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 Objections
Claims 1-4, 8, 16, 18, and 20 are objected to because of the following informalities:
In claim 1, lines 3 and 5: “the stem” should be “the elongate stem” for consistency
In claim 1, line 5: “said fluid outlets” should be “said at least one fluid outlet”
In claim 1, line 6: “the skirt” should be “the first skirt”
In claim 2, line 1: “the stem” should be “the elongate stem”
In claim 3, line 4: “the stem” should be “the elongate stem”
In claim 4, line 2: “the stem” should be “the elongate stem”
In claim 8, line 2: “the stem” should be “the elongate stem”
In claim 16, line 2: “a fluid outlet” should be “the fluid outlet”
In claim 18: “said skirt” should be “said first skirt” in every instance
In claim 20, line 3: “said skirts” should be “said first skirts”
Appropriate correction is required.
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, 3, 4, 6-10, and 12-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Robbins et al (GB 2565640, provided by applicant).
Regarding claim 1, Robbins discloses:
A nozzle (10; Fig. 1) suitable for irrigating the rectal and/or bowel cavities (page 5:14-18), the nozzle (10) comprising an elongate stem (13) incorporating a channel (15) extending there through; whereby fluid may flow, in use, through the channel (15) (page 5:14-15); the stem (13) incorporating a fluid inlet (25) and at least one fluid outlet (18, 53, 54); and a first skirt (20) projecting, when secured to the elongate stem (13), radially from the stem (13) and being provided as the first radially projecting member below said fluid outlets (18, 53, 54) (Fig. 1C); the first skirt (20) being inherently flexible (page 2:10-11); whereby the skirt (20) is sufficiently flexible for insertion through the anus (page 5:25-27) and to thereafter rest against the internal wall of the rectum (page 5:25-26); wherein said first skirt (20) comprises an annular hub (52); said elongate stem (13) and said first skirt (20) being formed as two separate components (page 9:30-31); said annular hub (52) being secured to said elongate stem (13).
Regarding claim 3, Robbins discloses:
The nozzle according to claim 1, wherein said nozzle (10) further incorporates a second skirt (26) projecting radially from said stem (13); said second skirt (26) being provided in a location which is closer to the fluid inlet (25) than the location of the first skirt (20); and wherein said elongate stem (13) has a smaller internal diameter (diameter at 34) in the region of the stem (13) where said annular hub (52) is secured than in the region (diameter at 47) immediately above said second skirt (26).
Regarding claim 4, Robbins discloses:
The nozzle according to claim 1, wherein said annular hub (52) is bonded to an outer portion of said stem (13) (page 9:30-31).
Regarding claim 6, Robbins discloses:
The nozzle according to claim 3, wherein said second skirt (26) is less flexible than said first skirt (20) (page 10:28-31).
Regarding claim 7, Robbins discloses:
The nozzle according to claim 3, wherein said second skirt (26) is thicker than said first skirt (20) (page 10:28-31).
Regarding claim 8, Robbins discloses:
The nozzle according to claim 3, wherein said stem (13) increases in outer diameter towards said second skirt (26) in a region above said second skirt (26) (Fig. 1C – the stem gets wider as it gets to the top 27 of the skirt 26).
Regarding claim 9, Robbins discloses:
The nozzle according to claim 1, wherein said first skirt (20; Fig. 2) further incorporates radial slits (61) extending inwardly from its peripheral edge (29), whereby a plurality of petals (60a-f) are formed (page 12:14-20).
Regarding claim 10, Robbins discloses:
The nozzle according to claim 9, wherein said first skirt (20) comprises five or fewer than five petals (page 12:26-28 – the skirt 20 can have 5 or fewer petals).
Regarding claim 12, Robbins discloses:
The nozzle according to claim 1, wherein said first skirt (20) comprises no fold lines (Fig. 1E).
Regarding claim 13, Robbins discloses:
The nozzle according to claim 1, wherein said elongate stem (13) incorporates a tip (40) and at least one of said fluid outlets (18, 53, 54) is formed as a first aperture (18) in said tip (40).
Regarding claim 14, Robbins discloses:
The nozzle according to claim 13, wherein said tip (40) comprises a side wall (49), wherein said side wall (49) further incorporates at least a fluid outlet (53).
Regarding claim 15, Robbins discloses:
The nozzle according to claim 14, wherein said side wall (49) incorporates a further fluid outlet (54).
Regarding claim 16, Robbins discloses:
The nozzle according to claim 15, wherein said further fluid outlet (54) is located diametrically opposite the fluid outlet (53) (Fig. 1B).
Regarding claim 17, Robbins discloses:
The nozzle according to claim 13, wherein said fluid outlet (40) has a distal lip (44) which is rounded (page 8:29-31).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1, 4, 19, 21, 23, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Alexandersen (US 2002/0019613) in view of Elmore et al (US 3916897).
