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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the sealing engaging and sealing against “a lowermost end of the radially inward facing surface of the neck portion” as recited in claim 5 must be shown or the feature(s) canceled from the claim(s). Applicant’s drawings do not show the seal 72 against a “lowermost” end but rather more toward a middle or toward a lower end, but not necessarily against the lowermost end. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 14-15, 17 are objected to because of the following informalities:
Claim 14 should recite “A [[M]]method of irrigating the bowels of [[a]]the user with [[a]]the bowel irrigation system of claim 13…”
Claim 15 should recite “A [[M]]method of sealing [[a]]the canister unit of [[a]]the bowel irrigation system of claim 13…” Furthermore, the recitation “AND” in part (d) should be “and”.
Claim 17 should recite “further comprising: a cap formed in the top of the lid; wherein the cap is removable from the lid to allow addition of the irrigation liquid into the volume of the canister unit while leaving the lid unit [[is]] closed relative to the canister unit.”
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 1-2, 4, 8-9, 11-12, 16, 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tsai et al (US 2021/0171267 A1).
Regarding claim 1, Tsai discloses a container capable of use as a portable base for a system for irrigating bowels of a user (Figure 1; Abstract), comprising: a canister unit (20) comprising a volume (45) for an irrigation liquid (Figures 1-2) and a neck portion (50) circumscribing an annular opening (55) around a central vertical axis of the portable base (Figure 1); and a lid unit (15) configured for closing of the annular opening of the canister unit, the lid unit having an axial extent along the central vertical axis between a top and a bottom of the lid unit (Figures 1-2), and comprising a rim portion (70; alternatively 65) and a rotatable skirt (see annotated Figure 2 below), the skirt being rotatably attached around the rim portion ([0020], [0022], [0024]); wherein the rotatable skirt of the lid unit and the neck portion of the canister unit comprise complementary threads ([0020], [0022], [0024]); wherein a sealing (see annotated Figure 2 below ([0020]), [0024]) is provided at the rim portion and configured to seal between a radially inward facing surface of the neck portion of the canister unit and the lid unit (see annotated Figure 2 below ([0020]), [0024]); wherein the portable base is adapted to be shifted between an unsealed configuration and a sealed configuration by rotation of the rotatable skirt and engagement of the complementary threads of the rotatable skirt with the neck portion ([0020], [0022], [0024]).
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Regarding claim 2, Tsai discloses the rotatable skirt is engaged with the neck portion, an air and liquid tight seal is formed between the neck and the lid unit and the canister unit is capable of being pressurized to 1-23 psi ([0024]-[0025]; [0007] Figures 1-2).
Regarding claim 4, Tsai discloses wherein the sealing is provided at a location of the rim portion closer to the bottom of the lid unit than to the top of the lid unit (Figure 2).
Regarding claim 8, Tsai discloses wherein the rotatable skirt comprising at least one second thread portion provided on a radially inward facing surface of the skirt (see at least two threads 40 in Figures 1-2; [0020], [0022]).
Regarding claim 9, Tsai discloses wherein the rotatable skirt includes a first flange configured to engage with a ledge of the rim portion of the lid unit to allow the first flange of the skirt to slide on the ledge during rotation of the skirt (see annotated Figure 2 above; [0020], [0022], [0024]).
Regarding claim 11, Tsai discloses wherein the lid unit comprises at least one internal chamber (75).
Regarding claim 12, Tsai discloses wherein the at least one internal chamber comprises one or more control elements (35) of a system for irrigating the bowels of a user (intended use; [0021], [0029]).
Regarding claim 16, Tsai discloses wherein the rim portion (65) is closer to the central vertical axis than the rotatable skirt is to the central vertical axis, and the rotatable skirt rotates and moves independent from movement of the rim portion and independent from the canister unit (Figures 1-2).
