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 Invention I: Claims 1-14 in the reply filed on 5/18/2026 is acknowledged.
Claims 15-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“Tension member” in claims 1-5, 9, and 11.
“Anchor member” in claims 1 and 2.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Accisano (US 2020/0338324)
With respect to Claim 1, Accisano teaches a drainage catheter comprising:
a catheter tube 110 comprising a drainage lumen 115 extending along a length of the catheter tube, the catheter tube defining a proximal region 121, a distal region 123, and a central region 122 disposed between the proximal region and the distal region; and
a tension member 130 disposed within the drainage lumen 115 along the proximal region, disposed external to the drainage lumen along the central region 122 (Figure 1; paragraph [0034]), and disposed within the drainage lumen along at least a portion of the distal region (Figures 1 and 4; paragraph [0038]);
wherein a distal portion of the tension member 130 is coupled to an anchor member 133 (Figure 4; paragraph [0038]), and
wherein the anchor member and the distal portion of the tension member are fixedly coupled to the catheter tube (Figure 4; paragraph [0038]).
With respect to Claim 2, Accisano teaches that the anchor member 133 is configured to be disposed within the drainage lumen 115. Specifically, Accisano teaches that the suture lumen may be disposed in fluid communication with the drainage lumen 115 (paragraph [0027]), and therefore has been interpreted as being part of the drainage lumen.
With respect to Claim 3, Accisano teaches a catheter hub 140 coupled to a proximal end of the catheter tube 110, the catheter hub comprising a tension member passageway 142 and a tension member lock 143, the tension member lock configured to selectively prevent and allow longitudinal displacement of the tension member along the tension member passageway (Figures 1-5; paragraphs [0037-0043]).
With respect to Claim 4, Accisano teaches that the drainage lumen 115 further comprises an exit port 124 defining an aperture through an annular wall of the catheter tube between the drainage lumen and an external surface of the catheter tube 110, the exit port 124 positioned at a distal end of the proximal region 121, and wherein the tension member 130 is disposed through the exit port 124 (Figures 1 and 5; paragraphs [0029-0029], [0032], and [0034-0036]).
With respect to Claim 5, Accisano teaches that the catheter tube 110 further comprises an entrance port 125 defining an aperture through the annular wall of the catheter tube 110 between the drainage lumen 115 and the external surface of the catheter tube 110, the entrance port 125 positioned at a proximal end of the distal region 123, and wherein the tension member 130 is disposed through the entrance port (Figures 1 and 5; paragraphs [0029], [0032], [0035-0036]).
With respect to Claim 6, Accisano teaches that the entrance port 125 and exit port 124 are disposed in axial alignment along the sidewall of the catheter tube (Figures 1 and 5), thereby allowing the distal tip of the catheter to be pulled toward the exit port by the tension member (as shown in Figure 5).
With respect to Claim 7, Accisano teaches a plurality of drainage ports 117 disposed along the catheter tube, wherein each of the plurality of drainage ports 117 define an aperture through an annular wall of the catheter tube berween the drainage lumen 115 and the external surface of the catheter tube (Figure 1 ; paragraphs [0023-0024]).
With respect to Claim 8, Accisano teaches a plurality of drainage ports 117 disposed along central region 122 of the catheter tube 110, wherein each of the plurality of drainage ports 117 define an aperture through an annular wall of the catheter tube between the drainage lumen 115 and the external surface of the catheter tube (Figure 1; paragraphs [0023-0024]).
With respect to Claim 9, Accisano teaches that the drainage catheter further comprises:
a plurality of drainage ports 117 disposed along central region 122 of the catheter tube 110, wherein each of the plurality of drainage ports 117 define an aperture through an annular wall of the catheter tube berween the drainage lumen 115 and the external surface of the catheter tube (Figure 1; paragraphs [0023-0024]);
an exit port 124 defining an aperture through an annular wall of the catheter tube between the drainage lumen and an external surface of the catheter tube 110, the exit port 124 positioned at a distal end of the proximal region 121, and wherein the tension member 130 is disposed through the exit port 124 (Figures 1 and 5; paragraphs [0029-0029], [0032], and [0034-0036]); and
an entrance port 125 defining an aperture through the annular wall of the catheter tube 110 between the drainage lumen 115 and the external surface of the catheter tube 110, the entrance port 125 positioned at a proximal end of the distal region 123, and wherein the tension member 130 is disposed through the entrance port (Figures 1 and 5; paragraphs [0029], [0032], [0035-0036]).
With respect to Claim 10, Accisano teaches that the plurality of drainage ports 117 may be disposed in axial alignment with the exit port 124 and the entrance port along the length of the catheter tube 110 (paragraph [0027]).
With respect to Claim 11, Accisano teaches that the drainage catheter further comprises:
a plurality of drainage ports 117 disposed along central region 122 of the catheter tube 110, wherein each of the plurality of drainage ports 117 define an aperture through an annular wall of the catheter tube between the drainage lumen 115 and the external surface of the catheter tube (Figure 1; paragraphs [0023-0024]);
wherein the plurality of drainage ports comprise a proximal port 124 and a distal port 125 (Figure 1; paragraphs [0028-0029]);
wherein the tension member 130 is disposed through the proximal port from the drainage lumen to external of the catheter tube (Figures 1-5; Accisano teaches that the suture lumen 120 may be disposed in fluid communication with the drainage lumen 115 (paragraph [0027]), and therefore has been interpreted as being part of the drainage lumen); and
wherein the tension member is disposed through the distal port 125 from external of the catheter tube into the drainage lumen (Figures 1-5; Accisano teaches that the suture lumen 120 may be disposed in fluid communication with the drainage lumen 115 (paragraph [0027]), and therefore has been interpreted as being part of the drainage lumen)
With respect to Claim 12, Accisano teaches that, when disposed in an anchor configuration, the central region 122 comprises a curved segment (as shown in Figure 5; paragraph [0036]).
With respect to Claim 13, Accisano teaches that a distal tip 113/118 of the catheter tube 110 extends distally beyond the curved segment of the catheter tube. Specifically, the central region 122 of the catheter tube 110 curves, and the distal tip 113/118 is disposed distal of the curved central region 122 (see Figures 5, 9, and 10; paragraphs [0022] and [0038]).
With respect to Claim 14, Accisano teaches that at least one radiopaque marker 150 may be disposed along the catheter tube 110 (Figure 1; paragraph [0041]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Accisano (US 2007/0032779) teaches a steerable catheter having a tension member that passes through the drainage lumen, through an opening to the exterior of the catheter, and to an anchor member at the distal end.
Bourne et al. (US 2011/0054448) teaches a catheter comprising a suture anchored to a lumen in the distal end.
Eells et al. (US 2011/0295237) teaches a drainage catheter having a suture for steering the catheter.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Philip R Wiest whose telephone number is (571)272-3235. The examiner can normally be reached M-F 9-6 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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