DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
The status of the claims as of the response filed 11/11/2025 is as follows: Claim 3 remains cancelled. Claims 1-2 and 8-19 are currently amended. Claims 4 and 20 are as previously presented. Claims 5-7 are original. Claims 1-2 and 4-20 are currently pending in the application and have been considered below.
Response to Amendment
Double Patenting Rejection
The claims have been amended, but they are still not patentably distinct from the cited claims of the ‘531 and ‘714 patents such that the double patenting rejections are upheld.
Rejection Under 35 USC 112(b)
The claims have been amended such that the 35 USC 112(b) rejections are withdrawn.
Rejection Under 35 USC 103
The amendments made to the claims introduce limitations that are not fully addressed in the previous office action, and thus the corresponding 35 USC 103 rejections are withdrawn. However, Examiner will consider the amended claims in light of an updated prior art search and address their patentability with respect to prior art below.
Response to Arguments
Rejection Under 35 USC 103
On page 9 of the response filed 11/11/2025 Applicant introduces argument 1, asserting that Vase does not teach or suggest comparison of an index value based on both midline shift from a CT scan and edema volume for the purpose of adjusting operation of the CSF treatment module. Examiner agrees, and notes that Vase is not relied upon to teach this subject matter in the 35 USC 103 rejections.
On pages 9-10 of the response Applicant introduces argument 2, asserting that Serena does not teach the specific index of the instant claims. Applicant specifically argues that Serena generally “describes stroke diagnosis and prognosis using various biomarkers in an algorithm” but does not teach or suggest “1. An index specifically combining midline shift measurements from CT scans with edema volume measurements, 2. Using such an index to control CSF treatment hardware in real-time, 3. Comparing such an index to thresholds for automated treatment control.” Applicant’s arguments are fully considered, but are not persuasive. Examiner agrees that Serena does not explicitly disclose all of features 1-3 alone, but maintains that it does suggest such features when considered in combination with the teachings of Vase. For example, Vase teaches comparison of individual parameter measurements to treatment targets for automated control of a CSF treatment device (see [0143]-[0144], [0154]-[0155], [0160], [0164]-[0165]), but fails to explicitly disclose generation and use of a composite index value for this purpose, nor the individual parameters of the index being (1) midline shift measurements from CT scans and (2) edema volume. However, Serena teaches an analogous neurological injury analysis system that combines multiple measured physiological parameters into an index (Serena [0029]-[0030], noting “when using multiple markers together which may or may not be correlated with each other it is necessary to provide interpretation through an algorithm that relates all markers together”; “a plurality of markers are combined using an algorithm to increase the predictive value of the analysis in comparison to that obtained from the markers taken individually or in smaller groups”; see also [0032]-[0033], noting determination of weighting factors representing relative contribution of each marker in the algorithm, indicating that a final combined output of the algorithm is equivalent to an index of the combined input factors) that may be utilized to guide treatment decisions for a patient (Serena [0021]-[0023], noting the results of combining the parameters can identify patients who could benefit from specific types of therapy and may be used for treating a patient and/or monitoring the course of a treatment regimen). Physiological parameters contemplated as predictors of the patient’s neurological condition are shown in Fig. 1 & [0194], and include intracranial hemorrhage volume (i.e. edema volume) and mass effect (i.e. as measured by a CT scan showing midline shift or shifting of the structures of the median line as in [0201]). Accordingly, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of parameters utilized to guide/adjust CSF treatment as in Vase to include consideration of additional mass effect-related parameters like CT scan midline shift and edema volume as contemplated by Serena in order to incorporate measured parameters known to be potentially indicative of cerebral injury (as suggested by Serena Fig. 1 & [0194]). Additionally, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of parameters utilized to guide/adjust treatment (including midline shift and edema volume) as in Vase and Serena such that they are combined and evaluated as an index value as in Serena in order to provide interpretation through an algorithm that relates all the parameters together, thereby increasing the predictive value of the analysis for guiding treatment decisions (as suggested by Serena [0021]-[0023] & [0029]-[0030]). The result of such a combination would include the use of a composite index value based on individual parameters like midline shift and edema volume as in Serena to guide CSF treatment device adjustments rather than simple comparison of individual parameters to targets as in Vase, thereby incorporating measured parameters known to be indicative of cerebral injury and facilitating consideration of all of the parameters together to guide treatment so that treatment adjustments are based on values with improved predictive power and patient care is enhanced.
