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 and amendments, filed 8/19/2026, with respect to the rejection(s) of claims 1 – 20 under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Olson et al. (US 2019/0331703 A1) have been fully considered, but are moot due to the new grounds of rejection necessitated by Applicant’s amendment. The previous rejection has been withdrawn, and a new ground(s) of rejection is made in view of Karli et al. (US 2012/0237490 A1). To the extent possible, Applicant’s arguments have been fully addressed in the rejections below.
Applicant canceled claims 8 and 17.
Applicant added new dependent claims 21 and 22.
No claims are allowed.
Note Regarding Prior Art
Examiner cites particular sections, columns, line numbers, paragraphs and figures, in the references as applied to the claims below for the convenience of the Applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the Applicant fully consider the references in their entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 – 7, 9 – 16 and 18 – 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Olson et al. (US 2019/0331703 A1; hereinafter “Olson”) in view of Karli et al. (US 2012/0237490 A1; hereinafter “Karli”).
Regarding claim 1, Olson teaches a method for processing a blood sample contained in a container in a test system (sample preparation device 10; paragraph 21; figures 1 – 3 and 5A – 5C), the method comprising:
setting a clotting start time for the blood sample and/or the container (e.g., the set period of time is intended to match the clotting time; paragraph 47);
setting a clotting wait time to allow the blood sample to clot (the staging module 40 is configured to hold multiple sample containers 90 for a set period of time. Typically, the set period of time is sufficient to allow the blood in the sample container to further clot; paragraph 40); and
c) on positive determination of completion of the clotting wait time, automatically providing the blood sample to a centrifuge coupled to the test system (the staging module 40 can release the sample container to one of the storage compartments 19a, 19b or to the centrifugation module 70; paragraph 41), wherein a time of a withdrawal of the blood sample into the container is obtained from a sample related data source, and wherein at least one statement from the following group of statements is true:
i) the clotting start time is set as the time of withdrawal of the blood sample into the container (a collection technician extracts blood and into sample container 90, then the scanning module 60 scans the identifier 99 on the sample container. The scanning module 90 transmits the time the sample container 90 is gripped and information, such as sample ID, to the controller 90; paragraphs 44 and 47); and
ii) the clotting wait time is set based on at least the time of withdrawal of the blood sample into the container (a collection technician extracts blood and into sample container 90, then the scanning module 60 scans the identifier 99 on the sample container. The scanning module 90 transmits the time the sample container 90 is gripped and information, such as sample ID, to the controller 90; paragraphs 44 and 47).
Olson does not explicitly teach wherein the clotting time is entered, received and/or provided via a user interface coupled to the test system.
Olson does teach wherein the clotting wait time can vary (the set period of wait time, or period of time to allow for the blood in the sample container 90 to further clot, can differ based on the sample type, additive type and environmental conditions (paragraphs 40 – 42, 47 and 48; claims 1, 17 and 20); according to the CLSI-GP44 standard, the set period of time is intended to match the clotting time; paragraph 47), and that the disclosed method employs a computer system (the use of a controller 80 including a processor 82 and memory 84, which constitutes a computer; paragraph 22). Although Olson teaches that the wait period is automated and their disclosed method operates automatically, it would have been within the ambit of a person of ordinary skill in the art to manually provide clotting wait time to the test system. It would have been considered logical to offer the option of entering and setting the clotting wait time manually depending on the sample conditions and requirements as indicated by Olson. The rationale to support an obviousness rejection under 35 U.S.C. 103 may rely on logic and sound scientific principle (see MPEP § 2144.02). Furthermore, there would be a reasonable expectation for success in setting the clotting wait time manually in order to provide an optimal and effective wait time in order to allow for sample clotting to occur. The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success (see MPEP § 2143.02). The Applicant is further advised that the recent Supreme Court decision in KSR International Co. v. Teleflex Inc., 550 U.S. 82 USPQ2d 1385 (2007) forecloses the argument that a specific teaching, suggestion or motivation is required to support a finding of obviousness. See Ex parte Smith, USPQd, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007). An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide wherein the clotting time is entered, received and/or provided manually to the test system.
