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 .
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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/30/2025 has been entered.
Withdrawn Rejections
The rejection of the claims under 103 are withdrawn in response to the amendments. However, new grounds of rejection are set forth below.
Priority
The present application was filed as a proper National Stage (371) entry of PCT Application No. PCT/EP2020/074233, filed 08/31/2020. Acknowledgment is also made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d) to Application No. FR1909561, filed on 8/30/2019 in France.
Status of the Claims
Claims 11-21 are pending; claims 11, 16 and 21 are amended, claims 1-10 are canceled; claims 16-20 are withdrawn. Claims 11-15 and 21 are examined below.
New Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are:
In claim 13:
(A) generic placeholder is “at least one additional magnetic field source”.
(B) linking word or phrase, “configured to”.
(C) the generic placeholder is not modified by sufficient structure, or acts for performing the claimed function “add an additional magnetic field”
In claim 21:
(A) generic placeholder is “capture receptacle”
(B) linking word or phrase, “configured to”
(C) the generic placeholder is not modified by sufficient structure, or acts for performing the claimed function “receive the sample”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
New Rejections
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 11-15 and 21 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.
Independent claim 1 recites “…b) a support for capturing and immobilizing said magnetic nanoparticles on a surface of the support, comprising or consisting essentially of at least one magnetic layer…”. However, it is not clear what is encompassed by “comprising or consisting essentially of” given that these two terms, although related, have different scopes. The specification fails to provide any disclosure regarding the scope of the terms “comprising” and “consisting essentially of”. Therefore, a person having ordinary skill in the art would not be able to readily recognize the metes and bounds of the claim.
Claims 12-15 and 21 are included in this rejection because they depend from rejected claim 11 but fail to clarify the scope of patent protection sought.
Regarding claim 13, the claim limitation “said additional magnetic field source being external to said at least one magnetic layer and configured to add an additional magnetic field to the magnetic field generated by the at least one magnetic layer” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification fails to disclose what is meant by "configured to add an additional magnetic field". The specification at page 24 paragraph 3 discloses "said at least one additional magnetic field source is configured to emit a uniform magnetic field"; at page 25 paragraph 3 "said at least one additional magnetic field source is advantageously configured to generate a magnetic field of 1 mT to 400 mT at the nanoparticles when using the kit", and at page 26 paragraphs 1-2 "said at least one additional magnetic field source is configured to emit a magnetic field continuously...said at least one additional magnetic field source is configured to emit a pulsed magnetic field". Thus, the specification does not provide sufficient structure to the configuration to add an additional magnetic field. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Similarly, regarding claim 21, the claim limitation “capture receptacle configured to receive the sample containing the molecule to be captured” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The only disclosure of the capture receptacle in the specification is in page 11 paragraph 7. The specification discloses "a capture receptacle configured to receive the sample containing the molecule to be captured and delimited by at least one wall comprising said at least one magnetic layer. This capture receptacle has, as the smallest dimension, a dimension of 20 μm to 1000 μm". However, this is not considered sufficient description for a person having ordinary skill in the art to recognize what is being claimed by “a capture receptacle configured to receive the sample containing the molecule to be captured”. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
New Rejections
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 11-14 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Coudron et al. Microfluid Nanofluid 14, 359–369 (2013) https://doi.org/10.1007/s10404-012-1057-9 Cite No. 2 of IDS filed 2/25/2022 (“Coudron”) in view of Zhou (US 20090065359 A1)-Cite No. A of PTO 892 9/30/2025 and Dremel (US 6479302 B1)-Cite No. 1 of IDS 2/25/2022, as evidenced by YANGGUANG RESIN CHEMICAL CO.,LTD (retrieved online https://www.ygresin.com/product/umoh-vinyl-resin/ on 4/22/2025)-Cite No. U of PTO 892 5/2/2025 and Li et al. Scientific REPORTS | 7: 9894 | DOI:10.1038/s41598-017-09897-5-Cite No. U of PTO 892 9/30/2025.
