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 .
The examiner on this application has changed.
Election/Restrictions
Applicant’s election of Group I (claims 1-16) and PMA from claim 12 in the reply filed on 2/19/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 17 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claims 4 and 11 are objected to because of the following informalities: “109” and “TM”, respectively. Appropriate correction is required.
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 1-16 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.
For claim 1, it is not clear what the predetermined threshold is as it relates to the onset or occurrence of an ARDS disease status. This amount lacks a knowable threshold and it is not clear how this relates to the preamble that is looking for progression and what is determined is status. This also applies to claim 8-10 where it appears status level is recited but it is not clear how the levels correlate to the pre-determined level. In claim 1 part C, it is not clear what derived means. Is it just doing a and b, or is there other processing. Also, “second comparator” is not clear as there is no first comparator. Is the first comparator missing? This also affects all dependent claims and especially the similar language presented in claim 2.
For claim 2, part b ”said test sample” lacks antecedent basis.
Claims 4, 10, and 11 contain the trademark/trade name LIT/N. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe neutrophil level at baseline and, accordingly, the identification/description is indefinite. It is not the specification uses “TM” and claim 11 attempts to use it so this is how it was identified; however, in the Trademarks database, the mark was not seen. Also, it is not clear if it is LIT/N or LIT-N, used in claims 4 and 11 respectively. It is also not clear how this level is determined and thus the limitation cannot be determined and claims 4, 10, and 11 are not further examined.
Claim 9 is not clear as to if the words in parenthesis are part of the claim.
Claim 10 is not clear because the limitations after “for example” and “e.g.” are limiting or included or optional.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1 and 12-16 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Stevens, et al. (The Journal of Infectious Diseases, Volume 170, Issue 6, December 1994, Pages 1463–1472).
For claim 1, Stevens et al. teach contacting whole blood with an inducer (PMA) for diagnosing and staging an infection including pneumonia and sepsis (abstract and methods). Pneumonia and sepsis are known to cause ARDS. Stevens et al. additionally teach “Longitudinal studies at different times during the course of infection demonstrate that the state of the circulating phagocytes reflects the clinical course ( e.g .. progression, resolution) or stage of infection” (page 1470, col 2 lower). Because of the 112 issues noted above, the comparison here shows disease progression and thus meets the limitation of the claim. For claims 12-16, Stevens et al. teach that PMA is used as an inducer, that luminol is used in the detection of a chemiluminescent signal that is measured (Materials and Methods section).
Thus, Stevens, et al. anticipate the claimed invention.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 2-3 and 5-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stevens, et al. (The Journal of Infectious Diseases, Volume 170, Issue 6, December 1994, Pages 1463–1472) as applied to claim1 and 12-16 above, and further in view of Li et al. (Predictive values of neutrophil-to-lymphocyte ratio on disease severity and mortality in COVID-19 patients: a systematic review and meta-analysis. Crit Care 24, 647 (2020).
Stevens, et al. is discussed above.
Stevens, et al. does not teach COVID-19 disease.
Li et al. teach that COVID-19 is caused by the coronavirus SARS-CoV-2, that “[a]lthough many patients have mild symptoms, they may suddenly progress to ARDS, septic shock or even MODS”, and that “[blood neutrophil-to-lymphocyte ratio] NLR has shown good predictive values on progression and clinical outcomes in various disease (Introduction).
One of ordinary skill in the art before the effective filing dare would be motivated to test for COVID-19 disease stage knowing it can rapidly progress and use assays known in the art to detect neutrophils. For claim 2, the assay of Stevens et al. shows regression. For claim 3, the neutrophils are counted to obtain the neutrophil-to-lymphocyte ratio (introduction). For claims 5-7, Li et al. teach the sample contains coronavirus SARS-CoV-2 (Introduction). For claims 8-9, it would have been obvious before the effective time of filing to make a scale of values to indicate severity and what stage/action the patient is in because both references teach the neutrophil response correlated with infection state.
One of ordinary skill in the art before the effective filing dare would have had the expectation of success testing for Sar-CoV-2 knowing that it induces neutrophils and that assays to test neutrophils are known in the art.
Thus, it would have been prima facie obvious before the effective date of filing to modify the assay of Stevens et al. to monitor the disease of Li et al. with the expectation of success.
Conclusion
Citation of related art for treatment of cancer WO2018060741A1 (related neutrophil method).
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MYRON G. HILL
Examiner
Art Unit 1671
/M.G.H/Examiner, Art Unit 1671
/Shanon A. Foley/Primary Examiner, Art Unit 1671
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