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
The amendments made to claims 1, 3, 6-8, 11, and 15-18 in the response filed on 5/29/2026 are acknowledged. Claims 1-3 and 6-22 are still pending in the application and are examined below.
Response to Arguments
Applicant's arguments, see page 9, filed 5/29/2026, with respect to the specification objections have been fully considered and are persuasive. Therefore, the specification objections have been withdrawn.
Applicant's arguments, see page 10, filed 5/29/2026, with respect to the drawing objection has been fully considered and are persuasive. Therefore, the drawing objection has been withdrawn.
Applicant's arguments, see page 10, filed 5/29/2026, with respect to the objections of claims 1, 3, and 16-18 have been fully considered and are persuasive. Therefore, the claim objections have been withdrawn.
Applicant's arguments, see page 10, filed 5/29/2026, with respect to the rejection of claims 7, 11, and 15 under 35 U.S.C. 112(b) have been fully considered and are persuasive. Therefore, the rejections have been withdrawn.
Applicant's arguments, see page 11, filed 5/29/2026, with respect to the rejection of claims 1-2, 5-, 12, 14, 17, and 19 under double patenting rejections have been fully considered and are persuasive. Therefore, the double patenting rejections have been withdrawn.
Applicant's arguments, see page 11, filed 5/29/2026, with respect to the rejection of claims 1-4, 6, 8-11, and 14-15 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. Therefore, the rejections have been withdrawn.
Applicant's arguments, see pages 11-12, filed 5/29/2026, with respect to the rejection of claims 17-20 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. However, a new ground of rejection was made in view of US 20160030083 A1 to address the newly added limitation of claim 17. Please see rejection below for more details.
Applicant's arguments, see pages 12-13, filed 5/29/2026, with respect to the rejection of claim 7 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blurton et al. (US 20160030083 A1).
Regarding claim 17, Blurton et al. discloses a perianal support device (1000 – figure 26C, an anococcygeal support device: paragraph 0227), comprising: a central support element (1003 – figure 26C) comprising a compression surface apex (AA – see annotated figure 1, a compression surface apex) configured to extend across an anal orifice of a patient in a sagittal plane of the patient (see annotated figure 1/figure 27, the compression surface apex [AA] of the central compression element [1003 – figure 26C] is formed to fit in the gluteal cleft [figure 27] in a sagittal plane of the patient: paragraph 0227); a first compression element (1001 – figure 26C, a first compression element: paragraph 0227) extending from the central support element (1003) in a first lateral direction (figure 26C, the first compression element [1001] extends from the central support element [1003] in a first lateral direction: paragraph 0228), the first compression element (1001) comprising a first resilient, flexible member (the first compression element [1001] is a resilient, flexible member that has varied flexibility due to its varied thickness: paragraph 0228) configured to follow a first contour of a first buttock (14 – figure 27, a buttock of a patient: paragraph 0227) within a gluteal cleft of the patient (13 – figure 27, a gluteal cleft: paragraph 0227) (figure 27, the first compression element [1001] follows a first contour of the first buttock [14] within the gluteal cleft of the patient [13]: paragraph 0227), the first compression element (1001) further comprising a first surface (AB – see annotated figure 1, a first surface of the first compression element) comprising a first attachment feature (1006 – figure 26C, an adhesive: paragraph 0227) configured to face the first buttock of the patient (14) (see annotated figure 1/figure 27, the first attachment feature [1006] is configured to face the first buttock of the patient [14]: paragraph 0227), and a second surface (AC – see annotated figure 1, a second surface of the first compression element) comprising a soft material (the first compression element [1001] is a flexible member that follows a contour of the first buttock of the patient [14] within the gluteal cleft [13]; therefore, it comprises a soft material due to its flexibility: paragraph 0227) configured to face away from the first buttock (14) (see annotated figure 1/figure 27, the second surface [AC] faces away from the first buttock [14]: paragraph 0227), a second compression element (1002 – figure 26C, a second compression element: paragraph 