DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-11) in the reply filed on 6/23/2026 is acknowledged. The traversal is on the ground(s) that the shared technical feature, as amended, constitutes a special technical feature and satisfies the unity of invention requirement. This is not found persuasive because the shared technical, as amended, does not make a contribution over the prior art. The arguments in the remarks filed 6/23/2026 will be addressed below to the extent that they apply to the current rejections.
The shared technical feature, as amended, is a nanopreparation comprising a glucocorticoid and a nanocarrier composed of a phospholipid and an auxiliary agent, wherein the phospholipid and auxiliary agent are present in a mass ratio of 1:20 to 20:1, and the auxiliary agent comprises one or more selected from the group consisting of polyoxyethylene 35 castor oil, polyoxyethylene 40 castor oil, polyoxyethylene 40 hydrogenated castor oil, and polyoxyethylene 60 hydrogenated castor oil. JPH04244018A (published 9/1/1992, hereinafter JP’018) teaches a drug-encapsulating liposome [0012] comprising phospholipids and nonionic surfactant, wherein the nonionic surfactant is preferably polyoxyethylene hydrogenated castor oil [0005-0006]. JP’018 teaches that the nonionic surfactant may be 150% by weight or more relative to the phospholipids [0007], which equates to a 3:2 ratio of nonionic surfactant to phospholipid or more. JP’018 teaches that the encapsulated drug may be prednisolone [0012] and further teaches that a suitable polyoxyethylene hydrogenated castor oil is HCO-60 ( polyoxyethylene 60 hydrogenated castor oil) [Examples 1 and 2].
Applicant also cites unexpected effects as support that the claimed composition makes a contribution over the prior art. This is not persuasive. Applicant has not explained why the results are significant and unexpected, nor demonstrated that the results are unexpected compared to the closest prior art (see rejection below). Applicant states that neither of the previously cited references contemplated the effects demonstrated by the claimed invention. However, it is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. MPEP 2144. As newly cited reference JP’018 teaches the identical structure, the same technical effects must necessarily be present in the composition of JP’018. A composition and its properties are inseparable; thus, the claimed properties are presumed to be inherent. MPEP 2112.01.
The requirement is still deemed proper and is therefore made FINAL.
Claim 12 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 6/23/2026.
Specification
The Specification references the Drawings using designations such as “FIG. 1” and “FIG. 2”. However, there are no corresponding labels of “FIG. 1” and “FIG. 2” in the replacement drawings. Conversely, the replacement sheet is labeled with references such as “Fig. 1a” and “Fig. 2a”, which do not appear in the Specification.
The use of the term Kolliphor HS15, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 1 is/are objected to because of the following informalities:
Claim 1 recites “nanopreparation formulated for administrating into a joint cavity”. This should read “administering”.
Claim 1 recites “the auxiliary agent comprises one or more selected from the group consisting of”. Examiner suggests amending to “the auxiliary agent comprises one or more auxiliary agents selected from the group consisting of” for clarity.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-3 and 10-11 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.
Claim 1 recites “(1:20)” and “(20:1)”. The parenthetical recitations of “(1:20)” and “(20:1)” render the claim indefinite because it is unclear whether the recitations in parentheses are part of the claimed invention. See MPEP 2173.05(d). For purposes of compact prosecution, the instant limitation will be interpreted to read “a mass ratio of the phospholipid to the auxiliary agent is “1:20 to 20:1”.
Claim 2 recites “wherein the glucocorticoid comprises one or more of clobetasol propionate, … , and triamcinolone acetonic palmitate”. “Comprising” is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim. MPEP 2111.03. The use of “and” also suggests that all the listed elements are required. In contrast, the use of “one or more” seems to imply that only one of the named elements must be present. Thus, the use of this contradicting language renders the scope of the claim indefinite. For purposes of compact prosecution, the instant limitation is being interpreted to read “wherein the glucocorticoid comprises one or more of clobetasol propionate, … , or triamcinolone acetonic palmitate”.
