DETAILED CORRESPONDENCE
Note: This office action is in response to communication filed on 04/07/2026.
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 .
Status of Claims
Claims 1, 12-16, 18, and 20-22 are pending in the application.
Claims 1, 12-16, 18, and 20-22 are examined on the merits.
Response to Arguments
Applicant’s arguments/remarks filed on 04/07/2026 have been fully considered.
Applicant argues that the presently claim invention is patentably distinct from the claims of the U.S. Patent No. 11833073 because of the distinct mechanisms for achieving convexity of the convexity adjusting devices of the reference patent and the instant application. The arguments are found persuasive. Thus, the rejection on the nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11833073 is withdrawn.
Applicant argues that Nielsen does not disclose the convexity adjusting device is configured to deform the skin barrier to adjust a convexity of the skin barrier around the inlet opening because Nielsen only discloses repositioning an elastic sealing element relative to other components of the device. The arguments are not found persuasive. When a movable portion 521 of the adjusting device 500 has been moved to a more inwards position relative to an anchoring portion 511, the skin barrier (200+300+400) is also moved to adapt to the convexity of a user’s skin (at least element 400 changes from an original configuration to a greater convexity angle. Thus, the convexity adjusting device 500 of Nielsen is capable of adjusting a convexity of the skin barrier: ¶0202-0203 and Figs. 12a-c. In addition, in Figs. 13a-b, element 321 of the skin barrier changes from an initially flat configuration to a greater convexity angle. Thus, the adjusting device 500 is configured to deform the skin barrier to adjust a convexity of the skin barrier around the inlet opening.
Applicant argues that Nielsen does not disclose incrementally increasing the convexity of the skin barrier to a selected convexity. The argument is not found persuasive. Each tooth 526 of the arms 524 of Nielsen represents an increment (¶0193, 0201-0204; Figs. 12a-c and Figs. 13a-b). The movable portion 521 of the adjusting device 500 has been moved to a more inwards position relative to an anchoring portion 511 by the increment 526 (¶0201-0203) and therefore, increasing the convexity of the skin barrier to a selected convexity (Figs. 12a-c and 13a-b).
Applicant argues that the skin barrier of Nielsen has different structural elements than the claimed skin barrier. The argument is not found persuasive. The claimed skin barrier comprising an adhesive for attachment to the peristomal skin of a user. There is no other structure from the claims to further describe the skin barrier. The skin barrier of Nielsen also comprising an adhesive ((200+300+400), wherein 400 comprises a skin friendly or silicone adhesive: ¶0167, 0178, 0190; Figs. 5d-e and 12a-c) for attachment to the peristomal skin of a user (¶0050 and 0166-0167). Thus, the skin barrier of Nielsen reads on the claimed skin barrier.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 18-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11-14 of U.S. Patent No. 12109145.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 and 11-14 of the reference patent contain the ostomy barrier appliance comprising a skin barrier comprising an adhesive; an inlet opening defined in the skin barrier for receiving a stoma; and a convexity adjusting device arranged adjacent the skin barrier; wherein the convexity adjusting device is configured to adjust a convexity of the skin barrier. The scope of the claimed limitations in the reference patent encompasses the claimed limitations in the instant application.
Regarding instant claim 1, claim 1 of the reference patent discloses all of the limitations of instant claim 1.
Regarding instant claim 18, claim 1 of the reference patent discloses all of the limitations of instant claim 11.
Regarding instant claim 19, claim 1 of the reference patent discloses all of the limitations of instant claim 12.
Regarding instant claim 20, claim 1 of the reference patent discloses all of the limitations of instant claim 13.
Regarding instant claim 21, claim 1 of the reference patent discloses all of the limitations of instant claim 14.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
In claim 1, the limitation “a convexity adjusting device arranged adjacent the skin barrier; wherein the convexity adjusting device is configured to adjust a convexity of the skin barrier” has been interpreted under 112(f) as a means plus function limitation because of the generic placeholder “device” and associated functional language “to adjust a convexity of the skin barrier” without reciting sufficient structure to achieve the function. Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification (the convexity adjusting device may include a fixed insert comprising a first plurality of tooth-like structures, and an adjustable insert comprising a second plurality of tooth-like structures: ¶0008 or 0014) as performing the claimed function, and equivalents thereof.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(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.
Claim(s) 1, 15-16, and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nielsen (US PGPUB 20160051394).
