DETAILED ACTION
The present Office Action is responsive to the Amendment received on May 4, 2026.
Preliminary Remark
Claim 2 is canceled.
Claim 12 remains withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on October 14, 2025.
Information Disclosure Statement
The IDS received on May 21, 2026 is proper and is being considered by the Examiner. The IDS was received with the fee under 37 CFR 1.17(p).
Claim Rejections - 35 USC § 112
The rejection of claims 3-5 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particularly point out and distinctly claim the subject matter, made in the Office Action mailed on December 4, 2025 is withdrawn in view of the Amendment received on May 21, 2026.
The written description rejection of claim 2 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, made in the Office Action mailed on December 4, 2025 is withdrawn in view of the Amendment received on May 21, 2026, canceling the rejected claim.
Rejection – Maintained & New Grounds, Necessitated by Amendment
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.
The rejection of claim 13 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, made in the Office Action mailed on December 4, 2025 is maintained for the reasons of record.
Applicants’ remark found on page 5 of the Amendment received on May 21, 2026 states that the claim has been canceled. The claim set submitted on May 21, 2026, however, shows the claim still pending.
Because Applicants did not present any arguments as to why the rejection was erroneous nor canceled the claim as they asserted, the rejection is maintained for the reasons already of record.
The Rejection:
Claim 13 is indefinite for reciting the phrase, “using the in vitro or ex vivo: of means for amplifying and/or means for detecting the expression of TAP2 …” because the claim does not have an antecedent basis to refer to the means recited as being “the in vitro or ex vivo”. Also, an embodiment of claim 13 embodies, “[a] method comprising using the in vitro or ex vivo: of means for amplifying …”. It is unclear what is meant by a method using an in vitro or ex vivo of means [or ‘of a kit’]…” For the purpose of prosecution, the phrase has been interpreted to mean that the claims is directed to an in vitro or ex vivo method for determining the risk of incidence of a healthcare associated infection in a patient by: means for amplifying and/or detecting the expression of TAP2; or using a kit of reagents for said amplifying and/or detection means.
New Grounds, Necessitated by Amendment
Claims 3-5 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.
Claims 3-5 depend from claim 1.
Claim 1 has been amended from the use of TAP2, to require a measurement of expression levels of additional genes recited in step (ii).
Claim 3 recites the phrase, “method as claimed in claim 1, comprising measuring, in the biological sample from the patient, the expression:” followed by a long list of genes which are not recited in step (ii) of the parent claim 1. Therefore, is it unclear whether the additional genes of claim 3 are measured in addition to the at least one gene recited in step (ii) of claim 1, or they are to replace the genes recited in step (ii) of claim 1 in their entirety. Because the latter interpretation will result in the claims being rejectable under 112(d), the former interpretation has been adopted for the purpose of prosecution.
Claims 4 and 5 are also indefinite for the same reasons.
Claim Rejections - 35 USC § 101
The rejection of claim 2 under 35 U.S.C. 101 because the claimed invention is directed to the law of nature (i.e., judicial exception) without significantly more, as discussed in the Office Action mailed on December 4, 2025 is withdrawn in view of the Amendment received on May 4, 2026, canceling the rejected claim.
Rejection - Maintained
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.
The rejection of claims 1, 3-11 and 13 under 35 U.S.C. 101 because the claimed invention is directed to the law of nature (i.e., judicial exception) without significantly more, as discussed in the Office Action mailed on December 4, 2025 is maintained for the reasons of record.
Applicants’ claim amendment and arguments presented in the Amendment received on May 4, 2026 have been carefully considered but they have not been found persuasive for the reasons discussed in the, “Response to Arguments” section below.
The Rejection:
The claims recite the correlation that exists between the level of TAP2 gene and combination of TAP2 gene and an additional gene from a category of genes (recited in claim 2) and a patient’s propensity to develop infection from healthcare visit. This judicial exception is not integrated into a practical application because the claims do not integrate this judicial exception into a practical application because reciting general means of detection that are either generic or conventionally employed are deemed to be insignificant extra-solution activity.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception based on the analysis under the current Patent Eligibility Guidelines (herein, “PEG”) as discussed below.
