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 .
Response to Arguments
The previous objections to claims 4 and 22 are withdrawn in light of the amendments to the claims (filed 06/12/2026).
The previous rejection to claim 24 under 35 U.S.C. § 112(a) is withdrawn in light of the cancellation of the claim (Claims, filed 06/12/2026).
The previous rejections to claims 1-15, 17, 20, and 22-24 under 35 U.S.C. § 112(b) are withdrawn in light of the amendments to the claims (filed 06/12/2026).
Applicant's arguments with regards to the rejection of claims 1-3 under 35 U.S.C. § 102 (Remarks, filed 06/12/2026, p. 5) have been fully considered but they are not persuasive.
Applicant argues that “[t]he Ballan disclosure is directed toward a device for use on a real stoma on a human body. Ballan’s use of the term ‘artificial’ is to indicate that a stoma is not a naturally occurring opening” and that “[n]othing in the Ballan disclosure would teach or suggest to a person of ordinary skill to use any such device therein on an artificial ostomy (artificial stoma)” (Id.). To this, Examiner asserts the device taught by Ballan is artificial and man-made (col. 8, ll. 14-35: “a body 26 of a soft, elastic, water-insoluble material, notably an open-cell polymer foam”) and further, it positively recites all the structural features of amended claim 1: (a) a body which has a peripheral surface, first end surface, and second end surface, and (b) a liquid-absorbing material on the peripheral surface of the body. Furthermore, Examiner notes that although the particular use case of “demonstrating to a user of ostomy appliance an impact of mucin-contamination of a base plate during application of the base plate around the ostomy” as recited by the preamble of claim 1 is not explicitly disclosed by Ballan, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Therefore, the rejection of claims 1-3 under 35 U.S.C. § 102 has been maintained. See rejection of claims, as presented in detail below.
Applicant's arguments with regards to the rejection of the claims under 35 U.S.C. § 103 (Id. at 9-11) have been fully considered but they are not persuasive.
Specifically regarding independent claim 1, Applicant argues that “[i]t is unclear how the Office envisions the apron of the Hooper disclosure, or any cloth for that matter, is to be used in connection with an article shaped into stoma… to teach ostomates how to properly apply an ostomy appliance. In no way would a person of ordinary skill in the art be motivated by the Wooldridge and/or Hooper disclosures to drape a cloth apron… onto an article shaped into stoma… with the expectation of teaching users about mucin transfer to their ostomy appliance” (Id. at 9-10). Examiner respectfully disagrees. Firstly, Examiner directs Applicant’s attention to figures 3-5 and paragraph 0023 of the Wooldridge disclosure, which clarifies that the artificial stoma 24 structure comprises a base 30 and a cover 32, and that the cover 32 may be a “fabric encasement for the base 30,” wherein cover 32 makes up the peripheral surface of the body (see fig. 3B). Using the cloth material described in the Hooper disclosure as that particular portion of the artificial stoma (i.e., the fabric encasement/peripheral surface) would therefore have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention as an inexpensive, common, and shapable type of fabric. Furthermore, Examiner reiterates that although the particular use case of “teach[ing] ostomates how to properly apply an ostomy appliance” and/or “teaching users about mucin transfer to their ostomy appliance” is not explicitly disclosed by Wooldridge nor Hooper, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Therefore, the rejection of the claims under 35 U.S.C. § 103 have been maintained. See rejection of claims, as presented in detail below.
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.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by the previously cited art Ballan (US 4,981,465).
Regarding Claim 1, Ballan discloses an artificial ostomy comprising a body (figs. 1-3: body 26; col. 8, ll. 14-35: “a body 26 of a soft, elastic, water-insoluble material, notably an open-cell polymer foam”) having a peripheral surface (figs. 1-3: curved siding 28 of body 26), a first end surface (figs. 1-3: first end 22), and a second end surface (figs. 1-3: second end 24); and
a liquid-absorbing material, wherein the liquid-absorbing material is provided on the peripheral surface of the body (col. 5, ll. 3-7: “The cover may also be prepared from a hydrocolloid in sheet or film form;” col. 5, ll. 28-40: “comes into contact with the moisture… the hydrocolloid will absorb water and thereby form a slimy layer;” col. 8, lines 22-30: “a body 26… is held in that state by a thin cover or wrapping 28”).
Regarding Claim 2, Ballan further discloses the liquid-absorbing material is configured to form a gel on the peripheral surface of the body upon contact with liquid (col. 5, ll. 3-7: “The cover may also be prepared from a hydrocolloid in sheet or film form;” col. 5, ll. 28-40: “comes into contact with the moisture… the hydrocolloid will absorb water and thereby form a slimy layer;” Examiner notes hydrocolloids are known to form a gel when put in contact with liquid).
