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 I in the reply filed on 03/30/2026 is acknowledged. The traversal is on the ground(s) that (A) the claimed biomarker combinations constitute a special technical feature not disclosed by the prior art; (B) Buendgens et al. does not disclose the claimed biomarker combinations or their use for early sepsis risk assessment; (C) Buendgens et al. does not teach the specific claimed combinations or their improved predictive performance; and (D) Groups I and V share a single general inventive concept and therefore should not have been separately restricted, as the method of determining biomarker amounts (Group V) is allegedly specially adapted for use in the method of assessment (Group I) and share a special technical feature.
This is not found persuasive because the determination of unity of invention under PCT Rule 13.1 requires that the claimed inventions be linked by a technical relationship involving one or more special technical features, as defined in PCT Rule 13.2. A special technical feature is a feature that defines a contribution over the prior art. In the present case, the only shared technical feature among Groups I–V is the use of GDF-15 in combination with a second biomarker selected from the recited group. However, this feature does not constitute a special technical feature because it does not represent a contribution over the prior art. Buendgens et al. discloses measuring GDF-15 together with additional clinical biomarkers, including procalcitonin, cystatin C, and bilirubin, in the same cohort of critically ill patients, and analyzing their relationship to disease conditions. Accordingly, the use of GDF-15 in combination with a second biomarker, as broadly recited in the claims, is known in the prior art. Therefore, this feature cannot qualify as a special technical feature under PCT Rule 13.2.
Applicant’s arguments in Sections A–C are not persuasive because they rely on limitations that are not recited in the claims. The claims do not require any specific biomarker pairings, improved predictive performance, or enhanced AUC values. Nor do the claims require any particular diagnostic use, such as early sepsis risk assessment within a defined predictive window. These features are described in the specification but are not positively recited in the claims and therefore cannot be relied upon to establish the presence of a special technical feature. Similarly, Applicant’s argument that the claimed invention is directed to a different patient population is not persuasive. The claims recite a “subject with suspected infection” and do not exclude subjects who may already have sepsis. The limitation that the subject does not yet suffer from sepsis is not present in the claims and cannot be imported from the specification. Accordingly, differences in clinical context, patient population, or intended purpose do not distinguish the claimed subject matter from the prior art for purposes of the unity analysis.
With respect to Section D, Applicant’s argument that Groups I and V share a single general inventive concept is also not persuasive. Although Applicant asserts that the method of claim 18 (Group V) is specially adapted for use in the method of claim 1 (Group I), unity of invention under PCT Rule 13.1 is only present where the inventions are linked by a common special technical feature within the meaning of PCT Rule 13.2. Here, Applicant’s argument again relies on the combination of GDF-15 with a second biomarker as the alleged linking feature. However, as discussed above, this combination does not constitute a special technical feature because it is known in the prior art. Therefore, even if the processes of Groups I and V are related in terms of their general subject matter, they are not linked by a common special technical feature, and thus do not form a single general inventive concept.
Accordingly, because the claimed groups do not share a technical relationship involving a special technical feature that contributes over the prior art, the claims lack unity of invention.
The requirement is still deemed proper and is therefore made FINAL.
Status of Claims
Claims 1-7, 9-12, 15, and 17-22 are currently pending.
Claims 1-7 and 17 are under consideration, as claims 9-12, 15, and 18-22 are withdrawn.
Priority
The present application claims status as a 371 (National Stage) of PCT/EP2022/061543 filed on 04/29/2022 and claims priority to international application EP21171497.7, filed on 04/30/2021. Acknowledgment is made of applicant’s claim for foreign priority and papers submitted under 35 U.S.C. 119 (a)-(d). The present application and all claims are being examined with an effective filing date of 04/30/2021. In future actions, the effective filing date may change due to amendments or further review of priority documents.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/27/2023, 09/12/2024, and 03/05/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112(b)
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 5 and 12 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.
