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 Objections
Claims 1, 11, 18, and 19 are objected to because of the following informalities:
Claim 1, line 13, it is recommended to change “operational operating position” to “operational position” or “operating position”
Claim 11, lines 4-5, “has flow-conveying line sections, of which respective associated sections of the virtual breathing gas flow path” should read “has flow-conveying line sections, of which respective associated section of the flow-conveying line section of the breathing gas flow path” or “has flow conveying line sections, where the flow-conveying line sections”
Claim 18, lines 2-3, “wherein one formation of coupling formation and coupling counter-formation” should read “wherein one of the coupling formation and the coupling counter-formation”
Claim 18, lines 3-4, “the respective other formation, of coupling formation and coupling counter-formation” should read “the other of one of the coupling formation and the coupling counter-formation”
Claim 19, lines 2-3, “wherein at least one formation out of coupling formation and coupling counter-formation” should read “wherein at least one of the coupling formation and the coupling counter-formation”
Claim 19, Line 5, “sealingly lies against the respective other formation” should read “sealingly lies against the respective at least one of coupling formation and the coupling counter-formation”.
Appropriate correction is required.
Claim Interpretation
In claim 22, “the proximal breathing gas outlet opening” and “the proximal breathing gas inlet opening” are being interpreted as the same opening as they are referred to as the same number in the original claim set and [0095] of the specification where “A proximal opening 62 of the endotracheal tube 60 is both a breathing gas outlet opening through which inspiratory breathing gas is conveyed through the endotracheal tube 60 into the patient and also a breathing gas inlet opening through which expiratory breathing gas is conveyed from the patient back into the endotracheal tube 60”.
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.
Claim 1-24 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.
The term “imaginary virtual breathing gas flow path” in claim 1 is referred to as an “imaginary virtual breathing gas flow path”, “the breathing gas flow path”, and “the virtual breathing gas flow path” throughout the claims. Imaginary makes it unclear whether this part exists or not which renders the claim indefinite. It is recommended to change “imaginary virtual breathing gas flow path” and any other recitations to “a breathing gas flow path” or “the breathing gas flow path”
Claim 1 also recites the term “can be” in lines 12-13 where “the breathing gas filter can be introduced into the filter receiving space”. It is unclear whether this limitation is optional or not since the terminology “can be” implies that it optional; therefore, making the claim indefinite.
Claims 2-24 are also rejected due to being dependent on claim 1.
Claim 4 recites the limitation "the removal opening" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim depends on claim 2; however, removal opening is introduced in claim 3. It is recommended to change claim 4 to depend on claim 3 and claim 3 to depend on claim 2.
Claim 5 is also rejected due to being dependent on claim 4.
Claim 15 recites the term “can be” in line 11-12, “wherein at least one wall section of the sleeve can be shifted relative to the coupling formation”. It is unclear whether this limitation is optional or not since the terminology “can be” implies that it optional; therefore, making the claim indefinite.
Claims 16-20 are also rejected due to being dependent on claim 15.
The term “quantitative acquisition” in claim 22 is a relative term which renders the claim indefinite. The term “quantitative acquisition” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For purposes of examination, “quantitative acquisition” is being interpreted as a pressure or flow measurement.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 23-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Revell (US 4124361).
Regarding claim 23, Revell discloses
A breathing gas filter arrangement (Fig. 1; filter arrangement; Col. 1, Lines 63-65) including a breathing gas filter (Figs. 1-3e; filter cells 12; Col. 2, Lines 36-41) accommodated in a sleeve (Figs. 3a-3e; bag 34; Col. 2, Lines 63-66),
wherein the sleeve (Figs. 3a-3e; bag 34; Col. 2, Lines 63-66) has a coupling formation for coupling to a coupling counter-formation of a filter carrier (Figs. 3a-3e; “a polyethylene bag 34 having an open end 36 is placed over the stub 32 (coupling formation) and around the flange 28 (coupling counter-formation)”; Col. 2, Lines 64-66) or of a filter heater as well as an access opening (Figs. 3a-3e; the opening of polyethylene bag 34 at open end 36; Col. 2, Lines 56-67 and Col. 3, Lines 1-5) for the delivery of the breathing gas filter from the sleeve (Figs 3b-3c; “On the opposed side, polyethylene stub 32 is hand manipulated into the bag 34 and the clean filter cell is pushed through the access opening 26”; Col. 2, Lines 56-67 and Col. 3, Lines 1-5),
wherein at least one wall section of the sleeve is shiftable relative to the coupling formation in such a manner that the breathing gas filter, as a result of displacement of the displaceable wall section relative to the coupling formation, is shifted through the access opening out of the sleeve (Figs. 3a-3e; it would have been readily understood by one of ordinary skill in the art that bag 34 would need to be compressed or pushed down towards open end 36 (coupling formation) to push the clean filter cell 12 through the access opening 26; Col. 2, Lines 56-67 and Col. 3, Lines 1-5).
Regarding claim 24, Revell discloses
the breathing gas filter arrangement (Fig. 1; filter arrangement; Col. 1, Lines 63-65) according to claim 23,
wherein the access opening (Figs. 3a-3e; the opening of polyethylene bag 34 at open end 36; Col. 2, Lines 56-67 and Col. 3, Lines 1-5), in the storage state before coupling to the filter carrier or to the filter heater (this is merely this is intended use and therefore not given any patentable weight; nevertheless, the opening of bag 34 is capable of being closed prior to being coupled to the filter carrier as the “bag can be heat sealed and then cut by any known means” Col. 3, Lines 7-8), is closed by means of a removable or destructible closure (Fig. 3d; bag 34 is heat sealed; Col. 3, Lines 6-13).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Wisniewski (US 20170021122) in view of Revell (US 4124361).
