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 .
Applicant' s arguments, filed 9/10/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 9/10/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 21, 23, 25-27, 29-30, 32-36, and 38-40 are the currently pending claims herby under examination. Claims 21, 23, 25-27, 29-30, 32-36, 38, and 39 have been amended. Claims 22, 24, 28, 31, and 37 have been canceled.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 38-40 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth the subject matter which the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the applicant regards as the invention.
Claim 38 recites “The blood management system of claim 31” in line 1, but claim 31 is canceled. The metes and the bounds of a claim are indeterminant when it depends from a cancelled claim. The Examiner is interpreting that claim 38 depends from claim 25.
Claim 39 recites “The blood management system of claim 1” in line 1, but claim 1 is canceled. The metes and the bounds of a claim are indeterminant when it depends from a cancelled claim. The Examiner is interpreting that claim 39 depends from claim 21.
Claim 40 is rejected by virtue of its dependence from claim 39.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 38-40 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 38 recites “The blood management system of claim 31” in line 1, but claim 31 is canceled, which is improper. A claim cannot depend from a cancelled claim. The Examiner is interpreting that claim 38 depends from claim 25.
Claim 39 recites “The blood management system of claim 1” in line 1, but claim 1 is canceled, which is improper. A claim cannot depend from a cancelled claim. The Examiner is interpreting that claim 39 depends from claim 21.
Claim 40 is rejected by virtue of its dependence from claim 39.
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.
Claims 21, 23, 29, and 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (US 20180266870 A1), hereto referred as Lin, and further in view of Bonutti et al. (US 20030060831 A1), hereto referred as Bonutti, and further in view of Rothrum et al. (US 5618278 A), hereto referred as Rothrum, and further in view of Tankersley et al. (US 20070135784 A1), hereto referred as Tankersley, and further in view of Lee et al. (US 20040149291 A1), hereto referred as Lee, and further in view of Wang et al. (US 20170254765 A1), hereto referred as Wang, and further in view of Konig et al. (Gerhardt Konig et al. “In Vitro Evaluation of a Novel Image Processing Device to Estimate Surgical Blood Loss in Suction Canisters.” Anesthesia and analgesia (2018): n. page. Web.), hereto referred as Konig.
Regarding claim 21, Lin teaches that a blood management system (Lin, Title: "Real-time intraoperative blood loss monitoring") comprises a blood container configured to receive the fluid from the drape and to measure the volume or the quantity of the fluids in the blood container (Lin, ¶[0041]: "...suctions are utilized on the sterile field that are connected to ... a non-sterile bucket, also known as a vacuum canister... The volume in the canister represents the liquid loss via suctioning. By incorporating weight sensors that transmit the actual weight via IoT, the real-time liquid loss via suctioning is always known", where the drape is part of the sterile field and thus the suction takes fluids from the drape to a container where volumes of fluids such as blood are measured; ¶[0022]:"or in the hanging visible pockets version described above (the bucket version would most likely use a loaded weight sensor, and the hanging visible pockets version would most likely use a hanging weight sensor)", demonstrating various versions of a blood container).
Also regarding claim 21, Lin does not fully teach that a drape comprises: a surgical site layer configured to be disposed on a surgical site of a person and to provide access to the surgical site, an adhesive layer configured to form a seal between the drape and a region around the surgical site, and a drape collector disposed adjacent with the surgical site layer and including a fluids enclosure comprising one or more fluid retention elements configured to absorb and store fluid spilled on the surgical site layer. Rather, Lin discloses adhesive surgical drapes used to segregate sterile and non‑sterile areas at the surgical site and thus reads on the presence of an adhesive layer forming a seal (Lin, ¶[0031]). However, Lin does not specifically disclose an incision film or transparent surgical site layer that provides access through a fenestration, nor does Lin identify a drape collector disposed adjacent with the surgical site layer that includes a fluids enclosure with fluid retention elements configured to absorb and store fluid spilled on the surgical site layer.
Bonutti investigates draping systems and teaches a surgical drape with a surgical site layer including a fenestration and an integral transparent incision region backed with adhesive, allowing adherence to tissue while maintaining visibility and access (Bonutti, ¶[0062]). However, it does not teach a drape collector disposed adjacent with the surgical site layer that includes a fluids enclosure with fluid retention elements configured to absorb and store fluid spilled on the surgical site layer.
Rothrum discloses a drape‑integrated fluid collection pouch disposed on the drape adjacent the surgical site to receive fluids directly from the site (Rothrum, Fig. 3a–3b; Col. 2, Lines 18–31), but it does not disclose that they are configured to absorb fluid.
Tankersley teaches a drape‑attached pocket containing a super‑absorbent polymer configured to absorb and retain surgical fluids within the pocket volume (Tankersley, ¶[0048]; see also ¶[0050]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lin in view of Bonutti, Rothrum, and Tankersley to provide a surgical site layer with an adhesive‑backed transparent panel and a drape collector disposed adjacent with the surgical site layer that includes a fluids enclosure having fluid retention elements configured to absorb and store fluid spilled on the surgical site layer. The combination is feasible because Lin already uses adhesive drapes in the same operative context, Bonutti’s incision film integrates as a standard fenestration panel, Rothrum’s pouch is a known drape‑mounted collector adjacent the site, and Tankersley’s absorbent elements are routinely incorporated into drape pockets; these components are commonly co‑designed in commercial draping systems. The motivated benefit is improved sterility and access at the incision while providing contained, absorbent capture and storage of site runoff in the drape collector for reliable intraoperative fluid management.
Also regarding claim 21, Lin does not fully teach that a blood container is configured to receive the fluid from the drape, the blood container comprising: a flexible wall configured to adapt its shape to surroundings, a plurality of electrodes disposed on an interior side of the flexible wall, and a control circuit configured to perform one or more of: control voltages on the electrodes, measure voltages on the electrodes, control currents through the electrodes, and measure currents through the electrodes. Rather, Lin teaches a container, such as a bucket or pocket, that receives fluid from the drape and whose quantity is monitored (Lin, ¶[0041], ¶[0022]), but does not specify a flexible wall that adapts to surroundings (although implied by "pocket") nor the presence of electrodes on the interior side of the flexible wall with a control circuit that drives and measures currents/voltages.
Lee teaches flexible, deformable fluid containers adapted to surrounding structures and suitable for medical fluid handling (Lee, ¶[0028]-[0029]: "fluid collection pouch 304", see also FIG. 1 and ¶[0017]-[0019]). However, it does not teach the presence of electrodes on the interior side of the flexible wall with a control circuit that drives and measures currents/voltages.
