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 Claims
This action is in reply to Applicant’s communication filed on July 28, 2025.
Claims 1 and 10-11 have been amended and are hereby entered.
Claims 1, 3-4 and 7-11 are currently pending and have been examined.
Foreign Priority
Acknowledgment is made of applicant's claim for foreign priority based on application
No. EP19212153.1 filed in Europe on 11/28/2019. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
A registration device (claims 1 and 10), configured for determining a patient id indicating an identity of the patient…and a first sample time point
An analyzer (claims 1 and 10) configured for determining a value of a medical biomarker from a biological sample for a medical test…
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Regarding Claim 1, Applicant’s specification recites that the registration device comprises a registration unit 31, in particular a scanner, configured for scanning the barcode 51 of the container 50 and further that the registration device 30 is configured to sample the time, for example of an internal clock of the registration device, at the time point at which the barcode 51 has been scanned by the registration device 30 (see page 13). Based off the 35 USC § 112(f) interpretation of claim 1 and Applicant’s description of the registration device, the Examiner will interpret “a registration device” to be any device capable of scanning a barcode and comprises an internal clock to sample the time at which the barcode is scanned. Claim 10 recites substantially similar limitations to those recited in claim 1 and will be interpreted under 35 USC § 112(f) for the basis and reasons as disclose above.
Further Regarding Claim 1, Applicant’s specification recites the following regarding the analyzer: The analyzer device 40 for example is a mobile analyzing device, like for example an AQT-analyzer, or a stationary analyzer in a laboratory (see page 16). Based off the 35 USC § 112(f) interpretation of claim 1 and Applicant’s description of the analyzer device, the Examiner will interpret “an analyzer” to be any stationary laboratory apparatus which is capable of performing the claimed functions. Claim 10 recites substantially similar limitations to those recited in claim 1 and will be interpreted under 35 USC § 112(f) for the basis and reasons as disclose above.
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, 3-4 and 7-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 analysis:
Claims 1 and 10 are directed to a system and a method respectively and therefore all fall into one of the four statutory categories (Step 1: Yes, the claims fall into one of the four statutory categories).
Step 2A analysis - Prong one:
The substantially similar independent system and method claims, taking claim 10 as exemplary, recite the following: determining a patient id indicating an identity of the patient and a first sample time point indicating a time of obtaining a first biological sample from the patient…,wherein the first sample time point is determined directly at the patient when obtaining the biological sample from the patient; determining a patient id and a second sample time point indicating a time of obtaining a second biological sample from the patient at a second time point different from the first sample time point; receiving the patient id and the first sample time point…; selecting…from a plurality of protocol rules each associated to a medical test, a protocol rule for the medical test relating to timing requirements of obtaining biological samples from the patient based on the determined medical test,…; determining a sample timing dependent on the protocol rule and the first sample time point; indicating when to obtain a second biological sample from the patient in compliance with the protocol rule; and providing a warning to a sample collector… when obtaining the second biological sample at a present time point is too early to gather a second of consecutive biological samples according to the protocol rule dependent on the determined sample timing, wherein the first biological sample and the second biological sample are provided…, …determining a value of a medical biomarker from a biological sample from the patient for the medical test, wherein a determined value of a medical biomarker of the second biological sample is marked as non-compliant when the second sample time point of the second biological sample does not comply with the determined sample timing.
The limitations above, as drafted, is a process that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for recitation of generic computer components. That is, other than reciting a system implemented by a processing system (computer), the claimed invention amounts to managing personal behavior or interaction between people. For example, but for the processing system, registration device, database, and analyzer, this claim encompasses a person collecting a sample from a patient and determining when a second sample should be obtained in the manner described in the identified abstract idea, supra. The Examiner notes that certain “method[s] of organizing human activity” includes a person’s interaction with a computer (see MPEP 2106.04(a)(2)(II)). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea. (Step 2A – Prong 1: Yes, the claims are abstract).
