DETAILED ACTION
Claims 1-8, 11-13, 18, 22-25, 30-31 and 34-36 are currently pending. Claims 1-5, 7-8, 11-13, 22-25, 30-31 and 36 are currently under examination.
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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 05/07/2026 is acknowledged. The traversal is on the ground(s) that the search for the claims of Group I would result in finding at that is applicable to the claims of Group II and therefore would not be a serious burden to search and examine all the claims. This is not found persuasive because the search for a use of a composition is not coextensive with a search for said composition, requiring the use of different search queries demonstrating a search burden.
The requirement is still deemed proper and is therefore made FINAL.
Claims 34-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05/07/2026.
Applicant's election with traverse of omega-3 fatty acid, lecithin, propylene glycol, liposome and dexamethasone in the reply filed on 05/07/2026 is acknowledged. The traversal is on the ground(s) that the species are related to each other and thus would not be a serious burden. This is not found persuasive because the search for the specifically elected oil phase, surfactant, co-surfactant, nanoparticle and therapeutic agent elected is not coextensive with a search for additional ingredients of oil phase, surfactant, co-surfactant, nanoparticle a therapeutic agent, requiring the use of different search queries demonstrating a search burden.
The requirement is still deemed proper and is therefore made FINAL.
Claim 6 and 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05/07/2026.
Priority
The instant application is a continuation of 16/955,319, filed 06/18/2020, which is a national stage entry of PCT/IB2018/060522, filed 12/21/2018, which claims priority to GB 1721840.5, filed 12/22/2017.
Information Disclosure Statement
Applicant’s Informational Disclosure Statement, filed on 03/21/2024 has been considered. Please refer to Applicant's copy of the 1449 submitted herein.
Claim Rejections - 35 USC § 102 (a)(1)
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.
Claim(s) 1-3, 5, 13, 22-23 and 30-31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2006/0251685 (Applicant provided).
Regarding claims 1, the limitation of a composition for ophthalmic delivery of a therapeutic agent, the composition comprising an oil in water emulsion comprising a fatty acid or fatty acid ester, as the oil phase, an aqueous phase, a surfactant and a co-surfactant wherein the composition further comprises a suspension of therapeutic agent loaded nanoparticles is met by the ‘685 publication teaching an ophthalmic composition includes oil globules dispersed in an aqueous phase wherein the globules include a surfactant composition, a polar oil component that includes omega-3 fatty acid (abstract). The oil droplets are very small, less than about 0.05 micron ([006], [0008], [0036]), reading on nanoparticle suspension in water. The composition includes an ingredient to have at least one therapeutic benefit [0088], wherein omega-3 fatty acids treat symptoms of dry eye [0006], thus oil globules contain active agent loaded nanoparticles. The composition includes two surfactants (claim 28).
Regarding claim 3, the limitation of wherein the omega-3-fatty acid comprises alpha-linolenic acid is met by the ‘685 publication teaches alpha linolenic acid [0051].
Regarding claim 5, the limitation of wherein the surfactant is selected from a group that includes sorbitan fatty acid esters is met by the ‘685 publication teaching polysorbate 80 (polyoxyethylene (20) sorbitan mono-oleate) [0071].
Regarding claim 13, the limitation of wherein the nanoparticle comprises a nanoparticle selected from a group including nanostructured lipid carrier is met by the ‘685 publication teaching oil globules (abstract).
Regarding claim 22-23, the limitation of wherein the therapeutic agent is suitable for treatment or prevention of an eye disorder is met by the ‘685 publication teaching wherein omega-3 fatty acids treat symptoms of dry eye [0006].
Regarding claims 30-31, the limitation of wherein the composition is an ophthalmically acceptable composition, suitable for topical administration to the eye is met by the ‘685 publication teaching composition for dry eye treatment (abstract).
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.
The factual inquiries 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 4-5, 7-8, 11-13, 22-25 and 30-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0017239.
Regarding claim 1, the limitation of a composition for ophthalmic delivery of a therapeutic agent, the composition comprising an oil-in-water microemulsion comprising a fatty acid, or fatty acid ester, as the oil phase; an aqueous phase, a surfactant and a co-surfactant and wherein the compristion further comprises a suspension of therapeutic agent-loaded nanoparticles and wherein the compristion further comprises a suspension of therapeutic agent-loaded nanoparticle is met by the ‘239 publication teaches a delivery system for active ingredients which comprises lipid nanoparticles such as solid lipid nanoparticles or nanostructured lipid carriers (abstract). The active is incorporated into lipid matrix [0022]. The microparticles are dispersed in cold aqueous solution which contains surfactants which optionally comprise other active ingredients, emulsifiers, polymers and/or other excipients to obtain a dispersion of lipid nanoparticles ([0028]-[0029]). The microemulsion is taught to include surfactants and co-surfactants ([0043]-[0045]).