Regarding claim 18, Tsai discloses wherein the canister unit comprises a sidewall that extends from the bottom of the canister unit to a shoulder of the canister unit, and the shoulder of the canister unit positions the neck portion of the canister between the rotatable skirt of the lid unit and the rim portion of the lid unit; wherein the rotatable skirt of the lid unit is located outside the rim portion of the lid unit with the rim portion of the lid unit positioned closer to the central vertical axis than the rotatable skirt is to the central vertical axis; and wherein rotation of the rotatable skirt forces the lid unit in a downward direction closer to the shoulder of the canister unit (Figures 1-2; [0020], [0022], [0024]).
Regarding claim 19, Tsai discloses wherein the sealing comprises an annular seal disposed around the rim portion of the lid unit to position the annular seal between the rim portion of the lid unit and the neck portion of the canister; wherein the rotation of the rotatable skirt forces the annular seal to move in an axial direction downward and into a sealing engagement with a radially inward facing surface of the neck portion of the canister (Figures 1-2; [0020], [0022], [0024]).
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.
Claims 3, 5, and 7 rejected under 35 U.S.C. 103 as being unpatentable over Tsai et al (US 2021/0171267 A1).
Regarding claim 3, Tsai discloses that as applied above but does not disclose the annular opening of the canister unit has a diameter between 100-150 mm. It would have been an obvious matter of design choice to make the diameter between 100-150 mm since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 5, Tsai discloses wherein the sealing engages and seals against the radially inward facing surface of the neck portion in the sealed configuration near the lowermost end (Figures 1-2). Tsai does not disclose the sealing is against the lowermost end. However, Applicant has not disclosed that applying against the lowermost end provides an advantage, is used for a particular purpose, or solves a stated problem. Applicant’s Figures show the sealing being somewhat spaced from the lowermost end and not necessarily against the lowermost end (see Figures). One of ordinary skill in the art, furthermore, would have expected the seal of Tsai and applicant' s invention, to perform equally well with either because both would perform the same function of sealing the canister. Therefore, it would have been prima facie obvious to modify Tsai to obtain the invention as specified in claim 5 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Tsai. Furthermore, it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 7, Tsai discloses a plurality of threads on a radially outward facing surface of the neck (25; Figures 1-2) but does not disclose 3 spaced apart threads. It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the assembly of Mackool having a plurality of bushings, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Tsai et al (US 2021/0171267 A1) in view of Andersson et al (US 2017/0157314 A1).
Regarding claim 6, Tsai discloses that as applied above including a sealing but does not specify the seal is an o-ring. Andersson teaches it is known to provide a seal in the form of an o-ring (15). It would have been obvious to one of ordinary skill in the art at the time of filing to replace the pointed seal of Tsai with the o-ring of Andersson to yield predictable results of providing a seal.
Claims 1, 10, 13- 15, 17 are rejected under 35 U.S.C. 103 as being unpatentable over Andersson et al (US 2017/0157314 A1) in view of Tsai et al (US 2021/0171267 A1).
Regarding claim 1, Andersson discloses a portable base for a system for irrigating bowels of a user (Figure 1; Abstract) comprising a canister unit (2) comprising a volume (17) for an irrigation liquid (Abstract; Figures 1-2) and an annular opening around a central vertical axis of the portable base (Figure 1-2); and a lid unit (4) configured for closing of the annular opening of the canister unit, the lid unit having an axial extent along the central vertical axis between a top and a bottom of the lid unit (Figures 1-2), and comprising a rim portion (portion engaged with 2; Figures 1-2). Andersson discloses that the seal between the lid and canister (top and side wall member) can comprise reversible connections ([0018]) but does not disclose a neck portion circumscribing the annular opening; and a rotatable skirt, the skirt being rotatably attached around the rim portion; wherein the rotatable skirt of the lid unit and the neck portion of the canister unit comprise complementary threads; wherein a sealing is provided at the rim portion and configured to seal between a radially inward facing surface of the neck portion of the canister unit and the lid unit; wherein the portable base is adapted to be shifted between an unsealed configuration and a sealed configuration by rotation of the rotatable skirt and engagement of the complementary threads of the rotatable skirt with the neck portion. Tsai teaches a resealable container comprising a neck portion (50) circumscribing the annular opening; and a rotatable skirt (see annotated Figure 2 below), the skirt being rotatably attached around the rim portion ([0020], [0022], [0024]); wherein the rotatable skirt of the lid unit and the neck portion of the canister unit comprise complementary threads ([0020], [0022], [0024]); wherein a sealing (see annotated Figure 2 below ([0020]), [0024]) is provided at the rim portion and configured to seal between a radially inward facing surface of the neck portion of the canister unit and the lid unit (see annotated Figure 2 below ([0020]), [0024]); wherein the portable base is adapted to be shifted between an unsealed configuration and a sealed configuration by rotation of the rotatable skirt and engagement of the complementary threads of the rotatable skirt with the neck portion ([0020], [0022], [0024]). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the device of Andersson having the resealable connection taught by Tsai for providing a removable and resealable connection between the top and sidewall.
