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 03/06/2026 in which claims 5 and 13-15 were amended, claims 2-16 are pending in the instant application and are examined on the merits herein.
Priority
The instant application is a 371 of PCT/DK2022/050066 filed 03/29/2022 which claims priority to DKPA/2021/00331 filed 03/30/2021.
Claims 2-16 receive priority to the prior-filed application, filed on 03/30/2021.
Response to Arguments
Objections to the Drawings
The objections to the drawings are withdrawn in view of the amendments to the drawings filed 03/06/2026.
Rejections of the Claims under 35 U.S.C. 112(b)
The rejections of the claims under 112(b) are withdrawn in view of the amendments to the claims filed 03/06/2026.
Rejections of the Claims under 35 U.S.C. 102 and 103
Applicant's arguments filed 03/06/2026 have been fully considered but they are not persuasive and/or wherein the claim amendments have necessitated new grounds of rejection.
Regarding claims 13-15, the applicant asserts on pg. 10-12 that Ballan fails to disclose an expandable elongated body comprising an absorbent material configured to absorb intestinal waste inside an ileum, placing the device inside an ileum of a subject, or a length of the expandable elongated body in the non-compressed state along a longitudinal axis of at least 15 cm.
In response to the applicant’s arguments, the examiner respectfully disagrees and further notes that Ballan was not used in the rejection of claims 13-15 to read on the newly added limitation regarding the length of the expandable elongated body in a non-compressed state.
The applicant asserts that Ballan’s device seals by elastic radial pressure against the intestinal wall, not by absorbing and retaining intestinal waste and that Ballan’s foam body is an elastic, pressure-sealing structural element, not a waste-absorption medium. Regarding the sealing mechanism of Ballan, the applicant is arguing limitations not claimed (see MPEP 2145(VI)). None of claims 13-15 require that the absorbent material seals against the intestine by absorbing and retaining intestinal waste. Further, Ballan discloses that the body may be formed from an open-cell hydrophilic foam that is swellable in the intestinal fluid to increase the tightening effect of the closure (col. 4 ln. 7-11) or a closed-cell polymer foam provided with a longitudinal channel consisting of open-cell polymer foam that may serve as a liquid absorption medium for absorbing liquid from the intestine, particularly in the case of ileostomy (col. 4 ln. 22-34); therefore, Ballan discloses not only an absorbent material, but that said absorbent material may provide increased tightening of the closure.
Further, the applicant asserts that Ballan discloses placing the device only at the outer portion of the stoma, such that it does not extend behind the fascia opening into the ileal lumen proper. Ballan discloses the use of their device within artificial intestinal openings, such as ileostomies (col. 1 ln. 13-18). The stoma in an ileostomy is created with the cut or looped end of the ileum. Any device that is placed through the stoma in an ileostomy is considered to be placed within the ileum.
Regarding claim 3, the applicant asserts on pg. 12-14 that Gardner v. TEC is not applicable in view of the disclosures of Ballan.
In response to the applicant’s argument, the examiner respectfully disagrees.
The applicant asserts that the body of Ballan does not comprise absorbent material in the functional sense required by the claims, making Ballan’s closure longer would not increase the absorption capacity as Ballan’s body has no absorptive function to begin with, and that liquid stool would accumulate behind an elongated device of Ballan due to its lack of absorbency. As discussed in para. 10 above, Ballan discloses not only an absorbent material, but that said absorbent material may provide increased tightening of the closure; therefore, Ballan is not fundamentally different in structure or function from the claimed device and any concerns from a non-absorbent closure device would not apply to the device of Ballan.
Further, the applicant asserts that Ballan expressly teaches away from axial lengthening of the device. Unless a reference criticizes, discredits, or otherwise discourages a specific combination, the reference does not constitute a “teaching away” from a claimed combination (see MPEP 2145(X)(D)(I)). The disclosure of Ballan that the applicant relies upon simply states that the device of their invention should only be compressed in the radial direction, not in the axial direction and that the length will typically be 3-6 cm. This is not an explicit criticism or discouragement of a longer length. Further, the claim does not require that the body of the device is configured to expand axially to this length. Modifying the Ballan device to have an increased length in a non-compressed state does not require that the Ballan device has a smaller length in a compressed state.
