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 .
Election/Restrictions
Claims 2, 11, and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/03/2025.
Applicant's election with traverse of the species of the antigen combination of PARP1, TRIM21, P53, BRCA2, Annexin 11, ATAD2, NY-ESO-1, and CAGE (Claims 1, 3-10, 12-18, and 20 read on this elected species), in the reply filed on 12/03/2025 is acknowledged. The traversal is on the ground(s) that there should be no undue burden on the Examiner to consider all claims in the single application. This is not found persuasive because said statement falls far short of the requirement to establish that inventions are not patentably distinct, as set forth in MPEP§ 809.02(a) (Should applicant traverse on the ground that the inventions or species are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions or species to be obvious variants or clearly admit on the record that this is the case).
The requirement is still deemed proper and is therefore made FINAL.
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, 3-10, 12-18, and 20 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 recites the limitation "the antigen" in line 9. There is insufficient antecedent basis for this limitation in the claim. The Applicants are advised, amending the limitation to recite “the antigen protein” is one way to resolve the indefiniteness issues.
Claim 3 recites the limitation "the antigen" in line 1. There is insufficient antecedent basis for this limitation in the claim. The Applicants are advised, amending the limitation to recite “the antigen protein” is one way to resolve the indefiniteness issues.
Claim 4 recites the limitation "the sample" in line 1. There is insufficient antecedent basis for this limitation in the claim. The Applicants are advised, amending the limitation to recite “the biological sample” is one way to resolve the indefiniteness issues.
Claims 5-7 depend on claim 1.
Claim 8 recites the limitation "the detection" in line 1. There is insufficient antecedent basis for this limitation in the claim. The Applicants are advised, amending the limitation to recite “the detecting” is one way to resolve the indefiniteness issues.
Claim 9 recites the limitation "the absorbance cutoff value of the autoantibody of the antigen" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. The Applicants are advised, amending the limitation to recite “the cutoff value of the autoantibody” is one way to resolve the indefiniteness issues.
Claim 10 recites the limitation "the detected autoantibody of the antigen" in line 6. There is insufficient antecedent basis for this limitation in the claim. The Applicants are advised, amending the limitation to recite “the detected autoantibody” is one way to resolve the indefiniteness issues.
Claim 10 recites the limitation "the detected autoantibody of the antigen" in line 8. There is insufficient antecedent basis for this limitation in the claim. The Applicants are advised, amending the limitation to recite “the detected autoantibody” is one way to resolve the indefiniteness issues.
Claim 10 recites the limitation "the antigen" in line 9. There is insufficient antecedent basis for this limitation in the claim. The Applicants are advised, amending the limitation to recite “the antigen protein” is one way to resolve the indefiniteness issues.
Claim 12 recites the limitation "the antigen" in line 1. There is insufficient antecedent basis for this limitation in the claim. The Applicants are advised, amending the limitation to recite “the antigen protein” is one way to resolve the indefiniteness issues.
Claim 13 recites the limitation "the sample" in line 1. There is insufficient antecedent basis for this limitation in the claim. The Applicants are advised, amending the limitation to recite “the biological sample” is one way to resolve the indefiniteness issues.
Claims 14-15 depend on claim 10.
Claim 16 recites the limitation "the detection" in line 1. There is insufficient antecedent basis for this limitation in the claim. The Applicants are advised, amending the limitation to recite “the detecting” is one way to resolve the indefiniteness issues.
Claim 17 recites the limitation "the absorbance cutoff value of the autoantibody of the antigen" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. The Applicants are advised, amending the limitation to recite “the cutoff value of the autoantibody” is one way to resolve the indefiniteness issues.
Claim 18 recites the limitation "the detected autoantibody of the antigen" in line 6. There is insufficient antecedent basis for this limitation in the claim. The Applicants are advised, amending the limitation to recite “the detected autoantibody” is one way to resolve the indefiniteness issues.
Claim 18 recites the limitation "the detected autoantibody of the antigen" in line 8. There is insufficient antecedent basis for this limitation in the claim. The Applicants are advised, amending the limitation to recite “the detected autoantibody” is one way to resolve the indefiniteness issues.
