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 .
Status of Claims
As directed by the amendment filed on 22 November 2023: claim(s) 5-10, 12-13, 15-18, and 20-21 have been amended, claim(s) 22-30 have been cancelled. Thus, claims 1-21 are presently pending.
Claim Objections
Claim 6 is objected to because of the following informalities: “storage try” should be –storage tray–. Appropriate correction is required.
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 “drainage system” must be shown or the feature(s) canceled from the claim(s). 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 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 & 8-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hughett (WO 2019246307 A1).
Regarding Claim 1, Hughett discloses a urinary catheter-insertion kit for a catheterization procedure ("urinary catheter-insertion kit 100" [0050]; FIG. 1A), comprising:
a tray assembly (comprised of "nested" working tray 110 and storage tray 120 [0051-0052]; FIG. 1A) contoured for a space between partially opened legs of a patient (see FIG. 1A), the tray assembly including:
a storage tray ("storage tray 120" [0051]; FIG. 1A); and
a working tray ("working tray 110" [0051]) including a plurality of preformed sections holding a plurality of components of the urinary catheter-insertion kit ("working tray 110 can include a number of preformed sections configured to respectively hold a number of components of the urinary catheter-insertion kit 100" [0052]),
the working tray suspended over the storage tray in the tray assembly, thereby forming a covered storage space in the storage tray ("suspending the working tray 110 from the storage tray 120" [0052]; FIG. 1A);
a urinary catheter ("urinary catheter 132" [0051]) disposed in a catheter section of the preformed sections ("at least one section of the preformed sections of the working tray 110 can include a catheter section 112 configured to hold the catheter 132" [0052]); and
a drainage system ("drainage system" [0051]) disposed in the storage space ("drainage system can be stored in the storage tray 120" [0053]), the drainage system including a drainage receptacle and drainage tubing connected to the urinary catheter ("including drainage tubing and a drainage receptacle" [0051] & [0055-0056]).
Regarding Claim 8, Hughett discloses the storage tray is folded paperboard ("storage tray 120 of FIG. 6A is a folded paperboard storage tray" [0054]; FIG. 6A).
Regarding Claim 9, Hughett discloses the preformed sections of the working tray are arranged in accordance with the catheterization procedure, earlier steps in the catheterization procedure utilizing the components in the preformed sections closer to a genital area of the patient and later steps in the catheterization procedure utilizing the components in the preformed sections farther from the genital area.
Regarding Claim 10, Hughett discloses step-by-step catheterization instructions arranged and marked on the working tray in accordance with the catheterization procedure ("step-by-step catheterization instructions 102 imprinted directly on at least the working tray 110" [0066]; FIG. 6B).
Regarding Claim 11, Hughett discloses steps of the catheterization instructions are marked on the working tray within the preformed sections of the working tray or alongside the preformed sections ("express instruction in the genital-preparation section 118 such as in the well 117" [0066]; FIG. 6B).
Regarding Claim 12, Hughett discloses the storage tray includes an opening in an end of the storage tray ("cutout 121 in an end of the storage tray 120" [0053]) to facilitate access to any of the components of the urinary catheter-insertion kit stored in the storage space of the storage tray while working from the working tray ("to facilitate access to any of the components of the urinary catheter-insertion kit 100 stored in the storage tray 120 while working from the working tray 110" [0053]).
Regarding Claim 13, Hughett discloses the working tray includes a cutout in a corner area of the catheter section formed between a bottom portion and an end portion of the catheter section ("working tray 110 can include a cutout 111 in a corner area of the catheter section 112 formed between a bottom portion and an end portion of the catheter section 112" [0055]; FIG. 1A), the drainage tubing connected to the urinary catheter through the cutout in the catheter section ("drainage tubing of the drainage system to pass from the storage tray 120 to the working tray 110 by way of a bottom of the cutout 111 when the drainage tubing is stored in the storage tray 120" [0055]; FIG. 1A).
Regarding Claim 14, Hughett discloses the cutout allows the drainage tubing to be removed from the storage tray without disconnecting the drainage tubing from the urinary catheter ("configured to allow the drainage tubing to be removed from the storage tray 120 without disconnecting the drainage tubing from the catheter 132" [0055]).
Regarding Claim 15, Hughett discloses the drainage system further comprising a connector including a urine-sampling port connecting the urinary catheter to the drainage tubing ("connector 134 can be used to connect the catheter 132 and the drainage tubing. The connector 134 can include a urine-sampling port configured to facilitate urine sampling" [0059]; FIG. 1A).
Regarding Claim 16, Hughett discloses a lubricant container ("lubricant container 136" [0061]; FIG. 1A) including lubricant for the urinary catheter ("including, containing, or filled with lubricant for the catheter 132" [0061]), at least one section of the preformed sections of the working tray including a lubricant-container section configured to hold the lubricant container ("lubricant-container section 114 (e.g., lubricant-syringe section, lubricant-packet section, lubricant-pod section, lubricant-vial section, etc.) configured to hold the lubricant container 136" [0061]).
