Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
1. Applicant’s election without traverse of Group I (claims 1-7, biosensor) in the reply filed on 7/7/26 is acknowledged.
2. The requirement is still deemed proper and is therefore made FINAL.
3. Claims 8-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/7/26. Currently claims 1-7 are under consideration.
Priority
4. The instant application has a priority date of August 2, 2022. This application claims priority from Taiwan Patent Application No. 111129000, filed on August 2, 2022, in the Taiwan Intellectual Property Office.
Information Disclosure Statement
5. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609 A(1) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the Examiner on form PTO-892 or Applicant on PTO-1449 cited the references they have not been considered.
Claim Objections
6. Claims 1-7 are objected to because of the following informalities: The claims utilize several acronyms/symbols “λ, °, and nm.” without first defining what they represent in the independent claim. While the claims can reference acronyms/symbols, the material presented by the acronym must be clearly set forth at the first use of the acronym/symbol. Although the term may have art recognized meaning, it is necessary to define the acronym/symbol to clearly set forth Applicant’s intent. For example, does ° refer to angel, degree, or some other unit. Please define. However, Applicant is cautioned not to introduce new matter into the claims. Appropriate correction is required
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.
7. Claims 1-7 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 pre-AIA the applicant regards as the invention.
A. Claim 1 is vague and indefinite because it is not clear if the “transverse electric field mode light wave” is a part of the normal incident guided-mode-resonance biosensor or a generated component that is only produced when the biosensor is in operation.
As recited the claim is drawn to a polarizer, disposed relative to the first lens to filter and remove a transverse electric field mode light wave in the parallel light. It is not clear as to the filtering and removing of transversed electric field mode light wave if it does not exist. Please clarify the biosensor components in relation to the “transverse electric field mode light wave”. Appropriate correction is required.
B. Claims 1-7 are vague and indefinite because the claims are drawn to a biosensor (product) while some of the recited claim language appears to include method/process limitations. For example, in claim 1 “the emitted light changes due to a change in a refractive index of a sample in the bio-sensing chip or an interaction with the sample” and in claim 5 “the target detection object is procalcitonin”. More specifically, the type of biological sample tested does not further limit the biosensor (product). And the use of the biosensor does not constitute a limitation with respect to the claimed product (biosensor). The product claims should be modified to reflect a structural characteristic in order to be given patentable weight. The claims are ambiguous because method limitations are not given patentable weight in product claims. The claims should recite structural changes to the biosensor product. It is suggested that the actual structural modifications are included in the claims in order to obviate the rejection. Applicant is cautioned not to introduce new matter into the modified claims.
Claim Rejections - 35 USC § 112
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.
8. 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.
In this case, claim 1 recites various substitutions for “means for”. See “to convert”, “to filter and remove”, “to selectively pass”, “to rotate”, “to focus”, and “to receive”.
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.
9. 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: “to convert”, “to filter and remove”, “to selectively pass”, “to rotate”, “to focus”, and “to receive” in claim 1.
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.
Claim Rejections - 35 USC § 103
10. 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.
11. Claim(s) 1-4 and 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (Sensors and Actuators B: Chemical, Vol.250, pages 659-666, 2017) in view of Cunningham et al. (7,371,562) and Chang et al. (US 20130023042) and further in view of Wawro et al.(US Patent No. 8,514,391).
Lin et al. disclose an intensity-detection-based optofluidic biosensing system with a disposable guided-mode resonance (GMR) biosensor chip for low-cost, rapid, label-free biosensing. The developed sensing system consists of a low-cost spectrally limited light-emitting diode (LED) as the light source and a photodetector as the optical receiver.
This detection instrument can transform the GMR wavelength shift induced by the change in the local refractive index (RI) near the chip’s grating surface into change in the light intensity, thus enabling label-free, real-time detection.
RI measurement experiments in both the transmission and reflection modes are performed to study the corresponding sensing mechanisms and compare detection performance. See abstract.