Regarding claim 1, Wisniewski discloses
A respiratory line (Fig. 1; breathing circuit; [0017], Lines 1-6 and [0018], Lines 1-12) for conveying inspiratory or/and expiratory breathing gas during at least partial artificial respiration of a patient (Fig. 1; “a gas supply line 14 supplying fresh or oxygenated air for inhalation by the patient and a return line 16 transporting air exhaled by the patient 12 to a re-breathing bag 18”; [0018], Lines 1-12),
wherein the respiratory line (Fig. 1; breathing circuit; [0017], Lines 1-6 and [0018], Lines 1-12) defines an imaginary virtual breathing gas flow path which is conceived as extending centrally through it, along which flow path the respiratory line conveys the breathing gas (Fig. 1; gas flows from gas supply to circuit tubing potion 20 through device 10 (with filter) to airway securing device 22 to patient 12; [0018], Lines 1-12),
wherein the respiratory line (Fig. 1; breathing circuit; [0017], Lines 1-6 and [0018], Lines 1-12) has a filter carrier (Figs. 1-5; “the device 10 serves at least to filter air”; [0017], Lines 10-17) in which a filter receiving space (Figs. 4 and 5; space between chamber portion 44 and 48 in chamber 50) which is passed through by the breathing gas flow path is formed (Figs. 1-5; gas flows from gas supply through device 10 through first port 42 and out second port 46 (inhalation); [0025], Lines 1-10), in which a breathing gas filter through which the breathing gas can flow (Figs. 3-5; filter 52; [0029], Lines 1-7; filters air/breathing gas),
wherein the filter carrier (Figs. 1-5; device 10; [0017], Lines 10-17) has a wall surrounding the filter receiving space (Figs. 4 and 5; chamber portion 44 and 48 that surrounds space that contains filter; [0025], Lines 1-10 and [0027]) with radial spacing from the virtual breathing gas flow path (Figs. 4 and 5; walls of chamber portion 44 and 48 is radially spaced from flow of gas passing through chamber 50)
Wisniewski does not disclose an introduction opening arranged with radial spacing from the virtual breathing gas flow path, through which the breathing gas filter can be introduced into the filter receiving space and be brought into its operational operating position.
Revell discloses a filter cell support housing
a breathing gas filter (Figs. 1-3e; filter cells 12; Col. 2, Lines 36-41) is replaceably accommodated (Figs. 2 and 3a-3e; filter cells 12 of the present invention are removed and replaced; Col. 2, Lines 56-58)
an introduction opening (Figs. 1-3e; opening 26; Col. 2, Lines 48-55) arranged with radial spacing (Figs. 1-2; opening 26 is radially spaced from plurality of passages 4) from the virtual breathing gas flow path (Figs. 1-2; plurality of passages 4; Col. 2, Lines 15-27), through which the breathing gas filter (Figs. 1-3e; filter cells 12; Col. 2, Lines 36-41) can be introduced into the filter receiving space and be brought into its operational operating position (Figs. 3a-3e; Col. 2, Lines 56-67 and Col. 3, Lines 1-5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device 10 of Wisniewski with the filter cell support housing and filter method of Revell to have an opening that allows the filter to be removed and replaced without subjecting the operator to contamination (Revell: Col. 2, Lines 56-58).
Regarding claim 2, the modified device of Wisniewski further discloses
the respiratory line (Wisniewski: breathing circuit; Revell: removable filter) according to claim 1,
wherein the filter carrier (Wisniewski: Figs. 1-5; device 10; [0017], Lines 10-17; Revell: Figs. 1-3e; flow through housing 2; Col. 2, Lines 15-24) has a guiding structure which guides an introduction movement (Revell; Figs. 1-6; inside surface/walls of housing 2 such as flanges 28, 29 along with slide rail 44; “bottom wall 40 of filter cell 12 is slidably received by slide rail 44”; Col. 3, Lines 26-30) of the breathing gas filter (Revell: Figs. 1-3e; filter cells 12; Col. 2, Lines 36-41) from the introduction opening (Revell: Figs. 1-3e; opening 26; Col. 2, Lines 48-55) into the filter receiving space (Revell: Figs. 3a-3e; space inside flow-through housing 2 where filter cell 12 sits), in particular into the operating position (Revell: Figs. 3a-3e).
Regarding claim 3, the modified device of Wisniewski further discloses
the respiratory line (Wisniewski: breathing circuit; Revell: removable filter) according to claim 1,
wherein the wall of the filter carrier (Wisniewski: Figs. 4 and 5; chamber portion 44 and 48; [0025], Lines 1-10 and [0027]) has a removal opening (Revell: Figs. 3c-3d; opening opposite to opening 26 where old filter is removed from; “clean filter cell is pushed through the access opening 26 and on the opposite side the dirty filter cell 12 (is pushed out)”; Col. 3, Lines 3-5) different from the introduction opening (Revell: Figs. 1-3e; opening 26; Col. 2, Lines 48-55) and arranged with radial spacing (Revell: Figs. 1-2; opening opposite to opening 26 is radially spaced from plurality of passages 4) from the virtual breathing gas flow path (Revell: Figs. 1-2; plurality of passages 4; Col. 2, Lines 15-27), through which removal opening a breathing gas filter arranged in the filter receiving space is removable from the filter receiving space (Revell: Figs. 3a-3e; “clean filter cell is pushed through the access opening 26 and on the opposite side the dirty filter cell 12 (is pushed out)”; Col. 2, Lines 56-67 and Col. 3, Lines 1-16).
