Prosecution Insights
Last updated: April 19, 2026
Application No. 18/075,464

NOVEL TUMOR MARKER FOR HEPATOCELLULAR CARCINOMA AND CLINICAL APPLICATION THEREOF

Non-Final OA §101§102§103§112
Filed
Dec 06, 2022
Examiner
BUCHANAN, BAILEY CHEYENNE
Art Unit
1682
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
The First Affiliated Hospital of Sun Yat-Sen University
OA Round
1 (Non-Final)
54%
Grant Probability
Moderate
1-2
OA Rounds
3y 9m
To Grant
99%
With Interview

Examiner Intelligence

Grants 54% of resolved cases
54%
Career Allow Rate
6 granted / 11 resolved
-5.5% vs TC avg
Strong +47% interview lift
Without
With
+46.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 9m
Avg Prosecution
56 currently pending
Career history
67
Total Applications
across all art units

Statute-Specific Performance

§101
15.0%
-25.0% vs TC avg
§103
32.0%
-8.0% vs TC avg
§102
18.6%
-21.4% vs TC avg
§112
24.9%
-15.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 11 resolved cases

Office Action

§101 §102 §103 §112
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 . Claim Status Claims 1-10 filed on 04/24/2023 are pending and under examination. Specification The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on pages 5 & 6 of the instant specification. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. Claim Objections Claims 1-10 are objected to because of the following informalities: the word "novel" in "novel tumor marker" is not a limitation. Appropriate correction and deletion of the word “novel” is required. 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 1-10 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. Regarding claim 1, the claim recites “the tumor biological behavior” in lines 4-5 of the claim. There is insufficient antecedent basis for this limitation in the claim. In addition, the recitation of “an expression level of the OIT3 in peripheral blood and HCC tissues of patients with HCC is detected using qRT-PCR … related to the tumor biological behavior of hepatoma cells” in lines 2-5 of the claim is unclear. It is not clear how these steps structurally affects the claimed marker. In addition, the recitations of “significantly lower” and “closely related” in line 4 of the claim is indefinite. Regarding claim 3, the claim recites “the clinical prognosis” in line 3 of the claim. There is insufficient antecedent basis for this limitation in the claim. In addition, the recitation of “is expressed at low levels … significantly related to the clinical prognosis of patients with HCC” in lines 2-3 of the claim is unclear. It is not clear how this intended use structurally affects the claimed marker. In addition, the recitation of “significantly related” in line 3 of the claim is indefinite. Regarding claim 4, the recitation of “wherein the tumor marker may be used as a key component of an HCC detection kit … are tested for the tumor marker” in lines 1-3 of the claim is unclear. It is not clear this how intended use structurally affects the claimed marker. Regarding claim 5, the claim recites steps for collection procedures of peripheral blood samples in lines 5-8 of the claim which is unclear as to whether the claim was intended to be a method claim or as an intended use as it is currently claimed as a tumor marker product. In addition, it is not clear how these steps structurally affects the claimed marker. In addition, the claim recites “the collection procedures of peripheral blood samples” in lines 3-4 of the claim. There is insufficient antecedent basis for this limitation in the claim. In addition, the claim recites the limitation “keeping the same vertically” in line 6 and the limitation “saving same at -80°C” in line 8 of the claim and it is unclear what “the same” is referring to. Does “the same vertically” refer to keeping the tube vertically, the clinical sample vertically, or the peripheral blood sample vertically? Does “saving same” refer to storing/ saving the tube, clinical sample, peripheral blood sample, or the transferred supernatant in a marker EP tube at -80°C? Finally, the recitation “EP tube” is unclear to what EP is referring to specifically. Regarding claim 6, the claim recites steps for collection procedures of HCC specimens in lines 2-4 of the claim which is unclear as to whether the claim was intended to be a method claim or as an intended use as it is currently claimed as a tumor marker product. In addition, it is not clear how these steps structurally affects the claimed marker. In addition, the claim recites “the collection procedures of HCC specimens” in lines 1-2 of the claim. There is insufficient antecedent basis for this limitation in the claim. Regarding claim 7, the recitation of “wherein the primer sequences of the OIT3 are as follows…” in lines 1-4 of the claim is unclear if the OIT3 gene is being claimed