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 .
Claim Status
Claims 1-5 and 25-34 are pending and being examined.
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 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.
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.
Claims 1-3, 25-28, 30-32, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Tan et al (US 20150204795 A1; hereinafter “Tan”; already of record) in view of Moddel (WO 9104491 A1; hereinafter “Moddel”; already of record).
Regarding claim 1, Tan teaches an interferometric sensor for detecting an analyte in a sample (Tan; Fig. 1; para [37]; bio-sensor interferometer 10), the interferometric sensor comprising:
a monolithic substrate (Tan; Fig. 1; para [37]; a monolithic substrate 17) that comprises glass that has first and second surfaces arranged substantially parallel to one another at opposite ends of the monolithic substrate (Tan; Fig. 1; para [31]; “A monolithic substrate,” as used herein, refers to a single piece of a solid material such as glass; the examiner interprets the bottom portion of the substrate as the first surface and the top portion as the second surface);
an interference layer coated on the second surface of the monolithic substrate (Tan; Fig. 1; para [43]; An interference layer (a thin-film layer) is a transparent material coated on the sensing side of the monolithic substrate); and
a layer of analyte-binding molecules coated on the interference layer (Tan; para [44]; Conventional immobilization chemistries are used in chemically, e.g., covalently, attaching a layer of analyte-binding molecules to the lower surface of the optical element);
wherein a first interface between the second surface of the monolithic substrate and the interference layer acts as a first reflecting surface when light is shone on the first surface of the interferometric sensor (Tan; para [12, 37, 48]; a second reflecting surface 23 between the thin film layer and the monolithic substrate); and
wherein a second interface between a biolayer formed by analyte molecules in a sample binding to the analyte-binding molecules and a solution containing the sample acts as a second reflecting surface when the light is shone on the first surface of the monolithic substrate (Tan; para [12, 37, 48]; the first reflecting surface is a surface between a layer of biomolecules (analyte binding molecules) 21 and the sample solution). The examiner notes that the “light shone” would contact the first surface of the respective reflecting surface because a portion of light refracts through each layer.
Tan does not teach the interference layer that consists of magnesium fluoride (MgF2).
However, Moddel teaches an analogous art of an analyte detection article (Moddel; Abstract) comprising a substrate (Moddel; page 8, line 13-15; the substrate can be formed of a transmissive material such as certain glass) and an interference layer (Moddel; page 10, line 12-17; Anti-reflective material serves two functions, first, to produce an interference color, and second, to provide a top layer onto which receptive material can be affixed in such a manner as to maintain the receptive material's capacity to selectively adsorb or bind any analyte of interest), wherein the interference layer that consists magnesium fluoride (MgF2) (Moddel; page 10, lines 22-23; page 12, lines 9-15; an anti-reflective layer of silicon dioxide… anti-reflective materials that have similar refractive index and could be utilized magnesium fluoride). The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B). The substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan at the time of invention could have substituted one known element with another (i.e., the silicone dioxide with magnesium fluoride), and the results of the substitution (i.e., the interference layer comprising magnesium fluoride) would have been predictable. Therefore, pursuant to MPEP §2143 (I), it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to substitute the interference layer of Tan in the manner of ----comprising magnesium fluoride as taught by Moddel as this is a known and suitable arrangement for material for interference layers since the result would have been predictable.
Regarding claim 2, modified Tan teaches the interferometric sensor of claim 1, wherein the monolithic substrate has a length, defined from the first surface to the second surface, of at least 5 millimeters (mm) (Tan; para [61, 76]; the monolithic substrate 104 is in a rod shape with its length at least 5 times greater than the diameter…A glass rod (a monolithic substrate), 1 mm diameter and 2 cm in length), and wherein an aspect ratio of the monolithic substrate is at least 5 to 1 (Tan; para [42]; the aspect ratio of the monolithic substrate (length to width or length to diameter) is at least 5:1).