0227) extending from the central support element (1003) in a second lateral direction opposite the first lateral direction (figure 26C, the second compression element [1002] extends from the central support element [1003] in a second lateral direction opposite the first lateral direction: paragraph 0228), the second compression (1002) element comprising a second resilient, flexible member (the second compression element [1002] is a resilient, flexible member that has varied flexibility due to its varied thickness: paragraph 0228) configured to follow a second contour of a second buttock (15 – figure 27, a buttock of a patient: paragraph 0227) within the gluteal cleft of the patient (13) (figure 27, the second compression element [1002] follows a second contour of the second buttock [15] within the gluteal cleft of the patient [13]: paragraph 0227), the second compression element (1002) further comprising a third surface (AD – see annotated figure 1, a third surface of the second compression element) comprising a second attachment feature (1006 – figure 26C, an adhesive on the second compression element [1002]: paragraph 0227) configured to face the second buttock of the patient (15) (see annotated figure 1/figure 27, the second attachment feature [1006] is configured to face the second buttock of the patient [15]: paragraph 0227), and a fourth surface (AE – see annotated figure 1, a second surface of the first compression element) comprising the soft material (the second compression element [1002] is a flexible member that follows a contour of the second buttock of the patient [15] within the gluteal cleft [13]; therefore, it comprises a soft material due to its flexibility: paragraph 0227) configured to face away from the second buttock (15) (see annotated figure 1/figure 27, the second surface [AE] faces away from the second buttock [15]: paragraph 0227); a first flex region (2020 – see annotated figure 2, an extending securing member: paragraph 0229) connected to said central support element (1003) (see annotated figure 2, the first flex region [2020] is connected to the central support element [1003] via the first compression element [1001]) and to a proximal end of said first compression element (AG – see annotated figure 2, a proximal end of the first compression element) (see annotated figure 2, the first flex region [2020] is connected to the proximal end of the first compression element [AG]); and a second flex region (2010 – see annotated figure 2, another extending securing member: paragraph 0229) connected to said central support element (1003) (see annotated figure 2, the second flex region [2010] is connected to the central support element [1003] via the second compression element [1002]) and to a proximal end of said second compression element (AI – see annotated figure 2, a proximal end of the second compression element) (see annotated figure 2, the second flex region [2010] is connected to the proximal end of the second compression element [AI]: paragraph 0229).
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Annotated figure 1: apparatus of Blurton et al.
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Annotated figure 2: apparatus showing the proximal ends of the first and second compression element
Regarding claim 18, Blurton et al. discloses the invention as discussed in claim 17. Blurton et al. further discloses wherein each of said first flex region (2020) and said second flex region (2010) comprises material different from each of said first (1001) and second compression elements (1002) respectively (the first [2020] and second flex regions [2010] can be made of hook and loop system while the first [1001] and second compression elements [1002] are not a hook and loop system: paragraph 0229).
Regarding claim 19, Blurton et al. discloses the invention as discussed in claim 18. Blurton et al. further discloses wherein the compression surface apex (AA) comprises a contact material (the compression surface apex [AA] comprises a material that contacts the gluteal cleft: paragraph 0227).
Regarding claim 20, Blurton et al. discloses the invention as discussed in claim 19. Blurton et al. further discloses wherein the respective materials of said first flex region (2020) and said second flex region (2010) each have a thickness thinner than said contact material (see annotated figure 2, the contact material that makes up the compression surface apex [AA] of the central support element [1003] is thicker than the materials of the first flex region [2020] and second flex region [2010]).
Claims 21-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blurton et al. (US 20070260163 A1).
