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 .
Status of the Claims
Claims 3, 6, 8-9, 11-15, 18, 20-22, and 24-28 are pending in the application.
Claims 12-15, 18, 20, and 24-28 are withdrawn.
Claims 3, 6, 8-9, 11, and 21-22 are the subject of this office action.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 13 January 2026 has been entered.
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.
Claims 3, 6, 8-9, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Anteo
Diagnostics Limited (AU 2016100182 A4, IDS entered), hereinafter Anteo, in view of OPS Diagnostics (OPS Diagnostics. Magnetic Tips-12 Pack. SKU: MGTP 12-03. 29 October 2017. Retrieved from the Internet < https:/ /opsdiagnostics.com/magnet-tips-12-pack-p358.html>; previously cited).
Regarding claims 3 and 6, Anteo teaches a method for removing an interference from a biological sample (Pg. 2, Ln. 22-27: a method to remove or decrease interference in an analyte. In some embodiments, the analyte is a bodily fluid or biological sample), the method comprising:
Combining the sample with a lyophilized particle, said particle being from 0.050 micrometers to 3 micrometers in diameter, comprising a capture moiety that binds the interference to provide a mixture (Pg. 3: invention comprises an apparatus for use in removing or decreasing interference in an analyte. The apparatus may be a magnetic bead which comprises an immobilized member of a binding pair, wherein the member of the binding pair is an antibody, antigen, Fab, SdAb, immunoglobulin, etc. that specifically binds the interfering substance; Pg. 14-15: “Uniform size, 1.0 to 3.0 micron, paramagnetic microparticles, functionalized with Mix&GoTM and coated with HAAA and/or MASI specific blocker(s)…This approach is the addition, mixing, and removal of the magnetic particles can easily be automated…With magnets to pull the magnetic beads to the sides of the sample tube as only the targeted interference will be captured and bound (sequestered) to the sample tube’s wall via the magnetic particles and magnets, while the supernatant in the sample tube will now be depleted and free of such interreference as well as depleted and free of the magnetic particles which could interfere in the assay if still present in the sample.”; Pg. 15, Ln. 27:, “magnetic beads dried/lyophilized in the primary sample tube”; Pg. 14, Ln. 6: uniform size 1.0 to 3.0 micron paramagnetic particles);
wherein the capture moiety is mouse IgG, sheep IgG, goat IgG, rabbit IgG, cow IgG, pig IgG or horse IgG (Pg. 18, Ln. 3-5: beads used in the method may be mouse IgG beads, goat IgG beads, sheep IgG beads, etc);
Mixing the mixture to provide particle complexes to the interference (Pg. 19, Ln. 8-10: Mix&Go Secondary tube + Mix&Go beads pretreatment- sample is transferred (aspirated and dispensed) into the Mix&Go specific secondary tube, and Mix&Go bead(s) are added to the sample, mixed, and removed with magnet”); and
Removing or eliminating the particle complexes to provide a depleted solution, thereby decreasing or reducing the amount of the interference (Pg. 14-15:, “Uniform size, 1.0 to 3.0 micron, paramagnetic microparticles, functionalized with Mix&GoTM and coated with HAAA and/or MASI specific blocker(s)…This approach is the addition, mixing, and removal of the magnetic particles can easily be automated…With magnets to pull the magnetic beads to the sides of the sample tube as only the targeted interference will be captured and bound (sequestered) to the sample tube’s wall via the magnetic particles and magnets, while the supernatant in the sample tube will now be depleted and free of such interreference as well as depleted and free of the magnetic particles which could interfere in the assay if still present in the sample”); and
Anteo further teaches the method as a process of creating a depleted sample for providing increased accuracy in downstream diagnostic testing (Pg. 16, Ln. 8-14: The Anteo Mix&GoTM technology can be used to prepare functionalized sample tubes, as well as paramagnetic particles for subsequent binding of functionally active blocking reagents for sample pre-treatment to mitigate, remove, and/or eliminate heterophiles and/or manufacture assay-specific interferences from patient specimens prior to testing these specimens on a given analyzer; Pg. 11, Ln. 1-6: the serum depletion approach can be used to develop new solid phase extraction products to support the LC-MS/MS diagnostic market for simple, inexpensive, and automatable serum depletion of target analytes for subsequent elution and analysis by LC-MS/MS, as well as the molecular diagnostics market for sample preanalytical processing and nucleic acid purification and concentration for accurate, reproducible, clinically relevant molecular diagnostics for precision medicine).
