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 .
Priority
This is a national stage application of PCT/EP2021/065196 filed on 06/07/2021, and claims priority to EP 20305604.9 filed on 6/5/2020, and EP 21160546.4 filed on 3/3/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Nucleotide and/or Amino Acid Sequence Disclosures
This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.831(a) and 1.831(b). However, this application fails to comply with the requirements of 37 CFR 1.831-1.834. The examiner has noted that the specification refers to SEQ ID NO: 21 in page 16, lines 20, 24 and 28; and in page 17. However the sequence listing in this application include only 14 sequences. The sequence of SEQ ID NO: 21 is not disclosed. It is not clear whether the application includes sequences of SEQ ID NO: 15-21. Applicant must provide:
• A replacement “Sequence Listing XML” part of the disclosure, as described above in item 1. or 2., as well as
• A statement that identifies the location of all additions, deletions, or replacements of sequence information in the “Sequence Listing XML” as required by 1.835(b)(3);
• A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.835(b)(4);
• A statement that the “Sequence Listing XML” includes no new matter in accordance with 1.835(b)(5); and
• A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(b)(2), consisting of:
o A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
o A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Abstract
The abstract of the disclosure is objected to because there are two copies of Abstract provided on 12/2/2022. It is not clear which is the final copy of the Abstract to be entered in this application. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Status of Claims
Claims 1-10 were canceled and new claims 11-30 were added by the amendment filed on 12/2/2022. Claims 11-30 are currently pending in this application.
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 11-30 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.
The method of independent claims 11 and 21 comprises a) measuring sTREM-1 level in the biological sample from the subject, and b) comparing the measured sTREM-1 levels to a reference value. However the claims do not recite how the comparing the sTREM-1 levels in the biological sample of the subject with the reference value will determine the severity of the disease (claim 21) or identifies the subject suffering from a disease caused by coronavirus (claim 1). The claims are silent to what is considered as reference value of the sTREM-1 levels, and what levels of sTREM-1 are considered to identify the subject is suffering from the disease or what are the levels of sTREM-1 to determine the severity of the disease caused by the coronavirus. Thus, claims 11 and 21 and claims depend from these claims are indefinite.
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 11-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
11. (New) An in vitro method for identifying a subject suffering from a disease caused by a coronavirus infection as being at risk of having or developing a severe form and/or a complication of the disease caused by a coronavirus infection, or at risk of death occurring after the coronavirus infection, said method comprising: measuring the level of soluble triggering receptor expressed on myeloid cells-1 (sTREM-1) in a biological sample from the subject; and comparing the level of sTREM-1 measured in the biological sample from the subject to a reference value.
21. (New) An in vitro method for determining the severity of a disease caused by a coronavirus infection in a subject, said method comprising: measuring the level of soluble triggering receptor expressed on myeloid cells-1 (sTREM-1) in a biological sample from the subject; and comparing the level of sTREM-1 measured in the biological sample from the subject to a reference value.
Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012).
Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. _, 134 S. Ct. 2347, 2354, 110 USPQ2d 1976, 1980 (2014).
Step 1 and Step 2, which is the Supreme Court’s Alice/Mayo test, is a two-part test to identify claims that are directed to a judicial exception (Step 2A) and to then evaluate what more such claims recite to provide an inventive concept (Step 2B) (also called a practical application) to the judicial exception. See MPEP § 2106.04 for more information on Step 2A, and MPEP § 2106.05 for more information on Step 2B. See MPEP 2106.III.
The present claims 11-30 are analyzed to determine whether the claims satisfy the criteria for the subject matter eligibility.
Step 1: Yes
The claimed method (claims 11-30) falls within the statutory category of invention. See MPEP 2106.03.
Claims 11 and 21
Step 2A Prong 1:
Independent claims 11 and 21 are directed to a judicial exception (See MPEP 2106.04). The claims include an abstract idea and a law of nature.
The claims recite “measuring” soluble triggering receptor expressed on myeloid cells-1 (sTREM-1) from a biological sample and “comparing” the measured level of sTREM-1 to a reference value.
