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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 9, 2026 has been entered. By way of this submission, Applicant has amended the specification and claims 1, 21 and 34-36, and cancelled claim 20.
Claims 1, 3-19, and 21-42 are pending in the application. Claims 9 and 37-42 remain withdrawn from consideration, pursuant to the Restriction Requirement mailed June 10, 2025.
Claims 1, 3-8, 10-19, and 21-36 are therefore under examination before the Office.
The rejections of record can be found in the previous Office action, dated August 13, 2025.
Specification
The disclosure was previously objected to because it contains an embedded hyperlink and/or other form of browser-executable code.
Applicant's amendment to the specification has addressed this issue, and this rejection is hereby withdrawn.
Claim Rejections - 35 USC § 101
Claims 1, 3-8, 10-19, 22-24, and 26-36 were previously rejected under 35 U.S.C. 101 because the claimed invention was directed to a judicial exception without significantly more.
Applicant's amendments to the claims have addressed this issue, and this rejection is hereby withdrawn.
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.
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.
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.
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.
Claims 1, 3-8, 10-12, 16-20, 22-24, 27-29, 31-32, and 34-36 were previously rejected under 35 U.S.C. 103 as being unpatentable over Valkirs (US20030109420A1) in view of Spencer (US20170009297A1) and Ekeloef (British Journal of Anaesthesia, 2016, 117(5), pp. 559-568, cited in IDS).
Claim 13 was previously rejected under 35 U.S.C. 103 as being unpatentable over Valkirs, Spencer, and Ekeloef as applied to claim 1 above, and further in view of Cahill (International Scholarly Research Notices, Vol. 2011, Article ID 403130).
Applicant argues that the references do not teach every aspect of the claims as amended; specifically, the references do not teach a major adverse cardio- or cerebrovascular event (MACCE) in combination with an infection related to a major gastrointestinal surgery or a postoperative course.
Applicant's arguments in view of the amendments to the claims have not addressed this issue fully. In the interest of compacting prosecution, the above rejections are withdrawn, and the following new grounds of rejection are issued, necessitated by Applicant's amendment to the claims:
Claims 1, 3-8, 10, 12-13, 16-19, 22-24, 27-29, 31-32, and 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over Valkirs (US20030109420A1) in view of Spencer (US20170009297A1) and Cahill (International Scholarly Research Notices, Vol. 2011, Article ID 403130).
Valkirs teaches a method of diagnosing acute coronary syndrome (i.e., myocardial infarction, see para. 0004) by analyzing a test sample obtained from a patient for the presence or amount of one or more markers for myocardial injury, and that said markers can be compared to a diagnostic level that is associated with the diagnosis, prognosis, or differentiation of acute coronary syndrome (ACS) (para. 0015).
Valkirs further teaches that markers may be combined to increase the predicative value of the analysis, such as one or more specific markers for myocardial injury can be combined with one or more non-specific markers for myocardial injury (para. 0017). Valkirs also teaches that the level of a biomarker may be compared to a threshold level (para. 0030).
Valkirs further teaches that one such biomarker may be cardiac troponin T (cTnT) (para. 0021), which is pertinent to claims 1 and 8. As Applicant's specification states that the diagnostic criteria for MINS is a postoperative troponin elevation judged to be due to myocardial ischemia (page 3), Valkirs also teaches MINS.
Valkirs further teaches that one such biomarker may be B-type natriuretic peptide (BNP) or its precursor, NT-proBNP (para. 0056), which is pertinent to claims 3-5.
Valkirs further teaches cardiac troponin may be increased in conjunction with sepsis (i.e., an infection) (para. 0058-0059).
Valkirs further teaches that this method is useful for determining a treatment regimen (para. 0037).
Valkirs further teaches that high levels of cardiac troponin T are associated with electrocardiographic changes (para. 0151), and that myocardial infarction can be diagnosed by electrocardiography Q-waves (para. 0007), which is pertinent to claim 6.
Valkirs further teaches that detection of biomarkers may also include fragments thereof (para. 0018), which is pertinent to claim 7.
Valkirs further teaches that the patient may be at least 65 years old (para. 0131), which is pertinent to claim 10.
Valkirs further teaches a plurality of test samples taken at different times (claim 56), which is pertinent to claim 19.
Valkirs further teaches that the level of an indicator can be compared to a threshold level (para. 0030), which is pertinent to claim 20.
Valkirs further teaches evaluation of myocardial infarction and mortality after 30 days (para. 0136), which is pertinent to claims 22-23.
Valkirs further teaches that changes in marker levels are relevant to the prognostic or diagnostic function of the test (para. 0031 and 0035), which is pertinent to claim 29.
However, Valkirs does not teach treatment with antibiotics or gastrointestinal surgery.