Claim 3 recites “wherein the phospholipid comprises one or more of natural soybean phospholipid, natural egg yolk phospholipid, and synthetic phospholipid”. “Comprising” is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim. MPEP 2111.03. The use of “and” also suggests that all the listed elements are required. In contrast, the use of “one or more” seems to imply that only one of the named elements must be present. Thus, the use of this contradicting language renders the scope of the claim indefinite. For purposes of compact prosecution, the instant limitation is being interpreted to read “wherein the phospholipid comprises one or more of natural soybean phospholipid, natural egg yolk phospholipid, or synthetic phospholipid”.
Claim 10 recites “(1:10)” and “(10:1)”. The parenthetical recitations of “(1:10)” and “(10:1)” render the claim indefinite because it is unclear whether the recitations in parentheses are part of the claimed invention. See MPEP 2173.05(d). For purposes of compact prosecution, the instant limitation will be interpreted to read “a mass ratio of the phospholipid to the auxiliary agent is “1:10 to 10:1”.
Claim 11 recites “wherein a drug load of the glucocorticoid is 0.5%-20%”. This renders the scope of the claim indefinite because it is unclear if the recited percentages are meant to indicate percentages in terms of weight %, volume %, mole %, or other unit of measurement. Additionally, it is unclear if the percentage is expressed relative to the entire nanopreparation (i.e. including the drug load) or is meant to be an expression of the ratio of glucocorticoid to the other ingredients. For purposes of compact prosecution, if the prior art teaches the recited values, it will be considered to read on the instant limitations.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over JPH04244018A (published 9/1/1992, hereinafter JP’018).
Regarding claims 1-2 and 10-11, JP’018 teaches a drug-encapsulating liposome [0012] comprising phospholipids and nonionic surfactant, wherein the nonionic surfactant is preferably polyoxyethylene hydrogenated castor oil [0005-0006]. JP’018 teaches that the nonionic surfactant may be 150% by weight or more relative to the phospholipids [0007], which equates to a 3:2 ratio of nonionic surfactant to phospholipid or more. The range taught in the prior art overlaps with and renders obvious the instantly claimed range. MPEP 2144.05. JP’018 teaches that the encapsulated drug may be prednisolone [0012] and further teaches that a suitable polyoxyethylene hydrogenated castor oil is HCO-60 (polyoxyethylene 60 hydrogenated castor oil) [Examples 1 and 2].
Examiner would like to note that the instant recitation of “formulated for administrating into a joint cavity” is interpreted as intended use and does not constitute a functional limitation. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. MPEP 2111.02. In the instant case, the preamble does not add a structural distinction to the claim. The prior art teaches a formulation that is capable of being injected (see Example 1), thus the prior art formulation is capable of performing the intended use as recited and meets the claim.
JP’018 does not explicitly discuss the release profile of the drug-encapsulating liposome. However, the instant specification states that the long-term sustained release effect of the claimed composition is achieved when the nanopreparation is composed of phospholipid and polyoxyethylene castor oil [Specification para. 0007]. As JP’018 teaches the claimed structure, the same sustained-release profile must necessarily be present in the composition of JP’018. A composition and its properties are inseparable; thus, the claimed properties are presumed to be inherent. MPEP 2112.01.
Regarding claim 3, JP’018 teaches that the phospholipid may comprise of synthetic phospholipids, egg yolk lecithin, soy lecithin, or any mixture thereof [0008].
Regarding claim 11, the drug encapsulating liposomes of JP’018 have a size of 100 nm [0015; see also Example 1]. JP’018 does not explicitly teach this particle size to be an average particle size. However, the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise. JP’018 teaches Reference Example 1 which comprises of 40 mg of α-tocopherol as a reference drug, 500 mg of soy phosphatidylcholine, and 500 mg of polyoxyethylene 60 hydrogenated castor oil [0021]. Reference Example 1 was prepared as an injection [0021, see Example 1]. JP’018 further teaches that the drug to be encapsulated may be prednisolone [0012], thus it would be obvious to include prednisolone in the same amount that Reference Example 1 teaches an encapsulated drug compound to be present in. 40 mg of reference drug in Reference Example 1 equates to a drug concentration (reads on drug load) of 3.85% by weight, relative to the entire nanopreparation (40 / (40+500+500) x 100 = 3.85%). This amount falls within the claimed drug load range of 0.5% to 20% and renders the instant limitation prima facie obvious.
Claims 5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over JPH04244018A (published 9/1/1992) as applied to claim 1 above, and further in view of CN112773776A (published 5/11/2021, hereinafter CN’776).
