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 Application, Amendments, And/Or Claims
The Applicants amendments/remarks received 4/13/2026 are acknowledged. Claims 7-8 are amended; claims 1-6, 9 and 15-21 are canceled; no claims are withdrawn; claims 7-8 and 10-14 are pending and have been examined on the merits.
Drawings
The replacement drawings received 4/13/2026 are accepted.
Claim Rejections - 35 USC § 101
The rejection of claims 1-6 and 18-21 under 35 U.S.C. § 101, as set forth at pp. 4-6 of the previous Office Action, is moot due to cancelation of the claims.
Claim Rejections - 35 USC § 102
The rejection of claims 1-6 and 18-21 under 35 U.S.C. § 102(a)(1) over Baek et al., published online 9/20/2019 (NPL cite 6, IDS, 10/5/2023; herein “Baek”) as set forth at pp. 6-7 of the previous Office Action, is moot due to cancelation of the claims.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 7-8 and 10-14 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Suovaniemi, US 2011/0104707 (cite A, PTO-892, 1/12/2026; herein “Suovaniemi”).
NOTE: Claims 7-14 are composition claims. Intended use recitations in composition claims are met when the composition could be used for the intended use regardless of whether the prior art discloses the intended use or not. The intended use recitations in claims 7-14 comprise “for predicting or diagnosing early-stage diffuse-type gastric cancer”, “of a subject under age of 40” and “wherein the kit predicts or diagnoses a subject to have early-stage diffuse-type gastric cancer when a detected amount of pepsinogen II acquired from a sample of the subject is equal to or greater than 20 μg/L” in claim 7; “wherein the kit is applied to serum of the subject” in claim 8; “wherein the kit has the following criteria to classify a Helicobacter pylori (HP) status of a subject as a positive or negative status: i) the Helicobacter pylori status is positive if one or more selected from the group consisting of the histological test, culture test, rapid urease test, and serological test are positive; ii) the Helicobacter pylori status is positive if the histological test, culture test, and rapid urease test are all negative and the serological test is positive; iii) the Helicobacter pylori status is positive if the histological test, culture test, rapid urease test, and serological test are negative and the subject has a history of eradication of Helicobacter pylori; and iv) the Helicobacter pylori status is negative if the histological test, culture test, rapid urease test, and serological test are negative and the subject does not have a history of eradication of Helicobacter pylori.” in claim 13; and “wherein the kit has the following criteria to classify a subject as a high-risk group, an intermediate-risk group, or a low-risk group for early-stage diffuse-type gastric cancer: a) a high-risk group for early-stage diffuse-type gastric cancer if the detected amount of pepsinogen II is equal to or greater than 20 μg/L and the Helicobacter pylori status is positive; b) an intermediate-risk group for early-stage diffuse-type gastric cancer if the detected amount of pepsinogen II is equal to or greater than 20 μg/L or the Helicobacter pylori status is positive; and c) a low-risk group for early-stage diffuse-type gastric cancer if the detected amount of pepsinogen II is less than 20 μg/L and the Helicobacter pylori status is negative” in claim 14.
Suovaniemi teaches a biomarker panel, i.e., kit, dubbed GastroPanel®, comprising enzyme-linked immunosorbent assays (ELISA) to quantify plasminogen II and antibodies against Helicobacter pylori (Abst.; [0021-22]) anticipating claims 7-8 and 10-14.
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.
Claims 1-14 and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Baek.
Baek teaches methods for predicting or diagnosing early-stage diffuse-type gastric cancer comprising measuring a level of pepsinogen II (PGII) and Helicobacter pylori infection status in a sample of a subject under age of 40, wherein the subject can be a female, wherein the sample is a serum sample, wherein the Helicobacter pylori infection status is considered positive if any of histology, culture or urease (CLO test) tests are positive or if the subject has a history of eradication of Helicobacter pylori, wherein the predicted risk group of early-stage diffuse-type gastric cancer of the subject is a high risk group if the detected amount of pepsinogen II is equal to or greater than 20 μg/L and the Helicobacter pylori status is positive, an intermediate-risk group if the detected amount of pepsinogen II is equal to or greater than 20 μg/L or the Helicobacter pylori status is positive and a low-risk group if the detected amount of pepsinogen II is less than 20 μg/L and the Helicobacter pylori status is negative (Abst.; p. 440, “2. Endoscopic testing for HP infection and histology”, “3. Serologic testing for pepsinogen and HP antibody”, “4. Identifying the history of HP infection”; p. 442, “4. Correlation among sPGs, HP status and gastric dysplasia or GC”; p. 444, “5. The detective power of sPGII for the diagnosis of GC”; p. 444, “6. Correlation between sPGII and HP status for the risk of DGC”; Tables 1 and 4).