Further still, the applicant asserts that the length of at least 15 cm is patentably critical. To provide support for this assertion, the applicant notes that the specification discloses that it was discovered by the inventors that the length of the body needs to be at least 15 cm in the non-compressed state for the device to provide any usable absorption capacity for a human being producing 500 to 1000 mL of liquid intestinal waste per day and points to para. 0005 and 0053 to expressly establish the clinical necessity of the length for adequate absorption capacity. To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. (see MPEP 716.02(d)(II)). The applicant’s specification does not correlate the length of the device to the absorption capacity in either of the cited para. and does not compare a sufficient number of tests both inside and outside the claimed range; therefore, the applicant has not shown the criticality of the claimed range.
Even further still, the applicant asserts that a device having the claimed length must be flexible to adjust to the twists and turns of the intestinal anatomy. The applicant is arguing limitations not claimed (see MPEP 2145(VI)). There is no requirement in the independent claim that the device be flexible. Further, Ballan’s device is clearly elastic to allow for it to expand from a compressed configuration, such that it would be able to at least partially conform to the intestinal anatomy.
Regarding claim 2, the applicant asserts on pg. 14-15 that Ballan does not inherently conform to a third diameter when pulled out of the ileum by the withdrawer, wherein the third diameter is the diameter of the ileostomy.
In response to the applicant’s argument, the examiner respectfully disagrees. First of all, the examiner notes that claim 2 covers the intended use of the claimed device and does not set forth any structural limitations that distinguish the instantly claimed apparatus from the cited prior art. The applicant argues that when Ballan’s expanded foam closure- having a cross-sectional area at least double that of the stoma- is pulled through the stoma, the stoma walls exert radially compressive force on the foam, effectively wringing it out such that any liquid absorbent would be squeezed back into the intestine. The applicant’s argument seems to agree that Ballan conforms to the diameter of the ileostomy when pulled out of the ileum by the withdrawer. The applicant further argues that the limitation requires the instant invention to conform to the diameter of the ileostomy upon withdrawal while retaining absorbent waste and that inherency requires that the unclaimed result necessarily flows from the prior art structure. The applicant is arguing limitations not claimed (see MPEP 2145(VI)). Further, the applicant’s specification requires that the instant invention retain a majority of the liquid content (pg. 4 ln. 1-5), which corresponds to at least 75%, at least 85%, or at least 95% (pg. 6 ln. 17-20). While Ballan discloses that the body of their device may expand to double the cross-sectional area of an intestinal opening to which it is adapted, withdrawal would not cause the device to be entirely wrung out, such that Ballan would comprise absorbed liquid upon withdrawal.
Regarding claim 11, the applicant asserts on pg. 15-16 that in re Harza is inapplicable because the multi-cylinder arrangement of claim 11 serves a distinct functional purpose of enabling independent withdrawal of each cylinder through the stoma.
In response to the applicant’s argument, the examiner respectfully disagrees. The applicant asserts that the multi-cylinder arrangement serves a distinct functional purpose; however, this purpose is not properly considered as a new and unexpected result. One of ordinary skill in the art when provided with two separable cylinders would understand that they would be able to be withdrawn independently. Applicant does not claim separate withdrawal, and there is nothing structurally claimed about the multi-cylinder arrangement that would indicate that the cylinders are capable of totally independent withdrawal.
The rejections of the claims are maintained and/or the amendments to the claims have necessitated new grounds of rejection.
Claim Rejections - 35 USC § 103
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.
Claims 3, 2, 11, and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent no. 4,981,465 A to Ballan.
