DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 11/06/2025 have been fully considered but they are not persuasive.
The examiner notes that previously the limitation (seen in claim 6) requiring perforated was required to be shown in the drawings. While a new drawing was provided showing perforations, newly amended limitation regarding the device being partitionable raises a concern of new matter (see 112a rejection below). The examiner notes that Jones, provided to previously reject claim 6 is interpreted to read to the new limitations and as such the rejection of claim 6 in view of Jones is maintained. In view of the amendments to claim 1, the scope of said claim was changed and as such the examiner updates the rejection of claim 1 to be in view of Jones.
Specifically regarding the argument to the rejection of claim 5, regarding Verhaalen being inoperative and hindsight, see page 7 of remarks, the examiner finds said argument to be nonpersuasive. The examiner clearly defines the obviousness motivation to combine, in that Verhaalen discloses a know measurement used in ostomy devices, where the prior art (now Jones) clearly discloses the device to be customizable to fit to various users (para. 0118 for example). As such the modification is merely using a known suitable measurement to apply to the same art (ostomy devices) to achieve a predictable result of creating an ostomy barrier.
Claim Objections
The examiner notes that claims 10 and 11 (newly added) appear to be improper Markush claims. The claims requires that the specific shapes into which the first sheet can be formed into includes rectangles, squares, circles, and ovals. The examiner notes that while disclosure for circles and squares (thus rectangles) can be seen in the original figures (3/14/2023), it is unclear how all of these are formed from the same first layer, as they appear to be different embodiments. Further, from the newly added figure, it is unclear how the perforation lines for forming the shapes would allow for a circle or oval to be created. The examiner suggests to amend the claim to require rectangles, squares, circles, or ovals, or to read one of circles includes rectangles, squares, circles, and ovals. For examination purposes, the language of rectangles….or ovals is used. Appropriate correction is requested.
Claim 1 and 6 requires the adhesive which is “adherable to a skin surface of the user”. The examiner is concerned that this limitation claims the human body and as such should read configured to adhered to a skin surface of the user.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1-11 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 1-3, 6-7 the limitation of the first material being “partitionable” is newly added. While incorporation of the new drawing shows the perforations in the first layer, where paragraph 0024 of the instant specification disclosures that these perforations allow a user to remove a pre-sized piece, there is no disclosure for partitionable. Specifically, as there is no limitation in claim 1 requiring the perforations the inclusion of partitionable shapes from the first layer is new matter. Further it is unclear from the figures how the limitation of “each partitionable shape comprises an opening. The examiner notes that if the newly added figure is showing the partitionable shapes, and one of the end “Strips” was removed, thus forming a rectangle with the remaining first layer, the examiner is unsure how there would be an opening in said formed rectangle.
Regarding claim 2 and 3, the same lack of clarity from claim 1 is applied, in that there is no support for partitionable shapes. The examiner notes that the newly added figure shows a first layer with various line of perforation, but this fails to show pre-formed partitionable shapes. Should applicant assert that the preformed shapes are shown in the 03/14 drawings (figure 3 for example), it is unclear how the perforations seen in the new figure would be formed into the shape seen in figure 3, as all of the perforations run parallel and thus would not be able to form a complete square.
Claim 4 and 5 are rejected based on dependency.
Claim 6 raises the same issues as claim 1.
Regarding 7, support for perforation is included, however the examiner notes that one definition of partition is “to divide into parts or shares” per Merriam Webster Dictionary, and while it may be argued that tearing a perforated piece off of the layer may fall under partitioning, the examiner suggests amending the language (of claims 1 and 6) to correspond to the instant specification. For example wherein the first material is perforated such that said first material is configured to be formed into various shapes by removal of a perforated segment, each shape comprising a perimeter.
The examiner notes that it is also unclear from the figure as to how each partitionable shape is spaced apart from adjacent partitionable shapes on the first material. As seen in the new figure, all of the perforations have adjacent segments touching. While removing the middle perforation shape, there would be two separate shapes, however if the furthest right or left strip is removed each strip is not spaced apart from one another, only the removed strip would be separated.
Claims 8-11 are rejected based on dependency.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 6-8 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Jones et al. US 2019/0125570, hereafter Jones.
