DETAILED ACTION
The Office Action is in response to the Applicant's reply filed May 8, 2026 to the non-final rejection made on March 25, 2026.
Status of the Claims
Claims 1-41 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 in view of amendments made to the claims. The rejection is herewith withdrawn.
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 not persuasive. The rejection is herewith maintained. The Examiner points out that, the argued and Declaration of 5/8/26, amounts of 100 nM is not a subclinical concentration in the pharmaceutical composition, but relates to administration to THP1-HMGB1 Lucia human monocytic cells which should not correlate to a therapeutic dose given to a subject. In fact, Applicant’s dose amounts of at least 100 ug to 2.5 mg, as claimed, are related to the pharmaceutical composition. In fact, these amounts do not correspond to a subclinical amount of dexamethasone.
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 synergistic effects of DA and low-dose Dex combination, while pointing to data in the Bar-Or Declaration.
In response, the Examiner states the amounts of 100 nM argued is not a subclinical concentration in a pharmaceutical composition. Administration to THP1-HMGB1 Lucia human monocytic cells should not correlate to a therapeutic dose given for treatment. In fact, Applicant’s claimed dose amounts of at least 100 ug to 2.5 mg are related to the pharmaceutical composition. These amounts fall within the scope of the prior art, and are not subclinical. Applicant’s arguments are not persuasive.
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 ODP rejection over Application No. 19079373 is withdrawn in view of the T.D. filed and approved on 5/8/26.
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 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 Examiner points out that the claims recite the term subclinical, which is contrary to the ordinary meaning of subclinical amounts of dexamethasone. For example, 100 micrograms of dexamethasone is not a subclinical concentration, but is clinically relevant. Subclinical does not appear to be the accurate description of the claimed concentration range.
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. A conversion of the exemplified amount of 0.01mg dexamethasone into nanomolar (as in the claims) in the 25 mL emulsion (using a molar mass of 392.46 g/mol of dexamethasone) would correspond to about 1019 nM and the amount of decanoic acid would correspond to 2.32 mM. Pelikaan et al. recites 80-99.9 wt.% of a continuous aqueous phase; 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))
While the reference teaches the components of the claim, the reference fails to specify the amounts, as claimed.
With respect to the amounts, 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.
Contact Information
The arguments are not persuasive and the rejection is made FINAL.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/LAYLA SOROUSH/ Primary Examiner, Art Unit 1622
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