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 8, 9, and 17 are objected to because of the following informalities:
In claim 8, line 1, “less then” should be amended to read --less than -- to correct a typographical error.
In claim 9, line 1, “less then” should be amended to read --less than -- to correct a typographical error.
In claim 17, line 1, “less then” should be amended to read --less than -- to correct a typographical error.
Appropriate correction is required.
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 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.
(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 12-16, and 17 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Leeflang (US 2012/0283513).
As to claim 12, Leeflang discloses a bite block 10 (Figs. 1A-1G) comprising:
a main body (flange 40) comprising a first surface (face 42 shown in Fig. 1A) and a second surface (the back/patient side surface of flange 40) opposite the first surface 42 (paragraph [0035]);
a mouthpiece (including proximal portion 20 and curved distal portion 30, see Fig. 1D) extending outward from the second surface of the main body 40 and configured to be positioned in a mouth of a subject when the bite block 10 is in use (paragraph [0036]), and wherein the mouthpiece comprises:
a main channel (instrument passage 12) configured to receive an endoscopic tube (paragraph [0034]); and
a sampling channel 50 configured to receive orally exhaled gases from the subject (Figs. 1A-1B, paragraph [0035]]);
a gas delivery channel 60 (oxygen, gas or other fluid delivery lumen 60, Figs. 1A, 1C-1G) configured to direct gases into the subject's mouth when the bite block 10 is in use, the gas delivery channel 60 extending through a portion of the main channel 12 (at opening 64, Fig. 1C) of the mouthpiece 20, 30 such that the gas delivery channel 60 is in fluid communication with the main channel 12 (paragraph [0035]); and
a recess 62 extending along a portion of the first surface 42 of the main body 12 proximate the gas delivery channel yes60, wherein the recess is configured to receive a portion of a gas delivery tube (see annotated Fig 1F, showing that the end of port 62 is recessed from the face 42; see also paragraph [0035] describing that the ports 52, 62 may be recessed within or behind the flange 40).
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As to claim 13, Leeflang discloses the bite block of Claim 12, wherein an axis extending through a center of the gas delivery channel is transverse relative to an axis extending through a center of the main channel (see annotated Fig. 1F below).
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As to claim 14, Leeflang discloses the bite block of Claim 12, wherein a first end of the recess is located at the gas delivery channel and a second end of the recess is spaced away from the gas delivery channel (see annotated Fig. 1F below).
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As to claim 15, Leeflang discloses the bite block assembly of Claim 14, wherein the main body 40 comprises a first wing, a second wing, and an intermediate portion between the first and second wings, and wherein the second end of the recess is located at a junction where the first wing and the intermediate portion of the main body 40 meet (see annotated Fig. 1F below).
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As to claim 16, Leeflang discloses the bite block of Claim 12, wherein the recess comprises a substantially semi- circular cross-section (see Figs. 1G, 1F).
As to claim 17, Leeflang discloses the bite block of Claim 12, wherein the recess is configured to surround less than an entire cross-section of the portion of the gas delivery tube (see Figs. 1G, 1F).
Claim Rejections - 35 USC § 103
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 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 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 1-9 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Leeflang (US 2012/0283513), in view of Thomas (US 2020/0282164).