In 2019 pandemic, the novel coronavirus (SARS-CoV-2) infected subjects exhibited hyperinflammation, acute respiratory distress syndrome (ADS) and cardiovascular disease, and the diseases caused by the novel coronavirus infected subject is considered COVID-19 disease. In the present claims the levels of sTREM-1 in the biological sample from a coronavirus infected subject correlates to the state of disease caused by the coronavirus. Thus, the claims clearly set forth a correlation between the sTREM-1 (markers) and the disease caused by the coronavirus, which is a natural law, similar to the correlation that the court found to be a natural law in Mayo v Prometheus. Thus, the present claims 11 and 21 are drawn to a judicial exception. Measuring the markers in a disease caused by coronavirus is simply another articulation of natural law that the markers correlate with the risk of coronavirus infection.
The method in claims 11 and 21 recite measuring the level of sTREM-1 in a biological sample, and comparing the level of sTREM-1 measured in biological sample from the subject to a reference value. Thus, the claims include an abstract idea (measuring and comparing the levels of sTREM-1). Further, the step of comparing the sTREM-1 level with the reference level is a mental step falling within an abstract idea grouping. The step of comparing does not require the user to do anything in light of correlation. See MPEP 2106.04(a)(2). Accordingly, claimed method of method of identifying a subject suffering from a disease caused by coronavirus (claim 1), or in invitro method for determining severity of a disease caused by a coronavirus infection (claim 21) constitutes “mental process” of an abstract idea grouping.
Step 2A Prong 2:
The exception is not integrated into a practical application of the exception. Claims 11 and 21 as a whole do not integrate the recited judicial exception into a practical application of that exception. The claims do not recite any additional elements that integrate the exception into a practical application.
The claims are not directed to new techniques for detecting the markers indicative of coronavirus disease (cardiovascular disease) caused by coronavirus or to new markers. Detecting sTREM-1 (markers) is simply another articulation of the natural law that the markers correlate with the diseases caused by coronavirus infection. There is nothing further that integrates the natural law.
Claims 11 and 21 do not include any additional steps and thus, there is no integration of exception into a practical application. Accordingly, Claims 11 and 21 recite a process that involves judicial exception of an abstract idea and a law of nature and natural phenomenon. The claims do not include additional elements that are sufficient to amount to significantly more than judicial exception. See MPEP 2106.04.II.A.2.
Step 2B:
The second part of the Alice/Mayo test involves determining the inventive concept by evaluating additional elements in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception itself. Alice Corp., 573 U.S. at 27-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966). See MPEP 2106.05.
The claims do not limit the steps to a particular machine and therefore do not meet the machine or transformation test on these grounds.
The claims also do not add a specific limitation other than what is well understood, routine and conventional in the field. The step of measuring the presence/concentration of sTREM-1 in a biological sample; and comparing the level of sTREM-1 measured in the biological sample from the subject to a reference value was well known in the art at the time of the invention. EP2835641 teaches methods for predicting the risk of having a cardiovascular disease or event in a subject by measuring sTREM-1 in the biological sample from the patient. Additionally, the present specification also teaches that methods for measuring the levels of sTREM-1 are well-known to the skilled artisan (0085 in page 22, 0088 in page 23).
Thus, the claims are set forth at a high level of generality such that methods for determining of the natural products are encompassed. As discussed above the claimed method steps include abstract idea, and further the use of well-known assay methods to determine the presence/absence of sTREM-1 in a biological sample are not sufficient to show an improvement in the technology. According to MPEP 2106.05(a)(II), an improvement in the abstract idea itself is not an improvement in technology. Accordingly, claims 11 and 21 do not recite a new, innovative method for identifying a subject suffering from a disease caused by a coronavirus infection by measuring sTREM-1 in an COVID-19 infected subject. Thus, for the reasons discussed above Claims 11 and 21 are directed to non-statutory subject matter.
Claim 12
The dependent claim 12 additionally recites “treating” the subject suffering from the disease by administering to the subject ….respiratory support, vasopressor therapy, fluid therapy, antimicrobial therapy, antiviral therapy, cardiovascular support, renal replacement therapy, sedation, an antiviral agent, an anti-interleukin 6 (anti-IL-6) agent or any mixes thereof. Claim 12 does not recite any particular treatment. The step of “treating the subject” recites such a high level of generality that does not require the physician to take sTREM-1 level into consideration when deciding which treatment is required. The treatment (as listed in the claim 12) is conventional and is administered regardless of the s-TREM-1 levels in a subject suffering from ARDS or cardiovascular disease or sepsis (severe form of viral infection), thus this is an integration of the judicial exception. The claim does not specify which patients with what levels of sTREM-1 are treated. Thus, claim 12 is directed to a judicial exception. Further the claim does not add anything more than what is known and understood, routine and conventional in the field. Thus, claim 12 is rejected as being directed to non-statutory subject matter.