Wang teaches multi‑electrode electrical tomography around a liquid volume vessel with electronics ("measurement means") to drive and measure currents and voltages between electrode pairs ("arranged around the perimeter of a sample-containing volume") and "processing means" to reconstruct internal electrical property distributions (Wang, Abstract; ¶[0002]; ¶[0008]–¶[0011]; ¶[0043]–¶[0047]; ¶[0076]-[0077]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Lin, Bonutti, Rothrum, and Tankersley in view of Lee and Wang to implement a flexible‑wall blood container having electrodes disposed on the interior side of the flexible wall and a control circuit configured to control and measure currents/voltages. Lee’s pouch is constructed with formed polymer walls and sealed edges and includes fluid connections for suction, providing stable interior wall regions and seam/port areas suitable for mounting and routing components; Wang’s tomography uses perimeter electrode arrays with a drive/measure circuit that operate irrespective of vessel rigidity; therefore, mounting conformal electrodes on the interior wall of Lee’s pouch and routing leads along seams/through existing ports to Wang’s control electronics is a straightforward packaging change that preserves Lin’s fluid routing. The motivation is to integrate the volume-sensing function directly into the collection vessel for continuous, in-container measurement, improving robustness over external scales while aligning with Lin’s modular, sensor-rich blood-loss monitoring.
Also regarding claim 21, Lin does not fully teach that a computing system is configured to determine a first volume or quantity of the fluid collected in the fluids enclosure. Rather, Lin teaches real‑time transmission of drape‑collected fluid weight from integrated sensors (Lin, ¶[0057]; ¶[0061]) and a modular computing system that aggregates sensor inputs to calculate blood loss (Lin, ¶[0036]). Rothrum supplies the defined drape collector (pouch) adjacent the site that accumulates fluid (Rothrum, Fig. 3a–3b; Col. 2, Lines 18–31). Lin does not explicitly state that the computing system determines a first volume or quantity of the fluid collected in a fluids enclosure; however, it provides the platform and data stream to do so once the drape collector is present as in Rothrum.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lin in view of Rothrum to configure Lin’s computing system to determine a first volume or quantity of the fluid collected in the fluids enclosure from the drape collector’s weight/collection signals. This is feasible because Lin already transmits real‑time weight data from the drape to the computing module and mapping weight to volume is routine calibration. The benefit is automated, continuous quantification of fluids collected in the drape’s fluids enclosure to support intraoperative decisions.
Also regarding claim 21, the combined Lin, Bonutti, Rothrum, Tankersley, Lee, and Wang does not fully teach determining a second volume or quantity of the fluid in the blood container via the control circuit, Lin states that container volume/weight represents liquid loss and is known in real time (Lin, ¶[0041]). Wang teaches a control/measurement circuit that drives and measures electrode pairs sampling the liquid volume to produce tomograms and quantitative electrical property data (Wang, ¶[0043]–¶[0046]). Lin does not expressly determine the container quantity via the same control circuit used for electrode measurements, but Wang provides exactly such a control/measurement framework inside the container volume.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Lin, Bonutti, Rothrum, Tankersley, Lee, and Wang in view of Wang to determine a second volume or quantity of the fluid in the blood container via the control circuit that drives/measures the container electrodes. The combination is feasible because electrode‑based volume/property estimation is routine in EIT/ERT systems and can be integrated with Lee's fluid collecting pouch. The motivation is to unify sensing and control in a single module, reducing hardware complexity while providing continuous container quantity updates.
Also regarding claim 21, the combined Lin, Bonutti, Rothrum, Tankersley, Lee, and Wang does not fully teach determining a composition of the fluids in the blood container based on information received from the blood container, and determine an amount of lost blood based on the composition of the fluids and the first and second volume or quantity of the fluid. Rather, Wang provides in‑container multi‑electrode acquisition and processing of electrical measurements from the liquid sample to compute internal electrical property distributions (as shown above). Lin teaches a modular computing system designed to integrate additional measurement modalities to improve blood‑loss accuracy in a system designed to measure overall total lost blood (Lin, ¶[0036]; ¶[0007]-[0017]). Neither reference alone explicitly states determining composition (blood fraction) from the container’s electrical signals nor using composition with the first and second quantities to compute lost blood.
Konig teaches, in the same canister context, determining the blood component of mixed canister contents by estimating hemoglobin mass (Konig, p.3, BACKGROUND; Abstract: “estimate the amount of Hb present in canisters” and doing so over a “wide range of blood dilutions commonly seen in suction canisters”) and converting that to estimated blood loss (Konig, p.5, Sample Preparation and Measurement: “Based on the Hb concentration… and the manually entered canister volume, the Triton device calculated the Hb mass”). The study reports agreement with the reference assay within “limits of agreement… ±30 g,” and concludes the method achieves “clinically acceptable accuracy… [across a] wide range of… dilutions, [and] hemolysis” (Konig, p.8, DISCUSSION; p.11, Key Points)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Lin, Bonutti, Rothrum, Tankersley, Lee, and Wang in view of Konig to determine a composition of the fluids in the blood container and, based on that composition together with the first and second quantities, determine an amount of lost blood. The combination is feasible because Wang and Konig are both instrumenting the same canister reservoir; Konig establishes the conventional need and workflow for in-canister composition-to-blood calculations in mixed fluids, while Wang supplies a known alternative sensing architecture (electrode-based tomography) feeding Lin’s modular computing. Substituting one known sensor modality (electrical tomography) for another known modality (optical/colorimetric) to achieve the same recognized objective (accurate blood quantification in mixed canister fluids) would have been a predictable design choice. The motivation is Konig’s documented benefit of reducing error in the presence of irrigation/mixed fluids and providing accurate, real-time blood-loss estimates, precisely aligned with Wang/Lin’s goal of modular, sensor-rich intraoperative blood management.
