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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/02/2026 has been entered.
Claim Status
Claims 1-11 and 13-14 are pending and under examination. Claims 12, 15-16 were cancelled previously. Claims 1 has been amended. Claim 1 is the only independent claim.
Response to Arguments
Rejections Withdrawn
The rejection of claims 1-11 and 13-14 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, is withdrawn following the applicants’ amendments.
The rejections of claims 1-11 and 13-14 under 35 U.S.C. 103 as being unpatentable over Quanjun (CN 104561290) in view of Long Feng (CN 105854962) and further in view of Hassibi (US 2017/0362648 A1) is withdrawn as neither Quanjun, Long Feng, nor Hassibi teach a checkpoint for the experimental assay to proceed “only when test results of the quality control area meet certain requirements”.
New Rejections
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 1-13 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.
In claim 1, the term “certain requirements” in the final limitation renders the scope of the claim indefinite. A person of ordinary skill in the art cannot determine the metes and bound of the claim because it is not clear what standard or threshold the quality control result must meet in order for the method to proceed to the immunological diagnosis step.
Claims 2-13 depend on claim 1 and do not rectify this deficiency and are therefore also subject to rejection under 35 U.S.C. 112(b).
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.
Claims 1-11 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Quanjun et al. (CN104561290, of record) in view of Long Feng (CN105854962, of record), Hassibi (US 2017/0362648 A1, of record) and Qiu et al. (“A new spot quality control for protein macroarray based on immunological detection”, Talanta, 138, 176–182, published Feb. 3, 2015)
In regards to claim 1, Quanjun teaches a quality detection method of biochip wherein part of the surface is modified with a modifying group (arm molecules), and applying a solution containing a labeled probe, wherein the probe is capable of reacting with the modifying group and bonding to the modifying group and removing the labeled probe that has not reacted with the modifying group, and detecting the content of residual labeled probe on the modified surface (see Quanjun Fig. 1, ¶ 0020, ¶0022- ¶0023, ¶0035, ¶0038, ¶0052-¶0053, and throughout). Quanjun further teaches identifying the quality of the chip according to the content of the residual labeled probe (see Quanjun ¶0022-¶0023, ¶0054-¶0055, and throughout).
Quanjun does not teach that the probe attached to the chip is an antibody, however Feng, who is also in the field of biochip production does teach using an antibody as a probe. Feng also teaches a chip with a modified surface with modifying groups (see Feng ¶0012) and applying biorecognition molecules (detection solution; see Feng ¶0013), wherein the biorecognition molecules are labeled antibodies (see Feng ¶0070).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to combine the chip quality control methods taught Quanjun with the antibody chip taught by Feng in order to provide a quality control step for producing biochips. One would be motivated to add these quality control steps for many reasons as it would ensure reproducible and consistent data generated from the chips, detect manufacturing defects, enable lot-to-lot comparability, validate binding activity, support regulatory compliance, build user confidence, and enable root cause analysis.
Quanjun also teaches using multiple areas on a slide and teaches the quality control methods involving modifying groups and detecting the contents of residual labeled probe on the modified surface (see Quanjun Fig. 1, ¶ 0020, ¶0022- ¶0023, ¶0035, ¶0038, ¶0052-¶0053, and throughout). While Quanjun does not specifically state a designated control and experimental areas, the use of control and experimental areas is well known in the art, and is explicitly taught by Hassibi and Qiu. Hassibi teaches multiple areas on an immunochip and specifically teaches areas in an array used as control and experimental as demonstrated in Fig. 15. Qiu also teaches multiple areas on an immunoassay including designated areas for each positive and negative controls (see Qiu Fig. 1).
