DETAILED ACTION
Claims 1-20 are pending.
Information Disclosure Statement
The information disclosure statements filed 10/03/2023 and 01/21/2026 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Copies of foreign patent documents WO- 2016/102693-A1 and JP-4649788-B2 were not included in the application file.
Claim Objections
Claim 1 is objected to because of the following informalities: A word is missing before “Optoelectronic chip”. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: Claim 12 is missing a word between “method” and “using” in the preamble. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: Claim 13 is missing a word before “Optical system”. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: Claim 15 misspells “using”. Appropriate correction is required.
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.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Duer et al., (US20140178861A1) (effectively filed on 02/28/2014).
Regarding claim 1, Duer teaches optoelectronic chip for receiving a sample in the visualization of temperature-dependent processes (see [0173] “The light source generates light in one or in several different wavelengths. In some cases, the wavelength of the light emitted by the light source can be tuned by changing its temperature or by placing a filter in front of the light source to pick one wavelength out of the emitted spectrum.”),
having a carrier layer (see [0276] “The substrate of the detection system can made up of any of a number of well known materials suitable for use in planar light wave circuits. For example, useful substrate materials include but are not limited to silica (SiO2), glass, epoxy, lithium niobate and indium phosphide as well as combinations thereof.”),
a thin-film lightguide and a thin- film heating element (see [0235] “In this embodiment, optical sensing site 912 of substrate 904 can include heater 905, for example, a thin-film heater, in the vicinity of each sensing sites 912.”, see [0009] “The first involve slab waveguide fluorescence excitation with light collection from above or below the chip. In this arrangement the bio-analyzed spots are located on the surface of a chip that contains a single slab-waveguide.”, It is known in the art that a slab waveguide is a thin film, page 2 of the instant application teaches that lightguide and waveguide are the same.),
wherein the thin-film lightguide and the thin-film heating element are arranged either on sides of the carrier layer that are opposite each other or on the same side of the carrier layer (see figures 9D and 9H. Figure 9D shows a schematic of the substrate. Figure 9D shows the collection waveguide (910) and the excitation waveguides (908) on the substrate. Figure 9H shows a close up of the substrates optical sensing site (912) which includes the heater (905). Figures 9D and 9H show the location relationship between the thin-film waveguide and the thin-film heating element being arranged on the same side of the carrier layer).
Regarding claims 2 and 16, Duer teaches the carrier layer consisting of a transparent material and comprises Si or another SiO2-based glass (see [0362] “In the deposition step a layer of well defined material having well controlled thickness is deposited across the entire wafer. The most common materials used for waveguide layer deposition are silica (SiO2), also known as glass, and silicon nitride (Si3N4). The optical properties of the silica (mainly its refractive index) is controlled by the amount of doping (Ge, P, and B etc.) introduced during the deposition”.)
Regarding claim 3, Duer teaches wherein between the carrier layer and the thin-film waveguide there is a further transparent layer that has a lower refractive index than the carrier layer (see [0246] “The bottom layer can have a higher refractive index in order to increase the evanescent field tail presence in the optical sensing sites. An upper layer, about 10 μm thick, can contain the optical sensing site and the light collection structures (funnels and waveguides). The upper layer can have a lower refractive index than the bottom layer in order to minimize light loss when coupling the light out of the substrate to the detector.”, [0278] “It is envisioned that the various layers of the substrate can include different refraction index properties. For example, a waveguide layer (e.g. SiN) has a higher refraction index than a cladding layer of silica deposited thereon.”).
Regarding claim 4, Duer teaches wherein the further transparent layer comprises of a polymer (see [0276] “The substrate of the detection system can made up of any of a number of well known materials suitable for use in planar lightwave circuits. For example, useful substrate materials include but are not limited to silica (SiO2), glass, epoxy, lithium niobate and indium phosphide as well as combinations thereof. The waveguides disclosed herein can be made up of silicon, silica (SiO2) and derivatives thereof, silicon oxynitride (SiON) and derivatives thereof, silicon nitride (SiN) and derivatives thereof, tantalum oxide (TaOx) and its derivatives thereof, polymers, lithium niobate and indium phosphide as well as combinations thereof. In one embodiment, UV light is used to change the refractive index of a waveguide material after deposition.”. Further, is known in the art that silicon is amorphous).
Regarding claims 5 and 18, Duer teaches wherein the thin-film heating element is equipped with a temperature sensor (see [0093] “FIG. 9H is a schematic of one embodiment of the substrate of the invention illustrating details of an optical sensing site including a heater and a thermistor.”, see figure 9H, see [0235]).