Regarding claim 3, Ballan discloses an absorbent insert ileostomy device for insertion through an ileostomy of a human being (Fig. 1-2, absorbent insert 20; col. 1 ln. 13-18; col 4 ln. 7-11 and 22-34), the device being configured to absorb intestinal waste inside an ileum of the human being and to form a leak-tight closure of an ileostomy (Fig. 1-2, absorbent insert 20; col. 1 ln. 13-18; col 4 ln. 7-11 and 22-34), the device comprising: an expandable elongated body comprising an absorbent material (Fig. 1-2, absorbent insert 20 comprising expandable elongated body 26; col. 1 ln. 13-18; col 4 ln. 7-11 and 22-34; col. 8 ln. 22- 37); a withdrawer attached to the expandable elongated body (col. 7 ln. 41-42); and a compressor (Fig. 1-2, absorbent insert 20 comprising compressor 28; col. 1 ln. 13-18; col 4 ln. 7-11 and 22-34; col. 8 ln. 22-37); wherein the compressor is configured to maintain the expandable elongated body in a compressed state, comprising a first diameter, prior to insertion (Fig. 1-2, absorbent insert 20 comprising compressor 28 compressing expandable elongated body 26; col. 1 ln. 13-18; col 4 ln. 7-11 and 22-34; col. 8 ln. 22-37); wherein the expandable elongated body is configured to expand radially to a non-compressed state, comprising a second diameter, when released from the compressor upon insertion into the ileum through the ileostomy (Fig. 1-2, absorbent insert 20 comprising compressor 28 compressing expandable elongated body 26; col. 1 ln. 13-18; col 4 ln. 7-11 and 22-34; col. 8 ln. 22-37); and wherein the first diameter is equal to or less than a diameter of the ileostomy of the human being and the second diameter is equal to or larger than a diameter of the ileum of the human being (col. 3 ln. 44-67); wherein a length of the expandable elongated body in the non-compressed state along a longitudinal axis of the expandable elongated body is 3-6 cm (col. 3 ln. 20-22).
Ballan differs from the instantly claimed invention in that Ballan fails to disclose wherein a length of the expandable elongated body in the non-compressed state along a longitudinal axis of the expandable elongated body is at least 15 cm.
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 Ballan to have a length in the non-compressed state of at least 15 cm 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 Ballan would not operate differently with the claimed length and since the expandable elongated body is meant to be placed in the ileum or another part of the intestines, the device would function appropriately having the claimed length. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the length is within the claimed range (specification pg. 13 ln. 14-17).
Regarding claim 2, Ballan suggests the invention of claim 3.
Ballan differs from the instantly claimed invention in that Ballan fails to explicitly disclose wherein the expandable elongated body comprising the absorbent material is configured to conform to a third diameter when pulled out of the ileum of the human being by the withdrawer; wherein the third diameter is the diameter of the ileostomy.
Regarding the limitation “wherein the expandable elongated body comprising the absorbent material is configured to conform to a third diameter when pulled out of the ileum of the human being by the withdrawer; wherein the third diameter is the diameter of the ileostomy” as that the invention of Ballan discloses substantially identical structure to the claimed prior art and is used in ostomy, it follows naturally that Ballan would function as claimed. As supported in MPEP 2112.01, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).”
Regarding claim 11, Ballan suggests the invention of claim 3. Ballan further discloses: wherein the expandable elongated body comprises a first cylinder (Fig. 1-2, absorbent insert 20 as a first cylinder), wherein the first cylinder comprises the absorbent material (col. 4 ln. 7-11) and the withdrawer is attached to the first cylinder so that the first cylinder may be withdrawn from the subject (col 7 ln. 41-42).
Ballan differs from the instantly claimed invention in that Ballan fails to disclose wherein the expandable elongated body comprises a second cylinder, wherein the first cylinder comprises a second absorbent material and a second withdrawer is attached to the second cylinder so that the second cylinder may be withdrawn from the subject.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to have duplicated the first cylinder such that the expandable elongated body comprises a second cylinder with a second withdrawer since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. Furthermore, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See MPEP 2144.