or if the primers of SEQ ID NO: 1 and SEQ ID NO: 2 are being claimed. In addition, the recitation of “the levels of expression of the OIT3 … are tested using fluorescence quantitative PCR (qRT-PCR) with specific primers” in lines 5-6 of the claim is unclear. It is not clear how these steps structurally affects the claimed marker. Regarding claim 8, the recitation of “wherein the tumor marker for HCC is applied as an HCC detection and diagnosis reagent and has value in a prediction model for clinical prognosis” in lines 1-3 of the claim is unclear. It is not clear this how intended use structurally affects the claimed marker. Regarding claim 9, the recitation of “an application of detection of the tumor marker for HCC according to claim 1 in the diagnosis of HCC” in lines 1-2 of the claim is unclear whether this claim is a method claim or is an intended use for the tumor marker product as no active steps are recited. Regarding claim 10, the recitation of “the application according to claim 9, wherein the application includes early screening of patients with HCC…” in lines 1-3 of the claim is unclear whether this claim is a method claim or is an intended use for the tumor marker product. In addition, the recitation of “having clinical transformation value” in line 3 of the claim is unclear what is encompassed by having a clinical transformation value. Does this require that the expression of OIT3 be decreased compared to a reference to have clinical transformation value? Increased? Claim 2 is rejected due to their dependence on claim 1. The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claims 2, 3, & 5-8 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claims are drawn to a novel tumor marker of OIT3 product for HCC in which the product is examined for what it is and not what is does. Therefore, claims 2, 3, & 5-8 recite wherein clauses about what the tumor marker product does and it is unclear how these wherein clauses further limit claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. 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 1-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to product of nature without significantly more. This judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below. 35 U.S.C. § 101 requires that to be patent-eligible, an invention (1) must be directed to one of the four statutory categories, and (2) must not be wholly directed to subject matter encompassing a judicially recognized exception. M.P.E.P. § 2106. Regarding judicial exceptions, “[p]henomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U.S. 63, 67 (1972); see also M.P.E.P. § 2106, part II. The unpatentability of natural products was confirmed by the U.S. Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc., , 133 S. Ct. 2107, 2116, (2013). Claims Analysis: As set forth in MPEP 2106, the claims have been analyzed to determine whether they are directed to one of the four statutory categories (STEP 1). The claims were then analyzed to determine if they recite a judicial exception (JE) (STEP 2A, prong 1) [Mayo Collaborative Services v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012), Alice Corp. Pry. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014)]. The claims were then analyzed to determine whether they recite an element or step that integrates the JE into a practical application (STEP 2A, prong 2) [Vanda Pharmaceuticals Inc., v. West-Ward Pharmaceuticals, 887 F.3d 1117 (Fed. Cir. 2018)]. In the absence of a step(s) or element(s) that integrate the JE into a practical application, the additional elements/steps have been considered to determine whether they add significantly more to the JE (STEP 2B) [Mayo Collaborative Services v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012), Alice Corp. Pry. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014)]. It was found that the present claims fail to meet the elements required for patent eligibility. The claims are directed to a nucleic acid sequences and kits comprising them, and as such are directed to products. Accordingly, the claims are directed to one of the four statutory categories of invention. The claims are drawn to nucleic acid sequences including DNA/RNA, which comprise the gene OIT3 as a tumor marker which is a naturally occurring sequence. As such the claims are directed to a product of nature which is a judicial exception. This judicial exception is not integrated into a practical application because the nucleic acid molecules encompassed by the claims convey the same genetic information as their naturally occurring counterparts. The Supreme Court has made clear "separating [DNA] from surrounding genetic material is not an act of invention" Myriad, 133 S. Ct. at 2117. In Myriad v. Ambry CAFC 2014-1361,1366, December 17, 2014, the CAFC further (regarding a