As to claim 1, Leeflang discloses a bite block 10 (Figs. 1A-1G) comprising:
a main body (flange 40) comprising a first surface (face 42 shown in Fig. 1A) and a second surface (the back/patient side surface of flange 40) opposite the first surface 42 (paragraph [0035]), a first wing, a second wing, and an intermediate portion between the first and second wings, the first and second wings extending laterally away from the intermediate portion (see annotated Fig. 1G below);
a mouthpiece (includes proximal portion 20 and distal portion 30, see Fig. 1D) extending outward from the second surface of the main body 40 and configured to be positioned in a mouth of a subject when the bite block 10 is in use, wherein the first and second wings of the main body 40 are configured to be positioned on opposite sides of the subject's mouth and adjacent the subject's face when the mouthpiece is positioned in the subject's mouth(see Fig. 1D, paragraph [0036]), and wherein the mouthpiece comprises:
a main channel (instrument passage 12) configured to receive an endoscopic tube (paragraph [0034]); and
a sampling channel 50 configured to receive orally exhaled gases from the subject (Figs. 1A-1B, paragraph [0035]]);
a gas delivery channel 60 (oxygen, gas or other fluid delivery lumen 60, Figs. 1A, 1C-1G) configured to direct gases into the subject's mouth when the bite block 10 is in use, the gas delivery channel 60 extending through the intermediate portion of the main body 40 (at port 62, Fig. 1A) and through a portion of the main channel 12 (at opening 64, Fig. 1C) of the mouthpiece 20, 30 such that the gas delivery channel 60 is in fluid communication with the main channel 12 (see paragraph [0035]; see also paragraph [0055] describing other locations for the channel 60 and port 62, such as on the opposite side of the flange 40 as the channel 50 and port 52); and
a gas delivery tube 160 (shown in Fig. 3B) configured to deliver gases to the gas delivery channel, the gas delivery tube 160 comprising a first end (at 168) and a second end (at 161) opposite the first end, wherein the second end is permanently secured within the gas delivery channel (lumen 160 may be bonded to airway tube 114by welding or fusing, paragraph [0066]); and
a recess 62 extending along a portion of the first surface 42 of the main body 12 proximate the gas delivery channel 60, wherein the recess is configured to receive a second portion of the gas delivery tube (see annotated Fig 1F, showing that the end of port 62 is recessed from the face 42; see also paragraph [0035] describing that the ports 52, 62 may be recessed within or behind the flange 40).
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Leflang does not disclose a tube clip located on a portion of the first wing of the main body, the tube clip comprising a first arm and a second arm, each of the first and second arms extending outward from the first wing and having free ends that are separated from one another by a gap, wherein the first and second arms are configured to secure a first portion of the gas delivery tube.
However, Thomas teaches a bite block 100 including a tube clip (fastener 110a, Fig. 1) located on a wing of a main body of the bite block 100 (on the left side of collar 108), the tube clip 110a comprising a first arm 112a and a second arm 114a, each of the first and second arms extending outward from the main body/collar 108 and having free ends that are separated from one another by a gap (slit 115a), wherein the first and second arms 112a,114a are configured to secure a first portion of a tube 122 (see Fig. 1, Fig. 2, paragraph [0034]).
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the bite block of Leeflang to include a tube clip 110a on the first wing of the main body/flange 40, as taught by Thomas, in order to provide a means to secure the gas delivery tube in place and direct it away from the opening of the main channel.
As to claim 2, modified Leeflang discloses the bite block of Claim 1, wherein an axis extending through a center of the gas delivery channel is transverse relative to an axis extending through a center of the main channel (see annotated Fig. 1F below).
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As to claim 3, modified Leeflang discloses the bite block of Claim 1, wherein a first end of the recess is located at the gas delivery channel and a second end of the recess is spaced away from the gas delivery channel (see annotated Fig. 1F below).
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As to claim 4, modified Leeflang discloses the bite block assembly of Claim 3, wherein the recess extends from the first end to the second end, and wherein the second end of the recess is located at a junction where the first wing and the intermediate portion of the main body meet (see annotated Fig. 1F below).
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As to claim 5, modified Leeflang discloses the bite block of Claim 1, wherein the recess extends from the gas delivery channel along the intermediate portion and toward the first wing.
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As to claim 6, modified Leeflang discloses the bite block of Claim 5, wherein the recess extends from the gas delivery channel along the intermediate portion and toward the tube clip (the modified Leeflang has the tube clip at the end of the flange, on the wing; thus, the recess will extend toward the tube clip, see Fig. 1 of Thomas).
As to claim 7, modified Leeflang discloses the bite block of Claim 1, wherein the recess comprises a substantially semi- circular cross-section (see Figs. 1G, 1F of Leeflang).
As to claim 8, modified Leeflang discloses the bite block of Claim 1, wherein the recess is configured to surround less than an entire cross-section of the first portion of the gas delivery tube (see Figs. 1G, 1F of Leeflang).
As to claim 9, modified Leeflang discloses the bite block of Claim 1, wherein the recess is configured to surround less than about 3/4 of a cross-section of the first portion of the gas delivery tube (see Figs. 1G, 1F of Leeflang).