Regarding claim 13, Ballan discloses use of an absorbent insert ileostomy device comprising: an expandable elongated body comprising an absorbent material (Fig. 1-2, absorbent insert 20 comprising expandable elongated body 26; col. 1 ln. 13-18; col 4 ln. 7-11 and 22-34; col. 8 ln. 22- 37); a withdrawer attached to the expandable elongated body (col. 7 ln. 41-42); and a compressor (Fig. 1-2, absorbent insert 20 comprising compressor 28; col. 1 ln. 13-18; col 4 ln. 7-11 and 22-34; col. 8 ln. 22-37); wherein the compressor is configured to maintain the expandable elongated body in a compressed state, comprising a first diameter, prior to insertion (Fig. 1-2, absorbent insert 20 comprising compressor 28 compressing expandable elongated body 26; col. 1 ln. 13-18; col 4 ln. 7-11 and 22-34; col. 8 ln. 22-37); wherein the expandable elongated body is configured to expand radially to a non-compressed state, comprising a second diameter, when released from the compressor upon insertion into the ileum through the ileostomy (Fig. 1-2, absorbent insert 20 comprising compressor 28 compressing expandable elongated body 26; col. 1 ln. 13-18; col 4 ln. 7-11 and 22-34; col. 8 ln. 22-37); and wherein the first diameter is equal to or less than a diameter of the ileostomy of the human being and the second diameter is equal to or larger than a diameter of the ileum of the human being (col. 3 ln. 44-67); wherein the absorbent insert ileostomy device is used to collect intestinal waste from the ileum of a subject (Fig. 1-2, absorbent insert 20; col. 1 ln. 13-18; col 4 ln. 7-11 and 22-34).
Ballan differs from the instantly claimed invention in that Ballan fails to disclose wherein a length of the expandable elongated body in the non-compressed state along a longitudinal axis of the expandable elongated body is at least 15 cm.
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 Ballan to have a length in the non-compressed state of at least 15 cm 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 Ballan would not operate differently with the claimed length and since the expandable elongated body is meant to be placed in the ileum or another part of the intestines, the device would function appropriately having the claimed length. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the length is within the claimed range (specification pg. 13 ln. 14-17).
Regarding claim 14, Ballan discloses use of an absorbent insert ileostomy device comprising: an expandable elongated body comprising an absorbent material (Fig. 1-2, absorbent insert 20 comprising expandable elongated body 26; col. 1 ln. 13-18; col 4 ln. 7-11 and 22-34; col. 8 ln. 22- 37); a withdrawer attached to the expandable elongated body (col. 7 ln. 41-42); and a compressor (Fig. 1-2, absorbent insert 20 comprising compressor 28; col. 1 ln. 13-18; col 4 ln. 7-11 and 22-34; col. 8 ln. 22-37); wherein the compressor is configured to maintain the expandable elongated body in a compressed state, comprising a first diameter, prior to insertion (Fig. 1-2, absorbent insert 20 comprising compressor 28 compressing expandable elongated body 26; col. 1 ln. 13-18; col 4 ln. 7-11 and 22-34; col. 8 ln. 22-37); wherein the expandable elongated body is configured to expand radially to a non-compressed state, comprising a second diameter, when released from the compressor upon insertion into the ileum through the ileostomy (Fig. 1-2, absorbent insert 20 comprising compressor 28 compressing expandable elongated body 26; col. 1 ln. 13-18; col 4 ln. 7-11 and 22-34; col. 8 ln. 22-37); and wherein the first diameter is equal to or less than a diameter of the ileostomy of the human being and the second diameter is equal to or larger than a diameter of the ileum of the human being (col. 3 ln. 44-67); wherein the absorbent insert ileostomy device is used for insertion through an ileostomy of a human being (Fig. 1-2, absorbent insert 20; col. 1 ln. 13-18; col 4 ln. 7-11 and 22-34).
Ballan differs from the instantly claimed invention in that Ballan fails to disclose wherein a length of the expandable elongated body in the non-compressed state along a longitudinal axis of the expandable elongated body is at least 15 cm.
