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 .
Response to Arguments
Applicant's arguments filed May 15, 2026 have been fully considered but they are not persuasive. Applicant has amended independent claim 21 to recite adding a red blood cell flocculant in a sufficient amount to impart a cationic charge to red blood cells, determining a volume of settle red blood cells in about 15 minutes, and utilizing the volume of blood to assess a clinical condition, and argued that the amended claim is directed to eligible subject matter. The Examiner respectfully disagrees.
The steps of determining a volume of settled red blood cells and approximating the volume of blood are mental steps in that they only require viewing the container to determine and/or approximate the volumes. As such, the Examiner contends that claim 21 recites an abstract idea. The step of combining an red blood cell flocculant with a fluid comprising red blood cells does not provide significantly more as separating components from a mixture with a flocculant is well known in the art, and widely utilized across various industries. As such, combining a fluid with a flocculant in a container does not qualify as significantly more, and is not a practical application of the claimed process. Also, the step of utilizing the blood volume to assess a clinical condition is not a practical application, nor is it a particular treatment. Assessing a clinical condition can also be viewed as a mental step as it only requires reading the blood volume, and thinking about what the blood volume means with respect to a clinical condition. As such, the step of utilizing the blood volume to assess a clinical condition does not render the claims patent eligible.
With respect to the claimed formula, the examiner contends that the formula is a mathematical concept that does not render the claim patent eligible (MPEP 2106.04(a)(2). Also, the Examiner notes that the claimed formula can be viewed as a mental process that can be performed in the human mind with or without the use of a physical aid (MPEP 2106.04(a)(2) III B). As such, the formula recited in claim 21 in combination with the additional elements of the claim do not overcome the rejection. As such, the Examiner contends that the instant claims are directed to a judicial exception without significantly more, and therefore are directed to ineligible subject matter under 35 U.S.C. 101.
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 3, 5, 6, 10-12, 20, 21, 24, and 28-34 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s) an abstract idea. This judicial exception is not integrated into a practical application because the claims do not recite any additional limitations that utilizes the abstract idea in a manner that imposes a meaningful limit on the exception. Independent claim 21 is directed to a method for accelerating a rate of sedimentation of red blood cells comprising combining in a container a volume of fluid and an amount of a red blood cell flocculant to accelerate red blood cell sedimentation wherein the flocculant imparts a cationic charge to the red blood cells, determining a volume of settled red blood cells in the container at room temperature in about 15 minutes and without centrifugation to provide a volumetric measurement of a stable red blood cell sedimentation, approximating the volume of blood in the fluid according to the formula Vb=Vm/(Hct X ɳ) wherein Vb is blood volume in milliliters, Vm is sedimentation of red blood cells in milliliters, Hct is an average hematocrit, and ɳ is the red blood cell packing ratio of the container, wherein approximating the blood volume is accelerated compared to approximating blood volume in the absence of the red blood cell flocculant, and using the blood volume to assess a clinical condition. Determining a volume of settled red blood cells, approximating the volume of blood, and assessing a clinical condition are mental steps that only require viewing the container, recording the volumes of sedimented red blood cells and blood volume, and mentally evaluating a clinical condition. The Examiner notes that the claims do not recite a practical application as assessing a clinical is a mental step, and is not a particular treatment. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements of the claim are directed to combining a fluid and a red blood cell flocculant in a container. Receiving a volume of fluid in a container is considered as routine and conventional activity as fluids are commonly received in containers. With respect to the flocculant, the Examiner makes note of reference to Sauvignet et al., (US 2011/0147304) and Chiattello (US 2018/0028431) who teach polyDADMAC added to a container. The Examiner also makes note of reference to Van Ness et al., (US 2004/0029143) who teach utilizing polyDADMAC to separate red blood cells from a whole blood sample. As such, the limitation of adding a red blood cell flocculant to a container is also known in the art and does not provide significantly more to the instant claims. Additionally, Therefore, based on the limitations of the instant claims, the Examiner contends that claims 3, 5, 6, 10-12, 20, 21, 24, and 28-33 are directed to an abstract idea without significantly more, and therefore are directed to ineligible subject matter under 35 U.S.C. 101.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWAN A GERIDO whose telephone number is (571)270-3714. The examiner can normally be reached Mon-Fri 10-6.
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/DWAN A GERIDO/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797
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