Regarding claim 1, Alexandersen discloses:
A nozzle (Fig. 10) suitable for irrigating the rectal and/or bowel cavities (¶0034), the nozzle comprising an elongate stem (2) incorporating a channel (lumen of stem 2) extending there through; whereby fluid may flow, in use, through the channel (2) (¶0034); the stem (2) incorporating a fluid inlet (10; Fig. 1) and at least one fluid outlet (7); and a first skirt (6; Fig. 10) projecting, when secured to the elongate stem (2), radially from the stem (2) and being provided as the first radially projecting member below said fluid outlets (7) (see Fig. 10); the first skirt (6) being inherently flexible (¶0037); whereby the skirt (6) is sufficiently flexible for insertion through the anus (¶0044) and to thereafter rest against the internal wall of the rectum (¶0044); said elongate stem (2) and said first skirt (6) being formed as two separate components (Fig. 15 – the stem 2 is a different material and component than the skirt 6); said first skirt (6) being secured to said elongate stem (2) (¶0067).
Alexandersen is silent regarding “said first skirt (6) comprises an annular hub.” However, Elmore teaches an irrigation device (Abstract; Fig. 1), thus being in the same field of endeavor, with a skirt (11) for sealing a body opening (Col. 2:30-32) where the skirt (11) has an annular hub (14) that forms part of the connection between the nozzle (19) and the skirt (11). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the skirt of Alexandersen to incorporate an annular hub as taught by Elmore in order to provide sufficient structure to connect the nozzle and the skirt.
Regarding claim 4, Alexandersen in view of Elmore discloses:
The nozzle according to claim 1, wherein said annular hub (taught in the rejection of claim 1) is bonded to an outer portion of said stem (2).
Regarding claim 12, Alexandersen in view of Elmore discloses:
The nozzle according to claim 1, wherein said first skirt (6) comprises no fold lines (Fig. 11).
Regarding claim 19, Alexandersen in view of Elmore discloses:
An anal irrigation system (Fig. 1) comprising a nozzle (Fig. 10) in accordance with claim 1.
Regarding claim 21, Alexandersen discloses:
A method of assembling a nozzle (Fig. 10) suitable for irrigating the rectal and/or bowel cavities comprising the steps of: providing an elongate stem (2) incorporating a channel (lumen of stem 2) extending there through; whereby fluid may flow, in use, through said channel (¶0034); said stem (2) incorporating a fluid inlet (10; Fig. 1) and one or more fluid outlets (7); selecting a first skirt (6; Fig. 10); and securing said first skirt (6) to said stem (2); wherein said first skirt (6) projects radially and is the first radially projecting member of the nozzle (Fig. 10) below said fluid outlets (7) (Fig. 10).
Alexandersen is silent regarding the skirt having “an annular hub.” However, Elmore teaches an irrigation device (Abstract; Fig. 1), thus being in the same field of endeavor, with a skirt (11) for sealing a body opening (Col. 2:30-32) where the skirt (11) has an annular hub (14) that forms part of the connection between the nozzle (19) and the skirt (11). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the skirt of Alexandersen to incorporate an annular hub as taught by Elmore in order to provide sufficient structure to connect the nozzle and the skirt.
Regarding claim 23, Alexandersen in view of Elmore discloses:
The method of assembling a nozzle according to claim 21, comprising the step of bonding said annular hub (taught by rejection of claim 21) to said stem (2) (¶0067).
Regarding claim 25, Alexandersen in view of Elmore discloses:
A method of anal irrigation comprises the steps of at least partially inserting a nozzle (Fig. 10) in accordance with claim 1 in a patient in need of anal irrigation (¶0038).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Alexandersen in view of Elmore further in view of Karmazyn et al (US 2014/0296832).
Regarding claim 24, Alexandersen in view of Elmore discloses a method of assembling an anal irrigation system (Fig. 1) comprising the steps of assembling a nozzle (Fig. 10) according to claim 21 but is silent regarding “further providing a plurality of tubular sections, a plurality of connectors suitable for connecting a plurality of tubular sections, and a pump for pressurising the liquid of the irrigation system, and connecting said nozzle, said tube sections and a pump.” However, Karmazyn teaches an irrigation device (Fig. 2), thus being in the same field of endeavor, that assembles a nozzle (14), a skirt (18), a plurality of tubular sections (26, 48) with a plurality of connectors (52) that connect to the tubular sections, and a pump (32) connected to each tube section in order to prevent leakage during irrigation as required by a user (¶0012). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the anal irrigation system of Alexandersen with a plurality of tubular sections and connectors as taught by Karmazyn in order to provide sufficient structure to pump desired fluid through the device.
Allowable Subject Matter
Claims 1, 3, 4, 6-10, and 12-17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
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/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783