Claim 13
Claim 13 depends from claim 11 and recites the complications caused by a coronavirus infection. The dependent claim 13 is directed to Judicial exception because the claim does not recite any additional steps. The listed complications in claim 13 are also known in the art as shown in EP2835641 and Merad. Thus claim 13 is directed to non-statutory subject matter.
Claims 14, 24
Claims 14 and 24 recite coronavirus is SARS-CoV-2 and the disease caused by a coronavirus infection is COVID-19, which is directed to judicial exception and the claims do not recite any additional steps.
Claims 15, 25
Claims 15, 25 recite that the sTREM-1 level is transcription level or translation level of sTREM-1, which is directed to judicial exception and the claims do not recite any additional steps.
Claim 16-20, 22-30
Claims 16-20 depend from claim 11 and claims 24-30 depend from claim 21 are also directed to Judicial exception because the claims do not recite any additional steps or elements that integrate the exception into a practical application. While the claims recite ‘the biological sample is a blood sample’ ‘subject requires hospitalization’ and ‘subject requires respiratory support’, and ‘level of sTREM-1 measured at day 3…., which are the steps performed or the steps required to gather the sample or in order to gather data for the mental analysis step, and are not considered as integration of exception into a practical application. Therefore these dependent claims 16-20 and 24-30 are directed to Judicial exception.
Claims 22, 23
Claims 22 and 23 recites that the method allows “monitoring” over time of the disease, which does not require any additional practical step. The step of “monitoring” constitutes “mental process”. Thus, claims 22 and 23 are not considered as integration of exception into a practical application.
Thus claims 11-30 are directed to non-statutory subject matter. Claims 11-30 do not include additional elements that are sufficient to significantly more than judicial exception.
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.
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 11-14, 16-24 and 26-30 are rejected under 35 U.S.C. 103 as being unpatentable over EP 2835641 A1 (Publication date 11/02/2015) (herein “the `641”) and Merad (Nature Reviews. Vol.20. Published 02 June 2020.pages 355-362).
The `641 teaches a method for diagnosing a cardiovascular event or disease in a subject by measuring sTREM-1 (soluble triggering receptors expressed on myeloid cells-1) level in a sample from a subject at risk of having a cardiovascular event or disease (abstract, 0009). The sTREM-1 is a soluble form of the extracellular domain of TREM-1 (p.5:5-15). TREM-1 is an immunoreceptor expressed by innate immune cells. TREM-1 activation leads to cytokines, chemokines production (TNF-α, IL-6, IL-8, MCP-1 and -3, MIP-1α ….) along with rapid neutrophil degranulation and oxidative burst (0005). The `641 defines cardio vascular disease is a general term used to classify numerous conditions affecting the heart, heart valve, and vasculature of the body and encompasses any disease affecting the heart or blood vessels including coronary artery disease (CAD) (0018). CAD encompasses disease state such as acute coronary syndrome (ACS), myocardial infarction (heart attack), atherosclerosis and atherothrombosis (page 3). The `641 teaches that the method comprises i) measuring the level of sTREM-1 in a sample from the subject, comparing the level measured in step i) with a reference value wherein a difference indicative of a risk having or developing a cardiovascular disease or event (0085). The `641 fails to teach identifying the subject having a severe form of disease or complications of the disease caused by the virus by comparing the sTREM-1 levels.
Merad in the same filed of endeavor teaches that coronavirus disease 2019 (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (a coronavirus) (abstract). Merad teaches that hyperinflammatory response induced by SARS-Cov-2 is a major cause of disease severity and death in infected patients (Abstract). Merad teaches that COVID-19 patients have acute respiratory distress syndrome (ARDS), which is a common complication of several viral pneumonia, and COVID-19 is associated with high levels of circulating cytokines in lungs and heart, lymph and kidney (355). Merad teaches that the systemic cytokine profiles observed in patients with severe COVID-19 show similarities to those observed in cytokine release syndromes, such as macrophage activation syndrome with increased production of cytokines such as IL-6, IL-7, tumor necrosis factor and inflammatory chemokines (355-356). Merad teaches treating COVID-19 by administering anti-IL-6 agent; combining IL-6 receptor and IL-1β blockade; myeloid derived cytokines such as TNF, and granulocyte-stimulating factor (GM-CSF); administration of IFNαβ, IFNγ receptors (page 356, 359).
