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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 8/3/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Status of Claims
Claims 1-20 are pending and currently under consideration for patentability.
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.
Claim(s) 1, 3-6, 10-16, and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rule (US 20200390974 A1).
Regarding Claim 1, Rule teaches an interoperative blood loss quantification device comprising:
a housing (pump housing, 1016);
a peristaltic pump (paragraph [0117]) positioned within the housing (paragraph [0156]);
a motor positioned within the housing and driving the peristaltic pump (motor is inherent part of a peristaltic pump);
a cuvette (test cartridge) positioned within the housing and configured to receive fluid moved by the peristaltic pump;
a spectrophotometer (optical system 412)(paragraph [0097])positioned within the housing and configured to provide an absorbance signal indicative of properties of the fluid flowing through the cuvette (paragraph [0176]); and
one or more processing circuits (paragraph [0459]) comprising one or more memory devices coupled to one or more processors (paragraph [0113]) , the one or more memory devices configured to store instructions thereon that [0310], when executed by the one or more processors (416) (paragraph [0112]), cause the one or more processors to: control operation of the motor, determine a volume of fluid moved through the peristaltic pump, determine a blood concentration based on the absorbance signal received from the spectrophotometer (paragraph [0310]) (paragraph [0365-0371]), and determine a total volume of blood moved by the peristaltic pump based on the volume of fluid [0357] and the blood concentration.
Rule fails to teach wherein the motor driving the pump is a stepper motor. However Rule teaches that a stepper motor may be used within the device in a different use (paragraph [0181]). Since the pump motor is unspecified, it would be obvious to use a stepper motor for the peristaltic pump as the invention already uses a stepper motor and using the same type of motor would be consistent with the rest of the invention.
Regarding Claim 3, Rule teaches an interoperative blood loss quantification device of claim 1, wherein the housing includes a caddy (removable sample holder, [105]) removably received within the housing and supporting the peristaltic pump, (removable portions, [0141-0142]) the stepper motor, the cuvette, the spectrophotometer, and the one or more processing circuits comprising one or more memory devices(paragraph [0459]).
Regarding Claim 4 Rule teaches an interoperative blood loss quantification device of claim 1. Rule fails to explicitly teach wherein the caddy includes a first caddy configured to support the cuvette and the spectrophotometer, and a second caddie configured to support the peristaltic pump and the stepper motor. However, paragraph [0141-0142]) of Rule teaches many arrangements are possible of the caddy system. It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to duplicate the caddy system so a first caddy configured to support the cuvette and the spectrophotometer, and a second caddie configured to support the peristaltic pump and the stepper motor since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding Claim 5, Rule teaches the interoperative blood loss quantification device of claim 1, further comprising a display (104) coupled to the housing, wherein the one or more memory devices are further configured to store instructions thereon that (paragraph ([0111]), when executed by the one or more processors, cause the one or more processors to generate a graphical user interface representing, the blood concentration [0262].
Regarding Claim 6, Rule teaches the interoperative blood loss quantification device of claim 1, further comprising a communications interface configured to wirelessly transmit (paragraph [0018]) information from the interoperative blood loss quantification device including the blood concentration (paragraph [0159]).
Regarding Claim 10, Rule teaches an interoperative blood loss quantification system comprising: a suction head (sampling probe, paragraph [0091]);
a main reservoir (saline) fluidly coupled to the suction head;
a vacuum configured to provide a negative pressure within the main reservoir (paragraph [0122: suction forces in the closed fluid system]) ;
a blood loss quantification device including:
a peristaltic pump (paragraph [0117]) configured to move fluid from the main reservoir, a motor driving the peristaltic pump (motor is inherent part of a peristaltic pump) (paragraph [0156]);, a cuvette (test cartridge)configured to receive fluid moved by the peristaltic pump, a spectrophotometer (optical system 412)(paragraph [0097]) configured to provide an absorbance signal indicative of properties of the fluid flowing through the cuvette (paragraph [0176]), and one or more processing circuits (paragraph [0159]) comprising one or more memory devices coupled to one or more processors (paragraph [0113]) , the one or more memory devices configured to store instructions thereon that [0310], when executed by the one or more processors (416) (paragraph [0112]), cause the one or more processors to:
control operation of the motor, determine a volume of fluid moved through the peristaltic pump, and determine a total volume of blood [0357] moved by the peristaltic pump based on the volume of fluid and the absorbance signal (paragraph [0310]) (paragraph [0365-0371]); and
an end reservoir fluidly connected to the blood loss quantification device (waste tank, figure 5).