Claim 18 recites the limitation "the antigen" in line 9. There is insufficient antecedent basis for this limitation in the claim. The Applicants are advised, amending the limitation to recite “the antigen protein” is one way to resolve the indefiniteness issues.
Claim 20 recites the limitation "the absorbance cutoff value of the autoantibody of the antigen" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. The Applicants are advised, amending the limitation to recite “the cutoff value of the autoantibody” is one way to resolve the indefiniteness issues.
Appropriate corrections are required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3-8, and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hong et al. (A Panel of Tumor-associated Autoantibodies for the Detection of Early-stage Breast Cancer).
Regarding claim 1, Hong discloses a method for detecting whether an individual suffers from a breast cancer, comprising the following steps:
providing a biological sample for an individual (pg. 2748/Patient selection, see: collected sera samples); and
detecting an autoantibody of an antigen protein in the biological sample to obtain a quantitative value of the autoantibody (pg. 2748/Enzyme‑linked immunosorbent assay (ELISA), see: reading of absorbance of each well comprising IgG),
wherein if the quantitative value of the autoantibody exceeds or equals to a cutoff value, the individual is determined to be a patient with a breast cancer; if the quantitative value of the autoantibody is less than the cutoff value, the individual is determined not to be a patient with a breast cancer (pg. 2749-2750/Diagnostic value of autoantibodies in breast cancer, see: diagnostic cutoff OD values for serum autoantibodies); and the antigen is selected from at least one or more than one antigen combination of the following antigens: PARP1, TRIM21, P53, BRCA2, Annexin 11, ATAD2, NY-ESO-1, and CAGE (pg. 2749-2750/Diagnostic value of autoantibodies in breast cancer, see: NY-ESO-1, p53).
Regarding claim 3, Hong further discloses the antigen is selected from one of the antigen combination: (1) PARP1, TRIM21, and CAGE; (2) PARP1, TRIM21, CAGE, and P53; (3) PARP1, TRIM21, CAGE, and Annexin 11; (4) PARP1, TRIM21, CAGE, and ATAD2; (5) PARP1, TRIM21, CAGE, and NY-ESO-1; (6) PARP1, TRIM21, CAGE, and BRCA2; (7) PARP1, TRIM21, CAGE, Annexin 11, and ATAD2; (8) PARP1, TRIM21, CAGE, Annexin 11, and NY-ESO-1; (9) PARP1, TRIM21, CAGE, Annexin 11, and P53; (10) PARP1, TRIM21, CAGE, ATAD2, and NY-ESO-1; (11) PARP1, TRIM21, CAGE, ATAD2, and P53; (12) PARP1, TRIM21, CAGE, NY-ESO-1, and P53; (13) PARP1, TRIM21, CAGE, Annexin 11, ATAD2, and NY-ESO-1; (14) PARP1, TRIM21, CAGE, Annexin 11, NY-ESO-1, and P53; (15) PARP1, TRIM21, CAGE, ATAD2, NY-ESO-1, and P53; or (16) PARP1, TRIM21, P53, BRCA2, Annexin 11, ATAD2, NY-ESO-1, and CAGE (pg. 2749-2750/Diagnostic value of autoantibodies in breast cancer, see: NY-ESO-1, p53).
Regarding claim 4, Hong further discloses the sample of the individual is selected from one or more of the following samples: whole blood, serum, plasma, a tissue, a cell, interstitial fluid, cerebrospinal fluid, or urine (pg. 2748/Patient selection, see: collected sera samples).
Regarding claim 5, Hong further discloses the individual is a mammal (pg. 2748/Patient selection, see: female breast cancer patients).
Regarding claim 6, Hong further discloses the autoantibody is IgA, IgM, or IgG (pg. 2748/Enzyme‑linked immunosorbent assay (ELISA), see: reading of absorbance of each well comprising IgG).
Regarding claim 7, Hong further discloses the breast cancer comprises a ductal carcinoma in situ and an invasive breast cancer; or a triple-negative breast cancer and a non-triple-negative breast cancer, or a stage I or II breast cancer (pg. 2748/Patient selection, see: tumors with stages I + II + IIIA were defined as early stage disease).
