DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 11, 2026 has been entered.
Status of the Claims
Claims 1-12, 14-41 are currently pending and Claims 1-11 and 35-41 are examined on the merits herein.
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 .
Priority
This Application filed on 03/13/2025 has PRO 63/564,880 filed on 03/13/2024.
Response to Arguments
The response herein is to the arguments filed on May 8, 2026:
The arguments over the rejection of claims 1-11 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is persuasive. The rejection is herewith withdrawn.
The arguments over the rejection of claims 1-5, and 10-11 under 35 U.S.C. 103 over Pelikaan et al. (EP2606896A) is not persuasive. The rejection is herewith maintained. Applicant argues the formulation comprising an aqueous solution comprising dex and effective to synergistically treat osteoarthritis is not taught by Pelikaan.
In response, the Examiner states that upon calculation of the prior art, a dose that is equivalent to 500-2,000 µg dexamethasone, overlaps with at least 100 micrograms to 2.5 milligrams claimed. A conversion of the mass of Dexamethasone (molecular weight: 392.46 g/mol)) into molar amounts: 500 µg = about 1.27 µmol to 2,000 µg = about 5.10 µmol, again the resulting concentration range overlaps with the 800 pM to 100 nanomolar range. These amounts claimed fall within the scope of the prior art. Additionally, a conversion of the exemplified emulsion 3 amount of decanoic acid would correspond to 2.32 mM. Applicant’s arguments are not persuasive. Further, the Examiner’s contention is that the emulsion of the pharmaceutical composition comprises an aqueous solution and depending on the specific solubility of the active components will partition between the oil and water phases. The Examiner points out dexamethasone and decanoic acid are both lipid soluble and practically insoluble in water. Lastly, Example 3 of Table 1, comprises DEX and DA in combination, used in the treatment of inflammatory joint disorder selected from rheumatoid arthritis, osteoarthritis and injury induced arthritis in mammals.
The arguments over the rejection of claims 6-7 under 35 U.S.C. 103 over Pelikaan et al. (EP2606896A), as applied to claims 1-5 and 10-11 above Deng et al. (Maresin Biosynthesis and ldentification of Maresin 2,a New Anti-Inflammatory and Pro- Resolving Mediator from Human Macrophages. July2014 | Volume 9 | Issue 7 | e102362) is not persuasive. Applicant’s argument over claims 6-7 rejections depends on the validity of the previous arguments which were not found persuasive. The rejection is herewith maintained.
The arguments over the rejection of claims 8-9 under 35 U.S.C. 103 over Pelikaan et al. (EP2606896A), as applied to claims 1-5 and 10-11 above further in view of Sekhar et al. (WO 2007139887 A2) is not persuasive. The rejection is herewith maintained. Applicant’s argument over claims 8-9 rejections depends on the validity of the previous arguments which were not found persuasive. The rejection is herewith maintained.
The rejections are as below:
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-11 and 35-41 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, 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. The claims recite dexamethasone and decanoic acid dissolved in water. The Examiner points out dexamethasone and decanoic acid are lipid soluble and practically insoluble in water.
Claims 1-11 and 35-41 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, 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. The claimed limitation “dexamethasone is selected from dexamethasone ester" in line 1-2” is not proper. Dexamethasone is a specific compound.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claims 1-5, 10-11 and 35-41 are rejected under 35 U.S.C. 103 as being unpatentable over Pelikaan et al. (EP2606896A).
Pelikaan et al. teaches a formulation of Table 1, comprising decanoic acid, dexamethasone, and a sterile solution of sodium hyaluronate. The reference teaches a dose that is equivalent to 500-2,000 µg dexamethasone, which overlaps with at least 100 micrograms to 2.5 milligrams claimed. [0045] A conversion of the mass of Dexamethasone (molecular weight: 392.46 g/mol)) into molar amounts: 500 µg = about 1.27 µmol to 2,000 µg = about 5.10 µmol, again the resulting concentration range overlaps with the 800 pM to 100 nanomolar range. Additionally, a conversion of the exemplified emulsion 3 amount of decanoic acid would correspond to about 2.3 mM. [0047] Pelikaan et al. recites 80-99.9 wt.% of a continuous aqueous phase (reads on a pharmaceutical composition comprising an aqueous solution); and 0.01-20 wt.% of a dispersed lipid phase, wherein the emulsion contains 0.1-10% of hyaluronate by weight of said aqueous phase; and 0.01-50% of lipophilic glucocorticoid by weight of said lipid phase. (The formulation reads on a hydrogel. (claim 1)) The reference teaches the use of the emulsion for the treatment of inflammatory joint disorder selected from rheumatoid arthritis, osteoarthritis and injury induced arthritis in mammals. [0039] [0042]
While the reference teaches the dexamethasone of the pharmaceutical composition in the lipid phase, the reference also teaches “therapeutic synergism between hyaluronic acid and dexamethasone in the intra-articular treatment of osteoarthritis of the knee. Patients received a weekly intra-articular injection of 20 mg sodium hyaluronate and 0.4 mg dexamethasone phosphate in 2 ml phosphate buffer for 5 weeks.”
