DETAILED 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 .
Election/Restrictions
Applicant's election with traverse of Group II, claims 7-15, drawn to a method for detecting the presence of analytes, in the reply filed on 07/06/2026 is acknowledged. The traversal is on the ground(s) that Groups I are linked by the same or corresponding special technical features, including the capture-zone arrangement and the use of magnetic microbeads, such that the claims possess unity of invention. This is not found persuasive because the common technical subject matter linking independent claim 1 of Group II and independent claim 7 of Group II does not define a contribution over the prior art.
In particular, Huang teaches that superparamagnetic nanoparticles (SMNPs) have been widely used in immunochromatographic assay (ICA) platform and that SMNPs also act as a novel label for the signal output of ICA (p. 151). Huang further teaches that ICA can be used to qualitatively detect target by the naked eye or quantitatively detect target by a simple reader (p. 151), and Figure 1 depicts an immunochromatographic strip including a sample pad, conjugate pad, nitrocellulose membrane, test line, control line, and absorbent pad.
Huang further teaches that the color of SMNPs on the T and C lines is correlated to the target concentration and that, for quantitative detection, the color density of the SMNPs can be transformed into a digital signal (p. 158). Huang also teaches magnetic detection wherein the most common strategy of the magnetic signal reading mode is based on a magnetic assay reader (MAR) to measure the magnetic field of SMNPs excited by an external magnetic field, further describes measurement of the magnetic response of SMNPs using magnetic sensors (pp. 158–159), and that multiple targets can be detected simultaneously in one test strip according to this strategy (pp. 158–160).
Accordingly, Huang establishes that the common subject matter linking independent claims 1 and 7—namely, use of an immunochromatographic analysis medium having test and control functionality together with superparamagnetic particles capable of providing a quantitatively detectable signal—was conventional in the art. The more specific two-type magnetic-microbead limitations having different superparamagnetic properties recited in dependent claims 2 and 3, and the additional magnetic-response and measurement-vector processing limitations of independent claim 7, do not constitute the common technical feature linking independent claims 1 and 7. Rather, those limitations further define the respective claimed inventions. Applicant’s reliance on additional limitations appearing in dependent claims 2 and 3 and in claim 7 therefore does not establish that the inventions of Groups I and II share a special technical feature defining a contribution over Huang. Likewise, the fact that Group II recites a process employing an analysis medium does not itself establish unity under 37 CFR 1.475(b)(2), because the inventions must still satisfy the special-technical-feature requirement.
Thus, the common feature between the independent inventions does not constitute a special technical feature defining a contribution over Huang. Accordingly, the requirement for restriction between Group I, claims 1–6 and 16–19, drawn to an analysis medium, and Group II, claims 7–15, drawn to a method for detecting the presence of analytes, is maintained. The requirement is still deemed proper and is therefore made FINAL. Hence, claims 1-6 and 16-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant’s arguments traversing the election-of-species requirement have also been considered but are not persuasive. Applicant elected, with traverse, sequence-of-application Species a (premixing) and signal-processing Species b (digitally searching for respective magnetic masses), and identified claims 7, 8, 10, and 14 as readable on the elected invention and species. Applicant argues that the sequence-of-application and signal-processing alternatives possess unity because they share the two-type magnetic-microbead system, selective retention in the capture zone, combined magnetic response, and measurement-vector framework of claims 7 and 8. However, the existence of this common generic framework does not establish that the distinct species themselves are linked by the same or corresponding special technical feature defining a contribution over the prior art. The identified alternatives further define different implementations of that generic framework: claim 7 expressly provides alternative sequences of application, while claims 9–15 recite distinct techniques for processing the resulting measurement information.
Applicant’s argument that the signal-processing alternatives have not been shown to be mutually exclusive is likewise not persuasive. The requirement does not rest solely on physical impossibility of performing more than one processing technique. Rather, the identified alternatives constitute distinct claimed approaches for processing the magnetic-response/measurement-vector information, notwithstanding their dependence from the same generic framework. The common framework therefore does not, by itself, establish unity among the identified species.
Accordingly, the traversal does not establish that the identified sequence-of-application and signal-processing species are so linked as to form a single general inventive concept. The election-of-species requirement is therefore maintained. Claims 7, 8, 10, and 14 are examined as readable on the elected Group II invention and elected species. Claims 9, 11–13, and 15 are nonelected and are withdrawn from further consideration.
