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
Claim 3 is objected to because of the following informalities:
Regarding claim 3, “the jets” should be rewritten as “the air jets” to maintain consistency.
Appropriate correction is required.
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.
Claim 3 is 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 3, it recites, “wherein the plurality of air jets are arranged parallel and are arranged in a row extending perpendicularly to a direction of flow of the jets”, however it is unclear which air jets are placed where and which set of air jets are perpendicular to each other. It is also unclear whether the air jet described in claim 1 is in the same position as described in claims 2 and 3.
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.
Claims 1, 2, and 16-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Adams et al. (US 10967204 B1) (hereon referred as Adams).
Regarding claim 1, Adams teaches a hood comprising:
A barrier defining an interior space for receiving the head of a patient (device 100, shown in annotated Fig. 5 below) and an opening through which the head may enter and leave the interior space (opening shown in annotated Fig. 5 below), the barrier being arranged to prevent the transmission of aerosol particles through the barrier (“invention is further operable to capture and remove airborne particulates…provides both barrier and aerosolization protection”, lines 15-19, Col. 12);
A suction port arranged to remove air from the interior space of the hood (“device includes an air supply and a vacuum suction tube to generate a negative pressure environment for the patient”, lines 5-7, Col. 112; vacuum port/connection port 112 shown in annotated Fig. 5 below);
An access hole within the barrier, arranged to allow a person external to the barrier to access the interior space (“the box includes at least one arm access hole to provide access to a patient”, lines 45-47, Col. 12, arm holes 104 shown in annotated Fig. 5 below); and
An air jet arranged to propel air across the access hole in order to inhibit the transmission of aerosols through the access hole (“at least one air management port to provide for the inflow and outflow of air”, lines 47-48, Col. 12; connection port 112).
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Regarding claim 2, Adams teaches the hood comprising a plurality of air jets arranged to drive air across the access hole (“at least one air management port to provide for the inflow and outflow of air”, lines 47-48, Col. 12, “connection port 112 is operable to attach to…air/oxygen tubing, and other tubing”, lines 29-30, Col. 17; connection port 112) in order to inhibit the transmission of aerosols through the access hole (“device includes an air supply…advantageously, the SCONE device…prevent healthcare personnel (HCP) exposure to pathogenic biological airborne particulates”, lines 5-11, Col. 12).
Regarding claim 16, Adams teaches an air flow system comprising:
The hood of claim 1 (device 100, shown in annotated Fig. 24 above; hood of claim 1 described above); and
A suction pump coupled to the suction port and arranged to remove air from the interior space (“barrier protection device 360 includes at least one connection port 112…operable to attach to vacuum tubing”, lines 27-31, Col. 17).
Regarding claim 17, Adams teaches a jet pump coupled to one or more air jets and arranged to provide air to the one or more air jets at a pressure above atmospheric pressure (“a pump adapted to pump air into the isolation chamber to increase the pressure within the isolation chamber”, lines 59-61, Col. 4).
Regarding claim 18, Adams teaches the suction pump and the jet pump are the same pump (“barrier protection device 360 includes at least one connection port 112…operable to attach to vacuum tubing, air/oxygen tubing, and other tubing used during medical procedures”, lines 27-31, Col. 17).
Regarding claims 19 and 20, Adams teaches further comprising an air decontamination device arranged to sanitize the air passing through the air flow system (“the HEPA air filter 106 captures airborne particulates”, lines 20-21, Col. 13) and the air decontamination device comprising an air filter or a UV sterilization device (“the device further including at least one High Efficiency Particulate Air (HEPA) filter connected to the at least one port”, lines 31-33, Col. 10).
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.
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being obvious over Adams in view of Underwood (US 20180168903 A1).
Regarding claim 3, Adams teaches all the limitations of claim 2, but does not teach the plurality of air jets being arranged parallel and are arranged in a row perpendicular to a direction of flow of the jets.
However, Underwood teaches a barrier (canopy 26, Fig. 2) comprising an access hole (arm ports 36, Fig. 2) and a plurality of air jets being arranged parallel and are arranged in a row (“align the vents 34 along the walls 24 in such a manner as to produce vertical jets of air along the walls 24”, paragraph [0031], row of vents 34 underneath arm ports 36 shown in annotated Fig. 2 below) extending perpendicularly to a direction of flow of the jets.
