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
This Office Action is in responsive to the preliminary amendment filed on 1/19/2024. As directed by the Preliminary amendment, claims 1-17 were cancelled and claims 18-35 have been added. Thus, claims 18-35 are currently pending in this application.
Drawings
The drawings are objected to because:
Figs. 2-3, 5, and 13A contain improper shading (see MPEP 608.02(V)(m))
Figs. 8-9 and 13A contain the unlabeled text boxes 112, 130, 132, 172 which should be provided with descriptive text labels (e.g. box 172 could have the label --control unit--) (see MPEP 608.02(d)(a))
Figs. 10-12 are photographs which are not ordinarily permitted unless they are the only practicable medium for illustrating the claimed invention (see MPEP 608.02(V)(b)(1))
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 18, 24-25, and 30-31 are objected to because of the following informalities:
Claim 18 recites “said control unit” in line 11 and is suggested to read --said medical gas input control unit-- in order to more clearly reference how the limitation was originally claimed.
Claim 18 recites “the control unit” in line 21 and is suggested to read --the medical gas input control unit-- in order to more clearly reference how the limitation was originally claimed.
Claim 24 recites “nasopharyngeal airway or tube,” in line 11 and is suggested to read --nasopharyngeal airway, nasopharyngeal tube,-- in order to be grammatically correct and to provide clarity to the claimed list.
Claim 25 recites “said control unit” in line 11 and is suggested to read --said medical gas input control unit-- in order to more clearly reference how the limitation was originally claimed.
Claim 25 recites “said control unit” in line 18 and is suggested to read --said medical gas input control unit-- in order to more clearly reference how the limitation was originally claimed.
Claim 25 recites “the control unit” in lines 23-24 and is suggested to read --the medical gas input control unit-- in order to more clearly reference how the limitation was originally claimed.
Claim 30 recites “nasopharyngeal airway or tube,” in line 11 and is suggested to read --nasopharyngeal airway, nasopharyngeal tube,-- in order to be grammatically correct and to provide clarity to the claimed list.
Claim 31 recites “said control unit” in line 10 and is suggested to read --said hand operated medical gas input control unit-- in order to more clearly reference how the limitation was originally claimed.
Appropriate correction is required.
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 limitations use 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 limitations are: “a pressure limiting device…is configured to be able to select a threshold pressure…” in claim 18 lines 12-15, claim 25 lines 12-15, and claim 31 lines 11-15 and “a hand-operated control mechanism for controlling both suction and medical gas flow” in claim 19 lines 3-4 and claim 25 lines 18-19.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
According to the Applicant’s specification page 4 lines 14-15, “a pressure limiting device…is configured to be able to select a threshold pressure…” in claim 18 lines 12-15, claim 25 lines 12-15, and claim 31 lines 11-15 is being interpreted as a pressure relief valve, a pressure regulating valve, a rupture disc, an aperture, or a breather vent, and equivalents thereof. According to the Applicant’s specification page 23 lines 10-12, “a hand-operated control mechanism for controlling both suction and medical gas flow” in claim 19 lines 3-4 and claim 25 lines 18-19 is being interpreted as a finger activated switch, and equivalents thereof.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid 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 limitations recite sufficient structure to perform the claimed functions so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 18-35 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 18, the limitation “wherein in operation, once the first end of the endotracheal tube is inserted into the patient's airway, a clinician operating the airway device can move the control unit independent of the airway access device adaptor and endotracheal tube to provide the clinician a clear and unobstructed view of the patient's airway” in lines 20-23 recites new matter, as this is from a newly added claim and this limitation was not described in the Applicant’s original disclosure.
Regarding claim 25, the limitation “wherein in operation, once the first end of the airway access device is operably coupled to the patient's airway, a clinician operating the airway device can move the control unit independent of the airway access device adaptor and airway access device to provide the clinician a clear and unobstructed view of the patient's airway” in lines 22-25 recites new matter, as this is from a newly added claim and this limitation was not described in the Applicant’s original disclosure.
Regarding claim 31, the limitation “wherein in operation, once the first end of the endotracheal tube is inserted into the patient's airway, a clinician operating the airway device can move the hand operated medical gas control unit independent of the airway access device adaptor and endotracheal tube to provide the clinician a clear and unobstructed view of the patient's airway” in lines 18-22 recites new matter, as this is from a newly added claim and this limitation was not described in the Applicant’s original disclosure.
Any remaining claims are rejected based on their dependency on a rejected base claim.
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 18-35 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.
Regarding claim 18, the limitation “in operation…is inserted” in line 20 is confusing, as this recites a method step when the device is directed to an apparatus, and thus the scope of the claim is unclear. It is suggested to use claim language such as --configured to-- or --adapted for-- in order to avoid such indefiniteness. Moreover, the limitation “can” in line 21 is confusing, as it is unclear as to whether the following limitations are required or not for the claimed invention. Furthermore, the limitation "said endotracheal tube" is recited in lines 18-19. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 24, the limitation “an endotracheal tube” in line 2 is confusing, as it is unclear whether this limitation is meant to be the same as or different from “said endotracheal tube” in claim 18. For the purposes of examination, they will be interrupted as the same limitation.