Status of the Claims
Claims 1-19 are pending. Claims 1-6, 9, 11-13, and 15-19 are withdrawn. Claims 7, 8, 10, and 14 are examined herein in view of the restriction.
Priority
The present application, filed 04/29/2022, is a 371 of PCT/FR2020/051551, filed 09/09/2020, which claims foreign priority of FR1912273, filed 10/31/2019. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The Information Disclosure Statement(s) filed 04/29/2022 are acknowledged and have been considered.
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.
Claims 8 are 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 8 recites the limitation "the function linking the excitation field to the magnetic induction of the microbeads of the first type and the microbeads of the second type" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Specifically, neither “the function,” “the excitation field,” nor “the magnetic induction” has proper antecedent basis in claim 7. Claim 7 instead recites a plurality of excitation magnetic fields and a combined magnetic response, without previously introducing the foregoing terms. Accordingly, it is unclear from the claim language alone what previously recited function, excitation field, and magnetic induction are intended by the definite articles “the.” For purposes of compact prosecution, the phrase "the function linking the excitation field to the magnetic induction of the microbeads of the first type and the microbeads of the second type" will be interpreted as referring to the relationship between an applied excitation magnetic field and the resulting magnetic induction of the respective first- and second-type magnetic microbeads. Appropriate correction is required.
Claims 14 depends from claim 8 and therefore incorporates all of the limitations of claim 8, including the indefinite terminology identified above. Claim 14 does not cure or otherwise resolve the antecedent-basis deficiency inherited from claim 8. Accordingly, claim 14 is likewise indefinite under 35 U.S.C. 112(b). Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 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 nonobviousness.
Claims 7-8, 10, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Lenglet (US 2010/0301850 A1) in view of Huang et al. (Application and Development of Superparamagnetic Nanoparticles in Sample Pretreatment and Immunochromatographic Assay. TrAC, Trends in Analytical Chemistry), vol. 114, May 2019 – IDS dated 04/29/2022)
Regarding claim 7, for detecting the presence of analytes in a liquid sample, Lenglet teaches application of its method to detection and/or quantification of a biological and/or chemical component (analyte) that may be present in a medium ([0103], p. 5), and further teaches specimens from body fluids, e.g. blood, plasma or urine ([0175], p. 8). Regarding bringing the sample together with marked test agents of a first type of magnetic microbeads capable of binding to the analytes, Lenglet teaches that the first type of magnetic material binds to the biological or chemical component to be quantified or to a reactant allowing this component to be detected and/or quantified is used with the specimen ([0170]–[0171], p. 8). Lenglet additionally teaches, in a sandwich-type test, that the reactant is a labelled antibody, that is to say one bound to the magnetic particles and that the analyzer detects the signal emitted by the reactant bound to the analyte ([0104], p. 5). Lenglet further identifies its magnetic particles as beads of a superparamagnetic material ([0083], p. 4).
Regarding marked reference agents of a second type of magnetic microbeads, Lenglet teaches use of a second, different, type of magnetic material that is inert relative to the analyte and expressly teaches that the second type of magnetic material serves as an internal reference ([0170]–[0174], p. 8). Lenglet further teaches that this internal reference accounts for the diffusion characteristics either into or onto a porous material ([0174], p. 8). Regarding the first and second types having different superparamagnetic characteristics, Lenglet teaches that using at least two points of the signature S(H), it becomes easier to discriminate between magnetic materials having different signatures ([0016], p. 1), and expressly applies its method to an assembly of several different magnetic materials ([0027]–[0041], pp. 2–3). Figure 4 is expressly described as a graph illustrating the second derivative of the magnetic induction with respect to the magnetic field for two different magnetic materials ([0071], p. 4; Fig. 4), with separate type-1 and type-2 magnetic responses ([0105]–[0110], p. 5). Regarding applying the sample to an analysis medium before or after bringing the sample together with the marked test and reference agents, Lenglet teaches the presently elected premixing alternative. In particular, Lenglet teaches that the assembly is obtained by mixing the specimen with a first magnetic material which binds to the biological or chemical component to be quantified or to a reactant for allowing this component to be detected and/or quantified, and with a second, different, magnetic material which is inert with respect to the aforementioned component ([0059]–[0061], p. 3). Lenglet therefore expressly brings the specimen together with both the analyte-associated first magnetic material and the inert reference second magnetic material before subsequent analysis. Lenglet further teaches that the receptacle may be a test strip having at least one porous material ([0087], p. 4), and that the assay may thereafter be carried out after diffusion of the complex onto or into a porous support, e.g., a strip or miniature column ([0175], p. 8).
