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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-8 in the reply filed on February, 27, 2026 is acknowledged.
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.
Claim 8 is 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.
The term “low” in claim 8 is a relative term which renders the claim indefinite. The term “low” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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) 1-3, 6, 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wodicka et al.(US 5,445,144, hereinafter Wodicka ‘144).
In re claim 1, Wodicka ‘144 teaches a device for measuring an obstruction of a tracheostomy tube, a trachea, and a bronchus, the device comprising: an obstruction measurement unit which is coupled (fig. 6, 108, 100, 104, 102, 110, 92, 94 which is coupled to 16; col. 9, lines 23-45) to a tracheostomy tube entrance where tracheostomy has been performed (fig. 6, element 16; col. 7, lines 10-26), and is configured to transmit a sound wave and receive a reflected sound wave to measure an obstruction degree in any one of the tracheostomy tube, the trachea, and the bronchus (col. 10, lines 5-55).
In re claim 2, Wodicka ‘144 teaches wherein the obstruction measurement unit comprises at least one processor including: a sound source generation unit configured to generate and output a sound source signal of the sound wave (fig. 6, amplifier 104); a sound wave transmission unit configured to receive the sound source signal, and generate and transmit a sound wave (fig. 6, speaker 100; col. 9, line 45-col.10, line 25); a sound wave reception unit configured to receive a reflected sound wave from an inside of any one of the tracheostomy tube, trachea, or bronchus (col. 10, line 24-55); and a sound wave analysis unit configured to calculate a reflected site using transmission and reception time of the received sound wave, and then calculate an internal cross-sectional area or volume of any one of the tracheostomy tube, trachea, or bronchus to output the obstruction degree (col. 12, lines 29-50).
In re claim 3, Wodicka ‘144 teaches wherein the obstruction degree comprises an obstruction site as distance information (col. 8, lines 4-40; col. 10, lines 43-63; col. 11, line 53-col. 13, line 15), and cross-sectional area or volume information of the obstruction site (col. 8, lines 4-40; col. 10, lines 43-63).
In re claim 6, Wodicka ‘144 teaches the device further comprising a display unit configured to indicate an obstruction site of one of the tracheostomy tube, trachea, or bronchus measured in the obstruction measurement unit (fig. 6, 98; col. 14, lines 12-25).
In re claim 8, Wodicka ‘144 teaches wherein the sound wave comprises at least one of a low frequency sound wave, an audible frequency sound wave or an ultrasonic wave (col. 14, lines 42-44, note that sounds an alarm which is an audible frequency sound wave).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wodicka ‘144.
In re claim 7, Wodicka ‘144 teaches wherein the display unit further comprises an obstruction notification unit configured to output an obstruction alarm when a calculated internal cross-sectional diameter (area or volume) of any one of the tracheostomy tube, trachea, or bronchus is smaller than a preset cross-sectional area or volume (col. 14, line 57-col. 15, line 2).
Wodicka ‘144 merely fails to teach cross-sectional area. However, it would have been obvious that when the cross-sectional diameter is known, the cross-sectional area can be easily estimated because area = pi * (diameter/2)^2.
It would have been a design choice to use either the cross-sectional diameter or area to trigger the alarm. Applicant has not indicated that the area would offer additional advantage than the diameter or areas derived from the diameter.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wodicka ‘144 in view of Goldsmith (US 2019/0247050, hereinafter Goldsmith ‘050).
In re claim 4, Wodicka ‘144 teaches wherein the sound wave analysis unit further comprises a tracheostomy tube, trachea or bronchus is smaller than a preset cross-sectional diameter
Wodicka ‘144 merely fails to teach cross-sectional area or volume. However, it would have been obvious that when the cross-sectional diameter is known, the cross-sectional area can be easily estimated because area = pi * (diameter/2)^2.
It would have been a design choice to use either the cross-sectional diameter or area to trigger the alarm. Applicant has not indicated that the area would offer additional advantage than the diameter or areas derived from the diameter.
Furthermore, Goldsmith ‘050 teaches near field communication unit configured to transmit signals (5048, 5073, 5219, 5143, 5148, 5149, 5152, 5153).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Wodicka ‘144 to include the features of Goldsmith ‘050 in order to reduce wiring and provide wireless communication for the sensors.
Allowable Subject Matter
Claim 5 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BO JOSEPH PENG whose telephone number is (571)270-1792. The examiner can normally be reached Monday thru Friday: 8:00 AM-5:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNE M KOZAK can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BO JOSEPH PENG/Primary Examiner, Art Unit 3797
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