Regarding claim 3, modified Tan teaches the interferometric sensor of claim 1, wherein the interference layer has a thickness of at least 500 nanometers (nm) (Tan; para [43]; The thin-film layer of the present invention typically has a thickness of preferably 400-1,000 nm). The claimed range overlaps or falls within the prior art range; in cases where the claimed range overlaps or falls within the prior art range, a prima facie case of obviousness of the range exists. It would have been obvious to one having ordinary skill in the art to have selected the thin-film layer thickness in the range that corresponds to the claimed range of at least 500 nanometers. See MPEP 2144.05(I).
Regarding claim 25, modified Tan teaches the interferometric sensor of claim 1, wherein the interference layer comprises a sufficient amount of magnesium fluoride (MgF2) to have a refractive index between 1.32 and 1.39. The interference layer of Tan is modified to comprise magnesium fluoride as taught by Moddel, thus products of identical chemical composition cannot have mutually exclusive properties, and thus, the claimed property (i.e. the refractive index), is necessarily present in the prior art material. The courts have held that “products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). MPEP § 2112.01(II).
Regarding claim 26, modified Tan teaches the interferometric sensor of claim 1, wherein a thickness of the interference layer is between 500 and 5,000 nm (Tan; para [43]; The thin-film layer of the present invention typically has a thickness of preferably 400-1,000 nm). The claimed range overlaps or falls within the prior art range; in cases where the claimed range overlaps or falls within the prior art range, a prima facie case of obviousness of the range exists. It would have been obvious to one having ordinary skill in the art to have selected the thin-film layer thickness in the range that corresponds to the claimed range between 500 and 5,000 nm. See MPEP 2144.05(I).
Regarding claim 27, modified Tan teaches the interferometric sensor of claim 26, wherein the thickness of the interference layer is between 800 and 1,200 nm (Tan; para [43]; The thin-film layer of the present invention typically has a thickness of preferably 400-1,000 nm). The claimed range overlaps or falls within the prior art range; in cases where the claimed range overlaps or falls within the prior art range, a prima facie case of obviousness of the range exists. It would have been obvious to one having ordinary skill in the art to have selected the thin-film layer thickness in the range that corresponds to the claimed range between 800 and 1,200 nm. See MPEP 2144.05(I).
Regarding claim 30, modified Tan teaches the interferometric sensor of claim 1, wherein the monolithic substrate has a columnar form (Tan; para [42]; The cross section of the monolithic substrate may be round). Tan teaches that the monolithic substrate comprises a length and the circular cross-section.
Regarding claim 31, modified Tan teaches the interferometric sensor of claim 1, further comprising: a flexible support component located in a central portion of the monolithic substrate (Tan; Fig. 10A; para [62]; the substrate's coupling surface 112 and the waveguide 113 that is installed inside the waveguide connector 102. The waveguide connector shown here has flexible gripping arms 107 to engage the hub 103 and maintain enough fictional force to hold the substrate 104 ), wherein a first portion of the monolithic substrate extends from a top side of the flexible support component, and wherein a second portion of the monolithic substrate extends from a bottom side of the flexible support component (Tan; Fig. 10C). Examiner notes that the removable probe 101 comprises the monolithic substrate 104, thus interprets the flexible support to be the waveguide connector. Additionally, the first portion, interpreted as the top, is positioned inside and towards the top of the flexible support component. While the second portion, interpreted as the bottom, extends outside of the flexible support component.
Regarding claim 32, modified Tan teaches the interferometric sensor of claim 31, wherein the flexible support component includes a flange and a sleeve located beneath the flange (Tan; Fig. 10B). The examiner interprets the gripping arms as the flange, and the sleeve as the opening in which the probe is inserted.
