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 Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/27/2026 has been entered.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 2, 6, 8-13 are rejected 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.
Regarding claim 1, the phrase “[...] formed as linear barcode-shaped [...] biosensor patterns on a substrate of the microfluidic chip” renders the claim unclear because it would appear the applicant is intending to claim what appear as ‘biosensor’ patterns but not positively claiming what the biosensor is. In addition, the claim is further unclear because the ‘substrate’ is not a positive element of the claim.
Claim 11 is unclear reciting “wherein each barcode channel is a localized surface plasmon resonance (LSPR) nanoplasmonic biosensor, and wherein the each LSPR nanoplasmonic biosensor is equally spaced from at least one other LSPR nanoplasmonic biosensor”, because it is unclear any distinction between the ‘formed as biosensor patterns’ in claim 1 and the biosensor in claim 11.
Claim 12 is unclear reciting “a plunger assembly engaged with the sensor [...]”, because it is unclear if the recitation is referring to the plunger assembly as recited in amended claim 1, or the device comprises a plurality of plunger assemblies.
Claim 12 recites the limitation "the sensor" in L2. There is insufficient antecedent basis for this limitation in the claim.
Claim limitation ‘configured to [...]’ has been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the term “means” or generic placeholder is modified by a word, which is ambiguous regarding whether it conveys structure or function; and/or the claim limitation uses the word “means” or a generic placeholder coupled with functional language, but it is modified by some structure or material that is ambiguous regarding whether that structure or material is sufficient for performing the claimed function. The boundaries of this claim limitation are ambiguous; therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may:
(a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function;
(b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function;
(c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or
(d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function.
Claim Rejections - 35 USC § 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 2, 6 and 8-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over of Holmes et al. (WO 2013/052318 A1) in view of Park et al. (WO 2018/200377 A1).
Regarding claims 1 & 11, Holmes et al. teach:
1. A biomarker detector device comprising:
a sealable housing (see i.e., The housing may form an air-tight enclosure around the module. ¶ 0593, ¶ 0039; e.g., 240);
an inlet (e.g., pipette tip of a fluid handling system ¶ 0030-0031+) configured to receive fluid (¶ 0099, 00545+; see also i.e., A fluid handling system may be provided to a module. The fluid handling system may permit the movement of a sample, reagent, or a fluid. ¶ 0587, a fluid handling system may incorporate one or more channels and/or conduits through which a fluid may flow. ¶ 0590); and
a sensor device (e.g., sensors/detectors) within the sealable housing (see Figs. 2, 7 & ¶ 0578 for example) and communicatively coupled to the inlet to receive the fluid (see ¶ 00303, 00545, 01049 for example),
the sensor further comprising an illumination source (e.g., light source ¶ 0944+), a photodetector array (see ¶ 01416 for example), and a microfluidic chip (e.g., vessel/cartridge/microcard ¶ 00550+) positioned between the illumination source and the photodetector array (¶ 01050-01051, 01054, 01056, 01060, 01072-01073+),
the microfluidic chip comprising a plurality of barcode channels and an inlet channel connected to the inlet for receiving the fluid (see i.e., Vessels may be comprised of microfluidic channels ¶ 01051; see also capillary on cartridges ¶ 00545), each barcode channel comprises a different antibody capable of detecting (¶ 0573-0576+) a different biomarker (¶ 01419, 01775-01778+) and each barcode channel capable of affecting (¶ 0573-0576+) illumination from the illumination source in response to detection of the respective biomarker (¶ 01419, 01775-01778+), where such affected illumination is detectable by the photodetector array (¶ 01416-01417).
a plunger assembly (e.g., at least one plunger within pipette head ¶ 0097-00100+) engaged comprising a push button (e.g., actuation mechanism may comprise one or more shaft ¶ 0839) and a spring assembly (see ¶ 0830 & Figs. 20-21 for example), the plunger assembly engaged with the sensor device (see ¶ 0099-00100+).
Regarding claims 1 & 11, Holmes et al. do not explicitly teach: wherein the plurality of barcode channels are formed as linear barcode-shaped localized surface plasmon resonance (LSPR) biosensor patterns on a substrate of the microfluidic chip [...]; wherein each barcode channel is a localized surface plasmon resonance (LSPR) nanoplasmonic biosensor, and wherein the each LSPR nanoplasmonic biosensor is equally spaced from at least one other LSPR nanoplasmonic biosensor.
Park et al. teach: a biomarker detector device (a photodetector device for detecting cytokines P4/L27-23) comprising a microfluidic chip (P7/L6-8; Fig. 14a),
the microfluidic chip comprising a plurality of barcode channels (Four barcode-shaped patterns of the plasmonic nano antenna arrays are lithographically fabricated on a PDMS substrate, P34/L17-29), each barcode channel configured to detect to a different biomarker (cytokine, Figs. 14a, 14c)
each barcode channel configured to affect illumination from the illumination source in response to detection of the respective biomarker (antibody surface binding effects on photo transmission, P5/L17-22, P24/L4-15),
where such affected illumination is detectable by the photodetector array (P29/L6-14, P30/L9-16),
wherein the plurality of barcode channels are formed as linear barcode-shaped localized surface plasmon resonance (LSPR) biosensor patterns on a substrate of the microfluidic chip (P2/L11-16; P10/L25-31), the barcode channels arranged in rows parallel to one another and generally orthogonal to a direction of fluid flow through the microfluidic chip (see Figs. 14-15 for example);
wherein each barcode channel is a localized surface plasmon resonance (LSPR) nanoplasmonic biosensor (P2/L11-16; P10/L25-31), and wherein the each LSPR nanoplasmonic biosensor is equally spaced from at least one other LSPR nanoplasmonic biosensor (LSPR patterned components (biosensor) are equally spaced from one another, P13/L22-24, P16/L4-5, Figs. 14a, 14c).