Step 1 Inquiry under PEG
Step 1 inquiry under Patent Eligibility Guidelines (herein, “PEG”) determines whether or not the claimed invention is drawn to one of the recognized statutory classes of invention. Claims 1-11 and 13 satisfy the present inquiry as being drawn to a method.
Step 2A Inquiry under PEG
A recently revised PEG now performs step 2A inquiry under a 2-prong analysis, and the subject claims analyzed accordingly as follows:
Prong 1:
Prong-1 inquiry under step 2A determines whether the claim(s) recites an abstract idea, a law of nature, or a natural phenomenon.
The specification discloses the natural correlation that exist between the level of TAP2 gene and a subject’s risk in developing healthcare-associated infection:
“It has now been discovered, entirely surprisingly, that measuring the expression of the TAP2 gene made it possible to determine the risk of incidence of a healthcare-associated infection in a patient. This has never been shown or suggested in the literature. Patients having a high risk of contracting a care-associated infection could advantageously benefit from customized treatment (page 2-3)
“A reduction in the expression of TAP2 at the mRNA level, measured on D5/7 from inclusion in the cohort, was associated with a greater risk of incidence of a healthcare-associated infection before D30 in the overall patient population … This association was always significant after adjustment with the SOFA and Charlson score” (page 80)
Moreover, the prediction models showed that the expression of TAP2 at the mRNA level, measured on D3/4 or D5/7 from inclusion in the cohort, made it possible to predict the incidence of a healthcare-associated infection before D15 from inclusion in the cohort (page 81)
The prediction models also showed that the expression of TAP2 at the mRNA level made it possible to predict the incidence of a healthcare-associated infection in the 4 days or 7 days following the sample being taken (page 81)
Thus, the results obtained show that the measurement of the expression of TAP2 alone makes it possible to predict the incidence of healthcare-associated infection(s) in the 15 days starting from the immunoinflammatory attack, in the 4 days following the sample being taken or in the 7 days following the sample being taken (page 82)
“the expression level of TAP2 and also that of other genes was measured by RT-qPCR … measurement of the expression of one of more of these other genes, in addition to the measurement of the expression of TAP2, makes it possible to improve the performance (compared to the measurement of the expression of TAP2 alone) in predicting the risk of incidence of a healthcare-associated infection, whether before D15 starting from inclusion in the cohort (table 6) or in the 4 days or in the 7 days following the sample being taken (table 7)” (page 82)
Therefore, the claims recite a judicial exception of a correlation that exists between TAP2 gene and additional gene(s) and a subject’s risk of developing an infection after receiving healthcare treatment. Therefore, claim recites a judicial exception.
Prong 2:
Prong-2 inquiry under step 2A determines whether or not the claims recite additional elements that integrate the judicial exception into a practical application in a manner that imposes a meaningful limit on the judicial exception.
Claim 1 does not recite any additional meaningful limit to the judicial exception as discussed above.
Claims 2-5 recite at least one additional gene(s) to be used in conjunction with TAP2 gene, but as discussed above, the combination of their genes and their expression is also tied to the natural correlation of the patient’s risk of developing healthcare-associated infection and therefore, do not recite any additional meaningful limit.
Claims 6 and 7 further recite the type of sample form which the genes are examined and the gene expression being measured at mRNA level. However, the gene expression at the mRNA level represents the above-discussed natural correlation; and the sample from which the mRNAs are examined is also based on natural correlation as the natural correlation exists from mRNA that are present in the isolated sample.
Claims 8-10 and 13 recite additional elements directed to the mean of determining the gene expression level, such as RT-PCR, sequencing, hybridization, and utilizing “amplification means”.
However, these means are recited in a highly generic manner and tantamount to “applying” the judicial exception without a meaningful limitation.
As to the use of a housekeeping gene expression level to normalize the expression of TAP2 and at least one additional genes, the use of a housekeeping gene is also recited in a highly generic manner and that which is employed when ascertaining gene expression levels of genes.
