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 .
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.
Status of Claims
Claims 13-15 and 17-27 are pending and under examination. Claims 1-12 and 16 are canceled.
Withdrawn Rejection
In light of the amendments, the previous 35 U.S.C. 103 rejection over Koninklijke Philips Electronics (KPE) in view of Nishio and He, as evidenced by Thermo Fisher is hereby withdrawn.
Claim Rejections - 35 USC § 103
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 13-15 and 17-27 are rejected under 35 U.S.C. 103 as being unpatentable over Theilacker et al. (“Multiplexed protein analysis using encoded antibody-conjugated microbeads”, Journal Royal Society Interface, vol. 8, pgs. 1104-1113, published 2011) in view of Cui et al. (EP2437048A1, published 04/04/2012) and He et al. (US20130065780A1, published 03/14/2013, of record dated 08/03/2023).
Theilacker teaches streptavidin-coated with 1µm beads and the microbeads are further conjugated with biotinylated capture antibodies (see abstract and Fig. 1). Fig. 1 shows a sandwich assay wherein the streptavidin-coated microbead is attached to the biotinylated capture antibody. Theilacker further teaches the unconjugated monoclonal antibodies were covalently labeled with NHS ester-activated biotin molecules via a long polyethylene glycol PEG linker and the antibodies were biotinylated by mixing with NHS-PEG12-biotin solution (see 1106, left col., middle of para. 1). Thus, would read on microparticles coated with a first partner of a binding pair and an analyte-specific binding agent bound to a second partner of said binding pair, wherein said second partner of the binding pair is bound to said analyte-specific binding agent via a linker comprising a discrete polyethylene glycol of from 12 to 24 ethylene glycol units. Theilacker further teaches that the sensitivity of the method is comparable to the sensitivity obtained by enzyme-linked immunosorbent assay (see abstract).
Theilacker does not explicitly teach a kit comprising in separate containers or in separate compartments of a single container.
Cui teaches sandwich immunoassay and kit (see abstract and para. [0031]). Cui teaches that the kit individually comprises elements A’ to E’ (see bottom of para. [0034], pg. 9). Cui teaches the present invention are of great commercial value (see para. [0032], element (4)).
He teaches fluorescent conjugated polymers in conjunction with barcoded nanoparticles (see abstract and para. [0002]). He teaches a kit comprising individual premeasured containers of reagents were used (see paras. [0019] and [0021]). He also teaches that streptavidin-biotin linkage (see paras. [0018] and [0081]). He teaches protein target is prostate specific antigen (PSA) (see para. [0022]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have employed the elements of Theilacker into a kit as taught by Cui and He because Cui teaches that the kit has great commercial value. Additionally, advantages of packaging essential reagents in a kit form have been well recognized in the art at the time of invention. For example, He teaches a kit comprising individual premeasured containers of reagents were used (see paras. [0019] and [0021]). Therefore, it would have been obvious to the person to have packaged and stored the biotinylated antibody of Theilacker separately from microparticles coated with streptavidins because separately packaging reagents can be premeasured for specific reactions/assays, as taught by He; and for the purpose of commercial sales, said reagents would stably be stored without premature reactivities.
The person would have a reasonable expectation of success in packaging the essential elements of Theilacker separately because it has been well understood in the art to keep the reactive elements separately prior to performing a reaction.
Note that the terminology “kit” is not found to further limit the scope of the claims beyond requiring the reagents to be separated in containers or compartments, as these are the sole constituent reagents of the kit. The terminology of a “kit” does not clearly invoke any additional ingredients or provide antecedent basis for terms appearing in the body of the claim. See also MPEP 2111.02.
With respect to claim 14, Theilacker teaches streptavidin-coated with 1µm beads and the microbeads are further conjugated with biotinylated capture antibodies (see abstract and Fig. 1).
With respect to claim 15, Theilacker teaches a second analyte-specific binding agent which is detectably labeled. As stated above, Theilacker does not teach in separate containers or in separated compartments of a single container. It would have been obvious to the person to have packaged and stored the fluorescently labelled secondary antibody of Theilacker separately because separately packaging reagents can be premeasured for specific reactions/assays, as taught by He; and for the purpose of commercial sales, said reagents would stably be stored without premature reactivities.
With respect to claim 17, Theilacker teaches streptavidin-coated with 1µm beads a (see abstract and Fig. 1) and the beads are 1µm superparamagnetic microbeads (see pg. 1105, left col., middle of para. 3).
With respect to claims 18-20, Theilacker teaches antibody (abstract and Fig. 1). It would read on the claimed ranges of at least 50 amino acids and at most 10,000 amino acids. The instant specification has disclosed that the analyte-specific agent is an antibody (see pg. 4 under Figure 3, as filed 06/13/2022).
With respect to claim 21, the recitation of “instructions for measuring an analyte” is not found to be limiting in such a case as this; where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). See MPEP 2112.01.
With respect to claim 22, Theilacker teaches the antibodies were biotinylated by mixing 1.35µ1 of a 4.95 mM NHS-PEG12-biotin solution (see 1106, left col., middle of para. 1).
With respect to claims 23-26, Theilacker teaches the antibodies were biotinylated by mixing 1.35µ1 of a 4.95 mM NHS-PEG12-biotin solution (see 1106, left col., middle of para. 1). Additionally, He teaches a kit comprising individual premeasured containers of reagents were used (see paras. [0019] and [0021]). The references do not explicitly teach the claimed molar ratio ranges. However, it has been settled to be no more than routine experimentation for one of ordinary skill in the art to discover optimum ranges of molar ratios of biotinylation to antibodies for a specific result-effective variable in streptavidin-biotin reaction. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation" Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” As stated above, biotinylated antibodies conjugated to the microbead via streptavidin-biotin reaction. Thus, it would have been obvious to the person of ordinary skill to discover the optimum molar ratios as claimed for a specific assay detection of antibodies on the microbeads.
With respect to claim 27, Theilacker, Cui, and He have been discussed above. Theilacker further teaches that the sensitivity of the method is comparable to the sensitivity obtained by enzyme-linked immunosorbent assay (see abstract). However, the references do not explicitly teach “consisting essentially” However, it would have been obvious to the person to have packaged and stored separately the microbeads coated streptavidin and biotinylated antibodies without the biotinylated fluorescent labels because (1) Theilacker recognizes ELISA can be performed with streptavidin-coated microbead and (2) separately packaged reagents can be premeasured for specific reactions/assays, as taught by He; and for the purpose of commercial sales, said reagents would stably be stored without premature reactivities.
Response to Arguments
Applicant’s arguments filed 06/30/2026 have been considered but are moot because Applicant’s amendments necessitated a new ground of rejection. However, the unexpected/superior result argument will be addressed.
Applicant argues on page 8, under C, that PEG linkers within the claimed 12-24 range achieve unexpected results.
The argument is not found persuasive with respect to the newly introduced prior art (Theilacker) because Theilacker teaches the discrete PEG12 was used in the biotinylation with the antibodies. Thus, the results would be expected.
Conclusion
No claim is allowed.
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.
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/N.P.N/Examiner, Art Unit 1678
/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678
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