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 3 and 15 objected to because of the following informalities:
Claim 3, line 2 recites “the edge portion”. This is unclear, as the component is introduced in claim 1 as “the outer edge”. For this reason, the aforementioned recitation in claim 3 should read “the outer edge”.
Claim 15, line 2 recites “sampling line / device”. This is unclear as the “/” may be interpreted in different ways. For sake of clarity, the aforementioned recitation should read “sampling line or device”.
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 (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 1-6, 8, and 12-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Colman et al. (US 20090275851 A1) (hereon referred to as Colman).
Regarding claim 1, Colman teaches an oral circumferential holding device (110, see Fig. 6A) adapted to hold the oral cavity of a patient open so as to allow breathing by the patient through the oral cavity and/or through the patient's nostril or nostrils while at the same time allowing surgery or instrumentation of the oral cavity and related areas of said patient to proceed unobstructed (see Para. [0005]), the holding device including:
an expandable internal flange (62) and an expandable external flange (70), the external flange (70) having an outer edge (52), the outer edge including an edge portion adapted to be placed adjacent the nostrils of a patient (see Fig. 5C), and
sampling tubing (118, 122) for collecting air exhaled by the nose and/or by the mouth of the patient (see Para. [0065]), said sampling tubing connectable to a capnography machine (see Para. [0010]) to enable the uninterrupted and unobstructed sampling of CO2 expired by said patient (see Para. [0063]).
Regarding claim 2, Colman teaches an oral circumferential holding device according to claim 1, wherein the sampling tubing (118, 122, 126) comprise nasal cannulae (118) arrangeable in or adjacent to the nostrils of the patient (see Para. [0082]).
Regarding claim 3, Colman teaches the oral circumferential holding device according to claim 2, wherein the nasal cannulae (118) are integrated into the outer edge (52) of the external flange (note that the connection with portion 52 via groove 172 integrates the two components, also see Fig. 9).
Regarding claim 4, Colman teaches an oral circumferential holding device according to claim 1, wherein the sampling tubing (118, 122, 126) comprises a mouth exhaust manifold (122, 126), preferably integrated in an edge (172) of the oral circumferential holding device (110), the mouth exhaust manifold (122, 126) comprising channels being interspaced along a circumference of the internal flange (note that both channels are centered over each other, thereby interspaced on the circumference of the flange, see Fig. 9).
Regarding claim 5, Colman teaches the oral circumferential holding device according to claim 1, comprising additional tubing (138, 142) for 02 nasal and mouth supply (see Para. [0066]).
Regarding claim 6, Colman teaches the oral circumferential holding device according to claim 5, including external connections (140) for connecting the additional tubing to 02 supply (see Para. [0066]) and connections for connecting the sampling tubing to the capnography machine (see Para. [0066]).
Regarding claim 8, Colman teaches the oral circumferential holding device according to claim 1, wherein the external flange (70) is contoured so as to fit in the full external circumference of the lips and oral cavity (see Fig. 10C).
Regarding claim 12, Colman teaches an oral and nasal capnography system adapted to facilitate monitoring of a patient (see claim 15), the system including the oral circumferential holding device of claim 1 (see rejection of claim 1 above), and further including a capnography machine which is adapted to analyze levels of CO2 in the patient (see Para. [0063]).
Regarding claim 13, Colman teaches the oral and nasal capnography system of claim 12, including an oxygen supply and monitoring system for administering oxygen to the patient (see claim 19).
Regarding claim 14, Colman teaches an oral circumferential holding device according to claim 1, wherein the sampling tubing (118, 122, 126) is at least partially integrated in the external flange (70; integrated via portion 126).
Regarding claim 15, Colman teaches the oral and nasal capnography system according to claim 12, comprising a capnography sampling device (see Para. [0063] and claim 15).
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.
Claims 7, 9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Colman as applied in the rejection of claim 1 above, and further in view of Robertson et al. (US 6679257 B2) (hereon referred to as Robertson).
Colman teaches an oral and nasal capnography system as outlined in the rejection of claim 1 above, however fails to teach wherein the internal flange and the external flange are biased to expand so as to help retract a patient's lip and/or cheek (claim 7), wherein an edge of the internal flange and/or an edge of the external flange is made of firm, reinforcing yet flexible and bendable plastic type tubing, connected by an elastic nonreinforced material (claim 9), and wherein the internal flange is internally contoured so as to fit in the full internal circumference of oral cavity and mucosa (claim 11).
Robertson teaches a mouthpiece (102) configured for breathing assistance with a shield to protect the mouth of the user (see Col. 2, ll. 34-42), wherein the mouthpiece has an internal flange (106) and an external flange (100), wherein the internal flange (106) and the external flange (100) are biased to expand so as to help retract a patient's lip and/or cheek (see Col. 6, ll. 37-46) (claim 7), wherein an edge of the internal flange (106) and/or an edge of the external flange (100) is made of firm, reinforcing yet flexible and bendable plastic type tubing (see Col. 6, ll. 27-29), connected by an elastic nonreinforced material (see Col. 2, ll. 34-42) (claim 9), and wherein the internal flange (106) is internally contoured so as to fit in the full internal circumference of oral cavity and mucosa (see Col. 6, ll. 17-22) (claim 11).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mouthpiece of Colman to be biased for retraction as taught by Robertson, wherein the flange is made of flexible tubing connected by an elastic nonreinforced material as taught by Robertson, and wherein the internal flange is internally contoured so as to fit in the full internal circumference of oral cavity and mucosa as taught by Robertson, as all of these modifications would improve patient comfort and safety with the use of the mouthpiece (see Col. 2, ll. 34-42).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Colman as applied in the rejection of claim 1 above, and further in view of Cipollone et al. (US 20110094518 A1) (hereon referred to as Cipollone).
Colman teaches an oral and nasal capnography system as outlined in the rejection of claim 1 above, further comprising a T-connector (140) adapted to join at least two branches of the sampling tubing into one tube for connection to the capnography machine (see Para. [0066]), however fails to teach a Y-connector adapted to join said at least two branches of the sampling tubing.
Cipollone teaches a ventilatory support system configured to provide ventilatory support to a patient (see Para. [0009]), wherein the device consists of tubing (511, 515) adapted to attach to a connector (605) via a Y connector (601) (see Para. [0090]).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the T-connector of Colman to be a Y-connector as taught by Cipollone, as this would be an obvious variant of the T-connector enable different configuration of tubing as desired (see Para. [0090]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See form PTO-892.
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/H.J.L./Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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