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 3, 4, and 8 are objected to because of the following informalities:
Claims 3 and 4 states “The cannula of claims 1” and shall be corrected to “The cannula of claim 1”.
Claim 8 recites “wherein the prong opening is configured to face the patient in a posterior direction when the prong is inserted in a nostril of the patient.” shall be corrected as “wherein the prong opening is configured to face the patient, facing a rear wall of the nostril when inserted in a nostril of the patient.” to mirror the language in the specification.
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 1, 2, 7, and 10-11 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kalnin (WO 2022251922 A1).
Regarding Claim 1, Kalnin discloses “a cannula comprising (nasal/oral cannula 1; Fig. 1; [0031]):
a cannula body (hollow manifold body 2) defining an exhalation lumen (internal cavity 3) configured to receive a volume of exhalation from a patient; and (Fig. 1; [0031])
at least one prong (nasal delivery stubs 8) extending from the cannula body and defining a prong lumen fluidically coupled to the exhalation lumen, wherein the prong lumen extends to a prong opening configured to introduce the volume of exhalation from the patient into the exhalation lumen (internal cavity 3) and wherein at least a portion of the prong opening (open distal end 9) faces radially outward from the at least one prong.” (Fig. 1; [0031-0032])
Regarding Claim 2, Kalnin discloses the cannula of claim 1, as mentioned above.
Kalnin further discloses wherein the cannula body extends along a cannula axis, and wherein the at least one prong extends along a prong axis substantially normal to the cannula axis.
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Regarding claim 7, Kalnin discloses the cannula of claim 1, as mentioned above.
Kalnin further discloses wherein the at least one prong is integral with the cannula body (“the nasal/oral cannula 1 is a singularly formed or moulded device whereby the delivery stubs 8 and fluid inlets 4, 5 are integrally formed.”; [0035]).
Regarding claim 10, Kalnin discloses the cannula of claim 1, as mentioned above.
Kalnin further discloses wherein the at least one prong comprises at least one polymer (“Most preferably, the nasal/oral cannula 1 is moulded from medical grade silicone rubber.”; [0035]).
Regarding claim 11, Kalnin discloses the cannula of claim 1, as mentioned above.
Kalnin further discloses wherein the at least one prong is a first prong (nasal delivery stubs 8), and wherein the cannula further comprises a second prong (nasal delivery stubs 8). (Figs. 1-3; [0032])
Claims 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chua (US 20140276169 A1).
Regarding Claim 13, Chua discloses a cannula comprising (nasal cannula 2; Figs. 1-3; [0029]):
a cannula body (tubular elongated face piece 4) defining a body lumen; (Figs. 1-3; [0029])
and a prong (second sampling snare 8) extending from the cannula body (tubular elongated face piece 4) and defining a prong lumen fluidically coupled to the body lumen, the prong defining a side opening (opening 40) open to the prong lumen. (Figs. 1-3; [0029-0032])
Regarding Claim 14, Chua discloses the cannula of claim 13, as mentioned above.
Chua further discloses wherein the prong defines the side opening (opening 40) with at least one connected or disconnected oval, circular, ellipsoidal, curved, or polygonal peripheral section (Figs. 1-3; [0033]).
Regarding Claim 15, Chua discloses the cannula of claim 13, as mentioned above.
Chua further discloses wherein the cannula body receives a volume of exhalation from a patient and is fluidically coupled to a capnography analysis module to deliver the volume of exhalation to the capnography analysis module (“A second opposed end of the end-tidal CO.sub.2 detection tube 22 is connected to a commercial carbon dioxide monitoring device or unit 26 which, in turn, has or is connected to a vacuum pump or other means or mechanism for drawing an exhaled breath (exhalation gases) from the patient. The exhaled breath, generally containing carbon dioxide, is drawn into a conventional instrument that is capable of measuring the concentration of the carbon dioxide contained within the sampled gas. As the source of the insufflating gas 24 and the carbon dioxide monitoring device or unit 26 are both conventional and well known in the art, a further detailed discussion concerning the same is not provided.”) [0030].
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Kalnin (WO 2022251922 A1) in view of Hobson (US 20150209542 A1).
Regarding Claim 3, Kalnin discloses the cannula of claim 1, as mentioned above.
Kalnin fails to disclose wherein the at least one prong extends from the cannula body to a closed prong end, and wherein the prong opening is between the closed prong end and the cannula body.
However, Hobson teaches the at least one prong (nasal prongs 33 and 34) extends from the cannula body to a closed prong end, and wherein the prong opening (cut-out section 41) is between the closed prong end and the cannula body (Fig. 7; [0119]), in order for the prongs to reduce air velocity and increase the flow rate of respiratory gases.
