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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/26/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Species B – claims 6, 7, 14, and 15, in the reply filed on 06/23/2026 is acknowledged.
Claims 4, 5, 8-10, 12, 16, and 17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Species A and Species C, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/26/2026.
Accordingly, claims 1-3, 6, 7, 11, 13-15, and 18-20 are pending and under examination.
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)(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.
Claims 1, 2, 6, 7, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spindell US 2,127,834 A (hereinafter Spindell).
Regarding claim 1, Spindell discloses a medical-device tensioning system (Fig. 1-2, and Page 1 of Specification, Col. 1, line 38-41 – “colostomy pouch… waistband”) for coupling a medical device 24 (Fig. 1 – pouch 24) to a subject (Fig. 2, Page 1 of Specification, Col. 1, line 42-45 – “human body”), the system (Fig. 1-2) comprising:
at least one flexible, stretchable strap 10, 11 (Fig. 1-3 – straps 10, 11, Page 1 of Specification, Col. 1, last paragraph and Col. 2, first paragraph – “two webs or straps 10 and 11 each of which is a woven textile fabric having elastic rubber warp threads incorporated therein throughout its width in the usual manner so that the web is longitudinally elastic and transversely nonelastic”), each flexible strap 10, 11 (Fig. 1-3) including –
a first end B (Fig. 4 – body section B, on the side of hook members 23) configured to removably couple to the medical device 24 (Fig. 1, and Page 2 of Specification, Col. 1, line 10-13 – “The apparatus is applied to the body of the wearer by extending the waistband around said body with the inlet of the pouch in register with and surrounding the opening in the wearer's body and after adjustment thereof the hook members 23…”),
a middle portion A (Fig. 2-3 – middle section A) configured to extend at least partially around a body of a user (Fig. 2); and
a second end B (Fig. 3 – body section B, on the side of eyes 18) configured to removably couple to a skin of the user (Page 2 of Specification, Col. 2, line 29-31 – “The body portion A–B of the waistband is not only longitudinally elastic and elastically conformable to the shape of the body”, indicating coupling via making contact with the skin and conforming to said skin).
Regarding claim 2, Spindell discloses the invention of claim 1. Spindell further discloses wherein each flexible strap 10, 11 (Fig. 1) comprises an adjustment mechanism 23+18 (Fig. 1-4 – hook member 23 and eye 18) configured to modify a length of the flexible strap 10, 11 (Fig. 1-4, and Page 1 of Specification, Col. 2, last paragraph – “The hook members 23 are independently adjustable so that the effective length of each strap 22 may be varied to suit the requirements imposed by the shape of the wearer's body”).
Regarding claim 6, Spindell discloses the invention of claim 1. Spindell further discloses wherein the first end B (Fig. 4 – body section B, on the side of hook members 23) of each flexible strap 10, 11 (Fig. 1-4) comprises one or more hooks 23 (Fig. 1-4 – hook members 23) configured to removably couple to the medical device 24 (Col. 1, line 10-13 – “The apparatus is applied to the body of the wearer by extending the waistband around said body with the inlet of the pouch in register with and surrounding the opening in the wearer's body and after adjustment thereof the hook members 23…”).
Regarding claim 7, Spindell discloses the invention of claim 1. Spindell further discloses wherein the first end B (Fig. 4 – body section B, on the side of hook members 23) of each flexible strap 10, 11 (Fig. 1-4) comprises a cord, laces, or hook and loop 23 (Fig. 1-4 – hook members 23) configured to removably couple to the medical device 24 (Col. 1, line 10-13 – “The apparatus is applied to the body of the wearer by extending the waistband around said body with the inlet of the pouch in register with and surrounding the opening in the wearer's body and after adjustment thereof the hook members 23…”).
Regarding claim 11, Spindell discloses the invention of claim 1. Spindell further discloses wherein the medical device 24 (Fig. 1) comprises an ostomy bag (Page 1 of Specification, Col. 1, line 39 – “a colostomy pouch”).
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.
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.
Claims 3, 13, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Spindell in view of Martz US 7,240,375 B2 (hereinafter Martz).
