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 .
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.
Withdrawn Objections/Rejections
The objection to claim 7 is withdrawn in response to the amendments.
Priority
The present application was filed as a proper National Stage (371) entry of PCT Application No. PCT/EP2020/067493, filed 06/23/2020. Acknowledgment is also made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d) to Application No. EP19182157.8, filed on 06/25/2019 in Europe.
Status of the Claims
Claims 1, 3, 5-13 and 25-26 are pending; claims 1, 3, 7-8 and 10 are amended; claims 2, 4 and 14-24 are canceled; claims 11-13 are withdrawn. Claims 1, 3, 5-10 and 25-26 are examined below.
Maintained Objections
Claim Objections
Claims 1 and 26 are objected to because of the following informalities:
In the last two lines of claim 1, “after to the hook point” appears to be a typographical error, namely it is suggested that ““after to the hook point” read as "“after
In the last line of claim 26, “after to the hook point” appears to be a typographical error, namely it is suggested that ““after to the hook point” read as "“after .
Appropriate correction is required.
Maintained Rejections
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, 3, 5-10 and 25-26 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 1 recites “bringing said two nonimmobilized analyte-specific binding components in contact with said analyte to produce a signal that depends on the concentration of bi-component/analyte complexes formed in said sample and one or more dilutions”. The limitation “bringing said two nonimmobilized analyte-specific binding components in contact with said analyte” in lines 9-10 is not clear, namely what is being referred to by “said analyte”. The limitation “said analyte” in claim 1 line 10 could be referring to the sample obtained in step a, the one or more dilutions of said sample prepared in step c., or both. Because of this, a person having ordinary skill in the art would not recognize the metes and bounds of the claim. Note that if “said analyte” is intended to be referring to the sample obtained in a. or the one or more dilutions of said sample prepared in step c, then it would not be clear how the signal produced would depend on the concentration of bi-component/analyte complexes formed in said sample and one or more dilutions (emphasis added). Notably, bringing the two nonimmobilized analyte-specific binding components in contact with the sample is not expected to produce a signal that depends on a separate dilution made of the sample.
Claim 1 further recites “f. determining the concentration of the analyte using the signals that depend on the concentration of bi-component/analyte complexes formed in said sample and in the one or more dilutions in step (e) as constraining inputs for a fit to said non-bijective analyte concentration reference curve at different analyte concentrations…”. However, the limitation “the signals that depend on the concentration of bi-component/analyte complexes formed in said sample and in the one or more dilutions in step (e)” lacks antecedent basis. It is not clear what “signals” are being referred to because “signals” is not recited in step (e). Note that step (e) recites “obtaining a two-segmented, non-bijective analyte concentration reference curve that reflects the dependence of a bi-component detection signal on the concentration of analyte, wherein the two-segmented, non-bijective analyte concentration reference curve comprises a first monotonic increasing segment prior to a hook point and a second monotonic decreasing segment after the hook point”. Therefore, using the broadest reasonable interpretation of the claim as currently recited, step (e) is drawn to obtaining a generic reference curve and fails to provide antecedent support for “the signals that depend on the concentration of bi-component/analyte complexes formed in said sample and in the one or more dilutions in step (e)”. Although step (d) recites “bringing said two nonimmobilized analyte-specific binding components in contact with said analyte to produce a signal that depends on the concentration of bi-component/analyte complexes formed in said sample and one or more dilutions”, this step also fails to provide antecedent support for the “signals” recited in step (f).
Furthermore, it is not clear how the two-segmented, non-bijective analyte concentration reference curve is used to determine the concentration of the analyte in step f. because the reference curve of step (e) is not clearly directed to the analyte in the sample of step a. A person having ordinary skill in the art would not be capable of recognizing the metes and bounds of the claim.
