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 Amendment
Amendments filed 06/22/26 have been entered. The amendments overcome the previous 112b and 101 rejections. Said rejections are withdrawn.
Response to Arguments
Applicant's arguments filed 06/22/26 have been fully considered but they are not persuasive. The applicant argues that the prior art Toda does not specifically detail that the overlap sheet is sealed at its entire contour and is configured to form an impermeable barrier that prevents moisture [in the sacral area]). Applicant argues that as Toda’s overlap sheet is designed to remain movable, it does not form a closed barrier. The examiner respectfully disagrees. The examiner previously cited that the overlap sheet of Toda is sealed along its periphery at bonded areas (15). Per the same figures and citations (namely para. 0061), the overlap sheet is bonded to the barrier cuff and para. 0068 evidences that said sheet is “leak proof”. To further support this, the examiner notes that figure 7 shows the rear (13b) of the same overlap sheet bonded with the edge of the device, where para. 0100 details that an overlap sheet is bonded directly to the inner sheet. Further, the “movable aspect” is achieved by the material of the sheet, not a bonding construction as detailed under para. 0069 and 0070, where the overlap sheet is made from a material that can expand/contract, preventing the occurrence of bedsores. The examiner further contends that the overlap sheet of Toda is superimposed on the diaper (As argued by the applicant in page 8 of the remarks) as seen in figure 5 and as detailed under the rejection of claim 1 (para. 0060,0061) as the overlap sheet is bonded (on top) of the diaper due to it contacting the sacrum of the user.
Applicant argues that Nakawa does not disclose that the multilayer construction does not form a closed barrier and that there is no complimentary part, however this argument is found to be non ]persuasive as it appears to be challenging Nakawa independent of the primary reference Toda, where Nakawa was merely used to teach a multilayer construction suitable for diapers, where the combination to include a second layer with the overlap sheet of Toda was found to be obvious by a use of a known technique for improving similar devices rationale.
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) 6,8-9,12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toda et al. US 2015/0366725, hereafter Toda, in view of Nakagawa JP 2002238935, hereafter Nakagawa.
Regarding Claim 6, Toda discloses a sacrum-protecting diaper (abstract) consisting of a diaper specially designed to provide protection to the sacral area against the effects of moisture, pressure and chafing in patients with urinary incontinence who must remain in bed for prolonged periods of time (abstract), wherein the sacrum protecting diaper is a support diaper with several absorbent inner layers and an impermeable outer layer (see claim 1 of Toda, see also figure 2 showing liquid impermeable outer layer (5) and absorbent inner layers (6,7) see paragraphs 0055-0059), wherein a complementary part (13) having the particularity of being sealed along its entire contour (see figures 1,2, where (13) is bonded at areas 15, and where in figure 2, the periphery [13R and 13L] of the defined complementary part (13) are bonded at areas 8s and 9s [para. 0058, 0061], and where said bonding is heat sealing or adhesive [para. 0063]), and is incorporated by adhering or by any other method (para. 0063), with the complementary part, and is placed to coincide with the sacral area (para. 0064). Per the amendments filed 06/22/26, the examiner notes that the overlap sheet is interpreted to be superimposed on the sheet as it contacts the sacral area (and is thus outermost), as seen in figure 5 is the top layer, and per para. 0061, is bonded to the barrier cuff.
The examiner notes per the amendments filed 06/22/26, requiring that the complimentary part has several absorbent layers which form a dry absorbent side and an impermeable outer layer forming an impermeable side, the examiner notes that Toda para. 0068 details that the overlap sheet may be hydrophobic, preventing dampening, and thus comprises an impermeable outer layer. However, that the defined complementary part fails to have a dry absorbent side which acts as a double padding, and an impermeable side, being provided with a sealing edge, as the overlap sheet of the prior art is seen to be one layer. As detailed above under the same paragraph, the sheet may be hydrophobic (per para. 0068), but alternatively, per the same citation, the sheet may be hydrophilic for absorbing sweat (para. 0068). Further, per the same rejection, the overlap sheet is provided with at least one sealing edge (figure 2, para. 0063).