It would have been obvious to a person of ordinary skill in the art at the time the invention was made to have modified the disclosure of Holmes et al. to include wherein each barcode channel is a localized surface plasmon resonance (LSPR) nanoplasmonic biosensor, and wherein the each LSPR nanoplasmonic biosensor is equally spaced from at least one other LSPR nanoplasmonic biosensor, as taught by Park et al., in order to provide a superior device for performing sensitive and rapid immunoassays using a small volume of sample.
With regard to limitations in claims 1, 2, 6, 8, 11, 13 (e.g., sealable [...] barcode [...] to detect to a different biomarker [...] to affect illumination from the illumination source in response to detection of the respective biomarker, where such affected illumination is detectable by the photodetector array, [...] activates the spring assembly to generate a negative pressure to draw the fluid through the inlet into the microfluidic chip for multichannel barcode detection of respective biomarkers, wherein the sensor device is removable from the sealable housing and replaceable with a replacement sensor device, [...] to send the plasma to the microfluidic chip, etc.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666,667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." See In re Young, 75 F.2d *>996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115).
Regarding claims 2, 6, 8, 10, 12 and 13, modified Holmes et al. teach:
2. The biomarker detector device of claim 1, wherein the microfluidic chip is a nanoplasmonic barcode chip (see ¶ 01442, 01772, 01785 for example) having a plurality of different nanoplasmonic barcode detectors (see ¶ 01419, 01775-01778+ for example).
6. The biomarker detector device of claim 1, wherein each barcode channel has an antibody selected to capture a cancer biomarker, human epidermal growth factor receptor HER2 (¶ 01778).
8. The biomarker detector device of claim 1, further comprising a separation chamber (e.g., tapered channel ¶ 01385, centrifuge ¶ 0009, chromatography ¶ 01870+) capable of separating the fluid into plasma and non-plasma (¶ 01385; Examiner notes that plasma separation using chromatography techniques such as size exclusion chromatography, ion exchange chromatography, and affinity chromatography, etc. (¶ 01870+) are known in the art; see also “Examples of sample processing with blood” in Fig. 57), wherein the plasma separation chamber is capable of being in communicating with the microfluidic chip (¶ 01385), and wherein the microfluidic chip is a nanoplasmonic barcode chip having a plurality of nanoplasmonic barcode detectors (see ¶ 01442, 01772, 01785 for example).
10. The biomarker detector device of claim 1, wherein the illumination source is an organic light emitting diode (OLED) source (¶ 01484).
12. The biomarker detector device of claim 1, the plunger assembly (e.g., at least one plunger within pipette head ¶ 0097-00100+) engaged with the sensor (see ¶ 0099-00100+), wherein the plunger assembly is housed with the housing (see Fig. 1, ¶ 0013 & i.e., modules 701-706 with pipette 711 heads (¶ 0639) in Fig. 7 for example).
13. The biomarker detector device of claim 1, further comprising a wireless data transmitter within the housing (e.g., transmission unit ¶ 00347, 00351; wireless bus ¶ 0647-0648) and configured to wirelessly transmit one or more detection signals from the photodetector array and corresponding to one or more different biomarkers detected by one or more of the barcode channels (¶ 0091, 00304, 01430+).
Regarding claim 9, Holmes et al. teach: a photodetector array (¶ 01416-01417). However, Holmes et al. do not explicitly teach: wherein the photodetector array comprises an array of photodetector channel array.
Park et al. teach: a biomarker detector device (a photodetector device for detecting cytokines P4/L27-23) comprising a microfluidic chip (P7/L6-8; Fig. 14a),
the microfluidic chip comprising a plurality of barcode channels (Four barcode-shaped patterns of the plasmonic nano antenna arrays are lithographically fabricated on a PDMS substrate, P34/L17-29), each barcode channel configured to detect to a different biomarker (cytokine, Figs. 14a, 14c)
each barcode channel configured to affect illumination from the illumination source in response to detection of the respective biomarker (antibody surface binding effects on photo transmission, P5/L17-22, P24/L4-15),
where such affected illumination is detectable by the photodetector array (P29/L6-14, P30/L9-16),
wherein the photodetector array comprises an array of photodetector channel array (P6/L30-34).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the disclosure of Holmes et al., to include wherein the photodetector array comprises an array of photodetector channel array, as taught by Park et al. (P6/L30-34), in order to provide a superior method for performing sensitive and rapid immunoassays using a small volume of sample.
Response to Arguments
Applicant’s arguments have been considered but are moot in view of the new ground(s) of rejection.
Applicant is thanked for their thoughtful amendments to the claims.
Conclusion
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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798
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