Rule fails to teach wherein the motor driving the pump is a stepper motor. However Rule teaches that a stepper motor may be used within the device in a different use (paragraph [0181]). Since the pump motor is unspecified, it would be obvious to use a stepper motor for the peristaltic pump as the invention already uses a stepper motor and using the same type of motor would be consistent with the rest of the invention.
Regarding Claim 11, Rule teaches the interoperative blood loss quantification device of claim 10. Rule further teaches further comprising a safety reservoir (542) (paragraph [0121]) positioned fluidly between the main reservoir and the vacuum (figure 5).
Regarding Claim 12, Rule teaches the interoperative blood loss quantification device of claim 10. Rule further teaches wherein the one or more memory devices are further configured to store instructions thereon that (paragraph ([0111]), when executed by the one or more processors, cause the one or more processors to: determine a blood concentration based on the absorbance signal (paragraph [0176]), and determine the total volume of blood moved by the peristaltic pump based on the volume of fluid and the blood concentration (volume [0357]).
Regarding Claim 13, Rule teaches the interoperative blood loss quantification device of claim 10. Rule further teaches wherein the blood loss quantification device further includes a housing, and wherein the peristaltic pump, the stepper motor, the cuvette, the spectrophotometer, and the one or more processing circuits comprising one or more memory devices ( paragraph [0113]) pare received within the housing.
`Regarding Claim 14, Rule teaches the interoperative blood loss quantification system of claim 10. Rule further teaches wherein the blood loss quantification device further includes a housing and an operating room attachment bracket (paragraph [0092] [0272]) .
Regarding Claim 15, Rule teaches the interoperative blood loss quantification system of claim 10. Rule further comprising a display (104), wherein the one or more memory devices are further configured to store instructions thereon that(paragraph ([0111]),, when executed by the one or more processors, cause the one or more processors to generate a graphical user interface representing the total volume of blood moved by the peristaltic pump (paragraph [0310]) (paragraph [0365-0371]).
Regarding Claim 16, Rule teaches the interoperative blood loss quantification system of claim 10. Rule further comprising wherein the blood loss quantification device further includes a communications interface configured to wirelessly transmit information including at least one of the volume of fluid moved through the peristaltic pump(paragraph [0018]), or the total volume of blood moved by the peristaltic pump (paragraph [0310]) (paragraph [0365-0371]).
Regarding Claim 18, Rule teaches a method of interoperative blood loss quantification comprising:
moving a fluid from a main reservoir to a cuvette of a blood loss quantification device with a peristaltic pump (paragraph [0117] and [0156]);
determining a blood concentration of the fluid (paragraph [0349-0350]);
determining a total volume of fluid moved by the peristaltic pump (paragraph [0085] and [0188]); and
determining a total blood volume moved by the peristaltic pump based on the blood concentration and the total volume of fluid (paragraph [0310]) (paragraph [0365-0371]).
Regarding Claim 19, Rule teaches the method of claim 18, further comprising determining the total blood volume based on a hemoglobin concentration (paragraph [0349-0350]).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rule (US 20200390974 A1) in view of Zafiris (US 20210228856 A1).
Regarding Claim 2, Rule teaches the interoperative blood loss quantification device of claim 1. Rule further teaches wherein the housing includes a vented body sized to contain the peristaltic pump (paragraph [0117]), the cuvette (paragraph [0117]), the spectrophotometer (optical system 412)(paragraph [0097]), and the one or more processing circuits (paragraph [0113]) comprising one or more memory devices [0310], and an operating room attachment bracket [0271].
Rule fails to teach wherein the motor driving the pump is a stepper motor. However Rule teaches that a stepper motor may be used within the device in a different use (paragraph [0181]). Since the pump motor is unspecified it would be obvious to use a stepper motor for the peristaltic pump as the invention already uses a stepper motor and using the same type of motor would be consistent with the rest of the invention.
Rule fails to teach wherein the housing further includes a vented cap, a vented bottom bumper. Zafiris teaches a blood processing unit wherein housing further includes a vented cap, a vented bottom bumper (paragraph [0028]) (paragraph [0037]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Rule to have a top and bottom to keep the blood at a safe temperature.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rule (US 20200390974 A1) in view of Rieders (US 6194218 B1).
Regarding Claim 7, Rule teaches the interoperative blood loss quantification device of claim 1. Rule fails to teach wherein the spectrophotometer includes a laser configured to obtain a dual isosbestic point measurement. In the same field of endeavor, Rieders teaches a Blood Methemoglobin Analysis spectrophotometer includes a laser configured to obtain a dual isosbestic point measurement (column 4, lines 47-52). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify Rule wherein the spectrophotometer includes a laser configured to obtain a dual isosbestic point measurement, similar to Rule as to not damage the hemoglobin.
