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 Non-Final Office Action based on application 18/028324 RCE filed 03/31/2026.
Claims 1-5 & 7-10 have been cancelled.
Claim 6 has been examined and fully considered.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/31/2026 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.
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).
Response to Arguments
Applicant's arguments filed 03/31/2026 have been fully considered but they are not persuasive.
The prior 112 (b) rejection has been overcome by amendments made 03/31/2026.
With respect to the prior art rejection--- applicant argues about the NIEMANN reference. The examiner notes that the name NIEMANN was accidentally left in the heading of the prior rejection, however it was clear from the rejection itself and the lack of associated patent or reference title inclusion, that this was a typo. The rejection in the Final rejection was TANAKA in US 20090098661 in view of WARD in Proteins and Tumor Markers (as cited on IDS dated 04/22/2024). Applicant acknowledged in their response, that this was likely the case, however provided arguments with respect to NIEMANN in case. The examiner thanks applicant for doing this, but they are correct that NIEMANN was not used in the rejection.
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).
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).
Notably, there in the claim preventing an additional molecule, in the case of TANAKA which would be an antigen bound/the first specific binding molecule which can be bound to the analyte as shown in the above rejection.
Applicant argues that TANAKA does not teach of the antibody being bound to the particle itself. The examiner disagrees, and maintains that TANAKA makes this obvious.
Specifically, 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.
Applicant makes no real substantive arguments about WARD other than to say that they do not think that WARD teaches of the same things that they think TANAKA does not teach of. Specifically applicant argues that WARD teaches of two-antibody immunoassays that are mechanistically different from the instant invention.
With respect to this--- the examiner notes that WARD was used to teach of the claimed concentration of ferritin and type of ferritin used for the instant calibration curve which is used for comparison of the instant assay, not the claimed assay itself. The examiner used WARD to shown the obviousness of using such concentrations for comparison.
Further--- the claimed standard solution concentrations would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to optimize as concentrations for 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).
Therefore, using the concentrations taught in WARD as standard solutions for a calibration curve would not change the principle of operation of TANAKA as argued by applicant, since the assay itself is not the reason WARD was used.
All claims remain rejected.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758
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