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 Ballan to have a length in the non-compressed state of at least 15 cm 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 Ballan would not operate differently with the claimed length and since the expandable elongated body is meant to be placed in the ileum or another part of the intestines, the device would function appropriately having the claimed length. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the length is within the claimed range (specification pg. 13 ln. 14-17).
Regarding claim 15, Ballan discloses a method for collecting intestinal waste from an ileum of a subject (Fig. 1-2, absorbent insert 20; col. 1 ln. 13-18; col 4 ln. 7-11 and 22-34), the method comprising: inserting an absorbent insert device through an ileostomy of a subject (Fig. 1-2, absorbent insert 20; col. 1 ln. 13-18; col. 2 ln. 41-48; col 4 ln. 7-11 and 22-34), thereby placing the absorbent insert device inside an ileum of the subject (Fig. 1-2, absorbent insert 20; col. 1 ln. 13-18; col 4 ln. 7-11 and 22-34), wherein the absorbent insert device comprises: an expandable elongated body comprising an absorbent material (Fig. 1-2, absorbent insert 20 comprising expandable elongated body 26; col. 1 ln. 13-18; col 4 ln. 7-11 and 22-34; col. 8 ln. 22- 37); a withdrawer attached to the expandable elongated body (col. 7 ln. 41-42); and a compressor (Fig. 1-2, absorbent insert 20 comprising compressor 28; col. 1 ln. 13-18; col 4 ln. 7-11 and 22-34; col. 8 ln. 22-37); wherein the compressor is configured to maintain the expandable elongated body in a compressed state, comprising a first diameter, prior to insertion (Fig. 1-2, absorbent insert 20 comprising compressor 28 compressing expandable elongated body 26; col. 1 ln. 13-18; col 4 ln. 7-11 and 22-34; col. 8 ln. 22-37); wherein the expandable elongated body is configured to expand radially to a non-compressed state, comprising a second diameter, when released from the compressor upon insertion into the ileum through the ileostomy (Fig. 1-2, absorbent insert 20 comprising compressor 28 compressing expandable elongated body 26; col. 1 ln. 13-18; col 4 ln. 7-11 and 22-34; col. 8 ln. 22-37); and wherein the first diameter is equal to or less than a diameter of the ileostomy of the human being and the second diameter is equal to or larger than a diameter of the ileum of the human being (col. 3 ln. 44-67); letting the absorbent material absorb intestinal waste from the subject (Fig. 1-2, absorbent insert 20; col. 1 ln. 13-18; col 4 ln. 7-11 and 22-34); and withdrawing the absorbent insert device from the subject by use of the withdrawer (col. 7 ln. 41-42).
Ballan differs from the instantly claimed invention in that Ballan fails to disclose wherein a length of the expandable elongated body in the non-compressed state along a longitudinal axis of the expandable elongated body is at least 15 cm.
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 Ballan to have a length in the non-compressed state of at least 15 cm 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 Ballan would not operate differently with the claimed length and since the expandable elongated body is meant to be placed in the ileum or another part of the intestines, the device would function appropriately having the claimed length. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the length is within the claimed range (specification pg. 13 ln. 14-17).
Regarding claim 16, Ballan suggests the invention of claim 3. Ballan further discloses: wherein the second diameter is at least 1-4 cm (col. 2 ln. 64-68 and col. 3 ln. 1-11, compressed diameter is 5-20 mm/0.5-2 cm; col. 3 ln. 33-39, expanded state is at least double the cross-section of the compressed state, at least 10-40 mm/1-4 cm).
Ballan differs from the instantly claimed invention in that Ballan fails to disclose wherein the second diameter is between 2 and 5 cm.
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 diameter of Ballan from between at least 1-4 cm to between 2-5 cm degrees 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). Further, applicant appears to have placed no criticality on the claimed range (see pg. 8 ln. 33-36 indicating the diameter “may” be within the claimed range).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Ballan as applied above, and further in view of DE/1994/8463 C2 to Willital.
Regarding claim 4, Ballan suggests the invention of claim 3.
Ballan suggests all aspects of the claimed invention with the exception of the absorbent insert device having an absorption capacity of at least 50 milliliters.
