DETAILED ACTION
Request for reconsideration of the application filed on 07/14/2026, is acknowledged. No amendment was made to the claims. Claims 1 and 14-18 are pending in the application and are considered on merits.
In response to reconsideration, the examiner modifies rejections over prior art established in the previous Office 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 .
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1 and 14-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Horiuchi et al. (Bioscience Reports, 2018, IDS) (Horiuchi) in view of Wong (US 5,610,274).
Regarding claim 1, Horiuchi teaches a method for measuring the cholesterol efflux capacity of an HDL-containing sample (abstract), the method comprises comprising:
(1) preparing liposomes comprising cholesterol that is at least partially labeled (page 2, par 7);
(2) freezing and thawing a suspension comprising the liposomes and porous beads, thereby clogging the liposomes inside the pores and preparing porous beads on which the cholesterol is immobilized (page 2, par 7);
(3) contacting the porous beads on which the cholesterol is immobilized with
the HDL-containing sample to be measured in a solution (page 3, par 2); and
(4) separating the porous magnetic beads from the solution and measuring the amount of cholesterol in the solution after separation of the porous beads, wherein the measured amount of cholesterol is based on a measured label signal intensity in the solution (page 3, par 2).
Horiuchi does not specifically teach that the porous beads are porous magnetic beads, wherein the porous magnetic beads are magnetic ceramic particles with a size of 5 to 400 μm having pores of 100 nm to 5 μm in diameter.
However, Wong teaches that the porous beads can be porous magnetic ceramic beads (col. 1, lines 59-63), wherein the porous ceramic magnetic beads are magnetic ceramic particles with a size of 5 to 400 μm (37-77 micron) having pores of 100 nm to 5 μm in diameter (3000 A) (col. 4, lines 9-11).
Horiuchi and Wong are analogous art because both relate to porous solid supports used in biochemical assay and separation procedures. Horiuchi teaches immobilizing cholesterol-containing liposomes in porous Sephacryl S-300 beads for use in a cholesterol-efflux assay and subsequently separating the beads from the assay solution by centrifugation. Wong teaches “[m]agnetic porous inorganic siliceous materials having a particle size of about 1 to about 200 microns useful as solid supports in various chromatography, immunoassays, synthesis and other separation and purification procedures.” (abstract). Thus, Wong expressly establishes that its porous magnetic ceramic particles are suitable for the same general intended use as Horiuchi’s porous gel beads—serving as solid supports in biochemical assays and subsequent separation procedures. One of ordinary skill in the art would therefore have been motivated to substitute Wong’s porous magnetic ceramic particles for Horiuchi’s porous gel beads because Wong identifies those particles as suitable assay supports and further teaches that “[s]eparation of magnetic solid supports is relatively easy and simple.” The substitution would have predictably retained Horiuchi’s porous support for freeze-thaw immobilization of the cholesterol-containing liposomes while permitting the resulting liposome-bearing particles to be separated magnetically instead of by repeated centrifugation.
Regarding claim 14, Horiuchi discloses a reagent kit for measuring the cholesterol efflux capacity of an HDL-containing sample (abstract), the reagent kit comprising porous beads on which cholesterol is immobilized (page 2, par 7), wherein the cholesterol is contained in liposomes, and wherein the liposomes are clogged inside the pores of the porous beads (page 2, par 7).
Horiuchi does not specifically teach that the porous beads are magnetic beads wherein the porous magnetic beads are magnetic ceramic particles with a size of 5 to 400 μm having pores of 100 nm to 5 μm in diameter.
Horiuchi does not specifically teach that the porous beads are porous magnetic beads, wherein the porous magnetic beads are magnetic ceramic particles with a size of 5 to 400 μm having pores of 100 nm to 5 μm in diameter.
However, Wong teaches that the porous beads can be porous magnetic ceramic beads (col. 1, lines 59-63), wherein the porous ceramic magnetic beads are magnetic ceramic particles with a size of 5 to 400 μm (37-77 micron) having pores of 100 nm to 5 μm in diameter (3000 A) (col. 4, lines 9-11).
Horiuchi and Wong are analogous art because both relate to porous solid supports used in biochemical assay and separation procedures. Horiuchi teaches immobilizing cholesterol-containing liposomes in porous Sephacryl S-300 beads for use in a cholesterol-efflux assay and subsequently separating the beads from the assay solution by centrifugation. Wong teaches “[m]agnetic porous inorganic siliceous materials having a particle size of about 1 to about 200 microns useful as solid supports in various chromatography, immunoassays, synthesis and other separation and purification procedures.” (abstract). Thus, Wong expressly establishes that its porous magnetic ceramic particles are suitable for the same general intended use as Horiuchi’s porous gel beads—serving as solid supports in biochemical assays and subsequent separation procedures. One of ordinary skill in the art would therefore have been motivated to substitute Wong’s porous magnetic ceramic particles for Horiuchi’s porous gel beads because Wong identifies those particles as suitable assay supports and further teaches that “[s]eparation of magnetic solid supports is relatively easy and simple.” The substitution would have predictably retained Horiuchi’s porous support for freeze-thaw immobilization of the cholesterol-containing liposomes while permitting the resulting liposome-bearing particles to be separated magnetically instead of by repeated centrifugation.
