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
Claim 1 has been amended. Claims 1-6 are pending and are examined herein.
Withdrawn Rejections/Objections
The rejection of claims 1-6 under 35 U.S.C. 112(b) is withdrawn in response to Applicant’s amendment.
Priority
This application, filed 01/07/2022, is a 371 of PCT/KR2020/008979, filed 07/09/2020, which claims foreign benefit to REPUBLIC OF KOREA 10-2019-0082497, filed 07/09/2019. This benefit is acknowledged and the claims examined herein are treated as having an effective filing date of 07/09/2019.
Information Disclosure Statement
In a previous Office Action, dated 06/11/2025, Examiner indicated that the Information Disclosure Statement filed 01/07/2022 was not in compliance with 37 CFR 1.98(a)(2); however, that was not correct; therefore, the IDS filed 01/07/2022 is considered herein.
The Information Disclosure Statements filed 01/07/2022 and 09/11/2025 are acknowledged and have been considered.
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 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Park et al., “Diagnostic performance enhancement of pancreatic cancer using proteomic multimarker panel” (published 10/16/2017, herein referred to as Park).
Regarding claim 1, Park teaches a biomarker panel for diagnosing pancreatic cancer (abstract, p. 93121, col. 1, lines 11-16. “a panel”. Supplementary Table 3). Park teaches that the panel is used to measure the protein expression level (p. 93121, col. 1, lines 11-16) of every claimed marker (Supplementary Figure 3).
Regarding claim 2, Park teaches CA19-9 as a marker within the panel (p. 93121, col. 1, lines 11-16).
Regarding claim 3-5, Park teaches the use of multiple reaction monitoring mode (“MRM-MS”, p. 93118, col. 2, para. 1, line 13-15) with tandem mass spectrometry (Figure 1, “Quantitation by MRM LC-MS/MS”).
Regarding claim 6, Park teaches the use of all of the claimed peptides (Supplementary Table 3) in MRM analysis (p. 93121, col. 1, lines 11-18).
Response to Arguments
Applicant's arguments filed 09/11/2025 have been fully considered but they are not persuasive for the following reasons:
Regarding the remarks about the rejection of claim 1 under 35 U.S.C. 102(a)(1), applicant argues that Park does not limit the diagnostic panel to exclusively the markers listed in claim 1.
Claim 1 recites “A biomarker panel…comprising a material for measuring expression level of a combination of two or more markers” [emphasis added]. The use of “comprising” as a transitional phrase is open-ended and does not exclude additional, unrecited elements (See MPEP 2111.01(I)). In this case, the panel taught by Park anticipates claim 1 even though Park recites additional markers as part of the panel because it discloses at least two markers from the claimed list.
Further regarding the remarks about claim 1, Applicant argues that Park merely provides a long list of candidate proteins and does not disclose that any particular combination was identified or proposed for diagnostic use. This argument is not persuasive.
The full list of proteins of Table 3 have been analyzed in patient groups (p. 93119, col. 2, para. 1, lines 3-7). As described above regarding claim 1, this panel anticipates the claimed panel.
Further regarding the remarks about claim 1, in response to applicant's argument that the claimed panel achieves superior diagnostic accuracy, the fact that the inventor has recognized another 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).
Regarding the remarks about claim 2, Applicant argues that Park discloses a panel of LFG1, TTR, and CA19-9 which is different than the panel of claim 2. This argument is not persuasive.
Park discloses a variety of panels including CA19-9 and 25 markers in combinations of 1 to 5 markers (p. 93119, col. 2, para. 6, lines 1-3). For example, a variety of 3 marker panels with CA19-9 are disclosed in Supplementary Table 4, such as CA19-9, CLU, and SERPINC1 (Supplementary Table 5).
Regarding the remarks about claim 3-5 and claim 6, Applicant argues that Park does not disclose performing MRM on the specific biomarker panel of claim 1. This argument is not persuasive.
Park discloses using MRM on the panel of 54 markers, which anticipates claim 1, as described above.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/C.E./Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 September 30, 2025