claim directed to a pair of primers) stated “In fact, the naturally occurring genetic sequences at issue here do not perform a significantly new function. Rather, the naturally occurring material is used to form the first step in a chain reaction—a function that is performed because the primer maintains the exact same nucleotide sequence as the relevant portion of the naturally occurring sequence. One of the primary functions of DNA’s structure in nature is that complementary nucleotide sequences bind to each other. It is this same function that is exploited here—the primer binds to its complementary nucleotide sequence. Thus, just as in nature, primers utilize the innate ability of DNA to bind to itself.” With regard to claim 4, although the claim recites a that the OIT3 gene tumor marker may be used as a key component of an HCC detection “kit” comprising primer sequences and clinical samples, these elements do not add meaningful limitations to the claims as they are merely nominal or token extra solution activity and are nothing more than an attempt to generally link the product of nature into a particular technological environment. Furthermore, these limitations do not change the structures of the encompassed natural products. The detection agents encompassed by the claims include nucleic acid sequences such as probes and primers that hybridize to, as well as fragments of the naturally occurring OIT3 gene. None of these molecules or cells are patent eligible, whether isolated or not, pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics Inc., US (June 13, 2013). Accordingly, the claims are rejected as being directed to non patentable subject matter. Claims 9 & 10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural correlation/law of nature without significantly more. This judicial exception is not integrated into a practical application and the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below. 35 U.S.C. § 101 requires that to be patent-eligible, an invention (1) must be directed to one of the four statutory categories, and (2) must not be wholly directed to subject matter encompassing a judicially recognized exception. M.P.E.P. § 2106. Regarding judicial exceptions, “[p]henomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U.S. 63, 67 (1972); see also M.P.E.P. § 2106. The unpatentability of abstract ideas was confirmed by the U.S. Supreme court in Bilski v. Kappos, 561 U.S. 593, 601 (June 28, 2010) and Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354 (2014). See also Myriad v Ambry, CAFC 2014-1361, -1366, December 17, 2014. The unpatentability of laws of nature was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66, 71 (2012). “[L]aws of nature, natural phenomena, and abstract ideas” are not patentable. Dia-mond v. Diehr, 450 U. S. 175, 185 (1981); see also Bilski v. Kappos, 561 U. S. at 601 (2010). Claims Analysis: As set forth in MPEP 2106, the claims have been analyzed to determine whether they are directed to one of the four statutory categories (STEP 1). The instant claims are directed to methods and therefore are directed to one of the four statutory categories of invention. The claims are then analyzed to determine if they recite a judicial exception (JE) (STEP 2A, prong 1) [Mayo Collaborative Services v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012), Alice Corp. Pry. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014)]. The claimed invention recites a method of the application of the tumor marker of OIT3 for the diagnosis of hepatocellular carcinoma (HCC). This recitation is a natural correlation between expression of OIT3 and diagnosis of HCC. With regard to the natural correlation, as in Mayo, the relationship is itself a natural process that exists apart from any human action. It is therefore determined that the claims are directed to judicial exceptions. The claims are then analyzed to determine whether they recite an element or step that integrates the JE into a practical application (STEP 2A, prong 2) [Vanda Pharmaceuticals Inc., v. West-Ward Pharmaceuticals, 887 F.3d 1117 (Fed. Cir. 2018)]. The claims do not recite active steps but recite “wherein the application includes early screening of patients with HCC and prediction of clinical prognosis based on the levels of OIT3, having clinical transformation value” however this does not integrate the JE into a practical application because it is an intended use of the correlation and does not add a meaningful limitation to the method. In the absence of steps or elements that integrate the JE into a practical application, the additional elements/steps are considered to determine whether they add significantly more to the JE either individually or as an ordered combination, to “’transform the nature of the claim’ into a patent eligible application” [Mayo Collaborative Services v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012), Alice Corp. Pry. