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 .
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 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 and 23-37 of copending Application No. 17/837687. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-16 are anticipated by claims 18 and 23-37 of application 17/837687. While application 17/837687 discloses a collection cup in addition to a collection container, the scope of the claims discloses the structure of the collection container as disclosed by claims 1-16 of the instant application.
Claim 17 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of copending Application No. 17/837687 in view of Shimada et al. (JP3228377U).
Application 17/837687 discloses the collection container of claim 1 (claim 18: “a collection container for use with a toilet bowl to collect a sample, including: a first end; a second end; a central recess disposed between the first end and the second end, the central recess configured to receive a sample; a first stopper disposed adjacent the first end; and a second stopper disposed adjacent the second end, the first stopper and the second stopper configured to together grasp opposite sides of the toilet bowl upon installation of the collection container on the toilet bowl and to selectively hold the collection container in place on the toilet bowl during collection of the sample;”), but fails to disclose the collection container is formed from polypropylene.
Shimada discloses a collection container wherein the collection container is formed from polypropylene ([0023]: “The stool receiving portion 10 is molded of a flexible resin. For example, polyethylene, polypropylene and the like can be used.”).
It would have been obvious to a person of ordinary skill in the art to modify the collection container disclosed in 17/837687 to be formed of a polypropylene as disclosed by Shimada in order to allow the container to be flexible while maintaining strength (Shimada [0032]).
Thes are provisional nonstautory double patenting rejections because the patentably indistinct claims have not in fact been patented.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 2 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Catlin (US 20180317892 A1, applicant cited in 02/20/23 IDS).
Regarding claim 1, Catlin discloses a collection container for use with a toilet bowl to collect a sample (Fig 1 element 01), including: a first end (Fig 1 end of element 03 left half); a second end (Fig 1 end of element 03 right half); a central recess disposed between the first end and the second end (Fig 1 element 02), the central recess configured to receive the sample ([0029]: “the collection bag is secured to the underside of the toilet frame directly under the opening of the toilet frame.”); a first stopper disposed adjacent the first end (Fig 1 element 04 left); and a second stopper disposed adjacent the second end (Fig 1 element 04 right), the first stopper and the second stopper configured to together grasp opposite sides of the toilet bowl upon installation of the collection container on the toilet bowl and to selectively hold the collection container in place on the toilet bowl during collection of the sample ([0072]: “Rubber grommets 04 are adhered to the underside of the toilet frame in order to prevent slipping or shifting while the patient is positioned on the toilet frame 01.”).
Regarding claim 2, Catlin further discloses the first end includes a first arm (Fig 1 element 03 left).
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.
Claim(s) 3-10 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Catlin in view of Paige (US 20180008238 A1).
Regarding claim 3, Catlin discloses the collection container of claim 2 but fails to disclose wherein the first arm includes a first handle.
Paige discloses a bodily fluids sample collection device (abstract) wherein the first arm (Fig 1 element 20) includes a first handle (Fig 1 element 23).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the sample collection kit disclosed by Catlin to include the handle as disclosed by Paige in order to enable the user to grasp the device without touching the toilet seat or bowl (Paige abstract).
Regarding claim 4, Catlin further discloses the first stopper is located on the first arm between the central recess and the first handle (Fig 1 element 04 left side, which with the modification of adding a handle is located between the handle and recess).
Regarding claim 5, Catlin further discloses the second end includes a second arm (Fig 1 element 03 right half).
Regarding claim 6, Catlin as modified by Paige discloses the collection container of claim 5, but fails to disclose wherein the second arm includes a second handle.
Paige further discloses the second arm (Fig 1 element 25) includes a second handle (Fig 1 element 23).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the sample collection kit disclosed by Catlin as modified by Skiba to include the handle as disclosed by Paige in order to enable the user to grasp the device without touching the toilet seat or bowl (Paige abstract).
Regarding claim 7, Catlin further discloses the second stopper is located on the second arm between the central recess and the second handle (Fig 1 element 04 right side, which with the modification of adding a handle is located between the handle and recess).
Regarding claim 8, Paige further discloses each of the first handle and the second handle is rounded (Fig 2, wherein both ends are rounded).
Regarding claim 9, Paige further discloses each of the first handle and the second handle has a hole configured to hang the collection container ([0049]: " plurality of handle slits 28 enables the bodily fluids sample collection device 10 to be attached to the patient's 40 clothing or to another prop to allow for additional support").
Regarding claim 10, Catlin further discloses the first arm and the second arm disposed in a same plane as the central recess (Fig 2).