Regarding claim 8, Hong further discloses the detection comprises one of the following modes: an enzyme-linked immunosorbent assay (ELISA), a protein/peptide fragment chip detection, an immunoblotting, a microbead immunoassay or a microfluidic immunoassay (pg. 2748/Enzyme‑linked immunosorbent assay (ELISA), see: reading of absorbance of each well comprising IgG).
Regarding claim 18, Hong discloses a method for detecting whether an individual suffers from a stage I or II breast cancer, comprising the following steps:
providing a biological sample for an individual (pg. 2748/Patient selection, see: collected sera samples); and
detecting an autoantibody of an antigen protein in the biological sample to obtain a quantitative value of the autoantibody (pg. 2748/Enzyme‑linked immunosorbent assay (ELISA), see: reading of absorbance of each well comprising IgG),
wherein if the quantitative value of the detected autoantibody of the antigen exceeds or equals to a cutoff value, the individual is determined to be a patient with a stage I or II breast cancer (pg. 2748/Patient selection, see: tumors with stages I + II + IIIA were defined as early stage disease); if the quantitative value of the detected autoantibody of the antigen is less than the cutoff value, the individual is determined not to be a patient with a breast cancer (pg. 2749-2750/Diagnostic value of autoantibodies in breast cancer, see: diagnostic cutoff OD values for serum autoantibodies); and the antigen is selected from at least one or more than one antigen combination of the following antigens: PARP1, TRIM21, P53, BRCA2, Annexin 11, ATAD2, NY-ESO-1, and CAGE (pg. 2749-2750/Diagnostic value of autoantibodies in breast cancer, see: NY-ESO-1, p53).
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(s) 9 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hong et al. (A Panel of Tumor-associated Autoantibodies for the Detection of Early-stage Breast Cancer).
Regarding claims 9 and 20, Hong discloses all of the claim limitations as set forth above, but does not explicitly disclose instantly recited absorbance cutoff values. As the sensitivity and specificity being variables that can be modified, among others, by adjusting said absorbance cutoff values, with said sensitivity decreasing and specificity increasing as the absorbance cutoff values is increased, the precise absorbance cutoff values would have been considered result effective variables by one having ordinary skill in the art, before the effective filing date of the claimed invention. As such, without showing unexpected results, the claimed absorbance cutoff values cannot be considered critical. Accordingly, one of ordinary skill in the art, before the effective filing date of the claimed invention, would have optimized, by routine experimentation, the absorbance cutoff values in the method of Hong to obtain the desired balance between the sensitivity and specificity (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Claim(s) 10 and 12-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hong et al. (A Panel of Tumor-associated Autoantibodies for the Detection of Early-stage Breast Cancer), in view of Qiu et al. (Autoantibodies as Potential Biomarkers in Breast Cancer).
Regarding claim 10, Hong discloses method for detecting whether an individual suffers from breast cancer, comprising the following steps:
providing a biological sample for an individual (pg. 2748/Patient selection, see: collected sera samples); and
detecting an autoantibody of an antigen protein in the biological sample to obtain a quantitative value of the autoantibody (pg. 2748/Enzyme‑linked immunosorbent assay (ELISA), see: reading of absorbance of each well comprising IgG),
wherein if the quantitative value of the detected autoantibody of the antigen exceeds or equals to a cutoff value, the individual is determined to be a patient with a breast cancer; if the quantitative value of the detected autoantibody of the antigen is less than the cutoff value, the individual is determined not to be a patient with a breast cancer (pg. 2749-2750/Diagnostic value of autoantibodies in breast cancer, see: diagnostic cutoff OD values for serum autoantibodies); and the antigen is selected from at least one or more than one antigen of the following antigens: PARP1, TRIM21, P53, BRCA2, Annexin 11, ATAD2, NY-ESO-1, and CAGE (pg. 2749-2750/Diagnostic value of autoantibodies in breast cancer, see: NY-ESO-1, p53).
