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 the Claims
The Amendment filed February 6, 2026 has been entered. Claims 1 and 3-4 have been amended; claims 5-6 have been withdrawn; and claim 2 has been cancelled. Claims 1 and 3-4 are currently examined herein.
Status of the Rejection
Applicant’s amendments to the Claims have overcome each objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed November 6, 2025.
New grounds of rejection under 35 U.S.C. § 112(b) are necessitated by the amendment.
All 35 U.S.C. § 102 rejections from the previous office action are essentially maintained and modified only in response to the amendment.
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 and 3-4 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Regarding claim 1, claim 1 recites “wherein the biosensor is configured to detect a rapid and significant change in capacitance in response to exposure of the microorganism to the antibiotic”, and the terms “rapid” and “significant” are relative terms which also render the claim indefinite. The terms “rapid” and “significant” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In this instant claim, it is unclear what is the requirement of the change in capacitance be considered as a rapid and significant change. Claims 3-4 are further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of indefinite claim 1.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 1 and 3-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by
Yoo et al. (KR20150014543A, English translation). Park et al. (Interdigitated and wave-shaped electrode-based capacitance sensor for monitoring antibiotic effects, Sensors, 2020, 20, 5237) is an evidence for claims 1 and 4.
Regarding claim 1, Yoo teaches a biosensor (a capacitance biosensor as shown in Fig.2 [claim 1; para. 0024]); “for inspecting a susceptibility of a microorganism to an antibiotic” is an intended use limitation [see MPEP 2111.02]. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, Yoo teaches the capacitance biosensor comprising interdigitated electrodes 10a and 10b on both sides of a substrate 14 which comprises polyethylene terephthalate [para. 0024], and the disclosed capacitance biosensor is essentially the same as the claimed biosensor. Yoo further teaches the capacitance biosensor is connected to an LCR meter capable of measuring capacitance, thereby enabling real-time monitoring of changes in the concentration of bacteria [para. 0029]. As evidenced by Park, which teaches an interdigitated electrode-based capacitance sensor for the label-free and real-time monitoring of the antibiotic effects on S. aureus and MRSA (abstract, section 2.2 Antimicrobial Susceptibility Testing), the capacitance biosensor of Yoo is thus capable of inspecting a susceptibility of a microorganism to an antibiotic by measuring electrical capacitances of a microorganism such as bacteria without and with a treatment of an antibiotic. Thus, the disclosed capacitance biosensor of Yoo is configured for performing the intended use. The biosensor comprising:
a substrate comprising polyethylene terephthalate (a substrate 14 which comprises polyethylene terephthalate [para. 0024]); and
an electrode layer formed on both surfaces of the substrate and comprising a first electrode and a second electrode which interdigitate with each other (interdigitated electrodes 10a and 10b formed on both sides of the substrate 14 [para. 0024; Fig.2]),
wherein the first electrode and the second electrode are made of gold (the above electrodes can be formed of gold [para. 0014]), and
“wherein the biosensor is configured to detect a rapid and significant change in capacitance in response to exposure of the microorganism to the antibiotic” is a functional recitation. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, Yoo teaches the capacitance biosensor comprising interdigitated electrodes (IDEs) 10a and 10b formed on both sides of a substrate 14 which comprises polyethylene terephthalate [para. 0024], and the first and second IDEs are made of gold, thus the disclosed capacitance biosensor is essentially the same as the claimed biosensor. Yoo further teaches the capacitance biosensor is connected to an LCR meter capable of measuring capacitance, thereby enabling real-time monitoring of changes in the concentration of bacteria [para. 0029]. As evidenced by Park, which teaches an interdigitated electrode-based capacitance sensor for the label-free and real-time monitoring of the antibiotic effects on S. aureus and MRSA (abstract, section 2.2 Antimicrobial Susceptibility Testing), the capacitance biosensor of Yoo is thus capable of detecting a rapid and significant change in capacitance in response to exposure of the microorganism to the antibiotic.
