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 .
Response to Amendment
Claim 1 has been amended as requested in the amendment filed on 30 March 2026. Following the amendment, claims 1-20 are pending in the instant application.
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions.
Claims 1-10 are under examination in the instant office action.
Withdrawn Claim Objections
The amendment to Claim 1 has obviated the objection set forth in the previous action.
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 following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Dutta et al., Nanotechnology 32: 095702, published online 7 December 2020 in view of Li et al., (2020). Clinical detection of neurodegenerative blood biomarkers using graphene immunosensor, Carbon, 168(0), 144-162; and, RayBiotech brochure, made of record in the prior office action.
On pages 7-10 of Remarks filed 20 March 2026, Applicant traverses the rejection based upon different prior art references on the following grounds. Applicant states the three solutions (biotin solution, avidin solution and biotinylated probe solution) are required for the preparing the biochip. Applicant argues, in contrast, the Kim prior art discloses fabrication of the PTFT device was completed before exposing the compound to detecting materials like BSA and avidin. Applicant asserts Kim is silent about providing any probe solution on an avidin/biotin-coated chip to fabricate the OTFT device. It is clear that Kim fails to disclose or teach "coating a chip with a first solution of biotin to form a biotin-coated chip, wherein the biotin in the first solution is in a first concentration ranging from 0.1 to 1 µg/ml", "providing the biotin-coated chip with a second solution of avidin to form an avidin/biotin-coated chip, wherein the avidin in the second solution is in a second concentration ranging from 30 to 100 µg/ml" and "providing the avidin/biotin-coated chip with a third solution of a biotinylated probe to form the biochip, wherein the biotinylated probe in the third solution is in a third concentration ranging from 1 to 3 µg/ml" recited in the amended claim 1 of the present application. Applicant asserts Kim fails to suggest the criticality of the claimed ranges, as currently amended. Applicant states: “Kim is silent on how to improve sensitivity through the specific concentrations of biotin solution, avidin solution and biotinylated probe solution, it is clear that Kim does not recognize concentration as a result-effective variable, a person having ordinary skill in the art would have had no motivation to select or optimize concentrations of biotin solution, avidin solution and biotinylated probe solution to improve biochip performance.” Lastly, Applicant asserts the current invention yields unexpected results. Specifically, Applicant argues the sensitivity of the biochip is more than 180-fold high than the SIMOA system and 340-fold higher than the ECL-based system.
New prior art has been applied in this Non-Final action and therefore, the arguments are moot in view of the following teachings.
Regarding claims 1, and 3 through 9, Dutta et al. disclose making biosensors comprising gold surface of a quartz-crystal microbalance sensor that has been functionalized using polymeric chains of biotin poly(ethylene glycol)(bPEG) molecules (Abstract and). Specifically the reference teaches a biotin-coated chip comprising a 100% bPEG and 50% bPEG solutions (pg. 3 at bullet 2.2). The prior art does not disclose the µg/mL but discloses the density of biotin-PEG molecules on the surface of the gold chip. Thus, the prior art teaches a biotin-coated chip by contacting the chip with a solution comprising biotin. The prior art further discloses, contacting the chip with a streptavidin solution (pg. 4, second column, first full paragraph). The prior art further states: the streptavidin surface produced, “has multiple biotin binding sites and can get adsorbed as a top layer on functionalized surface, which can further bind additional biotinylated ligands through their free binding sites” (pg. 2, last full paragraph). Thus, the prior art teaches providing the avidin-biotin coated chip with a biotinylated probe.
The only elements that are missing from the Dutta prior art are the specific micrograms per mL of each solution of instant claim 1 and claims 3 through 9. However, the Court has stated that, generally, such differences amount to mere optimization and will not support patentability unless there is evidence indicating the claimed feature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). In KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court held that "obvious to try" was a valid rationale for an obviousness finding, for example, when there is a "design need" or "market demand" and there are a "finite number" of solutions. 550 U.S. at 421.
MPEP 2144 sets forth Applicant' s burden for rebuttal of a prima facie case of obviousness based upon routine optimization. Applicant must provide either a showing that the particular amount or range recited within the claims is critical; and/or a showing that the prior art reference teaches away from the claimed amount. In the instant case, the specification as filed provides no evidence that the particular ranges recited within the claims are critical because, for example, the specification discloses the second solution concentration can range from 0.1 to 100 μg/ml (paragraph [0013]) and not the claimed concentration of 30 to 100 micrograms per mL.
Therefore, the Dutta et al. prior art renders obvious the method of the instant claims 1 and 3-9.
Regarding claim 2, Dutta et al. teach a gold surface biosensor but do not specifically disclose EGFET. The Li et al. prior art, however, remedies this deficiency.
Li et al. graphene oxide biosensors that can be modified by gold (Table 1 and pg. 16 at bullet 3.2) and further configured to form a biosensor FET (BioFET), in which a graphene channel acts as a transducer directly connected to source and drain electrodes, with an additional top or bottom electrode for providing a gate potential (pg. 9, at bullet 2.1).
Regarding claim 10, the Li et al. provide guidance for the detection of Tau (pgs. 16-18, entire section of bullet 3.2, and Table 1). Specifically, Table 1 discloses the use of Tau antibodies in electrochemical immunosensors and the reference states, these methods result in “adequate sensitivity to clinically distinguish the health controls from mild cognitive impairment (MCI) and AD patients” (pg. 16, last line).
Li et al. disclose the specific use of Tau antibodies Li et al. does not teach biotinylated anti-Tau antibody. The RayBiotech brochure prior art of record remedies these deficiencies by teaching biotinylated Tau antibody was commercially available in the art prior to filing. It would have been obvious to a person having ordinary skill in the art, before the effective filing date of the application, to use the biotinylated anti-Tau antibody in combination with the methods of Dutta, which explicitly suggest using the streptavidin-biotin binding surface to “further bind additional biotinylated ligands through their free binding sites” (Dutta pg. 2, last full paragraph). A person having ordinary skill would recognize this biotinylated antibody would predictably result in the detection of AD with “adequate sensitivity” since this methodology was successful in the Li et al. prior art. In KSR International Co. v. Teleflex, Inc., the Supreme Court has stated that combining prior art elements according to known methods to yield predictable results is prima facie obvious if the following rationale can be applied: Here, each element claimed is disclosed in the prior art, though not necessarily in the same reference. Following the guidance and direction in the Dutta et al. and Li et al. prior art references, it would have been well-within the technical grasp of one of ordinary skill in the art to combine the elements as claimed according to the known methods. In combination, each element is merely performing the same function as it did separately. One of ordinary skill in the art would have recognized that the results of such combination would predictably yield an biotin-avidin coated biochip that could then be successfully probed with biotinylated anti-Tau antibody, since success was demonstrated with non-biotinylated anti-Tau antibodies. (KSR International Co. v. Teleflex, Inc. 127 S. Ct. 1727, 82 USPQ2d 1385, Supreme Court, April 30, 2007).
Therefore, the method for preparing the biochip of the invention is obvious in view of methods for assembling biochips disclosed in art prior to the effective filing date of the application.
Conclusion
No claim is allowed.
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/STACEY N MACFARLANE/ Examiner, Art Unit 1675
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