Therefore, 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 system of Kalnin to include the prongs that have a prong opening between the closed prong end and the cannula body, as taught by Hobson, to allow a proportionally greater volume of gases to be delivered to a patient without causing discomfort (in comparison to a cannula prong which does not include a cut-out) [0127].
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kalnin (WO 2022251922 A1).
Regarding Claim 9, Kalnin is silent to the cannula of claim 1, wherein the cannula of claim 1, wherein a center of the prong opening is spaced from a distal end of the prong by a distance in a range from 5% to 100% of a length of the at least one prong, the length being measured along a longitudinal axis of the at least one prong, and wherein a maximum width of the prong opening in a direction transverse to a longitudinal axis of the at least one prong is in a range from 10% to 50% of a maximum diameter of the prong. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have a center of the prong opening spaced from a distal end of the prong by a distance in a range from 5% to 100% of a length of the at least one prong, the length being measured along a longitudinal axis of the at least one prong, and wherein a maximum width of the prong opening in a direction transverse to a longitudinal axis of the at least one prong is in a range from 10% to 50% of a maximum diameter of the prong since the size of the prong opening is matter of design choice and the optimal sizes could be discovered by routine experimentation.
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Kalnin (WO 2022251922 A1) in view of Beck (US 20190314588 A1).
Regarding Claim 4, Kalnin discloses the cannula of claim 1, as mentioned above.
Kalnin fails to disclose wherein the prong opening extends to an open prong end.
However, Beck teaches the prong opening (air passageway 26k) extends to an open prong end (Figs. 12-14; [0119]) to permit gas to pass into the nasal cavity.
Therefore, 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 system of Kalnin to include the prong opening that extends to an open prong end, as taught by Beck, to form a passageway with a surface of the nasal cavity and to permit gas to pass thereby [0047].
Regarding Claim 5, Kalnin discloses the cannula of claim 1, as mentioned above.
Kalnin fails to disclose wherein the prong opening defines a pair of opposing prong edges, and wherein the pair of opposing prong edges are substantially parallel.
However, Beck teaches the prong opening (air passageway 26k) defines a pair of opposing prong edges, and wherein the pair of opposing prong edges are substantially parallel to direct air to reach a region of the nasal cavity (Fig. 12; [0173]).
Therefore, 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 apparatus of Kalnin to include the prong opening defines a pair of opposing prong edges, and wherein the pair of opposing prong edges are substantially parallel, as taught by Beck, to form a passageway with a surface of the nasal cavity and to permit gas to pass thereby [0047].
Regarding Claim 6, Kalnin discloses the cannula of claim 5, as mentioned above.
Kalnin fails to disclose wherein the prong defines a central prong axis, and wherein the pair of opposing prong edges extend in a direction inclined relative to the central prong axis.
However, Beck teaches the prong (nasal insert body 8k) defines a central prong axis, and wherein the pair of opposing prong edges extend in a direction inclined relative to the central prong axis to direct air to reach a region of the nasal cavity (Fig. 12; [0173]).
Therefore, 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 system of Kalnin to include the prong defining a central prong axis, and wherein the pair of opposing prong edges extend in a direction inclined relative to the central prong axis, as taught by Beck, to form a passageway with a surface of the nasal cavity and to permit gas to pass thereby [0047].
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Kalnin (WO 2022251922 A1) in view of Eckerbom (US 20160213281 A1).
Regarding Claim 12, Kalnin discloses the cannula of claim 1, as mentioned above.
Kalnin further discloses an oxygen lumen (manifold body 2) extending between an oxygen inlet (air delivery tube 12) and an oxygen delivery opening configured to transport oxygen to the patient (Figs. 8-11; [0033; 0050]).
Kalnin fails to disclose a mouthpiece extending from the cannula body and fluidically coupled to the exhalation lumen.
However, Eckerbom teaches a mouthpiece (oral breath collector 15) extending from the cannula body and fluidically coupled to the exhalation lumen (hollow prong 14) to collect larger quantities of exhaled gases from the patient. (Figs, 2A-2B; [0064-0067])
Therefore, 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 system of Kalnin to include a mouthpiece extending from the cannular body and fluidically couple to the exhalation lumen, as taught by Eckerbom, enable collection of larger quantities of exhaled gases from such a patient compared to use of a nasal cannula without a mouthpiece [0096].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Landis (US 20230084620 A1) for its prong opening structures in Figures 1-4 and 8A.
Scampoli (US 20170049986 A1) for its nasal cannula with mouthpiece structures in Figures 8-11.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy S Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMIRAH WRIGHT/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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