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 .
Detailed Action
This is the Final Action for application 18/014901 response filed 03/31/2026.
Claims 1-17, 19, 27 & 37 are pending.
Claims 1-17 & 19 have been elected and fully considered.
Claims 27 & 37 are withdrawn from consideration.
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 1-17 & 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Independent Claims 1, & 15 claims are directed towards a machine.
For independent claims 1 & 15 it is considered whether the computer readable medium which includes transitory and non-transitory computer readable medium is eligible under Step 1.
See MPEP 2106 II- “For example, the broadest reasonable interpretation (BRI) of machine-readable/computer readable media, including the claimed “computer readable storage medium,” claimed can encompass non-statutory transitory forms of signal transmission, such as a propagating electrical or electromagnetic signal per se. See In re Nuijten, 500 F.3d 1346, 84 USPQ2d 1495 (Fed. Cir. 2007).
When the BRI encompasses transitory forms of signal transmission, a rejection under 35 U.S.C. 101 as failing to claim statutory subject matter would be appropriate.
Thus, a claim to a computer readable medium that can be a compact disc or a carrier wave covers a non-statutory embodiment and therefore should be rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter. See, e.g., Mentor Graphics v. EVE-USA, Inc., 851 F.3d at 1294-95, 112 USPQ2d at 1134 (claims to a “machine-readable medium” were non-statutory, because their scope encompassed both statutory random-access memory and non-statutory carrier waves).”
Suggested, that applicant should recite “non-transitory computer-readable storage medium” to preclude any Nuijten-type issue if there is disclosure for this in the instant specification.
Step 2A, Prong One: Claims 1 & 15 recite mental processes which are "in response to determining that at least one value indicative of a coagulation status of a perioperative patient is below a first threshold, determining a volume of platelets to transfuse to the perioperative patient based at least in part on the at least one value."
This is an abstract idea.
Step 2A, Prong Two: The claims 1, & 15 do not integrate the abstract idea into a practical application. The processor and storage medium are generic. The claim recites only outputting a recommendation which is considered extra solution activity or merely to "apply it," which is not enough to practically apply the judicial exception.
See MPEP 2106.05 (f). Mere Instructions To Apply An Exception
Step 2B: For claims 1 & 15 additional elements of the processor and computer readable medium are well understood routine and conventional (WURC) in the art. Things are WURC are not considered to be significantly more.
See MPEP 2106.05 (d) Well-Understood, Routine, Conventional Activity
Dependent claims 2-16 & 19 do not change the analysis above.
Claims 2-7 & 9-10 recite what the value is and how it is compared to a threshold and what the threshold is, and the timing of measurements (prior to administration of protamine, but not claiming of administration itself). This is still part of the claimed abstract idea.
Claim 8 claims that an outputting occurs. This is merely instruction to “apply,” the judicial exception and does not change the matters above.
Claim 11 claims that a level to transfuse is determined based on the result of the determining. However, as claimed—this still seems to be done through an abstract idea which is a mental decision or math.
Claim 12 claims that a level to administer of platelets is determined based on the result of the determining. However, as claimed—this still seems to be done through an abstract idea which is a mental decision or math, from simple regression analysis.
Claims 13-19 contain a combination of the above and these combinations do not change the matters as they are only making further specifications on the abstract ideas themselves or further specifying the math.
See MPEP 2106.04(a)(2) for abstract ideas groupings.
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.
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.
Claims 1-6, 10-17 & 19 are rejected under 35 U.S.C. 103 as being obvious over CHAPMAN in US 20190072570 in view of LIUMBRUNO in Recommendations for the transfusion management of patients in the peri-operative period. II The intra-operative period (as cited on IDS date 0106/2023).
With respect to Claim 1, CHAPMAN teaches an apparatus and method to determine a patients’ likelihood of requiring a transfusion comprising (abstract):
at least one processor (paragraph 0079, 0087-processor); and
at least one computer-readable storage medium having encoded thereon executable instructions that, when executed by the at least one processor, cause the at least one processor to carry out a method to inform blood product transfusion, the method comprising (paragraph 0015, 0079, 0087, 0152- control program; computer software provided with the apparatus; identifies the patient as likely to require a transfusion):
in response to determining that at least one value indicative of a coagulation status of a patient is below a first threshold (paragraph 0062, 0140-0144- obtaining a coagulation characteristic value that is independent of time using a viscoelastic analysis assay to analyze a sample of blood taken from the patient, coagulation characteristic value of the patient that is lower than a specified threshold),
determining transfusion to the patient based at least in part on the at least one value (paragraph 0062- predicts that the patient is likely to suffer a massive hemorrhage. Early prediction of massive hemorrhage can be lifesaving as it allows the clinician to initiate massive transfusion protocol—which reads on “volume of platelets,” or other resuscitative interventions in a timely manner, & 0067, 0161); and
outputting a recommendation of platelets/transfusion which includes platelets to the patient (paragraph 0078-0080- the strength of the clot over time, with the magnitude of the output directly proportional to the strength of the clot; visual display or be coupled to a printer to provide a visual representation of the hemostasis profile; 0067, 0009- “six units of blood in six hours or less,” reads in “volume of platelets”).