Regarding Claim 17, Hughett discloses an inflatant container ("inflatant container 138" [0062]; FIG. 1A) including an inflatant for inflating a balloon of the urinary catheter ("including, containing, or filled with an inflatant (e.g., saline) for inflating a balloon of the catheter 132" [0062]), at least one section of the preformed sections of the working tray including an inflatant-container section configured to hold the inflatant container ("inflatant-container section 116 (saline-syringe section) configured to hold the inflatant container 138" [0062]).
Regarding Claim 18, Hughett discloses a genital-preparation kit including a package of an antiseptic and one or more swab sticks ("genital-preparation kit including a package of an antiseptic (not shown) and one or more swab sticks 144" [0064]; FIG. 1A), at least one section of the preformed sections of the working tray including a genital-preparation section configured with a well to hold the antiseptic from the package ("At least one section of the preformed sections of the working tray 110 can include a genital -preparation section 118 configured with a well 117 to hold the antiseptic (e.g., povidone-iodine solution) from the package" [0064]) and one or more angled channels to respectively hold the one-or-more swab sticks with their corresponding one or more absorbent heads in the well ("one or more angled channels 119 to respectively hold the one or more swab sticks 144 with their corresponding one or more absorbent heads in the well 117" [0064]).
Regarding Claim 19, Hughett discloses the well is dimensioned to have a volume commensurate with an entire volume of the antiseptic from the package plus a volume of the one-or-more absorbent heads such that the one-or-more absorbent heads become saturated with the antiseptic when the antiseptic from the package is dispensed in the well ("well 117 is dimensioned to have a volume commensurate with an entire volume of the antiseptic from the package plus a volume of the one or more absorbent heads such that the one or more absorbent heads become saturated with the antiseptic when the antiseptic from the package is dispensed in the well 117" [0064]).
Regarding Claim 20, Hughett discloses a urine-sampling container disposed in the storage space of the storage tray ("urine-sampling container 152" & "storage tray 120 can be configured to hold the urine-sampling container 152" [0065]).
Regarding Claim 21, Hughett discloses protective paperboard configured to protect at least the components of the urinary catheter-insertion kit disposed in the working tray ("protective paperboard (not shown) configured to protect at least the components of the working tray 110" [0067]), the working tray including a lip around a perimeter of the working tray configured to hold the protective paperboard ("lip 101 around a perimeter of the working tray 110 configured to hold the paperboard" [0067]); and a peri-care kit between the protective paperboard and an outer packaging of the urinary catheter-insertion kit ("include the peri-care kit between the paperboard and an outer packaging (e.g., Tyvek®) of the urinary catheter-insertion kit 100" [0068]).
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.
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.
Claim(s) 2-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hughett in view of Glithero et al. (US 20160228676 A1).
Regarding Claims 2-6, Hughett fails to specify the tray assembly has a triangular prism or trapezoidal prism shape or flat-sided teardrop shape, flat sides of the flat-sided teardrop shape being major sides of the tray assembly; top edges of the working tray are chamfered or filleted for patient comfort; and corners between minor sides of the storage try are rounded for patient comfort.
However, Glithero teaches “medical procedure tray(s)” ([0073]; FIG. 1) wherein the “tray may have a generally or approximately rectangular, square, circular, oval, triangle, hexagonal, polygon, or other shape” ([0073]). Since the court has held that changes in shape is an obvious matter of choice in the absence of persuasive evidence that the claimed shapes are significant (In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966)), it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Hughett to have the claimed tray shapes “to improve ease of use, improve adherence to proper techniques, reduce the likelihood of infection” ([0072]).
Glithero further teaches the top edges of the working tray are chamfered or filleted for patient comfort ("upper portions of the walls (e.g., peripheral walls and/or separator walls) may have one or more chamfers or fillets 232" [0176]); corners between minor sides of the storage try are rounded for patient comfort ("compartment 230 may have rounded or chamfered interior corners 231" [0176]). Therefore, it would have been obvious to modify the device of Hughett as taught by Glithero “to better meet patients' needs, improve reliability and ease of use, reduce incidents of CAUTI, improve safety” ([0006]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hughett in view of Beddow (US 4226328 A).
Regarding Claim 7, Hughett fails to specify the working tray is molded plastic. However, Beddow teaches “a catheterization package 10” comprising “a generally rectangular box-like outer tray 11 having an open top within which a generally rectangular inner tray 12 is suspended” (col. 2 ln. 30-35; FIG. 1) wherein the working tray is molded plastic ("base and tray portions may be thermoformed by conventional methods from a thin plastic material" col. 2 ln. 55-57). Therefore, it would have been obvious to modify the device of Hughett as taught by Beddow “To provide a closed leak-resistant container for liquid collected during use of the catheterization package” (col. 1 ln. 56-58).
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, 12-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5, 7-11, 13, and 16 of U.S. Patent No. 11612715. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant Claims
U.S. Patent No. 11612715
1 & 13
1
12
3
14
5
15
7
16
8
17
9
18
10
19
11
20
13
21
16
Claims 2-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11612715 in view of Hughett (WO 2019246307 A1), Glithero et al. (US 20160228676 A1), and Beddow (US 4226328 A).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO-892 form are considered relevant to applicant’s disclosure and are cited to further show the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E. Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Adam Marcetich/Primary Examiner, Art Unit 3781
Cheng Fong "Ted" Yang
Examiner
Art Unit 3781