Step 2A analysis - Prong two:
Claims 1 and 10 recite the following additional elements beyond the abstract idea; a processing system communicatively connected to a registration device, a database and an analyzer. Based off the 35 USC § 112(f) interpretation of claims 1 and 10 as well as Applicant’s description of the registration device and the analyzer device, the Examiner interprets “a registration device” to be any device capable of scanning a barcode and comprises an internal clock to sample the time at which the barcode is scanned. Further, the Examiner will interpret “an analyzer” to be any stationary laboratory apparatus which is capable of performing the claimed functions. The claims are therefore applying generic computer components to the recited abstract limitations.
This judicial exception is not integrated into a practical application. In particular, the claims recite a processing system, a registration device, a database and an analyzer which are all recited at a high-level of generality (i.e., as a generic processor performing generic computer functions) such that it amounts to no more than mere instructions to apply the exceptions using a generic computer component. For example, Applicant’s specification explains that the processing system comprises a computer which receives input data, processes data, stores data, outputs data, connects to a network for communicating with additional devices, executes control functions, etc. (see Applicant’s specification pages 3-4, 6, 15). Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Therefore, Claims 1 and 10 are directed to an abstract idea without practical application. (Step 2A – Prong 2: No, the additional claimed elements are not integrated into a practical application).
Step 2B analysis:
For the next step of the analysis, it must be determined whether the limitations present in the claims represent a patent-eligible application of the abstract idea. A claim directed to a judicial exception must be analyzed to determine whether the elements of the claim, considered both individually and as an ordered combination are sufficient to ensure that the claim as a whole amounts to significantly more than the exception itself.
For the role of a computer in a computer implemented invention to be deemed meaningful in the context of this analysis, it must involve more than performance of well-understood, routine, and conventional activities previously known to the industry. Further, the mere recitation of a generic computer cannot transform a patent ineligible abstract idea into a patent-eligible invention. See MPEP 2106.05(d).
Applicant’s specification discloses the following:
Applicant describes embodiments of the disclosure at a very high level to include the use of a wide variety of processing systems and units, computers, devices, networks, analyzer devices and databases. (See Applicant’s specification pages 3, 15-16).
Generic computer components recited as performing generic computer functions that are well-understood, routine and conventional activities amount to no more than implementing the abstract idea with a computerized system.
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. The collective functions appear to be implemented using conventional computer systemization.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of a processing system, a registration device, a database and an analyzer to perform all of the steps discussed above amount to no more than mere instructions to apply the exceptions using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The claims do not provide an inventive concept significantly more than the abstract idea. Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. (Step 2B: No, the claims do not provide significantly more).
Dependent Claims 3-4, 7-9 and 11 further define the abstract idea that is presented in independent Claim 1 and are further grouped as certain methods of organizing human activity and are abstract for the same reasons and basis as presented above. Further, Claims 3-4 recite additional elements beyond the abstract idea. Claims 3-4 recite a display. These additional elements are recited at a high level of generality such that it amounts to no more than mere instructions to apply the exception using a generic computer component. For example, as noted above, the Applicant’s specification indicates the use of known analyzer devices. Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims do not recite additional elements that integrate the judicial exception into a practical application when considered both individually and as an ordered combination. Therefore, the dependent claims are also directed to an abstract idea.
Thus, Claims 1, 3-4 and 7-11 are rejected under 35 U.S.C. 101 as being directed to abstract ideas without significantly more.
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.
Claims 1, 3 and 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Basadonna et al. (US 20180284134) in view of Banerian (US 20190147987), further in view of Jackson (US 20100240079).