Regarding claim 1, Jones discloses
A sealing device for an ostomy bag (fig. 1, 2), the sealing device comprising: A first material having a top surface and a bottom surface (para. 0091 backing layer (12)), wherein the first material is malleable (para. 0093 where the backing layer is defined as a polymeric film, and therefore interpreted as malleable due to it being formed as a film); The first material has an adhesive along the bottom surface (adhesive layer (14), para. 0093) , which is adherable to a skin surface of a user (para. 0093); wherein the first material is partitionable into various shapes, each partitionable shape comprises a perimeter and is separable from a remainder of the first material: and wherein each partitionable shape further comprises an opening (para. 0091, where perforated feature (distinguished by lines 24,26) allow for the user to divide the layer thus changing the shape see figure 3,5 where perforated lines form multiple shapes capable being separated from the rest of the layer)). The examiner notes that various configurations of the perforation lines are shown in figures 7 (3 perforated lines), 8 (4 perforated lines), and figures 9-30 where different overall shapes are seen to be used. Therefore the material is interpreted to formed into different shapes by tearing off different pieces formed by the perforations. Any configuration of said shapes leaves an opening in the middle as seen in the figures such that the device can fit around an ostomy wound(see figure 5)
Regarding claim 2, Jones discloses
The sealing device for an ostomy bag of claim 1, wherein the partitionable shapes of the first material are pre-formed into specific shapes. The examiner notes that the figures of Jones (fig. 1-23) depict embodiments of the first material, where said material can be seen to be in specific shapes. Further, per figure 3, the shape of the defined first material can be torn prior to application, see also figure 5. As such it is interpreted that the device may be preformed in said specific shapes. The examiner notes further that, as written, the claim merely requires the shapes to be performed, and as the perforation lines are provided on the device prior to use, the perforations and thus the shapes are interpreted to be performed.
Regarding claim 3, Jones discloses
The sealing device for an ostomy bag of claim 1, wherein the partitionable shapes of the first material are pre-formed into specific shapes of specific sizes. The examiner notes that the figures of Jones (fig. 1-23) depict embodiments of the first material, where said material can be seen to be in specific shapes. Further, per figure 3, the shape and size of the defined first material can be torn prior to application, see also figure 5. As such it is interpreted that the device may be performed in said specific shapes and sizes. The examiner notes further that, as written, the claim merely requires the shapes and sizes to be performed, and as the perforation lines are provided on the device prior to use, the perforations and thus the shapes and sizes are interpreted to be performed.
Regarding claim 4, Jones discloses
The sealing device for an ostomy bag of claim 1, further comprising a thin sheet of material removably attached to the adhesive (para. 0091, release liner (16)).
Regarding claim 6, Jones discloses
A sealing device for an ostomy bag (figure 1,2), the sealing device comprising: A sheet first material having a top surface and a bottom surface (para. 0091 backing layer (12)), wherein the she first material is malleable (para. 0093 where the backing layer is defined as a polymeric film, and therefore interpreted as malleable due to it being formed as a film); The first material has an adhesive along bottom surface, wherein which is adherable to a skin surface of a user (adhesive layer (14), para. 0093); Wherein the sheet of first material can is partitionable into various shapes, each partitionable shape comprises a perimeter and is separable from the sheet first material, and where each partitionable shape is spaced apart from adjacent partitionable shapes on the sheet of first material. (para. 0091, where perforated feature (distinguished by lines 24,26) allow for the ser to divide the layer thus changing the shape see figures 3,5 where perforated lines form multiple shapes capable being separated from the rest of the layer)
The examiner notes that various configurations of the perforation lines are shown in figures 7 (3 perforated lines), 8 (4 perforated lines), and figures 9-30 where different overall shapes are seen to be used. Therefore the material is interpreted to formed into different shapes by tearing off different pieces formed by the perforations. Any configuration of said shapes leaves an opening in the middle as seen in the figures such that the device can fit around an ostomy wound(see figure 5).
Regarding claim 7, Jones discloses
The sealing device for an ostomy bag of claim 1, wherein the sheet of first material is perforated such that each partitionable shape is separatable from the sheet of first material (perforation lines 24,26, as detailed under the rejection of claim 6).
