Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 9-15 are being prosecuted. Claims 1-8 are cancelled.
Claim Rejections - 35 USC § 112
2. 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.
3. Claims 9-15 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 9 is vague. In step 4, the recitation of “relative value of the reference light intensity and the evaluation light intensity” is not clear as to what the value of the reference light intensity and the evaluation light intensity is relative to. Line 3 of step 4 is not clear as to which “relative value” is being referred to in lines 1-2 – the reference light intensity and the evaluation light intensity, and how these “relative value(s)” are determined with respect a known concentration of test substance. If the intent is to compare the measured test substance to a calibration curve then what is the function of the reference light intensity?
Claim Rejections - 35 USC § 102
4. 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.
5. 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.
6. Claim(s) 9 and 11-12 are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Cunningham et al (US 2009/0079976; herein referred to as Cunningham).
Cunningham et al disclose photonic crystal (PC) sensors (i.e. a photonic band gap device), and sensor arrays and sensing systems incorporating PC sensors which have integrated fluid containment and/or fluid handling structures. The PC sensors are further integrated into a sample handling device such as a microwell plate. Sensors and sensing systems are capable of high throughput sensing of analytes in fluid samples, bulk refractive index detection, and label-free detection of a range of molecules, including biomolecules and therapeutic candidates (See Abstract).
Photonic crystals, also commonly referred to as photonic bandgap structures, are periodic dielectric or metallic structures exhibiting a spatially periodic variation in refractive index that forbids propagation of certain frequencies of incident electromagnetic radiation. The photonic band gap of a photonic crystal refers to the range of frequencies of electromagnetic radiation for which propagation through the structure is prevented. The photonic band gap phenomenon may be conceptualized as complete reflection of incident electromagnetic radiation having selected frequencies due to interaction with the periodic structural domains of a photonic crystal. The spatial arrangement and refractive indices of these structural domains generate photonic bands gaps that inhibit propagation of electromagnetic radiation centered about a particular frequency (See paragraph [0003]).
In order to adapt a photonic crystal device to perform as a biosensor, some portion of the structure must be in contact with a test sample. By attaching biomolecules or cells to the portion of the photonic crystal where the locally confined electromagnetic field intensity is greatest, the resonant coupling of light into the crystal is modified, so the reflected/transmitted output is tuned. The highly confined electromagnetic field within a photonic crystal structure provides high sensitivity and a high degree of spatial resolution consistent with their use in imaging applications, much like fluorescent imaging scanners (See paragraph [0008]).
The disclosed PC sensors are capable of integration in a monolithic structure having fluid containment structures such as wells or flow channels, including arrays of wells and associated fluid flow channels. The sensors of the present disclosure have a great potential for implementation in microfluidic lab-on-a chip (LOC) devices, micro-total-analysis systems and biosensor-embedded microarray systems. The photonic crystal sensor with integrated fluid containment structure is furthermore integrated into a sample handling device, such as a microscope slide, microwell plate, petri dish, test tube, flask or other suitable device. Fluid containment structures, such as wells or fluid flow channels, are integrated with the sensor directly resulting in a monolithic, integral structure. The fluid containment structures can be designed to effectively convey the sample to the active area (periodic surface grating) of a photonic crystal. (See paragraphs [0016] and [0017]).
The grating structure of the photonic crystal is provided on a bottom or internal surface of the cavity of fluid containment structure, and in a configuration wherein the grating structures extend from one side of the cavity to the other side. For example, sensors of the present disclosure include configurations wherein the fluid containment structure is a fluid flow channel having a surface grating structure extending from one side of the channel to the opposite side. The periodic surface grating can take the form of a one dimensional spatially periodic configuration such as a parallel array of alternating high and low portions. Other periodic structures are possible including two-dimensional gratings (arrays of posts or holes) or two-level, two dimensional periodic structures (See paragraph [0025] and Figs. 1A-1F).
Sensors of the present disclosure may have a wide variety of integrated fluid containment structures, including active fluidic delivery and handling systems, passive fluid reservoirs and all combinations and arrays and systems thereof. In an embodiment, the cavity of the fluid containment structure is a fluidic channel, such as a microfluidic or nanofluidic channel. Fluidic channels useful as fluid containment structures of the present disclosure are optionally a component of an active fluidic system having pumps, valves, reservoirs and/or fluidic channel networks. In an embodiment, the cavity of the fluid containment structure is a static reservoir, such as a cuvette, microwell, microcuvette and microreservoir. Sensors of this aspect of the present disclosure may be provided in an array format wherein a plurality of fluid containment structures comprising microwells are provided in a microarray format, wherein each microwell has a photonic crystal structure provided on an internal surface (See paragraph [0029]).
In some embodiments, sensors of the present disclosure comprise a photonic crystal structure that is functionalized by incorporation of target material conjugated to an active surface of the photonic crystal such that the target material is exposed to the cavity of the fluid containment structure. In these embodiments, a target material may be provided having selective binding characteristics so as to provide selective detection and analysis of specific analytes present in a fluid sample. In these embodiments, binding of analyte to a target material conjugated to the active surface of the photonic crystal causes a change in refractive index in a probe region, thereby affecting the coupling of electromagnetic radiation into the photonic crystal and resulting in a change in photonic band gap. Useful target materials for biosensing applications include, but are not limited to, one or more: proteins, peptide, DNA molecules, RNA molecules, oligonucleotides, lipids, carbohydrates, polysaccharides; glycoproteins, lipoproteins, sugars, cells, bacteria, virus, candidate molecules and all derivatives, variants and complexes of these. As will be apparent to those skilled in the art, the target material may be conjugated to photonic crystal structures using a variety of techniques and linking systems know in the art of sensing and biosensing (See paragraph [0033]).