Regarding claim 11, Coudron teaches “Low-cost credit card-based microfluidic devices for magnetic bead immobilization” (Title). Coudron suggests a kit for capturing an analyte (“for applications such as immunomagnetic cell separation” Abstract). Coudron further suggests the kit comprising a) magnetic nanoparticles having the largest dimension of less than 1 µm (“a polystyrene microsphere containing 42.5 % by mass of iron oxide superparamagnetic nanoparticles. The predominant oxide constituent is Fe3O4 with unspecified quantities of Fe2O3. As supplied by the manufacturer, the beads have a mean diameter d = 1.63 µm and a magnetic susceptibility X = 0.1 (S.I.)” page 361 col. 1 para. 3). Note that Coudron teaches magnetic nanoparticles having the largest dimension of less than 1 µm when teaching the superparamagnetic nanoparticles contained in the polystyrene beads; also note, that the claims as currently recited are not limited to the exclusion of the magnetic nanoparticles being contained in a bead. Even though the beads have a diameter of 1.63 µm, the superparamagnetic nanoparticles, which are predominantly Fe3O4, contained in the beads would inherently be less than 1 µm in size as evidenced by Li (or render obvious over Li). Li teaches that “[t]he particle size required to achieve superparamagnetism in Fe3O4 NPs is widely estimated to be below 20 nm, whereas the critical size for forming a multi-domain structure has been theoretically estimated to be 76 nm for cubic and 128 nm for spherical Fe3O4 NPs. However, the critical size for cubic Fe3O4 NPs has been experimentally determined to be higher than 160 nm. Much smaller critical sizes of 30–46 nm have also been reported for cubic Fe3O4 NPs. Multi-granule Fe3O4 NPs with sizes of 16–512 nm showed a transitional size of approximately 120 nm” (page 1 last paragraph and page 2 paragraph 1). Coudron further suggests the nanoparticles being coupled to at least one capture element (“for applications such as immunomagnetic cell separation” Abstract). Note that the teaching of “immunomagnetic cell separation” inherently provides a coupled capture element, i.e. an antibody (“immunomagnetic”). Coudron further suggests the kit comprising b) a support for capturing and immobilizing said magnetic nanoparticles on a surface of the support (Title, “device for magnetic bead separation and immobilisation. One dimensional arrays of localised high magnetic field gradients are constructed at the interfaces between regions magnetised with opposing polarities on the magnetic Fe2O3 composite stripes of credit cards. The localized high magnetic field gradients are employed to trap magnetic beads on the surface of the magnetic stripe… The fabrication of the device is based on PDMS to credit card bonding of simple flow channels” Abstract, see figures 1 and 4-5). Coudron further teaches the support comprising or consisting essentially of at least one magnetic layer, said magnetic layer comprising a juxtaposition, possibly repeated, of at least a first and a second region, the first region comprising magnetic particles polarized in a first direction, and the second region comprising magnetic particles that are non-polarized or polarized in a second direction different from the first direction of polarization of the magnetic particles of the first region, wherein said at least one magnetic layer is a flexible magnetic tape comprising magnetic composite materials, randomly distributed or oriented along a preorientation axis in a polymer (“The magnetic stripe comprises of a polymer binder containing dispersed Fe2O3 micro-particles with a typical mass fraction from 15 to 20 %. The exact chemical formulation of the magnetic stripes is commercially confidential; however, it is generally understood that the binder is a high molecular weight, hydroxyl-functional, partially hydrolysed vinyl chloride/vinyl acetate resin cross linked with a urethane modified polyester resin. Magnetic cards often have an anti-abrasion layer (usually acrylics or urethanes) covering the magnetic stripe surface…When the magnetic stripe is blank, those elemental magnetic particles are aligned with their North–South (N–S) axes parallel to the magnetic stripe upper surface. Encoding the stripe consists of deterministically creating localised flux reversals, i.e. locally creating S–S and N–N interfaces” page 360 column 2 paragraph 2). Note that although Coudron fails to use the language “flexible magnetic tape” the teachings of the magnetic stripe material inherently teaches a “flexible magnetic tape” as evidenced by YANGGUANG RESIN CHEMICAL CO.,LTD. YANGGUANG RESIN CHEMICAL CO.,LTD teaches that “UMOH resin is a hydroxyl functional partially hydrolyzed vinyl chloride and vinyl acetate resin with a high molecular weight. It is available in powder form. It can also crosslink with amino resins and polyisocyanates, and it is compatible with a variety of resins” (page 1 paragraph 1). YANGGUANG RESIN CHEMICAL CO.,LTD further teaches that an application of UMOH is “magnetic tape flexible packaging and binder” (page 1 paragraph 4). Coudron further teaches the first direction and the second direction being opposite to each other and parallel to the surface of the support (see Fig. 1). Coudron further suggests that said at least one magnetic layer generates a magnetic field having at least one variation in intensity of at least 0.1 mT at a distance of at least 1 µm from said at least one magnetic layer (“Plot of the vertical component of the magnetic field By” page 362 col. 2, see Figure 2b and 2c showing that at a distance of 10 µm and 19.2 µm, there is a variation of intensity of the magnetic field of at least 0.03 T (30 mT) and 0.02 T (20 mT), respectively). Coudron further teaches that “credit card-based magnetic separator might offer an efficient, simple, low-cost alternative to traditional microfluidic magnetic separators for applications such as immunomagnetic cell separation” (Abstract).