Regarding claim 8, Jones discloses
The sealing device for an ostomy bag of claim 6, further comprising a thin sheet of material removably attached to the adhesive (para. 0091, release liner (16)).
Regarding claim 10, Jones discloses
The sealing device for an ostomy bag of claim 2, wherein the specific shapes comprise rectangles, squares, circles, or ovals. The examiner notes that as detailed under the rejection of claim 1, Jones discloses various different shapes and configurations of the perforations in the defined first layer. While figures 6-7 depicts the layer being formed in a circle and thus reads the claim in view of the interpretation provided under the objection of claim 10 above, figure 9 depicts an oval configuration, and figure 17 depicts a square configuration, and as such also a rectangle configuration.
Regarding claim 11, Jones discloses
The sealing device for an ostomy bag of claim 3, wherein the specific shapes comprise rectangles, squares, circles, or ovals. The examiner notes that as detailed under the rejection of claim 1, Jones discloses various different shapes and configurations of the perforations in the defined first layer. While figures 6-7 depicts the layer being formed in a circle and thus reads the claim in view of the interpretation provided under the objection of claim 10 above, figure 9 depicts an oval configuration, and figure 17 depicts a square configuration, and as such also a rectangle configuration.
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.
Claim(s) 5,9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jones in view of Verhaalen US 2010/0145293, hereafter Verhaalen.
Regarding claim 5, Jones discloses
The sealing device for an ostomy bag of claim 1, but fails to specifically disclose wherein the first material has a thickness of at least one quarter of an inch.
Verhaalen teaches an ostomy device and is thus considered analogous to the claimed invention. Verhaalen teaches that the size of the device will vary depending on the size of the wound, where a thickness may range from .25 to 1.5 inches. Therefore as Verhaalen teaches that ostomy devices vary in size depending on wound size, where said device are known to be made with a thickness of .25-1.5 inches, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Jones to have a thickness of at least .25 inches should the wound size require said thickness while achieving the predictable result of treating an ostomy wound. Should applicant disagree, the examiner further notes that per MPEP Section 2144.04 IV A In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955) (Claims directed to a lumber package "of appreciable size and weight requiring handling by a lift truck" were held unpatentable over prior art lumber packages which could be lifted by hand because limitations relating to the size of the package were not sufficient to patentably distinguish over the prior art. Therefore as reciting the thickness of the device does not patentably distinguish the device over the prior art and as the applicant’s claimed range is found to be non-critical (see applications spec para 0025, where the thickness is said to be no more than .25 inches, 3/8 inches, at least half an inch, where applicant further admits that “Different ostomy bags and connections will require different thickness as one of ordinary skill in the art will understand.”), it is interpreted that the prior art combination reads to the claimed limitation.
Regarding claim 9, Jones discloses
The sealing device for an ostomy bag of claim 6, but fails to specifically disclose wherein the first material has a thickness of at least one quarter of an inch.
Verhaalen teaches an ostomy device and is thus considered analogous to the claimed invention. Verhaalen teaches that the size of the device will vary depending on the size of the wound, where a thickness may range from .25 to 1.5 inches. Therefore as Verhaalen teaches that ostomy devices vary in size depending on wound size, where said device are known to be made with a thickness of .25-1.5 inches, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Jones to have a thickness of at least .25 inches should the wound size require said thickness while achieving the predictable result of treating an ostomy wound. Should applicant disagree, the examiner further notes that per MPEP Section 2144.04 IV A In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955) (Claims directed to a lumber package "of appreciable size and weight requiring handling by a lift truck" were held unpatentable over prior art lumber packages which could be lifted by hand because limitations relating to the size of the package were not sufficient to patentably distinguish over the prior art. Therefore as reciting the thickness of the device does not patentably distinguish the device over the prior art and as the applicant’s claimed range is found to be non-critical (see applications spec para 0025, where the thickness is said to be no more than .25 inches, 3/8 inches, at least half an inch, where applicant further admits that “Different ostomy bags and connections will require different thickness as one of ordinary skill in the art will understand.”), it is interpreted that the prior art combination reads to the claimed limitation.
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 Matthew Wrubleski whose telephone number is (571)272-1150. The examiner can normally be reached M-F 8:00-4:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781 /REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781