Regarding claim 3, Spindell discloses the invention of claim 1. Spindell further discloses wherein each flexible strap 10, 11 (Fig. 1-4) configured to couple the second end B (Fig. 3) of the strap 10, 11 (Fig. 1-4) to the skin of the user (Page 2 of Specification, Col. 2, line 29-31 – “The body portion A–B of the waistband is not only longitudinally elastic and elastically conformable to the shape of the body”, indicating coupling via making contact with the skin and conforming to said skin) and to be easily repositioned on the body for a comfortable and secure fit (Page 1 of Specification, Col. 2, line 46-50 – “Between the strip 15 and web 10 of the opposite body section B are disposed proximate ends of another pair of parallel straps 22 on each of which is adjustably mounted a hook member 23 to cooperate with one of the eyes 18”).
However, Spindell does not disclose wherein an underside of each flexible strap comprises a skin-safe adhesive coating configured to couple the second end of the strap to the skin of the user.
Martz, in the same field of endeavor of fabric strap and adhesives (Col. 5, line 34, 39) of special garments (Col. 3, first paragraph), teaches wherein an underside of each flexible strap 31 (Fig. 5 – stretch fabric strap 31) comprises a skin-safe adhesive coating (Fig. 5, and Col. 5, line 42-44 – “The underside of patch 32 and 33 has a nonallergenic adhesive covered by release liner 36 which is removed prior to attachment”) configured to couple the second end 32 (Fig. 5) of the strap 31 (Fig. 7-8) to the skin of the user (Fig. 7-8).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the underside of Spindell’s flexible strap to further include a nonallergenic adhesive as taught by Martz, in order to facilitate secure positioning (Col. 3, line 63-67 of Martz).
Regarding claim 13, Spindell discloses a medical-device tensioning system (Fig. 1-2, and Page 1 of Specification, Col. 1, line 38-41 – “colostomy pouch… waistband”) for coupling a medical device 24 (Fig. 1 – pouch 24) to a subject (Fig. 2, Page 1 of Specification, Col. 1, line 42-45 – “human body”), the system (Fig. 1-2) comprising:
a roll of flexible, stretchable material configured to be trimmed to a desired length 10, 11 (Fig. 1-3 – straps 10, 11, Page 1 of Specification, Col. 1, last paragraph and Col. 2, first paragraph – “two webs or straps 10 and 11 each of which is a woven textile fabric having elastic rubber warp threads incorporated therein throughout its width in the usual manner so that the web is longitudinally elastic and transversely nonelastic”) comprising a first end B (Fig. 4 – body section B, on the side of hook members 23), a middle portion A (Fig. 2-3 – middle section A), and a second end B (Fig. 3 – body section B, on the side of eyes 18);
a coupling device 23 (Fig. 1-4 – hook member 23) for removably coupling the first end B (Fig. 4 – body section B, on the side of hook members 23) to the medical device 24 (Fig. 1, and Page 2 of Specification, Col. 1, line 10-13 – “The apparatus is applied to the body of the wearer by extending the waistband around said body with the inlet of the pouch in register with and surrounding the opening in the wearer's body and after adjustment thereof the hook members 23…”); and
wherein the middle portion A (Fig. 2-3 – middle section A) configured to extend at least partially around a body of the subject (Fig. 2) when the first end B (Fig. 4 – body section B, on the side of hook members 23) is coupled to the medical device 24 (Fig. 1, and Page 2 of Specification, Col. 1, line 10-13 – “The apparatus is applied to the body of the wearer by extending the waistband around said body with the inlet of the pouch in register with and surrounding the opening in the wearer's body and after adjustment thereof the hook members 23…”) and the second end B (Fig. 3 – body section B, on the side of eyes 18) is coupled to the skin of the subject (Page 2 of Specification, Col. 2, line 29-31 – “The body portion A–B of the waistband is not only longitudinally elastic and elastically conformable to the shape of the body”, indicating coupling via making contact with the skin and conforming to said skin).
Examiner recognizes the limitation ”a roll of flexible, stretchable material configured to be trimmed to a desired length” as a "product-by-process" claim. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (see MPEP 2113).