Regarding claim 4, the modified device of Wisniewski further discloses
the respiratory line (Wisniewski: breathing circuit; Revell: removable filter) according to claim 2,
wherein the guiding structure (Revell; Figs. 1-6; inside surface/walls of housing 2 such as flanges 28, 29 along with slide rail 44; “bottom wall 40 of filter cell 12 is slidably received by slide rail 44”; Col. 3, Lines 26-30) is arranged between the introduction opening (Revell: Figs. 1-6; opening 26; Col. 2, Lines 48-55) and the removal opening (Revell: Figs. 3c-3d; opening opposite to opening 26; Col. 3, Lines 3-5), so that it also guides a removal movement (Figs. 3c-3d; removal of dirt filter cell 12; Col. 2, Lines 56-58 and Col. 3, Lines 3-5) of a breathing gas filter (Revell: Figs. 1-3e; filter cells 12; Col. 2, Lines 36-41) from the filter receiving space (Revell: Figs. 3a-3e; space inside flow-through housing 2 where filter cell 12 sits).
Regarding claim 5, the modified device of Wisniewski further discloses
the respiratory line (Wisniewski: breathing circuit; Revell: removable filter) according to claim 4,
wherein the breathing gas filter (Revell: Figs. 1-3e; filter cells 12; Col. 2, Lines 36-41) is movable along a bend-free, in particular straight, guide path defined by the guiding structure (Revell; Figs. 1-6; inside surface/walls of housing 2 such as flanges 28, 29 along with slide rail 44 move filter cell 12 in a straight guided path through the housing; “bottom wall 40 of filter cell 12 is slidably received by slide rail 44”; Col. 3, Lines 26-30) through the introduction opening (Revell: Figs. 1-6; opening 26; Col. 2, Lines 48-55) , toward the virtual breathing gas flow path (Revell: Figs. 1-2 and 3a-3e; plurality of passages 4; Col. 2, Lines 15-27), into the filter receiving space (Revell: Figs. 3a-3e; space inside flow-through housing 2 where filter cell 12 sits) and into the operating position as well as out of the operating position (Figs. 3a-3e), away from the virtual breathing gas flow path (Revell: Figs. 1-2 and 3a-3e; plurality of passages 4; Col. 2, Lines 15-27), out of the filter receiving space (Figs. 3a-3e; dirty filter cell 12 is removed from housing 2 see Figs. 3c-3d) through the removal opening (Revell: Figs. 3a-3e; “clean filter cell is pushed through the access opening 26 and on the opposite side the dirty filter cell 12 (is pushed out)”; Col. 2, Lines 56-67 and Col. 3, Lines 1-16).
Regarding claim 6, the modified device of Wisniewski discloses
the respiratory line (Wisniewski: breathing circuit; Revell: removable filter) according to claim 1,
The modified device of Wisniewski does not disclose wherein the filter carrier, in particular the guiding structure, has an inhibiting formation which allows a movement of the breathing gas filter through the introduction opening into the filter receiving space and which inhibits an oppositely directed movement of the breathing gas filter through the introduction opening.
However, Revell further discloses
wherein the filter carrier (Revell: Figs. 1-3e; flow through housing 2; Col. 2, Lines 15-24), in particular the guiding structure (Revell; Figs. 1-6; inside surface/walls of housing 2 such as flanges 28, 29 along with slide rail 44; “bottom wall 40 of filter cell 12 is slidably received by slide rail 44”; Col. 3, Lines 26-30), has an inhibiting formation (Revell: Figs 4-6; sliding rail 44 and finger 52; Col. 3, Lines 17-31) which allows a movement of the breathing gas filter (Revell: Figs. 1-3e; filter cells 12; Col. 2, Lines 36-41) through the introduction opening (Figs. 1-3e; opening 26; Col. 2, Lines 48-55) into the filter receiving space (Revell: Figs. 3a-3e; space inside flow-through housing 2 where filter cell 12 sits) and which inhibits an oppositely directed movement (“In FIG. 4 a sealing and retaining device is shown in sealing and retaining engagement with a filter cell 12”; Col. 3, Lines 17-18) of the breathing gas filter (Revell: Figs. 1-3e; filter cells 12; Col. 2, Lines 36-41) through the introduction opening (Figs. 1-3e; opening 26; Col. 2, Lines 48-55).
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 device 10 with the sealing and retaining engagement device of Revell to provide an effective seal along the overall peripheral sealing edge between a filter cell frame and a flow-through opening in a filter cell housing (Revell: Col. 1, Lines 29-34).
Regarding claim 7, the modified device of Wisniewski further discloses
the respiratory line (Wisniewski: breathing circuit; Revell: removable filter, sealing and retaining engagement device) according to claim 6,
wherein the breathing gas filter (Revell: Figs. 1-6; bottom wall 40 of filter cells 12; Col. 2, Lines 36-41 and Col. 3, Lines 17-31) has an inhibiting counter- formation (Revell: Figs. 4-6; U-shaped mounting section 41; Col. 3, Lines 17-31) which cooperates with the inhibiting formation of the filter carrier (Revell: Figs 4-6; sliding rail 44 and finger 52; Col. 3, Lines 17-31) for achieving the unidirectional movability (Figs. 3a-3e) of the breathing gas filter (Revell: Figs. 1-3e; filter cells 12; Col. 2, Lines 36-41).