Regarding claims 5 and 8, CN’776 teaches a drug-loaded micellar nanoparticle [0005] that self-assembles upon the addition and mixing of a lipophilic surfactant and one or more hydrophilic surfactants (reads on auxiliary agent) to an aqueous solution [0012; 0028]. The micellar nanoparticle may comprise of poorly water-soluble drugs including dexamethasone and hydrocortisone [0044]. The lipophilic surfactant may be selected from phospholipid compounds [0017-0023] and the hydrophilic surfactant may comprise of polyoxyethylene castor oil [0099]. CN’776 teaches polyethylene glycol-15 hydroxystearate as another suitable hydrophilic surfactant [0032]. The mass ratio of total lipophilic surfactant to hydrophilic surfactant/auxiliary agent may range from 1:99 to 999:1 [0011]. It would be obvious to one of ordinary skill before the effective date of the instantly claimed invention to modify the teachings of JP’018 with that of CN’776 to arrive at the instantly claimed composition with a reasonable expectation of success. The selection of a known material based on its suitability for its intended use is prima facie obvious. MPEP 2144.07. Furthermore, “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Polyoxyethylene 60 hydrogenated castor oil and polyethylene glycol-15 hydroxystearate are both taught in the art as hydrophilic surfactants suitable for the formation of drug-encapsulating liposomes comprising a phospholipid and a hydrophilic surfactant. Thus, it would be prima facie obvious for a skilled artisan modify the teachings of JP’018 with that of CN’776 to select both polyoxyethylene 60 hydrogenated castor oil and polyethylene glycol-15 hydroxystearate and arrive at the instantly claimed invention.
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over JPH04244018A (published 9/1/1992) as applied to claim 1 and 8 above, and further in view of CN112773776A (published 5/11/2021) and CN1823735A (published 8/30/2006, cited on the 8/24/2025 IDS, hereinafter CN’735).
Regarding claim 6, this claim recites the nanopreparation of claim 1 wherein the auxiliary agent comprises polyoxyethylene 60 hydrogenated castor oil, polyoxyethylene 35 castor oil, and polyethylene glycol 15-hydroxystearate. The composition of claim 8, wherein the auxiliary agent comprises polyoxyethylene 60 hydrogenated castor oil and polyethylene glycol 15-hydroxystearate, has been made obvious in the above rejection over JP’018A and CN’776. The analysis for the composition of claim 8 will not be repeated herein. CN’735 teaches a self-assembling precursor liposome comprising a poorly-soluble drug, a polyethylene glycol modifier, and a phospholipid [0021-0022]. The polyethylene glycol modifier may be a polyoxyethylene type nonionic surfactant comprising polyoxyethylene castor oil or polyoxyethylene hydrogenated castor oil [0026]. CN’735 teaches that suitable surfactants include Cremophor EL (polyoxyethylene 35 castor oil) and Cremophor RH60 (polyoxyethylene 60 hydrogenated castor oil) [0027]. It would be obvious to one of ordinary skill before the effective date of the instantly claimed invention to modify the teachings of JP’018 with that of CN’776 and CN’735 to arrive at the instantly claimed composition with a reasonable expectation of success. The selection of a known material based on its suitability for its intended use is prima facie obvious. MPEP 2144.07. Furthermore, “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Polyoxyethylene 60 hydrogenated castor oil ,polyethylene glycol-15 hydroxystearate, and polyoxyethylene 35 castor oil are taught in the art as hydrophilic surfactants suitable for the formation of drug-encapsulating liposomes comprising a phospholipid and a hydrophilic surfactant. Thus, it would be prima facie obvious for a skilled artisan modify the teachings of JP’018 with that of CN’776 and CN’735 to select polyoxyethylene 60 hydrogenated castor oil, polyoxyethylene 35 castor oil, and polyethylene glycol-15 hydroxystearate and arrive at the instantly claimed invention.
Regarding claim 7, this claim recites polyoxyethylene 60 hydrogenated castor oil and polyoxyethylene 35 castor oil. These limitations have been previously addressed and made obvious. The analysis for these limitations will not be repeated herein.
Conclusion
No claims are allowed.
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/AMANDA LYNN CHI/Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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