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 .
The claims dated 12/30/2025 are under consideration.
The amendments and arguments presented in the papers filed 12/30/2025 ("Remarks”) have been thoroughly considered. The issues raised in the Office action dated 10/2/2025 listed below have been reconsidered as indicated.
a) The objection to the abstract is withdrawn in view of the replacement abstract.
b) The amendments to the specification addressing trade name or mark usage are acknowledged.
c) The rejection of claim 11 under 35 U.S.C. 101 are withdrawn as being moot in view of the cancellation of claim 11.
d) The rejection of claim 11 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, are withdrawn as being moot in view of the cancellation of claim 11.
e) The rejections of: claim(s) 9-10 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Kim_1 (WO 2020/204665 A1; PCT/KR2020/004589); claim(s) 9-10 under 35 U.S.C. 102(a)(2) as being anticipated by Kim_2 (US 2022/0154283 A1); claim(s) 9-10 under 35 U.S.C. 102(a)(2) as being anticipated by Kim_3 (US 2025/0257410 A1); claim(s) 9-10 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Kim_4 (WO 2019/093717 A2); claim(s) 9-10 under 35 U.S.C. 102(a)(2) as being anticipated by Kim_5 (US 2021/0018505 A1); claim(s) 9-10 under 35 U.S.C. 102(a)(2) as being anticipated by Kim_6 (US 2022/0196664 A1); claim(s) 9-10 under 35 U.S.C. 102(a)(2) as being anticipated by Kim_7 (US 12,000,832); and claim(s) 9-10 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Dattar (WO 2019/008415 A1), are withdrawn in view of the amendments to claim 9 incorporating the “comparing” step of now cancelled claim 11.
f) The rejections of claims 9 and 10 on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 12,000,832 B2 are withdrawn in view of the amendments to claim 9 incorporating the “comparing” step of now cancelled claim 11.
The Examiner’s responses to the Remarks regarding issues not listed above are detailed below in this Office action.
New and modified grounds of rejection necessitated by amendment are detailed below and this action is made FINAL.
Election/Restrictions
Applicant elected Group IV, claims 9-11, in the reply filed on 8/27/2025. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-5 and 13-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/27/2025.
Priority
The present application is a 371 of national stage entry of PCT/KR2021/004187, and claims foreign priority to REPUBLIC OF KOREA 10-2020-0044608.
An English translation of the foreign priority document was provided on 12/30/2025.
Information Disclosure Statement
The listing of references in the specification or the citation of references within the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892 or cited on a submitted IDS, they have not been considered.
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 9 and 10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The following are new rejections necessitated by the amendments to the claims.
Claim 9 is a method and thus is one of the four statutory categories.
As amended the claim(s) recite(s) “comparing the measured expression level of the GCC2 protein with a predetermined cutoff value”. The step broadly encompasses an abstract idea because the step can be performed in a purely mental manner. The step encompasses the comparison of two values, which is simple enough to perform by thinking about two data points.
The amended claim also recites “when the expression level is higher than the predetermined cutoff value, it can be determined that thymic cancer has occurred or has a high probability of occurrence”. The clause puts forth the naturally occurring correlation between expression levels of GCC2 protein and the occurrence and/or probability of thymic cancer, which is also a judicial exception.
The judicial exceptions are not integrated into a practical application because the claims do not involve:
improvements to the functioning of a computer or to any other technology or technical field;
applying or using the judicial exceptions to effect a particular treatment or prophylaxis for a disease or medical condition;
applying the judicial exception with, or by use of, a particular machine; or
effecting a transformation or reduction of a particular article to a different state or thing.
The claimed limitations add insignificant extra-solution activity to the judicial exceptions. The steps broadly encompass mere data gathering steps, which is performing steps to obtain input for the comparison, including determining the level of a biomarker. These steps are analogous to steps found by the courts to be insignificant extra-solution activity. See MPEP 2106.05(g). The method of claim 9 overall is drawn to data gathering as its stated intended use in the preamble is for “providing information necessary for diagnosing thymic cancer or predicting a prognosis thereof”.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims encompass the use of well-known techniques in the art as acknowledged by the specification on p. 8, including ELISA, etc.
Response to the traversal of the 101 rejections
The Remarks argue claim 11 is now included in claim 9 and the Office did not reject original claim 9 for being directed to an abstract idea, and therefore amended claim 9 is also not directed to an abstract idea. See p. 6-7.
The arguments have been fully considered but are not persuasive. Claim 9 is now drawn to an embodiment of claim 11. Claim 9 as amended includes the above identified judicial exceptions and is not rejected for the reasons provided above. The arguments do not argue why the abstract ideas of claim 11, as now encompassed by claim 9, are not judicial exceptions, are integrated into a practical application and/or the methods require elements that are not routine or conventional.
Conclusion
No claims 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 JOSEPH G DAUNER whose telephone number is (571)270-3574. The examiner can normally be reached 7 am EST to 4:30 EST with second Fridays Off.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng Winston Shen can be reached at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOSEPH G. DAUNER/ Primary Examiner, Art Unit 1682
Prosecution Insights