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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 12-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 12 recites values that are “high” and “low” but it is unclear what values are considered high versus low. Relative to what?
Claim 13 recites values that are “middle” “high” and “low” but it is unclear what values are considered high versus low versus middle. Relative to what?
Claim 14 recites values that are “middle” “high” and “low” but it is unclear what values are considered high versus low versus middle. Relative to what?
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3, 8 and 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Allen et al. (US 2015/0059761 A1) in view of Kollmeyer et al. (US 2008/0029096 A1) in view of Mondry (US 5,315,990 A).
Regarding claim 1, Allen teaches a portable hyperbaric oxygen (PHBO) hood system (Fig. 6, 10-11; para [0093]) comprising:
a main hood (604; Fig. 6; para [0093]);
a neck sleeve configured to be disposed below the main hood (606, 620; Fig. 6; para [0093]);
a system configured to control a pressure in the main hood to create hyperbaric environment in the PHBO hood system (1000, 1100; Fig. 10-11; para [0114]-[0115]), wherein the system comprises:
a flow line configured to supply oxygen to the main hood (line not labeled configured to bring oxygen from 1006 to 602; Fig. 10; para [0114]); and is configured to change the pressure of the main hood to the target pressure (internal pressure control; Fig. 10; para [0114]).
Allen does not explicitly disclose wherein said system to control pressure is a pump system which comprises a pump, nor does Allen explicitly disclose that the flow line configured to supply oxygen to the main hood via the pump, nor does Allen explicitly disclose an intelligent controller configured to: receive an oxygen saturation value of a patient; receive an oxygen concentration value of the flow line; determine a target pressure of the main hood based on the oxygen saturation value and the oxygen concentration value; and control the pump system to change the pressure of the main hood to the target pressure.
However, Kollmeyer teaches a system (Fig. 1; para [0019]), comprising:
a breathing helmet (breathing helmet not shown but would be located at 10 in Fig. 1; para [0019]),
a pump system (12; Fig. 1, Fig. 6: para [0019]) comprising a pump (12; Fig. 1; para [0019]),
a flow line configured to supply oxygen to the breathing helmet via the pump (Line from 12 to 10; Fig. 1; para [0019]);
an intelligent controller (28; Fig. 1, Fig. 6; para [0019]) configured to:
determine a target pressure (via values 24, 26, from 20, 22; Fig. 1; para [0019]);
control the pump system to change the pressure of the main hood to the target pressure (changes made by control signal 44 sent from 28; Fig. 1; para [0021]); and
further appreciates a sensor of the flow line providing a value (flow sensor 32; Fig. 1; para [0020]-[0021]);
as well as the pump being in communication with a source of oxygen (tank of pressurized oxygen 88; Fig. 6; para [0032]).
It would have been obvious to one having ordinary skill in the art to have modified Allen to utilize a pump and control the pump based on feedback from sensors, a sensor being in the flow line, for the benefit of providing appropriate ventilation support [0001].
Allen as modified does not explicitly disclose wherein a controller is configured to: receive an oxygen saturation value of a patient; receive an oxygen concentration value of the flow line; determine a target pressure of the main hood based on the oxygen saturation value and the oxygen concentration value.
However, Mondry teaches a system (500; Fig. 14; col 14 In 63 to col 15 In 13), comprising: an intelligent controller (504; Fig. 14; col 14 In 63 to coll 15 In 2) configured to:
receive an oxygen saturation value of a patient (via oximeter 502; Fig. 14; col 14 ln 63 to col 15 ln 2);
receive an oxygen concentration value of the flow line (via 520, 506, 510; Fig. 14; col 15 In 4-13, col 15 In 46 to col 16 In 20);
determine a target pressure of the main hood based on the oxygen saturation value and the oxygen concentration value (dispensing of proper amounts of air and oxygen to a patient; Fig. 14; col 15 In 14-34).
Accordingly, it would have been obvious to a person having ordinary skill in the art to have employed the pump system of Kollmeyer and the controller arrangement of Mondry upon the system of Allen, in order to effectively and precisely control the amount of pressurized therapy received by a patient and prevent pulmonary damage.