Regarding claim 3, Yoo teaches the biosensor of claim , and the limitation “wherein the first electrode and the second electrode are formed through screen printing, Printed Circuit Board (PCB) fabrication process, or photolithography” is a product by process claim. The determination of patentability is based upon the product or apparatus structure itself. Patentability does not depend on its method of production or formation. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. See In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (see MPEP § 2113). In the instant case, the disclosed IDEs made of gold are formed on both surfaces of the PET substrate, as outlined in the rejection of claim 1 above. There is no evidence the recited methods of forming the IDEs impart any additional structure that is not already present or substantially similar to the interdigitated gold electrodes of Yoo.
Regarding claim 4, Yoo teaches the biosensor of claim 1, and the limitation “wherein the biosensor is for measuring the susceptibility of the microorganism to the antibiotic by measuring in real time a change in electrical properties occurring as the microorganism grows according to a treatment with the antibiotic” is an intended use limitation [see MPEP 2111.02]. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, Yoo teaches the capacitance biosensor comprising the interdigitated electrodes (IDEs) 10a and 10b formed on both sides of a PET substrate 14, and the IDEs are made of gold, thus the disclosed capacitance biosensor is essentially the same as the claimed biosensor as outlined in the rejection of claim 1 above. Yoo further teaches the capacitance biosensor is connected to an LCR meter capable of measuring capacitance, thereby enabling real-time monitoring of changes in the concentration of bacteria [para. 0029]. As evidenced by Park, which teaches an interdigitated electrode-based capacitance sensor for the label-free and real-time monitoring of the antibiotic effects on S. aureus and MRSA (abstract, section 2.2 Antimicrobial Susceptibility Testing and section 2.3 Electrical capacitance monitoring), the capacitance biosensor of Yoo is thus capable of measuring the susceptibility of the microorganism to the antibiotic by measuring in real time a change in electrical properties (capacitance) occurring as the microorganism grows according to a treatment with the antibiotic.
Response to Arguments
Applicant's arguments, see Remarks Pgs. 5-7, filed 2/6/2026, with respect to the 35 U.S.C. § 102(a)(1) rejections have been fully considered, but are not persuasive.
Applicant’s Argument #1:
Applicant argues at pages 5-7 that Yoo fails to specifically describe a sensor configuration for antibiotic susceptibility testing, nor does it disclose detecting early-stage capacitance changes that occur within a short time period after exposure to an antibiotic. Therefore, Yoo fails to disclose a sensor configured as recited in the present claims, such as a sensor configured to generate a sufficiently large and distinguishable capacitance change within a short time frame suitable for antibiotic susceptibility determination. Like Yoo, Park also fails to disclose or even suggest a configuration employing a PET substrate in combination with metal electrodes (e.g., silver or gold as recited in the present claims) to achieve capacitance changes detectable within a short time after antibiotic exposure.
Examiner’s Response #1:
Applicant’s arguments have been fully considered, but are moot in view of the modified rejection for the amended claim 1 above. Note that the feature that applicant relied upon (i.e., wherein the biosensor is configured to detect a rapid and significant change in capacitance in response to exposure of the microorganism to the antibiotic) is a functional recitation. As outlined in the rejection of the amended claim 1 above, the biosensor of Yoo is essentially the same as the claimed one, the disclosed capacitance biosensor comprises a pair of interdigitated electrodes (IDEs) formed on both sides of a PET substrate and the IDEs are made of gold. Yoo further teaches the capacitance biosensor is connected to an LCR meter capable of measuring capacitance, thereby enabling real-time monitoring of changes in the concentration of bacteria [para. 0029]. As evidenced by Park, which teaches an interdigitated electrode-based capacitance sensor for the label-free and real-time monitoring of the antibiotic effects on S. aureus and MRSA (abstract, section 2.2 Antimicrobial Susceptibility Testing and section 2.3 Electrical capacitance monitoring), the capacitance biosensor of Yoo is thus capable of detecting a rapid and significant change in capacitance in response to exposure of the microorganism to the antibiotic.
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 SHIZHI QIAN whose telephone number is (571)272-3487. The examiner can normally be reached Monday-Thursday 8:00 am-5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan V Van can be reached on 571-272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIZHI QIAN/Examiner, Art Unit 1795