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
Summary
This is the Final Office Action based on application 18/028324 response filed 07/22/2026.
Claims 1-5 & 7-10 have been cancelled.
Claims 6 & 11-20 have been examined and fully considered.
Claims 11-20 have been newly added.
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 non-obviousness.
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 6 is rejected under 35 U.S.C. 103 being unpatentable by TANAKA in US 20090098661 in view of WARD in Proteins and Tumor Markers (as cited on IDS dated 04/22/2024) and further in view of FUJIMURA in US 20200232977.
With respect to Claim 6, TANAKA teaches of a method for determining an analyte in a sample that, includes the steps of: (a) mixing the analyte (which can contain ferritin) and a first specific binding substance (can be anti-ferritin antibody), the first specific binding substance being a substance that can specifically bind to the analyte; (b) adding microparticles (which can be latex) having a second specific binding substance bound thereto to a mixture obtained in the step (a) and mixing therewith, the second specific binding substance being a substance that can specifically bind to the first specific binding substance; and (c) determining an agglutination reaction of the microparticles in a mixture obtained in the step (b) (abstract).
TANAKA teaches that the method can detect ferritin (paragraph 0025), by using and antigen-antibody reaction (paragraph 0001, 0027, 0026, 0025), specifically an anti-human ferritin antibody (paragraph 0052, 0058), in what can be a latex agglutination assay (paragraph 0002), in which the assay includes by binding a substance that specifically recognizes a substance that specifically binds the analyte (ferritin in this case) to microparticles of latex as the main part of an agglutination assay (paragraph 0006).
TANAKA teaches the microparticles of latex or gold bind to a second specific binding substance (paragraph 0019, 0029). The second specific binding substance specifically recognizes the first specific binding substance that specifically binds to the analyte (paragraph 0019-0020, 0039).
The second specific binding substances can be antibodies or antigens, that specifically bind to the first binding substance, which can also be antibodies or antigens (paragraph 0017, 0013, 0025-0028).
Using gold particles as an example—TANAKA teaches that the second specific binding substances is an antibody (paragraph 0030) and also teaches specifically of using an anti-ferritin antibody as instantly claimed (paragraph 0052, 0058).
Since TANAKA teaches that the second specific binding substance can be an antibody (which can be anti-ferritin), and it is bound to a particle which can be latex, and that the first specific binding substance which is bound to the analyte (which can be ferritin), this all together reads on the instant claim requirements of latex particles being bound to anti-ferritin antibodies, and then binding happening between the latex particles which are bound to anti-ferritin, and the analyte which is can be bound to an antigen which recognizes the anti-ferritin, which reads on the instantly claimed binding through broadest reasonable interpretation (BRI), as there is nothing in the claim preventing an additional molecule--- in this case, and antigen being used for the binding.
TANAKA further teaches that the particles are prepared in buffer solutions and that the solutions can be colloidal- which means that the particles are in suspension (paragraph 0030,0034, 0040, 0047).
TANAKA further teaches of measuring a change in absorbance based on agglutination due to the analyte- antigen-antibody/latex agglutination reaction binding (paragraph 0040, 0054, 0055, 0021-0023). This absorbance is quantified in comparison (by applying to) to a calibration curve to allow for determination of the final ferritin concentration in the sample (paragraph 0061, 0054, 0055).
TANAKA further teaches that the formation of the standard solutions of ferritin for the calibration curve are at the concentrations of 0, 50, 100, 250, 500, and 1000 ng/ml (paragraph 0059).
TANAKA does not teach of the standard solutions have at least one concentration in the range of 1,400 ng/ml and 2,000 ng/ml, nor do they teach of the standard solutions being prepared using liver-derived ferritin as raw material.
WARD is used to remedy this and more specifically teach of various ferritin kits which have dilutions of human liver 80/602 of 200 ng/ml (Radium Spa), 12 ng/ml (Roche Diagnostics), 1400 ng/ml (Nichols Institute Diagnostics), and also of having bead bound polyclonal anti-ferritin antibodies (Page 1186, right column, Page 11 87, left column, Page 1195, right column).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use the concentration of ferritin (liver-derived) as is done in the Radium, Roche, or Nichols diagnostic assay kits due to the advantages these kits offer for having high sensitivity and precision (Page 1186, right column, Page 11 87, left column, Page 1195, right column).
Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness. See MPEP § 2144.05.I.
Further--- it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to optimize the concentrations of the standard solutions used for the calibration curve used on TANAKA through routine optimization. See MPEP 2144.05 II. A. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
However, if it is still unclear to adjust/optimize the standard solutions for a calibration curve, FUJIMURA is used to remedy this.
