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 .
Claim 2 is cancelled.
Claims 1 and 3-15 are currently amended.
Claims 16-19 are new.
Claims 1 and 3-19 are pending and under examination on the merits.
Priority
This application is a 371 of PCT/IB2021/053195, filed 04/19/2021, and claims priority to SWITZERLAND 00785/20, filed 06/26/2020.
Withdrawn Objections/Rejections
The objections to claims 5 and 12-13 are withdrawn in light of the corrective claim amendments dated 12/12/2025. The rejections of claim 1 and its dependents under 35 USC §112(b) related to the recitation “for determining kinetic parameters” are withdrawn in light of the persuasive arguments presented in the remarks dated 12/12/2025. The rejection of claim 6 under 35 USC §112(a) are withdrawn in light of the persuasive arguments presented in the remarks dated 12/12/2025. The rejections of claim 1 under 35 USC §112(b) for lack of antecedent basis in step (f) and lack of a transition term connecting the claim limitation/method steps are withdrawn in light of the corrective claim amendments dated 12/12/2025. The rejection of claim 5 under 35 USC §112(b) for lack of antecedent basis is withdrawn in light of the corrective claim amendments dated 12/12/2025. The rejection of claim 6 under 35 USC § 112(b) for lack of a transition term connecting the claim limitation/method steps is withdrawn in light of the corrective claim amendments dated 12/12/2025. The rejection of claim 8 under 35 USC § 112(b) for lack of a transition term connecting the claim limitation/method steps is withdrawn in light of the corrective claim amendments dated 12/12/2025. The rejection of claim 9 under 35 USC § 112(b) for lack of a transition term connecting the claim limitation/method steps is withdrawn in light of the corrective claim amendments dated 12/12/2025. The rejection of claim 10 under 35 USC § 112(b) for lack of a transition term connecting the claim limitation/method steps is withdrawn in light of the corrective claim amendments dated 12/12/2025. The rejection of claim 11 under 35 USC § 112(b) for lack of a transition term connecting the claim limitation/method steps is withdrawn in light of the corrective claim amendments dated 12/12/2025. The rejection of claim 12 under 35 USC § 112(b) for lack of a transition term connecting the claim limitation/method steps is withdrawn in light of the corrective claim amendments dated 12/12/2025. The rejections of claims 1, 4, and 10 under 35 USC § 103 are withdrawn in light of the claim amendments where the limitations of previous claim 2 have been added into instant claim 1, dated 12/12/2025.
Notice
Based upon the entirety of the instant disclosure, when examining the instant figures and time points, the Examiner is interpreting the time points as follows:
1. t1-t2: flowing of analyte-containing sample (V1) over test surface;
2.t2-t3: flowing of analyte-free wash solution (Vb1) over test surface;
3. t3-t4: flowing of analyte-containing sample (V2) over test surface;
4. t4-t5: flowing of analyte-free wash solution (Vb2) over test surface;
5. t5-t6: flowing of analyte-containing sample (V3) over test surface;
6. t6-t7: flowing of analyte-free wash solution (Vb3) over test surface;
7. t7-t8: flowing of analyte-containing sample (V4) over test surface;
8. t8-t9: flowing of analyte-free wash solution (Vb4) over test surface;
9. t9-t10: flowing of analyte-containing sample (V5) over test surface;
10. t10-t11: flowing of analyte-free wash solution (Vb5) over test surface;
11. t11-t12: flowing of analyte-containing sample (V6) over test surface;
12. t12-t13: flowing of analyte-free wash solution (Vb6) over test surface,
(see for example paragraphs 0099).
Claim Interpretation
With respect to the recitation of a concentration curve and/or normalized concentration curve, as recited throughout the claims, it is presumed that the curves relate to the concentration of analyte on the test surface over time (see for example, paragraphs 0018 and 0056 of the instant specification).
Recitations of an Estimator are being interpreted to refer to the art-known definition such that an estimator is a mathematical function or rule that relates observed data alongside with other numerical information with the purpose of generating an estimate that approximates the value of a parameter in the probability distribution of a population (see supporting reference Olvera, O. (2014). Estimator. In: Michalos, A.C. (eds) Encyclopedia of Quality of Life and Well-Being Research. Springer, Dordrecht. https://doi.org/10.1007/978-94-007-0753-5_917).
