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 April 13, 2026 have been fully considered but they are not persuasive. Applicant has amended independent claim 1 to recite a method for approximating blood volume in a fluid comprising providing a series of volumetric blood volume onto a container wherein each of the markings correspond to a volume of blood in a defined volume of fluid, receiving the defined volume of fluid in the container, identifying the blood volume marking corresponding to a volume of sedimented red blood cells, and determining a volume of blood in the fluid with the identified blood volume marking, and argued that the claims are directed to eligible subject matter. The Examiner respectfully disagrees.
With respect to the series of volumetric blood volume markings, the Examiner contends that the markings can be considered as manual data provided by a user, and therefore does not constitute a functional relationship between the markings and the claimed method. For example, Vm, Hct, and ɳ can be determined by a user and inputted into the formula to calculate Vb which renders the markings as manual data provided by a user. Given this view, the Examiner contends that the series of markings does not make the claim patent eligible.
Applicant has also argued that the instant claims are integrated into a practical application by providing a series of volumetric blood volume markings on a container. The Examiner contends that providing a series of markings does not integrate the claims into a practical application as nothing occurs after the determining step. As such, the Examiner maintains that the claims do not recite a practical application to the judicial exception.
Finally, Applicant has argued that the additional elements of the claim are directed to significantly more, thus the claim should be considered to be eligible. The Examiner contends that the claim does not amount to significantly more as receiving a volume of fluid in a container is routine and conventional activity that is known in the art as conventional obvious post-solution activity does not transform an unpatentable principle into a patentable process. Additionally, forming a series of markings based on a formula is considered as a mathematical concept, which again does not amount to significantly more. Furthermore, the Examiner notes that Applicant’s arguments are not commensurate with the scope of the claims as the claims do not define a timeframe in which a blood volume is determined. Also, Applicant’s arguments regarding accuracy compared to the prior art are not commensurate with the scope of the claims do not recite an limitations regarding accuracy of the claimed process. Given these views, the Examiner contends that the additional limitations of independent claim 1 do not amount to significantly more. Therefore, in light of the limitations of the instant claims, and the arguments provided here, the Examiner contends that the limitations of the instant claims are directed to an abstract idea without significantly more, thus the claims recite 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 1-21 rejected under 35 U.S.C. 101 because the claimed invention is directed to 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 1 recites a method for approximating blood volume in a fluid comprising receiving a volume of fluid into a container having a series of volumetric markings for measuring a volume of sedimented red blood cells, identifying the blood volume marking corresponding to a volume of sedimented red blood cells in the fluid, and determining a volume of blood in the fluid wherein the volume of blood is determined according to the formula Vb=Vₘ/(Hct X ɳ) wherein Vb is the blood volume, Vₘ is the sedimented red blood cells, Hct is an average hematocrit, and ɳ is a cell packing ratio of the container. Identifying a blood volume marking corresponding to sedimented red blood cells and determining a volume of blood in a fluid are mental steps in that they only require viewing the container and recording the volume of sedimented red blood cells and blood volume based on the markings on the container. Additionally, independent claim 1 does not recite a practical application as nothing is done after the volume of blood in the fluid is determined. 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 receiving a fluid in a container having a series of markings based on a mathematical formula. As set forth in the MPEP a mathematical formula is not accorded protection of patent laws, thus the discovery of a mathematical formula cannot support a patent absent some other inventive concept in its application (MPEP 2106.04(a)(2). With respect to claims 4-10, the Examiner makes note of reference to Sauvignet et al., (US 2011/0147304), Chiattello (US 2018/0028431), and Van Ness et al., (US 2004/0029143) who teach polyDADMAC added to a container. As such, the limitation of adding a red blood flocculant to a container is also known in the art, and does not provide significantly more to the instant claims. Therefore, based on the limitations of the instant claims, the Examiner contends that claims 1-21 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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