically acceptable salt thereof that is topically administered to the eye of the patient in an amount ranging from (a) about 0.1 mg to about 0.125 mg or (b) about 0.125 mg to about 0.25 mg, and no guidance in the Cited References for how to manage the adverse side effects of phentolamine mesylate and pilocarpine, and further no information on how to achieve a sustained duration of pupil diameter in the optimal range for treating presbyopia without causing over-reduction of pupil diameter resulting in impaired visual performance as demonstrated by Applicant's experimental results….”. Applicant’s arguments have been considered. It is pointed out that it has been well-established that consideration of a reference is not limited to the preferred embodiments or working examples, but extends to the entire disclosure for what it fairly teaches, when viewed in light of the admitted knowledge in the art, to person of ordinary skill in the art. See M.P.E.P. § 2123. As discussed above, Feinbaum et al. in view of Kaufman, and further in view of Meyer renders obvious topical administration of pilocarpine or pilocarpine hydrochloride in combination with phentolamine mesylate in the amounts as in instant claims once per day to treat presbyopia. Regarding side effects, it is pointed out that side effects of any drug are evaluated first before employing the drug. Meyer teaches that the daily administration is one eye drop per eye of an ophthalmic solution comprising from 0.5 % (w/v) to 1.0 % (w/v) phentolamine mesylate. Meyer teaches in an overlapping patient population that phentolamine is long acting (sufficient to reduce pupil diameter for at least twenty hours) at concentrations of 0.5-1% (i.e 0.25 to 0.5 mg within the claimed range of 0.2 mg to 0.7 mg). See column 9, lines 39-41. Feinbaum et al. teaches treating presbyopia comprising administering topically to the eye of human patient an ophthalmic composition comprising pilocarpine or a pharmaceutically acceptable salt thereof such as pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.01 % w/w to 0.4 % w/w. Thus, Meyer and Feinbaum teach administration of the same compounds in particular amounts to the eye of a human patient.
Further, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to determine or optimize parameters such as effective amount of the phentolamine mesylate as in instant claims 1, 33, 40-42 and effective amount of the pilocarpine as in instant claims 3-4, 39, 43 to treat presbyopia.
Furthermore, Applicant’s remarks regarding pupil diameter, it is pointed out that these are the properties/result of the compounds on administration, Feinbaum et al. in view of Kaufman, and further in view of Meyer renders obvious topical administration of pilocarpine or pilocarpine hydrochloride in combination with phentolamine mesylate in the amounts as in instant claims once per day to treat presbyopia, the property of such a claimed compounds will also be rendered obvious by the prior art teachings, since the properties, are inseparable from the compounds.
Applicant argues that “the combined teachings in Kaufman, Meyer, and Feinbaum, to the extent a person of ordinary would have been motivated to make a combination therapy using pilocarpine, the person of ordinary skill in the art (without exercising inventive activity) would have used pilocarpine in combination with brimonidine in order to potentiate the activity of pilocarpine as taught in Kaufman. Any addition of phentolamine following the combined teachings of Kaufman, Meyer, and Feinbaum would be in the form of a three-component therapy: pilocarpine, brimonidine, and phentolamine mesylate. This is the result of following the combined teachings of the Cited References”. Applicant’s arguments have been considered, but not found persuasive because Applicant is arguing against an individual reference when the rejection is based on combination of references. Feinbaum et al. teaches treating presbyopia comprising administering topically to the eye of human patient an ophthalmic composition comprising pilocarpine or a pharmaceutically acceptable salt thereof such as pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.01 % w/w to 0.4 % w/w. Meyer teaches a method of improving visual performance in a patient comprising administering an ophthalmic solution comprising 1% w/v of phentolamine mesylate (see abstract; claims 1-4, 11; column 1, line 65-column 2, line 15); it is taught that visual performance can be visual acuity which is a measure of a patient’s ability to see clearly; Meyer teaches that the daily administration is one eye drop per eye of an ophthalmic solution comprising from 0.5 % (w/v) to 1.0 % (w/v) phentolamine mesylate. Kaufman teaches a method for ameliorating or reducing presbyopia of a patient having an eye, comprising administering to the eye a therapeutically effective amount of an ophthalmic preparation comprising one or more parasympathomimetic drugs such as pilocarpine or carbachol or their pharmaceutically acceptable salt thereof or one or more cholinesterase inhibitors, or their pharmaceutically acceptable salts, and one or more alpha agonists or antagonists, or their pharmaceutically acceptable salts, see abstract; column 3, lines 36-43; Kaufman teaches that the alpha antagonist is phentolamine or its pharmaceutically acceptable salt such as mesylate salt. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to administer to an eye of a patient suffering from presbyopia pilocarpine in combination with one eye drop of a composition comprising 1% (w/w) phentolamine mesylate solution with reasonable expectation of success of improving visual performance and patient’s ability to see clearly; since Meyer teaches a method of improving visual performance in a patient comprising administering an ophthalmic solution comprising 1% w/v of phentolamine mesylate improves visual performance and includes a patient’s ability to see clearly; Kaufman teaches treating presbyopia employing alpha antagonist phentolamine or its pharmaceutically acceptable salt such as mesylate salt; and Feinbaum et al., Kaufman teaches treating presbyopia comprising administering topically to the eye of human patient an ophthalmic composition comprising pilocarpine or a pharmaceutically acceptable salt thereof such as pilocarpine hydrochloride or pilocarpine nitrate at a concentration of 0.01 % w/w to 0.4 % w/w.
Prior Art made of Record:
US 10,610,518…. pilocarpine…for presbyopia;
US 10639297…pilocarpine…for presbyopia;
US 20140221445: AQUEOUS OPHTHALMIC SOLUTIONS OF PHENTOLAMINE AND MEDICAL USES THEREOF;
US 9,089,560 or WO2014/121028; PHENTOLAMINE AND MEDICAL USES THEREOF for visual performance;
WO2020033714A1.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 SHOBHA KANTAMNENI, Ph.D whose telephone number is (571)272-2930. The examiner can normally be reached on Monday to Friday; 8.00 am-4.30 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel, Ph.D can be reached on 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHOBHA KANTAMNENI/Primary Examiner, Art Unit 1627