Regarding claim 23, the combined Lin, Bonutti, Rothrum, Tankersley, Lee, Wang, and Konig does not fully teach that the fluids enclosure comprises an impermeable upper sheet, an impermeable lower sheet, and a permeable sheet; wherein the permeable sheet is disposed over a surgical site edge of the drape collector and is configured to allow the fluid from the surgical site layer to enter the fluids enclosure, and wherein the impermeable upper sheet is disposed on an outer edge of the drape collector and is configured to prevent the fluid in the fluids enclosure from spilling on the drape. Lin discloses a drape system designed to manage fluid accumulation during surgery, integrating structural features to assist in tracking surgical fluid loss (Lin, ¶[0061]). And the combined Lin, Rothrum, and Bonutti, as previously described above, discloses a drape collector for managing surgical fluids but does not explicitly disclose a defined impermeable and permeable layered structure. Rothrum discloses a fluid collection pouch that includes an impermeable polymeric film or sheet forming a containment enclosure with a top and bottom (Rothrum, FIG. 7, Col. 3-4, Lines 46-7). Rothrum explicitly states that the pouch material is fluid impervious, listing various plastic sheet materials including polyethylene, polypropylene, and nylon as preferred options. Rothrum further describes a sieve positioned at the top edge of the pouch, which contains perforations, slits, or small holes to allow fluid passage while retaining solid objects such as instruments and sponges within the pouch (Rothrum, Col. 10, Lines 1-19). Additionally, Rothrum describes a pouch design where the front and rear panels are joined along the edges to define a fluid-receiving chamber, preventing spillage onto the drape (Rothrum, Abstract; Figure 3B). The structure inherently prevents leakage by sealing the upper sheet to the lower sheet, forming a contained enclosure. It would have been prima facie obvious before the effective filing date of the claimed invention to modify the combined Lin, Bonutti, Rothrum, Tankersley, Lee, Wang, and Konig in view of Rothrum to incorporate a fluids enclosure comprising an impermeable upper sheet, an impermeable lower sheet, and a permeable sheet. Lin already describes a drape system designed to manage surgical fluids, and Rothrum provides a structurally defined fluid collection pouch with both impermeable and permeable components. A person of ordinary skill in the art would recognize that Lin’s drape system, which already manages fluid accumulation, could incorporate Rothrum’s impermeable pouch material and sieve-like permeable layer to enhance containment and controlled fluid passage without requiring substantial design changes. Rothrum’s pouch structure aligns with Lin’s goal of improving surgical fluid collection by ensuring that fluids are directed into a sealed enclosure for efficient management. This would have the benefit of improving surgical fluid containment by ensuring that collected fluids remain securely within the enclosure, while allowing controlled fluid entry and preventing spills, thereby enhancing surgical field cleanliness and efficiency.
Regarding claim 29, the combined Lin, Bonutti, Rothrum, Tankersley, Lee, Wang, and Konig does not fully teach that the fluids enclosure comprises one or more tube drains configured to drain the fluid from the drape collector into an outside fluid container. The combined Lin, Bonutti, Rothrum, Tankersley, Lee, Wang, and Konig, as previously described, disclose a drape collector that manages surgical fluids, incorporating a fluids enclosure for collecting excess fluids during a procedure. However, neither Lin nor Rothrum explicitly disclose a specific tube drain for directing the collected fluids from the drape collector into an outside fluid container. Lin describes systems that use fluid collection bags and direct drainage mechanisms to remove collected fluids from the surgical field (Lin, ¶[0041]). Rothrum further describes a fluid collection pouch that includes an outlet for draining collected fluids (Rothrum, Col. 8, Lines 24-41). Bonutti, discloses drain 160, which is depicted as a tube that drains fluid collected on the drape into an outside fluid container (Bonutti, Fig. 14, ¶[0059]). Together, these references establish that directing collected fluids from the drape area to an external container via a drainage mechanism, such as a tube, was a well-known practice in surgical fluid management. It would have been prima facie obvious before the effective filing date of the claimed invention to modify the combined Lin, Bonutti, Rothrum, Tankersley, Lee, Wang, and Konig to incorporate one or more tube drains configured to drain fluid from the drape collector into an outside fluid container. Bonutti’s explicit disclosure of a tube for fluid drainage further confirms the feasibility of this integration, especially when combined with Rothrum's drain outlet, as it provides a direct example of such functionality in a surgical drape and collector system. A person of ordinary skill in the art would recognize that using tube drains is a logical and predictable extension of known drainage mechanisms, facilitating continuous removal of excess fluids to maintain a clear surgical field and prevent overflow. Given Lin’s discussion of modular fluid management systems (Lin, ¶[0041]) and Rothrum’s disclosure of fluid drainage through an outlet (Rothrum, ¶[0010]), adding a tube drain would have been a straightforward improvement. This would have the benefit of improving surgical fluid management by ensuring continuous drainage, preventing excess fluid accumulation in the drape collector, and maintaining a sterile surgical environment.
Regarding claim 39, the combined Lin, Bonutti, Rothrum, Tankersley, Lee, Wang, and Konig does not fully teach that the blood container is a pocket blood container disposed at an edge of the drape and at an elevation which is substantially lower than the drape. The combined Lin, Bonutti, Rothrum, Tankersley, Lee, Wang, and Konig, as previously described, discloses a surgical drape incorporating an attached fluid collection pouch that gathers and stores fluids from the surgical site. Lee’s fluid collection pouch is structurally integrated with the drape and positioned to collect surgical fluids, demonstrating that a fluid-holding container can be directly attached to the edge of the drape for efficient collection (Lee, FIG. 3, ¶[0028]-[0029]). Since the pouch is designed for fluid collection, it is positioned at a lower elevation relative to the drape to allow gravity-assisted drainage and storage as show in the figure (Lee, FIG. 3). It would have been prima facie obvious before the effective filing date of the claimed invention to modify the combined Lin, Bonutti, Rothrum, Tankersley, Lee, Wang, and Konig in view of Lee to explicitly define the fluid collection pouch as a pocket blood container disposed at the edge of the drape at a lower elevation. Since Lee already teaches a structurally integrated pouch that collects and retains fluid, adapting its placement at the drape’s edge or the drape's lowest point would have been an expected design choice to further optimize fluid collection and drainage in the over-all system. This modification would provide a more efficient and self-contained blood collection system, ensuring improved fluid management by leveraging gravity for fluid flow into the container. By integrating the blood collection pocket directly with the drape, the system eliminates the need for separate external fluid containers, reducing setup complexity and enhancing sterility. Additionally, positioning the pocket container at a lower elevation minimizes fluid stagnation, ensuring continuous drainage and preventing overflow during surgical procedures.
