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 .
Status of the Claims
Applicant’s election of Group I, claims 1-4, 14-17, and 34 in the reply filed on September 4, 2025 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)).
Claims 27-33 are incorrectly indicated as currently amended. The claims are considered withdrawn as non-elected invention.
Claims 1-4, 14-17, and 34 are examined herein.
Claim Objections
Claims 1 and 14 are objected to because of the following informalities:
Claims 1 and 14 recite “NOX5 per ml fluid sample” (step c). Should be “NOX5 per ml of the fluid sample”.
Appropriate correction is required.
Specification
Applicant is advised to check spelling of Elbatrik. There are prior art publications with Mahmoud H. Elbatreek as a coauthor.
The disclosure is objected to because it contains an embedded hyperlink on pg. 44, line 2. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See M PEP § 608.01.
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 1-4, 14-17, and 34 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a naturally occurring correlation, without significantly more.
Claims 1 and 14 are directed to a process, which belongs to the four statutory categories.
The claims are related to methods of establishing a relationship between a hypertension endotype and a concentration of NADPH oxidase 5 protein (NOX5) in the endothelial microparticles a fluid sample from a human patient. This relationship is categorized as a naturally occurring correlation, and therefore it is a judicial exception.
The claims also recite additional steps of obtaining a fluid sample from the human patient, isolating the endothelial microparticles from the fluid sample, and measuring NOX5 in the endothelial microparticles. These additional steps of “obtaining”, “isolating”, and “measuring” are an insignificant extra-solution activity that amounts to mere data gathering necessary to apply the judicial exception.
The claims also recite additional steps of concluding that the human patient suffers from the hypertension endotype. The step of “concluding” amounts to mental processes, namely concepts performed in the human mind, since concluding is considered an observation, evaluation, and/or a judgement. The limitation of “concluding” falls into the mental process groupings of abstract ideas and therefore is a judicial exception.
When considering the elements in combination, the claims as a whole do not integrate the recited exceptions into a practical application.
Additional elements of measuring recited biomarker are recited at a high level of generality, and have been recognized as routine laboratory techniques.
The techniques for measuring NOX5 concentration are known in the art. It was routine and conventional to measure NOX5 concentration in the urinary microparticles using immunoblotting and HPLC - Battaion et al. (Podocyte Nox5 Expression Increases Microparticle Formation and Oxidative Stress in Mice, Kidney Week, Washington DC, Nov. 5-10, Poster # FR-PO200). The urinary microparticle are equivalent to endothelial microparticles of instant disclosure.
The NOX5 assay is recited at a high level of generality as “using a protein detection assay”.
Therefore, the claims as a whole do not amount to significantly more than the recited exception, because there are no additional elements, or combination of additional elements, that add an inventive concept to the claims and are not routine and conventional.
The dependent claims 2-4, 13-17, and 34 fail to add additional elements, or combination of additional elements, that contribute to an inventive concept to the claim.
For these reasons, claims 1-4, 14-17, and 34 are ineligible under 35 U.S.C. 101.
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 1-4, 14-17, and 34 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 1 and 14 recite “selected from the group comprising plasma, blood and serum” (step (a)). The claims are indefinite because they use the open “comprising” language.
Subject Matter Free of the Prior Art
Claims 1-4, 14-17, and 34 are free of the prior art.
The prior art neither teaches nor suggests measuring the level of NOX5 in the endothelial microparticles from fluid samples obtained from human patients suffering from essential arterial hypertension.
Battaion et al. (Podocyte Nox5 Expression Increases Microparticle Formation and Oxidative Stress in Mice, Kidney Week, Washington DC, Nov. 5-10, 2019, Poster # FR-PO200) teach measuring NOX5 concentration in the urinary microparticles of mice, but fail to teach endothelial microparticles from human patients with essential arterial hypertension.
Novus Biologicals (Human NOX5 ELISA Kit) as evidenced by Novus Biologicals (Material Safety Data Sheet, 2017) teaches an ELISA kit for measuring human NOX5 in serum, plasma, and other biological fluids, but fails to teach motivation for measuring NOX5 in endothelial microparticles.
Rios et al. (Molecular mechanisms of VEGFR inhibition-induced endothelial cell damage, Heart 2015;101: A13, Abstract #39) teach that anti-angiogenic drugs used to treat cancer, induce severe hypertension leading to increased mRNA levels of Nox5 (pg. A13, col. 1), but fail to provide motivation for measuring protein levels of NOX5 in the endothelial microparticles.
Serrander et al. (NOX5 is expressed at the plasma membrane and generates superoxide in response to protein kinase C activation. Biochimie. 2007 Sep;89(9):1159-67) teach detection of NOX5 expression and its subcellular localization in the plasma membrane (Abstract), but fail to teach measuring levels of NOX5 in the endothelial microparticles.
Please, see 101 and 112(b) rejections above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alexander Volkov whose telephone number is (571) 272-1899. The examiner can normally be reached M-F 9:00AM-5:00PM (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy Nguyen can be reached on (571) 272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDER ALEXANDROVIC VOLKOV/Examiner, Art Unit 1677
/REBECCA M GIERE/Primary Examiner, Art Unit 1677