On page 660, figure 1 a schematic of the guided-mode-resonance (GMR) optofluidic sensing system is presented. The GMR or biosensor includes an LED (light source), lens, polarizer, biosensor chip, and detection unit. The disposable GMR biosensor chip is a one-dimensional TiO2grating structure on a cyclic olefin copolymer (COC) substrate and a microfluidic module for handling the injection of fluid samples into the sensing area.
The researcher found that their biosensing system based on intensity detection provided for low-cost, rapid, and label-free biosensing. The developed detection system employed a low-cost spectrally limited light-emitting diode (LED) as the light source, and a low-cost photodetector (PD) as the optical receiver for the conversion of the GMR wavelength shifts produced by change in the local RI at the grating surface induced by a sample into a corresponding variation in the light intensity. See page 660.
Lin et al. differ from the instant invention in not specifically including a beam splitter or (quarter 1/4λ) waveplate in the biosensor.
Cunningham et al. disclose a subwavelength structured surface (SWS) or wave plate that is used to create a sharp optical resonant reflection at a particular wavelength that can be used to track with high sensitivity the interaction of biological materials, such as specific binding substances or binding partners or both. For example, see figure 2 and 9. A colorimetric resonant diffractive grating surface acts as a surface binding platform for specific binding substances. Column 9 lines 5-12. A SWS biosensor comprises a one-dimensional or two-dimensional grating, a substrate layer that supports the grating, and one or more specific binding substances immobilized on the surface of the grating opposite of the substrate layer. Column 10.
Detection sensitivity can be further enhanced through the use of chemically derivatized small particles. "Nanoparticles" made of colloidal gold, various plastics, or glass with diameters of about 3-300 nm can be coated with molecular species that will enable them to covalently bind selectively to a binding partner. For example, as shown in FIG. 7C, nanoparticles that are covalently coated with streptavidin can be used to enhance the visibility of biotin-tagged binding partners on the biosensor surface. While a streptavidin molecule itself has a molecular weight of 60 kDa, the derivatized bead can have a molecular weight of any size, including, for example, 60 KDa. Binding of a large bead will result in a large change in the optical density upon the biosensor surface, and an easily measurable signal. This method can result in an approximately 1000.times. enhancement in sensitivity resolution. Column 4 lines 16-19 and column 19 line 24 through Column 20 line 12.
Unlike Surface plasmon resonance, resonant mirrors, and waveguide biosensors, the described compositions and methods enable many thousands of individual binding reactions to take place simultaneously upon the biosensor surface. Column 4 lines 50-54.
Cunningham et al. present biosensor system embodiments that include lens (figure 18), a beam splitter (figure 20) and light detectors (figure 21).
While, Chang et al. teach a metal buffer layer assisted guided mode resonance (GMR) biosensor. The GMR biosensor includes a substrate, a metal buffer layer and a waveguide layer. The metal buffer layer is disposed on the substrate and the waveguide layer is disposed on the metal buffer layer. The metal buffer layer, which is disposed adjacent to the waveguide layer, can carry out the total reflection and provide extra phase compensation of the total reflection at the same time.
Accordingly, the propagation constant of the resonance wave would be much closer to the sensitivity of the phase, and the resonance electric field of the GMR biosensor would be much closer to the sensitive area. Consequently, the sensitivity of the GMR bio sensor could be improved. See abstract.
In figures 3A and 3B the sensor is demonstrated to measure transverse electric and transverse magnetic field light. Although Chang et al. are silent with respect to the term beam splitter and the size of the plate, these limitations are considered obvious design choices that are routinely adjusted in the prior art to maximize biosensor operations.
Absent evidence to the contrary the teachings of Chang et al. allow for improved bio detection sensitivity and the biosensor in Chang et al. is adapted to measure the parameters recited in the claims (transverse electric field, transverse magnetic field, and biomolecules). A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of applicant's invention to include a beam splitter and quarter wave plate as exemplified by Cunningham et al. and Chang et al. in the biosensor of Lin et al. because Cunningham and Chang et al. taught that their sensor can improve sensitivity and measure biomolecular specific binding interactions involving transverse electric or transverse magnetic field lights. See abstract and figures 3A/3B.