Claim 5 is indefinite and unclear due to the recitation of biomarker amounts that are “essentially identical or similar” to corresponding references are indicative of a subject being at risk (or not at risk), while amounts that are “different” from the corresponding references are indicative of the opposite condition. The terms “essentially identical,” “similar,” and “different” are relative terms that lack objective boundaries. The claim does not specify any threshold, range, degree of variation, or direction of change (e.g., higher or lower) required to determine when a biomarker amount is considered “similar” or “different” from a reference value. As a result, it is unclear how a person of ordinary skill in the art would determine whether a given biomarker value falls within the claimed categories. Furthermore, the claim does not define how deviations from the reference values (including magnitude or direction) correlate to the recited risk determinations, rendering the scope of the claim uncertain.
Claim 12 is indefinite because the recitation of “risk of developing sepsis within 48 hours is predicted” is unclear, as it does not specify whether the claim refers to predicting the occurrence of sepsis within a 48-hour time period or performing the prediction within 48 hours, thereby rendering the scope of the claim uncertain. For examination purposes, the examiner is interpreting the claim as referring to predicting the occurrence of sepsis within a 48 hour period.
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 1-7 and 17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The claim(s) recite(s) the steps of “comparing the amounts of the biomarkers to references for said biomarkers and/or calculating a score” and “assessing said subject based on the comparison and/or the calculation made”. The step of comparing values and making an assessment based on that comparison can be performed by a human using mental steps, observation, and basic reasoning, which are types of activities (i.e., mental processes) that have been found by the courts to represent abstract ideas (e.g., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). Moreover, the step of calculating a score is a mathematical calculation which represents a mathematical concept, which is also grouped as an abstract idea. Thus, the claims are directed to a judicial exception (Step 2A: YES), and the claims as a whole are focused on an abstract idea. Accordingly, the claims are directed to a judicial exception (Step 2A, Prong 1: YES).
As to Prong 2 of Step 2A, the instant claims do not recite additional elements that integrate the judicial exception (abstract idea) into a practical application. “Integration into a practical application’ requires an additional element(s) or combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception. The claims do not include any treatment step, therapeutic intervention, or other action that applies the judicial exception in a meaningful way. Rather, the claims are limited to measuring biomarkers and analyzing the resulting information to make an assessment. Such activity amounts to mere observation and evaluation of data and does not impose a meaningful limit on the judicial exception. Therefore, the claims do not integrate the exception into a practical application (Step 2A, Prong 2: NO).
Further, in view of Step 2B and the “No” pathway, the claims do not recite additional elements that amount to significantly more than the judicial exception. The instant claims recite further limitations related to determining amounts of biomarker, which constitute mere data gathering that are routine and conventional in the field of clinical diagnostics - in conjunction with an abstract idea (i.e., obtaining biomarker levels so that the information can be analyzed by an abstract idea). Further, the steps are recited at a high level of generality, and when viewed as a combination, the additional elements fail to transform the exceptions into a patent eligible application of that exception. Thus, the claims as a whole do not amount to significantly more than the exception.
Thus, it is asserted that the claims are directed to a judicial exception without reciting more or additional elements that amount to significantly more than the judicial exception. Therefore, claims 1-7 and 17 do not recite eligible subject matter under 35 U.S.C. 101 in view of the Subject Matter Eligibility Test for Products and Processes.
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 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Buendgens et al. (Growth Differentiation Factor-15 Is a Predictor of Mortality in Critically III Patients with Sepsis. Dis Markers. 2017;2017:5271203, cited in the IDS).
The preamble of claim 1 recites “a method for assessing a subject with suspected infection.” The recited steps of determining biomarker levels, comparing such levels to references, and assessing the subject fully define the claimed method. Pursuant to MPEP 2111.02, the determination of whether preamble recitations are structural limitations or mere statements of purpose or use "can be resolved only on review of the entirety of the [record] to gain an understanding of what the inventors actually invented and intended to encompass by the claim" as drafted without importing "‘extraneous’ limitations from the specification." Corning Glass Works, 868 F.2d at 1257, 9 USPQ2d at 1966. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (The court found that the preamble in one patent’s claim is limiting but is not in a related patent); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999).Thus, the preamble of instant claim 1 merely states the intended purpose or field of use of the method and does not impose a structural or functional limitation on the recited steps. Accordingly, the preamble is not given patentable weight.
