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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 1, 2025, has been entered.
Election/Restrictions
Applicant’s election of Group I (i.e., claims 1-13 directed to a pharmaceutical composition comprising insulin, DHA, and coenzyme Q10) in the reply filed on October 8, 2024, is acknowledged. Applicant’s election of Species A (i.e., a single and specific pharmaceutical composition as not containing IGF or a specific carrier, and where the insulin is amide-conjugated to DHA) in the reply filed on October 8, 2024, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Status of Claims
Claims 1-33 were originally filed on November 28, 2021.
The amendment received on November 28, 2021, canceled claims 15-24 and 29-33; and amended claims 25 and 27-28. The amendment received on March 26, 2025, canceled claims 3, 8-9, and 13; and amended claim 1. The amendment received on October 1, 2025, amended claim 1.
Claims 1-2, 4-5, 7, 10-12, 14 and 25-28 are currently pending and claims 1 and 10-12 under consideration as claims 14 and 25-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, and claims 2, 4-5, and 7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on October 8, 2024.
Priority
The present application claims status as a 371 (National Stage) of PCT/IL2020/050589 filed May 27, 2020, and claims priority under 119(e) to U.S. Provisional Application No. 62/853,179 filed on May 28, 2019.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on August 21, 2025; October 15, 2025; and December 15, 2025, are being considered by the examiner.
Response to Arguments
Applicant’s arguments, see Response, filed 10/1/25, with respect to the 112(a), new matter, rejection have been fully considered and are persuasive. The rejection of claims 1 and 10-12 as failing to comply with the written description requirement has been withdrawn.
Applicant’s arguments, see Response, filed 3/26/25, with respect to the 112(b) rejection have been fully considered and are persuasive. The rejection of claims 1 and 10-12 as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention has been withdrawn.
Maintained Rejections
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 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 pre-AIA 35 U.S.C. 103(a) 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 under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
103 - KSR Examples of 'Rationales' Supporting a Conclusion of Obviousness(Consistent with the "Functional Approach" of Graham)
Further regarding 35 USC 103(a) rejections, the Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) (KSR) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
Also, a reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976).
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Miller US 2011/0319325 A1 published on December 29, 2011 (cited in the Action mailed on 7/18/24), and further in view of Saallah et al., KONA Powder Particle J. 35:89-111 (2018) (cited in the Action mailed on 1/27/25).
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
For claim 1, with respect to a pharmaceutical composition comprising insulin, docosahexanoic acid (DHA) and coenzyme Q10:
Miller claims a method for treating diabetes by administering to an individual in need thereof a fatty acid component enriched for one or more activated fatty acids (See Miller claim 1). The fatty acid component can further comprise one or more non-activated fatty acids such as DHA (See Miller claim 5; [0040]-[0041]). Alternatively, Miller teaches that the composition can contain activated DHA and/or activated EPA (See Miller [0040]). Miller also claims that the method further comprises administering one or more secondary agents concurrently with or within the same course of treatment with the fatty acid component such as insulin where the secondary agent can be covalently linked to at least a portion of the fatty acid component (See Miller claims 7-8 and 13-14; [0034]-[0035], [0037]). Moreover, Miller claims that the method further comprises administering concurrently or within the same course of treatment with the fatty acid component one or more additional agents such as coenzyme Q10 (See Miller claim 12). Miller also claims a pharmaceutical composition comprising an effective amount of one or more activated fatty acids, an effective amount of one or more secondary agents such as insulin and a pharmaceutically acceptable excipient or carrier (See Miller claims 15-17 and 20; [0034]-[0036]). Therefore, the teachings of Miller suggest a pharmaceutical composition comprising insulin as a secondary agent, a fatty acid component enriched for one or more activated fatty acids and one or more non-activated fatty acids such as DHA, and coenzyme Q10 as an additional agent in order to treat diabetes in an individual as recited in instant claim 1.
For claim 1, with respect to where the composition includes a carrier formulated for topical ocular delivery:
Miller teaches that the pharmaceutical composition can be administered in any conventional manner by any route where they are active including systemic or local administration (See Miller [0044]). Administration routes includes oral, ocular, and topical (See Miller [0044]-[0045]). Local administration includes applying the composition as a salve or lotion directly to an area of inflammation (See Miller specification, [0045]). Such salves and lotions can include a topical formulation that contains a dermatologically acceptable vehicle such as hyaluronic acid, chondroitin sulphate, collagen glucosamine, keratan sulphate, vitamin C, etc. (See Miller specification, [0045]).
Furthermore, although Miller teaches that the composition can be formulated for topical and ocular delivery, such recitation constitutes the intended use of the claimed composition. Pursuant to MPEP 2112.02, the discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) and In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966). See M.P.E.P. § 2112.02. Thus, claim 3 is interpreted as reciting an intended use of the composition, i.e., for topical ocular delivery. A recitation of an intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Therefore, reciting that the composition is delivered via topical ocular administration only excludes a prior art reference if that reference requires that the composition could not be delivered via topical ocular administration or if the reference requires that the composition is in a form not suitable for topical ocular delivery. Thus, the teachings of Miller satisfy the claim limitation with respect to where the composition includes a carrier formulated for topical ocular delivery as recited in instant claim 1.