Karli further teaches system for processing plasma comprising a computer system 1400 having a processor 1401 and one or more input devices including a keyboard (paragraph 131). Consequently, as evidenced by Karli, providing a user interface coupled to the test system would have been considered to be suitable and predictable to a person of ordinary skill in the art. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Furthermore, the Supreme Court decision in KSR International Co. v. Teleflex Inc., 550 U.S. 82 USPQ2d 1385 (2007) has affirmed that the threshold requirement for a prima facie case of obviousness is “demonstrating that each element was, independently, known in the prior art.” In addition, the Supreme Court noted in KSR that although the test “captured a helpful insight,” an obviousness analysis “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person or ordinary skill in the art would employ.” See 127 S. Ct. at 1741, 82 USPQd at 1396. The Courts have made clear that the teaching, suggestion, or motivation test is flexible and an explicit suggestion to combine the prior art is not necessary. The motivation to combine may be implicit and may be found in the knowledge of one of ordinary skill in the art, or, in some cases, from the nature of the problem to be solved. Id. at 1366, 80 USPQ2d at 1649. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide wherein the clotting time is entered, received and/or provided via a user interface coupled to the test system. Examiner submits that these arguments are in line with the Supreme Court unanimous opinion, KSR International v. Teleflex, Inc., 127 S. Ct. 1727, 1741 (2007), in which the Court stated that “[a] court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions.” Id. at 1731.
Regarding claim 2, Olson teaches the method as claimed in claim 1, wherein the clotting start time is set as at least one of:
a) the time of withdrawal of the blood sample into the container (a collection technician extracts blood and into sample container 90, then the scanning module 60 scans the identifier 99 on the sample container. The scanning module 90 transmits the time the sample container 90 is gripped and information, such as sample ID, to the controller 90; paragraphs 25, 44 and 47); and
b) a time of loading the container containing the blood sample onto the test system (the scanning module 60 transmits the time that the sample container 90 is gripped; paragraph 45).
Regarding claim 3, Olson teaches the method as claimed in claim 1, wherein the clotting wait time is determined based on at least one of:
a) the time of withdrawal of the blood sample into the container (a collection technician extracts blood and into sample container 90, then the scanning module 60 scans the identifier 99 on the sample container. The scanning module 90 transmits the time the sample container 90 is gripped and information, such as sample ID, to the controller 90; paragraph 44);
b) a time of loading the blood sample in the container onto the test system (the scanning module 60 transmits the time that the sample container 90 is gripped; paragraph 45);
c) addition of at least one clotting agent to the blood sample and/or the container (the set period of time may differ based on the sample type, additive type and environmental conditions; paragraph 41); and
g) a predefined clotting wait time, optionally as specified by the test system manufacturer (paragraph 47).
Regarding claim 4, Olson teaches the method as claimed in claim 3, wherein:
the clotting wait time is determined based on the at least one patient specific coagulation parameter (paragraphs 4, 5, 25, 40 – 42 and 47).; and
the at least one patient specific coagulation parameter is derived from at least one of an electronic medical record (EMR), a Laboratory Information System (LIS), a Hospital Information System (HIS), and any other Personal Health Information (PHI) (the CLSI-GP44 standard is followed for sample handling, processing and preparation; paragraphs 4, 5, 25, 40 – 42 and 47).
Regarding claim 5, Olson teaches the method as claimed in claim 1, further comprising monitoring the clotting wait time with a timer of the test system (the controller 80 is also configured to monitor the time that the sample container 90 is held in the rack 42 of the staging module 402; paragraph 40).
Regarding claim 6, Olson teaches the method as claimed in claim 1, further comprising
a) subjecting the container comprising the blood sample to a centrifugation step to segregate a serum from a residual clot (separate serum from whole blood via centrifugation; paragraph 26); and
b) providing the serum to at least one test station, the at least one test station being part of or connected to the test system, for further analysis, preferably wherein the test station is a blood serum analyzer (prepare samples for testing and analysis via a test analyzer; paragraph 21).
