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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-12 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 2-3 recite structures of an ostomy bag, wherein the independent claim 1 describes a device as a cover for an ostomy bag. As such, it is unclear if claims 2-3 are meant to positively recite the ostomy bag, or if the cover is meant to accommodate the structures of a theoretical ostomy bag. For the purpose of examination, the claims will be interpreted as the ostomy bag being positively recited.
Claims 3-12 are rejected by virtue of being dependent on claim 2, and claims 4-12 are rejected by virtue of being dependent on claim 3
Claim Rejections - 35 USC § 102
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.
(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 1 is rejected under 35 U.S.C. 102(a)(1)(2) and 35 U.S.C. 102(a)(2) as being anticipated by Myhres (US 5759180).
Regarding claim 1, Myhres discloses a shield device that provides a user with a covering for an ostomy bag (abstract), the shield device comprising:
a body component (fig. 2, cover 44 has a component with a body), wherein the body component is opaque and secures to an ostomy bag to discreetly hide the ostomy bag from view during use (col. 2, lines 64-67, “It is preferred that the cover 44 be opaque such that waste in the ostomy bag 10 is not visible when the cover 44 is in place”)
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 2 and 13-4 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Myhres.
Regarding claim 2, Myhres is silent to wherein an ostomy bag comprises either colostomy and ileostomy bags.
However, Myhres teaches wherein the cover may be sized and shaped to fit other types of ostomy bags (col. 2, lines 29-45), and describes ostomies formed for different organs such as the colon (col. 1, lines 9-18), thus encompassing a colostomy bag.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Myhres such that the ostomy bag comprises a colostomy bag, for the purpose of providing a suitable means for the cover to fit the shape of an ostomy bag used for a specific treatment (col. 2, lines 29-45).
Regarding claim 13, Myhres discloses a shield device that provides a user with a covering for an ostomy bag (abstract), the shield device comprising:
a body component with a front surface and a rear surface (fig. 2, cover 44 with a body portion 50, neck portion 52, along with rear side 48 and front side 46) ;
wherein the body component is made from a single rectangle of material cut to cover an entire front of the ostomy bag (fig. 2 shows a single sheet covering an ostomy bag 10, with col. 2 lines 40-45 further clarifying “it would be within the scope of the present invention for the cover 44 to include a neck portion 52 which covers substantially all of the neck portion 38 of the front side 18 of the ostomy bag 10:);
wherein the body component is cut to mirror shape and size of the ostomy bag (fig. 2 shows the shape of the bag cover 44 be the same shape and size as the ostomy bag 10, with further clarification that the neck portion 52 of the cover 44 covering all of the neck portion 38 of the front side 18 of the ostomy bag 10, see col. 2, lines 29-45);
wherein the body component is sized to sufficiently cover the ostomy bag (col. 2, lines 29-45)
wherein the rear surface of the body component comprises an adhesive, which allows the body component to be releasably secured to the ostomy bag (col. 2, lines 45-63 describes rear side 48 with an adhesive that is releasable); and
further wherein the front surface of the body component is opaque, such that when positioned in front of the ostomy bag, view of the ostomy bag is blocked (col. 2, lines 45-63 describe the cover 44 being opaque).
Myhres is silent to wherein the body component is sized approximately six to twelve inches in length and approximately three to 6 inches in width.
However, Myhres teaches wherein the cover may be sized and shaped to fit multiple types of ostomy bags (col. 2, lines 46-63). As such, one of ordinary skill in the art would appreciate changing the size of the cover to fit these dimensions if the ostomy bag fits said dimensions would have been obvious.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Myhres such that the body component is sized approximately six to twelve inches in length and approximately three to 6 inches in width, for the purpose of providing a suitable size that allows the ostomy cover to cover a bag of the respective dimensions, and since a change in size is generally recognized as being within the level of ordinary skill in the art. See MPEP 2144.04 (IV)(A)
Regarding claim 14, Myhres discloses wherein the body component is a fabric cover (col. 3, lines 14-22 describes ostomy bag cover can be a moisture resistant fabric).