Claim(s) 8 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Rule (US 20200390974 A1) in view of Srivastava (US 20150192512 A1) in view of Scharf (US 20160007864 A1).
Regarding Claim 8, Rule teaches the interoperative blood loss quantification device of claim 1. Rule fails to teach wherein the spectrophotometer includes a first laser defining a first wavelength of about 520 nanometers, and a second laser defining a second wavelength of about 808 nanometers. In the same field of endeavor, Srivastava teaches a method for blood hemoglobin measurement, measuring absorbance or reflectance of lysed blood in its natural state at 523 nm, the natural isobestic point of all four forms of hemoglobin (paragraph [0014]). Scharf teaches the 805 nm isobestic point of hemoglobin absorption is particularly useful, and at this point the absorption of the emitted electromagnetic radiation by the blood 4 is unaffected by the presence or absence of oxygen bound to the hemoglobin molecules (paragraph [0051]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify Rule wherein the spectrophotometer includes a first laser defining a first wavelength of about 520 nanometers, and a second laser defining a second wavelength of about 808 nanometers to obtain a dual isosbestic point measurement and to not damage the blood.
Regarding Claim 20, Rule teaches the method of claim 18. Rule fails to teach wherein determining the blood concentration includes determining an absorbance value of the fluid using a spectrophotometer including a first laser defining a first wavelength of about 520 nanometers, and a second laser defining a second wavelength of about 808 nanometers. In the same field of endeavor, Srivastava teaches a method for blood hemoglobin measurement, measuring absorbance or reflectance of lysed blood in its natural state at 523 nm, the natural isobestic point of all four forms of hemoglobin (paragraph [0014]). Scharf teaches the 805 nm isobestic point of hemoglobin absorption is particularly useful, and at this point the absorption of the emitted electromagnetic radiation by the blood 4 is unaffected by the presence or absence of oxygen bound to the hemoglobin molecules (paragraph [0051]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify Rule wherein the spectrophotometer includes a first laser defining a first wavelength of about 520 nanometers, and a second laser defining a second wavelength of about 808 nanometers to obtain a dual isosbestic point measurement and to not damage the blood.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rule (US 20200390974 A1) in view of Dai (CN 210982208 U).
Regarding Claim 9, Rule teaches the interoperative blood loss quantification device of claim 1. Rule fails to teach wherein the cuvette includes a cover configured to inhibit light pollution of the cuvette during use. Dai teaches wherein the cuvette includes a cover configured to inhibit light pollution of the cuvette during use (page 4, paragraph 1). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device or Rule so the cuvette includes a cover configured to inhibit light pollution of the cuvette during use, similar to Dai, so that the display screen and other light sources do not affect the absorbance reading *page 4, paragraph 1).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rule (US 20200390974 A1) in view of Dai (CN 210982208 U)in view of Srivastava (US 20150192512 A1) in view of Scharf (US 20160007864 A1).
Regarding Claim 17, Rule teaches the interoperative blood loss quantification device of claim 10. Rule fails to teach wherein the cuvette includes a cover configured to inhibit light pollution of the cuvette during use. Dai teaches wherein the cuvette includes a cover configured to inhibit light pollution of the cuvette during use (page 4, paragraph 1). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device or Rule so the cuvette includes a cover configured to inhibit light pollution of the cuvette during use, similar to Dai, so that the display screen and other light sources do not affect the absorbance reading *page 4, paragraph 1).
Rule also fails to teach wherein the spectrophotometer includes a first laser defining a first wavelength of about 520 nanometers, and a second laser defining a second wavelength of about 808 nanometers. In the same field of endeavor, Srivastava teaches a method for blood hemoglobin measurement, measuring absorbance or reflectance of lysed blood in its natural state at 523 nm, the natural isobestic point of all four forms of hemoglobin (paragraph [0014]). Scharf teaches the 805 nm isobestic point of hemoglobin absorption is particularly useful, and at this point the absorption of the emitted electromagnetic radiation by the blood 4 is unaffected by the presence or absence of oxygen bound to the hemoglobin molecules (paragraph [0051]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify Rule wherein the spectrophotometer includes a first laser defining a first wavelength of about 520 nanometers, and a second laser defining a second wavelength of about 808 nanometers to obtain a dual isosbestic point measurement and to not damage the blood.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 20020198483 A1, US 20210059584 A1, US 20210330196 A1.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATE ELIZABETH STRACHAN whose telephone number is (571)272-7291. The examiner can normally be reached M-F: 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached on (571)-270-5879. The fax phone number for the organization where this application or proceeding is assigned is (571)-270-5879.
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/KATE ELIZABETH STRACHAN/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781