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
2. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/2/26 has been entered.
Claims 1, 8, 9, 11,12, 16, 33, and 35-47 are pending. Claims 2-7, 10, 13-15, 17-32 and 34 are cancelled.
3. However, claims 44-47 are withdrawn from prosecution because they are directed to a method that is independent and distinct from the claims previously examined. Per MPEP 706.07(h) - Applicants cannot file an RCE to obtain continued examination on the basis of claims that are independent and distinct from, or lack unity of invention with, the claims previously elected and examined as a matter of right. New claim 44 recites a method that has an anchor substance where a step requires the anchor substance form a monolayer directly on the piezoelectric surface. This method step and anchor substance being able to form a monolayer directly on the piezoelectric surface is not recited in the previously prosecuted claims or new claims 35-43. Had new claim 44 been originally presented along with claim 1 and new claim 36 it would have been subject to restriction because the anchor substance and step requiring formation of a monolayer on the piezoelectric surface is distinct from the method of claims 1 and 36 which do not recite such anchor substance and step of forming a monolayer on the piezoelectric surface and would require additional search terms and search strategy on data bases to create a search burden on the examiner.
Claim Rejections - 35 USC § 112
4. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
5. Claim 36 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The specification, as originally filed, does not provide support for the method of claim 39. Paragraph [0097] of the specification in the PGPub of the instant application appears to provide support for contacting the capture reagent with the sample prior to application to the piezoelectric surface but not both the anchor substance and the capture reagent.
6. 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.
7. Claim 43 is 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.
Claim 43 is vague and indefinite because the mass of the signal amplifying material is relative to the mass of an analyte that is not known. Thus, the metes and bounds of the claim cannot be determined with respect to the mass of the signal amplifying material.
Claim Rejections - 35 USC § 103
8. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
9. Claim(s) 1, 8, 9, 11, 12, 16, 33, 35-38, and 40-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanaka et al (US 2018/0149646, herein referred to as Tanaka) in view of Branch (US 8,436,509).
Tanaka teach a method of amplifying signal in a biosensor, comprising:
applying a sample to the biosensor having a capture reagent (sample applied to
the detection body, par. 21; sample is applied to the surface of the surface acoustic
wave element, seen as claimed the biosensor, par. 129), wherein the biosensor
comprises an acoustic wave transducer (detection body is a surface acoustic wave
element, which is an acoustic wave transducer that generates surface acoustic waves,
par. 39, 47, 119; surface acoustic wave transducer, par. 132-133), wherein the capture
reagent comprises first recognition moieties (i.e. antibodies, par. 41) for binding an analyte (analyte is the detection target that binds to the primary substance, seen as claimed first recognition moieties, par. 21; target antigen forms primary composite body with the primary antibody on the surface of the surface acoustic wave element, par. 120) and wherein the capture reagent is immobilized on the biosensor (primary substance immobilized to a detection body of a sensor, par. 20; primary antibody binds to surface of surface acoustic wave element, par. 119); and
introducing a signal amplifying material after the analyte is bound to the capture reagent and the capture reagent has been immobilized on the biosensor (after target antigen forms primary composite body with the primary antibody on the surface of the surface acoustic wave element, par. 120, labeled secondary antibody against the antigen is supplied to the surface acoustic wave element, par. 123), wherein the signal amplifying material has a second recognition moiety for binding to the analyte, and wherein the signal amplifying material is a metal (signal amplification substance is a secondary antibody labeled with a metallic particle, par. 50; labeled secondary element forms a secondary composite between the primary antibody, analyte and the labeled secondary antibody, par. 123). Tanaka teach the second recognition moiety is an antibody (secondary antibody, par. 50) for binding to a protein (antigen, par. 79).
Tanaka teach the sample is a biological sample of blood, urine or saliva (par. 34).
With respect to a capture reagent comprising at least 2 first recognition sites that each are capable of binding a first portion of an analyte, the primary substance on the biosensor specific for the analyte can be an antibody and antibodies are known to have 2 binding sites (recognition sites) at the top of their “Y” branch structure that are each capable of binding to an epitope (a portion) on the analyte.
Tanaka teaches a sandwich assay where the signal amplification material comprises an antibody labeled with a metallic particle. The antibody of the amplification material binds a second epitope different from the epitope (i.e. a different portion of the analyte) that the capture antibody binds to in sandwich assays.
With respect to claim 8, Tanaka teach measuring a base level signal prior to applying the sample to the biosensor (graph of signal is illustrated in Figs. 7 and 8, sample application is illustrated as first reaction step, measurement is performed before the first reaction step, par. 15-16).
With respect to claim 9, Tanaka teach measuring a test level signal after the binding of the signal amplifying material to the analyte (measurement is performed after binding of the signal amplifying material, which is the signal amplification step, Figs. 7-8). And Tanaka teach comparing the base level signal to the test level signal to determine the presence of the analyte in the sample (base level signal measured at time zero and during the first reaction step is plotted on the same graph as the first measurement step when the illustrated in Fig. 7; signal provides detection of presence of analyte, par. 64; graph of signal provides comparison of base level and test level signals, Figs. 7 and 8).
With respect to claims 11 and 12, Tanaka teach the first recognition moiety is an antibody (par. 41) for binding to a protein (antigen, par. 41).
With respect to claim 33, Tanaka teach the acoustic wave transducer generates surface acoustic waves (Surface acoustic wave element is the detection body, par. 39 and 83-90; surface acoustic wave element is a transducer that generates surface acoustic waves, par. 132-133).
Tanaka differs from the instant invention by not teaching an anchor substance on the piezoelectric substrate to fix the capture reagent thereon.
Branch teaches a Love-type SAW biosensor (Col. 3, lines 36-60). Branch teaches guiding layer (13) is a piezoelectric surface (Col. 3, lines 50-52, and Col. 4, lines 37-44; ZnO is taught by Branch as a piezoelectric material in line 35) and provides a biologically sensitive layer (15) with a primary substance thereon that captures the analyte. The biologically sensitive layer (15) can be prepared with an amine reactive surface on guiding layer (13) using (3-glycidoxypropyl)trimethoxysilane (3-GPS). NeutrAvidin is applied to the 3-GPS layer. Biotinylated antibodies are then applied to the NeutrAvidin which covalently attaches the biotinylated antibodies (Col. 8, lines 14-32).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the 3-GPC/NeutrAvidin/biotin reagent system taught by Branch to fix the capture reagent to the SAW piezoelectric substrate of Tanaka because Branch teaches a conventional reagent system to fix a capture reagent to a SAW piezoelectric substrate, such as the SAW piezoelectric substrate of Tanaka. A person of ordinary skill in the art reasonably would have expected success because both Tanaka and Branch teach biosensors with a SAW piezoelectric substrate.
With respect to claim 43, because the exact mass of the signal amplifying material cannot be determined per the 112(b) rejection above, the signal amplifying material of Tanaka appears to meet the mass limitations of claim 43.
10. The 35 U.S.C. 103 rejection of claim 34 as being unpatentable over Tanaka et al (US 2018/0149646, herein referred to as Tanaka) in view of Branch (US 8,436,509) as applied to claim 1 above, and further in view of Lee et al (US 2009/0170119, herein referred to as Lee) is withdrawn in view of Applicant’s cancelation of claim 34.
Conclusion
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER L CHIN whose telephone number is (571)272-0815. The examiner can normally be reached Monday - Friday, 10:00am - 6:30pm.
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/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677
3/28/26