On page 10 of the response Applicant introduces argument 3, asserting that “Serena teaches away from combining midline shift and edema volume in a single index” because it suggests that such parameters are “alternative indicators rather than complementary measurements to be combined,” which would provide “no motivation to combine them into a single index, as doing so would be redundant and provide no additional predictive value.” Applicant’s arguments are fully considered, but are not persuasive. Examiner respectfully disagrees that Serena describes midline shift and edema volume as “surrogate” or “alternative” indicators; Fig. 1 and paras. [0187] & [0201] show that both ICH/infarct volume (e.g. edema volume) measurements and mass effect potentially showing midline shift are gathered for patients and may be used as clinical predictors. Para. [0030] further notes that combining a plurality of markers together increases the predictive value of the algorithm in comparison to only using markers individually or in smaller groups, suggesting to one of ordinary skill in the art that combining any of the contemplated predictors/markers would increase the value/usefulness of the index. Accordingly, Examiner maintains that Serena does not teach away from utilizing both of these types of parameters together in an index value.
On page 10 of the response Applicant introduces a second aspect of argument 3, asserting that “Vase appears to focus on continuously monitoring and adjusting treatment based on real-time sensor data… while Serena focuses on diagnostic classification using blood samples taken at discrete time points for stroke subtype determination,” and concluding that “the different temporal frameworks and purposes of these systems make their combination illogical. Applicant’s arguments are fully considered, but are not persuasive. Examiner notes that Vase contemplates both intermittent and continuous sampling of its measurements (see [0129]), showing that it would easily be able to accommodate the intermittently sampled measurement types of Serena for inclusion in its treatment adjustment decisions without changing the principle of operation.
On pages 10-11 of the response Applicant introduces argument 4, asserting that “there is no motivation in the prior art to create an index specifically combining midline shift from CT scans with edema volume measurements for CSF control” and “the Office Action’s rationale relies on impermissible hindsight reasoning.” Applicant further submits that the reasoning supplied in the rejection “fails to explain why one would select these specific two parameters from among the many parameters disclosed in both references” and “fails to explain why these parameters would be combined into an integrated index rather than monitored separately.” Applicant’s arguments are fully considered, but are not persuasive. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case, Examiner maintains that the combined teachings of Vase and Serena adequately suggests Applicant’s invention. Serena explicitly discusses the benefits of considering multiple parameters via an algorithm rather than monitoring and considering them individually (see [0030], [0070]), and discusses how mass effect and ICH volume measurements are types of parameters indicative of cerebral injury (see Fig. 1, [0187], [0201]). Because Vase describes systems for managing treatments of cerebral injuries of various types (see [0007]-[0008], [0113]), it would have been obvious to one of ordinary skill in the art to utilize any of the additional parameters shown to be indicative of cerebral injury (including midline shift and edema volume) as at least part of an index value used for guiding treatment adjustments for managing the cerebral injuries.
On page 11 of the response Applicant introduces argument 5, asserting that “Vase and Serena operate in fundamentally different technological spaces” and “the Office Action has not established with the requisite degree of support that a person of ordinary skill in the art would look to diagnostic stroke classification literature when designing an automated CSF treatment control system” because they “solve different problems using different methodologies at different timescales.” Applicant’s arguments are fully considered, but are not persuasive. Examiner respectfully disagrees that Vase and Serena operate in fundamentally different technological spaces; both are directed to computerized methods of evaluating patient measurements indicative of neurological conditions for the purpose of guiding treatment decisions to manage those neurological conditions. Examiner maintains that one of ordinary skill in the art of neurological monitoring and treatment management would have reasonably been aware of both references and found them to be sufficiently analogous for the purposes of 35 USC 103 analysis.
On pages 11-12 of the response Applicant introduces argument 6, asserting that “Serena’s algorithm is designed for diagnostic classification… based on data collected at specific time points,” which “is fundamentally incompatible with Vase’s requirement for real-time treatment control.” Applicant’s arguments are fully considered, but are not persuasive. As explained above, Vase contemplates both intermittent and continuous sampling of its measurements (see [0129]), showing that it would easily be able to accommodate the intermittently sampled measurement types of Serena for inclusion in index-based treatment adjustment decisions without changing the principle of operation.
On page 12 of the response Applicant argues that “neither Vase nor Serena teaches or suggests [the] hierarchical index structure” of claim 4, requiring “multiple sub-indices (plural), each sub-index based on two or more parameters, the overall index based on the sub-indices.” Applicant’s arguments are fully considered, but are not persuasive. Examiner notes that various individual parameters of Serena are functionally equivalent to sub-indices themselves based on two or more parameters; for example, lesion volume as in the list of predictors of Fig. 1 is disclosed as being calculated by the formula 0.5*a*b*c in [0187] such that the ICH volume is a sub-index made up of the sub-parameters maximal longitudinal diameter, maximal transfers diameter, and number of 10-mm slices containing hemorrhage, while other predictors can include sub-index parameters like CSS score (which is an index known in the art that incorporates multiple vital sign measurements). Thus the citation to paras. [0029]-[0030] & [0032]-[0033] showing that each parameter (which may themselves be sub-indices, as clarified by previously-cited Fig. 1 & [0187]) may contribute to the combined index value via weighted contributions does sufficiently show the hierarchical index framework reflected in claim 4.