Claim 3 recites “wherein said non-bijective analyte concentration reference curve obtained in (e) is obtained experimentally by providing a reference sample of known analyte concentration, generating a series of known dilutions of said reference sample and obtaining the two non-immobilized analyte-specific binding components at known concentrations,…”. However, it is not clear how by providing a reference sample of known analyte concentration, generating a series of known dilutions of said reference sample and obtaining the two non-immobilized analyte-specific binding components at known concentrations enables the obtaining of the reference curve. Notably none of the claimed steps for experimentally obtaining the reference curve actually recite a step directed to the production/generation of the reference curve.
Claim 3 further recites “wherein said non-bijective analyte concentration reference curve is calculated analytically by solving chemical balance, and mass conservation equations or is provided by numerical solutions based upon the provision of dissociation constants for each of the two nonimmobilized analyte-specific binding components with the analyte”. However, given that the reference curve is obtained experimentally (line 2), it is not clear how it is also calculated analytically or provided by numerical solutions. Because of this, a person having ordinary skill in the art would not recognize the metes and bounds of the claim.
Claims 5-10 are included in this rejection because they depend from rejected claim 1 but fail to clarify the scope of patent protection sought.
Claim 25 recites “bringing said two nonimmobilized analyte-specific binding components in contact with said analyte” in lines 7-8. However, it is not clear what is being referred to by “said analyte”. The limitation “said analyte” in claim 25 line 8 could be referring to the sample obtained in step a, the one or more dilutions of said sample prepared in step c., or both. Because of this, a person having ordinary skill in the art would not recognize the metes and bounds of the claim. Note that if “said analyte” is intended to be referring to the sample obtained in a. or the one or more dilutions of said sample prepared in step c, then it would not be clear how the signal produced would depend on the concentration of bi-component/analyte complexes formed in said sample and one or more dilutions (emphasis added). Notably, bringing the two nonimmobilized analyte-specific binding components in contact with the sample is not expected to produce a signal that depends on a separate dilution made of the sample.
Claim 25 further recites “f. determining the concentration of the analyte by comparing the signals detected in the sample and in the one or more dilutions with the non-bijective analyte concentration reference curve…”. However, the limitation “the signals detected in the sample and in the one or more dilutions” lacks antecedent basis. It is not clear what “signals” are being referred to because “signals” is not recited in steps a-e. Note that d. recites “bringing said two nonimmobilized analyte-specific binding components in contact with said analyte to produce a signal that depends on the concentration of bi-component/analyte complexes formed in said sample and one or more dilutions”, this step fails to provide antecedent support for the “signals” recited in step (f). In fact note that there is no “detecting” step in the method at all. Furthermore, it is not clear how the two-segmented, non-bijective analyte concentration reference curve is used to determine the concentration of the analyte in step f. because the reference curve of step (e) is not clearly directed to the analyte in the sample of step a. A person having ordinary skill in the art would not be capable of recognizing the metes and bounds of the claim.
Claim 26 recites “bringing said two nonimmobilized analyte-specific binding components in contact with said analyte” in lines 7-8. However, it is not clear what is being referred to by “said analyte”. The limitation “said analyte” in claim 26 line 8 could be referring to the sample obtained in step a, the one or more dilutions of said sample prepared in step c., or both. Because of this, a person having ordinary skill in the art would not recognize the metes and bounds of the claim. Note that if “said analyte” is intended to be referring to the sample obtained in a. or the one or more dilutions of said sample prepared in step c, then it would not be clear how the signal produced would depend on the concentration of bi-component/analyte complexes formed in said sample and one or more dilutions (emphasis added). Notably, bringing the two nonimmobilized analyte-specific binding components in contact with the sample is not expected to produce a signal that depends on a separate dilution made of the sample.
