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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/30/26 has been entered. Claim 1 has been amended. Claims 2, 4, 6 and 8-16 have been canceled. Accordingly, claims 1, 3, 5 and 7 are under examination.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 the recitation “is 1 kDa or more and 5 kDa or less” should be recited as a specific range in order to avoid any possible ambiguity with the more or less statements exceeding or being less than the range of 1 kDa – 5 kDa. Appropriate correction is required.
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, 3, 5 and 7 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.
Claim 1, lines 19-20, the recitation “the antigen-antibody reaction” there is insufficient antecedent basis for this limitation. The claim only mentions first and second binding substance and never makes clear what these binding substances are. Also, the claim causes confusion as to if the applicant might be referring to the first binding substance, the second binding substance of if the applicant intends something else. Please clarify.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Weigl et al (US 2019/0126265) in view of Wada et al (US 2018/0292398) and further in view of Thomas et al (Cancer Epidemiol Biomarkers Prev; 19(4), April 2010, pages 953-959).
Weigl et al discloses an immunochromatographic method comprising adding a sample containing an analyte of interest to a lateral flow assay device wherein the assay device comprises a conjugate of antibody (first binding substance) which is specific for the analyte of interest and the antibodies are conjugated to a detectable component such as a colloidal metal particle (modified particles) (e.g. para’s 0006-0007, 0038-0046). Weigl et al discloses that the antibodies can be conjugated to colloidal gold particles (e.g. para 0038, page 12; claim 28). Weigl et al discloses that the analyte and conjugated antibody are brought into contact with a lateral flow membrane (insoluble carrier) wherein the membrane comprises a test line (reaction site) having antibodies (second binding substance) for the analyte and capturing the complex of analyte with the conjugated antibody at the reaction site and detecting the captured complex (e.g. para’s 0038-0046). Weigl et al discloses that the sample can be a urine sample (e.g. para 0067, 0102) wherein the urine sample is collected and concentrated by ultratiltraton and the resulting concentrated urine sample is taken and transferred to the lateral flow device (e.g. para 0102). Weigl et al discloses the sample is added by dropping sample onto the device (e.g. fig. 17).
Weigl et al differs from the instant invention in failing to teach the amplification of the information of the captured complex.
Wada et al teaches that it is known and conventional in the art to include silver amplification using a compound containing silver and a silver ion reducing agent which reacts with a label such as a metal colloid label (e.g. para’s 0007-0008). Wada et al discloses that this provides for detection with higher sensitivity even in a case where an amount of antigens is small (e.g. para’s 0007-0008).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate silver amplification such as taught by Wada et al into the method and device of Weigl et al because Wada et al shows that this technique is well known and conventional and provides for detection with higher sensitivity even in a case where an amount of antigens is small. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating silver amplification such as taught by Wada et al into the modified method and device of Weigl et al.
Weigl et al and Wada et al differ from the instant invention in failing to teach the ultrafiltration is between 1 and 5 kDa.
Thomas et al teaches that it is known and conventional in the art to use an ultrafiltration membrane with a 3 kDa molecular weight cutoff (e.g. page 955, Figure 1). Thomas et al teaches that ultrafiltration has been reported to be the best method for concentration and cleanup of peptide and protein complexes from urine and facilitates collection of lower molecular weight analytes (e.g. page 955).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate ultrafiltration such as taught by Thomas et al into the modified method of Weigl et al because Thomas et al shows that it is known and conventional in the art and that ultrafiltration has been reported to be the best method for concentration and cleanup of peptide and protein complexes from urine and facilitates collection of lower molecular weight analytes. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating ultrafiltration such as taught by Thomas et al into the modified method of Weigl et al.
