Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant has elected Group I, claims 1-8. Claims 9-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/24/2025.
Status of the Claims
Claims 9-30 have been withdrawn. Claims 1-8 are pending and are examined herein.
Priority
This application, filed 09/28/2022, claims benefit of 63/249,417, filed 09/28/2021. This benefit is acknowledged and the claims examined herein are treated as having an effective filing date of 09/28/2021.
Information Disclosure Statement
The Information Disclosure Statement filed 02/15/2023 is acknowledged and has been considered.
Claim Objections
Claim 3 is objected to because of the following informalities: the claim recites “captured agent” instead of “capture agent”. Appropriate correction is required.
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.
Claim 8 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea 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 "wellunderstood,
routine, conventional" in the field (see MPEP § 2106.0S(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 8 recites “determining an amount of free target from said signal by comparing the signal to a standard calibration curve”. The step of “determining” by “comparing the signal to a standard calibration curve” is characterized as an abstract idea. In particular, the act of “comparing” could, for example, include comparing performed solely in the human mind (such as comparing two numbers). Similarly, “determining” by “comparing the signal to a standard calibration curve” which could include using the numerical result of the sample in the assay into a mathematical formula produced by the standard calibration curve is a mathematical concept, which is also an abstract idea.
Step 2A, Prong 2
The above-discussed steps of “determining” by “comparing” are insufficient themselves to integrate into a practical application because, as discussed above, these steps are directed to abstract ideas; such steps represent judicial exceptions and not a practical application thereof.
Regarding the independent claim 1, this claim recites the steps of “adding said sample…to a solid support coated with a capture agent”, “adding a detection agent”, and “measuring a signal”. These steps fail to further amount to a practical application of the indicated judicial exception. In particular, these steps are considered to be insignificant extra-solution activity, as they are mere data gathering steps (necessary in order to gather the data.
ELIGIBILITY OF 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(s); the additional recited claim elements are recited at a high level of generality, and are not, for example, limited to any particular testing technique or platform as claimed.
Liu et al., “Development of a Meso Scale Discovery ligand-binding assay for measurement of free (drug-unbound) target in nonhuman primate serum” Bioanalysis (IDS filed 02/15/2023, published 03/22/2021, referred to herein as Liu), as cited in more detail below under 35 U.S.C. 102/103, support that adding a sample to a capture agent bound to a solid support, adding a detection agent, and measuring a signal from the detectable label (p. 580, para. 2) was routine and conventional activity previously performed by those of skill in the art.
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 biochemical assay methodologies.
For all of these reasons, the claims fail to include additional elements that are sufficient to either integrate the judicial exception into practical application thereof, or amount to significantly more than the judicial exception.
Claim Rejections - 35 USC § 102/103
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-8 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Liu et al., “Development of a Meso Scale Discovery ligand-binding assay for measurement of free (drug-unbound) target in nonhuman primate serum” Bioanalysis (IDS filed 02/15/2023, published 03/22/2021, referred to herein as Liu), as evidenced by “MSD SECTOR and QUICKPLEX Plates” published by Meso Scale Discovery in July 2014 (herein referred to as Meso).
Regarding claim 1, Liu teaches a method for determining concentration of free target in a sample (p. 580, para. 2). Liu teaches that the method comprises adding a sample having a target bound to a drug and free target to a solid support coated with a capture agent (p. 580, para. 2, lines 1-7). Liu teaches adding a detection agent that has a detectable label (p. 580, para. 1, lines 3-5). Liu teaches measuring the signal from the detectable label to determine the concentration of free target, whereby the signal is proportional to the concentration (p. 580, para. 2, lines 7-13). Liu teaches that the antibody used as the capture agent, “Ab2” (p. 580, para. 1, lines 2-3), has lower affinity for the target compared to the drug which reduces target-drug complex dissociation (p. 580, para. 1, lines 5-8). Further, Liu teaches that the assay results in a stable target-drug complex (p. 580, para. 2, lines 13-16). As disclosed in the instant specification, a capture antibody with lower affinity and slower association rate results in a stable target-drug complex, whereas an antibody with only a lower affinity for the target does not (instant specification para. 0105, lines 3-12, Figure 4). Therefore, because Liu teaches the use of a capture antibody with lower affinity for the target (p. 580, para. 1, lines 5-8) that results in a stable target-drug complex in the assay (p. 580, para. 2, lines 13-16), the capture antibody is also considered to have a slower association rate.
In the alternative interpretation where the capture antibody taught by Liu is not considered to have a slower association rate for the target compared to the drug, it would have been obvious for one of ordinary skill before the effective filing date of the claimed invention to modify the method taught by Liu by selecting a capture antibody with a slower association rate. An artisan would have been motivated and had a reasonable expectation of success in making this change in order to further stabilize the target-drug complex in the assay which is important to prevent over-estimation of the amount of free target in the assay, as taught by Liu (p. 580, para. 1, lines 5-8).
Regarding claim 2, Liu teaches that the solid support is streptavidin coated (p. 576, para. 4, line 1).
Regarding claim 3, Liu teaches that the capture agent is biotinylated (p. 576, para. 4, lines 1-2).
Regarding claim 4, Liu teaches incubating the sample for 30 or 60 minutes (p. 580, para. 2, lines 5-7, which is considered about 15 or 45 minutes.
In the alternative interpretation where 30 or 60 minutes is not considered to be about 15 or 45 minutes, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to perform routine optimization of the timing in the claimed invention to make and use the claimed invention. As noted in In re Aller, 105 USPQ 233 at 235, more particularly, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. Routine optimization is not considered inventive and no evidence has been presented that arriving at the claimed incubation time was anything other than routine, that the properties of the incubation from the optimization has any unexpected properties, or that the results should be considered unexpected in any way as compared to the closest prior art. Optimization of parameters is a routine practice that would be obvious for the artisan to employ. See MPEP § 2144.05. The artisan would have had a reasonable expectation of success based on the cumulative disclosure of Liu, which teaches that incubation from 30-60 minutes, which contains the claimed about 45-minute incubation time, can be used for the claimed immunoassay.
Regarding claim 5, Liu teaches that the detectable label is a sulfo-tag (Figure 1, p. 580, para. 1, line 5). As evidenced by Meso, the sulfo-tag is a ruthenium label (Meso Figure 2, “Ru(bpy)32+”).
Regarding claim 6, Liu teaches that the sulfo-tag label is an electrochemiluminescent substrate (p. 577, para. 1, line 10).
Regarding claim 7, Liu teaches detecting the sulfo-tag signal with the Meso Sector S600 (p. 576, para. 4, lines 10-12). As evidenced by Meso, the Sector imager applies a voltage to the plates (Meso p. 5, para. 2, lines 7-9) to produce a signal from a sulfo-tag label.
Regarding claim 8, Liu teaches determining the amount of free target by comparing to a standard calibration curve (p. 576, para. 4, lines 3-7) wherein the curve was produced with at least three standard solutions, i.e. recombinant AA reference standard (p. 576, para. 4, lines 3-7. Figure 5, Right panel).
Conclusion
No claims are allowable.
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/C.E./Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 February 20, 2026