Regarding claim 7, Olson teaches the method as claimed in claim 3, wherein at least one clotting agent is comprised in or added to the blood sample, which is configured to reduce the clotting wait time for the blood sample (EDTA containers must be inverted 10 times after collection to ensure proper mixing between whole blood and the K2EDTA anticoagulant; paragraph 26).
Regarding claim 9, Olson teaches method as claimed in claim 1, wherein:
the clotting wait time is selected, computed and/or determined automatically by the test system (according to the CLSI-GP44 standard, the set period of time is intended to match the clotting time; paragraph 47); and
entering, receiving and/or providing the clotting wait time via the use interface comprises modifying the clotting wait time selected, computed and/or determined automatically by the test system based on input from the user interface (the rejection for claim 1 applies here as well. The clotting wait time can be modified depending on sample type and environmental conditions).
Regarding claim 10, Olson teaches the method as claimed in claim 3, wherein the clotting wait time is adjusted to be either longer than or shorter than a predefined default clotting wait time based on the at least one patient specific coagulation parameter (according to the CLSI-GP44 standard, the set period of time is intended to match the clotting time, and can be adjusted within certain ranges depending on various conditions (e.g., whether additives are added to the sample or not, or different clot activators); paragraphs 25, 46 and 47).
Regarding claim 11, Olson teaches the method as claimed in claim 1, wherein the container is held in a vertical position during the clotting wait time, wherein a top of the container is either open or closed with a cap, a lid, a stopper, a film, or any other container closing structure (the sample container 90 includes a cap 98 that can close off the upper end 94 of the sample container 90; paragraph 24).
Regarding claim 12, Olson teaches method as claimed in claim 1, wherein the sample related data source is a unique identifier comprising at least one of a bar code, a MEMS, smart dust, an RFID chip or a NFC chip coupled to the container (the scanning module 60 is used to scan the identifier 99 of the sample container 90; paragraphs 25, 27, 46 and 47).
Regarding claim 13, Olson teaches a laboratory test system (sample preparation device 10; paragraph 21; figures 1 – 3 and 5A – 5C) comprising:
a) a container storage (sample preparation module 20 and sample staging module 40) for storing at least one container (process sample containers 90) containing a blood sample (paragraph 24) for a duration of a clotting wait time (paragraphs 40, 41 and 47);
b) an automated sample conveyance system (e.g., actuator 126; paragraphs 34 – 39) coupled to one or more test stations (staging module 40; paragraph 47); and the conveyance system configured to convey the at least one container to at least one of the one or more test stations, and
c) a processor (controller 80; paragraphs 22 and 23) configured to:
i) set a clotting start time for the blood sample and/or the container (e.g., the set period of time is intended to match the clotting time; paragraph 47);
ii) set a clotting wait time to allow the blood sample to clot (the staging module 40 is configured to hold multiple sample containers 90 for a set period of time. Typically, the set period of time is sufficient to allow the blood in the sample container to further clot; paragraph 40); and
iii) on positive determination of completion of the clotting wait time, automatically providing the blood sample to a centrifuge coupled to the test system (centrifuge module 70; paragraphs 41 – 43);
wherein a time of a withdrawal of the blood sample into the container is obtained from a sample related data source (a collection technician extracts blood and into sample container 90, then the scanning module 60 scans the identifier 99 on the sample container. The scanning module 90 transmits the time the sample container 90 is gripped and information, such as sample ID, to the controller 90; paragraphs 44, 46 and 47), and
wherein at least one statement from the following group of statements is true:
the clotting start time is set as the time of withdrawal of the blood sample into the container (paragraphs 44 and 47); and
the clotting wait time is set based on at least the time of withdrawal of the blood sample into the container (paragraphs 44 and 47).
Olson does not explicitly teach wherein the laboratory test system is configured to receive the clotting wait time via a user interface. However, the same rationale for the rejection of claim 1 for including a user interface coupled to the test system above applies here as well. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide wherein the laboratory test system is configured to receive the clotting wait time via a user interface.