Regarding claim 1, Nielsen discloses an ostomy barrier appliance for attaching an ostomy appliance to a peristomal skin surrounding a stoma (Abstract), the ostomy barrier appliance (a device 100: ¶0166 and Figs. 5a-e) comprising:
a skin barrier comprising an adhesive ((200+300+400), wherein 400 comprises a skin friendly or silicone adhesive: ¶0167, 0178, 0190; Figs. 5d-e and 12a-c) for attachment to the peristomal skin of a user (¶0050 and 0166-0167);
an inlet opening defined by an inner periphery of the skin barrier for receiving a stoma (a hole 305 defined by an inner periphery 300 of the skin barrier (200+300+400) for receiving the stoma: ¶0163 and Fig. 5b); and
a convexity adjusting device (an adjusting element 500: ¶0180; Figs. 12a-c and 5a-e) arranged adjacent the skin barrier (Figs. 12a-c and 5a-e), wherein the convexity adjusting device is positioned on an ostomy appliance facing side of the skin barrier (the convexity adjusting device 500 is positioned on an ostomy appliance facing side of the skin barrier (200+300+400): Fig. 8);
wherein the convexity adjusting device is configured to deform the skin barrier to adjust a convexity of the skin barrier around the inlet opening (when a movable portion 521 of the adjusting device 500 has been moved to a more inwards position relative to an anchoring portion 511, the skin barrier is also moved to adapt to the convexity of a user’s skin; thus, the convexity adjusting device 500 is capable of adjusting a convexity of the skin barrier: ¶0202-0203 and Figs. 12a-c; In addition, in Figs. 13a-b, element 321 of the skin barrier is configured to change from an initially flat configuration to a greater convexity angle; thus, the adjusting device 500 is configured to deform the skin barrier to adjust a convexity of the skin barrier around the inlet opening), and wherein the convexity adjusting device is configured to adjust the skin barrier from an initially flat configuration to increase the convexity of the skin barrier incrementally (arms 524 of the movable portion 511 of adjusting device 500 is configured to move to adjust at least a portion 400 of the skin barrier (200+300+400) from an initially flat configuration to increase the convexity of the skin barrier (200+300+400), each teeth 526 of the arms 524 represents an increment: ¶0193, 0201-0204; Figs. 12a-c and Figs. 13a-b) to set the convexity of the skin barrier at a selected convexity: ¶0201-0204; Figs. 12a-c and Figs. 13a-b).
Regarding claim 15, Nielsen further discloses the convexity adjusting device (500) includes a fixed insert (an anchoring portion 511: ¶0181 and Fig. 12a) and an adjustable insert (a movable portion 521: ¶0181 and Fig. 12a), wherein the fixed insert (511) includes a first plurality of toothed engagement structures (a tooth portion 516: ¶0193 and Figs. 9a-b), and the adjustable insert (521) includes a second plurality of toothed engagement structures (multiple teeth 526: ¶0193 and Figs. 9a-b), and wherein the first and second plurality of toothed engagement structures are configured to engage each other (¶0193 and Figs. 9a-b), such that the adjustable insert slides down along the fixed insert toward a body-side of the ostomy barrier appliance when pressed down (¶0201-0204; Figs. 12a-c and Figs. 13a-b).
Regarding claim 16, Nielsen implicitly discloses the convexity adjusting device is configured to provide an asymmetric convexity (Applicant is setting forth the intend use of the claimed device, which does not add patentable weight to the structural limitations of the convexity adjusting device. Thus, the convexity adjusting device of Nielsen is capable of providing an asymmetric convexity (See MPEP §§ 2112.01 (I), 2114 (I)-(II), and 2115)).
Nielsen further discloses the convexity adjusting device includes a plurality of engagement sections (arms 524: ¶0193 and Figs. 9a-d), each of the engagement sections includes the first and second plurality of toothed engagement structures (each arm 524 includes plurality of toothed engagement structures 526: ¶0193 and Figs. 9a-d), each of the engagement section is configured to be adjusted separately to set the convexity of the skin barrier at a selected convexity (toothed engagement structures 526 is configured for engagement and positioning of the movable portion 521 relative to the anchoring portion 511 and the movable portion 521 of the adjusting element has been moved to a more inwards position relative to the anchoring portion 511: ¶0193, 0203-204; Figs. 9a-d, 12a-c, and Figs. 13a-b; when the movable portion 521 of the adjusting element has been moved to a more inwards position relative to the anchoring portion 511, the skin barrier 400 has moved from a first convexity position to a second convexity position: see annotated Figs. 12b-c below; thus, each of the engagement section of Nielsen is capable of adjusting separately to set the convexity of the skin barrier at a selected convexity).
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Regarding claim 18, Nielsen discloses the ostomy barrier appliance 100 includes a flange with a body-side coupling ring (a ring-formed stretching element 200: ¶0167, 0190; Figs. 2a-b and 8), wherein the flange is attached to a portion of the convexity adjusting device (Figs. 2b and 4b), wherein the body-side coupling ring is configured to mate with a pouch side coupling ring to attach an ostomy pouch to the ostomy barrier appliance (an ostomy bag 600 is coupled to the stretching element 200 via a coupling arrangement: ¶0190 and Fig. 8).
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.
Claim(s) 12-13 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nielsen in view of Cline (US PGPUB 20040193122).