On page 13 of the response Applicant argues that “the Office Action has not explained why one of ordinary skill in the art would look to Martin’s dashboard navigation system when designing the specific user interface for an automated CSF treatment system” as reflected in claim 8, concluding that “the combination would require substantial modification of all three references thereby rendering the proposed combination non-obvious.” Applicant’s arguments are fully considered, but are not persuasive. Vase and Martin both include teachings related to the design of clinical user interfaces for the purpose of presenting clinically-relevant information to a user for guiding treatment. Vase shows that a user interface may display various selectable panes alongside graphs, gauges, or other real-time readouts of measured sensor data (see Fig. 37, [0078], [0183]), considered to also include the values of the index when considered in the context of the combination with Serena because the index value would be a derived value of interest to the user analogous to those listed, and Vase contemplates presenting “other information as desired.” Though Vase fails to explicitly disclose display of a medical image of the patient in the selectable pane, Martin teaches an analogous clinical user interface that may include many selectable panes with different types of relevant patient data displayed simultaneously, including a medical image of a patient and other patient data such as vital signs or other sensor data (Martin Fig. 6, [0025], [0069]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the multi-pane user interface of Vase to include a pane with a medical image of a patient as in Martin in order to display a wider range of situationally-relevant patient information, such as patient X-rays, MRIs, CT scans, and other medical imaging data (as suggested by Martin [0025] & [0069]), thereby providing “other information as desired” (as in Vase [0183]). Examiner respectfully disagrees that modifying the user interface of Vase to include display of the derived index values of Serena as well as a medical image of a patient as in Martin would “require substantial modification of all three references” as Applicant asserts. Merely rendering additional data types on a user interface already configured for graphically displaying a multitude of different clinical data types would not require a substantial redesign or modification of the user interface; Examiner maintains that the computerized hardware and user interface of Vase would be capable of undertaking this type of data display operation, and a mere reprogramming or expansion of clinical data display functions does not support a finding of a change in the principle of operation of the Vase reference.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 4, 6, 9-11, and 13-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 8, and 12 of U.S. Patent No. 11826531. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims of ‘531 recite a more specific version of the claims of ‘296. That is, claims 1, 3, 8, and 12 of the ‘531 patent include limitations analogous to all of the limitations of claims 1-2, 4, 6, 9-11, and 13-14 of the instant application. Because a species can anticipate a genus (i.e. a more specific claim with all the features of the more generic claim can anticipate the generic claim), the cited claims of the ‘531 patent are considered to anticipate those of the ‘296 application.
Claims 1-2, 5, 7-15, and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-6, 9-12, and 16-19 of U.S. Patent No. 12383714. The cited claims of the ‘714 patent include nearly every single limitation of the cited claims of ‘296, with the only difference being that ‘714 recites monitoring measurements of one or more physiological parameters, while ‘296 recites monitoring measurements of two or more physiological parameters and specifies that they are related to a mass effect of a patient and include a midline shift from a CT scan and edema volume. However, monitoring two or more physiological parameters is still encompassed by claim language directed to “one or more” physiological parameters, and paras. [0077] & [00165] of the specification of ‘714 show that physiological parameter values can include a midline shift from a CT scan and edema volume. Accordingly, the physiological parameters of the independent claims of ‘714 are considered to include those “related to a mass effect of a patient” such as a midline shift from a CT scan and edema volume, and it would be obvious to one of ordinary skill in the art to specify this type of physiological parameter in the claim language because it is specifically contemplated in the disclosure. Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a cerebrospinal fluid management module comprising one or more hardware sub-modules” that is “in communication with the controller” and “perform[s] a treatment on cerebrospinal fluid of the patient” in claims 1 and 2.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. In the instant case, paras. [00140]-[00144] of the specification disclose that the hardware sub-modules of the CSF management module may include examples like “a pump, a filtration treatment module and a waste control mechanism” as well as circulation and cooling treatment modules, and that “other combinations of hardware and/or software sub-modules 34 may form or may be part of the CSF management module.” In light of this disclosure, Examiner interprets the CSF management module as including any type of hardware device capable of performing any type of treatment on the CSF of a patient.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 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.
Claims 1-2, 4-7, and 9-20 are rejected under 35 U.S.C. 103 as being unpatentable over Vase et al. (US 20170095649 A1) in view of Serena et al. (US 20070005261 A1).