Regarding claim 8, the modified device of Wisniewski further discloses
the respiratory line (Wisniewski: breathing circuit; Revell: removable filter, sealing and retaining engagement device) according to claim 6,
wherein the inhibiting formation (Revell: Figs 4-6; sliding rail 44 and finger 52; Col. 3, Lines 17-31) and the inhibiting counter-formation (Revell: Figs. 4-6; U-shaped mounting section 41; Col. 3, Lines 17-31) form a plurality of unidirectionally (Figs. 3a-3e) surmountable catches located one after the other along the allowed movement direction (Figs. 3a-6; “a plurality of sealing devices may be utilized for each horizontal bank of filter cells 12 to give better sealing of the filter cells to the frame”; Col. 4, Lines 12-14).
Regarding claim 11, Wisniewski further discloses
the respiratory line (Wisniewski: breathing circuit) according to claim 1,
wherein the filter carrier (Figs. 1-5; device 10; [0017], Lines 10-17), on both sides of the filter receiving space (Figs. 4 and 5; chamber portion 44 and 48 that surrounds space that contains filter; [0025], Lines 1-10 and [0027]), has flow-conveying line sections (Figs. 1-5; ports 42, 46; Abstract, Lines 1-5; [0025] and [0026]), of which respective associated sections of the virtual breathing gas flow path (Figs. 1-5; gas flows from gas supply through tubing portion 20 to device 10 through first port 42 and out second port 46 (inhalation) to airway securing device 22; [0025], Lines 1-10) enclose an angle with one another (Figs. 1-5; ports 42 and 46 are angled to each other, see Figs. 4 and 5).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Wisniewski (US 20170021122) in view of Revell (US 4124361) and further in view of Feldhahn (EP 1277488) and its translation (EspaceNet Translation).
Regarding claim 10, the modified device of Wisniewski discloses
the respiratory line (Wisniewski: breathing circuit; Revell: removable filter) according to claim 1,
wherein the wall is part of a housing of the filter carrier, which surrounds the filter receiving space (Wisniewski: Figs. 4 and 5; walls of chamber portion 44 and 48 is part of chamber 50 (housing of filter carrier) that surrounds space that contains filter; [0025], Lines 1-10 and [0027]) in the operational state (Revell: 3a-3e), wherein the housing, as dividable housing, has at least two housing portions (Wisniewski: Figs. 4 and 5; chamber portion 44 and 48 are two housing portions that create chamber 50; [0025], Lines 1-10 and [0027]) which is movable apart and closer together.
Wisniewski does not disclose the at least two housing portions which is movable apart and closer together.
Feldhahn discloses a ventilation device with a filter housing 13 with
at least two housing portions (Fig. 2; “the filter housing (13) is formed from a lower housing part (16) and an upper housing part (17)”; [0029], Lines 1-3) which is movable apart and closer together (filter is held between lower housing 16 and upper housing 17 which has a taper 46 that mates with the web of the upper housing 18 [0034], Lines 2-6 and [0045], Lines 1-5; the filter is replaceable [0020], Lines 1-2; therefore, the two housing may be mated and unmated, moving apart and mated back together).
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 chamber portions of Wisniewski with the taper and web portions of Feldhahn to have two housings that can fasten and separate to hold the filter element is preferably held in such a way that the filter element can be exchanged (Feldhahn: [0034], Lines 1-6).
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Wisniewski (US 20170021122) in view of Revell (US 4124361) and further in view of Stenzler (US 20130152929).
Regarding claim 12, the modified device of Wisniewski discloses
the respiratory line (Wisniewski: breathing circuit; Revell: removable filter) according to claim 1,
The modified device of Wisniewski does not disclose wherein the respiratory line has a filter heater which surrounds the filter carrier in the operational state at least in sections.
Stenzler discloses a filter assembly
wherein the respiratory line (Fig. 1; ventilation circuit 60; [0028], Lines 1-11) has a filter heater (Figs. 1-7; filter heating chamber 30; [0028], Lines 1-11) which surrounds the filter carrier (Figs. 1-3; filter 20; [0028], Lines 1-11) in the operational state at least in sections (Figs. 1-3; locking mechanisms/elements “to secure the filter to the heating chamber, or otherwise hold it in place when it its operative position” [0032], Lines 13-16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device 10 of the modified device of Wisniewski with the filter heating chamber of Stenzler to transfer heat to the filter and reliably regulating and controlling the heat to provide a safe and more efficient heated pathogen filter (Stenzler: [0041], Lines 1-7).
Regarding claim 13, the modified device of Wisniewski further discloses
the respiratory line (Wisniewski: breathing circuit; Revell: removable filter; Stenzler: heating chamber) according to claim 12,
wherein the filter heater (Stenzler: Figs. 1-7; filter heating chamber 30; [0028], Lines 1-11) has a filter carrier accommodation formed as a component separate (Stenzler: Figs. 4-5; “outlet 22 of filter 20 extends through distal opening 32 of heating chamber 30”; [0036], Lines 1-8) from the filter carrier (Wisniewski: Figs. 1-5; device 10; [0017], Lines 10-17), into which filter carrier accommodation (Stenzler: Figs. 4-5; opening 32; 0036], Lines 1-8) the filter carrier is insertable (Wisniewski: Figs. 1-5; device 10; [0017], Lines 10-17; Stenzler: Figs. 4-5; “filter 20 is inserted through opening 37 heating chamber 30 with outlet 22 of filter 20 extending through distal opening 32 of heating chamber 30”; [0036], Lines 1-8) and from which an inserted filter carrier is removable (Wisniewski: Figs. 1-5; device 10; [0017], Lines 10-17; Stenzler: “heater is automatically shut off when a user of the present invention disengages the filter from the assembly“; [0042], Lines 9-11).