Coudron fails to teach the kit being for capturing a molecule in a sample comprising: a) each magnetic nanoparticle being free from one another, said nanoparticles being coupled to at least one capture element, said at least one capture element specifically binding to said molecule.
Zhou teaches “discrete contact MR Bio-sensor with magnetic label field alignment” (Title). Zhou further suggests a kit for capturing a molecule in a sample (“a family of sensors for assaying macro-molecules and/or biological cells in solution” Abstract). Zhou further suggests the kit comprising: a) magnetic nanoparticles, each magnetic nanoparticle being free from one another, said nanoparticles being coupled to at least one capture element, said at least one capture element specifically binding to said molecule (“Said molecules or cells have been rendered magnetic by magnetized nano-particles (labels) that bind to the molecules or to the surface of the cells as a result of biological recognition” paragraph 41, “The selective bindings commonly used are polynucleic acid bindings or hybridizations (RNA and DNA), many types of ligand to receptor bindings, as well as antibody to antigen bindings” paragraph 2, Fig. 6c, “a typical label size is preferably in the range of tens to hundreds of nanometer” para. 76). Zhou further teaches that “[f]or molecule detection, binding assay to detect target molecules is already a widely used technique in biological, bio-chemical and medical areas. The target molecules in these bindings, for example, proteins, RNA and DNA, can also be a distinctive component or product of viruses, bacteria and cells, which may be the actual objects of interest for the detection” (paragraph 4). Zhou further suggests the kit comprising b) a support for capturing and immobilizing said magnetic nanoparticles on a surface of the support, comprising or consisting essentially of at least one magnetic layer, said magnetic layer comprising a juxtaposition, possibly repeated, of at least a first and a second region, the first region polarized in a first direction, and the second region polarized in a second direction different from the first direction, so that said at least one magnetic layer generates a magnetic field having at least one variation in intensity, the first direction and the second direction being opposite to each other and parallel to the surface of the support (see Fig. 6c), said at least one variation in intensity defining a maximum and a minimum of the standard of the intensity of said magnetic field, so as to define, at said maximum of the standard of said magnetic field, a zone for capturing and immobilizing the magnetic nanoparticles on the capture support (“ FIGS. 6c and 6d show structures wherein the labels are magnetized at an angle. The underneath magnet has a clearance that is concentric with the well center. The magnetic field from the inner edge of the magnets attracts the labels to the well edge and aligns them in the same way as discussed in FIG. 3. The difference is only the magnet's magnetization direction” paragraph 72, “ there is a field gradient directed towards the magnet's edges, as indicated by the higher density of the field lines at the magnet edges in FIG. 3” paragraph 62, “[a] gradient near the edge of the field serves to line up the magnetic labels (or biological entities coated with magnetic labels) against the floor and the wall” paragraph 92).