CHAPMAN teaches that the patient could need the transfusion following or during surgery (paragraph 0003, 0006, 0059), but does not use the word phrase peri-operation and therefore does not teach perioperative patient or perioperative blood product. It is noted that “perioperative,” means around the time of surgery and includes three phases of preoperative, intraoperative and post operative.
Also, though CHAPMAN makes determining a volume of specifically platelets to transfuse to the patient based at least in part on the at least one value and administering or recommending to administer that volume obvious through the teaching that the transfusion can includes platelets (CHAPMAN, paragraph 0067) in case that is not clear to one of ordinary skill in the art LIUMBRUNO is used to remedy this.
LIUMBRUNO teaches of protocols and methods for determining the protocols for transfusion management in perioperative patient’s (title). LIUMBRUNO further teaches blood transfusion product being allogenic blood product (which means blood from different individual of the same species) (page 191, column 1, last paragraph and page 192, paragraphs 1-2, “allogenic RCC and platelet concentrates”).
LIUMBRUNO further teaches of determining a dose or volume of platelets to transfuse to the patient based at least in part on the at least one value (page 199, last paragraph-page 200 – paragraph 2 & formula 18); and
recommending administration of the volume of transfusion product or platelets to the perioperative patient which can include patients that have hemorrhaged (Table 2-2nd to right most column). LIUMBRUNO further teaches of making these recommendations by “Grades,” throughout the reference such as during the intra-operative period (Page 189, column 2, paragraph 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success to/of combining the volume determination as taught by LIUMBRUNO with the apparatus as taught by CHAPMAN since doing so would assist health care professionals in decision making to prevent adverse events during treatments and due to the advantage monitoring and determining the volume of platelets to transfuse offers in reducing the risk of hemorrhage (Page 199, right column, second paragraph from bottom).
Also, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success to/of performing this method on a perioperative patient as is done in LIUMBRUNO in the method using the apparatus of CHAPMAN due to the advantage monitoring and determining the volume of platelets to transfuse offers in reducing the risk of hemorrhage in perioperative patients (Page 199, right column, second paragraph from bottom).
With respect to Claim 2, CHAPMAN teaches the at least one value indicative of coagulation status of the patient comprises at least one value based on at least one thromboelastogram (TEG) measurement for the patient (paragraph 0064, 0077-0080).
CHAPMAN does not teach of the patient being perioperative. LIUMBRUNO teaches of protocols and methods for determining the protocols for transfusion management in perioperative patient’s (title). LIUMBRUNO further teaches blood transfusion product being allogenic blood product (which means blood from different individual of the same species) (page 191, column 1, last paragraph and page 192, paragraphs 1-2, “allogenic RCC and platelet concentrates”). See reason for combination from Claim 1.
With respect to Claim 3, CHAPMAN teaches the at least one value based on the at least one TEG measurement and indicative of the coagulation status of the patient comprises a maximum amplitude (MA) of a TEG measurement for the patient (paragraph 0033, 0084- 0087); and determining that the at least one value indicative of the coagulation status of the patient is below the first threshold comprises determining that the MA of the TEG measurement for the patient is below the first threshold (paragraph 0084-0087, 0140-0144).
CHAPMAN does not teach of the patient being perioperative. LIUMBRUNO teaches of protocols and methods for determining the protocols for transfusion management in perioperative patient’s (title). LIUMBRUNO further teaches blood transfusion product being allogenic blood product (which means blood from different individual of the same species) (page 191, column 1, last paragraph and page 192, paragraphs 1-2, “allogenic RCC and platelet concentrates”). See reason for combination from Claim 1.
With respect to Claim 4, neither CHAPMAN nor LIUMBRUNO teaches the first threshold is 45mm. However, CHAPMAN teaches the first threshold is a value between 54 and 72 mm (paragraph 0040, 0084, 54 mm to about 72 mm). CHAPMAN further teaches of setting the threshold by computer using an array of equations (paragraph 0140-0147), and further of setting the threshold based on empirical data (paragraph 0148). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention and one would have had reasonable expectation of success of/to optimize the threshold range of 54 to 72 mm through routine experimentation based on empirical observation of the situation at hand. See MPEP 2144.05.