Claim 26 further recites “f. determining the concentration of the analyte by comparing the signals that depend on the concentration of bi-component/analyte complexes formed in said sample and in the one or more dilutions in step e) with said non-bijective analyte concentration reference curve at different analyte concentrations…”. However, the limitation “the signals that depend on the concentration of bi-component/analyte complexes formed in said sample and in the one or more dilutions in step e)” lacks antecedent basis. It is not clear what “signals” are being referred to because “signals” is not recited in steps (e). Note that step (e) recites “obtaining a two-segmented, non-bijective analyte concentration reference curve that reflects the dependence of a bi-component detection signal on the concentration of analyte, wherein the two-segmented, non-bijective analyte concentration reference curve comprises a first monotonic increasing segment prior to a hook point and a second monotonic decreasing segment after the hook point”. Therefore, using the broadest reasonable interpretation of the claim as currently recited, step (e) is drawn to obtaining a generic reference curve and fails to provide antecedent support for “the signals that depend on the concentration of bi-component/analyte complexes formed in said sample and in the one or more dilutions in step (e)”. Although step (d) recites “bringing said two nonimmobilized analyte-specific binding components in contact with said analyte to produce a signal that depends on the concentration of bi-component/analyte complexes formed in said sample and one or more dilutions”, this step also fails to provide antecedent support for the “signals” recited in step (f). Furthermore, it is not clear how the two-segmented, non-bijective analyte concentration reference curve is used to determine the concentration of the analyte in step f. because the reference curve of step (e) is not clearly directed to the analyte in the sample of step a. A person having ordinary skill in the art would not be capable of recognizing the metes and bounds of the claim.
Maintained Rejections
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, 3, 5-10 and 25-26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea, i.e., mathematical concepts, without significantly more.
The U.S. Patent and Trademark Office recently revised the MPEP with regard to § 101 (see the MPEP at 2106). Regarding the MPEP at 2106, in determining what concept the claim is “directed to,” we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes); and
(2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim contains an “‘inventive concept’ sufficient to ‘transform’” the claimed judicial exception into a patent-eligible application of the judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82). In so doing, we thus consider whether the claim:
(3) adds a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field (see MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
See MPEP 2106.
ELIGIBILITY STEP 2A: WHETHER A CLAIM IS DIRECTED TO A JUDICIAL EXCEPTION
Step 2A, Prong 1
Claim 1 recites “f. determining the concentration of the analyte using the signals that depend on the concentration of bi-component/analyte complexes formed in said sample and in the one or more dilutions in step (e) as constraining inputs for a fit to said non-bijective analyte concentration reference curve at different analyte concentrations irrespective of whether the signals correspond to a point on the first segment of the non-bijective analyte concentration reference curve prior to the hook point and/or on the second segment of the non-bijective analyte concentration reference curve after
to the hook point”.
The limitation “constraining inputs for a fit to said non-bijective analyte concentration reference curve at different analyte concentrations ” describes a mathematical calculation, therefore, the determining step f. is directed to a judicial exception.
Claim 3, further limiting the non-bijective analyte concentration reference curve to be “calculated analytically by solving chemical balance, and mass conservation equations” or to be “provided by numerical solutions based upon the provision of dissociation constants for each of the two non-immobilized analyte-specific binding components with the analyte” are further abstract ideas, i.e., mathematical concepts, mathematical calculations.
Claim 10 further limiting the bi-component detection method to comprise “employing an absolute molecular count based analytical method” is an abstract idea, i.e., a mathematical concept, mathematical calculation.
Claim 25 recites “f) determining the concentration of the analyte by comparing the signals detected in the sample and in the one or more dilutions with the non-bijective analyte concentration reference curve in order to determine which point of the two-segmented non-bijective analyte concentration reference curve is applicable for determining the concentration of the analyte in the sample and comparing the signal reflecting the formation of bicomponent/analyte complexes in the sample with the applicable point of the analyte concentration reference curve”.
The limitations “comparing the signals detected in the sample and in the one or more dilutions with the non-bijective analyte concentration reference curve… and comparing the signal reflecting the formation of bicomponent/analyte complexes in the sample with the applicable point of the analyte concentration reference curve” are abstract ideas, i.e. mental steps that can be practiced using a pen and paper. Therefore, the determining step f. is directed to a judicial exception.
