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 .
Claims 1-19 are pending in the instant application and are examined on the merits herein.
Priority
This application is a continuation of U.S. Application no. 16/978,951 which is a 371 of PCT/IB2019/051873 filed on 03/08/2019, which claims priority to NZ/745086 filed on 08/08/2018, NZ/744989 filed on 08/07/2018, and NZ/740603 filed on 03/08/2018.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 112(a) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, Application No. NZ/740603, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior-filed application, NZ/740603, does not provide support in the specification for the limitations of claims 1-19 in the instant application. Specifically, the application fails to provide support for the shell as claimed in claim 1 and any accompanying structures.
Claims 1-19 receive priority to NZ/744989 filed on 08/07/2018.
Specification
The disclosure is objected to because of the following informalities:
The body portion is referred to by an incorrect reference number (pg. 18 ln. 32).
The specification refers to Fig. 12A-B that are not provided in the drawings (pg. 25 ln. 14-18).
Appropriate correction is required.
Claim Objections
Claims 9 and 15 are objected to because of the following informalities:
Claim 9 recites the limitations “to skin of a patient” in ln. 2 and “to a skin of a patient” in ln. 5. These should read “to the skin of a patient” and “to the skin of the patient”, respectively.
Claim 15 recites the limitation “one or more of the: a) First elongate tubular member” in ln. 2-3. This should read “one or more of the: a) first elongate tubular member”.
Appropriate correction is required.
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 15 and 17-19 are 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.
Claim 15 recites the limitation "one or more of the…longitudinal guide member" in ln. 6. There is insufficient antecedent basis for this limitation in the claim. This rejection could be rendered moot by changing “the” to “a”; however, this would cause a clarity problem regarding the other features claimed as a-c.
Claim 17 recites the limitation "a first side of a member of the plate structure" in ln. 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "coupling the shell to the plate structure by coupling the plate coupling member to the shell coupling member" in ln. 6-7. There is insufficient antecedent basis for this limitation in the claim.
Claims 17-19 are all method claims that refer back to the apparatus claim 1. The claims are indefinite in that they are unclear whether the entire apparatus of claim 1 is required to read on the claims. Claims 17 and 19 recite the limitation, “[a] method of connecting a surgically created orifice with a surgically created second orifice as claimed in claim 1” in ln. 1-2. This does not seem to require the connecting device of claim 1, but instead requires the orifices of claim 1. For the sake of compact prosecution the examiner is treating this limitation as though it reads “[a] method of connecting a surgically created orifice with a surgically created second orifice using the connecting device as claimed in claim 1”. Claim 18 recites the limitation “positioning a shell as claimed in claim 1” in ln. 3. This seems to only require the shell of claim 1 and not the rest of the connecting device of claim 1. For the sake of compact prosecution, the examiner is treating the limitation as though it reads “positioning the shell of the connecting device as claimed in claim 1”.
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 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.
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.
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Ex. Fig. 1 of Logier Fig. 1
Claims 1-2, 5-7, 9, 13-14, 16-17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over FR/3034984 A1 to Logier in view of U.S. Patent no. 10,028,893 B2 to Kane.
Regarding claim 1, Logier discloses a connecting device for connecting a surgically created first orifice with a surgically created second orifice and transferring contents from the surgically created first orifice to the surgically created second orifice (Fig. 1, connecting device 1; pg. 3 para. 4 and pg. 4 para. 1-2 and para. 3 ln. 1-6), the device comprising:
an elongate tubular member configured to, in use, be inserted into the surgically created second orifice (Fig. 1, flexible tube TS inserted into downstream stoma S2; pg. 4 para. 2),
an intermediate hollow body member having a body inlet and a body outlet (Ex. Fig. 1 showing intermediate hollow body member comprising body inlet 3 and body outlet 5), and
wherein the elongate tubular member is in fluid communication with and extends away from the body outlet, the elongate tubular member having an outlet located at a distal end away from the intermediate hollow body member (Ex. Fig. 1), and
wherein the intermediate hollow body member extends between the body inlet and the body outlet connected to the elongate tubular member (Ex. Fig. 1), and
wherein the intermediate hollow body member includes a body opening (Ex. Fig. 1), and the connecting device includes a cap for closing said body opening to complete a sealed pathway between the surgically created first orifice and the elongate tubular member for passive transfer of contents from the first orifice to the second orifice (Ex. Fig. 1), and
a shell configured to, in use, encompass and define a volume of space surrounding said surgically created first and second orifices (Ex. Fig. 1).
