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 .
In light of the amendments to the claims filed 04/16/2025 wherein claims 2, 18, and 21 were amended, claims 2-8 and 10-22 are pending in the instant application and are examined on the merits herein.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/19/2025 has been entered.
Priority
The instant application is a continuation of U.S. Application no. 17/412,864 filed 08/26/2021 which claims priority to U.S. Provisional Application no. 63/071,821 filed on 08/28/2020.
Claims 2-8 and 10-22 receive priority to the prior-filed application, filed on 08/28/2020.
Response to Arguments
Rejections under 35 U.S.C. 103
Applicant's arguments filed 04/16/2025 have been fully considered but they are not persuasive and/or wherein the claim amendments have necessitated new grounds of rejection.
Regarding the first rejection of claim 2, the applicant asserts on pg. 6-7 that the prior art fails to teach or suggest the newly added limitations.
In response to the applicant’s argument, the examiner acknowledges the applicant’s argument and respectfully notes that the prior art were not used in the previous Office Action filed 07/29/2025 to read on the newly added limitations.
Regarding claim 21, the applicant asserts on pg. 7-10 that the prior art fails to teach or suggest each and every limitation of claim 21.
In response to the applicant’s argument, the examiner acknowledges the applicant’s argument and respectfully notes that the applicant’s argument is moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding the second rejection of claim 2, the applicant asserts on pg. 11-12 that the prior art fails to teach or suggest the fluid impermeable barrier of Bharadwaj extending from an outer periphery of the annular body.
In response to the applicant’s argument, the examiner acknowledges the applicant’s argument and respectfully notes that the prior art were not used in the previous Office Action filed 07/29/2025 to read on the limitation at issue as the limitation was previously an alternative. Applicant further asserts that it would not be obvious to move the fluid impermeable barrier of Bharadwaj from the inner periphery to the outer periphery. The newly provided rejection below does not hinge on this assertion.
Regarding claim 18, the applicant asserts on pg. 12-13 that the prior art fails to teach or suggest the newly added limitations.
In response to the applicant’s argument, the examiner acknowledges the applicant’s argument and respectfully notes that the prior art were not used in the previous Office Action filed 07/29/2025 to read on the newly added limitations. The applicant asserts that Bharadwaj does not teach that the retaining component of their invention is flexible enough to fold in half, especially in view of the fact that the retaining component is also attached to the transit component and the transit component would inhibit folding of the retaining component. Bharadwaj discloses that the retaining component of their invention is configured for positioning so as to conform to the anatomy around the perineum and to extend posteriorly toward the sacral bone and that the posterior end is positioned over the buttocks and in the region between the anal opening and coccyx (para. 0027). Bharadwaj further discloses that the retaining component and transit component are pliant and flexible (para. 0021; para. 0041) and the retaining component conforms in a fluid tight seal immediately surrounding the anal opening (para. 0028). In order to conform sealingly to the anatomy within the gluteal cleft, the retaining component would need to be flexible enough to fold in half. Further, the transit component as disclosed as pliant and flexible would not inhibit folding of the retaining component as this is required to conform in a fluid tight seal immediately surrounding the anal opening; therefore, Bharadwaj discloses the limitations at issue.
Claim Interpretation
The Examiner recognizes claims 10 and 19 as "product-by-process" claims. 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).
As a product claim, Examiner has determined claims 10 and 19 require the bodily waste collection device to comprise the following structural elements in addition to those in the claims from which they depend: a connection between the filter bag and the annular body such that they are affixed to one another.
In the prior art rejection in this Office action, Examiner considers claims 10 and 19 to be met when a reference teaches these structural limitations.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 13, 15-17, and 19-20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. All of these claims have been amended without notice of amendment to have dependency on claims that do not exist in the claim list. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. As all of the claim dependencies seem to have been increased by 10 from their original dependencies, the examiner is treating the claims as though they are dependent upon the claims they were originally dependent upon.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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Ex. Fig. 1 of Bharadwaj Fig. 3a-b
Claims 2-8, 10-13, 18-20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over WO/2019/239433 A1 to Bharadwaj in view of US/2018/0028349 A1 to Newton, 9,833,352 B2 to Maidl, and DE/1975/2598 C1 to Riesinger.