Regarding claim 16, Myhres discloses the device further comprising a plurality of indicia (fig. 2 shows a plurality of flowers, col. 2, lines 64-67 and col. 3, lines 1-9. Instant specification, [0040] describes indicia being patterns designs, etc.).
Regarding claim 17, Myhres discloses wherein the front surface of the body component comprises a pattern and multiple designs (fig. 2, multiple designs of a flower forming a pattern), but is silent to wherein the body component comprises various colors, patterns, and designs.
However, wherein the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. See MPEP 2112.01(II). In this instance, as a plotter type printer is utilized for the design, one of ordinary skill in the art would be fully capable of making the body component comprise various colors, patterns, and designs.
Regarding claim 18, Myhres discloses wherein the body component is available in different sizes, depending on size of the ostomy bag it is to cover (col. 2, lines 40-45, “additionally, the cover 44 may be sized and shaped to fit other types of ostomy bags”).
Regarding claim 19, Myhres is silent to wherein an ostomy bag comprises either colostomy and ileostomy bags.
However, Myhres teaches wherein the cover may be sized and shaped to fit other types of ostomy bags (col. 2, lines 29-45), and describes ostomies formed for different organs such as the colon (col. 1, lines 9-18), thus encompassing a colostomy bag.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Myhres such that the ostomy bag comprises a colostomy bag, for the purpose of providing a suitable means for the cover to fit the shape of an ostomy bag used for a specific treatment (col. 2, lines 29-45).
Claims 3-12 are rejected under 35 U.S.C. 103 as being unpatentable over Myhres in view of Kingsdown Medical (GB 2058011).
Regarding claim 3, Myhres discloses wherein the ostomy bag is made of a translucent plastic film (col. 2, lines 19-28 describes the bag being translucent) and has a flange on its upper portion which is secured to a stoma on a user's abdomen (fig. 3, artificial stoma adhesive ring 24 to serve as a flange), but does not teach wherein the ostomy bag is made of a transparent plastic film, and includes a drain tube at a bottom of the ostomy bag for withdrawing liquid or fluid wastes from the ostomy bag.
However, Kingsdown Medical teaches wherein transparent plastic films and drain tubes at the bottom of the ostomy bag are known practices in the art (fig. 1, walls of ostomy pouch described as transparent, and includes a tube 40 for drainage).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Myhres such that the ostomy bag is made of a transparent plastic film, and a drain tube at a bottom of the ostomy bag for withdrawing liquid waste from the ostomy bag, as taught by Kingsdown Medical, for the purpose of providing a suitable structure that allows for a valve to be formed for drainage (see Kingsdown Medical, pg. 2, lines 39-53) and for more clearly visualizing the fluid on a part that’s not being covered for the sake of examination.
Regarding claim 4, Myhres is silent to wherein the body component is made from a single rectangle of material cut to cover an entire front of the ostomy bag.
However, this claim is interpreted as a product-by-process claim, whereby “if the product in the product-by-process claim is the same as or obvious from a product in the prior art, the claim is unpatentable even though the prior product was made by a different process”. In this instance, the cover (44) covers an entire front of the ostomy bag as a single sheet (fig. 2)
Regarding claim 5, Myhres discloses wherein the body component is cut to mirror shape and size of the ostomy bag (fig. 2 shows the shape of the bag cover 44 be the same shape and size as the ostomy bag 10, with further clarification that the neck portion 52 of the cover 44 covering all of the neck portion 38 of the front side 18 of the ostomy bag 10, see col. 2, lines 29-45).
Regarding claim 6, Myhres is silent to wherein the body component is sized approximately six to twelve inches in length and approximately three to six inches in width to sufficiently cover the entire front of the ostomy bag and block it from view.