Dremel teaches “mmunological determination of an analyte in a sample using magnetic particles coated with the analyte to be determined or analyte-specific bonding partners… The method is characterized in that the magnetic particles are subsequently separated from the reaction mixture using a magnetic test strip and the analyte concentration is determined directly” (Abstract). Dremel further teaches that “[t]he magnetic test strips according to the invention can be prepared, for example, from suitable magnetizable pigments similarly to diskettes, audio or video tapes” (col. 1 lines 51-53). Dremel further teaches that “[p]articles which can be used in principle are all commercially obtainable magnetic and non-magnetic particles, which can also be coloured, provided they have a size from 30 nm to 800 m” (col. 2 lines 14-17).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Coudron to rely on the kit being for capturing a molecule, and the magnetic nanoparticles, each being free from each other, being coupled to at least one captured element, said at least one capture element specifically binding to said molecule taught by Zhou because Zhou suggests that this enables the detection of distinctive components or products of viruses, bacteria and cells for medical purposes. A person having ordinary skill in the art would have had a reasonable expectation of success because Zhou teaches that “[f]or molecule detection, binding assay to detect target molecules is already a widely used technique in biological, bio-chemical and medical areas” (paragraph 4). Furthermore, both Coudron and Zhou teach magnetic nanoparticles coupled to a capture element and capturing and immobilizing said magnetic nanoparticles on a surface of a support, comprising or consisting essentially of at least one magnetic layer, said magnetic layer comprising a juxtaposition, possibly repeated, of at least a first and a second region, the first region polarized in a first direction, and the second region polarized in a second direction different from the first direction, so that said at least one magnetic layer generates a magnetic field having at least one variation in intensity, the first direction and the second direction being opposite to each other and parallel to the surface of the support, said at least one variation in intensity defining a maximum and a minimum of the standard of the intensity of said magnetic field, so as to define, at said maximum of the standard of said magnetic field, a zone for capturing and immobilizing the magnetic nanoparticles on the capture support. A person having ordinary skill in the art would have had a reasonable expectation of success in using the magnetic nanoparticles each free from each other taught by Zhou with the magnetic tape of Coudron because Dremel teaches that magnetic tapes can capture a magnetic nanoparticle as small as 30 nm in size (col. 2 lines 14-17) and further teaches that these magnetic particles are commercially available.
Regarding claim 12, Coudron in view of Zhou and Dremel address the kit of claim 11 as discussed above.
Coudron also suggests wherein said at least one magnetic layer has a retentivity of 2000 to 30,000 µm Gauss given that Coudron teaches a remanence of 0.1 T and a thickness of 10 µm, thereby inherently addressing a retentivity of: 10 µm x 0.1 T = 1 µm.T = 10,000 µm Gauss (“[t]he remanence (or retentivity) used was Br = 0.1 T” page 361 column 1 paragraph 1, “The magnetic stripe thickness is 10 µm” Fig. 1 page 361).
Regarding claim 13, although the claim is indefinite (see 112b rejection above), in the interest of compact prosecution, the external magnetic field configured to add an additional magnetic field is interpreted as an inherent property of the additional magnetic field. Coudron in view of Zhou and Dremel address the kit of claim 11 as discussed above.
Coudron fails to teach further comprising at least one additional magnetic field source, said additional magnetic field source being external to said at least one magnetic layer and configured to add an additional magnetic field to the magnetic field generated by the at least one magnetic layer.
Zhou teaches further comprising at least one additional magnetic field source, said additional magnetic field source being external to said at least one magnetic layer and configured to add an additional magnetic field to the magnetic field generated by the at least one magnetic layer (“[t]here is optionally a soft magnetic structure on top of the permanent magnet structure to assist magnetic field and gradient generation” paragraph 92). Zhou suggests that the additional magnetic field source assists in the capturing and immobilizing of the molecules, e.g. biological entities, in the sample (“A gradient near the edge of the field serves to line up the magnetic labels (or biological entities coated with magnetic labels) against the floor and the wall” paragraph 92). Note that although Zhou fails to use the language “external” and “magnetic field source” the teaching of “magnetic structure on top of the permanent magnet structure to assist magnetic field and gradient generation” inherently provides an external magnetic field source because the “magnetic structure” is “on top”, i.e. external, and generates a magnetic field, i.e. is a source of magnetic field.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Coudron in view of Zhou and Dremel to rely on the additional magnetic field source, said additional magnetic field source being external to said at least one magnetic layer and configured to add an additional magnetic field to the magnetic field generated by the at least one magnetic layer taught by Zhou because Zhou suggests this assists in the capturing and immobilizing of the molecules, e.g. biological entities, in the sample. A person having ordinary skill in the art would have had a reasonable expectation of success because both Coudron and Zhou teach a support, comprising or consisting essentially of at least one magnetic layer, said magnetic layer comprising a juxtaposition, possibly repeated, of at least a first and a second region, the first region polarized in a first direction, and the second region polarized in a second direction different from the first direction, so that said at least one magnetic layer generates a magnetic field having at least one variation in intensity, the first direction and the second direction being opposite to each other and parallel to the surface of the support, said at least one variation in intensity defining a maximum and a minimum of the standard of the intensity of said magnetic field, so as to define, at said maximum of the standard of said magnetic field, a zone for capturing and immobilizing the magnetic nanoparticles on the capture support.
Regarding claim 14, Coudron in view of Zhou and Dremel address the kit of claim 11 as discussed above.