Regarding selectively retaining the analyte-bound test agents and reference agents on or in a capture zone of the analysis medium, Lenglet teaches that the magnetic material may be concentrated in a reaction or detection zone of the analysis medium by immobilizing the analyte and/or possible binding partners or reactants, in the presence of magnetic beads specifically bound to one of these elements, on a ligand, especially a ligand immobilized on a solid support in the detection zone ([0103], p. 5), and further teaches specific retention of the complexes in a read zone following diffusion onto or into a porous support ([0175], p. 8). Regarding successively exposing the capture zone to a plurality of excitation magnetic fields of different average intensities, Lenglet teaches first and second period fractions in which the average of the instantaneous value of the low-frequency magnetic field over the first period fraction is different from the average of its instantaneous value over the second period fraction ([0005], p. 1). Lenglet further teaches that the value of the magnetic field takes eleven different values during the measurement ([0092]–[0093], p. 5), and that the averages of the instantaneous value of the magnetic field over each of the fractions are different from one another ([0225], p. 11).
Regarding measuring a combined magnetic response of the microbeads of the first type and of the second type, present in the capture zone, for each excitation magnetic field, thus forming a measurement vector, Lenglet teaches an assembly comprising a mixture of type 1 and type 2 magnetic materials and identifying and simultaneously determining the mass of each of the magnetic materials present in the assembly ([0140]–[0141], p. 7). The measured magnetic response is represented by multiple points S(H) of a signature is represented as S(H)1P is the vector [S(H)1, S(H)2, S(H)P] ([0142]–[0150], p. 7). Regarding processing the measurement vector to determine the absolute or relative amount of microbeads of the first type and microbeads of the second type, Lenglet teaches that solving the above matrix equation allows the mass of each of the magnetic materials contained in the assembly to be obtained simultaneously ([0041], p. 3). and further determines the mass Mi of each of the magnetic materials present in the assembly ([0154]–[0155], p. 7). In the mixture embodiment, Lenglet further teaches that the mass Mi of each of the magnetic materials present in the assembly is determined ([0154]–[0155], p. 7) and that the method permits a mixture of several different magnetic materials, and therefore a mixture of several biological or chemical components, to be analyzed simultaneously to be analyzed simultaneously ([0156], p. 7).
Lastly, Lenglet itself provides an express reason for a skilled artisan to look to conventional immunochromatographic capture arrangements. Lenglet teaches that the receptacle may be a test strip having at least one porous material, which is commonly used in fields of diagnostics ([0087], p. 4). More importantly, Lenglet teaches that its internal-reference embodiment accounts for diffusion characteristics either into or onto a porous material ([0174], p. 8), and immediately teaches that the assay may be carried out after diffusion of the complex onto or into a porous support (e.g. a strip or miniature column) and specific retention of the complexes in a read zone ([0175], p. 8).
However, Lenglet does not expressly teach the claimed arrangement wherein the analyte-associated first magnetic population and internal-reference second magnetic population are respectively selectively retained by a plurality of first capture agents and a plurality of second capture agents.