Regarding claim 6, Duer teaches wherein the heating element is optically transparent (see [0235] “FIG. 9H illustrates another embodiment of substrate 904 of the invention wherein optical sensing site 912 includes heater 905 and thermistor 907. In this embodiment, optical sensing site 912 of substrate 904 can include heater 905, for example, a thin-film heater, in the vicinity of each sensing sites 912. Heater 905 can be adapted to enable individual temperature control for each sensing site 912”. It is known in the art that thin-film heaters are optically transparent.).
Regarding claim 7, Duer teaches wherein the thin-film heating element is or comprises a resistance heating element (see [0235] teaching the use of a thermistor, which is a known resistor heating element).
Regarding claim 8, Duer teaches the sensor which has metal and is at least partially covers an outer surface of the optoelectronic chip and is further designed to come into thermal contact with a sample (see [0011] “A third waveguide based bio-sensor utilizes surface plasmon resonance (SPR). Here, in one example, a thin gold layer is deposited on top of a glass substrate. The bio-analyzed sample on top of the gold induces changes in the refractive index above the gold layer, thus changing the resonant angle for generating surface plasmons along the gold layer. The plasmon generation is detected as an enhanced peak in the reflected beam. Examples of the SPR method are covered, for example, in U.S. Pat. No. 6,956,651 B2. Other types of optical bio-sensors and array scanners exist such as described in U.S. Pat. No. 6,396,995 B1.”, see claim 6 of ‘861).
Regarding claim 9, Duer teaches temperature regulation/control by means of a feedback system between the sensor layer and the heating element (see [0235] “a thin-film heater, in the vicinity of each sensing sites 912. Heater 905 can be adapted to enable individual temperature control for each sensing site 912. In addition to heater 905, thermistor 907 can be located at or near each sensing site 912 thereby providing for measuring the local temperature. In use, this embodiment provides the capability of running the same or any desired different number of cycles and the same or any desired different temperature profiles for each and every sensing site.”).
Regarding claim 10, Duer teaches wherein an outer surface of the optoelectronic chip, which is designed to come into contact with a sample, at least partially or completely has a surface modification and/or surface functionalization in order to bind molecules contained in a sample (see [0306] “One example of such a ligand includes fluorescein. The additional antibody may be bound to a solid support (e.g., an optical sensing site of the detection system). The additional antibody binds to the ligand coupled with the antibody that binds in turn to the analyte or alternatively to the labeled analyte, forming a mass complex which allows isolation and measurement of the signal generated by the label coupled with the labeled analyte.”).
Regarding claim 11, Duer teaches A method of receiving a sample for visualization of temperature-sensitive processes, the method comprising applying an at least partially liquid, solid or gel-like sample to the optoelectronic chip according to claim 1 in such a way that the sample partially or completely surrounds the thin-film lightguide (see [0046] “In general, in yet another aspect, the invention provides a detection method comprising delivering a sample suspected of containing a biologically active analyte molecule to be detected to an optical sensing site on the substrate of a detection system, and spatially translating a scanning light source to a point at which the light source is coupled to and in optical communication with one or more of a plurality of waveguides in optical communication with the optical sensing site, thereby generating a first light wave within said waveguide, wherein the first light wave is transducable by a sensor associated with the optical sensing site to a second light wave. Furthermore, the method comprises detecting a measurable change in the second light wave using a detector in optical communication with the substrate, wherein a measurable change in the second light wave occurs when the sensor interacts with the biologically active analyte molecule.”, see [0238] “Microfluidics can be adapted to drive liquid (in this case the tested sample) using the capillary effect across the substrate. As illustrated in FIG. 9J, this can be achieved by an arrangement of microchannels 909, optionally of varying width, which force the sample from one or more reservoirs 913 to optical sensing sites 912 which can include etched wells to receive the sample. The microchannels can be either etched on the face of the chip itself or can be added as an external structure on a surface of the substrate.”, see [0280] “Where the optical sensing site is a well, it can act as a vessel for a liquid sample”).
Regarding claim 12, Duer teaches wherein the sample contains at least one or a plurality of particle(s) that is/are capable of and/or designed to interact with a guided mode of the thin-film lightguide (see [0306] The additional antibody binds to the ligand coupled with the antibody that binds in turn to the analyte or alternatively to the labeled analyte, forming a mass complex which allows isolation and measurement of the signal generated by the label coupled with the labeled analyte.”, see claim 6 of Duer).
