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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/21/2026 has been entered.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 4-5, 10-12 & 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Najarian et al. (U.S. Patent Application 2012/0269420 A1) and further in view of Mastrototaro et al. (U.S. Patent Application 2008/0269714 A1) and Vellinga et al. (Vellinga et al. Elevated central venous pressure is associated with impairment of microcirculatory blood flow in sepsis: a hypothesis generating post hoc analysis. BMC Anesthesiol 13, 17 (2013); enclosed herein).
Claim 1: Najarian teaches –
A medical system [a system] (Para 0011), comprising:
a microcirculation assessment (MCA) device [handheld microscan device] (Figure 1, Element 10) configured to generate microcirculation data [quantitative and qualitative measure of microcirculation] (Claim 1) pertaining to a defined location of a patient [obtain video images of the capillaries and small blood vessels in the lingual surface] (Para 0026); and
a system module [Microcirculation analysis software] (Figure 1, Element Microcirculation analysis software) having a console coupled with the MCA device, the console [desk top computer] (Figure 1, Element 12) including a processor [data processing system] (Para 0026) and a memory having logic stored thereon that [computer 12 is programmed] (Para 0026), when executed by the processor performs operations that include:
Examiner’s Note: The computer being programmed means the computer has memory in order for the computer to be programmed.
receiving the microcirculation data from the MCA device [the device is pressed against the patient's tongue to obtain video images of the capillaries and small blood vessels in the lingual surface] (Para 0026 and Figure 1);
determining a microcirculation assessment from the microcirculation data [results of the microcirculation analysis which follows stabilization and segmentation are displayed on the display] (Para 0026); and
determining a systemic response of the patient based on the microcirculation assessment [displayed on the display 13, with an indication of diagnostic decisions] (Para 0026) [to provide quantitative and qualitative measure of microcirculation] (Claim 1); and
a therapy delivery system [intravenous fluid resuscitation; for example…blood infusion] (Para 0065) coupled with the console [computer] (Figure 1, Element 12), the operations further including initiating the therapy delivery system [deciding when to start and stop resuscitation] (Para 0065) when the systemic response [Hemorrhaging subjects can be identified by their Functional Capillary Density (FCD) values] exceeds a defined threshold [subjects with FCD below a certain threshold level are considered to be hemorrhaging] (Para 0065).
Najarian fails to teach a console governing the operation of the therapy delivery system. However, Mastrototaro teaches a therapy delivery system [insulin delivery system] (Figure 1, Element 14) coupled with the console [controller] (Figure , Element 12) such that the console governs operation of the therapy delivery system [controller 12 includes controller electrical components and software to generate commands for the insulin delivery system 14] (Para 0053), the operations of the console further including initiating the therapy delivery system [the infusion device includes infusion electrical components to activate an infusion motor according to the commands 22, an infusion communication system to receive the commands 22 from the controller 12] (Para 0053) when the systemic response exceeds a defined threshold [In administering the insulin at the adjusted basal rate, the controller 12 preferably limits the adjusted basal rate to a maximum and/or minimum boundary on the adjusted basal rate] (Para 0104) in order to provide therapy modification and safeguards against the over-delivery or under-delivery of a therapy (Abstract)
Although Mastrototaro teaches an insulin delivery system and not a fluid resuscitation delivery system, the prior art of Mastrototaro is in the same field of endeavor of therapy delivery systems and the reference is reasonably pertinent to the problem faced by the inventor of governing the operation of therapy delivery systems based on thresholds of optimal delivery of a therapy.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Najarian to include the therapy delivery system and console operations as taught by Mastrototaro in order to provide therapy modification and safeguards against the over-delivery or under-delivery of a therapy (Abstract).
Najarian and Mastrototaro fail to teach the systemic response including a central venous pressure. However, Vellinga teaches the systemic response including a central venous pressure in order to understand early phases on human sepsis (Page 3 of 7, Section Discussion).