Regarding claim 2, Bharadwaj discloses a bodily waste collection device (Fig. 1a-b, bodily waste collection device 100), comprising:
an annular body defining an opening therein (Fig. 1a-b, annular body 102 defining opening 106), the annular body being configured to be positioned over the anus or the stoma of the wearer to position the opening around the anus or the stoma (para. 0020; para. 0022);
a barrier extending near an outer periphery of the annular body (Fig. 1a-b, barrier 104 extending directly from an area near an outer periphery of annular body 102; Ex. Fig 1 showing barrier 104 extending entirely downwards away from first end 304 which is meant to connect to annular body 102), the barrier including an upper portion and a lower portion (Ex. Fig. 1 showing barrier 104 including an upper portion and a lower portion), the barrier including an outer surface and an inner surface (Ex. Fig. 1 showing barrier 104 including an outer surface and an inner surface), the inner surface at least partially defining a chamber (Ex. Fig. 1 showing inner surface defining the chamber of barrier 104);
at least one input port located in the upper portion of the barrier (para. 0052 ln. 9-11; Ex. Fig. 1 showing input port 308 located in the upper portion of barrier 104); and
at least one output port located in the lower portion of the barrier (para. 0042; Ex. Fig. 1 showing output port 306 located in the lower portion of barrier 104) and
wherein the annular body forms an uppermost portion of the bodily waste collection device and the at least one output port is located at the lowermost portion of the bodily waste collection device, the uppermost portion positioned opposite the lowermost portion (Fig. 1a-b, annular body 102 shown connected to first end 304; Fig. 3a, output port 306).
Bharadwaj differs from the instantly claimed invention in that Bharadwaj fails to explicitly disclose wherein the barrier is fluid impermeable.
Newton teaches a bodily waste collection device comprising a fluid impermeable barrier (para. 0018 ln. 1-8; Fig. 1, fluid impermeable barrier 150).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the barrier of Bharadwaj to be fluid impermeable as taught by Newton, because Newton teaches that making the barrier of the bodily waste collection device fluid impermeable directs fluid to a dedicated reservoir while reducing and/or preventing fluid from exiting the device except via the outlet (para. 0026 ln. 14-18).
Bharadwaj further differs from the instantly claimed invention in that Bharadwaj fails to disclose wherein the barrier extends from an outer periphery of the annular body.
There is no evidence of record that establishes that changing the first end of the barrier would result in a difference in function of the Bharadwaj device. Further, a person having ordinary skill in the art, being faced with modifying the barrier of Bharadwaj, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended by extending the edges of the barrier to the outer periphery of the annular body. The body (302) of the barrier (104) is disclosed to be flexible and pliant (para. 0041) similar to that used for the annular body (102; para. 0021); therefore, extending the edges of the barrier to the edges of the annular body would not affect the ability of the annular body to conform to the anatomical region. It would further provide an increased connection area between said components. Lastly, applicant has not disclosed that the claimed arrangement solves any stated problem and further offers other acceptable arrangements (e.g., at one or more points internal to the outer periphery such as at the inner periphery or any points between the outer periphery and the opening); therefore, there appears to be no criticality placed on the arrangement as claimed such that it produces an unexpected result.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the connection of the barrier such that the first end is connected to the annular body from the interior out to the periphery of the annular body as an obvious matter of design choice within the skill of the art.
Further, Bharadwaj differs from the instantly claimed invention in that Bharadwaj fails to disclose a filter bag directly affixed to the annular body. Bharadwaj discloses that the bodily waste collection device of their invention may comprise safeguards to prevent backflow of fecal matter including fecal matter retaining elements (para. 0044) and that the disposable bag of their invention may be directly coupled to the bodily waste collection device (para. 0049), such that the device may be considered a more closed system.