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Regarding claim 10, Andersson further discloses the rotatable skirt (taught by Tsai) comprises a gripping tab extending in a direction radially outward in relation to the central vertical axis (7 of Andersson; Figures 1-20).
Regarding claim 13, Andersson discloses a bowel irrigation system ([0002]) comprising the portable base (Figures 1-2) of claim 1 and further comprising: irrigation tubing comprising a first end and a second end, the first end of the irrigation tubing configured to be connected to the lid unit of the portable base and an anal probe (40) configured to be connected to the second end of the irrigation tubing (Figure 5).
Regarding claim 14, Andersson in view of Tsai teach that as applied above and Andersson discloses a method of irrigating the bowels of a user ([0002]; Figures 1 and 5) with a bowel irrigation system of claim 13, comprising the steps of:- (a) providing the canister unit and the lid unit of the portable base (Figures 1 and 5); - (b) providing additional components of a bowel irrigation system (Figure 5); - (c) providing a volume of irrigation liquid in the canister unit; - (d) placing the lid unit on the neck portion of the canister unit to close the annular opening of the canister unit ([0062]); - (e) rotating the rotatable skirt on the rim portion of the lid unit such that the complementary threads of the rotatable skirt and the canister unit engage with each other to shift the portable base to a sealed configuration (Tsai Figures 1-2; ([0020], [0022], [0024]); and - (f) irrigating the bowels of the user (Andersson [0002]).
Regarding claim 15, Andersson in view of Tsai teach that as applied above and Andersson discloses a method of sealing a canister unit of a bowel irrigation system of claim 13, comprising the steps of:- (a) providing the canister unit and the lid unit of the portable base (Figures 1-2); - (b) providing additional components of a bowel irrigation system (Figure 5); - (c) providing a volume of irrigation liquid in the canister unit ([0062]); - (d) placing the lid unit on the neck portion of the canister unit to close the annular opening of the canister unit (Figure 1-2); AND - (e) rotating the rotatable skirt on the rim portion of the lid unit such that the complementary threads of the rotatable skirt and the canister unit engage with each other to shift the portable base to a sealed configuration (Tsai Figures 1-2; ([0020], [0022], [0024]).
Regarding claim 17, Andersson discloses a cap (7) formed in the top of the lid wherein the cap is removable from the lid to allow addition of the irrigation liquid into the volume of the canister unit while leaving the lid unit is closed relative to the canister unit ([0062]; Figure 1).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No. 18853439 in view of Tsai et al (US 2021/0171267 A1).
It is clear that all the elements of the application claim 1 are to be found in copending claim 1 (as the application claim 1 fully encompasses patent claim 1). The difference between the application claim 1 and the patent claim 1 lies in the fact that copending claim 1 recites at least one projecting jut instead of a thread. However, Tsai teaches a similar container wherein the jut is a thread to complement threads on the lid (25, 40). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the jut as threads as taught by Tsai for complementing and mating with threads of the lid to provide closure and sealing of the device.
This is a provisional nonstatutory double patenting rejection.
Claims 2-19 are found in copending 2-23.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kari Rodriquez whose telephone number is 571-270-1909. The examiner can normally be reached Monday-Friday 6-3 EST.
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/KARI K RODRIQUEZ/Primary Patent Examiner, Art Unit 3786
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