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 .
Response to Amendment
A preliminary amendment was filed on 12/04/2024 and has been entered. By this amendment, claims 1, 9-11, 13-15, 17, 18 and 20-23 were amended, and claims 5, 12, 16, 19, and 25 were canceled.
Claim Objections
Claim 13 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 11.
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 20 and 21 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.
Claim 20 recites the limitation “wherein the catheter is an open catheter assembly”, but it is unclear whether the catheter itself is open, or if the catheter assembly is open. Further, it is unclear what is meant by “open” in this context.
For the purpose of examination, the limitation will be interpreted to recite “wherein the packaged catheter assembly is an open catheter assembly”, meaning that the catheter tube is not connected to a urine bag (as defined on pg. 9, lines 25-27 of Applicant’s original specification).
Claim 21 recites the limitation “wherein the catheter is arranged within a sterile sealed pouch”, but claim 1 (upon which claim 21 depends) already recites a catheter arranged within a pouch; therefore, it is not clear whether the “sterile pouch” recited in claim 21 refers to a different pouch or refers back to the pouch recited in claim 1.
For the purpose of examination, the “sterile sealed pouch” in claim 21 will be interpreted to refer back to the pouch already recited in claim 1.
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.
Claims 1-4, 9, 17 and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hansen et al (U.S. Pat. 6,849,070 B1, hereinafter “Hansen”).
Regarding claim 1, Hansen discloses a packaged catheter assembly (see Fig. 1) comprising:
a catheter 1/3/4 (Figs. 1-3) and a container 8 (Fig. 1) of wetting fluid arranged within a pouch (col. 5, lines 28-29);
the pouch having a pair of lateral edges, a top (above seam 5; see Fig. 1) and an opposing base, wherein the base protrudes downwards beyond the point where it meets the lateral edges (see annotated Fig. 1, below).
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Hansen, Fig. 1, annotated.
Regarding claim 2, Hansen shows in annotated Fig. 1, above, that the base is contoured (as a curved area that can direct a material or substance up into the pouch 2).
Regarding claim 3, Hansen shows in annotated Fig. 1, above, that the base is rounded.
Regarding claim 4, Hansen shows in annotated Fig. 1, above, that the base is partially circular.
Regarding claim 9, Hansen discloses the packaged catheter assembly according to claim 1, including that the assembly comprises a combination of rounded and sloped features (i.e., the base is rounded and the lateral edges are sloped).
Regarding claim 17, Hansen discloses the packaged catheter assembly according to claim 1, wherein the top of the pouch is openable (along seam 5; see Fig. 1).
Regarding claim 24, Hansen discloses a method of forming a packaged catheter assembly, the method comprising providing a catheter 1/3/4 (Figs. 1-3) and a container 8 (Fig. 1) containing wetting fluid (col. 5, lines 28-29); and arranging the catheter and container within a pouch (see Fig. 1); the pouch having a pair of lateral edges, a top and an opposing base; wherein the base protrudes downwards beyond the point where it meets the lateral edges (see annotated Fig. 1, above).
Claims 1, 6, 7, 15, 17 and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Israelsson et al (U.S. Pat. 6,736,805 B2, hereinafter “Israelsson”).
Regarding claim 1, Israelsson discloses a packaged catheter assembly (see Fig. 1) comprising:
a catheter 18 (Figs. 2) and a container 6 (Fig. 2) of wetting fluid (col. 6, lines 52-56) arranged within a pouch 112/114 (Fig. 2);
the pouch having a pair of lateral edges, a top (forwardmost portion of pocket 2; see Fig. 1) and an opposing base, wherein the base protrudes downwards beyond the point where it meets the lateral edges (see annotated Fig. 2, below).
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Israelsson, Fig. 2, annotated.
Regarding claim 6, Israelsson shows in annotated Fig. 2, above, that the base is contoured (as a sloped area that can direct a material or substance up into the pouch).
Regarding claim 7, Israelsson shows in annotated Fig. 2, above, that the base is sloped on two sides.
Regarding claim 15, Israelsson discloses the packaged catheter assembly according to claim 1, wherein the container of wetting fluid is rupturable sachet of water and is configured to release the wetting fluid directly into the pouch such that the fluid may flow freely to the protruding base of the pouch (col. 6, lines 52-58).
