CTNF 18/568,510 CTNF 97698 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Drawings 06-36 AIA The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the "conventional diaper with several absorbent inner layers and an impermeable outer layer ” and “the complementary part…having a structure identical to that of the support diaper” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Claim Rejections - 35 USC § 112 07-30-02 AIA The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 07-34-01 Claims 6-13 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Regarding claim 6, it is unclear what is meant by “conventional diaper”. The claim further specifies that said structure involves several absorbent inner layers and an impermeable outer layer. The examiner notes that this limitation is unclear as the “conventional” is not consistent with the further clarification of several absorbent layers. The examiner notes that while it is known in the art for diapers to have multiple absorbent layers, it is also known in the art for diapers to have a single absorbent inner layer. Therefore it is unclear how the term conventional is to be interpreted in further view of the structural limitations further provided. The examiner notes that any diaper with multiple absorbing layers is interpreted to read to the claim. Further regarding claim 6, the limitation “the complementary part placed to coincide with the sacral area, having a structure identical to that of the support diaper” is unclear. The claim requires a support diaper having multiple inner absorbent layers, but as best understood from the applicant’s claimed limitation, the complementary part only has one absorbent side . As such it cannot be identical to the “conventional diaper” as described by the claims as the part is only one layer with an impermeable and absorbent side, not multiple absorbent layers and an impermeable layer. As best understood by the examiner the complementary part does not have multiple absorbing layers. Thus it is interpreted that a “complementary part” of the prior art that comprises an absorbent side reads to the claimed limitation. Regarding claim 12 , it is unclear what direct or return moisture are, and how moisture is “selected” feature of the device, when the device is merely configured to prevent moisture. As such it is interpreted that any diaper device capable of preventing moisture reads to the claimed limitation. Claims 6-13 recite various limitations, which combines both product and process in the same claims, which is considered indefinite under 35 USC 112, second paragraph, as it has been held that a single claim which claims both an apparatus and the method steps of making or using the apparatus is indefinite under 35 U.S.C. 112, second paragraph. See In re Katz , 639 F.3d 1303 (Fed. Cir. 2011) (citing IPXL Holdings v. Amazon.com, Inc. , 430 F.2d 1377, 1384, 77 USPQ2d 1140, 1145 (Fed. Cir. 2005); Ex parte Lyell , 17 USPQ2d 1548 (Bd. Pat. App. & Inter. 1990). MPEP 2173.05(p)(II). Regarding claim 6 said limitations include “forming an impermeable barrier” in line 6 of claim 6. It is interpreted that the limitation reads “configured to form an impermeable barrier”. Also in claim 6,“is incorporated” in line 7 of claim 6. It is interpreted that said limitation reads “configured to be incorporated”. Regarding claim 7 said limitation includes “which is sealed” in line 2 of claim 7. It is interpreted that the limitation reads “configured to be sealed”. Regarding claim 8 said limitation includes “which is sealed” in line 2 of claim 8. It is interpreted that the limitation reads “configured to be sealed”. Regarding claim 9 said limitation includes “is placed” in line 2 of claim 9. It is interpreted that the limitation reads “configured to be placed”. Regarding claim 10 said limitation includes “is placed” in line 2 of claim 10. It is interpreted that the limitation reads “configured to be placed”. Regarding claim 11 said limitation includes “is placed” in line 2 of claim 11. It is interpreted that the limitation reads “configured to be placed”. Regarding claim 13 said limitation includes “which is sealed” in line 2 of claim 13. It is interpreted that the limitation reads “configured to be sealed”. Appropriate correction is required. Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. 07-04-03 AIA 07-04-01 Section 33(a) of the America Invents Act reads as follows: Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism. Claim 6-13 rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability , 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 6 requires, in line 8, “placed to coincide with the sacral area. The examiner notes that this limitation encompasses a human organism and thus is rejected under 35 U.S.C 101. It is interpreted that the claim reads “configured to be placed to coincide with the sacral area”. Appropriate correction is required. Claims 7-13 are rejected based on dependency . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-23-aia AIA 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. 07-21-aia AIA 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 conventional diaper of the type normally used 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) . The examiner notes however that the defined complementary part fails to have a structure identical to that of the support diaper with 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. The sheet may be hydrophobic (per para. 0068), but alternatively, per the same citation, the sheet may be hydrophilic for absorbing sweat (para. 0068) . 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 12, Toda and Nakagawa teach The sacrum-protecting diaper according to claim 6, wherein the moisture is selected from direct moisture and return moisture. The examiner notes that as detailed under the 112 rejection it is unclear as to what direct or return moisture are. As such it is interpreted that any diaper capable of preventing moisture through an impermeable barrier directly from a patient would read to the claimed limitation. As detailed above under the rejection of claim 6 the prior art device prevents moisture from a patient and thus reads to the claimed limitation. 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 . 07-21-aia AIA 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 Any inquiry concerning this communication or earlier communications from the examiner should be directed to Matthew Wrubleski whose telephone number is (571)272-1150. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /MATTHEW WRUBLESKI/Examiner, Art Unit 3781 /ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781 Application/Control Number: 18/568,510 Page 2 Art Unit: 3781 Application/Control Number: 18/568,510 Page 3 Art Unit: 3781 Application/Control Number: 18/568,510 Page 4 Art Unit: 3781 Application/Control Number: 18/568,510 Page 5 Art Unit: 3781 Application/Control Number: 18/568,510 Page 6 Art Unit: 3781 Application/Control Number: 18/568,510 Page 7 Art Unit: 3781 Application/Control Number: 18/568,510 Page 8 Art Unit: 3781 Application/Control Number: 18/568,510 Page 9 Art Unit: 3781 Application/Control Number: 18/568,510 Page 10 Art Unit: 3781 Application/Control Number: 18/568,510 Page 11 Art Unit: 3781 Application/Control Number: 18/568,510 Page 12 Art Unit: 3781