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 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, 7, and 9-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goldberg et al. (2021/0322735).
With respect to claim 1, Goldberg discloses a thoracostomy tube, as disclosed in paragraph [0002], comprising a tube body 11, as shown in figure 1A, having a lumen, as disclosed in paragraph [0025], a proximal end 16, a distal end (shown but not numbered, opposite end as the proximal end), an inflatable balloon 12 carried on the tube body 11, and an adjustable external bolster 29 carried on the tube body 11 between the balloon 12 and the proximal end 16, as disclosed in paragraph [0029].
With respect to claim 2, a portion of the tube body 11 distal to the balloon 12 include sentinel apertures 15, as shown in figure 1A, in communication with the lumen, as disclosed in paragraph [0032].
With respect to claim 3, a port 19 is adapted for inflating and deflating the balloon 12, as shown in figure 1A and disclosed in paragraph [0029].
With respect to claim 4, the port 19 is in fluid communication with a dedicated balloon passageway 18 within the tube body 11, as shown in figure 1A and disclosed in paragraph [0029].
With respect to claim 7, the external bolster 20 has a face oriented towards the balloon 12, as shown in figure 1A.
With respect to claim 9, the external bolster 20 is cone-shaped, as shown in figure 1A.
With respect to claim 10, the balloon 12 is donut-shaped when inflated, as disclosed in paragraph [0028].
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) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goldberg et al. (2021/0322735) in view of Mullen (7,229,433).
With respect to claims 5-6, Goldberg discloses all aspects of the claimed invention with the exception of a radio-opaque strip on a portion of the tube body distal to the inflatable balloon. Mullen teaches providing a radio-opaque strip on a thoracostomy tube body to allow for determination of the path the tube has taken and the position of the tube relative to the patient’s chest wall, as disclosed in column 8, lines 1-13. It would therefore have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide the tube body distal to the inflatable balloon of Goldberg with a radio-opaque strip, as taught by Mullen, to allow for determination of the path the tube has taken and the position of the tube relative to the patient’s chest wall.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goldberg et al. (2021/0322735).
With respect to claim 8, Goldberg discloses all aspects of the claimed invention with the exception of the face of the external bolster including an antimicrobial coating. Goldberg discloses in paragraph [0025] that the outer surface of the tube body 11 can be coated with an antimicrobial agent, but remains silent as to the face of the external bolster. Goldberg discloses in paragraph [0009] that the bolster is adjusted to contact the patient’s skin. It would therefore have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide the face of the bolster of Goldberg with an antimicrobial coating to achieve the predictable result of reducing the risk of infection for the patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patents and Publications 2020/0272192; 2009/0205643; and 6,638,253 disclose thoracostomy tubes comprising external bolsters.
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/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781