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 .
Priority
Acknowledgment is made of applicant’s claim for priority under 35 U.S.C. § 120 with reference to Application Number: 14/251296 filed on 04/11/2014.
Information Disclosure Statement
The Information Disclosure Statement(s) have been reviewed by the examiner and are found to comply with the provisions of 37 CFR 1.97, 1.98, and MPEP § 609.
Drawings
The drawing(s) have been reviewed by the examiner and are found to comply with the provisions of 37 CFR 1.81 to 1.85.
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 5, 8, and dependents therein 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 5 and 8 recite the limitations "configured to indicate a first predetermined insertion depth range such that in use the first end of the body is positioned a first predetermined insertion depth range" and “"configured to indicate a second predetermined insertion depth range such that in use the first end of the body is positioned a second predetermined insertion depth range". There is insufficient antecedent basis for the limitations in the claims. Furthermore, the limitations create ambiguity over the exact meaning of the insertion depth ranges, especially with regard to the second predetermined insertion depth range.
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.
Claim(s) 1 - 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harms (WO 2008138119) in view of Yamashita (WO 2013129027) in view of Runnels (US 10744288).
1. Harms discloses a method, comprising: inserting a laryngoscope into the mouth of a patient to visualize a vocal cord of the patient (see Fig. 1, laryngoscope unlabeled); obtaining a bougie having a body (10); inserting a first end of the body into the mouth of the patient (see Fig. 1, wherein the second end remains outside of the mouth); and removing the laryngoscope from the mouth of the patient (see Fig. 2).
However, Harms does not disclose the body with a first insertion depth indicator spaced a first distance from a first end of the body and configured to indicate a first predetermined insertion depth, and a second insertion depth indicator spaced a second distance from a second end of the body and configured to indicate a second predetermined insertion depth that is different from the first predetermined insertion depth; determining whether the first predetermined insertion depth or the second predetermined insertion depth is appropriate for the patient; wherein the method is further performed by performing at least one of the following actions: inserting the first end of the body into the mouth of the patient responsive to a determination that the first predetermined insertion is appropriate for the particular patient; inserting the second end of the body into the mouth of the patient responsive to a determination that the second predetermined insertion is appropriate for the particular patient. Nonetheless, in the reasonably pertinent art of medical tubing inserted according to depth indicators, Yamashita discloses a medical device body (1) with a first insertion depth indicator spaced a first distance from a first end of the body (see Fig. 2, first proximal mark “M”) and configured to indicate a first predetermined insertion depth (see p. 5, para. 10, the marking portion “M” corresponds to insertion of the device at the affected portion of interest; the marking portion “M” is predetermined and formed at the appropriate position depending on whether the patient is an adult or child, see p. 3, para. 4) and a second insertion depth indicator spaced a second distance from a second end of the body (see Fig. 2, second distal mark “M”) and configured to indicate a second predetermined insertion depth that is different from the first predetermined insertion depth (see p. 5, para. 10, the marking portion “M” corresponds to insertion of the device at the affected portion of interest; the marking portion “M” is predetermined and formed at the appropriate position depending on whether the patient is an adult or child, see p. 3, para. 4); determining whether the first predetermined insertion depth or the second predetermined insertion depth is appropriate for the patient (the marks and corresponding insertion depths are appropriate depending on whether the patient is a child or adult); wherein the method is further performed by performing at least one of the following actions: inserting the first end of the body into the patient responsive to a determination that the first predetermined insertion is appropriate for the particular patient; inserting the second end of the body into the mouth of the patient responsive to a determination that the second predetermined insertion is appropriate for the particular patient (the first end of the device body would be inserted upon determining the first predetermined insertion depth or “M” is appropriate depending on whether the patient is a child or adult; it is noted that the claims do not require the method to perform both acts of inserting both first and second ends since the claim is directed to “at least one of the following actions”). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the bougie of Harms according to include a first and second predetermined insertion depth as taught in Yamashita for the benefit of ensuring the bougie has been placed at an appropriate location within the body depending on whether the patient is a child or adult.
However, Harms in view of Yamashita does not disclose that the first predetermined insertion depth is a depth range, and that the second predetermined insertion depth is a depth range. Nonetheless, Runnels discloses an endotracheal tube introducer (c. 6: 41 – 43, Fig. 10), wherein the introducer is provided with a first predetermined insertion depth range, or a second predetermined insertion depth range, depending on whether the introducer is used on a child or adult (see c. 12: 61 – c. 13: 8, c. 13: 20 - 45); determining whether the first predetermined insertion depth range or the second predetermined insertion depth range is appropriate for the patient (c. 13: 20 – 45); wherein the method is further performed by performing at least one of the following actions: inserting the first end of the introducer into the mouth of the patient responsive to a determination that the first predetermined insertion range is appropriate for the particular patient; inserting the second end of the body into the mouth of the patient responsive to a determination that the second predetermined insertion range is appropriate for the particular patient (see discussion in Yamashita above). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the bougie having marked insertion depths of Harms in view of Yamashita with appropriate ranges as taught in Runnels for the benefit of ease-of-use as well as reducing trauma, see Runnels c. 12: 91 – c. 13: 8. Runnels furthermore reinforces using different predetermined insertion depths depending on whether the patient is a child or adult, when specifically using an introducer/bougie.