Claim 1
Vase teaches an inflammation management system (Vase abstract, [0059], noting a system that may be used to minimize inflammation in neurocritical care), the system comprising:
a controller; a cerebrospinal fluid management module in communication with the controller, the cerebrospinal fluid management module comprising one or more hardware sub-modules (Vase [0077], noting processing unit 118 is a device configured to control treatment unit 106 by executing instructions stored in memory to make determinations; treatment unit 106 may be configured with hardware to treat a patient’s CSF per [0065]); wherein the controller is configured to:
monitor measurements of two or more physiological parameters related to a mass effect of a patient, (Vase [0116], [0129], [0159], noting multiple physiological parameters of a patient may be measured over time; such parameters can include intracranial pressure, fluid flow/volume, etc. per [0104]-[0110] & [0114], which are considered to be “related to a mass effect of a patient” in accordance with Applicant’s disclosures in at least paras. [0059] & [00174] of the specification);
compare values (Vase [0154], [0160], noting monitored values are compared to targets (i.e. one or more threshold values)); and
output a control signal to the one or more hardware sub-modules to cause the one or more hardware sub-modules to perform a treatment on cerebrospinal fluid of the patient, the controller configures the control signal based on the comparison of the values (Vase [0143]-[0144], [0154]-[0155], [0160], [0164]-[0165], noting the CSF treatment is adjusted or updated based on the result of the comparison step, e.g. via the processing unit (i.e. controller) sending signals to a pump or other component of the treatment unit to control the CSF treatment in accordance with the updated/adjusted treatment parameters).
In summary, Vase teaches a system for adjusting control of a CSF treatment device based on comparing at least two physiological parameter measurements to targets in order to treat a variety of conditions, such as traumatic brain injury, head trauma, etc. (see [0007]). Though Vase discloses many types of physiological parameters related to mass effect of a patient, it fails to explicitly disclose the physiological parameters including a midline shift from a CT scan and edema volume as required by the claim. Further, though Vase discloses considering a combination of physiological parameters to make CSF treatment adjustments based on comparisons to targets (see [0074], [0116], [0159]-[0160]), it fails to explicitly disclose an index being compared to one or more threshold values to guide control of treatment adjustments, wherein the index is based on measurements of the midline shift from the CT scan and measurements of the edema volume as required by the claim.
However, Serena teaches an analogous neurological injury analysis system that combines multiple measured physiological parameters into an index (Serena [0029]-[0030], noting “when using multiple markers together which may or may not be correlated with each other it is necessary to provide interpretation through an algorithm that relates all markers together”; “a plurality of markers are combined using an algorithm to increase the predictive value of the analysis in comparison to that obtained from the markers taken individually or in smaller groups”; see also [0032]-[0033], noting determination of weighting factors representing relative contribution of each marker in the algorithm, indicating that a final combined output of the algorithm is equivalent to an index of the combined input factors) that may be utilized to guide treatment decisions for a patient (Serena [0021]-[0023], noting the results of combining the parameters can identify patients who could benefit from specific types of therapy and may be used for treating a patient and/or monitoring the course of a treatment regimen). Physiological parameters contemplated as predictors of the patient’s neurological condition are shown in Fig. 1 & [0194], and include intracranial hemorrhage volume (i.e. edema volume) and mass effect (i.e. as measured by a CT scan showing midline shift or shifting of the structures of the median line as in [0201]). Accordingly, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of parameters utilized to guide/adjust CSF treatment as in Vase to include consideration of additional mass effect-related parameters like CT scan midline shift and edema volume as contemplated by Serena in order to incorporate measured parameters known to be potentially indicative of cerebral injury (as suggested by Serena Fig. 1 & [0194]). Additionally, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of parameters utilized to guide/adjust treatment (including midline shift and edema volume) as in Vase and Serena such that they are combined and evaluated as an index value as in Serena in order to provide interpretation through an algorithm that relates all the parameters together, thereby increasing the predictive value of the analysis for guiding treatment decisions (as suggested by Serena [0021]-[0023] & [0029]-[0030]).
Claim 2
Vase in view of Serena teaches the system of claim 1, and the combination further teaches wherein the controller is configured to automatically control the one or more hardware sub-modules to perform a treatment on cerebrospinal fluid of the patient when the values of the index reach or goes beyond the one or more threshold values (Vase [0143]-[0144], [0154]-[0155], [0160], [0164]-[0165], noting the CSF treatment is automatically adjusted or updated based on the result of the comparison step, e.g. via the processing unit (i.e. controller) sending signals to a pump or other component of the treatment unit to control the CSF treatment when a measured value reaches or exceeds a target threshold; see also Serena [0021]-[0023] & [0029]-[0030], noting multiple physiological parameters are combined via an algorithm whose output (i.e. the index value) is used to guide treatment decisions. Taken together in the context of the combination explained above, these disclosures show that the combined index value could be compared to a target threshold to guide or adjust treatment when the index value reaches or goes beyond the target threshold).