Thus, it would have been obvious to a person skilled in the art before the effective filing date of the claimed invention to measure the levels of sTREM-1 levels in a biological sample from a coronavirus infected person to identify the subject having a severe form of the disease caused by the virus or complications of the disease caused by the virus because the `641 teaches that diagnosing cardiovascular disease in a subject by measuring the levels of sTREM-1, and TREM-1 activation leads to chemokine and cytokine production, and Merad teaches that COVID-19 patients have ARDS and high levels of circulating cytokines. In view of the teachings in the `641 and Merad, one of ordinary skill in the art would have motivated to measure the sTREM-1 levels in a coronavirus infected subject to determine the severity of the disease or complications caused by the coronavirus infection or the coronavirus infected subject at risk of death. Thus, claims 11 and 21 are obvious in view of the teachings in the `641 and Merad.
Regarding claim 12, Merad teaches treating COVID-19 by administering anti-IL-6 agent, a combination of IL-6 receptor and IL-1β blockade; administering myeloid derived cytokines such as TNF, and granulocyte-stimulating factor (GM-CSF); administration of IFNαβ, IFNγ receptors (page 356, 359).
Regarding the complications of the disease in claim 13, the `641 teaches a method for identifying a subject having a risk of having cardiovascular disease including thrombosis or diseases associated with inflammation and TREM-1 activation leads to cytokine and chemokine production. Further, Merad teaches that severe COVID-19 patients complications include ARDS, and death, and the patients show hyper inflammation in severe COVID-19 (cytokine profiles observed in cytokine release syndrome with increased levels of inflammatory cytokines). Thus, in view of the combined teachings of the `641 and Merad, the cited complications listed in claim 13 would have been obvious to a person skilled in the art.
Regarding claims 14, 24, Merad teaches that the coronavirus disease 2019 (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (a coronavirus) (abstract).
Regarding claims 16-17, 26-27, the `641 teaches that the biological sample is a blood or serum sample from the subject (page 4, 0053).
Claims 18-20, 28-30 recite the subject requires hospitalization or requires respiratory support. Merad teaches that patients with COVID-19 require hospitalization or require respiratory support (page 355). Thus, it would have been obvious to a person skilled in the art to measure the sTREM-1 levels in the biological sample from the subject after hospitalization. Further, wherein the biological sample obtained on at least two occasions, or the two occasions are separated by at least 24 hours or day 3 following hospitalization are obvious to a person skilled in the art since these procedural steps seem to be mere routine optimization of the reference method of measuring sTREM-1 levels in the biological sample.
2. Claims 11-30 are rejected under 35 U.S.C. 103 as being unpatentable over Merad (Nature Reviews. Vol.20. Published 02 June 2020, pages 355-362) and WO 2020/065044 A1 (International publication date 02 April 2020) (herein “the `044”).
Claims 11, 21
Merad teaches that COVID-19 (a coronavirus disease) pandemic caused by infection with SARS-CoV-2 (coronavirus). Merad teaches that the hyperinflammatory response induced by SARS-CoV-2 is a major cause of disease severity and death in infected people (Abstract, middle column in page 355). Merad teaches that serum samples from the COVID-19 patients showed higher levels of inflammatory markers, and an increased number of inflammatory cytokines and chemokines (page 355). Merad teaches that acute respiratory distress syndrome (ARDS) was reported in COVID-19 patients (page 355).
Merad fails to teach a method for identifying a subject suffering from a coronavirus infection as being at risk of developing severe form of disease or complications from the disease or at risk of death by measuring the levels of sTREM-1 in the biological sample from the subject as in the present claimed method.
The `044 in the same field of endeavor teaches an in vitro method for identifying human subjects suffering from an inflammatory disorder, preferably an acute inflammatory disorder preferably sepsis or septic shock (Abstract). The method comprising a) measuring the level of soluble triggering receptor expressed on myeloid cells-1 (sTREM-1) in a biological sample from a human subject; b) comparing the level of sTREM-1 measured in step a) to predetermined sTREM-1 value; and c) identifying the human subject suffering from an inflammatory disorder (Abstract, pages 3, 4, 23, 40, 46-47, 61-62, claims). The `044 teaches that the inflammatory disorder is acute inflammatory disorder, sepsis, septic-shock, sepsis associated organ dysfunction, acute respiratory distress syndrome (ARDS), severe acute respiratory syndrome (SARS), acute kidney injury (AKI), pancreatitis, inflammatory bowel disease, pneumonia, endotoxemia, and hemorrhagic shock (page 75).