Regarding claim 21, Blurton et al. discloses a perianal support device (500 – figure 18, a support system to provide perianal support: paragraph 0049) for use on a patient (the patient support device [500] is to provide perianal support to a human patient: paragraph 0049), comprising: a central support element (410 – figure 18, a compliant pad to form a contact surface: paragraph 0047/0049) comprising a compression surface apex (A – see annotated figure 3, a compression surface apex) configured to extend across an anal orifice of the patient (38 – figure 19, anal orifice of a patient: paragraph 0051) in a sagittal plane of the patient (figure 19, the central support element [410] comprising the compression surface apex [A] is dimensioned to span across the anal orifice [38] when the perianal support device [500] is advanced toward the anal orifice [within the sagittal plane]: paragraph 0052), said compression surface apex (A) having a contact length (Z – see annotated figure 3, contact length of the compression surface apex); a first compression element comprising a first resilient, flexible member (530 – figure 19/figure 20, an elongated fixation member: paragraph 0049/0052) configured to follow a first contour of a first buttock of the patient (14 – figure 19, first buttock of the patient: paragraph 0051) (figure 19, the first resilient, flexible member [530] follows a contour of the first buttock of the patient [14]) and a first surface (532 – figure 18, a first surface containing the first half of a releasable fastening system, such as hook and loop: paragraph 0049) configured to face the first buttock of the patient (14) (figure 18/19, the first surface [532] faces the first buttock of the patient [14]), the first surface (532) having a first lateral extent (B – see annotated figure 4, a first lateral extent) configured to releasably attach to a first anchor pad (534 – figure 18/figure 19, an anchor pad that is rectangular in shape: paragraph 0049) placed on the first buttock (14) (figure 18/figure 19, the anchor pad [534] is adhered to the first buttock [14]; the first surface [532] having the first lateral extent [B] is releasably attached to the first anchor pad [534] via hook and loop system: paragraph 0049/0052); a second compression element comprising a second resilient, flexible member (520 – figure 19/figure 20, an elongated fixation member: paragraph 0049/0052) configured to follow a second contour of a second buttock of the patient (15 – figure 19, second buttock of the patient: paragraph 0051) (figure 19, the second resilient, flexible member [520] follows a contour of the second buttock of the patient [15]) and a second surface (522 – figure 18, a second surface containing the first half of a releasable fastening system, such as hook and loop: paragraph 0049) configured to face the second buttock of the patient (15) (figure 18/figure 19, the second surface [522] faces the second buttock of the patient [15]), the second surface (522) having a second lateral extent (C – see annotated figure 4, a second lateral extent) configured to releasably attach to a second anchor pad (524 – figure 18/figure 19, an anchor pad that is rectangular in shape: paragraph 0049) placed on the second buttock (15) (figure 18/figure 19, the second anchor pad [524] is adhered to the second buttock [15]; the second surface [522] having the second lateral extent [C] is releasably attached to the second anchor pad [524] via hook and loop system: paragraph 0049/0052); a first flex region (D – see annotated figure 4, a first flex region) between a proximal end of said first compression element (E – see annotated figure 4, proximal end of the first compression element) and said central support element (410) (see annotated figure 4, the first flex region [D] is between the proximal end of the first compression element [E] and the central support element [410]); and a second flex region (F – see annotated figure 4, a second flex region) between a proximal end of said second compression element (G – see annotated figure 4, proximal end of the second compression element) and said central support element (410) (see annotated figure 4, the second flex region [F] is between the proximal end of the second compression element [G] and the central support element [410]), wherein the first (D) and second flex regions (F) each comprise a respective first width (K – see annotated figure 3, a first width of the first [D] and second flex regions [F]) adjacent to the central support element (410) (see annotated figure 3/annotated figure 4, the first width [K] is near the central support element [410]), each first width (K) being less than the contact length (Z) of the compression surface apex (A) (see annotated figure 3/figure 20, the first width [K] is less than the contact length [Z] of the compression surface [A]), and wherein the first (530) and second compression elements (520) each comprise a second width (L – see annotated figure 3, a second width of the first [530] and second compression elements [520]) proximate to first (539 – see annotated figure 3, lateral end of the first compression element [530]: paragraph 0049) and second distal ends (529 – see annotated figure 3, lateral end of the second compression element [520]: paragraph 0049) of the respective first (530) and second compression elements (520) (see annotated figure 3, the second width [L] is proximate to the first [539] and second distal ends [529]), the first width (K) of each of said first (D) and second flex regions (F) being less than each second width (L) (see annotated figure 1/figure 20, the first width [K] is less than the second width [L]).
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Annotated figure 3: apparatus of Blurton et al.
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Annotated figure 4: apparatus of Blurton et al. in use
Regarding claim 22, Blurton et al. discloses the invention as discussed in claim 21. Blurton further discloses wherein each of said first (D) and second flex regions (F) is configured to bend and thereby allow said first (530) and second resilient, flexible members (520) to follow the contours of said respective first (14) and second buttocks (15) (annotated figure 4/figure 20, the first [D] and second flex regions [F] each comprises a compression element [330/340] that are flexible to bow or bend in response to force applied to the first [530] and second resilient, flexible members [520]; this allows the first [530] and second resilient, flexible members [520] to follow the contours of the respective first [14] and second buttocks [15]: paragraph 0050).