As the title indicates, Vellinga teaches that elevated central venous pressure is associated with impairment of microcirculatory blood flow. Vellinga teaches the percentage of perfused small vessels were significantly lower in the ‘high’ CVP ( > 12 mmHg) (Page 3 of 7, Section Results, Subsection Static Measurements). The Examiner contends that the percentage of perfused small vessels (PPV) of Vellinga is the proportion of perfused vessels (PPV) of Najarian. Vellinga and Najarian teach PPV measurements and Vellinga teaches the association of PPV to CVP.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Najarian and Mastrototaro to use the PPV measurement of Najarian with the PPV/CVP association determination as taught by Vellinga in order to understand early phases on human sepsis (Page 3 of 7, Section Discussion).
Examiner’s Note: The determining step is recited at a high level of generality. The Examiner contends that the obviousness determination also can be recited at a similarly high level of generality. The Examiner acknowledges that the prior art rejection would be overcome if more details with respect to the AI and the table from Para 0047-0048 of the Specification of the Applicant were amended in to the claims.
Claim 2/1: Najarian teaches wherein the systemic response [to provide quantitative and qualitative measure of microcirculation] (Claim 1) is related to a sepsis [sepsis] (Para 0066) condition of the patient [patient] (Para 0026).
Claim 4/1: Najarian teaches wherein the MCA device is configured to generate microcirculation data via transcutaneous oxygen measurement [level of tissue oxygenation for a patient (based on quantitative measures extracted from microcirculation video)] (Para 0063).
Claim 5/1: Najarian teaches wherein the defined location of a patient includes a sublingual tissue [capillaries and small blood vessels in the lingual surface] (Para 0026).
Examiner’s Note: While the prior art teaches the surface of the tongue, the microscan device of the prior art is capable of imaging the sublingual side of the tongue by the patient lifting their tongue during imaging.
Claim 10/1: Najarian teaches wherein the operations further include providing a notification [The results are displayed on display 14] (Para 0031) when the systemic response exceeds a defined threshold [Hemorrhaging subjects can be identified by their Functional Capillary Density (FCD) values; subjects with FCD below a certain threshold level are considered to be hemorrhaging] (Para 0064).
Claim 11/1: Najarian teaches wherein the operations further include providing a therapy notification [The results are displayed on display 14] (Para 0031) based on the systemic response [FCD values in real-time can assist physicians in deciding when to start and stop resuscitation] (Para 0065), the therapy notification including a recommended therapy for treating the patient [The results of quantitatively monitoring and assessing the changes that occur in microcirculation during resuscitation period assist physicians in making diagnostically and therapeutically important decisions such as determination of the degree of illness as well as the effectiveness of the resuscitation process] (Abstract).
Claim 12/1: Najarian teaches further including a display [display] (Figure 1, Element 14) coupled with the console [computer] (Figure 1, Element 12), the operations further including exhibiting a microcirculation assessment image [image processing and machine learning for diagnostic analysis of microcirculation] (Para 0031) on the display [The results are displayed on display 14] (Para 0031).
Claim 14/1: Najarian teaches wherein a therapy of the therapy delivery system includes providing oxygen [intravenous fluid resuscitation] [blood infusion] (Para 0065).
Examiner’s Note: Providing blood is the means to provide oxygen to the patient.
Claim 15/14/1: Najarian teaches wherein the operations further include adjusting the therapy [deciding when to start and stop resuscitation] (Para 0065) based on the systemic response [subjects with FCD below a certain threshold level are considered to be hemorrhaging] (Para 0065).
Examiner’s Note: The prior art is disclosed for monitoring a patient and the disclosure is that during the monitor deciding when to start and stop therapy, which reads on adjusting the therapy.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3, 6-7 & 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Najarian et al. (U.S. Patent Application 2012/0269420 A1); Mastrototaro et al. (U.S. Patent Application 2008/0269714 A1) and Vellinga et al. (cited above and enclosed herein) and further in view of Baker at el. (U.S. Patent Application 2018/0214091 A1).
