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 with traverse of Group II, in the reply filed on 7/13/26 is acknowledged. The traversal is on the ground(s) that the showing of a lack of unity was insufficient. This is not found persuasive for the reasons of record set forth in the Requirement and further evidence of a lack of a special technical feature is demonstrated by the prior art rejection of the claims.
“Applicant elects the species in which the first biomarker is IL-6, the second biomarker is creatinine, and the third biomarker is aspartate aminotransferase. This combination is recited in claim 2, in the alternative of claim 2(ii) directed to creatinine as the second biomarker. Within the elected Group II, claims 1-7 and 17 read on the elected species, with claim 2 being read on the creatinine and aspartate aminotransferase alternative of claim 2(ii).”
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 103
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 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 1-7 & 17 (as they read on the elected invention) are rejected under 35 U.S.C. 103 as being unpatentable over ANDALUZ-OJEDA ET AL. CYTOKINE, vol. 57, no. 3, 1 March 2012 (2012-03-01), pages 332-336 & VILLE ET AL. INTENSIVE CARE MEDICINE, vol. 28, no. 91 September 2002 (2002-09-01), pages 1220-1225 AND
YING ET AL, NT J CLIN EXP MED, vol. 7, no. 9 15 September 2014 (2014-09-15), pages 2593-2598.
Andaluz teaches levels in plasma of three pro-inflammatory mediators (IL-6, IL-8, MCP-1) and of an immunosuppressive one (IL-10) were higher in those patients with fatal outcome. A combined score with those cytokines showing to better predict
mortality in the cohort based on the results of Cox regression analysis (IL-6, IL-8
and IL-10) was developed. Andaluz (p 2.1.1) teaches using the sequential organ failure assessment (SOFA) score, which includes determination of creatinine. Predictive value of the combined interleukin score for mortality) describes the performance of the marker panel comprising IL-6, IL-8 and IL-10 in predicting mortality.
Ville (p. 1221) teaches patients with suspected sepsis were investigated for blood levels of IL-6, serum PCT, and serum creatinine and bilirubin. Sequential Organ Failure Assessment (SOFA) score, comprising creatinine values, was determined for days 1-3. The outcome measure was hospital mortality. Ville (abstract, p 1233) teaches
2 PCT and IL-6 had the best power of predicting mortality.
Andaluz and Ville teaches determining the amount of of IL-6 and creatine for assessing infection and or sepsis but do not also teach the determining of aspartate aminotransferase likewise however it would have been obvious at the time the invention was filed to assay for aspartate aminotransferase additionally in the methods of Andaluz and Ville because Ying teaches that determining the amount of aspartate aminotransferase especially along with the determination of IL-6 for the assessing of infection and/or sepsis (Fig 1-3). Applicant is directed to pages 12-13 of KSR v Teleflex (500 US 398 2007) “ … the Court has held that a “patent for a combination which only unites old elements with no change in their respective functions . . . obviously withdraws what is already known into the field of its monopoly and diminishes the resources available to skillful men.” Great Atlantic & Pacific Tea Co. v. Supermarket Equipment Corp., 340 U. S. 147, 152 (1950). This is a principal reason for declining to allow patents for what is obvious. The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” “When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one(emphasis added). If a person of ordinary skill can implement a predictable variation, §103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.”
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); >see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.");< ** In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
Accordingly, the claimed invention was prima facie obvious to one of ordinary
skill in the art at the time the invention was filed especially in the absence of evidence
to the contrary.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLAINE LANKFORD whose telephone number is (571)272-0917. The examiner can normally be reached M-Th 8-6:30.
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BLAINE LANKFORD
Examiner
Art Unit 1657
/BLAINE LANKFORD/Primary Examiner, Art Unit 1657
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