Claim Rejections
Maintained-35 U.S.C. 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 and 3-15 stand rejected and claims 16-19 are newly rejected under 35 U.S.C. 101, because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Regarding claim 1, the claim is directed to a judicial exception (mental steps/mathematical concepts), specifically, the determination of kinetic parameters using only certain parts of a binding curve. Furthermore the claim does not integrate said judicial exception in to practical application, and the claim does not recite additional elements that amount to significantly more than said judicial exception.
Where a claim describes a judicial exception, such a claim “requires closer scrutiny for eligibility because of the risk that it will ‘tie-up’ the excepted subject matter and pre-empt others from using [the judicial exception]" (federal register, p.74622, C1). While all inventions to some degree involve natural laws, products, and other judicial exceptions, the new guidance regarding patent eligibility makes clear that a practical application of these exceptions is necessary, offering “significantly more” than the exception itself. Limitations that were found not to be enough to qualify as “significantly more” include:
Mere instructions to implement an abstract idea on a computer;
Adding generic instructions that the judicial exception should be used ("apply it");
Simply appending well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality;
Adding insignificant extra solution activity to the exception ("mere data gathering"); and
Generally linking the use of the exception to a particular technological environment or field of use.
The MPEP (see § 2103-2106.07) provides a means of determining whether a particular claim is patent eligible under 35 U.S.C. 101. The Guidance requires an analysis of multiple steps, Steps 1, 2A, and 2B:
Step 1 - Following a determination of the broadest reasonable interpretation of a claim, is the claim drawn to a process, machine, manufacture, or composition of matter? If the answer to this inquiry is “Yes,” the analysis moves on to step 2A.
Step 2A - A two-prong analysis. For prong one, does the claim recite an abstract idea, law of nature, or natural phenomenon? If “Yes,” the analysis proceeds to prong two, which asks whether the claim recites additional elements that integrate the judicial exception into a practical application. If “No,” the analysis moves on to step 2B.
Step 2B - Does the claim recite additional elements that amount to significantly more than the judicial exception? If “No,” the claim is not eligible subject matter under 35 U.S.C. 101.
In the instant case, the claims are drawn to a process, so the answer to Step 1 is “Yes.”
With respect to prong one of Step 2A, the answer is “Yes,” because as indicated above, the claims are drawn to mathematical concepts.
Claim 1 is directed to a method of for determining kinetic parameters comprising steps (a)-(f).
Step 1 - Following a determination of the broadest reasonable interpretation of a claim, is the claim drawn to a process, machine, manufacture, or composition of matter? If the answer to this inquiry is “Yes,” the analysis moves on to step 2A. Here, the instant claim 1 recites, “A method for determining….” Therefore, the instant claim 1 is directed towards a method, which is a process under 35 U.S.C. 101. So the answer to step 1 is “YES.” Thus, the analysis proceeds to Step 2A.
Step 2A - A two-prong analysis. For prong 1, does the claim recite an abstract idea, law of nature, or natural phenomenon? If “Yes,” the analysis proceeds to prong 2, which asks whether the claim recites additional elements that integrate the judicial exception into a practical application. If “No,” the analysis moves on to step 2B. Here, the instant claim 1 includes step (f) directed to a mental step(s) of using portions of the binding curve, which is a judicial exception. Therefore, the answer to prong 1 of step 2A is “YES.” Thus, the analysis proceeds to prong 2 of step 2A. Here, the instant claim 1 fails to recite any claim limitations which would integrate the recited judicial exception, for example, by applying or using said judicial exception to affect a particular treatment, prophylaxis, or laboratory application which would limit the judicial exception to a defined, practical use. Therefore the answer to prong two of the Step 2A analysis is “No” and the analysis progresses to step 2B.
Step 2B - Does the claim recite additional elements that amount to significantly more than the judicial exception? If “No,” the claim is not eligible subject matter under 35 U.S.C. 101.
Here, the steps (a)-(e), directed to a wet assay comprising flowing analyte solution and wash buffer over test surface comprising immobilized ligand and sensor amount to no more than mere data gathering steps and do not add ‘significantly more,’ (see Mayo v. Prometheus, 566 U.S.66, 132 SA. Ct. 1289). The additional claim elements are insufficient to amount to significantly more than the judicial exception for the following reasons.
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, has been found to be insufficient to add “significantly more” (MPEP 2106.05(I)(A)).