With respect to Claim 5, CHAPMAN teaches the at least one value is indicative of the coagulation status of the patient is prior to protamine administration, as the blood sample can either have or not have protamine (paragraph 0065-0067).
CHAPMAN does not teach of the patient being perioperative. LIUMBRUNO teaches of protocols and methods for determining the protocols for transfusion management in perioperative patient’s (title). LIUMBRUNO further teaches blood transfusion product being allogenic blood product (which means blood from different individual of the same species) (page 191, column 1, last paragraph and page 192, paragraphs 1-2, “allogenic RCC and platelet concentrates”). See reason for combination from Claim 1.
With respect to Claim 6, CHAPMAN teaches performing at least one TEG measurement on a blood sample obtained from the patient prior to protamine administration, as the blood sample can either have or not have protamine to generate the at least one value indicative of the coagulation status of the patient (paragraph 0065-0067, 0077-0080).
CHAPMAN does not teach of the patient being perioperative. LIUMBRUNO teaches of protocols and methods for determining the protocols for transfusion management in perioperative patient’s (title). LIUMBRUNO further teaches blood transfusion product being allogenic blood product (which means blood from different individual of the same species) (page 191, column 1, last paragraph and page 192, paragraphs 1-2, “allogenic RCC and platelet concentrates”). See reason for combination from Claim 1.
With respect to Claim 10, neither CHAPMAN teaches of the patient being 14 years old (paragraph 0151). This is a pediatric patient, since pediatric patients are from birth up to 18 or 21 years.
CHAPMAN does not teach of the patient being perioperative. LIUMBRUNO teaches of protocols and methods for determining the protocols for transfusion management in perioperative patient’s (title). LIUMBRUNO further teaches blood transfusion product being allogenic blood product (which means blood from different individual of the same species) (page 191, column 1, last paragraph and page 192, paragraphs 1-2, “allogenic RCC and platelet concentrates”). See reason for combination from Claim 1.
With respect to Claim 11, CHAPMAN teaches in response to determining the at least one value indicative of the coagulation status of the patient is below the first threshold, determining a volume of fibrinogen to transfuse to the patient based at least in part on the at least one value (paragraph 0059-0063, 0150-0153, 0160).
CHAPMAN does not teach of the patient being perioperative. LIUMBRUNO teaches of protocols and methods for determining the protocols for transfusion management in perioperative patient’s (title). LIUMBRUNO further teaches blood transfusion product being allogenic blood product (which means blood from different individual of the same species) (page 191, column 1, last paragraph and page 192, paragraphs 1-2, “allogenic RCC and platelet concentrates”). See reason for combination from Claim 1.
With respect to Claim 12, CHAPMAN teaches of the claims as shown above for Claim 1, but does not teach of the claimed determining the volume of platelets to result in a target coagulation status.
LIUMBRUNO teaches determining the volume of platelets to administer comprises performing a regression analysis to determine an amount of platelets that, when administered to the perioperative patient having the coagulation status indicated by the at least one value, would result in the perioperative patient having a target coagulation status (page 202, column 2, paragraph 2- page 203, column 2, paragraph 5). See reason for combination from Claim 1.
With respect to Claim 13, CHAPMAN teaches the at least one value indicative of coagulation status of the patient comprises at least one value based on at least one thromboelastogram (TEG) measurement for the patient (paragraph 0064, 0077-0080). CHAPMAN does not teach specifically of the determination of the number of platelets to administer which would result in a threshold value above a certain level.
LIUMBRUNO teaches determining the amount of platelets that, when administered to the perioperative patient would result in the perioperative patient having the target coagulation status comprises determining an amount of platelets that, when administered to the perioperative patient, would result in the perioperative patient having at least one second value, based on the TEG measurement, above a second threshold (Page 190, column 1 paragraph 2, starting with “the platelet,” page 199, column 1, paragraph 4- page 201, paragraph 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success to/of performing this method determining the number of platelets to transfuse in a perioperative patients as is done in LIUMBRUNO in the method using the apparatus of CHAPMAN due to the advantage monitoring and determining the volume of platelets to transfuse offers in reducing the risk of hemorrhage in perioperative patients (Page 199, right column, second paragraph from bottom).
With respect to Claim 14, CHAPMAN teaches the at least one value based on the at least one TEG measurement and indicative of the coagulation status of the perioperative patient comprises a maximum amplitude (MA) of the TEG measurement for the perioperative patient and the at least one second value comprises an MA of the TEG measurement (paragraph 0084-0087, 0140-0144). CHAPMAN further teaches a threshold is a value between 54 and 72 mm (paragraph 0040, 0084, 54 mm to about 72 mm), which includes the claimed value of 55 mm within it for MA. It would have been obvious to one of ordinary skill in the art to modify the threshold range taught by CHAPMAN to select a value that would optimize the transfusion without risking the patient. CHAPMAN further teaches of setting the threshold by computer using an array of equations (paragraph 0140-0147), and further of setting the threshold based on empirical data (paragraph 0148). Therefore, it would have also been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention and one would have had reasonable expectation of success of/to optimize the threshold range of 54 to 72 mm through routine experimentation based on empirical observation of the situation at hand. See MPEP 2144.05.