Baek discloses methods for predicting or diagnosing early-stage diffuse-type gastric cancer comprising measuring a level of pepsinogen II (PGII) and Helicobacter pylori infection status in a sample of a subject, wherein the subject can be a female under age of 40, wherein the sample is a serum sample, wherein the Helicobacter pylori infection status is considered positive if any of histology, culture or urease (CLO test) tests are positive or if the subject has a history of eradication of Helicobacter pylori, wherein the predicted risk group of early-stage diffuse-type gastric cancer of the subject is a high risk group if the detected amount of pepsinogen II is equal to or greater than 20 μg/L and the Helicobacter pylori status is positive, an intermediate-risk group if the detected amount of pepsinogen II is equal to or greater than 20 μg/L or the Helicobacter pylori status is positive and a low-risk group if the detected amount of pepsinogen II is less than 20 μg/L and the Helicobacter pylori status is negative as discussed above.
Baek does not specifically teach a kit for practicing the claimed method; however, a person of ordinary skill in the art at the time of filing would have found it obvious to produce a kit for practicing the method comprising a composition comprising a preparation for measuring a level of pepsinogen II (PGII) in a sample of a subject wherein the kit predicts or diagnoses a subject to have early-stage diffuse-type gastric cancer when a detected amount of pepsinogen II acquired from a sample of the subject is equal to or greater than 20 μg/L, wherein the kit comprises a composition containing a preparation for detecting Helicobacter pylori comprising a histological test which is a staining test on a biopsy specimen isolated from stomach of the subject, a culture test of Helicobacter pylori on a biopsy specimen isolated from stomach of the subject, a rapid urease test and a serological test to measure immunoglobulin G (IgG), an antibody against Helicobacter pylori, in serum of the subject, wherein the serological test is an immunoassay which is an enzyme-linked immunosorbent assay (ELISA), wherein the kit has an information sheet defining the criteria for Helicobacter pylori positive status, i.e., positive if any of the histological test, culture test, rapid urease test, and serological test are positive or if the subject has a history of eradication of Helicobacter pylori, and the criteria to classify a subject as a high-risk group, an intermediate-risk group, or a low-risk group for early-stage diffuse-type gastric cancer, i.e., wherein the predicted risk group of early-stage diffuse-type gastric cancer of the subject is a high risk group if the detected amount of pepsinogen II is equal to or greater than 20 μg/L and the Helicobacter pylori status is positive, an intermediate-risk group if the detected amount of pepsinogen II is equal to or greater than 20 μg/L or the Helicobacter pylori status is positive and a low-risk group if the detected amount of pepsinogen II is less than 20 μg/L and the Helicobacter pylori status is negative (Abst.; p. 440, “2. Endoscopic testing for HP infection and histology”, “3. Serologic testing for pepsinogen and HP antibody”, “4. Identifying the history of HP infection”; p. 442, “4. Correlation among sPGs, HP status and gastric dysplasia or GC”; p. 444, “5. The detective power of sPGII for the diagnosis of GC”; p. 444, “6. Correlation between sPGII and HP status for the risk of DGC”; Tables 1 and 4) because providing a kit for a method is an obvious way to commercialize and market the method; therefore, claims 7-8 and 10-14 are prima facie obvious over Baek.
Response to Arguments
Applicant's arguments filed 4/13/2026 have been fully considered but they are not persuasive. Arguments of the Applicant’s Response on pp. 5-6 regarding the objection to the drawings and the rejections under 35 U.S.C. §§ 101 and 102(a)(1) over Baek are moot as the objection and rejections have been withdrawn.
Claims 1-6 and 18-21 have been canceled; hence, rejections of claims 1-6 and 18-21 in the previous Office action are moot.