Claim 4
Vase in view of Serena teaches the system of claim 1, and the combination further teaches wherein the values of the index are based on two or more sub-indices and each sub-index of the two or more sub-indices is based on the monitored measurements of two or more physiological parameters of the patient (Serena [0029]-[0030], [0032]-[0033], noting multiple physiological parameters (analogous to and expanding upon those disclosed in Vase) are evaluated with a weighted algorithm denoting the relative contribution of each parameter’s value (i.e. sub-index) to the final output (i.e. index)).
Claim 5
Vase in view of Serena teaches the system of claim 1, and the combination further teaches wherein the two or more physiological parameters include two or more physiological parameters selected from a group consisting of intracranial pressure, cerebral pressure perfusion, mean arterial pressure, heart rate, brain oxygenation, cerebral blood flow, and a cytokine level (Vase [0101]-[0110], [0116], [0159], noting the measured parameters may include a plurality of data types such as intracranial pressure, cerebral blood flow, heart rate, blood pressure, blood oxygen level, cytokine level, etc.).
Claim 6
Vase in view of Serena teaches the system of claim 1, and the combination further teaches a communications port in communication with the controller; and wherein the communications port is configured to receive the measurements of the two or more physiological parameters of the patient that are monitored by the controller (Vase Fig. 2, [0077], noting the processing device receives data from the sensors, indicating some manner of communications port allowing such data sharing, e.g. as represented by the dashed line connecting the processing unit 118 and sensor 114 in Fig. 2).
Claim 7
Vase in view of Serena teaches the system of claim 1, and the combination further teaches a user interface in communication with the controller; and wherein the user interface is configured to receive inputs that modify an operation of the controller (Vase Fig. 2, [0077]-[0078], [0183], noting interface 120 coupled to processing unit 118 that allows a user to input adjustments to operation of the treatment unit).
Claim 9
Vase teaches a method of managing inflammation (Vase abstract, [0059], noting a system and method that may be used to minimize inflammation in neurocritical care), the method comprising:
monitoring measurements of two or more physiological parameters of a patient over time, the two or more physiological parameters of the patient are related to a mass effect of the patient, (Vase [0116], [0129], [0159], noting multiple physiological parameters of a patient may be measured over time; such parameters can include intracranial pressure, fluid flow/volume, etc. per [0104]-[0110] & [0114], which are considered to be “related to a mass effect of a patient” in accordance with Applicant’s disclosures in at least paras. [0059] & [00174] of the specification);
comparing a value (Vase [0154], [0160], noting monitored values are compared to targets (i.e. one or more threshold values)); and
automatically adjusting operation of a hardware sub-module of a cerebrospinal fluid management module in response to the cerebrospinal fluid management module receiving a control signal configured based on the comparison of the value (Vase [0143]-[0144], [0154]-[0155], [0160], [0164]-[0165], noting a CSF treatment is adjusted or updated based on the result of the comparison step, e.g. via the processing unit (i.e. controller) sending signals to a pump or other component of a treatment unit to control the CSF treatment in accordance with the updated/adjusted treatment parameters).
In summary, Vase teaches a method for adjusting control of a CSF treatment device based on comparing at least two physiological parameter measurements to targets in order to treat a variety of conditions, such as traumatic brain injury, head trauma, etc. (see [0007]). Though Vase discloses many types of physiological parameters related to mass effect of a patient, it fails to explicitly disclose the physiological parameters including a midline shift from a CT scan and edema volume as required by the claim. Further, though Vase discloses considering a combination of physiological parameters to make CSF treatment adjustments based on comparisons to targets (see [0074], [0116], [0159]-[0160]), it fails to explicitly disclose an index being compared to one or more threshold values to guide control of treatment adjustments, wherein the index is based on measurements of the midline shift from the CT scan and measurements of the edema volume as required by the claim.