Regarding claim 2, Allen further discloses wherein the main hood is configured to cover a head of the patient and the neck sleeve is configured to surround a neck of the patient so that only the head and the neck of the patient are exposed to the hyperbaric environment when the patient uses the PHBO hood system, thereby enabling the PHBO hood system to be easily moved to a place where the patient is located (604, 606, 620 covering head and neck of patient; Fig. 6; para [0093]-[0094]). "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)
Regarding claim 3, Allen further discloses wherein the place comprises an intensive care unit (configured for use in a hospital setting; Fig. 6; para [0049]). "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)
Regarding claim 8, Allen further discloses wherein the neck sleeve comprises at least one of a suction vent, a gas or air vent (exit from 620 through which gas leaves towards exhaust; Fig. 10; para [0114]), and a speaker and microphone system.
Regarding claim 15, Mondry discloses a sensor configured to measure the oxygen saturation value of the patient (sensor of oximeter 502; Fig. 14; col 14 In 63 to col 15 In 2).
Regarding claim 16, Mondry further discloses wherein the sensor is configured to be worn on a finger of the patient (oximeter 502 disposed upon finger; Fig. 14; col 3 In 62-64).
Regarding claim 17, Allen teaches a portable hyperbaric oxygen (PHBO) hood system (Fig. 6, 10-11; para [0093]) comprising:
a hood (604, 606, 620; Fig. 6; para [0093]);
a system configured to control a pressure in the hood to create hyperbaric environment in the PHBO hood system (1000, 1100; Fig. 10-11; para [0114]-[0115]),
wherein the system comprises:
a flow line configured to supply oxygen to the hood (line not labeled configured to bring oxygen from 1006 to 602; Fig. 10; para [0114]); and
is configured to change the pressure of the main hood to the target pressure (internal pressure control; Fig. 10; para [0114]);
wherein the hood is configured to cover a head and a neck of the patient so that only the head and the neck of the patient are exposed to the hyperbaric environment when the patient uses the PHBO hood system, thereby enabling the PHBO hood system to be easily moved to a place where the patient is located (604, 606, 620 covering head and neck of patient; Fig. 6; para [0093]-[0094]).
Allen does not explicitly disclose wherein comprising: said system is a pump system comprising a pump; said flow line configured to supply oxygen to the hood via the pump; an intelligent controller configured to: receive an oxygen saturation value of a patient; receive an oxygen concentration value of the flow line; determine a target pressure of the main hood based on the oxygen saturation value and the oxygen concentration value; and control the pump system to change the pressure of the main hood to the target pressure.
However, Kollmeyer teaches a system (Fig. 1; para [0019]), comprising:
a breathing helmet (breathing helmet not shown but would be located at 10 in Fig. 1; para [0019]),
a pump system (12; Fig. 1, Fig. 6: para [0019]) comprising a pump (12; Fig. 1; para [0019]),
a flow line configured to supply oxygen to the breathing helmet via the pump (Line from 12 to 10; Fig. 1; para [0019]);
an intelligent controller (28; Fig. 1, Fig. 6; para [0019]) configured to:
determine a target pressure (via values 24, 26, from 20, 22; Fig. 1; para [0019]);
control the pump system to change the pressure of the main hood to the target pressure (changes made by control signal 44 sent from 28; Fig. 1; para [0021]); and
further appreciates a sensor of the flow line providing a value (flow sensor 32; Fig. 1; para [0020]-[0021]);
as well as the pump being in communication with a source of oxygen (tank of pressurized oxygen 88; Fig. 6; para [0032]).
It would have been obvious to one having ordinary skill in the art to have modified Allen to utilize a pump and control the pump based on feedback from sensors, a sensor being in the flow line, for the benefit of providing appropriate ventilation support [0001].
Allen as modified does not explicitly disclose wherein a controller is configured to: receive an oxygen saturation value of a patient; receive an oxygen concentration value of the flow line; determine a target pressure of the main hood based on the oxygen saturation value and the oxygen concentration value.
