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) 1-8 and 20-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pre-Grant Publication 2001/0022411 to Conway et al. (Conway hereinafter).
Regarding claim 1, Conway teaches a catheter comprising: a core tube (12) extending from a rear end (44) to a front end (42) along an elongation axis, the core tube comprising a lumen (8) extending between a front opening (25, see Fig. 19) in a front portion and a rear opening (receiving 44) in a rear portion, opposite said front portion, a flexible outer layer (14) disposed around the front portion, the flexible outer layer covering the front portion along the elongation axis and at least partially covering the front portion in a radial direction, the flexible outer layer forming a fluid reservoir (32) containing a fluid (24) between the flexible outer layer and at least a part of the front portion, such that the flexible outer layer and the fluid reservoir forms a resiliently deformable body covering at least a part of the front portion of the core tube, wherein the flexible outer layer further comprises one or more radial eyelet(s) (40) arranged in front of the front portion of the core tube and being in fluid communication with the front opening, and wherein the flexible outer layer is more flexible than the core tube (paragraph 57, “tubing [12] is... silicone rubber of 50-70 durometer” and paragraph 71, “overcoat preferably is soft, with a hardness of about 20 to 40 durometer”).
Regarding claim 2, Conway teaches a tip (at 56/60 in Fig. 3) supporting the flexible outer layer.
Regarding claim 3, Conway teaches a radial opening (at 40) of the core tube tip (see Fig. 19).
Regarding claim 4, Conway teaches that the flexible outer layer is attached to at least part (30) of the outside of the rear portion.
Regarding claim 5, Conway teaches that the part of the outside of the rear portion to which the flexible outer layer is attached is provided with at least one radial protrusion (substantially 30) configured to hold the flexible outer layer in place using friction.
Regarding claim 6, Conway teaches a connector (44).
Regarding claim 7, Conway teaches that the fluid reservoir(s) (32) extends along the axial direction of the front portion so as to radially cover a first and second section of the front portion, the first section being arranged in front of the second section, wherein a radial dimension of the fluid reservoir is different at the first section than at the second section (see shoulder between 32 and 8, i.e. between 32 and 30).
Regarding claim 8, Conway teaches an insertion stopper (44) provided on the outside of the rear portion, the insertion stopper having an outer radius larger than the outer radius of the flexible outer layer at a rear end of the front portion.
Regarding claim 20, Conway teaches a catheter suitable for rectal use.
Regarding claims 21-22, Conway teaches a method of manufacturing a catheter (paragraphs 63-77) comprising forming the catheter structure discussed with respect to claim 1 above, and filling the reservoir (32) with fluid (24) to form a resiliently deformable body covering at least a part of the front portion of the core tube.
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.
Claim(s) 9-19 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Conway in view of U.S. Patent 5,882,345 to Yoon (Yoon).
Regarding claim 9, Conway teaches the limitations of claim 1 as discussed above. Conway does not teach a flexible inner layer. Yoon teaches providing a flexible inner layer (18) used to adapt a catheter for use with an endoscope (col. 2, ln. 61-67). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide an absorbent layer and flexible inner layer as taught by Yoon in order to adapt the catheter for use with endoscope. Thus provided, the reservoirs would be located between the inner and outer layers, and the sleeve of Yoon would be more flexible than the tube of Conway (col. 7, ln. 65 through col. 8, ln. 4).
Regarding claim 11, Conway teaches a catheter comprising: a core tube (12) extending from a rear end (44) to a front end (42) along an elongation axis, the core tube comprising a lumen (8) extending between a front opening (25, see Fig. 19) in a front portion and a rear opening (receiving 44) in a rear portion, opposite said front portion, a flexible outer layer (14) disposed around the front portion, the flexible outer layer covering the front portion along the elongation axis and at least partially covering the front portion in a radial direction, the flexible outer layer forming a fluid reservoir (32) containing a fluid (24) between the flexible outer layer and at least a part of the front portion, such that the flexible outer layer and the fluid reservoir forms a resiliently deformable body covering at least a part of the front portion of the core tube, wherein the flexible outer layer further comprises one or more radial eyelet(s) (40) arranged in front of the front portion of the core tube and being in fluid communication with the front opening, and wherein the flexible outer layer is more flexible than the core tube (paragraph 57, “tubing [12] is... silicone rubber of 50-70 durometer” and paragraph 71, “overcoat preferably is soft, with a hardness of about 20 to 40 durometer”). Conway does not teach a flexible inner layer. Yoon teaches providing a flexible inner layer (18) used to adapt a catheter for use with an endoscope (col. 2, ln. 61-67). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide an absorbent layer and flexible inner layer as taught by Yoon in order to adapt the catheter for use with endoscope. Thus provided, the reservoirs would be located between the inner and outer layers, and the sleeve of Yoon would be more flexible than the tube of Conway (col. 7, ln. 65 through col. 8, ln. 4).
Regarding claim 12, Conway teaches a tip (at 56/60 in Fig. 3) supporting the flexible outer layer.
Regarding claim 13, Conway teaches a radial opening (at 40) of the core tube tip (see Fig. 19).
Regarding claim 14, Conway teaches that the flexible outer layer is attached to at least part (30) of the outside of the rear portion.
Regarding claim 15, Conway teaches that the part of the outside of the rear portion to which the flexible outer layer is attached is provided with at least one radial protrusion (substantially 30) configured to hold the flexible outer layer in place using friction.
Regarding claim 16, Conway teaches a connector (44).
Regarding claim 17, Conway teaches that the fluid reservoir(s) (32) extends along the axial direction of the front portion so as to radially cover a first and second section of the front portion, the first section being arranged in front of the second section, wherein a radial dimension of the fluid reservoir is different at the first section than at the second section (see shoulder between 32 and 8, i.e. between 32 and 30).
Regarding claim 18, Conway teaches an insertion stopper (44) provided on the outside of the rear portion, the insertion stopper having an outer radius larger than the outer radius of the flexible outer layer at a rear end of the front portion.
Regarding claims 10 and 19, where the difference between the prior art and the claimed invention is solely a difference in relative dimensions, a prima facie case of obvious exists in the absence of evidence of criticality (MPEP 2144.04 IV. A). The examiner is unaware of such evidence and therefore concludes that claim 19 is obvious over Conway in view of Yoon.
Regarding claim 23, Conway teaches a method of manufacturing a catheter (paragraphs 63-77) comprising forming the catheter structure discussed with respect to claim 1 above, and filling the reservoir (32) with fluid (24) to form a resiliently deformable body covering at least a part of the front portion of the core tube. Conway does not teach a flexible inner layer. Yoon teaches providing a flexible inner layer (18) used to adapt a catheter for use with an endoscope (col. 2, ln. 61-67). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide an absorbent layer and flexible inner layer as taught by Yoon in order to adapt the catheter for use with endoscope. Thus provided, the reservoirs would be located between the inner and outer layers, and the sleeve of Yoon would be more flexible than the tube of Conway (col. 7, ln. 65 through col. 8, ln. 4).
Conclusion
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 7 March 2026