Regarding claim 25, the limitation “in operation, once…is operably coupled” in lines 22-23 is confusing, as this recites a method step when the device is directed to an apparatus, and thus the scope of the claim is unclear. It is suggested to use claim language such as --configured to-- or --adapted for-- in order to avoid such indefiniteness. Moreover, the limitation “can” in line 23 is confusing, as it is unclear as to whether the following limitations are required or not for the claimed invention.
Regarding claim 31, the limitation “in operation…is inserted” in line 18 is confusing, as this recites a method step when the device is directed to an apparatus, and thus the scope of the claim is unclear. It is suggested to use claim language such as --configured to-- or --adapted for-- in order to avoid such indefiniteness. Moreover, the limitation “can” in line 19 is confusing, as it is unclear as to whether the following limitations are required or not for the claimed invention.
Any remaining claims are rejected based on their dependency on a rejected base claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 18 and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Voss et al. (US 2009/0277447 A1) in view of Behrstock (US 4,699,138), Palleni (US 3,964,476), Ledwith (US 2011/0023875 A1), and Brown et al. (US 2015/0306329 A1).
Regarding claim 18, as best understood, Voss discloses an airway device for delivering medical gas to a patient (airway system that can inject oxygen gas into the patient’s lungs) (abstract), comprising:
an airway access device having a first end configured to be operably coupled to a patient's airway (ventilation tube 404 has an end for coupling to the patient’s airway) (Fig. 4; para. [0052]);
a medical gas input control unit including a housing having first and second ends (device 40 used to control ventilation and suction has a housing with two ends) (Fig. 4; para. [0052]), said control unit including a medical gas supply coupling located at said first end of said housing connectable to a source of medical gas (one end of the device 40 has a coupling connected to mechanical ventilator 402 and/or O2 source 410) (Fig. 4; para. [0052]).
Voss does not disclose an airway access device adaptor having an adaptor body connected to an opposed second end of the airway access device along a first end of the adaptor body and connected to an elongate flexible tube component along a tubing port of the adaptor body and a first end of the elongate flexible tube component, the airway access device adaptor in flow communication with the airway access device; said second end of said housing being connected to a second end of the elongate flexible tube component; wherein in operation, once the first end of the endotracheal tube is inserted into the patient's airway, a clinician operating the airway device can move the control unit independent of the airway access device adaptor and endotracheal tube to provide the clinician a clear and unobstructed view of the patient's airway.
However, Behrstock teaches an intubation suction device (Behrstock; abstract) including an airway access device adaptor having an adaptor body connected to an opposed second end of the airway access device along a first end of the adaptor body (a device 10 comprising the tubular sections 26, 28 and the grip means 24 has a body with an end at tubular section 26 connected to the end of the endotracheal tube 22 not inside the patient) (Behrstock; Figs. 1-4; col. 4 lines 12-22) and connected to an elongate tube component along a tubing port of the adaptor body and a first end of the elongate tube component (the tubular section 28 has an end with a port for connecting to an end of suction tubing 20) (Behrstock; Figs. 1-4; col. 4 lines 12-22), the airway access device adaptor in flow communication with the airway access device (the device 10 comprising the tubular sections 26, 28 and the grip means 24 is fluidly connected to the endotracheal tube 22) (Behrstock; Figs. 1-4; col. 4 lines 41-55). Moreover, Palleni teaches a respiration device (Palleni; abstract) wherein the elongate tube component is an elongate flexible tube component (elongated, bendable but shape retaining tubular means to the source) (Palleni; Figs. 3, 5; claim 1).
Therefore, 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 Voss system to include an airway access device adaptor having an adaptor body connected to an opposed second end of the airway access device along a first end of the adaptor body and connected to an elongate tube component along a tubing port of the adaptor body and a first end of the elongate tube component, the airway access device adaptor in flow communication with the airway access device, as taught by Behrstock, for the purpose of enabling the device to be easily and accurately held by a doctor while simultaneously controlling the vacuum to the trachea (Behrstock; col. 4 lines 56-65). Moreover, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the modified Voss system such that the elongate tube component is an elongate flexible tube component, as taught by Palleni, for the purpose of enabling the tube to be bendable yet shape-retaining (Palleni; Figs. 3, 5; claim 1), thereby enabling a user to manipulate the shape and position of the tubing as needed.