Regarding claim 34, modified Tan teaches the interferometric sensor of claim 1, further comprising: a reflection layer interconnected between the monolithic substrate and the interference layer (Tan; para [6]; An additional reflective surface layer with a thickness between 5-50 nm and a refractive index greater than 1.8 is coated between the interference layer and the first element; the examiner notes the principle of detecting an analyte in a sample based on the changes of spectral interference is described in this reference, which is incorporated herein by reference), wherein the reflection layer has a refractive index that is higher than the refractive index of the monolithic substrate and the refractive index of the interference layer (Tan; para [36, 42]; a monolithic substrate in an optical assembly with higher refractive index over the interference layer… A preferred refractive index range of the monolithic substrate material is between about 1.55 to about 2.0). The claimed range overlaps or falls within the prior art range; in cases where the claimed range overlaps or falls within the prior art range, a prima facie case of obviousness of the range exists. It would have been obvious to one having ordinary skill in the art to have selected the preferred refractive index range of the monolithic substrate material be 1.55 that corresponds to the claimed range. See MPEP 2144.05(I). Specifically, the preferred refractive index for the monolithic substrate of 1.55 is less than the reflective layer having a refractive index greater than 1.8.
Claims 4-5 and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Tan in view of Moddel, and in further view of Bogart et al (US 5482830 A; hereinafter “Bogart”; already of record).
Regarding claim 4, modified Tan teaches the interferometric sensor of claim 1, with the interference layer and the layer of analyte-binding molecules.
Modified Tan does not teach the interferometric sensor further comprising: an adhesion layer that comprises silicon dioxide (SiO2) and that is positioned between the interference layer and the layer of analyte-binding molecules.
However, Bogart teaches an analogous art of a device for detecting the presence of an analyte of interest (Bogart; Abstract) comprising an interference layer (Bogart; Fig. 6B; col 10, line 44; optical thin film 2) and a layer of analyte-binding molecule (Bogart; Fig. 6B; col 10, line 45; receptive material 4), further comprising: an adhesion layer (Bogart; Fig. 6B; col 10, line 45; attachment layer 3) that comprises silicon dioxide (SiO2) (Bogart; Fig. 6B; col 24, line 63-66; siliceous materials for retention of specific binding molecules originated with affinity chromatography applications and used silica (SiO2) gel, and solid supports such as glass) and that is positioned between the interference layer and the layer of analyte-binding molecules (Bogart; Fig. 6B; col 45, lines 35-38; an attachment layer between the reflective substrate and the receptive, biological layer). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the interferometric sensor of modified Tan to comprise the adhesive layer is positioned between the interference layer and the layer of analyte-binding molecules as taught by Bogart, because Bogart teaches the attachment layer protects the receptive material from toxic effects of the reflective substrate (Bogart; col 24, lines 45-48).
Regarding claim 5, modified Tan teaches the interferometric sensor of claim 4 (the interferometric sensor of modified Tan is modified to comprise the adhesion layer as taught by Bogart discussed above in claim 4), wherein the adhesion layer has a thickness of less than 10 nm (Bogart; col 25, lines 55-58; the attachment layer is spin coated or aerosol spray coated in a uniform manner. The various intermediate materials are coated to the substrate at thicknesses between 5 Å and 500 Å). The claimed range overlaps or falls within the prior art range; in cases where the claimed range overlaps or falls within the prior art range, a prima facie case of obviousness of the range exists. It would have been obvious to one having ordinary skill in the art to have selected the thickness 5 Å to 100 Å in the range that corresponds to the claimed range. See MPEP 2144.05(I).
Regarding claim 28, modified Tan teaches the interferometric sensor of claim 1, with the interference layer and the layer of analyte-binding molecules.
Modified Tan does not teach the interferometric sensor further comprising: an adhesion layer that connects the layer of analyte-binding molecules to the interference layer.