For claim 1, with respect to where the composition is formulated as an oil-in-water nanodroplets emulsion where the insulin is amide-conjugated to DHA:
As discussed supra for claim 1, Miller teaches that the pharmaceutical composition can be administered in any conventional manner by any route where they are active including systemic or local administration (See Miller [0044]). Administration routes includes oral, ocular, and topical (See Miller [0044]-[0045]). Embodiments include gel capsules containing the activated fatty acids, one or more secondary agents and/or non-activated fatty acids (See Miller [0046]). The activated fatty acid can be encapsulated by a coating layer and mixed with one or more stabilizers such as antioxidants, wheat germ oil and the like, and/or combined with one or more solubilizers such as surfactants, hydrophilic or hydrophobic solvents, oils or combinations thereof (See Miller [0046]). Miller also teaches that the composition can be formulated in various forms including fluid emulsions (See Miller [0065], [0068]). Thus, the teachings of Miller suggest that the composition can be in a form such as an emulsion with carriers/solvents such as oils and/or aqueous medias.
Furthermore, as discussed supra for claim 1, Miller claims that the method further comprises administering concurrently or within the same course of treatment with the fatty acid component one or more additional agents such as coenzyme Q10 (See Miller claim 12). Since Miller teaches a pharmaceutical composition comprising the fatty acid component and insulin where the composition can be formulated as a fluid emulsion and teaches that coenzyme Q10 as an additional agent can be administered in the same course of treatment, it would follow that the additional agent also can be a component in the pharmaceutical composition. Thus, when considering the teachings of Miller as a whole, Miller suggests a pharmaceutical composition comprising insulin, DHA in a fatty acid component, and coenzyme Q10 as an additional agent where the composition can be formulated as an emulsion with carriers/solvents such as oils and/or aqueous medias.
Miller teaches that the composition can contain activated DHA and/or activated EPA (See Miller [0040]). Miller also teaches that the activated fatty acid and the one or more secondary diabetes therapeutic agents can be covalently bound to one another (See Miller [0037]). The covalent linkage can be a single bond or via a linker that include a functional group such as esters, amines, amides, or combinations thereof (See Miller [0037]). Given that the scope of claim 1 is not limited to how the insulin is amide-conjugated to DHA, the amide-conjugation encompasses where the amide linkage is via a linker functional group. Thus, when considering the teachings of Miller as a whole, the activated fatty acid encompasses DHA, the secondary diabetes therapeutic agent encompasses insulin, and the two agents can be covalently linked together via a linker having an amide functional group thereby suggestive of the claim limitation as recited in instant claim 1.
However, Miller does not expressly teach that the composition is formulated as an oil-in-water nanodroplet emulsion.
Saallah et al. teaches that nanotechnology deals with processing materials with size less than 1000 nm where the reduction of particle size to nanoscale offers remarkable improvement in the physical, mechanical, electrical, and optical properties when compared to bulk materials (See Saallah article, pg. 89, col. 1, 1st paragraph). Saallah et al. also teaches methods for the preparation of biological nanoparticles based on emulsification strategies have been evolved in the past decades due to the advancement in the technology and emulsification devices (See Saallah article, pg. 91, col. 1, 1st paragraph). The emulsion system can be in the form of oil in water (o/w), water in oil (w/o) and oil in oil (o/o), depending on the type of the dispersed phase and dispersion medium (See Saallah article, pg. 91, col. 1, 1st paragraph). As such, the teachings of Saallah demonstrate that emulsions include nanoemulsion technology that utilize a finite number of emulsion systems such as an oil in water emulsion. After generation of the emulsion nanodroplets, nanoparticles can be produced through precipitation induced by various solvent extractions mechanisms such as solvent evaporation, solvent diffusion or salting-out (See Saallah article, pg. 91, col. 1, 1st paragraph). The emulsification method offers high encapsulation efficiency and high batch-to-batch reproducibility (See Saallah article, pg. 91, col. 2, last paragraph).