However, Spindell does not disclose a source of adhesive configured to be coupled to the second end of the desired length such that the second end is configured to removably couple to a skin of the subject.
Martz, in the same field of endeavor of fabric strap and adhesives (Col. 5, line 34, 39) of special garments (Col. 3, first paragraph), teaches a source of adhesive configured to be coupled to the second end 32 (Fig. 5) of the desired length (Fig. 5, and Col. 5, line 42-44 – “The underside of patch 32 and 33 has a nonallergenic adhesive covered by release liner 36 which is removed prior to attachment”) such that the second end 32 (Fig. 5) is configured to removably couple to a skin of the subject (Fig. 7-8).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Spindell’s flexible strap to further include a nonallergenic adhesive as taught by Martz, in order to facilitate secure positioning (Col. 3, line 63-67 of Martz).
Regarding claim 14, Spindell in view of Martz discloses the invention of claim 13. The combination further discloses wherein the coupling device 23 (Fig. 1-4 of Spindell) comprises a hook 23 (Fig. 1-4 of Spindell – hook members 23) configured to be coupled to the first end B (Fig. 4 of Spindell – body section B, on the side of hook members 23) of the desired length 10, 11 (Fig. 4 of Spindell).
Regarding claim 15, Spindell in view of Martz discloses the invention of claim 13. The combination further discloses wherein the coupling device 23 (Fig. 1-4 of Spindell) comprises a cord, laces, or hook and loop 23 (Fig. 1-4 of Spindell – hook members 23) configured to be coupled to the first end B (Fig. 4 of Spindell – body section B, on the side of hook members 23) of the desired length 10, 11 (Fig. 1 of Spindell and Fig. 4 of Spindell, Col. 1, line 10-13 of Spindell – “The apparatus is applied to the body of the wearer by extending the waistband around said body with the inlet of the pouch in register with and surrounding the opening in the wearer's body and after adjustment thereof the hook members 23…”).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Spindell.
Regarding claim 18, Spindell discloses a medical-device tensioning kit (Fig. 1-2, and Page 1 of Specification, Col. 1, line 38-41 – “colostomy pouch… waistband”) for coupling a medical device 24 (Fig. 1 – pouch 24) to a subject (Fig. 2, Page 1 of Specification, Col. 1, line 42-45 – “human body”), the kit (Fig. 1-2) comprising:
a plurality of flexible, stretchable straps 10, 11 (Fig. 1-3 – straps 10, 11, Page 1 of Specification, Col. 1, last paragraph and Col. 2, first paragraph – “two webs or straps 10 and 11 each of which is a woven textile fabric having elastic rubber warp threads incorporated therein throughout its width in the usual manner so that the web is longitudinally elastic and transversely nonelastic”), each flexible strap 10, 11 (Fig. 1-3) including a first end B (Fig. 4 – body section B, on the side of hook members 23) configured to removably couple to the medical device 24 (Fig. 1, and Page 2 of Specification, Col. 1, line 10-13 – “The apparatus is applied to the body of the wearer by extending the waistband around said body with the inlet of the pouch in register with and surrounding the opening in the wearer's body and after adjustment thereof the hook members 23…”), a middle portion A (Fig. 2-3 – middle section A) configured to extend at least partially around a body of a user (Fig. 2); and
a second end B (Fig. 3 – body section B, on the side of eyes 18) configured to removably couple to a skin of the subject (Page 2 of Specification, Col. 2, line 29-31 – “The body portion A–B of the waistband is not only longitudinally elastic and elastically conformable to the shape of the body”, indicating coupling via making contact with the skin and conforming to said skin); and
each medical device 24 (Fig. 1) being configured to couple to one or more straps 10, 11 (Fig. 1) of the plurality of straps 10, 11 (Fig. 1).
However, Spindell does not disclose a plurality of medical devices.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have duplicated the medical device of Spindell, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. Furthermore, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See MPEP 2144. Furthermore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the kit of Spindell to have more than one medical device, in this instant case, a colostomy pouch, so that user can change or replace the old medical device with a new one.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Spindell as applied to claim 18 above, and further in view of Martz.
