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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/16/26 has been entered.
Claim Status
The claims are newly amended.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 2, 3, 6, 7, 8, 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mori (US Pub.: 2020/0017365) and in view of Ren (CN 101187060) and in view of Kashara (JP 2004/269653).
Mori teaches a hydrotalcite (title) particle (abstract) that is surface treated (para. 48). The hydrotalcite composition has the formula:
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94
474
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(abstract). M2+ is a divalent metal and M3+ is a trivalent metal. An- is an n valent anion, where n is an integer from 1 to 6 (abstract). The x is from 0.17 to 0.36. m is from zero to 10 (abstract). This formula matches the formula of Claim 1.
As to the size, Mori teaches that the primary particles have an average width of 5 to 200nm (abstract). Mori describes monodispersity, but not using the same parameters to determine this feature, which is the average width of the primary particle/average diameter in suspension x 100.
As to the surface treatment to hydrotalcite ratio, the surface treatment of the hydrotalcite is from 0.01 to 20wt% (para. 48). Mori does not disclose a higher range of 25-50 mass% or surface treatment. This feature is disclosed by the Kashara reference.
The width of the particle, according to the specification, is defined as “the long diameter measured as the length of the diagonal sides of the hexagon” (see published specification, para. 32). The diameter, as described by the equation is not defined. However, since the specification describes the width as “the long diameter”, where the width is measured across the flat surface of the particle (see Fig.1 of the Drawings), then the diameter, according to the specification is across the front face of the particle. If the width is the longest direction across the flat surface, then the diameter would be the direction across the particle because the direction perpendicular to the width would give the same length. Given that the value of the numerator divided by the denominator is at least 75% or higher, this describes a particle that has a greater length than diameter (the length is longer than the width).
As to this monodispersity feature, Ren describes a method for preparing a needle-like or sheet-like nano-single crystal magnesium aluminum hydrotalcite (para. 2). When making their product, Ren describes use of a modifier, which controls the growth shape of the magnesium aluminum layered double hydroxide crystals (para. 57) to produce a sheet-like nanocrystalline magnesium aluminum hydrotalcite (para. 65). This is more favorable over a spherical grain because a spherical grain becomes a stress point during tensile and fracture processes (para. 43), thereby making the product weaker. As to the dimensions, Ren teaches that the product made can have a needle-like configuration, where the diameter is 10-20 and the length is 60-130nm (para. 67) or a wider dimension, such that the thickness is 10-20nm and the diameter is 50-100nm (para. 70). Therefore, with the needle-like configuration, the monodispersity would be well greater than 75%.
Although the value of the longest diameter across the face of the sheet in Ren divided by the shortest length across the sheet is not calculable, since Ren describes adjusting the modifier in order to adjust the dimensions of the hydrotalcite, to include rendering the diameter so small that the particle is a needle (giving it high monodispersity), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the modifier, as taught by Ren in order to optimize the shape to obtain the desired properties, such as strength in the hydrotalcite product.
Therefore, it would have been obvious to one having ordinary skill in the art to have determined the optimum value of a cause effective variable such as shape and dimension optimization through routine experimentation in the absence of a showing of criticality. In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990).
As to how the dimensions of the particle are calculated, according to Claim 1, the references do not specifically describe calculating the particle using the steps described by Claim 1 (by suspending the hydrotalcite in a liquid medium at a concentration of 50g/L or less by agitation without dispersion-facilitating treatments using deionized water or physiological isotonic solution. However, given that Ren and Mori describe the length and width of their particle, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the measurement used to determine the dimensions of their particle is effective and an accurate reflection of the size and dimensions of those particles.
Kasahara describes a resin film composition (title) that is made using inorganic particles used as a light diffusing agent (para. 13). One of these inorganic particles used can include hydrotalcite for use in promoting transparency and light transmission (para. 13). These particles are used due to their excellent dispersibility and uniformity (para. 20). The surface of the inorganic particles can be coated with a surface treating agent to enhance the dispersibility and stability of the particles (para. 21). As to the amount, Kasahara explains that the amount used is not particularly limited, but the amount used is usually from 0.1 to 30 weight % (para. 26). In the context of the paragraph, Kashara is describing the amount of surface treating agent relative to the inorganic particle (para. 26). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the amount of surface treating agent added to the particle is in terms of the inorganic particle.
Therefore, since dispersibility is desirable and adding a surface treatment agent from 0.1-30wt% is known to be effective for particle dispersibility, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the surface treatment agent in an amount of 0.1-30wt%, as taught by Kashara for use with the inorganic particle of Mori and Ren because Kashara explains that this amount is usually used to promote dispersibility of inorganic particles in a resin film material to promote transparency and light transmission.
