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 .
Receipt of Applicant’s Response and Amended Claims filed on 01/05/26 is acknowledged. Claims 1-12 are pending. Claims 1-12 are rejected. Applicants IDS filed on 09/11/25 has been considered.
The amendments to the claims overcome the previous 112 scope of enablement, however all other rejections are maintained.
Maintained-Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al (2020) and Seen et al (2018).
Liu et al teaches that intravitreal application of apocynin can effectively treat UV radiation eye damage (abstract). According to Liu et al Apocynin is found in Canadian hemp, it is an antioxidant, and also inhibits NADPH oxidase complex activation which decreases production of ROS and has a wide range of treatment for oxidative stress or inflammatory diseases including retinopathy (pg. 330, para bridging col 1-col 2 and pg. 334 col 2 “discussion’). A 0.5% solution of apocynin in a vehicle was administered to the eye (i.e. drops) and found to reduce damage of UV and mediate retinal dysfunction thereby treating the damaged eye (p. 332, last para col 2-333, top of col. 1; pg. 337, “conclusion”).
Liu et al does not teach tear film, dry eye or corneal epithelial disorders including dry eye but does teach that apocynin inhibits NADPH oxidase complex activation which decreases production of ROS and has a wide range of treatment for oxidative stress or inflammatory diseases.
Seen et al teaches dry eye is a multi-factored disorder that is a disease of the tears, ocular surface, etc and causes discomfort, visual disturbances, tear film instability (pe412: abstract, Introduction). According to Seen et al the dry eye is brought about by environmental factors including UV radiation, etc. which increase oxidative stress and ocular surface inflammation and as such oxidative stress is implicated in dry eye disease and possibly inflammation (abstract). Figure 1 of Seen et al shows the various points that ROS plays in dry eye and surmises that the treatment of dry eye should be targeted to ROS and that treatment of various pathological pathways includes tears, conjunctiva, globlet cell function, etc would be possible by treating ROS (p. e413, all col and Fig 1). Seen et al teaches that oxidative stress is linked to dry eye in both in vitro and animal studies and are correlated with tear film break up and BUT, conjunctiva, etc (p. e414). Seen et al teaches that antioxidants both systemic and oral are known to treat dry eye (p e418, col 1-2). Seen et al teaches both decreased tear production (evaporative) and BUT types of dry eye generate ROS (p. e415, Pre clinical intervention studies). Seen et al teaches that oxidative stress on the epithelial cells/epithelium of the eye is the activating cascade of inflammatory events on the ocular surface and brought on by hyperosmolarity and that reducing ROS would treat epithelial issues (p. e413 e414 “oxidative stress and dry eye”).
As such it would be obvious to a person of ordinary skill in the art would at the time of filing combine the teachings of Liu et al and Seen et al. The combination of a known treatment of eye disoders such as UV damage with Apocynin in a 0.5% solution to the eye with the known method of treating dry eye, tear film damage, etc which includes UV damage of Seen et al via treating ROS specifically would be obvious to a person of ordinary skill in the art. The combination of a known method of treating of the antioxidant apocynin of Liu with the known method of dry eye/UV damage/tear film and the roll of ROS in the treatment of the various diseases and inflammation pathways of with antioxidants of Seen et al would be within the purview of the skilled artisan and yield predictable results. The combination of one known method with another in a same field of endeavor treating eye damage by UV and ROS with antioxidants is within the purview of the skilled artisan and yield predictable results.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Seen et al (2018) and US 10,058,517 (‘517). Seen et al is taught above.
Seen et al teaches treating dry eye, visual disturbances, tear film disfunction, etc with various antioxidants and teaches that dry eye is due to ROS (see above).
‘517 teaches that apocynin drops treat Ancanthamoeba infection of the eyes (abstract and claims). According to ‘517 the pathology of amoebic infections includes ROS generation and NADPH oxidase (col. 19, lines 55-65). ‘517 teaches ocular administration such as a liquid solution, cream or lotion (col. 26, lines 45-col. 27, lines 55 and col. 29, lines 40-24).
