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
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.
Previously presented rejection of claim(s) 1, 3-17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Horn WO2011075617 (herein after D1) further in view of US4470965, US9937230 and US11052094 is maintained for reasons of record.
Applicant points out that D1 clearly teaches away as per the at page 2 of D1.
Applicant also points to the instant Example 4 that allegedly demonstrates the beneficial aspects of the instant apraclonidine compositions (plural).
Applicant’s arguments are not persuasive for the following reasons:
The pointed out section of D1 is generic with respect to the active ingredient(s) and silent with respect to other excipients in the formulation.
The instant apraclonidine is one of many such agents relating to this ‘teaching away’.
Note that because of the structural differences and salt forms, the indicated agents are anticipated to have different molecular weights. What the instant claim recites is W/V weight by volume range (not molar concentration in an opened comprising language).
The exemplified composition contains many inactive ingredients (see Example 1 at page 16). It is one of commonsense to expect the ‘statistically higher levels of apraclonidine in the conjunctiva relative to brimonidine for all tested formulations’ to depend on other components, their amounts, pH (buffer) etc. These excipients, for example, are anticipated to be relevant for the tonicity, toxicity and other critical factors for safety profile of the formulation. Optimization, as per In re Aller cited earlier is routine in the art. For an example see US8445526 column 5 line 40 onwards.
In addition the “0.06% (w/v) to no more than 0.2% (w/v)” is ‘close’ to that found in D1. While D1 range is not ‘inside the range’, the about 0.05% weight by volume of D1 is ‘close’ to instant 06%. See MPEP 2144.05 Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions [R-01.2024 OVERLAPPING, APPROACHING, AND SIMILAR RANGES, AMOUNTS, AND PROPORTIONS
a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.--
Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art.
Accordingly, the claims do not recite an unobvious distinction over the prior art. Further, a reference is relevant not only for what it expressly teaches, but also for what it would have conveyed to one of ordinary skill in the art. See In re Opprecht, 12 USPQ2d 1235, 1236 (Fed. Cir. 1989); In re Bode, 193 USPQ 12 (CCPA 1976). In light of the foregoing discussion, the Examiner finds that the claimed subject matter as a whole would have been obvious to one of ordinary skill in the art at the time the invention was made, in view of the cited references and the knowledge generally available in the art. Accordingly, the claims are rejected under 35 U.S.C. § 103.
Suggestion:
Amend base consistent with the tested formulation that does provide for superior results including all the active and inactive ingredients.
From previous action:
D1 discloses in claim 1 a composition comprising a selective a-2 adrenergic receptor agonist for use in increasing whiteness of an eye. According to claim 3, said selective a-2 adrenergic receptor agonist is selected from a group comprising inter alia apraclonidine. According to claim 4 of D1, said a-2 adrenergic receptor agonist is present at a concentration from between about 0.001 % to about 0.05% weight by volume.
However, D1 does neither disclose compositions comprising apraclonidine, nor in amounts of greater than 0.05% (w/v) to no more than 0.2% (w/v) or comprising a polymer. The difference is the presence of a polymer and the concentration of apraclonidine of 0.05-0.2% (w/v).
Document D1 provides compositions and methods for achieving cosmetic eye whitening which utilize low concentrations of selective a-2 adrenergic receptor agonists. Document D1 discloses in preferred embodiments compositions with concentrations of the selective a-2 adrenergic receptor agonists from about 0.0001 % to about 0.05%; more preferably, from about 0.001 % to about 0.025%; even more preferably, from about 0.01 % to about 0.025%; and even more preferably, from about 0.01 % to about 0.02% weight by volume of the composition, wherein the selective a-2 adrenergic receptor agonist is selected from the group consisting inter alia of apraclonidine, mivazerol, clonidine or brimonidine (see D1, page 3, first three paragraphs). Further D1 prefers brimonidine over apraclonidine and does not report experimental data for apraclonidine. As taught in Fig 12 of D1, brimonidine with similar biochemical properties is useful for reducing redness in the eye.
The limitations of dependent claims are drawn to polymers, viscosity, buffer, citric acid or citrate, tonicity, osmolarity, chloride, benzalkonium and at different values/concentrations. Compositions to ophthalmic formulations with these parameters are well-known in the art.
The following are a sample of many relevant prior art.
US4470965 section under claims teaches
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374
520
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252
812
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138
826
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Similarly,
US9937230 section under claims:
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188
824
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138
816
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Similarly,
US11052094 section under claims:
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360
820
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132
814
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The active agent apraclonidine in D1 (and in US11052094, topical) and other inactive ingredients such as polymer at various concentrations are known in the art for making ophthalmic compositions.
The issue therefore is the different concentrations of the active and inactive agents.
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. The differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[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).
Again, the invention is a selective combination of the inventions by the prior arts done in a manner obvious to one of ordinary skill in the art. Patent for the combination of known elements wherein their functions remain the same withdraws “what is already known into field of its monopoly and diminishes resources available to skilled men”. Sakraida v. Ag Pro, Inc.189 USPQ 449, 425 US 273, (1976).
Accordingly, the claims do not recite an unobvious distinction over the prior art. Further, a reference is relevant not only for what it expressly teaches, but also for what it would have conveyed to one of ordinary skill in the art. See In re Opprecht, 12 USPQ2d 1235, 1236 (Fed. Cir. 1989); In re Bode, 193 USPQ 12 (CCPA 1976). In light of the foregoing discussion, the Examiner finds that the claimed subject matter as a whole would have been obvious to one of ordinary skill in the art at the time the invention was made, in view of the cited references and the knowledge generally available in the art. Accordingly, the claims are rejected under 35 U.S.C. § 103.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US Patent Nos. 9259425 11833245 11596600 8445526
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 NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625
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