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 .
DETAILED ACTION
Claims 1-15 are currently pending and a preliminary amendment to the claims filed on 12/11/2024 is acknowledged.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
Three (3) information disclosure statement (IDS) submitted on 12/30/2024; 01/09/2025; 04/28/2026 were filed before the mailing date of the instant first action on the merits. The submissions thereof are in compliance with the provisions of 37 CFR 1.97. It is noted that the foreign references have only been considered to the extent that an English language abstract, translation or statement of relevance has been provided to the examiner. Accordingly, the information disclosure statements have been considered by the examiner, and signed and initialed copies are enclosed herewith.
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.
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 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over JP 2016-204341A (IDS of 12/30/2024, hereinafter JP2016) in view of JP 2019-89574A (IDS of 12/30/2024, hereinafter JP2019).
Applicant claims the below claims 1 and 9 filed on 12/11/2024:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a medical/pharmaceutical nanoparticle carrier containing hyaluronic acid derivatives and phospholipid research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from nanoparticle carrier medicine, pharmacy, physiology and chemistry— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims (MPEP 2141.02); and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143)
JP2016 discloses hydrophilic base-in-oil type emulsion composition comprising (A) modified hyaluronic acid and/or salt thereof, (B) hydrophilic base component, and (C) oil (abstract); wherein the (A) derivative has the below formula wherein R1 represents a linear or branched alkyl or alkenyl group having 6 to 20 carbon atoms (abstract) that reads on the claimed hyaluronic acid derivative:
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; one example of this HA derivative include Hyalorepair® (see [0017] of JP2016, page 7 of translation), and the Hyalorepair® is C12-13 Alkyl Glyceryl Hydrolyzed Hyaluronate as evidenced by Kewpie (obtained from website: Hyalorepair® | Fine Chemicals | kewpie: (www.kewpie.com/en/finechemical/hyaluronic/hyalorepair.html) and Hyalorepair® contains glycerin backbone and hydrophobic group, and this evidentiary document was published in 2022-01-18. However, such factual document to disclose the characteristics and properties of that material needs not antedate the filing date. In this regard, please see MPEP2124: 2124 Exception to the Rule That the Critical Reference Date Must Precede the Filing Date [R-11.2013] IN SOME CIRCUMSTANCES A FACTUAL REFERENCE NEED NOT ANTEDATE THE FILING DATE. In the embodiment (Table 1 on page 11 of JP2016), the emulsion comprises (A) modified hyaluronic acid, soy lecithin that reads on the claimed phospholipid, i.e., phosphatidylcholine, and water; the external preparation contains pharmaceuticals, quasi-drugs, cosmetics, nucleic acid, fatty acid which is oil ([0036] of JP2016, page 7 of translation) which reads on the claimed water-insoluble substance; and the hydrophilic base oil-in-water emulsion composition is dispersed in an aqueous solvent and the dispersed phase has average particle size of 0.5 to 10 microns (=500nm – 100,000nm)([0034] of JP) that may read on the claimed nanoparticles; in the modified hyaluronic acid and / or salt thereof, the number of glycerin skeleton-containing groups contained in one structural unit of hyaluronic acid is 0.001 to 0.5 ([0017] of JP2016 and page 6 of translation) which may correspond to 0.1 to 50% modification rate; and the oil-in-water preparation method includes oil phase is dispersed in the aqueous phase ([0031]-[0033]) (instant claims 1 and 9, in part, and instant claims 3-8 and 10-15).
However, JP2016 does not expressly teach nanoparticle composition nanoparticles as claimed; and high-pressure emulsification treatment of instant claim 2. The deficiencies are cured by JP2019.
JP2019 discloses lipid nanoparticle useful as a carrier of a medicinal component and the lipid containing a hyaluronic acid derivative and glycerophospholipid (abstract and claim 1 of JP2019); the lipid nanoparticle carrier encapsulate medicinal component and such lipid nanoparticles are effective to selectively drug delivery ([0002] and [0006] of JP2019, and pages 2-3 of translation); and the form of the lipid nanoparticle is not particularly limited, and but examples of the form dispersed in an aqueous solvent include monolayer liposomes, multilamellar liposomes, spherical micelles, and amorphous layered structures; the method for producing lipid nanoparticles wherein all the lipid components are dissolved in an organic solvent, then dried with an aqueous solvent, and further emulsifying with high pressure jet emulsifier ([0044] of JP2019, and page 10, second para. of translation) which reads on the claimed production method. Finally the resulting aqueous dispersion of lipid nanoparticles is freeze-dried, and the component that the lipid nanoparticle encapsulates inside the particles wherein the component is selected from the group consisting of a low molecular compound, a low molecular nucleic acid, and a peptide ([0049] of JP2019, and page 10, the last second para of translation). Further the size of the lipid nanoparticle is preferably such that the average particle diameter is 500nm or less ([0033] of JP2019, and page 8, second para. of translation) that reads on the claimed nanoparticles. MPEP2144.05 states that [I]n 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).
It would have been obvious to modify the teachings of JP 2016 with lipid nanoparticles form of JP2019 in order to provide enhanced drug delivery by encapsulating the drug as taught by JP2019.
A person of ordinary skill in the art would have been motivated to modify the emulsion containing modified HA and phospholipid with lipid nanoparticle system of JP2019 because JP2019 teaches lipid nanoparticles comprising modified HA and phospholipid components and further teaches that such lipid nanoparticles can be prepared by conventional emulsification techniques, and JP 2016 teaches modified HA derivatives having glycerin-containing groups attached to the HA structure, with a controlled modification degree of 0.001 to 0.5, which provides a hydrophilic/hydrophobic balance suitable for interaction with lipid-containing system, and accordingly, the combination would have been obvious to achieve the claimed invention because the skilled artisan would have had a reasonable expectation of success in incorporating the known glycerin-modified hyaluronic acid derivative of JJP 2016 into the lipid nanoparticle composition carrier of JP2019 for effective delivery of drug into the target area.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined 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 combined references, especially in the absence of evidence to the contrary.
Conclusion
All examined claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/Primary Examiner, Art Unit 1613
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