Regarding claim 40, the combined Lin, Bonutti, Rothrum, Tankersley, Lee, Wang, and Konig does not fully teach that the blood container comprises one or more rigid or semi-rigid ribs configured to provide structure to the flexible wall of the blood container. The combined Lin, Bonutti, Rothrum, Tankersley, Lee, Wang, and Konig, as previously described, discloses a surgical drape integrating a fluid collection pouch with an inflatable bladder to provide structure and shape to the pouch. Lee explicitly describes the bladder as a structural component that maintains the pouch’s form and ensures proper fluid collection (Lee, FIGS. 1-3, ¶[0021], [0031]). While Lee does not refer to these structural components as rigid or semi-rigid ribs, the inflatable bladder functions equivalently by reinforcing the flexible container and preventing collapse, ensuring it retains an appropriate shape for collecting fluids. Since inflatable structural elements serve the same purpose as rigid or semi-rigid ribs by maintaining the shape of a flexible blood container, it would have been prima facie obvious before the effective filing date of the claimed invention to modify the combined Lin, Bonutti, Rothrum, Tankersley, Lee, Wang, and Konig in view of Lee to explicitly define these structural reinforcements as semi-rigid ribs. Given that Lee already teaches a flexible fluid collection pouch that incorporates a structural reinforcement feature, substituting or supplementing the inflatable component with semi-rigid ribs would have been an expected design choice to improve container stability and durability. This modification would provide an enhanced blood container structure, ensuring greater stability and shape retention during surgical fluid collection. By incorporating semi-rigid ribs, the container can maintain its form, reducing the risk of collapse and improving handling in surgical environments. Additionally, rigid or semi-rigid reinforcements would enable more predictable fluid distribution within the container, preventing pooling or uneven weight distribution, further optimizing surgical fluid management.
Claims 25-27, 30, 32-36, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (US 20180266870 A1), hereto referred as Lin, and further in view of Bonutti et al. (US 20030060831 A1), hereto referred as Bonutti, and further in view of Rothrum et al. (US 5618278 A), hereto referred as Rothrum, and further in view of Tankersley et al. (US 20070135784 A1), hereto referred as Tankersley, and further in view of Lee et al. (US 20040149291 A1), hereto referred as Lee, and further in view of Wang et al. (US 20170254765 A1), hereto referred as Wang, and further in view of Konig et al. (Gerhardt Konig et al. “In Vitro Evaluation of a Novel Image Processing Device to Estimate Surgical Blood Loss in Suction Canisters.” Anesthesia and analgesia (2018): n. page. Web.), hereto referred as Konig, and further in view of Cheatham et al. (US 20160331460 A1), hereto referred as Cheatham.
The combined Lin, Bonutti, Rothrum, Tankersley, Lee, Wang, and Konig teaches claim 21 as described above.
Regarding claim 25, the combined Lin, Bonutti, Rothrum, Tankersley, Lee, Wang, and Konig does not fully teach that the drape collector comprises a plurality of pressure sensors configured to measure the pressure generated by the fluids accumulated in the fluids enclosure, wherein the pressure sensors form one or more sensor arrays. Rather, the combined Lin, Bonutti, Rothrum, Tankersley, Lee, Wang, and Konig, as previously described, discloses a drape collector that manages surgical fluids, including a fluid retention element, but does not disclose pressure sensors for measuring the pressure generated by accumulated fluids. Cheatham, who investigates pressure sensors in surgical drapery, discloses that these sensors can be attached to, embedded in, or integral to a drape to monitor pressure changes, including those resulting from swelling or fluid accumulation (Cheatham, ¶[0038], ¶[0094]). Cheatham further describes the use of pressure sensors to detect swelling, a concept directly applicable to measuring pressure changes as a drape collector fills and swells with blood (Cheatham, ¶[0094]). This demonstrates that utilizing pressure sensors to monitor fluid accumulation and its resulting pressure variations was a well-understood application in the field. Cheatham also describes the embedded sensors as forming at least one sensor array (Cheatham, ¶[0033]). It would have been prima facie obvious before the effective filing date of the claimed invention to modify the combined Lin, Bonutti, Rothrum, Tankersley, Lee, Wang, and Konig in view of Cheatham to incorporate a plurality of pressure sensors configured to measure the pressure generated by the fluids accumulated in the drape collector’s fluids enclosure where the sensors form one or more sensor arrays. Given Cheatham’s explicit disclosure of pressure sensor arrays in surgical drapery and their ability to detect swelling, a person of ordinary skill in the art would recognize that adapting such sensors for use in monitoring collected fluid within the drape collector is a logical and predictable extension of existing technology, as both involve detecting pressure variations due to changes in volume and accumulation of fluids (Cheatham, ¶[0033], [0094]). Cheatham explicitly describes pressure sensors designed to monitor pressure variations in surgical applications, and a person of ordinary skill in the art would recognize that integrating such sensors within Rothrum’s fluid collection pouch would provide real-time pressure measurements to track fluid buildup and prevent overflow (Cheatham, ¶[0094]). This modification would allow for more accurate tracking of fluid buildup and enhance surgical fluid management without requiring substantial design changes. This would have the benefit of improving surgical fluid monitoring by enabling real-time pressure-based fluid volume assessments, ensuring more accurate blood loss estimation and better intraoperative decision-making. The adaptation of Cheatham’s pressure sensors to monitor accumulated fluid in the drape collector would provide a reliable and well-understood means of detecting fluid buildup and pressure changes during surgery, enhancing surgical efficiency and fluid management.
Regarding claim 26, the combined Lin, Bonutti, Rothrum, Tankersley, Lee, Wang, Konig, and Cheatham does not fully teach that a first one or more of the plurality of pressure sensors are disposed on the bottom of the fluids enclosure and under the fluid retention elements. Rather, as previously described, it discloses a drape collector that manages surgical fluids, incorporating fluid retention elements and pressure sensors for measuring the pressure generated by accumulated fluids. However, it does not explicitly disclose the placement of pressure sensors at the bottom of the fluids enclosure and under the fluid retention elements. Cheatham, who investigates pressure sensors in surgical drapery, teaches that these sensors can be attached to, embedded in, or integral to a drape to monitor pressure changes (Cheatham, ¶[0094]). Cheatham further suggests that the placement of sensors can be adapted to the desired monitoring outcome, as its system includes multiple types of sensors embedded throughout the drape (Cheatham, ¶[0038]). This demonstrates that sensor placement is a design choice dictated by the specific application, making it an expected design modification for measuring pressure in a fluid collection system. It would have been prima facie obvious before the effective filing date of the claimed invention to modify the combined Lin, Bonutti, Rothrum, Tankersley, Lee, Wang, Konig, and Cheatham in view of Cheatham to incorporate the pressure sensors at the bottom of the fluids enclosure and under the fluid retention elements. A person of ordinary skill in the art would recognize that such placement optimizes pressure measurement by aligning the sensors with the area where hydrostatic pressure is most stable and directly proportional to fluid volume. This approach is well-established in liquid level sensing, where bottom-positioned sensors eliminate inaccuracies caused by surface fluctuations or uneven fluid distribution. Additionally, sensors placed under the retention elements account for absorbed fluid mass, ensuring comprehensive pressure monitoring. This would have the benefit of improving surgical fluid monitoring by maximizing the accuracy of pressure-based volume assessments, ensuring real-time detection of fluid accumulation, and enabling more effective blood loss estimation. The adaptation of Cheatham’s pressure sensors in this manner would provide a predictable and logical improvement to existing surgical fluid management systems.