Regarding claim 14, the modified device of Wisniewski discloses
the respiratory line (Wisniewski: breathing circuit; Revell: removable filter; Stenzler: heating chamber) according to claim 12,
Stenzler does not disclose wherein the filter heater has a wall with a passage opening, wherein the passage opening, in the operational state, is aligned with the introduction opening in such a manner that a breathing gas filter is introduceable through the passage opening into the introduction opening and thus into the filter carrier.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to also modify the heating chamber of the modified device of Wisniewski with an opening and the filter replacing method as taught in the filter housing of Revell to allow the filter cell to be removed and replaced without subjecting the operator to contamination (Revell: Col. 2, Lines 56-58).
It directly follows that the resultant heating chamber of the modified device of Wisniewski combined with an opening as taught in Revell would meet the claimed structural limitations since:
wherein the filter heater (Stenzler: Figs. 1-7; filter heating chamber 30; [0028], Lines 1-11) has a wall with a passage opening (Stenzler: Figs. 1-7; outer wall/surface of heating chamber 30; Revell: Figs. 1-6; opening 26; Col. 2, Lines 48-55) , wherein the passage opening, in the operational state, is aligned with the introduction opening (Revell: Figs. 1-6; opening 26; Col. 2, Lines 48-55) in such a manner that a breathing gas filter (Wisniewski: Figs. 3-5; filter 52; [0029], Lines 1-7) is introduceable (Revell: 3a-3e) through the passage opening (Stenzler: Figs. 1-7; outer wall/surface of heating chamber 30; Revell: Figs. 1-6; opening 26; Col. 2, Lines 48-55) into the introduction opening (Revell: Figs. 3a-3e; opening 26; Col. 2, Lines 48-55 and thus into the filter carrier (Wisniewski: Figs. 1-5; device 10; [0017], Lines 10-17).
Claims 15 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Wisniewski (US 20170021122) in view of Revell (US 4124361) and further in view of Kim (US 20080223370).
Regarding claim 15, the modified device of Wisniewski discloses
the respiratory line (Wisniewski: breathing circuit; Revell: removable filter) according to claim 1,
wherein the breathing gas filter (Revell: Figs. 1-3e; filter cells 12; Col. 2, Lines 36-41) is introduced along an introduction movement path (Figs. 3a-3e) into the filter receiving space (Revell: Figs. 3a-3e; space inside flow-through housing 2 where filter cell 12 sits), wherein the breathing gas filter (Revell: Figs. 1-3e; filter cells 12; Col. 2, Lines 36-41), in a starting state before its introduction into the filter receiving space (Fig. 3b) , is accommodated in a sleeve (Revell: Figs. 3a-3e; bags 34, 35; Col. 2, Lines 63-66), wherein the sleeve has a coupling formation (Revell: Figs. 3a-3e; open end 36 of bag 34 and stub 32; Col. 2, Lines 64-66) which is coupled to a coupling counter-formation of the filter carrier (Revell: Figs. 3a-3e; flange 28; Col. 2, Lines 64-66) or of the filter heater in such a manner that, in a transfer state in which an access opening of the sleeve (Revell: Figs. 3a-3e; opening at open end 36 of bag 34; Col. 2, Lines 64-66), which is designed for the delivery of the breathing gas filter out of the sleeve, is aligned with the introduction opening along the introduction movement path (Revell: Figs. 3b-3c; clean filter cell is pushed through the access opening 26”; Col. 2, Lines 56-67 and Col. 3, Lines 1-5), wherein at least one wall section of the sleeve can be shifted relative to the coupling formation in such a manner that the breathing gas filter, as a result of displacement of the displaceable wall section relative to the coupling formation, is shifted through the access opening out of the sleeve (Revell: Figs. 3a-3e; it would have been readily understood by one of ordinary skill in the art that bag 34 would need to be compressed or pushed down towards open end 36 (coupling formation) to push the clean filter cell 12 through the access opening 26; Col. 2, Lines 56-67 and Col. 3, Lines 1-5).
The modified device of Wisniewski discloses the bag 34 being placed around flange 28; however, it is silent as to whether the sleeve is held on the coupling counter-formation.
Kim discloses a dustproof mask with a filter case formed with multiple assembling projection and grooves (Fig. 10; [0037], Lines 1-5 and [0038], Lines 1-11).
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 bag and flange of the modified device of Wisniewski with the protrusions and grooves respectively of Kim to allow for easy assembly and separation by inserting the protrusion into the matching groove (Kim: [0038], Lines 1-11) and form a stronger connection.
It directly follows that the resultant bag and flange of the modified device of Wisniewski combined with the projections 61 and grooves 51 of Kim would meet the claimed structural limitations since:
The modified device of Wisniewski and Kim combined disclose
the sleeve (Revell: Figs. 3a-3e; bags 34, 35; Col. 2, Lines 63-66) is held on the coupling counter-formation (Revell: Figs. 3a-3e; flange 28; Col. 2, Lines 64-66; Kim: projections 61 (of bag) is inserted into grooves 51 (of flange); Fig. 10; [0037], Lines 1-5 and [0038], Lines 1-11).