Regarding Claim 3, Ballan further discloses the liquid-absorbing material comprises a hydrocolloid (col. 5, ll. 3-7: “The cover may also be prepared from a hydrocolloid in sheet or film form;” col. 5, ll. 28-40: “comes into contact with the moisture… the hydrocolloid will absorb water and thereby form a slimy layer”).
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.
Claims 1 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over the previously cited art Wooldridge (US 2014/0051048) in view of Hooper (US 2006/0079855).
Regarding Claim 1, Wooldridge discloses an artificial ostomy comprising a body having a peripheral surface (figs. 3-5: artificial stoma 24 having a curved surface as peripheral surface 32; par. 0023: “the artificial stoma 24… is created using a base 30 and a cover 32 for the base. In the illustrated embodiment, the base 30 is a piece of foam piping. Moreover, in the illustrated embodiment, the cover 32 is a balloon. Although the illustrated embodiment uses a balloon and foam piping to create the artificial stoma, it should be appreciated that other materials may also be used to create a suitable artificial stoma. In that regard, it should be appreciated that the base 30 may be any suitable base that has structure to extend outwardly from the body attachment device 22, and the cover 32 may be any suitable plastic or fabric encasement for the base 30”), a first end surface (figs. 3-5: back end of artificial stoma 24, closest to body attachment device 22), and a second end surface (figs. 3-5: front end of artificial stoma 24, facing outward).
Wooldridge does not explicitly disclose a liquid-absorbing material. However, Hooper discloses a liquid-absorbing material, wherein the liquid-absorbing material is provided on the peripheral surface of the body (fig. 4; par. 0039: “the actual stoma is illustrated as a portion of the colon 39 is brought through slit 31. As described above, when a portion of a colon 29 (FIG. 1) may be raised through the abdominal wall incision, a stoma is created;” par. 0045: “In demonstrating a colostomy, the wearer may collect the colon-fashioned cloth and attach it to the front side of body portion 12;” Examiner notes the material used is cloth, which is known to be a liquid-absorbing material).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the material of Hooper for the fabric encasement/peripheral surface part of the artificial stoma of Wooldridge because cloth is well-known to be an inexpensive fabric, and it can be easily fashioned to form the appropriate shape if needed, such as part of the colon (Hooper, par. 0045).
Regarding Claim 4, Wooldridge modified by Hooper further discloses the liquid-absorbing material comprises a coloring agent (Hooper, par. 0031: “colon 27 may be fashioned in materials having a general color comparable to the actual organs in the human body;” Examiner notes for the cloth to be of a color comparable to an organ, a coloring agent must have been applied to it).
The combination of the artificial ostomy having a fabric material/peripheral surface of Wooldridge with the cloth material of Hooper described above for claim 1 would have included this coloring agent.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Wooldridge in view of Hooper as applied to claim 1 above, and further in view of the previously cited art Liu (CN 109830161).
Regarding Claim 5, modified Wooldridge does not disclose a silicone or polyurethane material. However, Liu discloses the artificial ostomy is formed of a silicone material or a polyurethane material (fig. 2; p. 3: “said ostomy model 2 is silicon rubber model”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the silicone rubber material of Liu with the base portion of the artificial stoma of Wooldridge because the silicone rubber material can enhance the overall quality of the simulation (Liu, p. 6) since silicone rubber is well-known within the industry to be a high-quality material used in such medical devices.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Wooldridge in view of Hooper and Liu as applied to claim 5 above, and further in view of the previously cited art Watanabe (JP 2003/210503).
Regarding Claim 6, Wooldridge modified by Liu discloses a silicone rubber but does not explicitly specify an addition-curing two-part silicone rubber. However, Watanabe discloses the silicone material comprises an addition-curing two-part silicone rubber (par. 0004: “The human body approximated skin product according to claim 1 or 2, which is dried. In the present invention, the room temperature vulcanizing type silicone rubber includes… two component RTV silicone rubbers”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the specific addition-cured two-part silicone rubber of Watanabe as the silicone rubber material of modified Wooldridge because this particular curing process improves the strength of the device (such as tear strength) (Watanabe, par. 0004).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Wooldridge in view of Hooper as applied to claim 1 above, and further in view of the previously cited art CPR Savers (a 2020 CPR Savers & First Aid Supply item listing entitled “Oval Ostomy”).
Regarding Claim 9, modified Wooldridge discloses the body has a height approximating the height of a real stoma (Wooldridge, par. 0025) but does not explicitly disclose exact dimensions. However, CPR Savers discloses the body is characterized by a height from the first end surface to the second end surface of 10-100 mm (p. 8: size of artificial ostomy/stoma is 1” x 1 2/8”, or 25.4 mm x 31.75 mm).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the specific height of the artificial ostomy of CPR Savers as the height of the ostomy of modified Wooldridge since Wooldridge already discloses its artificial ostomy is meant to model a real ostomy without disclosing any specific dimension (Wooldridge, par. 0025), and CPR Savers merely provides such a dimension that also models that of a real ostomy (CPR Savers, p. 8).
