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 .
Claims 1-14 are pending.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 9 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 is vague and indefinite. In line 1 and 2 the recitations of “preferably” and in line 3 “such as” is not clear if the follow materials are meant to be exemplary or limiting.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Van Der Donk et al (WO 99/50673; herein referred to as Van Der Donk).
Van Der Donk disclose a method and device for determining in a sample an analyte selected from a blood group antigen present on erythrocytes or an antibody binding to such a blood group antigen.
The method comprises:
treatment of the sample in an incubation zone of a reaction vessel with a reagent containing an analyte-binding partner, which analyte-binding partner, m the case where the analyte is a blood group antigen present on erythrocytes, is an antibody capable of binding to the blood group antigen, and in the case where the analyte is an antibody binding to a blood group antigen, is the blood group antigen present on erythrocytes, wherein in the incubation zone, if the sample contains the analyte, either a complex is formed of blood group antigen present on erythrocytes and antibody bound thereto, or a complex is formed of blood group antigen present on erythrocytes and antibody bound thereto, as well as a complex of complement factors bound to these erythrocytes if the antibody is complement-binding,
further comprising separation of erythrocytes, complexed or not, from non-bound antibodies using a separation medium, located in the reaction vessel under the incubation zone, of a density higher than that of the fluid containing the antibodies but lower than the density of erythrocytes, whereby erythrocytes pass through the separation medium and non-bound antibodies remain m the incubation zone,
separation of complexed erythrocytes from non-complexed erythrocytes by binding complexed erythrocytes in an immobilization zone of the reaction vessel to binding substance immobilized this zone, which binding substance comprises IgM-binding substance and/or complement-binding - substance, and optionally also IgG-binding substance, and discharging non-complexed erythrocytes to a collection-, zone of the reaction vessel, and
detection of erythrocytes in the immobilization zone and/or collection zone (See pages 6-7).
The “analyte binding partner” reads on the first antibody of the instant invention. Van Der Donk teaches that IgG is an incomplete antibody (See pages 1-2). The IgM or IgG binding substance reads on a binding element of the instant invention and suggests that the analyte binding partner/first antibody is IgG (an incomplete antibody).
The present invention also provides a test kit suitable for use in a method for determining an analyte m a sample, the analyte being a blood group antigen present on erythrocytes or an antibody binding to such a blood group antigen, comprising:
(a) a reagent containing an analyte-binding partner which, in the case where the analyte is a blood group antigen present on erythrocytes, is an antibody capable of binding to the blood group antigen, and in the case where the analyte is an antibody binding to a blood group antigen, is the blood group antigen present on erythrocytes,
(b) a reaction vessel comprising an incubation zone, an immobilization zone and a collection zone, there being immobilized in the immobilization zone a binding substance which comprises IgM-binding substance and/or complement- binding substance, and optionally also IgG-binding substance, and
(c) a separation medium having a density lower than the density of erythrocytes but higher than the density of an antibody-containing fluid (See page 7).
Blood group antigens that can be determined include C, D, E, c, e, Jka, Jkb, Lua, or Lub (See page 13).
The sample can be blood or materials derived therefrom (See page 13).
The immunoglobulin binding substance (i.e. binding element) can be polyclonal or monoclonal antibodies directed to immunoglobulin G (IgG) , immunoglobulin A (IgA) and/or immunoglobulin M (IgM), or the Fab or F(ab) '.sub.2 fragments thereof (See page 14).
The separation medium can be agarose (e.g. Sepharose 4 Fast Flow, Sepharose High Performance (Pharmacia)) or acrylic resin. Also of importance is the size of the particles: in a matrix with larger particles, and hence more interspace, the binding of sensitized erythrocytes will proceed slowly, so that insufficient cells can be bound. A finer matrix will lead to a more intensive contact of the sensitized cells with the immunoglobulin-binding ana complement -binding substances, so that optimum binding of the cells is possible. Too fine a matrix, however, will lead to clogging. The diameter of the particles will therefore have to lie between 10 and 125 μm, preferably between 20 and 50 μm. Substances for increasing the density of the medium can be many kinds of substances, including, e.g., albumin, dextran, Ficoll, lodixanol , sodium diatrizoate, Percoll, etc. The density of the medium should be higher than that of the antibody-containing fluid, but lower than that of erythrocytes, so the density must lie between 1.01 and 1.09 g/ml , preferably between 1.02 and 1.06 g/ml (See page 14).
With respect to claim 10, Example 1 (page 22) and 5 (page 26), teach dilution of the sample with LISS
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.
Claim(s) 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van Der Donk et al (WO 99/50673; herein referred to as Van Der Donk).
See above for the teachings of Van Der Donk.
Van Der Donk differs from the instant invention in not teaching a kit with more than one reaction vessel. However, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to add another reaction vessel because that would enable assaying a sample for more than one blood group antigen.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
WO 95/30904 teaches a method that is similar to WO 99/50673.
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/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677
3/21/2026