Regarding claim 4, the limitation of wherein the oil phase is in an amount between about 0.1 and 0.5 v/v% of the composition is met by the ‘239 publication teaching lecithin, glycolipids at 1 wt% (Example 8b). As MPEP 2144.05 recites “where 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 optimization”.
Regarding claims 5 and 7, the limitation of wherein the surfactant is selected from the group which include lecithin at 1 wt% (Example 8b). As MPEP 2144.05 recites “where 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 optimization”.
Regarding claim 8, the limitation of wherein the co-surfactant comprises alkane diol or alkane polyol is met by the ‘239 publication teaching propanediol is exemplified (Example 8b) and co-surfactants include cosurfactant such as glycols include propylene glycol ([0041], [0045]).
Regarding claim 11, the weight ratio of surfactant to co-surfactant is from about 4:1 to about 1:2 is met by the ‘239 publication teaching a 1:1 ratio of propanediol to lecithin (Example 1).
Regarding claim 12, the limitation of wherein the weight ratio of oil phase and surfactant/co-surfactant mixture between about 1.3 and about 1.9 is met by the ‘239 publication teaches oil and surfactant amounts (Examples e.g. 1, 8) wherein the amounts of oil and surfactant are optimizable parameters to obtain the desired nanoparticles.
Regarding claim 13, the limitation of wherein the nanoparticles comprises a nanoparticle selected from the group which includes liposome is met by the ‘239 publication teaching preparations of liposomes (Example 8b).
Regarding claim 22, the limitation of wherein the therapeutic agent is suitable for treatment or prevention of an eye disorder is met by the ‘239 publication teaching ophthalmic active agents (claim 11).
Regarding claims 23-25, the ‘239 publication teaches the elected active agent dexamethasone [0068] including corticosteroids (claim 11).
Regarding claim 30-31, the limitation of wherein the composition is an ophthalmically acceptable composition, wherein the compristion is suitable topical administration to the eye is met by the ‘239 publication teaching ophthalmic active agent (claim 11) wherein administration can be ophthalmic and topical [0089].
That being said, however, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of disclosed ingredients (for example dexamethasone nano liposome particles in an ophthalmically topical composition) from within the prior art disclosure of the ‘239 publication, to arrive at the instantly claimed composition “yielding no more than one would have expected from such an arrangement”.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to optimize the amount of surfactants, oil and active ingredients as the ‘239 publication teaches a range for the active ingredient in the compositions, examples using differing amounts and further teaches the active ingredient may be solubilized in the lipid matrix by addition of surfactants, thus teaching the optimization of ingredient to obtain the desired final lipid nanoparticle. As MPEP 2144.05 recites “where 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 optimization”.
Claim(s) 1-5, 7-8, 11-13, 22-25, 30-31 and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0017239 in view of US 2006/0251685 (Applicant provided) and WO 2015/142853.
Regarding claim 1, the limitation of a composition for ophthalmic delivery of a therapeutic agent, the composition comprising an oil-in-water microemulsion comprising a fatty acid, or fatty acid ester, as the oil phase; an aqueous phase, a surfactant and a co-surfactant and wherein the compristion further comprises a suspension of therapeutic agent-loaded nanoparticles and wherein the compristion further comprises a suspension of therapeutic agent-loaded nanoparticle is met by the ‘239 publication teaches a delivery system for active ingredients which comprises lipid nanoparticles such as solid lipid nanoparticles or nanostructured lipid carriers (abstract). The active is incorporated into lipid matrix [0022]. The microparticles are dispersed in cold aqueous solution which contains surfactants which optionally comprise other active ingredients, emulsifiers, polymers and/or other excipients to obtain a dispersion of lipid nanoparticles ([0028]-[0029]). The microemulsion is taught to include surfactants and co-surfactants ([0043]-[0045]).
Regarding claim 4, the limitation of wherein the oil phase is in ana mount between about 0.1 and 0.5 v/v% of the composition is met by the ‘239 publication teaching lecithin, glycolipids at 1 wt% (Example 8b). As MPEP 2144.05 recites “where 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 optimization”.
Regarding claims 5 and 7, the limitation of wherein the surfactant is selected from the group which include lecithin at 1 wt% (Example 8b). As MPEP 2144.05 recites “where 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 optimization”.
Regarding claim 8, the limitation of wherein the co-surfactant comprises alkane diol or alkane polyol is met by the ‘239 publication teaching propanediol is exemplified (Example 8b) and co-surfactants include cosurfactant such as glycols include propylene glycol ([0041], [0045]).