Lin et al. in view of Cunnigham et al. and Chang et al. differ from the instant invention in not specifically including a processing unit in the biosensor system.
However, Wawro et al. disclose biosensor systems coupled to PCs for data analysis. See figures 8 and columns 28-32. The use of PC or a processing unit for data analysis is taught to optimize input parameters to improve the convergence and the effectiveness of the analysis. See columns 28-35.
It would have been prima facie obvious to one of ordinary skill before the effective filing date of the instant invention to include a processing unit in the biosensor systems because Wawro et al. taught that the use of PCs or a processing unit for data analysis can optimize input parameters to improve the convergence and the effectiveness of the analysis. See columns 28-35.
One skill in the art would have been motivated to analyze the output with an automated processing unit to increase accuracy and produce quick turnaround in data interpretation/evaluation.
12. Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (Sensors and Actuators B: Chemical, Vol.250, pages 659-666, 2017) in view of Cunningham et al. (7,371,562) and Chang et al. (US 20130023042) and further in view of Wawro et al.(US Patent No. 8,514,391) as applied to claims 1-4 and 6-7 above, and further in view of Sener et al. (The Analyst, Vol.138, No.21, Pages 6422-6428, 11/7/2013) and Sun et al. Materials Science for Energy Technologies, 2020, Vol.3, pages 274-281.
Please see Lin et al. (Sensors and Actuators B: Chemical, Vol.250, pages 659-666, 2017) in view of Cunningham et al. (7,371,562) and Chang et al. (US 20130023042) and further in view of Wawro et al.(US Patent No. 8,514,391) as set forth above.
Lin et al. (Sensors and Actuators B: Chemical, Vol.250, pages 659-666, 2017) in view of Cunningham et al. (7,371,562) and Chang et al. (US 20130023042) and further in view of Wawro et al.(US Patent No. 8,514,391) differ from the instant invention in not detecting procalcitonin.
However, Sener et al. and Sun et al. both teach sensors that measure procalcitonin. Sener et al. disclose that procalcitonin (PCT) is a promising biomarker for identification of the origin and severity of sepsis, which is a deadly body infection. In their work, they prepared a surface plasmon resonance (SPR) biosensor which utilizes a molecular imprinted polymer surface for rapid and reliable detection of PCT. See abstract.
While, Sun et al. disclose a localized surface plasmon resonance (LSPR) enhanced quantum dot (QD) emission sandwich assay utilizing ‘‘capture PCT antibody/PCT/detection PCT antibody labelled with QD” on a gold nanoarray chip, a fully automated point-of-care (POC) system for quick quantitative analysis of procalcitonin (PCT) for sepsis diagnostics. See abstract.
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the invention, to employ the biosensors of Lin et al. (Sensors and Actuators B: Chemical, Vol.250, pages 659-666, 2017) in view of Cunningham et al. (7,371,562) and Chang et al. (US 20130023042) and further in view of Wawro et al.(US Patent No. 8,514,391) to detect PCT (procalcitonin) because both Sun et al. and Sener et al. disclose that procalcitonin (PCT) is a promising biomarker for identification of the origin and severity of sepsis, which is a deadly body infection. See abstracts.
The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960); Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
One skilled in the art would have been motivated to detect PCT as a means to diagnosis and treat diseases, such as sepsis.
13. For reasons aforementioned, no claims are allowed.
14. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to LISA COOK whose telephone number is (571)272-0816. The Examiner works a flexible schedule, however she can generally be reached 9AM-5PM, Monday, Thursday, and Friday.
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If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Misook Yu can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Lisa Cook
Patent Examiner
Art Unit 1641
9/18/26
/LISA V COOK/Primary Examiner, Art Unit 1641
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