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 .
Specification
The disclosure is objected to because of the following informalities:
In paragraph 2 of page 1, “challenges’” does not need an apostrophe.
In paragraph 1 of page 7, “camber” should be “chamber”.
In paragraph 2 of page 11, “manoeuvring” should be “maneuvering”.
Appropriate correction is required.
Claim Objections
Claim 9 is objected to because of the following informalities:
Regarding claim 9, “covers” should be “cover”.
Regarding claim 20, “camber” should be “chamber”.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-13 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.
Claim 1 recites the limitation "the flexible member" in “a flexible membrane attached to the device body opposite to the sealing means and comprising a plurality of longitudinally running tool passing channels mounted on the flexible member”. There is insufficient antecedent basis for this limitation in the claim. Claims 2-13 are also rejected due to its dependencies on claim 1.
Claim 8 recites the limitation “the flexible member” in “wherein the flexible member is comprised of elastomeric material”. There is insufficient antecedent basis for this limitation in the claim.
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 1-8 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pedro et al. (US 20170007795 A1).
Regarding claim 1, Pedro et al. teaches a teaches a protective nasal mask device comprising:
A sealing means adapted to hermetically seal the device to the nasal region of a user (shown in annotated Fig. 13 below), the sealing means having a bottom edge and a top edge disposed opposite to the bottom edge (shown in annotated Fig. 13 below);
A device body coupled to the top edge of the sealing means (nasal mask 500, shown in annotated Fig. 13 below);
A flexible membrane attached to the device body (“a flexible membrane with ports”, paragraph [0092]; shown in annotated Fig. 13 below) opposite to the sealing means and comprising a plurality of longitudinally running tool passing channels mounted on the flexible member and angled inwardly towards each other (ports 506, shown in annotated Fig. 13 below); and
Each tool passing channel having a bottom end with an access port (shown in annotated Fig. 13 below) formed on it and a top end kept open, wherein the flexible member enables independent movement of each tool passing channel and wherein each access port is adapted to seal itself (“membrane may be formed of a flexible self-sealing material”, paragraph [0092]) when a surgical tool inserted through it is removed.
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Regarding claims 2 and 3, Pedro et al. teaches the bottom edge of the sealing means being adapted to hermetically seal against the nasal region of the user (“seal readily deforms and stretches to intercept and conform to the nose of the patient”, paragraph [0048]), wherein the device body has mounted on it a plurality of fixing points capable of securing the device to the nasal region of the user (nasal bridge seal 100, lower lip seal 140, seal 62; shown in annotated Fig. 2 below).
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Regarding claim 4, Pedro et al. teaches the plurality of tool passing channels having a hollow flexible interior (flexible hollow interior shown in annotated Fig. 4A below).
Regarding claim 5, Pedro et al. teaches the top end of each tool passing channel opening to a nostril of the user (shown in annotated Fig. 14A below).
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Regarding claim 6, Pedro et al. teaches “one or more ports which contain…membrane seals that allow passage of a functional tool”, in paragraph [0015], wherein the number of tool passing channels could be four.
Regarding claim 7, Pedro et al. teaches the device body being comprised of transparent plastic (“nasal mask…formed of a transparent polymeric material”, paragraph [0048]).
Regarding claim 8, Pedro et al. teaches the flexible membrane being comprised of elastomeric material (paragraph [0092]). The flexible membrane of the tool passing channel should be made of an elastomeric material for easier access and maneuvering of tools.
Regarding claim 17, Pedro et al. teaches a protective nasal mask device comprising:
A sealing means adapted to hermetically seal the device to the nasal region of a user, the sealing means having a bottom edge and a top edge disposed opposite to the bottom edge (“seal readily deforms and stretches to intercept and conform to the nose of the patient”, paragraph [0048]);
A device body coupled to the top edge of the sealing means, the device body having a flexible member integrated to its bottom edge (“elastic membrane-like seal structure is provided spanning the right side and left side of the mask terminating at the inside edge of seal”, paragraph [0048]); and
At least one longitudinally running tool passing channel mounted on the flexible member and angled inwardly towards each other (shown in annotated Fig. 13 below), the tool passing channel having a bottom end with an access port formed on it and a top end kept open, wherein the flexible member enables independent movement of the tool passing channel and wherein the access port is adapted to seal itself when a surgical tool inserted through it is removed (“membrane may be formed of a flexible self-sealing material”, paragraph [0092]).