Logier differs from the instantly claimed invention in that Logier fails to disclose a first elongate tubular member configured to, in use, be inserted into the surgically created first orifice, wherein the first elongate tubular member is in fluid communication with and extends away from the body inlet, the first elongate tubular member having an inlet located at a distal end away from the intermediate hollow body member, a sealed pathway between the first elongate tubular member and the second elongate tubular member for passive transfer of contents from the first orifice to the second orifice, wherein said device further includes a shell configured to, in use, encompass and define a volume of space, wherein said volume of space is isolated from said pathway between the first elongate tubular member and the second elongate tubular member, so that the contents being transferred from the surgically created first orifice to the surgically created second orifice do not leak into the surrounding volume of space.
Kane teaches a connecting device for surgically created orifices comprising first and second tubular members configured to, in use, be inserted into first and second surgically created orifices (Fig. 1, hollow cover/shell 11 comprising passage 13 and elongate member 14 that together [13/14] may be considered the tubular member; Fig. 2, connecting device comprising hollow covers 11 in contact with upward and downward stomas), a sealed pathway between the first and second tubular members for transfer of contents from the first to the second orifice such that the tubular members prevent backflow to reduce leakage of the system (col. 5 ln. 23-51; Fig. 2, pathway may be considered path between tubular members [13/14] of the hollow covers/shells 11 at each orifice), and a shell for collection of any leaked flow from the patient configured to, in use, encompass and define a volume of space surrounding a surgically created orifice for the collection of any leaked backflow from the orifice, and wherein said volume of space is isolated from a pathway formed of a tube passed between the surgically created orifices, so that the contents being transferred within the pathway do not leak into the surrounding volume of space (col. 5 ln. 23-51; Fig. 1-2, hollow cover/shell 11 comprising volume of space in chamber 15 isolated from the pathway between tubular members [13/14] that may be disposed within the subject and are connected via tubing).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of Logier to comprise the first elongate tubular member while maintaining the shell as taught by Kane, because Logier teaches that skin irritation is caused by contact of the skin to the food bolus (pg. 4 para. 4) such that one of ordinary skill in the art would be motivated to modify the system to have as little contact of the skin to the food bolus. Kane teaches that the shape of their tubular members avoids backflow of bolus to reduce leakage of the system and contemplates that the connection of the tubular members should be fluid tight to further prevent backflow and leakage of bowel contents (col. 5 ln. 23-51). Kane further teaches that providing a chamber around the tubular members creates a space that may allow for collection of any leaked flow from the patient (col. 5 ln. 23-51), such that the system may have increased leakage protection.
Regarding claim 2, the cited prior art suggests the invention of claim 1; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the shell is rigid or semi-rigid.
Kane teaches wherein the shell is rigid or semi-rigid to act as an anchor to reduce leakage of bowel contents (Fig. 1, shell 11; col. 5 ln. 43-45).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the shell of the cited prior art to be rigid or semi-rigid as taught by Kane, because Kane teaches that the shell may act as a rigid anchor to reduce leakage of the bowel contents (col. 5 ln. 43-45).
Further, regarding the limitation “wherein the shell is… adapted to exert a downward pressure to keep the first and second elongate tubular members within the surgically created first and second orifices when the device is attached to a patient” as that the invention of the cited prior art suggests substantially identical structure to the claimed prior art, the claimed results are considered to be inherent. As supported in MPEP 2112.01, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).”
Regarding claim 5, the cited prior art suggests the invention of claim 1; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein said cap and said shell are integrally formed.
