DETAILED ACTION
Primary Examiner acknowledges Claims 16-31 are pending in this application, with Claims 16-31 having been newly added, and Claims 1-15 having been cancelled by preliminary amendment on January 3, 2024.
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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because:
Reference character “108” has been used to designate “flow sensor”, and “differential pressure flow sensor”. Appropriate correction is required.
Reference character “14” has been used to designate “proximal longitudinal end region”, and “proximal longitudinal end”. Appropriate correction is required.
Reference character “23a” has been used to designate “expiration lumen” and “lumina expiration lumen”. Appropriate correction is required.
Reference character “26” has been used to designate “straight expiration inlet section”, and “expiration inlet section”. Appropriate correction is required.
Reference character “30” has been used to designate “common linkage connector formation”, and “linkage connector formation”. Appropriate correction is required.
Reference character “30a” has been used to designate “inlet linkage formation”, and “inlet connector formation”. Appropriate correction is required.
Reference character “34” has been used to designate “cooperating linkage connector counter-formation”, and “linkage connector counter-formation”. Appropriate correction is required.
Reference character “36b” has been used to designate “inspiration lumen”, and “lumina”. Appropriate correction is required.
Reference character “46” has been used to designate “valve body”, “membrane valve body”, and “expiration valve”. Appropriate correction is required.
Reference character “58” has been used to designate “inlet connector formation”, and “duct component”. Appropriate correction is required.
Reference character “64” has been used to designate “elastomeric disc shaped valve body”, “valve body”, “built-in valve body”, and “membrane valve body”. Appropriate correction is required.
Reference characters “72a and 72b” have been used to designate “flow-through apertures”, and “feed -through apertures”. Appropriate correction is required.
Reference characters “74a and 74b” have been used to designate “built-in feed through components”, and “feed through components”. Appropriate correction is required.
Reference character “78” has been used to designate “first signaling line”, “signaling line”. Appropriate correction is required.
Reference character “84” has been used to designate “second signaling line”, and “signaling line”. Appropriate correction is required.
Reference character “92” has been used to designate “common linkage connector formation”, and “linkage connector formation”. Appropriate correction is required.
Reference characters “30” and “92” have been used to designate “common linkage connector formation”, and “linkage connector formation”. Appropriate correction is required.
Reference characters “18” and “58” have been used to designate “duct component”. Appropriate correction is required.
Reference characters “23a” and “36a” have been used to designate “expiration lumen”. Appropriate correction is required.
Reference characters “42” and “46” have been used to designate “expiration valve”. Appropriate correction is required.
Reference characters “30a” and “58” have been used to designate “inlet connector formation”. Appropriate correction is required.
Reference characters “23b” and “36b” have been used to designate “inspiration lumen”. Appropriate correction is required.
Reference characters “46” and “64” have been used to designate “membrane valve body”, and “valve body”. Appropriate correction is required.
Reference character “44” and “62b” have been used to designate “seat”, and “valve seat”. Appropriate correction is required.
Reference characters “26” and”28” have been used to designate “section”. Appropriate correction is required.
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. 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.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Specifically, the abstract, filed on January 3, 2024, has a word count greater than 150 words. Appropriate correction is required.
The disclosure is objected to because of the following informalities:
Reference character “108” has been used to designate “flow sensor”, and “differential pressure flow sensor”. Appropriate correction is required.
Reference character “14” has been used to designate “proximal longitudinal end region”, and “proximal longitudinal end”. Appropriate correction is required.
Reference character “23a” has been used to designate “expiration lumen” and “lumina expiration lumen”. Appropriate correction is required.
Reference character “26” has been used to designate “straight expiration inlet section”, and “expiration inlet section”. Appropriate correction is required.
Reference character “30” has been used to designate “common linkage connector formation”, and “linkage connector formation”. Appropriate correction is required.
Reference character “30a” has been used to designate “inlet linkage formation”, and “inlet connector formation”. Appropriate correction is required.
Reference character “34” has been used to designate “cooperating linkage connector counter-formation”, and “linkage connector counter-formation”. Appropriate correction is required.
Reference character “36b” has been used to designate “inspiration lumen”, and “lumina”. Appropriate correction is required.
Reference character “46” has been used to designate “valve body”, “membrane valve body”, and “expiration valve”. Appropriate correction is required.
Reference character “58” has been used to designate “inlet connector formation”, and “duct component”. Appropriate correction is required.
Reference character “64” has been used to designate “elastomeric disc shaped valve body”, “valve body”, “built-in valve body”, and “membrane valve body”. Appropriate correction is required.
Reference characters “72a and 72b” have been used to designate “flow-through apertures”, and “feed -through apertures”. Appropriate correction is required.