Regarding claim 17, the modified device of Wisniewski further discloses
the respiratory line (Wisniewski: breathing circuit; Revell: removable filter; Kim: protrusions and grooves) according to claim 15,
wherein the coupling formation (Revell: Figs. 3a-3e; open end 36 of bag 34 and stub 32; Col. 2, Lines 64-66; Kim: Fig. 10; projections 61; [0037], Lines 1-5 and [0038], Lines 1-11) and the coupling counter-formation (Revell: Figs. 3a-3e; flange 28; Col. 2, Lines 64-66; Kim: Fig. 10; grooves 51; [0037], Lines 1-5 and [0038], Lines 1-11) enable a displacement of the sleeve relative to the filter carrier (protrusions and grooves hold bag 34 around flange 28 as bag 34 is compressed or pushed down towards open end 36 to push filter cell into access opening 26) along a coupling path (see Figs 3b below) which runs transversely to the introduction movement path (see Figs 3b below) of the breathing gas filter into the filter carrier (Revell: Fig. 3c; clean filter cell 12 is inserted into space inside flow-through housing 2 where dirty filter cell 12 sits).
PNG
media_image1.png
474
688
media_image1.png
Greyscale
Regarding claim 18, the modified device of Wisniewski further discloses
the respiratory line (Wisniewski: breathing circuit; Revell: removable filter; Kim: protrusions and grooves) according to claim 17,
wherein one formation of coupling formation and coupling counter-formation (Revell: Figs. 3a-3e; open end 36 of bag 34 and stub 32; Col. 2, Lines 64-66), includes at least one protrusion (Kim: Fig. 10; projections 61; [0037], Lines 1-5 and [0038], Lines 1-11), and in that the respective other formation, of coupling formation and coupling counter-formation (Revell: Figs. 3a-3e; flange 28; Col. 2, Lines 64-66), has at least one groove (Kim: Fig. 10; grooves 51; [0037], Lines 1-5 and [0038], Lines 1-11), wherein the at least one protrusion engages, at least in the transfer state, in the at least one groove (Kim: Fig. 10; “matching projections (61) with and inserting them into said assembling grooves(51)”; [0038], Lines 1-11).
Regarding claim 19, the modified device of Wisniewski further discloses
the respiratory line (Wisniewski: breathing circuit; Revell: removable filter; Kim: protrusions and grooves) according to of claim 15,
wherein at least one formation out of coupling formation and coupling counter-formation (Revell: Figs. 3a-3e; open end 36 of bag 34 and stub 32; Col. 2, Lines 64-66) has a sealing structure (Revell: stub 32; Col. 2, Lines 51-55 and Lines 60-63) which, at least in the transfer state, sealingly lies against (Revell: Figs. 3a-3e; “flange member 28 being disposed to receive the stub 32 of a plastic bag” (bag 34) “with polyethylene stubs 32 and 33 mounted in sealing relation around the flanges 28 and 29, respectively”; Col. 2, Lines 51-55 and Lines 60-66) the respective other formation (Revell: Figs. 3a-3e; flange 28; Col. 2, Lines 64-66).
Regarding claim 20, the modified device of Wisniewski further discloses
the respiratory line (Wisniewski: breathing circuit; Revell: removable filter; Kim: protrusions and grooves) according to claim 15,
wherein the breathing gas filter is removable along a removal movement path from the filter receiving space (Revell: Figs. 3c-3d; dirty filter cell 12 is removed through opening opposite to opening 26 where old filter is removed from see Figs. 3c-3d; “clean filter cell is pushed through the access opening 26 and on the opposite side the dirty filter cell 12 is pushed out”; Col. 3, Lines 3-5), wherein the filter carrier (Wisniewski: Figs. 4 and 5; chamber portion 44 and 48; [0025], Lines 1-10 and [0027]; Revell: Figs. 3a-3e; flow though housing 2) or the filter heater has an additional coupling counter-formation (Revell: Figs. 3a-3e; flange 29; Col. 2, Lines 66-68 and Col. 3, Line 1; Kim: Fig. 10; grooves 51; [0037], Lines 1-5 and [0038], Lines 1-11), wherein a sleeve is coupled (Revell: Figs. 3a-3e; open end 36 of bag 35 and stub 33; Col. 2, Lines 64-66 Col. 2, Lines 66-68 and Col. 3, Line 1; Kim: Fig. 10; projections 61; [0037], Lines 1-5 and [0038], Lines 1-11) to the additional coupling counter-formation (Revell: Figs. 3a-3e; flange 29; Col. 2, Lines 66-68 and Col. 3, Line 1; Kim: Fig. 10; grooves 51; [0037], Lines 1-5 and [0038], Lines 1-11) in such a manner that, in a delivery state, in which the access opening of the sleeve (Revell: see modified Figs. 3c-3d below; opening of bag 34 at open end; Col. 3, Lines 3-5) is aligned with the removal opening (Revell: see modified Figs. 3c-3d below; opening opposite to opening 26; Col. 3, Lines 3-5) along the removal movement path (see modified Figs. 3c-3d below), the sleeve (Revell: Figs. 3a-3e; bags 34, 35; Col. 2, Lines 63-66) is held on the additional coupling counter-formation (Revell: Figs. 3a-3e; flange 29; Col. 2, Lines 66-68 and Col. 3, Line 1; Kim: Fig. 10; Kim: projections 61 (of bag) is inserted into grooves 51 (of flange); Fig. 10; [0037], Lines 1-5 and [0038], Lines 1-11).
PNG
media_image2.png
522
868
media_image2.png
Greyscale
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Wisniewski (US 20170021122) in view of Revell (US 4124361) and further in view of Kim (US 20080223370) and Excelsior NPL (Website Article: Why is Low Density Polyethylene so useful in plastic manufacturing?).