Regarding Claim 1, Basadonna discloses the following limitations:
A System for controlling a timing of consecutive biological samples from a patient for a medical test, comprising: a registration device configured for determining a patient id indicating an identity of the patient (Basadonna discloses systems and methods for performing consecutive high-sensitivity troponin (hsCTn) and conventional cardiac troponin (cCTn) tests (a medical test) for a subject (a patient). The system contains a port (a registration device) which receives a test consumable receptacle for a hsCTn or cCTn test. The port 210 is configured to read a tag (e.g., a barcode, RFID, etc.) (a patient id) on the test consumable receptacle so that the system can ascertain the type of test, phase of test, and/or kit that the test came from, which in turn can identify a particular patient (indicating an identity of the patient). – paras 34, 49, 57)
and a first sample time point indicating a time of obtaining a first biological sample from the patient at a first time point, wherein the first sample time point is determined directly at the patient when obtaining the first biological sample from the patient, (Basadonna discloses performing a first test on an initial sample (a time of obtaining a first biological sample from the patient) obtained from the subject (when obtaining the first biological sample from the patient) at the time the subject presents with acute coronary symptoms (a first sample time point). The tags can allow the system to track each patient and thus which phase the test is at (i.e., one-hour phase, two-hour phase, etc.) (a time of obtaining a first biological sample). – paras 32, 34, 75; FIG 3 item 110)
wherein the registration device is also configured for determining the patient id (Basadonna discloses that the port (the registration device) can read a barcode on the test consumable receptacle so that the system can ascertain the type of test, phase of test, and/or kit that the test came from (which in turn can identify a particular patient) (determining the patient id). – para 57)
and a second sample time point indicating a time of obtaining a second biological sample from the patient at a second time point different from the first sample time point; (Basadonna discloses performing a first test on an initial sample obtained from the subject. Then at the three-hour phase (a second sample time point… different from the first sample time point) (based off the time the subject presents with acute coronary symptoms (the first sample time point) a subsequent hsCTn test on a subsequent sample is performed (obtaining the second biological sample). – paras 21, 48-49; FIG. 2; FIG. 3 item 110)
a processing system, communicatively connected to the registration device, configured for receiving the patient id, the first sample time point, and the second sample time point from the registration device; (Basadonna discloses that the system contains a port 210 (the registration device) and a processor 250 (a processing system) in data communication with each other (communicatively connected to the registration device). The port 210 is configured to read a tag on the test consumable receptacle as described herein, for example so that the system can ascertain the type of test, phase of test (the first sample time point, and the second sample time point), and/or kit that the test came from (which in turn can identify a particular patient) (the patient id). – paras 57-58; FIG. 4B items 210 and 250; FIG. 6 items 210 and 250)
determining the medical test; (Basadonna discloses that the system can ascertain (determining) the type of test (the medical test). – para 57)
…a protocol rule for the determined medical test relating to timing requirements of obtaining biological samples from the patient based on the determined medical test; (Basadonna discloses systems and methods for performing hsCTn and cCTn tests in specific time-based phases where the time is based off when the patient presents with symptoms (a protocol rule for the determined medical test relating to timing requirements of obtaining biological samples from the patient). – para 49; FIG. 3 items 110, 120, 130)
determining a sample timing dependent on the protocol rule and the first sample time point, (Basadonna discloses that each phase is time-based (i.e., one-hour phase, three-hour phase, four-hour phase, etc.) (a sample timing) and dependent upon the time when the subject presents with acute coronary symptoms (the first sample time point). – paras 48-49, 55; FIG.3 items 110, 120, 130)
indicating when to obtain the second biological sample from the patient in compliance with the protocol rule, (Basadonna discloses that if the result of the first hsCTn test is positive 111, the method can comprise (indicating when) performing a second cCTn test on a second sample obtained from the subject (obtain the second biological sample) at a three-hour phase after the subject presents with acute coronary symptoms 120 (in compliance with the protocol rule). – paras 48-49, 58; FIG. 3 items 110, 120, 130)
and an analyzer, communicatively connected to the registration device and the processing system, configured for determining a value of a medical biomarker from a biological sample from the patient for the medical test, (Basadonna discloses that Troponins I and T can be used as biomarkers for diagnosing myocardial infarction (MI) (a value of a medical biomarker). (To perform hsCTn and cCTn tests, an immunoassay analyzer (an analyzer) is required. This position is further evidenced by Troponin test: Faster Triage with reliable results in 13-19 minutes 2018. See page 4). – para 18)
wherein a determined value of a medical biomarker of the second biological sample is marked as non-compliant when the second sample time point of the second biological sample does not comply with the determined sample timing. (Basadonna discloses that an alarm can be issued to a user (e.g. a health care provider), and/or the test can be disabled or prevented, and/or test results can be discarded or not saved or not used in the diagnostic algorithm (a medical biomarker of the second biological sample is marked as non-compliant), if the user attempts to perform a particular cardiac troponin test at an incorrect time (the second sample time point of the second biological sample does not comply with the determined sample timing). – para 49)
Basadonna does not disclose the following limitations met by Banerian:
requesting, from a database including a plurality of protocol rules each associated to a medical test, (Banerian teaches a test profile database (a database) containing electronically stored information (a plurality of protocol rules) including data regarding the relationships between blood tests, diagnosis, and related or commonly requested secondary and/or additional tests (each associated to a medical test). Further, information may be collected concerning blood laboratory procedures (a plurality of protocol rules). The central computer processor will use the information received from the data from the provider user interface and obtain relevant data from the test profile database (a database) and schedule database to establish parameters for the sample collection (a plurality of protocol rules). – paras 27, 29, 30, 33)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system for performing biological tests in time-based phases as disclosed by Basadonna to incorporate a test profile database as taught by Banerian in order to improve patient care and cut hospital costs (see Banerian para 11).