Regarding claim 14, Olson teaches laboratory test system as claimed in claim 13, wherein the processor is
configured to set the clotting start time based on at least one of:
a) the time of withdrawal of the blood sample into the container (a collection technician extracts blood and into sample container 90, then the scanning module 60 scans the identifier 99 on the sample container. The scanning module 90 transmits the time the sample container 90 is gripped and information, such as sample ID, to the controller 90; paragraphs 44 and 47); and
b) a time of loading the container containing the blood sample onto the test system (a collection technician extracts blood and into sample container 90, then the scanning module 60 scans the identifier 99 on the sample container. The scanning module 90 transmits the time the sample container 90 is gripped and information, such as sample ID, to the controller 90; paragraphs 44, 46 and 47).
Regarding claim 15, Olson teaches laboratory test system as claimed in claim 13, wherein the processor is configured to determine the clotting wait time based on at least one of:
a) the time of withdrawal of the blood sample into the container (a collection technician extracts blood and into sample container 90, then the scanning module 60 scans the identifier 99 on the sample container. The scanning module 90 transmits the time the sample container 90 is gripped and information, such as sample ID, to the controller 90; paragraphs 44, 46 and 47);
b) a time of loading the blood sample in the container onto the test system (a collection technician extracts blood and into sample container 90, then the scanning module 60 scans the identifier 99 on the sample container. The scanning module 90 transmits the time the sample container 90 is gripped and information, such as sample ID, to the controller 90; paragraphs 44, 46 and 47);
c) addition of at least one clotting agent to the blood sample and/or the container (paragraph 47);
f) at least one patient specific coagulation parameter (the CLSI-GP44 standard is followed for sample handling, processing and preparation; paragraphs 4, 5 and 41); and
g) a predefined clotting wait time, optionally as specified by the test system manufacturer (according to the CLSI-GP44 standard, the set period of time is intended to match the clotting time; paragraph 47).
Regarding claim 16, Olson teaches the laboratory test system as claimed in claim 15, wherein:
a) the processor is configured to determine the clotting wait time based on the at least one patient specific coagulation parameter (paragraphs 4, 5, 25, 40 – 42 and 47); and
b) the at least one patient specific coagulation parameter is derived from at least one of an electronic medical record (EMR), a laboratory information system (LIS), a hospital information system (HIS), and any other personal health information (PHI) (the CLSI-GP44 standard is followed for sample handling, processing and preparation; paragraphs 4, 5, 25 and 41).
Regarding claim 18, Olson teaches the laboratory test system as claimed in claim 13, wherein:
a) the test system is configured to automatically select, compute and/or determine the clotting wait time (paragraphs 41, 42 and 47); and
b) receiving the clotting wait time via a user interface comprises modifying the clotting wait time selected, computed and/or determined automatically by the test system based on input from the user interface (the rejection for claim 1 applies here as well. The clotting wait time can be modified depending on sample type and environmental conditions).
Regarding claim 19, Olson teaches a computer-readable medium (paragraph 22; figure 8) comprising instructions which, when executed by a processor of a computing device (controller 80) associated with a test system (sample preparation device 10; paragraph 21; figures 1 – 3 and 5A – 5C), causes the test system to:
a) set a clotting start time for a blood sample and/or a container (e.g., the set period of time is intended to match the clotting time; paragraph 47), wherein the clotting start time is set as at least one of:
i) a time of a withdrawal of the blood sample into the container (a collection technician extracts blood and into sample container 90, then the scanning module 60 scans the identifier 99 on the sample container. The scanning module 90 transmits the time the sample container 90 is gripped and information, such as sample ID, to the controller 90; paragraphs 25, 44 and 47); and
ii) a time of loading the container containing the blood sample onto the test system (a collection technician extracts blood and into sample container 90, then the scanning module 60 scans the identifier 99 on the sample container. The scanning module 90 transmits the time the sample container 90 is gripped and information, such as sample ID, to the controller 90; paragraphs 44 and 47);
b) set a clotting wait time to allow the blood sample to clot (paragraphs 40 and 47); and
c) on positive determination of completion of the clotting wait time (paragraphs 40 and 47), automatically providing the blood sample to a centrifuge coupled to the test system (the staging module 40 can release the sample container to one of the storage compartments 19a, 19b or to the centrifugation module 70; paragraph 41); wherein the time of the withdrawal of the blood sample into the container is obtained from a sample related data source (The scanning module 90 transmits the time the sample container 90 is gripped and information, such as sample ID, to the controller 90; paragraphs 44, 46 and 47); and wherein at least one statement from the following group of statements is true:
i) the clotting start time is set as the time of withdrawal of the blood sample into the container (paragraphs 40, 41 and 47); and
ii) the clotting wait time is set based on at least the time of withdrawal of the blood sample into the container (paragraphs 40, 41 and 47).