Claim 26 recites “f) determining the concentration of the analyte by comparing the signals that depend on the concentration of bi-component/analyte complexes formed in said sample and in the one or more dilutions in step e) with said non-bijective analyte concentration reference curve at different analyte concentrations irrespective of whether the signals correspond to a point on the first segment of the non-bijective analyte concentration reference curve prior to the hook point and/or on the second segment of the non-bijective analyte concentration reference curve after to the hook point”.
The limitation “comparing the signals that depend on the concentration of bi-component/analyte complexes formed in said sample and in the one or more dilutions in step e) with said non-bijective analyte concentration reference curve at different analyte concentrations” is an abstract idea, i.e. a mental step that can be practiced using a pen and paper. Therefore, the determining step f. is directed to a judicial exception.
Step 2A, Prong 2
The independent claims recite the additional limitations/steps “a method for determining the concentration of an analyte in a sample with an unknown concentration of analyte comprising: a. obtaining the sample with unknown concentration of analyte, b. obtaining two non-immobilized analyte-specific binding components at known concentrations, c. preparing one or more dilutions of said sample using defined dilution factors, d. bringing said two non-immobilized analyte-specific binding components in contact with said analyte to produce a signal that depends on the concentration of bi-component/analyte complexes formed in said sample and one or more dilutions, e. obtaining a two-segmented, non-bijective analyte concentration reference curve that reflects the dependence of a bi-component detection signal on the concentration of analyte, wherein the two-segmented, non-bijective analyte concentration reference curve comprises a first monotonic increasing segment prior to a hook point and a second monotonic decreasing segment after the hook point”. However, these steps fail to further amount to a practical application of the indicated judicial exception. Specifically, although, steps a-e amount to producing a signal as recited in step d, and obtaining a reference curve as recited in step e, steps a-e do not particularly or directly apply, rely on or use the abstract ideas in step f. such that they impose a meaningful limit on the judicial exception. Further, the “obtaining” steps in a-b and e, the “preparing” step c. and the “brining” step d., are considered to be insignificant extra-solution activity, as it is a mere data gathering steps (necessary in order to gather the data).
Similarly, claim 3 recites “wherein said non-bijective analyte concentration reference curve obtained in step (e) is obtained experimentally by providing a reference sample of known analyte concentration, generating a series of known dilutions of said reference sample and obtaining the two non-immobilized analyte-specific binding components at known concentrations …” which is insignificant extra-solution activity, as it is a mere data gathering step (necessary in order to gather the data).
Claims 5-6 further limit the “obtaining” steps a-b, however, these limitations also fail to practically apply the judicial exception. Claims 7-8 and 10 recite “employing a…assay”, however no particular active, wet method steps are recited/performed. Similarly, although claim 9 further limits the method “wherein multiple analytes are determined in parallel” this limitation does not further use, apply or rely on steps e-f as claimed in a meaningful way that would amount to a practical application thereof. Further, these limitations, including those recited at claims 3 and 10, read as limitation merely directed to data gathering for the purpose of performing the method for determining the concentration of an analyte in a sample.
ELIGIBILITY STEP 2B: WHETHER THE ADDITIONAL ELEMENTS CONTRIBUTE AN "INVENTIVE CONCEPT"
Further, the additional elements of the claims (the active method steps/limitations recited in addition to the judicial exceptions themselves) do not add significantly more to the judicial exception; the additional recited claim elements are recited at a high level of generality, and are not, for example limited to any particular testing technique of or platform as claimed.
