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 .
Claims Status
Applicant’s amendment submitted 7/24/2026 is acknowledged. Claims 4 and 13 are canceled. All of the remaining claims, claims 1-3, 5-12, and 14-18, are under examination on the merits.
Withdrawn Objections
The previous objections are hereby withdrawn due to Applicant’s amendment submitted on 7/24/2026:
Specification
Claim objections: claims 5 and 14 for minor informalities.
Withdrawn Rejections
The previous rejections are hereby withdrawn due to Applicant’s amendment submitted on 7/24/2026:
35 U.S.C. §112(b): Claims 1-9 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.
Maintained Rejections
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Previous Rejection Maintained) Claims 1-3, 5-12, and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Rashed, et al. (Biosens Bioelectron. 2021 Jan 1;171:112709) in view of Lee, et al. (Biosens Bioelectron. 2022 May 1;203:114034) and Soares, et al. (Talanta. 2022 Mar 1;239:123076). The rejection of claims 4 and 13 is withdrawn due to cancellation of those claims.
Applicant’s arguments have been carefully considered but are found to be unpersuasive:
Applicant presents the following arguments:
Applicant describes the requirements of establishing a prima facie case of obviousness, citing MPEP §2143 and KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 415-421 (2007) on p. 7 of their remarks.
The Office Action acknowledges that “Rashed does not teach a sensor that is configured to virions or bind virions specifically with ACE2 as antigen in particular,” and states that “Lee teaches an electro-chemical impedance-based sensing methods and sensors, and Lee teaches immobilized ACE2 to detect the presence of neutralizing SARS-CoV-2 antibodies in a sample” to support the rejection on the grounds that “[i]t would have been obvious. . . to modify the device and methods taught by Rashed to incorporate use of ACE2 as an immobilized receptor for SARS-CoV-2 RBD to detect and measure SARS-CoV-2 neutralizing antibodies.” Office Action, page 7. But Lee does not teach an electrochemical impedance-based sensing method or sensor; rather, Lee teaches an “ACE2-based biosensor, which is based on a lateral flow immunoassay (LFIA), [that] comprises paper-based pads and a membrane, which provides the capillary force that drives sample flow along the LFIA strip.” Lee does not disclose, teach, or suggest “an electrochemical impedance-based sensing method or sensor.” Because Lee teaches a “biosensor. . . based on a lateral flow immunoassay (LFIA),” there is no motivation to combine Rashed and Lee: there is no reason for one skilled in the art of biosensors to modify Rashed’s electrochemical impedance-based sensor to use the ACE2 of Lee’s lateral-flow-immunoassay sensor. Soares discloses a sensor that uses impedance spectroscopy and mentions hACE2 as a receptor, but Soares does not specifically teach the use of hACE2 as a receptor for the impedance spectroscopy sensor. As such, for at least these reasons, the combination of Rashed in view of Lee and Soares fails to teach each and every element or limitation of the invention as claimed, and the prima facie case of obviousness fails.
Claims 2-3 and 5-9 depend directly or indirectly from claim 1, and claims 11-12 and 14-18 depend directly or indirectly from claim 10. Claims 2-3, 5-9, 11-12, and 14-18 are non-obvious over Rashed, Lee, and Soares, alone or in combination, for at least the reasons given for claims 1 and 10.
Applicant’s arguments are not persuasive because:
In the Office Action (page 7), the Examiner made a clear typographical mistake when stating “Lee teaches an electro-chemical impedance-based sensing methods and sensors,” rather than Rashed teaches electro-chemical impedance-based, as previously described in the summary of Rashed’s teachings and obviousness argument section of the rejection under 35 U.S.C. §103. This obvious mistake is clearly a typographical mistake, as Applicant states “Because Lee teaches a “biosensor. . . based on a lateral flow immunoassay (LFIA),” there is no motivation to combine Rashed and Lee: there is no reason for one skilled in the art of biosensors to modify Rashed’s electrochemical impedance-based sensor to use the ACE2 of Lee’s lateral-flow-immunoassay sensor,” and thus Applicant clearly understood the impedance sensor to be taught by Rashed, rather than Lee.
Applicant cites MPEP and case law, but does not explain the pertinence to the instant case. Therefore, the argument on p. 7 of Applicant’s remarks cannot be found persuasive, as it appears to be incomplete.
Applicant’s claim amendments do not overcome the rejection of the instant claims for the reasons of record, as the claims were properly rejected under 35 U.S.C. §103 previously.
Regarding Applicant’s assertion that there is no motivation to combine Rashed and Lee, motivation was presented previously on p. 7 of the previous Office Action, and one of ordinary skill in the art would have been motivated to combine the teachings of the cited references to arrive at the obvious system and method.
Regarding Soares, Applicant’s argument appears to be that Soares mentions ACE2 but not in the context used in this rejection. However, that is not persuasive, because Soares is used to remedy the deficiency of impedance based sensors or methods of use thereof with particular frequencies. Lee is the reference that teaches use of immobilized ACE2 in SARS-CoV-2 and neutralizing antibody biosensors. Additionally, there is no requirement that an “express, written motivation to combine must appear in prior art references before a finding of obviousness.” See Ruiz v. A.B. Chance Co., 357 F.3d 1270, 1276, 69 USPQ2d 1686, 1690 (Fed. Cir. 2004).
New Objections
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: Applicant’s amendment introduced the limitation “wherein neutralizing antibodies in a sample from a subject compete with the SARS-CoV-2 receptor binding domains (RBD) or the virions attached to the angiotensin-converting enzyme 2 receptors” to claim 1 lines 9-11 and claim 10, lines 13-14, but it does not have proper antecedent basis in the specification.
New Rejections, Necessitated by Amendment
Claim Rejections - 35 USC § 112—New Matter
(New Rejection Necessitated by Amendment) Claims 1-3, 5-12, and 14-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a New Matter rejection.
The amendment filed 7/24/2026 introduced the new limitation “wherein neutralizing antibodies in a sample from a subject compete with the SARS-CoV-2 receptor binding domains (RBD) or the virions attached to the angiotensin-converting enzyme 2 receptors” to claim 1 lines 9-11 and claim 10, lines 13-14, and Applicant’s remarks do not appear to direct support for this limitation to any specific portion of the disclosure.
However, the specification as filed does not provide sufficient written description of the above-mentioned limitations. The specification does not provide sufficient support for “wherein neutralizing antibodies in a sample from a subject compete with the SARS-CoV-2 receptor binding domains (RBD) or the virions attached to the angiotensin-converting enzyme 2 receptors” to claim 1 lines 9-11 and claim 10, lines 13-14”. Therefore, the claims represent a departure from the specification and claims as originally filed. Applicant has not provided an explanation for where support for this limitation may be found in the originally-filed claims or specification. The instant claims now recite additional limitations that were not clearly disclosed in the specification as filed, and now change the scope of the instant disclosure as filed.
Applicant is required to cancel the new matter in the response to this Office Action. Alternatively, applicant is invited to provide sufficient written support for the “limitations” indicated above. See MPEP §714.02, §§2163.05-06, and §2173.05(i).
Conclusion
No claim is allowed.
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 JEFFREY MARK SIFFORD whose telephone number is (571)272-7289. The examiner can normally be reached 8:30 a.m. - 5:30 p.m. ET with alternating Fridays off.
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/JEFFREY MARK SIFFORD/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671