Nakagawa teaches a diaper device and is thus considered analogous to the claimed invention. Nakagawa that as a means to aid in prevention of bedsores (abstract) the diaper is provided with a diaper cover portion (5) that interfaces with the sacrum (para. 0006). Said cover portion (5) comprises (See figure 2) a first layer (4) and a second layer (3), where the first layer (4) is a pad with excellent hygroscopicity and air permeability for absorbed fluid including sweat (para. 0006) and second layer (3) is a waterproof sheet (para. 0006). Therefore, as Nakagawa teaches a sacrum support for attaching to a diaper, where said support comprises an absorbent layer for absorbing sweat of urine leaking from the diaper, and an impermeable sheet for substantially preventing urine from leaking, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the defined complementary sheet of Toda (13) to include an additional layer. Doing so would merely involve the use of known technique (adding an impermeable sheet between an absorbent cover for a sacrum and inner diaper absorbent) to improve similar devices (diaper device comprising an absorbent cover for a sacrum) in the same way. Said combination would achieve the predictable result of substantially preventing fluid from the diaper absorbent from entering the sacrum absorbent or skin. Further, as a result of the combination therefore teach that the two-layer complementary part forms an impermeable barrier that prevents in its entirety moisture resulting from incontinence.
Regarding Claim 8, Toda and Nakagawa teach the sacrum-protecting diaper according to claim 6, characterized in that the complementary part, which is sealed and, therefore, impermeable to moisture, is square-shaped, rectangular-shaped or has any other regular polygon shape. The examiner notes that as seen in figure 1 of Toda, the defined complementary part (13) is seen to be a square and thus reads to the claimed limitation.
Regarding Claim 9, Toda and Nakagawa teach the sacrum-protecting diaper according to claim 6, characterized in that the impermeable side of the complementary part is placed such that it is in contact with the absorbent side of the support diaper (Toda para. 0059,0061). The examiner notes that as detailed in para. 0059 and 0061, the overlap sheet moves against the urine absorption pad main body. It is therefore interpreted that the defined complementary part is in contact with the absorbent of the diaper. Per the combination provided in the rejection of claim 1, the impermeable layer would be in between the absorbent portion of the complementary layer and the absorbent portion of the diaper, and therefore the impermeable layer would be in contact with the diaper absorbent portion.
Regarding Claim 13, Toda and Nakagawa teach
The sacrum-protecting diaper according to claim 6, wherein the complementary part, which is sealed and impermeable to moisture, is a regular polygon shape. The examiner notes that as seen in figure 1 of Toda, the defined complementary part (13) is seen to be a square and thus reads to the claimed limitation of a regular polygon.
Claim(s) 7,10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toda in view of Nakagawa and further in view of Rogers et al. US 2009/0177135, hereafter Rogers.
Regarding Claim 7, Toda and Nakagawa teach the sacrum-protecting diaper according to claim 6, characterized in that the complementary part, which is sealed and, therefore, impermeable to moisture, but fails teach that said part is heart-shaped. The examiner notes that as seen in figure 1 of Toda, the defined complementary part (13) is seen to be a square and thus reads to the claimed limitation.
Rogers teaches an absorbent pad device and is thus considered analogous to the claimed invention. Rogers teaches that the where the dressing, applied to a sacral region is preferred to have generally triangle, heart, pear of square shaped (para. 0012). Therefore as Toda teaches a square shaped complementary part for interfacing with a sacrum, and Rogers teaches that sacrum portions of absorbent articles may be various shapes including square and heart shaped, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the sacrum portion of Toda to be a heart shaped, as Rogers teaches that heart shaped and square shaped portions are both used in sacrum portions of articles. Such a modification would merely involve some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention and thus a prima facie case of obviousness exists.
Regarding Claim 10, Toda, Nakagawa, and Rogers teach the sacrum-protecting diaper according to claim 7, characterized in that the impermeable side of the complementary part is placed such that it is in contact with the absorbent side of the support diaper (Toda para. 0059,0061). The examiner notes that as detailed in para. 0059 and 0061, the overlap sheet moves against the urine absorption pad main body. It is therefore interpreted that the defined complementary part is in contact with the absorbent of the diaper. Per the combination provided in the rejection of claim 6, the impermeable layer would be in between the absorbent portion of the complementary layer and the absorbent portion of the diaper, and therefore the impermeable layer would be in contact with the diaper absorbent portion.
Regarding Claim 11, Toda, Nakagawa, and Rogers teach the sacrum-protecting diaper according to claim 7, characterized in that the impermeable side of the complementary part is placed such that it is in contact with the absorbent side of the support diaper (Toda para. 0059,0061). The examiner notes that as detailed in para. 0059 and 0061, the overlap sheet moves against the urine absorption pad main body. It is therefore interpreted that the defined complementary part is in contact with the absorbent of the diaper. Per the combination provided in the rejection of claim 6, the impermeable layer would be in between the absorbent portion of the complementary layer and the absorbent portion of the diaper, and therefore the impermeable layer would be in contact with the diaper absorbent portion.
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
/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
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