With this modification, the modified Voss device would thus teach said second end of said housing being connected to a second end of the elongate flexible tube component (another end of the Voss device 40 housing would be connected to an end of the Berhstock tubing 20 farthest from the Behrstock device 10, wherein the tubing 20 would be flexible as taught by Palleni) (Voss, Fig. 4, para. [0052]; Behrstock, Figs. 1-4; Palleni, Figs. 3 and 5, claim 1); wherein in operation, once the first end of the endotracheal tube is inserted into the patient's airway, a clinician operating the airway device can move the control unit independent of the airway access device adaptor and endotracheal tube to provide the clinician a clear and unobstructed view of the patient's airway (as the Voss device 40 is not recited to be fixed in place and is connected to the Berhstock tubing 20 which is flexible/bendable as taught by Palleni, a clinician would be able to independently move the Voss device 40 attached to the end of the flexible Berhstock tubing 20 while the Voss ventilation tube 404/Behrstock endotracheal tube 22 is inside the patient’s airway, and thereby function to provide a clear and unobstructed view as claimed) (Voss, Fig. 4, para. [0052]; Behrstock, Figs. 1-4; Palleni, Figs. 3 and 5, claim 1).
Voss does not disclose said airway access device adaptor configured to form a gas tight seal with said endotracheal tube when coupled to said endotracheal tube.
However, Ledwith teaches a connector assembly to couple a tracheal tube and a ventilator (Ledwith; abstract) wherein said airway access device adaptor configured to form a gas tight seal with said endotracheal tube when coupled to said endotracheal tube (o-rings 48, 50 to form an airtight seal between the connector assembly 18 and the endotracheal tube 10) (Ledwith; Figs. 1a-2; para. [0021]).
Therefore, 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 modified Voss airway access device adaptor such that said airway access device adaptor is configured to form a gas tight seal with said endotracheal tube when coupled to said endotracheal tube, as taught by Ledwith, for the purpose of providing a an airtight seal to help ensure airflow to and from the patient does not leak (Ledwith; para. [0021]).
Voss does not disclose a pressure limiting device located downstream of said medical gas supply coupling, and wherein said pressure limiting device is configured to be able to select a threshold pressure in a preselected pressure range at which medical gas is vented in order to limit medical gas flow upon a pressure of medical gas in the pressure limiting device exceeding a selected threshold pressure.
However, Brown teaches an adapter for use in an airway exchange procedure (Brown; abstract) including a pressure limiting device located downstream of said medical gas supply coupling, and wherein said pressure limiting device is configured to be able to select a threshold pressure in a preselected pressure range at which medical gas is vented in order to limit medical gas flow upon a pressure of medical gas in the pressure limiting device exceeding a selected threshold pressure (relief valve 205 is downstream of the hollow main body 213 which provides the fluid; relief valve 205 can be adjusted to different levels via rotating a casing 206 to control the maximum pressure at which the valve 205 opens to release fluid, thereby limiting the pressure of the delivered fluid from exceeding that maximum) (Brown; Fig. 2; paras. [0026-0027]).
Therefore, 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 modified Voss system to include a pressure limiting device located downstream of said medical gas supply coupling, and wherein said pressure limiting device is configured to be able to select a threshold pressure in a preselected pressure range at which medical gas is vented in order to limit medical gas flow upon a pressure of medical gas in the pressure limiting device exceeding a selected threshold pressure, as taught by Brown, for the purpose of helping to ensure the maximum pressure delivered is appropriate for the physical characteristics of the patient (Brown; para. [0027]).
Regarding claim 22, the modified Voss teaches wherein said pressure limiting device is any one of a pressure relief valve or a pressure regulating valve (relief valve 205 is for controlling or regulating the delivered pressure) (Brown; Fig. 2; paras. [0026-0027]).
Regarding claim 23, the modified Voss teaches wherein said airway access device adaptor is connected to, and in flow communication with, said airway access device by means of elongate flexible tubing (the Voss device 40 housing would be fluidly connected to the Berhstock tubing 20, wherein the tubing 20 would be flexible as taught by Palleni) (Voss, Fig. 4, para. [0052]; Behrstock, Figs. 1-4; Palleni, Figs. 3 and 5, claim 1).
Regarding claim 24, as best understood, the modified Voss teaches wherein said airway access device is any one of an endotracheal tube or laryngeal mask airway (ventilator tube 404 can be an endotracheal tube or laryngeal mask airway) (Voss; Fig. 4; para. [0047]).
Claims 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Voss in view of Behrstock, Palleni, Ledwith, and Brown as applied to claim 18 above, and further in view of Jacobs (US 3,682,166).
Regarding claim 19, the modified Voss teaches the invention as previously claimed, including wherein said medical gas input control unit further comprises a suction supply coupling located at said first end of said housing and being connectable to a source of suction (one end of the device 40 housing has a coupling to vacuum source 407) (Voss; Fig. 4; para. [0052]), said control unit including a control mechanism for controlling both suction and medical gas flow (switching mechanisms/valves 409, 411, 415 to the O2 source 410, mechanical ventilator 402, and vacuum source 407, respectively) (Voss; Fig. 4; para. [0052]; para. [0054]), but is silent on the control mechanism being a hand-operated control mechanism.
However, Jacobs teaches a trans-tracheal oxygen resuscitator (Jacobs; abstract) wherein the control mechanism is a hand-operated control mechanism (valves to control the flow of oxygenated gas and suction can be shifted manually) (Jacobs; Fig. 6; col. 4 lines 39-49; col. 5 lines 60-68; col. 6 lines 1-7).