Huang teaches the conventional superparamagnetic nanoparticles (SMNPs)-based immunochromatographic arrangement that fills this deficiency. Huang teaches that SMNPs have been widely used in immunochromatographic assay (ICA) platform and that SMNPs also act as a novel label for the signal output of ICA (p. 151). Figure 1 depicts the conventional porous strip having a sample pad, conjugate pad, NC membrane, test line, control line, and absorbent pad (Fig. 1, p. 153). Huang more particularly teaches that specific bioreagents are typically used with SMNPs-ICA strips to capture labels at the T and C lines, which generate a detectable signal on the NC membranes (Section 3.4.1, p. 164). This provides the known respective test/control capture functionality applicable to the analyte-associated and reference-associated magnetic populations contemplated by Lenglet. Huang further confirms technical compatibility with magnetic readout because Huang teaches that the most common strategy of the magnetic signal reading mode is based on a magnetic assay reader (MAR) to measure the magnetic field of SMNPs excited by an external magnetic field (Section 3.1.2.2, p. 158), and that multiple targets can be detected simultaneously in one test strip according to this strategy (pp. 158–160). Huang also teaches that magnetic or optical signal intensity is directly positively correlated with the amount of SMNPs accumulating on the T or C line (Section 3.3.1, pp. 160–161).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lenglet’s expressly contemplated porous diagnostic-strip embodiment to employ Huang’s known test/control capture arrangement, including respective specific bioreagents for capturing the analyte-associated magnetic population and the reference-associated magnetic population, thereby providing the first and second capture-agent functionality recited in claim 7. A skilled artisan would have been motivated to make the modification because Lenglet itself expressly directs its magnetic analyte/internal-reference assay to a porous diagnostic strip with specific retention of the complexes in a read zone, while Huang teaches the established SMNP-ICA technique for accomplishing specific retention of magnetic labels at T and C capture regions. In particular, Lenglet teaches that its second magnetic material serves as an internal reference that permits the conditions under which the test is carried out to be taken into account, including diffusion characteristics in a porous material, thereby allowing adjustment of the measured amount of the first magnetic material and providing a quantitative result substantially independent of variations in test conditions, such as variations in diffusion from one specimen to another. Thus, Lenglet itself provides a reason to preserve and separately retain the analyte-associated and reference-associated magnetic populations when implementing the assay on a porous diagnostic medium. Huang further teaches that magnetic signal reading provides increased sensitivity because magnetic signals can be completely captured and biological samples exhibit low magnetic background signals, and further provides greater sensitivity and stability than conventional ICA. Accordingly, employing Huang’s respective capture regions in Lenglet’s porous assay would have advantageously permitted separate retention of the analyte-associated and internal-reference magnetic populations while preserving Lenglet’s correction for porous-medium/test-condition variability and providing Huang’s sensitive and stable magnetic ICA readout. The skilled artisan would have reasonably expected the modification to succeed because Lenglet and Huang employ technically compatible assay components—magnetic labels coupled to biological recognition reagents, porous diagnostic media, specific affinity retention, and magnetic detection—and Huang expressly demonstrates that SMNP labels can be specifically captured on immunochromatographic strips and quantitatively read magnetically. Thus, the modification would have predictably provided the claimed respective capture of analyte-bound test agents and reference agents while retaining Lenglet’s existing two-magnetic-population discrimination, measurement-vector, and quantitative processing functions.
Regarding claim 8, Lenglet teaches that the signature S(H) is approximately equal to the n-th derivative of the magnetic induction with respect to the magnetic field ([0012], p. 1), and Figure 4 expressly illustrates the second derivative of the magnetic induction with respect to the magnetic field for two different magnetic materials ([0071], p. 4; Fig. 4). Lenglet specifically teaches the variation of the second derivative of the magnetic induction as a function of the magnetic field for the type 1 magnetic material ([0106], p. 5), and the corresponding second-derivative response for the type-2 material ([0108]–[0110], p. 5).
Regarding claim 10, Lenglet teaches that its sensor output is digitized, stating that sensor comprises a measurement coil connected to the input of an analogue to digital converter. Lenglet further teaches a signature constructor and a module for identifying and determining the mass of the material, with the module determining the mass of magnetic material present in the analysis medium on the basis of several points of the signature S(H) ([0096]–[0100], p. 5). Lenglet processes the measurement vector by a matrix equation, which is solved using the pseudo-inverse method, and then the mass Mi of each of the magnetic materials present in the assembly contained in the receptacle is determined ([0148]–[0155], p. 7).
Regarding claim 14, claim 14 depends from claim 8 and therefore incorporates all of the limitations of claim 8 and adds the same digital respective-mass determination as claim 10. For the reasons stated above with respect to claims 8 and 10, Lenglet teaches both the second-derivative response and digital determination of the respective magnetic masses of the two magnetic-material populations.
Conclusion
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/E.O./Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 August 31, 2026
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