Regarding claim 11, the weight ratio of surfactant to co-surfactant is from about 4:1 to about 1:2 is met by the ‘239 publication teaching a 1:1 ratio of propanediol to lecithin (Example 1).
Regarding claim 12, the limitation of wherein the weight ratio of oil phase and surfactant/co-surfactant mixture between 1but 1.3 and about 1.9 is met by the ‘239 publication teaches oil and surfactant amounts (Examples e.g. 1, 8) wherein the amounts of oil and surfactant are optimizable parameters to obtain the desired nanoparticles.
Regarding claim 13, the limitation of wherein the nanoparticles comprises a nanoparticle selected from the group which includes liposome is met by the ‘239 publication teaching preparations of liposomes (Example 8b).
Regarding claim 22, the limitation of wherein the therapeutic agent is suitable for treatment or prevention of an eye disorder is met by the ‘239 publication teaching ophthalmic active agents (claim 11).
Regarding claims 23-25, the ‘239 publication teaches the elected active agent dexamethasone [0068] including corticosteroids (claim 11).
Regarding claim 30-31, the limitation of wherein the composition is an ophthalmically acceptable composition, wherein the compristion is suitable topical administration to the eye is met by the ‘239 publication teaching ophthalmic active agent (claim 11) wherein administration can be ophthalmic and topical [0089].
The ‘239 publication does not specifically teach omega-3-fatty acids (claim 2), specifically alpha-linolenic acid (claim 3).
The ‘239 publication does not specifically teach an eye drop dispenser or eye wash device (claim 36).
The ‘685 publication teaching an ophthalmic composition includes oil globules dispersed in an aqueous phase wherein the globules include a surfactant composition, a polar oil component that includes omega-3 fatty acid (abstract). The oil droplets are very small, less than about 0.05 micron ([006], [0008], [0036]), reading on nanoparticle suspension in water. The composition includes an ingredient to have at least one therapeutic benefit [0088], wherein omega-3 fatty acids treat symptoms of dry eye [0006], thus oil globules contain active agent loaded nanoparticles. The composition includes two surfactants (claim 28). The ‘685 publication teaches alpha linolenic acid [0051].
The ‘853 publication teaches ocular formulations for treating inflammatory disorders in the eye wherein the compositions include anti-inflammatory active agents (abstract). The administration to the eye is taught to be topical administration to the eye of an ophthalmic solution or suspension (page 7). Application in the form of two drops is taught (page 8). The active agent is taught to be present in the range of 05-50% (page 16) wherein dexamethasone is taught (page 17). The formation is taught to be in the form of eye drops (page 17) through the use of a dropper (page 40).
It would have been prima facie obvious to eon of ordinary skill in the art to use dexamethasone composition as taught by the ‘239 publication in the dropper taught by the ‘853 publication because the ‘239 publication and the ‘853 publication are both directed to compositions applied ophthalmically which include dexamethasone and the ‘853 publication teaches known methods of applying a topical ophthalmic composition in the form of a dropper. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to select dexamethasone as the ‘239 publication teaches dexamethasone as a possible active agent and the ‘853 publication specifically teaches the desire to use dexamethasone as a topically anti-inflammatory agent. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘239 publication teaches the composition may include dexamethasone and topical application and the ‘853 publication specifically teaches the inclusion of dexamethasone in an ophthalmic topical application.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use alpha linolenic acid and omega acid as the oil phase in the composition as taught by the ‘239 publication as the ‘685 publication teaches omega-3 fatty acids treat symptoms of dry eye and alpha linolenic acid are known to be used in ophthalmic compositions and the ‘239 publication teaches ophthalmic compositions. One of ordinary skill in the art before the filing date of the claimed invention to use alpha linolenic acid and omega acid in the compositions of the ‘239 publication as the ‘239 publication teaches the lipids are not restricted thus allowed for oils taught by the ‘685 publication. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to use the oils of the ‘685 publication in the compositions of the ’239 publication as the ‘685 publication teaches oils to be used to treat dry eye in an ophthalmic composition and the ‘239 publication is directed to an ophthalmic composition.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to optimize the amount of surfactants, oil and active ingredients as the ‘239 publication teaches a range for the active ingredient in the compositions, examples using differing amounts and further teaches the active ingredient may be solubilized in the lipid matrix by addition of surfactants, thus teaching the optimization of ingredient to obtain the desired final lipid nanoparticle. As MPEP 2144.05 recites “where 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 optimization”.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LYNDSEY M BECKHARDT/ Examiner, Art Unit 1613
Prosecution Insights