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 .
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.
Continued Examination under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/24/2025 has been entered.
Previous Rejections
Applicant’s arguments, filed 11/24/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Status
Claims 1-4 and 6-16 are pending and are examined on the merits in this prosecution.
CLAIM REJECTIONS
Obviousness Rejections
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 1-4 and 6-16 are rejected under 35 U.S.C. 103 as being unpatentable over Popov (US 2019/0125758 A1), in view of Patel (“Ophthalmic Drug Delivery system - A review,” Der Pharmacia Lettre, 2010, 2(4): 100-115).
Popov teaches methods and compositions for aiding transport of pharmaceutical agents through a mucous membrane. In certain embodiments , a pharmaceutical composition including such particles is well-suited for ophthalmic applications, and may be used for delivering pharmaceutical agents to the front of the eye and / or the back of the eye (Abstract). Popov teaches the compositions in the method may be formulated as eye drops. These formulations may be combined with a conventional additive, such as a buffering or pH-adjusting agents, tonicity adjusting agents, viscosity modifiers, suspension stabilizers, preservatives, and other pharmaceutical excipients (pg 33, [0251]).
Popov teaches the pharmaceutical agents include therapeutic agents, nucleic acids, nucleic acid analogs, small molecules, peptidomimetics, proteins, peptides, vaccines, viral vectors, and viruses (pg 31, [0240]).
Popov teaches the compositions of the method may have a pH of from 5-8, and the pH is dependent on where in the body the method is administered (pg 39, [0300]), reading on claims 1 and 12.
For claims 3, 15, and 16, Popov teaches the method may require multiple dosages over a period of up to 48 hours (pg 5, [0026] and [0027]). While these examples do not comprise a virus vaccine, one of ordinary skill would have the knowledge required to determine an effective dosing schedule for a method comprising a vaccine eye drop composition.
For claim 4, Popov teaches the volume instilled in the eye is 50-100 microliters (pg 41, [0315]).
For claims 1, 6, and 13, Popov teaches the osmolality of the composition of the method may be about 310 mOsm/L (pg 35, [0271]), within the claimed range
For the limitations of the number of virus particles set forth in claims 7, 9, and 14, while Popov does not teach the claimed number of particles, it would have been obvious to one of skill in the art to determine the number of virus particles required to elicit the desired vaccine effect using routine experimentation, according to the methods taught by Popov.
For claim 8, Popov teaches the formulation may be sterilized with gamma radiation prior to administration (pg 38, [0293]-[0294]).
Popov does not teach a composition having a viscosity of 50-100 cps. It is noted that Popov teaches viscosity modifiers ([0251]).
Patel teaches the missing element of Popov.
Patel teaches ophthalmic solution and suspension eye drops may contain viscosity-imparting polymers to thicken the tear film and increase corneal contact time. Patel teaches the hydrophilic polymers most often used for these purposes are methylcellulose, hydroxypropyl methylcellulose, hydroxyethyl cellulose and polyvinyl alcohol, and the polymers are used at concentrations that produce viscosities in the range of about 5 to 100 cps (pg 108, section 2.4 Viscosity), overlapping the claimed range. Because the claimed range in claims 1, 2, 9, and 11 overlaps with the range disclosed by the prior art, a prima facie case of obviousness exists.
The person of ordinary skill would have had a reasonable expectation of success in selecting a viscosity in the range of 50 to 100 cps, or a narrower range of 60-90 cps, which is within Patel's 5-100 cps range, in Popov's eye-drop vaccine method because Popov requires a vaccine eye-drop that is instilled on the surface of the eye and Patel teaches that a viscosity in the claimed range is useful for spreading the eye-drop on the surface of the eye and also has a residence time on the surface required for increased corneal contact time for a medication.
Examiner’s Reply to Attorney Arguments dated 11/14/2025
1. Rejection of claim 14 under 35 U.S.C. §112
Applicant' s arguments with respect to the rejection under 35 U.S.C. §112 have been fully considered and are persuasive. This rejection has been withdrawn.
2. Rejection of claims 1-4, 7, 9-11, and 14-16 under 35 U.S.C. §103 over Kim and Ophthalmic Products
Applicant’s arguments with respect to claims 1-4, 7, 9-11, and 14-16 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
3. Rejection of claims 5, 6, 12 and 13 over Kim, Ophthalmic Products and Popov (US 2018/0256497A1)
Applicant’s arguments with respect to claims 5, 6, 12 and 13 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
4. Rejection of claim 8 over Kim, Ophthalmic Products and Lyons
Applicant’s arguments with respect to claim 8 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
CONCLUSION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P COHEN whose telephone number is (571)270-7402. The examiner can normally be reached on M-Th 8:30-5:30; F 9-4.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup, can be reached on (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL P COHEN/Primary Examiner, Art Unit 1612