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 .
Election/Restrictions
Applicant’s election without traverse of Group and the species elections of the particular combination of at least two biomarkers LEP and IL-17 in claims 1, 2, 5, 9, 12, 14-17, & 22 and of detection of specific H. pylori IgA and IgG antibodies in claim 15 in the reply filed on 01/13/2026 is acknowledged. Group II, claims 18-21, Group III, claim 23, and Group IV, claims 25-27, are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Further, claims 2-4 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
A first office action on the merits of claims 1, 5, 9, 12, 14-17, & 22 is set forth herein and claims 2-4, 18-21, 23, & 25-27 are withdrawn from consideration.
Information Disclosure Statement
The listing of references in the specification, in pages 75-77 of the instant 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, they have not been considered.
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, 5, 9, 12, 14-17, & 22 are 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 limitation “said patient” in lines 2 & 23 of the claim and there is insufficient antecedent basis for this limitation in the claim and it is unclear if “said patient” is meant to refer back to “a human patient” in line 1 or is referring to a different patient. In addition, the claim recites the limitation of “the level” in line 8 of the claim and there is insufficient antecedent basis for this limitation in the claim. In addition, the recitation of “EGFR, STAT3 and mtDNA level” in line 18 of the claim is unclear if STAT3 and mtDNA level are part of the same biomarker, or if this is the result of a typographical error and should read “EGFR, STAT3, and mtDNA level”. In addition, the recitation of “needs further medical test in relation thereto, especially clinical investigation” in line 24 of the claim is unclear if the recitation of “clinical investigation” after the term “especially” is meant to be further limiting.
Regarding claim 5, the recitation of “MSLN, EGFR and STAT3” in line 5 of the claim is unclear if EGFR and STAT3 are part of the same biomarker, or if this is the result of a typographical error and should read “MSLN, EGFR, and STAT3”.
Regarding claim 9, the recitation of “a sensitivity of at least 80% and/or a specificity of at least 80%, in particular a sensitivity and a specificity of at least 80% each” in lines 3-4 of the claim is unclear if the recitation of “a sensitivity and a specificity of at least 80% each” after the term “in particular” is meant to be further limiting.
Regarding claim 12, the recitation of “a sensitivity of at least 75% and/or a specificity of at least 90%, in particular a sensitivity and a specificity of at least 90% each” in lines 2-4 of the claim is unclear if the recitation of “a sensitivity and a specificity of at least 90% each” after the term “in particular” is meant to be further limiting.
Regarding claim 14, the claim recites the limitation “the health status” in line 2 of the claim and there is insufficient antecedent basis for this limitation in the claim. In addition, the claim recites the limitation “said patient” in line 6 of the claim and there is insufficient antecedent basis for this limitation in the claim and it is unclear if “said patient” is meant to refer back to “a human patient” in claim 1, from which claim 14 depends from, or is referring to a different patient. In addition, the claim recites the limitation “the tested patient” in line 7 of the claim and there is insufficient antecedent basis for this limitation in the claim. In addition, the recitation of “shows an evolution, in particular for monitoring or diagnosing the health status of a patient diagnosed with gastric cancer” in lines 9-10 of the claim is unclear if the recitation of “for monitoring or diagnosing the health status of a patient diagnosed with gastric cancer” after the term “in particular” is meant to be further limiting.
Regarding claim 15, the claim recites the limitation “the tested patient” in lines 6 & 7 of the claim and there is insufficient antecedent basis for this limitation in the claim.
Regarding claim 22, the claim recites the limitation “said patient” in line 3 of the claim and there is insufficient antecedent basis for this limitation in the claim and it is unclear if “said patient” is meant to refer back to “a human patient” in lines 2-3 or is referring to a different patient. In addition, the claim is generally narrative and indefinite, failing to conform with current U.S. practice. It appears to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Claims 16 & 17 are rejected due to their dependence on claim 1.
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, 5, 9, 12, 14-17, & 22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural correlation/law of nature and an abstract idea 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 determining whether a human patient has lesions rendering said patient at risk of a gastric cancer condition comprising determining a level of at least two biomarkers selected from a group, comparing the determined levels to a control, and if the levels of the at least two biomarkers deviate from the controls, concluding that the human patient has lesions rending the patient at risk of a gastric cancer condition. This recitation is a natural correlation between levels of at least two biomarkers and risk of a gastric cancer condition. With regard to the natural correlation, as in Mayo, the relationship is itself a natural process that exists apart from any human action. The claimed invention also recites “determining the level of at least two biomarkers”, and “comparing the levels determined in step a. to a control”, and “conclusion is made that the human patient has lesions rendering said patient at risk of a gastric cancer condition” which are recitations of an abstract idea because it encompasses conclusions and determinations which can occur entirely within the mind. 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 recite steps of determining the level of at least two biomarkers selected from a group, comparing the levels to a control, and concluding that the patient is as risk for a gastric cancer condition if the determined levels of the at least two biomarkers deviate from their controls and further step of detecting a H. pylori infection, however this does not integrate the JE into a practical application because it is a mere data gathering step to use 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).
