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 .
Status of the claims
The amendment filed 08/04/26 is acknowledged and has been entered. Claims 1, 4 and 28-29 have been amended. Claim 27 has been canceled. New claim 65 has been added. Claims 2-3, 5, 9-11, 13, 15, 18-21, 23-26, 30, 34-35, 37-38, 40-43, 45, 47-48, 50-53, 55-58, 60 and 62-64 were previously canceled. Claims 32-33, 36, 39, 44, 46, 49, 54, 59 and 61 remain withdrawn as being directed to non-elected inventions. Accordingly, claims 1, 4, 6-8, 12, 14, 16-17, 22, 28-29, 31 and 65 are under examination.
Withdrawn Rejections
All rejections of claims not reiterated herein have been withdrawn.
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, 4, 6-8, 12, 14, 16-17, 22, 28-29, 31 and 65 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, step (i) the recitation “a sample” is vague and indefinite because it is unclear if the applicant intends the sample comprising an interfering agent recited in lines 1-2 or if the applicant intends another sample. 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.
Claims 1, 4, 6-8, 12, 14, 16-17, 22, 31 and 65 are rejected under 35 U.S.C. 103 as being unpatentable over Kumar et al (Human Antibodies 10, 2001, pages 143-147) in view of in view of Voller (Diagnostic Horizons, Dynasciences Corportion, Published by Microbiological Associates, The Enzyme Linked Immunosorbent Assay, Volume 2, Number 1, February 1978, pages 1-7) and further in view of Partridge et al (Bioanalysis, 2013, 5(15), 1897-1910) (submitted in the IDS filed 11/03/23).
Kumar a sandwich immunoassay method of detecting epidermal growth factor receptor (EGFR) (analyte) in a serum sample from a patient having cancer (disease) (e.g.pg 144). Kumar et al discloses that the method comprises adding the sample to well (solid support) having an immobilized antibody (capture reagent) for the EGFR and incubating and then washing to remove unbound material (e.g. page 67). Kumar et al discloses combining the captured EGFR with antibody and enzyme labeled antibody (detection reagent) and measuring the signal with a scanner and comparing to a calibration curve (e.g. page 114).
Kumar et al differs from the instant invention in failing to teach removing the detection reagent from the solid support and also fails to teach diluting the sample with a weak acid prior to contacting the sample with the immobilized reagent.
Voller teaches that it is known and conventional in a sandwich assay to provide a wash step after incubation with an enzyme labeled reagent. Voller teaches that this wash removes unreacted material (e.g. page 2, last line first col – first line 2nd col and in Fig 2).
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 a wash step such as taught by Voller after addition of the label in the method of Kumar et al as Kumar et al is silent with respect to a wash step after addition of a label and Voller shows that it is known and conventional to wash after addition of a label and that this provides for removal of unreacted material. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating a wash step such as taught by Voller after addition of the label in the method of Kumar et al.
Kumar et al and Voller differ from the instant invention in failing to teach diluting the sample with a weak acid prior to contacting the sample with the immobilized reagent.
Partridge et al teaches an immunoassay and teaches the dilution of a sample with mild acid (pH 4.5) before transferring to an immobilized capture antibody coated plate without neutralization (e.g. abstract, pgs 1905-1908). Partridge et al teaches that the acid can be acetic acid (e.g. page 1899). Partridge et al discloses determining a working pH for the acidified sample at which the interfering agent dissociated (e.g. pages 1902-1903). Partridge et al teaches that mild acid treatment without neutralization may be useful to minimize nonspecific interference and lessening nonspecific background signal (e.g. page 1909).
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 the dilution of a sample such as taught by Partridge et al with the sample of Kumar in the modified because Partridge et al teaches that mild acid treatment without neutralization may be useful to minimize nonspecific interference and lessening nonspecific background signal. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating the dilution of a sample such as taught by Partridge et al with the sample of Kumar in the modified assay of Kumar et al.