Regarding claim 17, Israelsson discloses the packaged catheter assembly according to claim 1, wherein the top of the pouch is openable (col. 7, lines 43-45).
Regarding claim 24, Israelsson discloses a method of forming a packaged catheter assembly, the method comprising providing a catheter 18 (Figs. 2) and a container 6 (Fig. 2) of wetting fluid (col. 6, lines 52-56); and arranging the catheter and container within a pouch (see Fig. 2); the pouch having a pair of lateral edges, a top and an opposing base; wherein the base protrudes downwards beyond the point where it meets the lateral edges (see annotated Fig. 2, above).
Claims 1, 6-8, 10, 11, 13, 17 and 20-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Golden (U.S. Pat. 5,226,530 B2, hereinafter “Golden”).
Regarding claim 1, Golden discloses a packaged catheter assembly (see Fig. 1) comprising:
a catheter 11 (Figs. 1-2) and a container 34 (Fig. 1) of wetting fluid (col. 3, lines 8-12) arranged within a pouch 30 (Fig. 1);
the pouch having a pair of lateral edges, a top and an opposing base, wherein the base protrudes downwards beyond the point where it meets the lateral edges (see annotated Fig. 1, below).
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Golden, Fig. 1, annotated.
Regarding claim 6, Golden shows in annotated Fig. 1, above, that the base is contoured (as a sloped area that can direct a material or substance up into the pouch).
Regarding claim 7, Golden shows in annotated Fig. 1, above, that the base is sloped on two sides.
Regarding claim 8, Golden shows in annotated Fig. 1, above, that the base is triangular (i.e., has two sloped sides extending from the point where the base meets the lateral edges and meeting at a corner, and a third side being defined as the line between the points where the base meets the lateral edges).
Regarding claim 10, Golden discloses the packaged catheter assembly according claim 1, wherein the top of the pouch is configured to be peeled open or torn open (such as at the top seal 80, indicated in annotated Fig. 1, above) that opposes the base), and the catheter is longer than the maximum length of the interior of the pouch (see Fig. 1).
Regarding claims 11 and 13, Golden discloses the packaged catheter assembly according to claim 1, wherein the catheter is longer than the maximum length of the interior of the pouch (see Fig. 1).
Regarding claim 17, Golden discloses the packaged catheter assembly according to claim 1, wherein the top of the pouch is openable (any part of seal 80 appears to be openable by hand, as suggested in col. 3, lines 62-67; see also col. 3, lines 60-62, disclosing that the pouch can also be cut open by hand to access the contents thereof, inherently including the top).
Regarding claim 20, Golden appears to teach the packaged catheter assembly according to claim 1, wherein the catheter is an open catheter assembly (i.e., the container in which the catheter tube is located is not disclosed to be a urine bag).
Regarding claim 22, Golden discloses the packaged catheter assembly according to claim 1, the pouch comprising first and second walls joined around the periphery thereof to define a pair of major edges, a base and a top edge (i.e., the four edges of the pouch 30);
the pouch having an openable top (at the location of the flaps 82; see Fig. 1), which when opened has a mouth at its upper end to allow the catheter to be withdrawn (i.e., grasping the flaps 82 and pulling them apart causes the pouch to open along the sealing surfaces 80; col. 3, line 67 to col. 4, line 3);
wherein a lateral join is provided, extending inwardly from a major edge, obscuring visibility of and restricting access to the container of wetting fluid (see annotated Fig. 3, below).
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Golden, Fig. 3, annotated.