In the instant situation, the steps of detecting the level of at least two biomarkers and comparing to a control 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 § 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) 1, 5, 9, 12, 16, 17, & 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Capelle (Capelle et al.; Heliobacter, Vol. 14, pages 596-604, November 2009), as cited on the IDS dated 01/13/2026, in view of Severin (WO 2015/003945 A1, January 2015).
Regarding claim 1, Capelle teaches a method for to identify patients at high risk for gastric cancer through serum markers for gastric precursor lesions (determining whether a human patient has lesion rendering said patient at risk of a gastric cancer condition) comprising obtaining serum (blood) samples from patients susceptible to evolve into a gastric cancer condition and measuring the level of leptin (LEP), pepsinogen I and II, and gastrin markers (determining the level of at least two biomarkers comprising LEP), comparing the markers level with controls (comparing the levels determined in a. to a control), and analyzing to determine the predictive power of the markers in which significantly different levels of leptin (LEP) and pepsinogen I indicated intestinal metaplasia (lesion rendering the human patient at risk of a gastric cancer condition) (if levels of at least two biomarkers deviate from the levels of their controls, conclusion is made that the human patient has lesions rendering said patient at risk of a gastric cancer condition) (abstract background lines 1-3; abstract aim lines 1-3; abstract materials and methods lines 1-6; abstract results lines 1-9; pg. 597 column 1 2nd full paragraph lines 1-8; pg. 597 column 1 3rd full paragraph lines 1-13; pg. 598 column 1 1st full paragraph lines 1-14; pg. 598 paragraph bridging column 1 & 2 lines 8-22; pg. 600 column 1 1st full paragraph lines 1-5; pg. 600 column 2 2nd full paragraph lines 1-4; pg. 601 column 1 1st full paragraph lines 1-11; pg. 601 column 2 1st full paragraph lines 1-6; pg. 602 column 2 1st full paragraph lines 1-11; Table 3).
Capelle does not teach determining the level of at least two biomarkers comprises IL-17.
Severin teaches a method for diagnosing cancer, in which the cancer comprises gastric cancer, through the expression levels of target analytes in the patient sample comprising measuring the expression level of at least one cytokine comprising IL-17 and further the expression level of at least one adipocytokine comprising leptin (LEP) in which the method comprises measuring the levels of at least two different target analytes (determining the levels of at least two biomarkers comprising IL-17) (paragraph [0019] lines 1-4; paragraph [0066] lines 1-12; paragraph [0067] lines 1-2; paragraph [0068] lines 1-4; paragraph [0074] lines 1-4; paragraph [0075] lines 1-2; paragraph [0080] lines 1-3). Severin also teaches that this method can be used to identify relevant biomarkers which is beneficial in developing diagnostic assays and effective treatment plans to minimize patients disease risk (paragraph [0002] lines 1-6; paragraph [0003] lines 1-7; paragraph [0004] lines 1-6).
Capelle and Severin are considered to be analogous to the claimed invention because they are all in the same field of measuring levels of biomarkers in samples at risk of gastric cancer. 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 method of identifying patients at high risk for gastric cancer through serum markers for gastric precursor lesions comprising measuring the levels of at least two biomarkers comprising leptin (LEP), pepsinogen I and II, and gastrin markers (determining the level of at least two biomarkers comprising LEP) in Capelle to incorporate measuring the level of IL-17 as taught in Severin because Severin teaches that doing so would provide a method useful to identify relevant biomarkers which is beneficial in developing diagnostic assays and effective treatment plans to minimize patients disease risk.
Regarding claim 5, Capelle teaches Capelle teaches measuring the level of leptin (LEP), pepsinogen I and II, and gastrin markers (determining the level of at least two biomarkers comprising LEP) (pg. 598 column 1 1st full paragraph lines 1-14).
Severin teaches measuring the expression level of at least one cytokine comprising IL-17 and further the expression level of at least one adipocytokine comprising leptin (LEP) in which the method comprises measuring the levels of at least two different target analytes (determining the levels of at least two biomarkers comprising IL-17).