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to have the cap and shell integrally formed, since the court has held that “the use of a one-piece construction instead of the structure disclosed in the prior art would be merely a matter of obvious engineering choice." In re Larson, 40 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965). Furthermore, applicant has provided no criticality in the specification for (pg. 30 ln. 27-29) or evidence of unexpected results that arose as a result of the one-piece construction.
Regarding claim 6, the cited prior art suggests the invention of claim 1; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the intermediate hollow body member and the first and second elongate tubular members are integrally formed.
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to have the intermediate hollow body member and the first and second elongate tubular members integrally formed, since the court has held that “the use of a one-piece construction instead of the structure disclosed in the prior art would be merely a matter of obvious engineering choice." In re Larson, 40 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965). Furthermore, applicant has provided no criticality in the specification for (pg. 22 ln. 6-7) or evidence of unexpected results that arose as a result of the one-piece construction.
Regarding claim 7, the cited prior art suggests the invention of claim 1; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the first and second elongate tubular members are separate and removable from the intermediate hollow body member.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to have modified the first and second elongate tubular members to be separate and removable from the intermediate hollow body member, since the court has held that “if it were considered desirable for any reason to obtain access to the [inside of the prior art’s device], it would be obvious to make the [structure] removable for that purpose” In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961). In the instant case, it could be considered desirable to make the elongate tubular members removable to increase ease of cleaning the device.
Regarding claim 9, the cited prior art suggests the invention of claim 1. Logier discloses wherein said device further comprises a plate structure for removable attachment to skin of a patient and around the surgically created first and second orifices (Fig. 1, plate structure 7; pg. 3 para. 4 and pg. 4 para. 1-2), the plate structure comprising:
a first side and a second side that are opposite to one another, and the first side of the plate structure is configured to be attached to a skin of a patient using an adhesive (Ex. Fig. 1, first side of plate structure 73 comprising an adhesive and a second side; pg. 3 para. 4 and pg. 4 para. 1-2); and
the second side of the plate structure is configured to be coupled to the shell (Ex. Fig. 1 showing second side connected with shell; pg. 3 para. 4 and pg. 4 para. 1-2).
Regarding claim 13, the cited prior art suggests the invention of claim 1. Logier discloses that the shell comprises an aperture to allow draining of digestive contents (Ex. Fig. 1 showing shell comprising at least one aperture through which flexible tube TS passes through to allow draining of digestive contents into second stoma S2).
Regarding claim 14, the cited prior art suggests the invention of claim 7. Logier discloses wherein the shell further comprises a flat rim extending from a perimeter of the shell (Fig. 1, plate structure 7; pg. 3 para. 4 and pg. 4 para. 1-2), the flat rim having an underside configured to sit against a patient's skin (Ex. Fig. 1, first side of plate structure 73 comprising an adhesive and a second side; pg. 3 para. 4 and pg. 4 para. 1-2), and
wherein the underside of the flat rim comprises an adhesive to adhere the shell to the patient's skin (Ex. Fig. 1, first side of plate structure 73 comprising an adhesive and a second side; pg. 3 para. 4 and pg. 4 para. 1-2).
Regarding claim 16, the cited prior art suggests the invention of claim 1. The cited prior art further suggests a method of connecting a surgically created first orifice with a surgically created second orifice, the method comprising:
providing a connecting device as claimed in claim 1 (as discussed in the rejection of claim 1). Logier further discloses inserting the outlet of the elongate tubular member into the surgically created second orifice so that the surgically created first and second orifices are connected by the device for passive transfer of contents from the surgically created first orifice to the surgically created second orifice (Fig. 1, connecting device 1 comprising flexible tube TS inserted into downstream stoma S2; pg. 3 para. 4 and pg. 4 para. 1-2 and para. 3 ln. 1-6).
Kane (as discussed in the rejection of claim 1) teaches inserting the inlet of the first elongate tubular member into the surgically created first orifice and the outlet of the second elongate tubular member into the surgically created second orifice (Fig. 1, hollow cover/shell 11 comprising passage 13 and elongate member 14 that together [13/14] may be considered the tubular member; Fig. 2, connecting device comprising hollow covers 11 in contact with upward and downward stomas; col. 5 ln. 23-51).