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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.
Claims 9, 10 and 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Pedro et al. in view of Lampotang et al. (US 20060060199 A1).
Regarding claim 9, Pedro et al. teaches all the limitations of claim 1, but does not teach the nasal mask device covering the mouth as well.
However, Lampotang et al. teaches the nasal mask covering the mouth and nasal region of the user (“facemask capable of providing a seal at a mouth and nose region of a patient”, paragraph [0035]).
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 nasal mask device of Pedro et al. with the mask of Lampotang et al., so that it covers both the nose and mouth of the patient in order to enclose the whole area for operations where surgical tools must enter through the mouth.
Regarding claim 10, Pedro et al. teaches all the limitations of claim 1, but does not teach one of the tool passing channels being adapted as an air passageway.
However, Lampotang et al. teaches at least one of the tool passing channels being adapted to provide an air passageway to enable a patient to breathe (“air way device may extend from the outlet valve assembly and be configured to b coupled to an airway of a patient”, paragraph [0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify one of the tool passing channels of the nasal mask device of Pedro et al. with the air passageway of Lampotang et al. in order to allow the patient to breathe while wearing the device during a procedure.
Regarding claim 19, Pedro et al. teaches all the limitations of claim 17, but does not teach an elongated flexible chamber coupled to the nasal mask device.
However, Lampotang et al. teaches the device and tool passing channel comprising an elongated flexible chamber (self inflating chamber 15, shown in annotated Fig. 1 below) and coupled at one end with a flexible sealing means (“self-inflating resuscitation bag may be flexible to an extent that as gas is forced from the self-inflating resuscitation bag, the exhaustion outlet port is sealed”, paragraph [0043]; self-inflating chamber 15, sealing means 14, 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 modify the nasal mask device of Pedro et al. with the elongated flexible chamber of Lampotang et al. in order to create a passageway for the patient to breathe while wearing the nasal mask device.
Regarding claim 20, a modified nasal mask device of Pedro et al. in view of Lampotang et al. teaches all the limitations of claim 19.
Furthermore, Lampotang et al. teaches the access port being positioned at the opposite end of the elongated flexible chamber (intake port 16, 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 further modify the nasal mask device of Pedro et al. in view of Lampotang et al. and incorporate an access port at the other end of the elongated flexible chamber in order to allow the insertion of an ENT tool into the device, or any other surgical tool.
Regarding claim 21, a modified nasal mask device of Pedro et al. in view of Lampotang et al. teaches all the limitations of claim 19.
Furthermore, Lampotang et al. teaches a second access port positioned near the flexible sealing means and is configured to provide an air passageway to enable a patient to breathe (“the bag self-inflates with fresh ambient gas from atmospheric air or oxygen supplied via a one-way inlet valve”, paragraph [0008]).
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 nasal mask device of Pedro et al. in view of Lampotang et al. and create a second access port for an air passageway to allow the patient to breathe while wearing the device during an operation.
Regarding claim 22, a modified nasal mask device of Pedro et al. in view of Lampotang et al. teaches all the limitations of claim 19.
Furthermore, Lampotang et al. teaches the elongated flexible chamber comprising a transparent material (“self-inflating resuscitation bag may be formed of a transparent or translucent plastic”, paragraph [0034]).
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 nasal mask device of Pedro et al. in view of Lampotang et al. and make the elongated flexible chamber from a transparent material in order to view the devices going in and out of the chamber to reach the patient during a procedure.