Furthermore, Hassibi teaches the generating an array where the amount of each probe is controlled in the size of the area and the density of probes within the area (see Hassibi ¶0305-¶0308). Hassibi further teaches methods for detecting the number of probes in a given area prior to using the chip, and methods to correct for the density of the probes between sample areas (see Hassibi ¶0217-¶0219, ¶0279, ¶0286, ¶0369 - ¶0386, and throughout). It would have been prima facie obvious to one of ordinary skill in the art at the time of filing that the amount of probes being able to bind the surface would impact the immunodetection ability of the chip. Hassibi acknowledges that that error can be introduced into an array in multiple ways, including array fabrication (see Hassibi Fig. 8). To minimize this error Hassibi suggest performing validation steps before experimental binding on surfaces to account for differences in manufacturing and “provides a measurement of the amount of probe actually on the surface, increasing the quality and reliability of the binding measurement” (see Hassibi [0104] (“Probe density variations can be measured prior to incubation and therefore accounted for in post-processing”), [0177], [0357] (disclosing “measuring the probe density variations prior to hybridization (thus allowing for pre-calibration of the experimental results)”). Hassibi doesn’t explicitly state any pass/fail criteria for the validation steps before proceeding, however this logic path is expressly taught by Qui.
Qui is in the field of array based immunological detection and teaches a protein array comprising designated positive and negative control regions that are evaluated to determine array quality before conducting the experimental assay (see Qui Fig. 1). Qui further teaches that assay is performed with the array only when the quality control evaluation indicates that the array satisfies predetermined quality requirements, thereby ensuring that subsequent experimental results are generated from a properly functioning array (see Qui pg. 178 sec. 2.4 (disclosing evaluating the spot morphology and uniformity, and pass/fail decision to proceed), pg. 178 sec 3.1 (disclosing QC decision point based on intensity and morphology of spots)). It would have been obvious to a person of ordinary skill in the art to incorporate the quality control decision process taught by Qiu to the quality assessment method of Quanjun, Feng, and Hassibi so that the quality determination generated would be evaluated before diagnostic testing is performed and diagnostic testing would proceed only when acceptable quality criteria are met. Such a modification merely uses the quality information already generated by Quanjun, Feng, and Hassibi in the manner taught by Qiu to improve confidence in subsequent assay results and avoid performing diagnostic analysis on a chip that does not satisfy quality requirements. One would be motivated to do quality control validation prior to running experimental assays, as this allows the experimenter to “avoid unexpected results”, “increase reliability”, and minimize sample loss.
In regards to claim 2-6, and 13-14, Feng teaches that the modifying groups are carboxyl groups (¶0011 and throughout) and teaches treating the modified surface of the immunochip with an activation treatment comprising 1-(3-dimethylaminopropyl)-3-ethylcarbodiimide hydrochloride (EDC) solution and N-hydroxy succinimide (NHS) solution, wherein the solutions are mixed in a ratio of 1:1 (¶0029, and throughout). Feng further teaches that the NHS solution contains 3% imine (¶0062). Feng teaches that the ratio of the EDC to NHS in solution is 1:1 and is applied for a reaction of 0.5 – 4 hours (¶0033). It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to perform routine optimization of Feng’s methods to achieve the desired activation effect of the carboxyl group, as such modification would constitute nothing more than the predictable use of prior art elements according to their established functions. As established In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), "where 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." Therefore, selecting or optimizing the concentration, ratio, temperature, or time as claimed would have been within the ordinary skill one in the art.
In regards to claims 7-9, Feng teaches that the condensation reaction time for applying antibodies to the biochip is 8-15 hours (¶0035, ¶0063) and that the chip was stored in a refrigerator at 4 °C (¶0063). One of ordinary skill in the art would recognize that a refrigerator “evades the light”, and humidity is around 50%. As mentioned above, selecting or optimizing the concentration, ratio, temperature, or time as claimed would have been within the ordinary skill of one in the art.
In regards to claims 10 and 11, Quanjun teaches detecting the fluorescent signal to determine the quality of the chip (¶0022-¶0023, ¶0054-¶0055, and throughout).
Conclusion
No claim is allowed.
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/MATTHEW HAROLD RAYMONDA/Examiner, Art Unit 1684
/AARON A PRIEST/Primary Examiner, Art Unit 1681
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