Maidl teaches a filter bag within a bodily waste collection assembly (col. 5 ln. 37-41; Fig. 3, 24 filter bag).
Riesinger teaches a filter bag directly affixed to an annular body and surrounding an opening of the annular body (para. 0045, membrane 60’ clipped onto annular body 15 and surrounding opening 4).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the bodily waste collection device of Bharadwaj to comprise a filter bag as taught by Maidl, because Bharadwaj discloses safeguards to prevent backflow of fecal matter (para. 0044) and Maidl teaches that providing a filter bag filters between the liquid and solid fractions of fecal matter to allow for the liquid fraction to be emptied separately to provide improved waste management options for ostomy patients (col. 1 ln. 38-51), such that liquid fecal matter would not backflow to the stoma or anus. Further, Riesinger discloses a similar body waste collection container to Maidl and Riesinger’s filter bag performs the same function of the filter bag of Maidl (para. 0023-0024); therefore, other arrangements of the filter bag are known and unobvious as shown in the figures of Riesinger.
Regarding claim 3, the cited prior art suggests the invention of claim 2. Bharadwaj further discloses wherein the annular body is a planar body (Fig. 1a showing annular body 102 in a planar configuration).
Regarding claim 4, the cited prior art suggests the invention of claim 2. Bharadwaj further discloses wherein the annular body is compliant and foldable (para. 0021; para. 0027-0028).
Regarding claim 5, the cited prior art suggests the invention of claim 2. Bharadwaj further discloses wherein the annular body is sized and shaped to fit within an intergluteal cleft of the wearer (para. 0027).
Regarding claim 6, the cited prior art suggests the invention of claim 2. Bharadwaj further discloses wherein the annular body includes an adhesive disposed on an outward facing surface, the adhesive at least partially around the opening (para. 0033, anatomy conforming surface 1040 comprises an adhesive disposed thereon).
Regarding claim 7, the cited prior art suggests the invention of claim 2. Bharadwaj further discloses wherein the fluid impermeable barrier is affixed to the annular body (para. 0024).
Regarding claim 8, the cited prior art suggests the invention of claim 2. Bharadwaj further discloses wherein the upper portion of the fluid impermeable barrier exhibits a generally cylindrical shape (Ex. Fig. 1 showing upper portion of barrier 104 exhibiting a generally cylindrical shape); however, the prior art differ from the instantly claimed invention in that they fail to disclose the lower portion exhibits a maximum outer dimension that is less than a maximum outer dimension of the upper portion.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Bharadwaj, Newton, Maidl, and Riesinger to have the maximum outer dimension of the lower portion be lesser than a maximum outer dimension of the upper portion since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Bharadwaj, Newton, Maidl, and Riesinger would not operate differently with the claimed proportion and since the lower portion of the fluid impermeable barrier has an average outer dimension roughly equal to the outer dimension of the upper portion, the device would function appropriately having the claimed proportion. Further, it appears that applicant places no criticality on the proportion claimed, indicating simply that the proportion “may” occur (specification pp. [0035]).
Regarding claim 10, the cited prior art suggests the invention of claim 2. Riesinger suggests the filter bag affixed to the annular body (rejection of claim 2 above: para. 0045).
Per the claim interpretation as explained above, the claim is considered to be read on by the prior art so long as the filter bag and the annular body are affixed to one another.
Regarding claim 11, the cited prior art suggests the invention of claim 2. Riesinger suggests the filter bag affixed to the annular body (rejection of claim 2 above: para. 0045)
However, the prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the filter bag is affixed to the annular body between the opening and an outer periphery of the annular body; and the fluid impermeable barrier extends from the outer periphery of the annular body.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the position of the fluid impermeable barrier and filter bag so the filter bag was at least partially affixed to the annular body between the opening and an outer periphery of the annular body since this claimed position of the fluid impermeable barrier and filter bag does not change the fluid impermeable barriers ability to filter bags ability to separate out different types of effluent. Since applicant has not given any criticality to why the position of the connection between the fluid impermeable barrier, annular body, and filter bag disclosed has any importance to the function of the claimed device, the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). Further, for the filter bag to be entirely within the fluid impermeable barrier, it would be obvious that it would be attached to the annular body radially inward from the attachment of the fluid impermeable body to the annular body.