Additionally, Saallah et al. teaches integrating biomolecules with biological nanoparticles as biomolecule-nanoparticle conjugates through various conjugation strategies including non-covalent or covalent interactions, and encapsulation in polymeric materials (See Saallah article, pg. 94, col. 2, last paragraph to pg. 99, col. 2, 2nd paragraph). Non-covalent biofunctionalization is a physical conjugation strategy that can be realized through electrostatic, hydrophobic, and affinity interactions (See Saallah article, pg. 95, col. 1, 1st paragraph). Electrostatic adsorption is useful for the assembly of biomolecules to nanoparticles that are stabilized by anionic ligands and biomolecules that rely on the opposite charged of both materials (See Saallah article, pg. 95, col. 1, 1st paragraph). Conjugation of biomolecules with nanoparticles via covalent interactions can be achieved by means of chemisorption of the biomolecules on the particle surface or through the use of a bifunctional linker (See Saallah article, pg. 98, col. 2, last paragraph). Chemisorption is a simple chemical reaction that occurs between thiol group of biomolecules and the nanoparticles through cysteine residues that are present on the surface of the biomolecule (See Saallah article, pg. 98, col. 2, last paragraph). If no thiolated residues available in the native biomolecules, the thiol group can be introduced chemically onto the outer part of biomolecules using Taut’s reagent (2-aminothiolane) to allow biomolecules-NP interaction (See Saallah article, pg. 98, col. 2, last paragraph). Covalent binding through bifunctional linkers provide a versatile means for biomolecule conjugation (See Saallah article, pg. 99, col. 1, 2nd paragraph). Bifunctional linkers that can be utilized contain functional groups such as thiols, disulfides, and phosphine ligands containing terminal carboxy, amino or maleimide groups (See Saallah article, pg. 99, col. 1, 2nd paragraph). Alternatively, Saallah et al. teaches that biomolecules can be encapsulated within nanospheres or nanocapsules (See Saallah article, pg. 99, col. 1, last paragraph). It is noted that the scope of claim 6 is not limited by the type of conjugation between insulin and the nanoparticle thereby encompassing any means of conjugation. As such, the scope of claim 6 encompasses where the insulin can be “conjugated” to the nanoparticles via the Saallah’s non-covalent, covalent or encapsulation methods. Thus, an ordinary skilled artisan would be motivated to prepare an emulsion of Miller’s composition as an oil in water nanodroplet emulsion that is then made into a nanoparticle where the secondary diabetic agent such as insulin is conjugated into the nanoparticles given that nanotechnology offers remarkable improvement in the physical, mechanical, electrical, and optical properties when compared to bulk materials, that the emulsification method offers high encapsulation efficiency and high batch-to-batch reproducibility, and that biomolecules, e.g., diabetic agents, are known to be integrated into the nanoparticles via known conjugation methods.
Ascertainment of the Difference Between Scope of the Prior Art and the Claims (MPEP §2141.012)
Miller does not teach a pharmaceutical composition comprising an oil-in-water nanodroplet emulsion including a carrier, insulin-amide-conjugated to DHA and coenzyme Q10 as recited in instant claim 1. However, the teachings of Miller and Saallah et al. cure these deficiencies by constituting the use of a known technique to improve similar devices (methods, or products) in the same way and/or the application of a known technique to a known device (method, or product) ready for improvement to yield predictable results and/or utilize an "Obvious to try" rationale - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success and/or some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention pursuant to KSR.
Finding of Prima Facie Obviousness Rationale and Motivation (MPEP §2142-4143)
With respect a pharmaceutical composition comprising an oil-in-water nanodroplet emulsion including a carrier, insulin-amide-conjugated to DHA and coQ10 as recited in instant claim 1, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the teachings of Miller and formulate a pharmaceutical composition comprising DHA in a fatty acid component, insulin and one or more insulin sensitizers, DPP IV inhibitors, GLP-1 analogs and insulin secretagogues as secondary agents, and coenzyme Q10 as an additional agent as an oil-in-water nanodroplet emulsion where the insulin is amide-conjugated to DHA in order to treat diabetes in an individual. One of ordinary skill in the art at the time the invention was made would have been motivated to do so because formulating biomolecules was known to include an oil-in-water nanodroplet emulsion that is used to produce nanoparticles thereof that offers remarkable improvement in the physical, mechanical, electrical, and optical properties when compared to bulk materials, and because biomolecules were known to be integrated into the produced nanoparticles via covalent or non-covalent conjugation methods that offer high encapsulation efficiency and high batch-to-batch reproducibility as taught by Saallah et al.
One of ordinary skill in the art at the time the invention was made would have had a reasonable expectation of success given that the pharmaceutical compositions of Miller comprise DHA in a fatty acid component, insulin and one or more of insulin sensitizers, DPP IV inhibitors, GLP-1 analogs and insulin secretagogues as secondary agents, and coenzyme Q10 as an additional agent where the composition is formulated as an emulsion and where the fatty acid component is covalently conjugated to the secondary diabetic agent via a linker having an amide functional group. Therefore, formulating the composition as an oil-in-water nanodroplet emulsion where the insulin is amide-conjugated to DHA would support the treatment of diabetes in an individual given that nanotechnology offers remarkable improvement in the physical, mechanical, electrical, and optical properties when compared to bulk materials; and given that the emulsification method offers high encapsulation efficiency and high batch-to-batch reproducibility by constituting the use of a known technique to improve similar devices (methods, or products) in the same way and/or the application of a known technique to a known device (method, or product) ready for improvement to yield predictable results and/or utilize an "Obvious to try" rationale - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success and/or some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention pursuant to KSR.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 1 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Miller US 2011/0319325 A1 published on December 29, 2011 (cited in the Action mailed on 7/18/24) in view of Saallah et al., KONA Powder Particle J. 35:89-111 (2018) (cited in the Action mailed on 1/27/25), as applied to claim 1 above, and further in view of Mianowska et al., J. Diabetes Sci. Technol. 6:1238-1239 (2012), as applied to claim 10 herewith.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
For claim 1, please see discussion of Miller and Saallah et al. supra.
