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 .
DETAILED ACTION
Status of Claims
Claims 1-10 are pending. Claims 6-10 have been withdrawn as drawn to a non-elected invention. Claims 1-5 have been examined.
Election/Restriction
Applicant’s election without traverse of Group I, claims 1-5, in the reply filed on 09/02/2026 is acknowledged.
Priority
This application, Serial No. 18/420,198 (PGPub: US2025/0164469) was filed 01/23/2024. This application claims priority to foreign application Taiwan 112145062 filed 11/22/2023.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)- (d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statements
No Information Disclosure Statements have been filed.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-5 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas without significantly more. The claim(s) recite(s) “generating a first difference value according to a difference between the first reflected light intensity and the third reflected light intensity, generating a second difference value according to a difference between the second reflected light intensity and the fourth reflected light intensity, and generating a third difference value according to a difference between the first difference value and the second difference value, wherein the third difference value is positively correlated with the concentration of the hapten”. The claimed limitation of using generated values and differences is a concept performed in the human mind belonging to the mental process grouping of the abstract ideas judicial exception (see MPEP § 2106.04(a)(2), subsection III). This judicial exception is not integrated into a practical application such as requiring an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception (see MPEP § 2106.05(a)-(c), (e)-(h)) such that the invention does not preempt every observance of the abstract idea itself.
Eligibility Step 1:
Claim 1 is directed to a method for detecting a concentrating of a hapten in a sample solution. Methods are one of the eligible statutory categories for invention (STEP 1: YES). However, eligibility of the claim is not self-evident, and therefore analysis must proceed to Step 2.
Eligibility Step 2A, Prong One:
The claim recites using the measured reflected light intensity and generating different values to positively correlate the values with the concentration of the hapten, which is an abstract mental concept that belongs to enumerated group (III) of the Abstract Idea Groupings described in MPEP § 2106.04(a)(2). Therefore, the claims recite at least one judicial exception (STEP 2A, Prong One: YES).
Eligibility Step 2A, Prong Two:
According to Step 2A, Prong Two, set forth in MPEP 2106.04 II A (2), the claims are next evaluated with respect to whether the judicial exception is integrated into a practical application. This analysis turns to the additional steps/elements recited within the claim. Claim 1 recites the additional steps of adding buffer solution, adding sample and antibody and measuring reflected light intensities.
Regarding the additional steps cited in claim 1, adding buffer and sample for reflected light intensity measurement is insufficient to integrate the judicial exception(s) because the purpose is merely to obtain data. This does not go beyond insignificant presolution activity, i.e., a mere data gathering step necessary to use the correlation, similar to the fact pattern in In re Grams, 888 F.2d 835 (Fed. Cir. 1989) and Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015). Furthermore, claims 2-5 are also drawn to limitations regarding the data gathering.
There are no other additional elements that apply, rely on or use the judicial exception such to integrate it into a practical application. For example, there are no additional elements that apply the abstract idea judicial exception to a particular treatment or which utilize a particular machine; there are no additional elements that effect a transformation; and, there are no additional elements that apply the judicial exception in some other meaningful way beyond generally linking it to a field, namely, detecting hapten concentration. In this way the claims, as drafted, do not integrate the judicial exception into a practical application that would overcome monopolizing the exception. ((STEP 2A, Prong Two: NO).
Eligibility Step 2B:
Lastly, the examiner cites publications within the field of technical expertise, that demonstrate the well-understood, routine, conventional nature of the additional element(s).
Regarding the steps/elements recited in addition to using generated values to correlate with hapten concentration, Mauriz et al. (Anal Bioanal Chem 2007, 287: 1449-1458) teaches SPR sampling to detect changes in the reflected light intensity ( see page 1451). Similarly, Manuel et al. (US 2017/0307514) teaches measurements comprising a difference between a baseline signal detected prior to interaction of the sample with the assay area and a post-amplification signal detected after interaction of the amplifier solution with target entities bound to the respective assay area wherein the post-amplification signal may be detected after the respective assay area has been washed with a buffer solution (paragraph 0036) while also using light sources and a detector to measure the reflected light intensity (paragraph 0075).