The additional steps (a)-(e) (step (f) being directed to the judicial exception) of twice contacting a test surface with a sensor to a solution of analyte followed by a wash step, do not add a meaningful limitation to the instant method as they would have been routinely used by those of ordinary skill in the art (see for example the written opinion of the International Search Authority for PCT/B2021/053195 (as cited on the 12/02/2022 IDS) and all art cited therein (further cited on the 12/02/2022 IDS) noting three exemplary references are provided to demonstrate the conventionality of the matter recited in steps (a)-(e) of claim 1; see further, for example, Stahelin (Surface plasmon resonance: a useful technique for cell biologists to characterize biomolecular interactions. Mol Biol Cell. 2013 Apr;24(7):883-6. doi: 10.1091/mbc.E12-10-0713) and note the high level of generality used to recite the test surface, ligand, analyte, sensor, and wash solutions which would suggest that the technology recited is so routine that Applicant need not provide written description, but may instead rely upon the prior art to provide said description to satisfy the requirements of 35 USC §112(a); see additionally Bates et al (Biosensor detection of triplex formation by modified oligonucleotides. Anal Biochem. 2002 Aug 15;307(2):235-43. doi: 10.1016/s0003-2697(02)00063-5) which teaches the use of the commercially obtained products from Biacore comprising the use of a flow cell and sensor to determine kinetic parameters such as Kd related to analyte-ligand binding where ligand is immobilized on the test surface; see further Yang et al (Comparison of biosensor platforms in the evaluation of high affinity antibody-antigen binding kinetics. Anal Biochem. 2016 Sep 1;508:78-96. doi: 10.1016/j.ab.2016.06.024. Epub 2016 Jun 27.)). This means that the method of contacting target and cells comprising a receptor for target and a fluorescence indicator for subsequent calculation of a fluorescence intensity increase rate is well-understood, routine, and conventional.
For all of these reasons, the claims fail to include additional elements that are sufficient to amount to significantly more than the judicial exception(s) recited in step (f).
Therefore, the answer to prong 2B is “No” and the instant claim 1 is therefore directed toward patent ineligible subject matter under 35 U.S.C. 101 and is therefore rejected under 35 U.S.C. 101.
Claim 3, being a process claim dependent from claim 1 (therefore incorporating the above noted deficiency of claim 1)[step 1 of the analysis under 35 USC §101], only recites matter directed to the judicial exception of mathematical concepts/mental steps (narrowing the predefined interval time periods without the addition of an active step) and does not add steps beyond the judicial exception which would practically limit the application of the judicial exception so as to integrate the recited judicial exception(s) [step 2A of the analysis under 35 USC §101]. The claims further fail to add significantly more beyond the recited judicial exception(s) [step 2B of the analysis under 35 USC §101].
Claim 4, being a process claim dependent from claim 1 (therefore incorporating the above noted deficiency of claim 1)[step 1 of the analysis under 35 USC §101], only recites matter directed to the judicial exception of mathematical concepts/mental steps (establishment of a concentration curve and use thereof) and does not add steps beyond the judicial exception which would practically limit the application of the judicial exception so as to integrate the recited judicial exception(s) [step 2A of the analysis under 35 USC §101]. The claims further fail to add significantly more beyond the recited judicial exception(s) [step 2B of the analysis under 35 USC §101].
Claim 5, being a process claim dependent from claim 1 (therefore incorporating the above noted deficiency of claim 1)[step 1 of the analysis under 35 USC §101], only recites matter directed to the judicial exception of mathematical concepts/mental steps (adding steps of selecting a threshold concentration and identifying the time instants which are mere mental steps) and does not add steps beyond the judicial exception which would practically limit the application of the judicial exception so as to integrate the recited judicial exception(s) [step 2A of the analysis under 35 USC §101]. The claims further fail to add significantly more beyond the recited judicial exception(s) [step 2B of the analysis under 35 USC §101].
Claim 6, being a process claim dependent from claim 1 (therefore incorporating the above noted deficiency of claim 1)[step 1 of the analysis under 35 USC §101], only recites matter directed to the judicial exception of mathematical concepts/mental steps (identifying the maximum value of the concentration curve and selecting a percentage value, which are mere mental steps) and does not add steps beyond the judicial exception which would practically limit the application of the judicial exception so as to integrate the recited judicial exception(s) [step 2A of the analysis under 35 USC §101]. The claims further fail to add significantly more beyond the recited judicial exception(s) [step 2B of the analysis under 35 USC §101].
