DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
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 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.
Claims 1-2, 4, 12, 21 and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shaw (US Pat. No. 7,284,554), hereinafter Shaw.
Regarding claim 1, Shaw teaches a ventilator for providing breathable air to a patient (Abstract CPAP device, Figs. 1, 4, 5, 10, 11 comprising:
an airbag defining a longitudinal axis (Figs. 4-5, 10-11, air bar 8 longitudinal axis from top to bottom of the device), comprising a first end (See annotated figure below), a second end (See annotated figure below), and a foldable wall extending from the first end to the second end (Figs. 4-5, 10-11, wall is foldable from open to compresses), and being movable from a decompressed state to a compressed state by moving the first end along the longitudinal axis relative to the second end (See Figs. 10-11 showing compressed and decompressed states), wherein the wall comprises fold lines formed therein (See annotated figure below, the airbag has a pleated bag with fold lines, Col. 4: lines 35-40, inner folds 8a) such that, during movement of the airbag from the decompressed state to the compressed state, the wall is folded along the fold lines (See Figs. 4-5, 10-11), and wherein the fold lines define at least one polygonal surface portion of the wall (See annotated figure below, each pleat forms a polygonal surface);
an actuator for driving compression and decompression of the airbag; (Col. 2: lines 43-47, plate being connected to the housing by an expandable frame which can expand or contract to permit movement of the plate, Col. 2: lines 65-67, cylinder, fan, forced air provides the air to inflate the bag and move the frame, Col. 7:lines 25-35, when the airbag is inflated by the air source the frame moves apart)
a controller for controlling the actuator. (Col. 9: lines 43-49, the speed of the fan is preferably controlled by pressure sensors which measure flow rate from the fan and measure cpap level by the patient. the sensor measurements are used to control the speed of the fan in a known manner)
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Regarding claim 2, Shaw teaches the ventilator of claim 1, further teaches comprising a conduit connected to the airbag for delivering the breathable air to the patient. (Fig. 1: conduit 4, Fig. 12, conduit 4 connected to mask 5)
Regarding claim 3, Shaw teaches the ventilator of claim 1, wherein the at least one polygonal surface portion comprises interconnected polygonal surface portions of the wall, and wherein the interconnected polygonal surface portions comprise an outer surface of the wall. (See Figs. 4-5, 10-11, the accordion pleats are interconnected and form the wall of the airbag)
Regarding claim 4, Shaw teaches the ventilator of claim 1 and further teaches wherein the at least one polygonal surface portion comprises at least one planar polygonal surface portion. (Figs. 4-5, 10-11, each pleat forms a planar polygonal portion)
Regarding claim 12, Shaw teaches the ventilator of claim 1, wherein the fold lines comprise inwardly-folding fold lines (Fig. 5: inward fold lines 8a) and outwardly-folding fold lines defining interconnected foldable portions of the wall (Fig. 5: fold lines between inward fold lines 8a), each inwardly folding fold line being closer to the longitudinal axis that each outwardly folding fold line. (See fig. 5, fold lines 8a are closer to center line)
Regarding claim 21, Shaw teaches the ventilator of claim 1, wherein the wall comprises a thermoplastic. (Col. 5: lines 35, the bag is made of Mylar which is a thermoplastic)
Regarding claim 27, Shaw teaches an airbag, comprising:
a first end (See annotated figure below), a second end (See annotated figure below), and a foldable wall extending from the first end to the second end (Figs. 4-5, 10-11, wall is foldable from open to compresses),
wherein the airbag defines a longitudinal axis (Figs. 4-5, 10-11, air bar 8 longitudinal axis from top to bottom of the device and is movable from a decompressed state to a compressed state by moving the first end along the longitudinal axis relative to the second end (See Figs. 10-11 showing compressed and decompressed states),
wherein the wall comprises fold lines formed therein (See annotated figure below, the airbag has a pleated bag with fold lines, Col. 4: lines 35-40, inner folds 8a) such that, during movement of the airbag from the decompressed state to the compressed state, the wall is folded along the fold lines (See Figs. 4-5, 10-11), and wherein the fold lines define at least one polygonal surface portion of the wall (See annotated figure below, each pleat forms a polygonal surface);
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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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Shaw in view of Tachi et al (Rigid-Foldable Cylinders and Cells, Journal of the International Association for Shell and Spatial Structures, 2012), Hereinafter Tachi.
Regarding claim 5, Shaw teaches the ventilator of claim 1, but does not teach wherein the fold lines define a Kresling pattern, a Yoshimura pattern, or a Tachi-Miura pattern on an outer surface of the wall.
However, Tachi teaches that collapsible cylinder surface may be made from a variety of different designs including a Tachi-Miura pattern, Section 4.2 page 221)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have substituted the shape of Shaw with the Tachi-Miura pattern of Tachi since Tachi teaches that a potential use of the shape is a bellows such as for a fluid actuator. (Page 225)
Claims 35 is rejected under 35 U.S.C. 103 as being unpatentable over Shaw in view of Cooper et al (US 2023/0181850), hereinafter Cooper.
Regarding claim 35, a method of making an airbag for a ventilator, comprising printing the airbag using a three-dimensional printer, wherein the printed airbag defines a longitudinal axis, comprises a first end (See annotated figure below), a second end (See annotated figure below), and a foldable wall extending from the first end to the second end (Figs. 4-5, 10-11, wall is foldable from open to compresses),
wherein the airbag defines a longitudinal axis (Figs. 4-5, 10-11, air bar 8 longitudinal axis from top to bottom of the device and is movable from a decompressed state to a compressed state by moving the first end along the longitudinal axis relative to the second end (See Figs. 10-11 showing compressed and decompressed states),
wherein the wall comprises fold lines formed therein (See annotated figure below, the airbag has a pleated bag with fold lines, Col. 4: lines 35-40, inner folds 8a) such that, during movement of the airbag from the decompressed state to the compressed state, the wall is folded along the fold lines (See Figs. 4-5, 10-11), and wherein the fold lines define at least one polygonal surface portion of the wall (See annotated figure below, each pleat forms a polygonal surface);
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Shaw does not teach the airbag is manufactured by printing the airbag using a three dimensional printer.
However, three dimensional printing of components is well-known. Cooper teaches a portable electromechanical resuscitator bag (Abstract) and teaches that components may be produced via three dimensional manufacturing. (paragraph 14, Paragraph 64)
It would have been obvious to a person of ordinary skill in the art to produce components of the ventilator such as the airbag through three dimensional printing as taught by Cooper to more quickly produce parts during times when demand is high. (paragraph 64)
Allowable Subject Matter
Claims 6-11 and 13-15 and 17-18 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.
The following is an examiner’s statement of reasons for allowance: the prior art does not teach the collapsible structure of the airbag as described in claims 6-11 and 13-18. Although NPL reference by Reid et al (Geometry and design of origami bellow with tunable response) discusses creating bellows using these types of structures, Reid teaches that construction of a sealed bellows with these techniques is complicated, requiring machined forms and molds to shape the substrate as needed. page 19) There is no suggestion in Reid to use the structures in a ventilation device.
Therefore, without prior knowledge of the present invention, a person of ordinary skill in the art would have not have motivation or reason to deviate from the bag of Shaw in order to arrive at the proposed structure in claims 6-11 or 13-18 without the benefit of impermissible hindsight.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARGARET M LUARCA whose telephone number is (303)297-4312. The examiner can normally be reached 6:30 am - 3:30 pm MT.
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/MARGARET M LUARCA/ Primary Examiner, Art Unit 3785
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