Regarding claim 9, Capelle teaches a method for to identify patients at high risk for gastric cancer through serum markers for gastric precursor lesions (assessing the risk of a human patient has an atrophic gastritis/pre-neoplasia) comprising determining the best cut-off values by Youdens index resulting in an AUC of 0.83 (sensitivity or specificity of at least 80%) (pg. 598 column 2 1st full paragraph lines 1-12; pg. 601 column 1 1st full paragraph lines 1-11).
Regarding claim 12, Capelle teaches a method for to identify patients at high risk for gastric cancer through serum markers for gastric precursor lesions (assessing the risk of a human patient has an atrophic gastritis/pre-neoplasia) comprising determining the best cut-off values by Youdens index resulting in an AUC of 0.83 (sensitivity of at least 75%) (pg. 598 column 2 1st full paragraph lines 1-12; pg. 601 column 1 1st full paragraph lines 1-11).
Regarding claim 16, Capelle teaches that the serum (blood) sample are obtained from patients diagnosed with intestinal metaplasia and dysplasia, an advanced precursor lesion for gastric cancer (blood sample is from a patient diagnosed with gastric carcinogenesis (developing gastric cancer)) (pg. 596 column 2 1st full paragraph lines 5-7; pg. 597 column 1 3rd full paragraph lines 1-13; pg. 598 column 1 1st full paragraph lines 1-14).
Regarding claim 17, Capelle teaches the levels of the serum markers are measured using an enzyme immunoassay (levels of biomarkers are determined by ELISA testing) (pg. 598 column 1 1st full paragraph lines 1-14).
Regarding claim 22, Capelle teaches a method to identify patients at high risk for gastric cancer through serum markers for gastric precursor lesions (determining whether a human patient has lesion rendering said patient at risk of a gastric cancer condition) comprising obtaining serum (blood) samples from patients susceptible to evolve into a gastric cancer condition and measuring the level of leptin (LEP), pepsinogen I and II, and gastrin markers (determining the level of at least two biomarkers comprising LEP in a biological sample from a human patient susceptible of suffering of condition(s) to evolve in a gastric cancer condition) (abstract background lines 1-3; abstract aim lines 1-3; abstract materials and methods lines 1-6; abstract results lines 1-9; pg. 597 column 1 2nd full paragraph lines 1-8; pg. 597 column 1 3rd full paragraph lines 1-13; pg. 598 column 1 1st full paragraph lines 1-14; pg. 598 paragraph bridging column 1 & 2 lines 8-22; pg. 600 column 1 1st full paragraph lines 1-5; pg. 600 column 2 2nd full paragraph lines 1-4; pg. 601 column 1 1st full paragraph lines 1-11; pg. 601 column 2 1st full paragraph lines 1-6; pg. 602 column 2 1st full paragraph lines 1-11; Table 3).
Capelle does not teach determining the level of at least two biomarkers comprises IL-17.
Severin teaches a method for diagnosing cancer, in which the cancer comprises gastric cancer, through the expression levels of target analytes in the patient sample comprising measuring the expression level of at least one cytokine comprising IL-17 and further the expression level of at least one adipocytokine comprising leptin (LEP) in which the method comprises measuring the levels of at least two different target analytes (determining the levels of at least two biomarkers comprising IL-17) (paragraph [0019] lines 1-4; paragraph [0066] lines 1-12; paragraph [0067] lines 1-2; paragraph [0068] lines 1-4; paragraph [0074] lines 1-4; paragraph [0075] lines 1-2; paragraph [0080] lines 1-3). Severin also teaches that this method can be used to identify relevant biomarkers which is beneficial in developing diagnostic assays and effective treatment plans to minimize patients disease risk (paragraph [0002] lines 1-6; paragraph [0003] lines 1-7; paragraph [0004] lines 1-6).
Capelle and Severin are considered to be analogous to the claimed invention because they are all in the same field of measuring levels of biomarkers in samples at risk of gastric cancer. 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 method of identifying patients at high risk for gastric cancer through serum markers for gastric precursor lesions comprising measuring the levels of at least two biomarkers comprising leptin (LEP), pepsinogen I and II, and gastrin markers (determining the level of at least two biomarkers comprising LEP) in Capelle to incorporate measuring the level of IL-17 as taught in Severin because Severin teaches that doing so would provide a method useful to identify relevant biomarkers which is beneficial in developing diagnostic assays and effective treatment plans to minimize patients disease risk.