Claim 7, being a process claim dependent from claim 1 (therefore incorporating the above noted deficiency of claim 1)[step 1 of the analysis under 35 USC §101], only recites matter directed to the judicial exception of mathematical concepts/mental steps (establishing a concentration curve, normalizing the curve, and then using the normalized curve to determine the predefined time intervals, which are mere mathematical concepts and mental steps) and does not add steps beyond the judicial exception which would practically limit the application of the judicial exception so as to integrate the recited judicial exception(s) [step 2A of the analysis under 35 USC §101]. The claims further fail to add significantly more beyond the recited judicial exception(s) [step 2B of the analysis under 35 USC §101].
Claim 8, being a process claim dependent from claim 1 (therefore incorporating the above noted deficiency of claim 1)[step 1 of the analysis under 35 USC §101], only recites matter directed to the judicial exception of mathematical concepts/mental steps (selecting a threshold concentration and identifying the time instants, which are mere mathematical concepts and mental steps) and does not add steps beyond the judicial exception which would practically limit the application of the judicial exception so as to integrate the recited judicial exception(s) [step 2A of the analysis under 35 USC §101]. The claims further fail to add significantly more beyond the recited judicial exception(s) [step 2B of the analysis under 35 USC §101].
Claim 9, being a process claim dependent from claim 1 (therefore incorporating the above noted deficiency of claim 1)[step 1 of the analysis under 35 USC §101], only recites matter directed to the judicial exception of mathematical concepts/mental steps (identifying the maximum value of the concentration curve and selecting a percentage value, which are mere mathematical concepts/mental steps) and does not add steps beyond the judicial exception which would practically limit the application of the judicial exception so as to integrate the recited judicial exception(s) [step 2A of the analysis under 35 USC §101]. The claims further fail to add significantly more beyond the recited judicial exception(s) [step 2B of the analysis under 35 USC §101].
Claim 10, being a process claim dependent from claim 1 (therefore incorporating the above noted deficiency of claim 1)[step 1 of the analysis under 35 USC §101], only recites matter directed to the judicial exception of mathematical concepts/mental steps (using a sensor and using only said extracted parts of the binding curve to determine kinetic parameters, noting that the use of the sensor is routine and conventional and the use of the binding curve represents a mathematical concept/mental step) and does not add steps beyond the judicial exception which would practically limit the application of the judicial exception so as to integrate the recited judicial exception(s) [step 2A of the analysis under 35 USC §101]. The claims further fail to add significantly more beyond the recited judicial exception(s) [step 2B of the analysis under 35 USC §101].
Claim 11, being a process claim dependent from claim 1 (therefore incorporating the above noted deficiency of claim 1)[step 1 of the analysis under 35 USC §101], only recites matter directed to the judicial exception of mathematical concepts/mental steps (using a sensor, zeroing the parts of the binding curve which are outside of the predefined interval time periods, and using only said extracted parts of the binding curve to determine kinetic parameters, noting that the use of the sensor is routine and conventional and the use of the binding curve represents a mathematical concept/mental step) and does not add steps beyond the judicial exception which would practically limit the application of the judicial exception so as to integrate the recited judicial exception(s) [step 2A of the analysis under 35 USC §101]. The claims further fail to add significantly more beyond the recited judicial exception(s) [step 2B of the analysis under 35 USC §101].
Claim 12, being a process claim dependent from claim 1 (therefore incorporating the above noted deficiency of claim 1)[step 1 of the analysis under 35 USC §101], only recites matter directed to the judicial exception of mathematical concepts/mental steps (consecutively flowing fluids over the test surface as recited in steps (a)-(d) of claim 1, using a sensor, and using only parts of the binding curve to determine kinetic parameters, noting that the use of the sensor is routine and conventional and the use of the binding curve represents a mathematical concept/mental step) and does not add steps beyond the judicial exception which would practically limit the application of the judicial exception so as to integrate the recited judicial exception(s) [step 2A of the analysis under 35 USC §101]. The claims further fail to add significantly more beyond the recited judicial exception(s) [step 2B of the analysis under 35 USC §101].
