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 .
Response to Amendment
This office action is responsive to the amendment filed on April 16, 2026. As directed by the amendment: claims 1, 4-5, 7, and 22 have been amended, claims 23-24 have been added, no claims have been canceled. Thus claims 1-2 and 4-24 are presently pending in this application, and claims 11-21 remain withdrawn. Applicant’s amendments to the Claims have overcome each and every 35 U.S.C. 112(b) rejection previously set forth in the Non-Final Office Action mailed December 19, 2025.
Response to Arguments
Applicant’s arguments, see Remarks, filed April 16, 2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 103 have been fully considered and are persuasive. Pennington, in view of Cho, does not disclose the amended limitation wherein the sensor data includes cortisol levels. Therefore, the rejection has been withdrawn, and the rejections of claims 2, 4-10 and 22 are also withdrawn due to their dependency on claim 1. However, upon further consideration, in light of the amendments, a new ground(s) of rejection is made below.
Claim Objections
Claim 1 objected to because of the following informalities: Claim 1 recites “wherein the sensor data is at least BGL and cortisol levels at least one of heart rate and pupillary response” should read “wherein the sensor data is at least BGL and cortisol levels and at least one of heart rate and pupillary response” for clarity. Appropriate correction is required.
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.
Claims 1-2, and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Pennington et al. (US 20180117249), hereinafter Pennington, in view of Constantin et al. (US 20190252079), hereinafter Constantin.
Regarding claim 1, Pennington discloses ---a system to induce a hypoglycemic condition within a predetermined blood glucose range for treating infection (Fig. 5 and [0053-0057, 0253], system 300 for inducing hypoglycemia within a blood glucose range for treating cancer and preventing opportunistic infection) comprising: one or more sensors which measure an aspect that is physiological (Fig. 5, EKG sensors 340 and BGL sensor 320); one or more fluid flow control devices (Fig. 5-6 and [0102], pumps 430 for controlling the delivery of fluids in the cartridges 420); insulin in a vessel in fluid communication with a fluid control device (Fig. 5-6 and [0101-0102], insulin in cartridge 310 connected to one of pumps 430); glucose in a vessel in fluid communication with a fluid control device (Fig. 5-6 and [0101-0102], glucose in cartridge 312 connected to one of pumps 430); at least one cocktail containing at least one of an antibiotic and an antiviral components in one or more vessels each vessel in fluid communication with a fluid control device (Fig. 5-6 and [0018, 0101-0102], at least one chemotherapy drugs (with various chemotherapeutic agents, including antibiotics, etc.) in cartridges 314 and 316 connected to at least one of pumps 430); one or more controllers ([0070, 0096, 0102], system contains controller software to communicate with and control the components of the system (see following components controller communicates with)) in signal communication with; at least one microprocessor (Fig. 7-9, microprocessor 710); a blood glucose level (BGL) measuring sensor (Fig.5, BGL sensor 320); memory (Fig. 9, memory 720); said one or more sensors (Fig. 5, EKG sensors 340); one or more databases or lookup tables ([0091], external databases); said fluid control devices (Fig. 6, pumps 430); wherein sensor data is BGL ([0102] and Fig. 5, sensor data includes BGL); and, wherein the controller controls the fluid control devices for at least insulin glucose, and the cocktail to keep blood glucose level (BGL) of the primate within a target hypoglycemic BGL range for the primate (Fig. 10 and [0056-0057, 0094-0096, 0131-0133], controller controls pumps for insulin, glucose, and chemotherapy drugs to keep BGL within target range).
Pennington fails to disclose wherein sensor data is at least cortisol levels, at least one of heart rate, and pupillary response. However, Constantin discloses wherein sensor data is at least cortisol levels (Fig. 16 and 23, and [0527, 0575], analyte sensor data may include cortisol levels), at least one of heart rate, and pupillary response (Fig. 16 and [0501], physiological sensor data may include heart rate).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pennington to incorporate the disclosures of Constantin and modify the sensor data to additionally include at least cortisol levels, at least one of heart rate, and pupillary response. Doing so would further determine the physiologic state of the patient which may be used to determine patient guidance, the timing of patient guidance or both when managing a physiological condition such as diabetes, which may lead to hypoglycemia (Constantin, [0005, 0298, 0300, 0317]).
Regarding claim 2 and Pennington, in view of Constantin, Pennington further discloses ---the system to induce a hypoglycemic condition within a predetermined blood glucose range for treating infection of claim 1, wherein the controller receives sensor data inputs and adjust the hypoglycemic target range for BGL in response to sensory data received (Fig. 10 and [0071, 0131-0133], controller receives data input from sensors and in response adjusts the target BGL to maintain hypoglycemic state).
Regarding claim 5 and Pennington, in view of Constantin, Pennington further discloses ---the system to induce a hypoglycemic condition within a predetermined blood glucose range for treating infection of claim 1 wherein the cocktail is at least one of, Quercetin, curcumin, vitamin C, clarithromycin, docycyclin, metronidazol. mezloxillian, piperacillin, azlocillin acylampicillin, amoxicillin, cefuroxime, Ceftriaxone, Acyclovir, Famciclovir, Valacyclovir and phenylbutyrate (PBA) ([0256-0257], immunologic agents used in chemotherapy drugs may include at least vitamin C).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Pennington (US 20180117249), in view of Constantin (US 20190252079), as applied to claim 1 above, and further in view of D’Agostino et al. (US 20150231172), hereinafter D’Agostino.