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the hood of Adams with the parallel arrangement of plurality of air jets of Underwood and provide an air curtain across the access hole in order to ensure that the air flow remains within the barrier and prevents it from escaping and reaching an operator (“these vertical jets of air further create a barrier across the arm ports 36 against transmission of viral or bacterial contaminants through the arm ports 36 from outside the microenvironment”, paragraph [0031]).
Regarding claim 4, Adams teaches all the limitations of claim 2, but does not teach the air jets being distributed around a boundary of the access hole and directed across the access hole.
However, Underwood teaches air jets along the walls of the barrier (“vents 34 along the walls 24 in such a manner as to produce vertical jets of air along the walls 24…jets of air further create a barrier across the arm ports 36”, paragraph [0031]).
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 positioning of the air jets of Adams in view of Underwood to be around the boundary of the access holes and directed across the access hole, in order to prevent the passage of aerosols in and out of the barrier. Additionally, since such a modification would simply involve merely rearranging the placement of the air jets without changing the operation of the device, a rearrangement of parts is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04).
Claims 5-8 are rejected under 35 U.S.C. 103 as being obvious over Adams in view of Smets (US 4422369 A).
Regarding claims 5 and 6, Adams teaches all the limitations of claim 2, but does not teach the air jets being powered via a common manifold or a common source.
However, Smets teaches a barrier (shown in annotated Fig. 1 below) with a plurality of air jets (“air jet originating from said blowing manifold”, lines 67-68, Col. 2) powered via a common manifold or a common source (“device for protecting an operating field…comprises a blowing manifold 1 for sterile air”, lines 35-37, Col. 2).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the hood of Adams with the plurality of air jets powered by a manifold and a common source of Smets in order to ensure uniform air flow across the barrier.
Regarding claim 7, Adams teaches all the limitations of claim 1, but does not teach the air jet being directed towards the suction port.
However, Smets teaches the air jet being directed towards the suction port (“device…comprises a blowing manifold 1 for sterile air and a sucking manifold 2, both manifolds…in vertical planes which are in substantially parallel relationship with one another”, lines 35-40, Col. 2; air jet/blowing manifold 1 and suction port/sucking manifold 2 shown in annotated Fig. 4 below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the hood of Adams with the air jet and suction port of Smets and arrange the air jet and suction port towards each other in order to create a uniform air curtain and ensure the flow of air remains within the enclosure (“curtain 3 formed by the sterile air stream between manifolds 1 and 2”, lines 23-24, Col. 3).
Regarding claim 8, Adams teaches all the limitations of claim 1, but does not teach the air jet being a hole in the barrier arranged to permit the flow of air therethrough when a low pressure is created in the interior space by the removal of air via the suction port.
However, Smets teaches the air jet being a hole in the barrier (“blowing manifold 1 comprises a distributing chamber 4 in the shape of an arc of circle…with a slot 6 that comprises the outlet from the blowing manifold”, lines 49-55, Col. 2; Fig. 2) arranged to permit the flow of air therethrough when a low pressure is created in the interior space by the removal of air via the suction port (“the sucking manifold 2…slot width is much larger than the slot width of blowing manifold 1 to take into consideration…the diverging air jet originating from said blowing manifold and on the other hand, the fact that part of the air from that zone to be protected proper has to be sucked by said manifold 2”, lines 60-70, Col. 2, lines 1-2, Col. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the hood of Adams with the air jet and suction port of Smets in order to ensure that air is still flowing therethrough the barrier while a low pressure is created in the interior space due to the suction port, preventing the transmission of aerosols through the access port.
Claim 9 is rejected under 35 U.S.C. 103 as being obvious over Adams in view of Hogan (US 4885000 A).
Regarding claim 9, Adams teaches all the limitations of claim 1, but does not teach a first flap extending at least partially across the access hole in a first direction.
However, Hogan teaches a barrier (tent 20, Fig. 1), with access holes (portholes 25, Fig. 2, Fig. 1) further comprising a first flap extending at least partially across the access hole in a first direction (“the tent may have one or more small sealable portholes or pockets 25 sealable with a flap 26 communicating with the interior of the tent to allow insertion of instruments into the tent 20”, lines 24-27, Col. 5; shown in annotated Fig. 2 below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the hood of Adams with the first flap over the access opening of Hogan in order to help inhibit the passage of aerosols through the access holes.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being obvious over Adams in view of Hogan and further in view of Lee (US 3826300 A).