Notwithstanding the above, Buendgens et al. discloses the evaluation of critically ill patients admitted to the intensive care unit, including a substantial subset of patients diagnosed with sepsis. Such patients are routinely evaluated for suspected infection at the time of admission. Accordingly, Buendgens also teaches or suggests assessing subjects with suspected infection as recited in the preamble.
Regarding claim 1, Buendgens et al. teaches a method involving the determination of biomarker levels in patient samples and the use of such measurements to assess patient condition, including the presence of sepsis and disease severity. With respect to step (a), Buendgens teaches determining the amount of GDF-15 in a sample of a subject. Specifically, Buendgens discloses that serum GDF-15 levels were measured in patients at the time of admission to the intensive care unit (ICU) prior to therapeutic intervention (see pg. 2, Materials and Methods). With respect to step (b), Buendgens further teaches determining the amount of additional biomarkers, including procalcitonin, in samples from the same patient cohort. In particular, Buendgens reports comparative analyses between GDF-15 and classical biomarkers such as procalcitonin and C-reactive protein using receiver operating characteristic (ROC) analysis, and further present correlation analyses between GDF-15 and multiple laboratory parameters, including procalcitonin, across the same patient population (see, e.g., ROC analysis comparing GDF-15 with procalcitonin and Table 2 reporting correlation coefficients (r values) for procalcitonin in all patients, sepsis patients, and non-sepsis patients). Such analyses necessarily require that procalcitonin levels be determined in the same patient samples. With respect to step (c), Buendgens teaches comparing the amounts of the biomarkers to references. For example, Buendgens compares GDF-15 levels in critically ill patients to those in healthy control subjects and further compare levels between septic and non-septic patient groups, noting GD-15 values in each of the populations (e.g., 3409 pg/mL in non-septic and 7410 pg/mL in septic patients, see pg. 2, Results), thereby providing reference populations against which biomarker levels are evaluated. Additionally, the ROC analyses performed by Buendgens inherently involve comparing biomarker values against known clinical classifications (e.g., sepsis vs. non-sepsis) to determine the predictive value of each biomarker, which constitutes comparison of biomarker levels to reference conditions. The same framework applies to procalcitonin, which is evaluated in parallel within the same patient cohort and clinical classifications (pg. 3). With respect to step (d), Buendgens teaches assessing the subject based on such comparisons. In particular, Buendgens discloses that GDF-15 levels are significantly increased in critically ill patients relative to healthy controls, and in septic patients relative to non-septic patients. Buendgens further evaluates the predictive value of GDF-15, procalcitonin, and other biomarkers for identifying sepsis at admission, as well as for assessing disease severity, organ dysfunction and prognosis (pg. 2-3). Such use of biomarker levels in relation to reference populations to determine the presence or severity of disease constitutes assessing the subject based on the comparison of biomarker values.
To the extent that Buendgens does not explicitly describe performing the assessment as a discrete step on an individual patient, it would have been obvious to one of ordinary skill in the art to apply the disclosed biomarker measurements and comparisons to the assessment of an individual subject. Buendgens explicitly teaches that GDF-15 and procalcitonin levels are associated with sepsis and have predictive value for identifying sepsis at admission. A person of ordinary skill in the art would have been motivated to measure such biomarkers in a subject suspected of infection and compare the measured values to known reference populations (e.g., septic vs. non-septic, healthy controls) in order to assess whether the subject has or is at risk of sepsis, since such application represents the routine clinical use of diagnostic biomarkers. Furthermore, Buendgens teaches that GDF-15 alone exhibits only moderate predictive performance (e.g., lower AUC compared to procalcitonin and CRP), while established biomarkers such as procalcitonin demonstrate superior predictive value. This would have provided additional motivation to determine multiple biomarkers, including both GDF-15 and procalcitonin, in order to obtain a more reliable assessment of the subject’s condition, as it is well understood in the art that evaluating multiple clinically relevant biomarkers can improve diagnostic or prognostic accuracy.