Claim 3/1: Najarian teaches a MCA device [handheld microscan device] (Figure 1, Element 10). Najarian, Mastrototaro and Vellinga fail to teach wirelessly. However, Baker teaches wherein the console is wirelessly coupled with the device [wireless] (Para 0019) in order to allow freedom of movement with the patient due to a lack of wires (Para 0019)
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 device of Najarian, Mastrototaro and Vellinga to be a wireless device as taught by Baker in order to allow freedom of movement with the patient due to a lack of wires (Para 0019)
Claim 6/1: Najarian teaches a MCA device [handheld microscan device] (Figure 1, Element 10). Najarian, Mastrototaro and Vellinga fail to teach a hospital bed. However, Baker teaches wherein the MCA device is incorporated [Sensor 103 is a physiological sensor typically mounted or connected to patient support assembly 104] (Para 0026) into a hospital bed [patient support assembly 104 is the Advanta™ 2 Med Surg Bed manufactured by Hill-Rom of Batesville, Ind] (Para 0027) in order to have patient monitoring components that move as patient beds are moved about a facility, thereby enabling increases and decreases in monitoring levels provided to the patient (Para 0017)
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 device of Najarian, Mastrototaro and Vellinga to be an incorporated device in a hospital bed as taught by Baker in order to have patient monitoring components that move as patient beds are moved about a facility, thereby enabling increases and decreases in monitoring levels provided to the patient (Para 0017).
Claim 7/1: Najarian teaches a MCA device [handheld microscan device] (Figure 1, Element 10). Najarian, Mastrototaro and Vellinga fail to teach a wearable device. However, Baker teaches wherein the device is a wearable device [wearable sensor] (Para 0003) in order to obtain data while the patient moves around (Para 0003).
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 device of Najarian, Mastrototaro and Vellinga to be a wearable device as taught by Baker in order to obtain data while the patient moves around (Para 0003).
Claim 9/1: Najarian teaches a MCA device [handheld microscan device] (Figure 1, Element 10). Najarian, Mastrototaro and Vellinga fail to teach an adhesive. However, Baker teaches wherein a patient contact surface of the MCA device includes an adhesive configured to secure the patient contact surface to the patient [Sensor 102 is capable of being removably coupled to the patient P, such as through an adhesive] (Para 0019) in order to obtain data while the patient moves around (Para 0003).
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 device of Najarian, Mastrototaro and Vellinga to have an adhesive as taught by Baker in order to obtain data while the patient moves around (Para 0003).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Najarian et al. (U.S. Patent Application 2012/0269420 A1); Mastrototaro et al. (U.S. Patent Application 2008/0269714 A1); Vellinga et al. (cited above and enclosed herein) and Baker at el. (U.S. Patent Application 2018/0214091 A1) and further in view of Ferren at el. (U.S. Patent Application 2009/0287093 A1).
Claim 8/7/1: Najarian teaches a MCA device [handheld microscan device] (Figure 1, Element 10). Najarian, Mastrototaro, Vellinga and Baker fail to teach an article of clothing. However, Ferren teaches wherein the device is incorporated into an article of clothing [sensors may be worn as clothing] (Para 00083) in order to obtain data while the patient moves around (Para 0083).
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 device of Najarian, Mastrototaro, Vellinga and Baker to be a wearable device as taught by Ferren in order to obtain data while the patient moves around (Para 0083).
Response to Arguments
Applicant’s arguments, see Page 8, filed 03/17/2026, with respect to the Claims Objections have been fully considered and are persuasive. The Claim Objection of Claim 15 has been withdrawn.
Applicant’s arguments with respect to claim(s) 1-12 & 14-15 have been considered but are moot because the new ground of rejection does not rely on the manner the references were applied in the prior rejection of record. The new claim amendment to Claim(s) 1-2, 4-5, 10-12 & 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Najarian et al. (U.S. Patent Application 2012/0269420 A1) and further in view of Mastrototaro et al. (U.S. Patent Application 2008/0269714 A1) and Vellinga et al. (Vellinga et al. Elevated central venous pressure is associated with impairment of microcirculatory blood flow in sepsis: a hypothesis generating post hoc analysis. BMC Anesthesiol 13, 17 (2013); enclosed herein). The arguments are unconvincing.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HELENE C BOR whose telephone number is (571)272-2947. The examiner can normally be reached Mon - Fri 10:30 - 6:30.
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/Helene Bor/Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797
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