Regarding claim 27, the combined Lin, Bonutti, Rothrum, Tankersley, Lee, Wang, Konig, and Cheatham does not fully teach that a second one or more of the plurality of pressure sensors are disposed on a side of the fluid retention elements and configured to measure a component of the pressure exerted parallel to the drape. Rather, as previously described, it discloses a drape collector that manages surgical fluids, incorporating fluid retention elements and pressure sensors for measuring the pressure generated by accumulated fluids. However, it does not explicitly disclose the placement of pressure sensors at the bottom of the fluids enclosure, under the fluid retention elements, or on the sides of the retention elements to measure lateral pressure variations. Cheatham, who investigates pressure sensors in surgical drapery, teaches that these sensors can be attached to, embedded in, or integral to a drape to monitor pressure changes (Cheatham, ¶[0094]). Cheatham further suggests that the placement of sensors can be adapted to the desired monitoring outcome, as its system includes multiple types of sensors embedded throughout the drape (Cheatham, ¶[0038]). This demonstrates that sensor placement is a design choice dictated by the specific application, making it an expected design modification for measuring pressure in a fluid collection system. It would have been prima facie obvious before the effective filing date of the claimed invention to modify the combined Lin, Bonutti, Rothrum, Tankersley, Lee, Wang, Konig, and Cheatham in view of Cheatham to incorporate the pressure sensors on the sides of the retention elements. Placing pressure sensors on both the bottom and sides of the retention elements enhances fluid pressure monitoring by accounting for both vertical and lateral hydrostatic forces. In fluid containment systems, pressure is exerted in multiple directions as fluid accumulates, necessitating strategic sensor placement to ensure comprehensive and accurate measurements. Sidewall sensors allow for real-time detection of pressure fluctuations caused by shifting fluid distributions, preventing errors that could arise from measuring pressure only at the bottom. A person of ordinary skill in the art would recognize that such placement aligns with established principles in liquid level sensing, where multi-point pressure detection eliminates inaccuracies from surface fluctuations and uneven fluid distribution. Additionally, lateral sensors ensure a complete pressure profile by capturing fluid accumulation along the enclosure’s sidewalls, enabling more precise detection of uneven fluid buildup and improving overall monitoring accuracy. This would have the benefit of improving surgical fluid monitoring by maximizing the accuracy of pressure-based volume assessments, ensuring real-time detection of fluid accumulation, and enabling more effective blood loss estimation. The adaptation of Cheatham’s pressure sensors in this manner would provide a predictable and logical improvement to existing surgical fluid management systems.
Regarding claim 30, the combined Lin, Bonutti, Rothrum, Tankersley, Lee, Wang, Konig, and Cheatham does not fully teach that the drape collector is formed as an essentially flexible layer contiguous with and incorporated into the drape; and wherein the sensor arrays and a signal reading system are implemented via a flexible electronics technology. Rather, as previously described, it disclose a drape collector that manages surgical fluids and includes sensor arrays, but do not explicitly state that the drape collector is a flexible layer that is both contiguous with and incorporated into the drape. Additionally, while sensor arrays are disclosed, the prior art does not explicitly describe a signal reading system implemented via flexible electronics technology. Rothrum discloses a fluid collection pouch that is made from flexible materials such as polyethylene and polyurethane, inherently confirming its flexibility (Rothrum, Col. 3-4, Lines 46-7). Additionally, Rothrum describes that the pouch may be constructed from a single piece of material that is folded and joined, further reinforcing that it is flexible (Rothrum, Col. 8, lines 52-59). Regarding incorporation, Rothrum states that the pouch is attached to the drape using adhesive tape on the backside of the rear panel (Rothrum, Col. 12, Lines 1-27). While this suggests attachment, it does not explicitly confirm full contiguity or integration into the drape itself. Tankersley, however, discloses a similar drape collector concept in which the collector is "incorporated as a component" of the drape system (Tankersley, FIGS. 1B-3B, ¶[0050]). This provides evidence that a fluid collection structure can be integrated into the drape itself rather than simply being attached, supporting the claimed feature of the drape collector being contiguous and incorporated. Cheatham discloses sensor arrays embedded within a surgical drape and describes that the arrays may consist of various sensors, including pressure sensors (Cheatham, ¶[0033]). Furthermore, Cheatham explicitly states that these sensor arrays are implemented via flexible electronics (Cheatham, ¶[0033], ¶[0118]). This establishes that embedding flexible electronic sensor arrays into a surgical drape was well known before the effective filing date. Cheatham also describes a signal reading system that is integrated with the interactive surgical drape, wherein electronic circuitry receives and processes signals from the sensor assembly to monitor physiological characteristics (Cheatham, ¶[0113]-[0114]). The electronic circuitry is configured to receive signals from the embedded sensor array, process the data, and transmit signals to a display or another system component. This demonstrates that the prior art includes a system capable of capturing sensor data and interpreting it through integrated electronic components, reinforcing the feasibility of embedding a signal reading system within a flexible drape structure. It would have been prima facie obvious before the effective filing date of the claimed invention to modify the combined Lin, Bonutti, Rothrum, Tankersley, Lee, Wang, Konig, and Cheatham in view of Rothrum, Cheatham, and Tankersley to incorporate a drape-integrated flexible electronics technology with sensor arrays and a signal reading system. Lin and Rothrum already disclose surgical drapes with fluid collection capabilities, and Rothrum further establishes that the collector can be made from flexible materials. While Rothrum describes attachment of the pouch to the drape, it does not explicitly teach full incorporation. However, Tankersley demonstrates that a fluid collection pocket can be incorporated as part of a drape structure rather than simply attached, supporting the claimed feature of contiguity and integration. Additionally, Cheatham discloses sensor arrays embedded within a surgical drape and describes how these arrays can be implemented via flexible electronics, confirming that flexible sensor integration was well known in the field. Cheatham further discloses a signal reading system that is operably connected to the embedded sensors and processes physiological signals, making it a logical and predictable extension to incorporate such a system into the flexible drape structure described in the combined prior art. A person of ordinary skill in the art would have recognized that incorporating Cheatham’s flexible electronics technology into a surgical drape with a fluid collector would allow for direct signal processing without requiring additional external hardware, enhancing the functionality of the drape system. This modification would have the benefit of providing a fully integrated and flexible drape collector with embedded flexible sensor arrays and a signal reading system, ensuring continuous and accurate fluid monitoring during surgery with a system that can adapt to different structural configurations while ensuring functionality. By incorporating the flexible sensor arrays directly into the drape rather than relying on separate external devices, this combination reduces the complexity of intraoperative blood monitoring, enhances the responsiveness of real-time fluid assessment, and improves surgical efficiency. Additionally, the incorporation of flexible electronics ensures that the drape collector maintains its structural adaptability while enabling advanced signal processing capabilities, where rigid monitoring components would have interfered with surgical procedures. Additionally, a contiguous an incorporated collector and drape would ensure there is no possibility of leakage between layers that would decrease sterility as well as affect the accuracy of the overall system.
