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 . Claims 1-18 are pending.
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 8, 10, 12, 14, 16 and 18 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.
Claims 8, 12 and 16 include the recitation that the first distance is adapted “to a second distance between incisor and glottis.” The Drawings and Specification fail to support or disclose the claimed “second distance.” It is further noted that applicant appears to be claiming a patient specific distance between an incisor and glottis making the recitation indefinite.
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.
Claim(s) 1, 4, 5 and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wu (U.S. 4,982,729).
Concerning claim 1, Wu discloses a guiding laryngoscope, comprising a holding part (10), a bending part (16), and a tongue lifting part (18), wherein the bending part is connected with an end of the holding part, and a guiding groove (47 and see below) for guiding an intubation tube is provided in the bending part; one end of the tongue lifting part (17) is connected with an end of the bending part away from the holding part and faces a side of the holding part, and the other end of the tongue lifting part is arranged to extend along a bending direction of the bending part; and the guiding groove has a tube-in end (near element 47) and a tube-out end (near element 36), and a first included angle (see Fig. 3 below) between an extension line of the tube-out end and a central axis of the holding part is smaller than a second included angle (see Fig. 3 below) between an extension line of an end of the tongue lifting part and the central axis of the holding part.
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Concerning claim 4, the holding part (10) is inclined towards a tongue lifting direction.
Concerning claim 5, further comprising an intubation-tube positioning part (12) provided at the tube-in end of the guiding groove, the intubation- tube positioning part protruding in the direction away from the holding part.
Concerning claim 6, further comprising: an intubation-tube guiding part (12) which is arranged at the tube-out end of the guiding groove and extends along the extension line of the tube-out end (see Fig. 2).
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 (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 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(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu (U.S. 4,982,729).
Wu discloses the invention substantially as described above. However, Wu does not explicitly disclose that the difference between the second included angle and the first included angle is greater than 0° and less than or equal to 4°.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form the blade such that the difference between the second included angle and the first included angle is greater than 0° and less than or equal to 4°. The specific angular differential of 0°–4° between the tube-out angle and the tongue-lifting-part angle constitutes a matter of routine optimization within the skill of the ordinary practitioner. A 0°–4° differential represents a minor, predictable design adjustment to minimize angular deviation between the tube exit path and the tongue-lifting axis, the optimization of which would have been well within the ordinary skill in the art.
Concerning claim 3, Wu discloses the invention substantially as described above. However, Wu does not explicitly disclose that the first included angle is 75° to 77°.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to form the first included angle to be 75 to 77 degrees. The specific value of 75°–77° for the first included angle represents a routine selection from a known range. Laryngoscope blade geometries in the art are routinely designed with blade-to-handle angles in the range of approximately 70°–90° to conform to the anatomy of the oral and pharyngeal cavity. Selecting 75°–77° for the tube-out angle is a routine design choice within this known range, the optimization of which would have been well within the level of ordinary skill in the art.
Claim(s) 7, 9, 11, 13, 15 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu (U.S. 4,982,729) as applied to claim 1 above, in view of Jiang et al. (U.S. 8,894,570).
Wu discloses the invention substantially as described above. However, Wu does not explicitly disclose that a camera, which is arranged at a side of the tube-out end of the guiding groove, and a central axis of a viewing angle of the camera being inclined towards a direction of a movement axis of the intubation tube after the intubation tube extends out along the tube-out end of the guiding groove.
Jiang et al. teaches a video laryngoscope having a camera (see Fig. 2, element 104) located at or adjacent the distal end of the laryngoscope groove (tube-out end side), wherein the central axis of the camera’s viewing angle is inclined toward the direction of the movement axis of the endotracheal tube as the tube exits the guiding groove, so that the camera can visualize the tube’s trajectory into the glottis.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the camera arrangement of Jiang et al. into the laryngoscope of Wu, in order to provide real-time video visualization of tube placement which is a well-recognized goal in the art. The combination involves only the application of a known technique (adding a camera inclined toward the tube path at the groove exit) to a known device (a grooved guiding laryngoscope) to achieve a predictable result (video guidance of tube trajectory into the glottis).
Concerning claims 9, 13 and 17, Jiang et al. discloses that the camera’s viewing axis is inclined toward the tube movement axis, with the angular offset between the camera axis and tube movement axis being optimized to ensure that the tube tip remains within the camera’s field of view as it exits the groove and advances toward the glottis. The specific value of 7°–10° for the included angle between the camera axis and tube movement axis represents a routine selection within a known optimization range. The angular offset between a camera and a tube guide in a video laryngoscope is a result-effective variable that one of ordinary skill in the art would optimize through routine experimentation to maintain tube tip visibility while minimizing image distortion. Selecting 7°–10° is a predictable design choice within the range suggested by the prior art
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLEN HAMMOND whose telephone number is (571)270-3819. The examiner can normally be reached Monday-Friday 8 - 4 PM .
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. Robert, at 571 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ELLEN C HAMMOND/Primary Examiner, Art Unit 3773