However, Serena teaches an analogous neurological injury analysis method that combines multiple measured physiological parameters into an index (Serena [0029]-[0030], noting “when using multiple markers together which may or may not be correlated with each other it is necessary to provide interpretation through an algorithm that relates all markers together”; “a plurality of markers are combined using an algorithm to increase the predictive value of the analysis in comparison to that obtained from the markers taken individually or in smaller groups”; see also [0032]-[0033], noting determination of weighting factors representing relative contribution of each marker in the algorithm, indicating that a final combined output of the algorithm is equivalent to an index of the combined input factors) that may be utilized to guide treatment decisions for a patient (Serena [0021]-[0023], noting the results of combining the parameters can identify patients who could benefit from specific types of therapy and may be used for treating a patient and/or monitoring the course of a treatment regimen). Physiological parameters contemplated as predictors of the patient’s neurological condition are shown in Fig. 1 & [0194], and include intracranial hemorrhage volume (i.e. edema volume) and mass effect (i.e. as measured by a CT scan showing midline shift or shifting of the structures of the median line as in [0201]). Accordingly, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of parameters utilized to guide/adjust CSF treatment as in Vase to include consideration of additional mass effect-related parameters like CT scan midline shift and edema volume as contemplated by Serena in order to incorporate measured parameters known to be potentially indicative of cerebral injury (as suggested by Serena Fig. 1 & [0194]). Additionally, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of parameters utilized to guide/adjust treatment (including midline shift and edema volume) as in Vase and Serena such that they are combined and evaluated as an index value as in Serena in order to provide interpretation through an algorithm that relates all the parameters together, thereby increasing the predictive value of the analysis for guiding treatment decisions (as suggested by Serena [0021]-[0023] & [0029]-[0030]).
Claim 10
Vase in view of Serena teaches the method of claim 9, and the combination further teaches determining a difference between the value of the index and the one or more threshold values; and wherein the adjusting operation of the hardware sub-module is based on the determined difference between the value of the index and the one or more threshold values (Vase [0143]-[0144], [0154]-[0155], [0160], [0164], noting the CSF treatment is adjusted or updated based on the result of a difference between the monitored values and one or more thresholds or targets; see also Serena [0021]-[0023] & [0029]-[0030], noting multiple physiological parameters are combined via an algorithm whose output (i.e. the index value) is used to guide treatment decisions. Taken together in the context of the combination explained above, these disclosures show that the combined index value could be compared to a target threshold to guide or adjust treatment based on a difference between the index value and the target threshold).
Claim 11
Vase in view of Serena teaches the method of claim 9, and the combination further teaches wherein the adjusting operation of the hardware sub-module is automatically initiated based on the comparison of the one or more values related to the monitored measurements of the two or more physiological parameters to the one or more threshold values (Vase [0143]-[0144], [0154]-[0155], [0160], [0164], noting the CSF treatment is automatically adjusted or updated based on the result of the comparison step (i.e. based on comparison of the combined index value when considered in the context of the combination with Serena)).
Claim 12
Vase in view of Serena teaches the method of claim 9, and the combination further teaches wherein the adjusting operation of the hardware sub-module initiates a treatment start protocol in response to the value of the index reaching or going beyond the one or more threshold values a first time (Vase [0143]-[0144], [0154]-[0155], [0160], [0164], noting the CSF treatment is adjusted or updated (i.e. including initiation of a new or updated treatment protocol) based on the monitored data value(s) reaching or exceeding a target; see also Serena [0021]-[0023] & [0029]-[0030], noting multiple physiological parameters are combined via an algorithm whose output (i.e. the index value) is used to guide treatment decisions. Taken together in the context of the combination explained above, these disclosures show that the combined index value could be compared to a target threshold to guide or adjust treatment when the index value reaches or goes beyond the target threshold).
Claim 13
Vase teaches a computer readable medium having stored thereon in a non-transitory state a program code for use by a computing device, the program code causing the computing device to execute a method for managing inflammation (Vase [0077], noting processing unit 118 executes instructions stored in memory to make determinations about controlling a treatment unit 106, which may be configured to treat a patient’s CSF per [0065] and manage inflammation per [0059]) comprising:
determining one or more values related to one or more measurements of two or more physiological parameters, the two or more physiological parameters of a patient are related to a mass effect of the patient (Vase [0116], [0129], [0159], noting multiple physiological parameters of a patient may be measured over time; such parameters can include intracranial pressure, fluid flow/volume, etc. per [0104]-[0110] & [0114], which are considered to be “related to a mass effect of a patient” in accordance with Applicant’s disclosures in at least paras. [0059] & [00174] of the specification);
comparing values (Vase [0154], [0160], noting monitored values are compared to targets (i.e. one or more threshold values)); and
outputting a control signal to adjust operation of a hardware sub-module of a cerebrospinal fluid management module and cause the cerebrospinal fluid management module to perform a treatment on cerebrospinal fluid of the patient, the control signal is based on the comparison of the values (Vase [0143]-[0144], [0154]-[0155], [0160], [0164]-[0165], noting the CSF treatment is adjusted or updated based on the result of the comparison step, e.g. via the processing unit (i.e. controller) sending signals to a pump or other component of the treatment unit to control the CSF treatment in accordance with the updated/adjusted treatment parameters).