With respect to the recitation “for detecting an analyte in a sample comprising an interfering agent that binds to the analyte” as recited in claim 1. This limitation occurs in the preamble of the claim and thus has not been given patentable weight. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951). In the instant case, the combination of Kumar et al., Voller and Patridge et al discloses the same sample, same analyte and performs every active method step and when every active method step has been performed the prior art method is met. Further, it is unclear if sample in the body of the claim is the same sample as in the preamble of the claim (see 112(b) supra) and as stated above Kumar, Voller and Patridge disclose the same sample and analyte to be detected and thus absent evidence to the contrary it is deemed that the sample comprises an interfering agent as recited. There is nothing in the body of the claims reciting an interfering agent. Thus, for the reasons stated supra the combination of Kumar et al, Voller and Patridge et al reads on the instantly recited claim.
With respect to claim 16 as currently recited. The combination of Kumar et al., Voller and Partridge et al teaches the same capture reagent as currently recited and therefore it is deemed that the capture antibody in the modified method of Kumar et al would have a dissociation constant value as currently recited.
With respect to the recovery percentage of analyte signal in the sample as recited in claim 29 The combination of Kumar et al., Voller and Partridge et al teaches reagent steps and reagents consonant to the instantly recited claims and therefore it is deemed that the recovery would be at least a percentage as currently recited.
Claims 1, 4, 7-8, 12, 14, 16-17, 22, 28-29 and 65 are rejected under 35 U.S.C. 103 as being unpatentable over Rosario et al (US 2019/0255172) in view of Voller (Diagnostic Horizons, Dynasciences Corportion, Published by Microbiological Associates, The Enzyme Linked Immunosorbent Assay, Volume 2, Number 1, February 1978, pages 1-7) and further in view of Partridge et al (Bioanalysis, 2013, 5(15), 1897-1910) (submitted in the IDS filed 11/03/23).
Rosario et al discloses a method of measuring antibody in a serum sample from a patient comprising adding the sample to an immobilized reagent which specifically binds to the antibody and washing the captured antibody (removing sample after a first incubation) (e.g. para’s 0079-0081). Rosario et al discloses contacting the captured antibody with a labeling binding reagent and measuring the captured label (e.g. para 0081). Rosario et al discloses that the immobilized reagent and the labeled reagent can be antibodies (e.g. e.g. para’s 0079-0081). Rosario et al discloses that the patient has a disease (e.g. para’s 0006, 0009-0010). Rosario et al discloses that the sample can have an anti-drug antibody as an interferant in it (e.g. para’s 0087-0090).
Rosario et al differs from the instant invention in failing to teach removing the detection reagent from the solid support and also fails to teach diluting the sample with a weak acid prior to contacting the sample with the immobilized reagent.
Voller teaches that it is known and conventional in a sandwich assay to provide a wash step after incubation with an enzyme labeled reagent. Voller teaches that this wash removes unreacted material (e.g. page 2, last line first col – first line 2nd col and in Fig 2).
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 a wash step such as taught by Voller after addition of the label in the method of Rosario et al as Rosario et al is silent with respect to a wash step after addition of a label and Voller shows that it is known and conventional to wash after addition of a label and that this provides for removal of unreacted material. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating a wash step such as taught by Voller after addition of the label in the method of Rosario et al.
Rosario et al and Voller differ from the instant invention in failing to teach diluting the sample with a weak acid prior to contacting the sample with the immobilized reagent.
Partridge et al teaches the minimization of target interference in PK immunoassay and teaches the dilution of a sample with mild acid (pH 4.5) before transferring to an immobilized capture antibody coated plate without neutralization (e.g. abstract, pgs 1905-1908). Partridge et al teaches that the acid can be acetic acid (e.g. page 1899). Partridge et al discloses determining a working pH for the acidified sample at which the interfering agent dissociated (e.g. pages 1902-1903). Partridge et al teaches that in addition to minimizing target interference in PK assays, mild acid treatment without neutralization may be useful to minimize nonspecific interference and lessening nonspecific background signal (e.g. page 1909).