Regarding claim 4, Pennington, in view of Constantin, discloses the system to induce a hypoglycemic condition within a predetermined BGL range for treating infection of claim 1.
Pennington, in view of Constantin, fails to disclose wherein the controller controls the administration of at least one of oxygen and hydrogen. However, D’Agostino discloses wherein the controller controls the administration of at least one of oxygen and hydrogen ([0012-0013], a system for treating cancer wherein the controller subjects the patient to a hyperbaric, oxygen-enriched environment).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pennington, in view of Constantin, to incorporate the disclosures of D’Agostino and modify the system to include the controller controlling the administration of oxygen. Doing so would reduce cancel cell load and limit metastasis, thus providing synergistic anticancer effects and increasing the effectiveness of the cancer treatment (D’Agostino, [0012-0013]).
Claims 6 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Pennington (US 20180117249), in view of Constantin (US 20190252079), as applied to claim 5 above, and further in view of Skurkovich et al. (US 20060194221), hereinafter Skurkovich.
Regarding claim 6, Pennington, in view of Constantin, discloses the system to induce a hypoglycemic condition within a predetermined BGL range for treating infection of claim 5.
Pennington, in view of Constantin, fails to disclose wherein the infection is herpes simplex virus, and the cocktail is at least one of Acyclovir, Famciclovir, Valacyclovir and phenylbutyrate (PBA). However, Skurkovich discloses wherein the infection is herpes simplex virus ([0014], the system is utilized to treat herpes simplex virus), and the cocktail is at least one of Acyclovir, Famciclovir, Valacyclovir and phenylbutyrate (PBA) ([00711], the chemotherapeutic agent utilized may include Acyclovir).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pennington, in view of Constantin, to incorporate the disclosures of Skurkovich and modify the system to be used to treat herpes simplex virus, and modify the cocktail to include at least Acyclovir. Doing so would provide the system with an anti-viral pharmaceutical composition which is effective in treating other infections and diseases, such as herpes simplex virus, thus expanding the usability of the system for treating a greater variety of conditions (Skurkovich, [0041-0043, 0071]).
Regarding claim 8 and Pennington, in view of Constantin and Skurkovich, Pennington further discloses ---the system to induce a hypoglycemic condition within a predetermined blood glucose range for treating infection of claim 6, wherein the active agents in the cocktail are each less than 50% the maximum tolerated dose (MTD) ([0168-0170], the effective dose of the agents in the drug may be lower than 50% of the standard dose ("maximums safe dosage") such as 1%-40%).
Regarding claim 9 and Pennington, in view of Constantin and Skurkovich, Pennington further discloses ---the system to induce a hypoglycemic condition within a predetermined blood glucose range for treating infection of claims 6, wherein the active agents in the cocktail are less than 50% the minimum effective dose (MED) ([0169-0170], the effective dose of the agents in the drug may be as low as 0.001-1% of the standard dose and additionally the drugs may not include certain active agents, thus the effective dose of these agents in drug will also be below 50% of the minimum effective dose. Examiner notes, the standard dose and therapeutically effect amount of an agent may vary from patient to patient due to the patient's overall health and any extenuating factors).
Claims 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Pennington (US 20180117249), in view of Constantin (US 20190252079), as applied to claim 1 above, and further in view of Cowley et al. (US 20070128298), hereinafter Cowley, and Zhang et al. (US 20190008848), hereinafter Zhang.
Regarding claim 7, Pennington, in view of Constantin, discloses the system to induce a hypoglycemic condition within a predetermined BGL range for treating infection of claim 1.
Pennington, in view of Constantin, fails to disclose further comprising: adding an antihistamine to the cocktail; wherein said antihistamine reduces the insulin required to reach a target hypoglycemic BGL range; and, wherein the infection is B. burgdorferi and the cocktail is at least one clarithromycin, docycyclin, metronidazol, mezloxillian, piperacillin, azlocillin acylampicillin, amoxicillin, cefuroxime, Ceftriaxone. However, Cowley discloses further comprising: adding an antihistamine to the cocktail; wherein said antihistamine reduces the insulin required to reach a target hypoglycemic BGL range ([0062, 0067-0068], an antihistamine may be added to the pharmaceutical composition with insulin, such that a lower amount of insulin is required to achieve the desired blood glucose level).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pennington, in view of Constantin, to incorporate the disclosures of Cowley and modify the cocktail to contain an antihistamine. Doing so would require a lower level of insulin in the pharmaceutical cocktail to be more effective in resulting in the desired goal (blood glucose level) (Cowley, [0067]).
