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 .
Status of Claims
The claim set submitted on 03 MARCH 2026 is acknowledged and considered. In the claim set Claims 1, 3, 4, 5, 7, 12, 16, and 20 are ‘Currently Amended’; Claim 2 is ‘Canceled’; Claims 6, 8-11, 13-15, and 17-19 are ‘Original’.
Current pending claims are Claims 1 and 3-20 and are considered on the merits below.
Response to Amendment/Arguments
Applicant’s arguments, see REMARKS, filed 03 MARCH 2026, with respect to the claim objections and the 112(b) rejections have been fully considered and are persuasive. The claim objections and the 112(b) rejections have been withdrawn.
In the arguments filed on 03 MARCH 2026, Applicant alleges on pages 8-10 that the instant invention is a technological improvement (page 10), but this improvement is disclosed.
In regards to the analysis that Applicant has mapped out regard the 101 rejection, the other elements of the claim do not go beyond generally what the abstract idea is to the field of endeavor. See MPEP 2106.05(h). As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible “simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use.” Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception do not amount to significantly more than the exception itself, and cannot integrate a judicial exception into a practical application.
In addition, all other elements in Claim 1 only represent extra solution activities. See MPEP 2106.05(g). As explained by the Supreme Court, the addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is well-understood or conventional. Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978). In Flook, the Court reasoned that “[t]he notion that post-solution activity, no matter how conventional or obvious in itself, can transform an unpatentable principle into a patentable process exalts form over substance. A competent draftsman could attach some form of post-solution activity to almost any mathematical formula”. 437 U.S. at 590; 198 USPQ at 197 . The term “extra-solution activity” can be understood as activities incidental to the primary process or product that are merely a nominal or tangential addition to the claim. Extra-solution activity includes both pre-solution and post-solution activity. An example of pre-solution activity is a step of gathering data for use in a claimed process.
In regards to the double patent rejection; Applicant asserts that the instant invention and the ‘808 application are directed to different inventive concepts. Examiner respectfully disagrees. While ‘808 recites a virion based oscillator; the instant invention recites receptors connected to a surface via a linker. A ‘receptor connected to a surface via a linker’ is more broadly claimed than a ‘virion based oscillator’. The instant claim generically recites a ‘receptor connected to a surface via a linker’. This extremely broadly claimed which can be anything including ‘virion based oscillator’.
In addition, all the other steps in both the ‘808 patent application and the instant invention are recited exactly the same.
Similarly, ‘963 recites ‘nucleic acid barcoded oscillator’; while the instant invention recites receptors connected to a surface via a linker. A ‘receptor connected to a surface via a linker’ is more broadly claimed than a ‘nucleic acid barcoded oscillator’. The instant claim generically recites a ‘receptor connected to a surface via a linker’. This extremely broadly claimed which can be anything including ‘nucleic acid barcoded oscillator’.
In addition, all the other steps in both the ‘963 patent application and the instant invention are recited exactly the same.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 6, 7, 8, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 3, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, and 20 of copending Application No. 18/185,808 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant invention is more broadly claimed than the ‘808 reference. The claims are verbatim the same other than the instant invention just generically claims linkers and receptors, rather than virions in ‘808.
Claims 1, 2, 5, 6, 8, 10, 12, 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 10, 14, 16, 20 of copending Application No. 19/213,763 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant invention is more broadly claimed than the ‘763 reference. The instant claim are more broadly claimed than the ‘763 reference. .
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
All independent claims and dependent claims upon the independent claims are claimed the same, generic (instant invention) versus more specific (‘808 reference and ‘763 reference). There is nothing distinguishing between the references. In the ‘808 reference, since it more specifically claims for example virions and HSV-1 and GPCR, it would be obvious to more generically claim the broad ‘ligands’ and ‘receptors’ to more broadly cover all aspects of kinetic of ALL ligands. In the ‘763 reference , the connection between the ligands and nucleic acid are more specifically claimed, but the same general concept of : contacting, inducing and detecting changes and thereby determining kinetics the same.