Regarding claim 13, Duer teaches an optical system which is designed to be used with an optoelectronic chip according to claim 1, having at least one emitter or scatterer that emits light for optical excitation of the sample parallel to the plane of the thin-film lightguide and having at least one detector that detects light deflected by the sample normal to the plane of the thin-film lightguide (see [0039] “the substrate comprises a plurality of substantially parallel excitation waveguides, and a plurality of substantially parallel collection waveguides, the excitation waveguides and collection waveguides crossing to form a two-dimensional array of intersection regions where an excitation waveguide and a collection waveguide cross and provide optical communication with the intersection region at each crossing; and a plurality of optical sensing sites each in optical communication with an intersection region. The system further comprises a scanning light source that is at some point along its scanning path coupled to and in optical communication with one or more of the excitation waveguides at a first edge of the substrate, and a detector that is coupled to and in optical communication with one or more of the collection waveguides at a second edge of the substrate”).
Regarding claim 14, Duer teaches the detector being an array detector (see [0044] “In carious embodiments, the detector elements of the detector or of the scanning light source chip may be PIN diodes, avalanche photo-diodes, or a group of pixels which are part of a charge coupled device (CCD) array. In some embodiments, the detector is a silicon photodiode array.").
Regarding claims 15 and 20, Duer teaches the examination of living cells under temperature-controlled conditions (see claims 6 and 8-9 of ‘861) and
the cells being biological molecules that contain an enzyme (see [0298]), a protein (see [0196]), DNA (see [0294]- [0295]), or RNA (see [0295]).
Regarding claim 17, Duer teaches wherein the refractive index is between 1.2 and 1.5 (see [0256] “In one embodiment the substrate consists of three waveguide layers having core refractive index of 1.7 and clad reflective index of 1.4. Useful core refractive index values range from about 1.45 to about 2.1, and useful clad refractive index values range from about 1.4 to about 1.5.”).
Regarding claim 19, Duer teaches comprising a control unit to control and/or regulate the thin-film heating element based on the measurement data acquired by means of the temperature sensor (see [0219] “The working system housing can optionally include temperature control and vibration isolation for the working system (not shown).”, see [0222] “. Electronic boards 807 can further be adapted to drive robotic system 803 and control its motion, to control the motion of the scanning light source chip, and optionally to monitor and control temperature in different areas of the system. Electronic boards can include logic elements and processors (not shown). It is envisioned that electronic boards can further include embedded software both for controlling the working system and for interfacing the outside world, for example by way of interface panel 805 which can include a key-pad or any other input/output port.”, see [0233]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 11-14, and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 8-13, and 15 of copending Application No. 18270163 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are not patentably distinct from each other for the reasons set forth below.
Regarding instant claim 1, ‘163 teaches an optoelectronic chip for receiving a sample in the visualization of temperature-dependent processes, having a carrier layer, a thin-film lightguide and a thin- film heating element, wherein the thin-film lightguide and the thin-film heating element are arranged either on sides of the carrier layer that are opposite each other or on the same side of the carrier layer (see claims 1 and 8 of ‘163).
Regarding instant claim 2, ‘168 teaches wherein the carrier layer consists completely or at least partially of an opaque or transparent material (see claim 8 of ‘163).
Regarding instant claim 11, ‘168 teaches applying an at least partially liquid, solid or gel-like sample to the optoelectronic chip according to claim 1 in such a way that the sample partially or completely surrounds the thin-film lightguide (see claim 9 of ‘163).
Regarding instant claim 12, ‘168 teaches wherein the sample contains at least one or a plurality of particle(s) that is/are capable of and/or designed to interact with a guided mode of the thin-film lightguide (see claims 4 and 10 of ‘163).
Regarding instant claim 13, ‘168 teaches having at least one emitter or scatterer that emits light for optical excitation of the sample parallel to the plane of the thin-film lightguide and having at least one detector that detects light deflected by the sample normal to the plane of the thin-film lightguide (see claims 1 and 11-12 of ‘163).
Regarding instant claim 14, ‘168 teaches wherein the detector is an array detector and/or the optical system is a microscope (see claim 13 of ‘163).
Regarding instant claim 20, ‘168 teaches wherein the biological molecule comprises an enzyme, a protein or a deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) (see claim 15 of ‘163).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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/MCKENZIE A DUNN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678