Furthermore, Laurie et al. (Biotechniques 2013 Vol 55 p. 61-67 Cite No. 11 on IDS filed 12/22/2021) teach a combination of 2 non-immobilized analyte binding components in a method for determining the concentration of an analyte using a droplet digital PCR assay (“[w]e have developed a new assay capable of concurrently measuring the absolute concentration and length of unknown amplifiable DNA templates” page 61 column 3 paragraph 2, “The equation describing the relationship between fluorescence amplitude and amplicon size can be used to calculate the size of any unknown ddPCR template that shares common primer and probe binding sites with the size standards” page 64 column 2 paragraph 3, “As primers and probe are specific to the MiSeq adapter sequences, only adapter-ligated molecules that will be amplifiable on the MiSeq flow cell will be quantified” page 64 column 2 paragraph 4). Laurie also teaches obtaining the sample with the unknown concentration of analyte (“Eight samples of sheared DNA were ligated…amplified…The amplified libraries were quantified using the ddPCR system” page 4 para. 2) and preparing one or more dilutions of said sample using defined dilutions factors (“The measured concentrations of the eight differently indexed libraries were used to dilute and combine the libraries in a molar ratio of 100:50:10:1 with two libraries at each concentration” page 4 para. 6). Laurie further suggests d. bringing said two nonimmobilized analyte-specific binding components in contact with said analyte to produce a signal that depends on the concentration of bi-component/analyte complexes formed in said sample and one or more dilutions (“ddPCR experiment was performed with the aforementioned size standards in separate wells of a 96-well plate. Droplets containing the target(positive) increased in fluorescence following amplification of the target whereas droplets lacking the target (negative) remained at the background level of fluorescence (Figure 1A)” page 64 col. 2 para. 5 and page 65 col. 1 para. 1).
Also, Yu-Tang Wu. Förster Resonance Energy Transfer Immunoassays Using Engineered Proteins for Breast Cancer Biomarker Detection. Biological Physics [physics.bio-ph]. Université Paris Saclay (COmUE), 2018. English. NNT : 2018SACLS340. tel-01909324 (Cite No. 9 of IDS filed 12/22/2021) teaches that employing a proximity-based assay to produce the bi-component/analyte complexes concentration depended signal, wherein the proximity-based assay uses two analyte- specific binding components at known concentrations that produce a detectable signal in dependence of their proximity and/or wherein the bi-component method comprises employing a resonance energy transfer assay is well-understood routine and conventional (“QDs and lanthanide complex as FRET pairs have been developed to detect prostate-specific antigen [Kupstat, Kumke, and Hildebrandt, 2011] and alpha-fetoprotein [Chen et al., 2012] in homogeneous sandwich immunoassay format” page 13 paragraph 1). Wu also teaches obtaining the sample with the unknown concentration of analyte, and preparing one or more dilutions of said sample using defined dilutions factors (“We demonstrate immediate applicability by the quantification of HER2 in serum containing samples using time-gated LTC-to-QD FRET detection on the clinical benchtop immunoassay analyzer KRYPTOR” page 36 paragraph 1, “we also tested the FRET assays in the sample containing 10%, 20% and 30% of serum (Figure 3.6)” page 42 paragraph 1). Wu further suggests d. bringing said two nonimmobilized analyte-specific binding components in contact with said analyte to produce a signal that depends on the concentration of bi-component/analyte complexes formed in said sample and one or more dilutions (“We demonstrate immediate applicability by the quantification of HER2 in serum containing samples using time-gated LTC-to-QD FRET detection on the clinical benchtop immunoassay analyzer KRYPTOR” page 36 paragraph 1).