Reference characters “74a and 74b” have been used to designate “built-in feed through components”, and “feed through components”. Appropriate correction is required.
Reference character “78” has been used to designate “first signaling line”, “signaling line”. Appropriate correction is required.
Reference character “84” has been used to designate “second signaling line”, and “signaling line”. Appropriate correction is required.
Reference character “92” has been used to designate “common linkage connector formation”, and “linkage connector formation”. Appropriate correction is required.
Reference characters “30” and “92” have been used to designate “common linkage connector formation”, and “linkage connector formation”. Appropriate correction is required.
Reference characters “18” and “58” have been used to designate “duct component”. Appropriate correction is required.
Reference characters “23a” and “36a” have been used to designate “expiration lumen”. Appropriate correction is required.
Reference characters “42” and “46” have been used to designate “expiration valve”. Appropriate correction is required.
Reference characters “30a” and “58” have been used to designate “inlet connector formation”. Appropriate correction is required.
Reference characters “23b” and “36b” have been used to designate “inspiration lumen”. Appropriate correction is required.
Reference characters “46” and “64” have been used to designate “membrane valve body”, and “valve body”. Appropriate correction is required.
Reference character “44” and “62b” have been used to designate “seat”, and “valve seat”. Appropriate correction is required.
Reference characters “26” and”28” have been used to designate “section”. Appropriate correction is required.
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 16-22 and 24-26 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Nowacki et al. (4,538,620).
As to Claim 16, Nowacki discloses an exhalation valve assembly (10, best seen Figure 1-5, “an inhalation valve 10” Column 1, Line 65 thru Column 2, Line 10) for a respiratory device for artificial ventilation of a patient, comprising: an expiration duct (12, “The valve includes a cylindrical body 12 of molded plastic construction having an open end 14 with a plurality of arcuately spaced notches 16 therein.” Column 1, Line 65 thru Column 2, Line 10) which at one end exhibits an expiration inlet (via 22, “At the opposite end of the body 12 in the upper portion thereof there is a wall portion including an upper arcuate section 18 of nearly a semi-circle in extent having the ends thereof connected by a transverse rib 20 which is spaced just above a diameter of the body 12. This provides an opening 22 which is essentially a segment of a circle.” Column 2, Lines 10-20) for introducing an expiratory breathing gas flow (via 60, “However, the upper portion 40 of the gasket deflects to the right as shown in broken lines in FIG. 5, so that air passes to the right as indicated by the arrow 60 in the upper portion of the body 12, such exhaled air simply being dispelled into the atmosphere.” Column 3, Lines 1-30) into the expiration duct (12) and an inlet linkage formation (18 proximate 40, “At the opposite end of the body 12 in the upper portion thereof there is a wall portion including an upper arcuate section 18 of nearly a semi-circle in extent having the ends thereof connected by a transverse rib 20 which is spaced just above a diameter of the body 12. This provides an opening 22 which is essentially a segment of a circle.” Column 2, Lines 10-20) which is configured for linking to an expiration breathing gas line (50 via 58 in the same direction of 60, wherein 50 – “A mouthpiece 48 is provided having a tubular portion 50 adapted to fit into a patient's mouth, and an enlarged portion 52 adapted for assembly with the body 12.” Column 2, Line 65 thru Column 3, Line 5; and wherein 58 – “Air flow continues through the mouthpiece to the left as indicated by the double ended arrow 58 in FIG. 1.” Column 3, Lines 1-30), and which at its other end exhibits an expiration outlet (14, “The valve includes a cylindrical body 12 of molded plastic construction having an open end 14 with a plurality of arcuately spaced notches 16 therein.” Column 1, Line 65 thru Column 2, Line 10) for discharging expiratory breathing gas (via 60), wherein the expiration duct (12) exhibits an expiration valve (40, “The upper portion 40 of the diaphragm lies inwardly of the arcuate section 18 and rib 20, fitting against the back side thereof as best seen in FIG. 5 in solid lines.” Column 2, Lines 40-65) which through an expiratory breathing gas flow (via 60) in the expiration direction from the expiration inlet (via 22) is movable (best seen Figure 5) into a feed-through position which lets the expiratory breathing gas flow (via 60) through, and inspiration duct (30, “An inhalation tube 30 of reduced diameter opens through the wall 24 and lies tangent to the wall of the body 12 along the bottom portion thereof, extending from the wall 24 approximately 3/4 of the distance toward the end 14.” Column 2, Lines 25-40) which exhibits at one end