In summary, Vase teaches a system for adjusting control of a CSF treatment device based on comparing at least two physiological parameter measurements to targets in order to treat a variety of conditions, such as traumatic brain injury, head trauma, etc. (see [0007]). Though Vase discloses many types of physiological parameters related to mass effect of a patient, it fails to explicitly disclose the physiological parameters including a midline shift from a CT scan and edema volume as required by the claim. Further, though Vase discloses considering a combination of physiological parameters to make CSF treatment adjustments based on comparisons to targets (see [0074], [0116], [0159]-[0160]), it fails to explicitly disclose an index being compared to one or more threshold values to guide control of treatment adjustments, wherein the index is based on measurements of the midline shift from the CT scan and measurements of the edema volume as required by the claim.
However, Serena teaches an analogous neurological injury analysis system that combines multiple measured physiological parameters into an index (Serena [0029]-[0030], noting “when using multiple markers together which may or may not be correlated with each other it is necessary to provide interpretation through an algorithm that relates all markers together”; “a plurality of markers are combined using an algorithm to increase the predictive value of the analysis in comparison to that obtained from the markers taken individually or in smaller groups”; see also [0032]-[0033], noting determination of weighting factors representing relative contribution of each marker in the algorithm, indicating that a final combined output of the algorithm is equivalent to an index of the combined input factors) that may be utilized to guide treatment decisions for a patient (Serena [0021]-[0023], noting the results of combining the parameters can identify patients who could benefit from specific types of therapy and may be used for treating a patient and/or monitoring the course of a treatment regimen). Physiological parameters contemplated as predictors of the patient’s neurological condition are shown in Fig. 1 & [0194], and include intracranial hemorrhage volume (i.e. edema volume) and mass effect (i.e. as measured by a CT scan showing midline shift or shifting of the structures of the median line as in [0201]). Accordingly, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of parameters utilized to guide/adjust CSF treatment as in Vase to include consideration of additional mass effect-related parameters like CT scan midline shift and edema volume as contemplated by Serena in order to incorporate measured parameters known to be potentially indicative of cerebral injury (as suggested by Serena Fig. 1 & [0194]). Additionally, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of parameters utilized to guide/adjust treatment (including midline shift and edema volume) as in Vase and Serena such that they are combined and evaluated as an index value as in Serena in order to provide interpretation through an algorithm that relates all the parameters together, thereby increasing the predictive value of the analysis for guiding treatment decisions (as suggested by Serena [0021]-[0023] & [0029]-[0030]).
Claim 14
Vase in view of Serena teaches the computer readable medium of claim 13, and the combination further teaches determining a difference between the values of the index and the one or more threshold values; and wherein the control signal adjusting operation of the hardware sub-module is based on the determined difference between the values of the index and the one or more threshold values (Vase [0143]-[0144], [0154]-[0155], [0160], [0164], noting the CSF treatment is adjusted or updated based on the result of a difference between the monitored values and one or more thresholds or targets; see also Serena [0021]-[0023] & [0029]-[0030], noting multiple physiological parameters are combined via an algorithm whose output (i.e. the index value) is used to guide treatment decisions. Taken together in the context of the combination explained above, these disclosures show that the combined index value could be compared to a target threshold to guide or adjust treatment based on a difference between the index value and the target threshold).
Claim 15
Vase in view of Serena teaches the computer readable medium of 13, and the combination further teaches wherein the outputted control signal adjusting operation of the hardware sub-module is configured to initiate a treatment start protocol in response to the values of the index related reaching or going beyond the one or more threshold values a first time (Vase [0143]-[0144], [0154]-[0155], [0160], [0164], noting the CSF treatment is adjusted or updated (i.e. including initiation of a new or updated treatment protocol) based on the monitored data value(s) reaching or exceeding a target; see also Serena [0021]-[0023] & [0029]-[0030], noting multiple physiological parameters are combined via an algorithm whose output (i.e. the index value) is used to guide treatment decisions. Taken together in the context of the combination explained above, these disclosures show that the combined index value could be compared to a target threshold to guide or adjust treatment when the index value reaches or goes beyond the target threshold).