Regarding claim 16, the modified device of Wisniewski discloses
the respiratory line (Wisniewski: breathing circuit; Revell: removable filter) according to claim 15,
wherein the sleeve (Revell: Figs. 3a-3e; polyethylene bags 34, 35; Col. 2, Lines 63-66;) is designed to be flexible, in such a manner that the displacement which shifts the breathing gas filter through the access opening out of the sleeve is a deformation of the displaceable wall section (Revell: Figs. 3a-3e; it would have been readily understood by one of ordinary skill in the art that bag 34 would need to be compressed or pushed down towards open end 36 (coupling formation) to push the clean filter cell 12 through the access opening 26; Col. 2, Lines 56-67 and Col. 3, Lines 1-5).
While the modified device of Wisniewski does not explicitly disclose the sleeve is designed to be flexible.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the polyethylene bags that are heat-sealed and cut (Revell: Col. 3, Lines 7-8) would have been made of a low-density polyethylene (LDPE) which are known in the art to be “flexible with low tensile strength making it fantastically useful for applications like plastic bags, bin bags, and other plastic films” (Excelsior: Page 1, Paragraph 1 under flexible, with a low tensile strength).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Wisniewski (US 20170021122) in view of Revell (US 4124361) and further in view of Billingsley (US 20150283493).
Regarding claim 21, the modified device of Wisniewski further discloses
the respiratory line (Wisniewski: breathing circuit; Revell: removable filter) according to claim 1,
wherein, with a spacing (Revell: Figs. 1 and 4-6; sealing means is in fluid tight relation to peripheral edge 14 or passages 4, space where gasket 42 sits; Col. 2, Lines 27-32 and Col. 3, Lines 34-38) from the breathing gas flow path (Revell: Figs. 1-2; plurality of passages 4; Col. 2, Lines 15-27), a sealing formation (Revell: Figs. 4-6; gasket 42; Col. 3, Lines 34-38), is provided, which, in the operating position of the breathing gas filter (Figs. 3a-3e; filter cell 12; ), sealingly lies against the frame of the breathing gas filter (Figs. 4-6; “forcing section 41 into sealing relation with back wall 9 with a gasket 42 disposed therebetween”; gasket 42 is adhesively secured to mounting section 41 of bottom wall 40 of filter cell 12; Col. 2, Lines 26-41).
The modified device of Wisniewski does not disclose wherein the breathing gas filter has a gas impermeable frame surrounding a filter material.
Billingsley discloses a protective and replaceable filtration device where
wherein the breathing gas filter (Fig. 3; filter device 300; Col. 5, Lines 19-27) has a gas impermeable frame (Fig. 3; fluid-impermeable housing 302; Col. 5, Lines 19-27) surrounding a filter material (Fig. 3; “Filter system 310 in the form of a packed mixed bed of filter media particles is disposed in the interior 312 of housing 302”; Col. 5, Lines 19-27).
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 filter of the modified device of Wisniewski with the fluid-impermeable housing of Billingsley to have a housing or frame that is impermeable therefore preventing premature contamination (Billingsley: Col. 3, Lines 55-60).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Wisniewski (US 20170021122) in view of Revell (US 4124361) and further in view of Van (US 20190255276) and Hunter (US 20170189727).
Regarding claim 22, the modified device of Wisniewski
A respiratory device (Wisniewski: Fig. 1; breathing system; [0017], Lines 1-6) for at least partial artificial respiration of a living patient (Wisniewski: Fig. 1; “breathing system or breathing circuit for ventilating a patient 12 with a gas (e.g. air or oxygenated air)”; [0017], Lines 1-6), including:
- a breathing gas source (Wisniewski: Fig. 1; a gas supply line 14; [0018], Lines 2-4),
- a respiratory line arrangement (Wisniewski: Fig. 1; breathing system with breathing circuit; “a gas supply line 14 supplying fresh or oxygenated air for inhalation by the patient and a return line 16 transporting air exhaled by the patient 12 to a re-breathing bag 18”; [0017], Lines 1-6 and [0018], Lines 1-12), in order to convey inspiratory breathing gas from the breathing gas source (Wisniewski: Figs. 1 and 4; “a gas supply line 14 supplying fresh or oxygenated air from a suitable ventilation apparatus, for inhalation by the patient”, inhaled gas flowing in direction D as shown in Fig. 4; [0018], Lines 2-5 and [0038], Lines 1-3) to a patient-side proximal breathing gas outlet opening (Wisniewski: Fig. 1; opening of airway securing device 22 that is connected to port 42; [0025], Lines 13-17) and in order to convey expiratory breathing gas away (Wisniewski: Figs. 1 and 4; “a return line 16 transporting air exhaled by the patient 12 to a re-breathing bag 18”, exhaled gas flowing in direction C as shown in Fig. 4; [0018], Lines 5-11 and [0038], Lines 1-3) from a proximal breathing gas inlet opening (Wisniewski: Fig. 1; opening of airway securing device 22 that is connected to port 42; [0025], Lines 13-17); wherein the respiratory line arrangement has a respiratory line (Wisniewski: Fig. 1; breathing circuit; “a gas supply line 14 supplying fresh or oxygenated air for inhalation by the patient and a return line 16 transporting air exhaled by the patient 12 to a re-breathing bag 18”; [0017], Lines 1-6 and [0018], Lines 1-12) according to claim 1 (see claim 1: Wisniewski: breathing circuit; Revell: removable filter).
The modified device of Wisniewski does not disclose a flow sensor arrangement for quantitative acquisition of the inspiratory or/and of the expiratory breathing gas in the respiratory line arrangement a pressure change device for changing the pressure of the breathing gas in the respiratory line arrangement as well as a control device for operating the breathing gas source or/and the pressure change device.