Regarding claim 23, Golden discloses a packaged catheter assembly according to claim1,the pouch comprising first and second walls joined around the periphery thereof to define a pair of major edges, a base and a top edge (i.e., the periphery of the pouch);
the pouch having an openable top (at the location of the flaps 82; see Fig. 1), which when opened has a mouth at its upper end to allow the catheter to be withdrawn;
wherein the pouch has a tear-away region defined proximal to an upper edge of the pouch, the tear away region comprising a tear line between a first end and a second end of the tear-away region defining a line along which the pouch may be torn to at least partially separate the tear-away region from the remainder of the pouch to form an open upper end of the pouch, in use (i.e., the pouch may be torn along the seam 80);
the tear-away region comprising a first interaction region defining a point of contact for a user to grasp the tear away region (such as one of the flaps 82);
and the remainder of the pouch having a corresponding second interaction region defining a point of contact for a user to grasp the remainder of the pouch (such as the other of the flaps 82);
the first and second interaction regions comprising one or more visual and/or tactile indicators, being provided at the same major edge and being separated from each other by the tear line (the flaps 82 provide tactility);
and the container of wetting fluid being arranged at the second interaction region (see Fig. 1).
Regarding claim 24, Golden discloses a method of forming a packaged catheter assembly, the method comprising providing a catheter 11 (Figs. 1-2) and a container 34 (Fig. 1) of wetting fluid (col. 3, lines 8-12); and arranging the catheter and container within a pouch (see Fig. 1); the pouch having a pair of lateral edges, a top and an opposing base; wherein the base protrudes downwards beyond the point where it meets the lateral edges (see annotated Fig. 1, above).
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 14 is rejected under 35 U.S.C. 103 as being unpatentable over Hansen in view of Hursman et al (U.S. Pat. 6,004,305, hereinafter “Hursman”), as evidenced by Gopalakrishnan (“Spunbonded Nonwovens – An Overview”, 2007, hereinafter “Gopalakrishnan”).
Regarding claim 14, it is noted that Hansen does not appear to disclose that the pouch is formed from an opaque material; has a textured or printed fabric-like appearance and/or feel and is a different colour from the other components of the packaged catheter assembly.
Hursman discloses a drainage catheter assembly, comprising a pouch that is formed from an opaque, textured-fabric-like material such as spunbonded polyolefin (col. 8, lines 58-60).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Hansen, such that the pouch is formed from an opaque material, with a textured or printed fabric-like appearance or feel, such as spunbonded polyolefin, because such material was known, in light of Gopalakrishnan, to have a high tear strength and provide good barrier properties while still being breathable. Since neither Hansen nor Hursman discloses or suggests that other components of the packaged catheter assembly should be made from the same material, the combination would have been known to result in a device where the other components of the assembly were a different color from the spunbonded polyolefin.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Golden.
Regarding claim 18, it is noted that Golden does not appear to disclose the packaged catheter assembly according claim 1 wherein at least 50% of the catheter tube is exposed.
However, Golden discloses that the pouch can be opened by pulling apart flaps 82 and then causing the pouch to part along the sealing surfaces 80 (col. 3, line 67 to col. 4, line 3). Fig. 1 shows that the sealing surfaces 80 extend around the entire periphery of the catheter. Therefore, a skilled artisan would have found it obvious at the time of the invention to open the entire pouch by pulling apart the flaps, causing the pouch to part along all of the sealing surfaces 80, thereby exposing the entire catheter tube so that it can be removed from the pouch. In doing so, at least 50% of the catheter tube would be exposed. This step would have led to a reasonable expectation of success by permitting the catheter to be removed from the pouch and used for the desired procedure.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Hansen, in view of Golden.
Regarding claim 21, Hansen discloses the packaged catheter assembly according to claim 1,wherein the catheter is arranged within the sealed pouch; and
the pouch having an openable edge (such as at the top of the device where seal 5 is located; Fig. 3); and resealing arrangement for resealing the pouch after use, such that a portion of the catheter is arranged in the sealed pouch so as to obstruct the resealing arrangement (see resealing arrangement shown in Figs. 3-5 and described at col. 6, lines 10-53; and the resealing arrangement is on the left side of the pouch such that the catheter obstructs its view from the right side of the pouch).
Hansen Israelsson does not appear to disclose that the pouch is sterile.
Golden discloses that its catheter assembly pouch can be sterile (col. 2, lines 49-50).
A skilled artisan would have found it obvious at the time of the invention to modify the pouch to be sterile, in order to maintain the sterility of the contents of the package with a reasonable expectation of success, thereby preventing possible contaminants from being transferred to the patient during use of the catheter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Notice of References Cited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 09/02/2026
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