an inspiration inlet (via 32, “Relatively toward the right end of the tube 30 there is provided a transverse fitting 32 for a flexible tube of plastic or rubber. The fitting 32 is hollow and communicates with the interior of the tube 30.” Column 2, Lines 25-40) for introducing an inspiratory breathing gas flow (via 56, “When a patient inserts the tubular portion 50 of the mouthpiece in his mouth and inhales, the lower portion 42 of the gasket will deflect to the left as shown in broken lines in FIG. 5, thereby permitting air to flow through the tube 30 as indicated by the arrow 56 in FIG. 1.” Column 3, Lines 1-30; “As will be apparent, the reduction in lateral pressure of air flow through the tube 50 as indicated by the arrow 56 is compared with ambient pressure to produce the desired readout in the accompanying electronic circuitry.” Column 3, Lines 40-55) into the inspiration duct (30) and an inlet connector formation (32 via 30, “Relatively toward the right end of the tube 30 there is provided a transverse fitting 32 for a flexible tube of plastic or rubber. The fitting 32 is hollow and communicates with the interior of the tube 30.” Column 2, Lines 25-40) which is configured for connecting with a breathing gas source supplying inspiratory breathing gas (“air”, “When a patient inserts the tubular portion 50 of the mouthpiece in his mouth and inhales, the lower portion 42 of the gasket will deflect to the left as shown in broken lines in FIG. 5, thereby permitting air to flow through the tube 30 as indicated by the arrow 56 in FIG. 1.” Column 3, Lines 1-30), and which at its other end exhibits an inspiration outlet (24 proximate 30, “An inhalation tube 30 of reduced diameter opens through the wall 24 and lies tangent to the wall of the body 12 along the bottom portion thereof, extending from the wall 24 approximately 3/4 of the distance toward the end 14.” Column 2, Lines 25-40) for letting out inspiratory breathing gas (via 56) and an outlet connector formation (18 proximate 42, “At the opposite end of the body 12 in the upper portion thereof there is a wall portion including an upper arcuate section 18 of nearly a semi-circle in extent having the ends thereof connected by a transverse rib 20 which is spaced just above a diameter of the body 12. This provides an opening 22 which is essentially a segment of a circle.” Column 2, Lines 10-20) which is configured for connecting with an inspiration breathing gas line (50 via 58 in the same direction of 60, wherein 50 – “A mouthpiece 48 is provided having a tubular portion 50 adapted to fit into a patient's mouth, and an enlarged portion 52 adapted for assembly with the body 12.” Column 2, Line 65 thru Column 3, Line 5; and wherein 58 – “Air flow continues through the mouthpiece to the left as indicated by the double ended arrow 58 in FIG. 1.” Column 3, Lines 1-30) leading to the patient, a control duct (52, “A mouthpiece 48 is provided having a tubular portion 50 adapted to fit into a patient's mouth, and an enlarged portion 52 adapted for assembly with the body 12.” Column 2, Line 65 thru Column 3) which branches off from the inspiration duct (12) at a branching point (54, “A gasket 54 of rubber or the like lies between the mouthpiece and the body 12 to insure an airtight seal.” Column 2, Line 65 thru Column 3) and leads to the expiration valve (40) in such a way that the expiration valve (40) can be strained by inspiratory breathing gas into a blocking position which blocks the expiratory breathing gas flow (60), wherein in the inspiration duct (12) there is arranged a one-way valve (42, “When a patient inserts the tubular portion 50 of the mouthpiece in his mouth and inhales, the lower portion 42 of the gasket will deflect to the left as shown in broken lines in FIG. 5, thereby permitting air to flow through the tube 30 as indicated by the arrow 56 in FIG. 1.” Column 3, Lines 1-30) which allows inspiration breathing gas flow (56) in the inspiration direction from the inspiration inlet (via 32) to the inspiration outlet (24 proximate 30) and prevents breathing gas flow in the opposite direction.
As to Claim 17, Nowacki discloses the branching point (54) lies upstream of the one way valve (42) in the inspiration direction (via 56).
As to Claim 18, Nowacki discloses an inspiration inlet section (lumen of 30) of the inspiration duct (30) which lies nearer to the inspiration inlet (via 32) than to the inspiration outlet (24 proximate 30) proceeds along an inspiration inlet axis (same as 56), wherein a valve movement (best seen Figure 5) along which a valve body of the expiration valve (40) can be raised from a valve seat (28 as engaging 38, “Slightly below the median line it is provided with a slot 38 for receipt of the tongue 28 for mounting of the diaphragm.” Column 2, Lines 40-65) of the expiration valve (40) from its blocking position and made to approach the valve seat (28 as engaging 38) is tilted relative to the inspiration inlet axis (same as 56) by a setting angle in the range of 10 to 45 degrees. As best seen in Figure 5, the offset of the expiration valve (40) appears to be approximately 20 degrees.
