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 .
Priority
This application is a 371 of PCT/KR2020/012575, filed 9/17/2020. This application claims benefit to foreign applications KOREA, REPUBLIC OF 10-2020-0086191, filed 7/13/2020 and KOREA, REPUBLIC OF 10-2020-0115244, filed 9/09/2020. Claims 1-14 and 18-21 are pending and have been examined on the merits.
Information Disclosure Statement
The information disclosure statements submitted on 10/5/2023 (2) and 11/26/2024 have been considered by the examiner. NPL cite 1 of the 11/26/2024 IDS is lined through because it is already of record (NPL cite 6, 8-page IDS, 10/5/2023).
Drawings
The drawings are objected to because the sheets of drawings are not numbered.
37 C.F.R. 1.84(t) states “Numbering of sheets of drawings. The sheets of drawings should be numbered in consecutive Arabic numerals, starting with 1, within the sight as defined in paragraph (g) of this section. These numbers, if present, must be placed in the middle of the top of the sheet, but not in the margin. The numbers can be placed on the right-hand side if the drawing extends too close to the middle of the top edge of the usable surface. The drawing sheet numbering must be clear and larger than the numbers used as reference characters to avoid confusion. The number of each sheet should be shown by two Arabic numerals placed on either side of an oblique line, with the first being the sheet number and the second being the total number of sheets of drawings, with no other marking.”
Hence, the sheets of drawings should be consecutively numbered with Arabic numerals, starting at 1, with each sheet showing two Arabic numerals placed on either side of an oblique line, with the first being the sheet number and the second being the total number of sheets of drawings, with no other marking, i.e., the page numbers at the bottom of the drawings should also be removed.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-6 and 18-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Claims 1-6 and 18-21 are drawn to methods comprising a mental step, i.e., a judicial exception.
The first question in the subject matter eligibility determination is “Is the claim to a process, machine, manufacture or composition of matter?” (Step 1)
Yes, claims 1-6 and 18-21 are drawn to methods, i.e., a process.
The second question (Step 2A, prong 1) in the subject matter eligibility determination asks “Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea (judicially recognized exceptions)?"
Yes, the claimed methods of claims 1-6 and 18-21 are drawn to processes comprising an abstract idea (mental step; judicial exception) and well understood, conventional and routine laboratory steps.
Regarding claims 1-6 and 18-21, the processes are drawn to a method for predicting or diagnosing early-stage diffuse-type gastric cancer, comprising measuring a level of pepsinogen II (PGII) in a sample of a subject under age of 40, i.e., a mental step, which is an abstract idea or intangible relationship, which is a judicial exception.
Step 2A, prong 2 asks “Does the claim recite additional elements that integrate the judicial exception into a practical application?”
Regarding claims 1-6 and 18-21, no, the claims do not integrate the judicial exception into a practical application because the claims do not recite any practical steps to be taken upon making the mental step of predicting or diagnosing early-stage diffuse-type gastric cancer.
The final question (Step 2B) in the subject matter eligibility determination to be asked is “Does the claim recite additional elements that amount to significantly more than the judicial exception?”
No, claims 1-6 and 18-21 do not recite additional elements that amount to significantly more than the judicial exception.
Regarding claims 1-6 and 18-21, measuring a pepsinogen II level is well-understood, routine and conventional as demonstrated at [0021-22] in Suovaniemi, US 2011/0104707 (cite A, attached PTO-892; herein “Suovaniemi”).
Regarding claims 5-6 and 19-21, detecting Helicobacter pylori infection is well-understood, routine and conventional as demonstrated at [0021-22] in Suovaniemi.
These well-understood, routine, conventional activities are not part of a specific transformative method, but rather represent generalized method steps which are executed solely for the production of data for the mental step. Accordingly, claims 1-6 and 18-21 do not amount to significantly more than the judicial exceptions and are not patent eligible.
Thus, claims 1-6 and 18-21 are rejected under U.S.C. 101 as not being drawn to patent eligible subject matter.
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.
(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 1-6 and 18-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baek et al., published online 9/20/2019 (NPL cite 6, IDS, 10/5/2023; herein “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) anticipating claims 1-6 and 18-21.
Claims 7-14 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Suovaniemi, US 2011/0104707 (cite A, attached PTO-892; 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” and “of a subject under age of 40” in claim 7; “wherein the kit is applied to serum of a subject” in claim 8; “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 9; “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 7-14.
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.
The discussion of Baek regarding claims 1-6 and 18-21 set forth in the rejection above is incorporated herein.
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 7-14 are prima facie obvious over Baek.
Conclusion
No claims are allowed.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TRENT R CLARKE/ Examiner, Art Unit 1651
/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651