As to claim 18, Leeflang discloses the bite block of Claim 12, does not disclose a tube clip located on a portion of the first wing of the main body, the tube clip comprising a first arm and a second arm, each of the first and second arms extending outward from the first wing and having free ends that are separated from one another by a gap, wherein the first and second arms are configured to secure a first portion of the gas delivery tube.
However, Thomas teaches a bite block 100 including a tube clip (fastener 110a, Fig. 1) located on a wing of a main body of the bite block 100 (on the left side of collar 108), the tube clip 110a comprising a first arm 112a and a second arm 114a, each of the first and second arms extending outward from the main body/collar 108 and having free ends that are separated from one another by a gap (slit 115a), wherein the first and second arms 112a,114a are configured to secure a first portion of a tube 122 (see Fig. 1, Fig. 2, paragraph [0034]).
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the bite block of Leeflang to include a tube clip 110a on the first wing of the main body/flange 40, as taught by Thomas, in order to provide a means to secure the gas delivery tube in place and direct it away from the opening of the main channel.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Leeflang (US 2012/0283513), in view of Thomas (US 2020/0282164), as applied to claim 1 above, and further in view of Geraghty et al. (US 2016/0296719).
As to claim 10, modified Leeflang discloses the bite block of Claim 1, but does not expressly disclose that a first portion of the gas delivery channel comprises a first cross-section and a second portion of the gas delivery channel comprises a second cross-section that is different than the first cross-section.
However, Geraghty teaches a delivery channel 96, 116 (Fig. 2) which has a first cross section 96 and a second larger cross section (at 116) where the channel receives tubing 26 (paragraph [0141]).
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the bite block of Leeflang so that the gas delivery channel has a larger cross section at the port opening 62 than through the rest of the channel 60, as taught by Geraghty, so that, when connected, the inner diameter of the oxygen tubing will line up with the inner diameter of the gas delivery channel for a smooth transition of gas flow.
As to claim 11, modified Leeflang discloses the bite block of Claim 10, further comprising said gas delivery tube 26 (see Geraghty, Fig. Fig. 2) said gas delivery tube 26 comprising a first end and a second end, wherein a ledge is defined at a juncture of the first and second cross-sections of the gas delivery channel 116, and wherein the second end of the gas delivery tube 26 abuts the ledge (see Fig. 2A of Geraghty below, paragraph [0141]).
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Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Leeflang (US 2012/0283513), in view of Geraghty et al. (US 2016/0296719).
As to claim 19, Leeflang discloses the bite block of Claim 12, but does not expressly disclose that a first portion of the gas delivery channel comprises a first cross-section and a second portion of the gas delivery channel comprises a second cross-section that is different than the first cross-section.
However, Geraghty teaches a delivery channel 96, 116 (Fig. 2) which has a first cross section 96 and a second larger cross section (at 116) where the channel receives tubing 26 (paragraph [0141]).
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the bite block of Leeflang so that the gas delivery channel has a larger cross section at the port opening 62 than through the rest of the channel 60, as taught by Geraghty, so that, when connected, the inner diameter of the oxygen tubing will line up with the inner diameter of the gas delivery channel for a smooth transition of gas flow.
As to claim 20, modified Leeflang discloses the bite block of Claim 19, further comprising said gas delivery tube 26 (see Geraghty, Fig. Fig. 2) said gas delivery tube 26 comprising a first end and a second end, wherein a ledge is defined at a juncture of the first and second cross-sections of the gas delivery channel 116, and wherein the second end of the gas delivery tube 26 abuts the ledge (see Fig. 2A of Geraghty below, paragraph [0141]).
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Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Colman et al. (US 2010/0262033) and Weisman (US 2016/0256652) each disclose a bite block having a main channel and a gas delivery channel.
Palmer (US 2003/0154987) discloses a tube stabilizer (Fig. 1) having a combination of channels 61 and clasps 60 for holding a tube.
Slaughter (US 2024/0066246) discloses an oral airway having a recess (notch 108a,b, Fig. 2) in a flange for holding a gas delivery tube.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALERIE L WOODWARD whose telephone number is (571)270-1479. The examiner can normally be reached on Monday - Friday 8:30 am - 4:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KENDRA CARTER can be reached on 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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/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785