Therefore, the steps/elements recited in addition to the judicial exception were all well understood, routine, conventional activities in the field of assessing analyte concentration prior to filing the application at hand (STEP 2B: NO).
The claimed steps/elements recited in addition to the judicial exception(s), alone or in combination, do not amount to significantly more than that which was routine and conventional in the art prior to filing.
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 1-5 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.
Regarding claim 1, the claim preamble recites the detection of a concentration of a hapten in a sample solution, however the claims fail to provide a correlation or connection as to how adding a buffer, volume of sample solution or amount of an antibody could allow measured reflected light intensity to be correlated with the concentration of the hapten For example, what is the hapten in the sample solution reacting with in order to provide the concentration correlation.
State of the Prior Art
Mauriz et al. (Anal Bioanal Chem (2007) 387: 1449-1459) teaches SPR detection of pesticides (abstract). The SPR sensor system comprises a laser diode source allowing two-channeled simultaneous measurements onto the gold-coated film used as sensing surface. Variations of the refractive index are detected as changes in the reflected light intensity by a photodiode (page 1451). The methods comprise a mixture of different analyte concentrations and a fixed antibody dilution being flowed over a sensing layer modified with the hapten derivative of the target analyte, where continuous analysis of samples was achieved by regenerating the sensing surface after each antibody-hapten association (page 1452).
Cappo et al. (US 2018/0313754) teaches an SPR detection apparatus (abstract). A typical measurement then would involve passing a buffered solution over sensor surface followed by the fluid to be measured. The data recordation would be done as a function of time, and first a signal would be obtained for the buffer and later a change in signal for the fluid under test (paragraph 0049). Cappo also teaches one reference and one measurement would be delivered simultaneously to the detector array and processed such that the resultant measurement would involve the difference in pixel spacing between the two and when compared to a calibration table unknown sample concentration can be measured with precision (paragraph 0064).
Manuel et al. (US 2017/0307514) teaches determination of a sample concentration of target entities in a sample (abstract). More specifically, Manuel teaches local measurement comprises a difference between a baseline signal detected prior to interaction of the sample with the assay area and a post-amplification signal detected after interaction of the amplifier solution with target entities bound to the respective assay area. For example, the post-amplification signal may be detected after the respective assay area has been washed with a buffer solution (paragraph 0036). In some embodiments, a plurality of assay areas is provided in a single chamber, for example as part of a contiguous functionalized surface, the assay areas being solely defined by the locus where measurements are taken (paragraph 0045). The system comprises a processor arranged to obtain assay data comprising data points of respective local measurements indicative of a local concentration of target entities immobilized at each of a plurality of assay areas of an assay assembly, wherein the assay areas are connected in series such that a sample flowing through the assay assembly flows past each assay area in sequence, and wherein each assay area comprises a plurality of probe entities immobilized at a surface of the assay area. And further wherein the processor is also arranged to model the assay data with a parameterized function of the local measurements against a quantity indicative of the position of the respective assay areas in the sequence, wherein one or more of the parameters are dependent on the sample concentration (paragraph 0049).
While the references above teach that it is well-known in the art to utilize SPR for concentration analysis by introducing sample solutions and buffers to the sensor surface, the references fail to specifically teach or provide motivation for modifying the methods to add a second volume of the sample solution and an amount of an antibody to the first sample area, while only adding the second volume of the sample solution to the second sample area, and after a period of time adding a third volume of the buffer solution to each of the first sample area and the second sample area, and then performing the reflected light intensity detection operation on each of the first sample area and the second sample area to obtain a third reflected light intensity and a fourth reflected light intensity respectively which would then allow for subsequent generation of a first difference value according to a difference between the first reflected light intensity and the third reflected light intensity, generating a second difference value according to a difference between the second reflected light intensity and the fourth reflected light intensity, and generating a third difference value according to a difference between the first difference value and the second difference value, wherein the third difference value is positively correlated with the concentration of the hapten
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Dawodu et al. (SN Applied Sciences Research Article 2019) teaches silver nanoparticles as adsorbents for malachite green (abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M GIERE whose telephone number is (571)272-5084. The examiner can normally be reached M-F 8:30-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy L Nguyen can be reached at 571-272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677