For claim 10, with respect to where a concentration of the insulin is 0.001U to 20U per ml:
Miller teaches that the amount of the secondary diabetes therapeutic agents present in the composition ranges from about 1 mg to about 1000 mg, about 5 mg to about 500 mg, and about 5 mg to about 100 mg (See Miller [0043]). Miller also teaches that the specific route of administration and the dose regimen may be adjusted or titrated according to known methods in order to obtain the optimal response (See Miller [0098]). The dosage to be administered will depend on the characteristics of the subject being treated, e.g., the particular animal treated, age, weight, health, types of concurrent treatment, if any, and frequency of treatments, and can be easily determined by one of skill in the art (See Miller [0098]). However, Miller does not expressly teach a concentration of the secondary diabetes therapeutic agent.
Mianowska et al. teaches that in very young children with type 1 diabetes mellitus (T1DM), insulin dose is often below 5-10 U/day, which necessitates infusion of volumes lower than 0.05-0.1 ml/day of 100 U/ml insulin (See Mianowska article, pg. 1238, 1st paragraph). Some children require as little as 0.2-0.3 U of bolus insulin (0.002-0.003 ml of 100 U/ml) to cover 10 g of meal carbohydrates (See Mianowska article, pg. 1238, 1st paragraph). However, Mianowska et al. teaches that these factors pose a challenge for precise and stable continuous subcutaneous insulin delivery as well as for occlusion alarm triggering in insulin pumps (See Mianowska article, pg. 1238, 1st paragraph). Lispro insulin diluted with a dedicated diluent has been used in neonates or young children on pump therapy (See Mianowska article, pg. 1238, 1st paragraph). As such, Mianowska et al. evaluated diluting lispro insulin to a concentration of 10 U/ml in normal saline that can be administered via an insulin pump to overcome the challenges identified (See Mianowska article, pg. 1238, 1st paragraph; pg. 1239, 1st paragraph). This administration concentration and route of administration seemed sage and effective, and thus, insulin dilution can be considered in the development of “closed-loop” insulin delivery systems for the youngest age group (See Mianowska article, pg. 1239, 1st paragraph). Therefore, the teachings of Mianowska et al. suggest diluting a known amount of an insulin, i.e., lispro insulin at 100 U/ml, to 10 U/ml (i.e., a concentration that lies within the claimed concentration range) in order for the insulin to be administered at a very low dose to young children whereby such diluted concentration overcomes challenges of continuous insulin delivery.
Ascertainment of the Difference Between Scope of the Prior Art and the Claims (MPEP §2141.012)
Miller does not teach where a concentration of the insulin is 0.001U to 20U per ml as recited in instant claim 10. The teachings of Mianowska et al. cure this deficiency by constituting some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention pursuant to KSR.
Finding of Prima Facie Obviousness Rationale and Motivation (MPEP §2142-4143)
With respect to a concentration of the insulin is 0.001U to 20U per ml as recited in instant claim 10, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the teachings of Miller and utilize the insulin in the pharmaceutical composition at a concentration of 10 U/ml in order to treat diabetes in young children. One of ordinary skill in the art at the time the invention was made would have been motivated to do so because adjusting the concentration of insulin to treat diabetes was known to be conducted by diluting a known insulin, lispro insulin 100 U/ml, to a concentration of 10 U/ml to be administered as an insulin pump to young children in order to overcome challenges with continuous insulin delivery as taught by Mianowska et al. One of ordinary skill in the art at the time the invention was made would have had a reasonable expectation of success given that the pharmaceutical compositions of Miller comprise insulin to treat diabetes, and therefore, utilizing 10 U/ml of lispro insulin by diluting 100 U/ml lispro insulin would support treatment of diabetes in young children by constituting some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention pursuant to KSR.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 1 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Miller US 2011/0319325 A1 published on December 29, 2011 (cited in the Action mailed on 7/18/24) in view of Saallah et al., KONA Powder Particle J. 35:89-111 (2018) (cited in the Action mailed on 1/27/25), as applied to claim 1 above, and further in view of Hageman et al. EP Publication No. 1 800 675 A1 published June 27, 2007, as applied to claim 11 herewith.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
For claim 1, please see discussion of Miller and Saallah et al. supra.
For claim 11, with respect to where a concentration of DHA is 1-3 mg/ml:
Miller teaches that the activated fatty acid can be present in an amount from about 1 mg to about 3000 mg (See Miller specification, [0043]). However, Miller does not expressly teach the concentration of the activated fatty acid.
Hageman et al. teaches a nutraceutical or pharmaceutical compositing comprising a lipid fraction comprising at least one of DHA, DPA and EPA; a protein fraction comprising proteinaceous material from non-human origin which provide at least cysteine and/or taurine; and a mineral fraction comprising at least one of manganese and molybdene (See Hageman [0020], [0025]). The composition is used for the manufacture of a medicament for the treatment of a number of diseases including diabetes (See Hageman [0022]). The amount of the gamma-3 lipid fraction ranges from 400 mg-3300 mg per day, and the concentration of the sum of EPA, DHA, and DPA in a liquid product is minimally 0.2 mg to maximally 15 mg per ml, and more preferably 0.4-11 mg/ml (See Hageman [0030]). As such, the amount of the fatty acid taught by Hageman overlaps with the amount taught by Miller. Thus, an ordinary skilled artisan would be motivated to utilize 0.4 to 11 mg/ml DHA in the composition as further articulated below.