Therefore, 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 Voss control mechanism to be a hand-operated control mechanism, as taught by Jacobs, for the purpose of enabling the system to be operated in accordance with the judgement of the operator as they observe the condition of the patient (Jacobs; col. 1 lines 61-68).
Regarding claim 20, the modified Voss teaches wherein said hand-operated control mechanism is a finger activated switch for switching between the source of suction and the source of medical gas (the Voss switching mechanisms 409, 411, 415 to the O2 source 410, ventilator 402, and vacuum source 407, respectively, as modified by Jacobs to be manually operated) (Voss, Fig. 4, para. [0052], para. [0054]; Jacobs, Fig. 6, col. 4 lines 39-49, col. 5 lines 60-68, col. 6 lines 1-7), said control unit being configured such that when said finger activated mechanism is not activated, medical gas flows to the airway access device (when Voss switching mechanism 415 to the vacuum source 407 is not activated, air can still flow from mechanical ventilator 402 and/or O2 source 410) (Voss, Fig. 4, para. [0052], para. [0054]; Jacobs, Fig. 6, col. 4 lines 39-49, col. 5 lines 60-68, col. 6 lines 1-7), and when activated the medical gas flow is stopped and suction is applied to the airway access device, so that medical gas and suction cannot be provided at the same time (when Voss switching mechanism 415 to the vacuum source 407 is activated for a continuous vacuum, air flow can be stopped from mechanical ventilator 402 and/or O2 source 410) (Voss, Fig. 4, para. [0052], para. [0054]; Jacobs, Fig. 6, col. 4 lines 39-49, col. 5 lines 60-68, col. 6 lines 1-7).
Regarding claim 21, the modified Voss teaches wherein said hand-operated control mechanism is a finger activated switch for switching between the source of suction and the source of medical gas (the Voss switching mechanisms 409, 411, 415 to the O2 source 410, ventilator 402, and vacuum source 407, respectively, as modified by Jacobs to be manually operated) (Voss, Fig. 4, para. [0052], para. [0054]; Jacobs, Fig. 6, col. 4 lines 39-49, col. 5 lines 60-68, col. 6 lines 1-7), said control unit being configured such that when said finger activated mechanism is not activated, medical gas flows to the airway access device (when Voss switching mechanism 415 to the vacuum source 407 is not activated, air can still flow from mechanical ventilator 402 and/or O2 source 410) (Voss, Fig. 4, para. [0052], para. [0054]; Jacobs, Fig. 6, col. 4 lines 39-49, col. 5 lines 60-68, col. 6 lines 1-7), and when activated the medical gas flow is reduced to a preselected flow rate and suction is simultaneously applied to the airway access device, so that medical gas and suction are provided at the same time (when switching mechanism 415 to the vacuum source 407 is activated, air can still flow from mechanical ventilator 402 and/or O2 source 410; as there is no control of air flow rate recited other than the switches turning the flows on and off, the overall flow rate of air would result from the one flow rate from the O2 source 410 when switched on and which would be reduced by the vacuum source 407 being simultaneously switched on) (Voss, Fig. 4, paras. [0052-0054]; Jacobs, Fig. 6, col. 4 lines 39-49, col. 5 lines 60-68, col. 6 lines 1-7).
Claims 25-35 are rejected under 35 U.S.C. 103 as being unpatentable over Voss in view of Behrstock, Palleni, Ledwith, Brown, and Jacobs.
Regarding claim 25, as best understood, Voss discloses an airway device for delivering medical gas to a patient (airway system that can inject oxygen gas into the patient’s lungs) (abstract), comprising:
an airway access device having a first end configured to be operably coupled to a patient's airway (ventilation tube 404 has an end for coupling to the patient’s airway) (Fig. 4; para. [0052]);
a medical gas input control unit including a housing having first and second ends (device 40 used to control ventilation and suction has a housing with two ends) (Fig. 4; para. [0052]), said control unit including a medical gas supply coupling located at said first end of said housing connectable to a source of medical gas (one end of the device 40 has a coupling connected to mechanical ventilator 402 and/or O2 source 410) (Fig. 4; para. [0052]);
a suction supply coupling located at said first end of said housing and being connectable to a source of suction (one end of the device 40 housing has a coupling to vacuum source 407) (Fig. 4; para. [0052]), said control unit including a control mechanism for controlling both suction and medical gas flow (switching mechanisms/valves 409, 411, 415 to the O2 source 410, mechanical ventilator 402, and vacuum source 407, respectively) (Fig. 4; para. [0052]; para. [0054]).
Voss does not disclose an airway access device adaptor having an adaptor body connected to an opposed second end of the airway access device along a first end of the adaptor body and connected to an elongate flexible tube component along a tubing port of the adaptor body and a first end of the elongate flexible tube component, the airway access device adaptor in flow communication with the airway access device; said second end of said housing being connected to a second end of the elongate flexible tube component; wherein in operation, once the first end of the airway access device is operably coupled to the patient's airway, a clinician operating the airway device can move the control unit independent of the airway access device adaptor and airway access device to provide the clinician a clear and unobstructed view of the patient's airway.