As such it would be obvious to a person of ordinary skill in the art would at the time of filing combine the teachings of Seen et al and ‘517. The combination of a known treatment of eye disoders caused by ROS and NADPH with Apocynin solution to the eye with the method of Seen et al via treating ROS specifically would be obvious to a person of ordinary skill in the art. The combination of a known method of treating ROS mediated eye diseases with apocynin of ‘517 with the known method of dry eye/UV damage/tear film and the roll of ROS in the treatment of the various diseases and inflammation pathways of with antioxidants of Seen et al would be within the purview of the skilled artisan and yield predictable results. The combination of one known method with another in a same field of endeavor treating eye damage caused by ROS with antioxidants is within the purview of the skilled artisan and yield predictable results.
Response to Arguments
Applicant's arguments filed 01/05/2026 have been fully considered but they are not persuasive. Applicant argues that Liu states that the ‘potential clinical application of apocynin has been explored in a wide range of oxidative-stress or inflammatory related diseases’ which is speculative and not supported by experimental data and only concludes that the drug is implicated in UV radiation protection of retina. The prior art is enabled for all that it teaches furthermore applicant is reminded that this is an obviousness rejection not anticipation. Applicant’s argue that there is no prima facie case of obviousness and no motivation to combine Liu and Seen, and the examiner respectfully points out that applicant's argue against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). It should be noted that the motivation to combine references can be different from the ones set forth by Applicant. That is, as long as motivation exists to combine the elements, the problem to be solved does not have to involve the same reason for making the antimicrobial or antibacterial composition. As such, the examiner respectfully submits that there is motivation to combine the teachings of a known treatment of eye disoders such as UV damage with Apocynin in a 0.5% solution to the eye of Liu with the known method of treating dry eye, tear film damage, etc which includes UV damage of Seen et al via treating ROS specifically would be obvious to a person of ordinary skill in the art. The combination of a known method of treating of the antioxidant apocynin of Liu with the known method of dry eye/UV damage/tear film and the roll of ROS in the treatment of the various diseases and inflammation pathways of with antioxidants of Seen et al would be within the purview of the skilled artisan and yield predictable results. Again separately Applicant argues that Liu and Seen only ‘imply’ that environmental factors, ROS, etc are involved in eye damage (and dry eye specifically in Seen) but that these finding are not established and similarly applicant argues against the combination of Seen with ‘517 stating that the ROS of ‘517 has nothing to do with dry eye. The examiner again reiterates that the art is enabled for all that it teaches references all teach eye disorders/diseases and links to ROS/environmental factors and treatment with antioxidants generally whereas Liu and ‘517 specifically treat these eye disorders with apocynin and as further evidence the Kojima et al ref cited in the IDS of 09/11/25 also clearly states that environmental factors and ROS are involved in the etiology of dry eye (pgs. 17-21, section 3.7 lifestyle intervention) and term it a lifestyle disease. Kojima lay out that minimized inflammation and ROS treat dry eye as do antioxidants in general. Again these things are confirmed as well in the 103 rejections of record as shown above and as such one of ordinary skill in the art would be motivate to combine with administration of the specific apocyinin which is known to be delivered/administered to the eye to treat inflammation/ROS/environmental damage. Thus applicants arguments are not persuasive and not supported by the prior art of record.
Additionally, applicant argues that they have data and that the comparisons show that the apocynin works better than other actives such as hyaluronic acid/diquafosol. The Examiner points out that the instant claims are not commensurate in scope with the data shown in the instant spec which has amounts such as 0.0003% and 0.03% given 4 times a day, etc. In fact the instant claims require no amounts of apocynin nor any type of dosing but merely require ‘administrating… apocynin’ which is taught in the art as cited above. Will 1 atom provide treatment? Or 1 mg? or 1000 PPM? Or will only the amounts in the data provided? The burden is on applicant to show data that is commensurate with the scope of the instant claims and currently that is not the case since the claims require no dosing/amounts or ranges/values.
Conclusions
Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611