FUJIMURA teaches of a method of using a latex agglutination assay which is an immunoassay (abstract), wherein the analyte measured can be ferritin (paragraph 0079), and of measuring absorbances during the measuring method and of applying these measurements to a standard calibration curve (paragraph 0153).
FUJIMURA further teaches that the standard substances are purely samples which contain a known concentration of the sample--- which allow for comparison to a measured sample and allow for calculation of a quantitative value of the analyte in samples (paragraph 0076). FUJIMURA further teaches that any “known concentrations,” for the standard substances can be used--- so that it would be obvious to optimize of choose the concentration (paragraph 0153).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to measure absorbances and to then apply or use with a standard curve made from standards at known concentrations as is done in FUJIMURA in the methods of TANAKA and WARD due to the advantage knowing the known concentrations of the standards offers for knowing the concentration of analyte in the sample based on comparison of absorbances (FUJIMURA, paragraph 0153, 0076).
With respect to Claim 11, TANAKA teaches that latex or gold particles can be used and that if gold particles are used they have a size of 10nm to 100 nm (paragraph 0029). TANAKA does not specifically teach of the latex particles having a size in the range of 30nm to 600 nm.
FUJIMURA is used to remedy this and teaches of a latex agglutination assay(abstract) wherein latex particles are used in a size of 0.02um (20 nm) to 1.6 um(1600 nm)(paragraph 0086), which includes the claimed range of 30nm to 600nm. It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use latex particles the size used in FUJIMURA in the method of TANAKA due to the advantage selecting and adjusting particle size in this range gives for desired performance (FUJIMURA, paragraph 0086).
With respect to Claim 12, TANAKA teaches of the invention as shown above including using anti-ferritin antibodies but does not teach of the anti-ferritin antibodies having a concentration of 0.01 mg/ml to 2.0 mg/ml.
FUJIMURA is used to remedy this and teach of using antibodies in a concentration of 0.36 mg/ml in a solution with the latex particles (paragraph 0142). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use the antibody in the concentration taught by FUJIMURA in the method of TANAKA due to the advantage this gives for building a sensitized latex particle solution (paragraph 0142).
With respect to Claim 13, TANAKA teaches of the invention as shown above but does not teach of the particles/latex particles being used in concentration in 0.01% to 0.5%.
FUJIMURA is used to remedy this and teaches of using a 1% solution of latex particles and then mixing it with other things so knocking down the 1%(paragraph 0142-0151). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use the latex particles % in the concentration taught by FUJIMURA in the method of TANAKA due to the advantage this gives for building a sensitized latex particle solution (paragraph 0142).
With respect to Claim 14, TANAKA teaches that in the binding reaction between the analyte and the first specific binding substance and the agglutination reaction between the bound matter and the second specific binding substance, reaction conditions such as the reaction temperature, the pH, the type of the buffer solution, the type of the coexistent salt and the concentration thereof, and the other coexistent substances are the same as those in conventional immunological reactions (paragraph 0034), however does not teach of using a temperature of 30 to 40 degrees Celsius for agglutination reaction.
FUJIMURA is used to remedy this and teaches of performing the measuring method with the reagents and agglutination assay at 37 degrees Celsius (paragraph 0153). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to perform the agglutination assay at the temperature as is done in FUJIMURA in the method of TANAKA due to the advantage this has for allowing for appropriate combination of components by stirring (FUJIMURA, paragraph 0153).
With respect to Claim 15, TANAKA teaches that in the binding reaction between the analyte and the first specific binding substance and the agglutination reaction between the bound matter and the second specific binding substance, reaction conditions such as the reaction temperature, the pH, the type of the buffer solution, the type of the coexistent salt and the concentration thereof, and the other coexistent substances are the same as those in conventional immunological reactions (paragraph 0034), however does not teach of using a temperature of 37 degrees Celsius for agglutination reaction.
FUJIMURA is used to remedy this and teaches of performing the measuring method with the reagents and agglutination assay at 37 degrees Celsius (paragraph 0153). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to perform the agglutination assay at the temperature as is done in FUJIMURA in the method of TANAKA due to the advantage this has for allowing for appropriate combination of components by stirring (FUJIMURA, paragraph 0153).
With respect to Claim 16, TANAKA teaches that the sample is blood, plasma, serum, urine, feces (paragraph 0024).
With respect to Claim 17, TANAKA teaches of using 0.35 w/v % polyoxyethylene lauryl ether (14 carbons if only one ethylene oxide unit since adds 2 carbons to the 12 carbon lauryl ether) ( a surfactant) (paragraph 0052), and mixing it with the sample (paragraph 0053).