Further, there is no evidence of record that establishes that changing the first end of the barrier would result in a difference in function of the Bharadwaj device. Further, a person having ordinary skill in the art, being faced with modifying the barrier of Bharadwaj, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended by extending the edges of the barrier to the outer periphery of the annular body. The body (302) of the barrier (104) is disclosed to be flexible and pliant (para. 0041) similar to that used for the annular body (102; para. 0021); therefore, extending the edges of the barrier to the edges of the annular body would not affect the ability of the annular body to conform to the anatomical region. It would further provide an increased connection area between said components. Lastly, applicant has not disclosed that the claimed arrangement solves any stated problem and further offers other acceptable arrangements (e.g., at one or more points internal to the outer periphery such as at the inner periphery or any points between the outer periphery and the opening); therefore, there appears to be no criticality placed on the arrangement as claimed such that it produces an unexpected result.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the connection of the barrier such that the first end is connected to the annular body from the interior out to the periphery of the annular body as an obvious matter of design choice within the skill of the art.
Regarding claim 12, the cited prior art suggests the invention of claim 2. Maidl suggests the filter bag constructed of a mesh material (rejection of claim 2 above: col. 3 ln. 61-67 and col. 4 ln. 1-40).
Regarding claim 13, the cited prior art suggests the invention of claim 2. Maidl suggests the mesh material having a sieve size of 0.5-1000 µm (rejection of claim 2 above: col. 3 ln. 61-67 and col. 4 ln. 1-40).
However, the prior art differs from the instantly claimed invention in that the prior art fails to explicitly disclose wherein the filter bag has a sieve size of about 100 µm to about 1000 µm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the sieve size of the device of Bharadwaj, Newton, Maidl, and Riesinger from between 0.5-1000 µm to about 100 µm to about 1000 µm as applicant appears to have placed no criticality on the claimed range (see pp. [0037] indicating the sieve size “may” be within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 18, Bharadwaj discloses a bodily waste collection device (Fig. 1a-b, bodily waste collection device 100), comprising:
an annular body defining an opening therein (Fig. 1a-b, annular body 102 defining opening 106), the annular body being configured to be positioned over the anus of a wearer to position the opening around the anus (para. 0020; para. 0022), the annular body foldable in half, sized, and shaped to fit within an intergluteal cleft of the wearer (para. 0020-0021; para. 0026-0027);
a barrier extending from the annular body (Fig. 1a-b, barrier 104), the barrier including an upper portion and a lower portion (Ex. Fig. 1), the barrier including an outer surface and an inner surface (Ex. Fig. 1), the inner surface at least partially defining a chamber (Ex. Fig. 1);
at least one input port located in the upper portion of the barrier (para. 0052 ln. 9-11; Ex. Fig. 1, input port 308); and
at least one output port located in the lower portion of the barrier (para. 0042; Ex. Fig. 1, output port 306).
Bharadwaj differs from the instantly claimed invention in that Bharadwaj fails to explicitly discloses wherein the barrier is fluid impermeable.
Newton teaches a bodily waste collection device comprising a fluid impermeable barrier (para. 0018 ln. 1-8; Fig. 1, fluid impermeable barrier 150).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the barrier of Bharadwaj to be fluid impermeable as taught by Newton, because Newton teaches that making the barrier of the bodily waste collection device fluid impermeable directs fluid to a dedicated reservoir while reducing and/or preventing fluid from exiting the device except via the outlet (para. 0026 ln. 14-18).
