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 7, 2026 have been fully considered but they are not persuasive. Applicant has amended independent claim 1 to recite scanning a QR code affixed to a container to obtain a red blood cell packing ratio of the container, and argued that the step of scanning a QR code overcomes the rejection under 35 U.S.C. 101. The Examiner respectfully disagrees.
Independent claims 1 and 8 are directed to an abstract idea in that the determining step only requires analyzing results from the computing device. In support of this view, the Examiner points to MPEP 2106.04(a)(2) III) which states that performing a mental process on a generic computer, and using a computer as a tool to perform a mental process is an abstract idea. As such, the Examiner contends that utilizing a generic computer to perform a process that includes an abstract idea does not render the claims patent eligible. With respect to the scanning step, the Examiner notes that QR codes are well-established and routine technology that are prevalent in various industries, including healthcare. Given this view, the Examiner contends that scanning a QR code is insignificant extra-solution activity and not a meaningful technological improvement. In support of this view, the Examiner makes note of references to Burkholz et al., (US 2023/0360790) and Olson et al., (US 2019/0331703) who teach QR codes attached to blood sampling devices. Burkholz et al., teach identification tags attached to containers and/or blood sampling devices wherein the identification tag can be a QR code (paragraph 0075). Burkholz et al., also teach the identification tag comprising information about a container (paragraph 0075). Reference to Olson et al., teach a sample preparation device wherein a sample container includes a QR code as an identifier (paragraph 0025). Olson et al., teach the QR code containing information related to both the sample container, and the sample contained within the container (paragraph 0025). As such, the Examiner contends that providing QR codes on a container wherein the QR code encodes information related to the container is known in the art, thus a step of scanning a QR code to obtain information about a container is deemed to be insignificant extra-solution activity.
Applicant has also argued that utilizing the claimed formula amounts to significantly more than the judicial exception. The Examiner notes that the claimed formula is being read as a mathematical calculation that is performed on a generic computer (MPEP 2106.05 A). Given this view, the Examiner contends that the claimed formula does not amount to significantly more than the judicial exception.
Therefore, based on the limitations of the instant claims, the Examiner contends that claims 1-13 are directed to an abstract idea without significantly more, thus the claims are ineligible 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 1-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to 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 1 is directed to a method for determining a volume of blood in a fluid comprising scanning a QR code affixed to a container wherein the QR code provides a red blood cell packing ratio of the container, identifying a numerical volume of settled and/or sedimented red blood cells in a fluid in a container, a hematocrit, and a red blood cell packing ratio of the container, inputting the numerical volume of settled and/or sedimented red blood cells into a user interface, determining a numerical volume of blood in the fluid using a computing device having an executable program that applies an algorithm Vb = Vm/(Hct x ɳ) wherein Vb is the numerical volume of blood, Vm is the numerical volume of settled and/or sedimented red blood cells, Hct is an average blood hematocrit, and ɳ is the red blood cell packing ratio of the container. Determining a numerical volume of blood in a fluid is an abstract idea in that it only requires analyzing results from the claimed computing device. The Examiner notes that mental processes performed on a computer are patent ineligible where there is nothing in the claims that foreclose them from being performed by a human mentally, or with pen and paper (MPEP 2106.04(a)(2) III). Additionally, the Examiner notes that using a computer as a tool to perform a mental process when the process steps are recited at a high level of generality and merely uses the computer as a tool to perform the process is also a mental step (MPEP 2106.04(a)(2) III). In the instant case, the steps of identifying and determining are recited at a high level of generality. The computing device recited in the instant claims is also recited at a high level of generality as the claims merely recite a computing device, a graphical user interface, and an executable program. As such, the Examiner contends that utilizing a generic computer to perform a process the includes an abstract idea does not render the claims patent eligible. 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 scanning a QR code to obtain a red blood cell packing ratio of the container, identifying a numerical volume of settled and/or sedimented red blood cells in a fluid, inputting the numerical volume of red blood cells into a graphical user interface, and providing an electronic display of the numerical volume of blood. Identifying, inputting, and displaying data into/on a user interface is well known, and practiced widely throughout the art as evidenced by references to Satish et al., (US 2013/0303870) and Fletcher-Haynes et al., (US 2005/0209883). Additionally, scanning a QR code to obtain information about a container is insignificant extra-solution activity and not a meaningful technological improvement. In support of this view, the Examiner makes note of references to Burkholz et al., (US 2023/0360790) and Olson et al., (US 2019/0331703) who teach QR codes attached to blood sampling devices. Burkholz et al., teach identification tags attached to containers and/or blood sampling devices wherein the identification tag can be a QR code (paragraph 0075). Burkholz et al., also teach the identification tag comprising information about a container (paragraph 0075). Reference to Olson et al., teach a sample preparation device wherein a sample container includes a QR code as an identifier (paragraph 0025). Olson et al., teach the QR code containing information related to both the sample container, and the sample contained within the container (paragraph 0025). As such, the Examiner contends that providing QR codes on a container wherein the QR code encodes information related to the container is known in the art, thus a step of scanning a QR code to obtain information about a container is deemed to be insignificant extra-solution activity. As such, the Examiner contends that the additional limitations of independent claim 1 do not amount to significantly more than the abstract idea. Therefore, based on the limitations of the instant claims, the examiner contends that claims 1-7 are directed to an abstract idea without significantly more, and therefore are directed to ineligible subject matter under 35 U.S.C. 101.