However, Behrstock teaches an intubation suction device (Behrstock; abstract) including an airway access device adaptor having an adaptor body connected to an opposed second end of the airway access device along a first end of the adaptor body (a device 10 comprising the tubular sections 26, 28 and the grip means 24 has a body with an end at tubular section 26 connected to the end of the endotracheal tube 22 not inside the patient) (Behrstock; Figs. 1-4; col. 4 lines 12-22) and connected to an elongate tube component along a tubing port of the adaptor body and a first end of the elongate tube component (the tubular section 28 has an end with a port for connecting to an end of suction tubing 20) (Behrstock; Figs. 1-4; col. 4 lines 12-22), the airway access device adaptor in flow communication with the airway access device (the device 10 comprising the tubular sections 26, 28 and the grip means 24 is fluidly connected to the endotracheal tube 22) (Behrstock; Figs. 1-4; col. 4 lines 41-55). Moreover, Palleni teaches a respiration device (Palleni; abstract) wherein the elongate tube component is an elongate flexible tube component (elongated, bendable but shape retaining tubular means to the source) (Palleni; Figs. 3, 5; claim 1).
Therefore, 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 Voss system to include an airway access device adaptor having an adaptor body connected to an opposed second end of the airway access device along a first end of the adaptor body and connected to an elongate tube component along a tubing port of the adaptor body and a first end of the elongate tube component, the airway access device adaptor in flow communication with the airway access device, as taught by Behrstock, for the purpose of enabling the device to be easily and accurately held by a doctor while simultaneously controlling the vacuum to the trachea (Behrstock; col. 4 lines 56-65). Moreover, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the modified Voss system such that the elongate tube component is an elongate flexible tube component, as taught by Palleni, for the purpose of enabling the tube to be bendable yet shape-retaining (Palleni; Figs. 3, 5; claim 1), thereby enabling a user to manipulate the shape and position of the tubing as needed.
With this modification, the modified Voss device would thus teach said second end of said housing being connected to a second end of the elongate flexible tube component (another end of the Voss device 40 housing would be connected to an end of the Berhstock tubing 20 farthest from the Behrstock device 10, wherein the tubing 20 would be flexible as taught by Palleni) (Voss, Fig. 4, para. [0052]; Behrstock, Figs. 1-4; Palleni, Figs. 3 and 5, claim 1); wherein in operation, once the first end of the airway access device is operably coupled to the patient's airway, a clinician operating the airway device can move the control unit independent of the airway access device adaptor and airway access device to provide the clinician a clear and unobstructed view of the patient's airway (as the Voss device 40 is not recited to be fixed in place and is operably connected to the Berhstock tubing 20 which is flexible/bendable as taught by Palleni, a clinician would be able to independently move the Voss device 40 attached to the end of the flexible Berhstock tubing 20 while the Voss ventilation tube 404/Behrstock endotracheal tube 22 is inside the patient’s airway, and thereby function to provide a clear and unobstructed view as claimed) (Voss, Fig. 4, para. [0052]; Behrstock, Figs. 1-4; Palleni, Figs. 3 and 5, claim 1).
Voss does not disclose said airway access device adaptor configured to form a gas tight seal with said airway access device when coupled to said airway access device.
However, Ledwith teaches a connector assembly to couple a tracheal tube and a ventilator (Ledwith; abstract) said airway access device adaptor configured to form a gas tight seal with said airway access device when coupled to said airway access device (o-rings 48, 50 to form an airtight seal between the connector assembly 18 and the endotracheal tube 10) (Ledwith; Figs. 1a-2; para. [0021]).
Therefore, 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 modified Voss airway access device adaptor such that said airway access device adaptor configured to form a gas tight seal with said airway access device when coupled to said airway access device, as taught by Ledwith, for the purpose of providing a an airtight seal to help ensure airflow to and from the patient does not leak (Ledwith; para. [0021]).
Voss does not disclose a pressure limiting device located downstream of said medical gas supply coupling, and wherein said pressure limiting device is configured to limit medical gas flow upon a pressure of medical gas in the pressure limiting device exceeding a preselected threshold pressure.
However, Brown teaches an adapter for use in an airway exchange procedure (Brown; abstract) including a pressure limiting device located downstream of said medical gas supply coupling, and wherein said pressure limiting device is configured to limit medical gas flow upon a pressure of medical gas in the pressure limiting device exceeding a preselected threshold pressure (relief valve 205 is downstream of the hollow main body 213 which provides the fluid; relief valve 205 can be adjusted to different levels via rotating a casing 206 to control the maximum pressure at which the valve 205 opens to release fluid, thereby limiting the pressure of the delivered fluid from exceeding that maximum) (Brown; Fig. 2; paras. [0026-0027]).