As to Claim 19, Nowacki discloses the setting angle in the range of 15 to 35 degrees. As best seen in Figure 5, the offset of the expiration valve (40) appears to be approximately 20 degrees.
As to Claim 20, Nowacki discloses an expiration inlet section (lumen of 12) of the expiration duct (12) which lies nearer to the expiration inlet (via 22) than to the expiration outlet (14) proceeds along an expiration inlet axis (same as 60), wherein the valve movement path is tilted about a parallel to the expiration inlet axis (same as 60) with respect to the inspiration inlet axis (same as 56).
As to Claim 21, Nowacki discloses the valve seat (28 as engaging 38) exhibits a proximity section approaching and tilted towards the inspiration inlet section (lumen of 30) and a distanced section laying further away and tilted away from the inspiration inlet section (lumen of 30), wherein the control duct (52) runs nearer to proximity section than to the distanced section from the branching point (54) to the expiration valve (40).
As to Claim 22, Nowacki discloses in a region between the inspiration inlet section (lumen of 30) and the expiration inlet section (lumen of 12) and/or in a region between the inspiration inlet section (lumen of 30) and an inspiration outlet section (lumen of 30 as engaging 52/54/10) lying nearer to the inspiration outlet (24 proximate 30) than to the inspiration inlet (32) there is configured at least one feed through aperture (defined by the passage of flow from 56 to 58) which penetrates through a duct wall (defined by the engagement of 52/54/10) which bounds the inspiration duct (30) and/or the expiration duct (12).
As to Claim 24, Nowacki discloses the at least one feed through aperture (defined by the passage of flow from 56 to 58) runs along a feed through axis which is parallel to the expiration inlet axis (same as 60) and/or to an inspiration outlet axis (same as 56) which the inspiration outlet section (lumen of 30 as engaging 52/54/10) extends.
As to Claim 25, Nowacki discloses an expiration inlet section (lumen of 12) of the expiration duct (12) which lies nearer to the expiration inlet (via 22) than to the expiration outlet (14) proceeds along an expiration inlet axis (same as 60), wherein the valve movement path is tilted about a parallel to the expiration inlet axis (same as 60) with respect to the inspiration inlet axis (same as 56); in a region between the inspiration inlet section (lumen of 30) and the expiration inlet section (lumen of 12) and/or in a region between the inspiration inlet section (lumen of 30) and an inspiration outlet section lying nearer to the inspiration outlet (24 proximate 30) than to the inspiration inlet (32) there is configured at least one feed through aperture (defined by the passage of flow from 56 to 58) which penetrates through a duct wall (defined by the engagement of 52/54/10) which bounds the inspiration duct (30) and/or the expiration duct (12); the expiration inlet section (lumen of 12) and the inspiration outlet section (24 proximate 30) are configured in a common multi-lumen end section (proximate 52 and leading to the patient via 50).
As to Claim 26, Nowacki discloses an expiration inlet section (lumen of 12) of the expiration duct (12) which lies nearer to the expiration inlet (via 22) than to the expiration outlet (14) proceeds along an expiration inlet axis (same as 60), wherein the valve movement path is tilted about a parallel to the expiration inlet axis (same as 60) with respect to the inspiration inlet axis (same as 56); in a region between the inspiration inlet section (lumen of 30) and the expiration inlet section (lumen of 12) and/or in a region between the inspiration inlet section (lumen of 30) and an inspiration outlet section lying nearer to the inspiration outlet (24 proximate 30) than to the inspiration inlet (32) there is configured at least one feed through aperture (defined by the passage of flow from 56 to 58) which penetrates through a duct wall (defined by the engagement of 52/54/10) which bounds the inspiration duct (30) and/or the expiration duct (12); the inspiration inlet section (lumen of 30), the expiration inlet section (lumen of 12) and the inspiration outlet section (24 proximate 30) are realized through an integral duct component (proximate 52 and leading to the patient via 50).
Allowable Subject Matter
Claims 23, and 27-31 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hay (3,933,171) and Rusher (2012/0272956) each disclose a bidirectional respiratory device having an expiration duct with exhalation valve and an inspiration duct with inhalation valve to separate the bidirectional flow from the patient.
DeVries (6,102,038) discloses a bidirectional respiratory device having an expiration duct with exhalation valve and an inspiration duct with inline flow resistor.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNETTE F DIXON whose telephone number is (571)272-3392. The examiner can normally be reached M-F 9-5 EST with flexible hours.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra D Carter can be reached at 571-272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785
Prosecution Insights