Regarding claims 12 and 13, Nielsen does not disclose the convexity adjusting device includes an inflatable bladder, wherein the convexity adjusting device is configured to increase a volume when a medium is inserted into the inflatable bladder, and wherein the skin barrier is configured to protrudes in a transverse direction to provide a convexity as the volume of the inflatable bladder increases; and the inflatable bladder includes a valve, wherein the medium is inserted through the valve into the inflatable bladder.
In the same field of endeavor, ostomy appliance, Cline discloses an ostomy comprising a controlled discharge device for controlling discharge from the stoma and/or an ostomy pouch configured to apply a force in a direction to increase the sealing force on the stoma seal (Abstract). Cline further discloses a convexity adjusting device includes an inflatable bladder (an inflatable balloon 94: ¶0137 and Fig. 10), wherein the convexity adjusting device is configured to increase a volume when a medium is inserted into the inflatable bladder (the convexity adjusting device increases a volume when the balloon 94 is inflated using any suitable inflation fluid: ¶0137 and Fig. 10), wherein a skin barrier is configured to protrudes in a transverse direction to provide a convexity as the volume of the inflatable bladder increases ("When the balloon 94 is inflated, a stoma occluding surface 100 of the balloon 94 may be urged against the stoma 22": ¶0138 and Fig. 10; when the volume of the inflatable bladder increases by inflating the balloon, the balloon will be positioned/placed against the stoma 22 and skin barrier 18 in a transverse direction; thus, the balloon 94 will adjust a convexity of the skin barrier 18) for the benefits of providing a sealing surface for contacting with the skin and/or stoma and preventing leakage of stomal discharge (¶0027). Cline also discloses the inflatable bladder 94 includes a valve (inflation/deflation valve: ¶0137) and the medium is inserted through the valve into the inflatable bladder (¶0137).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the ostomy barrier appliance of Nielsen in view of Cline by incorporating an inflatable bladder with a valve in the convexity adjusting device, in order to provide a sealing surface for contacting with the skin and/or stoma and prevent leakage of stomal discharge, as suggested in ¶0027 of Cline.
Regarding claim 22, Nielsen further discloses the convexity adjusting device surrounds a stoma opening (Figs. 12a-c).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nielsen in view of Mustafa (US PGPUB 20130053740).
Regarding claim 14, Nielsen does not disclose the ostomy barrier appliance includes an air pump device with a pump tab, wherein the air pump device is configured to inflate the inflatable bladder when a pressure is applied to the pump tab.
In an analogous art for being directed to solve the same problem, inflating an inflatable bladder/splint to a desired pressure and firmness, Mustafa discloses an inflatable splint that maintains a desired shape of an area of the body (¶0008-0009). Mustafa further discloses the inflatable splint comprising an air pump device (an inflation device 138: ¶0019) with a pump tab (manually actuated squeeze bulb: ¶0019), wherein the air pump device is configured to inflate the inflatable bladder when a pressure is applied to the pump tab (inflated to the desired pressure and firmness: ¶0019).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the ostomy barrier appliance of Nielsen in view of Mustafa by incorporating an air pump device with a pump tab, in order to inflate the inflatable bladder/splint to a desired pressure and firmness, as suggested in ¶0019 of Mustafa.
Claim(s) 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nielsen in view of Cline (US PAT 6210384).
Regarding claims 20-21, Nielsen does not disclose the ostomy barrier appliance is configured to provide a convexity depth of the skin barrier of 0 mm to 15 mm; or provide a convexity angle of the skin barrier of 0 to 60 degree and the convexity angle = tan-1 (convexity depth /convexity width).
In the same field of endeavor, ostomy barrier appliance, Cline discloses a convex insert system for an ostomy appliance comprising a convex curvature which when properly positioned helps the patient’s stoma protrude (Abstract) in order to desirably provide a fluid tight and weight for supporting seal and cause a stoma that does not normally protrude to protrude into the ostomy appliance (Col. 1, lines 33-36). From the teaching of Cline, a person having ordinary skill in the art would have understood/recognized protrusion would cause convexity depth and/or angle of the skin barrier. The optimum depth and/or angle of the skin barrier is mostly dependent on the user.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the ostomy barrier appliance of Nielsen in view of Cline to optimize the convexity curvature by providing a convexity depth of the skin barrier of 0 mm to 15 mm and/or providing a convexity angle of the skin barrier of 0 to 60 degree and the convexity angle = tan-1, in order to provide a fluid tight and weight for supporting seal and help stoma to protrude as needed, as suggested in Col. 1, lines 33-36 of Cline and as it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Further, Applicant places no criticality on the claimed convexity depth/angle range, indicating simply that the ostomy barrier appliance may be configured to provide a convexity depth of the skin barrier of about 0 mm to about 15 mm and/or a convexity angle of the skin barrier of about 0° to about 60°, wherein convexity angle=tan−1(convexity depth/convexity width) (¶0017 of the instant application).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NHU Q TRAN whose telephone number is (571)272-2032. The examiner can normally be reached Monday-Thursday 8:00-5:00 (PST).
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/NHU Q. TRAN/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
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