Regarding claim 32, the combined Lin, Bonutti, Rothrum, Tankersley, Lee, Wang, Konig, and Cheatham does not fully teach that the computing system is configured to communicate with and control the plurality of electrodes, and wherein the computing system is configured to implement impedance tomographic measurements on the fluids in the blood container via the electrodes and to evaluate the volume of the fluids in the blood container based on the impedance tomographic measurements. Rather, as previously described, it disclose a system for collecting and monitoring fluid in a flexible blood container with a measurement system utilizing an array of electrodes and a computing system to process sensor data. Lin describes a computing system that integrates fluid measurement sensors to continuously calculate total blood loss in real-time (Lin, ¶[0036]), while Cheatham discloses a system that receives and processes sensor signals, providing electronic control over electrode-based sensors (Cheatham, ¶[0113]-[0114]). Wang further details how electrodes arranged around a liquid volume can generate electrical measurements to determine conductivity and volume (Wang, Abstract, ¶[0077]). However, while these references establish that fluid volume measurement using electronic sensors was well-known, they do not explicitly describe impedance tomography as the method of evaluation. Wang provides additional support for impedance tomography (EIT) measurements using electrode arrays. Wang explicitly discloses a tomography system that measures conductivity and impedance using multiple electrodes in a liquid sample volume (Wang, Abstract, ¶[0002], ¶[0077]). Wang also describes an electrode-based measurement system that applies current to an array of electrodes and measures voltage differentials across the liquid, demonstrating that it was already used for real-time fluid characterization. Given that Wang's system is designed to assess the electrical properties of fluid in a structured manner, applying impedance tomography is a straightforward extension that refines its existing capabilities to provide volumetric data. This logical progression would have been readily apparent to one skilled in the art, given the known advantages of impedance tomography in enhancing the precision of fluid measurement systems. It would have been prima facie obvious before the effective filing date of the claimed invention to modify the combined Lin, Bonutti, Rothrum, Tankersley, Lee, Wang, Konig, and Cheatham in view of Wang to configure a computing system capable of receiving and processing impedance tomography signals to evaluate the volume of fluids in a blood container. Lin already teaches a computing system for processing fluid measurement data, and Cheatham describes an electronic control system that interfaces with embedded sensors. Wang’s system, which already integrates an array of electrodes for electrical characterization of fluid properties, naturally lends itself to impedance tomography as a refined application of its existing measurement methodology. This demonstrates that Wang’s system is not only compatible with the claimed features but was already performing similar measurements with a different processing technique, making its extension to impedance tomography both feasible and expected. This modification would have the benefit of enabling a computing system that can process real-time impedance tomography signals to evaluate blood volume dynamically using any shaped vessel. By leveraging Wang’s well-known EIT techniques and Cheatham’s electronic control systems, this configuration improves the accuracy of intraoperative fluid monitoring while integrating seamlessly into existing surgical data processing workflows.
Regarding claim 33, the combined Lin, Bonutti, Rothrum, Tankersley, Lee, Wang, Konig, and Cheatham does not fully teach that the computing system is configured to implement electrical resistance tomographic measurements on the fluids in the blood container via the electrodes and to evaluate the volume of the fluids in the blood container based on the electrical resistance tomographic measurements. Rather, as previously described, it disclose a system for collecting and monitoring fluid in a flexible blood container with a measurement system utilizing an array of electrodes and a computing system to process sensor data. Lin describes a computing system that integrates fluid measurement sensors to continuously calculate total blood loss in real-time (Lin, ¶[0036]), while Cheatham discloses a system that receives and processes sensor signals, providing electronic control over electrode-based sensors (Cheatham, ¶[0113]-[0114]). Wang further details how electrodes arranged around a liquid volume can generate electrical measurements to determine conductivity and volume (Wang, Abstract, ¶[0077]). However, while these references establish that fluid volume measurement using electronic sensors was well-known, they do not explicitly describe electrical resistance tomography as the method of evaluation. Wang provides additional support for electrical resistance tomography (ERT) measurements using electrode arrays. Wang explicitly discloses a tomography system that measures conductivity and resistivity using multiple electrodes in a liquid sample volume (Wang, Abstract, ¶[0002]). Additionally, Wang states that the system's processing means is specifically arranged to ‘calculate sample conductivity values’ and generate tomograms based on those values (Wang, ¶[0012]). Since ERT reconstructs images based solely on conductivity (or its inverse, resistivity), Wang’s description inherently aligns with ERT functionality. Furthermore, the reference states that these calculations use an 'assumption of symmetry', reinforcing that the system processes conductivity values as the primary measurement for tomographic reconstruction (Wang, ¶[0012]). While someone might argue that conductivity calculations are part of a broader EIT system, ERT is a subset of EIT, and Wang's system explicitly isolates conductivity-based reconstruction, making it clear that ERT is inherently supported by its methodology. It would have been prima facie obvious before the effective filing date of the claimed invention to modify the combined Lin, Bonutti, Rothrum, Tankersley, Lee, Wang, Konig, and Cheatham in view of Wang to configure a computing system capable of receiving and processing electrical resistance tomography signals to evaluate the volume of fluids in a blood container. Lin already teaches a computing system for processing fluid measurement data, and Cheatham describes an electronic control system that interfaces with embedded sensors. Wang’s system, which already integrates an array of electrodes for electrical characterization of fluid properties, naturally lends itself to electrical resistance tomography as a refined application of its existing measurement methodology. This demonstrates that Wang’s system is not only compatible with the claimed features but was already performing similar measurements with a different processing technique, making its extension to electrical resistance tomography both feasible and expected. This modification would have the benefit of enabling a computing system that can process real-time electrical resistance tomography signals to evaluate blood volume dynamically in any shape vessel. By leveraging Wang’s well-known ERT techniques and Cheatham’s electronic control systems, this configuration improves the accuracy of intraoperative fluid monitoring while integrating seamlessly into existing surgical data processing workflows.
