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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 5, 2026 has been entered. The original restriction election is carried over from the response to the office action mailed on May 21, 2025.
Status of the Claims
Claims 1-34 are currently pending and Claims 1-11 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 January 20, 2026:
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 concentration of Dexamethasone is 28 folds higher than the upper bound of 900 nM claimed, therefore, there is no overlap or similarity.
Applicant re-argues the synergistic effects of DA and dex combination.
In response, the Examiner points to Example 1, Table 1:
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582
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Based on Applicant’s assumption that the units of the decanoic acid and dexamethasone being milligrams, a conversion of the amount 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. This amount is close to the subclinical concentration argued of the dexamethasone and within the claimed range of the decanoic acid. The Examiner points out Applicant’s specification does not have a single recitation for the end value of 900 nM as newly claimed. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of Americav.Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) “The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.”). See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Applicant’s arguments are not persuasive.
Furthermore, the data presented for synergistic effects are dose dependent, specifically, showing the best efficacy at the tested higher concentration of dexamethasone compared to the lower concentrations. These dose dependent effects do not appear to be unexpected, as routinely optimizing the amount of an active ingredient depending on the particular condition being treated, for example, with higher concentrations could result in greater therapeutic effect.
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Applicant’s specification does not have a single recitation for the subclinical concentration range of 900 nM, as newly claimed.
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, 900 nM 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, and 10-11 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.
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 and 10-11 above Deng et al. MaresinBiosynthesisandldentificationofMaresin2,a NewAnti-InflammatoryandPro- ResolvingMediator fromHumanMacrophages. 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 and 10-11 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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 19079373 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the references claims teaches a pharmaceutical composition comprising dexamethasone and decanoic acid at the same concentration as the instant application.
Reference claims 1-4 teaches instant claims 1-4. Reference claim 5 teaches instant claim 5, drawn to the same. Reference claims 6-7, drawn to lipid mediator, teaches instant claims 6-7, drawn to the same. Reference claims 8-9, drawn to one or more amino acids, teaches instant claims 8-9, drawn to the same. Reference claim 10, drawn to other forms of dexamethasone, teaches instant claim 10. Reference claim 11, drawn to the pharmaceutical composition comprising a hydrogel, teaches instant claim 11.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims allowed.
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/LAYLA SOROUSH/ Primary Examiner, Art Unit 1622