Although Anteo does not explicitly recite the step of subjecting the depleted solution to a diagnostic test, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Anteo to include a step of subjecting the depleted solution to diagnostic testing, because preparation of depleted samples for improved performance in diagnostic testing is an explicitly stated purpose of the method of Anteo, and one of ordinary skill in the art would be motivated to remove interferences using the method of Anteo for the purpose of improving the accuracy of downstream diagnostic testing. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because Anteo explicitly teaches that sample depletion can be performed to prepare a sample for downstream diagnostic testing.
Regarding claims 3, 6, and 8-9 Anteo further teaches that the at least 90% of the interference is removed (claims 3 and 6); that a sufficient amount of interference is removed to provide less than 100 ppm interference in the biological sample (claim 8); and that a sufficient amount of interference is removed to provide a less than detectable amount of the interference in a diagnostic test (claim 9) (Pg. 14 Ln. 1-Pg. 15, Ln. 2: The approach requires magnetic particles with excellent magnetic susceptibility and size uniformity for 100% removal after addition, and good colloidal stability (slow settling rate) to maximize binding kinetics and minimize incubation time needed. Magnets are used to restrain the magnetic beads which have bound to the interference, such that only the targeted interference will be captured by the magnetic sequestration of the magnetic beads, while the supernatant in the sample tube will now be depleted and free of such interference as well as depleted and free of the magnetic particles which could interfere in the assay if still present in the sample), wherein the teaching that the sample is free of interference requires that enough of the interference is removed to meet the limitations of claims 3, 6, 8, and 9.
Additionally, Anteo is understood to meet these limitations because they are understood to be a result of the recited active method steps and reagents of the instant claim. That is, because Anteo teaches the same reagents and the same steps as the instantly claimed method, it is assumed herein to achieve the same claimed results.
Regarding claims 3 and 21-22, Anteo teaches the method of claim 3, and further teaches the method wherein the removing or eliminating is a separation (Pg. 3, Ln. 7-23: the apparatus is exposed to the analyte, and when the apparatus is separated from the analyte, one or more interfering substances are removed from the analyte without adulterating the analyte or changing its form). Anteo further teaches the method wherein the separation comprises physical separation such as magnetic separation, and wherein the magnetic separation uses a strong magnet to provide a pellet and a supernatant (Pg. 14-15:, “Uniform size, 1.0 to 3.0 micron, paramagnetic microparticles, functionalized with Mix&GoTM and coated with HAAA and/or MASI specific blocker(s)…This approach is the addition, mixing, and removal of the magnetic particles can easily be automated…With magnets to pull the magnetic beads to the sides of the sample tube as only the targeted interference will be captured and bound (sequestered) to the sample tube’s wall via the magnetic particles and magnets, while the supernatant in the sample tube will now be depleted and free of such interreference as well as depleted and free of the magnetic particles which could interfere in the assay if still present in the sample”). The disclosure of Anteo is understood to read on the instantly claimed pellet and supernatant insofar as the solid particles which have captured the interference are understood to read on pellets which are separated from the supernatant in the sample tube.
Anteo does not specifically teach the method wherein the magnet is a magnet within a disposable pipette tip cover or sheath.