With respect to Claim 15, CHAPMAN teaches of at least one computer-readable storage medium having encoded thereon executable instructions that, when executed by the at least one processor, cause the at least one processor to carry out a method to inform blood product transfusion, the method comprising (abstract, paragraph 0015, 0079, 0087, 0152- control program; computer software provided with the apparatus; identifies the patient as likely to require a transfusion):
in response to determining that at least one value indicative of a coagulation status of a patient is below a first threshold (paragraph 0062, 0140-0144- obtaining a coagulation characteristic value that is independent of time using a viscoelastic analysis assay to analyze a sample of blood taken from the patient, coagulation characteristic value of the patient that is lower than a specified threshold),
determining transfusion to the patient based at least in part on the at least one value (paragraph 0062- predicts that the patient is likely to suffer a massive hemorrhage. Early prediction of massive hemorrhage can be lifesaving as it allows the clinician to initiate massive transfusion protocol—which reads on “volume of platelets,” or other resuscitative interventions in a timely manner, & 0067, 0161); and
outputting a recommendation of platelets/transfusion which includes platelets to the patient (paragraph 0078-0080- the strength of the clot over time, with the magnitude of the output directly proportional to the strength of the clot; visual display or be coupled to a printer to provide a visual representation of the hemostasis profile; 0067, 0009- “six units of blood in six hours or less,” reads in “volume of platelets”). CHAPMAN teaches that this is monitored and outputted by a computer electrical signal with a visual display to show the visual representation of a hemostasis profile (paragraph 0079).
CHAPMAN teaches that the patient could need the transfusion following or during surgery (paragraph 0003, 0006, 0059), but does not use the word phrase peri-operation and therefore does not teach perioperative patient or perioperative blood product transfusion. It is noted that “perioperative,” means around the time of surgery and includes three phases of preoperative, intraoperative and post operative. Also, though CHAPMAN makes determining a volume of specifically platelets to transfuse to the patient based at least in part on the at least one value and administering or recommending to administer that volume obvious through the teaching that the transfusion can includes platelets (CHAPMAN, paragraph 0067) in case that is not clear to one of ordinary skill in the art LIUMBRUNO is used to remedy this.
LIUMBRUNO teaches of protocols and methods for determining the protocols for transfusion management in perioperative patient’s (title). LIUMBRUNO further teaches blood transfusion product being allogenic blood product (which means blood from different individual of the same species) (page 191, column 1, last paragraph and page 192, paragraphs 1-2, “allogenic RCC and platelet concentrates”).
LIUMBRUNO further teaches of determining a dose or volume of platelets to transfuse to the patient based at least in part on the at least one value (page 199, last paragraph-page 200 – paragraph 2 & formula 18); and
recommending administration of the volume of transfusion product or platelets to the perioperative patient which can include patients that have hemorrhaged (Table 2-2nd to right most column). LIUMBRUNO further teaches of making these recommendations by “Grades,” throughout the reference such as during the intra-operative period (Page 189, column 2, paragraph 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success to/of combining the volume determination as taught by LIUMBRUNO with the apparatus as taught by CHAPMAN since doing so would assist health care professionals in decision making to prevent adverse events during treatments and due to the advantage monitoring and determining the volume of platelets to transfuse offers in reducing the risk of hemorrhage (Page 199, right column, second paragraph from bottom).
Also, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success to/of performing this method on a perioperative patient as is done in LIUMBRUNO in the method using the apparatus of CHAPMAN due to the advantage monitoring and determining the volume of platelets to transfuse offers in reducing the risk of hemorrhage in perioperative patients (Page 199, right column, second paragraph from bottom).
With respect to Claim 16, CHAPMAN teaches the at least one value indicative of coagulation status of the patient comprises at least one value based on at least one thromboelastogram (TEG) measurement for the patient (paragraph 0064, 0077-0080).
CHAPMAN does not teach of the patient being perioperative. LIUMBRUNO teaches of protocols and methods for determining the protocols for transfusion management in perioperative patient’s (title). LIUMBRUNO further teaches blood transfusion product being allogenic blood product (which means blood from different individual of the same species) (page 191, column 1, last paragraph and page 192, paragraphs 1-2, “allogenic RCC and platelet concentrates”). See reason for combination from Claim 1.