As stated above, claims 7-14 are composition claims. Intended use recitations in composition claims are met when the composition could be used for the intended use regardless of whether the prior art discloses the intended use or not. The intended use recitations in claims 7-14 comprise “for predicting or diagnosing early-stage diffuse-type gastric cancer”, “of a female subject under age of 40” and “wherein the kit predicts or diagnoses a subject to have early-stage diffuse-type gastric cancer when a detected amount of pepsinogen II acquired from a sample of the subject is equal to or greater than 20 μg/L” in claim 7; “wherein the kit is applied to serum of the subject” in claim 8; “wherein the kit has the following criteria to classify a Helicobacter pylori (HP) status of a subject as a positive or negative status: i) the Helicobacter pylori status is positive if one or more selected from the group consisting of the histological test, culture test, rapid urease test, and serological test are positive; ii) the Helicobacter pylori status is positive if the histological test, culture test, and rapid urease test are all negative and the serological test is positive; iii) the Helicobacter pylori status is positive if the histological test, culture test, rapid urease test, and serological test are negative and the subject has a history of eradication of Helicobacter pylori; and iv) the Helicobacter pylori status is negative if the histological test, culture test, rapid urease test, and serological test are negative and the subject does not have a history of eradication of Helicobacter pylori.” in claim 13; and “wherein the kit has the following criteria to classify a subject as a high-risk group, an intermediate-risk group, or a low-risk group for early-stage diffuse-type gastric cancer: a) a high-risk group for early-stage diffuse-type gastric cancer if the detected amount of pepsinogen II is equal to or greater than 20 μg/L and the Helicobacter pylori status is positive; b) an intermediate-risk group for early-stage diffuse-type gastric cancer if the detected amount of pepsinogen II is equal to or greater than 20 μg/L or the Helicobacter pylori status is positive; and c) a low-risk group for early-stage diffuse-type gastric cancer if the detected amount of pepsinogen II is less than 20 μg/L and the Helicobacter pylori status is negative” in claim 14.
The amendment to the claims received 4/13/2026 only amend the intended use of the composition (kit); hence, the anticipation rejection of claims 7-14 over Suovaniemi and the obviousness rejection of claims 7-14 over Baek are maintained with modification to address claim amendments.
Regarding the rejection of claims 7-14 under 35 U.S.C. 102(a)(1)/102(a)(2) over Suovaniemi, Applicant argues that the intended use of the composition is different from the use disclosed in Suovaniemi (pp. 5-6), but Applicant does not set forth any persuasive argument that the composition, i.e., kit, disclosed by Suovaniemi does not anticipate the composition, i.e., kit, of claims 7-14 which could be used for the intended use recitations of claims 7-14; hence, the rejections are maintained with modification to address claim amendments.
Regarding the rejection of claims 7-14 under 35 U.S.C. 103 over Baek, Applicant argues that the intended use of the composition is different from the use disclosed in Suovaniemi (pp. 6-10), but Applicant does not set forth any persuasive argument that the composition, i.e., kit, made obvious by Baek could be used for the intended use recitations of claims 7-14; hence, the rejections are maintained with modification to address claim amendments.
Applicant argues (p. 7) that Baek does not render the claimed kit obvious because Baek does not specifically recite assembling these preparations into a packaged diagnostic kit product. Applicant admits that “Baek reports statistical correlations from data gathered through existing hospital laboratory procedures and concludes that sPGII and HP status are "useful to detect" early-stage DGC” (p. 7), but then asserts “A study reporting epidemiological associations does not teach or render obvious the specific combination of reagents and diagnostic criteria integrated into a physical kit as claimed”. The assertion is unpersuasive - prior art disclosing that sPGII and HP status are "useful to detect" early-stage DGC is clearly a prima facie obvious reason to produce a kit comprising reagents to quantify sPGII and HP status in individuals to detect early stage diffuse gastric cancer; hence, the obviousness rejection of claims 7-14 over Baek is maintained with modification to address claim amendments
Applicant argues (pp. 7-10) that the dataset is too small to warrant the expenditure of producing a commercial diagnostic kit. The financial wisdom of producing a commercial kit has no bearing on whether such a kit is obvious over the prior art of Baek or Suovaniemi; hence, the argument is unpersuasive.
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 Trent R Clarke whose telephone number is (571)272-2904. The examiner can normally be reached M-F 10-7 MST.
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/TRENT R CLARKE/ Examiner, Art Unit 1651
/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651
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