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014)] (STEP 2B). The application of detecting expression of the OIT3 tumor marker are generally recited and do not provide any particular reagents that might be considered elements that transform the nature of the claims into a patent eligible application because no specific elements/steps are recited. This step is not only a mere data gathering step, but the general recitation of detection of known nucleic acids is well understood, routine, and conventional activity (See MPEP 2106.05(d)(II)). Applicant is reminded that in Mayo, the Court found that “[i]f a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself." Further "conventional or obvious" "[pre]solution activity" is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law”. Flook, 437 U. S., at 590; see also Bilski, 561 U. S., at ___ (slip op., at 14) (“[T]he prohibition against patenting abstract ideas ‘cannot be circumvented by’ . . . adding ‘insignificant post-solution activity’” (quoting Diehr, supra, at 191–192)). The Court also summarized their holding by stating “[t]o put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.” Therefore these limitations/steps do not “‘transform the nature of the claim’ into a patent-eligible application.’” Alice, 134 S. Ct. at 2355 (quoting Mayo, 132 S. Ct. at 1297). When viewed as an ordered combination, the claimed limitations are directed to nothing more than the determination that a natural correlation/phenomena exists. Any additional element consists of using well understood, routine and conventional activity, and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. Accordingly, it is determined that the instant claims are not directed to patent eligible subject matter. Claim Rejections - 35 USC § 102 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) 1-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xu (Xu et al.; Hepatology, Vol. 38, pages 735-744, September 2003), as evidenced by GenBank Accession Number AY013707.2 (April 2004). It is noted that another alias for Oncoprotein Induced Transcript 3 (OIT3) is Liver-Specific ZP Domain-Containing Protein (LZP). It is also noted, as discussed above, that the claims are drawn to a tumor marker of OIT3 product for HCC in which the product is examined for the product itself and the determination of patentability does not depend on its method of production (see MPEP §2113.I). Therefore, claims 1-8 are being examined pertaining to what the tumor marker product is. Regarding claims 1-3 & 8, Xu teaches a tumor marker of liver-specific ZP domain-containing protein (LZP) (OIT3) that is downregulated in hepatocellular carcinoma (HCC) and HCC cell lines and involved in hepatocellular function and development and could be used as a potential negative biomarker for HCC pathologic diagnosis (abstract lines 1-13 & 16-18; pg. 735-736 paragraph bridging pg. 735 & 736 lines 5-20; pg. 736 paragraph bridging column 1 & 2 lines 1-17; pg. 740-741 paragraph bridging pg. 740 & pg. 741 lines 1-26). Regarding claims 4-6, Xu teaches a tumor marker of liver-specific ZP domain-containing protein (LZP) (OIT3) that is downregulated in hepatocellular carcinoma (HCC) and HCC cell lines and involved in hepatocellular function and development and could be used as a potential negative biomarker for HCC pathologic diagnosis (abstract lines 1-13 & 16-18; pg. 735-736 paragraph bridging pg. 735 & 736 lines 5-20; pg. 736 paragraph bridging column 1 & 2 lines 1-17; pg. 740-741 paragraph bridging pg. 740 & pg. 741 lines 1-26). Xu also teaches that primers are specifically designed for the detection of LZP (OIT3) (tumor marker) in clinical HCC samples from patients (used as a key component of an HCC detection kit by designing primer sequences) (abstract lines 1-13 & 16-18; pg. 735-736 paragraph bridging pg. 735 & 736 lines 5-20; pg. 736 column 1 1st full paragraph lines 2-7; pg. 736 paragraph bridging column 1 & 2 lines 1-17; pg. 740-741 paragraph bridging pg. 740 & pg. 741 lines 1-26). Regarding claim 7, as discussed above, it is unclear if the OIT3 gene is being claimed or if the primers of SEQ ID NO: 1 and SEQ ID NO: 2 are being claimed. Xu teaches a tumor marker of liver-specific ZP domain-containing protein (LZP) (OIT3) that is downregulated in hepatocellular carcinoma (HCC) and HCC cell lines and involved in hepatocellular function and development and could be used as a potential negative biomarker for HCC pathologic diagnosis (abstract lines 1-13 & 16-18; pg. 735-736 paragraph bridging pg. 735 & 736 lines 5-20; pg. 736 paragraph bridging column 1 & 2 lines 1-17; pg. 740-741 paragraph bridging pg. 740 & pg. 741 lines 1-26), in which LZP (OIT3) comprises SEQ ID NO: 1 and SEQ ID NO: 2 of the