With respect to Claim 17, CHAPMAN teaches the at least one value based on the at least one TEG measurement and indicative of the coagulation status of the patient comprises a maximum amplitude (MA) of a TEG measurement for the patient (paragraph 0033, 0084- 0087); and determining that the at least one value indicative of the coagulation status of the patient is below the first threshold comprises determining that the MA of the TEG measurement for the patient is below the first threshold (paragraph 0084-0087, 0140-0144).
CHAPMAN does not teach of the patient being perioperative. LIUMBRUNO teaches of protocols and methods for determining the protocols for transfusion management in perioperative patient’s (title). LIUMBRUNO further teaches blood transfusion product being allogenic blood product (which means blood from different individual of the same species) (page 191, column 1, last paragraph and page 192, paragraphs 1-2, “allogenic RCC and platelet concentrates”). See reason for combination from Claim 1.
Regarding claim 19, CHAPMAN teaches the at least one value is indicative of the coagulation status of the patient is prior to protamine administration, as the blood sample can either have or not have protamine (paragraph 0065-0067).
CHAPMAN does not teach of the patient being perioperative. LIUMBRUNO teaches of protocols and methods for determining the protocols for transfusion management in perioperative patient’s (title). LIUMBRUNO further teaches blood transfusion product being allogenic blood product (which means blood from different individual of the same species) (page 191, column 1, last paragraph and page 192, paragraphs 1-2, “allogenic RCC and platelet concentrates”). See reason for combination from Claim 1.
Claims 7-9 are rejected under 35 U.S.C. 103 as being obvious over CHAPMAN in US 20190072570 in view of LIUMBRUNO in Recommendations for the transfusion management of patients in the peri-operative period. II The intra-operative period (as cited on IDS date 01/06/2023) and further in view of GORLINGER in Perioperative coagulation management and control of platelet transfusion by point-of-care platelet function analysis (as cited on IDS dated 01/06/2023).
With respect to Claim 7, CHAPMAN and LIUMBRUNO teach of the invention as shown above Claim 1.
CHAPMAN further teaches the at least one value based on the at least one TEG measurement and indicative of the coagulation status of the perioperative patient comprises a maximum amplitude (MA) of the TEG measurement for the perioperative patient and the at least one second value comprises an MA of the TEG measurement (paragraph 0084-0087, 0140-0144). CHAPMAN further teaches a threshold is a value between 54 and 72 mm (paragraph 0040, 0084, 54 mm to about 72 mm), which includes the claimed value of 55 mm within it for MA. It would have been obvious to one of ordinary skill in the art to modify the threshold range taught by CHAPMAN to select a value that would optimize the transfusion without risking the patient. CHAPMAN further teaches of setting the threshold by computer using an array of equations (paragraph 0140-0147), and further of setting the threshold based on empirical data (paragraph 0148). Therefore, it would have also been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention and one would have had reasonable expectation of success of/to optimize the threshold range of 54 to 72 mm through routine experimentation based on empirical observation of the situation at hand. See MPEP 2144.05.
CHAPMAN and LIUMBRUNO do not teach of in response to determining that at least one value indicative of the coagulation status of the perioperative patient is between the first threshold and a second threshold higher than the first threshold, in response to determining that the perioperative patient is experiencing bleeding, determining a volume of platelets to transfuse to the perioperative patient based at least in part on the at least one value.
GORLINGER is used to remedy this and teaches in response to determining that at least one value indicative of the coagulation status of the perioperative patient is between the first threshold and a second threshold higher than the first threshold, in response to determining that the perioperative patient is experiencing bleeding, determining a volume of platelets to transfuse to the perioperative patient based at least in part on the at least one value (figure 3 and 4; page 8, col 2 to page 11, col1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success of/ to modifying CHAPMAN in view of LIUMBRUNO with those of GORLINGER to use a second threshold for determining if or if not to administer platelets, since doing so would improve the efficiency of the recommendation system and due to the advantage this offers in perioperative coagulation management and in reducing mortality of patients ( Page 397, column 1, conclusion).
With respect to Claim 8, CHAPMAN and LIUMBRUNO teach of the invention as shown above Claim 1 and 7.
CHAPMAN and LIUMBRUNO do not teach of in response to determining that at least one value indicative of the coagulation status is above a second value, recommending and outputting that no platelets be transfused.
GORLINGER remedies this and teaches in response to determining that at least one value indicative of the coagulation status of the perioperative patient is above the second threshold, outputting a recommendation that no platelets be transfused to the perioperative patient (fig. 3 and 4; page 8, col 2 to page 11, col 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success of/ to modifying CHAPMAN in view of LIUMBRUNO with those of GORLINGER to use a second threshold for determining if or if not to administer platelets, since doing so would improve the efficiency of the recommendation system and due to the advantage this offers in perioperative coagulation management and in reducing mortality of patients ( Page 397, column 1, conclusion).