However, Mondry teaches a system (500; Fig. 14; col 14 In 63 to col 15 In 13), comprising: an intelligent controller (504; Fig. 14; col 14 In 63 to col 15 In 2) configured to:
receive an oxygen saturation value of a patient (via oximeter 502; Fig. 14; col 14 In 63 to col 15 In 2);
receive an oxygen concentration value of the flow line (via 520, 506, 510; Fig. 14; col 15 In 4-13, col 15 In 46 to col 16 In 20);
determine a target pressure of the main hood based on the oxygen saturation value and the oxygen concentration value (dispensing of proper amounts of air and oxygen to a patient; Fig. 14; col 15 In 14-34).
Accordingly, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have employed the pump system of Kollmeyer and the controller arrangement of Mondry upon the system of Allen, in order to effectively and precisely control the amount of pressurized therapy received by a patient and prevent pulmonary damage.
Regarding claim 18, Allen further discloses wherein the hood comprises: a main hood configured to cover the head of the patient (604; Fig. 6; para [0093]); a neck sleeve configured to be disposed below the main hood and surround the neck of the patient (606, 620; Fig. 6; para [0093]).
Regarding claim 19, Allen further discloses wherein the neck sleeve comprises at least one of a suction vent, a gas or air vent (exit from 620 through which gas leaves towards exhaust; Fig. 10; para [0114]), and a speaker and microphone system.
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Allen et al. (US 2015/0059761 A1) in view of Kollmeyer et al. (US 2008/0029096 A1) in view of Mondry (US 5,315,990 A) in further view of Loveland et al. (US 3,889,670 A).
Regarding claim 4, Allen as modified teaches the PHBO hood system of claim 1, but does not explicitly disclose wherein the main hood comprises one or more intervention ports that allows a physical touch of a head or a neck of the patient without decompressing the main hood and without removing the main hood from the patient when the patient is wearing the main hood.
However, Loveland teaches a hyperbaric system (10; Fig. 1; col 3 In 48-68), comprising: a main hood (12; Fig. 1; col 3 In 48-68) which comprises one or more intervention ports that allows a physical touch of a head or a neck of the patient without decompressing the main hood and without removing the main hood from the patient when the patient is wearing the main hood (port covered by 46 with extended length rubber glove, not shown, sealed to port; Fig. 1; col 4 In 43-56).
Accordingly, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have employed the port of Loveland upon the system of Allen in view of Kollmeyer in view of Mondry, in order to allow for user manipulation of a patient while providing uninterrupted hyperbaric pressure.
Regarding claim 5, Loveland further discloses wherein the one or more intervention ports comprise one or more intervention gloves (glove not shown sealed around 46; Fig. 1; coll 4 In 43-56).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Allen et al. (US 2015/0059761 A1) in view of Kollmeyer et al. (US 2008/0029096 A1) in view of Mondry (US 5,315,990 A) in further view of Luppi (US 2003/0135915 A1).
Regarding claim 6, Allen as modified teaches the PHBO hood system of claim 1, but does not explicitly disclose a pillow base configured to be coupled with the main hood and receive a pillow for the patient.
However, Luppi teaches a hood system (1; Fig. 1-6; para [0017]), comprising: a pillow base (11; Fig. 1-6; para [0018])
with the main hood and receive a pillow for the patient (40; Fig. 1-6; para [0028]-[0029]).
Accordingly, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have employed the pillow of Luppi upon the system of Allen in view of Kollmeyer in view of Mondry, in order to increase wearer comfort during use.
Claim(s) 9 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Allen et al. (US 2015/0059761 A1) in view of Kollmeyer et al. (US 2008/0029096 A1) in view of Mondry (US 5,315,990 A) in further view of Terhaar (US 2,543,426).
Regarding claim 9, Allen as modified does not explicitly disclose wherein the neck sleeve comprises a joint configured to open and close the neck sleeve to receive a neck of the patient.