Ascertainment of the Difference Between Scope of the Prior Art and the Claims (MPEP §2141.012)
Miller does not teach where a concentration of the DHA is 1-3 mg/ml as recited in instant claim 11. The teachings of Hageman et al. cure this deficiency by constituting some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention pursuant to KSR.
Finding of Prima Facie Obviousness Rationale and Motivation (MPEP §2142-4143)
With respect to where a concentration of the DHA is 1-3 mg/ml as recited in instant claim 11, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the teachings of Miller and utilize DHA in the fatty acid component in the pharmaceutical composition at a concentration ranging 0.4-11 mg/ml in order to treat diabetes. One of ordinary skill in the art at the time the invention was made would have been motivated to do so because a pharmaceutical composition comprising a lipid fraction containing at least one of DHA, EPA and DPA in an amount ranging from 400-3300 mg/day and in a concentration of 0.4-11 mg/ml was known to treat diabetes as taught by Hageman et al. One of ordinary skill in the art at the time the invention was made would have had a reasonable expectation of success given that the pharmaceutical compositions of Miller comprise DHA in a fatty acid component in an amount ranging from 1-3000 mg for treating diabetes, and therefore, utilizing DHA at a concentration ranging from 0.4-11 mg/ml in the composition would support treatment of diabetes by constituting some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention pursuant to KSR.
Additionally, MPEP 2144.05(I) states that "[i]n the case where the claimed ranges "overlap or lie inside ranges discloses by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%". The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.) Moreover, the Federal Circuit found that a prima facie case existed where a claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms and the prior art taught that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." In re Geisler, 116 F.3d 1465, 1469-82, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997). Therefore, the claimed concentration range of DHA would have been obvious to one of ordinary skill in the art since the claimed range (i.e., 1 mg/mL to 3 mg/mL) overlaps with the prior art concentration range of DHA (i.e., 0.4 mg/mL to 11 mg/mL).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 1 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Miller US 2011/0319325 A1 published on December 29, 2011 (cited in the Action mailed on 7/18/24) in view of Saallah et al., KONA Powder Particle J. 35:89-111 (2018) (cited in the Action mailed on 1/27/25), as applied to claim 1 above, and further in view of Shen et al., Healthcare 3:296-309 (2015), and “Vitamins and minerals: Indications and dosages”, available online at https://cdnproxy.thepoint.lww.com/securedownload/downloads/prod-assets/e90706a5-e111-4178-b3a8-3cbd0085805d/9781496353597-NDH2018-App17.pdf?token=method=ExpireAbsolute;source=PT;ttl=1737573809006;hash=Gs02ObNExaG9OPDdj6mRhQ==, 7 pages (September 1, 2018 per Google) (hereinafter referred to as the “V&M reference”), as applied to claim 12 herewith.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
For claim 1, please see discussion of Miller and Saallah et al. supra.
For claim 12, with respect to where a concentration of the coenzyme Q10 is 1-3 mg/ml:
Miller does not expressly teach the concentration of coenzyme Q10 or an additional agent.
Shen et al. reviews the potential use of coenzyme Q10 as a supplement for the treatment of T2DM (See Shen article, abstract). In Table 1, Shen et al. lists a number of studies examining the effect of coenzyme Q10 supplementation on glycemic control in T2DM patients (See Shen article, Table 1). Shen et al. concludes that it is clear that mitochondrial dysfunction secondary to oxidative stress contributes to the pathogenesis of T2DM (See Shen article, pg. 305, 1st paragraph). Deficiency in CoQ10 is often present among patients with T2DM due to various reasons (See Shen article, pg. 305, 1st paragraph). As a potent antioxidant, CoQ10 is assumed to scavenge excessive ROS and provide protection to cells, especially mitochondria from oxidative damage (See Shen article, pg. 305, 1st paragraph). Therefore, restoration of CoQ10 level among patients with T2DM by supplementation of exogenous CoQ10 could potentially alleviate oxidative stress, preserve mitochondrial function, and eventually lead to improvement of glycemic control (See Shen article, pg. 305, 1st paragraph). However, as depicted in Table 1, the studies conducted have mixed results (See Shen article, pg. 305, 1st paragraph). Thus, Shen et al. concludes that further investigation in large randomized clinical trials is needed (See Shen article, pg. 305, 1st paragraph). Although Shen et al. does not demonstrate that the efficacy of CoQ10 provides a definite beneficial effect for patients with T2DM in light of mixed study results, an ordinary skilled artisan would be motivated with a reasonable expectation of success to continue to explore and investigate the potential use of CoQ10, especially the ubiquinol form, in improvement glycemic control in T2DM patients. However, Shen et al. does not expressly teach the concentration of CoQ10 in mg/ml.