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 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Instant Claim 1 recites: A method of determining binding kinetics of a ligand, the method comprising: contacting the ligand with a first surface of a substrate, which first surface comprises an electrically conductive coating and a population of receptors connected to the first surface via one or more linker moieties, wherein the receptors bind, or are capable of binding, to the ligand; inducing the receptors to oscillate proximal to the first surface of the substrate by applying an alternating current electric field to the electrically conductive coating; and, introducing incident light toward a second surface of the substrate to excite a surface plasmon wave at least proximal to the first surface; detecting, using plasmonic imaging and/or microscopic imaging, changes in oscillation amplitudes of the individual receptors over a duration by separating a detected optical signal into a direct current (DC) component corresponding to mass change and an alternating current (AC) component corresponding to charge change; and determining association and dissociation rate constants of the ligand from the separated AC component in substantially real time based on time-dependent oscillation amplitude changes, wherein the determining comprises computationally fitting the time-dependent oscillation amplitude changes to a kinetic binding model.
Step 1: The claim recites at least one step or act. Thus, the claim is to a method, which is one of the statutory categories of invention (Step 1: YES).
Step 2A Prong One: The claim recites a judicial exception. The limitation of detecting, using plasmonic imaging and/or microscopic imaging, changes in oscillation amplitudes of the receptors over a duration,…. ; and determining association and dissociation rate constants….wherein determining comprises computationally fitting…to a kinetic binding model is an abstract idea. The detecting changes (and inherently comparing data to a reference) to determine binding kinetic are data gathering to be used in the abstract idea and are insignificant extra solution activities. Once the steps of determining performed, that under its broadest reasonable interpretation, covers performance of the limitation of the mind. This limitation sets forth a judicial exception and can be performed by a human using mental steps or basic critical thinking which is an abstract idea, MPEP 2106.040 (a)(2)(III). The observation and determination of data and assessing are abstract ideas as they encompass observations and evaluations. In addition, all other elements of the claim do not go beyond generally linking the abstract idea to the field of endeavor, MPEP 2106.05(h), as the abstract is not applied.
Step 2A Prong Two: The claim as a whole integrates the recited judicial exception into a practical application of the exception; No. Once the determination steps are performed, nothing is basically done. While in the beginning part of Claim 1 recites other steps of contacting and inducing, these steps no nothing with the findings of the determining steps. Therefore there is no application of the abstract ideas much less a particular practical application. There does not appear to have any additional steps which are significantly more than the abstract idea. The elements in Claim 1 represent extra solution activities, pre- and post- solution activities, MPEP 2106.05(g)
Step 2B: does the claim recite any elements which are significantly more than the abstract idea? This does not appear to have ‘significantly’ more; all steps in the method are well-understood routine and convention (WURC). The prior art to MA, cited on the IDS, see Rejection below, anticipates all claim limitations.
All steps in Claim 1 are WURC and anticipated a prior art.
The dependent claims, Claims 2-11 do not solve the issues of above and are rejected by MA below.
The claim is ineligible.
Claim Rejections - 35 USC § 102
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.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by MA, G. et al, Quantifying Ligand−Protein Binding Kinetics with Self-Assembled Nano-oscillators, Anal. Chem. 2019, 91, 14149−14156, submitted on the Information Disclosure Statement on 02 APRIL 2024; Non-Patent Literature Documents, Cite No. 7.
Applicant’s invention is directed towards a method.