Olson does not explicitly teach wherein the medium comprises instructions which when executed by the processor cause the test system to receive the clotting wait time via a user interface. However, the same rationale for the rejection of claim 1 for including a user interface coupled to the test system above applies here as well. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide wherein the medium comprises instructions which when executed by the processor cause the test system to receive the clotting wait time via a user interface.
Regarding claim 20, Olson teaches computer-readable medium as claimed in claim 19, wherein the processor is configured to determine the clotting wait time based on at least one of:
a) the time of withdrawal of the blood sample into the container (paragraphs 44 and 47);
b) a time of loading the blood sample in the container onto the test system (paragraphs 44 and 47);
c) addition of at least one clotting agent to the blood sample and/or the container (the set period of time may differ based on the sample type, additive type and environmental conditions; paragraph 41);
f) at least one patient specific coagulation parameter (the CLSI-GP44 standard is followed for sample handling, processing and preparation; paragraphs 4, 5, 25 and 41); and
g) a predefined clotting wait time, optionally as specified by the test system manufacturer (according to the CLSI-GP44 standard, the set period of time is intended to match the clotting time; paragraph 47).
Regarding claim 21, Olson does not specifically teach the method of claim 9, wherein the method comprises displaying, on the user interface, one or more factors which may impact the clotting waiting time selected, computed and/or determined automatically by the test system.
Olson does teach that the clotting wait time period can be automated (paragraph 42), and that various factors can impact the clotting wait time (paragraphs 40 – 42 and 47).
Karli further teaches that the computer system 1400 comprises a display 1432 (paragraph 131).
It would have been within the ambit of a person of ordinary skill in the art to also display one or more factors which may impact the clotting wait time selected, computed and/or determined automatically by the test system. It would also have been considered to be suitable and predictable to a person of ordinary skill in the art to provide a display with the user interface. The rationale to support an obviousness rejection under 35 U.S.C. 103 may rely on logic and sound scientific principle (see MPEP § 2144.02). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success (see MPEP § 2143.02). The Applicant is further advised that the recent Supreme Court decision in KSR International Co. v. Teleflex Inc., 550 U.S. 82 USPQ2d 1385 (2007) forecloses the argument that a specific teaching, suggestion or motivation is required to support a finding of obviousness. See Ex parte Smith, USPQd, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007). An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide wherein the method comprises displaying, on the user interface, one or more factors which may impact the clotting waiting time selected, computed and/or determined automatically by the test system.
Regarding claim 22, Olson does not specifically teach the laboratory test system of claim 18, wherein the processor is configured to display, on the user interface, one or more factors which may impact the clotting waiting time selected, computed and/or determined automatically by the test system. However, the same rationale for the rejection of claim 21 applies here as well. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide wherein the processor is configured to display, on the user interface, one or more factors which may impact the clotting waiting time selected, computed and/or determined automatically by the test system.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J. SINES whose telephone number is (571)272-1263. The examiner can normally be reached 9 AM-5 PM EST M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth A Robinson can be reached at (571) 272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BRIAN J. SINES
Primary Patent Examiner
Art Unit 1796
/BRIAN J. SINES/Primary Examiner, Art Unit 1796