Therefore, 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 modified Voss system to include a pressure limiting device located downstream of said medical gas supply coupling, and wherein said pressure limiting device is configured to limit medical gas flow upon a pressure of medical gas in the pressure limiting device exceeding a preselected threshold pressure, as taught by Brown, for the purpose of helping to ensure the maximum pressure delivered is appropriate for the physical characteristics of the patient (Brown; para. [0027]).
Voss is silent on the control mechanism being a hand-operated control mechanism.
However, Jacobs teaches a trans-tracheal oxygen resuscitator (Jacobs; abstract) wherein the control mechanism is a hand-operated control mechanism (valves to control the flow of oxygenated gas and suction can be shifted manually) (Jacobs; Fig. 6; col. 4 lines 39-49; col. 5 lines 60-68; col. 6 lines 1-7).
Therefore, 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 Voss control mechanism to be a hand-operated control mechanism, as taught by Jacobs, for the purpose of enabling the system to be operated in accordance with the judgement of the operator as they observe the condition of the patient (Jacobs; col. 1 lines 61-68).
Regarding claim 26, the modified Voss teaches wherein said hand-operated control mechanism is a finger activated switch for switching between the source of suction and the source of medical gas (the Voss switching mechanisms 409, 411, 415 to the O2 source 410, ventilator 402, and vacuum source 407, respectively, as modified by Jacobs to be manually operated) (Voss, Fig. 4, para. [0052], para. [0054]; Jacobs, Fig. 6, col. 4 lines 39-49, col. 5 lines 60-68, col. 6 lines 1-7), said control unit being configured such that when said finger activated mechanism is not activated, medical gas flows to the airway access device (when Voss switching mechanism 415 to the vacuum source 407 is not activated, air can still flow from mechanical ventilator 402 and/or O2 source 410) (Voss, Fig. 4, para. [0052], para. [0054]; Jacobs, Fig. 6, col. 4 lines 39-49, col. 5 lines 60-68, col. 6 lines 1-7), and when activated the medical gas flow is stopped and suction is applied to the airway access device, so that medical gas and suction cannot be provided at the same time (when Voss switching mechanism 415 to the vacuum source 407 is activated for a continuous vacuum, air flow can be stopped from mechanical ventilator 402 and/or O2 source 410) (Voss, Fig. 4, para. [0052], para. [0054]; Jacobs, Fig. 6, col. 4 lines 39-49, col. 5 lines 60-68, col. 6 lines 1-7).
Regarding claim 27, the modified Voss teaches wherein said hand-operated control mechanism is a finger activated switch for switching between the source of suction and the source of medical gas (the Voss switching mechanisms 409, 411, 415 to the O2 source 410, ventilator 402, and vacuum source 407, respectively, as modified by Jacobs to be manually operated) (Voss, Fig. 4, para. [0052], para. [0054]; Jacobs, Fig. 6, col. 4 lines 39-49, col. 5 lines 60-68, col. 6 lines 1-7), said control unit being configured such that when said finger activated mechanism is not activated, medical gas flows to the airway access device (when Voss switching mechanism 415 to the vacuum source 407 is not activated, air can still flow from mechanical ventilator 402 and/or O2 source 410) (Voss, Fig. 4, para. [0052], para. [0054]; Jacobs, Fig. 6, col. 4 lines 39-49, col. 5 lines 60-68, col. 6 lines 1-7), and when activated the medical gas flow is reduced to a preselected flow rate and suction is simultaneously applied to the airway access device, so that medical gas and suction are provided at the same time (when switching mechanism 415 to the vacuum source 407 is activated, air can still flow from mechanical ventilator 402 and/or O2 source 410; as there is no control of air flow rate recited other than the switches turning the flows on and off, the overall flow rate of air would result from the one flow rate from the O2 source 410 when switched on and which would be reduced by the vacuum source 407 being simultaneously switched on) (Voss, Fig. 4, paras. [0052-0054]; Jacobs, Fig. 6, col. 4 lines 39-49, col. 5 lines 60-68, col. 6 lines 1-7).
Regarding claim 28, the modified Voss teaches wherein said pressure limiting device is any one of a pressure relief valve or a pressure regulating valve (relief valve 205 is for controlling or regulating the delivered pressure) (Brown; Fig. 2; paras. [0026-0027]).
Regarding claim 29, the modified Voss teaches wherein said airway access device adaptor is connected to, and in flow communication with, said airway access device by means of elongate flexible tubing (the Voss device 40 housing would be fluidly connected to the Berhstock tubing 20, wherein the tubing 20 would be flexible as taught by Palleni) (Voss, Fig. 4, para. [0052]; Behrstock, Figs. 1-4; Palleni, Figs. 3 and 5, claim 1).
Regarding claim 30, the modified Voss teaches wherein said airway access device is any one of an endotracheal tube or laryngeal mask airway (ventilator tube 404 can be an endotracheal tube or laryngeal mask airway) (Voss; Fig. 4; para. [0047]).