Regarding claim 12, Catlin further discloses each of the first stopper and the second stopper is hollow ([0072]: “Rubber grommets”, wherein grommets are hollow).
Claims 11 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Catlin in view of Shimada et al. (JP3228377U), hereinafter Shimada.
Regarding claim 11, Catlin discloses the collection container of claim 1, but fails to disclose the central recess has a pour spout.
Shimada discloses a portable toilet (abstract) wherein the central recess has a pour spout (Fig 6 element 25 b).
Shimada and Catlin are considered analogous art as they pertain to specimen collection. It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the sample collection kit disclosed by Catlin to include the pour spout as disclosed by Shimada in order to allow for the disposal of unwanted or excess urine samples (Shimada [0040]).
Regarding claim 17, Catlin discloses the collection container of claim 1, but fails to disclose the collection container is formed from polypropylene.
Shimada discloses a collection container wherein the collection container is formed from polypropylene ([0023]: “The stool receiving portion 10 is molded of a flexible resin. For example, polyethylene, polypropylene and the like can be used.”).
It would have been obvious to a person of ordinary skill in the art to modify the collection container disclosed in Catlin to be formed of a polypropylene as disclosed by Shimada in order to allow the container to be flexible while maintaining strength (Shimada [0032]).
Claim(s) 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Catlin in view of Enos et al. (US 20120316462 A1, applicant cited in 02/20/23 IDS), hereinafter Enos.
Regarding claim 13, Catlin discloses the collection container of Claim 1 but fails to disclose each of the first stopper and the second stopper has an arcuate surface with a curvature configured to match the curvature of the toilet bowl.
Enos discloses a stool specimen collection system (title) including a stopper ([0006]: “a removable retainer to secure the bowl to the frame at the hole”) that has an arcuate surface with a curvature configured to match the curvature of the toilet bowl ([0016]: “U-channel retainer securing the bowl to the frame.”, Fig 3B).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to substitute the stopper disclosed by Catlin with the stopper with an arcuate surface with curvature disclosed by Enos for the predictable result of securing the collection container to a toilet.
Regarding claim 14, Catlin discloses the collection container of Claim 1, but fails to disclose wherein each of the first stopper and the second stopper is hollow and has an arcuate surface with a curvature configured to match the curvature of the toilet bowl.
Enos discloses a stool specimen collection system (title) including a stopper ([0006]: “a removable retainer to secure the bowl to the frame at the hole”) is hollow (Fig 3B, wherein the U-shape has a cavity) that has an arcuate surface with a curvature configured to match the curvature of the toilet bowl ([0016]: “U-channel retainer securing the bowl to the frame.”, Fig 3B).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to substitute the stopper disclosed by Catlin with the hollow and arcuate stopper disclosed by Enos in for the predictable result of securing the device to the toilet seat.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Catlin in view of Paasch et al (US 20060184064), hereinafter Paasch.
Catlin as modified by Skiba discloses the sample collection kit of Claim 18 but fails to disclose wherein the first end and the second end have triangular cut outs.
Paasch discloses a urine sample collection device (abstract) wherein the first end and the second end have triangular cut outs (Fig 7 element 43).
It would have been obvious to a person of ordinary skill in the art to modify the first and second end disclosed by Catlin to include the cutouts as disclosed by Paasch in order to reduce the cost of manufacturing ([0044]: “the openings 43 in the intermediate sections 40 reduce material cost for the USCD 12.”).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Catlin in view of Sidorsky et al. (US 20140017720 A1 applicant cited in 02/20/23 IDS), hereinafter Sidorsky.
Catlin as discloses the collection container of claim 1 but fails to disclose the collection container is formed as a unitary piece.
Sidorsky discloses a stool collection device (abstract) wherein the collection container is formed as a unitary piece (Fig 1, [0074]: “In an alternate embodiment, it is expressly contemplated that the entire bracket 102 can be permanently connected to the container 302 and provided as one solitary unit.”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the collection container disclosed by Catlin to be a unitary piece as disclosed by Sidorsky in order to reduce cost of manufacturing.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Clark (GB2576743A) – discloses a stool/urine sample collection system
Fiedler et al. (US 20140329273 A1) – stool collection device
Saptya (USD489453S1) – Urine specimen cup holder with cutouts
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAVYA SHOBANA BALAJI whose telephone number is (703)756-5368. The examiner can normally be reached Monday - Friday 8:30 - 5:30 ET.
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/KAVYA SHOBANA BALAJI/Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791