Further, Bharadwaj differs from the instantly claimed invention in that Bharadwaj fails to disclose a filter bag directly affixed to the annular body. Bharadwaj discloses that the bodily waste collection device of their invention may comprise safeguards to prevent backflow of fecal matter including fecal matter retaining elements (para. 0044) and that the disposable bag of their invention may be directly coupled to the bodily waste collection device (para. 0049), such that the device may be considered a more closed system.
Maidl teaches a filter bag within a bodily waste collection assembly (col. 5 ln. 37-41; Fig. 3, 24 filter bag).
Riesinger teaches a filter bag directly affixed to an annular body and surrounding an opening of the annular body (para. 0045, membrane 60’ clipped onto annular body 15 and surrounding opening 4).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the bodily waste collection device of Bharadwaj to comprise a filter bag as taught by Maidl, because Bharadwaj discloses safeguards to prevent backflow of fecal matter (para. 0044) and Maidl teaches that providing a filter bag filters between the liquid and solid fractions of fecal matter to allow for the liquid fraction to be emptied separately to provide improved waste management options for ostomy patients (col. 1 ln. 38-51), such that liquid fecal matter would not backflow to the stoma or anus. Riesinger discloses a similar body waste collection container to Maidl and Riesinger’s filter bag performs the same function of the filter bag of Maidl (para. 0023-0024); therefore, other arrangements of the filter bag are known and unobvious as shown in the figures of Riesinger.
Regarding claim 19, the cited prior art suggests the invention of claim 18. Riesinger suggests the filter bag affixed to the annular body (rejection of claim 18 above: para. 0045).
Per the claim interpretation as explained above, the claim is considered to be read on by the prior art so long as the filter bag and the annular body are affixed to one another.
Regarding claim 20, the cited prior art suggests the invention of claim 18. Riesinger suggests the filter bag affixed to the annular body (rejection of claim 18 above: para. 0045)
However, the prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the filter bag is affixed to the annular body between the opening and an outer periphery of the annular body; and the fluid impermeable barrier extends from the outer periphery of the annular body.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the position of the fluid impermeable barrier and filter bag so the filter bag was at least partially affixed to the annular body between the opening and an outer periphery of the annular body since this claimed position of the fluid impermeable barrier and filter bag does not change the fluid impermeable barriers ability to filter bags ability to separate out different types of effluent. Since applicant has not given any criticality to why the position of the connection between the fluid impermeable barrier, annular body, and filter bag disclosed has any importance to the function of the claimed device, the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). Further, for the filter bag to be entirely within the fluid impermeable barrier, it would be obvious that it would be attached to the annular body radially inward from the attachment of the fluid impermeable body to the annular body.
Further, there is no evidence of record that establishes that changing the first end of the barrier would result in a difference in function of the Bharadwaj device. Further, a person having ordinary skill in the art, being faced with modifying the barrier of Bharadwaj, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended by extending the edges of the barrier to the outer periphery of the annular body. The body (302) of the barrier (104) is disclosed to be flexible and pliant (para. 0041) similar to that used for the annular body (102; para. 0021); therefore, extending the edges of the barrier to the edges of the annular body would not affect the ability of the annular body to conform to the anatomical region. It would further provide an increased connection area between said components. Lastly, applicant has not disclosed that the claimed arrangement solves any stated problem and further offers other acceptable arrangements (e.g., at one or more points internal to the outer periphery such as at the inner periphery or any points between the outer periphery and the opening); therefore, there appears to be no criticality placed on the arrangement as claimed such that it produces an unexpected result.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the connection of the barrier such that the first end is connected to the annular body from the interior out to the periphery of the annular body as an obvious matter of design choice within the skill of the art.
Regarding claim 22, the cited prior art suggests the invention of claim 2. Bharadwaj further discloses wherein the annular body is spaced further from the lower portion than all of the upper portion (Ex. Fig. 1 showing upper portion comprising 304 first end for connection to 102 annular body closer to 304 first end than all of lower portion).
Claims 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Bharadwaj, Newton, Maidl, and Riesinger as applied above, and further in view of US/2012/0233762 A1 to Huang.