Claims 11-16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Pedro et al. in view of Horne et al. (US 20070044802 A1).
Regarding claim 11, Pedro et al. teaches all the limitations of claim 1, but does not teach a pouch adjacent to at least one access port.
However, Horne et al. teaches at least one pouch formed adjacent to the nasal region (“two-compartment waterproof carrying pouch”, paragraph [0023]; 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 modify the nasal mask device of Pedro et al. with the pouch of Horne et al. and attach the pouches adjacent to at least one access port such that the pouch opens towards the top end of the tool passing channel, in order to collect any excess waste in the filters.
Regarding claim 12, a modified nasal mask device of Pedro et al. in view of Horne et al. teaches the pouch being designed to securely store hazardous material from a patient during a procedure (“pouch to hold filters and pads”, paragraph [0023], “filter out particles…viruses and bacteria or extremely very fine dust or smoke particles”, paragraph [0007]).
Regarding claim 13, a modified nasal mask device of Pedro et al. in view of Horne et al. teaches at least one pouch being adapted as a store area for storage of materials required during a procedure. The pouch of Horne et al. holds humidifying pads and filters that can be disposed after a procedure.
Regarding claim 14, Pedro et al. teaches a method for performing an Ears, Nose and Throat (ENT) Procedure, the method comprising the steps of:
Hermetically sealing the nasal region of a patient using a nasal mask device (paragraph [0048]), the nasal device comprising a plurality of longitudinally running tool passing channels angled inwardly towards each other, each tool passing channel having a bottom end with an access port formed on it and a top end opening to a nostril of the patient (shown in annotated Fig. 13 below), wherein each of the plurality of tool passing channels is capable of independent movement;
Introducing at least one surgical tool through the plurality of access ports, wherein at a time only one surgical tool can be introduced through each access port (paragraph [0093]);
Sealing each access port when the surgical tool is removed (paragraph [0092]).
Pedro et al. does not teach the plurality of pouches placed adjacently to the access ports.
However, Horne et al. teaches at least one pouch formed adjacent to the nasal region and collecting biohazardous waste generated during the procedure in the plurality of pouches (paragraphs [0007] and [0023]; shown in annotated Fig. 4 above, mentioned regarding claim 11).
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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 nasal mask device of Pedro et al. with the pouch of Horne et al., by making each access port have at least one pouch adjacent to it and inside the tool passing channel such that each pouch opens towards the top end of the tool passing channel (shown in annotated Fig. 2 above). This would allow for the healthcare worker to carry out the ENT procedure of putting on the nasal mask device for the patient, introducing a surgical tool into one of the access ports, collecting biohazardous waste within the pouches, and sealing the access ports when the procedure is completed.
Regarding claim 15, Pedro et al. teaches “one or more ports which contain…membrane seals that allow passage of a functional tool”, in paragraph [0015], wherein the number of tool passing channels could be four.
Regarding claim 16, Pedro et al. teaches all the limitations of claim 1, and also the nasal mask covering the mouth and nasal region of the user (nasal chamber 200, oral chamber 210, shown in annotated Fig. 4 and 5 above, as mentioned regarding to claim 9).
Pedro et al. does not teach the nasal region of the mask covering both the nasal region and the mouth, however it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine both separate parts and make one whole mask to cover both regions in order to create an airtight seal between the nose and mouth, making a more convenient design for the healthcare worker.
Regarding claim 18, Pedro et al. teaches all the limitations of claim 17, but does not teach a pouch adjacent to at least one access port.
However, Horne et al. teaches at least one pouch formed adjacent to the nasal region (“two-compartment waterproof carrying pouch”, paragraph [0023]; shown in annotated Fig. 4 above, as mentioned regarding claim 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 nasal mask device of Pedro et al. with the pouch of Horne et al. and attach the pouches adjacent to at least one access port such that the pouch opens towards the top end of the tool passing channel, in order to collect any excess waste as surgical tools enter and exit the nasal mask.
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