Claims 8-13 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 that imposes a meaningful limit on the exception. Independent claim 8 is directed to a method for approximating blood volume loss from a subject comprising, introducing a fluid from a subject comprising red blood cells into a container, scanning a QR code affixed to the container wherein the QR code provides a value for red blood cell packing ratio for the container, providing through a user interface, a value for a volume of settled and/or sedimented red blood cells from a fluid, a value for an average blood hematocrit, approximating via a computing device a numerical volume of blood loss from the subject using the algorithm is Vb = Vm/(Hct x ɳ) wherein Vb is the blood volume, Vm is the volume of settled and/or sedimented red blood cells, Hct is an average blood hematocrit, and ɳ the red blood cell packing ratio for a container, and transmitting the volume of blood loss to the user interface over a network. Approximating a volume of blood loss from a subject is a mental step is an abstract idea in that it only requires analyzing results from the claimed computing device. The Examiner notes that mental processes performed on a computer are patent ineligible where there is nothing in the claims that foreclose them from being performed by a human mentally, or with pen and paper (MPEP 2106.04(a)(2) III). Additionally, the Examiner notes that using a computer as a tool to perform a mental process when the process steps are recited at a high level of generality and merely uses the computer as a tool to perform the process is also a mental step (MPEP 2106.04(a)(2) III). In the instant case, the steps of receiving and approximating are recited at a high level of generality. The computing device recited in the instant claims is also recited at a high level of generality as the claims merely recite a computing device, a user interface, a network, and an executable program. As such, the Examiner contends that utilizing a generic computer to perform a process the includes the abstract idea does not render the claims patent eligible. The claim(s) docs/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 scanning a QR code affixed to a container wherein the QR code provides a red blood cell packing ratio of the container, providing over a network a volume of settled and/or sedimented red blood cells, an average blood hematocrit, and transmitting a volume of blood loss over the network. Receiving, transmitting, and displaying data into/on a user interface is well known, and practiced widely throughout the art as evidenced by references to Satish et al., (US 2013/0303870) and Fletcher Haynes et al., (US 2005/0209883). Additionally, scanning a QR code to obtain information about a container is insignificant extra-solution activity and not a meaningful technological improvement. In support of this view, the Examiner makes note of references to Burkholz et al., (US 2023/0360790) and Olson et al., (US 2019/0331703) who teach QR codes attached to blood sampling devices. Burkholz et al., teach identification tags attached to containers and/or blood sampling devices wherein the identification tag can be a QR code (paragraph 0075). Burkholz et al., also teach the identification tag comprising information about a container (paragraph 0075). Reference to Olson et al., teach a sample preparation device wherein a sample container includes a QR code as an identifier (paragraph 0025). Olson et al., teach the QR code containing information related to both the sample container, and the sample contained within the container (paragraph 0025). As such, the Examiner contends that providing QR codes on a container wherein the QR code encodes information related to the container is known in the art, thus a step of scanning a QR code to obtain information about a container is deemed to be insignificant extra-solution activity. As such, the Examiner contends that the additional limitations of independent claim 8 do not amount to significantly more than the abstract idea. Therefore, based on the limitations of the instant claims, the examiner contends that claims 8-13are 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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