Claim 13, being a process claim dependent from claim 1 (therefore incorporating the above noted deficiency of claim 1)[step 1 of the analysis under 35 USC §101], only recites matter directed to the judicial exception of mathematical concepts/mental steps (establishing a normalized concentration function, estimating values for kinetic parameters, using said normalized concentration curve and estimated values to solve the recited differential equation to obtain a simulated binding curve, extracting part of the binding curve in said predefined interval time periods and determining a partial chi square according to the further recited equation represents mathematical concepts/mental steps) and does not add steps beyond the judicial exception which would practically limit the application of the judicial exception so as to integrate the recited judicial exception(s) [step 2A of the analysis under 35 USC §101]. The claims further fail to add significantly more beyond the recited judicial exception(s) [step 2B of the analysis under 35 USC §101].
Claim 14, being a process claim dependent from claim 1 (therefore incorporating the above noted deficiency of claim 1)[step 1 of the analysis under 35 USC §101], only recites matter directed to the judicial exception of mathematical concepts/mental steps (using a Levenberg-Marquad algorithm, which represents mathematical concepts/mental steps) and does not add steps beyond the judicial exception which would practically limit the application of the judicial exception so as to integrate the recited judicial exception(s) [step 2A of the analysis under 35 USC §101]. The claims further fail to add significantly more beyond the recited judicial exception(s) [step 2B of the analysis under 35 USC §101].
Claim 15, being a process claim dependent from claim 1 (therefore incorporating the above noted deficiency of claim 1)[step 1 of the analysis under 35 USC §101], only recites matter directed to the judicial exception of mathematical concepts/mental steps (using Estimators) and does not add steps beyond the judicial exception which would practically limit the application of the judicial exception so as to integrate the recited judicial exception(s) [step 2A of the analysis under 35 USC §101]. The claims further fail to add significantly more beyond the recited judicial exception(s) [step 2B of the analysis under 35 USC §101].
The MPEP provides that:
" The mathematical concepts grouping is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations.... The Court’s rationale for identifying these “mathematical concepts” as judicial exceptions is that a ‘mathematical formula as such is not accorded the protection of our patent laws,’ Diehr, 450 U.S. at 191, 209 USPQ at 15 (citing Benson, 409 U.S. 63, 175 USPQ 673), and thus ‘‘the discovery of [a mathematical formula] cannot support a patent unless there is some other inventive concept in its application.’’ Flook, 437 U.S. at 594, 198 USPQ at 199.... More recent opinions of the Supreme Court, however, have affirmatively characterized mathematical relationships and formulas as abstract ideas. See, e.g., Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 218, 110 USPQ2d 1976, 1981 (2014),"
(see MPEP §2106.04(a)(2)(I)).
Claim 16, being a process claim dependent from claim 1 (therefore incorporating the above noted deficiency of claim 1) [step 1 of the analysis under 35 USC §101], only recites further limitation of the predefined time intervals (no active steps are recited) and does not add steps beyond the judicial exception which would practically limit the application of the judicial exception so as to integrate the recited judicial exception(s) [step 2A of the analysis under 35 USC §101]. The claim further fail to add significantly more beyond the recited judicial exception(s) [step 2B of the analysis under 35 USC §101].
Claim 17, being a process claim dependent from claim 1 (therefore incorporating the above noted deficiency of claim 1) [step 1 of the analysis under 35 USC §101], only recites further limitation of the predefined time intervals (no active steps are recited) and does not add steps beyond the judicial exception which would practically limit the application of the judicial exception so as to integrate the recited judicial exception(s) [step 2A of the analysis under 35 USC §101]. The claims further fail to add significantly more beyond the recited judicial exception(s) [step 2B of the analysis under 35 USC §101].
Claim 18, being a process claim dependent from claim 1 (therefore incorporating the above noted deficiency of claim 1) [step 1 of the analysis under 35 USC §101], only further limitation of the threshold concentration (no active steps are recited) and does not add steps beyond the judicial exception which would practically limit the application of the judicial exception so as to integrate the recited judicial exception(s) [step 2A of the analysis under 35 USC §101]. The claims further fail to add significantly more beyond the recited judicial exception(s) [step 2B of the analysis under 35 USC §101].