As explained by the Supreme Court, in order to transform a judicial exception into a patent-eligible application, the additional element or combination of elements must do ‘more than simply stat[e] the [judicial exception] while adding the words ‘apply it’”. Alice Corp. v. CLS Bank, 573 U.S. __, 134 S. Ct. 2347, 2357, 110 USPQ2d 1976, 1982-83 (2014) (quoting Mayo Collaborative Servs. V. Prometheus Labs., Inc., 566 U.S. 66, 72, 101 USPQ2d 1961, 1965). Thus, for example, claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 134 S. Ct. at 2358, 110 USPQ2d at 1983. See also 134 S. Ct. at 2389, 110 USPQ2d at 1984 (warning against a § 101 analysis that turns on “the draftsman’s art”) (MPEP 2106.05(f))
Step 2B Inquiry under PEG
Step 2B inquiry of the PEG determines whether or not additional elements are provided and whether such elements amount to significantly more than the judicial exception in the claims.
As discussed above, claims 1-7 do not recite any additional elements other that that which are representation of the judicial exception.
The additional elements recited in claims 8-11 and 13 discussed further add more than the judicial exception because the assays such as RT-PCR, hybridization, and sequencing as well as utilizing the expression of housekeeping genes in an expression determination assay, are routinely and conventionally employed in the area of molecular diagnostics.
Therefore, these elements are not deemed significantly more than inclusion of that are commonly used, routine and conventional.
Therefore, the present claims lack patent eligibility.
Response to Arguments:
Applicants traverse the rejection.
Applicants contend that claims are patent eligible under Step 2A, Prong One because it does not recite a natural correlation and the Office has not identified any feature in the claim that is a natural correlation, but instead has only pointed to the specification as allegedly describing a natural correlation (page 6, Response).
This argument has not been found persuasive.
The natural correlation is the risk that exists between the expression level of TAP2 and additional genes. The fact that the risk assessment is based on the level of TAP2 and the recited genes is a prima facie case that a natural correlation exists. This is no different from a method of diagnosing a cancer based on an expression level of, for example, marker X. No diagnostics is 100% and therefore, the diagnostics is based on risk of such a diagnosis being correct. The risk itself is therefore associated with the expression level of the recited genes, TAP2, as well as the additionally recited genes. Therefore, the claims do recite a natural phenomenon.
Next, Applicants argue that claim 1 integrates any alleged judicial exception into a practical application (page 7, Response). Applicants’ argument is based on the added step that adapts the healthcare management provision of the patient based on the risk of occurrence of a healthcare-associated infection, said provision being selected from a list of potential actions.
One of the listed such actions is “admittance to an ongoing care unit.” Such an action is not specific to the condition so determined as the action embraces “do nothing but monitor” approach. Such adoption of action does not apply the naturally existing phenomenon in a specific way so as to provide a meaningful application of the judicial exception.
The rejection is maintained therefore.
Claim Rejections - 35 USC § 102
The rejection of claims 1-4, 6-8, 10, and 11 under 35 U.S.C. 102(a)(1) as being anticipated by Scicluna et al. (WO 2018/146162 A1, published August 2018; IDS reference), made in the Office Action mailed on December 4, 2025 is withdrawn in view of the Amendment received on May 4, 2026.
Rejection - Maintained
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.
The rejection of claim 13 under 35 U.S.C. 102(a)(1) as being anticipated by Scicluna et al. (WO 2018/146162 A1, published August 2018; IDS reference), made in the Office Action mailed on December 4, 2025 is maintained for the reasons of record.
Applicants’ argument presented in the Amendment received on May 4, 2026 have been considered but has not been found persuasive because the purported limitation argued by Applicants on page 8 of the Response is missing from claim 13.
As discussed above, it appears that Applicants had intended to cancel claim 13, but have not done so by an apparent oversight.
Since neither the argument nor cancelation apply to claim 13, the rejection is maintained for the reasons already of record.
The Rejection:
The present rejection is based on the claim interpretation that the method only requires the measurement of expression of TAP2 in a biological sample from a patient because the intent of the method of “for determining the risk of incidence of a healthcare-associated infection” is not actively recited in the steps of the method.
A rejection directed to an alternative claim interpretation where the determination is made is also made below.
Scicluna et al. teach a method of measuring the expression of TAP2 in a biological sample of a patient (“[m]ethod of determining the survival of a patient admitted to an intensive care unit … determining the expression level of at least … TAP2 in a biological sample of said patient”, see claim 1).
BPGM expression is also measured (“determining the expression level of at least BPGM and/or TAP2 in a biological sample of said patient”, see claim 1).
The biological sample is blood sample (“wherein said biological sample contains white blood cells”, see claim 1).
