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 .
Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 10, 2026 has been entered.
Status of the Claims
Claim 1 has been amended; claims 5-6 have been withdrawn; and claim 2 has been cancelled. Claims 1 and 3-4 are examined herein.
Status of the Rejection
All 35 U.S.C. § 112(b) rejections from the previous office action are withdrawn in view of the Applicant’s amendment.
All 35 U.S.C. § 102 rejections from the previous office action are essentially maintained and modified in response to the amendment.
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]. Fig.8 shows capacitance change as a function of time for media (0 E coli), 10#, 80#, and 160# E. colis [para. 0045-0046]. Furthermore, 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 change in capacitance within 4 hours 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]. Fig.8 also shows the disclosed biosensor is configured to detect a change in capacitance within 4 hours for 80# and 160# E. colis relative the media (corresponding to 0 E. colis) [para. 0045-0046]. 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 Fig.5c shows the detected change in the capacitance index for MRSA and S. aureus within 4 hours relative to the media and 0.9% NaCl. Thus, the capacitance biosensor of Yoo is capable of detecting a change in capacitance within 4 hours 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. 4-10, filed 6/10/2026, with respect to the 35 U.S.C. § 102 rejections have been fully considered, but are not persuasive.
Applicant’s Argument #1:
Regarding claim 1, Applicant argues at pages 4-10 that Yoo does not expressly or inherently disclose that claimed biosensor having the recited feature and that “is configured to detect a change in capacitance within 4 hours in response to exposure of the microorganism to antibiotic”. The present invention achieves the capability to detect antibiotic-induced capacitance changes within 4 hours specifically by virtue of the combination of a PET substrate and metal electrodes (silver or gold). This particular material combination results in a biosensor that exhibits a significantly larger and more rapidly detectable capacitance change compare to biosensors employing other substrate.
Examiner’s Response #1:
Applicant’s arguments have been fully considered, but are moot in view of the new grounds of rejection for claim 1 above. As Applicant stated that the present invention achieves the capability to detect antibiotic-induced capacitance changes within 4 hours specifically by virtue of the combination of a PET substrate and metal electrodes (silver or gold). Yoo teaches the same combination of PET substrate and gold IDEs as the applicant. Furthermore, Fig. 8 shows the biosensor of Yoo is capable of detect a capacitance change for 80# and 160# E. colis relative to the media within 4 hours. Furthermore, 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 Fig.5c shows the detected change in the capacitance index for MRSA and S. aureus within 4 hours relative to the media and 0.9% NaCl. Since the biosensor of Yoo has the same combination of PET and gold IDEs as the instant application; Fig.8 of Yoo also shows the biosensor is configured to detect a change in capacitance for 80# and 160# E. colis relative to the media within 4 hours; and as evidenced by Park the biosensor of Yoo can also be used for the label-free and real-time monitoring of the antibiotic effects on S. aureus and MRSA (abstract, section 2.2 Antimicrobial Susceptibility Testing), thus, the capacitance biosensor of Yoo is capable of detecting a change in capacitance within 4 hours in response to exposure of the microorganism to the antibiotic.
Examiner suggests applicant to further recite the thickness of the PET substrate and the thickness of gold or Ag electrodes disposed on the PET substrate such that the combined PET and gold or Ag electrodes provides a structure that is different from that of the combined PET/gold electrodes in Yoo to achieve the feature “configured to detect a change in capacitance within 4 hours”.
Conclusion
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.
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/SHIZHI QIAN/Primary Examiner, Art Unit 1795
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