An invention would have been obvious to a person of ordinary skill in the art if some teaching in the prior art would have led that person to arrive at the claimed invention. Prior to the effective filing date of the claimed invention, the teachings of Buendgens et al., that GDF-15 is significantly increased in septic patients, and biomarkers such as procalcitonin are established markers of inflammation with demonstrated predictive value for identifying sepsis, as evidenced by ROC analysis, would have been motivated a person of ordinary skill in the art to evaluate a patient suspected of having an infection by determining GDF-15 and procalcitonin levels and using such biomarkers as predictive indicators of sepsis. There is a reasonable expectation of success in doing so, given that Buendgens demonstrates that both GDF-15 and procalcitonin are measurable in the same patient population and provide clinically relevant information for evaluating sepsis, such that their use in assessing a patient represents the application of known techniques for their intended diagnostic purpose. Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Claim 2 depends from claim 1 and recites conditional limitations that apply when the second biomarker is selected from specific recited biomarkers (e.g., sFLT1, cystatin C, IGFBP7, bilirubin, or sTREM1). In the present rejection of claim 1, the second biomarker is procalcitonin, which is not among the recited options in claim 2. Accordingly, the additional limitations of claim 2 are not applicable to the embodiment relied upon in the rejection of claim 1. Therefore, claim 2 is rejected with claim 1.
Regarding claim 3, Buendgens et al. discloses patients admitted to the intensive care unit, which is a closely related acute clinical setting for patients presenting with severe illness, including sepsis. It would have been obvious to a person of ordinary skill in the art to apply the disclosed biomarker-based assessment to subjects presenting at the emergency department, as such patients are routinely evaluated for suspected infection or sepsis prior to potential ICU admission, and the use of diagnostic biomarkers in both settings represents a predictable use of known techniques.
Regarding claim 4, as described above, Buendgens et al. teaches that GDF-15 levels are significantly elevated in septic patients relative to non-septic patients and evaluates the predictive value of GDF-15, along with procalcitonin, for identifying sepsis at admission. Additionally, Buendgens discloses that GDF-15 levels correlate with established clinical severity scores (e.g., APACHE II, SOFA) and are associated with organ dysfunction and mortality. Such teachings demonstrate the use of biomarker levels to assess disease severity and prognosis, including the likelihood of clinical deterioration. Accordingly, Buendgens teaches or suggests the limitations of claim 4.
Claim 5 depends from claim 1 and further specifies that the references used for comparison are derived from subjects known to be at risk for developing sepsis and/or subjects known not to be at risk for developing sepsis. As discussed above with respect to claim 1, Buendgens et al. measures biomarker levels, including GDF-15 and procalcitonin, in a cohort of critically ill patients and compare such levels across clinically defined groups, including septic patients, non-septic ICU patients, and healthy control subjects. Buendgens discloses that GDF-15 levels are significantly higher in septic patients compared to non-septic patients and further compares biomarker levels between critically ill patients and healthy controls. Such comparisons establish reference populations corresponding to subjects at risk for sepsis (septic patients) and subjects not at risk for sepsis (non-septic patients and healthy controls). Furthermore, the ROC analyses performed by Buendgens inherently involve comparing biomarker values between these reference populations in order to evaluate the ability of the biomarkers, including GDF-15 and procalcitonin, to distinguish between septic and non-septic subjects. This constitutes comparing biomarker amounts to references derived from both at-risk and not-at-risk populations.
Buendgens et al. further teaches that biomarker levels, including GDF-15 and procalcitonin, are interpreted relative to reference populations (e.g., septic versus non-septic patients and healthy controls), wherein differences in biomarker levels are indicative of differing clinical states, including the presence or severity of sepsis. In particular and discussed above, Buendgens discloses that GDF-15 levels are significantly elevated in septic patients compared to non-septic patients and that biomarkers such as procalcitonin exhibit predictive value for identifying sepsis. Therefore, it would have been obvious to a person of ordinary skill in the art to interpret measured biomarker values relative to such reference populations in order to assess a patient’s risk of sepsis, as this represents the routine clinical use of diagnostic biomarkers.