Van discloses a flow therapy apparatus that has a filter module with
- a flow sensor arrangement for quantitative acquisition of the inspiratory or/and of the expiratory breathing gas in the respiratory line arrangement (Fig. 1; “Operation sensors 3a, 3b, 3c, 20, and 25, such as flow, temperature, humidity, and/or pressure sensors, can be placed in various locations in the flow therapy apparatus 10 and/or the patient breathing conduit 16” [0333], Lines 1-4; a flow and pressure sensor in the breathing conduit would be able to measure pressure/flow of gas in the conduit), a control device (Fig. 1; controller 13 for controlling the flow generator 11; [0333], Lines 5-15).
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 breathing circuit and breathing system of Wisniewski with the operational sensors and controller of Van to operate the flow therapy apparatus in a manner that provides optimal therapy using output from the sensors received by the controller (Van: [0332] and [0333])
Van does not disclose a pressure change device for changing the pressure of the breathing gas in the respiratory line arrangement as well as the control device for operating the breathing gas source or/and the pressure change device
Hunter discloses an air filtration system with
- a pressure change device (Fig. 4; one or more fans 224; [0068]) for changing the pressure of the breathing gas (“ the one or more fans 224 operate at high hydrostatic pressures (e.g., 3-5 inches of water) and generate high flow rates up to 300 SLM”; [0068], Lines 8-10) in the respiratory line arrangement (fans 224 are disposed along the air path; [0068], Line 3) as well as
- a control device (Fig. 4; controller 240; [0333], Lines 5-15) for operating the breathing gas source or/and the pressure change device (Fig. 4; “the controller 240 receives an input from the user device 112 and/or controls on the respirator 102 and in response, activates the one or more fans 224 for providing airflow”; [0085], Lines 4-7).
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 controller and breathing circuit of the modified device of Wisniewski with the one or more fans and controller of Hunter to provide high hydrostatic pressures (e.g., 3-5 inches of water) and generate high flow rates up to 300 SLM ([0068], Lines 8-10).
Claims 1 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Wisniewski (US 20170021122) in view of Merz (DE 4216343)
Regarding claim 1, Wisniewski discloses
A respiratory line (Fig. 1; breathing circuit; [0017], Lines 1-6 and [0018], Lines 1-12) for conveying inspiratory or/and expiratory breathing gas during at least partial artificial respiration of a patient (Fig. 1; “a gas supply line 14 supplying fresh or oxygenated air for inhalation by the patient and a return line 16 transporting air exhaled by the patient 12 to a re-breathing bag 18”; [0018], Lines 1-12),
wherein the respiratory line (Fig. 1; breathing circuit; [0017], Lines 1-6 and [0018], Lines 1-12) defines an imaginary virtual breathing gas flow path which is conceived as extending centrally through it, along which flow path the respiratory line conveys the breathing gas (Fig. 1; gas flows from gas supply to circuit tubing potion 20 through device 10 (with filter) to airway securing device 22 to patient 12; [0018], Lines 1-12),
wherein the respiratory line (Fig. 1; breathing circuit; [0017], Lines 1-6 and [0018], Lines 1-12) has a filter carrier (Figs. 1-5; “the device 10 serves at least to filter air”; [0017], Lines 10-17) in which a filter receiving space (Figs. 4 and 5; space between chamber portion 44 and 48 in chamber 50) which is passed through by the breathing gas flow path is formed (Figs. 1-5; gas flows from gas supply through device 10 through first port 42 and out second port 46 (inhalation); [0025], Lines 1-10), in which a breathing gas filter through which the breathing gas can flow (Figs. 3-5; filter 52; [0029], Lines 1-7; filters air/breathing gas),
wherein the filter carrier (Figs. 1-5; device 10; [0017], Lines 10-17) has a wall surrounding the filter receiving space (Figs. 4 and 5; chamber portion 44 and 48 that surrounds space that contains filter; [0025], Lines 1-10 and [0027]) with radial spacing from the virtual breathing gas flow path (Figs. 4 and 5; walls of chamber portion 44 and 48 is radially spaced from flow of gas passing through chamber 50)
Wisniewski does not disclose an introduction opening arranged with radial spacing from the virtual breathing gas flow path, through which the breathing gas filter can be introduced into the filter receiving space and be brought into its operational operating position.
Merz discloses a replaceable filter in a duct in a ventilating system where
an introduction opening (Figs. 1a-2b; opening 5; [0012], Lines 1-5) arranged with radial spacing from the virtual breathing gas flow path (Figs. 1a-2b; opening is radially spaced from air conditioning duct 1; [0012], Lines 1-2), through which the breathing gas filter can be introduced into the filter receiving space (Figs. 1a-2b; filter 2 is inserted into air conditioning duct 1; [0012], Lines 1-5) and be brought into its operational operating position (Figs. 1a and 2a).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device 10 of Wisniewski with the opening, filter with the filter cover and bag, and filter removal method to provide a filter that is easily removed and that enables hygienic disposal of an aged filter (Merz: [0006], Lines 7-9 and [0015], Lines 7-11).
Regarding claim 9, the modified device of Wisniewski discloses
the respiratory line (Wisniewski: breathing circuit; Merz: replaceable/removable filter) according to claim 1,
wherein the breathing gas filter (Merz: Figs. 1a-2b; filter 2; [0012], Lines 1-5) has a gas impermeable shoulder (Merz: Figs. 1a-2b; filter cover 6 with bag 8; [0006], Lines 1-9, [0012], Lines 4-6, [0013], Lines 1-7, and [0015], Lines 5-11; filter cover and