It would have been obvious to one of ordinary skill in the art at the time of filing to use dexamethasone phosphate in an aqueous solution. The motivation to use dexamethasone phosphate in an aqueous solution is because dexamethasone is lipid soluble, while dexamethasone phosphate is soluble. Hence, a skilled artisan would have reasonable expectation of success in achieving similar efficacy and results.
With respect to the concentration of decanoic acid, in the case where the claimed ranges “overlap or lie inside ranges disclosed 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). (MPEP § 2144.05(1)) Moreover, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[VW]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” /n re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Substitution of the acid addition salt formulation for an active pharmaceutical ingredient is obvious where the acid addition salt formulation has no effect on the therapeutic effectiveness of the active ingredient and the prior art suggests the particular anion used to form the salt. Pfizer v. Apotex, 82 USPQ2d 1321, 1336 (Fed. Cir. 2007). Moreover, one skilled in the art would expect various anions to provide salts having a range of properties, some of which would be superior, and some of which would be inferior, to any given salt. Id. 1338.
The recitations in claims 35-41 to synergistically effective to reduce inflammasome-mediated inflammation, IL-1beta concentration and PGE2, inhibit MRP4, and promote specialized pro-resolving lipid mediators, is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Claims 6-7 are rejected under 35 U.S.C. 103(a) as being unpatentable over Pelikaan et al. (EP2606896A), as applied to claims 1-5, 10-11 and 35-41 above Deng et al. MaresinBiosynthesisandldentificationofMaresin2,a New Anti-Inflammatory and Pro- Resolving Mediator from Human Macrophages. July2014 | Volume9 | Issue7 | e102362).
Pelikaan et al. fails to teach a lipid mediator.
Deng et al. teaches maresins are a new family of anti-inflammatory and pro- resolving lipid mediators biosynthesized from docosahexaenoic acid (DHA) by macrophages. Here we identified a novel pro-resolving product, 13R,14S-dihydroxy- docosahexaenoic acid (13R,14S-diHDHA), produced by human macrophages.
It would have been obvious to one of ordinary skill in the art at the time of the invention to treat osteoarthritis with 13R,14S-diHDHA. The motivation comes from the teaching in Deng et al. that maresins are a new family of anti-inflammatory and pro- resolving lipid mediators biosynthesized from docosahexaenoic acid (DHA) by macrophages. Here we identified a novel pro-resolving product, 13R,14S-dihydroxy- docosahexaenoic acid (13R,14S-diHDHA), produced by human macrophages. Hence, a skilled artisan would have reasonable expectation of success in achieving similar efficacy and results.
Claims 8-9 are rejected under 35 U.S.C. 103(a) as being unpatentable over Pelikaan et al. (EP2606896A), as applied to claims 1-5, 10-11 and 35-41 above further in view of Sekhar et al. (WO 2007139887 A2).
Pelikaan et al. fails to teach an amino acid.
Sekhar et al. teaches methods for promoting bone and joint health with certain compositions described herein or with optionally enriched extracts of plant material comprising such compositions. The composition may further comprise vitamins, minerals, coenzymes, organic or inorganic antioxidants or precursors thereof. Inclusive is the amino acids may be selected from the group L-alanine, L-arginine, L-aspartic acid, L-cystine, L-glutamic acid, L- glutamine, glycine, L-histidine, L-isoleucine, L- leucine, L-lysine, L-methionine, L-proline. L- serine, L-threonine, L-tryptophan, L- tyrosine and L-valine.
It would have been obvious to one of ordinary skill in the art at the time of the invention to treat joint health with tryptophan. The motivation comes from the teaching in Sekhar et al. that tryptophan is an amino acid used for promoting bone and joint health . Hence, a skilled artisan would have reasonable expectation of success in achieving similar efficacy and results.
Conclusion
No claims allowed.
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/LAYLA SOROUSH/ Primary Examiner, Art Unit 1622
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