Regarding claim 17, the cited prior art suggests the invention of claim 1. The cited prior art further suggests a method of connecting a surgically created first orifice with a surgically created second orifice as claimed in claim 1 (as explained in the rejection of claim 1). Logier further discloses wherein the method further comprises a step of positioning and adhering a first side of a membrane of a plate structure to the skin of a patient (Fig. 1, connecting device 1 comprising first side 73 comprising an adhesive of a plate structure 7; pg. 3 para. 4 and pg. 4 para. 1-2 and para. 3 ln. 1-6).
Regarding claim 19, the cited prior art suggests the invention of claim 1. The cited prior art further suggests a method of connecting a surgically created first orifice with a surgically created second orifice as claimed in claim 1 (as explained in the rejection of claim 1). Logier further discloses wherein the method further includes the step of positioning the cap over the body opening to close the pathway (Ex. Fig. 1, cap is shown to be positioned above the body opening in an integrated body; pg. 3 para. 4 and pg. 4 para. 1-2 and para. 3 ln. 1-6).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Logier and Kane as applied above, and further in view of US/2002/0077611 A1 to Dyck.
Regarding claim 3, the cited prior art suggests the invention of claim 1; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein said cap comprises a pathway seal on an inner surface of the cap adapted to seal the body opening.
Dyck discloses an ostomy implant comprising a seal on an inner surface of the cap to seal a body opening in a secure, leak-free fashion (para. 0057; Fig. 11, annular ridge 136 on neck 138 of cap 128).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the cap of the cited prior art to comprise a seal as taught by Dyck, because Dyck teaches that that creates a secure and leak-free connection (para. 0057).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Logier and Kane as applied above, and further in view of CN/107625573 A to Yangchun.
Regarding claim 4, the cited prior art suggests the invention of claim 1; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein said cap is separate and removable and when removed allows access to an internal surface of the intermediate hollow body member.
Yangchun teaches a connecting device comprising a cap that is separate and at least partially removable to allow access to an internal surface of the intermediate member of the connecting device to allow for the system to be flushed or drained (Fig. 1-2, connecting device 10 comprising cap 40; para. 0049-0050).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the cap of the cited prior art to be separate and at least partially removable as taught by Yangchun, because Yangchun teaches that this allows for the system to be flushed or drained if the device becomes blocked or stool accumulates (para. 0049-0050).
Claims 8 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Logier and Kane as applied above, and further in view of U.S. Patent no. 4,721,508 A to Burton.
Regarding claim 8, the cited prior art suggests the invention of claim 1; however, the prior art differs from the instantly claimed invention in that the cited prior art fails to disclose wherein the first and second elongate tubular members are flexible and resilient.
Burton teaches an ostomy implant comprising a tubular member that is made from a biologically compatible silicone rubber which is flexible and resilient to be able to draw through a snug orifice (Fig. 1, ostomy implant comprising tubular member 12; col. 2 ln. 40-43; col. 6 ln. 62-66).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the tubular members of the cited prior art to be made from flexible and resilient silicone rubber as taught by Burton, because Burton teaches that this material is biologically compatible and is able to be drawn through a snug orifice due to at least it’s marginal flexibility (col. 2 ln. 40-43; col. 6 ln. 62-66).
Regarding claim 15, the cited prior art suggests the invention of claim 1; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein silicone, rubber, latex or plastic form one or more of the: a) first elongate tubular member, b) second elongate tubular member, c) intermediate hollow body member, d) longitudinal guide member.
Burton teaches an ostomy implant comprising a tubular member that is made from a biologically compatible silicone rubber which is flexible and resilient to be able to draw through a snug orifice (Fig. 1, ostomy implant comprising tubular member 12; col. 2 ln. 40-43; col. 6 ln. 62-66).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the tubular members of the cited prior art to be made from flexible and resilient silicone rubber as taught by Burton, because Burton teaches that this material is biologically compatible and is able to be drawn through a snug orifice due to at least it’s marginal flexibility (col. 2 ln. 40-43; col. 6 ln. 62-66).
Claims 10-12 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Logier and Kane as applied above, and further in view of FR/3034983 A1 to Logier (hereinafter referred to as Logier ‘983).