Regarding Claim 1, the reference MA discloses a method of determining binding kinetics of a ligand, abstract, Figure 1(a), Figure 5, page 14153-14154, Sections: BSA-Anti-BSA Binding Kinetics, Membrane Protein -Small Molecule Binding Kinetics, the method comprising:
contacting the ligand with a first surface of a substrate, Figure 1(a-b), particle is functionalized with protein molecules which can bind the ligand molecules introduced into the system , which first surface comprises an electrically conductive coating and a population of receptors connected to the first surface via one or more linker moieties, page 14150, Fabrication of Nano-oscillators, Figure 1(a-d), wherein the receptors bind, or are capable of binding, to the ligand, abstract, page 14149, left column, Figure 1(b);
inducing the receptors to oscillate proximal to the first surface of the substrate by applying an alternating current electric field to the electrically conductive coating, Figure 1(a), nano-oscillators are assembled on a gold surface and driven into oscillation by an alternating electric field which is applied via a three-electrode system, page 14151, Section : Results; and,
detecting, using plasmonic imaging and/or microscopic imaging , changes in oscillation amplitudes of individual receptors over a duration by separating a detected optical signal into a direct current component corresponding to mass change and alternating current component corresponding to charge change;, abstract, Figure 1(a), 1(d), Figure 2(a-c), page 14151-14152, Sections: Experimental Setup, Signal Processing and Results;
determining association and dissociation rate constants of the ligand from the separated AC component in substantially real time based on time-dependent oscillation amplitude changes, wherein the determining comprises computationally fitting the time-dependent oscillation amplitude changes to a kinetic binding model, page 14153, BSA-Anti-BSA Binding Kinetics
Additional Disclosures Included are: Claim 3: wherein the method of claim 1, wherein: the detecting step comprises detecting a change in intensity of the incident light reflected at an interface of the first surface of the substrate, Figure 1(a-d), page 14151-14152, Section: Results.; Claim 4: wherein the method of claim 1, wherein the alternating current electric field is applied to the substrate using an electrode system that comprises a reference electrode, a counter electrode, and a working electrode, Figure 1(a), alternating electric field which is applied via a three-electrode system, where the gold surface, a Pt coil, and a Ag/AgCl wire serve as the working, counter, and reference electrode, respectively, page 14151, Section: Experimental Setup. ; Claim 5: wherein the method of claim 1, comprising: determining a change in mass of one or more of the receptors from a detected reflectivity change of a surface of the substrate; determining a change in charge of one or more of the receptors from a detected oscillation amplitude change of the one or more of the receptors; determining size, charge, and/or conformation alterations of one or more of the receptors from the changes in oscillation amplitudes; and/or, determining the binding kinetics of the ligand in substantially real-time, wherein the determining step occurs during or after the detecting step, Figure 1, page 14154-14155, Sections: Charge Screening Effect, Charge Fluctuations, Particle – Surface Interactions, Towards High-throughput … Conclusions.; Claim 6: wherein the method of claim 1, wherein: the linker moieties comprise polymers; the linker moieties comprise polyethylene glycol (PEG) moieties and/or biomolecules; and/or, the receptors comprise a charge, page 14151, Section: Results, page 14154, Sections: Charge of Screening Effect, Charge Fluctuations.; Claim 7: wherein the method of claim 1, comprising: detecting the changes in the oscillation amplitudes of the receptors over the duration using a CMOS camera, abstract, Figure 1(d), Figure 2(a-c), page 14151-14152, Sections: Experimental Setup, Signal Processing and Results. ; Claim 8: wherein the method of claim 1, wherein the electrically conductive coating comprises gold (Au), indium tin oxide (ITO), silver (Ag), copper (Cu), and/or aluminum (Al), Figure 1(a), gold surface, page 14150-14151, Sections: Synthesis of DNA Linkers, Fabrication of Nano-oscillators. ; Claim 9: wherein the method of claim 1, further comprising one or more spacer moieties connected to the first surface and/or to the linker moieties, page 14151, Section: Results.; Claim 10: wherein the method of claim 1, comprising quantifying the binding kinetics and binding affinity of the ligand using the detected changes in the oscillation amplitudes of the receptors over the duration, abstract, measure and quantify the binding kinetics of both large and small molecules with self-assembled nano-oscillators, page 14155, Section: Towards High-Throughput Screening of Small Molecules, Conclusions. ; and Claim 11: wherein the method of claim 1, comprising: introducing the incident light via at least one objective lens and/or at least one prism; and/or, introducing the incident light using a superluminescent diode (SLED), a laser and/or a light emitting diode (LED), Figure (a-d), page 14151, Section : Experimental Setup.
Applicant’s invention is directed to a device.
Regarding Claim 12, the reference MA discloses a receptor oscillator array device, Figure 1(b), page 14150, Section: Fabrication of Nano-oscillators, comprising:
a substrate that comprises a first surface, page 14150, Fabrication of Nano-oscillators, Figure 1(a), that comprises an electrically conductive coating and a population of charged receptors connected to the first surface via flexible polymer linker moieties configured to electrically driven oscillatory motion of individual receptors relative to the first surface in response to an applied alternating electric field , abstract, page 14150, Fabrication of Nano-oscillators, Figure 1(a-d), wherein the device is configured to permit optical excitation of a surface plasmon wave at the first surface for detection of oscillation amplitude of the individual receptors, abstract, page 14149, left column, Figure 1(b).