instant application, as evidenced by GenBank Accession Number AY013707.2 (positions 147-167 and positions 233-212, respectively, from AYO13707.2). Regarding claim 9, Xu teaches a tumor marker of liver-specific ZP domain-containing protein (LZP) (OIT3) that is downregulated in hepatocellular carcinoma (HCC) and HCC cell lines and involved in hepatocellular function and development and could be used as a potential negative biomarker for HCC pathologic diagnosis (application of the tumor marker OIT3 in the diagnosis of HCC) (abstract lines 1-13 & 16-18; pg. 735-736 paragraph bridging pg. 735 & 736 lines 5-20; pg. 736 paragraph bridging column 1 & 2 lines 1-17; pg. 740-741 paragraph bridging pg. 740 & pg. 741 lines 1-26). Claim(s) 1-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by GenBank Accession Number AY013707.2 (April 2004). It is noted that another alias for Oncoprotein Induced Transcript 3 (OIT3) is Liver-Specific ZP Domain-Containing Protein (LZP). It is also noted, as discussed above, that the claims are drawn to a tumor marker of OIT3 product for HCC in which the product is examined for the product itself and the determination of patentability does not depend on its method of production (see MPEP §2113.I). Therefore, claims 1-8 are being examined pertaining to what the tumor marker product is. Regarding claims 1-8, GenBank Accession Number AY013707.2 teaches the homo sapiens LZP (OIT3) mRNA sequence (tumor marker is OIT3) (see claims 1-6 & 8). In addition, GenBank Accession Number AY013707.2 also teaches that LZP (OIT3) comprises SEQ ID NO: 1 and SEQ ID NO: 2 of the instant application (positions 147-167 and positions 233-212, respectively, from AYO13707.2) (see claim 7). Claim Rejections - 35 USC § 103 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. 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) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xu (Xu et al.; Hepatology, Vol. 38, pages 735-744, September 2003), as evidenced by GenBank Accession Number AY013707.2 (April 2004), in view of Yang (Yang et al.; Cancer Immunology , Immunotherapy, Vol. 71, pages 2677-2689, March 2022). The teachings of Xu with respect to claim 9 is discussed above and incorporated herein. Regarding claim 10, Xu does not teach the application of the tumor marker for HCC includes screening patients with HCC and prediction of clinical prognosis based in the levels of expression of the OIT3 have clinical transformation value. Yang teaches that OIT3 (LZP) and is primarily expressed in hepatocytes and that the expression of OIT3 (LZP) significantly decreases in HCC and is a novel marker of M2 macrophages and facilitates HCC metastasis (screening patients with HCC and applying the expression levels of the tumor marker OIT3 (LZP) to predict clinical prognosis of HCC) (abstract lines 1-11; pg. 2686-2688 paragraph bridging pg. 2686 & pg. 2688 lines 1-4). Finally, Yang teaches that targeting OIT3 in macrophages can potentially impede cancer cell migration and invasion and dampen cancer development (pg. 2688 1st column 2nd full paragraph lines 4-6). Xu and Yang are considered to be analogous to the claimed invention because they are all in the same field of detection of the expression levels of OIT3 (LZP) as a tumor marker for hepatocellular carcinoma (HCC). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the application of the detection of the tumor marker LZP (OIT3) in HCC tissue samples as a biomarker for HCC pathologic diagnosis in Xu to incorporate the measuring the expression level of OIT3 (LZP) as a means to screen patients with HCC and assess and predict the clinical prognosis of HCC as taught in Yang because Yang teaches that doing so would provide a biomarker that could potentially be targeted for treatment in HCC development. Conclusion Claims 1-10 are rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAILEY C BUCHANAN whose telephone number is (703)756-1315. The examiner can normally be reached Monday-Friday 8:00am-5:00pm ET. 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, Winston Shen can be reached on (571) 272-3157. 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. /BAILEY BUCHANAN/Examiner, Art Unit 1682 /JEHANNE S SITTON/ Primary Examiner, Art Unit 1682
Read full office action

Prosecution Timeline

Dec 06, 2022
Application Filed
Apr 24, 2023
Response after Non-Final Action
Aug 20, 2025
Non-Final Rejection — §101, §102, §103 (current)

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Study what changed to get past this examiner. Based on 3 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
54%
Grant Probability
99%
With Interview (+46.7%)
3y 9m
Median Time to Grant
Low
PTA Risk
Based on 11 resolved cases by this examiner. Grant probability derived from career allow rate.

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