With respect to Claim 9, With respect to Claim 7, CHAPMAN and LIUMBRUNO teach of the invention as shown above Claim 1.
CHAPMAN further teaches the at least one value based on the at least one TEG measurement and indicative of the coagulation status of the perioperative patient comprises a maximum amplitude (MA) of the TEG measurement for the perioperative patient and the at least one second value comprises an MA of the TEG measurement (paragraph 0084-0087, 0140-0144). CHAPMAN further teaches a threshold is a value between 54 and 72 mm (paragraph 0040, 0084, 54 mm to about 72 mm), which includes the claimed value of 55 mm within it for MA. It would have been obvious to one of ordinary skill in the art to modify the threshold range taught by CHAPMAN to select a value that would optimize the transfusion without risking the patient. CHAPMAN further teaches of setting the threshold by computer using an array of equations (paragraph 0140-0147), and further of setting the threshold based on empirical data (paragraph 0148). GORLINGER also teaches of the second thresholds and them being around 55mm (50 mm, 60 mm)(Fig. 3 and 4).Therefore, it would have also been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention and one would have had reasonable expectation of success of/to optimize the threshold range of 54 to 72 mm through routine experimentation based on empirical observation of the situation at hand. See MPEP 2144.05.
Response to Arguments
Applicant's arguments filed 03/31/2026 have been fully considered but they are not persuasive.
With respect to the 103 rejection and independent claims 1 & 15, applicant argues that the combination of CHAPMAN and LIUMBRUNO does not teach of the claimed “determining a volume of platelets to transfuse to the perioperative patient based at least in part of the at least one value,” and “outputting a recommendation to administer the volume of platelets to the perioperative patient,” wherein the “at least one value,” is “indicative of coagulation status of the perioperative patient.” Applicant gives three reasons for their opinion.
First, applicant argues that CHAPMANs teaching of the need to transfuse “six units of blood in size hours or less,” based on factors like the strength of the patients blood clot over time does not teach of the above, and that this is distinctly different than the claimed determining a volume of platelets to transfuse based on value indicative of coagulation status.
The examiner disagrees with applicant’s arguments and maintains that CHAPMAN, and CHAPMAN in view of LIUMBRUNO teach of the claim, with respect to how it can be interpreted through broadest reasonable interpretation (BRI).
Applicant argues that CHAPMAN does not teach of determining a “particular volume of blood to administer,” and instead teaches of determining “whether to administer 6 units across 6 hours,” that makes up CHAPMAN’s “massive transfusion protocol,” and that CHAPMAN’s decision is a binary yes/no decision. With respect to this, the examiner sees applicant’s point with respect to how CHAPMAN is different from what applicant intends to claim--- however the examiner maintains that the binary yes/no decision in CHAPMAN is still a determination of whether or not to administer a volume of blood (which includes platelets), and therefore this still reads on the instant claims.
Secondly, applicant argues that CHAPMAN teaches of administering blood and not platelets. Again, with respect to this--- the examiner disagrees with applicant and maintains that blood includes platelets. Therefore, any determination to administer blood, includes administration of platelets, as instantly claimed, so the teachings of CHAPMAN read on the instant claims, especially through broadest reasonable interpretation of the claims.
Thirdly, applicant argues that CHAPMAN’s decision does not do, “determining a volume of platelets to transfuse to the perioperative patient based at least in part on the at least one value,” wherein the at least one value is “indicative of coagulation status of the perioperative patient.” Further- applicant argues that CHAPMAN does not teach of determining a volume of platelets to transfuse based on the at least one value. The examiner disagrees with applicant on both counts.
Specifically, CHAPMAN teaches of determination of at least one value indicative of a coagulation status of a patient is below a first threshold (paragraph 0062, 0140-0144- obtaining a coagulation characteristic value that is independent of time using a viscoelastic analysis assay to analyze a sample of blood taken from the patient, coagulation characteristic value of the patient that is lower than a specified threshold), and determining transfusion to the patient based at least in part on the at least one value (paragraph 0062- predicts that the patient is likely to suffer a massive hemorrhage. Early prediction of massive hemorrhage can be lifesaving as it allows the clinician to initiate massive transfusion protocol—which reads on “volume of platelets,” or other resuscitative interventions in a timely manner, & 0067, 0161). CHAPMAN also teaches that the patient could need the transfusion following or during surgery (paragraph 0003, 0006, 0059). The word “perioperative,” means around the time of surgery and includes three phases of preoperative, intraoperative and post operative, so CHAPMAN teaches of making the determinations during “perioperative,” times.