While Ballan doesn’t disclose the absorption capacity in their invention, Willital teaches that absorption capacity is a desired property in an absorbent feces collector (para. 0016 ln. 30-31). Absorption capacity is concerned with improving liquid intake and retention, and it is known in the art to improve absorbent retention.
It would therefore have been obvious before the effective filing date of the instant application in view of Willital to provide the absorbent insert device of Ballan with an absorption capacity of at least 50 milliliters to achieve the predictable result of improving liquid intake and retention of the absorbent insert and to allow for longer use of the article.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Ballan as applied above, and further in view of U.S. Patent no. 4,328,804 to Shimatani.
Regarding claim 5, Ballan suggests the invention of claim 3.
Ballan differs from the instantly claimed invention in that Ballan fails to disclose wherein the expandable elongated body is curled around a longitudinal axis of the expandable elongated body to form a helix comprising a plurality of turns.
Shimatani teaches wherein an expandable elongated body is curled around a longitudinal axis of the expandable elongated body to form a helix comprising a plurality of turns (Fig. 2; col. 1 ln. 66-68 and col. 2 ln. 1-4), and wherein the helix has increased absorption effectiveness and can be easily withdrawn from a body orifice (col. 3 ln. 15-17).
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 elongated body of Ballan to comprise a curled body as taught by Shimatani, because Shimatani teaches that providing a helix obtains a final product having increased absorption effectiveness and which can be easily withdrawn from a body orifice (col. 3 ln. 5-17).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Ballan as applied above, and further in view of U.S. Patent no. 8,777,916 B2 to Van Ingelgem (hereinafter referred to as Ingelgem).
Regarding claim 6, Ballan suggests the invention of claim 3.
Ballan differs from the instantly claimed invention in that Ballan fails to disclose wherein the expandable elongated body comprises a plurality of flexible protrusions extending radially from the expandable elongated body, such that the expandable elongated body resembles a brush.
Ingelgem teaches an expandable elongated body comprises a plurality of flexible protrusions extending radially from the expandable elongated body, such that the expandable elongated body resembles a brush (Fig. 2B, tampon 23 comprising ribs 32 extending radially; col. 11 ln. 21-50), and wherein the protrusions enlarge the total surface of the body to increase absorption and expansion capacity (col. 11 ln. 21-50).
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 elongated body of Ballan to comprise flexible protrusions as taught by Ingelgem, because Ingelgem teaches that these protrusions enlarge the total outer surface of the body to increase absorption capacity and expansion capacity to reduce risk of leakage (col. 11 ln. 21-50).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Ballan as applied above, and further in view of US/2005/0143708 A1 to Hagberg.
Regarding claim 7, Ballan suggests the invention of claim 3. Ballan further discloses: wherein the expandable elongated body is formed from absorbent material (Fig. 1-2, absorbent insert 20; col. 1 Ln. 13-18; col 4 Ln. 7-11 and 22-34).
Ballan differs from the instantly claimed invention in that Ballan fails to disclose wherein the expandable elongated body is provided as a flexible tube, which is partly or entirely filled with the absorbent material.
Hagberg teaches an expandable elongated body provided as a flexible tube, which is partly or entirely filled with the absorbent material (Fig. 6, expandable elongated body 601 provided as flexible tube 612 filled with absorption body 602; para. 0048-0049), wherein the flexible tube facilitates removal from the body (para. 0009; para. 0048-0049).
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 elongated body of Ballan to be provided as a flexible tube as taught by Hagberg, because Hagberg teaches that the flexible tube of their invention facilitates removal of the absorbent body from the body (para. 0009; para. 0048-0049).
Regarding claim 8, the combination of Ballan and Hagberg suggests the invention of claim 7. Hagberg further discloses: wherein the flexible tube is a woven crinoline tube (Fig. 6, flexible tube 612; para. 0048, large mesh net) comprising a material selected from the group consisting of: nylon, polyester, polyvinylidene fluoride (PVDF), and polypropylene (para. 0033, cover may be made from polypropylene; para. 0048, flexible tube 612 may be made from the same material as cover 603).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Ballan as applied above, and further in view of U.S. Patent no. 9,226,736 B2 to Obermiller.