Hong does not explicitly disclose determining if the patient suffers from a triple-negative breast cancer.
Qiu teaches the ELISA detection of autoantibodies for early stage screening and diagnosis of triple-negative breast cancer (TNBC) tumors was well known in the art at the time of the invention (Table 1). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to apply the method taught by Hong to diagnosing TNBC tumors, as taught by Qiu, since clinical trials have demonstrated higher response rates to immune checkpoint blockade in triple-negative breast cancer (TNBC) tumors when compared with estrogen-receptor positive (ER+) tumors, allowing for potential discrimination (pg. 2-4/2. Autoantibodies in Breast Cancer).
Regarding claim 12, Hong further discloses the antigen is selected from one of the antigen combination: (1) PARP1, TRIM21, and CAGE; (2) PARP1, TRIM21, CAGE, and P53; (3) PARP1, TRIM21, CAGE, and Annexin 11; (4) PARP1, TRIM21, CAGE, and ATAD2; (5) PARP1, TRIM21, CAGE, and NY-ESO-1; (6) PARP1, TRIM21, CAGE, and BRCA2; (7) PARP1, TRIM21, CAGE, Annexin 11, and ATAD2; (8) PARP1, TRIM21, CAGE, Annexin 11, and NY-ESO-1; (9) PARP1, TRIM21, CAGE, Annexin 11, and P53; (10) PARP1, TRIM21, CAGE, ATAD2, and NY-ESO-1; (11) PARP1, TRIM21, CAGE, ATAD2, and P53; (12) PARP1, TRIM21, CAGE, NY-ESO-1, and P53; (13) PARP1, TRIM21, CAGE, Annexin 11, ATAD2, and NY-ESO-1; (14) PARP1, TRIM21, CAGE, Annexin 11, NY-ESO-1, and P53; (15) PARP1, TRIM21, CAGE, ATAD2, NY-ESO-1, and P53; or (16) PARP1, TRIM21, P53, BRCA2, Annexin 11, ATAD2, NY-ESO-1, and CAGE (pg. 2749-2750/Diagnostic value of autoantibodies in breast cancer, see: NY-ESO-1, p53).
Regarding claim 13, Hong further discloses the sample of the individual is selected from one or more of the following samples: whole blood, serum, plasma, a tissue, a cell, interstitial fluid, cerebrospinal fluid, or urine (pg. 2748/Patient selection, see: collected sera samples).
Regarding claim 14, Hong further discloses the individual is a mammal (pg. 2748/Patient selection, see: female breast cancer patients).
Regarding claim 15, Hong further discloses the autoantibody is IgA, IgM, or IgG (pg. 2748/Enzyme‑linked immunosorbent assay (ELISA), see: reading of absorbance of each well comprising IgG).
Regarding claim 16, Hong further discloses the detection comprises one of the following modes: an enzyme-linked immunosorbent assay (ELISA), a protein/peptide fragment chip detection, an immunoblotting, a microbead immunoassay or a microfluidic immunoassay (pg. 2748/Enzyme‑linked immunosorbent assay (ELISA), see: reading of absorbance of each well comprising IgG).
Regarding claim 17, modified Hong discloses all of the claim limitations as set forth above, but does not explicitly disclose instantly recited absorbance cutoff values. As the sensitivity and specificity being variables that can be modified, among others, by adjusting said absorbance cutoff values, with said sensitivity decreasing and specificity increasing as the absorbance cutoff values is increased, the precise absorbance cutoff values would have been considered result effective variables by one having ordinary skill in the art, before the effective filing date of the claimed invention. As such, without showing unexpected results, the claimed absorbance cutoff values cannot be considered critical. Accordingly, one of ordinary skill in the art, before the effective filing date of the claimed invention, would have optimized, by routine experimentation, the absorbance cutoff values in the method of modified Hong to obtain the desired balance between the sensitivity and specificity (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT J EOM whose telephone number is (571)270-7075. The examiner can normally be reached Monday-Friday (9:00AM-5:00PM).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at 5712721254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT J EOM/ Primary Examiner, Art Unit 1797
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