Regarding claim 34, the combined Lin, Bonutti, Rothrum, Tankersley, Lee, Wang, Konig, and Cheatham does not fully teach that the system further comprises a resistivity measuring system configured to measure a resistivity of the fluids in the blood container, the resistivity measuring system comprising: two or more resistivity measuring electrodes disposed close to a bottom of the blood container. Rather, as previously described, it disclose a system for collecting and monitoring fluid in a flexible blood container with a measurement system utilizing an array of electrodes and a computing system to process sensor data. Lin describes a computing system that integrates fluid measurement sensors to continuously calculate total blood loss in real-time (Lin, ¶[0036]), while Cheatham discloses a system that receives and processes sensor signals, providing electronic control over electrode-based sensors (Cheatham, ¶[0113]-[0114]). Wang further details how electrodes arranged around a liquid volume can generate electrical measurements to determine conductivity and volume (Wang, Abstract, ¶[0077]). However, while these references establish that fluid volume measurement using electronic sensors was well-known, they do not explicitly describe a resistivity measuring system placed at the bottom of the blood container. Wang provides additional support for resistivity measurement using electrode arrays. Wang explicitly discloses a tomography system that measures conductivity and resistivity using multiple electrodes in a liquid sample volume (Wang, Abstract, ¶[0002]). Wang also describes an electrode-based measurement system that applies current to an array of electrodes and measures voltage differentials across the liquid, demonstrating that it was already used for real-time fluid characterization (Wang, Abstract). Furthermore, Wang states that the system's processing means is specifically arranged to calculate sample conductivity values and generate tomograms based on those values (Wang, ¶[0012]). Since resistivity is the inverse of conductivity, Wang inherently supports resistivity measurement as part of its tomographic reconstruction process. Given that blood resistivity varies with hematocrit concentration, placing resistivity measuring electrodes at the bottom of the blood container would have been an expected adaptation to facilitate accurate fluid property analysis. Additionally, placing the resistivity measuring electrodes near the bottom of the blood container is obvious as it ensures that even small quantities of fluid can be effectively analyzed, maintaining system functionality across varying fluid levels. This arrangement allows for continuous monitoring without requiring a minimum fluid threshold, making it a practical and expected implementation of Wang’s known measurement techniques. It would have been prima facie obvious before the effective filing date of the claimed invention to modify the combined Lin, Bonutti, Rothrum, Tankersley, Lee, Wang, Konig, and Cheatham in view of Wang to include a resistivity measuring system within the blood container. Lin already teaches a computing system for processing fluid measurement data, and Cheatham describes an electronic control system that interfaces with embedded sensors. Wang’s system, which already integrates an array of electrodes for electrical characterization of fluid properties, naturally lends itself to direct resistivity measurement. Given that resistivity is inherently linked to conductivity, it would have been a predictable and beneficial extension to incorporate dedicated resistivity measuring electrodes at the bottom of the blood container to enhance measurement accuracy. This modification would provide the benefit of a resistivity measuring system capable of assessing hematocrit levels and fluid conductivity in real time, improving blood composition analysis and fluid monitoring precision. By leveraging Wang’s well-known resistivity-based measurement techniques and Cheatham’s electronic control systems, this configuration enhances intraoperative blood loss assessment while integrating seamlessly into existing surgical fluid monitoring workflows.
Regarding claim 35, the combined Lin, Bonutti, Rothrum, Tankersley, Lee, Wang, Konig, and Cheatham does not fully teach that the fluid measurement system is configured to perform on the fluids in the blood container one or more of: impedance tomographic measurements, resistance tomographic measurements, fluid resistivity measurements, fluid density measurements, colorimetric measurements, temperature measurements, pH measurements, and ultrasound measurements. Rather, as previously described, it disclose a system for collecting and monitoring fluid in a flexible blood container with a measurement system utilizing an array of electrodes and a computing system to process sensor data. Lin describes a computing system that integrates fluid measurement sensors to continuously calculate total blood loss in real-time (Lin, ¶[0036]), while Cheatham discloses a system that receives and processes sensor signals, providing electronic control over electrode-based sensors (Cheatham, ¶[0113]–[0114]). Wang further details how electrodes arranged around a liquid volume can generate electrical measurements to determine conductivity and volume (Wang, Abstract, ¶[0077]). However, while these references establish that fluid volume measurement using electronic sensors was well-known, they do not explicitly describe all of the listed evaluation modalities. Wang addresses electrical impedance/resistance tomography and resistivity-based evaluations, and, for the colorimetric modality specifically in suction canisters, Konig teaches estimating hemoglobin mass in mixed canister fluids and converting that to estimated blood loss with clinically acceptable accuracy across dilutions and hemolysis (Konig, p.3 BACKGROUND; Abstract; p.5 Sample Preparation and Measurement; p.8 Discussion; p.11 Key Points).
Wang provides additional support for impedance and resistance tomographic measurements using electrode arrays, explicitly describing a tomography system that measures conductivity and resistivity using multiple electrodes in a liquid sample volume (Wang, Abstract, ¶[0002]; see also Wang, ¶[0012] for calculation of sample conductivity values and tomogram generation). For colorimetric evaluation among the listed alternatives, Konig demonstrates canister-based composition determination (hemoglobin mass) from mixed blood + irrigation contents and its conversion to estimated blood loss under clinically acceptable agreement (Konig, p.3 BACKGROUND; Abstract; p.5; p.8; p.11). Temperature, pH, and ultrasound are routine alternatives in surgical monitoring and are presented in the claim as optional modalities rather than cumulative requirements.
It would have been prima facie obvious before the effective filing date of the claimed invention to modify the combined Lin, Bonutti, Rothrum, Tankersley, Lee, Wang, Konig, and Cheatham in view of Wang (for impedance/resistance tomography and resistivity) and Konig (for the colorimetric canister pathway) to configure a fluid-measurement system capable of performing the recited modalities within the same container locus. One of ordinary skill would have recognized that integrating electrical (Wang) and/or colorimetric (Konig) sensing within Lin’s modular computing framework yields predictable improvements in intraoperative assessment by enabling composition-aware measurements from canister contents (including mixed fluids) with established workflows.
This modification would provide the benefit of a multi-functional fluid measurement system capable of evaluating not only the volume and resistivity of the fluid (Wang) but also composition in a mixed canister environment via hemoglobin mass and estimated blood loss (Konig), thereby improving surgical blood management and decision-making while integrating seamlessly with existing sensor processing (Lin; Cheatham).