The V&M reference teaches available dosage forms and amounts of CoQ10 (See V&M reference, pg. 2, col. 2, last section to pg. 3, col. 1, 1st section). When CoQ10 is provided in an oral liquid form, the amount ranges from 2.5 mg/drop up to 100 mg/ml with intermediates amounts of 6 mg/ml and 20 mg/ml (See V&M reference, pg. 2, col. 2, last section). Although not indicated as 2.5 mg/ml, an ordinary skilled artisan would be motivated to optimize the concentration of oral liquid CoQ10 is a range from 2.5 to 100 mg/ml thereby overlapping with the instantly claimed range of 1-3 mg/ml as further articulated below.
Ascertainment of the Difference Between Scope of the Prior Art and the Claims (MPEP §2141.012)
Miller does not teach where a concentration of the CoQ10 is 1-3 mg/ml as recited in instant claim 12. The teachings of Shen et al. and the V&M reference cure this deficiency by constituting some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention and/or a known technique to improve similar devices (methods, or products) in the same way and/or the application of a known technique to a known device (method, or product) ready for improvement to yield predictable results pursuant to KSR. Moreover, an ordinary skilled artisan would be motivated to optimize the concentration of CoQ10 in light of the teachings of the V&M reference as further articulated below.
Finding of Prima Facie Obviousness Rationale and Motivation (MPEP §2142-4143)
With respect to where a concentration of the CoQ10 is 1-3 mg/ml as recited in instant claim 12, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the teachings of Miller and utilize CoQ10 as an additional agent in the pharmaceutical composition at a concentration ranging 2.5 to 100 mg/ml in order to treat diabetes. One of ordinary skill in the art at the time the invention was made would have been motivated to do so because CoQ10 was known to be a potent antioxidant capable of scavenging excessive ROS and providing protection to cells, especially mitochondria from oxidative damage, and therefore, CoQ10 supplementation in patients with T2DM was known to potentially alleviate oxidative stress, preserve mitochondrial function, and eventually lead to improvement of glycemic control as taught by Shen et al.; and because CoQ10 was known to be available in an oral liquid form at a concentration ranging from 2.5 mg/drop to 100 mg/ml as taught by the V&M reference. One of ordinary skill in the art at the time the invention was made would have had a reasonable expectation of success given that the pharmaceutical compositions of Miller comprise an additional agent such as CoQ10 and were used for treating diabetes and therefore utilizing CoQ10 as the additional agent at a concentration ranging from 2.5-100 mg/ml in the composition would support treatment of diabetes by potentially alleviating oxidative stress, preserving mitochondrial function, and eventually leading to improvement of glycemic control by constituting some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention pursuant to KSR.
Additionally, MPEP 2144.05(I) states that "[i]n the case where the claimed ranges "overlap or lie inside ranges discloses by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%". The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.) Moreover, the Federal Circuit found that a prima facie case existed where a claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms and the prior art taught that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." In re Geisler, 116 F.3d 1465, 1469-82, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997). Therefore, the claimed concentration range of CoQ10 would have been obvious to one of ordinary skill in the art since the claimed range (i.e., 1 mg/mL to 3 mg/mL) overlaps with the prior art concentration range of CoQ10 (i.e., 2.5 mg/drop to 100 mg/mL).
Additionally and/or alternatively, the concentration of CoQ10 in the composition is clearly a result specific parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal concentration of the CoQ10 in the composition needed to achieve the desired results. Thus, an ordinary skilled artisan would have been motivated to modify the concentration of the CoQ10 given the oral liquid concentration amounts of the V&M reference, for scavenging excessive ROS and providing protection to cells, especially mitochondria from oxidative damage thereby resulting in alleviating oxidative stress, preserving mitochondrial function, and eventually leading to improvement of glycemic control in patients with T2DM, because an ordinary skilled artisan would have been able to utilize the teachings of Shen et al. and the V&M reference to obtain various concentration parameters with a reasonable expectation of success. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the concentration of the CoQ10 in the composition would have been obvious at the time of applicant's invention. Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, because the combined teachings of the prior art are fairly suggestive of the claimed invention.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Applicants’ Arguments
Applicants contend that the claimed invention is nonobvious because there is no motivation in the cited references to conjugate insulin to DHA, include DHA in an oil-in-water nanoemulsion, and reformulate the composition of Miller as a topical agent for application to a cornea (See Applicant’s Response received on 10/1/25, pg. 6). Instead, an ordinary skilled artisan would understand the Miller reference as teaching diabetes treatment that would benefit from systemic delivery of insulin and the activated fatty acid is used as an active ingredient that is preferably administered prior to diabetes medication or less preferably co-administered but not in conjugated form and would consider the many templates provided by Miller as irrelevant to the actual science presented by Miller (See Applicant’s Response received on 10/1/25, pg. 6). Applicants further assert that the instant invention was specifically formulated for intraocular delivery of insulin in order to treat a retinal disorder (retinopathy), and found that attaching insulin to the nanodroplets of the nanoemulsion by conjugating it with DHA that is in the oil phase along with CoQ10 overcomes the drawbacks of insulin’s inability to penetrate the corneal epithelium (See Applicant’s Response received on 10/1/25, pg. 6). Thus, Applicant’s assert that the choice of DHA as the fatty acid used to transport insulin across the epithelial barrier was base on its structure along with the pharmacokinetics and pharmacodynamics of the entire drug composition such that conjugation of insulin with DHA alters the polarity of insulin molecules to a level sufficient for their transport across the corneal epithelium into the eye (See Applicant’s Response received on 10/1/25, pg. 6). The specific tissue target and pharmacokinetics of such a formulation would make it less suitable for the treatment of T2D (See Applicant’s Response received on 10/1/25, pg. 6).