Pennington, in view of Constantin and Cowley, fails to disclose wherein the infection is B. burgdorferi and the cocktail is at least one clarithromycin, docycyclin, metronidazol, mezloxillian, piperacillin, azlocillin acylampicillin, amoxicillin, cefuroxime, Ceftriaxone. However, Zhang discloses wherein the infection is B. burgdorferi and the cocktail is at least one clarithromycin, docycyclin, metronidazol, mezloxillian, piperacillin, azlocillin acylampicillin, amoxicillin, cefuroxime, Ceftriaxone ([0036,0039], system is used to treat B. burgdorferi by utilizing a cocktail comprising at least clarithromycin).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pennington, in view of Constantin and Cowley, to incorporate the disclosures of Zhang and modify the system to treat B. burgdorferi and modify the cocktail to contain at least clarithromycin. Doing so would provide a system which utilizes a pharmaceutical composition which is effective in treating other infections and diseases, such as Lyme disease, thus expanding the usability of the system for treating a greater variety of conditions (Zhang, [0048]).
Regarding claim 8 and Pennington, in view of Constantin, Cowley and Zhang, Pennington further discloses ---the system to induce a hypoglycemic condition within a predetermined blood glucose range for treating infection of claim 7, wherein the active agents in the cocktail are each less than 50% the maximum tolerated dose (MTD) ([0168-0170], the effective dose of the agents in the drug may be lower than 50% of the standard dose ("maximums safe dosage") such as 1%-40%).
Regarding claim 9 and Pennington, in view of Constantin, Cowley and Zhang, Pennington further discloses ---the system to induce a hypoglycemic condition within a predetermined blood glucose range for treating infection of claim 7, wherein the active agents in the cocktail are less than 50% the minimum effective dose (MED) ([0169-0170], the effective dose of the agents in the drug may be as low as 0.001-1% of the standard dose and additionally the drugs may not include certain active agents, thus the effective dose of these agents in drug will also be below 50% of the minimum effective dose. Examiner notes, the standard dose and therapeutically effect amount of an agent may vary from patient to patient due to the patient's overall health and any extenuating factors).
Regarding claim 10 and Pennington, in view of Constantin, Cowley and Zhang, Pennington further discloses ---the system to induce a hypoglycemic condition within a predetermined blood glucose range for treating infection of claim 7, wherein the active agents in the cocktail are less than 25% the minimum effective dose (MED) ([0169-0170], the effective dose of the agents in the drug may be as low as 0.001-1% of the standard dose and additionally the drugs may not include certain active agents, thus the effective dose of these agents in drug will also be below 25% of the minimum effective dose. Examiner notes, the standard dose and therapeutically effect amount of an agent may vary from patient to patient due to the patient's overall health and any extenuating factors).
Claims 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Pennington (US 20180117249), in view of Constantin (US 20190252079), as applied to claim 1 above, and further in view of Bevan (US 20200178906).
Regarding claim 22 and Pennington, in view of Constantin, Pennington further discloses ---the system to induce a hypoglycemic condition within a predetermined blood glucose range for treating infection of claim 1 wherein the sensor data is at least BGL ([0102] and Fig. 5, sensor data includes BGL).
Pennington, in view of Constantin, fails to disclose wherein sensor data is at least skin moisture. However, Bevan discloses wherein sensor data is at least skin moisture (Fig. 2 and [0084], sensor data skin moisture level).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pennington, in view of Constantin, to incorporate the disclosures of Bevan and modify the sensor data to additionally include skin moisture. Doing so would allow the information to be applied to other sensed data to determine potential infection which may further indicate medical conditions, such as diabetes (Bevan, [0084,0090]).
Regarding claim 23, Pennington, in view of Constantin and Bevan, discloses the system to induce a hypoglycemic condition within a predetermined blood glucose range for treating infection of claim 22, as explained above. Pennington and Bevan are silent to wherein the sensor data also includes oxygen saturation. However, Constantin further discloses wherein the sensor data also includes oxygen saturation ([0379], sensor data may include oxygen saturation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pennington, in view of Constantin and Bevan, to further incorporate the disclosures of Constantin and modify the sensor data to additionally include oxygen saturation. Doing so would further detect illness and determine the physiologic state of the patient which may be used to determine patient guidance, the timing of patient guidance or both when managing a physiological condition such as diabetes, which may lead to hypoglycemia (Constantin, [0005, 0298, 0300, 0317, 0379]).
Regarding claim 24, Pennington, in view of Constantin and Bevan, discloses the system to induce a hypoglycemic condition within a predetermined blood glucose range for treating infection of claim 22, as explained above. Pennington and Constantin are silent to wherein the sensor data also includes skin moisture levels. However, Bevan further discloses wherein the sensor data also includes skin moisture levels (Fig. 2 and [0084], sensor data skin moisture level).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pennington, in view of Constantin and Bevan, to further incorporate the disclosures of Bevan and modify the sensor data to additionally include skin moisture levels. Doing so would allow the information to be applied to other sensed data to determine potential infection which may further indicate medical conditions, such as diabetes (Bevan, [0084,0090]).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH D GRASMEDER whose telephone number is (571)272-0258. The examiner can normally be reached M-F 8 am-5 pm EST.
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/SARAH DYMPNA GRASMEDER/Examiner, Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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