2. The method of claim 1, wherein the insertion depth range for the patient is determined by an age range of the patient (see discussion in Yamashita and Runnels above, where “child” versus “adult” is characterized by a difference in age range).
3. The method of claim 2, wherein the age range is a first predetermined age range and a second predetermined age range, and wherein the first predetermined insertion depth range corresponds to the first predetermined age range and the second predetermined insertion depth range corresponds to the second predetermined age range (see discussion above).
4. The method of claim 1, wherein the first insertion depth range is to be used on adult patients and the second insertion depth range is be used on pediatric patients (proximal mark would travel furthest into the body, as best described in Runnels).
5. A method of making a bougie, comprising: forming a first insertion depth range indicator on a body of the bougie, the body of the bougie having a first end and a second end and at least one surface extending between the first and second ends (see Harms and Yamashita as disclosed in claim 1 above), the first and second end each being configured to be inserted into the mouth and trachea of the patient (see Harms, Fig. 2, p. 6: 22 – 24, wherein both first and second portions 22 are disclosed as end portions), the body having an elongated shape that is sized and dimensioned to pass through a mouth and into a trachea of a patient (see Harms, claim 1 above), the body being constructed of a flexible and non-immunogenic material (Harms, p. 7: 16 – 19), wherein the first insertion depth range indicator is formed on the body and spaced a first distance from the first end of the body and configured to indicate a first predetermined insertion depth range such that in use the first end of the body is positioned a first predetermined insertion depth range past the mouth of the patient when the body is positioned into the mouth of the patient with the first insertion depth indicator (see discussion in Yamashita and Runnels, claim 1 above); forming a second insertion depth range indicator on the body of the bougie which is different from the first insertion depth range indicator, the second insertion depth indicator formed on the body and spaced a second distance from the second end of the body and configured to indicate a second predetermined insertion depth range (see discussion in Yamashita and Runnels, claim 1 above) such that in use the second end of the body is positioned a second predetermined insertion depth range past the mouth of the patient when the body is positioned into the mouth of the patient with the second insertion depth range indicator (examiner notes that the second end of the body can be considered to be past the mouth of the patient, by virtue of it lying outside the mouth of the patient; this is not inconsistent with an interpretation in which the first end of the body is considered to be past the mouth of the patient by virtue of register in the trachea; in an alternative interpretation, examiner notes that the clause is claimed in an intended use, and Harms would be fully capable of placing the second end of the bougie into the trachea of the patient); and wherein the first insertion depth range and the first distance are based upon an analysis of a first subset of patients within a group of possible patients (see discussion of Yamashita and Runnels, claim 1 above) and the second insertion depth range and second distance are based upon an analysis of a second subset of patients within the group of possible patients (see discussion of Yamashita and Runnels, claim 1 above; the second insertion depth determined based upon the analysis would also determine the second distance by virtue of subtracting the overall length).
6. The method of claim 5, wherein the first and second insertion depth range indicators have contrasting areas which are selected from a group consisting of a lowered section, a textured section, and a colored section (see Yamashita, abstract).
7. The method of claim 5, wherein the first insertion depth range is to be used on adult patients and the second insertion depth range is be used on pediatric patients (see discussion above).
8. A method of making a bougie, comprising: forming a first insertion depth range indicator on a body of the bougie, and a second insertion depth range indicator on the body of the bougie which is different from the first insertion depth range indicator, the body having a first end, a second end, and at least one surface extending between the first and second ends, the first insertion depth range indicator spaced a first distance from the first end of the body and configured to indicate a first predetermined insertion depth range such that in use the first end of the body is positioned a first predetermined insertion depth range past the mouth of a patient when the body is positioned in a mouth of the patient, the second insertion depth range indicator spaced a second distance from the second end of the body and configured to indicate a second predetermined insertion depth range such that in use the second end of the body is positioned a second predetermined insertion depth range past the mouth of the patient when the body is positioned into the mouth of the patient with the second insertion depth range indicator; and wherein the first insertion depth range and the first distance are based upon an analysis of a first subset of patients within a group of possible patients, and the second insertion depth range and second distance are based upon an analysis of a second subset of patients within the group of possible patients (see claim 5 above).
9. The method of claim 8, wherein the body is constructed of a flexible and non-immunogenic material (see claim 5 above).
10. The method of claim 8, wherein the first and second insertion depth range indicators have contrasting areas which are selected from a group consisting of a raised section, a lowered section, a textured section, and a colored section (see above).
11. The method of claim 8, wherein the first insertion depth range is to be used on adult patients and the second insertion depth range is be used on pediatric patients (see above).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY H PHILIPS whose telephone number is (571)270-5180. The examiner can normally be reached 8:00 - 5:00 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Casler can be reached at (571) 272-4956. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799