Regarding claim 19, Spindell discloses the invention of claim 18. Spindell further discloses wherein the first end B (Fig. 4 – body section B, on the side of hook members 23) of each strap 10, 11 (Fig. 1) includes one or more hooks 23 (Fig. 4 – hook member 23) configured to removably couple to the medical device 24 (Col. 1, line 10-13 – “The apparatus is applied to the body of the wearer by extending the waistband around said body with the inlet of the pouch in register with and surrounding the opening in the wearer's body and after adjustment thereof the hook members 23…”),
wherein each medical device 24 (Fig. 1) of the plurality of medical devices (Claim 18 upon modification as established above) is an ostomy bag (Page 1 of Specification, Col. 1, line 39 – “a colostomy pouch”).
However, Spindell does not disclose wherein the second end of each strap includes an adhesive for removably securing the second end of the strap to the skin of the subject.
Martz, in the same field of endeavor of fabric strap and adhesives (Col. 5, line 34, 39) of special garments (Col. 3, first paragraph), teaches wherein the second end 32 (Fig. 5) of each strap 31 (Fig. 5 – stretch fabric strap 31) includes an adhesive (Fig. 5, and Col. 5, line 42-44 – “The underside of patch 32 and 33 has a nonallergenic adhesive covered by release liner 36 which is removed prior to attachment”) for removably securing the second end 32 (Fig. 7-8) of the strap 31 (Fig. 7-8) to the skin of the subject (Fig. 7-8).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the flexible strap of Spindell to further include a nonallergenic adhesive as taught by Martz, in order to facilitate secure positioning (Col. 3, line 63-67 of Martz).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Spindell as applied to claim 18 above, and further in view of Scott US 2014/0276500 A1 (hereinafter Scott), as cited in the IDS.
Regarding claim 20, Spindell discloses the invention of claim 18. Spindell further discloses further comprising the steps of:
positioning the medical device 24 (Fig. 1) on the subject (Fig. 1-2);
securing the first end B (Fig. 4 – body section B, on the side of hook members 23) of a strap 10, 11 (Fig. 1) of the plurality of straps 10, 11 (Fig. 1) to the medical device 24 (Fig. 1-2);
positioning the second end B (Fig. 3 – body section B, on the side of eyes 18) of a strap 10, 11 (Fig. 1) of the plurality of straps 10, 11 (Fig. 1) to the skin of the subject (Fig. 2, Page 1 of Specification, Col. 2, line 47-50 – “…opposite body section B are disposed proximate ends of another pair of parallel straps 22 on each of which is adjustably mounted a hook member 23 to cooperate with one of the eyes 18”, and Page 2 of Specification, Col. 2, line 29-31 – “The body portion A–B of the waistband is not only longitudinally elastic and elastically conformable to the shape of the body”); and
optionally repositioning the second end of the strap to the skin of the subject (Page 1 of Specification, last paragraph; Examiner notes that “optionally” is also broadly interpreted such that the limitation is not be a part of the claimed invention).
However, Spindell does not disclose comprising instructions for use, the instructions for use including the steps.
Scott, in the same field of endeavor of medical device for ostomy sites or stoma (Par. 3), teaches comprising instructions for use, the instructions for use including the steps (Par. 32 – “an emergency medical kit for treating one or more of ileostomy, colostomy, and urostomy leaks, changes, and blowouts, includes… (j) instructions for using the contents container and the contents of the contents container”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the kit of Spindell to further include instructions for use as taught by Scott, in order to provide instructions of a medical kit for treating colostomy leaks, changes, etc. (Par. 32 of Scott). It also would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have had the instructions in accordance to the kit of Spindell, such that they include the steps of Spindell, so that a user can easily operate the colostomy kit.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Pizanias US 2018/0325520 A1 teaches a wound closure system.
Doshi et al. US 2016/0256665 A1 teaches support devices used in ostomy devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH DAO LE whose telephone number is (571)272-7198. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
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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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/QUYNH DAO LE/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781
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