Coudron further suggests wherein said at least one magnetic layer having a capture surface (“The localized high magnetic field gradients are employed to trap magnetic beads on the surface of the magnetic stripe” Abstract), said at least one magnetic layer is at least partially covered on said capture surface by a non-magnetic layer (“Magnetic cards often have an anti-abrasion layer (usually acrylics or urethanes) covering the magnetic stripe surface” page 360 col. 2 para. 2).
Regarding claim 21, although the claim is indefinite (see 112b rejection above), in the interest of compact prosecution, the capture receptacle configured to receive the sample is interpreted as an inherent property. Coudron in view of Zhou and Dremel address the kit of claim 11 as discussed above.
Coudron further suggests wherein the support comprises a capture receptacle configured to receive the sample containing the molecule to be captured, the capture receptacle being delimited by at least one wall comprising said at least one magnetic layer and having a depth between 100 µm to 1000 µm (“The fabrication of the device is based on PDMS to credit card bonding of simple flow channels” Abstract, “600 µm holes were then drilled through the PDMS microstructures to provide fluid connectivity” page 364 col. 1 para. 3). Note that the claim recites the capture receptacle using functional language “configured to receive the sample containing the molecule to be captured”, therefore, even though Coudron fails to teach a sample containing the molecule to be captured, the capture receptacle taught by Coudron would still be capable of receiving the sample containing the molecule to be captured. Also note, that although the capture receptacle is the inlet/outlet of the microfluidic device taught by Coudron, using the broadest reasonable interpretation of a “support compris[ing] a capture receptacle configured to receive the sample containing the molecule to be captured having a depth between 100 µm to 1000µm”, the inlet/outlet holes of 600 µm in depth for fluid connectivity taught by Coudron addresses the claim. Furthermore, the inlet/outlet holes of 600 µm in depth for fluid connectivity taught by Coudron also addresses the capture receptacle being delimited by at least one wall comprising said at least one magnetic layer. Note that the specification discloses that “the capture support is … a well… In the case of a well, said at least one magnetic layer is arranged at one, and if several magnetic layers are present, at least one, wall of said well. Advantageously, said at least one magnetic layer is arranged at the wall forming the bottom of said well” (page 12 paras. 1 and 4). Therefore, the inlet/outlet holes of 600 µm in depth for fluid connectivity taught by Coudron are reasonably interpreted as a capture receptacle in the form of a well. As per the specification page 12 paragraph 4, the delimitation by at least one wall comprising said at least one magnetic layer is the bottom of the hole/well, i.e. the bottom wall of the hole/well. Therefore, Coudron suggests the claim.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Coudron in view of Zhou and Dremel as applied to claims 11 and 14 above, and further in view of Adams (US 7658332 B1).
Regarding claim 15, Coudron in view of Zhou and Dremel address the kit of claim 14 as discussed above.
Coudron fails to teach wherein said non-magnetic layer has a thickness of 1 to 300 µm.
Adams teaches “[a]n overlay is provided which can be adhered over the front and/or rear faces of a transaction card (e.g., a credit card) to protect it from wear, and also to lend it a personalized appearance” (Abstract). Adams further teaches that “[t]he overlay 100/200/300 is preferably formed of thin flexible sheet material, preferably a plastic film such as vinyl, polyester, or polyvinyl chloride having a thickness of 5 mil (5 thousandths of an inch) or less, and most preferably 2 mil or less. The overlay 100/200/300 is also preferably formed of materials which do not interfere with the electromagnetic transmission of data from magnetic strips” (paragraph 15). Note that 5 mil is equivalent to 127 microns and 2 mil is equivalent to 50.8 microns. Therefore, Adams teaches said non-magnetic layer having a thickness of 1 to 300 µm.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Coudron in view of Zhou and Dremel to rely on the thickness of the non-magnetic layer being 1 to 300 µm taught by Adams because Adams suggests that this thickness can both protect the card from wear and not interfere with the electromagnetic transmission of the magnetic strip. A person having ordinary skill in the art would have had a reasonable expectation of success because both Coudron and Adams teach a protective non-magnetic layer covering the magnetic layer of a credit card.
Response to Arguments
Applicant's arguments filed 12/1/2025 have been fully considered but they are not persuasive.
Regarding the 103 rejections,
Applicant argues that “The magnetic labels are uniformly distributed. Thus, Zhou teaches away from localized immobilization, and therefore its teaching is incompatible with Coudron' s disclosure” (page 8 para. 1).