Regarding claim 3 and 6, OPS Diagnostics teaches a commercially available pipette tip which contains a rare earth magnet which can be used to isolate and retrieve magnetic particles (see product listing). As confirmed by the Internet Archive Wayback Machine, the pipette tips disclosed by OPS Diagnostics have been publicly available since at least 29 October 2017. With respect to the pipette tips being disposable, while OPS Diagnostics teaches that the pipette tips are reusable, at some point the pipette tip cannot be re-used and would be disposed of, and is therefore understood to be disposable as required in the instant claim.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Anteo to use the magnetic pipette tips disclosed by OPS Diagnostics for the magnetic separation. The magnetic separation method disclosed by Anteo uses a magnet for separating magnetic particles from the supernatant of a sample, while the magnetic pipette tips disclosed by OPS Diagnostics serve the equivalent function of isolating magnetic particles. Substitution of one method for the other in this instance amounts to simple substitution of known elements to achieve predictable results, because one can predictably isolate magnetic particles from a solution using either the method disclosed by Anteo or the pipette tips disclosed by OPS Diagnostics . This amounts to equivalent means for performing the same function. Additionally, use of the pipette tips would provide the additional advantage of allowing a user to easily manipulate or physically remove the magnetic particles from the sample solution. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because both Anteo and OPS Diagnostics disclose means of pelleting and isolating magnetic particles.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Anteo Diagnostics Limited (AU 2016100182 A4, IDS entered), hereinafter Anteo, in view of OPS Diagnostics (OPS Diagnostics. Magnetic Tips-12 Pack. SKU: MGTP 12-03. 29 October 2017. Retrieved from the Internet < https://opsdiagnostics.com/magnet-tips-12-pack-p358.html>; previously cited), as applied to claim3 above, and further in view of Gorman et al (WO 91/06559; previously cited).
Regarding claim 11, Anteo in view of OPS diagnostics teaches the method of claim 3, as described above. Anteo teaches that the capture moiety may be IgG, but does not specifically teach that the capture moiety is any of the species recited in claim 11.
Regarding claim 11, Gorman teaches a method of reducing false positive results in an immunoassay using polymerized IgG to overcome non-specific binding (Abstract). Gorman teaches that the polymerized IgG can be useful and advantageous in reducing false positive results by limiting nonspecific binding caused by a variety of interferences (RF, heterophilic antibodies, etc.) (Pg. 4, Ln. 16-19; Pg. 5, Ln. 17-20; Pg. 12-13, Example III.2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Anteo in view of OPS diagnostics such that the capture moiety comprises polymerized IgG as taught by Gorman. Though Anteo does not specifically teach the use of polymerized IgG, one of ordinary skill in the art would be motivated to use polymerized IgG because Gorman teaches that the polymerized IgG is effective in removing interferences and reducing false positive results, and can be advantageous over prior art methods employing monomeric IgG (Table 2). One of ordinary skill in the art would have a reasonable expectation of success in making this modification because both Anteo and Gorman teach methods of reducing false positive results in an immunoassay by removing an interference, and both Anteo and Gorman teach that IgG may be used as a capture moiety in this context.
Response to Arguments
Applicant’s arguments filed 13 January 2026 have been fully considered.
Regarding the 103 rejections, applicant argues that the cited prior art does not teach the amended limitation that specifies that the particle has a diameter from 0.050 micrometers to 3 micrometers. This argument is not persuasive because Anteo teaches specifically that the particles have a uniform size from 1.0-3.0 microns, a range which falls entirely within the claimed range and therefore reads on the amended limitations.
Regarding the 103 rejection, Applicant argues that the claimed “disposable pipette tip, cover, or sheath” is not sufficiently taught by OPS Diagnostics because the reference discloses a reusable tip. Applicant further argues that the rare earth magnets disclosed in OPS Diagnostics are not disposable. These arguments are not persuasive because even if something may be reused, it is still capable of being disposed of, and even if a material requires a specific procedure for disposal, it is still capable of being disposed of and is thus considered to read on the broadest reasonable interpretation of the term “disposable” in the claims. This is further evidenced by Applicant’s reference to “Disposing of Rare Earth Magnets” on Pg. 2 of the Remarks which discusses options for the proper disposal of rare earth magnets, such that these are understood to be disposable.
Conclusion
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/ELLIS FOLLETT LUSI/Examiner, Art Unit 1677
/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677