Regarding claim 10, Adams in view of Hogan teaches all the limitations of claim 9, but does not teach a second flap extending at least partially across the access hole in a second direction different from the first direction and arranged to overlap the first flap.
However, Lee teaches a barrier with access holes (shown in annotated Fig. 1 below) further comprising a second flap extending at least partially across the access hole in a second direction different from the first direction and arranged to overlap the first flap (“the light seal is formed from four substantially triangular elastic sealing elements”, lines 56-57, Col. 1; hand openings 10 and elastic sealing elements shown in annotated Fig. 2 below).
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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 flaps of Adams in view of Hogan with the flap arrangement over the access holes of Lee, in order to further cover the access holes with a multilayer configuration in order to create a secure seal around the arms of an operator when entering into the barrier.
Regarding claim 11, Adams in view of Hogan and further in view of Lee teaches all the limitations of claim 10, but does not teach the first and second flaps having edges that are shaped as sinusoids in the region where flaps overlap, and wherein the sinusoids are 180 degrees out of phase.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the edges of the first and second flaps to be shaped as sinusoids in order to provide a curved shape to seal tightly around the wrist or forearm of an operator. It would have been obvious to one having ordinary skill in the art to modify the first and second flaps to be a sinusoidal shape as an obvious matter of design choice. Moreover, it would have also been obvious to one of ordinary skill in the art at the time of the invention to modify the sinusoids and choose the instantly claimed ranges through process optimization, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05 II and in re Boesch, 205 USPQ 215 (1980).
Claims 12-15 are rejected under 35 U.S.C. 103 as being obvious over Adams in view of Giulianotti et al. (US 20160107006 A1) (hereon referred as Gui).
Regarding claim 12, Adams teaches all the limitations of claim 1, but does not teach a first skirt extending from the barrier and is arranged to at least partially obstruct the opening.
However, Gui teaches a barrier (lower half-shell 804 and upper half-shell 802, shown in annotated Fig. 1 below) that further comprises a first skirt extending from the barrier and is arranged to at least partially obstruct the opening (“the helmet has an anatomically shaped portion is designed to form an airtight seal to the neck or torso of the patient…airtight flap 806 that seals around the neck of the patient”, paragraph [0020]; airtight flap 806 shown in annotated Fig. 1 below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the hood of Adams with the hood of Gui and incorporate the skirt to form a seal around the torso of the patient and prevent any leakage of airborne particles.
Regarding claim 13, Adams in view of Gui teaches all the limitations of claim 12.
Furthermore, Gui teaches the first skirt having a quarter-spheroidal or quarter-ellipsoidal shape (airtight flap 806 conforms to the circular shape of the patient’s neck shown above in Fig. 1).
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 first skirt of Adams in view of Gui and have a quarter-spheroidal or quarter-ellipsoidal shape for the skirt in order to create a seal that fits snugly against the patient and prevent leakage of airborne particles.
Regarding claim 14, Adams teaches all the limitations of claim 1, but does not teach a second skirt extending from the barrier and having an edge distal from the barrier, the edge having a concave shape.
However, Gui teaches a skirt extending from the barrier and having an edge distal from the barrier, the edge having a concave shape (“the helmet has an anatomically shaped portion is designed to form an airtight seal to the neck or torso of the patient…airtight flap 806 that seals around the neck of the patient”, paragraph [0020]; airtight flap 806 shown in annotated Fig. 1 above).
Adams in view of Gui does not teach a second skirt though Gui teaches a skirt surrounding the entrance and having opposing shapes to contour to the person inserted through the opening.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add a second skirt since it has been held that mere duplication of essential working parts of a device involves only routine skill in the art and one of ordinary skill in the art would have had reasonable expectation of success. See MPEP 2144.04 St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. Essentially the difference between the prior art and the claim language is having two separate skirts instead of one larger skirt in the same positions.
Regarding claim 15, Adams teaches all the limitations of claim 1, but does not teach the barrier being hemispheroidal or hemiellipsoidal.
However, Gui teaches the barrier being a hemispheroidal shape (barrier shown in annotated Fig. 1 above).
It would have been obvious to one of ordinary skill in the art before the effective filing date, to further modify the hood of Adams in view of Gui, to make the barrier more of a hemispheroidal or hemiellipsoidal shape, accommodating for the curvature of the head of a patient and making it easier to access through an opening.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARA LINH TRAN whose telephone number is (571)272-3598. The examiner can normally be reached 7:30am-5:00pm M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at 5712724233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.L.T./Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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