Basadonna and Banerian do not disclose the following limitations met by Jackson:
and providing a warning to a sample collector via the registration device when obtaining the second biological sample at a present time point is too early to gather a second of consecutive biological samples according to the protocol rule dependent on the determined sample timing; (Jackson teaches receiving at least first and second blood test samples spaced apart by a predetermined time interval/delay period (protocol rule dependent on the determined sample timing). Progress of the delay period may be indicated on a display using an LED light (providing a warning to a sample collector via the registration device), e.g., FIG. 3 shows an LED lights displaying that there is still “2 hours to go” before collecting the next blood sample (a present time point is too early to gather a second of consecutive biological samples according to the protocol rule).– abstract; paras 13-14, 72, 75, 102; FIG. 3 item 39)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the system for performing biological tests in time-based phases as disclosed by Basadonna to incorporate displaying the time until the next sample is to be collected as taught by Jackson in order to simplify administration of a predetermined glucose tolerance test protocol (see Jackson para 1).
Regarding Claim 3, Basadonna, Banerian and Jackson disclose all the limitations above and further disclose the following limitations:
The system of claim 1, wherein the registration device comprises a display, configured for displaying the warning provided by the processing system. (Basadonna discloses that in some embodiments, the system (which contains the port (the registration device)) further comprises a user-alert or reporting function (the warning provided by the processing system) and/or structure, such as a visible notice (e.g., on a screen or with a flashing light or a protruding or flagging device) (a display). – para58)
Regarding Claim 7, Basadonna, Banerian and Jackson disclose all the limitations above and further disclose the following limitations:
wherein the sample timing comprises a minimal time difference between the first sample time point and the second sample time point indicating a time of obtaining the second biological sample from the patient at the second sample time point different from the first sample time point in order to comply with the protocol rule. (Basadonna discloses that in some embodiments, the subsequent phase and therefore the collection of the subsequent sample (the second sample time point) can occur in a range of time such as 160-200 minutes (a minimal time difference) after the collection of the initial sample (the first sample time point). – para 39; FIG. 3 items 110, 120, 130)
Regarding Claim 8, Basadonna, Banerian and Jackson disclose all the limitations above and further disclose the following limitations:
wherein the requesting the protocol rule for the determined medical test comprises selecting the protocol rule for the medical test from the plurality of protocol rules of the database based on the determined medical test. (Banerian teaches that based on the data from the provider order user interface (dependent on the medical test) and obtained relevant data from the test profile database (the plurality of protocol rules of the database), the central computer processor determines (selecting the protocol rule for the medical test from the plurality of protocol rules) a schedule for receiving a patient blood sample, including the patient's identifying information, the patient's location, the type of draw required, the amount of blood to be samples, the schedule for test required, the schedule for predicted tests, and other parameters (the protocol rule for the determined medical test). – paras 27, 29-30, 35)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system for performing hsCTn and cCTn tests in time-based phases as disclosed by Basadonna to incorporate a test profile database as taught by Banerian in order to improve patient care and cut hospital costs (see Banerian para 11).