Additional Disclosures Included are: Claim 13: wherein the receptor oscillator array device of claim 12, wherein the electrically conductive coating comprises gold (Au), indium tin oxide (ITO), silver (Ag), copper (Cu), and/or aluminum (Al), Figure 1(a), gold surface, page 14150-14151, Sections: Synthesis of DNA Linkers, Fabrication of Nano-oscillators. ; Claim 14: wherein the receptor oscillator array device of claim 12, wherein the linker moieties comprise polyethylene glycol (PEG) moieties and/or biomolecules, page 14151, Section: Results.; and Claim 15: wherein the receptor oscillator array device of claim 12, further comprising one or more spacer moieties connected to the first surface and/or to the linker moieties, page 14150, Section: Fabrication of Nano-oscillators, page 14151, Section: Results, page 14154-14155, Section: Particle-Surface Interactions, Brownian Motion.
Applicant’s invention is directed to a system.
Regarding Claim 16, the reference MA discloses a system for determining binding kinetics of a ligand, Figure (1a-d), page 14151, Experimental Setup, comprising:
a substrate having a first surface and a second surface opposite the first surface, page 14150, Fabrication of Nano-oscillators, Figure 1(a), wherein the first surface comprises an electrically conductive coating and a population of charged receptors connected to the first surface via flexible polymer linker moieties, page 14150, Fabrication of Nano-oscillators, Figure 1(a-d), abstract, page 14149, left column, Figure 1(b);
a power source electrically connected to the substrate and configured to apply an alternating current electric field to induce oscillatory motion of individual receptors, Figure 1(a), page 14151, Section : Results;
an objective lens or a prism disposed proximal to the second surface of the substrate, Figure 1(a), page 14154, Section: Multiplexed Detection with Improved Signal to Noise Ratio;
a light source configured to introduce light through the objective lens or the prism to induce a plasmonic wave at least proximal to the first surface of the substrate, Figure 1(a), page 14151, Experimental Setup;
a detector configured to collect reflected light modulated by oscillation amplitude of the individual receptors , Figure 1(a-d), Figure 2, page 14151-14154, Experimental Setup, Signal Processing, Results; and
a controller that comprises, or is capable of accessing, a computer readable media comprising non-transitory computer-executable instructions which, when executed by at least one electronic processor, page 14151, Experimental Setup, cause the system to : (i) separate a detected optical signal into DC and AC components corresponding respectively to receptor mass change and receptor charge change; and (ii) computationally determine association and dissociation rate constants from time- dependent AC amplitude variations using a kinetic binding model , page 14153, BSA-Anti BSA Binding Kinetics.
.
Additional Disclosures Included are: Claim 17: wherein the system of claim 16, wherein the electrically conductive coating comprises gold (Au), indium tin oxide (ITO), silver (Ag), copper (Cu), and/or aluminum (AI), Figure 1(a), gold surface, page 14150-14151, Sections: Synthesis of DNA Linkers, Fabrication of Nano-oscillators. ; Claim 18: wherein the system of claim 16, wherein the linker moieties comprise polyethylene glycol (PEG) moieties and/or biomolecules, page 14151, Section: Results.; Claim 19: wherein the system of claim 16, further comprising one or more spacer moieties connected to the first surface and/or to the linker moieties, page 14150, Section: Fabrication of Nano-oscillators, page 14151, Section: Results, page 14154-14155, Section: Particle-Surface Interactions, Brownian Motion. ; and Claim 20: wherein the system of claim 16, wherein the non-transitory computer-executable instructions which, when executed by the electronic processor, further performs at least: quantifying binding kinetics and binding affinity of the ligand using detected changes in the oscillation amplitudes of the receptors over a duration, abstract, measure and quantify the binding kinetics of both large and small molecules with self-assembled nano-oscillators, page 14155, Section: Towards High-Throughput Screening of Small Molecules, Conclusions.
Conclusion
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 CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
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