Regarding claim 31, as best understood, Voss discloses an airway device for delivering medical gas to a patient (airway system that can inject oxygen gas into the patient’s lungs) (abstract), comprising:
an endotracheal tube having a first end configured to be operably inserted into a patient's airway and an opposed second end (ventilator tube 404 can be an endotracheal tube, and so would have an end inserted into a patient’s airway and an opposite end coupled to device 40) (Fig. 4; para. [0047]; para. [0052]);
a medical gas input control unit including a housing having first and second opposed ends (device 40 used to control ventilation and suction has a housing with two ends) (Fig. 4; para. [0052]), said control unit including a medical gas supply coupling connectable to a source of medical gas (one end of the device 40 has a coupling connected to mechanical ventilator 402 and/or O2 source 410) (Fig. 4; para. [0052]).
Voss does not disclose an endotracheal tube adaptor having an adaptor body connected to the opposed second end along a first end of the adaptor body and connected to a first end of an elongate flexible tube component along a tube port of the adaptor body, the airway access device adaptor in flow communication with the endotracheal tube; a second end of said elongate flexible tube component being connected to said second end of said housing; wherein in operation, once the first end of the endotracheal tube is inserted into the patient's airway, a clinician operating the airway device can move the hand operated medical gas control unit independent of the airway access device adaptor and endotracheal tube to provide the clinician a clear and unobstructed view of the patient's airway.
However, Behrstock teaches an intubation suction device (Behrstock; abstract) including an endotracheal tube adaptor having an adaptor body connected to the opposed second end along a first end of the adaptor body (a device 10 comprising the tubular sections 26, 28 and the grip means 24 has a body with an end at tubular section 26 connected to the end of the endotracheal tube 22 not inside the patient) (Behrstock; Figs. 1-4; col. 4 lines 12-22) and connected to a first end of an elongate tube component along a tube port of the adaptor body (the tubular section 28 has an end with a port for connecting to an end of suction tubing 20) (Behrstock; Figs. 1-4; col. 4 lines 12-22), the airway access device adaptor in flow communication with the endotracheal tube (the device 10 comprising the tubular sections 26, 28 and the grip means 24 is fluidly connected to the endotracheal tube 22) (Behrstock; Figs. 1-4; col. 4 lines 41-55). Moreover, Palleni teaches a respiration device (Palleni; abstract) wherein the elongate tube component is an elongate flexible tube component (elongated, bendable but shape retaining tubular means to the source) (Palleni; Figs. 3, 5; claim 1).
Therefore, 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 Voss system to include an endotracheal tube adaptor having an adaptor body connected to the opposed second end along a first end of the adaptor body and connected to a first end of an elongate tube component along a tube port of the adaptor body, the airway access device adaptor in flow communication with the endotracheal tube, as taught by Behrstock, for the purpose of enabling the device to be easily and accurately held by a doctor while simultaneously controlling the vacuum to the trachea (Behrstock; col. 4 lines 56-65). Moreover, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the modified Voss system such that the elongate tube component is an elongate flexible tube component, as taught by Palleni, for the purpose of enabling the tube to be bendable yet shape-retaining (Palleni; Figs. 3, 5; claim 1), thereby enabling a user to manipulate the shape and position of the tubing as needed.
With this modification, the modified Voss device would thus teach a second end of said elongate flexible tube component being connected to said second end of said housing (another end of the Voss device 40 housing would be connected to an end of the Berhstock tubing 20 farthest from the Behrstock device 10, wherein the tubing 20 would be flexible as taught by Palleni) (Voss, Fig. 4, para. [0052]; Behrstock, Figs. 1-4; Palleni, Figs. 3 and 5, claim 1); wherein in operation, once the first end of the endotracheal tube is inserted into the patient's airway, a clinician operating the airway device can move the hand operated medical gas control unit independent of the airway access device adaptor and endotracheal tube to provide the clinician a clear and unobstructed view of the patient's airway (as the Voss device 40 is not recited to be fixed in place and is connected to the Berhstock tubing 20 which is flexible/bendable as taught by Palleni, a clinician would be able to independently move the Voss device 40 attached to the end of the flexible Berhstock tubing 20 while the Voss ventilation tube 404/Behrstock endotracheal tube 22 is inside the patient’s airway, and thereby function to provide a clear and unobstructed view as claimed) (Voss, Fig. 4, para. [0052]; Behrstock, Figs. 1-4; Palleni, Figs. 3 and 5, claim 1).
Voss is silent on the medical gas input control unit being a hand operated medical gas input control unit.
However, Jacobs teaches a trans-tracheal oxygen resuscitator (Jacobs; abstract) wherein the medical gas input control unit is a hand-operated medical gas input control unit (valves to control the flow of oxygenated gas and suction can be shifted manually) (Jacobs; Fig. 6; col. 4 lines 39-49; col. 5 lines 60-68; col. 6 lines 1-7).
Therefore, 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 Voss medical gas input control unit to be a hand-operated medical gas input control unit, as taught by Jacobs, for the purpose of enabling the system to be operated in accordance with the judgement of the operator as they observe the condition of the patient (Jacobs; col. 1 lines 61-68).