Claim 19, being a process claim dependent from claim 1 (therefore incorporating the above noted deficiency of claim 1) [step 1 of the analysis under 35 USC §101], only recites further limitation of the threshold concentration (no active steps are recited) and does not add steps beyond the judicial exception which would practically limit the application of the judicial exception so as to integrate the recited judicial exception(s) [step 2A of the analysis under 35 USC §101]. The claims further fail to add significantly more beyond the recited judicial exception(s) [step 2B of the analysis under 35 USC §101].
The MPEP provides that:
" The mathematical concepts grouping is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations.... The Court’s rationale for identifying these “mathematical concepts” as judicial exceptions is that a ‘mathematical formula as such is not accorded the protection of our patent laws,’ Diehr, 450 U.S. at 191, 209 USPQ at 15 (citing Benson, 409 U.S. 63, 175 USPQ 673), and thus ‘‘the discovery of [a mathematical formula] cannot support a patent unless there is some other inventive concept in its application.’’ Flook, 437 U.S. at 594, 198 USPQ at 199.... More recent opinions of the Supreme Court, however, have affirmatively characterized mathematical relationships and formulas as abstract ideas. See, e.g., Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 218, 110 USPQ2d 1976, 1981 (2014),"
(see MPEP §2106.04(a)(2)(I)).
Therefore, newly added claims 16-19 are now added to the previous rejections under 35 USC §101 and are rejected under 35 USC §101 as directed towards patent ineligible mathematical concepts, failing to integrate or add substantially more so as to transform the claim metes and bounds into subject matter eligible for patentability.
Therefore, claims 1, 3-19 are rejected under 35 USC §101 as directed towards patent ineligible mathematical concepts, failing to integrate or add substantially more so as to transform the claim metes and bounds into subject matter eligible for patentability.
Claim Rejections - 35 USC § 112
Maintained and New (with respect to altering claims included in pre-existing rejections to account for newly added and cancelled claims-35 U.S.C. 112(b)
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, 3-11, 13, and 18 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.
Claims 1 and 3 vaguely define the interval time periods, however for their obtention a calibration step is needed (claims 4 and 7) to establish a concentration curve. Said concentration curve is necessary to determine the predefined interval time periods by i. a. selecting threshold concentrations (claims 5, 6, 8, 9).
Claim 4 requires the use of a concentration curve to determine the predefined time intervals, but does not layout steps for or otherwise define said use, leaving artisans to arrive at their own and possible conflicting time intervals.
Claim 5 lacks a transitional term linking the steps. It is unclear whether the steps are linked by ‘and’, ‘or’, or ‘and/or’. Therefore, the number of steps required by the claim is ambiguous, leaving artisans to dispute whether one or all of the steps are required by the claim as presently drafted.
Claim 5 requires the use of a threshold concentration, but does not layout steps for or otherwise define a threshold, leaving artisans to arrive at their own and possible conflicting threshold concentrations (additionally, no percentage value is defined until claim 6).
Claim 6 requires the selection of a percentage value for calculation, but does not layout steps for or otherwise define selecting a percentage value, leaving artisans to arrive at their own and possible conflicting percentage values.
Claim 7 requires the use of a normalized curve to determine predefined time intervals, but does not layout steps for or otherwise define said use, leaving artisans to arrive at their own and possible conflicting percentage values.
Claim 8 requires the selection of a threshold concentration, but does not layout steps for or otherwise define said selection, leaving artisans to arrive at their own and possible conflicting threshold concentrations.
Claim 9 requires the selection of a percentage value, but does not layout steps for or otherwise define said selection, leaving artisans to arrive at their own and possible conflicting percentage values.
Claim 10 recites ‘a sensor’ in line 1. This leads to ambiguity as to whether this recitation is intended to refer back to the sensor recited in instant claim 1 or if this recitation is intended to add a further sensor beyond the recitation of claim 1, from which claim 10 depends.
Claim 11 recites “using only said parts of the binding curve which are not zeroed to determine the kinetic parameters.” The claim does not define how the kinetic parameters are determined from only said parts of the binding curve which are not zeroed.
Claim 13 recites ‘comprises the steps of’ in line 4. This leads to ambiguity as to whether this recitation is intended to refer back to steps which do not appear to be recited in instant claim 1 or if this recitation is intended to add a further steps beyond the recitation of claim 1, from which claim 13 depends.