Regarding claim 36, the combined Lin, Bonutti, Rothrum, Tankersley, Lee, Wang, Konig, and Cheatham does not fully teach that the fluid measurement system is further configured to evaluate the composition of the fluids in the blood container or the amount of blood in the blood container based on at least two of: impedance tomographic measurements, resistance tomographic measurements, fluid resistivity measurements, fluid density measurements; colorimetric measurements, temperature measurements, pH measurements, and ultrasound measurements. Rather, the combined Lin, Bonutti, Rothrum, Tankersley, Lee, Wang, Konig, and Cheatham, as previously described, disclose a system for collecting and monitoring fluid in a flexible blood container with a measurement system utilizing an array of electrodes and a computing system to process sensor data. Lin describes a computing system that integrates fluid measurement sensors to continuously calculate total blood loss in real-time (Lin, ¶[0036]), while Cheatham discloses a system that receives and processes sensor signals, providing electronic control over electrode-based sensors (Cheatham, ¶[0113]-[0114]). Wang further details how electrodes arranged around a liquid volume can generate electrical measurements to determine conductivity and support impedance/resistance tomography among the listed modalities (Wang, Abstract; ¶[0012]). However, while these references establish that sensor-based evaluation was well-known, they do not explicitly describe composition analysis in a mixed canister fluid or using such composition with measured quantities to compute an amount of blood.
Konig provides the missing composition-to-amount-of-blood teaching specifically in the canister context. Konig evaluates suction canister contents comprising mixed fluids (blood + irrigation), determines a blood-related component (hemoglobin mass) from those contents, and converts that to estimated blood loss with clinically acceptable agreement across dilutions and hemolysis (Konig, p.3 BACKGROUND; Abstract; p.5; p.8; p.11). In parallel, Wang supplies an alternative, known electrical sensing modality (impedance/resistance tomography; resistivity) listed in the claim’s alternatives, which a computing system as in Lin can ingest alongside or instead of colorimetric signals.
It would have been prima facie obvious before the effective filing date of the claimed invention to modify the combined Lin, Bonutti, Rothrum, Tankersley, Lee, Wang, Konig, and Cheatham in view of Konig (and Wang for the electrical alternatives) to configure the fluid measurement system to evaluate composition of the fluids in the blood container and, based on that composition together with measured quantities, determine an amount of blood, using at least two of the listed modalities (e.g., colorimetric per Konig and impedance/resistance tomography or resistivity per Wang). This combination is feasible because Konig and Wang both instrument the same locus (the canister) and produce composition-informative signals that Lin’s modular computing is expressly designed to integrate. The motivation is Konig’s documented improvement in accuracy in mixed-fluid conditions and the recognized clinical need to avoid irrigation-driven overestimation, aligned with Lin’s goal of accurate, sensor-rich intraoperative blood management.
Regarding claim 38, the combined Lin, Bonutti, Rothrum, Tankersley, Lee, Wang, Konig, and Cheatham does not fully teach that the drape comprises one or more of: one or more raised edges; one or more gutters disposed at the edges, one or more rigid supports or frames, one or more inflatable supports or frames, and one or more rigid or elastic strings incorporated into the edges of the drape. Rather, the combined Lin, Bonutti, Rothrum, Tankersley, Lee, Wang, Konig, and Cheatham, as previously described, disclose a system for managing surgical fluids using a drape with integrated structural components. Bonutti explicitly describes a surgical drape designed to collect and direct fluids, incorporating structural features that align with the claimed raised edge, gutter, and rigid support elements (Bonutti, FIG. 4-5, 14, ¶[0059]). Bonutti discloses that the drape naturally forms a trough or gutter when suspended between the surgical table, patient, and practitioner, allowing fluids to collect and be directed away from the surgical site (Bonutti, FIG. 4-5, 14, ¶[0059]). While not explicitly labeled as a raised edge, the drape’s flexible but structured positioning inherently creates a fluid-retaining barrier, functioning in the same way as a raised edge by preventing fluid spillage. Additionally, Bonutti describes a drain (160) integrated into the drape, which removes fluids that collect at the bottom, ensuring efficient fluid removal and preventing fluid buildup (Bonutti, FIG. 4-5, 14, ¶[0059]). This drain system reinforces the drape’s function as a gutter, directing fluids toward an external collection system. Even though the gutter is not strictly placed at the drape’s outer edge, it serves the same purpose by ensuring that collected fluids do not spill back onto the surgical field. Furthermore, Bonutti explains that the practitioner supports the drape’s weight and the weight of collected fluids, transferring tension through the drape material (Bonutti, FIG. 4-5, 14,¶[0059]). This demonstrates that the practitioner acts as a rigid support, stabilizing the drape’s shape and fluid collection function during surgery. While not a rigid frame in the conventional sense, this form of drape suspension provides the same structural integrity as a rigid support, ensuring the drape maintains its intended shape for optimal fluid collection and drainage. It would have been prima facie obvious before the effective filing date of the claimed invention to modify the combined Lin, Bonutti, Rothrum, Tankersley, Lee, Wang, Konig, and Cheatham in view of Bonutti to include raised edges, gutters, rigid or elastic frames, and inflatable supports as structural enhancements to a surgical drape. Bonutti already discloses a drape with inherent raised edges and gutter functionality, and its method of suspension provides rigid support. A person skilled in the art would have recognized that explicitly incorporating these structural features would be a logical and predictable extension of known drape designs to improve fluid containment and direction. This modification provides an enhanced surgical drape system, ensuring better fluid containment, reduced fluid spillage, and improved efficiency in surgical environments. By integrating raised edges and gutters, the system minimizes fluid overflow, enhances sterility at the surgical site, and optimizes fluid management. Additionally, the structural features improve adaptability for different surgical setups while maintaining an effective fluid collection system, reducing manual intervention and increasing intraoperative efficiency.
Response to Arguments
Objections
Applicant's arguments filed 9/10/2025, page 6, regarding the previous Objections of claims 21, 25-27, 30-31, and 39 have been fully considered and are persuasive or moot. The previous Objections have been withdrawn.
35 U.S.C. §112(b)
Applicant's arguments filed 9/10/2025, page 6, regarding the previous 112(b) Rejections of claims 21-40 have been fully considered and are persuasive. The previous 112(b) rejections have been withdrawn. However, there are new grounds of rejection as shown above.
Claim Interpretations
Applicant's arguments filed 9/10/2025, pages 6-7, regarding the previous claim interpretation of claim 21 is persuasive and claim 28 is moot. The previous claim interpretations have been withdrawn.
35 U.S.C. §103
Applicant's arguments filed 9/10/2025, pages 7-9, regarding the previous 103 Rejections of claims 21, 23, 25 -27, 29-30, 32-36, and 38-40 have been fully considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. That is, there are new grounds of rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/AARON MERRIAM/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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