Regarding claim 15, Horiuchi teaches a method for obtaining information on a condition related to the cholesterol efflux capacity of a subject or risk thereof (abstract), the method comprising measuring the cholesterol efflux capacity of an HDL-containing sample derived from the subject using porous beads on which cholesterol is immobilized (page 3, par 2), wherein the cholesterol is contained in liposomes, and wherein the liposomes are clogged inside the pores of the porous beads (page 2, par 7).
Horiuchi does not specifically teach that the porous beads are magnetic beads, wherein the porous magnetic beads are magnetic ceramic particles with a size of 5 to 400 μm having pores of 100 nm to 5 μm in diameter.
However, Wong teaches that the porous beads can be porous magnetic ceramic beads (col. 1, lines 59-63), wherein the porous ceramic magnetic beads are magnetic ceramic particles with a size of 5 to 400 μm (37-77 micron) having pores of 100 nm to 5 μm in diameter (3000 A) (col. 4, lines 9-11).
Horiuchi and Wong are analogous art because both relate to porous solid supports used in biochemical assay and separation procedures. Horiuchi teaches immobilizing cholesterol-containing liposomes in porous Sephacryl S-300 beads for use in a cholesterol-efflux assay and subsequently separating the beads from the assay solution by centrifugation. Wong teaches “[m]agnetic porous inorganic siliceous materials having a particle size of about 1 to about 200 microns useful as solid supports in various chromatography, immunoassays, synthesis and other separation and purification procedures.” (abstract). Thus, Wong expressly establishes that its porous magnetic ceramic particles are suitable for the same general intended use as Horiuchi’s porous gel beads—serving as solid supports in biochemical assays and subsequent separation procedures. One of ordinary skill in the art would therefore have been motivated to substitute Wong’s porous magnetic ceramic particles for Horiuchi’s porous gel beads because Wong identifies those particles as suitable assay supports and further teaches that “[s]eparation of magnetic solid supports is relatively easy and simple.” The substitution would have predictably retained Horiuchi’s porous support for freeze-thaw immobilization of the cholesterol-containing liposomes while permitting the resulting liposome-bearing particles to be separated magnetically instead of by repeated centrifugation.
Regarding claim 16, Liposomes generally range from 50 nm to 500 nm in diameter for most biomedical applications, with a mean size of around 100-150 nm typically favored for optimal cellular uptake and stability. Thus, liposomes in Horiuchi should have average particle size of 10 to 300 nm.
Regarding claim 17, Horiuchi in view of Wong teaches the method of claim 1 as discussed above.
Wong teaches:
“The magnetic products of the invention have a pore diameter of from about 60 to about 6,000 Angstroms (A), preferably between about 300 A to about 5,000 A.” (col. Lines 1-3).
Wong further discloses in Example I:
“5 gm of controlled pore glass (CPG, pore diameter of 3000 Angstrom, 37–77 microns) was added to a 70 ml container containing 50 ml of deionized water.” (col. 4, lines 9-11).
A pore diameter of 3,000 Å corresponds to 300 nm, which falls directly within the claimed range of 300 nm to 2 µm. Wong’s magnetic controlled-pore glass therefore expressly satisfies the claimed pore-diameter limitation. It would have been obvious to use Wong’s 300-nm-pore magnetic porous particles as the porous support in Horiuchi’s cholesterol-efflux assay for the reasons discussed regarding claim 1, including Wong’s express teaching that its magnetic porous inorganic particles are suitable solid supports for assay and separation procedures.
Regarding claim 18, Horiuchi in view of Wong teaches the method of claim 1 as discussed above.
Wong teaches:
“Particle size is from about 1 to about 200 microns, preferably from about 5 to about 50 microns.” (col. 2, lines 6-8)
Wong additionally discloses:
“5 gm of controlled pore glass (CPG, pore diameter of 3000 Angstrom, 37–77 microns) was added to a 70 ml container containing 50 ml of deionized water.” (col. 4, lines 9-11).
Wong’s disclosed particle-size range of 5-50 µm substantially overlaps the claimed range of 10–200 µm. Moreover, Wong’s specific particles measuring 37-77 µm fall entirely within the claimed range of 10-200 µm. Wong therefore expressly teaches porous magnetic ceramic particles having the claimed particle size.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 14-15 have been considered but are moot in view of new ground of rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to XIAOYUN R XU, Ph. D. whose telephone number is (571)270-5560. The examiner can normally be reached M-F 8am-5pm.
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/XIAOYUN R XU, Ph.D./ Primary Examiner, Art Unit 1797
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