The disclosed PC sensors measure changes in the resonant peak reflected wavelength from the photonic crystal structure induced by changes in dielectric permittivity within an evanescent field region near its surface, detection of bulk refractive index changes in the fluid channel, or adsorption of biological material to the sensor surface is demonstrated (See paragraph [0079]).
The instruments are disclosed for use with the PC sensors, including a light source positioned in optical communication with the PC sensor such that the photonic crystal structure is illuminated with electromagnetic radiation having a selected wavelength distribution, for example electromagnetic radiation having a wavelength distribution in the visible, ultraviolet or infrared regions of the electromagnetic spectrum. A photodetector is positioned in optical communication with the photonic crystal structure such that it is capable of analyzing and detecting electromagnetic radiation reflected, scattered or transmitted by the photonic crystal structure (See paragraph [0092]).
Paragraphs [0106]-[0117] disclose detection of antibodies where protein A is immobilized on the PC sensor surface.
Cunningham discloses a PC sensor (photonic bandgap structure) with a periodic structure. The periodic structure is on a bottom surface but a bottom surface is also considered a “wall portion” (see Fig. 1A). The active surface or periodic structure can be functionalized with a target material that selectively binds to specific test substance. The target material reacts with a test substance and in doing so forms a granular substance.
With respect to taking a reference light intensity when the test substance is not introduced, Cunningham teaches taking a reference light intensity measurement prior to contact with the test substance which is subsequently subtracted from the measurement that is taken after contact with the test substance (see paragraphs [0096] – [0108]). As step 4 of instant claim 9 is not clear under 112(b), Cunningham’s use of the reference measurement that is subtracted from the test substance measurement appears to meet step 4.
With respect to claim 12, the complex of target material and test substance is considered to read on an aggregated state because they are a compacted mass of particles – an aggregate.
Claim Rejections - 35 USC § 103
7. 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.
8. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Cunningham et al (US 2009/0079976; herein referred to as Cunningham) in view of Kaplan et al (US 2010/0046902).
See above for the teachings of Cunningham et al.
Cunningham differs from the instant invention in not teaching the use of antibody as the target material (i.e. compound) on the periodic structure to bind an antigen test substance.
Kaplan et al teach a photonic crystal biosensor where antibodies are immobilized on a nanopatterned film on the biosensor to bind to an analyte (paragraph [0025]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to immobilize an antibody, as taught by Kaplan et al, on the periodic structure of the photonic crystal sensor of Cunningham because Cunningham teach immobilizing proteins (paragraph [0033]) that specifically bind to a test substance and antibodies are proteins that specifically to test substances, such as antigens, which can be immobilized to a photonic crystal as taught by Kaplan et al.
9. Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Cunningham et al (US 2009/0079976; herein referred to as Cunningham) in view of Regan et al (US 2004/0002121; herein referred to as Regan).
See above for the teachings of Cunningham.
Cunningham differ from the instant invention in failing to teach the test substance being a glycolipid and the reagent on the sensor is an enzyme specific for a glycolipid.
Regan discloses a microplate for performing assays. Regan teaches detection of a glycolipid as a test substance (paragraph [0037]) and the use of an enzyme that is specific for the glycolipid as a capture regent in the microplate (paragraph [0052]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to detect glycolipids with the use of an enzyme specific for glycolipids, as taught by Regan, in the sensor of Cunningham because Cunningham teaches the detection of lipids in general and one would use the appropriate reagents, such as the enzyme of Regan, to detect the desired test substance. A person of ordinary skill in the art reasonably would have expected success because both Regan and Cunningham are directed to specific binding assays.
10. Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Cunningham et al (US 2009/0079976; herein referred to as Cunningham) in view of Takahashi et al (“Detection of endotoxin using a photonic crystal nanolaser”, Applied Physics Letters, 106, published online April 3, 2015, 131112; herein referred to as Takahashi).
See above for the teachings of Cunningham.
Cunningham differ from the instant invention in failing to teach the test substance being an endotoxin and the reagent in the sensor is LAL reagent specific for endotoxin.
Takahashi teaches a method for the detection of endotoxin on a GaInAsP single quantum well slab. LAL reagent is mixed with a sample to detect endotoxin on the photonic crystal (131112-1 to 131112-2).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to detect endotoxins (lipopolysaccharides) with the use LAL, as taught by Takahashi, in the sensor of Cunningham because Cunningham teaches the detection of polysaccharides in general and one would use the appropriate reagents, such as the LAL reagent of Takahashi, to detect the desired test substance. A person of ordinary skill in the art reasonably would have expected success because both Takahashi and Cunningham are directed to specific binding assays.
Allowable Subject Matter
11. Claim 10 is objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The closest prior art of is Cunningham and Cunningham does not teach immobilizing a capture reagent for a test substance on a wall portion distant from the periodic structure.
Conclusion
12. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent 6,300,141 teaches a biosensor for the detection of analytes. The biosensor collects test data which is compared to standard curve data to determine the concentration of the analyte (Col. 10, lines 10-35).
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER L CHIN whose telephone number is (571)272-0815. The examiner can normally be reached on Monday - Friday, 10:00am - 6:30pm.
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/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677
2/7/2026