Arkin, Michelle R., et al, “inhibition of Protein-Protein Interactions: Non-Cellular Assay Formats’, (2012) (28 pages)(Cite No. 18 of IDS filed 12/22/2021) teaches that “AlphaScreen™ is bead-based format commercialized by PerkinElmer (http://www.perkinelmer.com) and used to study biomolecular interactions in a microplate format… Like FRET, AlphaScreen is a non-radioactive, homogeneous proximity assay. Binding of two molecules captured on the beads leads to an energy transfer from one bead to the other, ultimately producing a fluorescent signal” (page 14 paragraph 3). Arkin further suggests obtaining the sample with the unknown concentration of analyte (“AlphaScreen assays have been developed to quantify enzymes, molecular (protein, peptide, small molecule) interactions, as well as DNA and RNA hybridizations” page 15 para. 2, “Performing a TR-FRET Assay” page 13 para. 8) and preparing one or more dilutions of said sample using defined dilutions factors (“choose a protein concentration below the hook point (or saturation point) for your assay” page 15 para. 3, “All assay components are combined with assay buffer (e.g. 20 mM Tris, pH 7.5, 0.01% Nonidet P40, and 50 mM NaCl) to their optimized concentrations and 19 µL are transferred to each well of a 384-well plate” page 13 para. 8). Arkin further suggests further suggests d. bringing said two nonimmobilized analyte-specific binding components in contact with said analyte to produce a signal that depends on the concentration of bi-component/analyte complexes formed in said sample and one or more dilutions (“It may also be necessary to vary the order of addition of the components to permit the most efficient interactions. 4. Incubation times need also to be optimized” page 18 paras. 2-3, “Test compounds are added…The plate is incubated” page 13 paras9 and 11).
The specification page 1 last paragraph and page 2 paragraph 1 suggests that FRET, PCA, Alphascreen, and DNA labeled proximity methods for homogeneous assays are well-understood routine and conventional (“Bi-component detection systems are typically exploited in homogeneous assays where two components are applied to produce detection signals. Many of these assays apply a proximity concept and the analyte and the components need to be brought in proximity to produce a signal. Proximity assay technologies such as FRET (fluorescence resonance energy transfer), BRET (bioluminescence resonance energy transfer) (Pfleger, Seeber, &Eidne, 2006), cyan fluorescent protein (CFP) - yellow fluorescent protein (YFP) pair, PCA (protein complementation assays) (Mrell, Ventura, &Avil6s, 2009), Alphascreen (Taouji, Dahan, Bosse, &Chevet, 2009), and DNA labeled proximity methods (PLA - proximity ligation assay, PEA - proximity extension assay) (S6derberg et al., 2006), and a not proximity based assay called emulsion coupling are representative examples of bimolecular (bi-component) detection systems and methods”).
It does not appear to be the case that the active steps recited, which are performed in order to gather the data or perform the assay, are steps recited or performed in an unconventional or non-routine way, such to provide an inventive concept under step 2B.
The claimed limitations as currently presented fail to recite limitations that add a feature that is more than well understood, conventional or routine in the field of diagnostics and biochemical assay methodologies.
Mathematical concepts (calculations and/or equations), which represent abstract ideas, are not themselves patentable. The claims fail to set forth additional steps or elements that would amount to significantly more; the additional steps and elements recited do no more than setting forth the abstract idea(s) with generalized instructions to "apply it". A process of using mathematical calculations and equations would need to integrate the mathematical concepts into the process, as a whole, using additional steps that are not already conventional; and which are sufficient to narrow the scope of the claim so that others are not foreclosed from using the equations/calculations in different applications. Such additional steps could involve, for example, a testing technique or treatment step that would be performed dependent on the outcome, that would not be conventional or routine, so as to ensure that the judicial exception is being practically applied.
For all of these reasons, the claims fail to include additional elements that are sufficient to amount to significantly more than the judicial exception.
Response to Arguments
Applicant's arguments filed 4/27/2026 have been fully considered but they are not persuasive.
Regarding the 101 rejections,
Applicant argues that “Employing the fit in step f) does not cause the claim to be directed to mathematical concepts or an abstract idea….while the step of determining the concentration of the analyte includes a fit, the fit is clearly integrated into a practical application, i.e., the determination of the concentration of the analyte based upon the measured signal. Thus, the Applicant respectfully submits that the claims clearly recite additional elements that amount to significantly more than any judicial exception” (page 9 paras 2-3).