Allowable Subject Matter
Claims 1-3 and 6-16 are allowed. The following is a statement of reasons for the indication of allowable subject.
Claim 1 contains allowable subject matter because the prior art fails to disclose, either singly or in combination, the limitations of the claim. The closest prior art made of record was Blurton et al. (US 20070260163 A1).
Blurton et al. discloses a perianal support device (500 – figure 18, a support system to provide perianal support: paragraph 0049) for use on a patient (the patient support device [500] is to provide perianal support to a human patient: paragraph 0049), comprising: a central support element (410 – figure 18, a compliant pad to form a contact surface: paragraph 0047/0049) comprising a compression surface apex (A – see annotated figure 3, a compression surface apex) configured to extend across an anal orifice of the patient (38 – figure 19, anal orifice of a patient: paragraph 0051) in a sagittal plane of the patient (figure 19, the central support element [410] comprising the compression surface apex [A] is dimensioned to span across the anal orifice [38] when the perianal support device [500] is advanced toward the anal orifice [within the sagittal plane]: paragraph 0052); a first compression element comprising a first resilient, flexible member (530 – figure 19/figure 20, an elongated fixation member: paragraph 0049/0052) configured to follow a first contour of a first buttock of the patient (14 – figure 19, first buttock of the patient: paragraph 0051) and a first surface (532 – figure 18, a first surface containing the first half of a releasable fastening system, such as hook and loop: paragraph 0049) configured to face the first buttock of the patient (14) (figure 18/figure 19, the first surface [532] faces the first buttock of the patient [14]), the first surface (532) having a first lateral extent (B – see annotated figure 4, a first lateral extent) configured to releasably attach to a first anchor pad (534 – figure 18/figure 19, an anchor pad that is rectangular in shape: paragraph 0049) placed on the first buttock (14) (figure 18/figure 19, the anchor pad [534] is adhered to the first buttock [14]; the first surface [532] having the first lateral extent [B] is releasably attached to the first anchor pad [534] via hook and loop system: paragraph 0049/0052); a second compression element comprising a second resilient, flexible member (520 – figure 19/figure 20, an elongated fixation member: paragraph 0049/0052) configured to follow a second contour of a second buttock of the patient (15 – figure 19, second buttock of the patient: paragraph 0051) and a second surface (522 – figure 18, a second surface containing the first half of a releasable fastening system, such as hook and loop: paragraph 0049) configured to face the second buttock of the patient (15) (figure 18/figure 19, the second surface [522] faces the second buttock of the patient [15]), the second surface (522) having a second lateral extent (C – see annotated figure 4, a second lateral extent) configured to releasably attach to a second anchor pad (524 – figure 18/figure 19, an anchor pad that is rectangular in shape: paragraph 0049) placed on the second buttock (15) (figure 18/figure 19, the second anchor pad [524] is adhered to the second buttock [15]; the second surface [522] having the second lateral extent [C] is releasably attached to the second anchor pad [524] via hook and loop system: paragraph 0049/0052); a first flex region (D – see annotated figure 4, a first flex region) between a proximal end of said first compression element (E – see annotated figure 4, proximal end of the first compression element) and said central support element (410) (see annotated figure 4, the first flex region [D] is between the proximal end of the first compression element [E] and the central support element [410]); and a second flex region (F – see annotated figure 4, a second flex region) between a proximal end of said second compression element (G – see annotated figure 4, proximal end of the second compression element) and said central support element (410) (see annotated figure 4, the second flex region [F] is between the proximal end of the second compression element [G] and the central support element [410]).
However, none of the relevant prior art discloses wherein the first and second resilient, flexible members comprise a thin plastic substrate, and wherein the thin plastic substrate comprises a common substrate extending continuously from a first distal end of the first compression element, across the central support element, to a second distal end of the second compression element. Therefore, claim 1 is allowable.
Claims 2-3 and 6-16 are allowable based on their dependence on claim 1.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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 ANDREW JUN-WAI MOK whose telephone number is (703)756-4605. The examiner can normally be reached 8am-4pm.
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/ANDREW JUN-WAI MOK/Examiner, Art Unit 3786
/KARI K RODRIQUEZ/Primary Patent Examiner, Art Unit 3786
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