Regarding claims 10-12, the cited prior art suggests the invention of claim 1; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose
(Claim 10) wherein the coupling of the shell to the plate structure is located around the perimeter of the shell;
(Claim 11) wherein the coupling of the shell to the plate structure comprises complementary features in the form of a groove and a complementary protrusion; and
(Claim 12) wherein the coupling of the shell to the plate structure forms a watertight coupling.
Logier ‘983 teaches a connecting device that comprises a plate structure for removable attachment to skin of a patient and around the surgically created first and second orifices (Fig. 1, collecting device 1 comprising base 7 as a plate structure), the plate structure comprising:
a first side and a second side that are opposite to one another (Fig. 1, first side of base 7 comprising fixing face 73, second side of base 7 comprising horizontal plate 81), and the first side of the plate structure is configured to be attached to a skin of a patient using an adhesive (pg. 3 para. 2); and
the second side of the plate structure is configured to be coupled to a shell (Fig. 1, horizontal plate 81 comprising horizontal rim 85 configured to be coupled to seal 4 which is glued to the wall 135 of shell 13; pg. 4 para. 3-4 and pg. 5 para. 1);
wherein the coupling of the shell to the plate structure is located around the perimeter of the shell (Fig. 1);
wherein the coupling of the shell to the plate structure comprises complementary features in the form of a groove and a complementary protrusion (Fig. 1, horizontal rim 85 may be considered a complementary protrusion to groove created by lip 47 of seal 4); and
wherein the coupling of the shell to the plate structure forms a watertight coupling (pg. 3 para. 2); and
wherein providing a plate structure provides the ability to remove the connecting device from the body for easy cleaning without having to take off the adhesive body from the patient and makes it easier to connect the collecting device to the body (pg. 1 para. 0001 and pg. 2 para. 2).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the connecting device mechanism to comprise a removable attachment as taught by Logier ‘983, because Logier ‘983 teaches that it is useful to be able to remove the connecting device from a support to clean the support and that it is easier to place the plate structure before connecting the collecting device to the body (pg. 1 para. 0001 and pg. 2 para. 2).
Regarding claim 18, the cited prior art suggests the invention of claim 1 The cited prior art further suggests a method of connecting a surgically created first orifice with a surgically created second orifice, wherein the method includes the steps of:
positioning a shell as claimed in claim 1 over the surgically created first and second orifices to substantially encompass and define a volume of space surrounding said surgically created first and second orifices (as explained in the rejection of claim 1); however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose that the method comprises coupling the shell to a plate structure by coupling a plate coupling member to a shell coupling member.
Logier ‘983 teaches a method of connecting a surgically created first orifice with a surgically created second orifice, wherein the method comprises coupling a shell to a plate structure by coupling the plate coupling member to the shell coupling member (Fig. 1, horizontal plate 81 comprising horizontal rim 85 configured to be coupled to seal 4 which is glued to the wall 135 of shell 13; pg. 4 para. 3-4 and pg. 5 para. 1), wherein providing a plate structure provides the ability to remove the connecting device from the body for easy cleaning without having to take off the adhesive body from the patient and makes it easier to connect the collecting device to the body (pg. 1 para. 0001 and pg. 2 para. 2)..
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of connecting the connecting device mechanism to a user to comprise a removable attachment as taught by Logier ‘983, because Logier ‘983 teaches that it is useful to be able to remove the connecting device from a support to clean the support and that it is easier to place the plate structure before connecting the collecting device to the body (pg. 1 para. 0001 and pg. 2 para. 2).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US/2023/0277361 A1 to Ito discloses a shell for a dual ileostomy. US/2015/0351954 A1 to Logier discloses a device for passing a food bolus between two stomas. WO/03032878 A1 to Olsen discloses an ostomy applicant for two stomas.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Linnae Raymond whose telephone number is (571)272-6894. The examiner can normally be reached M-F 8:00am to 4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Linnae E. Raymond/Examiner, Art Unit 3781
/LESLIE R DEAK/Primary Examiner, Art Unit 3799 24 February 2026