However, the claims are not limited to the magnetic labels not being uniformly distributed. Zhou teaches that “there is a field gradient directed towards the magnet's edges, as indicated by the higher density of the field lines at the magnet edges in FIG. 3” (paragraph 62), “[a] gradient near the edge of the field serves to line up the magnetic labels (or biological entities coated with magnetic labels) against the floor and the wall” (paragraph 92). Therefore, the teachings of lining up the magnetic nanoparticles against the floor and wall provides localized immobilization, and certainly does not teach away from localized immobilization.
Applicant further argues that “The magnet illustrated in Fig. 6c does not correspond to a magnetic layer with different magnetizations regions” (page 8 para. 2).
However, contrary to Applicant’s remark, Fig. 6c does correspond to a magnetic layer with different magnetizations regions given that the magnet shown in Fig. 6c is a layer and on the left region the magnetic field arrow is pointing to the right and on the right region the magnetic field arrow is pointing to the left.
Applicant further argues that “Zhou does not teach or suggest a magnetic layer comprising a juxtaposition, possibly repeated, of at least a first and a second region, the first region comprising magnetic particles polarized in a first direction, and the second region comprising magnetic particles that are nonpolarized or polarized in a second direction different from the first direction of polarization of the magnetic particles of the first region, the first direction and the second direction being opposite to each other and parallel to the surface of the support, said at least one variation in intensity defining a maximum and a minimum of the standard of the intensity of said magnetic field, so as to define, at said maximum of the standard of said magnetic field, a zone for capturing and immobilizing the magnetic nanoparticles on the capture support” (page 8 para. 3).
However, Zhou is not relied upon for the teachings cited above. Note that Zhou is relied upon for the teachings of the kit being for capturing a molecule in a sample comprising each magnetic nanoparticle being free from one another, said nanoparticles being coupled to at least one capture element, said at least one capture element specifically binding to said molecule (see new grounds of rejection above over Coudron in view of Zhou and Dremel).
Applicant further argues that “Zhou's use of a strong permanent magnet reinforces the argument that a person of ordinary skill in the art would tum to strong magnetic sources to manipulate nanoparticles, further highlighting the counterintuitive nature of the presently claimed kit and device's use of a weak flexible tape” (page 8 para. 4).
However, new grounds of rejection rely on Dremel. Dremel teaches using a weak flexible magnetic tape to manipulate nanoparticles, thereby providing a reasonable expectation of success in combining Coudron with Zhou.
Applicant further argues that “Adams does not remedy the deficiencies of Coudron and Zhou detailed above” (page 9 para. 3).
However, there are no deficiencies in the new grounds of rejection set forth above over Coudron in view of Zhou and Dremel (see rejection above).
Applicant further argues that “The drilled holes in Coudron are used for fluidic connectivity and are not delimited by at least one wall comprising said at least one magnetic layer, as defined in present claim 21” (page 9 para. 5).
However, although the drilled holes in Coudron are used for fluidic connectivity, these would still be capable of receiving the sample containing the molecule to be captured (see rejection above). Furthermore, note the new 112b rejection over the language “capture receptacle configured to receive the sample”. The specification does not provide a structure corresponding to the apparent 112(f) claim interpretation. Therefore, in the interest of compact prosecution, the holes taught by Coudron inherently provide the capture receptacle configured to receive the sample. Furthermore, the specification discloses that the bottom of a well can be considered as the delimited wall comprising said at least one magnetic layer (page 12 para. 4). Therefore, the holes taught by Coudron read on claim 21 (see rejection above).
Applicant further argues that “The additional soft magnetic structure does not add an additional magnetic field - the soft structure used by Zhou only concentrates an existing field generated by the magnets. As defined in present claim 13, the additional magnetic field source overlaps the field generated by the magnetic tape, which adds an additional magnetic field to the magnetic field generated by the at least one magnetic layer” (page 10 para. 4).
However, the claim is not limited to the additional magnetic field source overlapping the field generated by the magnetic tape. Furthermore, note the new 112b rejection over the language “said additional magnetic field source…configured to add an additional magnetic field”. The specification does not provide a structure corresponding to the apparent 112(f) claim interpretation. Therefore, given that Zhou teaches “a soft magnetic structure on top of the permanent magnet structure to assist magnetic field and gradient generation” (paragraph 92), the teaching of Zhou addresses the claim.
Conclusion
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/Fernando Ivich/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678