Response to Arguments
Applicant's arguments filed 10/1/25 for claims 1 and 10-12 have been fully considered but they are not persuasive for the following reasons.
As an initial matter, the Examiner would like to discuss the scope of amended claim 1. Pursuant to MPEP 2111, the pending claims must be “given their broadest reasonable interpretation consistent with the specification.” The Federal Circuit’s en banc decision in Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) expressly recognized that the USPTO employs the “broadest reasonable interpretation” standard:
The Patent and Trademark Office ("PTO"“ determines the scope of claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction “in light of the specification as it would be interpreted by one of ordinary skill in the art.” In re Am. Acad. Of Sci. Tech. Ctr., 367 F.3d 1359, 1364[, 70 USPQ2d 1827, 1830] (Fed. Cir. 2004). Indeed, the rules of the PTO require that application claims must “conform to the invention as set forth in the remainder of the specification and the terms and phrases used in the claims must find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable by reference to the description.” 37 CFR 1.75(d)(1).
In the instant case, it is noted that claim 1 is directed to a composition of matter and not a method of using the composition. As such, even if the intended use of the composition is recited in the claims, it is not given patentable weight unless it imparts a structural limitation on the claimed composition. The claimed composition requires several structural elements: namely, (1) an oil-in-water nanodroplet emulsion that comprises (2) insulin amide-conjugated to DHA and (3) coenzyme Q10, and the composition also comprises (4) a carrier. It is noted that there is no indication that the DHA is the carrier. Rather, the carrier can be any carrier suitable for topical ocular delivery. For example, another solvent can be a carrier. The question is whether an ordinary skilled artisan would be motivated with a reasonable expectation of success to achieve a pharmaceutical composition comprising the four structural limitations indicated above. The Examiner maintains that the answer is yes for the following reasons.
The Examiner recognizes that obviousness may 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. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). The Examiner addressed each of the required structural elements of the claimed composition in the Action mailed on 7/8/25, albeit, the carrier is now not required to be a component of the nanoemulsion, and the carrier is suitable for topical ocular application. Thus, the response in the Action mailed on 7/8/25 is incorporated herewith, and will not be reiterated.
Regarding the Miller reference, it is acknowledged that Miller teaches various embodiments with respect to the compositional structure and form. However, pursuant to MPEP 2141, “[a] prior art reference must be considered in its entirety, i.e., as a whole, including portions that would lead away from the claimed invention. W.L. Gore & Assoc., Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983), cert. denied, 469 U.S. 851 (1984). Plus MPEP § 2123 states that patents are relevant as prior art for all they contain. In the instant case, it is acknowledged that the specific examples reduced-to-practice taught in paragraph [0101]-[0108] of Miller et al. utilize a different pharmaceutical composition comprising nitro-oleic acid where this composition is administered prior to administration of insulin thereby suggesting that the fatty acid is not conjugated to the insulin. However, these teachings do not represent the teachings of Miller as a whole, which encompasses the composition being in the form of a fluid emulsion where the fatty acid, e.g., DHA, is covalently conjugated to insulin. In fact, Miller expressly claims where the diabetic agent is covalently linked to the fatty acid component (See Miller, claim 8). It is unnecessary for each limitation to be present in the same example or embodiment for a prior art reference to render the claimed invention obvious. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). See MPEP 2123. A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including non-preferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). It is the position of the examiner that one of ordinary skill in the art, given both the prior art and the claims in their present form in their broadest reasonable interpretation, would find the claimed invention obvious in view of the prior art. See MPEP § 2111 and 2123. Therefore, contrary to Applicants’ arguments, the Examiner utilizes the teachings of the Miller et al. reference, as a whole, in order to render the claimed invention obvious for the reasons stated in the rejection supra.
Furthermore, Applicant’s argument that an ordinary skilled artisan would only takeaway from the teachings of Miller that activated fatty acid administration prior to administration of insulin enhances insulin sensitivity and dismiss the remaining teachings of Miller as irrelevant is merely the argument of counsel and is unsupported by evidence or declarations of those skilled in the art. Attorney argument is not evidence unless it is an admission, in which case, an examiner may use the admission in making a rejection. See M.P.E.P. § 2129 and § 2144.03 for a discussion of admissions as prior art. Counsel's arguments cannot take the place of objective evidence. In re Schulze, 145 USPQ 716 (CCPA 1965); In re Cole, 140 USPQ 230 (CCPA 1964); and especially In re Langer, 183 USPQ 288 (CCPA 1974). See M.P.E.P. § 716.01(c) for examples of attorney statements that are not evidence and that must be supported by an appropriate affidavit or declaration.