With respect to LIUMBRUNO, applicant argues that the LIUMBRUNO also does not teach of determining a volume of platelets to transfuse based on the at least one value. With respect to this, the examiner notes—that through BRI--- CHAPMAN teaches of this as shown above. LIUMBRUNO was just used to strengthen the case.
Specifically, LIUMBRUNO teaches of protocols and methods for determining the protocols for transfusion management in perioperative patient’s (title). LIUMBRUNO teaches blood transfusion product being allogenic blood product (which means blood from different individual of the same species) (page 191, column 1, last paragraph and page 192, paragraphs 1-2, “allogenic RCC and platelet concentrates”).
LIUMBRUNO further teaches of determining a dose or volume of platelets to transfuse to the patient based at least in part on the at least one value (page 199, last paragraph-page 200 – paragraph 2 & formula 18); and
recommending administration of the volume of transfusion product or platelets to the perioperative patient which can include patients that have hemorrhaged (Table 2-2nd to right most column). LIUMBRUNO further teaches of making these recommendations by “grades,” throughout the reference such as during the intra-operative period (Page 189, column 2, paragraph 2).
Applicant argues that LIUMBRUNO does not teach of determining the platelet volume for the infusion based on a coagulation status, the “at least one value,” as claimed. With respect to this—the examiner points out that CHAPMAN already taught of this as shown above, so LIUMBRUNO does not need to since a 103 rejection was made.
In response to applicant's arguments against the references individually, one cannot show non-obviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Specifically--- the examiner maintains that the instant invention is obvious from CHAPMAN, but that LIUMBRUNO does not call out transfusion of only platelets, but instead teaches of transfusion of blood (which includes platelets), and that it would be obvious to one of ordinary skill to also consider infusion of only platelets, based on LIUMBRUNO. However- through BRI, the instant claims transfusion product of platelets--- the blood transfusion in CHAPMAN, reads on this through BRI.
Applicant argues that the equation in LIUMBRUNO to determine the platelet infusion does not include any indicator of coagulation status. Again--- the examiner maintains that it does not need to, as this was already taught by CHAPMAN.
Applicant argues that there is no reason one of ordinary skill in the art would have modified LIUMBRUNO’s equation. With respect to this--- this is not what the examiner suggested. Again, as broadly claimed, CHAPMAN teaches of any “equation,” to the extend in which any is claimed, which seems to be only through incorporation of very broad “based on,” language indicating broad relationship between variables.
Applicant further argues that it would not have been obvious to combine LIUMBRUNO with CHAPMAN. The examiner disagrees. It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success to/of combining the volume determination as taught by LIUMBRUNO with the apparatus as taught by CHAPMAN since doing so would assist health care professionals in decision making to prevent adverse events during treatments and due to the advantage monitoring and determining the volume of platelets to transfuse offers in reducing the risk of hemorrhage (Page 199, right column, second paragraph from bottom).
Also, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success to/of performing this method on a perioperative patient as is done in LIUMBRUNO in the method using the apparatus of CHAPMAN due to the advantage monitoring and determining the volume of platelets to transfuse offers in reducing the risk of hemorrhage in perioperative patients (Page 199, right column, second paragraph from bottom).
Applicant also argues that CHAPMAN in view of LUIMBRUNO do not teach of the claimed “outputting,” a recommendation to administer the volume of platelets to the perioperative patient.
The examiner disagrees. CHAPMAN teaches of outputting a recommendation of platelets/transfusion which includes platelets to the patient (paragraph 0078-0080, 0087- the strength of the clot over time, with the magnitude of the output directly proportional to the strength of the clot; visual display or be coupled to a printer to provide a visual representation of the hemostasis profile; 0067, 0009- “six units of blood in six hours or less,” reads in “volume of platelets”). CHAPMAN teaches that this is monitored and outputted by a computer electrical signal with a visual display to show the visual representation of a hemostasis profile (paragraph 0079).
With respect to the 101 rejection, applicant argues that the instant claims are eligible subject matter and that they should not be rejected under 101.
The examiner disagrees.
Applicant argues that the instant claims are eligible since they provide “ an improvement in the functioning of a computer, or an improvement to other technology or technology field,” and further with respect to the August 4th, 2025 Memorandum by the USPTO title “Reminders in evaluating subject matter eligibility of claims under 35 U.S.C. 101.” Applicant notes with respect to this memo that this memo was specific to Technology Centers 2100, 2600, and 3600 and that the instant application is being examined in Technology Center 2800. The examiner notes--- that in fact this application is being examined in Technology Center 1700, not Technology Center 2800.