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 the dilution of a sample such as taught by Partridge et al with the sample of Rosario in the modified pharmacokinetic assay (PK assay) of Rosario because Partridge et al teaches that in addition to minimizing target interference in PK assays, mild acid treatment without neutralization may be useful to minimize nonspecific interference and lessening nonspecific background signal. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating the dilution of a sample such as taught by Partridge et al with the sample of Rosario in the modified pharmacokinetic assay (PK assay) of Rosario et al.
With respect to claim 16 as currently recited. The combination of Rosario et al., Voller and Partridge et al teaches the same capture reagent as currently recited and therefore it is deemed that the capture antibody in the modified method of Rosario et al would have a dissociation constant value as currently recited.
With respect to the recovery percentage of analyte signal in the sample as recited in claim 29 The combination of Rosario et al., Voller and Partridge et al teaches reagent steps and reagents consonant to the instantly recited claims and therefore it is deemed that the recovery would be at least a percentage as currently recited.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Rosario et al in view of Voller and Partridge et al as applied to claims 1, 4, 7-8, 12, 14, 16-17, 22 and 27-29 above, and further in view of Renske et al (Inflammatory Bowel Diseases, 2021, 27, pgs 1813-1820).
See above for the teachings of Rosario et al., Voller, and Partridge et al.
Rosario et al., Voller, and Partridge et al differ from the instant invention in failing to teach the comparison to a predetermined reference standard.
Renske et al teaches that it is well known and conventional in the art to calculate the concentration of the analyte by comparing signal from the serum sample to that of a standard curve (e.g. pg. 1814, laboratory analysis).
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 a standard curve such as taught by Renske et al into the modified method of Rosario et al because Rosario is generic with respect to the calculation of the amount and Renske et al shows that it is known and conventional in the art to use a standard curve for the calculation of the analyte. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating a standard curve such as taught by Renske et al into the modified method of Rosario et al.
Response to Arguments
Applicant's arguments filed 08/04/26 have been fully considered but they are not persuasive.
103 Rejections of Kumar et al in view of Voller and Partridge et al:
Applicant argues that the current claims have been amended to recite a method for detecting an analyte in a sample comprising an interfering agent that binds to the analyte” and that Kumar does not disclose detecting an analyte sample wherein the sample comprises an interfering agent that binds to the analyte.
This argument is not found persuasive because as stated above this limitation occurs in the preamble of the claim and thus has not been given patentable weight. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951). In the instant case, the combination of Kumar et al., Voller and Patridge et al discloses the same sample, same analyte and performs every active method step and when every active method step has been performed the prior art method is met. Further, it is unclear if sample in the body of the claim is the same sample as in the preamble of the claim (see 112(b) supra) and as stated above Kumar, Voller and Patridge disclose the same sample and analyte to be detected and thus absent evidence to the contrary it is deemed that the sample comprises an interfering agent as recited. There is nothing in the body of the claims reciting an interfering agent. Thus, for the reasons stated supra the combination of Kumar et al, Voller and Patridge et al reads on the instantly recited claim.
103 Rejections of Kumar et al in view of Voller and Partridge et al:
Applicant argues that the combination of Kumar et al., Voller and Partridge is improper because there is not motivation to combine Rosario with Partridge and that Rosario actually teaches away from the presently claimed invention.
This argument is not found persuasive because (1) the motivation to combine is explicitly taught by Partridge et al because Partridge et al specifically teaches that mild acid treatment without neutralization may be useful to minimize nonspecific interference and lessening nonspecific background signal (e.g. page 1909); (2) although Rosario may have an embodiment using a neutralization step there is nothing in Rosario providing evidence that the method will not work without neutralization and as stated supra Partridge teaches that by not providing neutralization one may have the advantage to minimize nonspecific interference and lessening nonspecific background noise and; (3) the applicant is arguing Rosario individually and not considering the combination of Rosario, Voller and Partridge. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
No claims are 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY W COUNTS whose telephone number is (571)272-0817. The examiner can normally be reached M-F 7:00-4:00.
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/GARY COUNTS/ Primary Examiner, Art Unit 1678
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