Thus in view of the teachings in Merad and the `044, it would have been obvious to a person skilled in the art before the effective filing date of the invention to use the in vitro method of identifying a human subject suffering from a disease caused by coronavirus as being at risk of having or developing severe disease or complications of the disease or at risk of death by measuring the sTREM-1 levels in the blood or serum samples from the human patient as taught by the `044. A person skilled in the art would have been motivated to apply the known method for identifying a subject suffering from coronavirus disease (COVID-19) as being at risk of developing a severe form of the disease, or complications of the disease or at risk of death because hyperinflammation was observed in severe COVID-19 patients, and the `044 teaches a method for identifying a human subjects suffering from acute inflammatory disorder including ARDS, sepsis, SARS and kidney injury by measuring sTREM-1 and comparing the levels of the sTREM-1 levels with the predetermined levels of sTREM-1. Since the pandemic caused by the infection with SARS-CoV-2 led to more than 200,000 deaths worldwide, the nature of the problem to be solved may lead inventors to look at references relating to possible solutions to that problem. Thus, one of ordinary skill in the art would have been capable of applying the known method of identifying a subject suffering from COVID-19 disease or complications of the disease (acute inflammatory disease, ARDS) in a patient using the known method of measuring the sTREM-1 levels in the blood or serum samples of the patient as in the `044 and the results would have been predictable to one of ordinary skill in the art.
Regarding claim 12, Merad teaches treating COVID-19 by administering anti-interleukin 6 agent (anti-IL-6); combining IL-6 receptor and IL-1β blockade; administering myeloid derived cytokines such as TNF, and granulocyte-stimulating factor (GM-CSF); administration of IFNαβ, IFNγ receptors (page 356, 359). The `044 teaches treating the human subject suffering from the inflammatory disorder (ARDS) by administering vasopressor therapy, fluid therapy, cardiovascular support, respiratory support (such as mechanical ventilation), renal support and/or sedation (page 80).
Regarding the complications of the disease in claim 13, the`044 teaches that the inflammatory disorder is acute inflammatory disorder, sepsis, septic-shock, sepsis associated organ dysfunction, acute respiratory distress syndrome (ARDS), severe acute respiratory syndrome (SARS), acute kidney injury (AKI), pancreatitis, inflammatory bowel disease, pneumonia, endotoxemia, and hemorrhagic shock (page 75). Further, Merad teaches that severe COVID-19 patients complications include ARDS, and death, and the patients show hyper inflammation in severe COVID-19 (cytokine profiles observed in cytokine release syndrome with increased levels of inflammatory cytokines). Thus, in view of the combined teachings of the `044 and Merad, the cited complications listed in claim 13 would have been obvious to a person skilled in the art.
Regarding claims 14, 24, Merad teaches that coronavirus disease 2019 (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (a coronavirus) (abstract).
Regarding claims 15, 25, the `044 teaches that the level of sTREM-1 is a transcription level of sTREM-1 or a translation level of sTREM-1 (page 29).
Regarding claims 16-17, 26-27, the `044 teaches that the biological sample is a blood or serum sample from the subject (pages 28-30).
Claims 18-20, 28-30 recite the subject requires hospitalization or requires respiratory support. Merad teaches that patients with COVID-19 require hospitalization or require respiratory support (page 355). The `044 teaches sTREM-1 is measured in a biological sample between the first 2 hours and 48 hours following hospitalization, in particular admission in ICU, or emergency unit (page 35). Thus, it would have been obvious to a person skilled in the art to measure the sTREM-1 levels in the biological sample from the subject after hospitalization. Further, wherein the biological sample obtained on at least two occasions, or the two occasions are separated by at least 24 hours or day 3 following hospitalization are obvious to a person skilled in the art since these procedural steps seem to be mere routine optimization of the reference method of measuring sTREM-1 levels in the biological sample.
Conclusion
Claims 11-30 are rejected.
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/Padmashri Ponnaluri/ Primary Examiner
Art Unit 3991