Regarding Claim 9, Basadonna, Banerian and Jackson disclose all the limitations above and further disclose the following limitations:
wherein the first biological sample and the second biological sample are blood samples. (Basadonna discloses that the tests performed on the subjects samples (the first biological sample and the second biological sample) are high-sensitivity troponin tests and conventional troponin tests in order to detect troponin in the patients’ blood (blood samples). – paras 18, 35)
Regarding Claim 10, this independent claim recites substantially similar limitations to those recited in claim 1 above; thus, the same rejection applies.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Basadonna et al. (US 20180284134) in view of Banerian (US 20190147987) in view of Jackson (US 20100240079), further in view of Kenig et al. (US 20200160995).
Regarding Claim 4, Basadonna, Banerian and Jackson disclose all the limitations above and further disclose the following limitations:
wherein the display is configured for displaying the warning… (Basadonna discloses that the user alert function (the warning) can be configured to produce a visible notice such as with a flashing light. – para 58)
Basadonna, Banerian and Jackson do not disclose the following limitations met by Kenig:
…in form of a colour code. (Kenig teaches a user interface display which displays a visualization of the patient status, wherein the patient status may include a color scale (e.g., red, yellow, green) (a colour code). – para 62)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the user alert function and visible flashing lights as disclosed by Basadonna to incorporate a visualization in the form of a color scale as taught by Kenig in order to narrow the diagnosis of the patient in the most efficient manner possible (see Kenig para 57).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Basadonna et al. (US 20180284134) in view of Banerian (US 20190147987) in view of Jackson (US 20100240079), further in view of Stanford (Medical history questionnaire. Stanford Blood Center. (2018, April 13). https://stanfordbloodcenter.org/medical-history-questionnaire/).
Regarding Claim 11, Basadonna, Banerian and Jackson disclose all the limitations above, however do not disclose the following limitations met by NHS:
The method of claim 10, wherein: the method comprises, prior to providing the warning to the registration device and before the second biological sample is obtained, making a prematureness determination, wherein the prematureness determination is a determination of whether the present time is too early for obtaining the second biological sample based on the selected protocol rule for the medical test and the determined sample timing; and the act of providing the warning to the registration device is performed based on the prematureness determination before the second biological sample is obtained. (Stanford teaches that a person wanting to donate blood is asked a series of questions in order to determine donor eligibility. This includes first time blood donors as well as repeat donors (prior to providing the warning to the registration device and before the second biological sample is obtained). Question #8: “in the past 8 weeks have you donated blood, platelets or plasma?” is asked and the person seeking eligibility must answer yes or no, establishing a minimum amount of time between donating blood, platelets or plasma (making a prematureness determination, wherein the prematureness determination is a determination of whether the present time is too early for obtaining the second biological sample based on the selected protocol rule for the medical test and the determined sample timing). If the answer is yes, then the person must call a phone number to determine eligibility (the act of providing the warning is performed based on the prematureness determination before the second biological sample is obtained). See also question #29. Further, the person must certify that they understand that their blood will be tested (the medical test) for evidence of exposure to infectious agents that can be transmitted through transfusion when donating blood. – page 1; page 2 question 8; page 3 question 29)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the system for performing biological tests in time-based phases as disclosed by Basadonna to incorporate a questionnaire including a time requirement between collecting blood, platelets or plasma as taught by Stanford in order to determine donor eligibility prior to the donation taking place (see Stanford page 1, paragraph 1).
Response to Arguments
Regarding rejections under 35 USC § 112(a) to Claim 11, Applicant’s arguments have been fully considered and are persuasive regarding sufficient description and support in Applicant’s specification for limitations in claim 11. Examiner has withdrawn the rejection.
