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 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 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) NOVELTY; PRIOR ART.—A person shall be entitled to a patent unless—
(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; or
(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 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Villefrance, Tine et al. (US 20050131360 A1).
Regarding claim 1, Villefrance discloses an external device (¶ [0001], a drainable ostomy pouch; ¶ [0030] Referring now to FIGS. 1-3, the currently preferred embodiment of an ostomy pouch);
comprising: a planar base (¶ [0033], A face plate 8 of a skin friendly adhesive barrier material is attached to film 1);
having a central aperture therethrough (¶ [0034] The face plate 8 and the film 1 to which the face plate is attached are provided with aligned stoma-receiving apertures 8a);
a back surface of the base comprising an adhesive material; wherein the adhesive material is configured to removably secure the base to a skin; wherein the base is configured to mimic the contours of the skin (¶ [0033], A face plate 8 of a skin friendly adhesive barrier material is attached to film 1. The face plate 8 serves to attach the pouch to the peristomal skin surface of a wearer of the ostomy pouch in a manner well known in the art);
a tubular member disposed on a front side of the planar base about the central aperture (¶ [0030], FIGS. 1-3 … three sheets or films of a liquid and gas impermeable flexible material, a body side or proximal film 1, an opposed or distal film 2 and an intermediate film 3 having a bottom edge 4 and dividing the pouch into a flatus gas chamber 3a and a faeces chamber 3b);
wherein the tubular member is configured to store a fluid therein (¶ [0030], an intermediate film 3 having a bottom edge 4 and dividing the pouch into a flatus gas chamber 3a and a faeces chamber 3b);
a vent disposed on a front surface of the tubular member (¶ [0034], an opening 8b for allowing flatus gasses to pass from the faeces chamber 3b to the flatus gas chamber 3a while at same time preventing or restraining the passage of faecal material from chamber 3b to chamber 3a, as shown and described in U.S. Pat. No. 5,690,623); and
a sealable drain disposed at a terminal end of the tubular member (¶ [0035] A strip 9 of an interlocking means such as Velcro … DUOTEC … or well known repeatedly releasable adhesive coatings, is attached to film 1; ¶ [0038] In use, the discharge portion of the pouch is closed in the following manner after having been emptied through the drainage aperture 5; ¶ [0041] Finally, the strips 6 and 7 are rotated … the two Velcro strips 9 and 12 abut and engage each other for locking said coil in the final closed and secured position of the discharge portion; ¶ [0050] Furthermore, by locating the edge 4 between the strips 6 and 7 it is ensured that film 3 is held flat without wrinkles and folded just as many times as the films 1 and 2 such that there is no risk of leaks below the intermediate film 3 between the flatus gas chamber 3a and the faeces chamber 3b in the rolled-up closed position of the drainage portion).
Villefrance does not explicitly describe an external catheter, and instead refers to the device as an ostomy pouch (¶ [0009], [0013], [0029], [0030]).
If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See MPEP 2111.02(II).
In the instant case, the language “an external catheter” represents an intended use since it does not describe any structure of the device and instead describes that the device is intended to collect urine, fluids or waste material. Villefrance explicitly configures the device to collect waste materials from a wearer (¶ [0030], [0034], [0050]).
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Christensen; Claus Bo Voege et al. (US 20090163883 A1).
Regarding claim 1, Christensen discloses an external device (¶ [0008], an adapter for connecting the anus or a perianal stoma of a user to a peripheral device; ¶ [0061] FIGS. 1 and 2 shows an adapter 1; ¶ [0068] FIGS. 3 and 4 shows a first embodiment of a peripheral device 20);
comprising: a planar base having a central aperture therethrough (¶ [0063] A first through going hole 5 is formed in the flexible adhesive plate and a second through going hole 6 is formed in the flexible coupling flange; ¶ [0069], a through going hole 25 is provided which provides access to the compartment 26 of the bag);
a back surface of the base comprising an adhesive material; wherein the adhesive material is configured to removably secure the base to a skin (¶ [0062] The adapter is formed of a flexible adhesive plate 2 formed of an hydrocolloid adhesive arranged on a polymer backing layer; ¶ [0069], flexible coupling plate 24 … The coupling plate is formed of a hydrocolloid adhesive provided on a backing layer of polyurethane);
wherein the base is configured to mimic the contours of the skin (¶ [0078] When attached to the adapter the peripheral device will typically abut against the skin of a user; ¶ [0095], Compared to mechanical couplings this provides a much more comfortable and capable of following the contour of the body);
a tubular member disposed on a front side of the planar base about the central aperture; wherein the tubular member is configured to store a fluid therein (¶ [0069] The peripheral device 20 is formed of a bag 21 made of a thin polymer film; ¶ [0070] Thus the peripheral device 20 will collect stool from an adapter when the adhesive plate of the adapter is adhered around the anus);
a vent disposed on a front surface of the tubular member (¶ [0071] The bag of the peripheral device is further provided with a gas filter 27, which provides communication with the outside of the bag through the hole 28. This allows for example flatulence to escape, so that the bag does not get bloated and uncomfortable to wear); and
a sealable drain disposed at a terminal end of the tubular member (¶ [0076] In the second half of the bag 21 there is provided a drainage port 47. The drainage allows for thin stool to be emptied easily, whereby the peripheral device 20 may be worn for an extended period of time).
Christensen does not explicitly describe an external catheter, and instead refers to the device as an ostomy pouch, “peripheral device” or bag (¶ [0011], Such construction is for example known from adhesive ostomy devices; ¶ [0068] FIGS. 3 and 4 shows a first embodiment of a peripheral device 20; ¶ [0070] Thus the peripheral device 20 will collect stool; ¶ [0071] The bag of the peripheral device). However, the preamble of this claim does not distinguish the invention from Christensen’s device, which is configured to collect waste materials (¶ [0070] Thus the peripheral device 20 will collect stool). Regarding the rationale that the preamble describes an intended use, see the discussion of Villefrance and claim 1 above.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claim 1 is rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 14 and 15 of Pinlac; Rosemarie (US 11877948 B2).
Regarding pending claim 1, Pinlac claims all limitations in patented claims 1 and 15, namely an external catheter (claims 1 and 14, An external catheter);
comprising: a planar base having a central aperture therethrough (claim 1 and 14, a planar base having a central aperture therethrough);
a back surface of the base comprising an adhesive material (claim 1 and 14, an entire back surface of the base comprising an adhesive material applied directly to the planar base);
wherein the adhesive material is configured to removably secure the base to a skin (claim 1 and 14, the adhesive material is configured to removably secure the base to a skin);
wherein the base is configured to mimic the contours of the skin (claim 15, wherein the flexible planar base is configured to mimic the contours of the skin when secured thereto);
a tubular member disposed on a front side of the planar base about the central aperture (claim 1 and 14, an upper end of a tubular member disposed on a front side of the planar base about the central aperture,);
wherein the tubular member is configured to store a fluid therein (claim 1 and 14, the tubular member is configured to store a fluid therein);
a vent disposed on a front surface of the tubular member (claim 1 and 14, a vent disposed on a front surface of the tubular member); and
a sealable drain disposed at a terminal end of the tubular member (claim 1 and 14, a sealable drain disposed at a terminal end of the tubular member).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Canela; Heriberto US 5690621 A
Burt; Margaret US 20080275410 A1
Ugarte; Roland Rene US 20170042724 A1
Young; Alice et al. US 20210369493 A1
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/Adam Marcetich/
Primary Examiner, Art Unit 3781