The means of detection is directed to RT-PCR (thus targets mRNA and based on amplification), microarray analysis (thus hybridization):
“the step of determining the expression level comprises the use of at least one techniques selected from the group consisting of: i. PCR-based methods, preferably RT-PCR, Quantitative RT-PCR, nucleic acid microarray analysis … in situ hybridization …” (page 5, lines 26-29)
Scicluna et al. teach a well-known means of normalizing the expression levels with an expression level of a housekeeping gene:
“method further comprises the step of normalizing at least one of the determined gene expression levels … Normalization can be carried out against an endogenous unregulated reference gene transcript … These unregulated genes are termed housekeeping genes” (page 19, line 31 to page 20, line 6)
Therefore, the invention as claimed is anticipated by Scicluna et al.
Claim Rejections - 35 USC § 103
The rejection of claim 2 under 35 U.S.C. 103 as being unpatentable over Scicluna et al. (WO 2018/146162, published August 2018; IDS reference) in view of Jain, Mukesh (Briefings in Functional Genomics, 2011, vol. 11, no. 1, pages 63-70) made in the Office Action mailed on December 4, 2025 is withdrawn in view of the Amendment received on May 4, 2026, canceling the rejected claim.
The rejection of claims 1, 3, 4, 6-11, and 13 under 35 U.S.C. 103 as being unpatentable over Scicluna et al. (WO 2018/146162, published August 2018; IDS reference) in view of Jain, Mukesh (Briefings in Functional Genomics, 2011, vol. 11, no. 1, pages 63-70) made in the Office Action mailed on December 4, 2025 is withdrawn in view of the Amendment received on May 4, 2026.
Specifically, the references of record do not teach the at least one of additional markers recited in step (i) of claim 1.
The rejection of claim 5 under 35 U.S.C. 103 as being unpatentable over Scicluna et al. (WO 2018/146162, published August 2018; IDS reference) in view of Jain, Mukesh (Briefings in Functional Genomics, 2011, vol. 11, no. 1, pages 63-70), as applied to claims 1, 3, 4, 6-11, and 13 above, and further in view of Friggeri et al. (Critical Care, 2016, vol. 20, pages 1-13) made in the Office Action mailed on December 4, 2025 is withdrawn in view of the Amendment received on May 4, 2026, canceling the rejected claim.
Rejection – New Grounds, Necessitated by Amendment
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.
Claims 1, 3, 4, 6-11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Scicluna et al. (WO 2018/146162, published August 2018; IDS reference) in view of Fontaine et al. (Crit. Care Med., 2011, vol. 39, no. 12, pages 2684-2690) and Jain, Mukesh (Briefings in Functional Genomics, 2011, vol. 11, no. 1, pages 63-70).
With regard to claim 1, Scicluna et al. performed genome-wide blood gene expression in blood of adult patients admitted to the ICUs and of patients with sepsis caused by CAP 1admitted to 29 ICUs (see page 1, bottom paragraph).
From the study, the artisans reached a, “consensus in portioning at four molecular endotypes … designed Mars 1-4 … In so doing, we identified 140 genes that clearly stratified Mars1 and Mars4 endotypes” (page 2, lines 1-4).
Scicluna et al. teach that patients classified to Mars1 had the worst outcome with 39% mortality at 28-days as well as the worst outcome until 1 year of patient follow up (page 2, lines 10-12), wherein TAP2 and BPGM as being directed to Mars1 sepsis endotype (“8 genes were derived as candidate biomarker for the identification of sepsis endotypes at ICU admission, with BPGM and TAP2 transcripts delineating the poor prognosis Mars1 sepsis endotype”, page 4, lines 9-11), wherein Mars1 was characterized by “decreased expression in genes that function in both innate and adaptive immune mechanisms” (page 4, lines 21-23) concluding that Mars1 classified patients may represent an “immunoparalyzed” endotype with poor prognosis (see page 4, lines 25-26).