Regarding Claim 10, modified Wooldridge discloses the body has a diameter approximating the height of a real stoma (Wooldridge, par. 0025) but does not explicitly disclose exact dimensions. However, CPR Savers discloses the body is characterized by a diameter in a range of 10-70 mm (p. 8: size of artificial ostomy/stoma is 1” x 1 2/8”, or 25.4 mm x 31.75 mm).
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to use the specific diameter of the artificial ostomy of CPR Savers
as the diameter of the ostomy of modified Wooldridge since Wooldridge already discloses its
artificial ostomy is meant to model a real ostomy without disclosing a specific dimension
(Wooldridge, par. 0025), and CPR Savers merely provides such a dimension that also models
that of a real ostomy (CPR Savers, p. 8).
Claims 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Wooldridge in view of Hooper as applied to claim 1 above, and further in view of the previously cited art Blaine (US 4,439,162).
Regarding Claim 11, modified Wooldridge does not explicitly disclose an internal passage with two openings. However, Blaine discloses the body comprises an internal passage extending between a first opening in the first end surface and a second opening in the second end surface of the body (col. 6, ll. 5-15: “stomas 73 and 74 are formed with openings which are connected to the intestinal reservoir 10”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the internal passage described by Blaine with the artificial ostomy of Wooldridge in order to increase the realism and to provide more specific training/teaching (Blaine, col. 8, ll. 44-52).
Regarding Claim 12, Wooldridge modified by Blaine further discloses the internal passage is configured to allow flow of a fluid between the first opening in the first end surface and the second opening in the second end surface (col. 8, ll. 44-52: “For teaching ostomy care, the intestinal reservoir 10 is filled either via one of ostomies 73 or 74 or via the rectal passage and drainage or excretion at the ileostomy or colostomy is effected”).
The combination of the artificial stoma of modified Wooldridge with the internal passage of Blaine described above for claim 11 would have included this allowance for a flow of fluid.
Regarding Claim 13, Wooldridge modified by Blaine further discloses a system for advancing the fluid through the internal passage (col. 8, ll. 44-52: “drainage or excretion at the ileostomy or colostomy is effected;” Examiner notes this system of drainage or excretion inherently involves advancing the fluid), the system adapted to make the fluid enter the internal passage at the first opening and adapted to make the fluid exit the internal passage at the second opening (col. 8, ll. 44-52: “the intestinal reservoir 10 is filled… via the rectal passage and drainage or excretion at the ileostomy or colostomy is effected;” Examiner further notes the fluid enters the internal passage on one end and exits at the other).
The combination of the artificial stoma of Wooldridge with the internal passage of Blaine described above for claim 11 would have included this system for advancing the fluid.
Regarding Claim 14, Wooldridge modified by Blaine further discloses a base connected to the first end surface of the body (figs. 1, 9-12: base is the body/skin of mannequin, which is connected to the first end of each of ostomies 73-74).
The combination of the artificial stoma of Wooldridge with the internal passage of Blaine described above for claim 11 would have included this base.
Regarding Claim 15, Wooldridge modified by Blaine further discloses the system for advancing fluid is integrated with the base (figs. 9-12; “drainage or excretion at the ileostomy or colostomy is effected;” Examiner notes the system of drainage or excretion, which inherently involves advancing the fluid, is integrated within the base).
The combination of the artificial stoma of Wooldridge with the internal passage of Blaine described above for claim 11 would have included this base-integrated system.
Allowable Subject Matter
Claims 17, 20, and 22-23 are objected to as being dependent upon a rejected base claim,but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding Claim 17, as presented, the combination of all the elements of claim 17 do not appear in a single reference of prior art. Additionally, based on the art of record, it does not appear that it would have been obvious to a person having ordinary skill in the art at the time the application was filed to combine various pieces of the cited prior art to obtain each and every limitation as currently required by the independent claims. Specifically, the previously cited prior art Wooldridge fails to disclose, teach, or suggest “applying liquid to the liquid-absorbing material to form a gel on the peripheral surface of the generally cylindrical body” and “inspecting a distribution pattern of the gel on a proximal surface of the base plate.” Additional relevant art fails to cure this deficiency: for example, Hooper teaches a method for training surgeons on performing an ostomy, and Blaine teaches a method for providing basic maintenance exercises (such as dressing the ostomy) and demonstrating the movement of the internal fluid/waste. In other words, although the demonstration tool described in claim 17 has been rendered obvious over prior art, the prior art of record does not appear to cover the claimed method of using that apparatus.
Claims 20 and 22-23 would be allowable because they depend upon and further narrow the scope of claim 17.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/J.G.D./Examiner, Art Unit 3715
/DMITRY SUHOL/Supervisory Patent Examiner, Art Unit 3715
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