Regarding rejections under 35 USC § 101 to Claims 1, 3-4 and 7-11, Applicant’s arguments have been fully considered, and are not persuasive. The rejection has been updated in light of latest amendments. Applicant argues:
(a) applicant submits that the rejections under 35 U.S.C. § 101 are improper and should be withdrawn. In response, the applicant submits that this is improper because it does not account for the fact none of the examples of "managing personal behavior including following rules or instructions" - i.e., the specific type of organizing human activity the Office Action asserted was covered by the present claim - provide for improvements in tangible, physical things, while the present claims - which result in collection of more usable biological samples - do. Given that the Federal Circuit has found a method which provides such an improvement can be eligible even when every step of the method is performed by human beings, the applicant submits that failure to consider this characteristic was an error, and that, when it is considered, the rejections under 35 U.S.C. § 101 should be reconsidered and withdrawn because the claims cannot properly be treated as reciting an abstract idea. (p. 7-8).
Regarding (a), Examiner respectfully disagrees. MPEP 2106.04(a)(2)(II) states that a claimed invention is directed to certain methods of organizing human activity if the identified claim elements contain limitations that encompass fundamental economic behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). The Examiner submits that the identified claim elements represent a series of rules or instructions that a person or persons, with or without the aid of a computer, would follow to collect timed biological samples from a patient. For example, but for the processing system, registration device, database, and analyzer, the claim encompasses a person collecting a biological sample from a patient and determining when a second sample should be obtained from the patient in the manner described in the identified abstract idea, supra. Applicant has not pointed to anything in the claims that fall outside of this characterization. Because the claim elements fall under a series of rules or instruction that a person or persons would follow to collect timed biological samples from a patient, the claimed invention is directed to an abstract idea.
Further, MPEP 2106.04(d)(1) and MPEP 2106.05(a) indicate that a practical application may be present where the claimed invention provides a technical solution to a technical problem. See, e.g., DDR Holdings, LLC. V. Hotels.com, L.P., 773 F.3d 1245, 1259 (Fed. Cir. 2014). MPEP 2106.04(d)(1) states that a practical application may be present where the claimed invention improves the functioning of a computer. See also MPEP2106.05(a)(I). The technological environment of Applicant’s claim is a general-purpose computer (see Applicant’s Spec. pages 3, 15-16). Applicant has not identified nor can the Examiner locate any physical improvement to the functioning of the computer that results from the implementation of Applicant’s claim. There is no indication that the computer is made to reduce computing resources or network load. In fact, the computer may be caused to operate less efficiently through the implementation of Applicant’s claimed invention; we do not know. Further, the Examiner cannot find, nor has the Applicant identified, any technological problem that was caused by the technological environment to which the claims are confined. Because there is no improvement to the functioning of the computer, nor a technical solution being provided for a technical problem, a practical application is not present.
Regarding rejections under 35 USC § 103 to Claims 1, 3-4 and 7-11, Applicant’s arguments have been fully considered and are persuasive regarding the newly added limitations to independent claims 1 and 10. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection necessitated by Applicant’s amendments is made in view of Jackson (US 20100240079), as per the rejection above.
Applicant further argues the following regarding rejections under 35 USC § 103 to Claim 11:
(b) Additionally, the applicant notes that amended claim 11 recites that the warning is provided based on a prematureness determination based on a selected protocol for a medical test, and that the blood donation questionnaire is entirely unrelated to such a medical test protocol as recited in claim 11. As a result, the applicant submits that the rejection of claim 11 should be reconsidered and withdrawn based on the additional features recited in that claim, even if the arguments set forth above regarding claim 10 are not found to be persuasive. (p. 10).
Regarding (b), Examiner respectfully disagrees. Amended claim 11 recites wherein the prematureness determination is a determination of whether the present time is too early for obtaining the second biological sample based on the selected protocol rule for the medical test and the determined sample timing; and the act of providing the warning to the registration device is performed based on the prematureness determination before the second biological sample is obtained. Examiner relies upon Stanford to teach these limitations. Stanford teaches providing a medical questionnaire to people who desire to donate blood. The donation process includes a blood test (the medical test) prior to obtaining a blood donation and when a person donates multiple times there is a waiting period between donations (e.g., see page 2 question 8). Therefore, the Examiner notes that the blood donation questionnaire is related to a medical test and a respective protocol. See updated rejection above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/K.E.V./Examiner, Art Unit 3681
/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681