Terhaar teaches it is known for a neck sleeve (60) to comprise a joint (66) to open and close the neck sleeve to receive a neck of a patient (col. 3, lines 45-53).
It would have been obvious to have incorporated a joint configured to open and close the neck sleeve to receive a neck of a patient as taught by Terhaar for the benefit of ensuring an effective seal about the patient’s neck (col. 3, lines 52-53).
Regarding claim 20, Allen as modified does not explicitly disclose wherein the neck sleeve comprises a joint configured to open and close the neck sleeve to receive a neck of the patient.
Terhaar teaches it is known for a neck sleeve (60) to comprise a joint (66) to open and close the neck sleeve to receive a neck of a patient (col. 3, lines 45-53).
It would have been obvious to have incorporated a joint configured to open and close the neck sleeve to receive a neck of a patient as taught by Terhaar for the benefit of ensuring an effective seal about the patient’s neck (col. 3, lines 52-53).
Allowable Subject Matter
Claims 7 and 10-14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 7, Allen in view of Kollmeyer in view of Mondry in view of Luppi teaches the PHBO hood system of claim 6, but the prior art does not teach nor fairly suggest wherein the pillow base is configured to be coupled with the main hood via one or more slide connectors. There exists no motivation without benefit of hindsight for placing the pillow base of Luppi upon slide connectors.
Regarding claim claim 10, Allen in view of Kollmeyer in view of Mondry teaches the PHBO hood system of claim 1, but is silent wherein the intelligent controller is configured to utilize deep learning algorithms to develop an intelligent model to optimize operating conditions of the PHBO hood system for the patient. While the prior art of Hedner (US 2008/0029096 A1) teaches a system (Fig. 1; para [0025]), comprising: an intelligent controller is configured to utilize deep learning algorithms to develop an intelligent model to optimize operating conditions (11 utilizing neural network; Fig. 1; para [0028]); the prior art does not teach nor fairly suggest employment of the controller of Hedner upon the system of Allen in view of Kollmeyer in view of Mondry. There exists no motivation for further modification of the controller of Allen modified by Kollmeyer in view of Mondry.
Regarding claim 11, the prior art does not teach nor fairly suggest the claimed limitations, because claim 11 depends from claim 10.
Regarding claim 12, Allen in view of Kollmeyer in view of Mondry teaches the PHBO hood system of claim 1, but the prior art does not teach nor fairly suggest wherein the intelligent controller is configured to: set the target pressure to have a high value responsive to determining that the oxygen saturation value is low and the oxygen concentration value is high; and set the target pressure to have a middle value responsive to determining that the oxygen saturation value is low and the oxygen concentration value is low. There exists no motivation without benefit of hindsight for selection of an arbitrary high or middle value of pressure responsive to values determined by the system.
Regarding claim 13, Allen in view of Kollmeyer in view of Mondry teaches the PHBO hood system of claim 1, but the prior art does not teach nor fairly suggest wherein the intelligent controller is configured to: set the target pressure to have a high value responsive to determining that the oxygen saturation value is middle and the oxygen concentration value is middle; and set the target pressure to have a middle value responsive to determining that the oxygen saturation value is middle and the oxygen concentration value is low. There exists no motivation without benefit of hindsight for selection of an arbitrary high or middle value of pressure responsive to values determined by the system.
Regarding claim 14, Allen in view of Kollmeyer in view of Mondry teaches the PHBO hood system of claim 1, but the prior art does not teach nor fairly suggest wherein the intelligent controller is configured to: set the target pressure to have a low value responsive to determining that the oxygen saturation value is high and the oxygen concentration value is high; set the target pressure to have a middle value responsive to determining that the oxygen saturation value is high and the oxygen concentration value is middle; and set the target pressure to have a high value responsive to determining that the oxygen saturation value is high and the oxygen concentration value is low. There exists no motivation without benefit of hindsight for selection of an arbitrary high or middle or low value of pressure responsive to values determined by the system.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Villareal et al. (US 2002/0069877 A1), Taube (US 4,889,116 A1), Kinsky et al. (US 2018/0099109 A).
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/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785
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