Voss does not disclose said endotracheal tube adaptor configured to form a gas tight seal with said endotracheal tube when coupled to said airway access device.
However, Ledwith teaches a connector assembly to couple a tracheal tube and a ventilator (Ledwith; abstract) wherein said endotracheal tube adaptor configured to form a gas tight seal with said endotracheal tube when coupled to said airway access device (o-rings 48, 50 to form an airtight seal between the connector assembly 18 and the endotracheal tube 10) (Ledwith; Figs. 1a-2; para. [0021]).
Therefore, 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 modified Voss airway access device adaptor such that said endotracheal tube adaptor configured to form a gas tight seal with said endotracheal tube when coupled to said airway access device, as taught by Ledwith, for the purpose of providing a an airtight seal to help ensure airflow to and from the patient does not leak (Ledwith; para. [0021]).
Voss does not disclose a pressure limiting device located downstream of said medical gas supply coupling between said medical gas supply coupling and said first end of said housing, wherein said pressure limiting device is configured to vent the medical gas out of said housing upon a pressure of medical gas in the flexible tube exceeding a preselected threshold pressure.
However, Brown teaches an adapter for use in an airway exchange procedure (Brown; abstract) including a pressure limiting device located downstream of said medical gas supply coupling between said medical gas supply coupling and said first end of said housing, wherein said pressure limiting device is configured to vent the medical gas out of said housing upon a pressure of medical gas in the flexible tube exceeding a preselected threshold pressure (relief valve 205 is downstream of the hollow main body 213 which provides the fluid; relief valve 205 can be adjusted to different levels via rotating a casing 206 to control the maximum pressure at which the valve 205 opens to release fluid, thereby limiting the pressure of the delivered fluid from exceeding that maximum) (Brown; Fig. 2; paras. [0026-0027]).
Therefore, 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 modified Voss system to include a pressure limiting device located downstream of said medical gas supply coupling between said medical gas supply coupling and said first end of said housing, wherein said pressure limiting device is configured to vent the medical gas out of said housing upon a pressure of medical gas in the flexible tube exceeding a preselected threshold pressure, as taught by Brown, for the purpose of helping to ensure the maximum pressure delivered is appropriate for the physical characteristics of the patient (Brown; para. [0027]).
Regarding claim 32, the modified Voss teaches wherein said hand operated medical gas input control unit further comprises a suction supply coupling coupled to said first end of said housing and being connectable to a source of suction (one end of the device 40 housing has a coupling to vacuum source 407) (Voss; Fig. 4; para. [0052]), said hand operated medical gas input control unit including a hand-operated control mechanism for controlling both suction and medical gas flow (Voss switching mechanisms/valves 409, 411, 415 to the O2 source 410, mechanical ventilator 402, and vacuum source 407, respectively, previously modified by Jacobs to be manually operated) (Voss, Fig. 4, para. [0052], para. [0054]; Jacobs, Fig. 6, col. 4 lines 39-49, col. 5 lines 60-68, col. 6 lines 1-7).
Regarding claim 33, the modified Voss teaches wherein said pressure limiting device is a pressure relief valve located adjacent to said second end of said housing with the medical gas supply coupling being located between said pressure relief valve and said suction supply coupling (Brown relief valve 205 for controlling the delivered fluid pressure would be adjacent to the end of the Voss device 40 housing to the ventilation tube 404 through which the total fluid pressure is delivered; the Voss device 40 coupling to the O2 source 410 would be between the Voss vacuum source 407 and the Brown relief valve 205 from top to bottom) (Voss, Fig. 4, para. [0052]; Brown, Fig. 2, paras. [0026-0027]).
Regarding claim 34, the modified Voss teaches wherein said medical gas supply coupling is coupled to said second opposed end, and wherein said pressure limiting device is a pressure relief valve located between said medical gas supply coupling and said suction supply coupling (the Voss O2 source 410 and/or the mechanical ventilator 402 are coupled to the Voss device 40, and so would be coupled to all of the ends of the Voss device 40; the Brown relief valve 205 would be located at the Voss ventilation tubing 404 through which the total fluid pressure is delivered, and so would be between the Voss the Brown relief valve 205 and the Voss vacuum source 407 from left to right) (Voss, Fig. 4, para. [0052]; Brown, Fig. 2, paras. [0026-0027]).
Regarding claim 35, the modified Voss teaches wherein said pressure limiting device is any one of a pressure relief valve or a pressure regulating valve (relief valve 205 is for controlling or regulating the delivered pressure) (Brown; Fig. 2; paras. [0026-0027]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 4,300,550 by Gandi et al. is considered to be relevant as it discloses a catheter for simultaneous tracheal oxygenation and aspiration.
US 2012/0199127 A1 by Garde et al. is considered to be relevant as it discloses a system for ventilation along with suctioning, wherein the pressurized flow is adjustable before, during, and/or after suctioning.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE M PINDERSKI whose telephone number is (571)272-7032. The examiner can normally be reached Monday-Friday 7:00-4:00.
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/JACQUELINE M PINDERSKI/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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