As to Claim 2, Mori teaches that the average width of the primary particle is from 38-68 (Table 2) and the average width of the secondary particles is from 45-85 nm (Table 2). These are all less than 120nm, as required by Claim 2.
As to Claim 3, Mori teaches that the surface treatment agent can be an anionic surfactant, cationic surfactant, silane coupling agent, phosphoric acid ester-based treatment agent, titanate coupling agent, aluminum coupling agent, a silicone-based treatment agent, water glass and the like (para. 48).
As to Claim 6, Mori teaches that the hydrotalcite is suspended in a solvent that can be water (para. 53).
As to Claim 7, Mori teaches that the surface treatment step uses some deionized water (para. 100) and that this treatment was a suspension (para. 101).
As to Claim 8, Mori teaches that the monodispersity is 50% or greater (abstract) or can be 80% or greater (para. 46). As to the solvent, Mori describes using water (see above), but Mori does not teach that the solvent used is a physiological isotonic solution. Mori teaches formation of an aqueous, water soluble salt solution (see example 1). This can be considered a physiological isotonic solution.
As to Claim 9, Mori teaches that a complexing agent may be present between the layers of the hydrotalicite (para. 64). This can be considered a functional molecular.
Claim(s) 4, 5, 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mori, Ren and Kashara as applied to claim 1 above, and further in view of Wang “Recent Advances in the Synthesis and Application of Layered Double Hydroxide Nanosheets”, attached.
Mori does not describe use of a functional molecular between the layers of the hydrotalcite.
Wang describes mothers of modifying layered double hydroxide (LDH) compositions (title and pg. 4124, right col, last para). Various LDH used can include hydrotalcite (page 4129, right col, para. 2). The reference explains that delamination of LDH produces thin platelets (pg. 4124, right col, last para), which are useful for a variety of applications, such as electronics and mechanical materials (page 4124, right col, para. 2). Other uses for delaminated LDH are described in section 3, which span catalysis and adsorption (page 4132, section 3, para. 1). In various applications, Wang teaches that the LDH nanocomposites can be delaminated and exfoliatated with polymers (see Fig. 16) and/or insertion with epoxy/amino compounds (Fig. 17). Other compounds that can be inserted into the layers are described on page 4136, Fig. 20. Wang explains that these LDH can be adapted with other molecules for catalytic activities (page 4146, left col, para. 1).
In some processes, Wang teaches that the LDH can be first exfoliated into nanosheets using an exfoliating agents (page 4146, left col, para. 2) and surface functionalized with compounds for use of their catalytic activity (page 4146, left col, para. 2, using iron). Some other ligands that are useable can include amino acid, which is an efficient chiral catalyst (page 4146, left col, last para). Use of amino acids in the layers of a LDH nanosheets can be effective in epoxidation and other catalysis reactions (page 4146, right col, para. 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add amino acids to the layers of the LDH, as taught by Wang for use with Mori, Ren and Kashara because amino acids used within the LDH are effective for certain catalytic reactions and Wang explains that the insertion of different compounds into the LDH by delamination and then insertion of these compounds are effective for a wide variety of uses and applications.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mori, Ren and Kashara as applied to claim 1 above, and further in view of Wang “Recent Advances in the Synthesis and Application of Layered Double Hydroxide Nanosheets” and in view of Liang (CN 109432424).
As to Claim 11, Wang explains that delamination of LDH produces thin platelets (pg. 4124, right col, last para), which are useful for a variety of applications, such as electronics and mechanical materials (page 4124, right col, para. 2). Alternatively, Wang teaches that the LDH material can contain drugs and can be part of a drug delivery system (see page 4140, left col. second to last para).
Wang does not describe that the anti-cancer drug includes a pharmaceutically acceptable carrier.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the hydrotalcite of Mori, Ren and Kashara for use in an anti-cancer drug, as taught by Wang because Wang explains that these hydrotalcite compounds are effective for use in anti-cancer drugs in lieu of other applications, such as electronics and other uses.
As to the use of a carrier with the anti-cancer drug, Liang describes a hydrotalcite compound used for delivering tumor therapy (title). The hydrotalcite used to treat cancer and tumor cells can be paired with a brucite carrier for use with the hydrotalcite (Claims 1 and 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a brucite carrier with the anti-cancer drug, as taught by Liang for use with the cancer drug applied to a hydrotalcite, as taught by Wang with the hydrotalcite of Mori, Ren and Kashara because Liang explains that use of a brucite carrier with the anti-cancer drug is known to yield predictable anti-cancer drugs.
Conclusion
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/SHENG H DAVIS/Primary Examiner, Art Unit 1732 June 8, 2026
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