Regarding claim 14, the cited prior art suggests the invention of claim 2. Bharadwaj further discloses a bodily waste collection system (Fig. 5, bodily waste collection system), comprising: the bodily waste collection device of claim 2 (as explained in the rejection of claim 2 above); a fluid storage container configured to hold a fluid (Fig. 5, fluid container 410; para. 0048-0049) and a vacuum source configured to apply a vacuum to draw the fluid from the chamber (para. 0054 ln. 26-29; para. 0059), the fluid storage container and the vacuum source in fluid communication with the chamber via the at least one output port (Fig. 5 showing fluid container 410 in fluid communication with chamber 104 through conduit 402 in connection with output port 306 and control device 412 comprising pump in fluid communication with chamber 104 through second fluid passageway 416, fluid container 410, conduit 402 in connection with output port 306; para. 0054 ln. 26-29); and a positive pressure source in fluid communication with the chamber via the at least one input port (para. 0052; para. 0059-0060; Fig. 5 showing control device 412 comprising pump in fluid communication with chamber 104 through first fluid passageway 414 in connection with input port 308); however, the prior art differs from the instantly claimed invention in that the prior art fails to explicitly suggest the vacuum and positive pressure source being different structures.
Huang teaches a bodily waste collection system comprising a vacuum source (Fig. 2, negative pressure device 2 comprising a vacuum pump) and positive pressure source (Fig. 7, positive pressure source 7 comprising air pump 71).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the single pump providing positive and negative pressure of Bharadwaj, Newton, Maidl, and Riesinger that allows the device to provide both fluid and vacuum, for the multiple pumps of Huang since these mechanisms perform the same function of providing fluid and vacuum to the bodily waste collection device. Simply substituting one positive and negative pressure means for another would yield the predicable result of allowing the device to provide both suction and fluid to the waste collection device. See MPEP 2143.
Regarding claims 15, the cited prior art suggests the invention of claim 14; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the positive pressure source is configured to periodically input fluid into the chamber to create periodic pressure in the chamber in combination with the vacuum source.
Huang teaches wherein the positive pressure source is configured to periodically input fluid into the chamber to create periodic pressure in the chamber in combination with the vacuum source (para. 0042 ln. 1-8; para. 0047 ln. 8-24).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the current combination of Bharadwaj, Newton, Maidl, Riesinger, and Huang to have the positive pressure source be configured as taught by Huang, because Huang teaches that providing positive pressure in combination with the vacuum source acts to expand a chamber, so that the excrement collecting area increases to allow for the negative pressure to draw the excrement more smoothly into the waste storage container (para. 0042 ln. 1-8).
Regarding claim 16, the cited prior art suggests the invention of claim 14. Bharadwaj further discloses a controller operably coupled to the positive pressure source and the vacuum source (Fig. 5, 412 control device comprising controller; para. 0054 ln. 19-29; para. 0060), wherein the controller is configured to selectively control the positive pressure source to periodically input fluid into the chamber (para. 0054-0055, first and second operations comprise at least control device 412 comprising controller controlling air inlet into chamber 104; para. 0057, first and second operations occur every 30, 60, 90 seconds; para. 0059-0060, pump as positive pressure source injects fluids such as air into chamber 104) and to control application of vacuum by the vacuum source to create periodic pressure within the bodily waste collection device (para. 0054-0055).
Regarding claim 17, the cited prior art suggests the invention of claim 16. Bharadwaj further discloses wherein the controller is configured to selectively control the positive pressure source to periodically input fluid into the chamber at least once every 3 hours (para. 0054-0055, first and second operations comprise at least control device 412 comprising controller controlling air inlet into chamber 104; para. 0057, first and second operations occur every 30, 60, 90 seconds; para. 0059-0060, pump as positive pressure source injects fluids such as air into chamber 104).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over US/2014/0323909 A1 to Kyoung-Hun, and further in view of DE/1975/2598 C1 to Riesinger (hereinafter referred to as Riesinger ‘598), US/2006/0189957 A1 to Howlett, and WO/0152780 A1 to Riesinger (hereinafter referred to as Riesinger ‘780).