Be that as it may, and even with respect to the fact that the office has been slow to train the examiners, not offering official training the examiners in light of Desjardins until and machine learning examples and memo, officially until this week--- the examiner assures applicant that she has reviewed the materials including the memo and Desjardins. However, the examiner disagrees that any of these notices make the instant claims patent eligible.
As is noted in the 101 rejection above--- the instant claims when read in light of the broadest reasonable interpretation (BRI), which it is the examiner’s job to review in light of, the instant claimed computer readable medium can be read as encompassing non-transitory forms of signal transmission.
The examiner notes that the instant independent Claims 1 & 15, recite, “in response to determining that at least one value indicative of a coagulation status of a perioperative patient is below a first threshold, determining a volume of platelets to transfuse to the perioperative patient based at least in part on the at least one value," which is a mental process which is an abstract idea judicial exception and that the instant processor and storage medium are generic.
According to MPEP 2106 II as the instant computer readable medium is not claimed as non transitory, “For example, the broadest reasonable interpretation (BRI) of machine-readable/computer readable media, including the claimed “computer readable storage medium,” claimed can encompass non-statutory transitory forms of signal transmission, such as a propagating electrical or electromagnetic signal per se. See In re Nuijten, 500 F.3d 1346, 84 USPQ2d 1495 (Fed. Cir. 2007).
When the BRI encompasses transitory forms of signal transmission, a rejection under 35 U.S.C. 101 as failing to claim statutory subject matter would be appropriate.
Thus, a claim to a computer readable medium that can be a compact disc or a carrier wave covers a non-statutory embodiment and therefore should be rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter. See, e.g., Mentor Graphics v. EVE-USA, Inc., 851 F.3d at 1294-95, 112 USPQ2d at 1134 (claims to a “machine-readable medium” were non-statutory, because their scope encompassed both statutory random-access memory and non-statutory carrier waves).”
It is noted that the examiner suggested that, applicant should recite “non-transitory computer-readable storage medium” to preclude any Nuijten-type issue if there is disclosure for this in the instant specification, however applicant has made no such amendments. Though— in addition to this applicant would likely need to make claim clarifications to show that the claimed processor and computer readable medium are not generic, which they read on as instantly claimed.
Therefore--- 101 rejection is proper, even in light of the memo applicant argues about, and with respect to the Desjardin’s case, and applicant’s arguments that the instant claims recite improvements to the functioning of a computer or improvement in technology or field, is not convincing, especially in light of how it is instantly claimed.
Applicant also argues that claimed computer readable medium causes, “the at least one processor to carry out a method to inform perioperative blood product transfusion.” The examiner notes that informing/ “to inform,” is a mental process/abstract idea through broadest reasonable interpretation as well, so the examiner disagrees with applicant. If applicant means something more specific with respect to informing, then they should claim it.
Applicant also argues that the judicial exceptions in the claims are integrated into a practical application. The examiner disagrees. The claim only recites outputting a recommendation, in addition to the generically claimed processor and computer readable medium, which is considered extra solution activity or merely to "apply it," which is not enough to practically apply the judicial exception. Applicant argues that the instant claims require dosing, like Vanda. The examiner disagrees again--- as the instant claims only require outputting, which no real actual dosing or treatment, nor other practical application put into place.
Therefore, all claims remain rejected under 101.
All claims remain rejected.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
NADKAMI in US 20150305681, teaches of a thromboelastographic sensor and method of using the same for simultaneous assessment of multiple parameters of blood coagulation at a point-of-care. The sensor includes an optical system registering laser speckle intensity associated with a stationary blood sample and data-processing circuitry programmed to derive the multiple parameters from speckle intensity. The circuitry may be part of a mobile device configured to operate without communication with a central server and/or data storage (abstract). The system includes multiple processors (paragraph 0076) and recommends individualized transfusion protocols including recommendations of platelets or no platelets (paragraph 0073).
SNIADECKI in US 20150056643, teaches of microfluidic devices for measuring platelet coagulation, and associated systems and methods. In some embodiments, a fluidics device includes an array of microstructures including pairs of generally rigid blocks and generally flexible posts. The fluidics device further includes at least one fluid channel configured to accept the array. The fluid channel is configured to induce fluid flow of a biological sample, such as whole blood, through the array. The fluidics device can further include a detection component configured to measure a degree of deflection of one or more of the flexible posts in the array. In some embodiments, the fluidics device comprises a handheld device and usable for point of care testing of platelet forces and coagulation (abstract).
THIS ACTION IS MADE FINAL. 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 REBECCA M FRITCHMAN whose telephone number is (303)297-4344. The examiner can normally be reached 9:30-4:30 MT Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel, can be reached on 571-270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758
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