Claim(s) 14 & 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Capelle (Capelle et al.; Heliobacter, Vol. 14, pages 596-604, November 2009), as cited on the IDS dated 01/13/2026, and Severin (WO 2015/003945 A1, January 2015) as applied to claims 1, 5, 9, 12, 16, 17, & 22 above, and further in view of Tu (Tu et al.; International Journal of Cancer, Vol. 136, pages 425-434, June 2014).
The teachings of Capelle and Severin with respect to claim 1 is discussed above.
Regarding claim 14, Capelle and Severin does not teach repeating the method of measuring at least two biomarkers at least once over time to conclude about the health status of the patient.
Tu teaches a method to measure multiple serological markers (at least two biomarkers) multiple times over a time period to measure temporal changes in the serological markers to asses risk for progression of gastric precancerous lesions (measuring at least two biomarkers at least once over time to conclude about the health status of the patient ) (abstract lines 1-14; pg. 426 paragraph bridging column 1 & 2 lines 1-27). In addition, Tu teaches that measuring temporal changes in serological markers may be useful for assessing and managing risk for progression of gastric precancerous lesions (abstract lines 1-14).
Capelle, Severin, and Tu are considered to be analogous to the claimed invention because they are all in the same field of measuring levels of biomarkers in samples at risk of gastric cancer. 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 method of identifying patients at high risk for gastric cancer through serum markers for gastric precursor lesions comprising measuring the levels of at least two biomarkers comprising leptin (LEP), pepsinogen I and II, and gastrin markers (determining the level of at least two biomarkers comprising LEP) in Capelle to incorporate repeating this measurement to identify temporal changes in the levels of the markers as taught in Tu because Tu teaches that doing so would be useful for assessing and managing risk for progression of gastric precancerous lesions.
Regarding claim 17, Capelle teaches the levels of the serum markers are measured using an enzyme immunoassay (levels of biomarkers are determined by ELISA testing) (pg. 598 column 1 1st full paragraph lines 1-14).
Tu measuring serological biomarkers from the patients blood sample using an enzyme-linked immunosorbent assay (ELISA) (pg. 426 column 21sat full paragraph lines 1-9).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Capelle (Capelle et al.; Heliobacter, Vol. 14, pages 596-604, November 2009), as cited on the IDS dated 01/13/2026, and Severin (WO 2015/003945 A1, January 2015) as applied to claims 1, 5, 9, 12, 16, 17, & 22 above, and further in view of Pandya (Pandya, Patel, Agravat, & Singh; Journal of Clinical and Diagnostic Research, Vol. 8, pages 12-15, June 2014).
The teachings of Capelle and Severin with respect to claim 1 are discussed above.
Regarding claim 15, Capelle teaches measuring the level of leptin (LEP), pepsinogen I and II, and gastrin markers and also measuring H. pylori antibodies in an enzyme immunoassay to detect H. pylori infection (simultaneous or parallel step of detecting Helicobacter pylori infection through detection of the presence of specific H. pylori IgG antibodies in a biological sample) (pg. 597 column 1 1st full paragraph lines 21-23; pg. 598 column 1 1st full paragraph lines 1-14).
Capelle and Severin does not teach detection of the presence of specific H. pylori comprising IgA antibodies.
Pandya teaches detection of H. pylori infection through the use of and ELISA-A and ELISA-G kit detecting both H. pylori IgG and IgA antibodies in gastrointestinal samples (abstract context lines 1-3; abstract objectives lines 1-3; abstract materials and methods lines 1-8; pg. 12 column 1 1st full paragraph lines 1-9). In addition, Pandya teaches that there is an important clinical association between H. pylori IgA and gastric cancer and that testing for both IgG and IgA antibodies in H. pylori infection improves the diagnostic value over detection of IgG antibody alone (abstract conclusion lines 1-6; pg. 12-13 paragraph bridging pg. 12 & 13 lines 1-5).
Capelle, Severin, and Pandya are considered to be analogous to the claimed invention because they are all in the same field of measuring levels of biomarkers in samples at risk of gastric cancer. 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 method of identifying patients at high risk for gastric cancer through serum markers for gastric precursor lesions comprising measuring the levels of at least two biomarkers comprising leptin (LEP), pepsinogen I and II, and gastrin markers (determining the level of at least two biomarkers comprising LEP) and simultaneously measuring H. pylori antibodies in an enzyme immunoassay to detect H. pylori infection in Capelle to incorporate detecting both H. pylori IgG and IgA antibodies as taught in Pandya because Pandya teaches that doing so would improves the diagnostic value over detection of IgG antibody alone in detecting H. pylori infection.
Conclusion
Claims 1, 5, 9, 12, 14-17, & 22 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 at (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
Prosecution Insights