Spencer teaches methods for analyzing a biological sample to predict and monitor the development of sepsis utilizing a biomarker (para. 0001). Spencer further teaches that this method may be useful in identifying patients likely to develop sepsis, to monitor patients with sepsis, and potentially inform patient treatment (para. 0029).
Spencer further teaches that samples may be taken from patients who were undergoing elective abdominal surgery (para. 0060-0062).
Spencer further teaches that samples may be taken multiple times before and after surgery and several days apart from patients in a hospital (para. 0061), which is pertinent to claims 12 and 16-18.
Spencer further teaches that monitoring biomarker levels is useful to predict and monitor the development of sepsis (para. 0039).
Spencer further teaches administration of antibiotics (para. 0070).
Spencer further teaches that different thresholds may be applied to different samples (para. 0098) and different time points (para. 0069), which is pertinent to claims 27-29.
Spencer further teaches comparing the data with reference data (para. 0048), which is pertinent to claim 31.
Cahill teaches that monitoring levels of troponin and B-type natriuretic peptide (BNP) is useful in predicting myocardial injury and infarction after gastrointestinal surgery (page 4, left column, second through fourth paragraph).
Cahill also includes colorectal surgery as part of this patient cohort (page 2, left column, second paragraph). According to Applicant's specification at page 17, rectal surgery is within the scope of large intestine surgery, which in turn is within the scope of gastrointestinal surgery.
Cahill also teaches that the surgery may be open (page 2, right column, third paragraph).
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the teachings of Valkirs, Spencer, and Cahill to arrive at the claimed invention. As Valkirs teaches, cardiac troponin may be increased in conjunction with sepsis. Valkirs also teaches that comparing levels of biomarkers such as cardiac troponin and NT-proBNP is useful to assess acute coronary syndrome, which is a major adverse cardio-or cerebrovascular event (see pages 2 and 11 of the instant specification). Spencer teaches that patients who have a marker for sepsis may be treated with antibiotics. Cahill gives further guidance as to the cohort of gastrointestinal surgery patients being suitable for such an assessment. One of ordinary skill could apply the method of Valkirs and Spencer to the patient population of Cahill by known methods, with each component of the combination performing its known, usual function, and the combination would produce nothing more than predictable results.
In response to Applicant's arguments, Spencer teaches that patients who undergo surgery are at risk of developing sepsis (para. 0060: "Patients were admitted to the study if they gave informed consent, were between 18 and 80 years of age and undergoing a procedure that, in the clinician's opinion, had a risk of causing infection and ultimately sepsis. Typically, these were abdominal and thoracic surgeries. However, other surgical procedures were permitted and included..."). This is a clear teaching that a patient who underwent surgery should be assessed for sepsis (i.e., an infection). Spencer further teaches that this method may be useful in identifying patients likely to develop sepsis, to monitor patients with sepsis, and potentially inform patient treatment (para. 0029).
There is nothing in the claims that requires the levels of any biomarkers to be associated with infection, nor do the claims require any step of diagnosing or predicting. The only step that is necessary is to measure said biomarkers.
Applicant's arguments appear contradictory. At pages 13 and 14 of the Remarks submitted on March 31, 2026, Applicant states that the claims "do not require any correlation whatsoever" between biomarker levels and prognosis, risk assessment, or diagnosis of a MACCE in combination with an infection. However, at page 16, Applicant states that the claims have been amended to establish a "clear link" between MACCE and infection after gastrointestinal surgery, and at page 17, the fact that the cited references do not teach such a relationship distinguishes the claims from the prior art. Clarification is requested.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Valkirs, Spencer, Cahill as applied to claim 1 above, and further in view of STARSurg Collaborative (Br J Surg. 2014 Oct;101(11):1413-23).
The teachings of Valkirs, Spencer, and Cahill have been discussed supra. However, Valkirs, Spencer, and Cahill do not teach analgesics after gastrointestinal surgery.
STARSurg Collaborative teaches that analgesics such as non-steroidal anti-inflammatory drugs are recommended after gastrointestinal surgery (page 1413, left column, first paragraph).
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the teachings of Valkirs, Spencer, Cahill, and STARSurg Collaborative to arrive at the claimed invention. As Valkirs, Spencer, and Cahill teach, methods of assessing biomarkers in patients after gastrointestinal surgery were known. STARSurg Collaborative teaches that analgesic treatment is recommended after gastrointestinal surgery. One of ordinary skill could therefore apply the analgesic treatment of STARSurg Collaborative to the method of Valkirs, Spencer, and Cahill by known methods, with each component of the combination performing its known, usual function, to affect a predictable result.
Allowable Subject Matter
Claims 14-15, 21, 25-26, 30, and 33 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claim is allowed.
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/PETER JOHANSEN/Examiner, Art Unit 1644
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