Regarding claim 9, Ballan suggests the invention of claim 3.
Ballan differs from the instantly claimed invention in that Ballan fails to disclose wherein the expandable elongated body is formed from a sheet, which is rolled into an elongated conical shape.
Obermiller teaches an elongated body that is formed from a sheet, which is rolled into an elongated conical shape (Fig. 1-3; col. 15 ln. 40-55), wherein the formation of the body in a rolled conical sheet allows for the material to occupy a unitary volume and to be adjusted to enhance closure of an opening (col. 2 ln. 58-64; col. 15 ln. 40-55).
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 elongated body of Ballan to be formed in a rolled conical sheet as taught by Obermiller, because Obermiller teaches that this allows for the material to occupy a substantially unitary volume and to be shaped and adjusted into a configuration that enhances closure of an opening (col. 2 ln. 58-64; col. 15 ln. 40-55).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ballan as applied above, and further in view of U.S. Patent no. 2,603,213 A to Buryan.
Regarding claim 10, Ballan suggests the invention of claim 3. Ballan further discloses: wherein the expandable elongated body is formed with closed ends (Fig. 1-2).
Ballan differs from the instantly claimed invention in that Ballan fails to disclose wherein the expandable elongated body is formed from a tube comprising a closed end, the tube being folded one or more times inside itself, wherein the tube is configured to unfold upon pulling the absorbent insert ileostomy device out of the ileostomy by use of the withdrawer.
Buryan teaches an expandable elongated body that is formed from a tube, the tube being folded one or more times inside itself, wherein the tube is configured to unfold upon pulling the absorbent insert ileostomy device out of the ileostomy by use of the withdrawer (Fig. 1-2, tube 10 folded inside itself; col. 1 ln. 15-22), and wherein the folded tube allows for the bandage to be withdrawn from a body cavity while decreasing the diameter of the bandage (col. 1 ln. 15-22).
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 elongated body of Ballan to be formed from a folded tube as taught by Buryan, because Buryan teaches that providing a folded tube allows for the bandage to be withdrawn from a body cavity while decreasing the diameter of the bandage, facilitating removal and avoiding pain (col. 1 ln. 15-22).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Ballan as applied above, and further in view of U.S. Patent no. 10,143,457 to Agnew.
Regarding claim 12, Ballan suggests the invention of claim 3.
Ballan differs from the instantly claimed invention in that Ballan fails to disclose wherein the expandable elongated body comprises a support structure configured to increase axial stability of the expandable elongated body, wherein the support structure comprises a material selected from the group of: silicone, rubber, latex, polyethylene, polyvinyl chloride, nitinol, and/or combinations thereof.
Agnew teaches an elongated body comprising a support structure configured to increase axial stability of the elongated body (Fig. 4A, support structure 152 of elongated body; col. 23 ln. 58-64),
wherein the support structure comprises a material selected from the group of: silicone, rubber, latex, polyethylene, polyvinyl chloride, nitinol, and/or combinations thereof (col. 23 ln. 58-64), and
wherein the support structure increases the column strength of the body to enable the plug body to be pushed into and through an open passageway of the body (col. 4 ln. 46-54; col. 23 ln. 58-64).
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 elongated body of Ballan to comprise the support structure of Agnew, because Agnew teaches that their support structure increases the column strength of the body (col. 23 ln. 58-64) and an increase in column strength will enable the plug body to be pushed into and through an open passageway of the body where it would have been somewhat difficult to be pushed into (col. 4 ln. 46-54).
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 Linnae Raymond whose telephone number is (571)272-6894. The examiner can normally be reached M-F 8:00am to 4:00pm.
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/Linnae E. Raymond/Examiner, Art Unit 3781
/LESLIE R DEAK/Primary Examiner, Art Unit 3799 29 May 2026
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