Regarding claim 20, Kyoung-Hun discloses a bodily waste collection device (para. 0001), comprising:
an annular body defining an opening therein (Fig. 7-8, 100 fixing plate), the annular body being configured to be positioned over the anus or the stoma of the wearer to position the opening around the anus or the stoma (para. 0043-0044);
a fluid impermeable barrier extending from or near an outer periphery of the annular body (para. 0040; Fig. 7-8, collection bag 200 formed from waterproof layer 201 and absorbent felt layer 202), the fluid impermeable barrier including an upper portion and a lower portion, the upper portion of the fluid impermeable barrier exhibits a generally cylindrical shape having a generally uniform maximum outer dimension and the lower portion exhibits a maximum outer dimension that is less than a maximum outer dimension of the upper portion (Fig. 7-8, collection bag 200 formed generally cylindrically with a smaller dimension on the lower end), the fluid impermeable barrier including an outer surface and an inner surface, the inner surface at least partially defining a chamber (Fig. 8, collection bag 200 forming chamber).
Kyoung-Hun differs from the instantly claimed invention in that Kyoung-Hun fails to disclose a filter bag disposed within the chamber and positioned to receive waste via the opening, the filter bag extending from a location adjacent to an intersection of the upper portion and the lower portion of the fluid impermeable barrier to the annular body, the filter bag directly affixed to the annular body or the fluid impermeable barrier, the filter bag constructed of a mesh material having a sieve size of about 5 µm to about 1500 µm.
Riesinger ‘598 teaches a filter bag disposed within the chamber and positioned to receive waste via the opening, the filter bag extending from a location adjacent to an intersection of the upper portion and the lower portion of the fluid impermeable barrier to the annular body, the filter bag directly affixed to the annular body or the fluid impermeable barrier (para. 0024; para. 0045-0046, sieve-like membrane 60’ clipped onto annular body 15 and surrounding opening 4; Fig. 14A-B).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of Kyoung-Hun to comprise a filter bag as taught by Riesinger ‘598, because Riesinger ‘598 teaches that a filter bag used in conjunction with absorbent bodies in a waste collection device creates a trough at a lower portion of the device to allow the aqueous components of a secretion to be tightly bound in absorbent bodies disposed there, which stops a creeping effect of liquid components of exudate that can impair wearing comfort of the device (para. 0022; para. 0045-0046).
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kyoung-Hun and Riesinger ‘598 to have a sieve size of between 5-1500 µm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Kyoung-Hun and Riesinger ‘598 would not operate differently with the claimed sieve size and since the sieve is sized to separate the liquid and solid materials from the waste the system would be considered to function appropriately with the claimed sieve size. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the sieve size “may” be within the claimed ranges (specification pp. [0037]).
Further, Kyoung-Hun differs from the instantly claimed invention in that Kyoung-Hun fails to disclose at least one input port located in the upper portion of the fluid impermeable barrier.
Howlett teaches an input port in an upper portion of a waste collection device (para. 0028-0029; Fig. 3, 33 inlet port).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of Kyoung-Hun to comprise an input port as taught by Howlett, because Howlett teaches that an inlet port in a bodily waste collection device can be used to allow for an irrigating tube to pass through the barrier, which would allow for relief of fecal impaction (para. 0005; para. 0028-0029).
Further still, Kyoung-Hun differs from the instantly claimed invention in that Kyoung-Hun fails to disclose at least one output port located in the lower portion of the fluid impermeable barrier.
Riesinger ‘780 teaches an output port located in the lower portion of a waste collection device (Fig. 25A-B; pg. 9-10).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of Kyoung-Hun to comprise an output port as taught by Riesinger ‘780, because Riesinger ‘780 teaches than an output port can allow for draining of a waste collection device comprising absorbent material (Fig. 25B; pg. 9-10), which would allow for longer use of the waste collection device.
Conclusion
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/Linnae E. Raymond/Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781