However, the determination step f. as a whole is reasonably interpreted as being directed to the judicial exception because the determination of the concentration of the analyte in a sample is based on a fit, i.e. mathematical concepts; or is based on a comparison, i.e. mental steps, which are abstract ideas (see rejection above) not patent eligible. Therefore, the determination of the concentration cannot be considered an additional limitation that may integrate the abstract idea or add significantly more than the abstract idea because itself is directed to the abstract idea.
Applicant further argues that “In contrast, in the prior art, only the first segment (half of the dynamic range) was used for determining the concentration…The presently claimed method thereby provides for an improved accuracy for the determination of the concentration of an analyte in a sample using fewer dilutions. By means of determining the non-bijective signal-concentration relationship of a bicomponent method… it is now possible to constrain the measurement to avoid failures of a hook point determination of the two-segment non-bijective standard curve…Since for methods of the prior art, it was important to leave a considerable distance from the hook point, the presently claimed approach of using all signals from all dilutions (irrespective of the hook point) effectively leads to well more than a doubling of the dynamic range” (page 9 para. 4).
However, although the determining step f. may be free of the prior art, the claims are rejected under 101 because they are directed to a judicial exception (the determining step f.) and all the additional limitations (steps a-e) fail to add significantly more.
Applicant further argues that “In particular, the step of "preparing one or more dilutions of said sample using defined dilutions factors and bringing said the non-immobilized analyte-specific binding components in contact with said analyte to produce a signal that depends on the concentration of bi-component/analyte complexes formed in said sample and the one more dilutions" independent of the determination of a hook point, constitutes a deviation from approaches in the prior art” (page 10 para. 2).
However, contrary to Applicant’s argument, it appears that preparing one or more dilutions of said sample using defined dilutions factors and bringing said the non-immobilized analyte-specific binding components in contact with said analyte to produce a signal that depends on the concentration of bi-component/analyte complexes formed in said sample and the one more dilutions is well-understood, routine and conventional (see rejection above).
Applicant further argues that “New claim 25 clarifies how the signals detected in the sample and in the one or more dilutions may be compared to the non-bijective reference curve for determining which point of the two-segmented non-bijective analyte concentration reference curve is applicable…Support for new claim 26 can be found in paragraph [0042] of the specification” (page 11 para. 3 and page 12 para. 1).
However, new independent claims 25-26 fail to clarify independent claim 1. Furthermore, claims 25-26 are also rejected under 112b and 101 (see rejections above).
Regarding the 112b rejections
Applicant argues that “the feature "applying a bi-component detection method to the sample and the one or more dilutions, wherein the bi-component detection method comprises" has been deleted, thereby rendering the rejection moot…the feature "conducting for the reference sample and each known dilution thereof said bi-component detection method and/or ... " has been deleted and replaced by the feature "obtaining the two non-immobilized analyte-specific binding components at known concentrations". Thus, the objection is rendered moot.” (page 12 para. 3, page 13 para. 1).
However, the amendments raise new issues that render the claims indefinite. Therefore, the rejection of the claims under 112b is maintained (see rejection above).
Applicant further argues that “claims 7, 8 and 10 have been amended by deleting the wording "bi-component detection", in accordance with the amendments introduced in claim 1. Claim 7 impermissibly contained the trademark/trade name ALPHASCREEN (line 6). In response, claim 7 is amended by replacing the trademark/trade name ALPHASCREEN with the generic terminology "amplified luminescent proximity homogeneous assay", thereby obviating the rejection. In view of the amendments, the claims are believed to be in compliance” (page 13 paras. 2-4).
However, dependent claims remain rejected because they depend from rejected claim 1 but fail to clarify the scope of patent protection sought.
Applicant further “respectfully requests the withdrawal of all claim rejections and prompts allowance of the claims” (page 13 para. 5).
However, no claim is allowed.
Applicant further “requests Examiner review of the disclosure, claims, and prosecution history of such additional applications” (page 14 para. 2).
However, the instant case is the application under examination.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory S. Emch can be reached at (571) 272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Fernando Ivich/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
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