The Examiner would also like to reiterate that Applicant’s argument that insulin cannot penetrate the corneal epithelium to reach its intended intraocular receptors, and thus, choice of DHA as the fatty acid used to transport insulin across the epithelial barrier is critical to delivering insulin to these intraocular receptors, this argument is merely the argument of counsel and is unsupported by evidence or declarations of those skilled in the art. Attorney argument is not evidence unless it is an admission, in which case, an examiner may use the admission in making a rejection. See M.P.E.P. § 2129 and § 2144.03 for a discussion of admissions as prior art. Counsel's arguments cannot take the place of objective evidence. In re Schulze, 145 USPQ 716 (CCPA 1965); In re Cole, 140 USPQ 230 (CCPA 1964); and especially In re Langer, 183 USPQ 288 (CCPA 1974). See M.P.E.P. § 716.01(c) for examples of attorney statements that are not evidence and that must be supported by an appropriate affidavit or declaration. In the instant case, Applicants have not provided evidence to support that insulin cannot penetrate the corneal epithelium without the aid of DHA, nor to demonstrate that selecting DHA as the fatty acid is critical in delivering insulin to the intraocular receptors. Applicants are invited to provide evidence of such criticality of the selection of DHA, for example, DHA is superior to EPA in transporting insulin to the intraocular receptors. Such evidence may demonstrate unexpected results overcoming the prima facie case of obviousness as long as the unexpected results are commensurate in scope with the claimed invention.
Furthermore, as stated in the Action mailed on 7/8/25, Leong et al. reviews the use of topical insulin for the treatment of diabetic keratopathy including corneal epithelial defects and found topical insulin that is not modified by DHA conjugation is effective for corneal re-epithelialization in patients with diabetes based on corneal wound size and healing rate (See Leong et al., World J. Diabetes 14:930-938 (2023) at abstract). Leong et al. teaches that there are insulin receptors found in the corneal epithelium and ocular surface tissue (See Leong, pg. 931, 3rd paragraph). In particular, Leong et al. discusses a study by Chen et al. that demonstrated that daily topical insulin in an amount of 0.1 IU administration to rats with diabetes significantly reduced nerve occupancy in the subbasal plexus at week 40 (See Leong, pg. 932, last paragraph to pg. 933, 1st paragraph). Tables 1-2 summarize studies reviewed by Leong et al. where topical insulin was administered as drops (See Leong, Tables 1-2). Leong et al. also discusses studies examining the storage stability of a topical insulin formulations where the formulation contain diluted insulin Lispro solution (100 IU/ml) with polyethylene and propylene glycol-based artificial eye drops, or a combination of insulin and m-cresol (See Leong, pg. 935, 3rd to last paragraph). These formulations exhibit stable physicochemical stability after 12 months of storage (See Leong, pg. 935, 3rd to last paragraph). Thus, contrary to Applicant’s assertion, it appears insulin is capable of reaching the insulin receptors in the corneal epithelium without the need for DHA conjugation.
Regarding Miller teaching the treatment of diabetes as opposed to the treatment of an ocular disorder such as retinopathy, as stated in the Action mailed on 7/8/25, it is noted that the features upon which applicant relies (i.e., treatment of an ocular disorder) is not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). However, even if the claimed invention recited that the composition is for the treatment of an ocular disorder such a retinopathy, a prior art reference is not required to teach or suggest such limitation because it constitutes the intended use of the composition. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. As discussed in the rejection supra, Miller expressly teaches that the composition can be administered ocularly. Moreover, Miller teaches that the composition can further comprise a carrier such as hyaluronic acid (See Miller specification, [0045]). As demonstrated by Hynnekleiv et al., hyaluronic acid is commonly used to treat dry eye disease and applied as drops to an eye (See Hynnekleiv et al., Acta Ophthalmol. 100:844-860 (2022) at abstract and Figure 4). As such, it would necessarily follow that Miller suggests a composition that can contain a carrier rendering the composition in a form capable of topical ocular administration.
Furthermore, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). A difference in objectives, if any, does not defeat the case for obviousness because, as MPEP § 2144 states, the “reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. In re Linter, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) …; In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991) … .” Here, even if the objective of the claimed invention is for the development of the claimed composition for the treatment of ROP where DHA is used as a carrier for insulin penetration, the scope of claim 1 is directed to a composition and not a method of use. As long as the cited prior art renders obvious the claimed pharmaceutical composition structure, then the fact that Applicants have found a new use for the suggested composition would flow naturally in light of the prior art.
Accordingly, the rejections of claims 1 and 10-12 are maintained as Applicants’ arguments are found unpersuasive.
Conclusion
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/THEA D' AMBROSIO/Primary Examiner, Art Unit 1654