Claim 13 recites ‘a test surface” in the final two lines. This leads to ambiguity as to whether this recitation is intended to refer back to the test surface recited in instant claim 1 or if this recitation is intended to add a further test surface beyond the recitation of claim 1, from which claim 13 depends.
Claim 13 requires establishing a concentration function c(t), but does not layout steps for or otherwise define said establishment, leaving artisans to arrive at their own and possible conflicting concentration functions.
Claim 13 requires estimating values for kinetic parameters Rmax, Ka, and Kd but does not layout steps for or otherwise define said estimation, leaving artisans to arrive at their own and possible conflicting estimated values.
Claim 13 lacks a transitional term linking the steps. It is unclear whether the steps are linked by ‘and’, ‘or’, or ‘and/or’. Therefore, the number of steps required by the claim is ambiguous, leaving artisans to dispute whether one or all of the steps are required by the claim as presently drafted.
Claim 18 recites that the threshold concentration of claim 6 is defined as a percentage value of the maximum value of the concentration curve. This fails to sufficiently convey the means for obtaining/determining/selecting the threshold concentration as any numeric value could be considered to be a percentage value of the maximum concentration.
Maintained-35 U.S.C. 112(d):
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 12 fails to add a step or limitation which is not present in claim 1, from which claim 12 depends. The flowing of a plurality of analyte-containing solutions over the test surface, where between flowing of the analyte-containing solution, analyte-free solution is flowed merely reflects the recitation of claim 1, steps (a)-(d). The use of the sensor to measure analyte-ligand binding on the test surface reflects step (e) of claim 1. Using only parts of the binding curve which are in a plurality of predefined interval time periods, to determine the kinetic parameters reflects step (f) of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Applicant’s Arguments and Responses:
A. Applicant argues for withdrawal of the rejections under 35 USC §101 on the grounds that the claims, while reciting mathematical concepts and mental steps, recite significantly more and are sufficiently integrated into a practical implementation (see pages 12-14 of the 12/12/2025 remarks).
Response: Applicant points to physical steps (such as the use of a sensor) which allegedly cannot be accomplished in the human mind as reason to withdraw the rejections. Applicant further cites to a Memorandum dated 08/04/2025 which, combined with Applicant’s assertion that the claims do not recite a mathematical relationship, but are directed towards an analytical approach, forms the basis of Applicant’s argument for withdrawal.
This is currently unpersuasive because there is no articulation that experimental limitations (such as use of a sensor) add significantly more or sufficiently integrate the claims so as to transform the claims as a whole into patent eligible subject matter. The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). See MPEP 2145 (I).
Therefore, the rejections are maintained at this time.
B. Applicant Argues for withdrawal of the rejections under 35 USC §112(b) on the grounds that the limitations would have been obvious to the artisan in light of the specification.
Response: There is no clear and convincing showing that the limitations/claim scope would have been clearly conveyed to the artisan when read as part of the total disclosure. The scope of the claims has not been amended or otherwise sufficiently shown to be definite. Therefore, the rejections as they appear in this Office Action are maintained at this time.
C. Applicant makes no mention of or argument requesting withdrawal of the rejections under 35 USC §112(d) and has failed to make any corrective amendment to the claims.
Response: There being no argument or amendment for the Examiner to consider, the rejection is maintained.
Conclusion
No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The translated written opinion and Decision to grant of the Japanese Patent Office (Patent Application No. 2022/579934) and the European Patent Office (patent No. 4172625) are deemed relevant to the claimed matter.
Yang et al (as cited on the 12/02/2022 IDS), Liu et al (as cited on the 12/02/2022 IDS), and Sparks et al (Use of Surface Plasmon Resonance (SPR) to Determine Binding Affinities and Kinetic Parameters Between Components Important in Fusion Machinery. Methods Mol Biol. 2019;1860:199-210. doi: 10.1007/978-1-4939-8760-3_12)) contain teaching related to the claimed subject matter.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY GAO whose telephone number is (571) 272-5695. The examiner can normally be reached on M-F 9:00 am - 6:00 pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
supervisor, Gregory Emch can be reached on (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 an application may be obtained from the Patent
Application Information Retrieval (PAIR) system. Status information for published applications
may be obtained from either Private PAIR or Public PAIR. Status information for unpublished
applications is available through Private PAIR only. For more information about the PAIR
system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR
system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would
like assistance from a USPTO Customer Service Representative or access to the automated
information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Ashley Gao/
Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678