However, Myhres teaches wherein the cover may be sized and shaped to fit multiple types of ostomy bags (col. 2, lines 46-63). As such, one of ordinary skill in the art would appreciate changing the size of the cover to fit these dimensions if the ostomy bag fits said dimensions would have been obvious.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Myhres such that the body component is sized approximately six to twelve inches in length and approximately three to 6 inches in width, for the purpose of providing a suitable size that allows the ostomy cover to cover a bag of the respective dimensions, and since a change in size is generally recognized as being within the level of ordinary skill in the art. See MPEP 2144.04 (IV)(A)
Regarding claim 7, Myhres discloses wherein the body component is available in different sizes, depending on size of the ostomy bag it is to cover (col. 2, lines 40-45, “additionally, the cover 44 may be sized and shaped to fit other types of ostomy bags”).
Regarding claim 8, Myhres discloses wherein the body component has a front surface and a rear surface (fig. 2, cover 44 with a rear side 48 and a front side 46).
Regarding claim 9, Myhres discloses wherein the rear surface of the body component comprises an adhesive, which allows the body component to be releasably secured to the ostomy bag (col. 2, lines 45-63 describes rear side 48 with an adhesive that is releasable).
Regarding claim 10, Myhres discloses wherein the front surface of the body component is opaque, such that when positioned in front of the ostomy bag, view of the ostomy bag is blocked (col. 2, lines 64-67, “It is preferred that the cover 44 be opaque such that waste in the ostomy bag 10 is not visible when the cover 44 is in place”).
Regarding claim 11, Myhres discloses wherein the front surface of the body component comprises a pattern and multiple designs (fig. 2, multiple designs of a flower forming a pattern), but does not teach the body component comprising various colors, patterns, and designs.
However, wherein the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. See MPEP 2112.01(II). In this instance, as a plotter type printer is utilized for the design, one of ordinary skill in the art would be fully capable of making the body component comprise various colors, patterns, and designs.
Regarding claim 12, Myhres discloses the device further comprising a plurality of indicia (fig. 2 shows a plurality of flowers, col. 2, lines 64-67 and col. 3, lines 1-9. Instant specification, [0040] describes indicia being patterns designs, etc.).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Myhres in view of Burroughs (US 20120123362).
Regarding claim 15, Myhres fails to teach wherein the fabric cover encompasses an entire ostomy bag
However, Burroughs teaches a cover that encompasses an entire collection device (fig. 2, ostomy bag 150 with a bag cover 102 encompassing the entire bag 150)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Myhres such that the fabric cover encompasses an entire ostomy bag, as taught by Burroughs, for the purpose of providing a suitable structure that further conceals the ostomy pouch (see Burroughs, paragraph 0013).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Myhres in view of Trousil (US 3897780).
Regarding claim 20, Myhres discloses a method of covering an ostomy bag (abstract), the method comprising the following steps:
providing a shield device (44) comprising a body component with an adhesive back (fig. 2, ostomy bag cover 44 with an adhesive on the rear side 48)
choosing a body component of a specific color and design (col. 3, lines 1-9 describes a pattern or design being specific to the user, using a plotter printer that is capable of also printing in color)
securing the body component to an ostomy bag via the adhesive back (col. 2, lines 46-50), and
covering the ostomy bag with the device in a discrete fashion (col. 2, lines 64-67, “It is preferred that the cover 44 be opaque such that waste in the ostomy bag 10 is not visible when the cover 44 is in place”)
Myhres does not teach the method comprising removing a release liner from the adhesive back.
However, Trousil teaches wherein release liners (50) used to protect adhesive linings are known in the art (fig. 1, rip-strip 50 protecting a face 48 of an adhesive patch, col. 4, lines 7-34)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Myhres such that it comprises removing a release liner from the adhesive back, as taught by Trousil, for the purpose of providing a suitable method of protecting the adhesive cover prior to use (col. 5, lines 57-62, and col. 6, lines 1-11)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hogan (US 4439191) discloses an ostomy bag cover.
Honig (US 5843054) discloses an ostomy bag cover.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON W LEVY whose telephone number is (571)272-7582. The examiner can normally be reached M-F 7:30AM- 4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 5712705879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Brandon W. Levy/Examiner, Art Unit 3781
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