Claim 16
Vase in view of Serena teaches the computer readable medium of claim 15, and the combination further teaches wherein the outputted control signal adjusting operation of the hardware sub-module is configured to initiate a treatment stop protocol in response to the values of the index reaching or going beyond the one or more threshold values a second time after reaching or going beyond the one or more threshold values the first time (Vase [0143], [0154], [0160], [0164]-[0165], noting the CSF treatment may be stopped or ended once a target is reached or exceeded; see also [0015], [0160], noting there may be two or more interrelated thresholds as well as Figs. 15-17 noting that the method may be iteratively performed, indicating that Vase contemplates a target being reached/exceeded and resulting in an adjustment to treatment, followed by stopping treatment when a target is reached/exceeded a second time. See also Serena [0021]-[0023] & [0029]-[0030], noting multiple physiological parameters are combined via an algorithm whose output (i.e. the index value) is used to guide treatment decisions. Taken together in the context of the combination explained above, these disclosures show that the combined index value could be compared to one or more target thresholds to adjust treatment (e.g. by stopping it) when the index value reaches or goes beyond one of the target thresholds after having previously met or exceeded a target threshold for starting treatment).
Claim 17
Vase in view of Serena teaches the computer readable medium of claim 13, and the combination further teaches wherein the outputted control signal adjusting operation of the hardware sub-module is configured to initiate a treatment stop protocol in response to the values of the index reaching or going beyond the one or more threshold values (Vase [0143], [0154], [0160], [0164]-[0165], noting the CSF treatment may be stopped or ended once a target is reached or exceeded; see also Serena [0021]-[0023] & [0029]-[0030], noting multiple physiological parameters are combined via an algorithm whose output (i.e. the index value) is used to guide treatment decisions. Taken together in the context of the combination explained above, these disclosures show that the combined index value could be compared to a target threshold to guide or adjust treatment (e.g. by stopping it) when the index value reaches or goes beyond the target threshold).
Claim 18
Vase in view of Serena teaches the computer readable medium of claim 13, and the combination further teaches wherein the outputted control signal adjusting operation of the hardware sub-module is configured to initiate a predetermined treatment protocol based on a type of physiological parameter associated with the one or more measurements (Vase [0138]-[0148], noting different types of operating parameters of the treatment unit may be adjusted based on determining that different types of monitored data have reached or exceeded a threshold, e.g. a temperature adjustment may be made based on measured temperature as in [0139] while a flow rate of the treatment may be adjusted based on comparisons of the volume or flow rate of a fluid at a treatment site to a threshold as in [0140]-[0141]).
Claim 19
Vase in view of Serena teaches the computer readable medium of claim 13, and the combination further teaches wherein the outputted control signal adjusting operation of the hardware sub-module is configured to initiate a predetermined treatment protocol based on the comparison of the values of the index to the one or more threshold values and a type of physiological parameter associated with the one or more measurements (Vase [0143]-[0144], [0154]-[0155], [0160], [0164], noting the CSF treatment is automatically adjusted or updated based on the result of the comparison step (i.e. based on comparison of the combined index value when considered in the context of the combination with Serena); see also [0138]-[0148], noting different types of operating parameters of the treatment unit may be adjusted based on determining that different types of monitored data have reached or exceeded a threshold, e.g. a temperature adjustment may be made based on measured temperature as in [0139] while a flow rate of the treatment may be adjusted based on comparisons of the volume or flow rate of a fluid at a treatment site to a threshold as in [0140]-[0141]).
Claim 20
Vase in view of Serena teaches the computer readable medium of claim 13, and the combination further teaches wherein the outputted control signal adjusting operation of the hardware sub-module causes the cerebrospinal fluid management module to initiate one or both of a filtration treatment protocol and a cooling treatment protocol (Vase [0065], [0175], noting the treatment unit can provide filtration and/or cooling treatments in accordance with determined operating parameters as in [0077]-[0078]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Vase and Serena as applied to claims 1 and 7 above, and further in view of Martin et al. (US 20100083164 A1).
Claim 8
Vase in view of Serena teaches the system of claim 7, and the combination further teaches wherein the user interface is configured to display one or both of the measurements of the two or more physiological parameters of the patient and the values of the index in a real-time updating pane on the user interface adjacent the selectable pane (Vase Fig. 37, [0078], [0183], noting the interface 120 may display various selectable panes alongside graphs, gauges, or other real-time readouts of measured sensor data, considered to also include the values of the index when considered in the context of the combination with Serena because the index value would be a derived value of interest to the user analogous to those listed, and Vase contemplates presenting “other information as desired”).
However, Vase fails to explicitly disclose that the user interface displays a medical image of the patient in a selectable pane alongside real-time sensor data. However, Martin teaches that a clinical user interface may include many selectable panes with different types of relevant patient data displayed simultaneously, including a medical image of a patient and other patient data such as vital signs or other sensor data (Martin Fig. 6, [0025], [0069]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the multi-pane user interface of Vase to include a pane with a medical image of a patient as in Martin in order to display a wider range of situationally-relevant patient information, such as patient X-rays, MRIs, CT scans, and other medical imaging data (as suggested by Martin [0025] & [0069]).
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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/KAREN A HRANEK/ Primary Examiner, Art Unit 3684