DETAILED CORRESPONDENCE
Note: This office action is in response to communication filed on 08/27/2026.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/27/2026 has been entered.
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 but are moot because the independent claim(s) has/have been amended and the new ground of rejection does not rely on the same combination references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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, 18, and 20-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11, and 13-14 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, 11, and 13-14 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 11 of the reference patent discloses all of the limitations of instant claim 18.
Regarding instant claim 20, claim 13 of the reference patent discloses all of the limitations of instant claim 20.
Regarding instant claim 21, claim 14 of the reference patent discloses all of the limitations of instant claim 21.
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, 12-13, 18, and 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cline (US PGPUB 20080119804).
Regarding claim 1, Cline discloses an ostomy barrier appliance for attaching an ostomy appliance to a peristomal skin surrounding a stoma (Abstract, ¶0016, 0021, and Figs. 4-5), the ostomy barrier appliance (a device 10: ¶0088 and Figs. 4-5) comprising:
a skin barrier formed from an adhesive for attachment to the peristomal skin of a user ((12+18): ¶0014, 0016, 0088, 0090 and Figs. 4-5);
an inlet opening (an opening 38: ¶0091 and Fig. 2) defined by an inner periphery of the skin barrier for receiving a stoma (the opening 38 is defined by an inner periphery 18 of the skin barrier for receiving a stoma 22: ¶0093 and Figs. 4-5); and
a convexity adjusting device (a shape defining member 50: ¶0103, 0110, and Figs. 4-5) arranged adjacent the skin barrier (Figs. 4-5), wherein the convexity adjusting device is positioned on an ostomy appliance facing side of the skin barrier (Figs. 4-5);
wherein the convexity adjusting device is configured to deform the skin barrier to adjust a convexity of the skin barrier around the inlet opening (¶0103, 0110-0111, and Figs. 4-5), and wherein the convexity adjusting device is configured to adjust the skin barrier from an initially flat configuration (Fig. 3 shows initially flat configuration of the skin barrier before the convexity adjusting device is attached) to increase the convexity of the skin barrier incrementally to set the convexity of the skin barrier at a selected convexity (¶0103, 0110-0111, and Figs. 4-5).
Regarding claim 12, Cline further discloses the convexity adjusting device (50) includes an inflatable bladder (an inflatable balloon 94: ¶0132-0133 and Fig. 10), wherein the convexity adjusting device is configured to increase a volume when a medium is inserted into the inflatable bladder (¶0132-0133), and wherein the skin barrier is configured to protrude 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": ¶0133 and Fig. 10; when the volume of the inflatable bladder increases by inflating the balloon, the balloon will be positioned/placed the skin barrier (12+18) in a transverse direction; thus, the skin barrier is capable of providing a convexity).
Regarding claim 13, Cline further discloses the inflatable bladder 94 includes a valve (inflation/deflation valve: ¶0132) and the medium is inserted through the valve into the inflatable bladder (¶0132).
Regarding claim 18, Cline further discloses the ostomy barrier appliance includes a flange with a body-side coupling ring (a flange 24 with walls 26: ¶0089 and Fig. 2), wherein the flange is attached to a portion of the convexity adjusting device (Figs. 4-5), and 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 (the body-side coupling ring 26 is configured for guiding engagement with a complementary coupling member mounted to a collection pouch: ¶0089; thus, the body-side coupling ring 26 is capable of mating with a pouch side coupling ring to attach an ostomy pouch to the ostomy barrier appliance).
Regarding claim 22, Cline further discloses the convexity adjusting device surrounds the inlet opening (Figs. 4-5 and 7).
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) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cline (US PGPUB 20080119804) in view of Mustafa (US PGPUB 20130053740).
Regarding claim 14, Cline further discloses 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 further modified the ostomy barrier appliance of Cline 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 Cline (US PGPUB 20080119804) in view of Cline (US PAT 6210384).
Regarding claims 20-21, Cline’804 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’384 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’384, 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 further modified the ostomy barrier appliance of Cline’804 in view of Cline’384 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’384 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).
Allowable Subject Matter
Claim(s) 15-16 is/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:
The closest prior art is Cline (US PGPUB 20080119804) and Nielsen (US PGPUB 20160051394).
Regarding claim 15, Cline further discloses the convexity adjusting device 50 comprising a fixed insert (a support portion 62: ¶0110 and Fig. 5) and an adjustable insert (a convex projection 64: ¶0110 and Fig. 5), but Cline does not disclose “the fixed insert includes a first plurality of toothed engagement structures, and the adjustable insert includes a second plurality of toothed engagement structures, and wherein the first and second plurality of toothed engagement structures are configured to engage each other, such that the adjustable insert slides down along the fixed insert toward a body-side of the ostomy barrier appliance when pressed down”.
Although Nielsen discloses a convexity adjusting device 500 (¶0180 and Figs. 12a-c) comprising an anchoring portion 511 and a movable portion 521 (¶0181 and Fig. 12a-c), wherein the anchoring portion 511 comprising a tooth portion 516 and the movable portion 521 comprising multiple teeth 526 (¶0193 and Fig. 9a-b), the convexity adjusting device of Cline and the convexity adjusting device of Nielsen have different structures. There is no apparent reason or motivation that would have prompted a person of ordinary skill in the art to modify the fixed insert and the adjustable insert of Cline to incorporate Nielsen’s tooth engagement structures as this modification increases the complexity of the system in the prior art in terms of structure, function, and design (See MPEP §2143.01 (IV)).
No other prior art was located that fairly suggested the claimed invention in whole or in part, along with the requisite motivation for combining to render the claimed invention obvious.
Therefore, claim 15 and its dependent claims 16 are deemed novel and non-obvious over the prior art of record.
Conclusion
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
