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
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) 1-6, 8-14, and 16-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Andino et al. (US 20120271240).
Regarding claim 1, Andino et al. discloses an integrated dressing 100 for use with a catheter assembly (210, 220, and associated elements; see fig. 1-2), comprising: a base 110 defining a perimeter (perimeter of 110), the base comprising a bottom surface configured to contact skin of a patient (par. 0030); a cover portion 120 attached to the base (see fig. 1-2) and configured to cover a site of a catheter insertion (see fig. 2); and a stabilizing clip 130, attached to the base or the cover portion (see fig. 1-2), and configured to releasably couple to a catheter adapter (see fig. 1-2).
Regarding claim 2, Andino et al. discloses the base comprises a fabric (woven material; par. 0030, 0033).
Regarding claim 3, Andino et al. discloses the fabric comprises an adhesive on the bottom surface thereof (par. 0030).
Regarding claim 4, Andino et al. discloses a peelable tab arranged on the bottom surface of the base, covering the adhesive (release liner; par. 0032, 0034).
Regarding claim 5, Andino et al. discloses the base further comprises one or more arms extending inward from the perimeter (arms of element 132, see fig. 1-2), and wherein the stabilizing clip is coupled to the one or more arms (see fig. 1-2).
Regarding claim 6, Andino et al. discloses the stabilizing clip is configured such that the catheter adapter is maintained at an angle relative to the skin of the patient (via angled support 138; par. 0044, 0051).
Regarding claim 8, Andino et al. discloses the cover portion comprises an opening 128 configured to allow at least a portion of the catheter assembly to pass therethrough (see fig. 1-2, particularly fig. 2).
Regarding claim 9, Andino et al. discloses a stabilized catheter set (fig. 1-2), comprising: a catheter assembly (210, 220, and associated elements) comprising: a catheter adapter 222, comprising: a distal end (end of 222 towards the right of fig. 1); a proximal end (end of 222 towards the left of fig. 1); a lumen (lumen of 222 visible in fig. 1) arranged between and in fluid communication with the distal end and the proximal end (see fig. 1); and a catheter 210 arranged at the distal end of the catheter adapter and in fluid communication with the lumen (see fig. 2); and an integrated dressing 100, comprising: a base 110 defining a perimeter (perimeter of 110), the base comprising a bottom surface configured to contact skin of a patient (par. 0030); a cover portion 120 attached to the base (see fig. 1-2) and configured to cover a site of a catheter insertion (see fig. 2); and a stabilizing clip 130, attached to the base or the cover portion (see fig. 1-2), and configured to releasably couple to a catheter adapter (see fig. 1-2).
Regarding claim 10, Andino et al. discloses the base comprises a fabric (woven material; par. 0030, 0033).
Regarding claim 11, Andino et al. discloses the fabric comprises an adhesive on the bottom surface thereof (par. 0030).
Regarding claim 12, Andino et al. discloses a peelable tab arranged on the bottom surface of the base, covering the adhesive (release liner; par. 0032, 0034).
Regarding claim 13, Andino et al. discloses the base further comprises one or more arms extending inward from the perimeter (arms of element 132, see fig. 1-2), and wherein the stabilizing clip is coupled to the one or more arms (see fig. 1-2).
Regarding claim 14, Andino et al. discloses the stabilizing clip is configured such that the catheter adapter is maintained at an angle relative to the skin of the patient (via angled support 138; par. 0044, 0051).
Regarding claim 16, Andino et al. discloses the cover portion comprises an opening 128 configured to allow at least a portion of the catheter assembly to pass therethrough (see fig. 1-2, particularly fig. 2).
Regarding claim 17, Andino et al. discloses a method of securing a catheter at a site of insertion (fig. 1-2), comprising: providing a catheter assembly (210, 220, and associated elements) comprising: a catheter adapter 222, comprising: a distal end (end of 222 towards the right of fig. 1); a proximal end (end of 222 towards the left of fig. 1); a lumen (lumen of 222 visible in fig. 1) arranged between and in fluid communication with the distal end and the proximal end (see fig. 1); and a catheter 210 arranged at the distal end of the catheter adapter and in fluid communication with the lumen (see fig. 2); inserting the catheter into a patient (fig. 2); providing an integrated 100 dressing comprising: a base 110 defining a perimeter (perimeter of 110), the base comprising a bottom surface configured to contact skin of a patient (par. 0030); a cover portion 120 attached to the base (see fig. 1-2) and configured to cover a site of a catheter insertion (see fig. 2); and a stabilizing clip 130, attached to the base or the cover portion (see fig. 1-2), and configured to releasably couple to a catheter adapter (see fig. 1-2); coupling the stabilizing clip to the catheter adapter (pre-coupled in fig. 1, coupled in fig. 2); and securing the base to the skin of the patient (see fig. 2; par. 0030).
Regarding claim 18, Andino et al. discloses the integrated dressing further comprises an adhesive on the bottom surface thereof (par. 0030) and a peelable tab arranged on the bottom surface of the base, covering the adhesive (par. 0032, 0034), and wherein the method further comprises, prior to securing the base to the skin of the patient, removing the peelable tab from the bottom surface of the base (par. 0032, 0034).
Regarding claim 19, Andino et al. discloses the bottom surface of the base further comprises an antimicrobial coating (par. 0031).
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.
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, 15, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Andino et al. in view of Howell et al. (US 20150224285).
Regarding claims 7, 15, and 20, Andino et al. discloses the assembly, set, and method as claimed, respectively, but fails to specifically disclose the stabilizing clip is configured such that the catheter adapter is maintained at an angle of about 3 degrees to about 10 degrees relative to the skin of the patient. However, Howell et al. teaches providing a catheter-to-skin insertion angle of 7 degrees. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize an angle of 7 degrees, as taught by Howell et al., for the angled position of the catheter/stabilizing clip in Andino et al., since 7 degrees is a desirable angle of incidence for a catheter to the skin of the patient for intravenous applications (par. 0144).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Godfrey (US 20100100049)
Buchanan (US 11272941)
Kovac (US 3856020)
Aviles (US 8679066)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783