With respect to the recitation “wherein urea in the urine is, together with water in the urine, passed through the ultrafiltration membrane in the concentration step, whereby inhibition of the antigen-antibody reaction is suppressed in the spreading step and the capturing step, and whereby detection sensitivity is improved”. Weigl et al teaches that the sample that is to be concentrated is urine (comprises both urea and water) and thus the urine sample (same sample as currently recited) is passed through the membrane in the combined method of Weigl et al., Wada et al and Thomas et al. The combination of Weigl et al., Wada et al and Thomas et al teaches the same sample, the same concentration step utilizing the same molecular weight cut-off membrane and therefore it is deemed that inhibition of the antigen-antibody reaction (Note: it is also unclear what antigen-antibody reaction the applicant is referring to – see 122(b) supra) would be suppressed in the spreading step and the capturing steps in the modified method of Weigl et al and thus detection sensitivity would be improved. Thus, it appears that applicant has recognized an advantage which would flow naturally from following the suggestion of the prior art and the recognition of an advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Weigl et al in view of Wada et al and Thomas et al as applied to claims 1 and 9 above, and further in view of Lin et al (Electrophoresis, 2008, 29 pages 3024-3031).
See above for the teachings of Weigl et al and Wada et al.
Weigl et al., Wada et al., and Thomas et al differ from the instant invention in failing to specifically teach the ultrafiltration 3 kda is performed with a centrifugal ultrafiltraton ..
Lin et al teaches that it is known and conventional in the art to use a centrifugal ultrafiltration device with a 3 kda cut-off (e.g. page 3029).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate ultrafiltration device such as taught by Lin et al into the modified method of Weigl et al because Lin et al shows that it is known and conventional in the art, Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating ultrafiltration device such as taught by Lin et al into the modified method of Weigl et al.
Claims 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Weigl et al in view of Wada et al and Thomas et al as applied to claims 1, 3, 9 and 11 above, and further in view of Ziomek et al (US 2007/0037192).
See above for the teachings of Weigl et al., Wada et al., Thomas et al and Lin et al.
Weigl et al., Wada et al., Thomas et al and Lin et al differ from the instant invention in failing to teach putting a part of the solution capable of containing an antigen remained into a centrifugal separation and repeating the operation.
Ziomek et al teaches that it is known and conventional in the art that of ultrafiltration that a filtrate (permeate) (sample capable of containing an antigen) can be recycled and then repeated in the process of filtration (e.g. page 2, lines 1-12).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to recycle the filtrate in the modified method of Weigl et al and repeat the modified method of Weigl using the recycled filtrate because Ziomek et al shows that it is known and conventional in the art and one of ordinary skill in the art would recognize that this would provide for a more concentrated sample. Thus, one of ordinary skill in the art would have a reasonable expectation of success recycling the filtrate in the modified method of Weigl et al and repeating the modified method of Weigl using the recycled filtrate.
Response to Arguments
Applicant's arguments filed 01/30/26 have been fully considered but they are not persuasive.
103 Rejections:
Applicant states that amended claim 1 recites “wherein urea in the urine is, together with water in the urine, passed through the ultrafiltration membrane in the concentration step, whereby inhibition of the antigen-antibody reaction is suppressed in the spreading step and the capturing step, and whereby detection sensitivity is improved”. Applicant argues that the cited references fail to disclose these limitations.
This argument is not found persuasive because as stated supra Weigl et al teaches that the sample that is to be concentrated is urine (comprises both urea and water) and thus the urine sample (same sample as currently recited) is passed through the membrane in the combined method of Weigl et al., Wada et al and Thomas et al. The combination of Weigl et al., Wada et al and Thomas et al teaches the same sample, the same concentration step utilizing the same molecular weight cut-off membrane and therefore it is deemed that inhibition of the antigen-antibody reaction (Note: it is also unclear what antigen-antibody reaction the applicant is referring to – see 122(b) supra) would be suppressed in the spreading step and the capturing steps in the modified method of Weigl et al and thus detection sensitivity would be improved. Thus, it appears that applicant has recognized an advantage which would flow naturally from following the suggestion of the prior art and the recognition of an advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Conclusion
No claims are allowed.
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/GARY COUNTS/ Primary Examiner, Art Unit 1678