Scicluna et al., teach that these findings are applied in a method of determining the risk of a patients’ adverse outcome due to sepsis (“expression levels of the genes BPGM and TAP2 as prognostic biomarker for a high risk mortality sepsis endotype”, page 1, first paragraph), wherein the determining involves a method analyzing the expression level of, inter alia, the genes TAP2 and/or BPGM from blood a patient (claim 6), wherein the expression is measured at mRNA level (claim 7) involving assays such as RT-PCR (claims 8 and 13), involving hybridization (claim 10), involving normalization with housekeeping gene(s) (claim 11):
“determining the expression level of at least BPGM and/or TAP2 in a biological sample of said patient” (claim 1)
“wherein said biological sample contains white blood cells” (claim 1).
“the step of determining the expression level comprises the use of at least one techniques selected from the group consisting of: i. PCR-based methods, preferably RT-PCR, Quantitative RT-PCR, nucleic acid microarray analysis … in situ hybridization …” (page 5, lines 26-29)
“method further comprises the step of normalizing at least one of the determined gene expression levels … Normalization can be carried out against an endogenous unregulated reference gene transcript … These unregulated genes are termed housekeeping genes” (page 19, line 31 to page 20, line 6)
While Scicluna et al. teach that the TAP2 and/or BPGM gene levels are prognostic markers for determining a patient’s risk of mortality sepsis endotype, the artisans do not explicitly state that the method is for determining the risk of incidents of a healthcare associated infection (claim 1, in-part).
Scicluna et al. do not explicitly teach that a way for measuring a gene expression level is by sequencing (claim 9).
Fontaine et al. teach that the expression of S100A9 messenger RNA can predict hospital-acquired infection:
“To predict the risk of ICU-acquired infection, only the patients with samples obtained on both days 1-3 and 7-10 were taken in to account, which added up to 93 patients. Of these 93 remaining patients, 27 had HAI [hospital acquired infection] described in Table 2” (page 2686, 3rd column)
“on days 7-10, the median S100A9 mRNA level was significantly higher in the HAI-positive group … S100A9 mRNA predicted HAI with an area under the receiver operating characteristic curve of 0.673 … the sensitivity of S100A9 mRNA for predicting HAI was 89% and its specificity 44%” (page 2687, 3rd column)
Jain teaches well-known technological advancements which have been available before the effective filing date of the claimed invention wherein sequencing reaction can also be employed to analyze gene expression levels from samples:
“The unprecedented level of sensitivity and high-throughput nature make NGS technologies as the method of choice for gene expression analysis … absolute measurement of gene-expression using RNA-seq provides greater quantitative and qualitative insight, and accuracy than microarray” (page 63)
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 combine the teachings of Scicluna et al. Fontaine et al., and Jain, thereby arriving at the invention as claimed for the following reasons.
As to the use of an alternatively and conventionally known means of determining the gene expression levels of TAP2, S100A9 and/or BPGM, such as sequencing means, doing so would have been an obvious application of routinely employed means that yield no more than a predictable outcome based on the knowledge and advantages of utilizing a sequencing means to determine gene expression levels, as discussed by Jain.
As expressed by the Supreme Court, a combination of teachings that add no more than a predictable outcome is likely to be obvious.
In KSR, the Supreme Court particularly emphasized “the need for caution in granting a patent based on the combination of elements found in the prior art,” Id. at 415, 82 USPQ2d at 1395, and discussed circumstances in which a patent might be determined to be obvious. Importantly, the Supreme Court reaffirmed principles based on its precedent that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” Id. at 415-16, 82 USPQ2d at 1395. The Supreme Court stated that there are “[t]hree cases decided after Graham [that] illustrate this doctrine.” Id. at 416, 82 USPQ2d at 1395. (1) “In United States v. Adams, . . . [t]he Court recognized that when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.”
As to utilizing the findings of Scicluna et al. and Fontaine et al. for determining a subject’s risk of developing healthcare associated infection, arriving at such an application would have been obvious based on the naturally led conclusion to an ordinarily skilled artisan because Scicluna et al. taught that the genes categorized under Mars1 exhibit lower expression levels and are associated with, “function in both innate and adaptive immune mechanisms”, wherein Mars1 classified patients may represent an “immunoparalyzed [or immunocompromise]” endotype with poor prognosis (see page 4, lines 21-26).
Given that the genes TAPS2 and BGPM are categorized under Mars1 that represent patients with immunoparalysis, and adverse sepsis (inflammatory reaction to infection) outcome, being motivated to assay for these genes and their levels that result in immunoparalysis that protect a subject’s ability to fight infections in hospital, would have been a natural conclusion made by an ordinarily skilled artisan.