However, Bogart teaches an analogous art of a device for detecting the presence of an analyte of interest (Bogart; Abstract) comprising an interference layer (Bogart; Fig. 6B; col 10, line 44; optical thin film 2) and a layer of analyte-binding molecule (Bogart; Fig. 6B; col 10, line 45; receptive material 4), further comprising: an adhesion layer (Bogart; Fig. 6B; col 10, line 45; attachment layer 3) that connects the layer of analyte-binding molecules to the interference layer (Bogart; Fig. 6B; col 45, lines 35-38; an attachment layer between the reflective substrate and the receptive, biological layer). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the interferometric sensor of modified Tan to comprise the adhesive layer is positioned between the interference layer and the layer of analyte-binding molecules as taught by Bogart, because Bogart teaches the attachment layer protects the receptive material from toxic effects of the reflective substrate (Bogart; col 24, lines 45-48).
Regarding claim 29, modified Tan teaches the interferometric sensor of claim 28 (the interferometric sensor of modified Tan is modified to comprise the adhesion layer as taught by Bogart discussed above in claim 28), wherein the adhesion layer comprises silicon dioxide, and wherein the adhesion layer has a thickness of less than 10 nm (Bogart; col 25, lines 55-58; the attachment layer is spin coated or aerosol spray coated in a uniform manner. The various intermediate materials are coated to the substrate at thicknesses between 5 Å and 500 Å). The claimed range overlaps or falls within the prior art range; in cases where the claimed range overlaps or falls within the prior art range, a prima facie case of obviousness of the range exists. It would have been obvious to one having ordinary skill in the art to have selected the thickness 5 Å to 100 Å in the range that corresponds to the claimed range. See MPEP 2144.05(I).
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Tan in view of Moddel, and in further view of Wang et al (US 7317847 B1; hereinafter “Wang”; already of record).
Regarding claim 33, modified Tan teaches the interferometric sensor of claim 31, with the flexible support component.
Modified Tan does not teach wherein the flexible support component comprises silicone rubber.
However, Wang teaches an analogous art of a fiber-optic sensing mechanism (Wang; Abstract) comprising a flexible support (Wang; col 5, line 12; Functional cladding 20), wherein the flexible support component comprises silicone rubber (Wang; col 5, line 12-13; Functional cladding 20 may comprise a silicone gel or a flexible silicone polymer). Examiner further finds that the prior art contained the flexible support component which differed from the claimed flexible support component by the substitution of component(s) (i.e., silicone rubber), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan at the time of invention could have substituted one known element with another (i.e., silicone rubber), and the results of the substitution (i.e., flexible support component comprising silicone rubber) would have been predictable. Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan at the time of invention to substitute the flexible support component of modified Tan with the flexible support component comprising silicone rubber of Wang, since the result would have been predictable.
Response to Arguments
Applicant’s arguments filed, 1/26/2026, have been fully considered. The arguments are not found to be persuasive, and the non-persuasive arguments are addressed below.
In the Applicants’ arguments, on page 6-7, the Applicant argues Moddel does not teach the use of glass, which is interpreted as monolithic substrate, in combination with magnesium fluoride. The Examiner respectfully disagrees. The Examiner relies on Moddel to teach the composition of the interference layer and as bolded by the Applicant, Moddel teaches that the anti-reflective layer can be selected from the list of compounds. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Applicant argues that magnesium fluoride could not be substituted and used with glass because of the “restrictions” set forth by Moddel. However, this is under the assumption that glass has a refractive index of only about 1.51. The Examiner notes that the refractive index of glass may vary depending on the composition of the glass. Further, the deviation between the refractive indexes of magnesium fluoride and glass as noted by the Applicant would not render the device inoperable.
In the Applicants’ arguments, on page 8-9, the Applicant argues that the SiO2 interference layer of Tan does not teach MgF2. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The Examiner relies on Moddel to teach the MgF2 interference layer. Thus, Applicants’ arguments which compares the results of silicon dioxide and magnesium fluoride are not found to be persuasive.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Austin Q Le whose telephone number is (571)272-7556. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/A.Q.L./Examiner, Art Unit 1796
/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796
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