Regarding claim 6, Buendgens et al. discloses a cohort of critically ill patients, including patients with sepsis, i.e., patients suffering from an infection.
Regarding claim 7, Buendgens et al. explicitly discloses that blood samples were collected at ICU admission and processed to obtain serum and plasma for biomarker analysis (pg. 2, Materials and Methods).
Regarding claim 17, in view of the teachings described above, that GDF-15 and procalcitonin are clinically relevant biomarkers for assessing sepsis and disease severity, it would have been obvious to a person of ordinary skill in the art to establish biomarker-based decision criteria, including appropriate cutoff values based on GDF-15 and procalcitonin levels, to identify patients likely to develop sepsis within a short-term clinically relevant period, such as 48 hours, since defining a clinically useful predictive time window represents routine refinement of a known diagnostic approach. There is a reasonable expectation of success because Buendgens demonstrates close associations between GDF-15 and inflammation, and are significantly elevated in critically ill septic patients, while procalcitonin exhibits predictive value for identify sepsis, thereby showing that these biomarkers are useful for distinguishing between patients with and without sepsis.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 (and claims 2-7 and 17 dependent therefrom) are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of copending Application No. 18696730 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 2 of application ‘730 recites a method for assessing a subject with suspected infection comprising the steps: (a) determining an amount of a first biomarker in a sample of the subject, said first biomarker being MR-proADM; (b) determining an amount of a second biomarker in a sample of the subject, wherein said second biomarker is selected from the group consisting of sFlt-1, GDF15 and ESM1; (c) comparing the amounts of the biomarkers to references for said biomarkers and/or calculating a score for assessing the subject with suspected infection based on the amounts of the biomarkers; and (d) assessing said subject based on the comparison and/or the calculation made in step (c); wherein in step (b) the amount of GDF-15 is determined as the second biomarker, and further comprising determining the amount of Aspartate aminotransferase or Alanine aminotransferase as a third biomarker.
The claims overlap in requiring the determination and comparing amounts of GDF-15 and Aspartate aminotransferase or Alanine aminotransferase in a method for assessing a subject with suspected infection, and the difference in biomarker ordering are deemed an obvious variation and do not render the claims patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 (and claims 2-7 and 17 dependent therefrom) are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of copending Application No. 18557890 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 2 of application ‘890 recites a method for assessing a subject with suspected infection comprising the steps: (a) determining the amount of a first biomarker in a sample of the subject, said first biomarker being Presepsin; (b) determining the amount of a second biomarker in a sample of the subject, wherein said second biomarker is selected from the group consisting of: GDF-15, Creatinine, sFlt1, IGFBP7, sTREM1, Cystatin C and PSP (Pancreatic Stone Protein); (c) comparing the amounts of the biomarkers to references for said biomarkers and/or calculating a score for assessing the subject with suspected infection based on the amounts of the biomarkers; and (d) assessing said subject based on the comparison and/or the calculation made in step (c); wherein in step (b) (i) if the amount of GDF-15 is determined as the second biomarker, the method will further comprise determining the amount of sFlt1, IGFBP7 or sTREM1 as a third biomarker; or (ii) if the amount of Cystatin C is determined as the second biomarker, the method will further comprise determining the amount of Aspartate aminotransferase as a third biomarker.
The claims overlap in requiring the determination and comparing amounts of GDF-15 and sFlt1, IGFBP7 or sTREM1 in a method for assessing a subject with suspected infection, and the difference in biomarker ordering are deemed an obvious variation and do not render the claims patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is in condition for allowance.
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/NAGHMEH NINA MOAZZAMI/Examiner, Art Unit 1652
/ROBERT B MONDESI/Supervisory Patent Examiner, Art Unit 1652
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