With respect to Claim 18, TANAKA teaches of using 0.35 w/v % polyoxyethylene lauryl ether) ( a surfactant) (paragraph 0052), and mixing it with the sample (paragraph 0053).
With respect to Claim 19, TANAKA teaches of using 0.35 w/v % polyoxyethylene lauryl ether) ( a surfactant) (paragraph 0052), and mixing it with the sample (paragraph 0053), .35 % falling in the claimed range.
With respect to Claim 20, TANAKA teaches of using 0.35 w/v % polyoxyethylene lauryl ether) ( a surfactant) (paragraph 0052), and mixing it with the sample (paragraph 0053), .35 % falling in the claimed range.
Response to Arguments
Applicant's arguments filed 07/22/2026 have been fully considered but they are not persuasive.
The examiner notes that during interview dated 07/13/2026, she thought that applicant’s arguments regarding TANAKA might be convincing, however upon further search and consideration the arguments with respect to TANAKA were not found convincing. The examiner apologizes for any inconvenience this causes however this unfortunately sometimes happens as examiner are not given much time to fully consider arguments during interviews. During the time of the interview applicant’s representative said that if needed they would be willing to consider amending into the claims that direct binding and immobilization occurs between the latex particles bound to the anti-ferritin antibodies and the ferritin in the test sample. From the examiners full review- she does not currently think this would be a successful avenue to pursue for amendments, however it is possible that applicant means something more specific than the above, so the examiner would need to see what this amendment would be to fully consider. Applicant should also see the piece of prior art cited in the conclusion section of this action.
With respect to the primary reference, TANAKA, applicant argues that TANAKA teaches of a two-antibody assay, wherein the second antibody, which had a binding affinity for the analyte is not immobilized on the microparticles (paragraph 0019) and therefore that TANAKA does not teach of every aspect of the instant claims. Applicant more specifically argues that paragraph 0019, 0067, 0052, and 0058 of TANAKA teaches that the first specific binding substance is NOT bound to the microparticles of latex or gold. The examiner disagrees, however sees why applicant finds this language confusing.
Applicant argues that this two-antibody immunoassay is mechanistically different from the latex immune-agglutination method claimed wherein binding occurs between ferritin (analyte) and the anti-ferritin antibodies bound to the latex particles.
Though the examiner can see the slight different in what occurs in TANAKA (two antibodies are used) and in the instant invention (one antibody is used), the examiner disagrees that TANAKA has deficiencies with respect to what is claimed, and how the claim can be interpreted through broadest reasonable interpretation (BRI).
Specifically, TANAKA teaches of an additional molecule being bound in a chain of molecules to what the applicant claims. Specifically, TANAKA teaches of binding the analyte (ferritin) and a first specific binding substance the first specific binding substance being a substance that can specifically bind to the analyte(anti-ferritin antibody); then (b) adding microparticles having a second specific binding substance bound thereto to a mixture obtained in the step (a) and mixing therewith, the second specific binding substance being a substance that can specifically bind to the first specific binding substance (TANAKA, Claim 1). Therefore TANAKA teaches of a chain of ferritin, bound to anti-ferritin, bound to a second binding substance, bound to the latex particle. Therefore, all of the claimed particles are in fact bound and connecting as claimed.
Notably, the claims do preventing an additional molecule, and allowing for this interpretation.
Applicant further argues that paragraphs 0003-0004 teaches away from the concept of having a second specific binding substance capable of binding to the analyte. While the examiner sees this section of TANAKA, the examiner disagrees that this is teaching away from what is actually claimed. Though the binding of the chain of molecules taught by TANAKA does contain an additional molecule from what is claimed, all components still are bound together (TANAKA Claim 1). Therefore, what is cited in paragraphs 0003-0004 of TANAKA is not teaching away from what is taught in TANAKA, Claim 1, which reads on what is actually claimed through broadest reasonable interpretation.
Applicant even further argues that “modification of Tanaka’s methods to arrive at the instantly claimed methods would change the principle of operation of Tanakas method and render them unsatisfactory for their intended purpose.” The examiner disagrees. Applicant argues that Tanakas purpose is to avoid binding the analyte to the antibodies directly bound to the microparticles. The examiner notes that the instant claims allow for this to happen as well, so no modification of Tanaka is needed or proposed for this part.
All claims remain rejected.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kitahara in US 20150080542 teaches of a latex particle for latex agglutination assay (abstract) and further teaches that it can be used for antigen-antibody assays and reactions including for detection of ferritin by antibodies (paragraphs 0033-0036).
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M FRITCHMAN whose telephone number is (303)297-4344. The examiner can normally be reached 9:30-4:30 MT Monday-Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached on 571-270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758
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