As well, Fontaine et al. also discuss that S100A9 is one of the neutrophil stimulators that are involved in neutrophil migration to inflammatory sites as well as having pro- and anti-inflammatory function (page 2684, 3rd column), and teach that this fact motivated to determine whether the decreased state of this marker that is part of a subject’s ability to fight infection can, “predict survival and occurrence of ICU-acquired infections” (page 2684, 3rd column).
Therefore, the one of ordinary skill in the art would have been motivated with a reasonable expectation of success at combining the markers known in the art to affect a subject’s ability to fight infections and apply them in a means to predict a patient’s risk of developing an infection from a hospital stay.
Therefore, the invention as claimed is deemed prima facie obvious over the cited references.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Scicluna et al. (WO 2018/146162, published August 2018; IDS reference) in view of Fontaine et al. (Crit. Care Med., 2011, vol. 39, no. 12, pages 2684-2690) and Jain, Mukesh (Briefings in Functional Genomics, 2011, vol. 11, no. 1, pages 63-70), as applied to claims 1, 3, 4, 6-11, and 13 above, and further in view of Friggeri et al. (Critical Care, 2016, vol. 20, pages 1-13).
The teachings of Scicluna et al., Fontaine et al., and Jain have already been discussed above.
While Scicluna et al. explicitly teach assaying for gene expression profiles for identifying genes which are prognosticative for a patient’s risk of developing sepsis after a healthcare treatment, wherein the artisans teach various Mars categories of genes that relate to cytokine signaling, cell growth/proliferation/mobility, lymphocyte pathways, protein catabolism/translations (see Figure 1.3D, also see page 7), the artisans do not explicitly teach an additional gene recited in claim 5.
Friggeri et al. teach that CXCR1 messenger RNA expression is decreased in patients associated with mortality from septic shock:
“we observed an association between decreased CX3CR1 on monocytes after septic shock and decreased functional response of monocytes ex vivo … This provides a link between decreased CX3CR1 and immune dysfunction after sepsis and suggests that the measure of such a host response messenger RNA (mRNA) marker may be useful in evaluation of injury-induced immune alterations” (page 2, 1st column)
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 combine the teachings of Scicluna et al., Fontaine et al., and Jain with the teachings of Friggeri et al., thereby arriving at the invention as claimed for the following based on the rationale provided for by the court in In re Kerkhoven:
MPEP 2144.06, in discussing art recognized equivalence for the same purpose, mentions In re Kerkhoven, wherein the court expressed the following:
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose…[T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
The inclusion of additional genes to the TAP2, BPGM, and S100A9, such as CX3CR1 which have been suggested as being useful as a marker for sepsis based on the similar function (i.e., immune dysfunction)2 would have been expected to provide additional information relating to the outcome of the patient’s outlook from infections.
Therefore, the invention as claimed is deemed prima facie obvious over the cited references.
Conclusion
No claims are 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.
Inquiries
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Young J. Kim whose telephone number is (571) 272-0785. The Examiner can best be reached from 7:30 a.m. to 4:00 p.m (M-F). The Examiner can also be reached via e-mail to Young.Kim@uspto.gov. However, the office cannot guarantee security through the e-mail system nor should official papers be transmitted through this route.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's supervisor, Gary Benzion, can be reached at (571) 272-0782.
Papers related to this application may be submitted to Art Unit 1681 by facsimile transmission. The faxing of such papers must conform with the notice published in the Official Gazette, 1156 OG 61 (November 16, 1993) and 1157 OG 94 (December 28, 1993) (see 37 CFR 1.6(d)). NOTE: If applicant does submit a paper by FAX, the original copy should be retained by applicant or applicant’s representative. NO DUPLICATE COPIES SHOULD BE SUBMITTED, so as to avoid the processing of duplicate papers in the Office. All official documents must be sent to the Official Tech Center Fax number: (571) 273-8300. Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-1600.
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/YOUNG J KIM/Primary Examiner
Art Unit 1637 July 7, 2026
/YJK/
1 a.k.a. Community Acquired Pneumonia
2 Scicluna et al. also teach that the expression level of TAP2 is indicative of immunoparalysis, see page 4, lines 21-26
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